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"content": "\u003cp>In the long-running debate over just what causes Alzheimer’s disease, one side looks to have scored a victory with \u003ca href=\"https://www.statnews.com/2018/07/25/experimental-alzheimers-drug-biogen-eisai/\" target=\"_blank\" rel=\"noopener\">new results with an in-development drug\u003c/a>. But there’s enough variation in the data to ensure that the squabbling factions of Alzheimer’s will have plenty to fight about.[contextly_sidebar id=\"A04l79ZF49Fepp9ayXq47IfI7cWrtD3j\"]\u003c/p>\n\u003cp>At issue is the so-called amyloid hypothesis, a decades-old theory claiming that Alzheimer’s gradual degradation of the brain is caused by the accumulation of sticky plaques. And the new drug is BAN2401, designed by Biogen and Eisai to prevent those amyloid plaques from clustering and attack the clumps that already have.\u003c/p>\n\u003cp>In data presented last week, one group of patients receiving BAN2401 saw their amyloid levels plummet, a result that was tied to a significant reduction in cognitive decline compared with placebo.\u003c/p>\n\u003cp>To the amyloid-inclined, like Dr. Howard Fillit of the Alzheimer’s Drug Discovery Foundation, that marks a clear affirmation of the linkage between plaques and mental fortitude.\u003c/p>\n\u003cp>“I mean if you asked me five or 10 years ago if we’re going to have a drug that can remove the plaques from the brain, I would have thought this was space technology,” Fillit said. “And there was definitely a signal, in my opinion, on clinical outcomes, which is what we’ve all been looking for.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>But to skeptics, the trial was laden with confounding details that make it impossible to draw conclusions.\u003c/p>\n\u003cp>“These results are a mess,” wrote Baird biotech analyst Brian Skorney. “Not so much that they indicate an outright failure of the [amyloid] hypothesis, but they don’t really say anything informative at all.”\u003c/p>\n\u003cp>In the trial, every single tested dose had a significant effect on plaques as measured by a brain scan, and the more BAN2401 patients got, the less amyloid they had after 18 months. But looking at cognition, only the highest tested dose was significantly better than placebo at slowing down mental decline. And some of the patients who received lower doses actually declined faster than those who received no treatment at all.[contextly_sidebar id=\"TAyKNwsnIzWapwgWfQcwbB5f1ZW4XVH2\"]\u003c/p>\n\u003cp>If amyloid really is the driving factor behind Alzheimer’s, why didn’t each incremental reduction in plaques lead to a corresponding improvement in cognition?\u003c/p>\n\u003cp>Dr. Al Sandrock, Biogen’s chief scientific officer, said there is likely a threshold of amyloid reduction that must be reached before patients actually benefit. The low doses, despite their effect on plaques, might not have hit that threshold, Sandrock said, thus accounting for their poor performance on cognitive decline.\u003c/p>\n\u003cp>The divergence in the two curves is what gives Dr. Reisa Sperling, who was overall encouraged by the results, “the most pause.” But Sperling, director Center for Alzheimer Research and Treatment at Brigham and Women’s Hospital, noted that some of the study’s arms had small numbers of patients, making it difficult to draw conclusions. She said while there is a biological argument that could underpin the threshold hypothesis, she wanted to see more data from a larger trial with a more traditional design.\u003c/p>\n\u003cp>Even if Sandrock’s theory holds up, what happened to BAN2401 is not a new phenomenon. This year a drug from Merck, meant to shut off the production of plaques by blocking an enzyme called BACE, was successful in reducing amyloid but fared so dismally on cognitive measures that researchers terminated the trial early. A second BACE drug, from Biogen and Eisai, had similar results in miniature, hitting the mark on plaque reduction in a Phase 2 trial but failing to significantly outperform placebo on cognition.\u003c/p>\n\u003cp>The underlying issue, according Dr. Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California, is that “the plaques are not the target — those are biomarkers.”\u003c/p>\n\u003cp>“A target is something that, as a result of hitting it, there will be change downstream in behavior, cognition, and illness course,” Schneider said. “So, yeah we’re knocking down amyloid, but so far we’re not changing behavior much.”\u003c/p>\n\u003cp>Even BAN2401’s saving grace — that its highest dose appeared to both reduce amyloid and improve patient’s clinical results — has come under scrutiny.\u003c/p>\n\u003cp>In the BAN2401 trial, about 70 percent of patients getting placebo had a genetic mutation that triples the risk of Alzheimer’s. But in the high-dose BAN2401 group, just 30 percent of patients had the mutation, called APOE4.[contextly_sidebar id=\"tcdS8fDReoUFY02DP3vnBwSqYDEV9wHe\"]\u003c/p>\n\u003cp>That could explain why BAN2401 seemed to outperform a saline injection in the high-dose group, skeptics say, as past trials suggest that APOE4 carriers have more rapidly progressing Alzheimer’s than patients without the mutation.\u003c/p>\n\u003cp>And it could mean that the drug’s seeming promise is a mirage.\u003c/p>\n\u003cp>Dr. Paul Aisen, who runs the Alzheimer’s Therapeutic Research Institute at the University of Southern California, said the discrepancy “does create a potential bias.” But in trials where patients are confirmed to have amyloid in their brains at the outset, as was the case with BAN2401, “the impact of [APOE4] on progression is modest,” Aisen wrote in an email. “I don’t think this accounts for the apparent slowing of cognitive decline in the high-dose arm.”\u003c/p>\n\u003cp>Sperling agreed that she did not think the arms’ different populations skewed the data, in part because the group that received the second highest dose of the drug had a larger share of APOE4 carriers and saw results that were similar — though not as substantial — as the high dose group.\u003c/p>\n\u003cp>“It’s a similar pattern,” she said. “For me that partially mitigates that concern.”\u003c/p>\n\u003cp>Biogen and Eisai have promised to dig into the data and parse out the effect APOE4 had on whether patients responded to BAN2401, but those results likely won’t be ready for months.\u003c/p>\n\u003cp>In the meantime, companies are still queueing up to take cracks at amyloid.\u003c/p>\n\u003cp>Eli Lilly, which has spent billions on failed Alzheimer’s drugs in recent years, has designed a trial that will test the amyloid hypothesis “in the most definitive way possible,” said Mark Mintun, the company’s vice president of neurodegeneration.\u003c/p>\n\u003cp>The plan is to take a BACE inhibitor and pair it with an injected treatment that targets amyloid already in the brain. That should address the two major concerns with each approach, Mintun said: BACE inhibitors prevent amyloid but don’t address plaques that already exist, while amyloid-targeting therapies don’t stem the flow of new toxic clumps.\u003c/p>\n\u003cp>“I equate it to going down to your basement and finding three feet of water and there’s been a slow drip for four weeks,” Mintun said. “You can turn off the spigot, but it won’t feel like you’ve made much progress, so you’ve got to pump it out, too.”\u003c/p>\n\u003cp>That study is enrolling 375 patients into three groups, planning to study whether the combination can improve cognition compared with placebo over 18 months.\u003c/p>\n\u003cp>\u003cem>Andrew Joseph contributed reporting.\u003c/em>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This story was originally published by \u003ca href=\"https://www.statnews.com/2018/07/30/alzheimers-amyloid-hypothesis/\" target=\"_blank\" rel=\"noopener\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n",
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"headline": "Alzheimer’s Study Sparks New Debate Over Amyloid Hypothesis",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>In the long-running debate over just what causes Alzheimer’s disease, one side looks to have scored a victory with \u003ca href=\"https://www.statnews.com/2018/07/25/experimental-alzheimers-drug-biogen-eisai/\" target=\"_blank\" rel=\"noopener\">new results with an in-development drug\u003c/a>. But there’s enough variation in the data to ensure that the squabbling factions of Alzheimer’s will have plenty to fight about.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>At issue is the so-called amyloid hypothesis, a decades-old theory claiming that Alzheimer’s gradual degradation of the brain is caused by the accumulation of sticky plaques. And the new drug is BAN2401, designed by Biogen and Eisai to prevent those amyloid plaques from clustering and attack the clumps that already have.\u003c/p>\n\u003cp>In data presented last week, one group of patients receiving BAN2401 saw their amyloid levels plummet, a result that was tied to a significant reduction in cognitive decline compared with placebo.\u003c/p>\n\u003cp>To the amyloid-inclined, like Dr. Howard Fillit of the Alzheimer’s Drug Discovery Foundation, that marks a clear affirmation of the linkage between plaques and mental fortitude.\u003c/p>\n\u003cp>“I mean if you asked me five or 10 years ago if we’re going to have a drug that can remove the plaques from the brain, I would have thought this was space technology,” Fillit said. “And there was definitely a signal, in my opinion, on clinical outcomes, which is what we’ve all been looking for.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>But to skeptics, the trial was laden with confounding details that make it impossible to draw conclusions.\u003c/p>\n\u003cp>“These results are a mess,” wrote Baird biotech analyst Brian Skorney. “Not so much that they indicate an outright failure of the [amyloid] hypothesis, but they don’t really say anything informative at all.”\u003c/p>\n\u003cp>In the trial, every single tested dose had a significant effect on plaques as measured by a brain scan, and the more BAN2401 patients got, the less amyloid they had after 18 months. But looking at cognition, only the highest tested dose was significantly better than placebo at slowing down mental decline. And some of the patients who received lower doses actually declined faster than those who received no treatment at all.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>If amyloid really is the driving factor behind Alzheimer’s, why didn’t each incremental reduction in plaques lead to a corresponding improvement in cognition?\u003c/p>\n\u003cp>Dr. Al Sandrock, Biogen’s chief scientific officer, said there is likely a threshold of amyloid reduction that must be reached before patients actually benefit. The low doses, despite their effect on plaques, might not have hit that threshold, Sandrock said, thus accounting for their poor performance on cognitive decline.\u003c/p>\n\u003cp>The divergence in the two curves is what gives Dr. Reisa Sperling, who was overall encouraged by the results, “the most pause.” But Sperling, director Center for Alzheimer Research and Treatment at Brigham and Women’s Hospital, noted that some of the study’s arms had small numbers of patients, making it difficult to draw conclusions. She said while there is a biological argument that could underpin the threshold hypothesis, she wanted to see more data from a larger trial with a more traditional design.\u003c/p>\n\u003cp>Even if Sandrock’s theory holds up, what happened to BAN2401 is not a new phenomenon. This year a drug from Merck, meant to shut off the production of plaques by blocking an enzyme called BACE, was successful in reducing amyloid but fared so dismally on cognitive measures that researchers terminated the trial early. A second BACE drug, from Biogen and Eisai, had similar results in miniature, hitting the mark on plaque reduction in a Phase 2 trial but failing to significantly outperform placebo on cognition.\u003c/p>\n\u003cp>The underlying issue, according Dr. Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California, is that “the plaques are not the target — those are biomarkers.”\u003c/p>\n\u003cp>“A target is something that, as a result of hitting it, there will be change downstream in behavior, cognition, and illness course,” Schneider said. “So, yeah we’re knocking down amyloid, but so far we’re not changing behavior much.”\u003c/p>\n\u003cp>Even BAN2401’s saving grace — that its highest dose appeared to both reduce amyloid and improve patient’s clinical results — has come under scrutiny.\u003c/p>\n\u003cp>In the BAN2401 trial, about 70 percent of patients getting placebo had a genetic mutation that triples the risk of Alzheimer’s. But in the high-dose BAN2401 group, just 30 percent of patients had the mutation, called APOE4.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>That could explain why BAN2401 seemed to outperform a saline injection in the high-dose group, skeptics say, as past trials suggest that APOE4 carriers have more rapidly progressing Alzheimer’s than patients without the mutation.\u003c/p>\n\u003cp>And it could mean that the drug’s seeming promise is a mirage.\u003c/p>\n\u003cp>Dr. Paul Aisen, who runs the Alzheimer’s Therapeutic Research Institute at the University of Southern California, said the discrepancy “does create a potential bias.” But in trials where patients are confirmed to have amyloid in their brains at the outset, as was the case with BAN2401, “the impact of [APOE4] on progression is modest,” Aisen wrote in an email. “I don’t think this accounts for the apparent slowing of cognitive decline in the high-dose arm.”\u003c/p>\n\u003cp>Sperling agreed that she did not think the arms’ different populations skewed the data, in part because the group that received the second highest dose of the drug had a larger share of APOE4 carriers and saw results that were similar — though not as substantial — as the high dose group.\u003c/p>\n\u003cp>“It’s a similar pattern,” she said. “For me that partially mitigates that concern.”\u003c/p>\n\u003cp>Biogen and Eisai have promised to dig into the data and parse out the effect APOE4 had on whether patients responded to BAN2401, but those results likely won’t be ready for months.\u003c/p>\n\u003cp>In the meantime, companies are still queueing up to take cracks at amyloid.\u003c/p>\n\u003cp>Eli Lilly, which has spent billions on failed Alzheimer’s drugs in recent years, has designed a trial that will test the amyloid hypothesis “in the most definitive way possible,” said Mark Mintun, the company’s vice president of neurodegeneration.\u003c/p>\n\u003cp>The plan is to take a BACE inhibitor and pair it with an injected treatment that targets amyloid already in the brain. That should address the two major concerns with each approach, Mintun said: BACE inhibitors prevent amyloid but don’t address plaques that already exist, while amyloid-targeting therapies don’t stem the flow of new toxic clumps.\u003c/p>\n\u003cp>“I equate it to going down to your basement and finding three feet of water and there’s been a slow drip for four weeks,” Mintun said. “You can turn off the spigot, but it won’t feel like you’ve made much progress, so you’ve got to pump it out, too.”\u003c/p>\n\u003cp>That study is enrolling 375 patients into three groups, planning to study whether the combination can improve cognition compared with placebo over 18 months.\u003c/p>\n\u003cp>\u003cem>Andrew Joseph contributed reporting.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This story was originally published by \u003ca href=\"https://www.statnews.com/2018/07/30/alzheimers-amyloid-hypothesis/\" target=\"_blank\" rel=\"noopener\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Most People Think Pot's Totally Safe. But We Don't Actually Know",
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"content": "\u003cp>When it comes to pot, many Americans seem to think it is a magic cure-all despite the lack of scientific data to corroborate that view.[contextly_sidebar id=\"qbIMJ6HAj7B7PdjXyzZ3WGlgtNv4dD58\"]\u003c/p>\n\u003cp>Those are the findings of a new survey, published this week in the journal \u003ca href=\"http://annals.org/aim/article/doi/10.7326/M18-0810\">\u003cem>Annals of Internal Medicine\u003c/em>. \u003c/a>The online survey, conducted by researchers at UC San Francisco, found that many Americans believe marijuana has significant health benefits, despite a lack of scientific data to support that view.\u003c/p>\n\u003cp>That data lack is largely due to marijuana's restricted legal status in the U.S., which makes it difficult for scientists to study the drug's impact on human health, according to Timothy Fong, a professor of addiction psychiatry at UC Los Angeles.\u003c/p>\n\u003cp>[contextly_sidebar id=\"1hOtotjglJ20ftdvAgNx5fpFHerDNbOZ\"]Without actual data to go on, people fall back on personal or anecdotal evidence.\u003c/p>\n\u003cp>\"We want to do more studies, but we can’t do a darn thing if the federal government handcuffs us,” Fong told \u003ca href=\"https://www.reuters.com/article/us-health-marijuana/americans-view-of-marijuana-is-rosy-and-unscientific-idUSKBN1KD2IR\" target=\"_blank\" rel=\"noopener\">Reuters.\u003c/a> “This is the kind of study that I think elevates the discussion. And it shows we have a long way to go.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Researchers surveyed 16,280 people in the U.S. and found that 81 percent of respondents believe that smoking marijuana has at least one health benefit, with pain management being the most commonly cited one.\u003c/p>\n\u003cp>Yet a separate study \u003ca href=\"https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(18)30110-5/fulltext?code=lancet-site\" target=\"_blank\" rel=\"noopener\">spanning four years\u003c/a> found no evidence that marijuana use improves the symptoms of chronic pain.\u003c/p>\n\u003cp>The survey also found that 91 percent of respondents believe that marijuana has at least one risk, but the most commonly cited risk — legal trouble — wasn't health related, a finding researchers found troubling because it indicates that many people are downplaying potential harm, according to \u003ca href=\"http://chime.ucsf.edu/people/salomeh-keyhani-md\" target=\"_blank\" rel=\"noopener\">Dr. Salomeh Keyhani,\u003c/a> a professor of medicine at UC San Francisco.\u003c/p>\n\u003cp>“The American public has a much more favorable point of view than is warranted by the evidence,” Dr. Keyhani told \u003ca href=\"https://www.reuters.com/article/us-health-marijuana/americans-view-of-marijuana-is-rosy-and-unscientific-idUSKBN1KD2IR\" target=\"_blank\" rel=\"noopener\">Reuters.\u003c/a> “Perhaps most concerning is that they think that it prevents health problems.”\u003c/p>\n\u003cp>The survey found that 18 percent of respondents believe that smoking marijuana is somewhat or completely safe for adults.\u003c/p>\n\u003cp>In addition, nearly half of those surveyed believe that marijuana can alleviate insomnia, anxiety and depression, none of which are scientifically established, says Dr. Keyhani.[contextly_sidebar id=\"llwIT8YXMfGYSqJGFFEv4ackgmMz0K5Q\"]\u003c/p>\n\u003cp>\"The bottom line is that there's no evidence for the vast majority of this,\" Dr. Keyhani told \u003ca href=\"https://www.livescience.com/63141-marijuana-assumed-beneficial.html\" target=\"_blank\" rel=\"noopener\">Livescience\u003c/a>. \"There's limited data on harm, and people think that means it's OK.\"\u003c/p>\n\u003cp>Researchers created the survey to examine the impact of marketing on the public's perception of marijuana. From \u003ca href=\"https://www.theguardian.com/society/2018/jul/23/cannabis-health-benefits-american-attitudes-study\" target=\"_blank\" rel=\"noopener\">the Guardian\u003c/a>:\u003c/p>\n\u003cblockquote>\u003cp>Mixed signals regarding marijuana’s potential dangers and benefits have enabled the commercial marijuana industry to promote a maximalist view of marijuana’s possible benefits. Since direct unproven claims of marijuana’s medical benefits, and assertions such as that a product cures cancer, can lead to unwanted attention from the FDA regulators, cannabis companies have learned to be much more subtle.\u003c/p>\u003c/blockquote>\n\u003cp>Despite the federal ban on marijuana, the Food and Drug Administration \u003ca href=\"https://www.kqed.org/futureofyou/443383/meet-sam-the-berkeley-kid-who-inspired-first-marijuana-based-drug\" target=\"_blank\" rel=\"noopener\">recently approved Epidiolex, an epilepsy drug\u003c/a> derived from marijuana. Medical marijuana is also legal in 31 states, a fact that only contributes to its rosy reputation.\u003c/p>\n\u003cp>Still, Keyhani says more research needs to be done. Until that happens, most of the health claims touted by the industry remain unproven.\u003c/p>\n\u003cp>“We need better data,” Keyhani told the Guardian. “We need any data.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp> \u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>When it comes to pot, many Americans seem to think it is a magic cure-all despite the lack of scientific data to corroborate that view.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Those are the findings of a new survey, published this week in the journal \u003ca href=\"http://annals.org/aim/article/doi/10.7326/M18-0810\">\u003cem>Annals of Internal Medicine\u003c/em>. \u003c/a>The online survey, conducted by researchers at UC San Francisco, found that many Americans believe marijuana has significant health benefits, despite a lack of scientific data to support that view.\u003c/p>\n\u003cp>That data lack is largely due to marijuana's restricted legal status in the U.S., which makes it difficult for scientists to study the drug's impact on human health, according to Timothy Fong, a professor of addiction psychiatry at UC Los Angeles.\u003c/p>\n\u003cp>\u003c/p>\u003cp>\u003c/p>\u003cp>Without actual data to go on, people fall back on personal or anecdotal evidence.\u003c/p>\n\u003cp>\"We want to do more studies, but we can’t do a darn thing if the federal government handcuffs us,” Fong told \u003ca href=\"https://www.reuters.com/article/us-health-marijuana/americans-view-of-marijuana-is-rosy-and-unscientific-idUSKBN1KD2IR\" target=\"_blank\" rel=\"noopener\">Reuters.\u003c/a> “This is the kind of study that I think elevates the discussion. And it shows we have a long way to go.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Researchers surveyed 16,280 people in the U.S. and found that 81 percent of respondents believe that smoking marijuana has at least one health benefit, with pain management being the most commonly cited one.\u003c/p>\n\u003cp>Yet a separate study \u003ca href=\"https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(18)30110-5/fulltext?code=lancet-site\" target=\"_blank\" rel=\"noopener\">spanning four years\u003c/a> found no evidence that marijuana use improves the symptoms of chronic pain.\u003c/p>\n\u003cp>The survey also found that 91 percent of respondents believe that marijuana has at least one risk, but the most commonly cited risk — legal trouble — wasn't health related, a finding researchers found troubling because it indicates that many people are downplaying potential harm, according to \u003ca href=\"http://chime.ucsf.edu/people/salomeh-keyhani-md\" target=\"_blank\" rel=\"noopener\">Dr. Salomeh Keyhani,\u003c/a> a professor of medicine at UC San Francisco.\u003c/p>\n\u003cp>“The American public has a much more favorable point of view than is warranted by the evidence,” Dr. Keyhani told \u003ca href=\"https://www.reuters.com/article/us-health-marijuana/americans-view-of-marijuana-is-rosy-and-unscientific-idUSKBN1KD2IR\" target=\"_blank\" rel=\"noopener\">Reuters.\u003c/a> “Perhaps most concerning is that they think that it prevents health problems.”\u003c/p>\n\u003cp>The survey found that 18 percent of respondents believe that smoking marijuana is somewhat or completely safe for adults.\u003c/p>\n\u003cp>In addition, nearly half of those surveyed believe that marijuana can alleviate insomnia, anxiety and depression, none of which are scientifically established, says Dr. Keyhani.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\"The bottom line is that there's no evidence for the vast majority of this,\" Dr. Keyhani told \u003ca href=\"https://www.livescience.com/63141-marijuana-assumed-beneficial.html\" target=\"_blank\" rel=\"noopener\">Livescience\u003c/a>. \"There's limited data on harm, and people think that means it's OK.\"\u003c/p>\n\u003cp>Researchers created the survey to examine the impact of marketing on the public's perception of marijuana. From \u003ca href=\"https://www.theguardian.com/society/2018/jul/23/cannabis-health-benefits-american-attitudes-study\" target=\"_blank\" rel=\"noopener\">the Guardian\u003c/a>:\u003c/p>\n\u003cblockquote>\u003cp>Mixed signals regarding marijuana’s potential dangers and benefits have enabled the commercial marijuana industry to promote a maximalist view of marijuana’s possible benefits. Since direct unproven claims of marijuana’s medical benefits, and assertions such as that a product cures cancer, can lead to unwanted attention from the FDA regulators, cannabis companies have learned to be much more subtle.\u003c/p>\u003c/blockquote>\n\u003cp>Despite the federal ban on marijuana, the Food and Drug Administration \u003ca href=\"https://www.kqed.org/futureofyou/443383/meet-sam-the-berkeley-kid-who-inspired-first-marijuana-based-drug\" target=\"_blank\" rel=\"noopener\">recently approved Epidiolex, an epilepsy drug\u003c/a> derived from marijuana. Medical marijuana is also legal in 31 states, a fact that only contributes to its rosy reputation.\u003c/p>\n\u003cp>Still, Keyhani says more research needs to be done. Until that happens, most of the health claims touted by the industry remain unproven.\u003c/p>\n\u003cp>“We need better data,” Keyhani told the Guardian. “We need any data.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp> \u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>When people think of particle accelerators, they tend to think of giant structures: tunnels many miles long that electrons and protons race through at tremendous speeds, packing enormous energy.\u003c/p>\n\u003cp>But scientists in California think small is beautiful. They want to build an accelerator on semiconductor chips. An accelerator built that way won't achieve the energy of its much larger cousins, but it could accelerate material research and revolutionize medical therapy.\u003c/p>\n\u003cp>First of all, what is an accelerator?\u003c/p>\n\u003cp>\"An accelerator is a way to add energy to particles,\" says \u003ca href=\"https://web.stanford.edu/~rlbyer/\" target=\"_blank\" rel=\"noopener\">Robert Byer\u003c/a>, a physicist at Stanford University. Once you have those energetic particles, you can do things with them, like irradiate tumors or generate X-rays that scientists use to investigate new materials. An accelerator built this way would bring an accelerator's usefulness within the reach of more researchers.\u003c/p>\n\u003cp>Byer has been trying to shrink the size of particle accelerators for more than 40 years. His idea is to use lasers to add energy to electrons as they zip through a tiny channel in a semiconductor chip. Byer says this is a miniaturized version of what goes on in larger accelerators, but there are big challenges to doing this on such a small scale.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"We need to focus the electrons,\" Byer says. \"We need to bunch them so they surf the wavelength of light right at the crest, so they get the maximum acceleration.\"\u003c/p>\n\u003cp>Byer and his colleagues are working on those challenges in a laboratory in the basement of the Spilker Engineering and Applied Sciences building on the Stanford campus. Byer took me on a tour there.\u003c/p>\n\u003cp>We put on glasses to protect our eyes from the powerful laser light used in the pint-sized accelerator.\u003c/p>\n\u003cp>A big red emergency shut-off button attached to a shelf suggests this is not equipment to trifle with.\u003c/p>\n\u003cp>\u003ca href=\"https://www.laserphysics.nat.fau.eu/person/peter-hommelhoff/\" target=\"_blank\" rel=\"noopener\">Peter Hommelhoff\u003c/a> of the Friedrich-Alexander-Universität Erlangen-Nürnberg in Germany says one of the big challenges is to keep the electrons in the accelerator traveling where you want them to.\u003c/p>\n\u003cp>\"The acceleration channel is very narrow, so you have to generate a very, very narrow electron beam that you can send through the channel,\" Hommelhoff says.\u003c/p>\n\u003cp>\"It's a little like threading an invisible needle,\" says Dylan Black, a Stanford graduate student in physics.\u003c/p>\n\u003cp>Testing their accelerator requires lasers and lenses and pumps scattered around benches in the lab, it takes up a fair amount of space. But this is just a prototype.\u003c/p>\n\u003cp>Black points to a bright circle of light on a monitor's screen.\u003c/p>\n\u003cp>\"That there is a picture of what the electron beam would look like if you put your eye right in front of the beam,\" Black says.\u003c/p>\n\u003cp>\"Which I would not recommend,\" interjects Ken Leedle, a research engineer working on the accelerator-on-a-chip project.\u003c/p>\n\u003cp>I asked \u003ca href=\"https://portal.slac.stanford.edu/sites/ard_public/people/joen/Pages/default.aspx\" target=\"_blank\" rel=\"noopener\">R. Joel England\u003c/a>, a physicist at the SLAC National Accelerator Laboratory who has been working on the accelerator-on-a-chip project, how long it will be before the prototype turns into a working instrument.\u003c/p>\n\u003cp>\"Depending on how much progress gets made, I would say five to 10 years,\" England says. England is enthusiastic about the promise of these small-scale accelerators.\u003c/p>\n\u003cp>\"One of the applications could be to take one of the fairly bulky, 10,000-pound accelerator devices that's used in hospitals for radiation therapy and make that into something that's chip-sized,\" he says.\u003c/p>\n\u003cp>In addition to saving huge costs and space, it might eventually be possible to insert a chip-sized accelerator into a patient's body, where it could directly irradiate a tumor.\u003c/p>\n\u003cp>Even though it may take a decade or more, Robert Byer is convinced smaller accelerators will become a reality. His isn't the only lab working on the idea. And besides, he points out, new technologies often start out bulky. Take the first laser to come on the scene.\u003c/p>\n\u003cp>\"Early on, lasers were big — and they were inefficient and they took all the power and water in your building to operate them,\" Byer says. \"They got more and more efficient because we converted to semiconductor lasers and solid state lasers — and all of a sudden, lasers then became everywhere.\"\u003c/p>\n\u003cp>Even new mobile phones have lasers in them, Byer says.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>The day of the accelerator on a chip, he believes, is coming.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Physicists+Go+Small%3A+Let%27s+Put+A+Particle+Accelerator+On+A+Chip&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>When people think of particle accelerators, they tend to think of giant structures: tunnels many miles long that electrons and protons race through at tremendous speeds, packing enormous energy.\u003c/p>\n\u003cp>But scientists in California think small is beautiful. They want to build an accelerator on semiconductor chips. An accelerator built that way won't achieve the energy of its much larger cousins, but it could accelerate material research and revolutionize medical therapy.\u003c/p>\n\u003cp>First of all, what is an accelerator?\u003c/p>\n\u003cp>\"An accelerator is a way to add energy to particles,\" says \u003ca href=\"https://web.stanford.edu/~rlbyer/\" target=\"_blank\" rel=\"noopener\">Robert Byer\u003c/a>, a physicist at Stanford University. Once you have those energetic particles, you can do things with them, like irradiate tumors or generate X-rays that scientists use to investigate new materials. An accelerator built this way would bring an accelerator's usefulness within the reach of more researchers.\u003c/p>\n\u003cp>Byer has been trying to shrink the size of particle accelerators for more than 40 years. His idea is to use lasers to add energy to electrons as they zip through a tiny channel in a semiconductor chip. Byer says this is a miniaturized version of what goes on in larger accelerators, but there are big challenges to doing this on such a small scale.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"We need to focus the electrons,\" Byer says. \"We need to bunch them so they surf the wavelength of light right at the crest, so they get the maximum acceleration.\"\u003c/p>\n\u003cp>Byer and his colleagues are working on those challenges in a laboratory in the basement of the Spilker Engineering and Applied Sciences building on the Stanford campus. Byer took me on a tour there.\u003c/p>\n\u003cp>We put on glasses to protect our eyes from the powerful laser light used in the pint-sized accelerator.\u003c/p>\n\u003cp>A big red emergency shut-off button attached to a shelf suggests this is not equipment to trifle with.\u003c/p>\n\u003cp>\u003ca href=\"https://www.laserphysics.nat.fau.eu/person/peter-hommelhoff/\" target=\"_blank\" rel=\"noopener\">Peter Hommelhoff\u003c/a> of the Friedrich-Alexander-Universität Erlangen-Nürnberg in Germany says one of the big challenges is to keep the electrons in the accelerator traveling where you want them to.\u003c/p>\n\u003cp>\"The acceleration channel is very narrow, so you have to generate a very, very narrow electron beam that you can send through the channel,\" Hommelhoff says.\u003c/p>\n\u003cp>\"It's a little like threading an invisible needle,\" says Dylan Black, a Stanford graduate student in physics.\u003c/p>\n\u003cp>Testing their accelerator requires lasers and lenses and pumps scattered around benches in the lab, it takes up a fair amount of space. But this is just a prototype.\u003c/p>\n\u003cp>Black points to a bright circle of light on a monitor's screen.\u003c/p>\n\u003cp>\"That there is a picture of what the electron beam would look like if you put your eye right in front of the beam,\" Black says.\u003c/p>\n\u003cp>\"Which I would not recommend,\" interjects Ken Leedle, a research engineer working on the accelerator-on-a-chip project.\u003c/p>\n\u003cp>I asked \u003ca href=\"https://portal.slac.stanford.edu/sites/ard_public/people/joen/Pages/default.aspx\" target=\"_blank\" rel=\"noopener\">R. Joel England\u003c/a>, a physicist at the SLAC National Accelerator Laboratory who has been working on the accelerator-on-a-chip project, how long it will be before the prototype turns into a working instrument.\u003c/p>\n\u003cp>\"Depending on how much progress gets made, I would say five to 10 years,\" England says. England is enthusiastic about the promise of these small-scale accelerators.\u003c/p>\n\u003cp>\"One of the applications could be to take one of the fairly bulky, 10,000-pound accelerator devices that's used in hospitals for radiation therapy and make that into something that's chip-sized,\" he says.\u003c/p>\n\u003cp>In addition to saving huge costs and space, it might eventually be possible to insert a chip-sized accelerator into a patient's body, where it could directly irradiate a tumor.\u003c/p>\n\u003cp>Even though it may take a decade or more, Robert Byer is convinced smaller accelerators will become a reality. His isn't the only lab working on the idea. And besides, he points out, new technologies often start out bulky. Take the first laser to come on the scene.\u003c/p>\n\u003cp>\"Early on, lasers were big — and they were inefficient and they took all the power and water in your building to operate them,\" Byer says. \"They got more and more efficient because we converted to semiconductor lasers and solid state lasers — and all of a sudden, lasers then became everywhere.\"\u003c/p>\n\u003cp>Even new mobile phones have lasers in them, Byer says.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>The day of the accelerator on a chip, he believes, is coming.\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Physicists+Go+Small%3A+Let%27s+Put+A+Particle+Accelerator+On+A+Chip&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Insurers And Government Are Slow To Cover Expensive CAR-T Cancer Therapy",
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"content": "\u003cp>Patients whose blood cancers have failed to respond to repeated rounds of chemotherapy may be candidates for a new type of gene therapy that could send their cancers into remission for years. But the two approved therapies, with price tags of hundreds of thousands of dollars, have roiled the insurance approval process, leading to delays and, in some cases, denials of coverage, clinicians and analysts say.[contextly_sidebar id=\"ReV9Gv0J6j7ADmv2dqbEuegAVdiLN5dE\"]\u003c/p>\n\u003cp>The therapy involves collecting patients' own T cells, a type of white blood cell, genetically modifying them, and then infusing them back into patients, where they hunt down and kill cancer cells. Known as \u003ca href=\"https://www.cancer.gov/about-cancer/treatment/research/car-t-cells\" target=\"_blank\" rel=\"noopener\">CAR-T cell therapy\u003c/a>, it's been characterized as a \"living drug\" by some researchers.\u003c/p>\n\u003cp>Two different CAR-T drugs — \u003ca href=\"https://www.us.kymriah.com/diffuse-large-b-cell-lymphoma-adults/?site=KYDDAY0DTCBR0040&source=01030&gclid=CNDIg4PMpNwCFRj1swod-MwKyw&gclsrc=ds\" target=\"_blank\" rel=\"noopener\">Kymriah\u003c/a> and \u003ca href=\"https://www.yescarta.com/therapy#how-yescarta-is-different\" target=\"_blank\" rel=\"noopener\">Yescarta\u003c/a> — were approved by the FDA last year to treat patients whose blood cancers haven't responded to at least two other rounds of treatment.\u003c/p>\n\u003cp>Kymriah is \u003ca href=\"https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm574154.htm\">approved\u003c/a> for people up to age 25 with a form of acute lymphoblastic leukemia, the most common cancer in children. Kymriah and Yescarta are \u003ca href=\"https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm606540.htm\" target=\"_blank\" rel=\"noopener\">both\u003c/a> \u003ca href=\"https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm581296.htm\" target=\"_blank\" rel=\"noopener\">approved\u003c/a> for adults with advanced lymphomas.\u003c/p>\n\u003cp>Researchers report that some critically ill patients who received the therapy have remained cancer-free for as long as five years.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"This is what patients need,\" says \u003ca href=\"https://www.mayo.edu/research/faculty/lin-yi-m-d-ph-d/bio-00092684\" target=\"_blank\" rel=\"noopener\">Dr. Yi Lin\u003c/a>, a hematologist who oversees the CAR-T cell practice and research for the Mayo Clinic. \"With the likelihood of getting patients into durable survival, we don't want to deny them the therapy.\" She says she receives no personal financial support from the drugs' makers.[contextly_sidebar id=\"nsB5Luqi8Mrdsb9vLceD3T77zYYY4sKK\"]\u003c/p>\n\u003cp>But the treatment comes at a cost — the drug treatments are hugely expensive. Kymriah and Yescarta cost $373,000 for a one-time infusion to treat adults with advanced lymphomas, while Kymriah costs $475,000 to treat acute lymphoblastic leukemia in children and young adults. That's the cost of the drug itself; in addition, many patients experience serious side effects that can land them in a hospital intensive care unit for weeks, \u003ca href=\"https://khn.org/news/cascade-of-costs-could-push-new-gene-therapy-above-1-million-per-patient/\" target=\"_blank\" rel=\"noopener\">pushing treatment costs to more than $1 million\u003c/a>.\u003c/p>\n\u003cp>All of this gives government and private insurers pause.\u003c/p>\n\u003cp>Most commercial insurers are covering CAR-T cell therapies now, but they do so on an individual basis, writing single-patient agreements each time, say cancer specialists. Large insurers that are already familiar with complicated therapies like stem-cell transplants are getting speedier at handling requests for CAR-T cell treatment, they say. But that's not always the case at smaller or regional plans, where delays can add weeks to the approval process.\u003c/p>\n\u003cp>\"A request for CAR-T may end up with somebody on the payer authorization team who doesn't understand the technology or the urgency of the request, when somebody has only weeks or months to live,\" says \u003ca href=\"https://www.asbmt.org/about/contact-us\" target=\"_blank\" rel=\"noopener\">Stephanie Farnia\u003c/a>, director of health policy and strategic relations at the American Society for Blood and Marrow Transplantation.\u003c/p>\n\u003cp>Farnia is in contact with many of the more than 50 medical centers that are authorized to provide treatment. The process of getting to a treatment center and evaluated for therapy is involved, she says. \"To then be substantially delayed due to paperwork is incredibly frustrating\" for patients.[contextly_sidebar id=\"mCjXSziNW7nkG4M52QmA48lgOAVmv3eg\"]\u003c/p>\n\u003cp>Medicare and Medicaid often pose greater coverage challenges than do private insurers, according to insurance experts.\u003c/p>\n\u003cp>Some Medicaid programs don't cover the treatment, says \u003ca href=\"AndrewsCAR-TandInsuranceDFedit.docx\" target=\"_blank\" rel=\"noopener\">Dr. Michael Bishop\u003c/a>, director of the cellular therapy program in the hematology/oncology section at the University of Chicago. Medicaid, the state-federal health program, covers children in low-income households and some adults.\u003c/p>\n\u003cp>\"Medicaid has been very tough,\" he says. \"Certain states just deny coverage — even states with balanced budgets.\"\u003c/p>\n\u003cp>States \u003ca href=\"https://icer-review.org/wp-content/uploads/2017/07/ICER_CAR_T_Final_Evidence_Report_032318.pdf\" target=\"_blank\" rel=\"noopener\">have to evaluate the cost as well as the drugs' effectiveness\u003c/a>, says \u003ca href=\"http://medicaiddirectors.org/about/staff/\" target=\"_blank\" rel=\"noopener\">Matt Salo\u003c/a>, executive director of the National Association of Medicaid Directors.\u003c/p>\n\u003cp>\"Medicaid is a finite pot of money, and it's stretched threadbare even on a good day,\" he says.\u003c/p>\n\u003cp>People who are on Medicare, the health insurance program for people age 65 and older and some people with disabilities, typically haven't faced coverage denials to date, clinicians say. But the government's reimbursement rates are raising concerns for providers.\u003c/p>\n\u003cp>Last spring, Medicare announced payment rates for providers who administer Yescarta and Kymriah on an outpatient basis. The payments would more than cover the costs of the drugs. Medicare beneficiaries' out-of-pocket costs would be capped at $1,340 plus the beneficiaries' Part B deductible (if that hasn't already been met), the agency says.[contextly_sidebar id=\"zRKGtFwAO4CBGEIycv3lNE5oWVwoZuVf\"]\u003c/p>\n\u003cp>The problem with this plan? Facilities typically provide treatment on an inpatient basis, not outpatient, because of the potential for severe, systemic side effects.\u003c/p>\n\u003cp>\"There's a lot of toxicity and questions about whether it can even be provided in an outpatient setting,\" says Gary Goldstein, the business manager at the blood and marrow transplant program at Stanford Health Care in Stanford, Calif.\u003c/p>\n\u003cp>For inpatient care, \"CAR-T cell therapy ... would be paid at a much lower amount compared to outpatient hospital use,\" according to officials at the Centers for Medicare & Medicaid Services.\u003c/p>\n\u003cp>The agency is considering how to handle payment for inpatient CAR-T care for the fiscal year that starts in October. For now, some medical centers are absorbing whatever Medicare doesn't pay.\u003c/p>\n\u003cp>\"How can you tell a patient who's 66, 'If only you'd gotten lymphoma when you were 64'?\" Goldstein asks.\u003c/p>\n\u003cp>But the current approach can't continue indefinitely, he says.\u003c/p>\n\u003cp>\"Even if there aren't any centers that are making that decision today, if coverage doesn't change for Medicare, it absolutely is going to be a problem tomorrow,\" says Goldstein.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003ca href=\"http://khn.org/\" target=\"_blank\" rel=\"noopener\">\u003cem>Kaiser Health News\u003c/em>\u003c/a>\u003cem>, a nonprofit news service, is an editorially independent program of the Kaiser Family Foundation, and is not affiliated with Kaiser Permanente. Michelle Andrews is on Twitter \u003c/em>\u003ca href=\"https://twitter.com/mandrews110\" target=\"_blank\" rel=\"noopener\">\u003cem>@mandrews110\u003c/em>\u003c/a>\u003cem>.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 Kaiser Health News. To see more, visit \u003ca href=\"http://www.kaiserhealthnews.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Health News\u003c/a>.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Insurers+And+Government+Are+Slow+To+Cover+Expensive+CAR-T+Cancer+Therapy&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Patients whose blood cancers have failed to respond to repeated rounds of chemotherapy may be candidates for a new type of gene therapy that could send their cancers into remission for years. But the two approved therapies, with price tags of hundreds of thousands of dollars, have roiled the insurance approval process, leading to delays and, in some cases, denials of coverage, clinicians and analysts say.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The therapy involves collecting patients' own T cells, a type of white blood cell, genetically modifying them, and then infusing them back into patients, where they hunt down and kill cancer cells. Known as \u003ca href=\"https://www.cancer.gov/about-cancer/treatment/research/car-t-cells\" target=\"_blank\" rel=\"noopener\">CAR-T cell therapy\u003c/a>, it's been characterized as a \"living drug\" by some researchers.\u003c/p>\n\u003cp>Two different CAR-T drugs — \u003ca href=\"https://www.us.kymriah.com/diffuse-large-b-cell-lymphoma-adults/?site=KYDDAY0DTCBR0040&source=01030&gclid=CNDIg4PMpNwCFRj1swod-MwKyw&gclsrc=ds\" target=\"_blank\" rel=\"noopener\">Kymriah\u003c/a> and \u003ca href=\"https://www.yescarta.com/therapy#how-yescarta-is-different\" target=\"_blank\" rel=\"noopener\">Yescarta\u003c/a> — were approved by the FDA last year to treat patients whose blood cancers haven't responded to at least two other rounds of treatment.\u003c/p>\n\u003cp>Kymriah is \u003ca href=\"https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm574154.htm\">approved\u003c/a> for people up to age 25 with a form of acute lymphoblastic leukemia, the most common cancer in children. Kymriah and Yescarta are \u003ca href=\"https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm606540.htm\" target=\"_blank\" rel=\"noopener\">both\u003c/a> \u003ca href=\"https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm581296.htm\" target=\"_blank\" rel=\"noopener\">approved\u003c/a> for adults with advanced lymphomas.\u003c/p>\n\u003cp>Researchers report that some critically ill patients who received the therapy have remained cancer-free for as long as five years.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"This is what patients need,\" says \u003ca href=\"https://www.mayo.edu/research/faculty/lin-yi-m-d-ph-d/bio-00092684\" target=\"_blank\" rel=\"noopener\">Dr. Yi Lin\u003c/a>, a hematologist who oversees the CAR-T cell practice and research for the Mayo Clinic. \"With the likelihood of getting patients into durable survival, we don't want to deny them the therapy.\" She says she receives no personal financial support from the drugs' makers.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>But the treatment comes at a cost — the drug treatments are hugely expensive. Kymriah and Yescarta cost $373,000 for a one-time infusion to treat adults with advanced lymphomas, while Kymriah costs $475,000 to treat acute lymphoblastic leukemia in children and young adults. That's the cost of the drug itself; in addition, many patients experience serious side effects that can land them in a hospital intensive care unit for weeks, \u003ca href=\"https://khn.org/news/cascade-of-costs-could-push-new-gene-therapy-above-1-million-per-patient/\" target=\"_blank\" rel=\"noopener\">pushing treatment costs to more than $1 million\u003c/a>.\u003c/p>\n\u003cp>All of this gives government and private insurers pause.\u003c/p>\n\u003cp>Most commercial insurers are covering CAR-T cell therapies now, but they do so on an individual basis, writing single-patient agreements each time, say cancer specialists. Large insurers that are already familiar with complicated therapies like stem-cell transplants are getting speedier at handling requests for CAR-T cell treatment, they say. But that's not always the case at smaller or regional plans, where delays can add weeks to the approval process.\u003c/p>\n\u003cp>\"A request for CAR-T may end up with somebody on the payer authorization team who doesn't understand the technology or the urgency of the request, when somebody has only weeks or months to live,\" says \u003ca href=\"https://www.asbmt.org/about/contact-us\" target=\"_blank\" rel=\"noopener\">Stephanie Farnia\u003c/a>, director of health policy and strategic relations at the American Society for Blood and Marrow Transplantation.\u003c/p>\n\u003cp>Farnia is in contact with many of the more than 50 medical centers that are authorized to provide treatment. The process of getting to a treatment center and evaluated for therapy is involved, she says. \"To then be substantially delayed due to paperwork is incredibly frustrating\" for patients.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Medicare and Medicaid often pose greater coverage challenges than do private insurers, according to insurance experts.\u003c/p>\n\u003cp>Some Medicaid programs don't cover the treatment, says \u003ca href=\"AndrewsCAR-TandInsuranceDFedit.docx\" target=\"_blank\" rel=\"noopener\">Dr. Michael Bishop\u003c/a>, director of the cellular therapy program in the hematology/oncology section at the University of Chicago. Medicaid, the state-federal health program, covers children in low-income households and some adults.\u003c/p>\n\u003cp>\"Medicaid has been very tough,\" he says. \"Certain states just deny coverage — even states with balanced budgets.\"\u003c/p>\n\u003cp>States \u003ca href=\"https://icer-review.org/wp-content/uploads/2017/07/ICER_CAR_T_Final_Evidence_Report_032318.pdf\" target=\"_blank\" rel=\"noopener\">have to evaluate the cost as well as the drugs' effectiveness\u003c/a>, says \u003ca href=\"http://medicaiddirectors.org/about/staff/\" target=\"_blank\" rel=\"noopener\">Matt Salo\u003c/a>, executive director of the National Association of Medicaid Directors.\u003c/p>\n\u003cp>\"Medicaid is a finite pot of money, and it's stretched threadbare even on a good day,\" he says.\u003c/p>\n\u003cp>People who are on Medicare, the health insurance program for people age 65 and older and some people with disabilities, typically haven't faced coverage denials to date, clinicians say. But the government's reimbursement rates are raising concerns for providers.\u003c/p>\n\u003cp>Last spring, Medicare announced payment rates for providers who administer Yescarta and Kymriah on an outpatient basis. The payments would more than cover the costs of the drugs. Medicare beneficiaries' out-of-pocket costs would be capped at $1,340 plus the beneficiaries' Part B deductible (if that hasn't already been met), the agency says.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The problem with this plan? Facilities typically provide treatment on an inpatient basis, not outpatient, because of the potential for severe, systemic side effects.\u003c/p>\n\u003cp>\"There's a lot of toxicity and questions about whether it can even be provided in an outpatient setting,\" says Gary Goldstein, the business manager at the blood and marrow transplant program at Stanford Health Care in Stanford, Calif.\u003c/p>\n\u003cp>For inpatient care, \"CAR-T cell therapy ... would be paid at a much lower amount compared to outpatient hospital use,\" according to officials at the Centers for Medicare & Medicaid Services.\u003c/p>\n\u003cp>The agency is considering how to handle payment for inpatient CAR-T care for the fiscal year that starts in October. For now, some medical centers are absorbing whatever Medicare doesn't pay.\u003c/p>\n\u003cp>\"How can you tell a patient who's 66, 'If only you'd gotten lymphoma when you were 64'?\" Goldstein asks.\u003c/p>\n\u003cp>But the current approach can't continue indefinitely, he says.\u003c/p>\n\u003cp>\"Even if there aren't any centers that are making that decision today, if coverage doesn't change for Medicare, it absolutely is going to be a problem tomorrow,\" says Goldstein.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003ca href=\"http://khn.org/\" target=\"_blank\" rel=\"noopener\">\u003cem>Kaiser Health News\u003c/em>\u003c/a>\u003cem>, a nonprofit news service, is an editorially independent program of the Kaiser Family Foundation, and is not affiliated with Kaiser Permanente. Michelle Andrews is on Twitter \u003c/em>\u003ca href=\"https://twitter.com/mandrews110\" target=\"_blank\" rel=\"noopener\">\u003cem>@mandrews110\u003c/em>\u003c/a>\u003cem>.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 Kaiser Health News. To see more, visit \u003ca href=\"http://www.kaiserhealthnews.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Health News\u003c/a>.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Insurers+And+Government+Are+Slow+To+Cover+Expensive+CAR-T+Cancer+Therapy&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Potential DNA Damage From CRISPR ‘Seriously Underestimated,’ Study Finds",
"title": "Potential DNA Damage From CRISPR ‘Seriously Underestimated,’ Study Finds",
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"content": "\u003cp>From the earliest days of the CRISPR-Cas9 era, scientists have known that the first step in how it \u003ca href=\"https://www.statnews.com/2018/04/04/how-crispr-works-visualized/\">edits genomes\u003c/a> — snipping DNA — creates an unholy mess: Cellular repairmen frantically try to fix the cuts by throwing random chunks of DNA into the breach and deleting other random bits. \u003ca href=\"https://www.nature.com/articles/Nbt.4192\" target=\"_blank\" rel=\"noopener\">Research\u003c/a> published on Monday suggests that’s only the tip of a Titanic-sized iceberg: CRISPR-Cas9 can cause significantly greater genetic havoc than experts thought, the study concludes, perhaps enough to threaten the health of patients who would one day receive \u003ca href=\"https://www.statnews.com/2018/02/21/crispr-sickle-cell-clinical-trials/\">CRISPR-based therapy\u003c/a>.[contextly_sidebar id=\"y9TqAZzR84fJHw52DmhRAZZb04jkzjxD\"]\u003c/p>\n\u003cp>The results come hard on the heels of two \u003ca href=\"https://www.statnews.com/2018/06/11/crispr-hurdle-edited-cells-might-cause-cancer/\">studies\u003c/a> that identified a related issue: Some CRISPR’d cells might be missing a key anti-cancer mechanism and therefore be able to initiate tumors.\u003c/p>\n\u003cp>The DNA damage found in the new study included deletions of thousands of DNA bases, including at spots far from the edit. Some of the deletions can silence genes that should be active and activate genes that should be silent, including cancer-causing genes.\u003c/p>\n\u003cp>The DNA chaos that CRISPR unleashes has been “seriously underestimated,” said geneticist Allan Bradley of England’s Wellcome Sanger Institute, who led the study. “This should be a wake-up call.”\u003c/p>\n\u003cp>Leading CRISPR companies scrambled to play down the latest threat to what they hope will be a multibillion-dollar business \u003cstrong>— \u003c/strong>and to their stock prices, but investors reacted with alarm. Within the first 20 minutes of when the study was released, the three publicly traded CRISPR companies lost more than $300 million in value, and it was downhill from there: CRISPR Therapeutics ended down 8.6 percent, Editas Medicine fell 7 percent, and Intellia Therapeutics lost nearly 10 percent.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The companies questioned whether the CRISPR-caused DNA damage reported in the new study applied to the kind of cells they’re planning to CRISPR. They emphasized that if genomic scrambling is at all common then it should also be seen in earlier forms of genome-editing such as \u003ca href=\"https://www.statnews.com/2017/11/30/crispr-talens-gene-editing/\">zinc fingers and TALENs\u003c/a> (but apparently isn’t). And they insisted they’re on the case.\u003c/p>\n\u003cp>“We’re not Pollyannaish about this,” said geneticist Tom Barnes, chief innovation officer at Intellia. For its mouse experiments, Intellia analyzes edited genomes for collateral damage both near the editing target and tens of thousands of DNA letters away, he said, but “we have not seen any [cancer-causing] transformation of these cells, even with all the edits we’ve introduced.”[contextly_sidebar id=\"X3REPdHlQY5Hjsf4rQxCF5iuUbyNXJ8K\"]\u003c/p>\n\u003cp>In a statement, Editas spokeswoman Cristi Barnett said the possibility of genetic chaos from CRISPR is “an interesting topic” that the company “actively examine[s].” The reported DNA havoc, she said, is not “specifically problematic in our work to make CRISPR-based medicines.” CRISPR Therapeutics did not respond to requests for comment.\u003c/p>\n\u003cp>Academic scientists were less dismissive of the new study, in Nature Biotechnology. One leading CRISPR developer called it “well-done and credible,” “a cautionary note to the [genome-editing] community,” and consistent with other research showing that the DNA cuts that CRISPR makes, called double-stranded breaks, “can induce the types of genomic DNA rearrangements and deletions they report.” He asked not to be identified so as not to jeopardize business relationships with genome-editing companies.\u003c/p>\n\u003cp>But just as critics of last month’s studies asked why, if CRISPR’d cells can initiate cancer, no CRISPR’d mice had turned up with tumors, so scientists raised similar questions about the new genomic havoc finding: Why don’t scientists see it when they analyze the DNA of CRISPR’d cells?\u003c/p>\n\u003cp>“You find what you look for,” said Bradley. “No one is looking at the impact [of these DNA changes] on downstream genes.”\u003c/p>\n\u003cp>And few studies conduct full-out genome sequencing of CRISPR’d cells. Moreover, scientists typically search for one form of the collateral damage the Sanger study found — deletions of thousands of DNA bases (the double helix’s famous A’s, T’s, C’s, and G’s) — using a standard technique called PCR, which makes millions of DNA copies. But to work, PCR must attach to a “binding site” on DNA; CRISPR sometimes deletes that binding site, said Bradley, whose team used a different technique to analyze the double helix for collateral damage from CRISPR.\u003c/p>\n\u003cp>The Sanger scientists didn’t set out to find collateral DNA damage from CRISPR. As they investigated how CRISPR might change gene expression, a “weird thing” showed up, Bradley said: The target DNA was accurately changed, but that set off a chain reaction that engulfed genes far from the target. The scientists therefore changed course.[contextly_sidebar id=\"dkt97iGOrAQULIvrxP1t89Dkl2rYRsky\"]\u003c/p>\n\u003cp>When they aimed CRISPR at different targets in mouse embryonic stem cells, mouse blood-making cells, and human retinal cells, “extensive on-target genomic damage [was] a common outcome,” they wrote in their paper. In one case, genomes in about two-thirds of the CRISPR’d cells showed the expected small-scale inadvertent havoc, but 21 percent had DNA deletions of more than 250 bases and up to 6,000 bases long.\u003c/p>\n\u003cp>Since therapeutic uses of CRISPR would edit the genomes of billions of cells in, say, a patient’s liver, even rare DNA damage “makes it likely that one or more edited cells … would be endowed with an important [disease-causing] lesion,” the scientists wrote.\u003c/p>\n\u003cp>Nature Biotechnology took a year to publish the paper, after asking Bradley numerous variations of “are you sure?” and “did you consider this?” and asking him to run additional experiments, Bradley said. The results all held up.\u003c/p>\n\u003cp>The one U.S. \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT03399448\" target=\"_blank\" rel=\"noopener\">clinical trial\u003c/a> using CRISPR’d cells began recruiting patients this year. It will use CRISPR to make immune cells, removed from patients with any of four types of cancer, attack telltale molecules on the tumor cells’ surface. Asked what genome analysis he plans to do, lead investigator Dr. Edward Stadtmauer of the University of Pennsylvania said, “We are doing extensive testing of the final cellular product as well as the cells within the patient.”\u003c/p>\n\u003cp>The possibility of adverse consequences from CRISPR’d cells has caused some company officials to argue that if, say, their therapy cures a child of a devastating disease, but increases her risk of cancer, that might be an acceptable trade-off.\u003c/p>\n\u003cp>That argument may well prevail. In 2003, however, when a boy in a gene therapy trial in France \u003ca href=\"https://www.nejm.org/doi/full/10.1056/NEJM200301163480314\" target=\"_blank\" rel=\"noopener\">developed leukemia\u003c/a> because the repair gene landed in the wrong place in his genome and activated a cancer-causing gene, it shut down gene therapy development on both sides of the Atlantic for years.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This\u003ca href=\"https://www.statnews.com/2018/07/16/crispr-potential-dna-damage-underestimated/\" target=\"_blank\" rel=\"noopener\"> story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>From the earliest days of the CRISPR-Cas9 era, scientists have known that the first step in how it \u003ca href=\"https://www.statnews.com/2018/04/04/how-crispr-works-visualized/\">edits genomes\u003c/a> — snipping DNA — creates an unholy mess: Cellular repairmen frantically try to fix the cuts by throwing random chunks of DNA into the breach and deleting other random bits. \u003ca href=\"https://www.nature.com/articles/Nbt.4192\" target=\"_blank\" rel=\"noopener\">Research\u003c/a> published on Monday suggests that’s only the tip of a Titanic-sized iceberg: CRISPR-Cas9 can cause significantly greater genetic havoc than experts thought, the study concludes, perhaps enough to threaten the health of patients who would one day receive \u003ca href=\"https://www.statnews.com/2018/02/21/crispr-sickle-cell-clinical-trials/\">CRISPR-based therapy\u003c/a>.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The results come hard on the heels of two \u003ca href=\"https://www.statnews.com/2018/06/11/crispr-hurdle-edited-cells-might-cause-cancer/\">studies\u003c/a> that identified a related issue: Some CRISPR’d cells might be missing a key anti-cancer mechanism and therefore be able to initiate tumors.\u003c/p>\n\u003cp>The DNA damage found in the new study included deletions of thousands of DNA bases, including at spots far from the edit. Some of the deletions can silence genes that should be active and activate genes that should be silent, including cancer-causing genes.\u003c/p>\n\u003cp>The DNA chaos that CRISPR unleashes has been “seriously underestimated,” said geneticist Allan Bradley of England’s Wellcome Sanger Institute, who led the study. “This should be a wake-up call.”\u003c/p>\n\u003cp>Leading CRISPR companies scrambled to play down the latest threat to what they hope will be a multibillion-dollar business \u003cstrong>— \u003c/strong>and to their stock prices, but investors reacted with alarm. Within the first 20 minutes of when the study was released, the three publicly traded CRISPR companies lost more than $300 million in value, and it was downhill from there: CRISPR Therapeutics ended down 8.6 percent, Editas Medicine fell 7 percent, and Intellia Therapeutics lost nearly 10 percent.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The companies questioned whether the CRISPR-caused DNA damage reported in the new study applied to the kind of cells they’re planning to CRISPR. They emphasized that if genomic scrambling is at all common then it should also be seen in earlier forms of genome-editing such as \u003ca href=\"https://www.statnews.com/2017/11/30/crispr-talens-gene-editing/\">zinc fingers and TALENs\u003c/a> (but apparently isn’t). And they insisted they’re on the case.\u003c/p>\n\u003cp>“We’re not Pollyannaish about this,” said geneticist Tom Barnes, chief innovation officer at Intellia. For its mouse experiments, Intellia analyzes edited genomes for collateral damage both near the editing target and tens of thousands of DNA letters away, he said, but “we have not seen any [cancer-causing] transformation of these cells, even with all the edits we’ve introduced.”\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>In a statement, Editas spokeswoman Cristi Barnett said the possibility of genetic chaos from CRISPR is “an interesting topic” that the company “actively examine[s].” The reported DNA havoc, she said, is not “specifically problematic in our work to make CRISPR-based medicines.” CRISPR Therapeutics did not respond to requests for comment.\u003c/p>\n\u003cp>Academic scientists were less dismissive of the new study, in Nature Biotechnology. One leading CRISPR developer called it “well-done and credible,” “a cautionary note to the [genome-editing] community,” and consistent with other research showing that the DNA cuts that CRISPR makes, called double-stranded breaks, “can induce the types of genomic DNA rearrangements and deletions they report.” He asked not to be identified so as not to jeopardize business relationships with genome-editing companies.\u003c/p>\n\u003cp>But just as critics of last month’s studies asked why, if CRISPR’d cells can initiate cancer, no CRISPR’d mice had turned up with tumors, so scientists raised similar questions about the new genomic havoc finding: Why don’t scientists see it when they analyze the DNA of CRISPR’d cells?\u003c/p>\n\u003cp>“You find what you look for,” said Bradley. “No one is looking at the impact [of these DNA changes] on downstream genes.”\u003c/p>\n\u003cp>And few studies conduct full-out genome sequencing of CRISPR’d cells. Moreover, scientists typically search for one form of the collateral damage the Sanger study found — deletions of thousands of DNA bases (the double helix’s famous A’s, T’s, C’s, and G’s) — using a standard technique called PCR, which makes millions of DNA copies. But to work, PCR must attach to a “binding site” on DNA; CRISPR sometimes deletes that binding site, said Bradley, whose team used a different technique to analyze the double helix for collateral damage from CRISPR.\u003c/p>\n\u003cp>The Sanger scientists didn’t set out to find collateral DNA damage from CRISPR. As they investigated how CRISPR might change gene expression, a “weird thing” showed up, Bradley said: The target DNA was accurately changed, but that set off a chain reaction that engulfed genes far from the target. The scientists therefore changed course.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>When they aimed CRISPR at different targets in mouse embryonic stem cells, mouse blood-making cells, and human retinal cells, “extensive on-target genomic damage [was] a common outcome,” they wrote in their paper. In one case, genomes in about two-thirds of the CRISPR’d cells showed the expected small-scale inadvertent havoc, but 21 percent had DNA deletions of more than 250 bases and up to 6,000 bases long.\u003c/p>\n\u003cp>Since therapeutic uses of CRISPR would edit the genomes of billions of cells in, say, a patient’s liver, even rare DNA damage “makes it likely that one or more edited cells … would be endowed with an important [disease-causing] lesion,” the scientists wrote.\u003c/p>\n\u003cp>Nature Biotechnology took a year to publish the paper, after asking Bradley numerous variations of “are you sure?” and “did you consider this?” and asking him to run additional experiments, Bradley said. The results all held up.\u003c/p>\n\u003cp>The one U.S. \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT03399448\" target=\"_blank\" rel=\"noopener\">clinical trial\u003c/a> using CRISPR’d cells began recruiting patients this year. It will use CRISPR to make immune cells, removed from patients with any of four types of cancer, attack telltale molecules on the tumor cells’ surface. Asked what genome analysis he plans to do, lead investigator Dr. Edward Stadtmauer of the University of Pennsylvania said, “We are doing extensive testing of the final cellular product as well as the cells within the patient.”\u003c/p>\n\u003cp>The possibility of adverse consequences from CRISPR’d cells has caused some company officials to argue that if, say, their therapy cures a child of a devastating disease, but increases her risk of cancer, that might be an acceptable trade-off.\u003c/p>\n\u003cp>That argument may well prevail. In 2003, however, when a boy in a gene therapy trial in France \u003ca href=\"https://www.nejm.org/doi/full/10.1056/NEJM200301163480314\" target=\"_blank\" rel=\"noopener\">developed leukemia\u003c/a> because the repair gene landed in the wrong place in his genome and activated a cancer-causing gene, it shut down gene therapy development on both sides of the Atlantic for years.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"disqusTitle": "Pulses of Light Restored Hearing in Gerbils. Could that Lead to Better Implants?",
"title": "Pulses of Light Restored Hearing in Gerbils. Could that Lead to Better Implants?",
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"content": "\u003cp>Could light one day be used to restore hearing loss?\u003c/p>\n\u003cp>To try to answer that question, a team of German bioengineers surgically installed coiled strips of optical fibers in the ears of deaf gerbils.\u003c/p>\n\u003cp>While they still had their hearing, the gerbils had learned to hurdle a small barrier upon hearing an alarm. Now researchers sent a pulse of blue laser light deep into the animals’ ears. They jumped.\u003c/p>\n\u003cp>The experiment was part of a \u003ca href=\"http://stm.sciencemag.org/content/10/449/eaaq1564\" target=\"_blank\" rel=\"noopener\">study\u003c/a> published Wednesday seeking to improve upon cochlear implants — electronic devices that stimulate auditory neurons to partially restore hearing. Instead of using electrical currents, scientists are trying to determine whether optogenetics, a new field that uses light to control living cells, could one day help improve someone’s sense of hearing.\u003c/p>\n\u003cp>Although it could take decades to use optogenetics-based technologies in humans, researchers are beginning to demonstrate that light, not electricity, may be the best way to convey the rich information contained in sound.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“Through my experience with patients, I’ve recognized the huge potential of cochlear implants,” said Tobias Moser, director of the Institute for Auditory Neuroscience at the University Medical Center Göttingen and lead author of the new study. “At the same time I’ve also witnessed the shortcomings.”\u003c/p>\n\u003cp>Patients with cochlear implants often describe the sound quality through the devices as harsh and tinny. Listening to music or picking out one voice from several others is often impossible. The goal of the new research, said Moser, is to improve the technology and create “a more natural hearing so that patients can recognize the melody in music and speech.”\u003c/p>\n\u003cp>At the most basic level, the act of hearing is transforming sound into electrochemical signals, the language of neurons, that the brain can then interpret.\u003c/p>\n\u003cp>Much of this process occurs in the cochlea, a snail-shaped organ within the inner ear lined with specialized sensory cells called hair cells. When hair cells detect vibration through thin protrusions on their surface, they generate electrical current in neighboring nerve cells that travel to the brain.\u003c/p>\n\u003cp>In people who have dysfunctional or dead hair cells, cochlear implants work by electrically stimulating auditory nerve cells directly.\u003c/p>\n\u003cp>According to Dan Polley, an associate professor at Harvard Medical School and director of the Lauer Tinnitus Research Center who was not involved in the study, the successes and limitations of the cochlear implant are determined by the anatomy of the inner ear.\u003c/p>\n\u003cp>Within the cochlea, hair cells rest on an organic platform known as the basilar membrane that is floppy and wide on one end and narrow and taut on the other. This biomechanical organization causes hair cells to wiggle in response to specific sound frequencies or pitches that are mapped out smoothly from low to high, like keys on a piano.\u003c/p>\n\u003cp>When implanting cochlear implants, Polley explained, surgeons thread electrodes into specific locations along the basilar membrane to target nerves that are sensitive to particular frequencies.\u003c/p>\n\u003cp>With cochlear implants, however, electrical current spreads itself over a large area and activates not only the targeted nerves but also neighboring cells as well. This impercision distorts and muffles sound.\u003c/p>\n\u003cp>Moser and other scientists believe that using light, which can be more finely targeted, will improve the performance of implants.\u003c/p>\n\u003cp>“Using electricity to control neurons is like playing the piano with your elbow,” said Polley. “Whereas light is better. It is more like playing the piano while wearing mittens.”\u003c/p>\n\u003cp>Auditory neurons normally don’t respond to light. However, the rapidly growing field of optogenetics has made this possible. The key is to genetically engineer neurons so that they contain light-sensitive proteins that are found elsewhere in nature including bacteria, algae, and the human eye.\u003c/p>\n\u003cp>Moser and his team of scientists performed this technique in adult Mongolian gerbils instead of mice or rats, which were used in previous studies. Gerbils, in contrast to other rodents, are a better proxy for humans because they hear low frequencies used by the human ear and have relatively large cochleas that are only two-and-a-half times smaller than those of humans.\u003c/p>\n\u003cp>The researchers also used a new version of light-sensitive proteins, called CatCh, to increase how quickly nerve cells could respond to light stimulation. Previous versions of the protein worked sluggishly to move ions in and out of neurons — a critical step in generating electrical signals to the brain conveying the rapidly changing characteristics of sound like loudness and pitch.\u003c/p>\n\u003cp>This really hampers our ability to “capture the dynamics of speech,” said Polley. “If you have to deliver pulses [of light] more slowly, you can’t keep up.”\u003c/p>\n\u003cp>To test how quickly neurons equipped with CatCh could process information, researchers exposed neurons to rapid bursts of laser light, up to 300 flashes per second. They observed that individual neurons and groups of neurons were able to keep pace with the flashes by releasing their own corresponding surges of electrical energy.\u003c/p>\n\u003cp>“This is a big improvement over our previous work, “ said Moser. The response “is quick and approaches physiological performance of normal neurons.”\u003c/p>\n\u003cp>Aside from faster processing, the neurons also showed a graded response to different intensities of light. This suggests that the gerbils could experience an accurate representation of loudness that is proportional to how strongly neurons are activated by light.\u003c/p>\n\u003cp>But how could researchers be sure that all this promising electrical activity was actually creating a sense of hearing in gerbils?\u003c/p>\n\u003cp>Scientists first surgically implanted a loop of optical fibers — a primitive prototype of high-tech cochlear implants that could one day be used in humans — into the gerbils’ inner ear. They then trained the animals to jump over a fence-like obstacle dividing two halves of a box. Once the gerbils learned this behavior, scientists deafened the animals, causing them to become unresponsive to the loudspeaker. However, when researchers pulsed blue laser light through the optic fiber, the gerbils leapt into the air again.\u003c/p>\n\u003cp>“It’s not hearing until you measure behavior,” said Polley. “Because hearing is a psychological property. [This experiment] shows that the animals generalize light stimulation to sound, they treat it as if it were sound.”\u003c/p>\n\u003cp>Despite these dramatic results, Moser is quick to point out that light-based cochlear implants are not ready for human use.\u003c/p>\n\u003cp>The most obvious hurdle is that installing light-sensitive proteins into cells requires genetic engineering. In the case of gerbils, scientists accomplished the feat by injecting viruses carrying specially designed DNA into the animals’ ears. While gene therapy is being used to treat certain diseases in clinical trials — and has been approved for a \u003ca href=\"https://www.statnews.com/2018/03/21/gene-therapy-luxturna-launch/\">rare form of blindness\u003c/a> — it remains a long way from reality for most conditions.\u003c/p>\n\u003cp>“Right now,” said Polley, “ I doubt anyone would suggest that you get this gene therapy instead of cochlear implants.”\u003c/p>\n\u003cp>Even if gene therapy was a proven technology, light-based implants have other restrictions. In humans, bioengineers imagine using tiny light-emitting diodes (LEDs) to stimulate genetically engineered auditory neurons. However these machines consume a lot of power and dissipate heat, making it unclear how patients would wear or operate such a device.\u003c/p>\n\u003cp>“Optogenetics is the most sophisticated way we have to stimulate nerves in the cochlea,” said Adrien Eshraghi, a professor at the Miller School of Medicine and director of the Hearing Research Laboratory at the University of Miami who was not involved with the study. “It is still [in] the early basics of science research, but I think optogenetics has a good future.”\u003c/p>\n\u003cp>Another source of optimism is the power of the brain to adapt to new signaling inputs.\u003c/p>\n\u003cp>In the case of cochlear implants, patients initially experience the human voice as high-pitched and scratchy (think Mickey Mouse) but adapt over time. Although researchers don’t know what light will sound like, they expect a similar adjustment process.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>“At the end of the day for engineers,” said Polley, “the brain is the hero … it is one of the best players on their team because they don’t have to perfect the signal, they just have to make it reasonably good, and then the brain can take it the rest of the way.”\u003c/p>\n\u003cdiv> \u003cem>This\u003ca href=\"https://www.statnews.com/2018/07/11/optogenetics-hearing-gerbils-cochlear-implants/\" target=\"_blank\" rel=\"noopener\"> story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Could light one day be used to restore hearing loss?\u003c/p>\n\u003cp>To try to answer that question, a team of German bioengineers surgically installed coiled strips of optical fibers in the ears of deaf gerbils.\u003c/p>\n\u003cp>While they still had their hearing, the gerbils had learned to hurdle a small barrier upon hearing an alarm. Now researchers sent a pulse of blue laser light deep into the animals’ ears. They jumped.\u003c/p>\n\u003cp>The experiment was part of a \u003ca href=\"http://stm.sciencemag.org/content/10/449/eaaq1564\" target=\"_blank\" rel=\"noopener\">study\u003c/a> published Wednesday seeking to improve upon cochlear implants — electronic devices that stimulate auditory neurons to partially restore hearing. Instead of using electrical currents, scientists are trying to determine whether optogenetics, a new field that uses light to control living cells, could one day help improve someone’s sense of hearing.\u003c/p>\n\u003cp>Although it could take decades to use optogenetics-based technologies in humans, researchers are beginning to demonstrate that light, not electricity, may be the best way to convey the rich information contained in sound.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“Through my experience with patients, I’ve recognized the huge potential of cochlear implants,” said Tobias Moser, director of the Institute for Auditory Neuroscience at the University Medical Center Göttingen and lead author of the new study. “At the same time I’ve also witnessed the shortcomings.”\u003c/p>\n\u003cp>Patients with cochlear implants often describe the sound quality through the devices as harsh and tinny. Listening to music or picking out one voice from several others is often impossible. The goal of the new research, said Moser, is to improve the technology and create “a more natural hearing so that patients can recognize the melody in music and speech.”\u003c/p>\n\u003cp>At the most basic level, the act of hearing is transforming sound into electrochemical signals, the language of neurons, that the brain can then interpret.\u003c/p>\n\u003cp>Much of this process occurs in the cochlea, a snail-shaped organ within the inner ear lined with specialized sensory cells called hair cells. When hair cells detect vibration through thin protrusions on their surface, they generate electrical current in neighboring nerve cells that travel to the brain.\u003c/p>\n\u003cp>In people who have dysfunctional or dead hair cells, cochlear implants work by electrically stimulating auditory nerve cells directly.\u003c/p>\n\u003cp>According to Dan Polley, an associate professor at Harvard Medical School and director of the Lauer Tinnitus Research Center who was not involved in the study, the successes and limitations of the cochlear implant are determined by the anatomy of the inner ear.\u003c/p>\n\u003cp>Within the cochlea, hair cells rest on an organic platform known as the basilar membrane that is floppy and wide on one end and narrow and taut on the other. This biomechanical organization causes hair cells to wiggle in response to specific sound frequencies or pitches that are mapped out smoothly from low to high, like keys on a piano.\u003c/p>\n\u003cp>When implanting cochlear implants, Polley explained, surgeons thread electrodes into specific locations along the basilar membrane to target nerves that are sensitive to particular frequencies.\u003c/p>\n\u003cp>With cochlear implants, however, electrical current spreads itself over a large area and activates not only the targeted nerves but also neighboring cells as well. This impercision distorts and muffles sound.\u003c/p>\n\u003cp>Moser and other scientists believe that using light, which can be more finely targeted, will improve the performance of implants.\u003c/p>\n\u003cp>“Using electricity to control neurons is like playing the piano with your elbow,” said Polley. “Whereas light is better. It is more like playing the piano while wearing mittens.”\u003c/p>\n\u003cp>Auditory neurons normally don’t respond to light. However, the rapidly growing field of optogenetics has made this possible. The key is to genetically engineer neurons so that they contain light-sensitive proteins that are found elsewhere in nature including bacteria, algae, and the human eye.\u003c/p>\n\u003cp>Moser and his team of scientists performed this technique in adult Mongolian gerbils instead of mice or rats, which were used in previous studies. Gerbils, in contrast to other rodents, are a better proxy for humans because they hear low frequencies used by the human ear and have relatively large cochleas that are only two-and-a-half times smaller than those of humans.\u003c/p>\n\u003cp>The researchers also used a new version of light-sensitive proteins, called CatCh, to increase how quickly nerve cells could respond to light stimulation. Previous versions of the protein worked sluggishly to move ions in and out of neurons — a critical step in generating electrical signals to the brain conveying the rapidly changing characteristics of sound like loudness and pitch.\u003c/p>\n\u003cp>This really hampers our ability to “capture the dynamics of speech,” said Polley. “If you have to deliver pulses [of light] more slowly, you can’t keep up.”\u003c/p>\n\u003cp>To test how quickly neurons equipped with CatCh could process information, researchers exposed neurons to rapid bursts of laser light, up to 300 flashes per second. They observed that individual neurons and groups of neurons were able to keep pace with the flashes by releasing their own corresponding surges of electrical energy.\u003c/p>\n\u003cp>“This is a big improvement over our previous work, “ said Moser. The response “is quick and approaches physiological performance of normal neurons.”\u003c/p>\n\u003cp>Aside from faster processing, the neurons also showed a graded response to different intensities of light. This suggests that the gerbils could experience an accurate representation of loudness that is proportional to how strongly neurons are activated by light.\u003c/p>\n\u003cp>But how could researchers be sure that all this promising electrical activity was actually creating a sense of hearing in gerbils?\u003c/p>\n\u003cp>Scientists first surgically implanted a loop of optical fibers — a primitive prototype of high-tech cochlear implants that could one day be used in humans — into the gerbils’ inner ear. They then trained the animals to jump over a fence-like obstacle dividing two halves of a box. Once the gerbils learned this behavior, scientists deafened the animals, causing them to become unresponsive to the loudspeaker. However, when researchers pulsed blue laser light through the optic fiber, the gerbils leapt into the air again.\u003c/p>\n\u003cp>“It’s not hearing until you measure behavior,” said Polley. “Because hearing is a psychological property. [This experiment] shows that the animals generalize light stimulation to sound, they treat it as if it were sound.”\u003c/p>\n\u003cp>Despite these dramatic results, Moser is quick to point out that light-based cochlear implants are not ready for human use.\u003c/p>\n\u003cp>The most obvious hurdle is that installing light-sensitive proteins into cells requires genetic engineering. In the case of gerbils, scientists accomplished the feat by injecting viruses carrying specially designed DNA into the animals’ ears. While gene therapy is being used to treat certain diseases in clinical trials — and has been approved for a \u003ca href=\"https://www.statnews.com/2018/03/21/gene-therapy-luxturna-launch/\">rare form of blindness\u003c/a> — it remains a long way from reality for most conditions.\u003c/p>\n\u003cp>“Right now,” said Polley, “ I doubt anyone would suggest that you get this gene therapy instead of cochlear implants.”\u003c/p>\n\u003cp>Even if gene therapy was a proven technology, light-based implants have other restrictions. In humans, bioengineers imagine using tiny light-emitting diodes (LEDs) to stimulate genetically engineered auditory neurons. However these machines consume a lot of power and dissipate heat, making it unclear how patients would wear or operate such a device.\u003c/p>\n\u003cp>“Optogenetics is the most sophisticated way we have to stimulate nerves in the cochlea,” said Adrien Eshraghi, a professor at the Miller School of Medicine and director of the Hearing Research Laboratory at the University of Miami who was not involved with the study. “It is still [in] the early basics of science research, but I think optogenetics has a good future.”\u003c/p>\n\u003cp>Another source of optimism is the power of the brain to adapt to new signaling inputs.\u003c/p>\n\u003cp>In the case of cochlear implants, patients initially experience the human voice as high-pitched and scratchy (think Mickey Mouse) but adapt over time. Although researchers don’t know what light will sound like, they expect a similar adjustment process.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“At the end of the day for engineers,” said Polley, “the brain is the hero … it is one of the best players on their team because they don’t have to perfect the signal, they just have to make it reasonably good, and then the brain can take it the rest of the way.”\u003c/p>\n\u003cdiv> \u003cem>This\u003ca href=\"https://www.statnews.com/2018/07/11/optogenetics-hearing-gerbils-cochlear-implants/\" target=\"_blank\" rel=\"noopener\"> story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/div>\n\n\u003c/div>\u003c/p>",
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"title": "Tweeting Oncologist Draws Ire And Admiration For Calling Out Hype",
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"content": "\u003cp>New advances in medicine also tend to come with a hefty dose of hype. Yes, some new cancer drugs in the hot field of \u003ca href=\"https://ghr.nlm.nih.gov/primer/precisionmedicine/definition\" target=\"_blank\" rel=\"noopener\">precision medicine\u003c/a>, which takes into account variables for individual patients, have worked remarkably well for some patients. But while many patients clamor for them, they aren't currently effective for the vast majority of cancers.[contextly_sidebar id=\"qJjTcMLEVnnz6nmsz9HyyAbHaAtlwa0j\"]\u003c/p>\n\u003cp>This stubborn fact has become a sticking point for an equally stubborn cancer doctor. At just 35 years old, \u003ca href=\"http://www.vinayakkprasad.com/\" target=\"_blank\" rel=\"noopener\">Dr. Vinay Prasad\u003c/a> has made a name for himself by calling out the hype surrounding precision medicine and confronting other examples of hype in his field.\u003c/p>\n\u003cp>Prasad is a hematologist-oncologist and an assistant professor of medicine at Oregon Health and Science University in Portland. Some have called him a professional troublemaker, a gadfly or a provocateur as he tweets to his 20,000-plus followers. He has sent nearly 30,000 tweets out to the Twitterverse, putting him within hailing distance of President Trump, at least in terms of output.\u003c/p>\n\u003cp>He is also a prolific author of scientific papers, \u003ca href=\"https://www.amazon.com/Ending-Medical-Reversal-Improving-Outcomes/dp/1421417723\" target=\"_blank\" rel=\"noopener\">as well as a book\u003c/a>, that call out uncomfortable facts about the science of cancer and the business and regulation of medical treatments.\u003c/p>\n\u003cp>Giant cancer conventions are ripe targets for Prasad's sometimes prickly observations. We caught up with him in early June at the \u003ca href=\"https://www.npr.org/sections/health-shots/2018/06/05/617104810/doctors-scrutinize-overtreatment-as-cancer-death-rates-decline\" target=\"_blank\" rel=\"noopener\">American Society of Clinical Oncology meeting\u003c/a>, which drew about 40,000 attendees to Chicago's sprawling McCormick Place convention center.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Prasad's main event at the conference was to be a debate/discussion about whether precision cancer treatment is \"ready for prime time.\" But that debate really started as soon as Prasad stepped into the convention center.[contextly_sidebar id=\"eXHk9LJ63jzmXFh4iRHsnqgQFsERUauR\"]\u003c/p>\n\u003cp>Another young cancer researcher — who feared having a public spat with Prasad and asked not to be identified — ran into Prasad while he was walking over to view the scientific posters. After thanking Prasad for raising some important issues, she chided him for his tone.\u003c/p>\n\u003cp>\"I think both sides are too emotional,\" she told him, \"and I think the truth is something in the middle.\"\u003c/p>\n\u003cp>He aggressively defended his position, often not letting her finish her sentences. Genetic tests now commonly given to cancer patients only identify clear treatments about 8 percent of the time, he argued, citing \u003ca href=\"https://jamanetwork.com/journals/jamaoncology/fullarticle/2678901\" target=\"_blank\" rel=\"noopener\">one of his research papers\u003c/a> — and only 5 percent show even a temporary response to the treatment.\u003c/p>\n\u003cp>Cancer drugs that modify the immune system, such as checkpoint inhibitors, aren't, strictly speaking, precision medicine, since they don't depend on the results of the genome tests. But they also only work well in a minority of patients.\u003c/p>\n\u003cp>So, Prasad points out, most successful cancer treatment still involves much less expensive conventional chemotherapy, radiation and surgery.\u003c/p>\n\u003cp>He is not arguing that precision medications are all useless, as his critics sometimes seem to imply.\u003c/p>\n\u003cp>\"I use those drugs,\" he says. \"There are some good drugs. No one said there are no good drugs.\"\u003c/p>\n\u003cp>The problem, in his eyes, is that the field has gotten so enthusiastic about these drugs that doctors aren't waiting for actual science to distinguish between the conditions for which they are useful and for which they are, instead, a very expensive, wasted effort.[contextly_sidebar id=\"kaAhMLBgUooXKJyU79C6nwxwlorkR0R3\"]\u003c/p>\n\u003cp>\"A lot of people want to push it to the treatment side,\" he says. \"They want to get Medicare to pay for it,\" even before the drug is approved for that specific purpose.\u003c/p>\n\u003cp>Prasad says drug companies are happy not to shoulder the costs of research when doctors will prescribe their medicine anyway. \"And that's the root of what bothers me about this.\"\u003c/p>\n\u003cp>Indeed, the high costs of these unproven — and often failed — treatments fall to people who buy health insurance and who pay taxes. It is, in essence, a massive uncontrolled experiment, and nobody is collecting the data most of the time to find out what might be useful.\u003c/p>\n\u003cp>Often, doctors run genetic tests on tumors to see if they carry a mutation that will respond to a targeted drug. More than 90 percent of the time, there is no match.\u003c/p>\n\u003cp>But doctors are increasingly giving these targeted drugs anyway to patients who have the mutation in a type of tumor that has not been shown to respond to the drug. While that sounds rational, it often doesn't work in patients.\u003c/p>\n\u003cp>One study to explore these nonapproved uses is the National Cancer Institute's Molecular Analysis for Therapy Choice trial. At the ASCO meeting, scientists reported on early results from about 150 patients who were matched to drugs based on their tumor's genetic fingerprint, rather than the type of tumor. \u003ca href=\"https://twitter.com/ShaalanBeg/status/1002891737063481344/photo/1\" target=\"_blank\" rel=\"noopener\">The results were disappointing\u003c/a>. The tumors responded poorly or not at all to the targeted drugs.\u003c/p>\n\u003cp>Prasad says that when he was in medical school, he assumed he would just learn how to treat cancer and spend his career doing that. But then he discovered how much of medical practice was based on traditions rather than on actual science.\u003c/p>\n\u003cp>Those traditions, sometimes called \"eminence-based medicine,\" have slowly been giving way to \"evidence-based medicine.\"\u003c/p>\n\u003cp>\"Even the most respected, charismatic and thoughtful experts often are incorrect,\" he says. That realization drew Prasad to consider a career beyond just treating patients.\u003c/p>\n\u003cp>\"I found it harder just to observe things that troubled me and not study them,\" he says. \"And at some point, I made the conscious decision that if it troubles me enough, I want to look at it and study it. Maybe somebody else will carry the torch and actually fix that problem someday.\"\u003c/p>\n\u003cp>Prasad got on this path after he graduated from the University of Chicago Pritzker School of Medicine. (He also has a master's degree in public health from the Johns Hopkins University.) He really launched his research career while a fellow at the National Institutes of Health.\u003c/p>\n\u003cp>His prolific research output is supported in part by funding from Texas billionaires \u003ca href=\"https://www.wired.com/2017/01/john-arnold-waging-war-on-bad-science/\" target=\"_blank\" rel=\"noopener\">Laura and John Arnold\u003c/a>. Their foundation has a soft spot for supporting scientists who are calling out shortcomings in scientific research and suggesting ways to improve it.[contextly_sidebar id=\"rjuDJW5XLRAljfFEw7wLAbdChQrd8eYS\"]\u003c/p>\n\u003cp>Prasad's skeptical approach was on display at the ASCO meeting. As the crowd was gathering, he fired off a tweet encouraging the attendees to play \"ASCO Bingo.\" He had filled a five-by-five grid with words such as \"unprecedented,\" \"breakthrough,\" \"game changer\" and \"transformative\" and invited his colleagues to listen for these words during the scientific presentations.\u003c/p>\n\u003cp>As thousands of doctors filed into a massive meeting room to hear the plenary talk, random tweets about the meeting flashed up on the screens, including Prasad's ASCO Bingo card. \"I guess it has almost 100 retweets now,\" he said as the tweet flashed by.\u003c/p>\n\u003cp>He actually \u003ca href=\"https://jamanetwork.com/journals/jamaoncology/fullarticle/2464965\">published a scientific paper\u003c/a> in 2016 about the overuse of superlatives in presentations and news coverage.\u003c/p>\n\u003cp>\"What really got me,\" he says, \"was [that for] 14 percent of the drugs, the superlative was used based only on mouse or laboratory results, and they'd never given it to a human being!\"\u003c/p>\n\u003cp>Finally, it was time for Prasad's presentation at the meeting — an informal debate of the value of precision medicine in cancer treatment. His opponent, Jeremy Warner, had suggested the discussion, which was limited to an audience of 55 to allow a more intimate conversation than is typical at the vast conference.\u003c/p>\n\u003cp>\"So the first thing I have to say is, I'm the underdog,\" said Warner, a cancer doctor and researcher at Vanderbilt University. For starters, he admitted that Prasad has 40 times more Twitter followers, many of them avid supporters.[contextly_sidebar id=\"GqxqGRIpmfzYIwm7c6DOwB7bmKuXaKY0\"]\u003c/p>\n\u003cp>The back-and-forth turned out to be surprisingly friendly, with many points of agreement. Warner agreed that in an ideal world there would be a lot more scientific studies to figure out which drugs work in which circumstances. \"But just saying that somebody should be on a clinical trial — I mean it sounds easy, but it's actually not easy at all.\"\u003c/p>\n\u003cp>Dr. Richard Schilsky, \u003ca href=\"https://www.asco.org/people/richard-l-schilsky-md-fasco-facp\" target=\"_blank\" rel=\"noopener\">ASCO's chief medical officer\u003c/a>, moderated the conversation and came away in considerable agreement with Prasad.\u003c/p>\n\u003cp>\"I enjoy his remarks very much,\" he says afterward. \"I mean, he's a bit of a gadfly. He's a bit of a provocateur. But frankly, he's taking a very hard and objective look at a very complex area and ... he's saying what's behind the curtain. 'Let's celebrate what really works, let's look hard at what doesn't, and let's try to develop the evidence that we need to make important decisions for patients.' \"\u003c/p>\n\u003cp>\"I think it's unfortunate that I'm thought of as a professional troublemaker,\" Prasad says. \"We really try to find those instances where the evidence and the narrative are divergent and try to ask what we can do to bring those two closer together.\"\u003c/p>\n\u003cp>Prasad says he can't tell at this point whether he is building a strong reputation for himself or potentially damaging his career.\u003c/p>\n\u003cp>\"I don't want to be the person to be doing all this work,\" he says. \"I wish there were senior people doing this work.\"\u003c/p>\n\u003cp>But by and large, they aren't.\u003c/p>\n\u003cp>It bothers him, he says, when his colleagues think he is simply being cynical or contrary. The ultimate point is to call out the problems in this critical field so everyone does science better, he says. And, in the end, the rewards of that will flow to the patients.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>You can contact Richard Harris at \u003c/em>\u003ca href=\"mailto:rharris@npr.org\">\u003cem>rharris@npr.org\u003c/em>\u003c/a>\u003cem>.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Tweeting+Oncologist+Draws+Ire+And+Admiration+For+Calling+Out+Hype&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>New advances in medicine also tend to come with a hefty dose of hype. Yes, some new cancer drugs in the hot field of \u003ca href=\"https://ghr.nlm.nih.gov/primer/precisionmedicine/definition\" target=\"_blank\" rel=\"noopener\">precision medicine\u003c/a>, which takes into account variables for individual patients, have worked remarkably well for some patients. But while many patients clamor for them, they aren't currently effective for the vast majority of cancers.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>This stubborn fact has become a sticking point for an equally stubborn cancer doctor. At just 35 years old, \u003ca href=\"http://www.vinayakkprasad.com/\" target=\"_blank\" rel=\"noopener\">Dr. Vinay Prasad\u003c/a> has made a name for himself by calling out the hype surrounding precision medicine and confronting other examples of hype in his field.\u003c/p>\n\u003cp>Prasad is a hematologist-oncologist and an assistant professor of medicine at Oregon Health and Science University in Portland. Some have called him a professional troublemaker, a gadfly or a provocateur as he tweets to his 20,000-plus followers. He has sent nearly 30,000 tweets out to the Twitterverse, putting him within hailing distance of President Trump, at least in terms of output.\u003c/p>\n\u003cp>He is also a prolific author of scientific papers, \u003ca href=\"https://www.amazon.com/Ending-Medical-Reversal-Improving-Outcomes/dp/1421417723\" target=\"_blank\" rel=\"noopener\">as well as a book\u003c/a>, that call out uncomfortable facts about the science of cancer and the business and regulation of medical treatments.\u003c/p>\n\u003cp>Giant cancer conventions are ripe targets for Prasad's sometimes prickly observations. We caught up with him in early June at the \u003ca href=\"https://www.npr.org/sections/health-shots/2018/06/05/617104810/doctors-scrutinize-overtreatment-as-cancer-death-rates-decline\" target=\"_blank\" rel=\"noopener\">American Society of Clinical Oncology meeting\u003c/a>, which drew about 40,000 attendees to Chicago's sprawling McCormick Place convention center.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Prasad's main event at the conference was to be a debate/discussion about whether precision cancer treatment is \"ready for prime time.\" But that debate really started as soon as Prasad stepped into the convention center.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Another young cancer researcher — who feared having a public spat with Prasad and asked not to be identified — ran into Prasad while he was walking over to view the scientific posters. After thanking Prasad for raising some important issues, she chided him for his tone.\u003c/p>\n\u003cp>\"I think both sides are too emotional,\" she told him, \"and I think the truth is something in the middle.\"\u003c/p>\n\u003cp>He aggressively defended his position, often not letting her finish her sentences. Genetic tests now commonly given to cancer patients only identify clear treatments about 8 percent of the time, he argued, citing \u003ca href=\"https://jamanetwork.com/journals/jamaoncology/fullarticle/2678901\" target=\"_blank\" rel=\"noopener\">one of his research papers\u003c/a> — and only 5 percent show even a temporary response to the treatment.\u003c/p>\n\u003cp>Cancer drugs that modify the immune system, such as checkpoint inhibitors, aren't, strictly speaking, precision medicine, since they don't depend on the results of the genome tests. But they also only work well in a minority of patients.\u003c/p>\n\u003cp>So, Prasad points out, most successful cancer treatment still involves much less expensive conventional chemotherapy, radiation and surgery.\u003c/p>\n\u003cp>He is not arguing that precision medications are all useless, as his critics sometimes seem to imply.\u003c/p>\n\u003cp>\"I use those drugs,\" he says. \"There are some good drugs. No one said there are no good drugs.\"\u003c/p>\n\u003cp>The problem, in his eyes, is that the field has gotten so enthusiastic about these drugs that doctors aren't waiting for actual science to distinguish between the conditions for which they are useful and for which they are, instead, a very expensive, wasted effort.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\"A lot of people want to push it to the treatment side,\" he says. \"They want to get Medicare to pay for it,\" even before the drug is approved for that specific purpose.\u003c/p>\n\u003cp>Prasad says drug companies are happy not to shoulder the costs of research when doctors will prescribe their medicine anyway. \"And that's the root of what bothers me about this.\"\u003c/p>\n\u003cp>Indeed, the high costs of these unproven — and often failed — treatments fall to people who buy health insurance and who pay taxes. It is, in essence, a massive uncontrolled experiment, and nobody is collecting the data most of the time to find out what might be useful.\u003c/p>\n\u003cp>Often, doctors run genetic tests on tumors to see if they carry a mutation that will respond to a targeted drug. More than 90 percent of the time, there is no match.\u003c/p>\n\u003cp>But doctors are increasingly giving these targeted drugs anyway to patients who have the mutation in a type of tumor that has not been shown to respond to the drug. While that sounds rational, it often doesn't work in patients.\u003c/p>\n\u003cp>One study to explore these nonapproved uses is the National Cancer Institute's Molecular Analysis for Therapy Choice trial. At the ASCO meeting, scientists reported on early results from about 150 patients who were matched to drugs based on their tumor's genetic fingerprint, rather than the type of tumor. \u003ca href=\"https://twitter.com/ShaalanBeg/status/1002891737063481344/photo/1\" target=\"_blank\" rel=\"noopener\">The results were disappointing\u003c/a>. The tumors responded poorly or not at all to the targeted drugs.\u003c/p>\n\u003cp>Prasad says that when he was in medical school, he assumed he would just learn how to treat cancer and spend his career doing that. But then he discovered how much of medical practice was based on traditions rather than on actual science.\u003c/p>\n\u003cp>Those traditions, sometimes called \"eminence-based medicine,\" have slowly been giving way to \"evidence-based medicine.\"\u003c/p>\n\u003cp>\"Even the most respected, charismatic and thoughtful experts often are incorrect,\" he says. That realization drew Prasad to consider a career beyond just treating patients.\u003c/p>\n\u003cp>\"I found it harder just to observe things that troubled me and not study them,\" he says. \"And at some point, I made the conscious decision that if it troubles me enough, I want to look at it and study it. Maybe somebody else will carry the torch and actually fix that problem someday.\"\u003c/p>\n\u003cp>Prasad got on this path after he graduated from the University of Chicago Pritzker School of Medicine. (He also has a master's degree in public health from the Johns Hopkins University.) He really launched his research career while a fellow at the National Institutes of Health.\u003c/p>\n\u003cp>His prolific research output is supported in part by funding from Texas billionaires \u003ca href=\"https://www.wired.com/2017/01/john-arnold-waging-war-on-bad-science/\" target=\"_blank\" rel=\"noopener\">Laura and John Arnold\u003c/a>. Their foundation has a soft spot for supporting scientists who are calling out shortcomings in scientific research and suggesting ways to improve it.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Prasad's skeptical approach was on display at the ASCO meeting. As the crowd was gathering, he fired off a tweet encouraging the attendees to play \"ASCO Bingo.\" He had filled a five-by-five grid with words such as \"unprecedented,\" \"breakthrough,\" \"game changer\" and \"transformative\" and invited his colleagues to listen for these words during the scientific presentations.\u003c/p>\n\u003cp>As thousands of doctors filed into a massive meeting room to hear the plenary talk, random tweets about the meeting flashed up on the screens, including Prasad's ASCO Bingo card. \"I guess it has almost 100 retweets now,\" he said as the tweet flashed by.\u003c/p>\n\u003cp>He actually \u003ca href=\"https://jamanetwork.com/journals/jamaoncology/fullarticle/2464965\">published a scientific paper\u003c/a> in 2016 about the overuse of superlatives in presentations and news coverage.\u003c/p>\n\u003cp>\"What really got me,\" he says, \"was [that for] 14 percent of the drugs, the superlative was used based only on mouse or laboratory results, and they'd never given it to a human being!\"\u003c/p>\n\u003cp>Finally, it was time for Prasad's presentation at the meeting — an informal debate of the value of precision medicine in cancer treatment. His opponent, Jeremy Warner, had suggested the discussion, which was limited to an audience of 55 to allow a more intimate conversation than is typical at the vast conference.\u003c/p>\n\u003cp>\"So the first thing I have to say is, I'm the underdog,\" said Warner, a cancer doctor and researcher at Vanderbilt University. For starters, he admitted that Prasad has 40 times more Twitter followers, many of them avid supporters.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The back-and-forth turned out to be surprisingly friendly, with many points of agreement. Warner agreed that in an ideal world there would be a lot more scientific studies to figure out which drugs work in which circumstances. \"But just saying that somebody should be on a clinical trial — I mean it sounds easy, but it's actually not easy at all.\"\u003c/p>\n\u003cp>Dr. Richard Schilsky, \u003ca href=\"https://www.asco.org/people/richard-l-schilsky-md-fasco-facp\" target=\"_blank\" rel=\"noopener\">ASCO's chief medical officer\u003c/a>, moderated the conversation and came away in considerable agreement with Prasad.\u003c/p>\n\u003cp>\"I enjoy his remarks very much,\" he says afterward. \"I mean, he's a bit of a gadfly. He's a bit of a provocateur. But frankly, he's taking a very hard and objective look at a very complex area and ... he's saying what's behind the curtain. 'Let's celebrate what really works, let's look hard at what doesn't, and let's try to develop the evidence that we need to make important decisions for patients.' \"\u003c/p>\n\u003cp>\"I think it's unfortunate that I'm thought of as a professional troublemaker,\" Prasad says. \"We really try to find those instances where the evidence and the narrative are divergent and try to ask what we can do to bring those two closer together.\"\u003c/p>\n\u003cp>Prasad says he can't tell at this point whether he is building a strong reputation for himself or potentially damaging his career.\u003c/p>\n\u003cp>\"I don't want to be the person to be doing all this work,\" he says. \"I wish there were senior people doing this work.\"\u003c/p>\n\u003cp>But by and large, they aren't.\u003c/p>\n\u003cp>It bothers him, he says, when his colleagues think he is simply being cynical or contrary. The ultimate point is to call out the problems in this critical field so everyone does science better, he says. And, in the end, the rewards of that will flow to the patients.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>You can contact Richard Harris at \u003c/em>\u003ca href=\"mailto:rharris@npr.org\">\u003cem>rharris@npr.org\u003c/em>\u003c/a>\u003cem>.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Tweeting+Oncologist+Draws+Ire+And+Admiration+For+Calling+Out+Hype&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>Now that the world’s leading public health group says too much Minecraft can be an addiction, could overindulging in chocolate, exercise, even sex, be next?[contextly_sidebar id=”01ODny8j1QsQF9gorizQRnBzsbgXPKRY”]\u003c/p>\n\u003cp>The short answer is probably not.\u003c/p>\n\u003cp>The new “gaming disorder” classification from the World Health Organization revives a debate in the medical community about whether behaviors can cause the same kind of addictive illness as drugs.\u003c/p>\n\u003cp>The strictest definition of addiction refers to a disease resulting from changes in brain chemistry caused by compulsive use of drugs or alcohol. The definition includes excessive use that damages health, relationships, jobs and other parts of normal life. Brain research supports that definition, and some imaging studies have suggested that excessive gaming might affect the brain in similar ways.\u003c/p>\n\u003cp>Under a looser definition, addiction is considered “a disease of extreme behavior. Any behavior carried to extreme that consumes you and keeps you from doing what you should be doing becomes an addiction as far as life is concerned,” said Dr. Walter Ling, a UCLA psychiatrist.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>In its widely used manual for diagnosing mental illness, the American Psychiatric Association calls excessive video gaming a “condition” but not a formal diagnosis or disease, and says more research is needed to determine if it qualifies as an addiction.[contextly_sidebar id=”Wl5OAMpArUdB6zi7q3hdM5GrzcPwa5h3″]\u003c/p>\n\u003cp>\u003cstrong>Drugs and the Brain\u003c/strong>\u003c/p>\n\u003cp>Certain drugs including opioids and alcohol can over-activate the brain’s reward circuit. That’s the system that under normal circumstances is activated when people engage in “behaviors conducive to survival” including eating and drinking water when thirsty, explained Dr. Andrew Saxon, chairman of the association’s addiction psychiatry council. The brain chemical dopamine regulates these behaviors, but narcotic drugs can flood the brain with dopamine, encouraging repeated use and making drug use more rewarding that healthy behaviors, Saxon said. Eventually increasing amounts are needed to get the same effect, and brain changes lead to an inability to control use.\u003c/p>\n\u003cp>\u003cstrong>What About Other Substances\u003c/strong>\u003c/p>\n\u003cp>Caffeine is a stimulant and also activates the brain’s reward system, but to a much lesser degree than addictive drugs. The “reward” can make people feel more alert, and frequent users can develop mild withdrawal symptoms when they stop, including headaches and tiredness. Caffeine-containing chocolate may produce similar effects. Neither substance causes the kinds of life problems found in drug addiction, although some coffee drinkers develop a tolerance to caffeine and need to drink more to get the same “buzz” or sense of alertness.[contextly_sidebar id=”mhQtfvihYwLCtDzX98xiu7QDvAtMJa4g”]\u003c/p>\n\u003cp>The World Health Organization recognizes caffeine “dependence” as a disorder; the American Psychiatric Association does not and says more research is needed.\u003c/p>\n\u003cp>“The term ‘addiction’ is tossed around pretty commonly, like ‘chocoholic’ or saying you’re addicted to reality TV,” said Dr. Ellen Selkie, a University of Michigan physician who studies teens’ use of digital technology. But addiction means an inability to control use “to the point where you’re failing at life,” she said.\u003c/p>\n\u003cp>\u003cstrong>What About Behavior\u003c/strong>\u003c/p>\n\u003cp>The only behavior classified as an addiction in the American Psychiatric Association’s diagnostic manual is compulsive gambling. To be diagnosed, gamblers must have several symptoms including repeatedly gambling increasing amounts of money, lying to hide gambling activity, feeling irritable or restless when trying to stop, and losing jobs or relationships because of gambling. Research suggests excessive gambling can affect the brain in ways similar to addictive drugs. Since the diagnostic manual was last updated, in 2013, studies have bolstered evidence that excessive video gaming may do the same thing, and some experts speculate that it may be added to the next update.\u003c/p>\n\u003cp>The manual doesn’t include sex addiction because there’s little evidence that compulsive sexual behavior has similar effects on the brain.[contextly_sidebar id=”WREHBIaI0tAVtsrRyKdECjzCVCBZe8oy”]\u003c/p>\n\u003cp>Many excessive gamblers, gamers and sex “addicts” have other psychiatric conditions, including anxiety, attention deficit disorder and depression, and some mental health specialists believe their compulsive behaviors are merely symptoms of those diseases rather than separate addictions.\u003c/p>\n\u003cp>Excessive use of the internet and smartphones is also absent from the psychiatric manual and World Health Organization’s update. Psychiatrists disagree on whether that is a true addiction — partly because overuse is hard to measure when so many people need to use their smartphones and the internet for their jobs.\u003c/p>\n\u003cp>\u003cstrong>Does the Term Matter?\u003c/strong>\u003c/p>\n\u003cp>The World Health Organization’s decision to classify excessive video gaming as an addiction means “gaming disorder” will be added to this year’s update to the organization’s International Classification of Diseases. Doctors worldwide use that document to diagnose physical and mental illnesses. Insurers, including Medicaid and Medicare, use billing codes listed there to make coverage decisions. The American Psychiatric Association’s manual is widely used for defining and diagnosing mental disorders. If conditions aren’t listed in these documents, insurance coverage for treatment is unlikely.\u003c/p>\n\u003cp>___\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>This Associated Press \u003ca href=\"https://apnews.com/tag/ScienceSays\" target=\"_blank\" rel=\"noopener\">series\u003c/a> was produced in \u003ca href=\"http://bit.ly/2ptoKnW\" target=\"_blank\" rel=\"noopener\">partnership\u003c/a> with the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Now that the world’s leading public health group says too much Minecraft can be an addiction, could overindulging in chocolate, exercise, even sex, be next?\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The short answer is probably not.\u003c/p>\n\u003cp>The new “gaming disorder” classification from the World Health Organization revives a debate in the medical community about whether behaviors can cause the same kind of addictive illness as drugs.\u003c/p>\n\u003cp>The strictest definition of addiction refers to a disease resulting from changes in brain chemistry caused by compulsive use of drugs or alcohol. The definition includes excessive use that damages health, relationships, jobs and other parts of normal life. Brain research supports that definition, and some imaging studies have suggested that excessive gaming might affect the brain in similar ways.\u003c/p>\n\u003cp>Under a looser definition, addiction is considered “a disease of extreme behavior. Any behavior carried to extreme that consumes you and keeps you from doing what you should be doing becomes an addiction as far as life is concerned,” said Dr. Walter Ling, a UCLA psychiatrist.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>In its widely used manual for diagnosing mental illness, the American Psychiatric Association calls excessive video gaming a “condition” but not a formal diagnosis or disease, and says more research is needed to determine if it qualifies as an addiction.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\u003cstrong>Drugs and the Brain\u003c/strong>\u003c/p>\n\u003cp>Certain drugs including opioids and alcohol can over-activate the brain’s reward circuit. That’s the system that under normal circumstances is activated when people engage in “behaviors conducive to survival” including eating and drinking water when thirsty, explained Dr. Andrew Saxon, chairman of the association’s addiction psychiatry council. The brain chemical dopamine regulates these behaviors, but narcotic drugs can flood the brain with dopamine, encouraging repeated use and making drug use more rewarding that healthy behaviors, Saxon said. Eventually increasing amounts are needed to get the same effect, and brain changes lead to an inability to control use.\u003c/p>\n\u003cp>\u003cstrong>What About Other Substances\u003c/strong>\u003c/p>\n\u003cp>Caffeine is a stimulant and also activates the brain’s reward system, but to a much lesser degree than addictive drugs. The “reward” can make people feel more alert, and frequent users can develop mild withdrawal symptoms when they stop, including headaches and tiredness. Caffeine-containing chocolate may produce similar effects. Neither substance causes the kinds of life problems found in drug addiction, although some coffee drinkers develop a tolerance to caffeine and need to drink more to get the same “buzz” or sense of alertness.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The World Health Organization recognizes caffeine “dependence” as a disorder; the American Psychiatric Association does not and says more research is needed.\u003c/p>\n\u003cp>“The term ‘addiction’ is tossed around pretty commonly, like ‘chocoholic’ or saying you’re addicted to reality TV,” said Dr. Ellen Selkie, a University of Michigan physician who studies teens’ use of digital technology. But addiction means an inability to control use “to the point where you’re failing at life,” she said.\u003c/p>\n\u003cp>\u003cstrong>What About Behavior\u003c/strong>\u003c/p>\n\u003cp>The only behavior classified as an addiction in the American Psychiatric Association’s diagnostic manual is compulsive gambling. To be diagnosed, gamblers must have several symptoms including repeatedly gambling increasing amounts of money, lying to hide gambling activity, feeling irritable or restless when trying to stop, and losing jobs or relationships because of gambling. Research suggests excessive gambling can affect the brain in ways similar to addictive drugs. Since the diagnostic manual was last updated, in 2013, studies have bolstered evidence that excessive video gaming may do the same thing, and some experts speculate that it may be added to the next update.\u003c/p>\n\u003cp>The manual doesn’t include sex addiction because there’s little evidence that compulsive sexual behavior has similar effects on the brain.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Many excessive gamblers, gamers and sex “addicts” have other psychiatric conditions, including anxiety, attention deficit disorder and depression, and some mental health specialists believe their compulsive behaviors are merely symptoms of those diseases rather than separate addictions.\u003c/p>\n\u003cp>Excessive use of the internet and smartphones is also absent from the psychiatric manual and World Health Organization’s update. Psychiatrists disagree on whether that is a true addiction — partly because overuse is hard to measure when so many people need to use their smartphones and the internet for their jobs.\u003c/p>\n\u003cp>\u003cstrong>Does the Term Matter?\u003c/strong>\u003c/p>\n\u003cp>The World Health Organization’s decision to classify excessive video gaming as an addiction means “gaming disorder” will be added to this year’s update to the organization’s International Classification of Diseases. Doctors worldwide use that document to diagnose physical and mental illnesses. Insurers, including Medicaid and Medicare, use billing codes listed there to make coverage decisions. The American Psychiatric Association’s manual is widely used for defining and diagnosing mental disorders. If conditions aren’t listed in these documents, insurance coverage for treatment is unlikely.\u003c/p>\n\u003cp>___\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>This Associated Press \u003ca href=\"https://apnews.com/tag/ScienceSays\" target=\"_blank\" rel=\"noopener\">series\u003c/a> was produced in \u003ca href=\"http://bit.ly/2ptoKnW\" target=\"_blank\" rel=\"noopener\">partnership\u003c/a> with the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "First Phage Center In The U.S. Signals Growing Acceptance",
"title": "First Phage Center In The U.S. Signals Growing Acceptance",
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"content": "\u003cp>When her husband was dying of a drug-resistant infection, Steffanie Strathdee had a last-ditch idea. They could try treating him with a virus that would kill the bacteria colonizing his insides. The method, called \u003ca href=\"https://www.statnews.com/2017/11/28/phage-therapy-mallory-smith/\" target=\"_blank\" rel=\"noopener\">phage therapy\u003c/a>, was popular in former Soviet republics, but had mostly been abandoned in the U.S. Researchers had to \u003ca href=\"https://www.motherjones.com/environment/2018/05/the-best-viral-news-youll-ever-read-antibiotic-resistance-phage-therapy-bacteriophage-virus/\" target=\"_blank\" rel=\"noopener\">hunt\u003c/a> for the right virus in Texas pigsties and sewage treatment plants.[contextly_sidebar id=\"arHYIuUonCY76BgMGAom8CdlRJtFsuZL\"]\u003c/p>\n\u003cp>That was 2016. Phage therapy is still very much experimental — but it’s come a long way since then. New companies have popped up, hoping to get approval to sell these viruses as drugs. A \u003ca href=\"https://phage.directory/\" target=\"_blank\" rel=\"noopener\">phage directory\u003c/a> has come together, lab by lab, helping doctors figure out who has which virus.\u003c/p>\n\u003cp>Now, the U.S. is getting its first \u003ca href=\"https://medschool.ucsd.edu/som/medicine/divisions/infectious-diseases/research/center-innovative-phage-applications-and-therapeutics/Pages/default.aspx\" target=\"_blank\" rel=\"noopener\">phage therapy center\u003c/a>, at the University of California, San Diego. Its mission is to run clinical trials, but also to streamline the mad dash to secure the right phage before a patient dies.\u003c/p>\n\u003cp>In some ways, the Center for Innovative Phage Applications and Therapeutics simply gives a name — and $1.2 million — to an institute that already exists. After word got out that Strathdee and her husband’s doctors had managed to save his life with a bacteriophage — literally, a bacteria-eater — her inbox filled with pleas for a repeat performance. They came from all over: the U.S., the U.K., Australia, India, China, Albania. In almost every case, there was someone dying because of antibiotic-resistant bacteria. Viruses that had specifically evolved to kill those microbes might be able to help.\u003c/p>\n\u003cp>Sometimes, Strathdee and her network couldn’t act fast enough, and the patient died. But occasionally, it worked out. “I’ve had a second job as a phage-wrangler,” said Strathdee, who is the associate dean of global health sciences at UCSD, and who has been named a co-director of the new center. “When we started to treat patients, each one was like reinventing the wheel all over again: The phone calls at the 11th hour, the paperwork.”[contextly_sidebar id=\"HWlHiwtZ3b4aS5iux0NZv3CbgJWJOIOp\"]\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Getting phage therapy to a patient can be a bit a puzzle. These viruses are picky about the microbes they feast on, so you often need to take a swab of the patient’s bacteria, nurture it in a dish, and then test which phages are able to kill it off. You need to make sure that the phages in question will explode a bacterial cell, rather than settling comfortably in its nucleus like lice on a kindergartener’s scalp. And then you need to purify it before delivery, so there aren’t any bacterial leftovers that might poison the person instead of saving them.\u003c/p>\n\u003cp>There’s also plenty of bureaucracy, because phages have not been approved by the Food and Drug Administration.\u003c/p>\n\u003cp>It’s often a crazy rush to find the right phage with emails and calls and tweets, then getting emergency experimental approval — and that was largely what happened for the five other patients who’ve been treated with phages at UCSD since Strathdee’s husband was revived.\u003c/p>\n\u003cp>“We wanted to make it so it isn’t such a scramble,” said Dr. Robert “Chip” Schooley, an infectious disease \u003ca href=\"https://www.tuftsmedicalcenter.org/PhysicianDirectory/Helen-Boucher.aspx\" target=\"_blank\" rel=\"noopener\">specialist\u003c/a> at UCSD, who administered the phage to Strathdee’s husband, and who is also co-director of the new center.\u003c/p>\n\u003cp>The announcement is also symbolic of a wider shift. With the rise of antibiotics in the 1930s and ’40s, phages went out of fashion in the U.S. But the person who had named them, a Canadian microbiologist named Felix d’Herelle, moved to Tbilisi, in the republic of Georgia, continuing his research at an institute that attracted the admiration of Joseph Stalin himself. Even after d’Herelle’s death, the \u003ca href=\"http://www.eliava-institute.org/\" target=\"_blank\" rel=\"noopener\">Eliava Institute\u003c/a> kept the flame of phage therapy alive.[contextly_sidebar id=\"HGcjrnDFzg80OPCbEp1ow35PtAMePTXI\"]\u003c/p>\n\u003cp>That hardly helped the viruses’ reputation in America during the Cold War. “It was commie science; there was a taint to it,” explained Dr. William Summers, a phage biologist, historian, and professor emeritus at Yale University.\u003c/p>\n\u003cp>Even though phages continued to be an important part of lab science, the researchers who used them thought they were good for just that: research. The idea of using them for therapy was almost a joke.\u003c/p>\n\u003cp>Then, as antibiotic resistance grew into a worldwide crisis — one that \u003ca href=\"https://www.cdc.gov/drugresistance/threat-report-2013/index.html\" target=\"_blank\" rel=\"noopener\">kills\u003c/a> some 23,000 Americans a year — that joke started sounding more and more appealing. The funding of a center to administer and collect data on phage therapy is a reversal, of sorts: An admission that this long-disparaged idea is worth a million-dollar second glance.\u003c/p>\n\u003cp>“Trust me, at the Eliava, we have tried to convince people that phages are a safe and good alternative to antibiotics for many years,” said Mzia Kutateladze, the director of the Eliava Institute. “Finally the people agreed to use it, and we are very happy, of course.” She estimated that Eliava’s phage therapy center gets around 15 to 20 Americans every year.\u003c/p>\n\u003cp>“There really is, thankfully, some momentum building … around these non-traditional therapies,” said Dr. Helen Boucher, an infectious disease specialist at Tufts Medical Center in Boston, who is not involved with the UCSD project. “I would think of this more in a high-risk, high-reward category. This is largely uncharted territory. … At the end of the day, if you have a product that can work against antibiotic-resistant organisms that isn’t antibiotics, that would be huge.”[contextly_sidebar id=\"oZXWClXhDyGosKyti4BoRnGzhEfmXr3I\"]\u003c/p>\n\u003cp>The news that her brainchild had been funded took Strathdee by surprise in late May. She was at a ceremony for UCSD professors with endowed chairs, at which all of them received medals. “The chancellor’s literally putting the medal around my neck, and he said, ‘Hey, I just sent you some money today,’” she recalled.\u003c/p>\n\u003cp>The new center will collaborate with companies such as \u003ca href=\"http://www.ampliphibio.com/\" target=\"_blank\" rel=\"noopener\">AmpliPhi Biosciences\u003c/a> and \u003ca href=\"http://www.aphage.com/\" target=\"_blank\" rel=\"noopener\">Adaptive Phage Therapeutics\u003c/a> to treat future patients. Some of them will have cystic fibrosis, which causes mucus in the lungs to be overly sticky, often allowing drug-resistant microbes to proliferate. Others might have long-term infections that are preventing them from getting organ transplants. Yet others will have implanted devices, which sometimes provide the nooks and crannies where bacteria can grow into a slimy film.\u003c/p>\n\u003cp>“The sad thing is that there is going to be no shortage of patients,” said Strathdee.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This\u003ca href=\"https://www.statnews.com/2018/06/21/first-phage-therapy-center-in-us/\" target=\"_blank\" rel=\"noopener\"> story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\u003cdiv class=\"ctx-subscribe-container ctx-personalization-container ctx_default_placement ctx-clearfix\">\u003c/div>\n\u003cdiv class=\"ctx-social-container ctx_default_placement ctx-clearfix\">\u003c/div>\n\u003cdiv class=\"ctx-module-container ctx_default_placement ctx-clearfix\">\n\u003cdiv class=\"ctx-module ctx-nodefs ctx-content-block2 ctx-module-default\">\n\u003cdiv class=\"ctx-sections-container ctx-nomar\">\n\u003cdiv class=\"ctx-section ctx-clearfix ctx-section-previous\">\n\u003cdiv class=\"ctx-links-header\">\u003c/div>\n\u003c/div>\n\u003c/div>\n\u003c/div>\n\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>When her husband was dying of a drug-resistant infection, Steffanie Strathdee had a last-ditch idea. They could try treating him with a virus that would kill the bacteria colonizing his insides. The method, called \u003ca href=\"https://www.statnews.com/2017/11/28/phage-therapy-mallory-smith/\" target=\"_blank\" rel=\"noopener\">phage therapy\u003c/a>, was popular in former Soviet republics, but had mostly been abandoned in the U.S. Researchers had to \u003ca href=\"https://www.motherjones.com/environment/2018/05/the-best-viral-news-youll-ever-read-antibiotic-resistance-phage-therapy-bacteriophage-virus/\" target=\"_blank\" rel=\"noopener\">hunt\u003c/a> for the right virus in Texas pigsties and sewage treatment plants.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>That was 2016. Phage therapy is still very much experimental — but it’s come a long way since then. New companies have popped up, hoping to get approval to sell these viruses as drugs. A \u003ca href=\"https://phage.directory/\" target=\"_blank\" rel=\"noopener\">phage directory\u003c/a> has come together, lab by lab, helping doctors figure out who has which virus.\u003c/p>\n\u003cp>Now, the U.S. is getting its first \u003ca href=\"https://medschool.ucsd.edu/som/medicine/divisions/infectious-diseases/research/center-innovative-phage-applications-and-therapeutics/Pages/default.aspx\" target=\"_blank\" rel=\"noopener\">phage therapy center\u003c/a>, at the University of California, San Diego. Its mission is to run clinical trials, but also to streamline the mad dash to secure the right phage before a patient dies.\u003c/p>\n\u003cp>In some ways, the Center for Innovative Phage Applications and Therapeutics simply gives a name — and $1.2 million — to an institute that already exists. After word got out that Strathdee and her husband’s doctors had managed to save his life with a bacteriophage — literally, a bacteria-eater — her inbox filled with pleas for a repeat performance. They came from all over: the U.S., the U.K., Australia, India, China, Albania. In almost every case, there was someone dying because of antibiotic-resistant bacteria. Viruses that had specifically evolved to kill those microbes might be able to help.\u003c/p>\n\u003cp>Sometimes, Strathdee and her network couldn’t act fast enough, and the patient died. But occasionally, it worked out. “I’ve had a second job as a phage-wrangler,” said Strathdee, who is the associate dean of global health sciences at UCSD, and who has been named a co-director of the new center. “When we started to treat patients, each one was like reinventing the wheel all over again: The phone calls at the 11th hour, the paperwork.”\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Getting phage therapy to a patient can be a bit a puzzle. These viruses are picky about the microbes they feast on, so you often need to take a swab of the patient’s bacteria, nurture it in a dish, and then test which phages are able to kill it off. You need to make sure that the phages in question will explode a bacterial cell, rather than settling comfortably in its nucleus like lice on a kindergartener’s scalp. And then you need to purify it before delivery, so there aren’t any bacterial leftovers that might poison the person instead of saving them.\u003c/p>\n\u003cp>There’s also plenty of bureaucracy, because phages have not been approved by the Food and Drug Administration.\u003c/p>\n\u003cp>It’s often a crazy rush to find the right phage with emails and calls and tweets, then getting emergency experimental approval — and that was largely what happened for the five other patients who’ve been treated with phages at UCSD since Strathdee’s husband was revived.\u003c/p>\n\u003cp>“We wanted to make it so it isn’t such a scramble,” said Dr. Robert “Chip” Schooley, an infectious disease \u003ca href=\"https://www.tuftsmedicalcenter.org/PhysicianDirectory/Helen-Boucher.aspx\" target=\"_blank\" rel=\"noopener\">specialist\u003c/a> at UCSD, who administered the phage to Strathdee’s husband, and who is also co-director of the new center.\u003c/p>\n\u003cp>The announcement is also symbolic of a wider shift. With the rise of antibiotics in the 1930s and ’40s, phages went out of fashion in the U.S. But the person who had named them, a Canadian microbiologist named Felix d’Herelle, moved to Tbilisi, in the republic of Georgia, continuing his research at an institute that attracted the admiration of Joseph Stalin himself. Even after d’Herelle’s death, the \u003ca href=\"http://www.eliava-institute.org/\" target=\"_blank\" rel=\"noopener\">Eliava Institute\u003c/a> kept the flame of phage therapy alive.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>That hardly helped the viruses’ reputation in America during the Cold War. “It was commie science; there was a taint to it,” explained Dr. William Summers, a phage biologist, historian, and professor emeritus at Yale University.\u003c/p>\n\u003cp>Even though phages continued to be an important part of lab science, the researchers who used them thought they were good for just that: research. The idea of using them for therapy was almost a joke.\u003c/p>\n\u003cp>Then, as antibiotic resistance grew into a worldwide crisis — one that \u003ca href=\"https://www.cdc.gov/drugresistance/threat-report-2013/index.html\" target=\"_blank\" rel=\"noopener\">kills\u003c/a> some 23,000 Americans a year — that joke started sounding more and more appealing. The funding of a center to administer and collect data on phage therapy is a reversal, of sorts: An admission that this long-disparaged idea is worth a million-dollar second glance.\u003c/p>\n\u003cp>“Trust me, at the Eliava, we have tried to convince people that phages are a safe and good alternative to antibiotics for many years,” said Mzia Kutateladze, the director of the Eliava Institute. “Finally the people agreed to use it, and we are very happy, of course.” She estimated that Eliava’s phage therapy center gets around 15 to 20 Americans every year.\u003c/p>\n\u003cp>“There really is, thankfully, some momentum building … around these non-traditional therapies,” said Dr. Helen Boucher, an infectious disease specialist at Tufts Medical Center in Boston, who is not involved with the UCSD project. “I would think of this more in a high-risk, high-reward category. This is largely uncharted territory. … At the end of the day, if you have a product that can work against antibiotic-resistant organisms that isn’t antibiotics, that would be huge.”\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The news that her brainchild had been funded took Strathdee by surprise in late May. She was at a ceremony for UCSD professors with endowed chairs, at which all of them received medals. “The chancellor’s literally putting the medal around my neck, and he said, ‘Hey, I just sent you some money today,’” she recalled.\u003c/p>\n\u003cp>The new center will collaborate with companies such as \u003ca href=\"http://www.ampliphibio.com/\" target=\"_blank\" rel=\"noopener\">AmpliPhi Biosciences\u003c/a> and \u003ca href=\"http://www.aphage.com/\" target=\"_blank\" rel=\"noopener\">Adaptive Phage Therapeutics\u003c/a> to treat future patients. Some of them will have cystic fibrosis, which causes mucus in the lungs to be overly sticky, often allowing drug-resistant microbes to proliferate. Others might have long-term infections that are preventing them from getting organ transplants. Yet others will have implanted devices, which sometimes provide the nooks and crannies where bacteria can grow into a slimy film.\u003c/p>\n\u003cp>“The sad thing is that there is going to be no shortage of patients,” said Strathdee.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This\u003ca href=\"https://www.statnews.com/2018/06/21/first-phage-therapy-center-in-us/\" target=\"_blank\" rel=\"noopener\"> story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\u003cdiv class=\"ctx-subscribe-container ctx-personalization-container ctx_default_placement ctx-clearfix\">\u003c/div>\n\u003cdiv class=\"ctx-social-container ctx_default_placement ctx-clearfix\">\u003c/div>\n\u003cdiv class=\"ctx-module-container ctx_default_placement ctx-clearfix\">\n\u003cdiv class=\"ctx-module ctx-nodefs ctx-content-block2 ctx-module-default\">\n\u003cdiv class=\"ctx-sections-container ctx-nomar\">\n\u003cdiv class=\"ctx-section ctx-clearfix ctx-section-previous\">\n\u003cdiv class=\"ctx-links-header\">\u003c/div>\n\u003c/div>\n\u003c/div>\n\u003c/div>\n\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Anti-Aging Researcher Faces Loss of His Inspiration: His 96-Year-Old Dad",
"title": "Anti-Aging Researcher Faces Loss of His Inspiration: His 96-Year-Old Dad",
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"content": "\u003cp>Leonid Peshkin calmly strokes his father’s thin, white hair. He gently exercises the old man’s arms to activate his muscles and get the blood flowing. He speaks, voice raised to reach him through the fog of age, poor hearing, and illness. “Papa,” he asks in their native Russian, “are you in pain?”\u003c/p>\n\u003cp>Almost imperceptibly, Miron Peshkin, age 96 and silenced by a minor heart attack, delirium, antibiotic-resistant infections, and six months of medical care, shifts his head to indicate “no.”\u003c/p>\n\u003cp>The younger Peshkin, 48, studies the biology of aging at Harvard Medical School in Boston. A broad-shouldered man with a twinkle always lurking in his brown eyes, Peshkin has been obsessed with aging since childhood because he worried that his father — then as old as other kids’ grandparents — would soon pass away.\u003c/p>\n\u003cp>“How funny it is,” Peshkin said, “that I had to be super worried he was going to die when I was 10. And here I am almost 50, and he’s still around.”\u003c/p>\n\u003cp>Now, as Miron lies virtually motionless in a nursing home, Peshkin fights his own battles with aging a few miles away, in a fifth-floor lab just off the Harvard Medical School quad.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The lab’s main attraction is a mammoth, glass-fronted incubator stocked with tiny crustaceans called water fleas. Peshkin is raising them to try to understand their natural lifespan. Once he knows how unusual it is for these bugs to survive past the 40 days they typically live at room temperature, he will begin dosing them with drugs to see if he can extend that trajectory.\u003c/p>\n\u003cfigure class=\"clear\">\n\u003cfigure class=\"wp-caption aligncenter\" style=\"max-width: 1024px\">\u003ca href=\"https://www.statnews.com/wp-content/uploads/2018/06/0613_STAT_LeonidPeshkin003.jpg\">\u003cimg class=\"extendsBeyondTextColumn\" src=\"https://www.statnews.com/wp-content/uploads/2018/06/0613_STAT_LeonidPeshkin003-1024x683.jpg\" alt=\"\" width=\"1024\" height=\"683\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Peshkin prepares to feed water fleas in his lab at Harvard Medical School. He studies their life cycle to better understand aging in humans. (Ruby Wallau/STAT)\u003c/figcaption>\u003c/figure>\n\u003c/figure>\n\u003cp>Peshkin and his parents also contribute to research in a less conventional way. All three have donated their genetic code and cells to science.\u003c/p>\n\u003cp>Those cells have been altered to reproduce indefinitely. Their usefulness to research will far outlast Miron’s life, and probably his mother’s and Peshkin’s too.\u003c/p>\n\u003cp>But that’s not what Peshkin’s aiming for, he said, quoting Woody Allen’s famous line about wanting to achieve immortality — not through his work — but by not dying.\u003c/p>\n\u003cp>That’s why Peshkin continues to fight for his father’s life, despite the increasing futility.\u003c/p>\n\u003cp>Yes, he understands that his father is old and unlikely to recover. But no, he isn’t ready to stop aggressive medical care, Peshkin has told the chaplain at the Catholic hospital that treated his father, and at the Jewish nursing home where Miron now lies in a world mostly his own.\u003c/p>\n\u003cp>Peshkin highlights the irony: Persecuted for decades in Russia for being Jewish, Miron has no real faith — except in science. And yet these people of faith want to decide his fate. Plus, Peshkin has come, over the six months of his father’s illness, to doubt the medical care that keeps him alive. Too many times doctors told him his father was gone; only to have him bounce back and become himself once again.\u003c/p>\n\u003cp>So every day Peshkin drives to the nursing home to stroke his father’s head, stretch his arms, talk to him, and check in with caregivers.\u003c/p>\n\u003cp>And Peshkin continues to struggle with the question that has haunted him since childhood: Why must his father die?\u003c/p>\n\u003cp>“It just didn’t make sense the whole idea that you have to get old, your parents, your loved ones have to get old and die,” Peshkin said. “It just made absolutely no sense to me and it still doesn’t.”\u003c/p>\n\u003cfigure class=\"clear\">\n\u003cfigure class=\"wp-caption aligncenter\" style=\"max-width: 993px\">\u003ca href=\"https://www.statnews.com/wp-content/uploads/2018/06/Leonid_Composite.jpg\">\u003cimg class=\"extendsBeyondTextColumn\" src=\"https://www.statnews.com/wp-content/uploads/2018/06/Leonid_Composite.jpg\" alt=\"Leon Peshkin 04\" width=\"993\" height=\"509\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">\u003cstrong>(Left) Aaron Peshkin with young Miron Peshkin in 1924. (Right) Miron Peshkin and Leonid Peshkin in 1973. Courtesy Leon Peshkin.\u003c/strong>\u003c/figcaption>\u003c/figure>\n\u003c/figure>\n\u003cp>\u003cstrong>A Lifelong Interest in Longevity\u003c/strong>\u003c/p>\n\u003cp>Anti-aging research is one of today’s \u003ca href=\"https://www.statnews.com/2018/05/22/laura-deming-profile-longevity-fund/\" target=\"_blank\" rel=\"noopener\">hottest fields\u003c/a>. Billionaires donate fortunes to advance work aimed at slowing the hands of time.\u003c/p>\n\u003cp>But the genesis of Peshkin’s interest in longevity goes back 43 years, to the streets of Moscow.\u003c/p>\n\u003cp>Walking in the park with his babysitter, they crossed paths with a fancy funeral — big crowd, brass band, bright red open casket. Peshkin doesn’t remember who died, but he does remember the questions it left him with: What is death? Why do we have to die? Why put someone in a box who looks so alive?\u003c/p>\n\u003cp>His parents had always answered his questions before. But this time, their explanations were inadequate and awkward. Their inability to satisfy his curiosity made as big an impression on him as the funeral.\u003c/p>\n\u003cp>His father was a scientist, first in the aviation industry and then — when he was kicked out for being Jewish — in the oil and gas business, studying how liquified gas moves through sand. Working for the state, Miron didn’t earn much, so he translated technical documents from German and English into Russian for extra cash. Peshkin’s mother, Klavdia Logvinskaya, worked herself up from lab technician to engineer, researching additives that influence the properties of metal alloys.\u003c/p>\n\u003cp>They were always demanding of their son. They told Peshkin he had to be 10 times better than everyone else to overcome the discrimination he would face as a Jew.\u003c/p>\n\u003cp>Growing up, almost all the adults Peshkin knew were the Ph.D.-level scientists who were his parents’ friends. “It was clear that science is the only thing worth doing in life,” he said. As a young boy, a family friend showed him how to memorize a string of 50 facts after just a few minutes of study. “It gave me this idea of power over nature,” he said.\u003c/p>\n\u003cp>At age 10, after watching some television hospital dramas, Peshkin remembers taking a cord from an old desk lamp and having it at the ready to shock his father’s heart, in case he went into cardiac arrest. “It’s very good he never had a heart attack, because I would have finished him,” Peshkin said dryly.\u003c/p>\n\u003cp>Peshkin came to the United States in 1995 to attend Brown University, where he trained in statistical machine learning, a type of artificial intelligence, before switching to systems biology. His parents joined him in Boston a decade ago as political refugees, fleeing anti-Semitism.\u003c/p>\n\u003cp>His mother, sitting in his office recently after a nearby doctor’s appointment, reminds him in Russian that he also promised to build an engine to replace their failing hearts, so they would never die.\u003c/p>\n\u003cp>He still holds onto that dream of keeping them alive.\u003c/p>\n\u003cp>“I guess I’m not a very religious man. I don’t think there is some kind of rational design or purpose,” he said. “Even if there is, I’m not ready to accept [it].”\u003c/p>\n\u003cp>\u003cstrong>Searching for Clues to Reverse Aging\u003c/strong>\u003c/p>\n\u003cp>Some of the most exciting, perhaps fanciful, biomedical research involves slowing the aging process. Research in animals is especially tantalizing. Deprive a worm of calories and it will live longer. A number of drugs extend life in animals and are being studied to see if they can reduce the risk of age-related diseases in people.\u003c/p>\n\u003cp>Many anti-aging scientists themselves pop supplements or gratefully accept diagnoses of pre-diabetes so they can start taking drugs that have shown promise.\u003c/p>\n\u003cp>Peshkin’s own research focuses on the water flea, Latin name Daphnia, an insect barely visible to the naked eye. Known primarily as food for aquarium fish, these mostly transparent crustaceans eat algae and protozoa and survive for about 40 days when kept at room temperature. (They live longer in warmer environments.)\u003c/p>\n\u003cp>It’s that “on average” that troubles Peshkin. No one knows the full range of a Daphnia’s lifespan. So, if a Daphnia lives for 60 days while given a particular drug, is that a potential silver bullet or simply the water flea equivalent of human outlier, akin to his father living to 96? Or if they continue having offspring and resist turning opaque — the water flea version of going gray — does that mean that he’s extended their “healthspan,” which is the true goal of all anti-aging research?\u003c/p>\n\u003cp>Peshkin said water fleas make a good research species because of their relatively short lifespans, and because unlike flies or worms, they can be precisely dosed with medication. It’s hard to tell how much an individual fly is consuming; worms are very efficient at excreting nutrients they don’t need. Water fleas, on the other hand, have to absorb the medication Peshkin gives them, because they’re swimming in it, he said.\u003c/p>\n\u003cp>They can reproduce asexually, unless under stress, so all of his Daphnia are identical genetic clones.\u003c/p>\n\u003cp>He mentioned one cool trick with Daphnia that many middle school sciences classes try: Add caffeine to their water and you can watch their heartbeats speed up. (When Peshkin’s wife was pregnant seven yeas ago, he was worried about her addiction to coffee. He pumped tadpoles full of caffeine during their entire developmental process — and saw no issues in their offspring. His wife remains addicted.)\u003c/p>\n\u003cp>Last year, before Peshkin’s research funding didn’t come through and his water fleas died, he got encouraging early results from the fleas when he tried them on a drug called Wortmannin, shown to extend the life of fruit flies. He froze one Daphnia every day so he could later examine the genes that were turned on and off during development, and as the animal aged.\u003c/p>\n\u003cp>Now, he’s starting to build up his colony again in collaboration with Marc Kirschner, the founding director of Harvard’s systems biology department. “Our target is getting a steady supply of old animals. It’s trickier than it sounds,” he said.\u003c/p>\n\u003cp>He compares his scientific process to the child’s game Twenty Questions. “I use drugs as questions,” he said, interrogating them to see if they can extend the life of water fleas, and therefore, potentially, humans. “I want to find the minimal number of questions that allow you to get an answer.”\u003c/p>\n\u003cfigure class=\"clear\">\n\u003cfigure class=\"wp-caption aligncenter\" style=\"max-width: 1024px\">\u003ca href=\"https://www.statnews.com/wp-content/uploads/2018/06/0613_STAT_LeonidPeshkin001.jpg\">\u003cimg class=\"extendsBeyondTextColumn\" src=\"https://www.statnews.com/wp-content/uploads/2018/06/0613_STAT_LeonidPeshkin001-1024x683.jpg\" alt=\"Leon Peshkin 01\" width=\"1024\" height=\"683\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Peshkin in his office at Harvard Medical School. His genome will become the reference for labs all over the world. (Ruby Wallau/STAT)\u003c/figcaption>\u003c/figure>\n\u003c/figure>\n\u003cp>\u003cstrong>Henrietta Lacks 2.0\u003c/strong>\u003c/p>\n\u003cp>The human cells used most often in research labs around the world came originally from a Maryland woman named \u003ca href=\"http://www.lacksfamily.net/\" target=\"_blank\" rel=\"noopener\">Henrietta Lacks\u003c/a>, who died of cervical cancer in 1951. The doctors who treated her did not get her permission before shipping descendants of her cells all over the world. The ethics of that were questionable back then and are certainly unacceptable today.\u003c/p>\n\u003cp>So when Harvard geneticist George Church set out to amass human genome, health and trait data for research, he made informed consent a huge part of the process.\u003c/p>\n\u003cp>Miron was the 15th person to sign up for the Personal Genome Project, which now counts hundreds of participants; Peshkin and his mother soon followed. The three don’t share the privacy concerns some people have about making their genetic information public.\u003c/p>\n\u003cp>“I didn’t invent my genome,” Peshkin said. “This idea that it’s mine in the sense of property is sort of foreign to me.”\u003c/p>\n\u003cp>His mother said she can’t imagine ways that publishing her genome might hurt her. “This is for science and scientists,” Logvinskaya said in Russian, while Peshkin translated. “Those are not villains. Those are not random people.”\u003c/p>\n\u003cp>A few years after volunteering their information, Personal Genome Project organizers approached the family with a request: Would they participate in a federally funded effort to develop a standard for genetic sequencing?\u003c/p>\n\u003cp>Other fields set standards. A cylinder of platinum-iridium alloy, for instance, sits in a basement vault in the U.K., providing the \u003ca href=\"http://www.npl.co.uk/reference/faqs/where-and-how-is-the-uks-national-standard-kilogram-stored-(faq-mass-and-density)\" target=\"_blank\" rel=\"noopener\">reference weight\u003c/a> used around the world for a kilogram.\u003c/p>\n\u003cp>But when scientists sequence a genome, they have no way of knowing the accuracy of that sequence or whether it’s good enough, because they have no high-quality benchmark to compare it to. It’s that benchmark that the Genome in a Bottle project is working to create, said Justin Zook, a scientist at the National Institute of Standards and Technology and co-leader of the initiative. In addition to the Peshkin family, they’ve now sequenced one pilot genome and one man of Han Chinese descent. They plan to add that man’s parents soon, and eventually others that reflect more ethnic and racial diversity, Zook said.\u003c/p>\n\u003cdiv>\n\u003cdiv>\n\u003cdiv>\n\u003cp>Peshkin said he briefly contemplated one far-out concern with the project: If his was the reference genome, could his own body become valuable to a scientist who wanted to, say, test an Alzheimer’s drug on the real person it was designed to treat?\u003c/p>\n\u003c/div>\n\u003c/div>\n\u003c/div>\n\u003cp>“If my brain is the best brain for the experiment because they’ve been working with cells derived from me, maybe there’s suddenly a price on my head,” Peshkin said. “It’s more like a great plot for a movie, and I dismissed it because I thought it’s a very, very unlikely scenario to worry about.”\u003c/p>\n\u003cp>So he agreed.\u003c/p>\n\u003cp>Data associated with the Genome in a Bottle samples were downloaded to about 15,000 computers worldwide in 2017, Zook said, suggesting that there’s a strong appetite for the information.\u003c/p>\n\u003cp>Weirdly, Peshkin won’t be able to study his own samples; it wouldn’t be safe. Like Henrietta Lacks’ original cells, the ones he donated have been modified to reproduce indefinitely, which is essential for their scientific usefulness. But that makes them extremely dangerous to Peshkin himself — and only him. If he comes into contact with his own modified cells, his body won’t recognize them as foreign. “They will keep multiplying and growing on me and eventually will kill me,” he said matter-of-factly.\u003c/p>\n\u003cfigure class=\"clear\">\n\u003cfigure class=\"wp-caption aligncenter\" style=\"max-width: 1024px\">\u003ca href=\"https://www.statnews.com/wp-content/uploads/2018/06/0613_STAT_LeonidPeshkin010.jpg\">\u003cimg class=\"extendsBeyondTextColumn\" src=\"https://www.statnews.com/wp-content/uploads/2018/06/0613_STAT_LeonidPeshkin010-1024x683.jpg\" alt=\"Leon Peshkin 05\" width=\"1024\" height=\"683\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Peshkin exercises his father’s arm to activate his muscles and get the blood flowing. (Ruby Wallau/STAT)\u003c/figcaption>\u003c/figure>\n\u003c/figure>\n\u003cp>\u003cstrong>Privacy vs. Science\u003c/strong>\u003c/p>\n\u003cp>The Personal Genome Project is now considering what tissue to collect from Miron when his heart or another organ finally gives out, said Michael F. Chou, a lecturer in genetics and director of human subjects research for the project.\u003c/p>\n\u003cp>Miron’s gene sequence and tissue will be publicly available and connected with his health records; \u003ca href=\"https://www.broadinstitute.org/blog/gtex-useful-expression-cancer-research\" target=\"_blank\" rel=\"noopener\">other\u003c/a> gene expression data from tissue has been anonymized. Without that personal data, researchers can’t know if their pancreatic tissue sample came from a diabetic who died of a heart attack in his 50s, for instance, or from someone like Miron, who has lived nearly two decades longer than the average American male.\u003c/p>\n\u003cp>It may sound morbid to contemplate such ideas. But though Peshkin still sees death as pointless and illogical, it would be even more meaningless in his view to bury an intact body in the ground where it can do no good.\u003c/p>\n\u003cp>“I think the best we can do is leave our body to science, even though a lot of science is also a waste,” Peshkin said. “I think that science is the best thing we have.”\u003c/p>\n\u003cp>There isn’t much more time left to make these kinds of decisions.\u003c/p>\n\u003cp>Over the last two weeks Miron has slipped further away. Peshkin is sure his father, whose 97th birthday is July 9, can still hear him. But Miron is not as responsive as he was, his eyes are less alert, his stare more vacant. Peshkin would have given up already if his father hadn’t bounced back twice before, though he concedes that chances are now slim.\u003c/p>\n\u003cp>His father’s palliative care team has scheduled a meeting for Wednesday afternoon. Peshkin expects they will pressure him to dial back on Miron’s aggressive medical care, potentially hastening his demise.\u003c/p>\n\u003cp>He wonders aloud when he will be ready to accept what he still doesn’t think should be inevitable.\u003c/p>\n\u003cp>“I think I will try to fend it off for a little longer,” Peshkin said.\u003c/p>\n\u003cp>\u003cem>Correction: An earlier version of this story misclassified Daphnia on first reference and Peshkin’s field of research.\u003c/em>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This story was originally published by \u003ca href=\"https://www.statnews.com/2018/06/20/anti-aging-researcher-father-death/\" target=\"_blank\" rel=\"noopener\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n",
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"description": "Leonid Peshkin calmly strokes his father’s thin, white hair. He gently exercises the old man’s arms to activate his muscles and get the blood flowing. He speaks, voice raised to reach him through the fog of age, poor hearing, and illness. “Papa,” he asks in their native Russian, “are you in pain?” Almost imperceptibly, Miron",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Leonid Peshkin calmly strokes his father’s thin, white hair. He gently exercises the old man’s arms to activate his muscles and get the blood flowing. He speaks, voice raised to reach him through the fog of age, poor hearing, and illness. “Papa,” he asks in their native Russian, “are you in pain?”\u003c/p>\n\u003cp>Almost imperceptibly, Miron Peshkin, age 96 and silenced by a minor heart attack, delirium, antibiotic-resistant infections, and six months of medical care, shifts his head to indicate “no.”\u003c/p>\n\u003cp>The younger Peshkin, 48, studies the biology of aging at Harvard Medical School in Boston. A broad-shouldered man with a twinkle always lurking in his brown eyes, Peshkin has been obsessed with aging since childhood because he worried that his father — then as old as other kids’ grandparents — would soon pass away.\u003c/p>\n\u003cp>“How funny it is,” Peshkin said, “that I had to be super worried he was going to die when I was 10. And here I am almost 50, and he’s still around.”\u003c/p>\n\u003cp>Now, as Miron lies virtually motionless in a nursing home, Peshkin fights his own battles with aging a few miles away, in a fifth-floor lab just off the Harvard Medical School quad.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The lab’s main attraction is a mammoth, glass-fronted incubator stocked with tiny crustaceans called water fleas. Peshkin is raising them to try to understand their natural lifespan. Once he knows how unusual it is for these bugs to survive past the 40 days they typically live at room temperature, he will begin dosing them with drugs to see if he can extend that trajectory.\u003c/p>\n\u003cfigure class=\"clear\">\n\u003cfigure class=\"wp-caption aligncenter\" style=\"max-width: 1024px\">\u003ca href=\"https://www.statnews.com/wp-content/uploads/2018/06/0613_STAT_LeonidPeshkin003.jpg\">\u003cimg class=\"extendsBeyondTextColumn\" src=\"https://www.statnews.com/wp-content/uploads/2018/06/0613_STAT_LeonidPeshkin003-1024x683.jpg\" alt=\"\" width=\"1024\" height=\"683\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Peshkin prepares to feed water fleas in his lab at Harvard Medical School. He studies their life cycle to better understand aging in humans. (Ruby Wallau/STAT)\u003c/figcaption>\u003c/figure>\n\u003c/figure>\n\u003cp>Peshkin and his parents also contribute to research in a less conventional way. All three have donated their genetic code and cells to science.\u003c/p>\n\u003cp>Those cells have been altered to reproduce indefinitely. Their usefulness to research will far outlast Miron’s life, and probably his mother’s and Peshkin’s too.\u003c/p>\n\u003cp>But that’s not what Peshkin’s aiming for, he said, quoting Woody Allen’s famous line about wanting to achieve immortality — not through his work — but by not dying.\u003c/p>\n\u003cp>That’s why Peshkin continues to fight for his father’s life, despite the increasing futility.\u003c/p>\n\u003cp>Yes, he understands that his father is old and unlikely to recover. But no, he isn’t ready to stop aggressive medical care, Peshkin has told the chaplain at the Catholic hospital that treated his father, and at the Jewish nursing home where Miron now lies in a world mostly his own.\u003c/p>\n\u003cp>Peshkin highlights the irony: Persecuted for decades in Russia for being Jewish, Miron has no real faith — except in science. And yet these people of faith want to decide his fate. Plus, Peshkin has come, over the six months of his father’s illness, to doubt the medical care that keeps him alive. Too many times doctors told him his father was gone; only to have him bounce back and become himself once again.\u003c/p>\n\u003cp>So every day Peshkin drives to the nursing home to stroke his father’s head, stretch his arms, talk to him, and check in with caregivers.\u003c/p>\n\u003cp>And Peshkin continues to struggle with the question that has haunted him since childhood: Why must his father die?\u003c/p>\n\u003cp>“It just didn’t make sense the whole idea that you have to get old, your parents, your loved ones have to get old and die,” Peshkin said. “It just made absolutely no sense to me and it still doesn’t.”\u003c/p>\n\u003cfigure class=\"clear\">\n\u003cfigure class=\"wp-caption aligncenter\" style=\"max-width: 993px\">\u003ca href=\"https://www.statnews.com/wp-content/uploads/2018/06/Leonid_Composite.jpg\">\u003cimg class=\"extendsBeyondTextColumn\" src=\"https://www.statnews.com/wp-content/uploads/2018/06/Leonid_Composite.jpg\" alt=\"Leon Peshkin 04\" width=\"993\" height=\"509\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">\u003cstrong>(Left) Aaron Peshkin with young Miron Peshkin in 1924. (Right) Miron Peshkin and Leonid Peshkin in 1973. Courtesy Leon Peshkin.\u003c/strong>\u003c/figcaption>\u003c/figure>\n\u003c/figure>\n\u003cp>\u003cstrong>A Lifelong Interest in Longevity\u003c/strong>\u003c/p>\n\u003cp>Anti-aging research is one of today’s \u003ca href=\"https://www.statnews.com/2018/05/22/laura-deming-profile-longevity-fund/\" target=\"_blank\" rel=\"noopener\">hottest fields\u003c/a>. Billionaires donate fortunes to advance work aimed at slowing the hands of time.\u003c/p>\n\u003cp>But the genesis of Peshkin’s interest in longevity goes back 43 years, to the streets of Moscow.\u003c/p>\n\u003cp>Walking in the park with his babysitter, they crossed paths with a fancy funeral — big crowd, brass band, bright red open casket. Peshkin doesn’t remember who died, but he does remember the questions it left him with: What is death? Why do we have to die? Why put someone in a box who looks so alive?\u003c/p>\n\u003cp>His parents had always answered his questions before. But this time, their explanations were inadequate and awkward. Their inability to satisfy his curiosity made as big an impression on him as the funeral.\u003c/p>\n\u003cp>His father was a scientist, first in the aviation industry and then — when he was kicked out for being Jewish — in the oil and gas business, studying how liquified gas moves through sand. Working for the state, Miron didn’t earn much, so he translated technical documents from German and English into Russian for extra cash. Peshkin’s mother, Klavdia Logvinskaya, worked herself up from lab technician to engineer, researching additives that influence the properties of metal alloys.\u003c/p>\n\u003cp>They were always demanding of their son. They told Peshkin he had to be 10 times better than everyone else to overcome the discrimination he would face as a Jew.\u003c/p>\n\u003cp>Growing up, almost all the adults Peshkin knew were the Ph.D.-level scientists who were his parents’ friends. “It was clear that science is the only thing worth doing in life,” he said. As a young boy, a family friend showed him how to memorize a string of 50 facts after just a few minutes of study. “It gave me this idea of power over nature,” he said.\u003c/p>\n\u003cp>At age 10, after watching some television hospital dramas, Peshkin remembers taking a cord from an old desk lamp and having it at the ready to shock his father’s heart, in case he went into cardiac arrest. “It’s very good he never had a heart attack, because I would have finished him,” Peshkin said dryly.\u003c/p>\n\u003cp>Peshkin came to the United States in 1995 to attend Brown University, where he trained in statistical machine learning, a type of artificial intelligence, before switching to systems biology. His parents joined him in Boston a decade ago as political refugees, fleeing anti-Semitism.\u003c/p>\n\u003cp>His mother, sitting in his office recently after a nearby doctor’s appointment, reminds him in Russian that he also promised to build an engine to replace their failing hearts, so they would never die.\u003c/p>\n\u003cp>He still holds onto that dream of keeping them alive.\u003c/p>\n\u003cp>“I guess I’m not a very religious man. I don’t think there is some kind of rational design or purpose,” he said. “Even if there is, I’m not ready to accept [it].”\u003c/p>\n\u003cp>\u003cstrong>Searching for Clues to Reverse Aging\u003c/strong>\u003c/p>\n\u003cp>Some of the most exciting, perhaps fanciful, biomedical research involves slowing the aging process. Research in animals is especially tantalizing. Deprive a worm of calories and it will live longer. A number of drugs extend life in animals and are being studied to see if they can reduce the risk of age-related diseases in people.\u003c/p>\n\u003cp>Many anti-aging scientists themselves pop supplements or gratefully accept diagnoses of pre-diabetes so they can start taking drugs that have shown promise.\u003c/p>\n\u003cp>Peshkin’s own research focuses on the water flea, Latin name Daphnia, an insect barely visible to the naked eye. Known primarily as food for aquarium fish, these mostly transparent crustaceans eat algae and protozoa and survive for about 40 days when kept at room temperature. (They live longer in warmer environments.)\u003c/p>\n\u003cp>It’s that “on average” that troubles Peshkin. No one knows the full range of a Daphnia’s lifespan. So, if a Daphnia lives for 60 days while given a particular drug, is that a potential silver bullet or simply the water flea equivalent of human outlier, akin to his father living to 96? Or if they continue having offspring and resist turning opaque — the water flea version of going gray — does that mean that he’s extended their “healthspan,” which is the true goal of all anti-aging research?\u003c/p>\n\u003cp>Peshkin said water fleas make a good research species because of their relatively short lifespans, and because unlike flies or worms, they can be precisely dosed with medication. It’s hard to tell how much an individual fly is consuming; worms are very efficient at excreting nutrients they don’t need. Water fleas, on the other hand, have to absorb the medication Peshkin gives them, because they’re swimming in it, he said.\u003c/p>\n\u003cp>They can reproduce asexually, unless under stress, so all of his Daphnia are identical genetic clones.\u003c/p>\n\u003cp>He mentioned one cool trick with Daphnia that many middle school sciences classes try: Add caffeine to their water and you can watch their heartbeats speed up. (When Peshkin’s wife was pregnant seven yeas ago, he was worried about her addiction to coffee. He pumped tadpoles full of caffeine during their entire developmental process — and saw no issues in their offspring. His wife remains addicted.)\u003c/p>\n\u003cp>Last year, before Peshkin’s research funding didn’t come through and his water fleas died, he got encouraging early results from the fleas when he tried them on a drug called Wortmannin, shown to extend the life of fruit flies. He froze one Daphnia every day so he could later examine the genes that were turned on and off during development, and as the animal aged.\u003c/p>\n\u003cp>Now, he’s starting to build up his colony again in collaboration with Marc Kirschner, the founding director of Harvard’s systems biology department. “Our target is getting a steady supply of old animals. It’s trickier than it sounds,” he said.\u003c/p>\n\u003cp>He compares his scientific process to the child’s game Twenty Questions. “I use drugs as questions,” he said, interrogating them to see if they can extend the life of water fleas, and therefore, potentially, humans. “I want to find the minimal number of questions that allow you to get an answer.”\u003c/p>\n\u003cfigure class=\"clear\">\n\u003cfigure class=\"wp-caption aligncenter\" style=\"max-width: 1024px\">\u003ca href=\"https://www.statnews.com/wp-content/uploads/2018/06/0613_STAT_LeonidPeshkin001.jpg\">\u003cimg class=\"extendsBeyondTextColumn\" src=\"https://www.statnews.com/wp-content/uploads/2018/06/0613_STAT_LeonidPeshkin001-1024x683.jpg\" alt=\"Leon Peshkin 01\" width=\"1024\" height=\"683\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Peshkin in his office at Harvard Medical School. His genome will become the reference for labs all over the world. (Ruby Wallau/STAT)\u003c/figcaption>\u003c/figure>\n\u003c/figure>\n\u003cp>\u003cstrong>Henrietta Lacks 2.0\u003c/strong>\u003c/p>\n\u003cp>The human cells used most often in research labs around the world came originally from a Maryland woman named \u003ca href=\"http://www.lacksfamily.net/\" target=\"_blank\" rel=\"noopener\">Henrietta Lacks\u003c/a>, who died of cervical cancer in 1951. The doctors who treated her did not get her permission before shipping descendants of her cells all over the world. The ethics of that were questionable back then and are certainly unacceptable today.\u003c/p>\n\u003cp>So when Harvard geneticist George Church set out to amass human genome, health and trait data for research, he made informed consent a huge part of the process.\u003c/p>\n\u003cp>Miron was the 15th person to sign up for the Personal Genome Project, which now counts hundreds of participants; Peshkin and his mother soon followed. The three don’t share the privacy concerns some people have about making their genetic information public.\u003c/p>\n\u003cp>“I didn’t invent my genome,” Peshkin said. “This idea that it’s mine in the sense of property is sort of foreign to me.”\u003c/p>\n\u003cp>His mother said she can’t imagine ways that publishing her genome might hurt her. “This is for science and scientists,” Logvinskaya said in Russian, while Peshkin translated. “Those are not villains. Those are not random people.”\u003c/p>\n\u003cp>A few years after volunteering their information, Personal Genome Project organizers approached the family with a request: Would they participate in a federally funded effort to develop a standard for genetic sequencing?\u003c/p>\n\u003cp>Other fields set standards. A cylinder of platinum-iridium alloy, for instance, sits in a basement vault in the U.K., providing the \u003ca href=\"http://www.npl.co.uk/reference/faqs/where-and-how-is-the-uks-national-standard-kilogram-stored-(faq-mass-and-density)\" target=\"_blank\" rel=\"noopener\">reference weight\u003c/a> used around the world for a kilogram.\u003c/p>\n\u003cp>But when scientists sequence a genome, they have no way of knowing the accuracy of that sequence or whether it’s good enough, because they have no high-quality benchmark to compare it to. It’s that benchmark that the Genome in a Bottle project is working to create, said Justin Zook, a scientist at the National Institute of Standards and Technology and co-leader of the initiative. In addition to the Peshkin family, they’ve now sequenced one pilot genome and one man of Han Chinese descent. They plan to add that man’s parents soon, and eventually others that reflect more ethnic and racial diversity, Zook said.\u003c/p>\n\u003cdiv>\n\u003cdiv>\n\u003cdiv>\n\u003cp>Peshkin said he briefly contemplated one far-out concern with the project: If his was the reference genome, could his own body become valuable to a scientist who wanted to, say, test an Alzheimer’s drug on the real person it was designed to treat?\u003c/p>\n\u003c/div>\n\u003c/div>\n\u003c/div>\n\u003cp>“If my brain is the best brain for the experiment because they’ve been working with cells derived from me, maybe there’s suddenly a price on my head,” Peshkin said. “It’s more like a great plot for a movie, and I dismissed it because I thought it’s a very, very unlikely scenario to worry about.”\u003c/p>\n\u003cp>So he agreed.\u003c/p>\n\u003cp>Data associated with the Genome in a Bottle samples were downloaded to about 15,000 computers worldwide in 2017, Zook said, suggesting that there’s a strong appetite for the information.\u003c/p>\n\u003cp>Weirdly, Peshkin won’t be able to study his own samples; it wouldn’t be safe. Like Henrietta Lacks’ original cells, the ones he donated have been modified to reproduce indefinitely, which is essential for their scientific usefulness. But that makes them extremely dangerous to Peshkin himself — and only him. If he comes into contact with his own modified cells, his body won’t recognize them as foreign. “They will keep multiplying and growing on me and eventually will kill me,” he said matter-of-factly.\u003c/p>\n\u003cfigure class=\"clear\">\n\u003cfigure class=\"wp-caption aligncenter\" style=\"max-width: 1024px\">\u003ca href=\"https://www.statnews.com/wp-content/uploads/2018/06/0613_STAT_LeonidPeshkin010.jpg\">\u003cimg class=\"extendsBeyondTextColumn\" src=\"https://www.statnews.com/wp-content/uploads/2018/06/0613_STAT_LeonidPeshkin010-1024x683.jpg\" alt=\"Leon Peshkin 05\" width=\"1024\" height=\"683\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">Peshkin exercises his father’s arm to activate his muscles and get the blood flowing. (Ruby Wallau/STAT)\u003c/figcaption>\u003c/figure>\n\u003c/figure>\n\u003cp>\u003cstrong>Privacy vs. Science\u003c/strong>\u003c/p>\n\u003cp>The Personal Genome Project is now considering what tissue to collect from Miron when his heart or another organ finally gives out, said Michael F. Chou, a lecturer in genetics and director of human subjects research for the project.\u003c/p>\n\u003cp>Miron’s gene sequence and tissue will be publicly available and connected with his health records; \u003ca href=\"https://www.broadinstitute.org/blog/gtex-useful-expression-cancer-research\" target=\"_blank\" rel=\"noopener\">other\u003c/a> gene expression data from tissue has been anonymized. Without that personal data, researchers can’t know if their pancreatic tissue sample came from a diabetic who died of a heart attack in his 50s, for instance, or from someone like Miron, who has lived nearly two decades longer than the average American male.\u003c/p>\n\u003cp>It may sound morbid to contemplate such ideas. But though Peshkin still sees death as pointless and illogical, it would be even more meaningless in his view to bury an intact body in the ground where it can do no good.\u003c/p>\n\u003cp>“I think the best we can do is leave our body to science, even though a lot of science is also a waste,” Peshkin said. “I think that science is the best thing we have.”\u003c/p>\n\u003cp>There isn’t much more time left to make these kinds of decisions.\u003c/p>\n\u003cp>Over the last two weeks Miron has slipped further away. Peshkin is sure his father, whose 97th birthday is July 9, can still hear him. But Miron is not as responsive as he was, his eyes are less alert, his stare more vacant. Peshkin would have given up already if his father hadn’t bounced back twice before, though he concedes that chances are now slim.\u003c/p>\n\u003cp>His father’s palliative care team has scheduled a meeting for Wednesday afternoon. Peshkin expects they will pressure him to dial back on Miron’s aggressive medical care, potentially hastening his demise.\u003c/p>\n\u003cp>He wonders aloud when he will be ready to accept what he still doesn’t think should be inevitable.\u003c/p>\n\u003cp>“I think I will try to fend it off for a little longer,” Peshkin said.\u003c/p>\n\u003cp>\u003cem>Correction: An earlier version of this story misclassified Daphnia on first reference and Peshkin’s field of research.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This story was originally published by \u003ca href=\"https://www.statnews.com/2018/06/20/anti-aging-researcher-father-death/\" target=\"_blank\" rel=\"noopener\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"title": "Little Evidence for Alternative Autism Treatment Sold by 'Brain Balance' Franchise",
"headTitle": "KQED Future of You | KQED Science",
"content": "\u003cp>Some parents see it coming. Natalie was not that kind of parent.[contextly_sidebar id=\"uOHnnzKYOmBeTGoKuvAQzedxhPZkeU99\"]\u003c/p>\n\u003cp>Even after the director and a teacher at her older son's day care sat her down one afternoon in 2011 to detail the 3-year-old's difficulty socializing and his tendency to chatter endlessly about topics his peers showed no interest in, she still didn't get the message.\u003c/p>\n\u003cp>Her son, the two educators eventually spelled out, might be on the autism spectrum.\u003c/p>\n\u003cp>\"I was in tears at the end,\" she says. \"When I got home, I was just devastated.\"\u003c/p>\n\u003cp>Natalie broke the news to her wife, Stephanie, whose mind fast-forwarded to a distressing future. Would her son — a squat, cheerful boy who, despite his affectionate nature, didn't have any playmates — ever be able to make friends?\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>When a doctor eventually confirmed he had an autism spectrum disorder, the diagnosis came with a suggestion: Perhaps the boy would benefit from Prozac when he turned 7.\u003c/p>\n\u003cp>\"That was when both of us fell apart in that meeting,\" Natalie says. For both parents, medication wasn't an option.\u003c/p>\n\u003cp>\"Prozac is a very powerful drug for adults. Why would you give it to a 7-year-old?\" Stephanie wondered after the doctor's visit. \"I welled up with all of this emotion. And I said I will not let that happen.\"[contextly_sidebar id=\"4sXIngF1woiIEbdfxhHX6lYzTUKP5vdD\"]\u003c/p>\n\u003cp>(To protect their privacy, we are only using Natalie's and Stephanie's first names. We are not naming their children.)\u003c/p>\n\u003cp>The fear of psychotropic drugs led the family to pursue alternative treatments for autism.\u003c/p>\n\u003cp>To start, they dropped gluten.\u003c/p>\n\u003cp>Then one day, as Natalie roamed the aisles of a gluten-free expo in a Chicago suburb not far from where the family lives, she came across a booth for a Brain Balance Achievement Center.\u003c/p>\n\u003cp>Natalie says the program claimed to help with disorders ranging from dyslexia to ADHD and autism. Best of all, it didn't involve prescription drugs.\u003c/p>\n\u003cp>\"We were very excited,\" Stephanie says. \"Maybe we found a solution that wasn't going to be about medicine. I was very, very hopeful.\"\u003c/p>\n\u003cp>\"\u003cstrong>It will completely, absolutely, 100 percent change your life\"\u003c/strong>\u003c/p>\n\u003cp>Natalie had stumbled upon one of 113 Brain Balance franchises across the country. Seventeen more are in the works. In the dozen years since its inception, Brain Balance says, it has helped roughly 25,000 children. The company says it is currently taking in over $50 million in annual revenue.\u003c/p>\n\u003cp>Although Brain Balance isn't the only purveyor of alternative approaches for developmental disorders in the U.S., the scale of the enterprise sets it apart. The company's approach is still relatively new and not widely known, meaning many experts in the field of childhood development have not vetted its effectiveness.\u003c/p>\n\u003cp>Brain Balance says its nonmedical and drug-free program helps children who struggle with ADHD, autism spectrum disorders and learning and processing disorders. The company says it addresses a child's challenges with a combination of physical exercises, nutritional guidance and academic training.\u003c/p>\n\u003cp>An NPR investigation of Brain Balance reveals a company whose promises have resonated with parents averse to medication. But Brain Balance also appears to have overstated the scientific evidence in its messaging to families, who can easily spend over $10,000 in six months, a common length of enrollment.\u003c/p>\n\u003cp>Brain Balance's metrics for consumer satisfaction are impressive. Customers rate the program, on average, an 8.5 on a 10-point scale in surveys, according to the company.\u003c/p>\n\u003cp>The ratings square with comments in online forums and in interviews NPR conducted with 18 parents who enrolled their children. Across the country, about three dozen centers are run by parents who began as happy customers.\u003c/p>\n\u003cp>\u003ca href=\"https://www.brainbalancecenters.com/\" target=\"_blank\" rel=\"noopener\">Brain Balance's website\u003c/a> is where caretakers encounter the company's strongest pitch: dozens upon dozens of \u003ca href=\"https://www.brainbalancecenters.com/our-stories/\" target=\"_blank\" rel=\"noopener\">parent testimonials\u003c/a>.\u003c/p>\n\u003cp>One of the company's \u003ca href=\"https://www.youtube.com/watch?v=OAaow0Kk0g8\" target=\"_blank\" rel=\"noopener\">television commercials\u003c/a> begins with a montage of formerly frustrated mothers. But, they all agree, Brain Balance put an end to their kids' challenges. One woman insists \"it will completely, absolutely, 100 percent change your life.\"\u003c/p>\n\u003cp>\u003cstrong>Autism \"can become a thing of the past\"\u003c/strong>\u003c/p>\n\u003cp>The man who created Brain Balance, Robert Melillo, is often introduced as \"Dr. Melillo\" in media appearances. He has a doctorate and an active license in chiropractic. He is also acknowledged as an expert in the field of \u003ca href=\"https://www.youtube.com/watch?v=3tQtAs3d05E\" target=\"_blank\" rel=\"noopener\">functional neurology\u003c/a>, chiropractic's \u003ca href=\"https://chiromt.biomedcentral.com/articles/10.1186/s12998-017-0151-1\" target=\"_blank\" rel=\"noopener\">controversial alternative\u003c/a> to mainstream neurology.\u003c/p>\n\u003cp>Melillo's \u003ca href=\"http://drrobertmelillo.com/about/\">biography\u003c/a> states he has master's degrees in neuroscience and clinical rehabilitation neuropsychology, though it does not say from where. A \u003ca href=\"http://members.fclb.org/staff_online/staff/uploads/individual/0_34022299_Melillo%20CV.pdf\" target=\"_blank\" rel=\"noopener\">curriculum vitae for Melillo\u003c/a> that NPR found on a website for chiropractic licensing boards says the master's in neuroscience came from the Carrick Institute for Graduate Studies, a chiropractic academy in Florida that isn't accredited by any of the agencies recognized by the Department of Education. His second master's degree is from a now-defunct program at Touro College, a private educational organization based in New York.[contextly_sidebar id=\"qHKhvNx0WtImHmg2ZAaY7Wq5YHOgE9Ba\"]\u003c/p>\n\u003cp>Melillo says it was during an intense period of research in the 1990s, while his own son struggled with attention issues, that he conceived of a single disorder to explain everything from autism to ADHD to dyslexia. He called it functional disconnection syndrome.\u003c/p>\n\u003cp>As he writes in his book, \u003cem>Disconnected Kids,\u003c/em> the syndrome occurs when \"areas in the brain, especially the two hemispheres of the brain, are not electrically balanced, or synchronized.\" The particulars of this imbalance are not clearly defined in the book, but numerous metaphors — some involving concert orchestras with bad timing or tuning — paint a picture of a child's brain unable to communicate with itself.\u003c/p>\n\u003cp>According to Melillo, a weak right hemisphere (the emotional half) can lead to autism and ADHD; a weak left hemisphere (the logical half) often causes learning disorders like dyslexia.\u003c/p>\n\u003cp>And he argues in the book that for people who follow his program, \"ADHD, dyslexia, and even autism, among others, can become a thing of the past.\"\u003c/p>\n\u003cp>He even appears to see his program as the answer to societal problems.\u003c/p>\n\u003cp>In February, one day after the mass shooting at Marjory Stoneman Douglas High School in Parkland, Fla., Melillo used his public Facebook page to envision a world where Brain Balance had reached the shooter.\u003c/p>\n\u003cp>\"I can't help but wonder if Brain Balance and Brain Integration could have prevented this tragedy,\" Melillo \u003ca href=\"https://www.facebook.com/DrRobertMelillo/photos/a.262064050637436.1073741828.262055963971578/902197553290746/?type=3&theater\" target=\"_blank\" rel=\"noopener\">wrote in the post\u003c/a> alongside a news report in which the shooter's relatives said the teenager had been diagnosed with autism and took medication.\u003c/p>\n\u003cp>\"We have to make the whole world more aware of Brain Imbalances and how they can be helped especially in kids,\" he added. \"This is my mission now.\"\u003c/p>\n\u003cp>\u003cstrong>What happens at Brain Balance\u003c/strong>\u003c/p>\n\u003cp>Stephanie and Natalie say they watched their older son from the other side of a two-way mirror as a Brain Balance staff member ran him through a series of tests during his baseline assessment. Later, they received his results: eight pages of ratings in unfamiliar categories.[contextly_sidebar id=\"AjksKQkvNBCw7ARjvhMRqANHG340k0k4\"]\u003c/p>\n\u003cp>\"I have two master's [degrees] and a Ph.D., and I needed them explained to me,\" Natalie says. Their son had a weak right hemisphere. Additionally, his \"frontal lobe acquisition\" was lacking. His primitive reflexes were also in bad shape, according to the assessment, portions of which were shared with NPR.\u003c/p>\n\u003cp>The center recommended six months of one-hour sessions three times a week, a common course of intervention.\u003c/p>\n\u003cp>Brain Balance's approach breaks down into three broad categories: academic, nutrition and sensory-motor.\u003c/p>\n\u003cp>The \u003ca href=\"https://www.brainbalancecenters.com/our-program/integrated-approach/academic/\" target=\"_blank\" rel=\"noopener\">academic exercises\u003c/a> focus on the same areas targeted by many after-school tutoring programs. The \u003ca href=\"https://www.brainbalancecenters.com/our-program/integrated-approach/nutrition/\" target=\"_blank\" rel=\"noopener\">nutritional component\u003c/a> recommends decreasing a child's intake of gluten, dairy and refined sugar.\u003c/p>\n\u003cp>The third, and most complex, prong of Brain Balance's intervention is its \u003ca href=\"https://www.brainbalancecenters.com/our-program/integrated-approach/sensory-motor/\" target=\"_blank\" rel=\"noopener\">sensory-motor training\u003c/a>, a diverse set of physical exercises. Parents and former employees describe activities like walking across balance beams, syncing actions with a computerized metronome and being spun in swivel chairs.[contextly_sidebar id=\"X9IS4CBjwH4LHwMmOzWNlEgWq0OztSoK\"]\u003c/p>\n\u003cp>Consistent with Melillo's theory, Brain Balance focuses much of its sensory-motor training on one-half of the child's body to send strengthening signals up and across to the supposedly weak, opposite hemisphere of the brain. (Much of the human brain indeed \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/23931149\">maps to the opposite\u003c/a> half of the human body.)\u003c/p>\n\u003cp>For instance, with a \"right brain weak\" child like Stephanie and Natalie's son, Brain Balance may have him wear a vibrating armband on his left biceps or eyeglasses that allow light only onto the left visual field. Or they may simply have him stand on his left leg.\u003c/p>\n\u003cp>It has not been uncommon for parents to enroll their children for at least six months, costing roughly $12,000. The company recently said its average enrollment is now about four months. Assessments and optional nutritional supplements and blood tests can add hundreds of dollars.\u003c/p>\n\u003cp>The program isn't covered by insurance. Brain Balance offers payment plans to parents who can't cover the cost immediately. As of publication, close to 200 families have solicited money from relatives and friends with \u003ca href=\"https://www.gofundme.com/mvc.php?route=category&term=%22brain%20balance%22\" target=\"_blank\" rel=\"noopener\">GoFundMe.com\u003c/a> campaigns.\u003c/p>\n\u003cp>Natalie and Stephanie were quoted $5,000 for their first three months, with the option to re-up for more after.\u003c/p>\n\u003cp>\"When you're talking about your child's self-esteem and knowing it's the most important thing, what are you going to do?\" Stephanie says. \"Maybe work a few more years and take a little bit out of your retirement so that maybe — if you nip this thing in the bud — he's able to have a better life going forward?\"\u003c/p>\n\u003cp>They dipped into their retirement savings and enrolled both their sons at a total cost of more than $15,000.\u003c/p>\n\u003cp>\"\u003cstrong>Cutting edge\" science\u003c/strong>\u003c/p>\n\u003cp>In numerous media appearances, Melillo hasn't been shy about publicizing the strength of his program's scientific evidence.\u003c/p>\n\u003cp>\"This isn't smoke and mirrors. This is real stuff. ... [Parents] are going to get real answers,\" Melillo \u003ca href=\"https://youtu.be/uaMbTtcFhvU?t=5m16s\" target=\"_blank\" rel=\"noopener\">told a radio host in 2010\u003c/a>. \"We've shown in our centers that we can correct these problems completely. We've proved that in research,\" he \u003ca href=\"https://youtu.be/7XJ8ouQgmtA?t=1m56s\" target=\"_blank\" rel=\"noopener\">said on TV in 2014\u003c/a>. \"We use really cutting-edge brain science to address the issue,\" he \u003ca href=\"https://youtu.be/KhmgeWUrkwo?t=49s\" target=\"_blank\" rel=\"noopener\">said in 2016\u003c/a>.\u003c/p>\n\u003cp>Yet a dozen experts in autism spectrum disorder, ADHD, dyslexia and childhood psychiatry interviewed by NPR all identified flaws in Brain Balance's approach.\u003c/p>\n\u003cp>They said the company's idea of imbalanced hemispheres was too simplistic and built upon the popular, discredited myth of the logical left brain and the intuitive right brain.[contextly_sidebar id=\"cWTrlOd6AlGxpGOvjVNIxgehcBIwY6uh\"]\u003c/p>\n\u003cp>\"It doesn't make sense,\" says \u003ca href=\"https://www.kennedykrieger.org/professional-training/training-disciplines/special-education-fellowship/leadership/mark-mahone-phd\" target=\"_blank\" rel=\"noopener\">Mark Mahone\u003c/a>, a pediatric neuropsychologist at the Kennedy Krieger Institute in Baltimore. \"In virtually every activity that one does ... both hemispheres of the brain are very, very active. ... It's not as simple as just being a left- or a right-hemisphere problem. Nothing is that simple.\"\u003c/p>\n\u003cp>As for the three-pronged Brain Balance regimen, experts NPR spoke with said there is no solid evidence suggesting gluten, dairy or sugar consumption affects ADHD, autism or dyslexia. And although physical exercise may have modest impacts on inattention and tutoring can help in school, these interventions can be found elsewhere for much less money. No expert suggested either as a front-line remedy for ADHD or autism.\u003c/p>\n\u003cp>Doctors and researchers NPR interviewed also questioned the diagnostic metrics Brain Balance uses.\u003c/p>\n\u003cp>For example, the company tests children for the primitive reflexes that drive infants to instinctively suckle or grab a finger. Natalie and Stephanie were told their son's lingering primitive reflexes were connected to his behavioral issues.\u003c/p>\n\u003cp>But multiple pediatricians said it is exceptionally rare for children older than 4 to retain any primitive reflexes.\u003c/p>\n\u003cp>\"Typically by 1 year of age these primitive reflexes have disappeared,\" says Dr. Andrew Adesman, a developmental pediatrician at Cohen Children's Medical Center of New York. \"The major exception is children who have cerebral palsy.\"\u003c/p>\n\u003cp>Melillo disagreed with the experts' opinions. \"I think they're completely wrong,\" he says.\u003c/p>\n\u003cp>\"Pediatricians rarely look at primitive reflexes after infancy, but if they did, they will find that, in many cases, they are still there,\" he wrote in an email.\u003c/p>\n\u003cp>Melillo also pushed back against the medical consensus that autism, ADHD and dyslexia aren't caused by hemispheric differences and that gluten doesn't affect such disorders.\u003c/p>\n\u003cp>\"I can show you a lot of papers that actually say that there is a relationship between food sensitivities, gluten sensitivity and different types of issues and conditions,\" he says. \"So again, it depends on the expert.\"\u003c/p>\n\u003cp>\"\u003cstrong>Evidence based\"?\u003c/strong>\u003c/p>\n\u003cp>There are two published studies of Brain Balance, which the company has said show that 81 percent of children with ADHD no longer displayed symptoms after three months in the program.\u003c/p>\n\u003cp>\"We have two studies now,\" Melillo said \u003ca href=\"https://youtu.be/AVp295htBVI?t=4m52s\" target=\"_blank\" rel=\"noopener\">on local TV\u003c/a> in 2013. \"So that means that we qualify as what we call 'evidence based' at this point.\"\u003c/p>\n\u003cp>Brain Balance \u003ca href=\"https://blog.brainbalancecenters.com/2013/07/control-study-shows-brain-balance-eliminates-adhd-symptoms\" target=\"_blank\" rel=\"noopener\">touted one of the studies on its blog\u003c/a> with the headline, \"Control Study Shows Brain Balance Eliminates ADHD Symptoms.\"\u003c/p>\n\u003cp>The studies, however, have serious scientific shortcomings.\u003c/p>\n\u003cp>Melillo, someone with a clear financial interest in the outcome, co-authored \u003ca href=\"http://www.carolinabraincenter.com/wp-content/uploads/2014/03/The_effect_of_hemisphere_specific_remediation_strategies_on_the_academic_performance_outcome_of_children_with_ADD_ADHD_.pdf\" target=\"_blank\" rel=\"noopener\">the first one\u003c/a>.\u003c/p>\n\u003cp>He also had parents rate their own children's improvement in ADHD symptoms but \u003ca href=\"https://www.documentcloud.org/documents/4420809-2010-BB-Study.html#document/p5/a415343\" target=\"_blank\" rel=\"noopener\">didn't compare\u003c/a> them with other kids who weren't in Brain Balance.[contextly_sidebar id=\"40It7ERz2X1PbU5Xz4PrJhqRCedRiEbu\"]\u003c/p>\n\u003cp>Without a control group, a study cannot definitively determine whether an intervention — a pill or procedure or program — is the reason for improvement or whether any change is simply the placebo effect.\u003c/p>\n\u003cp>The \u003ca href=\"http://www.feingold.org/Research/PDFstudies/Leisman2013.pdf\" target=\"_blank\" rel=\"noopener\">second study\u003c/a> did feature a control group of children with ADHD who didn't do Brain Balance. But it compared them with the same children from the first study published years earlier instead of randomly assigning children into simultaneous treatment and control groups.\u003c/p>\n\u003cp>\"My issue with these data is that there's no legitimate comparison for the treatment group, so we really don't know if [Brain Balance] helps,\" says Dr. Paul Wang, deputy director for clinical research at the Simons Foundation.\u003c/p>\n\u003cp>The experts NPR consulted took issue with other aspects of the studies as well.\u003c/p>\n\u003cp>The kids in the treatment and control groups \u003ca href=\"https://www.documentcloud.org/documents/4420810-2013-BB-Study.html#document/p3/a415322\" target=\"_blank\" rel=\"noopener\">differed in important ways\u003c/a>, the experts said, rendering comparisons between them less meaningful. The two groups weren't drawn from the same centers; all of the treatment group was medicated while only 60 percent of the controls were; and at baseline the controls scored more severe on an ADHD rating scale.\u003c/p>\n\u003cp>Curiously, even though the \u003ca href=\"https://www.documentcloud.org/documents/4420810-2013-BB-Study.html#document/p5/a429871\" target=\"_blank\" rel=\"noopener\">second\u003c/a> study reused the treatment group data from the \u003ca href=\"https://www.documentcloud.org/documents/4420809-2010-BB-Study.html#document/p6/a415327\" target=\"_blank\" rel=\"noopener\">first\u003c/a> study published years earlier, it reported different improvements on those same kids' test scores. The lead author on both studies, Gerry Leisman, a professor of neuro and rehabilitation sciences at the University of Haifa in Israel, explained one of the test score differences as a \"reviewer correction\" but did not provide explanations for any of the six remaining discrepancies.\u003c/p>\n\u003cp>Dr. James McGough, a professor of clinical psychiatry at UCLA's David Geffen Medical School, wasn't convinced by Brain Balance's published research. \"It means absolutely nothing. ... What we have here, in my view, is a marketing piece.\"[contextly_sidebar id=\"ul2FBC3owyMkUEM8UijiLxV0mmmsmz4s\"]\u003c/p>\n\u003cp>At least one state remains similarly unconvinced.\u003c/p>\n\u003cp>In 2015, Wisconsin's Department of Health Services determined Brain Balance had \"\u003ca href=\"https://www.dhs.wisconsin.gov/tiac/brain-balance-january-2015.pdf\" target=\"_blank\" rel=\"noopener\">insufficient evidence\u003c/a>\" to show it was a \"proven and effective treatment for individuals with autism spectrum disorder and/or other developmental disabilities,\" as the \u003cem>Milwaukee Journal-Sentinel \u003c/em>\u003ca href=\"http://archive.jsonline.com/business/company-pushes-brain-balancing-program-for-learning-disabilities-evidence-lacking-b99551698z1-324854621.html\">reported\u003c/a>. The state assigned Brain Balance to the second-lowest ranking on its five-tier system. The only lower ranking is for \"potentially harmful\" treatments.\u003c/p>\n\u003cp>\u003cstrong>Brain Balance defends its approach\u003c/strong>\u003c/p>\n\u003cp>Asked by NPR why Brain Balance hadn't been tested more thoroughly before its nationwide expansion began a decade ago, Melillo says the company was \"faced with a dilemma.\" While he did feel an obligation to validate his approach, he says he knew Brain Balance worked and didn't want to deprive his clients of its benefits while waiting for clinical trials. \"All these 25,000 families that we've helped, are they left suffering for years on end?\"\u003c/p>\n\u003cp>\"What was done to date was commensurate to the resources that we had,\" says Aleem Choudhry, the chairman of Brain Balance and a managing member at Crane Street Capital, which invested in the franchise in 2013.\u003c/p>\n\u003cp>The company says ADHD was the only disorder to be studied thus far because — contrary to the opinion of all the experts contacted by NPR — it is neurologically equivalent to others like autism, dyslexia and OCD. If Brain Balance improves ADHD symptoms, Melillo says, \"then we believe that we're going to get the same results in the other types of issues, because they're really the same problem.\"\u003c/p>\n\u003cp>Melillo also says the company's proprietary records from about 80,000 before-and-after client assessments qualify as corroboration. Melillo disputed the idea that his company's own data may require third-party review. \"Data is data,\" he says. \"There's no bias in the way we collect this.\"\u003c/p>\n\u003cp>A new study of a \u003ca href=\"https://drteicher.wordpress.com/2015/11/20/non-pharmacological-treatment-for-adhd/\" target=\"_blank\" rel=\"noopener\">computerized version of Brain Balance\u003c/a> is underway at a Harvard-affiliated hospital and features a concurrent control group of children.\u003c/p>\n\u003cp>But Melillo says that questions about the research behind Brain Balance ultimately miss a larger, more important point.\u003c/p>\n\u003cp>\"Families are out there struggling and suffering, and they don't really give a crap about the data or the research, to be quite honest,\" he says. \"When they go through it and they see the difference in their child ... that's what matters to them.\"\u003c/p>\n\u003cp>Choudhry, the company's chairman, later clarified that \"we very much do care about the data.\"\u003c/p>\n\u003cp>\u003cstrong>No easy answer\u003c/strong>\u003c/p>\n\u003cp>With both their boys enrolled in Brain Balance, the routine for Stephanie and Natalie's family was frantic.\u003c/p>\n\u003cp>Three times a week, Stephanie would ferry their sons against traffic to and from their sessions. Family dinners became more rushed. Soccer and swimming were abandoned.\u003c/p>\n\u003cp>Lost time is often a hidden cost of any form of treatment.\u003c/p>\n\u003cp>The mothers began observing changes in their older son. They say his previously weak sense of smell suddenly blossomed, first for brownies and then other foods. And he became less obsessed with characters he had repetitively sketched in his notebooks and imbued with rich inner lives. (His parents are torn as to whether this was a positive development.) He also advanced in certain Brain Balance measures, including his primitive reflexes.\u003c/p>\n\u003cp>\"It's not that the needle didn't move on some of those dimensions,\" says Natalie. \"But if you step back at the 10,000- or 100,000-foot view and say, 'Is this kid different in a way that his life is going to be better or altered?' the answer is 'No.' OK, so now he can smell brownies that he couldn't smell before but is his life different?\"\u003c/p>\n\u003cp>She says she and her wife began to feel discouraged, thinking about the \"aura around this program that says your child's going to be different and better-adjusted.\"\u003c/p>\n\u003cp>Eric Rossen of the National Association of School Psychologists isn't surprised by Brain Balance's popularity as an option beyond what schools and insurance will cover.\u003c/p>\n\u003cp>He says many parents are frustrated by mainstream medicine's limits when it comes to complex disorders like autism. And schools are sometimes too strapped for resources to provide students with learning disorders all the help their parents may want.\u003c/p>\n\u003cp>\"Most parents will say they would die for their children,\" Rossen says. \"So to say, 'I want to provide some therapy and pay a few thousand dollars' is quite short of dying for them and it's totally reasonable.\"[contextly_sidebar id=\"trKt9lVGGL2hYvUb63mGVzd7zTqN7BTZ\"]\u003c/p>\n\u003cp>But he says \"the problem is they are easy prey for certain providers that can make promises that cannot necessarily be kept or are not necessarily backed by scientific data.\"\u003c/p>\n\u003cp>For parents looking to find evidence-based third-party interventions, experts suggest the \u003ca href=\"https://ies.ed.gov/ncee/wwc/\" target=\"_blank\" rel=\"noopener\">What Works Clearinghouse\u003c/a>, which is backed by the Department of Education, or the Substance Abuse and Mental Health Services Administration's \u003ca href=\"https://www.samhsa.gov/nrepp\" target=\"_blank\" rel=\"noopener\">own resource\u003c/a>.\u003c/p>\n\u003cp>Brain Balance's protocol doesn't appear to pose any physical or developmental harms to children. Instead, the program's costs may come in other ways: siphoning away time and money, and prolonging the hope in some parents that their child may one day shed his or her disorder.\u003c/p>\n\u003cp>Dr. Susan Hyman, a professor of pediatrics at the University of Rochester who has studied autism treatments for decades, says many alternative providers do this by offering an unrealistically simple solution.\u003c/p>\n\u003cp>\"If you were to come to a traditional provider who said, 'You know I'm going to have you work really, really, really hard. ... I might have some drugs. Drugs have side effects. And 90 percent of the time, as an adult, he is still going to have autism,' that's a far less attractive message than 'I can help you.' \"\u003c/p>\n\u003cp>\u003cstrong>Beyond Brain Balance\u003c/strong>\u003c/p>\n\u003cp>By the end of their older son's second three-month session at Brain Balance, Stephanie and Natalie had completely soured on it. They stopped believing that vibrating armbands and spinning in swivel chairs would translate to social success.\u003c/p>\n\u003cp>They decided to not continue.\u003c/p>\n\u003cp>Later, in second grade, their older son began to work with a social worker at school who taught him how to have socially acceptable conversation with his peers.\u003c/p>\n\u003cp>And Stephanie and Natalie did something else — the unthinkable.\u003c/p>\n\u003cp>They put their son on a medication called Strattera. Calibrating the proper dosage with tolerable side effects was a drawn-out process, but eventually they reached an equilibrium. Their older son ended up with a new diagnosis that has some overlap with autism but is more consistent with ADHD, which the medication treats.[contextly_sidebar id=\"Mk0Q9RIDdUaNoWDya3YvMRUEK35nUdWD\"]\u003c/p>\n\u003cp>Today, he seems to be navigating the world more successfully than before.\u003c/p>\n\u003cp>On a Saturday last August, their older son — who once plaintively asked his parents, \"Why aren't I invited to birthday parties?\" — had just wrapped up a party to celebrate turning 10 years old.\u003c/p>\n\u003cp>Natalie and Stephanie had pizzas delivered and rented a truck lined with pleather sofas on one side and video game systems along the other. The children sat in pairs and used their greasy fingers to dispatch their avatars against each other in virtual battle.\u003c/p>\n\u003cp>\"They were yelling my son's name and saying 'Come play with me! Come play with me!' \" recalls Natalie.\u003c/p>\n\u003cp>The birthday boy says he invited almost all of his friends, from school and camp, and all but one showed up, which was more than he could have ever imagined before.\u003c/p>\n\u003cp>\"Because,\" he says before pausing. \"I haven't had friends for a bit. Until I got my medicine. I got some treatment. I got help. Now, I have tons of friends.\"\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>The reporter, Chris Benderev, can be contacted at cbenderev@npr.org.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=%27Cutting+Edge%27+Program+For+Children+With+Autism+And+ADHD+Rests+On+Razor-Thin+Evidence&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"excerpt": "With 113 locations in the U.S., Brain Balance says its drug-free approach has helped tens of thousands of children. But experts say there's insufficient proof of its effectiveness.",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Some parents see it coming. Natalie was not that kind of parent.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Even after the director and a teacher at her older son's day care sat her down one afternoon in 2011 to detail the 3-year-old's difficulty socializing and his tendency to chatter endlessly about topics his peers showed no interest in, she still didn't get the message.\u003c/p>\n\u003cp>Her son, the two educators eventually spelled out, might be on the autism spectrum.\u003c/p>\n\u003cp>\"I was in tears at the end,\" she says. \"When I got home, I was just devastated.\"\u003c/p>\n\u003cp>Natalie broke the news to her wife, Stephanie, whose mind fast-forwarded to a distressing future. Would her son — a squat, cheerful boy who, despite his affectionate nature, didn't have any playmates — ever be able to make friends?\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>When a doctor eventually confirmed he had an autism spectrum disorder, the diagnosis came with a suggestion: Perhaps the boy would benefit from Prozac when he turned 7.\u003c/p>\n\u003cp>\"That was when both of us fell apart in that meeting,\" Natalie says. For both parents, medication wasn't an option.\u003c/p>\n\u003cp>\"Prozac is a very powerful drug for adults. Why would you give it to a 7-year-old?\" Stephanie wondered after the doctor's visit. \"I welled up with all of this emotion. And I said I will not let that happen.\"\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>(To protect their privacy, we are only using Natalie's and Stephanie's first names. We are not naming their children.)\u003c/p>\n\u003cp>The fear of psychotropic drugs led the family to pursue alternative treatments for autism.\u003c/p>\n\u003cp>To start, they dropped gluten.\u003c/p>\n\u003cp>Then one day, as Natalie roamed the aisles of a gluten-free expo in a Chicago suburb not far from where the family lives, she came across a booth for a Brain Balance Achievement Center.\u003c/p>\n\u003cp>Natalie says the program claimed to help with disorders ranging from dyslexia to ADHD and autism. Best of all, it didn't involve prescription drugs.\u003c/p>\n\u003cp>\"We were very excited,\" Stephanie says. \"Maybe we found a solution that wasn't going to be about medicine. I was very, very hopeful.\"\u003c/p>\n\u003cp>\"\u003cstrong>It will completely, absolutely, 100 percent change your life\"\u003c/strong>\u003c/p>\n\u003cp>Natalie had stumbled upon one of 113 Brain Balance franchises across the country. Seventeen more are in the works. In the dozen years since its inception, Brain Balance says, it has helped roughly 25,000 children. The company says it is currently taking in over $50 million in annual revenue.\u003c/p>\n\u003cp>Although Brain Balance isn't the only purveyor of alternative approaches for developmental disorders in the U.S., the scale of the enterprise sets it apart. The company's approach is still relatively new and not widely known, meaning many experts in the field of childhood development have not vetted its effectiveness.\u003c/p>\n\u003cp>Brain Balance says its nonmedical and drug-free program helps children who struggle with ADHD, autism spectrum disorders and learning and processing disorders. The company says it addresses a child's challenges with a combination of physical exercises, nutritional guidance and academic training.\u003c/p>\n\u003cp>An NPR investigation of Brain Balance reveals a company whose promises have resonated with parents averse to medication. But Brain Balance also appears to have overstated the scientific evidence in its messaging to families, who can easily spend over $10,000 in six months, a common length of enrollment.\u003c/p>\n\u003cp>Brain Balance's metrics for consumer satisfaction are impressive. Customers rate the program, on average, an 8.5 on a 10-point scale in surveys, according to the company.\u003c/p>\n\u003cp>The ratings square with comments in online forums and in interviews NPR conducted with 18 parents who enrolled their children. Across the country, about three dozen centers are run by parents who began as happy customers.\u003c/p>\n\u003cp>\u003ca href=\"https://www.brainbalancecenters.com/\" target=\"_blank\" rel=\"noopener\">Brain Balance's website\u003c/a> is where caretakers encounter the company's strongest pitch: dozens upon dozens of \u003ca href=\"https://www.brainbalancecenters.com/our-stories/\" target=\"_blank\" rel=\"noopener\">parent testimonials\u003c/a>.\u003c/p>\n\u003cp>One of the company's \u003ca href=\"https://www.youtube.com/watch?v=OAaow0Kk0g8\" target=\"_blank\" rel=\"noopener\">television commercials\u003c/a> begins with a montage of formerly frustrated mothers. But, they all agree, Brain Balance put an end to their kids' challenges. One woman insists \"it will completely, absolutely, 100 percent change your life.\"\u003c/p>\n\u003cp>\u003cstrong>Autism \"can become a thing of the past\"\u003c/strong>\u003c/p>\n\u003cp>The man who created Brain Balance, Robert Melillo, is often introduced as \"Dr. Melillo\" in media appearances. He has a doctorate and an active license in chiropractic. He is also acknowledged as an expert in the field of \u003ca href=\"https://www.youtube.com/watch?v=3tQtAs3d05E\" target=\"_blank\" rel=\"noopener\">functional neurology\u003c/a>, chiropractic's \u003ca href=\"https://chiromt.biomedcentral.com/articles/10.1186/s12998-017-0151-1\" target=\"_blank\" rel=\"noopener\">controversial alternative\u003c/a> to mainstream neurology.\u003c/p>\n\u003cp>Melillo's \u003ca href=\"http://drrobertmelillo.com/about/\">biography\u003c/a> states he has master's degrees in neuroscience and clinical rehabilitation neuropsychology, though it does not say from where. A \u003ca href=\"http://members.fclb.org/staff_online/staff/uploads/individual/0_34022299_Melillo%20CV.pdf\" target=\"_blank\" rel=\"noopener\">curriculum vitae for Melillo\u003c/a> that NPR found on a website for chiropractic licensing boards says the master's in neuroscience came from the Carrick Institute for Graduate Studies, a chiropractic academy in Florida that isn't accredited by any of the agencies recognized by the Department of Education. His second master's degree is from a now-defunct program at Touro College, a private educational organization based in New York.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Melillo says it was during an intense period of research in the 1990s, while his own son struggled with attention issues, that he conceived of a single disorder to explain everything from autism to ADHD to dyslexia. He called it functional disconnection syndrome.\u003c/p>\n\u003cp>As he writes in his book, \u003cem>Disconnected Kids,\u003c/em> the syndrome occurs when \"areas in the brain, especially the two hemispheres of the brain, are not electrically balanced, or synchronized.\" The particulars of this imbalance are not clearly defined in the book, but numerous metaphors — some involving concert orchestras with bad timing or tuning — paint a picture of a child's brain unable to communicate with itself.\u003c/p>\n\u003cp>According to Melillo, a weak right hemisphere (the emotional half) can lead to autism and ADHD; a weak left hemisphere (the logical half) often causes learning disorders like dyslexia.\u003c/p>\n\u003cp>And he argues in the book that for people who follow his program, \"ADHD, dyslexia, and even autism, among others, can become a thing of the past.\"\u003c/p>\n\u003cp>He even appears to see his program as the answer to societal problems.\u003c/p>\n\u003cp>In February, one day after the mass shooting at Marjory Stoneman Douglas High School in Parkland, Fla., Melillo used his public Facebook page to envision a world where Brain Balance had reached the shooter.\u003c/p>\n\u003cp>\"I can't help but wonder if Brain Balance and Brain Integration could have prevented this tragedy,\" Melillo \u003ca href=\"https://www.facebook.com/DrRobertMelillo/photos/a.262064050637436.1073741828.262055963971578/902197553290746/?type=3&theater\" target=\"_blank\" rel=\"noopener\">wrote in the post\u003c/a> alongside a news report in which the shooter's relatives said the teenager had been diagnosed with autism and took medication.\u003c/p>\n\u003cp>\"We have to make the whole world more aware of Brain Imbalances and how they can be helped especially in kids,\" he added. \"This is my mission now.\"\u003c/p>\n\u003cp>\u003cstrong>What happens at Brain Balance\u003c/strong>\u003c/p>\n\u003cp>Stephanie and Natalie say they watched their older son from the other side of a two-way mirror as a Brain Balance staff member ran him through a series of tests during his baseline assessment. Later, they received his results: eight pages of ratings in unfamiliar categories.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\"I have two master's [degrees] and a Ph.D., and I needed them explained to me,\" Natalie says. Their son had a weak right hemisphere. Additionally, his \"frontal lobe acquisition\" was lacking. His primitive reflexes were also in bad shape, according to the assessment, portions of which were shared with NPR.\u003c/p>\n\u003cp>The center recommended six months of one-hour sessions three times a week, a common course of intervention.\u003c/p>\n\u003cp>Brain Balance's approach breaks down into three broad categories: academic, nutrition and sensory-motor.\u003c/p>\n\u003cp>The \u003ca href=\"https://www.brainbalancecenters.com/our-program/integrated-approach/academic/\" target=\"_blank\" rel=\"noopener\">academic exercises\u003c/a> focus on the same areas targeted by many after-school tutoring programs. The \u003ca href=\"https://www.brainbalancecenters.com/our-program/integrated-approach/nutrition/\" target=\"_blank\" rel=\"noopener\">nutritional component\u003c/a> recommends decreasing a child's intake of gluten, dairy and refined sugar.\u003c/p>\n\u003cp>The third, and most complex, prong of Brain Balance's intervention is its \u003ca href=\"https://www.brainbalancecenters.com/our-program/integrated-approach/sensory-motor/\" target=\"_blank\" rel=\"noopener\">sensory-motor training\u003c/a>, a diverse set of physical exercises. Parents and former employees describe activities like walking across balance beams, syncing actions with a computerized metronome and being spun in swivel chairs.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Consistent with Melillo's theory, Brain Balance focuses much of its sensory-motor training on one-half of the child's body to send strengthening signals up and across to the supposedly weak, opposite hemisphere of the brain. (Much of the human brain indeed \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/23931149\">maps to the opposite\u003c/a> half of the human body.)\u003c/p>\n\u003cp>For instance, with a \"right brain weak\" child like Stephanie and Natalie's son, Brain Balance may have him wear a vibrating armband on his left biceps or eyeglasses that allow light only onto the left visual field. Or they may simply have him stand on his left leg.\u003c/p>\n\u003cp>It has not been uncommon for parents to enroll their children for at least six months, costing roughly $12,000. The company recently said its average enrollment is now about four months. Assessments and optional nutritional supplements and blood tests can add hundreds of dollars.\u003c/p>\n\u003cp>The program isn't covered by insurance. Brain Balance offers payment plans to parents who can't cover the cost immediately. As of publication, close to 200 families have solicited money from relatives and friends with \u003ca href=\"https://www.gofundme.com/mvc.php?route=category&term=%22brain%20balance%22\" target=\"_blank\" rel=\"noopener\">GoFundMe.com\u003c/a> campaigns.\u003c/p>\n\u003cp>Natalie and Stephanie were quoted $5,000 for their first three months, with the option to re-up for more after.\u003c/p>\n\u003cp>\"When you're talking about your child's self-esteem and knowing it's the most important thing, what are you going to do?\" Stephanie says. \"Maybe work a few more years and take a little bit out of your retirement so that maybe — if you nip this thing in the bud — he's able to have a better life going forward?\"\u003c/p>\n\u003cp>They dipped into their retirement savings and enrolled both their sons at a total cost of more than $15,000.\u003c/p>\n\u003cp>\"\u003cstrong>Cutting edge\" science\u003c/strong>\u003c/p>\n\u003cp>In numerous media appearances, Melillo hasn't been shy about publicizing the strength of his program's scientific evidence.\u003c/p>\n\u003cp>\"This isn't smoke and mirrors. This is real stuff. ... [Parents] are going to get real answers,\" Melillo \u003ca href=\"https://youtu.be/uaMbTtcFhvU?t=5m16s\" target=\"_blank\" rel=\"noopener\">told a radio host in 2010\u003c/a>. \"We've shown in our centers that we can correct these problems completely. We've proved that in research,\" he \u003ca href=\"https://youtu.be/7XJ8ouQgmtA?t=1m56s\" target=\"_blank\" rel=\"noopener\">said on TV in 2014\u003c/a>. \"We use really cutting-edge brain science to address the issue,\" he \u003ca href=\"https://youtu.be/KhmgeWUrkwo?t=49s\" target=\"_blank\" rel=\"noopener\">said in 2016\u003c/a>.\u003c/p>\n\u003cp>Yet a dozen experts in autism spectrum disorder, ADHD, dyslexia and childhood psychiatry interviewed by NPR all identified flaws in Brain Balance's approach.\u003c/p>\n\u003cp>They said the company's idea of imbalanced hemispheres was too simplistic and built upon the popular, discredited myth of the logical left brain and the intuitive right brain.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\"It doesn't make sense,\" says \u003ca href=\"https://www.kennedykrieger.org/professional-training/training-disciplines/special-education-fellowship/leadership/mark-mahone-phd\" target=\"_blank\" rel=\"noopener\">Mark Mahone\u003c/a>, a pediatric neuropsychologist at the Kennedy Krieger Institute in Baltimore. \"In virtually every activity that one does ... both hemispheres of the brain are very, very active. ... It's not as simple as just being a left- or a right-hemisphere problem. Nothing is that simple.\"\u003c/p>\n\u003cp>As for the three-pronged Brain Balance regimen, experts NPR spoke with said there is no solid evidence suggesting gluten, dairy or sugar consumption affects ADHD, autism or dyslexia. And although physical exercise may have modest impacts on inattention and tutoring can help in school, these interventions can be found elsewhere for much less money. No expert suggested either as a front-line remedy for ADHD or autism.\u003c/p>\n\u003cp>Doctors and researchers NPR interviewed also questioned the diagnostic metrics Brain Balance uses.\u003c/p>\n\u003cp>For example, the company tests children for the primitive reflexes that drive infants to instinctively suckle or grab a finger. Natalie and Stephanie were told their son's lingering primitive reflexes were connected to his behavioral issues.\u003c/p>\n\u003cp>But multiple pediatricians said it is exceptionally rare for children older than 4 to retain any primitive reflexes.\u003c/p>\n\u003cp>\"Typically by 1 year of age these primitive reflexes have disappeared,\" says Dr. Andrew Adesman, a developmental pediatrician at Cohen Children's Medical Center of New York. \"The major exception is children who have cerebral palsy.\"\u003c/p>\n\u003cp>Melillo disagreed with the experts' opinions. \"I think they're completely wrong,\" he says.\u003c/p>\n\u003cp>\"Pediatricians rarely look at primitive reflexes after infancy, but if they did, they will find that, in many cases, they are still there,\" he wrote in an email.\u003c/p>\n\u003cp>Melillo also pushed back against the medical consensus that autism, ADHD and dyslexia aren't caused by hemispheric differences and that gluten doesn't affect such disorders.\u003c/p>\n\u003cp>\"I can show you a lot of papers that actually say that there is a relationship between food sensitivities, gluten sensitivity and different types of issues and conditions,\" he says. \"So again, it depends on the expert.\"\u003c/p>\n\u003cp>\"\u003cstrong>Evidence based\"?\u003c/strong>\u003c/p>\n\u003cp>There are two published studies of Brain Balance, which the company has said show that 81 percent of children with ADHD no longer displayed symptoms after three months in the program.\u003c/p>\n\u003cp>\"We have two studies now,\" Melillo said \u003ca href=\"https://youtu.be/AVp295htBVI?t=4m52s\" target=\"_blank\" rel=\"noopener\">on local TV\u003c/a> in 2013. \"So that means that we qualify as what we call 'evidence based' at this point.\"\u003c/p>\n\u003cp>Brain Balance \u003ca href=\"https://blog.brainbalancecenters.com/2013/07/control-study-shows-brain-balance-eliminates-adhd-symptoms\" target=\"_blank\" rel=\"noopener\">touted one of the studies on its blog\u003c/a> with the headline, \"Control Study Shows Brain Balance Eliminates ADHD Symptoms.\"\u003c/p>\n\u003cp>The studies, however, have serious scientific shortcomings.\u003c/p>\n\u003cp>Melillo, someone with a clear financial interest in the outcome, co-authored \u003ca href=\"http://www.carolinabraincenter.com/wp-content/uploads/2014/03/The_effect_of_hemisphere_specific_remediation_strategies_on_the_academic_performance_outcome_of_children_with_ADD_ADHD_.pdf\" target=\"_blank\" rel=\"noopener\">the first one\u003c/a>.\u003c/p>\n\u003cp>He also had parents rate their own children's improvement in ADHD symptoms but \u003ca href=\"https://www.documentcloud.org/documents/4420809-2010-BB-Study.html#document/p5/a415343\" target=\"_blank\" rel=\"noopener\">didn't compare\u003c/a> them with other kids who weren't in Brain Balance.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Without a control group, a study cannot definitively determine whether an intervention — a pill or procedure or program — is the reason for improvement or whether any change is simply the placebo effect.\u003c/p>\n\u003cp>The \u003ca href=\"http://www.feingold.org/Research/PDFstudies/Leisman2013.pdf\" target=\"_blank\" rel=\"noopener\">second study\u003c/a> did feature a control group of children with ADHD who didn't do Brain Balance. But it compared them with the same children from the first study published years earlier instead of randomly assigning children into simultaneous treatment and control groups.\u003c/p>\n\u003cp>\"My issue with these data is that there's no legitimate comparison for the treatment group, so we really don't know if [Brain Balance] helps,\" says Dr. Paul Wang, deputy director for clinical research at the Simons Foundation.\u003c/p>\n\u003cp>The experts NPR consulted took issue with other aspects of the studies as well.\u003c/p>\n\u003cp>The kids in the treatment and control groups \u003ca href=\"https://www.documentcloud.org/documents/4420810-2013-BB-Study.html#document/p3/a415322\" target=\"_blank\" rel=\"noopener\">differed in important ways\u003c/a>, the experts said, rendering comparisons between them less meaningful. The two groups weren't drawn from the same centers; all of the treatment group was medicated while only 60 percent of the controls were; and at baseline the controls scored more severe on an ADHD rating scale.\u003c/p>\n\u003cp>Curiously, even though the \u003ca href=\"https://www.documentcloud.org/documents/4420810-2013-BB-Study.html#document/p5/a429871\" target=\"_blank\" rel=\"noopener\">second\u003c/a> study reused the treatment group data from the \u003ca href=\"https://www.documentcloud.org/documents/4420809-2010-BB-Study.html#document/p6/a415327\" target=\"_blank\" rel=\"noopener\">first\u003c/a> study published years earlier, it reported different improvements on those same kids' test scores. The lead author on both studies, Gerry Leisman, a professor of neuro and rehabilitation sciences at the University of Haifa in Israel, explained one of the test score differences as a \"reviewer correction\" but did not provide explanations for any of the six remaining discrepancies.\u003c/p>\n\u003cp>Dr. James McGough, a professor of clinical psychiatry at UCLA's David Geffen Medical School, wasn't convinced by Brain Balance's published research. \"It means absolutely nothing. ... What we have here, in my view, is a marketing piece.\"\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>At least one state remains similarly unconvinced.\u003c/p>\n\u003cp>In 2015, Wisconsin's Department of Health Services determined Brain Balance had \"\u003ca href=\"https://www.dhs.wisconsin.gov/tiac/brain-balance-january-2015.pdf\" target=\"_blank\" rel=\"noopener\">insufficient evidence\u003c/a>\" to show it was a \"proven and effective treatment for individuals with autism spectrum disorder and/or other developmental disabilities,\" as the \u003cem>Milwaukee Journal-Sentinel \u003c/em>\u003ca href=\"http://archive.jsonline.com/business/company-pushes-brain-balancing-program-for-learning-disabilities-evidence-lacking-b99551698z1-324854621.html\">reported\u003c/a>. The state assigned Brain Balance to the second-lowest ranking on its five-tier system. The only lower ranking is for \"potentially harmful\" treatments.\u003c/p>\n\u003cp>\u003cstrong>Brain Balance defends its approach\u003c/strong>\u003c/p>\n\u003cp>Asked by NPR why Brain Balance hadn't been tested more thoroughly before its nationwide expansion began a decade ago, Melillo says the company was \"faced with a dilemma.\" While he did feel an obligation to validate his approach, he says he knew Brain Balance worked and didn't want to deprive his clients of its benefits while waiting for clinical trials. \"All these 25,000 families that we've helped, are they left suffering for years on end?\"\u003c/p>\n\u003cp>\"What was done to date was commensurate to the resources that we had,\" says Aleem Choudhry, the chairman of Brain Balance and a managing member at Crane Street Capital, which invested in the franchise in 2013.\u003c/p>\n\u003cp>The company says ADHD was the only disorder to be studied thus far because — contrary to the opinion of all the experts contacted by NPR — it is neurologically equivalent to others like autism, dyslexia and OCD. If Brain Balance improves ADHD symptoms, Melillo says, \"then we believe that we're going to get the same results in the other types of issues, because they're really the same problem.\"\u003c/p>\n\u003cp>Melillo also says the company's proprietary records from about 80,000 before-and-after client assessments qualify as corroboration. Melillo disputed the idea that his company's own data may require third-party review. \"Data is data,\" he says. \"There's no bias in the way we collect this.\"\u003c/p>\n\u003cp>A new study of a \u003ca href=\"https://drteicher.wordpress.com/2015/11/20/non-pharmacological-treatment-for-adhd/\" target=\"_blank\" rel=\"noopener\">computerized version of Brain Balance\u003c/a> is underway at a Harvard-affiliated hospital and features a concurrent control group of children.\u003c/p>\n\u003cp>But Melillo says that questions about the research behind Brain Balance ultimately miss a larger, more important point.\u003c/p>\n\u003cp>\"Families are out there struggling and suffering, and they don't really give a crap about the data or the research, to be quite honest,\" he says. \"When they go through it and they see the difference in their child ... that's what matters to them.\"\u003c/p>\n\u003cp>Choudhry, the company's chairman, later clarified that \"we very much do care about the data.\"\u003c/p>\n\u003cp>\u003cstrong>No easy answer\u003c/strong>\u003c/p>\n\u003cp>With both their boys enrolled in Brain Balance, the routine for Stephanie and Natalie's family was frantic.\u003c/p>\n\u003cp>Three times a week, Stephanie would ferry their sons against traffic to and from their sessions. Family dinners became more rushed. Soccer and swimming were abandoned.\u003c/p>\n\u003cp>Lost time is often a hidden cost of any form of treatment.\u003c/p>\n\u003cp>The mothers began observing changes in their older son. They say his previously weak sense of smell suddenly blossomed, first for brownies and then other foods. And he became less obsessed with characters he had repetitively sketched in his notebooks and imbued with rich inner lives. (His parents are torn as to whether this was a positive development.) He also advanced in certain Brain Balance measures, including his primitive reflexes.\u003c/p>\n\u003cp>\"It's not that the needle didn't move on some of those dimensions,\" says Natalie. \"But if you step back at the 10,000- or 100,000-foot view and say, 'Is this kid different in a way that his life is going to be better or altered?' the answer is 'No.' OK, so now he can smell brownies that he couldn't smell before but is his life different?\"\u003c/p>\n\u003cp>She says she and her wife began to feel discouraged, thinking about the \"aura around this program that says your child's going to be different and better-adjusted.\"\u003c/p>\n\u003cp>Eric Rossen of the National Association of School Psychologists isn't surprised by Brain Balance's popularity as an option beyond what schools and insurance will cover.\u003c/p>\n\u003cp>He says many parents are frustrated by mainstream medicine's limits when it comes to complex disorders like autism. And schools are sometimes too strapped for resources to provide students with learning disorders all the help their parents may want.\u003c/p>\n\u003cp>\"Most parents will say they would die for their children,\" Rossen says. \"So to say, 'I want to provide some therapy and pay a few thousand dollars' is quite short of dying for them and it's totally reasonable.\"\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>But he says \"the problem is they are easy prey for certain providers that can make promises that cannot necessarily be kept or are not necessarily backed by scientific data.\"\u003c/p>\n\u003cp>For parents looking to find evidence-based third-party interventions, experts suggest the \u003ca href=\"https://ies.ed.gov/ncee/wwc/\" target=\"_blank\" rel=\"noopener\">What Works Clearinghouse\u003c/a>, which is backed by the Department of Education, or the Substance Abuse and Mental Health Services Administration's \u003ca href=\"https://www.samhsa.gov/nrepp\" target=\"_blank\" rel=\"noopener\">own resource\u003c/a>.\u003c/p>\n\u003cp>Brain Balance's protocol doesn't appear to pose any physical or developmental harms to children. Instead, the program's costs may come in other ways: siphoning away time and money, and prolonging the hope in some parents that their child may one day shed his or her disorder.\u003c/p>\n\u003cp>Dr. Susan Hyman, a professor of pediatrics at the University of Rochester who has studied autism treatments for decades, says many alternative providers do this by offering an unrealistically simple solution.\u003c/p>\n\u003cp>\"If you were to come to a traditional provider who said, 'You know I'm going to have you work really, really, really hard. ... I might have some drugs. Drugs have side effects. And 90 percent of the time, as an adult, he is still going to have autism,' that's a far less attractive message than 'I can help you.' \"\u003c/p>\n\u003cp>\u003cstrong>Beyond Brain Balance\u003c/strong>\u003c/p>\n\u003cp>By the end of their older son's second three-month session at Brain Balance, Stephanie and Natalie had completely soured on it. They stopped believing that vibrating armbands and spinning in swivel chairs would translate to social success.\u003c/p>\n\u003cp>They decided to not continue.\u003c/p>\n\u003cp>Later, in second grade, their older son began to work with a social worker at school who taught him how to have socially acceptable conversation with his peers.\u003c/p>\n\u003cp>And Stephanie and Natalie did something else — the unthinkable.\u003c/p>\n\u003cp>They put their son on a medication called Strattera. Calibrating the proper dosage with tolerable side effects was a drawn-out process, but eventually they reached an equilibrium. Their older son ended up with a new diagnosis that has some overlap with autism but is more consistent with ADHD, which the medication treats.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Today, he seems to be navigating the world more successfully than before.\u003c/p>\n\u003cp>On a Saturday last August, their older son — who once plaintively asked his parents, \"Why aren't I invited to birthday parties?\" — had just wrapped up a party to celebrate turning 10 years old.\u003c/p>\n\u003cp>Natalie and Stephanie had pizzas delivered and rented a truck lined with pleather sofas on one side and video game systems along the other. The children sat in pairs and used their greasy fingers to dispatch their avatars against each other in virtual battle.\u003c/p>\n\u003cp>\"They were yelling my son's name and saying 'Come play with me! Come play with me!' \" recalls Natalie.\u003c/p>\n\u003cp>The birthday boy says he invited almost all of his friends, from school and camp, and all but one showed up, which was more than he could have ever imagined before.\u003c/p>\n\u003cp>\"Because,\" he says before pausing. \"I haven't had friends for a bit. Until I got my medicine. I got some treatment. I got help. Now, I have tons of friends.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>The reporter, Chris Benderev, can be contacted at cbenderev@npr.org.\u003c/em>\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=%27Cutting+Edge%27+Program+For+Children+With+Autism+And+ADHD+Rests+On+Razor-Thin+Evidence&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Results Of At-Home Genetic Tests For Health Can Be Hard To Interpret",
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"content": "\u003cp>Rita Adele Steyn's mother had a double mastectomy in her 40s because she had so many lumps in her breasts. Her first cousin died of breast cancer. And Steyn's sister is going through chemotherapy for the disease now. Steyn worries she might be next.[contextly_sidebar id=\"2jv7QCmynDbyHW9qUVcm6pRU4NOR220R\"]\u003c/p>\n\u003cp>\"Sometimes you feel like you beat the odds. And sometimes you feel like the odds are against you,\" said Steyn, 42, who lives in Tampa, Fla. \"And right now I feel like the odds are against me.\"\u003c/p>\n\u003cp>So Steyn jumped at the chance when she heard about a company offering an inexpensive and easy new way to get her DNA tested for genetic mutations that sharply increase the risk for \u003ca href=\"https://www.cancer.org/cancer/breast-cancer.html\" target=\"_blank\" rel=\"noopener\">breast cancer\u003c/a>.\u003c/p>\n\u003cp>\"I thought it would be good to get tested,\" says Steyn. \"I thought this is something I should know.\"\u003c/p>\n\u003cp>She ordered a $200 testing kit from the company, 23andme, spit into a small plastic tube, sent it back and waited for the results.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Genetic testing used to be uncommon and ordered only by doctors. They used it mainly to diagnose rare conditions, to find out whether prospective parents are carrying genetic diseases, or to determine whether patients are at risk for diseases in the future.\u003c/p>\n\u003cp>Now, more people are getting their DNA analyzed for health reasons, in the comfort of their own homes. As genetic testing has gotten easier, faster and more affordable, it has become a multimillion-dollar industry, with many companies aggressively marketing convenient, inexpensive tests directly to consumers. About one-third of Americans say they or a family member have considered getting a genetic test, \u003ca href=\"https://www.npr.org/sections/health-shots/2018/06/01/616126056/poll-genealogical-curiosity-is-a-top-reason-for-dna-tests-privacy-a-concern\" target=\"_blank\" rel=\"noopener\">according to a recent NPR-IBM Watson Health Poll\u003c/a>. And millions of people have gotten them, for a variety of reasons.[contextly_sidebar id=\"5sGM4fbYVp0AOmgc16BrIla2iYM1tjtz\"]\u003c/p>\n\u003cp>\"This health-related testing is probably the next big step in using genomic information in our lives,\" says \u003ca href=\"https://isearch.asu.edu/profile/2783639\" target=\"_blank\" rel=\"noopener\">Robert Cook-Deegan\u003c/a>, who studies health policy at Arizona State University.\u003c/p>\n\u003cp>But others find the trend troubling. The tests have limitations and can be hard to interpret without a doctor or genetic counselor to weigh in.\u003c/p>\n\u003cp>\u003cstrong>Pros and Cons\u003c/strong>\u003c/p>\n\u003cp>The company Steyn used, \u003ca href=\"https://www.23andme.com/\" target=\"_blank\" rel=\"noopener\">23andMe\u003c/a>, recently \u003ca href=\"https://www.npr.org/2018/03/07/591423146/test-for-breast-cancer-gene-will-be-available-in-weeks\" target=\"_blank\" rel=\"noopener\">became the first to win approval\u003c/a> from the Food and Drug Administration to market a genetic test for cancer directly to consumers without a doctor's order. It spent $27.9 million on advertising in the first quarter of 2018, according to the tracking firm Kantar Media. (NPR receives financial support from 23andMe.)\u003c/p>\n\u003cp>The industry is set to grow even more as restrictions on the medical uses of these tests are eased. The Food and Drug Administration recently \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583885.htm\">announced\u003c/a> plans to make it easier for these kinds of tests to win approval.[contextly_sidebar id=\"6BR65Pmc5xtQQjBssPMWnhSlrwXrhHIz\"]\u003c/p>\n\u003cp>Many physicians welcome the trend, saying it's giving people valuable information. Consumers can find out early whether they are at increased risk for cancer, Alzheimer's and other diseases — and take steps to protect themselves. The testing can also sometimes help identify the safest and most effective medications to use.\u003c/p>\n\u003cp>\"Direct-to-consumer genetics companies are leading the way toward democratizing genetics and making it available to more and more people to learn about their risks and intervene in ways to keep themselves healthy,\" says \u003ca href=\"http://personalizedmedicine.partners.org/About/Leadership-Team/Robert%20Green.aspx\" target=\"_blank\" rel=\"noopener\">Robert Green\u003c/a>, a medical geneticist at Harvard.\u003c/p>\n\u003cp>But other genetic specialists, including \u003ca href=\"https://www.med.unc.edu/im/patients/general-medicine-internal-medicine-clinic/james-evans-md-phd\" target=\"_blank\" rel=\"noopener\">James Evans\u003c/a>, a professor of genetics and medicine at the University of North Carolina, Chapel Hill, argue genetic testing is still in its infancy and that the results are often inconclusive and confusing.\u003c/p>\n\u003cp>\"I think that it's an unfortunate development that will likely cause considerable mischief,\" Evans says.\u003c/p>\n\u003cp>One problem is that patients can be easily overwhelmed when results are misleading or murky. Genetic testing is still best done through doctors, he says, working with specially trained genetic counselors who can guide patients every step of the way.[contextly_sidebar id=\"xJAmUsouQpJLM7V2Qt8t7fJx04FgVQwG\"]\u003c/p>\n\u003cp>\"What people deserve is well-thought-out information,\" Evans says. \"The only people who will really benefit are the investors in these companies that market these incomplete and misleading tests.\"\u003c/p>\n\u003cp>Some companies are offering newer forms of genetic testing that decipher and analyze every gene known to carry instructions for producing proteins that might reveal mutations — a process called \u003ca href=\"https://ghr.nlm.nih.gov/primer/testing/sequencing\" target=\"_blank\" rel=\"noopener\">whole exome sequencing\u003c/a>. Still others analyze the entire genetic code, which is called \u003ca href=\"https://www.fda.gov/Food/FoodScienceResearch/WholeGenomeSequencingProgramWGS/\" target=\"_blank\" rel=\"noopener\">whole genome sequencing\u003c/a>, which may find additional clues to disease. They will then analyze customers' genomes for any variations known to be associated with diseases.\u003c/p>\n\u003cp>The approach 23andMe takes is a rapid, but older, process. It analyzes short pieces of DNA for genetic variations known as \u003ca href=\"https://ghr.nlm.nih.gov/primer/genomicresearch/snp\" target=\"_blank\" rel=\"noopener\">single nucleotide variations (SNPs)\u003c/a> associated with specific diseases.\u003c/p>\n\u003cp>Except for 23andMe, all of the companies still require a doctor's order to get this testing. But an increasing number of these companies will find a physician to sign off on that for customers.\u003c/p>\n\u003cp>\"We're all about empowering consumers and making it as easy as possible for people to get these insights,\" says \u003ca href=\"https://www.helix.com/blog/author/elissa-levin/\" target=\"_blank\" rel=\"noopener\">Elissa Levin\u003c/a>, director of policy and clinical services at \u003ca href=\"https://www.helix.com/\">Helix\u003c/a>, a genetic testing company.\u003c/p>\n\u003cp>Dr. \u003ca href=\"https://profiles.stanford.edu/louanne-hudgins\" target=\"_blank\" rel=\"noopener\">Louanne Hudgins\u003c/a>, president of the \u003ca href=\"https://www.acmg.net/\" target=\"_blank\" rel=\"noopener\">American College of Medical Genetics and Genomics\u003c/a>, says she's \"very concerned\" about this.\u003c/p>\n\u003cp>\"Individuals should be evaluated by medical professionals who are not conflicted, meaning they do not somehow work for a company,\" Hudgins says. \"Doctors who are contracted by companies are going to say, 'Do the test' no matter what, even if the test may not be indicated.\"\u003c/p>\n\u003cp>The companies defend the practice, saying the doctors they find for customers may be better suited than the average physician.\u003c/p>\n\u003cp>\"The majority of doctors have had maybe one class in genetics,\" says \u003ca href=\"https://www.color.com/team\" target=\"_blank\" rel=\"noopener\">Othman Laraki\u003c/a>, CEO of Color Genomics, another genetic testing company. \"I think it's much more important to have someone who has a background in genetics than just simply have someone who you can physically meet with.\"[contextly_sidebar id=\"z5IAPc8KdOy51FSsfsI8mbgyU8TgOGr0\"]\u003c/p>\n\u003cp>Privacy is another concern. Genetic testing companies say they have strict policies and procedures to protect customers' information. But some firms provide access to the genetic information they collect on an anonymous basis to drug companies and others to use for research.\u003c/p>\n\u003cp>Recent breaches of privacy by companies that collect information about people, such as Facebook, have underscored the risks of electronic data.\u003c/p>\n\u003cp>\"I'm really hoping that the security practices associated with genetic information are quite strong,\" says Cook-Deegan. \"The companies say they're strong. Time will tell if that's true.\"\u003c/p>\n\u003cp>A \u003ca href=\"https://www.eeoc.gov/laws/statutes/gina.cfm\">federal law\u003c/a> prohibits the use of genetic information to discriminate against the people for health insurance or jobs. But that law does not protect against the use of genetic information in making decisions about other things, such as life and long-term care insurance.\u003c/p>\n\u003cp>\"These are the types of things you really ought to consider when thinking about doing this kind of genetic testing — not whether there's a special on the testing this week,\" says \u003ca href=\"https://louisville.edu/bioethics/directory/mark-a.-rothstein\" target=\"_blank\" rel=\"noopener\">Mark Rothstein\u003c/a>, a professor of medicine and a bioethicist at the University of Louisville School of Medicine.\u003c/p>\n\u003cp>\u003cstrong>Results — With Limitations\u003c/strong>\u003c/p>\n\u003cp>About a month after sending in her sample, Steyn got a notice that the results of her breast cancer test were ready.\u003c/p>\n\u003cp>\"I'm really nervous,\" she said as she read through the company's explanation of what her results do and do not mean.\u003c/p>\n\u003cp>She paused in silence after she clicked to get the results.\u003c/p>\n\u003cp>\"It says zero variants detected,\" Steyn finally said, meaning the test had not found any mutations that would increase her risk.\u003c/p>\n\u003cp>\"I guess I do feel really relieved. It does make me feel better,\" she said, her voice cracking. \"I guess I just feel my chances are better now, you know?\"\u003c/p>\n\u003cp>Critics worry the testing is misleading — and relying on it could be dangerous. It tests for only three mutations in two genes known as \u003ca href=\"https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet\" target=\"_blank\" rel=\"noopener\">BRCA1 and BRCA2\u003c/a> that can increase the risk for breast and \u003ca href=\"https://www.cancer.org/cancer/ovarian-cancer.html\" target=\"_blank\" rel=\"noopener\">ovarian cancer\u003c/a>. Women could still have one of the thousands of other mutations that increase the risk, or be at risk for other, nongenetic reasons.[contextly_sidebar id=\"yoPuviqWfqVzH92JGqeNFv9hvL3T9Qlf\"]\u003c/p>\n\u003cp>The concern is that if a woman's 23andMe test shows she's free of the risky mutations, she may think she's in the clear and not do things she should do, such as get regular mammograms or undergo more thorough genetic testing.\u003c/p>\n\u003cp>\"To be very blunt, I worry that women who undertake testing from 23andMe could believe that they do not carry a mutation when in fact they do, and as a consequence could die of breast or ovarian cancer,\" says \u003ca href=\"http://www.gs.washington.edu/faculty/king.htm\" target=\"_blank\" rel=\"noopener\">Mary-Claire King\u003c/a>, a University of Washington geneticist who helped identify the breast cancer genes. \"I do not want to see that happen.\"\u003c/p>\n\u003cp>The company argues that it makes the test's limitations very clear and encourages women to talk to their doctor about the results and possibly seek more extensive genetic testing.\u003c/p>\n\u003cp>For women who discover they have one of the risky gene variants, the information could be crucial, according to \u003ca href=\"https://medical.23andme.com/medical-team/\" target=\"_blank\" rel=\"noopener\">Stacey Detweiller\u003c/a>, a medical affairs associate and genetic counselor at 23andMe.\u003c/p>\n\u003cp>\"Our mission is helping people access, understand and benefit from the human genome,\" Detweiller says. \"There's steps that can be taken from knowing this information that could be life-saving.\"\u003c/p>\n\u003cp>Steyn and the two other women NPR followed through the process of taking the test seemed to understand the test's limitations. They said they knew they couldn't rely on it, but they were curious to see the results.\u003c/p>\n\u003cp>But Steyn admits that she felt somewhat less urgency to get a mammogram or additional testing because of the 23andMe test results, especially since she doesn't have health insurance at the moment.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\"I'm glad I did it, especially in light of the fact that I find myself in a position where I do have to wait to see a doctor now because of the insurance situation I find myself in,\" Steyn says. \"Now I feel a little bit better about waiting. Beforehand, I probably would have not waited and figure out a way to afford this.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Results+Of+At-Home+Genetic+Tests+For+Health+Can+Be+Hard+To+Interpret+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Rita Adele Steyn's mother had a double mastectomy in her 40s because she had so many lumps in her breasts. Her first cousin died of breast cancer. And Steyn's sister is going through chemotherapy for the disease now. Steyn worries she might be next.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\"Sometimes you feel like you beat the odds. And sometimes you feel like the odds are against you,\" said Steyn, 42, who lives in Tampa, Fla. \"And right now I feel like the odds are against me.\"\u003c/p>\n\u003cp>So Steyn jumped at the chance when she heard about a company offering an inexpensive and easy new way to get her DNA tested for genetic mutations that sharply increase the risk for \u003ca href=\"https://www.cancer.org/cancer/breast-cancer.html\" target=\"_blank\" rel=\"noopener\">breast cancer\u003c/a>.\u003c/p>\n\u003cp>\"I thought it would be good to get tested,\" says Steyn. \"I thought this is something I should know.\"\u003c/p>\n\u003cp>She ordered a $200 testing kit from the company, 23andme, spit into a small plastic tube, sent it back and waited for the results.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Genetic testing used to be uncommon and ordered only by doctors. They used it mainly to diagnose rare conditions, to find out whether prospective parents are carrying genetic diseases, or to determine whether patients are at risk for diseases in the future.\u003c/p>\n\u003cp>Now, more people are getting their DNA analyzed for health reasons, in the comfort of their own homes. As genetic testing has gotten easier, faster and more affordable, it has become a multimillion-dollar industry, with many companies aggressively marketing convenient, inexpensive tests directly to consumers. About one-third of Americans say they or a family member have considered getting a genetic test, \u003ca href=\"https://www.npr.org/sections/health-shots/2018/06/01/616126056/poll-genealogical-curiosity-is-a-top-reason-for-dna-tests-privacy-a-concern\" target=\"_blank\" rel=\"noopener\">according to a recent NPR-IBM Watson Health Poll\u003c/a>. And millions of people have gotten them, for a variety of reasons.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\"This health-related testing is probably the next big step in using genomic information in our lives,\" says \u003ca href=\"https://isearch.asu.edu/profile/2783639\" target=\"_blank\" rel=\"noopener\">Robert Cook-Deegan\u003c/a>, who studies health policy at Arizona State University.\u003c/p>\n\u003cp>But others find the trend troubling. The tests have limitations and can be hard to interpret without a doctor or genetic counselor to weigh in.\u003c/p>\n\u003cp>\u003cstrong>Pros and Cons\u003c/strong>\u003c/p>\n\u003cp>The company Steyn used, \u003ca href=\"https://www.23andme.com/\" target=\"_blank\" rel=\"noopener\">23andMe\u003c/a>, recently \u003ca href=\"https://www.npr.org/2018/03/07/591423146/test-for-breast-cancer-gene-will-be-available-in-weeks\" target=\"_blank\" rel=\"noopener\">became the first to win approval\u003c/a> from the Food and Drug Administration to market a genetic test for cancer directly to consumers without a doctor's order. It spent $27.9 million on advertising in the first quarter of 2018, according to the tracking firm Kantar Media. (NPR receives financial support from 23andMe.)\u003c/p>\n\u003cp>The industry is set to grow even more as restrictions on the medical uses of these tests are eased. The Food and Drug Administration recently \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583885.htm\">announced\u003c/a> plans to make it easier for these kinds of tests to win approval.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Many physicians welcome the trend, saying it's giving people valuable information. Consumers can find out early whether they are at increased risk for cancer, Alzheimer's and other diseases — and take steps to protect themselves. The testing can also sometimes help identify the safest and most effective medications to use.\u003c/p>\n\u003cp>\"Direct-to-consumer genetics companies are leading the way toward democratizing genetics and making it available to more and more people to learn about their risks and intervene in ways to keep themselves healthy,\" says \u003ca href=\"http://personalizedmedicine.partners.org/About/Leadership-Team/Robert%20Green.aspx\" target=\"_blank\" rel=\"noopener\">Robert Green\u003c/a>, a medical geneticist at Harvard.\u003c/p>\n\u003cp>But other genetic specialists, including \u003ca href=\"https://www.med.unc.edu/im/patients/general-medicine-internal-medicine-clinic/james-evans-md-phd\" target=\"_blank\" rel=\"noopener\">James Evans\u003c/a>, a professor of genetics and medicine at the University of North Carolina, Chapel Hill, argue genetic testing is still in its infancy and that the results are often inconclusive and confusing.\u003c/p>\n\u003cp>\"I think that it's an unfortunate development that will likely cause considerable mischief,\" Evans says.\u003c/p>\n\u003cp>One problem is that patients can be easily overwhelmed when results are misleading or murky. Genetic testing is still best done through doctors, he says, working with specially trained genetic counselors who can guide patients every step of the way.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>\"What people deserve is well-thought-out information,\" Evans says. \"The only people who will really benefit are the investors in these companies that market these incomplete and misleading tests.\"\u003c/p>\n\u003cp>Some companies are offering newer forms of genetic testing that decipher and analyze every gene known to carry instructions for producing proteins that might reveal mutations — a process called \u003ca href=\"https://ghr.nlm.nih.gov/primer/testing/sequencing\" target=\"_blank\" rel=\"noopener\">whole exome sequencing\u003c/a>. Still others analyze the entire genetic code, which is called \u003ca href=\"https://www.fda.gov/Food/FoodScienceResearch/WholeGenomeSequencingProgramWGS/\" target=\"_blank\" rel=\"noopener\">whole genome sequencing\u003c/a>, which may find additional clues to disease. They will then analyze customers' genomes for any variations known to be associated with diseases.\u003c/p>\n\u003cp>The approach 23andMe takes is a rapid, but older, process. It analyzes short pieces of DNA for genetic variations known as \u003ca href=\"https://ghr.nlm.nih.gov/primer/genomicresearch/snp\" target=\"_blank\" rel=\"noopener\">single nucleotide variations (SNPs)\u003c/a> associated with specific diseases.\u003c/p>\n\u003cp>Except for 23andMe, all of the companies still require a doctor's order to get this testing. But an increasing number of these companies will find a physician to sign off on that for customers.\u003c/p>\n\u003cp>\"We're all about empowering consumers and making it as easy as possible for people to get these insights,\" says \u003ca href=\"https://www.helix.com/blog/author/elissa-levin/\" target=\"_blank\" rel=\"noopener\">Elissa Levin\u003c/a>, director of policy and clinical services at \u003ca href=\"https://www.helix.com/\">Helix\u003c/a>, a genetic testing company.\u003c/p>\n\u003cp>Dr. \u003ca href=\"https://profiles.stanford.edu/louanne-hudgins\" target=\"_blank\" rel=\"noopener\">Louanne Hudgins\u003c/a>, president of the \u003ca href=\"https://www.acmg.net/\" target=\"_blank\" rel=\"noopener\">American College of Medical Genetics and Genomics\u003c/a>, says she's \"very concerned\" about this.\u003c/p>\n\u003cp>\"Individuals should be evaluated by medical professionals who are not conflicted, meaning they do not somehow work for a company,\" Hudgins says. \"Doctors who are contracted by companies are going to say, 'Do the test' no matter what, even if the test may not be indicated.\"\u003c/p>\n\u003cp>The companies defend the practice, saying the doctors they find for customers may be better suited than the average physician.\u003c/p>\n\u003cp>\"The majority of doctors have had maybe one class in genetics,\" says \u003ca href=\"https://www.color.com/team\" target=\"_blank\" rel=\"noopener\">Othman Laraki\u003c/a>, CEO of Color Genomics, another genetic testing company. \"I think it's much more important to have someone who has a background in genetics than just simply have someone who you can physically meet with.\"\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Privacy is another concern. Genetic testing companies say they have strict policies and procedures to protect customers' information. But some firms provide access to the genetic information they collect on an anonymous basis to drug companies and others to use for research.\u003c/p>\n\u003cp>Recent breaches of privacy by companies that collect information about people, such as Facebook, have underscored the risks of electronic data.\u003c/p>\n\u003cp>\"I'm really hoping that the security practices associated with genetic information are quite strong,\" says Cook-Deegan. \"The companies say they're strong. Time will tell if that's true.\"\u003c/p>\n\u003cp>A \u003ca href=\"https://www.eeoc.gov/laws/statutes/gina.cfm\">federal law\u003c/a> prohibits the use of genetic information to discriminate against the people for health insurance or jobs. But that law does not protect against the use of genetic information in making decisions about other things, such as life and long-term care insurance.\u003c/p>\n\u003cp>\"These are the types of things you really ought to consider when thinking about doing this kind of genetic testing — not whether there's a special on the testing this week,\" says \u003ca href=\"https://louisville.edu/bioethics/directory/mark-a.-rothstein\" target=\"_blank\" rel=\"noopener\">Mark Rothstein\u003c/a>, a professor of medicine and a bioethicist at the University of Louisville School of Medicine.\u003c/p>\n\u003cp>\u003cstrong>Results — With Limitations\u003c/strong>\u003c/p>\n\u003cp>About a month after sending in her sample, Steyn got a notice that the results of her breast cancer test were ready.\u003c/p>\n\u003cp>\"I'm really nervous,\" she said as she read through the company's explanation of what her results do and do not mean.\u003c/p>\n\u003cp>She paused in silence after she clicked to get the results.\u003c/p>\n\u003cp>\"It says zero variants detected,\" Steyn finally said, meaning the test had not found any mutations that would increase her risk.\u003c/p>\n\u003cp>\"I guess I do feel really relieved. It does make me feel better,\" she said, her voice cracking. \"I guess I just feel my chances are better now, you know?\"\u003c/p>\n\u003cp>Critics worry the testing is misleading — and relying on it could be dangerous. It tests for only three mutations in two genes known as \u003ca href=\"https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet\" target=\"_blank\" rel=\"noopener\">BRCA1 and BRCA2\u003c/a> that can increase the risk for breast and \u003ca href=\"https://www.cancer.org/cancer/ovarian-cancer.html\" target=\"_blank\" rel=\"noopener\">ovarian cancer\u003c/a>. Women could still have one of the thousands of other mutations that increase the risk, or be at risk for other, nongenetic reasons.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The concern is that if a woman's 23andMe test shows she's free of the risky mutations, she may think she's in the clear and not do things she should do, such as get regular mammograms or undergo more thorough genetic testing.\u003c/p>\n\u003cp>\"To be very blunt, I worry that women who undertake testing from 23andMe could believe that they do not carry a mutation when in fact they do, and as a consequence could die of breast or ovarian cancer,\" says \u003ca href=\"http://www.gs.washington.edu/faculty/king.htm\" target=\"_blank\" rel=\"noopener\">Mary-Claire King\u003c/a>, a University of Washington geneticist who helped identify the breast cancer genes. \"I do not want to see that happen.\"\u003c/p>\n\u003cp>The company argues that it makes the test's limitations very clear and encourages women to talk to their doctor about the results and possibly seek more extensive genetic testing.\u003c/p>\n\u003cp>For women who discover they have one of the risky gene variants, the information could be crucial, according to \u003ca href=\"https://medical.23andme.com/medical-team/\" target=\"_blank\" rel=\"noopener\">Stacey Detweiller\u003c/a>, a medical affairs associate and genetic counselor at 23andMe.\u003c/p>\n\u003cp>\"Our mission is helping people access, understand and benefit from the human genome,\" Detweiller says. \"There's steps that can be taken from knowing this information that could be life-saving.\"\u003c/p>\n\u003cp>Steyn and the two other women NPR followed through the process of taking the test seemed to understand the test's limitations. They said they knew they couldn't rely on it, but they were curious to see the results.\u003c/p>\n\u003cp>But Steyn admits that she felt somewhat less urgency to get a mammogram or additional testing because of the 23andMe test results, especially since she doesn't have health insurance at the moment.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"I'm glad I did it, especially in light of the fact that I find myself in a position where I do have to wait to see a doctor now because of the insurance situation I find myself in,\" Steyn says. \"Now I feel a little bit better about waiting. Beforehand, I probably would have not waited and figure out a way to afford this.\"\u003c/p>\n\u003cdiv class=\"fullattribution\">Copyright 2018 NPR. To see more, visit http://www.npr.org/.\u003cimg src=\"https://www.google-analytics.com/__utm.gif?utmac=UA-5828686-4&utmdt=Results+Of+At-Home+Genetic+Tests+For+Health+Can+Be+Hard+To+Interpret+&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"info": "\u003cem>Code Switch\u003c/em>, which listeners will hear in the first part of the hour, has fearless and much-needed conversations about race. Hosted by journalists of color, the show tackles the subject of race head-on, exploring how it impacts every part of society — from politics and pop culture to history, sports and more.\u003cbr />\u003cbr />\u003cem>Life Kit\u003c/em>, which will be in the second part of the hour, guides you through spaces and feelings no one prepares you for — from finances to mental health, from workplace microaggressions to imposter syndrome, from relationships to parenting. The show features experts with real world experience and shares their knowledge. Because everyone needs a little help being human.\u003cbr />\u003cbr />\u003ca href=\"https://www.npr.org/podcasts/510312/codeswitch\">\u003cem>Code Switch\u003c/em> offical site and podcast\u003c/a>\u003cbr />\u003ca href=\"https://www.npr.org/lifekit\">\u003cem>Life Kit\u003c/em> offical site and podcast\u003c/a>\u003cbr />",
"airtime": "SUN 9pm-10pm",
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"meta": {
"site": "radio",
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"id": "commonwealth-club",
"title": "Commonwealth Club of California Podcast",
"info": "The Commonwealth Club of California is the nation's oldest and largest public affairs forum. As a non-partisan forum, The Club brings to the public airwaves diverse viewpoints on important topics. The Club's weekly radio broadcast - the oldest in the U.S., dating back to 1924 - is carried across the nation on public radio stations and is now podcasting. Our website archive features audio of our recent programs, as well as selected speeches from our long and distinguished history. This podcast feed is usually updated twice a week and is always un-edited.",
"airtime": "THU 10pm, FRI 1am",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Commonwealth-Club-Podcast-Tile-360x360-1.jpg",
"officialWebsiteLink": "https://www.commonwealthclub.org/podcasts",
"meta": {
"site": "news",
"source": "Commonwealth Club of California"
},
"link": "/radio/program/commonwealth-club",
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"google": "https://podcasts.google.com/feed/aHR0cDovL3d3dy5jb21tb253ZWFsdGhjbHViLm9yZy9hdWRpby9wb2RjYXN0L3dlZWtseS54bWw",
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}
},
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"id": "forum",
"title": "Forum",
"tagline": "The conversation starts here",
"info": "KQED’s live call-in program discussing local, state, national and international issues, as well as in-depth interviews.",
"airtime": "MON-FRI 9am-11am, 10pm-11pm",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Forum-Podcast-Tile-703x703-1.jpg",
"imageAlt": "KQED Forum with Mina Kim and Alexis Madrigal",
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"source": "kqed",
"order": 9
},
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"google": "https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkM5NTU3MzgxNjMz",
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"id": "freakonomics-radio",
"title": "Freakonomics Radio",
"info": "Freakonomics Radio is a one-hour award-winning podcast and public-radio project hosted by Stephen Dubner, with co-author Steve Levitt as a regular guest. It is produced in partnership with WNYC.",
"imageSrc": "https://ww2.kqed.org/news/wp-content/uploads/sites/10/2018/05/freakonomicsRadio.png",
"officialWebsiteLink": "http://freakonomics.com/",
"airtime": "SUN 1am-2am, SAT 3pm-4pm",
"meta": {
"site": "radio",
"source": "WNYC"
},
"link": "/radio/program/freakonomics-radio",
"subscribe": {
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"apple": "https://itunes.apple.com/us/podcast/freakonomics-radio/id354668519",
"tuneIn": "https://tunein.com/podcasts/WNYC-Podcasts/Freakonomics-Radio-p272293/",
"rss": "https://feeds.feedburner.com/freakonomicsradio"
}
},
"fresh-air": {
"id": "fresh-air",
"title": "Fresh Air",
"info": "Hosted by Terry Gross, \u003cem>Fresh Air from WHYY\u003c/em> is the Peabody Award-winning weekday magazine of contemporary arts and issues. One of public radio's most popular programs, Fresh Air features intimate conversations with today's biggest luminaries.",
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"link": "/radio/program/fresh-air",
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"apple": "https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?s=143441&mt=2&id=214089682&at=11l79Y&ct=nprdirectory",
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"rss": "https://feeds.npr.org/381444908/podcast.xml"
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"id": "here-and-now",
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"info": "A live production of NPR and WBUR Boston, in collaboration with stations across the country, Here & Now reflects the fluid world of news as it's happening in the middle of the day, with timely, in-depth news, interviews and conversation. Hosted by Robin Young, Jeremy Hobson and Tonya Mosley.",
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"rss": "https://feeds.npr.org/510051/podcast.xml"
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},
"hidden-brain": {
"id": "hidden-brain",
"title": "Hidden Brain",
"info": "Shankar Vedantam uses science and storytelling to reveal the unconscious patterns that drive human behavior, shape our choices and direct our relationships.",
"imageSrc": "https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/05/hiddenbrain.jpg",
"officialWebsiteLink": "https://www.npr.org/series/423302056/hidden-brain",
"airtime": "SUN 7pm-8pm",
"meta": {
"site": "news",
"source": "NPR"
},
"link": "/radio/program/hidden-brain",
"subscribe": {
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"tuneIn": "https://tunein.com/podcasts/Science-Podcasts/Hidden-Brain-p787503/",
"rss": "https://feeds.npr.org/510308/podcast.xml"
}
},
"how-i-built-this": {
"id": "how-i-built-this",
"title": "How I Built This with Guy Raz",
"info": "Guy Raz dives into the stories behind some of the world's best known companies. How I Built This weaves a narrative journey about innovators, entrepreneurs and idealists—and the movements they built.",
"imageSrc": "https://ww2.kqed.org/news/wp-content/uploads/sites/10/2018/05/howIBuiltThis.png",
"officialWebsiteLink": "https://www.npr.org/podcasts/510313/how-i-built-this",
"airtime": "SUN 7:30pm-8pm",
"meta": {
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"source": "npr"
},
"link": "/radio/program/how-i-built-this",
"subscribe": {
"npr": "https://rpb3r.app.goo.gl/3zxy",
"apple": "https://itunes.apple.com/us/podcast/how-i-built-this-with-guy-raz/id1150510297?mt=2",
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"rss": "https://feeds.npr.org/510313/podcast.xml"
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},
"hyphenacion": {
"id": "hyphenacion",
"title": "Hyphenación",
"tagline": "Where conversation and cultura meet",
"info": "What kind of no sabo word is Hyphenación? For us, it’s about living within a hyphenation. Like being a third-gen Mexican-American from the Texas border now living that Bay Area Chicano life. Like Xorje! Each week we bring together a couple of hyphenated Latinos to talk all about personal life choices: family, careers, relationships, belonging … everything is on the table. ",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2025/03/Hyphenacion_FinalAssets_PodcastTile.png",
"imageAlt": "KQED Hyphenación",
"officialWebsiteLink": "/podcasts/hyphenacion",
"meta": {
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"order": 15
},
"link": "/podcasts/hyphenacion",
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"spotify": "https://open.spotify.com/show/2p3Fifq96nw9BPcmFdIq0o?si=39209f7b25774f38",
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"amazon": "https://music.amazon.com/podcasts/6c3dd23c-93fb-4aab-97ba-1725fa6315f1/hyphenaci%C3%B3n",
"rss": "https://feeds.megaphone.fm/KQINC2275451163"
}
},
"jerrybrown": {
"id": "jerrybrown",
"title": "The Political Mind of Jerry Brown",
"tagline": "Lessons from a lifetime in politics",
"info": "The Political Mind of Jerry Brown brings listeners the wisdom of the former Governor, Mayor, and presidential candidate. Scott Shafer interviewed Brown for more than 40 hours, covering the former governor's life and half-century in the political game – and Brown has some lessons he'd like to share. ",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/The-Political-Mind-of-Jerry-Brown-Podcast-Tile-703x703-1.jpg",
"imageAlt": "KQED The Political Mind of Jerry Brown",
"officialWebsiteLink": "/podcasts/jerrybrown",
"meta": {
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"order": 18
},
"link": "/podcasts/jerrybrown",
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"apple": "https://itunes.apple.com/us/podcast/id1492194549",
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}
},
"latino-usa": {
"id": "latino-usa",
"title": "Latino USA",
"airtime": "MON 1am-2am, SUN 6pm-7pm",
"info": "Latino USA, the radio journal of news and culture, is the only national, English-language radio program produced from a Latino perspective.",
"imageSrc": "https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/latinoUsa.jpg",
"officialWebsiteLink": "http://latinousa.org/",
"meta": {
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"source": "npr"
},
"link": "/radio/program/latino-usa",
"subscribe": {
"npr": "https://rpb3r.app.goo.gl/xtTd",
"apple": "https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?s=143441&mt=2&id=79681317&at=11l79Y&ct=nprdirectory",
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"rss": "https://feeds.npr.org/510016/podcast.xml"
}
},
"marketplace": {
"id": "marketplace",
"title": "Marketplace",
"info": "Our flagship program, helmed by Kai Ryssdal, examines what the day in money delivered, through stories, conversations, newsworthy numbers and more. Updated Monday through Friday at about 3:30 p.m. PT.",
"airtime": "MON-FRI 4pm-4:30pm, MON-WED 6:30pm-7pm",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Marketplace-Podcast-Tile-360x360-1.jpg",
"officialWebsiteLink": "https://www.marketplace.org/",
"meta": {
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"source": "American Public Media"
},
"link": "/radio/program/marketplace",
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"rss": "https://feeds.publicradio.org/public_feeds/marketplace-pm/rss/rss"
}
},
"masters-of-scale": {
"id": "masters-of-scale",
"title": "Masters of Scale",
"info": "Masters of Scale is an original podcast in which LinkedIn co-founder and Greylock Partner Reid Hoffman sets out to describe and prove theories that explain how great entrepreneurs take their companies from zero to a gazillion in ingenious fashion.",
"airtime": "Every other Wednesday June 12 through October 16 at 8pm (repeats Thursdays at 2am)",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Masters-of-Scale-Podcast-Tile-360x360-1.jpg",
"officialWebsiteLink": "https://mastersofscale.com/",
"meta": {
"site": "radio",
"source": "WaitWhat"
},
"link": "/radio/program/masters-of-scale",
"subscribe": {
"apple": "http://mastersofscale.app.link/",
"rss": "https://rss.art19.com/masters-of-scale"
}
},
"mindshift": {
"id": "mindshift",
"title": "MindShift",
"tagline": "A podcast about the future of learning and how we raise our kids",
"info": "The MindShift podcast explores the innovations in education that are shaping how kids learn. Hosts Ki Sung and Katrina Schwartz introduce listeners to educators, researchers, parents and students who are developing effective ways to improve how kids learn. We cover topics like how fed-up administrators are developing surprising tactics to deal with classroom disruptions; how listening to podcasts are helping kids develop reading skills; the consequences of overparenting; and why interdisciplinary learning can engage students on all ends of the traditional achievement spectrum. This podcast is part of the MindShift education site, a division of KQED News. KQED is an NPR/PBS member station based in San Francisco. You can also visit the MindShift website for episodes and supplemental blog posts or tweet us \u003ca href=\"https://twitter.com/MindShiftKQED\">@MindShiftKQED\u003c/a> or visit us at \u003ca href=\"/mindshift\">MindShift.KQED.org\u003c/a>",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Mindshift-Podcast-Tile-703x703-1.jpg",
"imageAlt": "KQED MindShift: How We Will Learn",
"officialWebsiteLink": "/mindshift/",
"meta": {
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"source": "kqed",
"order": 12
},
"link": "/podcasts/mindshift",
"subscribe": {
"apple": "https://podcasts.apple.com/us/podcast/mindshift-podcast/id1078765985",
"google": "https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkM1NzY0NjAwNDI5",
"npr": "https://www.npr.org/podcasts/464615685/mind-shift-podcast",
"stitcher": "https://www.stitcher.com/podcast/kqed/stories-teachers-share",
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}
},
"morning-edition": {
"id": "morning-edition",
"title": "Morning Edition",
"info": "\u003cem>Morning Edition\u003c/em> takes listeners around the country and the world with multi-faceted stories and commentaries every weekday. Hosts Steve Inskeep, David Greene and Rachel Martin bring you the latest breaking news and features to prepare you for the day.",
"airtime": "MON-FRI 3am-9am",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Morning-Edition-Podcast-Tile-360x360-1.jpg",
"officialWebsiteLink": "https://www.npr.org/programs/morning-edition/",
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"link": "/radio/program/morning-edition"
},
"onourwatch": {
"id": "onourwatch",
"title": "On Our Watch",
"tagline": "Deeply-reported investigative journalism",
"info": "For decades, the process for how police police themselves has been inconsistent – if not opaque. In some states, like California, these proceedings were completely hidden. After a new police transparency law unsealed scores of internal affairs files, our reporters set out to examine these cases and the shadow world of police discipline. On Our Watch brings listeners into the rooms where officers are questioned and witnesses are interrogated to find out who this system is really protecting. Is it the officers, or the public they've sworn to serve?",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/On-Our-Watch-Podcast-Tile-703x703-1.jpg",
"imageAlt": "On Our Watch from NPR and KQED",
"officialWebsiteLink": "/podcasts/onourwatch",
"meta": {
"site": "news",
"source": "kqed",
"order": 11
},
"link": "/podcasts/onourwatch",
"subscribe": {
"apple": "https://podcasts.apple.com/podcast/id1567098962",
"google": "https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5ucHIub3JnLzUxMDM2MC9wb2RjYXN0LnhtbD9zYz1nb29nbGVwb2RjYXN0cw",
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"stitcher": "https://www.stitcher.com/show/on-our-watch",
"rss": "https://feeds.npr.org/510360/podcast.xml"
}
},
"on-the-media": {
"id": "on-the-media",
"title": "On The Media",
"info": "Our weekly podcast explores how the media 'sausage' is made, casts an incisive eye on fluctuations in the marketplace of ideas, and examines threats to the freedom of information and expression in America and abroad. For one hour a week, the show tries to lift the veil from the process of \"making media,\" especially news media, because it's through that lens that we see the world and the world sees us",
"airtime": "SUN 2pm-3pm, MON 12am-1am",
"imageSrc": "https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/onTheMedia.png",
"officialWebsiteLink": "https://www.wnycstudios.org/shows/otm",
"meta": {
"site": "news",
"source": "wnyc"
},
"link": "/radio/program/on-the-media",
"subscribe": {
"apple": "https://itunes.apple.com/us/podcast/on-the-media/id73330715?mt=2",
"tuneIn": "https://tunein.com/radio/On-the-Media-p69/",
"rss": "http://feeds.wnyc.org/onthemedia"
}
},
"pbs-newshour": {
"id": "pbs-newshour",
"title": "PBS NewsHour",
"info": "Analysis, background reports and updates from the PBS NewsHour putting today's news in context.",
"airtime": "MON-FRI 3pm-4pm",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/PBS-News-Hour-Podcast-Tile-360x360-1.jpg",
"officialWebsiteLink": "https://www.pbs.org/newshour/",
"meta": {
"site": "news",
"source": "pbs"
},
"link": "/radio/program/pbs-newshour",
"subscribe": {
"apple": "https://itunes.apple.com/us/podcast/pbs-newshour-full-show/id394432287?mt=2",
"tuneIn": "https://tunein.com/radio/PBS-NewsHour---Full-Show-p425698/",
"rss": "https://www.pbs.org/newshour/feeds/rss/podcasts/show"
}
},
"perspectives": {
"id": "perspectives",
"title": "Perspectives",
"tagline": "KQED's series of daily listener commentaries since 1991",
"info": "KQED's series of daily listener commentaries since 1991.",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2025/01/Perspectives_Tile_Final.jpg",
"imageAlt": "KQED Perspectives",
"officialWebsiteLink": "/perspectives/",
"meta": {
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"source": "kqed",
"order": 14
},
"link": "/perspectives",
"subscribe": {
"apple": "https://podcasts.apple.com/us/podcast/id73801135",
"npr": "https://www.npr.org/podcasts/432309616/perspectives",
"rss": "https://ww2.kqed.org/perspectives/category/perspectives/feed/",
"google": "https://podcasts.google.com/feed/aHR0cHM6Ly93dzIua3FlZC5vcmcvcGVyc3BlY3RpdmVzL2NhdGVnb3J5L3BlcnNwZWN0aXZlcy9mZWVkLw"
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},
"planet-money": {
"id": "planet-money",
"title": "Planet Money",
"info": "The economy explained. Imagine you could call up a friend and say, Meet me at the bar and tell me what's going on with the economy. Now imagine that's actually a fun evening.",
"airtime": "SUN 3pm-4pm",
"imageSrc": "https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/planetmoney.jpg",
"officialWebsiteLink": "https://www.npr.org/sections/money/",
"meta": {
"site": "news",
"source": "npr"
},
"link": "/radio/program/planet-money",
"subscribe": {
"npr": "https://rpb3r.app.goo.gl/M4f5",
"apple": "https://itunes.apple.com/us/podcast/planet-money/id290783428?mt=2",
"tuneIn": "https://tunein.com/podcasts/Business--Economics-Podcasts/Planet-Money-p164680/",
"rss": "https://feeds.npr.org/510289/podcast.xml"
}
},
"politicalbreakdown": {
"id": "politicalbreakdown",
"title": "Political Breakdown",
"tagline": "Politics from a personal perspective",
"info": "Political Breakdown is a new series that explores the political intersection of California and the nation. Each week hosts Scott Shafer and Marisa Lagos are joined with a new special guest to unpack politics -- with personality — and offer an insider’s glimpse at how politics happens.",
"airtime": "THU 6:30pm-7pm",
"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/Political-Breakdown-2024-Podcast-Tile-703x703-1.jpg",
"imageAlt": "KQED Political Breakdown",
"officialWebsiteLink": "/podcasts/politicalbreakdown",
"meta": {
"site": "radio",
"source": "kqed",
"order": 5
},
"link": "/podcasts/politicalbreakdown",
"subscribe": {
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"amazon": "https://music.amazon.com/podcasts/e0c2d153-ad36-4c8d-901d-f1da6a724824/political-breakdown",
"npr": "https://www.npr.org/podcasts/572155894/political-breakdown",
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