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"content": "\u003cp class=\"danger-zone\">\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">A \u003c/span>\u003c/span>mere decade ago, 45,000 Americans a year were contracting HIV. Since the Centers for Disease Control and Prevention started collecting data on HIV-related deaths just over 30 years ago, more than half a million of those people have died from AIDS.[contextly_sidebar id=\"lO0syDiO3AlElegX7fRdQulfH7k681UG\"]\u003c/p>\n\u003cp class=\"danger-zone\">And yet, today, the struggle against HIV may be undergoing a sea change.\u003c/p>\n\u003cp class=\"danger-zone\">U.S. health officials and HIV experts are beginning to talk about a future \u003ca href=\"https://www.statnews.com/2018/03/29/cdc-director-hiv-remarks/\" target=\"_blank\" rel=\"noopener\">in which transmission in the United States could be halted\u003c/a>. 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Let’s put it into action.‘’\u003c/p>\n\u003cp class=\"\">Other leaders in the HIV field have been musing about the idea, buoyed by the astonishing impact effective HIV medications have wrought, both on the lives of people infected with or at risk of contracting the virus, and on the trajectory of the epidemic.\u003c/p>\n\u003cp class=\"\">“It’s certainly doable in the United States,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a researcher whose study focused on HIV from the earliest days of the AIDS epidemic.\u003c/p>\n\u003cp>Fauci and other health experts are quick to point out that the goal of stopping transmission entirely is largely theoretical. There will always be some new cases, and the barriers to providing treatment to existing cases remain significant. There are still just under 40,000 people in the U.S. each year contracting HIV. As Fauci put it: “We live in a real world, we don’t live in a theoretical world.”\u003c/p>\n\u003cp>But “if we implement all the tools that we have and if we can theoretically, conceptually, get everybody who’s HIV infected on antiretroviral drug so that they will not transmit the infection to anyone else, theoretically you could end the epidemic tomorrow by doing that,” he added.[contextly_sidebar id=\"wauS1YFripUOWbpsTIa7lXm8j8pGcJjw\"]\u003c/p>\n\u003cp>In the absence of a highly effective vaccine — and likely, even, in the presence of one — consigning the global HIV/AIDS epidemic to the history books would be impossible. And at the moment, that’s moot: Despite decades of research on HIV vaccines, the holy grail of HIV control remains an unmet goal.\u003c/p>\n\u003cp>Still, even without a vaccine, experts believe transmission could be largely stopped in this country — a goal that until the past few years would have been unthinkable.\u003c/p>\n\u003cp>In March, Redfield told CDC staff that he believed HIV transmission in the United States \u003ca href=\"https://www.statnews.com/2018/03/29/cdc-director-hiv-remarks/\" target=\"_blank\" rel=\"noopener\">could be halted over the next three to seven years\u003c/a>.\u003c/p>\n\u003cp>The foundation of the dream is the realization that, if taken correctly, today’s potent antiretroviral drugs will drive down the amount of virus in an HIV-infected person’s system to undetectable levels. People who reach that state, known as viral suppression, are not contagious — even, it seems, if they have unprotected sex.\u003c/p>\n\u003cp>Accumulated data from several studies show that in nearly 80,000 condomless sex acts between pairs of men who had discordant HIV status — one was negative, the other was positive, but virally suppressed — not a single new infection occurred.\u003c/p>\n\u003cp>In the HIV world, that finding has given rise to a slogan: U = U, or undetectable equals untransmissible. To maximize the benefits of viral suppression, though, people must know their HIV status and start treatment if they are infected. Currently the CDC estimates that 15 percent of infected Americans are unaware they are HIV positive.\u003c/p>\n\u003cp>“People with HIV infection need to be diagnosed, getting care, stay in care, get on antiretrovirals, and get their viral load down to undetectable,” Redfield said.\u003c/p>\n\u003cp>Pairing the power of viral suppression with another tool further increases the chances of stopping spread of the virus. That other tool is \u003ca href=\"https://www.statnews.com/2018/07/24/digital-pill-prep-truvada/\">PrEP\u003c/a>, pre-exposure prophylaxis — antiretroviral drugs used to prevent infection in people who are at high risk of contracting the virus.\u003c/p>\n\u003cp>Taken correctly, PrEP reduces the risk of contracting HIV from an infected partner by 95 percent. If the infected partner is virally suppressed, the risk is lower still.\u003c/p>\n\u003cp>But the benefits of PrEP can only be reaped if people use it. Currently too few do. The CDC estimates that about 1.1 million people in the U.S. should be taking PrEP, including men who have sex with men, sex workers, and transgender women, a population with a highly elevated risk of contracting HIV. But only about 200,000 are actually using it, Redfield said.[contextly_sidebar id=\"cMA1JnuuPTnJDbxO5uh5Kz0WejZJ8v2u\"]\u003c/p>\n\u003cp>Paradoxically, doctors bear part of the blame for that gap.\u003c/p>\n\u003cp>“There is a large number of people who are not comfortable prescribing PrEP or have not been taught how to prescribe PrEP, whether it be in their residency, fellowship, or post-graduate training,” said Dr. Robert Goldstein, medical director of the transgender health program at Massachusetts General Hospital and an instructor at Harvard Medical School.\u003c/p>\n\u003cp>“We’re limited by stigma within the medical community and within the LGBT community. We’re limited by lack of provider knowledge. We’re limited by awareness among those at highest risk of HIV infection,” Goldstein said. “And those limitations result in rising rates of new HIV infections in men who have sex with men while we see across the country actually dropping rates of new HIV infections year after year.”\u003c/p>\n\u003cp>In some cases, the problem of too little PrEP prescribing is due to a lack of training, and in other cases, something else may be at play, suggested Dr. Demetre Daskalakis, the New York Department of Health’s deputy commissioner of disease control.\u003c/p>\n\u003cp>“We still have to sell this to [clinicians] who are like, ‘Why would I be offering people PrEP, if it’s going to encourage them to have condomless sex?’” he said. “And our answer tends to be, ‘They’re already having condomless sex and this prevents HIV.’”\u003c/p>\n\u003cp>New York is one of several cities — San Francisco and Washington, D.C., among them — that have moved aggressively to harness the power of the treatment and prevention, working to actively identify people who are HIV-positive but who haven’t yet been tested, or haven’t yet started taking antiretroviral drugs, as well as people who should be using PrEP, but are not.\u003c/p>\n\u003cp>New York has expanded the remit of its sexual health clinics to help identify these patients and get them into treatment, said Daskalakis, who explained it’s about “snagging” the people most at risk “where they come for service.”\u003c/p>\n\u003cp>Anyone who is newly diagnosed with HIV is offered antiretroviral drugs immediately. No waiting for a follow-up appointment, which increases the possibility the patient won’t return. And it’s working “with just staggering success,” said Daskalakis.\u003c/p>\n\u003cp>“What we’re finding is that they get virally suppressed faster,” he said. “It’s sort of the dream, that when you start people on medicines for infections they have on the day of their diagnosis, all of a sudden you see that they’re interested in connecting to care and actually follow through.”\u003c/p>\n\u003cp>Likewise, people who test negative for HIV but who are deemed at risk of becoming infected are offered a starter pack of PrEP. The efforts led to a sharp upswing in the number of people taking PrEP — and a swift decline in the number of new HIV diagnoses. In 2016, new infections dropped 10 percent overall, and 15 percent among men who have sex with men, Daskalakis said.\u003c/p>\n\u003cp>The cost of PrEP is steep — $1,500 a month without insurance or assistance from the manufacturer. But New York state has an assistance program that helps with the cost of the medical care PrEP use requires, and there’s a patient assistance program for those who can’t pay for the drug. At the end of the day, Daskalakis said, with a combination of programs, most patients can access PrEP.\u003c/p>\n\u003cp>“In New York, the answer is yes. But I would be more worried about talking to someone in Mississippi,” he said.\u003c/p>\n\u003cp>That isn’t an insignificant consideration. The epidemic in the United States is currently being driven, in large part, by infections among African-American and Latino men who have sex with men in several Southern states.\u003c/p>\n\u003cp>Fauci is a believer in the active style of HIV interventions New York and other cities are employing. “You can’t do business as usual,” he said. “You’ve got to have an aggressive approach.”\u003c/p>\n\u003cp>But he’s always cognizant that translating the successes of Washington or New York to less urban settings — where access to care is more limited and stigma may be greater — likely won’t be as simple as changing some wording on some brochures.\u003c/p>\n\u003cp>“Is that going to work in Alabama? In Georgia? In Mississippi and Louisiana? That’s where we’ve got to put the focus on,” Fauci said.\u003c/p>\n\u003cp>Another challenge that likely won’t be easily overcome relates to the opioid epidemic. The growth in the use of injectable drugs — specifically the sharing of syringes — has driven up HIV and hepatitis C rates in people using illicit substances.\u003c/p>\n\u003cp>Research shows that needle exchange programs reduce those infections. Separately, a number of cities — San Francisco, Philadelphia, New York, and Seattle, among them— have been exploring opening \u003ca href=\"https://www.statnews.com/2017/12/13/supervised-injection-facilities-doctor/\" target=\"_blank\" rel=\"noopener\">safe injection sites\u003c/a>.\u003c/p>\n\u003cp>But just as some doctors associate PrEP prescription with enabling unsafe behavior, the notion of sanctioned injection sites and syringe programs draws the ire of people who believe they encourage illegal activity.\u003c/p>\n\u003cp>In an opinion piece in the New York Times, Deputy Attorney General Rod Rosenstein warned the Department of Justice would take swift action against cities that open such facilities, calling them illegal.\u003c/p>\n\u003cp>“Americans struggling with addiction need treatment and reduced access to deadly drugs. They do not need a taxpayer-sponsored haven to shoot up,” he wrote.\u003c/p>\n\u003cp>Public health experts counter that criminalizing drug use hasn’t worked. Officials can’t “punish people into getting well,” said Dr. Sarah Wakeman, medical director of the substance use disorder program at Mass. General.\u003c/p>\n\u003cp>“At the highest levels of our government, there’s a lot of opposition and antipathy to the idea of harm reduction,” Wakeman said of Rosenstein’s commentary. “And in fact, in that op-ed, it was very clearly stated that these efforts are ‘enabling’ — which I think is one of the many kind of myths around harm reduction.”\u003c/p>\n\u003cp>“We’ll never get to a place where we can stop the spread of HIV unless we are willing to rethink the way we take care of, and our policy towards people who use drugs in this country,” she said.\u003c/p>\n\u003cp>Needle exchange programs have some high-profile supporters, including top officials who have had up-close experience with the problem. The CDC’s Redfield has a son \u003ca href=\"https://www.apnews.com/8cc276150f7e4860bc05bdd4ac04d5e0\" target=\"_blank\" rel=\"noopener\">who has struggled with opioid addiction\u003c/a>; Surgeon General Jerome Adams \u003ca href=\"https://www.statnews.com/2017/12/07/surgeon-general-and-his-brother/\" target=\"_blank\" rel=\"noopener\">has a younger brother who has fought addiction\u003c/a> for two decades.\u003c/p>\n\u003cp>“We believe there is clear evidence that needle exchange programs can reduce the risk of transmission of HIV infection,” said Redfield. Adams \u003ca href=\"https://www.statnews.com/2018/09/20/surgeon-general-jerome-adams-year-one/\" target=\"_blank\" rel=\"noopener\">told STAT\u003c/a> last week: “When I see a [needle exchange] program close, what that says to me is that we haven’t done a good enough job communicating to the community why this program is important and the value that it provides.”\u003c/p>\n\u003cp>The hardest sell yet may be to convince authorities that successfully containing the spread of HIV in the U.S. requires addressing transmission in prisons. Prisons, in theory, “should be easy, because it’s a confined population,” said Fauci. He acknowledged, however, the gap is wide here between theory and reality.\u003c/p>\n\u003cp>“You’ve just got to get really flexible in what you do and recognize that there is sex going on, there is injection drug use going on. And if you really want to address it, you really have to address it in those settings,” he said. “And that, I know, is going to raise a lot of eyebrows. But it’s got to be done.”\u003c/p>\n\u003cp>\u003ci>\u003cspan style=\"font-weight: 400\">This \u003c/span>\u003c/i>\u003ca href=\"https://www.statnews.com/2018/09/26/hiv-aids-end-of-transmission-goal/\" target=\"_blank\" rel=\"noopener\">\u003ci>\u003cspan style=\"font-weight: 400\">story\u003c/span>\u003c/i>\u003c/a>\u003ci>\u003cspan style=\"font-weight: 400\"> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/span>\u003c/i>\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n",
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"description": "A mere decade ago, 45,000 Americans a year were contracting HIV. Since the Centers for Disease Control and Prevention started collecting data on HIV-related deaths just over 30 years ago, more than half a million of those people have died from AIDS. And yet, today, the struggle against HIV may be undergoing a sea change.",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp class=\"danger-zone\">\u003cspan class=\"big-cap-wrap\">\u003cspan class=\"big-cap\">A \u003c/span>\u003c/span>mere decade ago, 45,000 Americans a year were contracting HIV. Since the Centers for Disease Control and Prevention started collecting data on HIV-related deaths just over 30 years ago, more than half a million of those people have died from AIDS.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp class=\"danger-zone\">And yet, today, the struggle against HIV may be undergoing a sea change.\u003c/p>\n\u003cp class=\"danger-zone\">U.S. health officials and HIV experts are beginning to talk about a future \u003ca href=\"https://www.statnews.com/2018/03/29/cdc-director-hiv-remarks/\" target=\"_blank\" rel=\"noopener\">in which transmission in the United States could be halted\u003c/a>. And that future, they say, could come not within a generation, but in the span of just a few years.\u003c/p>\n\u003cp class=\"\">“We have the science to solve the AIDS epidemic,” Dr. Robert Redfield, the director of the CDC, himself a longtime HIV researcher and clinician, told STAT in a recent interview. “We’ve invested in it. Let’s put it into action.‘’\u003c/p>\n\u003cp class=\"\">Other leaders in the HIV field have been musing about the idea, buoyed by the astonishing impact effective HIV medications have wrought, both on the lives of people infected with or at risk of contracting the virus, and on the trajectory of the epidemic.\u003c/p>\n\u003cp class=\"\">“It’s certainly doable in the United States,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a researcher whose study focused on HIV from the earliest days of the AIDS epidemic.\u003c/p>\n\u003cp>Fauci and other health experts are quick to point out that the goal of stopping transmission entirely is largely theoretical. There will always be some new cases, and the barriers to providing treatment to existing cases remain significant. There are still just under 40,000 people in the U.S. each year contracting HIV. As Fauci put it: “We live in a real world, we don’t live in a theoretical world.”\u003c/p>\n\u003cp>But “if we implement all the tools that we have and if we can theoretically, conceptually, get everybody who’s HIV infected on antiretroviral drug so that they will not transmit the infection to anyone else, theoretically you could end the epidemic tomorrow by doing that,” he added.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>In the absence of a highly effective vaccine — and likely, even, in the presence of one — consigning the global HIV/AIDS epidemic to the history books would be impossible. And at the moment, that’s moot: Despite decades of research on HIV vaccines, the holy grail of HIV control remains an unmet goal.\u003c/p>\n\u003cp>Still, even without a vaccine, experts believe transmission could be largely stopped in this country — a goal that until the past few years would have been unthinkable.\u003c/p>\n\u003cp>In March, Redfield told CDC staff that he believed HIV transmission in the United States \u003ca href=\"https://www.statnews.com/2018/03/29/cdc-director-hiv-remarks/\" target=\"_blank\" rel=\"noopener\">could be halted over the next three to seven years\u003c/a>.\u003c/p>\n\u003cp>The foundation of the dream is the realization that, if taken correctly, today’s potent antiretroviral drugs will drive down the amount of virus in an HIV-infected person’s system to undetectable levels. People who reach that state, known as viral suppression, are not contagious — even, it seems, if they have unprotected sex.\u003c/p>\n\u003cp>Accumulated data from several studies show that in nearly 80,000 condomless sex acts between pairs of men who had discordant HIV status — one was negative, the other was positive, but virally suppressed — not a single new infection occurred.\u003c/p>\n\u003cp>In the HIV world, that finding has given rise to a slogan: U = U, or undetectable equals untransmissible. To maximize the benefits of viral suppression, though, people must know their HIV status and start treatment if they are infected. Currently the CDC estimates that 15 percent of infected Americans are unaware they are HIV positive.\u003c/p>\n\u003cp>“People with HIV infection need to be diagnosed, getting care, stay in care, get on antiretrovirals, and get their viral load down to undetectable,” Redfield said.\u003c/p>\n\u003cp>Pairing the power of viral suppression with another tool further increases the chances of stopping spread of the virus. That other tool is \u003ca href=\"https://www.statnews.com/2018/07/24/digital-pill-prep-truvada/\">PrEP\u003c/a>, pre-exposure prophylaxis — antiretroviral drugs used to prevent infection in people who are at high risk of contracting the virus.\u003c/p>\n\u003cp>Taken correctly, PrEP reduces the risk of contracting HIV from an infected partner by 95 percent. If the infected partner is virally suppressed, the risk is lower still.\u003c/p>\n\u003cp>But the benefits of PrEP can only be reaped if people use it. Currently too few do. The CDC estimates that about 1.1 million people in the U.S. should be taking PrEP, including men who have sex with men, sex workers, and transgender women, a population with a highly elevated risk of contracting HIV. But only about 200,000 are actually using it, Redfield said.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Paradoxically, doctors bear part of the blame for that gap.\u003c/p>\n\u003cp>“There is a large number of people who are not comfortable prescribing PrEP or have not been taught how to prescribe PrEP, whether it be in their residency, fellowship, or post-graduate training,” said Dr. Robert Goldstein, medical director of the transgender health program at Massachusetts General Hospital and an instructor at Harvard Medical School.\u003c/p>\n\u003cp>“We’re limited by stigma within the medical community and within the LGBT community. We’re limited by lack of provider knowledge. We’re limited by awareness among those at highest risk of HIV infection,” Goldstein said. “And those limitations result in rising rates of new HIV infections in men who have sex with men while we see across the country actually dropping rates of new HIV infections year after year.”\u003c/p>\n\u003cp>In some cases, the problem of too little PrEP prescribing is due to a lack of training, and in other cases, something else may be at play, suggested Dr. Demetre Daskalakis, the New York Department of Health’s deputy commissioner of disease control.\u003c/p>\n\u003cp>“We still have to sell this to [clinicians] who are like, ‘Why would I be offering people PrEP, if it’s going to encourage them to have condomless sex?’” he said. “And our answer tends to be, ‘They’re already having condomless sex and this prevents HIV.’”\u003c/p>\n\u003cp>New York is one of several cities — San Francisco and Washington, D.C., among them — that have moved aggressively to harness the power of the treatment and prevention, working to actively identify people who are HIV-positive but who haven’t yet been tested, or haven’t yet started taking antiretroviral drugs, as well as people who should be using PrEP, but are not.\u003c/p>\n\u003cp>New York has expanded the remit of its sexual health clinics to help identify these patients and get them into treatment, said Daskalakis, who explained it’s about “snagging” the people most at risk “where they come for service.”\u003c/p>\n\u003cp>Anyone who is newly diagnosed with HIV is offered antiretroviral drugs immediately. No waiting for a follow-up appointment, which increases the possibility the patient won’t return. And it’s working “with just staggering success,” said Daskalakis.\u003c/p>\n\u003cp>“What we’re finding is that they get virally suppressed faster,” he said. “It’s sort of the dream, that when you start people on medicines for infections they have on the day of their diagnosis, all of a sudden you see that they’re interested in connecting to care and actually follow through.”\u003c/p>\n\u003cp>Likewise, people who test negative for HIV but who are deemed at risk of becoming infected are offered a starter pack of PrEP. The efforts led to a sharp upswing in the number of people taking PrEP — and a swift decline in the number of new HIV diagnoses. In 2016, new infections dropped 10 percent overall, and 15 percent among men who have sex with men, Daskalakis said.\u003c/p>\n\u003cp>The cost of PrEP is steep — $1,500 a month without insurance or assistance from the manufacturer. But New York state has an assistance program that helps with the cost of the medical care PrEP use requires, and there’s a patient assistance program for those who can’t pay for the drug. At the end of the day, Daskalakis said, with a combination of programs, most patients can access PrEP.\u003c/p>\n\u003cp>“In New York, the answer is yes. But I would be more worried about talking to someone in Mississippi,” he said.\u003c/p>\n\u003cp>That isn’t an insignificant consideration. The epidemic in the United States is currently being driven, in large part, by infections among African-American and Latino men who have sex with men in several Southern states.\u003c/p>\n\u003cp>Fauci is a believer in the active style of HIV interventions New York and other cities are employing. “You can’t do business as usual,” he said. “You’ve got to have an aggressive approach.”\u003c/p>\n\u003cp>But he’s always cognizant that translating the successes of Washington or New York to less urban settings — where access to care is more limited and stigma may be greater — likely won’t be as simple as changing some wording on some brochures.\u003c/p>\n\u003cp>“Is that going to work in Alabama? In Georgia? In Mississippi and Louisiana? That’s where we’ve got to put the focus on,” Fauci said.\u003c/p>\n\u003cp>Another challenge that likely won’t be easily overcome relates to the opioid epidemic. The growth in the use of injectable drugs — specifically the sharing of syringes — has driven up HIV and hepatitis C rates in people using illicit substances.\u003c/p>\n\u003cp>Research shows that needle exchange programs reduce those infections. Separately, a number of cities — San Francisco, Philadelphia, New York, and Seattle, among them— have been exploring opening \u003ca href=\"https://www.statnews.com/2017/12/13/supervised-injection-facilities-doctor/\" target=\"_blank\" rel=\"noopener\">safe injection sites\u003c/a>.\u003c/p>\n\u003cp>But just as some doctors associate PrEP prescription with enabling unsafe behavior, the notion of sanctioned injection sites and syringe programs draws the ire of people who believe they encourage illegal activity.\u003c/p>\n\u003cp>In an opinion piece in the New York Times, Deputy Attorney General Rod Rosenstein warned the Department of Justice would take swift action against cities that open such facilities, calling them illegal.\u003c/p>\n\u003cp>“Americans struggling with addiction need treatment and reduced access to deadly drugs. They do not need a taxpayer-sponsored haven to shoot up,” he wrote.\u003c/p>\n\u003cp>Public health experts counter that criminalizing drug use hasn’t worked. Officials can’t “punish people into getting well,” said Dr. Sarah Wakeman, medical director of the substance use disorder program at Mass. General.\u003c/p>\n\u003cp>“At the highest levels of our government, there’s a lot of opposition and antipathy to the idea of harm reduction,” Wakeman said of Rosenstein’s commentary. “And in fact, in that op-ed, it was very clearly stated that these efforts are ‘enabling’ — which I think is one of the many kind of myths around harm reduction.”\u003c/p>\n\u003cp>“We’ll never get to a place where we can stop the spread of HIV unless we are willing to rethink the way we take care of, and our policy towards people who use drugs in this country,” she said.\u003c/p>\n\u003cp>Needle exchange programs have some high-profile supporters, including top officials who have had up-close experience with the problem. The CDC’s Redfield has a son \u003ca href=\"https://www.apnews.com/8cc276150f7e4860bc05bdd4ac04d5e0\" target=\"_blank\" rel=\"noopener\">who has struggled with opioid addiction\u003c/a>; Surgeon General Jerome Adams \u003ca href=\"https://www.statnews.com/2017/12/07/surgeon-general-and-his-brother/\" target=\"_blank\" rel=\"noopener\">has a younger brother who has fought addiction\u003c/a> for two decades.\u003c/p>\n\u003cp>“We believe there is clear evidence that needle exchange programs can reduce the risk of transmission of HIV infection,” said Redfield. Adams \u003ca href=\"https://www.statnews.com/2018/09/20/surgeon-general-jerome-adams-year-one/\" target=\"_blank\" rel=\"noopener\">told STAT\u003c/a> last week: “When I see a [needle exchange] program close, what that says to me is that we haven’t done a good enough job communicating to the community why this program is important and the value that it provides.”\u003c/p>\n\u003cp>The hardest sell yet may be to convince authorities that successfully containing the spread of HIV in the U.S. requires addressing transmission in prisons. Prisons, in theory, “should be easy, because it’s a confined population,” said Fauci. He acknowledged, however, the gap is wide here between theory and reality.\u003c/p>\n\u003cp>“You’ve just got to get really flexible in what you do and recognize that there is sex going on, there is injection drug use going on. And if you really want to address it, you really have to address it in those settings,” he said. “And that, I know, is going to raise a lot of eyebrows. But it’s got to be done.”\u003c/p>\n\u003cp>\u003ci>\u003cspan style=\"font-weight: 400\">This \u003c/span>\u003c/i>\u003ca href=\"https://www.statnews.com/2018/09/26/hiv-aids-end-of-transmission-goal/\" target=\"_blank\" rel=\"noopener\">\u003ci>\u003cspan style=\"font-weight: 400\">story\u003c/span>\u003c/i>\u003c/a>\u003ci>\u003cspan style=\"font-weight: 400\"> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/span>\u003c/i>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cp class=\"big-cap-wrap danger-zone\">\u003cspan class=\"big-cap\">A\u003c/span>t his surgery center near San Diego, Rodney Davis wore scrubs, was referred to as “Dr. Rod” and carried the title of director of surgery. But he was a physician assistant, not a doctor, who anesthetized patients and performed liposuction with little input from his supervising doctor, court records show.[contextly_sidebar id=\"bCRm0bBe62YWgmRvlJ4eqKPxhXeHZ0tw\"]\u003c/p>\n\u003cp class=\"danger-zone\">So it was perhaps no surprise, in 2016, when an administrative judge stripped Davis of his license, concluding it was the only way to “protect the public.” State officials also accused two former medical directors of Pacific Liposculpture of enabling Davis to act as a doctor.\u003c/p>\n\u003cp class=\"danger-zone\">One powerful authority in California took a different view. The state-approved private accreditation agency that oversees the center left its approval in place. So the center is still operating and Davis remains an owner and administrator, state records show.\u003c/p>\n\u003cp class=\"\">California is the only state with more than 1,000 surgery centers that has given private accreditors a lead role in oversight. Those accreditors are typically paid by the same centers they evaluate.\u003c/p>\n\u003cp class=\"\">That approach to oversight has created a troubling legacy of laxity, an investigation by Kaiser Health News shows. In case after case, as federal or state authorities waved red flags, state-approved accreditation agencies affixed gold seals of approval, according to a KHN review of hundreds of pages of doctors’ disciplinary records, court files and accreditor reports — which are public only for California surgery centers.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>One accreditation inspector called a doctor’s anesthesia technique “impressive” just months before the state medical board accused her of “gross negligence” for putting patients in deep sedation without the training to save them if they stopped breathing. Another doctor who is fighting a medical board accusation of “gross negligence” over two patient deaths in 2014 and 2015 got his own surgery center approved by an accreditor in 2016.\u003c/p>\n\u003cp>In yet another case, Medicare officials declared a state of “immediate jeopardy” at a center that put an untrained receptionist in charge of disinfecting surgical scopes, a Medicare inspection report says. Its accreditor renewed its approval within a week.[contextly_sidebar id=\"lK5aJFVogwX549hMBzzMFFOmow6d8C4T\"]\u003c/p>\n\u003cp>Patient deaths after care in a California surgery center reached a 14-year high with 18 cases in 2016, though the total dipped to 14 the following year, according to state records based on reports filed by the centers. Since 2010, at least 102 patients have died after care in the state’s surgery centers. Such facilities perform a variety of outpatient surgeries and now outnumber hospitals nationally.\u003c/p>\n\u003cp>State Sen. Jerry Hill, a San Francisco Bay Area Democrat, chairs the committee that oversees the state medical board, which reviews and approves the state’s surgery center accreditation agencies every three years.\u003c/p>\n\u003cp>Briefed on the investigation’s findings, Hill said this “definitely warrants a deeper examination into what’s going on at the surgery centers and how the accreditation process is working today — and [whether it’s] providing the patient protection I was hoping for when we established it.”\u003c/p>\n\u003cp>\u003cstrong>‘Impressive’ or Negligent?\u003c/strong>\u003c/p>\n\u003cp>California’s oversight of surgery centers was upended about a decade ago when a physician’s legal victory led the Department of Public Health to conclude it could no longer license doctor-owned surgery centers. The doctor had filed suit, challenging the requirement that he and his surgery center both maintain a license. He prevailed, putting state oversight of the doctor-owned centers in flux.\u003c/p>\n\u003cp>In 2011, state lawmakers came up with a solution, mandating that the state medical board approve the private accreditors that would be on the front lines of oversight. Today, five accreditors are allowed to both inspect surgery centers and to grant or deny surgery centers approval to operate. (Centers can also operate with just Medicare approval.)\u003c/p>\n\u003cp>State medical board officials denied a request for death reports that included centers’ names, making a more comprehensive review of the centers or their accreditors difficult. Some of the same accreditation agencies that approve surgery centers, though, have been under fire with members of Congress after a \u003ca href=\"https://www.wsj.com/articles/house-panel-probes-organizations-that-accredit-most-u-s-hospitals-1520871334\" target=\"_blank\" rel=\"noopener\">Wall Street Journal report\u003c/a> pinpointed gaps in their oversight of hospitals.[contextly_sidebar id=\"GZDqkzFYmuqwUdKOmAXYWO5uBzHekwGH\"]\u003c/p>\n\u003cp>With the change in California, the state-approved accreditation agencies got a guaranteed source of income, since the centers each pay their accrediting agency about $15,000 every three years for their oversight role. In turn, the accreditors made a first-of-its kind concession: They agreed to make their inspection reports open to the public on a \u003ca href=\"http://www2.mbc.ca.gov/OSSDPublic/\" target=\"_blank\" rel=\"noopener\">state website\u003c/a>.\u003c/p>\n\u003cp>Those reports show that accreditors, at times, were at odds with other officials.\u003c/p>\n\u003cp>On May 1, 2012, the Institute for Medical Quality, or IMQ, a San Francisco-based accreditor, inspected Advanced Medical Spa in Rocklin, Calif. The inspectors were required to check whether the person administering anesthesia was “qualified and working within their scope of practice.”\u003c/p>\n\u003cp>The inspector’s note says the surgeon’s wife, a pediatrician, was performing “conscious sedation” anesthesia and said her technique with the drug propofol was “impressive.” The standard was marked as “met” and accreditation was awarded through 2015.\u003c/p>\n\u003cp>A month later, the state medical board launched an investigation of the pediatrician, Dr. Yessennia Candelaria, over complaints that she was handling anesthesia for plastic surgery procedures without “requisite training in anesthesia, including Propofol,” the board’s records show.\u003c/p>\n\u003cp>Investigators for the Medical Board of California found that before and after the accreditor’s review, Candelaria was using propofol to put patients in a state of “deep sedation” even though she didn’t have the “advanced airway” training in how to rescue them if their breathing shut down. Medical board authorities deemed the lapse “gross negligence” in an accusation filed in 2014 that also accused her of abusing controlled drugs. Her medical license was put on probation for seven years. Medical board authorities recently moved to revoke her license over unauthorized prescribing, and she has not yet filed a written response.\u003c/p>\n\u003cp>An attorney for Candelaria declined to comment and Candelaria did not respond to a request for comment.\u003c/p>\n\u003cp>In February 2013, IMQ revoked its approval of Advanced Medical Spa. The following month, Candelaria and her husband, Dr. Efrain Gonzalez, were arrested in a separate criminal case. Gonzalez was charged with 37 felony counts that included mayhem and conspiracy for allegedly disfiguring the women he operated on at the center. Candelaria was charged with 24 felony counts, including mayhem and grand theft by false pretense.[contextly_sidebar id=\"XjXuoZ0eDhIzUgAewGXLnaDK92lSSe13\"]\u003c/p>\n\u003cp>Gonzalez pleaded guilty to three felonies and was sentenced to three months of house arrest in the criminal case and surrendered his medical license. Charges were ultimately dismissed against Candelaria, who pleaded not guilty.\u003c/p>\n\u003cp>Victoria Samper, vice president of ambulatory programs with IMQ, said she could not comment on specific facilities. But she did note that California law allows doctors to practice outside of the field they initially train in. She also said if a doctor is doing so, an inspector would be expected to “drill down” into the physician’s practices.\u003c/p>\n\u003cp>The medical board said in a statement that the private accreditor who dubbed Candelaria’s technique “impressive” reviewed her work with a different patient than those cited in the board’s accusation.\u003c/p>\n\u003cp>“If the Board becomes aware that there is an accreditation agency that is not following the law when accrediting outpatient surgery settings, the Board would look into it,” the statement said.\u003c/p>\n\u003cp>\u003cstrong>Decertified, Yet Still Operating\u003c/strong>\u003c/p>\n\u003cp>Accreditation agencies have stood by eight California surgery centers facing the federal Medicare program’s harshest consequence — “involuntary decertification.” It’s a rare sanction that amounts to being deemed unfit to care for seniors.\u003c/p>\n\u003cp>On March 22, 2016, California Department of Public of Health inspectors notified federal authorities about a state of “immediate jeopardy” at Digestive Diagnostic Center, a small endoscopy center south of San Francisco.\u003c/p>\n\u003cp>A state inspection report said the center had pressed its new receptionist into duty to disinfect medical devices that probe patients’ colons — with no formal training. The center failed to protect patients and had “ineffective infection-control policies which did not address hiring … of qualified individuals,” the report concluded.\u003c/p>\n\u003cp>Something else happened that day as well. The Accreditation Association for Ambulatory Health Care, or AAAHC, renewed its approval of the center, which the agency describes as a “widely recognized symbol of quality” to patients and health insurers.\u003c/p>\n\u003cp>Medicare involuntarily decertified the facility a month later, which meant the federal agency would no longer pay for seniors’ care at the center. But with private accreditation still in place, private insurers would be likely to continue funding care there.[contextly_sidebar id=\"jNKvzLso8luG5OZDShUhWdxY6YuZm4id\"]\u003c/p>\n\u003cp>Dr. Michael Bishop, a former California medical board member, said the case exposes a gap in state oversight if a center falls below one overseer’s standard but meets another’s. “You want no one to have easier [approval] process than any other one,” he said. “That’s quite egregious.”\u003c/p>\n\u003cp>Kevin Calisher, president of the surgery center management firm Calisher & Associates, said his company took over management of the center in 2017, and that he could not comment on Medicare’s findings.\u003c/p>\n\u003cp>AAAHC said in a statement that it could not discuss individual facilities.\u003c/p>\n\u003cp>The medical board’s statement said Medicare is not required to notify the board when it decertifies a surgical center. “Now that this situation has been brought to the Board’s attention, however, the Board will be looking into the matter,” the statement said.\u003c/p>\n\u003cp>\u003cstrong>The Case of ‘Doctor’ Davis\u003c/strong>\u003c/p>\n\u003cp>On April 9, 2015, an inspector from AAAHC arrived to perform an initial inspection of Pacific Liposculpture, which had been operating since 2011.\u003c/p>\n\u003cp>The inspectors’ checklist included a review of complaints filed against the center by a state “licensure board.” Davis had already been publicly accused by the state physician assistant board of engaging in the unlawful practice of medicine and gross negligence for failing to appropriately care for patients who experienced complications.\u003c/p>\n\u003cp>The inspector checked the box for “substantial compliance” and awarded the center approval through April 2018.\u003c/p>\n\u003cp>That decision was “enraging actually, outrageous,” said Todd Glanz, a San Diego-area attorney. He represents a patient, Cecilia O’Neill, who went to the center for liposuction a few weeks after it was accredited.\u003c/p>\n\u003cp>O’Neill returned a few days after her May 28, 2015, procedure, complaining of pain, dizziness and signs of infection, her lawsuit alleges. But she claims her condition got worse. On June 9, 2015, she went to an emergency room, where she was told she had sepsis and needed emergency surgery followed by a stay in the ICU, according to her lawsuit.\u003c/p>\n\u003cp>Glanz said O’Neill was left with a hospital bill of nearly $200,000 and ongoing disfigurement. Davis and Dr. Harrison Robbins, the facility’s former medical director and other owner, have denied wrongdoing and are fighting the ongoing lawsuit.\u003c/p>\n\u003cp>The following year, in February 2016, Davis faced an eight-day administrative hearing over whether he should keep his license as a physician assistant. A central issue was whether he truly worked under a doctor’s supervision, as the law requires, or hired a figurehead who would exert little control.[contextly_sidebar id=\"j894jyuCZ3utDZHFwJB18y3NZzmqzLVt\"]\u003c/p>\n\u003cp>One 2010 email discussed in court was by Davis, saying he hoped his new supervising physician, Dr. Jerrell Borup, would not be “another clumsy physician getting in the way.”\u003c/p>\n\u003cp>His attorney presented experts and argued that he should keep his license. At its conclusion, the administrative judge revoked his license and reached a searing conclusion.\u003c/p>\n\u003cp>Davis “purposefully and intentionally set out to create a business arrangement that looked legitimate on paper,” Judge Susan Boyle wrote, “but allowed him to manipulate the system and run a liposuction business without the interference of a physician.”\u003c/p>\n\u003cp>The two former medical directors of the center were accused by the Medical Board of California of “aiding and abetting” Davis’ unlicensed practice of medicine. Neither doctor actively supervised Davis, who performed all the procedures, the accusations say.\u003c/p>\n\u003cp>Davis has denied wrongdoing in each proceeding and declined to comment for this report through an attorney. One of the former medical directors, Borup, surrendered his license in 2016. The other, Dr. Harrison Robbins, is fighting the medical board’s similar case against him. The controversy did not deter AAAHC, which earlier this year approved the center through April 2021.\u003c/p>\n\u003cp>Robert Frank, a San Diego attorney who represented Davis and Robbins, said Robbins has retired and the public should have no concerns about Davis’ ongoing administrative role at Pacific Liposculpture.\u003c/p>\n\u003cp>“[Davis] knows the business, he knows the procedure and he knows he’s being watched and scrutinized” during the ongoing legal case, Frank said.\u003c/p>\n\u003cp>Davis contested his license revocation but lost that case in Sacramento Superior Court. He’s now challenging that decision in appeals court.\u003c/p>\n\u003cp>Betsy Imholz, former director of special projects for Consumers Union, who reviewed the findings for this report, said the case was shocking. “There are huge gaps in California law, clearly,” she said.\u003c/p>\n\u003cp>\u003cstrong>Two Deaths — And Then a Green Light\u003c/strong>\u003c/p>\n\u003cp>The families of two women in their 40s sued Diamond Surgery Center in Encino, Calif., and its surgeon, alleging wrongdoing in their 2014 and 2015 deaths.\u003c/p>\n\u003cp>The incidents did not stop the facility from getting accreditation in 2017 from the Chicago-based Joint Commission, the nation’s most prominent accreditor.\u003c/p>\n\u003cp>Oneyda Mata, 40, was the first to die, on March 29, 2014. According to her autopsy, she called 911 from her car, struggling to breathe. Although her liposuction at the surgery center was 22 days earlier, the autopsy lists Diamond Surgery Center as the “place of injury” in her death from a blood clot lodged in her lung.\u003c/p>\n\u003cp>Dr. Roya Dardashti admitted no fault, but reached a $200,000 settlement in the family’s lawsuit. The sum became public only because the family filed legal records saying Dardashti failed to make some payments.\u003c/p>\n\u003cp>MaryCruz Elizalde, 42, was the second to die, on Dec. 10, 2015. She was in recovery after a tummy tuck and liposuction at Diamond Surgery Center when she went into cardiac arrest and was taken to a hospital. Her autopsy says she died from internal bleeding and shock “as a consequence of complications of surgery.”\u003c/p>\n\u003cp>Elizalde’s partner’s lawsuit alleged that an unlicensed anesthesia provider at the center was involved in her care. The case was voluntarily dismissed after the partner was imprisoned in an unrelated fraud case.\u003c/p>\n\u003cp>State law bars doctors from operating in an unapproved facility at levels of anesthesia that rob people of their “life-preserving” reflexes.\u003c/p>\n\u003cp>Whether the facility operated outside of that limit or erred in either woman’s care wasn’t noted when the center got its initial approval to operate in 2017.\u003c/p>\n\u003cp>With a slightly different, new name, Diamond Surgical Institute, the same location and same lead doctor, the facility now appears to have full accreditation on the state’s website for surgery centers.\u003c/p>\n\u003cp>Joint Commission spokeswoman Katherine Bronk said the center was awarded “limited temporary accreditation” in 2017 and 2018 after “limited” inspections. Those limited inspections did not include a check of patient medical records because they’re designed for facilities “not actively caring for patients.”\u003c/p>\n\u003cp>Bronk said in an email that past problems might not affect an accreditation decision.\u003c/p>\n\u003cp>“If the surgery center had not been following the law but made compliance with the law part of its corrective action plan, it would not necessarily be denied accreditation,” she wrote. “As a private accreditor, our goal is to help organizations identify deficiencies in care and correct them as quickly and sustainably as possible.”\u003c/p>\n\u003cp>Dardashti did not respond to calls or email requests for an interview. The medical board declined to say whether it has received a report of a patient death from the facility since 2014, saying the information is “confidential.”\u003c/p>\n\u003cp>State law requires accreditors to perform a “reasonable investigation” of a surgery center’s past, which includes a check to see if its doctors have a license, which Dardashti did. The checks should go deeper, said Imholz, of Consumers Union.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>“If past is prologue, we should be looking at what the key players, owners and doctors involved, what they have in their records,” she said. “It’s relevant; it should be looked at.”\u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp class=\"big-cap-wrap danger-zone\">\u003cspan class=\"big-cap\">A\u003c/span>t his surgery center near San Diego, Rodney Davis wore scrubs, was referred to as “Dr. Rod” and carried the title of director of surgery. But he was a physician assistant, not a doctor, who anesthetized patients and performed liposuction with little input from his supervising doctor, court records show.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp class=\"danger-zone\">So it was perhaps no surprise, in 2016, when an administrative judge stripped Davis of his license, concluding it was the only way to “protect the public.” State officials also accused two former medical directors of Pacific Liposculpture of enabling Davis to act as a doctor.\u003c/p>\n\u003cp class=\"danger-zone\">One powerful authority in California took a different view. The state-approved private accreditation agency that oversees the center left its approval in place. So the center is still operating and Davis remains an owner and administrator, state records show.\u003c/p>\n\u003cp class=\"\">California is the only state with more than 1,000 surgery centers that has given private accreditors a lead role in oversight. Those accreditors are typically paid by the same centers they evaluate.\u003c/p>\n\u003cp class=\"\">That approach to oversight has created a troubling legacy of laxity, an investigation by Kaiser Health News shows. In case after case, as federal or state authorities waved red flags, state-approved accreditation agencies affixed gold seals of approval, according to a KHN review of hundreds of pages of doctors’ disciplinary records, court files and accreditor reports — which are public only for California surgery centers.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>One accreditation inspector called a doctor’s anesthesia technique “impressive” just months before the state medical board accused her of “gross negligence” for putting patients in deep sedation without the training to save them if they stopped breathing. Another doctor who is fighting a medical board accusation of “gross negligence” over two patient deaths in 2014 and 2015 got his own surgery center approved by an accreditor in 2016.\u003c/p>\n\u003cp>In yet another case, Medicare officials declared a state of “immediate jeopardy” at a center that put an untrained receptionist in charge of disinfecting surgical scopes, a Medicare inspection report says. Its accreditor renewed its approval within a week.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Patient deaths after care in a California surgery center reached a 14-year high with 18 cases in 2016, though the total dipped to 14 the following year, according to state records based on reports filed by the centers. Since 2010, at least 102 patients have died after care in the state’s surgery centers. Such facilities perform a variety of outpatient surgeries and now outnumber hospitals nationally.\u003c/p>\n\u003cp>State Sen. Jerry Hill, a San Francisco Bay Area Democrat, chairs the committee that oversees the state medical board, which reviews and approves the state’s surgery center accreditation agencies every three years.\u003c/p>\n\u003cp>Briefed on the investigation’s findings, Hill said this “definitely warrants a deeper examination into what’s going on at the surgery centers and how the accreditation process is working today — and [whether it’s] providing the patient protection I was hoping for when we established it.”\u003c/p>\n\u003cp>\u003cstrong>‘Impressive’ or Negligent?\u003c/strong>\u003c/p>\n\u003cp>California’s oversight of surgery centers was upended about a decade ago when a physician’s legal victory led the Department of Public Health to conclude it could no longer license doctor-owned surgery centers. The doctor had filed suit, challenging the requirement that he and his surgery center both maintain a license. He prevailed, putting state oversight of the doctor-owned centers in flux.\u003c/p>\n\u003cp>In 2011, state lawmakers came up with a solution, mandating that the state medical board approve the private accreditors that would be on the front lines of oversight. Today, five accreditors are allowed to both inspect surgery centers and to grant or deny surgery centers approval to operate. (Centers can also operate with just Medicare approval.)\u003c/p>\n\u003cp>State medical board officials denied a request for death reports that included centers’ names, making a more comprehensive review of the centers or their accreditors difficult. Some of the same accreditation agencies that approve surgery centers, though, have been under fire with members of Congress after a \u003ca href=\"https://www.wsj.com/articles/house-panel-probes-organizations-that-accredit-most-u-s-hospitals-1520871334\" target=\"_blank\" rel=\"noopener\">Wall Street Journal report\u003c/a> pinpointed gaps in their oversight of hospitals.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>With the change in California, the state-approved accreditation agencies got a guaranteed source of income, since the centers each pay their accrediting agency about $15,000 every three years for their oversight role. In turn, the accreditors made a first-of-its kind concession: They agreed to make their inspection reports open to the public on a \u003ca href=\"http://www2.mbc.ca.gov/OSSDPublic/\" target=\"_blank\" rel=\"noopener\">state website\u003c/a>.\u003c/p>\n\u003cp>Those reports show that accreditors, at times, were at odds with other officials.\u003c/p>\n\u003cp>On May 1, 2012, the Institute for Medical Quality, or IMQ, a San Francisco-based accreditor, inspected Advanced Medical Spa in Rocklin, Calif. The inspectors were required to check whether the person administering anesthesia was “qualified and working within their scope of practice.”\u003c/p>\n\u003cp>The inspector’s note says the surgeon’s wife, a pediatrician, was performing “conscious sedation” anesthesia and said her technique with the drug propofol was “impressive.” The standard was marked as “met” and accreditation was awarded through 2015.\u003c/p>\n\u003cp>A month later, the state medical board launched an investigation of the pediatrician, Dr. Yessennia Candelaria, over complaints that she was handling anesthesia for plastic surgery procedures without “requisite training in anesthesia, including Propofol,” the board’s records show.\u003c/p>\n\u003cp>Investigators for the Medical Board of California found that before and after the accreditor’s review, Candelaria was using propofol to put patients in a state of “deep sedation” even though she didn’t have the “advanced airway” training in how to rescue them if their breathing shut down. Medical board authorities deemed the lapse “gross negligence” in an accusation filed in 2014 that also accused her of abusing controlled drugs. Her medical license was put on probation for seven years. Medical board authorities recently moved to revoke her license over unauthorized prescribing, and she has not yet filed a written response.\u003c/p>\n\u003cp>An attorney for Candelaria declined to comment and Candelaria did not respond to a request for comment.\u003c/p>\n\u003cp>In February 2013, IMQ revoked its approval of Advanced Medical Spa. The following month, Candelaria and her husband, Dr. Efrain Gonzalez, were arrested in a separate criminal case. Gonzalez was charged with 37 felony counts that included mayhem and conspiracy for allegedly disfiguring the women he operated on at the center. Candelaria was charged with 24 felony counts, including mayhem and grand theft by false pretense.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Gonzalez pleaded guilty to three felonies and was sentenced to three months of house arrest in the criminal case and surrendered his medical license. Charges were ultimately dismissed against Candelaria, who pleaded not guilty.\u003c/p>\n\u003cp>Victoria Samper, vice president of ambulatory programs with IMQ, said she could not comment on specific facilities. But she did note that California law allows doctors to practice outside of the field they initially train in. She also said if a doctor is doing so, an inspector would be expected to “drill down” into the physician’s practices.\u003c/p>\n\u003cp>The medical board said in a statement that the private accreditor who dubbed Candelaria’s technique “impressive” reviewed her work with a different patient than those cited in the board’s accusation.\u003c/p>\n\u003cp>“If the Board becomes aware that there is an accreditation agency that is not following the law when accrediting outpatient surgery settings, the Board would look into it,” the statement said.\u003c/p>\n\u003cp>\u003cstrong>Decertified, Yet Still Operating\u003c/strong>\u003c/p>\n\u003cp>Accreditation agencies have stood by eight California surgery centers facing the federal Medicare program’s harshest consequence — “involuntary decertification.” It’s a rare sanction that amounts to being deemed unfit to care for seniors.\u003c/p>\n\u003cp>On March 22, 2016, California Department of Public of Health inspectors notified federal authorities about a state of “immediate jeopardy” at Digestive Diagnostic Center, a small endoscopy center south of San Francisco.\u003c/p>\n\u003cp>A state inspection report said the center had pressed its new receptionist into duty to disinfect medical devices that probe patients’ colons — with no formal training. The center failed to protect patients and had “ineffective infection-control policies which did not address hiring … of qualified individuals,” the report concluded.\u003c/p>\n\u003cp>Something else happened that day as well. The Accreditation Association for Ambulatory Health Care, or AAAHC, renewed its approval of the center, which the agency describes as a “widely recognized symbol of quality” to patients and health insurers.\u003c/p>\n\u003cp>Medicare involuntarily decertified the facility a month later, which meant the federal agency would no longer pay for seniors’ care at the center. But with private accreditation still in place, private insurers would be likely to continue funding care there.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Dr. Michael Bishop, a former California medical board member, said the case exposes a gap in state oversight if a center falls below one overseer’s standard but meets another’s. “You want no one to have easier [approval] process than any other one,” he said. “That’s quite egregious.”\u003c/p>\n\u003cp>Kevin Calisher, president of the surgery center management firm Calisher & Associates, said his company took over management of the center in 2017, and that he could not comment on Medicare’s findings.\u003c/p>\n\u003cp>AAAHC said in a statement that it could not discuss individual facilities.\u003c/p>\n\u003cp>The medical board’s statement said Medicare is not required to notify the board when it decertifies a surgical center. “Now that this situation has been brought to the Board’s attention, however, the Board will be looking into the matter,” the statement said.\u003c/p>\n\u003cp>\u003cstrong>The Case of ‘Doctor’ Davis\u003c/strong>\u003c/p>\n\u003cp>On April 9, 2015, an inspector from AAAHC arrived to perform an initial inspection of Pacific Liposculpture, which had been operating since 2011.\u003c/p>\n\u003cp>The inspectors’ checklist included a review of complaints filed against the center by a state “licensure board.” Davis had already been publicly accused by the state physician assistant board of engaging in the unlawful practice of medicine and gross negligence for failing to appropriately care for patients who experienced complications.\u003c/p>\n\u003cp>The inspector checked the box for “substantial compliance” and awarded the center approval through April 2018.\u003c/p>\n\u003cp>That decision was “enraging actually, outrageous,” said Todd Glanz, a San Diego-area attorney. He represents a patient, Cecilia O’Neill, who went to the center for liposuction a few weeks after it was accredited.\u003c/p>\n\u003cp>O’Neill returned a few days after her May 28, 2015, procedure, complaining of pain, dizziness and signs of infection, her lawsuit alleges. But she claims her condition got worse. On June 9, 2015, she went to an emergency room, where she was told she had sepsis and needed emergency surgery followed by a stay in the ICU, according to her lawsuit.\u003c/p>\n\u003cp>Glanz said O’Neill was left with a hospital bill of nearly $200,000 and ongoing disfigurement. Davis and Dr. Harrison Robbins, the facility’s former medical director and other owner, have denied wrongdoing and are fighting the ongoing lawsuit.\u003c/p>\n\u003cp>The following year, in February 2016, Davis faced an eight-day administrative hearing over whether he should keep his license as a physician assistant. A central issue was whether he truly worked under a doctor’s supervision, as the law requires, or hired a figurehead who would exert little control.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>One 2010 email discussed in court was by Davis, saying he hoped his new supervising physician, Dr. Jerrell Borup, would not be “another clumsy physician getting in the way.”\u003c/p>\n\u003cp>His attorney presented experts and argued that he should keep his license. At its conclusion, the administrative judge revoked his license and reached a searing conclusion.\u003c/p>\n\u003cp>Davis “purposefully and intentionally set out to create a business arrangement that looked legitimate on paper,” Judge Susan Boyle wrote, “but allowed him to manipulate the system and run a liposuction business without the interference of a physician.”\u003c/p>\n\u003cp>The two former medical directors of the center were accused by the Medical Board of California of “aiding and abetting” Davis’ unlicensed practice of medicine. Neither doctor actively supervised Davis, who performed all the procedures, the accusations say.\u003c/p>\n\u003cp>Davis has denied wrongdoing in each proceeding and declined to comment for this report through an attorney. One of the former medical directors, Borup, surrendered his license in 2016. The other, Dr. Harrison Robbins, is fighting the medical board’s similar case against him. The controversy did not deter AAAHC, which earlier this year approved the center through April 2021.\u003c/p>\n\u003cp>Robert Frank, a San Diego attorney who represented Davis and Robbins, said Robbins has retired and the public should have no concerns about Davis’ ongoing administrative role at Pacific Liposculpture.\u003c/p>\n\u003cp>“[Davis] knows the business, he knows the procedure and he knows he’s being watched and scrutinized” during the ongoing legal case, Frank said.\u003c/p>\n\u003cp>Davis contested his license revocation but lost that case in Sacramento Superior Court. He’s now challenging that decision in appeals court.\u003c/p>\n\u003cp>Betsy Imholz, former director of special projects for Consumers Union, who reviewed the findings for this report, said the case was shocking. “There are huge gaps in California law, clearly,” she said.\u003c/p>\n\u003cp>\u003cstrong>Two Deaths — And Then a Green Light\u003c/strong>\u003c/p>\n\u003cp>The families of two women in their 40s sued Diamond Surgery Center in Encino, Calif., and its surgeon, alleging wrongdoing in their 2014 and 2015 deaths.\u003c/p>\n\u003cp>The incidents did not stop the facility from getting accreditation in 2017 from the Chicago-based Joint Commission, the nation’s most prominent accreditor.\u003c/p>\n\u003cp>Oneyda Mata, 40, was the first to die, on March 29, 2014. According to her autopsy, she called 911 from her car, struggling to breathe. Although her liposuction at the surgery center was 22 days earlier, the autopsy lists Diamond Surgery Center as the “place of injury” in her death from a blood clot lodged in her lung.\u003c/p>\n\u003cp>Dr. Roya Dardashti admitted no fault, but reached a $200,000 settlement in the family’s lawsuit. The sum became public only because the family filed legal records saying Dardashti failed to make some payments.\u003c/p>\n\u003cp>MaryCruz Elizalde, 42, was the second to die, on Dec. 10, 2015. She was in recovery after a tummy tuck and liposuction at Diamond Surgery Center when she went into cardiac arrest and was taken to a hospital. Her autopsy says she died from internal bleeding and shock “as a consequence of complications of surgery.”\u003c/p>\n\u003cp>Elizalde’s partner’s lawsuit alleged that an unlicensed anesthesia provider at the center was involved in her care. The case was voluntarily dismissed after the partner was imprisoned in an unrelated fraud case.\u003c/p>\n\u003cp>State law bars doctors from operating in an unapproved facility at levels of anesthesia that rob people of their “life-preserving” reflexes.\u003c/p>\n\u003cp>Whether the facility operated outside of that limit or erred in either woman’s care wasn’t noted when the center got its initial approval to operate in 2017.\u003c/p>\n\u003cp>With a slightly different, new name, Diamond Surgical Institute, the same location and same lead doctor, the facility now appears to have full accreditation on the state’s website for surgery centers.\u003c/p>\n\u003cp>Joint Commission spokeswoman Katherine Bronk said the center was awarded “limited temporary accreditation” in 2017 and 2018 after “limited” inspections. Those limited inspections did not include a check of patient medical records because they’re designed for facilities “not actively caring for patients.”\u003c/p>\n\u003cp>Bronk said in an email that past problems might not affect an accreditation decision.\u003c/p>\n\u003cp>“If the surgery center had not been following the law but made compliance with the law part of its corrective action plan, it would not necessarily be denied accreditation,” she wrote. “As a private accreditor, our goal is to help organizations identify deficiencies in care and correct them as quickly and sustainably as possible.”\u003c/p>\n\u003cp>Dardashti did not respond to calls or email requests for an interview. The medical board declined to say whether it has received a report of a patient death from the facility since 2014, saying the information is “confidential.”\u003c/p>\n\u003cp>State law requires accreditors to perform a “reasonable investigation” of a surgery center’s past, which includes a check to see if its doctors have a license, which Dardashti did. The checks should go deeper, said Imholz, of Consumers Union.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“If past is prologue, we should be looking at what the key players, owners and doctors involved, what they have in their records,” she said. “It’s relevant; it should be looked at.”\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "IVF And Infertility Tech May Lead To Health Risks For The Baby",
"title": "IVF And Infertility Tech May Lead To Health Risks For The Baby",
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"content": "\u003cp>When patients come to Dr. Molly Quinn for infertility treatments, they usually aren't too interested in hearing about the possible downsides, she says. They just want to get pregnant.[contextly_sidebar id=\"ey0hWotixUsdyo0wQnYUMCoyOptxLTRK\"]\u003c/p>\n\u003cp>Still, she always discusses the risks. For example, there's an increased likelihood of twins or triplets — which increases the chances of \u003ca href=\"https://www.urmc.rochester.edu/encyclopedia/content.aspx?ContentTypeID=85&ContentID=P08021\" target=\"_blank\" rel=\"noopener\">medical complications\u003c/a> for both moms and babies. And stimulating the ovaries to ripen extra eggs can, in a small number of cases, cause the ovaries to rupture.\u003c/p>\n\u003cp>\u003ca href=\"https://www.uclahealth.org/molly-quinn\" target=\"_blank\" rel=\"noopener\">Quinn\u003c/a>, an infertility specialist and assistant professor of obstetrics and gynecology at the University of California, Los Angeles, now has a new hazard to consider. According to \u003ca href=\"https://www.sciencedirect.com/science/article/pii/S0735109718354809?via%3Dihub\" target=\"_blank\" rel=\"noopener\">research\u003c/a> published this month in the \u003cem>Journal of the American College of Cardiology\u003c/em>, children conceived through certain infertility treatments may be at a higher risk for cardiovascular disease.\u003c/p>\n\u003cp>Parents shouldn't panic, the study's authors say: The findings are preliminary, and the study cohort was fairly small. Still, they say, it means that families who used infertility treatments should be particularly vigilant about screening for high blood pressure in their children and help them avoid other cardiovascular risk factors, such as smoking, obesity and a sedentary lifestyle.\u003c/p>\n\u003cp>\"Fertility clinics should really ... counsel about potential risks for their kids,\" says \u003ca href=\"http://www.dbmr.unibe.ch/research/research_groups/personenpool/cardiology/prof_dr_med_scherrer_urs/index_eng.html\" target=\"_blank\" rel=\"noopener\">Dr. Urs Scherrer\u003c/a>, a visiting professor at the University of Bern in Switzerland and a senior author of the study.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Scherrer and his colleagues followed the health of children conceived through assisted reproductive technology for more than a decade. \u003ca href=\"https://medlineplus.gov/assistedreproductivetechnology.html\" target=\"_blank\" rel=\"noopener\">ART\u003c/a> is an umbrella term that covers a number of different types of procedures, including in vitro fertilization, in which sperm and eggs are mixed in a lab dish, and intracytoplasmic sperm injection, in which sperm are inserted directly into eggs. Today, roughly 2 percent of all births in the U.S are conceived via ART.[contextly_sidebar id=\"QmmfxSiEfwbF2B1GB9guL21XilL52eqX\"]\u003c/p>\n\u003cp>In 2012, the same team of scientists published a \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/22434595\" target=\"_blank\" rel=\"noopener\">major paper\u003c/a> showing that 65 healthy kids born with the help of ART were more likely than their peers to have early signs of problematic blood vessels. The current study, comparing 54 of those original children with 43 age- and sex-matched peers, shows those early irregularities — signs of \"premature vascular aging\", the scientists say — persist into adolescence and young adulthood.\u003c/p>\n\u003cp>Kids in the study who were conceived via ART are now 16 years old, on average, but have blood vessels resembling those of middle-aged adults, the scientists found.\u003c/p>\n\u003cp>And those differences seemed to be enough to boost the teens' blood pressure. Everyone in the study underwent round-the-clock blood pressure monitoring for 24 hours, and the differences between a group conceived by ART and teens in the control group were significant. The ART group had markedly higher blood pressure; about 15 percent met the criteria for hypertension.\u003c/p>\n\u003cp>The study adds to a small but \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/24270419\" target=\"_blank\" rel=\"noopener\">growing\u003c/a> \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/27420642\">body\u003c/a> of research suggesting that children conceived this way may have an elevated risk of hypertension and its health complications.\u003c/p>\n\u003cp>Scientists say they don't yet know why that would be true, but they hypothesize that \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1392256/\" target=\"_blank\" rel=\"noopener\">epigenetics\u003c/a> — the interplay of environment and genes — plays a role. Something about the manipulation of the eggs and sperm in the lab might affect which genes are turned on or off as embryos develop.\u003c/p>\n\u003cp>Medical specialists who study high blood pressure in kids called the research striking.\u003c/p>\n\u003cp>\"The fact that these kids already have abnormal vasculature is quite concerning,\" says \u003ca href=\"http://www.seattlechildrens.org/medical-staff/joseph-t-flynn/\" target=\"_blank\" rel=\"noopener\">Dr. Joseph Flynn\u003c/a>, a pediatrician who helped write the American Academy of Pediatrics' guidelines about blood pressure management. \"I think the fact that they saw these changes at an early age and that they're still persisting into adolescence is worrisome for these kids.\"[contextly_sidebar id=\"85O7WjzrUHwoOFYBW2OgPx9FMGcZx2CI\"]\u003c/p>\n\u003cp>Still, he says, it's unclear what the long-term effects on their cardiovascular health will be. Conception through ART, Flynn says, may confer the same amount of risk as, say, teenage smoking or alcohol use.\u003c/p>\n\u003cp>Quinn says she would like to see more longitudinal research that tracks long-term consequences of infertility treatments.\u003c/p>\n\u003cp>\"We need to connect these kinds of studies,\" she says. Such research can be more difficult to do in the United States, she notes, because there is no unified medical record, so it's hard to track the babies who are conceived through ART.\u003c/p>\n\u003cp>Still, she says, it's important for all doctors working in the infertility field to acknowledge that the techniques they use are still evolving.\u003c/p>\n\u003cp>\"We appreciate that there is quite a bit unknown about we do on a day-to-day basis,\" says Quinn. \"We have to be humble.\"\u003c/p>\n\u003cp>For now, \u003ca href=\"http://pediatrics.aappublications.org/content/early/2017/08/21/peds.2017-1904\" target=\"_blank\" rel=\"noopener\">the American Academy of Pediatrics recommends\u003c/a> that every child over the age of 3 get a yearly blood pressure test at the doctor's office — whether or not their parents underwent infertility treatments.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>Mara Gordon is a family physician in Washington, D.C., and a health and media fellow at NPR and Georgetown University School of Medicine.\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=Do+IVF+And+Other+Infertility+Tech+Lead+To+Health+Risks+For+The+Baby%3F+Maybe&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>When patients come to Dr. Molly Quinn for infertility treatments, they usually aren't too interested in hearing about the possible downsides, she says. They just want to get pregnant.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Still, she always discusses the risks. For example, there's an increased likelihood of twins or triplets — which increases the chances of \u003ca href=\"https://www.urmc.rochester.edu/encyclopedia/content.aspx?ContentTypeID=85&ContentID=P08021\" target=\"_blank\" rel=\"noopener\">medical complications\u003c/a> for both moms and babies. And stimulating the ovaries to ripen extra eggs can, in a small number of cases, cause the ovaries to rupture.\u003c/p>\n\u003cp>\u003ca href=\"https://www.uclahealth.org/molly-quinn\" target=\"_blank\" rel=\"noopener\">Quinn\u003c/a>, an infertility specialist and assistant professor of obstetrics and gynecology at the University of California, Los Angeles, now has a new hazard to consider. According to \u003ca href=\"https://www.sciencedirect.com/science/article/pii/S0735109718354809?via%3Dihub\" target=\"_blank\" rel=\"noopener\">research\u003c/a> published this month in the \u003cem>Journal of the American College of Cardiology\u003c/em>, children conceived through certain infertility treatments may be at a higher risk for cardiovascular disease.\u003c/p>\n\u003cp>Parents shouldn't panic, the study's authors say: The findings are preliminary, and the study cohort was fairly small. Still, they say, it means that families who used infertility treatments should be particularly vigilant about screening for high blood pressure in their children and help them avoid other cardiovascular risk factors, such as smoking, obesity and a sedentary lifestyle.\u003c/p>\n\u003cp>\"Fertility clinics should really ... counsel about potential risks for their kids,\" says \u003ca href=\"http://www.dbmr.unibe.ch/research/research_groups/personenpool/cardiology/prof_dr_med_scherrer_urs/index_eng.html\" target=\"_blank\" rel=\"noopener\">Dr. Urs Scherrer\u003c/a>, a visiting professor at the University of Bern in Switzerland and a senior author of the study.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Scherrer and his colleagues followed the health of children conceived through assisted reproductive technology for more than a decade. \u003ca href=\"https://medlineplus.gov/assistedreproductivetechnology.html\" target=\"_blank\" rel=\"noopener\">ART\u003c/a> is an umbrella term that covers a number of different types of procedures, including in vitro fertilization, in which sperm and eggs are mixed in a lab dish, and intracytoplasmic sperm injection, in which sperm are inserted directly into eggs. Today, roughly 2 percent of all births in the U.S are conceived via ART.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>In 2012, the same team of scientists published a \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/22434595\" target=\"_blank\" rel=\"noopener\">major paper\u003c/a> showing that 65 healthy kids born with the help of ART were more likely than their peers to have early signs of problematic blood vessels. The current study, comparing 54 of those original children with 43 age- and sex-matched peers, shows those early irregularities — signs of \"premature vascular aging\", the scientists say — persist into adolescence and young adulthood.\u003c/p>\n\u003cp>Kids in the study who were conceived via ART are now 16 years old, on average, but have blood vessels resembling those of middle-aged adults, the scientists found.\u003c/p>\n\u003cp>And those differences seemed to be enough to boost the teens' blood pressure. Everyone in the study underwent round-the-clock blood pressure monitoring for 24 hours, and the differences between a group conceived by ART and teens in the control group were significant. The ART group had markedly higher blood pressure; about 15 percent met the criteria for hypertension.\u003c/p>\n\u003cp>The study adds to a small but \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/24270419\" target=\"_blank\" rel=\"noopener\">growing\u003c/a> \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/27420642\">body\u003c/a> of research suggesting that children conceived this way may have an elevated risk of hypertension and its health complications.\u003c/p>\n\u003cp>Scientists say they don't yet know why that would be true, but they hypothesize that \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1392256/\" target=\"_blank\" rel=\"noopener\">epigenetics\u003c/a> — the interplay of environment and genes — plays a role. Something about the manipulation of the eggs and sperm in the lab might affect which genes are turned on or off as embryos develop.\u003c/p>\n\u003cp>Medical specialists who study high blood pressure in kids called the research striking.\u003c/p>\n\u003cp>\"The fact that these kids already have abnormal vasculature is quite concerning,\" says \u003ca href=\"http://www.seattlechildrens.org/medical-staff/joseph-t-flynn/\" target=\"_blank\" rel=\"noopener\">Dr. Joseph Flynn\u003c/a>, a pediatrician who helped write the American Academy of Pediatrics' guidelines about blood pressure management. \"I think the fact that they saw these changes at an early age and that they're still persisting into adolescence is worrisome for these kids.\"\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Still, he says, it's unclear what the long-term effects on their cardiovascular health will be. Conception through ART, Flynn says, may confer the same amount of risk as, say, teenage smoking or alcohol use.\u003c/p>\n\u003cp>Quinn says she would like to see more longitudinal research that tracks long-term consequences of infertility treatments.\u003c/p>\n\u003cp>\"We need to connect these kinds of studies,\" she says. Such research can be more difficult to do in the United States, she notes, because there is no unified medical record, so it's hard to track the babies who are conceived through ART.\u003c/p>\n\u003cp>Still, she says, it's important for all doctors working in the infertility field to acknowledge that the techniques they use are still evolving.\u003c/p>\n\u003cp>\"We appreciate that there is quite a bit unknown about we do on a day-to-day basis,\" says Quinn. \"We have to be humble.\"\u003c/p>\n\u003cp>For now, \u003ca href=\"http://pediatrics.aappublications.org/content/early/2017/08/21/peds.2017-1904\" target=\"_blank\" rel=\"noopener\">the American Academy of Pediatrics recommends\u003c/a> that every child over the age of 3 get a yearly blood pressure test at the doctor's office — whether or not their parents underwent infertility treatments.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\u003cem>Mara Gordon is a family physician in Washington, D.C., and a health and media fellow at NPR and Georgetown University School of Medicine.\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=Do+IVF+And+Other+Infertility+Tech+Lead+To+Health+Risks+For+The+Baby%3F+Maybe&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "WATCH: This Rapper Used Neuroscience To Get Over Her Ex",
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"content": "\u003cp>https://youtu.be/_zptWlAxYk0\u003c/p>\n\u003cp>When a relationship ends but love remains, it can be both frustrating and embarrassing.\u003c/p>\n\u003cp>Dessa, \u003ca href=\"http://www.doomtree.net/dessa/\" target=\"_blank\" rel=\"noopener\">a well-known rapper, singer and writer from Minneapolis,\u003c/a> knows the feeling well. She'd spent years trying to get over an ex-boyfriend, but she was still stuck on him.[contextly_sidebar id=\"mlbMdLIlSsXEMYXBPWlqFIXoZNq8obvy\"]\u003c/p>\n\u003cp>\"You're not only suffering,\" she says, \"you're just sort of ridiculous. Discipline and dedication are my strong suits — it really bothered me that, no matter how much effort I tried to expend in trying to solve this problem, I was stuck.\"\u003c/p>\n\u003cp>But things changed when Dessa turned to the frontiers of neuroscience for help. She came across a \u003ca href=\"https://www.ted.com/talks/helen_fisher_studies_the_brain_in_love\" target=\"_blank\" rel=\"noopener\">TED Talk by Helen Fisher\u003c/a>, a biological anthropologist and visiting research associate at Rutgers University. Using a type of brain scan called functional MRI, or fMRI, Fisher had looked into the brains of love-struck people and noticed that certain parts of their brains were unusually active.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"That you could objectively measure and observe 'love' — that had never occurred to me before,\" Dessa says.\u003c/p>\n\u003cp>She wondered: If science could map the sources of love in her brain, could it somehow make that love go away?\u003c/p>\n\u003cp>The question led her to a controversial therapy technique called \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4892319/\" target=\"_blank\" rel=\"noopener\">neurofeedback\u003c/a>.\u003c/p>\n\u003cp>The idea is simple: If you want to learn to lower your heart rate, it helps to be able to hear your pulse. And if you want to change patterns of brain activity, it might be helpful to be able to see what your brain is up to.\u003c/p>\n\u003cp>One flavor of neurofeedback therapy uses a technology called electroencephalography (EEG). A cap full of electrical leads picks up brain waves and translates them into visual or audio cues — like shifting colors on a screen or a series of dings.[contextly_sidebar id=\"1fHutBtcW68QYfMP3EG9cUp4qyVAiRXb\"]\u003c/p>\n\u003cp>The idea is that people can use this feedback to retrain those brain waves, changing underlying patterns in the process — turning down unwanted brain activity or turning up regions that are too quiet.\u003c/p>\n\u003cp>Clinicians have used neurofeedback to try and treat all kinds of mental health issues: anxiety, depression, autism, and ADHD. And they say they've \u003ca href=\"https://www.isnr.org/in-defense-of-neurofeedback\" target=\"_blank\" rel=\"noopener\">seen some positive results\u003c/a>. Patients say they feel better.\u003c/p>\n\u003cp>The growing popularity of EEG-neurofeedback has been met with skepticism. Some scientists say the power of this therapy \u003ca href=\"https://s3.ca-central-1.amazonaws.com/razlab.org/publications/NF_AMP_2017.pdf\" target=\"_blank\" rel=\"noopener\">may stem from the placebo effect\u003c/a>. (They also point out that a lot of neurofeedback research is done by \u003ca href=\"https://s3.ca-central-1.amazonaws.com/razlab.org/publications/NF_Brain_Climate_2018.pdf\" target=\"_blank\" rel=\"noopener\">people who have a financial stake in the industry\u003c/a>.)\u003c/p>\n\u003cp>But more rigorous research from the past couple of years supports the idea that, at least in some cases, neurofeedback can be used to train the brain. Most of this research uses fMRI brain scans — not EEG — to peek inside the skull.\u003c/p>\n\u003cp>In \u003ca href=\"https://www.cell.com/neuron/abstract/S0896-6273(16)00095-7\" target=\"_blank\" rel=\"noopener\">one study\u003c/a>, participants learned to turn up a brain region linked to motivation and focus. In \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/28407727\" target=\"_blank\" rel=\"noopener\">another\u003c/a>, patients with depression were able to alleviate some of their symptoms. But scientists doing this research say there's a lot of work to be done before it can be applied clinically.[contextly_sidebar id=\"ZTOJcPBkTbqiXR1MSox5O57wZuSuzU4T\"]\u003c/p>\n\u003cp>Could neurofeedback provide a balm for broken hearts? No research has been done in this area. But that didn't stop Dessa from trying a sort of experiment on herself: nine EEG-neurofeedback sessions aimed at helping her brain escape the rut of romantic obsession.\u003c/p>\n\u003cp>She says she felt different when she was done.\u003c/p>\n\u003cp>\"Before, I felt that I was really under the thumb of a fixation and a compulsion,\" she says. \"And now it feels like those feelings have been scaled down.\"\u003c/p>\n\u003cp>Now, maybe the neurofeedback had worked as practitioners suggest it does. Or maybe, alternatively, Dessa got the therapy she wanted in other ways — by talking through her experiment, by writing about it, by composing songs for her new album.\u003c/p>\n\u003cp>Or maybe, her neurofeedback sessions helped her via the placebo effect. They suggested that her emotions are grounded in a physical organ \u003cem> — \u003c/em>one that she might be able to influence. Maybe simply believing that she wasn't helpless helped her change her mind and heal her heartbreak.\u003c/p>\n\u003cp>Whatever the reason, Dessa is happy to begin to move on and to start a new chapter with her music.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\"I've written a bunch of sad rap bangers — I'd like to write other kinds of songs,\" she says.\u003c/p>\n\u003cdiv>\u003c/div>\n\u003cdiv class=\"fullattribution\">\u003cem>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=This+Rapper+Tried+To+Use+Neuroscience+To+Get+Over+Her+Ex&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/em>\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"That you could objectively measure and observe 'love' — that had never occurred to me before,\" Dessa says.\u003c/p>\n\u003cp>She wondered: If science could map the sources of love in her brain, could it somehow make that love go away?\u003c/p>\n\u003cp>The question led her to a controversial therapy technique called \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4892319/\" target=\"_blank\" rel=\"noopener\">neurofeedback\u003c/a>.\u003c/p>\n\u003cp>The idea is simple: If you want to learn to lower your heart rate, it helps to be able to hear your pulse. And if you want to change patterns of brain activity, it might be helpful to be able to see what your brain is up to.\u003c/p>\n\u003cp>One flavor of neurofeedback therapy uses a technology called electroencephalography (EEG). A cap full of electrical leads picks up brain waves and translates them into visual or audio cues — like shifting colors on a screen or a series of dings.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The idea is that people can use this feedback to retrain those brain waves, changing underlying patterns in the process — turning down unwanted brain activity or turning up regions that are too quiet.\u003c/p>\n\u003cp>Clinicians have used neurofeedback to try and treat all kinds of mental health issues: anxiety, depression, autism, and ADHD. And they say they've \u003ca href=\"https://www.isnr.org/in-defense-of-neurofeedback\" target=\"_blank\" rel=\"noopener\">seen some positive results\u003c/a>. Patients say they feel better.\u003c/p>\n\u003cp>The growing popularity of EEG-neurofeedback has been met with skepticism. Some scientists say the power of this therapy \u003ca href=\"https://s3.ca-central-1.amazonaws.com/razlab.org/publications/NF_AMP_2017.pdf\" target=\"_blank\" rel=\"noopener\">may stem from the placebo effect\u003c/a>. (They also point out that a lot of neurofeedback research is done by \u003ca href=\"https://s3.ca-central-1.amazonaws.com/razlab.org/publications/NF_Brain_Climate_2018.pdf\" target=\"_blank\" rel=\"noopener\">people who have a financial stake in the industry\u003c/a>.)\u003c/p>\n\u003cp>But more rigorous research from the past couple of years supports the idea that, at least in some cases, neurofeedback can be used to train the brain. Most of this research uses fMRI brain scans — not EEG — to peek inside the skull.\u003c/p>\n\u003cp>In \u003ca href=\"https://www.cell.com/neuron/abstract/S0896-6273(16)00095-7\" target=\"_blank\" rel=\"noopener\">one study\u003c/a>, participants learned to turn up a brain region linked to motivation and focus. In \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/28407727\" target=\"_blank\" rel=\"noopener\">another\u003c/a>, patients with depression were able to alleviate some of their symptoms. But scientists doing this research say there's a lot of work to be done before it can be applied clinically.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Could neurofeedback provide a balm for broken hearts? No research has been done in this area. But that didn't stop Dessa from trying a sort of experiment on herself: nine EEG-neurofeedback sessions aimed at helping her brain escape the rut of romantic obsession.\u003c/p>\n\u003cp>She says she felt different when she was done.\u003c/p>\n\u003cp>\"Before, I felt that I was really under the thumb of a fixation and a compulsion,\" she says. \"And now it feels like those feelings have been scaled down.\"\u003c/p>\n\u003cp>Now, maybe the neurofeedback had worked as practitioners suggest it does. Or maybe, alternatively, Dessa got the therapy she wanted in other ways — by talking through her experiment, by writing about it, by composing songs for her new album.\u003c/p>\n\u003cp>Or maybe, her neurofeedback sessions helped her via the placebo effect. They suggested that her emotions are grounded in a physical organ \u003cem> — \u003c/em>one that she might be able to influence. Maybe simply believing that she wasn't helpless helped her change her mind and heal her heartbreak.\u003c/p>\n\u003cp>Whatever the reason, Dessa is happy to begin to move on and to start a new chapter with her music.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\"I've written a bunch of sad rap bangers — I'd like to write other kinds of songs,\" she says.\u003c/p>\n\u003cdiv>\u003c/div>\n\u003cdiv class=\"fullattribution\">\u003cem>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=This+Rapper+Tried+To+Use+Neuroscience+To+Get+Over+Her+Ex&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/em>\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "Turmoil Erupts Over Expulsion of Vaccine Critic from Leading Medical Group",
"title": "Turmoil Erupts Over Expulsion of Vaccine Critic from Leading Medical Group",
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"content": "\u003cp>One of the medical world’s most respected expert bodies is in turmoil as its annual meeting gets underway in Edinburgh, Scotland, after its governing board voted to expel a member.[contextly_sidebar id=\"Kn64ul6ElC5kMYHks5hc2dO2RuxcXwvM\"]\u003c/p>\n\u003cp>The Cochrane Collaboration, which reviews the scientific literature in areas of clinical research and produces widely cited analyses that help guide clinical practice, kicked out a member who has been an outspoken critic of certain vaccines and has blasted the profession of psychiatry for pushing unsafe drugs on unsuspecting patients.\u003c/p>\n\u003cp>The expulsion of Peter Gøtzsche sparked accusations that the Collaboration is too friendly toward the drug industry. Four other members of the organization’s governing board resigned in response, citing concerns that the action “goes against Cochrane ethos.”\u003c/p>\n\u003cp class=\"\">The vote appears to have been 6 of 13 in favor of the move, according to statements from the board members who resigned and Gøtzsche — short of a majority but enough to pass because only 11 voted.\u003c/p>\n\u003cp class=\"\">“This unprecedented action taken by a minority of the Governing Board is disproportionate and damaging to Cochrane, as well as to public health interests,” Gøtzsche said in a \u003ca href=\"https://nordic.cochrane.org/sites/nordic.cochrane.org/files/public/uploads/moral_crisis_in_cochrane.pdf\" target=\"_blank\" rel=\"noopener\">letter he circulated on Friday\u003c/a>.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The Collaboration \u003ca href=\"https://www.cochrane.org/news/message-governing-board\" target=\"_blank\" rel=\"noopener\">posted a statement\u003c/a> on its website Saturday, saying, “Cochrane’s Governing Board considered, as planned, the findings of an independent review and additional complaints related to the conduct of a Member.” The complaints were not specified, but the statement said the board’s co-chairs will provide more details “once this process is complete.”[contextly_sidebar id=\"ynjsrFwcYBXkogb3iv2lea34bcxV6tJK\"]\u003c/p>\n\u003cp>In a longer \u003ca href=\"https://www.cochrane.org/news/statement-cochranes-governing-board\" target=\"_blank\" rel=\"noopener\">response posted Monday\u003c/a>, Cochrane’s governing board said that it finds itself in “an extraordinary situation” and that the four board members who resigned “actively disseminated an incomplete and misleading account of events.”\u003c/p>\n\u003cp>The decision, the board said, “is not about freedom of speech. It is not about scientific debate. It is not about tolerance of dissent. It is not about someone being unable to criticize a Cochrane Review.”\u003c/p>\n\u003cp>Instead, the board said, “It is about a long-term pattern of behaviour that we say is totally, and utterly, at variance with the principles and governance of the Cochrane Collaboration.” Although the board did not describe the behavior, the pattern, it claimed, dated back to complaints since 2003, and included three new complaints in March of this year. “All our staff, and our members, have the right to do their work without harassment and personal attacks,” the statement said.\u003c/p>\n\u003cp>Gøtzsche, the director of the \u003ca href=\"https://nordic.cochrane.org/\" target=\"_blank\" rel=\"noopener\">Nordic Cochrane Center\u003c/a>, in Copenhagen, Denmark, has cast doubts about the safety of a vaccine against human papillomavirus (HPV), a cause of cervical cancer, and \u003ca href=\"https://www.youtube.com/watch?v=DiJcSoo3C4Q\" target=\"_blank\" rel=\"noopener\">says\u003c/a> psychiatry has “gone astray” by coercing patients into taking medication, such as antidepressants, they don’t want to use and that cause “brain damage” over the long run. “The way these drugs are used today cause[s] more harm than good. So it would be better for us if the drugs didn’t exist.”\u003c/p>\n\u003cp>Gøtzsche, Cochrane member Tom Jefferson, and another colleague ruffled feathers at Cochrane with a \u003ca href=\"https://ebm.bmj.com/content/early/2018/07/27/bmjebm-2018-111012\" target=\"_blank\" rel=\"noopener\">July 2018 article\u003c/a> that criticized a recent paper from the Collaboration on the safety of the HPV vaccine. The paper prompted a \u003ca href=\"https://www.cochrane.org/news/cochranes-editor-chief-responds-bmj-ebm-article-criticizing-hpv-review\" target=\"_blank\" rel=\"noopener\">rebuttal\u003c/a> from Cochrane that dismissed the concerns and stood behind the original findings.\u003c/p>\n\u003cp>Hilda Bastian, a founding member of the Cochrane Collaboration and an influential writer about science, \u003ca href=\"https://hildabastian.net/index.php/67-the-hpv-vaccine\" target=\"_blank\" rel=\"noopener\">called the review\u003c/a> “a manufactured controversy — a hatchet job by people with such strong intellectual and ideological biases, that they didn’t even pick up that some of their most implausible allegations were based on their own analytical and investigative slip-ups.”[contextly_sidebar id=\"lCLNW34bypWghzUhqKu6Xt2EeSW06udI\"]\u003c/p>\n\u003cp>Complaints about the review that Gotzsche co-authored came late in the process, according to the \u003ca href=\"https://www.cochrane.org/news/statement-cochranes-governing-board\" target=\"_blank\" rel=\"noopener\">board’s Monday statement\u003c/a>, and were not the initial trigger of the investigation.\u003c/p>\n\u003cp>As of now, the board said, Gotzsche remains a member of the organization. He was given seven days to respond to the board’s vote. He did not immediately respond to a request for comment from STAT and Retraction Watch.\u003c/p>\n\u003cp>Gøtzsche, who was \u003ca href=\"https://nordic.cochrane.org/news/prof-peter-c-g%C3%B8tzsche-becomes-member-cochrane-governing-board\" target=\"_blank\" rel=\"noopener\">elected to the group’s board of governors in 2017\u003c/a>, blamed the vote on his stance on the drug industry. “As most people know, much of my work is not very favourable to the financial interests of the pharmaceutical industry. Because of this Cochrane has faced pressure, criticism and complaints. My expulsion is one of the results of these campaigns.”\u003c/p>\n\u003cp>Jefferson, speaking from a reception at the Edinburgh meeting, told Retraction Watch and STAT that people he’s spoken to are outraged. “I’ve been in Cochrane 25 years, this is not how we do things,” he said. “Peter Gotzsche was a democratically elected member of the board. It’s really unheard of.”\u003c/p>\n\u003cp>At least one prominent scientist expressed alarm that the move to jettison Gøtzsche was an assault on free speech. \u003ca href=\"https://profiles.stanford.edu/john-ioannidis\" target=\"_blank\" rel=\"noopener\">John Ioannidis\u003c/a>, of Stanford University, said he is “disturbed” by Gøtzsche’s expulsion and stressed the importance of heterodox views in science.\u003c/p>\n\u003cp>“I adore Peter for his courage and I highly value his major contributions to evidence-based medicine … even if I don’t agree with all of Peter’s views and inferences,” Ioannidis wrote Sunday in an email to a group of more than 100 experts in evidence-based medicine. “I think it is important to make sure that people who disagree with us will get the most opportunity to express and support their views with arguments and evidence and, of course, not get expelled.”[contextly_sidebar id=\"odd8SE7t4b9S7rToLgrBZZS25O72EdXO\"]\u003c/p>\n\u003cp>But at least one other expert defended Cochrane. Allen Frances, chair of the Department of Psychiatry at Duke University, in Durham, N.C., dismissed the notion that Gøtzsche was being unfairly muzzled.\u003c/p>\n\u003cp>“This has nothing to do with freedom of speech,” Frances wrote in the thread that included Ioannidis. Rather, he said, Cochrane is justifiably concerned about remaining an “impartial evaluator of evidence” and providing reliable information to doctors and their patients.\u003c/p>\n\u003cp>“At least in psychiatry, Peter is anything but impartial,” Frances wrote. “He consistently expresses the most extreme views in the most dramatic and misleading way. His role at Cochrane lends its legitimacy to opinions that are dangerous to patients with severe mental illness. As an individual, Peter has total freedom to express extreme opinions, but he has no inherent right to cloak them with Cochrane’s hard won mantle of neutrality.”\u003c/p>\n\u003cp>The four board members who resigned in the wake of the vote said in a statement Saturday that “the expulsion of inconvenient members from the Collaboration goes against Cochrane ethos and neither reflects its founding spirit nor promotes the Collaboration’s best interests. We are concerned that these actions might cause great damage to the reputation of the Collaboration.”\u003c/p>\n\u003cp>\u003ca href=\"https://www.cochrane.org/news/message-governing-board\" target=\"_blank\" rel=\"noopener\">In its own statement\u003c/a>, the governing board said that two other members had resigned because the “situation required further changes in the composition of the Board in order to comply with \u003ca href=\"https://www.cochrane.org/sites/default/files/public/uploads/cochrane_-_articles_of_association_-_final_and_approved_-_october_2016.pdf\" target=\"_blank\" rel=\"noopener\">Cochrane’s Articles of Association\u003c/a>.” Neither of the board’s co-chairs immediately responded to requests for comment.\u003c/p>\n\u003cp>“There appears to be no confidence in the management board at this point,” Jefferson said. “I think the only honorable thing for the rest of the board to do is resign.”\u003c/p>\n\u003cp>\u003cem>This story has been updated with a statement from Cochrane’s governing board. The story is a collaboration between STAT and \u003c/em>\u003ca href=\"https://retractionwatch.com/\" target=\"_blank\" rel=\"noopener\">\u003cem>Retraction Watch\u003c/em>\u003c/a>\u003cem>.\u003c/em>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003ci>\u003cspan style=\"font-weight: 400\">This \u003c/span>\u003c/i>\u003ca href=\"https://www.statnews.com/2018/09/16/expulsion-cochrane-peter-gotzsche-medicine/\" target=\"_blank\" rel=\"noopener\">\u003ci>\u003cspan style=\"font-weight: 400\">story\u003c/span>\u003c/i>\u003c/a>\u003ci>\u003cspan style=\"font-weight: 400\"> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/span>\u003c/i>\u003c/p>\n\n",
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"excerpt": "One of the medical world’s most respected body of experts is in turmoil after its governing board voted to expel an outspoken critic of certain vaccines and the psychiatry profession for pushing unsafe drugs. The move has sparked accusations that the group is too friendly with drugmakers.",
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"description": "One of the medical world’s most respected body of experts is in turmoil after its governing board voted to expel an outspoken critic of certain vaccines and the psychiatry profession for pushing unsafe drugs. The move has sparked accusations that the group is too friendly with drugmakers.",
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"headline": "Turmoil Erupts Over Expulsion of Vaccine Critic from Leading Medical Group",
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"nprByline": "Adam Marcus\u003cbr />Ivan Oransky\u003cbr />STAT",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>One of the medical world’s most respected expert bodies is in turmoil as its annual meeting gets underway in Edinburgh, Scotland, after its governing board voted to expel a member.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The Cochrane Collaboration, which reviews the scientific literature in areas of clinical research and produces widely cited analyses that help guide clinical practice, kicked out a member who has been an outspoken critic of certain vaccines and has blasted the profession of psychiatry for pushing unsafe drugs on unsuspecting patients.\u003c/p>\n\u003cp>The expulsion of Peter Gøtzsche sparked accusations that the Collaboration is too friendly toward the drug industry. Four other members of the organization’s governing board resigned in response, citing concerns that the action “goes against Cochrane ethos.”\u003c/p>\n\u003cp class=\"\">The vote appears to have been 6 of 13 in favor of the move, according to statements from the board members who resigned and Gøtzsche — short of a majority but enough to pass because only 11 voted.\u003c/p>\n\u003cp class=\"\">“This unprecedented action taken by a minority of the Governing Board is disproportionate and damaging to Cochrane, as well as to public health interests,” Gøtzsche said in a \u003ca href=\"https://nordic.cochrane.org/sites/nordic.cochrane.org/files/public/uploads/moral_crisis_in_cochrane.pdf\" target=\"_blank\" rel=\"noopener\">letter he circulated on Friday\u003c/a>.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The Collaboration \u003ca href=\"https://www.cochrane.org/news/message-governing-board\" target=\"_blank\" rel=\"noopener\">posted a statement\u003c/a> on its website Saturday, saying, “Cochrane’s Governing Board considered, as planned, the findings of an independent review and additional complaints related to the conduct of a Member.” The complaints were not specified, but the statement said the board’s co-chairs will provide more details “once this process is complete.”\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>In a longer \u003ca href=\"https://www.cochrane.org/news/statement-cochranes-governing-board\" target=\"_blank\" rel=\"noopener\">response posted Monday\u003c/a>, Cochrane’s governing board said that it finds itself in “an extraordinary situation” and that the four board members who resigned “actively disseminated an incomplete and misleading account of events.”\u003c/p>\n\u003cp>The decision, the board said, “is not about freedom of speech. It is not about scientific debate. It is not about tolerance of dissent. It is not about someone being unable to criticize a Cochrane Review.”\u003c/p>\n\u003cp>Instead, the board said, “It is about a long-term pattern of behaviour that we say is totally, and utterly, at variance with the principles and governance of the Cochrane Collaboration.” Although the board did not describe the behavior, the pattern, it claimed, dated back to complaints since 2003, and included three new complaints in March of this year. “All our staff, and our members, have the right to do their work without harassment and personal attacks,” the statement said.\u003c/p>\n\u003cp>Gøtzsche, the director of the \u003ca href=\"https://nordic.cochrane.org/\" target=\"_blank\" rel=\"noopener\">Nordic Cochrane Center\u003c/a>, in Copenhagen, Denmark, has cast doubts about the safety of a vaccine against human papillomavirus (HPV), a cause of cervical cancer, and \u003ca href=\"https://www.youtube.com/watch?v=DiJcSoo3C4Q\" target=\"_blank\" rel=\"noopener\">says\u003c/a> psychiatry has “gone astray” by coercing patients into taking medication, such as antidepressants, they don’t want to use and that cause “brain damage” over the long run. “The way these drugs are used today cause[s] more harm than good. So it would be better for us if the drugs didn’t exist.”\u003c/p>\n\u003cp>Gøtzsche, Cochrane member Tom Jefferson, and another colleague ruffled feathers at Cochrane with a \u003ca href=\"https://ebm.bmj.com/content/early/2018/07/27/bmjebm-2018-111012\" target=\"_blank\" rel=\"noopener\">July 2018 article\u003c/a> that criticized a recent paper from the Collaboration on the safety of the HPV vaccine. The paper prompted a \u003ca href=\"https://www.cochrane.org/news/cochranes-editor-chief-responds-bmj-ebm-article-criticizing-hpv-review\" target=\"_blank\" rel=\"noopener\">rebuttal\u003c/a> from Cochrane that dismissed the concerns and stood behind the original findings.\u003c/p>\n\u003cp>Hilda Bastian, a founding member of the Cochrane Collaboration and an influential writer about science, \u003ca href=\"https://hildabastian.net/index.php/67-the-hpv-vaccine\" target=\"_blank\" rel=\"noopener\">called the review\u003c/a> “a manufactured controversy — a hatchet job by people with such strong intellectual and ideological biases, that they didn’t even pick up that some of their most implausible allegations were based on their own analytical and investigative slip-ups.”\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Complaints about the review that Gotzsche co-authored came late in the process, according to the \u003ca href=\"https://www.cochrane.org/news/statement-cochranes-governing-board\" target=\"_blank\" rel=\"noopener\">board’s Monday statement\u003c/a>, and were not the initial trigger of the investigation.\u003c/p>\n\u003cp>As of now, the board said, Gotzsche remains a member of the organization. He was given seven days to respond to the board’s vote. He did not immediately respond to a request for comment from STAT and Retraction Watch.\u003c/p>\n\u003cp>Gøtzsche, who was \u003ca href=\"https://nordic.cochrane.org/news/prof-peter-c-g%C3%B8tzsche-becomes-member-cochrane-governing-board\" target=\"_blank\" rel=\"noopener\">elected to the group’s board of governors in 2017\u003c/a>, blamed the vote on his stance on the drug industry. “As most people know, much of my work is not very favourable to the financial interests of the pharmaceutical industry. Because of this Cochrane has faced pressure, criticism and complaints. My expulsion is one of the results of these campaigns.”\u003c/p>\n\u003cp>Jefferson, speaking from a reception at the Edinburgh meeting, told Retraction Watch and STAT that people he’s spoken to are outraged. “I’ve been in Cochrane 25 years, this is not how we do things,” he said. “Peter Gotzsche was a democratically elected member of the board. It’s really unheard of.”\u003c/p>\n\u003cp>At least one prominent scientist expressed alarm that the move to jettison Gøtzsche was an assault on free speech. \u003ca href=\"https://profiles.stanford.edu/john-ioannidis\" target=\"_blank\" rel=\"noopener\">John Ioannidis\u003c/a>, of Stanford University, said he is “disturbed” by Gøtzsche’s expulsion and stressed the importance of heterodox views in science.\u003c/p>\n\u003cp>“I adore Peter for his courage and I highly value his major contributions to evidence-based medicine … even if I don’t agree with all of Peter’s views and inferences,” Ioannidis wrote Sunday in an email to a group of more than 100 experts in evidence-based medicine. “I think it is important to make sure that people who disagree with us will get the most opportunity to express and support their views with arguments and evidence and, of course, not get expelled.”\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>But at least one other expert defended Cochrane. Allen Frances, chair of the Department of Psychiatry at Duke University, in Durham, N.C., dismissed the notion that Gøtzsche was being unfairly muzzled.\u003c/p>\n\u003cp>“This has nothing to do with freedom of speech,” Frances wrote in the thread that included Ioannidis. Rather, he said, Cochrane is justifiably concerned about remaining an “impartial evaluator of evidence” and providing reliable information to doctors and their patients.\u003c/p>\n\u003cp>“At least in psychiatry, Peter is anything but impartial,” Frances wrote. “He consistently expresses the most extreme views in the most dramatic and misleading way. His role at Cochrane lends its legitimacy to opinions that are dangerous to patients with severe mental illness. As an individual, Peter has total freedom to express extreme opinions, but he has no inherent right to cloak them with Cochrane’s hard won mantle of neutrality.”\u003c/p>\n\u003cp>The four board members who resigned in the wake of the vote said in a statement Saturday that “the expulsion of inconvenient members from the Collaboration goes against Cochrane ethos and neither reflects its founding spirit nor promotes the Collaboration’s best interests. We are concerned that these actions might cause great damage to the reputation of the Collaboration.”\u003c/p>\n\u003cp>\u003ca href=\"https://www.cochrane.org/news/message-governing-board\" target=\"_blank\" rel=\"noopener\">In its own statement\u003c/a>, the governing board said that two other members had resigned because the “situation required further changes in the composition of the Board in order to comply with \u003ca href=\"https://www.cochrane.org/sites/default/files/public/uploads/cochrane_-_articles_of_association_-_final_and_approved_-_october_2016.pdf\" target=\"_blank\" rel=\"noopener\">Cochrane’s Articles of Association\u003c/a>.” Neither of the board’s co-chairs immediately responded to requests for comment.\u003c/p>\n\u003cp>“There appears to be no confidence in the management board at this point,” Jefferson said. “I think the only honorable thing for the rest of the board to do is resign.”\u003c/p>\n\u003cp>\u003cem>This story has been updated with a statement from Cochrane’s governing board. The story is a collaboration between STAT and \u003c/em>\u003ca href=\"https://retractionwatch.com/\" target=\"_blank\" rel=\"noopener\">\u003cem>Retraction Watch\u003c/em>\u003c/a>\u003cem>.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003ci>\u003cspan style=\"font-weight: 400\">This \u003c/span>\u003c/i>\u003ca href=\"https://www.statnews.com/2018/09/16/expulsion-cochrane-peter-gotzsche-medicine/\" target=\"_blank\" rel=\"noopener\">\u003ci>\u003cspan style=\"font-weight: 400\">story\u003c/span>\u003c/i>\u003c/a>\u003ci>\u003cspan style=\"font-weight: 400\"> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/span>\u003c/i>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "For Older, Healthy People, Taking a Daily Aspirin Has No Benefit",
"title": "For Older, Healthy People, Taking a Daily Aspirin Has No Benefit",
"headTitle": "KQED Future of You | KQED Science",
"content": "\u003cp>Many healthy Americans take a baby aspirin every day to reduce their risk of having a heart attack, getting cancer and even possibly dementia. But is it really a good idea?[contextly_sidebar id=\"TeVgffLo8LYnxiLIJLovHnm2siFYHMFR\"]\u003c/p>\n\u003cp>Results released Sunday from a major \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMoa1800722\" target=\"_blank\" rel=\"noopener\">study\u003c/a> of low-dose aspirin contain a disappointing answer for older, otherwise healthy people.\u003c/p>\n\u003cp>\"We found there was no discernible benefit of aspirin on prolonging independent, healthy life for the elderly,\" says \u003ca href=\"https://www.hennepinhealthcare.org/provider/anne-m-murray-md/\" target=\"_blank\" rel=\"noopener\">Anne Murray\u003c/a>, a geriatrician and epidemiologist at Hennepin Healthcare in Minneapolis, who helped lead the study.\u003c/p>\n\u003cp>The study involved more than 19,000 people ages 65 and older in the United States and Australia. The results were published in three papers in the \u003cem>New England Journal of Medicine.\u003c/em>\u003c/p>\n\u003cp>There is still strong evidence that a daily baby aspirin can \u003ca href=\"https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/aspirin-to-prevent-cardiovascular-disease-and-cancer\" target=\"_blank\" rel=\"noopener\">reduce the risk\u003c/a> that many people who have already suffered a heart attack or stroke will suffer another attack.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>And there is some evidence that daily low-dose aspirin may help people younger than 70 who have at least a 10 percent risk of having a heart attack avoid a heart attack or stroke, according to the latest \u003ca href=\"https://www.npr.org/sections/health-shots/2015/09/15/440337151/panel-says-aspirin-lowers-heart-attack-risk-for-some-but-not-all\" target=\"_blank\" rel=\"noopener\">recommendations\u003c/a> from the U.S. Preventive Services Task Force.\u003c/p>\n\u003cp>But for older, healthy people, \"the risks outweigh the benefits for taking low-dose aspirin,\" Murray says.[contextly_sidebar id=\"06i7Zbzq5DlgqfooOTFa4lgjt6Ui9wr1\"]\u003c/p>\n\u003cp>The primary risk is bleeding. The study \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMoa1805819\" target=\"_blank\" rel=\"noopener\">confirmed\u003c/a> that a daily baby aspirin increases the risk for serious, potentially life-threatening bleeding.\u003c/p>\n\u003cp>Surprisingly, those who took daily aspirin also appeared to be \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMoa1803955\" target=\"_blank\" rel=\"noopener\">more likely\u003c/a> to die overall, apparently from an increased risk of succumbing to cancer. That was especially unexpected given previous evidence that aspirin might reduce the risk for colorectal cancer.\u003c/p>\n\u003cp>The researchers stressed, however, that the cancer finding might have been a fluke. There's also a possibility that any colorectal cancer benefit wasn't seen because the subjects had only been followed for about five years.\u003c/p>\n\u003cp>Regardless, the findings raise serious questions as to whether otherwise healthy older people should routinely take low-dose aspirin.\u003c/p>\n\u003cp>\"A lot of people read, 'Well, aspirin is good for people who have heart problems. Maybe I should take it, even if they haven't really had a heart attack,' \" Murray says. But \"for a long time there's been a need to establish appropriate criteria for when healthy people — elderly people — need aspirin.\"\u003c/p>\n\u003cp>That's why the researchers launched their study, called \u003ca href=\"https://www.aspree.org/\" target=\"_blank\" rel=\"noopener\">ASPREE\u003c/a>, in 2010. It involved 19,114 older people, with 16,703 in Australia and 2,411 in the United States. The U.S. portion included white volunteers ages 70 and older, and African-Americans and Hispanics subjects ages 65 and older.[contextly_sidebar id=\"lMIuMVSFXI9eLmCGzVINxi5SI7xGl6IV\"]\u003c/p>\n\u003cp>Participants took either 100 milligrams of aspirin every day or a placebo. People in the study were followed for an average of 4.7 years.\u003c/p>\n\u003cp>\"We were hoping that an inexpensive, very accessible medication might be something that we could recommend to elderly to maintain their independence but also decrease their risk of cardiovascular disease,\" Murray says.\u003c/p>\n\u003cp>But based on the findings, \u003ca href=\"https://www.nia.nih.gov/about/staff/hadley-evan\" target=\"_blank\" rel=\"noopener\">Dr. Evan Hadley\u003c/a> of the National Institute on Aging, which helped fund the study, says any elderly people taking aspirin or thinking about it should think twice.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\"This gives pause and a reason for older people and their physician to think carefully about the decision whether to take low-dose aspirin regularly or not,\" Hadley says. \"And in many cases the right answer may be: Not.\"\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=Study%3A+A+Daily+Baby+Aspirin+Has+No+Benefit+For+Healthy+Older+People&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"excerpt": "Results from a large international study show that risks from taking daily low-dose aspirin outweigh the potential benefits for older people in generally good health.",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Many healthy Americans take a baby aspirin every day to reduce their risk of having a heart attack, getting cancer and even possibly dementia. But is it really a good idea?\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Results released Sunday from a major \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMoa1800722\" target=\"_blank\" rel=\"noopener\">study\u003c/a> of low-dose aspirin contain a disappointing answer for older, otherwise healthy people.\u003c/p>\n\u003cp>\"We found there was no discernible benefit of aspirin on prolonging independent, healthy life for the elderly,\" says \u003ca href=\"https://www.hennepinhealthcare.org/provider/anne-m-murray-md/\" target=\"_blank\" rel=\"noopener\">Anne Murray\u003c/a>, a geriatrician and epidemiologist at Hennepin Healthcare in Minneapolis, who helped lead the study.\u003c/p>\n\u003cp>The study involved more than 19,000 people ages 65 and older in the United States and Australia. The results were published in three papers in the \u003cem>New England Journal of Medicine.\u003c/em>\u003c/p>\n\u003cp>There is still strong evidence that a daily baby aspirin can \u003ca href=\"https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/aspirin-to-prevent-cardiovascular-disease-and-cancer\" target=\"_blank\" rel=\"noopener\">reduce the risk\u003c/a> that many people who have already suffered a heart attack or stroke will suffer another attack.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>And there is some evidence that daily low-dose aspirin may help people younger than 70 who have at least a 10 percent risk of having a heart attack avoid a heart attack or stroke, according to the latest \u003ca href=\"https://www.npr.org/sections/health-shots/2015/09/15/440337151/panel-says-aspirin-lowers-heart-attack-risk-for-some-but-not-all\" target=\"_blank\" rel=\"noopener\">recommendations\u003c/a> from the U.S. Preventive Services Task Force.\u003c/p>\n\u003cp>But for older, healthy people, \"the risks outweigh the benefits for taking low-dose aspirin,\" Murray says.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The primary risk is bleeding. The study \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMoa1805819\" target=\"_blank\" rel=\"noopener\">confirmed\u003c/a> that a daily baby aspirin increases the risk for serious, potentially life-threatening bleeding.\u003c/p>\n\u003cp>Surprisingly, those who took daily aspirin also appeared to be \u003ca href=\"http://www.nejm.org/doi/full/10.1056/NEJMoa1803955\" target=\"_blank\" rel=\"noopener\">more likely\u003c/a> to die overall, apparently from an increased risk of succumbing to cancer. That was especially unexpected given previous evidence that aspirin might reduce the risk for colorectal cancer.\u003c/p>\n\u003cp>The researchers stressed, however, that the cancer finding might have been a fluke. There's also a possibility that any colorectal cancer benefit wasn't seen because the subjects had only been followed for about five years.\u003c/p>\n\u003cp>Regardless, the findings raise serious questions as to whether otherwise healthy older people should routinely take low-dose aspirin.\u003c/p>\n\u003cp>\"A lot of people read, 'Well, aspirin is good for people who have heart problems. Maybe I should take it, even if they haven't really had a heart attack,' \" Murray says. But \"for a long time there's been a need to establish appropriate criteria for when healthy people — elderly people — need aspirin.\"\u003c/p>\n\u003cp>That's why the researchers launched their study, called \u003ca href=\"https://www.aspree.org/\" target=\"_blank\" rel=\"noopener\">ASPREE\u003c/a>, in 2010. It involved 19,114 older people, with 16,703 in Australia and 2,411 in the United States. The U.S. portion included white volunteers ages 70 and older, and African-Americans and Hispanics subjects ages 65 and older.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Participants took either 100 milligrams of aspirin every day or a placebo. People in the study were followed for an average of 4.7 years.\u003c/p>\n\u003cp>\"We were hoping that an inexpensive, very accessible medication might be something that we could recommend to elderly to maintain their independence but also decrease their risk of cardiovascular disease,\" Murray says.\u003c/p>\n\u003cp>But based on the findings, \u003ca href=\"https://www.nia.nih.gov/about/staff/hadley-evan\" target=\"_blank\" rel=\"noopener\">Dr. Evan Hadley\u003c/a> of the National Institute on Aging, which helped fund the study, says any elderly people taking aspirin or thinking about it should think twice.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>\"This gives pause and a reason for older people and their physician to think carefully about the decision whether to take low-dose aspirin regularly or not,\" Hadley says. \"And in many cases the right answer may be: Not.\"\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=Study%3A+A+Daily+Baby+Aspirin+Has+No+Benefit+For+Healthy+Older+People&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"disqusTitle": "'Germ Theory' of Alzheimer's May Trigger a Seismic Shift in Treatment",
"title": "'Germ Theory' of Alzheimer's May Trigger a Seismic Shift in Treatment",
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"content": "\u003cp>Dr. Leslie Norins is willing to hand over $1 million of his own money to anyone who can clarify something: Is Alzheimer's disease, the most common form of dementia worldwide, caused by a germ?[contextly_sidebar id=\"MVU0oAlLJAOY5cRLFm8SgRXzH5ufmBIa\"]\u003c/p>\n\u003cp>By \"germ\" he means microbes like bacteria, viruses, fungi and parasites. In other words, Norins, a physician turned publisher, wants to know if Alzheimer's is infectious.\u003c/p>\n\u003cp>It's an idea that just a few years ago would've seemed to many an easy way to drain your research budget on bunk science. Money has poured into Alzheimer's research for years, but until very recently not much of it went toward investigating infection in causing dementia.\u003c/p>\n\u003cp>But this \"germ theory\" of Alzheimer's, as Norins calls it, has been fermenting in the literature for decades. Even early 20th century Czech physician Oskar Fischer — who, along with his German contemporary Dr. Alois Alzheimer, was integral in first describing the condition — noted a possible connection between the newly identified dementia and tuberculosis.\u003c/p>\n\u003cp>If the germ theory gets traction, even in some Alzheimer's patients, it could trigger a seismic shift in how doctors understand and treat the disease.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>For instance, would we see a day when dementia is prevented with a vaccine, or treated with antibiotics and antiviral medications? Norins thinks it's worth looking into.\u003c/p>\n\u003cp>Norins received his medical degree from Duke in the early 1960s, and after a stint at the Centers for Disease Control and Prevention he fell into a lucrative career in medical publishing. He eventually settled in an admittedly aged community in Naples, Fla., where he took an interest in dementia and began reading up on the condition.[contextly_sidebar id=\"Xrb4XR0KXYySlI7ldjHh45GWXuqxKcIS\"]\u003c/p>\n\u003cp>After scouring the medical literature he noticed a pattern.\u003c/p>\n\u003cp>\"It appeared that many of the reported characteristics of Alzheimer's disease were compatible with an infectious process,\" Norins tells NPR. \"I thought for sure this must have already been investigated, because \u003ca href=\"http://act.alz.org/site/DocServer/2015_Appropriations_Fact_Sheet__FY16_.pdf?docID=3641\" target=\"_blank\" rel=\"noopener\">millions and millions of dollars\u003c/a> have been spent on Alzheimer's research.\"\u003c/p>\n\u003cp>But aside from scattered interest through the decades, this wasn't the case.\u003c/p>\n\u003cp>In 2017, Norins launched \u003ca href=\"https://alzgerm.org/about/\" target=\"_blank\" rel=\"noopener\">Alzheimer's Germ Quest Inc.\u003c/a>, a public benefit corporation he hopes will drive interest into the germ theory of Alzheimer's, and through which his prize will be distributed. A white paper he penned for the site reads: \"From a two-year review of the scientific literature, I believe it's now clear that just one germ — identity not yet specified, and possibly not yet discovered — causes most AD. I'm calling it the 'Alzheimer's Germ.' \"\u003c/p>\n\u003cp>Norins is quick to cite sources and studies supporting his claim, among them a 2010 study published in the \u003cem>Journal of Neurosurgery\u003c/em> showing that \u003ca href=\"http://thejns.org/doi/pdf/10.3171/2010.1.JNS091740\" target=\"_blank\" rel=\"noopener\">neurosurgeons die from Alzheimer's at a seven-fold higher rate\u003c/a> than they do from other disorders.\u003c/p>\n\u003cp>Another study from that same year, published in The \u003cem>Journal of the American Geriatric Society,\u003c/em> found that people whose \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/20722820/\" target=\"_blank\" rel=\"noopener\">spouses have dementia are at a six-times greater risk\u003c/a> for the condition themselves.\u003c/p>\n\u003cp>Contagion does come to mind. And Norins isn't alone in his thinking.\u003c/p>\n\u003cp>In 2016, 32 researchers from universities around the world signed an editorial in the \u003cem>Journal of Alzheimer's Disease\u003c/em> calling for \"further research on the role of infectious agents in [Alzheimer's] causation.\" Based on much of the same evidence Norins encountered, the authors concluded that clinical trials with antimicrobial drugs in Alzheimer's are now justified.[contextly_sidebar id=\"TlULmPwfIfLNT30W6fAdCGOQeBCymn7e\"]\u003c/p>\n\u003cp>NPR reported on an intriguing \u003ca href=\"https://www.npr.org/sections/health-shots/2018/06/21/621908340/researchers-find-herpes-viruses-in-brains-marked-by-alzheimers-disease\" target=\"_blank\" rel=\"noopener\">study\u003c/a> published in \u003cem>Neuron\u003c/em> in June that suggested that viral infection can influence the progression of Alzheimer's. Led by Mount Sinai genetics professor Joel Dudley, the work was intended to compare the genomes of healthy brain tissue with that affected by dementia.\u003c/p>\n\u003cp>But something kept getting in the way: herpes.\u003c/p>\n\u003cp>Dudley's team noticed an unexpectedly high level of viral DNA from two human herpes viruses, HHV-6 and HHV-7. The viruses are common and cause a rash called roseola in young children (not the sexually transmitted disease caused by other strains).\u003c/p>\n\u003cp>Some viruses have the ability to lie dormant in our neurons for decades by incorporating their genomes into our own. The classic example is chickenpox: A childhood viral infection resolves and lurks silently, returning years later as \u003ca href=\"https://www.cdc.gov/shingles/about/symptoms.html\" target=\"_blank\" rel=\"noopener\">shingles\u003c/a>, an excruciating rash. Like it or not, nearly all of us are chimeras with viral DNA speckling our genomes.\u003c/p>\n\u003cp>But having the herpes viruses alone doesn't mean inevitable brain decline. After all, up to 75 percent of us may \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/11285567\" target=\"_blank\" rel=\"noopener\">harbor HHV-6\u003c/a> .\u003c/p>\n\u003cp>But Dudley also noticed that herpes appeared to interact with human genes known to increase Alzheimer's risk. Perhaps, he says, there is some toxic combination of genetic and infectious influence that results in the disease; a combination that sparks what some feel is the main contributor to the disease, an overactive immune system.\u003c/p>\n\u003cp>The hallmark pathology of Alzheimer's is accumulation of a protein called amyloid in the brain. Many researchers have assumed these aggregates, or plaques, are simply a byproduct of some other process at the core of the disease. Other scientists posit that the protein itself contributes to the condition in some way.\u003c/p>\n\u003cp>The theory that amyloid is the root cause of Alzheimer's is losing steam. But the protein may still contribute to the disease, even if it winds up being deemed infectious.[contextly_sidebar id=\"reNe9dG45Jm18II65oxyuE0ETmculfjN\"]\u003c/p>\n\u003cp>Work by Harvard neuroscientist Rudolph Tanzi suggests it might be a bit of both. Along with colleague Robert Moir, Tanzi has shown that amyloid is lethal to viruses and bacteria in the test tube, and also in mice. He now believes the protein is part of our ancient immune system that like antibodies, ramps up its activity to help fend off unwanted bugs.\u003c/p>\n\u003cp>So does that mean that the microbe is the cause of Alzheimer's, and amyloid a harmless reaction to it? According to Tanzi it's not that simple.\u003c/p>\n\u003cp>Tanzi believes that in many cases of Alzheimer's, microbes are probably the initial seed that sets off a toxic tumble of molecular dominoes. Early in the disease amyloid protein builds up to fight infection, yet too much of the protein begins to impair function of neurons in the brain. The excess amyloid then causes another protein, called tau, to form tangles, which further harm brain cells.\u003c/p>\n\u003cp>But as Tanzi explains, the ultimate neurological insult in Alzheimer's is the body's reaction to this neurotoxic mess. All the excess protein revs up the immune system, causing inflammation — and it's this inflammation that does the most damage to the Alzheimer's-afflicted brain.\u003c/p>\n\u003cp>So what does this say about the future of treatment? Possibly a lot. Tanzi envisions a day when people are screened at, say, 50 years old. \"If their brains are riddled with too much amyloid,\" he says, \"we knock it down a bit with antiviral medications. It's just like how you are prescribed preventative drugs if your cholesterol is too high.\"\u003c/p>\n\u003cp>Tanzi feels that microbes are just one possible seed for the complex pathology behind Alzheimer's. Genetics may also play a role, as certain genes produce a type of amyloid more prone to clumping up. He also feels environmental factors like pollution might contribute.\u003c/p>\n\u003cp>Dr. James Burke, professor of medicine and psychiatry at Duke University's Alzheimer's Disease Research Center, isn't willing to abandon the amyloid theory altogether, but agrees it's time for the field to move on. \"There may be many roads to developing Alzheimer's disease and it would be shortsighted to focus just on amyloid and tau,\" he says. \"A million-dollar prize is attention- getting, but the reward for identifying a treatable target to delay or prevent Alzheimer's disease is invaluable.\"[contextly_sidebar id=\"VDtvU3haNd1M74SuCUvVZuAz4hFEV5iO\"]\u003c/p>\n\u003cp>Any treatment that disrupts the cascade leading to amyloid, tau and inflammation could theoretically benefit an at-risk brain. The vast majority of Alzheimer's treatment trials have failed, including many targeting amyloid. But it could be that the patients included were too far along in their disease to reap any therapeutic benefit.\u003c/p>\n\u003cp>If a microbe is responsible for all or some cases of Alzheimer's, perhaps future treatments or preventive approaches will prevent toxin protein buildup in the first place. Both Tanzi and Norins believe Alzheimer's vaccines against viruses like herpes might one day become common practice.\u003c/p>\n\u003cp>In July of this year, in collaboration with Norins, the Infectious Diseases Society of America announced that they plan to offer two $50,000 grants supporting research into a microbial association with Alzheimer's. According to Norins, this is the first acknowledgement by a leading infectious disease group that Alzheimer's may be microbial in nature – or at least that it's worth exploring.\u003c/p>\n\u003cp>\"The important thing is not the amount of the money, which is a pittance compared with the $2 billion NIH spends on amyloid and tau research,\" says Norins, \"but rather the respectability and more mainstream status the grants confer on investigating of the infectious possibility. Remember when we thought ulcers were caused by stress?\"\u003c/p>\n\u003cp>Ulcers, we now know, are \u003ca href=\"https://www.nobelprize.org/prizes/medicine/2005/press-release/\" target=\"_blank\" rel=\"noopener\">caused by a germ\u003c/a>.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>Bret Stetka is a writer based in New York and an editorial director at \u003c/em>\u003ca href=\"http://www.medscape.com/public/bios/bio-bretstetka\">Medscape\u003c/a>.\u003cem> His work has appeared in \u003c/em>Wired, Scientific American\u003cem> and on The Atlantic.com. He graduated from the University of Virginia School of Medicine. He's also on Twitter: \u003c/em>\u003ca href=\"https://twitter.com/BretStetka\" target=\"_blank\" rel=\"noopener\">@BretStetka\u003c/a>.\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=Infectious+Theory+Of+Alzheimer%27s+Disease+Draws+Fresh+Interest&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Dr. Leslie Norins is willing to hand over $1 million of his own money to anyone who can clarify something: Is Alzheimer's disease, the most common form of dementia worldwide, caused by a germ?\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>By \"germ\" he means microbes like bacteria, viruses, fungi and parasites. In other words, Norins, a physician turned publisher, wants to know if Alzheimer's is infectious.\u003c/p>\n\u003cp>It's an idea that just a few years ago would've seemed to many an easy way to drain your research budget on bunk science. Money has poured into Alzheimer's research for years, but until very recently not much of it went toward investigating infection in causing dementia.\u003c/p>\n\u003cp>But this \"germ theory\" of Alzheimer's, as Norins calls it, has been fermenting in the literature for decades. Even early 20th century Czech physician Oskar Fischer — who, along with his German contemporary Dr. Alois Alzheimer, was integral in first describing the condition — noted a possible connection between the newly identified dementia and tuberculosis.\u003c/p>\n\u003cp>If the germ theory gets traction, even in some Alzheimer's patients, it could trigger a seismic shift in how doctors understand and treat the disease.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>For instance, would we see a day when dementia is prevented with a vaccine, or treated with antibiotics and antiviral medications? Norins thinks it's worth looking into.\u003c/p>\n\u003cp>Norins received his medical degree from Duke in the early 1960s, and after a stint at the Centers for Disease Control and Prevention he fell into a lucrative career in medical publishing. He eventually settled in an admittedly aged community in Naples, Fla., where he took an interest in dementia and began reading up on the condition.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>After scouring the medical literature he noticed a pattern.\u003c/p>\n\u003cp>\"It appeared that many of the reported characteristics of Alzheimer's disease were compatible with an infectious process,\" Norins tells NPR. \"I thought for sure this must have already been investigated, because \u003ca href=\"http://act.alz.org/site/DocServer/2015_Appropriations_Fact_Sheet__FY16_.pdf?docID=3641\" target=\"_blank\" rel=\"noopener\">millions and millions of dollars\u003c/a> have been spent on Alzheimer's research.\"\u003c/p>\n\u003cp>But aside from scattered interest through the decades, this wasn't the case.\u003c/p>\n\u003cp>In 2017, Norins launched \u003ca href=\"https://alzgerm.org/about/\" target=\"_blank\" rel=\"noopener\">Alzheimer's Germ Quest Inc.\u003c/a>, a public benefit corporation he hopes will drive interest into the germ theory of Alzheimer's, and through which his prize will be distributed. A white paper he penned for the site reads: \"From a two-year review of the scientific literature, I believe it's now clear that just one germ — identity not yet specified, and possibly not yet discovered — causes most AD. I'm calling it the 'Alzheimer's Germ.' \"\u003c/p>\n\u003cp>Norins is quick to cite sources and studies supporting his claim, among them a 2010 study published in the \u003cem>Journal of Neurosurgery\u003c/em> showing that \u003ca href=\"http://thejns.org/doi/pdf/10.3171/2010.1.JNS091740\" target=\"_blank\" rel=\"noopener\">neurosurgeons die from Alzheimer's at a seven-fold higher rate\u003c/a> than they do from other disorders.\u003c/p>\n\u003cp>Another study from that same year, published in The \u003cem>Journal of the American Geriatric Society,\u003c/em> found that people whose \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/20722820/\" target=\"_blank\" rel=\"noopener\">spouses have dementia are at a six-times greater risk\u003c/a> for the condition themselves.\u003c/p>\n\u003cp>Contagion does come to mind. And Norins isn't alone in his thinking.\u003c/p>\n\u003cp>In 2016, 32 researchers from universities around the world signed an editorial in the \u003cem>Journal of Alzheimer's Disease\u003c/em> calling for \"further research on the role of infectious agents in [Alzheimer's] causation.\" Based on much of the same evidence Norins encountered, the authors concluded that clinical trials with antimicrobial drugs in Alzheimer's are now justified.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>NPR reported on an intriguing \u003ca href=\"https://www.npr.org/sections/health-shots/2018/06/21/621908340/researchers-find-herpes-viruses-in-brains-marked-by-alzheimers-disease\" target=\"_blank\" rel=\"noopener\">study\u003c/a> published in \u003cem>Neuron\u003c/em> in June that suggested that viral infection can influence the progression of Alzheimer's. Led by Mount Sinai genetics professor Joel Dudley, the work was intended to compare the genomes of healthy brain tissue with that affected by dementia.\u003c/p>\n\u003cp>But something kept getting in the way: herpes.\u003c/p>\n\u003cp>Dudley's team noticed an unexpectedly high level of viral DNA from two human herpes viruses, HHV-6 and HHV-7. The viruses are common and cause a rash called roseola in young children (not the sexually transmitted disease caused by other strains).\u003c/p>\n\u003cp>Some viruses have the ability to lie dormant in our neurons for decades by incorporating their genomes into our own. The classic example is chickenpox: A childhood viral infection resolves and lurks silently, returning years later as \u003ca href=\"https://www.cdc.gov/shingles/about/symptoms.html\" target=\"_blank\" rel=\"noopener\">shingles\u003c/a>, an excruciating rash. Like it or not, nearly all of us are chimeras with viral DNA speckling our genomes.\u003c/p>\n\u003cp>But having the herpes viruses alone doesn't mean inevitable brain decline. After all, up to 75 percent of us may \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/11285567\" target=\"_blank\" rel=\"noopener\">harbor HHV-6\u003c/a> .\u003c/p>\n\u003cp>But Dudley also noticed that herpes appeared to interact with human genes known to increase Alzheimer's risk. Perhaps, he says, there is some toxic combination of genetic and infectious influence that results in the disease; a combination that sparks what some feel is the main contributor to the disease, an overactive immune system.\u003c/p>\n\u003cp>The hallmark pathology of Alzheimer's is accumulation of a protein called amyloid in the brain. Many researchers have assumed these aggregates, or plaques, are simply a byproduct of some other process at the core of the disease. Other scientists posit that the protein itself contributes to the condition in some way.\u003c/p>\n\u003cp>The theory that amyloid is the root cause of Alzheimer's is losing steam. But the protein may still contribute to the disease, even if it winds up being deemed infectious.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Work by Harvard neuroscientist Rudolph Tanzi suggests it might be a bit of both. Along with colleague Robert Moir, Tanzi has shown that amyloid is lethal to viruses and bacteria in the test tube, and also in mice. He now believes the protein is part of our ancient immune system that like antibodies, ramps up its activity to help fend off unwanted bugs.\u003c/p>\n\u003cp>So does that mean that the microbe is the cause of Alzheimer's, and amyloid a harmless reaction to it? According to Tanzi it's not that simple.\u003c/p>\n\u003cp>Tanzi believes that in many cases of Alzheimer's, microbes are probably the initial seed that sets off a toxic tumble of molecular dominoes. Early in the disease amyloid protein builds up to fight infection, yet too much of the protein begins to impair function of neurons in the brain. The excess amyloid then causes another protein, called tau, to form tangles, which further harm brain cells.\u003c/p>\n\u003cp>But as Tanzi explains, the ultimate neurological insult in Alzheimer's is the body's reaction to this neurotoxic mess. All the excess protein revs up the immune system, causing inflammation — and it's this inflammation that does the most damage to the Alzheimer's-afflicted brain.\u003c/p>\n\u003cp>So what does this say about the future of treatment? Possibly a lot. Tanzi envisions a day when people are screened at, say, 50 years old. \"If their brains are riddled with too much amyloid,\" he says, \"we knock it down a bit with antiviral medications. It's just like how you are prescribed preventative drugs if your cholesterol is too high.\"\u003c/p>\n\u003cp>Tanzi feels that microbes are just one possible seed for the complex pathology behind Alzheimer's. Genetics may also play a role, as certain genes produce a type of amyloid more prone to clumping up. He also feels environmental factors like pollution might contribute.\u003c/p>\n\u003cp>Dr. James Burke, professor of medicine and psychiatry at Duke University's Alzheimer's Disease Research Center, isn't willing to abandon the amyloid theory altogether, but agrees it's time for the field to move on. \"There may be many roads to developing Alzheimer's disease and it would be shortsighted to focus just on amyloid and tau,\" he says. \"A million-dollar prize is attention- getting, but the reward for identifying a treatable target to delay or prevent Alzheimer's disease is invaluable.\"\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>Any treatment that disrupts the cascade leading to amyloid, tau and inflammation could theoretically benefit an at-risk brain. The vast majority of Alzheimer's treatment trials have failed, including many targeting amyloid. But it could be that the patients included were too far along in their disease to reap any therapeutic benefit.\u003c/p>\n\u003cp>If a microbe is responsible for all or some cases of Alzheimer's, perhaps future treatments or preventive approaches will prevent toxin protein buildup in the first place. Both Tanzi and Norins believe Alzheimer's vaccines against viruses like herpes might one day become common practice.\u003c/p>\n\u003cp>In July of this year, in collaboration with Norins, the Infectious Diseases Society of America announced that they plan to offer two $50,000 grants supporting research into a microbial association with Alzheimer's. According to Norins, this is the first acknowledgement by a leading infectious disease group that Alzheimer's may be microbial in nature – or at least that it's worth exploring.\u003c/p>\n\u003cp>\"The important thing is not the amount of the money, which is a pittance compared with the $2 billion NIH spends on amyloid and tau research,\" says Norins, \"but rather the respectability and more mainstream status the grants confer on investigating of the infectious possibility. Remember when we thought ulcers were caused by stress?\"\u003c/p>\n\u003cp>Ulcers, we now know, are \u003ca href=\"https://www.nobelprize.org/prizes/medicine/2005/press-release/\" target=\"_blank\" rel=\"noopener\">caused by a germ\u003c/a>.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>Bret Stetka is a writer based in New York and an editorial director at \u003c/em>\u003ca href=\"http://www.medscape.com/public/bios/bio-bretstetka\">Medscape\u003c/a>.\u003cem> His work has appeared in \u003c/em>Wired, Scientific American\u003cem> and on The Atlantic.com. He graduated from the University of Virginia School of Medicine. He's also on Twitter: \u003c/em>\u003ca href=\"https://twitter.com/BretStetka\" target=\"_blank\" rel=\"noopener\">@BretStetka\u003c/a>.\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=Infectious+Theory+Of+Alzheimer%27s+Disease+Draws+Fresh+Interest&utme=8(APIKey)9(MDAxOTAwOTE4MDEyMTkxMDAzNjczZDljZA004)\">\u003c/div>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp class=\"danger-zone\">A federal appeals court on Monday struck another blow against the \u003ca href=\"https://www.statnews.com/2018/06/13/university-of-california-granted-a-key-crispr-patent/\">University of California’s\u003c/a> hopes of invalidating key CRISPR patents \u003ca href=\"https://www.statnews.com/2017/02/15/crispr-patent-ruling/\">held by the Broad Institute of MIT and Harvard\u003c/a>, ruling unanimously that a U.S. patent board correctly concluded that the Broad’s patents did not “interfere” with those that UC had applied for.\u003c/p>\n\u003cp class=\"danger-zone\">Barring an appeal to the U.S. Supreme Court, which is highly unlikely to accept the case, or a request for the full U.S. Court of Appeals for the Federal Circuit to consider the case, the \u003ca href=\"https://www.statnews.com/2017/04/13/crispr-patent-uc-appeal/\">long and bitter legal saga\u003c/a> is largely over, at least in the U.S. (The \u003ca href=\"https://www.statnews.com/2017/03/28/crispr-university-of-california-patent/\">fight over CRISPR patents in Europe\u003c/a> continues.)\u003c/p>\n\u003cp class=\"danger-zone\">The Court of Appeals \u003ca href=\"http://www.cafc.uscourts.gov/opinions-orders\" target=\"_blank\" rel=\"noopener\">decision\u003c/a> held that there was “no interference in fact” between CRISPR patents awarded to the Broad and CRISPR patents that UC had applied for. That is what three judges on the Patent Trial and Appeal Board, part of the U.S. patent office, had ruled unanimously in 2017.\u003c/p>\n\u003cp class=\"danger-zone\">The decision turned on two key and related points: whether the work that Broad scientist \u003ca href=\"https://www.statnews.com/2015/11/06/hollywood-inspired-scientist-rewrite-code-life/\">Feng Zhang\u003c/a> did to make CRISPR edit the genome of mammalian cells was “obvious” in light of what Jennifer Doudna, of the University of California, Berkeley, and her colleagues accomplished in editing free floating DNA in test tubes, and whether Zhang and other scientists trying to do that had a “reasonable expectation of success.”\u003c/p>\n\u003cp class=\"danger-zone\">There was “conflicting evidence,” patent expert Jacob Sherkow of New York Law School said in an interview, on whether any sufficiently skilled scientist could have taken Doudna’s breakthrough (done with her key collaborator, Emmanuelle Charpentier) using CRISPR in test tubes and turned it into a system that worked in human and other mammalian cells, as Zhang (and other scientists) did.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>But in her sweeping opinion, Judge Kimberly Moore wrote that “substantial evidence supports [PTAB’s] finding that there was not a reasonable expectation of success, and we affirm…. [PTAB] did not err in its analysis.” The decision, said Sherkow, “is absolutely 100 percent correct on the law,” leaving UC essentially no path to a re-hearing by the full court, let alone by the Supreme Court.\u003c/p>\n\u003cp>PTAB had ruled that Zhang’s success was by no means assured, citing Doudna’s own comments about how techniques that work in bacteria or test tubes often fail in higher-order cells, and that what Zhang did to turn CRISPR, a bacterial immune system, into a human-genome-editing tool was far from obvious. In an analysis that could well make scientists think twice about discussing the challenges of building on very basic discoveries, Moore cited Doudna’s acknowledgement of a “huge bottleneck” in modifying the genomes of humans and other animals, after Doudna and\u003c/p>\n\u003cp>Charpentier \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/22745249\" target=\"_blank\" rel=\"noopener\">reported\u003c/a> doing so in their test tube DNA in 2012. Doudna had also said that “2012 paper was a big success, but there was a problem. We weren’t sure if CRISPR/Cas9 would work in eukaryotes,” and conceded having “many frustrations” in getting CRISPR-Cas9 to work in human cells.” Those words came back to haunt her and sink UC’s hopes for a foundational CRISPR patent.\u003c/p>\n\u003cp>The central issue before the appeals court was whether the patent board had based its pro-Broad decision on “substantial evidence.” That, Sherkow \u003ca href=\"https://twitter.com/jsherkow/status/1039159547049504769\" target=\"_blank\" rel=\"noopener\">tweeted,\u003c/a>was “an extremely high bar.” The appeals court ruled that the board did have substantial evidence for its decision that the Broad’s CRISPR patents did not overlap with UC’s, nor were they obvious from UC’s. That leaves UC extremely little ground on which to base any appeal.\u003c/p>\n\u003cp>In a statement, the Broad called the court’s decision “correct,” upholding a PTAB ruling that “was clearly supported by sufficient evidence and followed applicable legal standards.’ As for what happens now, the Broad said, “It is time for all institutions to move beyond litigation. We should work together to ensure wide, open access to this transformative technology.”\u003c/p>\n\u003cp>The appeals court decision, in the case \u003ca href=\"https://www.statnews.com/2018/04/30/crispr-patent-appeal-hearing/\">argued\u003c/a> on April 30, clarifies the commercial landscape only partly, however. It allows the Broad to keep its patents, the first of which was awarded in 2014, on the foundational CRISPR-Cas9 genome editing technology for eukaryotic cells invented by Zhang. And it lets the Broad’s many licensees (notably Editas Medicine, which paid the Broad’s eight-figure legal costs) breathe easier. Since CRISPR Therapeutics licensed Charpentier’s invention (which is covered by the UC patent) and Intellia Therapeutics licensed Doudna’s, they now face a tougher but not impossible IP landscape.\u003c/p>\n\u003cp>Wall Street reacted calmly to the news, which analysts and investors had largely expected. Stocks of the major CRISPR companies were largely unchanged in midday trading, with Editas and Intellia slightly up and CRISPR Therapeutics down just under 3 percent. Gena Wang, a biotech analyst at Barclays, said any additional appeals by UC are unlikely to succeed, meaning the Broad should retain its U.S. patents. “We believe cross-licensing likely could occur and do not expect these proceedings to have direct impact on the clinical development of each company,” she said.\u003c/p>\n\u003cp>\u003cem>With additional reporting by Adam Feuerstein\u003c/em>\u003c/p>\n\u003cp>\u003cem>This story has been updated with additional analysis and expert comment. It\u003c/em> \u003cspan style=\"font-weight: 400\">was \u003cem>originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery. \u003c/em>\u003c/span>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp> \u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp class=\"danger-zone\">A federal appeals court on Monday struck another blow against the \u003ca href=\"https://www.statnews.com/2018/06/13/university-of-california-granted-a-key-crispr-patent/\">University of California’s\u003c/a> hopes of invalidating key CRISPR patents \u003ca href=\"https://www.statnews.com/2017/02/15/crispr-patent-ruling/\">held by the Broad Institute of MIT and Harvard\u003c/a>, ruling unanimously that a U.S. patent board correctly concluded that the Broad’s patents did not “interfere” with those that UC had applied for.\u003c/p>\n\u003cp class=\"danger-zone\">Barring an appeal to the U.S. Supreme Court, which is highly unlikely to accept the case, or a request for the full U.S. Court of Appeals for the Federal Circuit to consider the case, the \u003ca href=\"https://www.statnews.com/2017/04/13/crispr-patent-uc-appeal/\">long and bitter legal saga\u003c/a> is largely over, at least in the U.S. (The \u003ca href=\"https://www.statnews.com/2017/03/28/crispr-university-of-california-patent/\">fight over CRISPR patents in Europe\u003c/a> continues.)\u003c/p>\n\u003cp class=\"danger-zone\">The Court of Appeals \u003ca href=\"http://www.cafc.uscourts.gov/opinions-orders\" target=\"_blank\" rel=\"noopener\">decision\u003c/a> held that there was “no interference in fact” between CRISPR patents awarded to the Broad and CRISPR patents that UC had applied for. That is what three judges on the Patent Trial and Appeal Board, part of the U.S. patent office, had ruled unanimously in 2017.\u003c/p>\n\u003cp class=\"danger-zone\">The decision turned on two key and related points: whether the work that Broad scientist \u003ca href=\"https://www.statnews.com/2015/11/06/hollywood-inspired-scientist-rewrite-code-life/\">Feng Zhang\u003c/a> did to make CRISPR edit the genome of mammalian cells was “obvious” in light of what Jennifer Doudna, of the University of California, Berkeley, and her colleagues accomplished in editing free floating DNA in test tubes, and whether Zhang and other scientists trying to do that had a “reasonable expectation of success.”\u003c/p>\n\u003cp class=\"danger-zone\">There was “conflicting evidence,” patent expert Jacob Sherkow of New York Law School said in an interview, on whether any sufficiently skilled scientist could have taken Doudna’s breakthrough (done with her key collaborator, Emmanuelle Charpentier) using CRISPR in test tubes and turned it into a system that worked in human and other mammalian cells, as Zhang (and other scientists) did.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>But in her sweeping opinion, Judge Kimberly Moore wrote that “substantial evidence supports [PTAB’s] finding that there was not a reasonable expectation of success, and we affirm…. [PTAB] did not err in its analysis.” The decision, said Sherkow, “is absolutely 100 percent correct on the law,” leaving UC essentially no path to a re-hearing by the full court, let alone by the Supreme Court.\u003c/p>\n\u003cp>PTAB had ruled that Zhang’s success was by no means assured, citing Doudna’s own comments about how techniques that work in bacteria or test tubes often fail in higher-order cells, and that what Zhang did to turn CRISPR, a bacterial immune system, into a human-genome-editing tool was far from obvious. In an analysis that could well make scientists think twice about discussing the challenges of building on very basic discoveries, Moore cited Doudna’s acknowledgement of a “huge bottleneck” in modifying the genomes of humans and other animals, after Doudna and\u003c/p>\n\u003cp>Charpentier \u003ca href=\"https://www.ncbi.nlm.nih.gov/pubmed/22745249\" target=\"_blank\" rel=\"noopener\">reported\u003c/a> doing so in their test tube DNA in 2012. Doudna had also said that “2012 paper was a big success, but there was a problem. We weren’t sure if CRISPR/Cas9 would work in eukaryotes,” and conceded having “many frustrations” in getting CRISPR-Cas9 to work in human cells.” Those words came back to haunt her and sink UC’s hopes for a foundational CRISPR patent.\u003c/p>\n\u003cp>The central issue before the appeals court was whether the patent board had based its pro-Broad decision on “substantial evidence.” That, Sherkow \u003ca href=\"https://twitter.com/jsherkow/status/1039159547049504769\" target=\"_blank\" rel=\"noopener\">tweeted,\u003c/a>was “an extremely high bar.” The appeals court ruled that the board did have substantial evidence for its decision that the Broad’s CRISPR patents did not overlap with UC’s, nor were they obvious from UC’s. That leaves UC extremely little ground on which to base any appeal.\u003c/p>\n\u003cp>In a statement, the Broad called the court’s decision “correct,” upholding a PTAB ruling that “was clearly supported by sufficient evidence and followed applicable legal standards.’ As for what happens now, the Broad said, “It is time for all institutions to move beyond litigation. We should work together to ensure wide, open access to this transformative technology.”\u003c/p>\n\u003cp>The appeals court decision, in the case \u003ca href=\"https://www.statnews.com/2018/04/30/crispr-patent-appeal-hearing/\">argued\u003c/a> on April 30, clarifies the commercial landscape only partly, however. It allows the Broad to keep its patents, the first of which was awarded in 2014, on the foundational CRISPR-Cas9 genome editing technology for eukaryotic cells invented by Zhang. And it lets the Broad’s many licensees (notably Editas Medicine, which paid the Broad’s eight-figure legal costs) breathe easier. Since CRISPR Therapeutics licensed Charpentier’s invention (which is covered by the UC patent) and Intellia Therapeutics licensed Doudna’s, they now face a tougher but not impossible IP landscape.\u003c/p>\n\u003cp>Wall Street reacted calmly to the news, which analysts and investors had largely expected. Stocks of the major CRISPR companies were largely unchanged in midday trading, with Editas and Intellia slightly up and CRISPR Therapeutics down just under 3 percent. Gena Wang, a biotech analyst at Barclays, said any additional appeals by UC are unlikely to succeed, meaning the Broad should retain its U.S. patents. “We believe cross-licensing likely could occur and do not expect these proceedings to have direct impact on the clinical development of each company,” she said.\u003c/p>\n\u003cp>\u003cem>With additional reporting by Adam Feuerstein\u003c/em>\u003c/p>\n\u003cp>\u003cem>This story has been updated with additional analysis and expert comment. It\u003c/em> \u003cspan style=\"font-weight: 400\">was \u003cem>originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery. \u003c/em>\u003c/span>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp> \u003c/p>\n\n\u003c/div>\u003c/p>",
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"content": "\u003cp>Gwyneth Paltrow's lifestyle company goop has agreed to pay $145,000 in civil penalties over products including egg-shaped stones that are meant to be inserted into the vagina to improve health.\u003c/p>\n\u003cp>Prosecutors in eight California counties jointly announced the settlement on Tuesday after a task-force investigation found some of goop's health claims were unfounded.\u003c/p>\n\u003cp>The settlement involves advertisements saying goop's Jade Egg and Rose Quartz Egg could balance hormones, regulate menstrual cycles and improve bladder control.\u003c/p>\n\u003cp>In addition to the penalty, the company will provide refunds to customers who ask.\u003c/p>\n\u003cp>A goop statement says the settlement acknowledges no liability on the company's part and addresses only advertising, not the products themselves. The statement says there is honest disagreement between the sides, but goop wanted to settle the matter quickly and amicably.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>A goop statement says the settlement acknowledges no liability on the company's part and addresses only advertising, not the products themselves. The statement says there is honest disagreement between the sides, but goop wanted to settle the matter quickly and amicably.\u003c/p>\n\n",
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"content": "\u003cp>Alzheimer's is currently the sixth leading cause of death in the U.S., according to the Alzheimer's Association. About 5.7 million Americans currently suffer from the disease, with around a half-million new cases diagnosed every year. Fourteen million Americans are projected to have Alzheimer's by 2050.\u003c/p>\n\u003caside class=\"pullquote alignright\">A review of 112 experimental Alzheimer's drugs in clinical trials shows only one aimed at slowing the course of the disease in patients with moderate to severe forms of the disease.\u003c/aside>\n\u003cp>That is an enormous toll taken on patients and families. But unfortunately, the outlook on finding a cure is equally grim, as STAT reporter Sharon Begley recently \u003ca href=\"https://www.statnews.com/2018/08/15/alzheimers-patients-drug-development-outrage/\" target=\"_blank\" rel=\"noopener\">reported\u003c/a>. After more than 20 years of failure to reverse or slow the disease by targeting amyloid plaques in the brain, Begley writes, there are now literally \u003cem>no experimental drugs in late-stage clinical trials\u003c/em> to treat moderate to severe Alzheimer's, the latter of which is characterized by extreme confusion requiring round-the-clock care patient care.\u003c/p>\n\u003cp>Begley spoke about her reporting with KQED's Brian Watt on Friday. The following is a transcript of the interview, edited for length and clarity.\u003c/p>\n\u003cp>\u003cstrong>On the lack of progress in Alzheimer's drug development\u003c/strong>\u003c/p>\n\u003cp>The last drug for Alzheimer's was approved in 2003. So 15 years and we have had nothing.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The drug companies have spent and lost billions of dollars trying to find something that works for Alzheimer's patients. And they're giving up.'\u003c/aside>\n\u003cp>I talked about the situation with patient advocates and neurologists and people in the lab desperately trying to come up with something to help people. One expert used a term that made me just sit up and practically gasp. He called it \"therapeutic nihilism.\" And by that he meant the disease has proved so challenging to scientists that people have almost given up.\u003c/p>\n\u003cp>In studies, drug after drug has failed. The drug companies have spent and lost billions of dollars trying to find something that works for Alzheimer's patients. And they're giving up.\u003c/p>\n\u003cp>\u003cstrong>On the contrast between activism around HIV/AIDS and the lack of advocacy around Alzheimer's \u003c/strong>\u003c/p>\n\u003cp>The amount of attention, drug development, et cetera for HIV/AIDS have been hugely impressive. And that's why I contrasted it with Alzheimer's, wondering: Where is the outrage over the lack of progress?\u003c/p>\n\u003cp>And there you have things like the age of patients. With HIV/AIDS, the tragic toll was, at least initially, on men in their prime. For Alzheimer's, primarily affecting people 65 and older, there's at least some sentiment that they've had a good life, that's the way it goes.\u003c/p>\n\u003cp>\u003cstrong>On the lack of drugs being tested for moderate to severe Alzheimer's\u003c/strong>\u003c/p>\n\u003cp>There's what's called a pipeline analysis done every year by researchers at the Cleveland Clinic. They look at all the experimental compounds being tested in patients, and they ask, \"What kind of patients are they being tested in?\"\u003c/p>\n\u003caside class=\"pullquote alignright\">'There are 5.5 million people and growing that already have the disease. So what we're essentially saying to them is that it's really unfortunate but we have nothing that will help you.'\u003c/aside>\n\u003cp>They broke it down into people who do not have Alzheimer's but have some of the risk factors, and people who have mild, moderate or severe Alzheimer's. What really made me sit up was that the number of drugs being tested to see whether they can stop or even reverse the actual course of the disease in people with moderate or severe Alzheimer's is 1 out of 112.\u003c/p>\n\u003cp>We all hope they can stop Alzheimer's at earlier stages. We all know somebody who has Alzheimer's, and when they first get it if you could look at that person and say, wow, you don't actually have a diagnosis yet, but you're on the cusp, so here's a drug that will help you from getting Alzheimer's ... .\u003c/p>\n\u003cp>But there are 5.5 million people and growing that already have the disease. So what we're essentially saying to them is that it's really unfortunate but we have nothing that will help you. And if there's nothing in the pipeline for people with moderate to severe Alzheimer's, that means there will be nothing for anybody who is diagnosed in 2018, in 2019, and probably for the next 10 years.\u003c/p>\n\u003cp>[ad fullwidth]\u003cbr>\n\u003cstrong>On the response from patient advocates\u003c/strong>\u003c/p>\n\u003cp>I thought I would call them and give them a softball. Let them say, \"This is untenable. We know it's expensive, but these drug companies just really have to step up.\"\u003c/p>\n\u003caside class=\"pullquote alignright\">'I will simply note without comment that the patient advocacy groups get buckets of money from drug developers.'\u003c/aside>\n\u003cp>Instead they told me things like, \"Boy, it's really hard to develop drugs. It's understandable that the drug companies have pulled back.\"\u003c/p>\n\u003cp>I will simply note without comment that the patient advocacy groups get buckets of money from drug developers.\u003c/p>\n\u003cp>The market for preventing the development of Alzheimer's is much greater than for even the people who have it. If you develop something to prevent Alzheimer's that you can give to tens of millions of healthy people, that would be a huge profit boost for your company.\u003c/p>\n\u003cp>So I think it would be naïve of anyone to say that there are no financial considerations here.\u003c/p>\n\u003cp>\u003c/p>\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Alzheimer's is currently the sixth leading cause of death in the U.S., according to the Alzheimer's Association. About 5.7 million Americans currently suffer from the disease, with around a half-million new cases diagnosed every year. Fourteen million Americans are projected to have Alzheimer's by 2050.\u003c/p>\n\u003caside class=\"pullquote alignright\">A review of 112 experimental Alzheimer's drugs in clinical trials shows only one aimed at slowing the course of the disease in patients with moderate to severe forms of the disease.\u003c/aside>\n\u003cp>That is an enormous toll taken on patients and families. But unfortunately, the outlook on finding a cure is equally grim, as STAT reporter Sharon Begley recently \u003ca href=\"https://www.statnews.com/2018/08/15/alzheimers-patients-drug-development-outrage/\" target=\"_blank\" rel=\"noopener\">reported\u003c/a>. After more than 20 years of failure to reverse or slow the disease by targeting amyloid plaques in the brain, Begley writes, there are now literally \u003cem>no experimental drugs in late-stage clinical trials\u003c/em> to treat moderate to severe Alzheimer's, the latter of which is characterized by extreme confusion requiring round-the-clock care patient care.\u003c/p>\n\u003cp>Begley spoke about her reporting with KQED's Brian Watt on Friday. The following is a transcript of the interview, edited for length and clarity.\u003c/p>\n\u003cp>\u003cstrong>On the lack of progress in Alzheimer's drug development\u003c/strong>\u003c/p>\n\u003cp>The last drug for Alzheimer's was approved in 2003. So 15 years and we have had nothing.\u003c/p>\n\u003caside class=\"pullquote alignright\">'The drug companies have spent and lost billions of dollars trying to find something that works for Alzheimer's patients. And they're giving up.'\u003c/aside>\n\u003cp>I talked about the situation with patient advocates and neurologists and people in the lab desperately trying to come up with something to help people. One expert used a term that made me just sit up and practically gasp. He called it \"therapeutic nihilism.\" And by that he meant the disease has proved so challenging to scientists that people have almost given up.\u003c/p>\n\u003cp>In studies, drug after drug has failed. The drug companies have spent and lost billions of dollars trying to find something that works for Alzheimer's patients. And they're giving up.\u003c/p>\n\u003cp>\u003cstrong>On the contrast between activism around HIV/AIDS and the lack of advocacy around Alzheimer's \u003c/strong>\u003c/p>\n\u003cp>The amount of attention, drug development, et cetera for HIV/AIDS have been hugely impressive. And that's why I contrasted it with Alzheimer's, wondering: Where is the outrage over the lack of progress?\u003c/p>\n\u003cp>And there you have things like the age of patients. With HIV/AIDS, the tragic toll was, at least initially, on men in their prime. For Alzheimer's, primarily affecting people 65 and older, there's at least some sentiment that they've had a good life, that's the way it goes.\u003c/p>\n\u003cp>\u003cstrong>On the lack of drugs being tested for moderate to severe Alzheimer's\u003c/strong>\u003c/p>\n\u003cp>There's what's called a pipeline analysis done every year by researchers at the Cleveland Clinic. They look at all the experimental compounds being tested in patients, and they ask, \"What kind of patients are they being tested in?\"\u003c/p>\n\u003caside class=\"pullquote alignright\">'There are 5.5 million people and growing that already have the disease. So what we're essentially saying to them is that it's really unfortunate but we have nothing that will help you.'\u003c/aside>\n\u003cp>They broke it down into people who do not have Alzheimer's but have some of the risk factors, and people who have mild, moderate or severe Alzheimer's. What really made me sit up was that the number of drugs being tested to see whether they can stop or even reverse the actual course of the disease in people with moderate or severe Alzheimer's is 1 out of 112.\u003c/p>\n\u003cp>We all hope they can stop Alzheimer's at earlier stages. We all know somebody who has Alzheimer's, and when they first get it if you could look at that person and say, wow, you don't actually have a diagnosis yet, but you're on the cusp, so here's a drug that will help you from getting Alzheimer's ... .\u003c/p>\n\u003cp>But there are 5.5 million people and growing that already have the disease. So what we're essentially saying to them is that it's really unfortunate but we have nothing that will help you. And if there's nothing in the pipeline for people with moderate to severe Alzheimer's, that means there will be nothing for anybody who is diagnosed in 2018, in 2019, and probably for the next 10 years.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cbr>\n\u003cstrong>On the response from patient advocates\u003c/strong>\u003c/p>\n\u003cp>I thought I would call them and give them a softball. Let them say, \"This is untenable. We know it's expensive, but these drug companies just really have to step up.\"\u003c/p>\n\u003caside class=\"pullquote alignright\">'I will simply note without comment that the patient advocacy groups get buckets of money from drug developers.'\u003c/aside>\n\u003cp>Instead they told me things like, \"Boy, it's really hard to develop drugs. It's understandable that the drug companies have pulled back.\"\u003c/p>\n\u003cp>I will simply note without comment that the patient advocacy groups get buckets of money from drug developers.\u003c/p>\n\u003cp>The market for preventing the development of Alzheimer's is much greater than for even the people who have it. If you develop something to prevent Alzheimer's that you can give to tens of millions of healthy people, that would be a huge profit boost for your company.\u003c/p>\n\u003cp>So I think it would be naïve of anyone to say that there are no financial considerations here.\u003c/p>\n\u003cp>\u003c/p>\n\u003c/div>\u003c/p>",
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"disqusTitle": "Historic Gene Editing Attempt in First Human Off to a Positive Start",
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"content": "\u003cp>Early, partial results from a historic gene editing study give encouraging signs that the treatment may be safe and having at least some of its hoped-for effect, but it’s too soon to know whether it ultimately will succeed.[contextly_sidebar id=\"nLB0LaskunDkFSzX8O5LVSxfj3Ayt7CZ\"]\u003c/p>\n\u003cp>The results announced Wednesday are from the first human \u003ca href=\"//mps2study.com/study-overview/?pn=\">test\u003c/a> of gene editing in the body, an attempt to permanently change someone’s DNA to cure a disease — in this case, a genetic disorder called \u003ca href=\"https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Mucopolysaccharidoses-Fact-Sheet\">Hunter syndrome\u003c/a> that often kills people in their teens.\u003c/p>\n\u003cp>In two patients who got a medium dose of the treatment, urine levels of large sugar compounds that are hallmarks of Hunter syndrome had fallen by half, on average, four months later — a possible sign the treatment is working. Two others who got a low dose have seen little change in these sugars so far.\u003c/p>\n\u003cp>There’s no way to know yet whether the change in the middle-dose patients is due to the gene editing or something else, but the fact their sugars have declined consistently since treatment suggests it might be.\u003c/p>\n\u003cp>“I cannot absolutely say it’s a treatment effect” but the drop is “really encouraging,” said the study leader, Dr. Joseph Muenzer of the University of North Carolina, Chapel Hill. The main goal of early treatment studies is to test safety, though researchers also look for hints that the therapy is working. Muenzer gave the results at a conference in Greece and consults for the treatment’s maker, California-based Sangamo Therapeutics.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The company’s president, Dr. Sandy Macrae, said tests in about five months will reveal more, but the change in the middle-dose group so far “looks really good.”[contextly_sidebar id=\"FMPymRVSamCP4f8RpmzlwSdu0yioj0rt\"]\u003c/p>\n\u003cp>“The most rational explanation for this is that what we hoped was going to happen has happened,” he said.\u003c/p>\n\u003cp>Several independent experts agreed.\u003c/p>\n\u003cp>“The results are exciting” and suggest that the gene editing is working to some degree, without safety concerns so far, said Dr. Howard Kaufman, a Boston scientist and member of a National Institutes of Health panel that reviewed the study before it began.\u003c/p>\n\u003cp>Dr. Matthew Porteus, a genetics expert at Stanford University who consults for two other companies developing gene therapies, said more time is needed to see how the patients’ immune system continues to react to the treatment and whether the effects last, but added, “I would be excited about continuing to push along” based on these results.\u003c/p>\n\u003cp>\u003cstrong>How It Works\u003c/strong>\u003c/p>\n\u003cp>Gene editing is intended as a more precise way to do gene therapy, to knock out a bad gene or supply a good one that’s missing. Doctors hope it will give a way to address a host of diseases that can’t be treated well now.\u003c/p>\n\u003cp>In November, a Phoenix-area man with Hunter syndrome, Brian Madeux, became the first person to test this inside the body. He lacks a gene that makes an enzyme that breaks down certain large sugar compounds called GAGs. These build up in cells and cause havoc throughout the body.\u003c/p>\n\u003cp>Through an IV, Madeux received many copies of a corrective gene and a gene-editing tool called zinc finger nucleases to help put it in a precise spot in his DNA. He was one of the two patients given a very low dose of the treatment, because this first-in-human testing called for extreme caution.\u003c/p>\n\u003cp>\u003cstrong>Early Results\u003c/strong>\u003c/p>\n\u003cp>In Madeux and the other low-dose patient, levels of the tell-tale sugar compounds in urine rose 9 percent on average after four months. Muenzer said it’s hard to know whether this is a significant change; little is known about the biology of these compounds, including whether they fluctuate during the day or before or after meals.[contextly_sidebar id=\"g6IAb2xjtv0z0Te9cBhCwQAn8pi68Yxx\"]\u003c/p>\n\u003cp>A liver biopsy on one patient given a low dose of the therapy found no evidence that the gene editing had occurred, but Sangamo scientists said this dose is far below the level at which such signs had been detected in research on primates.\u003c/p>\n\u003cp>Two other patients were given a middle dose that was twice what the first two patients received. Their GAG levels declined by 51 percent after four months, on average. Two of the main types of these sugars that accumulate in tissues declined 32 percent and 61 percent, respectively.\u003c/p>\n\u003cp>It is not yet known if declines like these can improve patients’ health or slow the progression of the disease.\u003c/p>\n\u003cp>“This is not proof that this is a successful therapy yet, that these patients had enough gene editing to now supply them with the enzyme they need for the rest of their life,” Muenzer said.\u003c/p>\n\u003cp>But he said an important goal was met: the treatment seems safe. There were two serious side effects — one patient was hospitalized for bronchitis and another for an irregular heartbeat — but those were deemed due to their disease and pre-existing conditions, not the gene treatment.\u003c/p>\n\u003cp>Blood tests did not detect the missing enzyme. Company scientists said this could be because any that was being made was rapidly used by cells rather than getting into the bloodstream — an explanation some outside experts agreed with. What counts, they said, was seeing the result of enzyme activity, the drop in sugars.\u003c/p>\n\u003cp>\u003cstrong>Next Steps\u003c/strong>\u003c/p>\n\u003cp>Two more patients have been given the highest dose being tested — 10 times the starting dose — for a total of six patients in the study. The next step is to start taking patients off the weekly enzyme treatments they’ve been receiving to see if the gene therapy has changed their bodies so they make enough of the enzyme themselves.\u003c/p>\n\u003cp>More results are expected at a medical meeting in February.\u003c/p>\n\u003cp>“We need to see sustained levels for this to be practical. If this only works for six months, that’s not very beneficial,” Muenzer said. “Time’s going to tell.”\u003c/p>\n\u003cp>In an interview at his home in Arizona last month, Madeux, 45, told The Associated Press he volunteered for the study in hope of being able to stop the weekly, three-hour enzyme infusions, but also to help find a treatment for future generations with the disease.\u003c/p>\n\u003cp>“I’m old and having Hunter’s has done a lot of damage to my body,” Madeux said. “I’m actually pretty lucky I’ve lived this long.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp> \u003c/p>\n\n",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Early, partial results from a historic gene editing study give encouraging signs that the treatment may be safe and having at least some of its hoped-for effect, but it’s too soon to know whether it ultimately will succeed.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>The results announced Wednesday are from the first human \u003ca href=\"//mps2study.com/study-overview/?pn=\">test\u003c/a> of gene editing in the body, an attempt to permanently change someone’s DNA to cure a disease — in this case, a genetic disorder called \u003ca href=\"https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Mucopolysaccharidoses-Fact-Sheet\">Hunter syndrome\u003c/a> that often kills people in their teens.\u003c/p>\n\u003cp>In two patients who got a medium dose of the treatment, urine levels of large sugar compounds that are hallmarks of Hunter syndrome had fallen by half, on average, four months later — a possible sign the treatment is working. Two others who got a low dose have seen little change in these sugars so far.\u003c/p>\n\u003cp>There’s no way to know yet whether the change in the middle-dose patients is due to the gene editing or something else, but the fact their sugars have declined consistently since treatment suggests it might be.\u003c/p>\n\u003cp>“I cannot absolutely say it’s a treatment effect” but the drop is “really encouraging,” said the study leader, Dr. Joseph Muenzer of the University of North Carolina, Chapel Hill. The main goal of early treatment studies is to test safety, though researchers also look for hints that the therapy is working. Muenzer gave the results at a conference in Greece and consults for the treatment’s maker, California-based Sangamo Therapeutics.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The company’s president, Dr. Sandy Macrae, said tests in about five months will reveal more, but the change in the middle-dose group so far “looks really good.”\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>“The most rational explanation for this is that what we hoped was going to happen has happened,” he said.\u003c/p>\n\u003cp>Several independent experts agreed.\u003c/p>\n\u003cp>“The results are exciting” and suggest that the gene editing is working to some degree, without safety concerns so far, said Dr. Howard Kaufman, a Boston scientist and member of a National Institutes of Health panel that reviewed the study before it began.\u003c/p>\n\u003cp>Dr. Matthew Porteus, a genetics expert at Stanford University who consults for two other companies developing gene therapies, said more time is needed to see how the patients’ immune system continues to react to the treatment and whether the effects last, but added, “I would be excited about continuing to push along” based on these results.\u003c/p>\n\u003cp>\u003cstrong>How It Works\u003c/strong>\u003c/p>\n\u003cp>Gene editing is intended as a more precise way to do gene therapy, to knock out a bad gene or supply a good one that’s missing. Doctors hope it will give a way to address a host of diseases that can’t be treated well now.\u003c/p>\n\u003cp>In November, a Phoenix-area man with Hunter syndrome, Brian Madeux, became the first person to test this inside the body. He lacks a gene that makes an enzyme that breaks down certain large sugar compounds called GAGs. These build up in cells and cause havoc throughout the body.\u003c/p>\n\u003cp>Through an IV, Madeux received many copies of a corrective gene and a gene-editing tool called zinc finger nucleases to help put it in a precise spot in his DNA. He was one of the two patients given a very low dose of the treatment, because this first-in-human testing called for extreme caution.\u003c/p>\n\u003cp>\u003cstrong>Early Results\u003c/strong>\u003c/p>\n\u003cp>In Madeux and the other low-dose patient, levels of the tell-tale sugar compounds in urine rose 9 percent on average after four months. Muenzer said it’s hard to know whether this is a significant change; little is known about the biology of these compounds, including whether they fluctuate during the day or before or after meals.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>A liver biopsy on one patient given a low dose of the therapy found no evidence that the gene editing had occurred, but Sangamo scientists said this dose is far below the level at which such signs had been detected in research on primates.\u003c/p>\n\u003cp>Two other patients were given a middle dose that was twice what the first two patients received. Their GAG levels declined by 51 percent after four months, on average. Two of the main types of these sugars that accumulate in tissues declined 32 percent and 61 percent, respectively.\u003c/p>\n\u003cp>It is not yet known if declines like these can improve patients’ health or slow the progression of the disease.\u003c/p>\n\u003cp>“This is not proof that this is a successful therapy yet, that these patients had enough gene editing to now supply them with the enzyme they need for the rest of their life,” Muenzer said.\u003c/p>\n\u003cp>But he said an important goal was met: the treatment seems safe. There were two serious side effects — one patient was hospitalized for bronchitis and another for an irregular heartbeat — but those were deemed due to their disease and pre-existing conditions, not the gene treatment.\u003c/p>\n\u003cp>Blood tests did not detect the missing enzyme. Company scientists said this could be because any that was being made was rapidly used by cells rather than getting into the bloodstream — an explanation some outside experts agreed with. What counts, they said, was seeing the result of enzyme activity, the drop in sugars.\u003c/p>\n\u003cp>\u003cstrong>Next Steps\u003c/strong>\u003c/p>\n\u003cp>Two more patients have been given the highest dose being tested — 10 times the starting dose — for a total of six patients in the study. The next step is to start taking patients off the weekly enzyme treatments they’ve been receiving to see if the gene therapy has changed their bodies so they make enough of the enzyme themselves.\u003c/p>\n\u003cp>More results are expected at a medical meeting in February.\u003c/p>\n\u003cp>“We need to see sustained levels for this to be practical. If this only works for six months, that’s not very beneficial,” Muenzer said. “Time’s going to tell.”\u003c/p>\n\u003cp>In an interview at his home in Arizona last month, Madeux, 45, told The Associated Press he volunteered for the study in hope of being able to stop the weekly, three-hour enzyme infusions, but also to help find a treatment for future generations with the disease.\u003c/p>\n\u003cp>“I’m old and having Hunter’s has done a lot of damage to my body,” Madeux said. “I’m actually pretty lucky I’ve lived this long.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"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. ",
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"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. ",
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"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.",
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"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>",
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"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?",
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"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",
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"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.",
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"possible": {
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"title": "Possible",
"info": "Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. The show features interviews with visionary guests like Trevor Noah, Sam Altman and Janette Sadik-Khan. Possible paints an optimistic portrait of the world we can create through science, policy, business, art and our shared humanity. It asks: What if everything goes right for once? How can we get there? Each episode also includes a short fiction story generated by advanced AI GPT-4, serving as a thought-provoking springboard to speculate how humanity could leverage technology for good.",
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"pri-the-world": {
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"title": "PRI's The World: Latest Edition",
"info": "Each weekday, host Marco Werman and his team of producers bring you the world's most interesting stories in an hour of radio that reminds us just how small our planet really is.",
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"imageSrc": "https://cdn.kqed.org/wp-content/uploads/2024/04/The-World-Podcast-Tile-360x360-1.jpg",
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},
"radiolab": {
"id": "radiolab",
"title": "Radiolab",
"info": "A two-time Peabody Award-winner, Radiolab is an investigation told through sounds and stories, and centered around one big idea. In the Radiolab world, information sounds like music and science and culture collide. Hosted by Jad Abumrad and Robert Krulwich, the show is designed for listeners who demand skepticism, but appreciate wonder. WNYC Studios is the producer of other leading podcasts including Freakonomics Radio, Death, Sex & Money, On the Media and many more.",
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},
"reveal": {
"id": "reveal",
"title": "Reveal",
"info": "Created by The Center for Investigative Reporting and PRX, Reveal is public radios first one-hour weekly radio show and podcast dedicated to investigative reporting. Credible, fact based and without a partisan agenda, Reveal combines the power and artistry of driveway moment storytelling with data-rich reporting on critically important issues. The result is stories that inform and inspire, arming our listeners with information to right injustices, hold the powerful accountable and improve lives.Reveal is hosted by Al Letson and showcases the award-winning work of CIR and newsrooms large and small across the nation. In a radio and podcast market crowded with choices, Reveal focuses on important and often surprising stories that illuminate the world for our listeners.",
"airtime": "SAT 4pm-5pm",
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"officialWebsiteLink": "https://www.revealnews.org/episodes/",
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},
"rightnowish": {
"id": "rightnowish",
"title": "Rightnowish",
"tagline": "Art is where you find it",
"info": "Rightnowish digs into life in the Bay Area right now… ish. Journalist Pendarvis Harshaw takes us to galleries painted on the sides of liquor stores in West Oakland. We'll dance in warehouses in the Bayview, make smoothies with kids in South Berkeley, and listen to classical music in a 1984 Cutlass Supreme in Richmond. Every week, Pen talks to movers and shakers about how the Bay Area shapes what they create, and how they shape the place we call home.",
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"order": 16
},
"link": "/podcasts/rightnowish",
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