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Freeze-dried drug factories could make various medicines, just add water

The team envisions that freeze-dried components could be carried in portable kits, such as this mock-up. Photo via Wyss
         Institute/Harvard University

The team envisions that freeze-dried components could be carried in portable kits, such as this mock-up. Photo via Wyss Institute/Harvard University

The contraption looks and sounds like a washing machine: a rumbling box with a circular window near the floor.

But if you look inside, you won’t see a whir of clothes; instead you’ll see a ring of crystalline ice. This device is called the Freezemobile, and it isn’t your standard household appliance. By hooking up a few test tubes to its metal piping, chemists have used the Freezemobile to make drug ingredients designed to be transported into the remotest corners of the developing world.

That might sound like overkill when you could just send blister packs of pills. Yet for some medicines and vaccines, pills don’t do the trick. That’s because those types of drugs are often harvested from living cells — and just like your leftover lasagna, they probably won’t still be good after days in a hot car.

On Thursday, researchers at Harvard’s Wyss Institute, the Massachusetts Institute of Technology, and University of Toronto published a possible solution. Instead of making the drugs and then trying to keep them refrigerated over thousands of miles, they want to give people the ingredients. These components don’t require refrigeration, and the instructions are as simple as they come: Just add water.

“It’s essentially how you make ramen,” said Peter Nguyen, a research fellow at the Wyss, and one of the first authors on the paper.

But creating those tiny make-your-own-drug kits is hard.

Usually, to produce biologics — as these drugs are called — a company uses living cells as their factories, often turning to bacteria like E. coli. By injecting new bits of DNA into the bacteria, the researchers modify them to produce proteins that prevent or beat back disease.

These proteins, however, can be delicate things, destroyed by deep freezing or temperatures warmer than a refrigerated chill.

So Nguyen and his team set about extracting cells’ innards to create what amounts to cellular machinery in powder form. To break open the cell membranes, they used a needle vibrating at supersonic frequencies. The metal moves so fast that it can cause test tubes to shatter or melt. “It feels like a tuning fork times a hundred,” said Nguyen.

With a centrifuge, they separated out the molecules important for protein production from all the other gunk, such as baubles of fat and the cell’s own DNA.

Sprinkle in some fuel and preservative, put into the Freezemobile, and voila — a speck comes out, looking like cotton candy, which could potentially be shipped out to some remote location. Tip in a pinch of freeze-dried DNA and a bit of sterile water, and a chemical reaction would begin, with the genetic material programming the cell innards to make the desired protein. The more different kinds of DNA you take with you, the more different kinds of drugs and vaccines you can make.

“It’s no longer living, but all of its internal components are still there, the ribosomes, all of the machinery that makes that protein,” said Nguyen.

The project was partly funded by Department of Defense. As Nguyen explained, with a little tweaking, these technologies could allow soldiers to carry a whole arsenal of drug ingredients into the field so they are ready for all kinds of medical needs.

To prove that this technology works, Nguyen’s team made and tested four different categories of biologics, including a diphtheria vaccine, an antimicrobial peptide, and a bacteria-fighting antibody. Their results were published in Cell.

To other scientists, the prospect is exciting. Bradley Bundy, an engineer at Brigham Young University, had already used similar technology to produce what may be a cancer-fighting protein. “Instead of stockpiling a whole bunch of vaccines and therapeutics, this allows us to stockpile the machinery that makes them,” he explained. That would “be more cost-effective and a little bit more versatile.”

Yet there is still a ways to go. For the diphtheria vaccine, the scientists had to filter out the active proteins from the cellular factories before they could inject them into mice — and they still don’t know exactly how that purification would happen, say, in a village with no electricity, or behind enemy lines.

David Shoultz, a drug development specialist at the global health nonprofit PATH, said that while he loves that these labs are thinking about using their technologies in the developing world, this kind of gizmo is not about to solve vaccine and medication shortages in one fell swoop.

“In two or three years, will we be able to ship these freeze-dried materials and have an instant vaccine, or an instant drug?” he asked. “Probably not. It’ll probably be more like 10 to 12 years. And we’re still going to need facilities, know-how, and people to implement them.”

This article is reproduced with permission from STAT. It was first published on Sept. 22, 2016. Find the original story here.

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The drug industry might finally have an answer for migraines

Businesswoman sitting at table in restaurant with head resting on hand

Businesswoman sitting at table in restaurant with head resting on hand

It often starts with the aura.

Zig-zagging lines come into view, everyday light becomes searingly bright, and vision starts to slip. These are signals that a debilitating migraine is on its way.

“It’s like you’re possessed,” said Lorie Novak, who has suffered from chronic migraines since childhood. “I almost feel separate from my body, like it’s just this painful shell around me that’s not me.”

Novak, now in her 60s, is one of the roughly 35 million Americans who suffer from migraines. There are few effective treatments, and no new drugs have been developed since the early 1990s.

But that could soon change. A handful of drug companies are pressing ahead with novel injectable therapies for migraines, chasing a blockbuster market that Wall Street analysts say could reach $8 billion a year in worldwide sales.

The new drugs target a bodily protein called CGRP, which plays a role in the dilation of blood vessels in the brain. Scientists haven’t nailed down just how the protein affects migraines, but they’re sure about two things: CGRP levels rocket up when headaches attack and normalize when they go away.

And thus four drug makers — Amgen, Eli Lilly, Teva Pharmaceuticals, and Alder Biopharmaceuticals — have fashioned antibodies that can bind to CGRP molecules and block their activity. The goal: to relieve the scourge of chronic migraines by stopping CGRP in its tracks.

So far, it seems to be working. In mid-stage clinical trials, each of the four treatments has eased symptoms for about half of study participants, cutting the number of days they’re afflicted by migraines roughly in half. It’s by no means a cure for migraines, but it should be enough to merit Food and Drug Administration approvals if the companies can replicate those results in larger trials, according to Eric Schmidt, a securities analyst at Cowen and Co.

Each treatment is now in late-stage development, targeting the roughly 38 percent of migraine sufferers who, like Novak, have at least four headache days per month. The first therapy could hit the market in 2018, and, if everything works out, all four could available by the end of the decade.

So far, the four drugs have performed similarly in clinical trials, and analysts expect the contenders will have to compete on price to grab market share.

“There will certainly be hypercompetition,” said William Ratner, Lilly’s senior director of global headache marketing. But the companies’ fortunes are intertwined, he said, and “the class only wins if headache care in America improves.”

Aiming to prevent migraines before they start

There’s plenty of room for improvement. Existing therapies are plagued by inconsistent efficacy and troublesome side effects, and patients are often left to rely on a repurposed treatment for epilepsy. That medication, Topamax, has been dubbed dubbed “Sleepomax” by doctors and patients because it’s also a heavy sedative.

“I’m very enthusiastic, as I think everyone in the field is, about having another treatment option for people with migraines,” said Dr. Elizabeth Loder, a professor of neurology at Harvard Medical School and chief of the headache division in the department of neurology at Brigham and Women’s Hospital.

Targeting CGRP is not a particularly new idea. Researchers picked up on the protein’s scent more than 30 years ago, and drug companies spent years trying to craft pills that might block its activity. Merck got all the way into late-stage trials with an anti-CGRP tablet, spending more than $1 billion only to find in 2011 that the drug had toxic effects on the liver and thus no future.

With the “exquisite sensitivity” of an antibody, however, scientists believe they can block CGRP without triggering dangerous side effects, Alder CEO Randy Schatzman said.

Because antibodies stay active in the body for weeks, the drug companies see their new products as preventative therapies, injected monthly or quarterly to keep headaches at bay. (Merck’s failed pill, by contrast, was meant as an on-the-spot treatment after the pain started.)

“So in some senses, it’s a paradigm shift,” Schatzman said.

But there are still hurdles to clear. Only about half of patients seem to respond to CGRP antibodies, and the companies have no way of predicting who they are ahead of time. A genetic test would be “the Holy Grail of personalized medicine,” said Rob Lenz, Amgen’s global development lead for neuroscience, but no one has made one yet.

And long-term safety remains a major question mark. To date, none of the companies has reported serious side effects in clinical trials, but they’ve only reported data from 12-week studies on about 1,500 total patients. It will take years to determine just what the new therapies do to the body over time, Loder said.

‘I felt like my life was being stolen from me’

Any advance, even an incremental one, would be a major leap for the field, said Emily Bates, who studies the genetic causes of headaches at the University of Colorado and is not affiliated with any of the companies working on migraine treatment.

Bates struggled with chronic migraines in high school and college. Like many patients, she didn’t respond to any of the preventative therapies available.

“The pain is more than anything I’ve ever experienced, and I’ve run on broken legs before,” she said. “I felt like my life was being stolen from me.”

Collectively, Americans miss about 113 million workdays each year because of migraine. That lost productivity costs society about $13 billion each year, according to the Migraine Research Foundation.

Yet scientific progress has been slow, in part because migraine was long considered a psychosomatic condition not worthy of serious research funding, Bates said.

It’s a “subjective symptom that predominantly affects women,” said Loder, the Harvard neurologist. “That’s a perfect combination of things that make people feel able to dismiss it.”

Novak, a professor of photography at New York University’s Tisch School of the Arts, spent years trying to hide her migraines because of the stigma attached to the condition. But she decided to change all that in 2009 with a project called Migraine Register. She posts a photo of herself each day she has a migraine. Some years, that’s more than 120 pictures.

The idea, in part, was to humanize chronic migraines. But the project also forced Novak to reckon with the toll of the disease, something she had tried to ignore for years.

“That for me was like a concrete proof of how it really does affect my life,” Novak said, “of how much time I lose.”

This article is reproduced with permission from STAT. It was first published on Sept. 23, 2016. Find the original story here.

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With an increase in EpiPen use among seniors, Medicare spending up 1,100 percent

EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers.
         Photo by Jim Bourg/Reuters

EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers. Photo by Jim Bourg/Reuters

Even as the cost of EpiPens dramatically rose, so too did the number of prescriptions written for patients in Medicare, sending spending by the program skyrocketing nearly 1,100 percent from 2007 to 2014, a new report shows.

During the same period, the total number of Medicare beneficiaries using EpiPens climbed 164 percent, from nearly 80,000 users in 2007 to more than 211,000 in 2014, according to the analysis by the Kaiser Family Foundation. While the report does not delve into what’s behind the increase, factors could include increased awareness among people with allergies, marketing efforts and access to insurance coverage.

The abrupt rise is notable because many people think that life-threatening allergies are less common among the elderly. In addition, epinephrine — the active ingredient in EpiPens — can pose greater risks to older adults. Food and Drug Administration labeling urges caution when prescribing to this age group.

“That level of increase gives me pause,” said Martha Twaddle, senior medical officer for Illinois at Aspire Health, which provides home-based supportive care for people with serious illness. She did not work on the study. Epinephrine — the active ingredient in EpiPens — can cause side effects including chest pain, rapid increase in blood pressure or irregular heart rhythms, which could be fatal, for people with certain medical conditions, including heart disease.

The foundation study comes amid ongoing scrutiny — including congressional testimony Wednesday by Mylan CEO Heather Bresch — over EpiPen price increases. (Kaiser Health News is an editorially independent program of the Foundation.)

EpiPens are used in cases of severe allergic reactions. Costs for a two-pack of the pens has gone from about $94 in January 2007 to $609 in May of this year. In response to criticism of its price increase, Mylan announced in late August that it would make a generic version and price it at half of its current brand name price.

The new numbers from Medicare could add fuel to the debate over these price increases and voters’ demands that Congress take action to roll back the cost of the popular medication.

The health insurance program for senior citizens and disabled people spent about $6.4 million on the devices in 2007, but spent $75.3 million in 2014, with sharp price hikes by the manufacturer driving much of the increase. Those figures reduce the amount spent based on estimates of how much Medicare saved in rebates from manufacturers, although the agency would not disclose the exact amounts.

Still, when patients show up in emergency rooms with life-threatening allergic reactions, epinephrine is a first line of defense, said Robert Glatter, emergency room physician at Lenox Hill Hospital in Manhattan. Those whose allergic reaction isn’t immediately life threatening would more likely get a mix of steroids and antihistamines, he said.

All patients with suspected severe allergic reactions — even the elderly — are given either a prescription or an actual epinephrine auto injector upon discharge, he said.

“We tell them to have it and use it if they have a lip or tongue swelling, shortness of breath, a skin rash [or other symptoms] of a problem,” said Glatter, adding that adults tend to become more susceptible to food allergies as they age.

WATCH: Did outcry on social media lead to Mylan’s generic EpiPen?

Increased awareness among doctors and patients about the importance of epinephrine could account for some of the increase seen in the study, said Richard Lockey, a past president of both the World Allergy Organization and the American Academy of Allergy, Asthma & Immunology.

“Most people survive an allergic reaction … the people who don’t survive are those who don’t get epinephrine or don’t get it soon enough,” said Lockey, who says it is necessary to balance this idea with the possible risks epinephrine poses for older patients. “It’s a matter of clinical judgment.”

Although Medicare is generally thought of as the government health program for older people, about 16 percent — or 9.1 million beneficiaries — are younger than 65. They are generally disabled or have kidney problems requiring dialysis. According to foundation researchers, although the majority of users were older than 65, a disproportionate share – 35 percent — of the EpiPen users were younger than 65. Additionally, 26 percent were between 65 and 69. Use fell off with age, with only 15 percent of the users being between ages 75-85.

“You can come up with a ton of reasons why the under-65 population might see an increase in EpiPen use,” said James Goodwin, an expert in geriatric medicine at the University of Texas Medical Branch in Galveston. He did not work on the study.

As for the overall increase, Goodwin said there are likely many factors and it isn’t necessarily evidence of overutilization. Still, Goodwin says he specializes in patients older than age 80 and has never prescribed an EpiPen, nor had three of his colleagues, who work with slightly younger elderly patients.

One geriatrician said he has patients who are on it with prescriptions from their allergists, who weigh the pros and cons of having the drug. Those physicians “are the ones to say your allergy is serious enough to potentially become life threatening.”

At the American Geriatrics Society, epinephrine is not included on the organization’s list of potentially inappropriate medicines, said Nicole Brandt, a professor at the School of Pharmacy at the University of Maryland.

“When you look at in context of someone having a severe anaphylactic reaction, which is life threatening, you want access to treatment,” said Brandt. She said doctors should caution patients about the appropriate use of the devices and encourage them to seek additional medical attention if they experience side effects.

She suggested the increase in Medicare prescriptions seen in the study reflects access to insurance more than overuse.

Since Medicare drug plans cover part of enrollees’ total drug costs, beneficiaries in prescription drug plans pay less that the full retail price. But beneficiaries still paid significantly more of their own money for EpiPens during the seven-year period studied in the report. Average out-of-pocket spending for beneficiaries with Medicare drug coverage nearly doubled for each EpiPen, from $30 to $56. The report does not include price increases beyond 2014.

Still, those costs are far less than what some people with private insurance might pay, particularly those with high deductibles. As a result, at least one doctor — geriatrician David Barile from Princeton, New Jersey — who did not work on the study, speculated that the rise in Medicare use of EpiPens might simply be older people getting them for their grandchildren.

Liz Szabo contributed to this report.

Kaiser Health News is an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente. You can view the original report on its website.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

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20 million would lose health coverage under Trump plan, study says

Patient sitting on hospital bed waiting for surgery looking out window. Photo by Portra Images/via Getty Images

The analysis was carried out by the RAND Corporation, a global research organization that uses computer simulation to test the potential effects of health care proposals. Photo by Portra Images/via Getty Images

WASHINGTON — A new study that examines some major health care proposals from the presidential candidates finds that Donald Trump would cause about 20 million to lose coverage while Hillary Clinton would provide coverage for an additional 9 million people.

The 2016 presidential campaign has brought voters to a crossroads on health care yet again. The U.S. uninsured rate stands at a historically low 8.6 percent, mainly because of President Barack Obama’s health care law, which expanded government and private coverage. Yet it’s uncertain if the nation’s newest social program will survive the election.

Republican candidate Trump would repeal “Obamacare” and replace it with a new tax deduction, insurance market changes, and a Medicaid overhaul. Democrat Clinton would increase financial assistance for people with private insurance and expand government coverage as well.

The two approaches would have starkly different results, according to the Commonwealth Fund study released Friday.

The analysis was carried out by the RAND Corporation, a global research organization that uses computer simulation to test the potential effects of health care proposals. Although the New York-based Commonwealth Fund is nonpartisan, it generally supports the goals of increased coverage and access to health care.

Economist Sara Collins, who heads the Commonwealth Fund’s work on coverage and access, said RAND basically found that Trump’s replacement plan isn’t robust enough to make up for the insurance losses from repealing the Affordable Care Act. “Certainly it doesn’t fully offset the effects of repeal,” Collins said.

One worrisome finding is that the number of uninsured people in fair or poor health could triple under Trump. It would rise from an estimated 2.1 million people under current laws to between 5.7 million and 7.1 million under Trump’s approach, depending on which of his policy proposals was analyzed.

When uninsured people wind up in the hospital, the cost of their treatment gets shifted to others, including state and federal taxpayers. Trump has said he doesn’t want people “dying on the street.”

The study panned one of Trump’s main ideas: allowing insurers to sell private policies across state lines. Collins said insurers would cherry-pick the healthiest customers and steer them to skimpy plans. Other experts don’t see it as bleakly, believing that interstate policies could attract customers through lower premiums.

A prominent Republican expert who reviewed the study for The Associated Press questioned some of its assumptions, but said the overall conclusion seems to be on target. “You could quibble about some of the modeling, but directionally I think it’s right,” said economist Douglas Holtz-Eakin, president of the American Action Forum, a center-right public policy center.

Collins said the analysis examined some major proposals from each candidate, but did not test every idea.

The Trump proposals included repealing the Obama health care law, as well as a host of replacement ideas consisting of a new income tax deduction for health insurance, allowing policies to be sold across state lines, and turning the Medicaid program for low-income people into a block grant, which would mean limiting federal costs.

The study estimated that Trump’s repeal of “Obamacare” would increase the number of uninsured people from 24.9 million to 44.6 million in 2018. But then his replacement proposals would have a push-pull effect. The tax deduction and interstate health insurance sales would help some stay covered, but the Medicaid block grant would make even more people uninsured.

“The people who would actually gain coverage tend to have higher incomes,” said Collins.

The result would be an estimated 45.1 million uninsured people in 2018 under Trump — an increase of 20.2 million, reversing the coverage gains under Obama.

The Clinton proposals analyzed included a new tax credit for deductibles and copayments not covered by insurance, a richer formula for health law subsidies, a fix for the law’s “family glitch” that can deny subsidies to some dependents, and a new government-sponsored “public option” health plan.

Taken together, the analysis estimated that Clinton’s proposals would reduce the number of uninsured people in 2018 to 15.8 million, which translates to a gain of 9.1 million people with coverage. Not included were Clinton’s idea for allowing middle-aged adults to buy into Medicare and her plan to convince more states to expand Medicaid.

Collins said the researchers will update their estimates for both campaigns as more details become available.

The health care report follows another recent analysis that delved into the candidates’ tax proposals. That study by the nonpartisan Committee for a Responsible Federal Budget found that Trump’s latest tax proposals would increase federal debt by $5.3 trillion over the next decade, compared with $200 billion if Clinton’s ideas were enacted. The Trump campaign disputed those findings.

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