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How We Got Here: Treating Addiction In 28 Days

10 hours 21 min ago
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After a string of inpatient rehabilitation stays, Louis Casanova, who lives near Philadelphia, says he is still trying to break his addiction.

Ben Allen/WITF

Louis Casanova is playing cards with a friend on the back deck of a recovery house in Philadelphia's northern suburbs.

He's warm and open as he talks about his past few years. The guy everyone calls Louie started using drugs like Xanax and Valium during his freshman year of high school. At age 18, Casanova turned to heroin. About two years later, the rehab shuffle began.

"I relapsed and then I was just getting high. And then I went to treatment again in February of 2015," he says. "Then I relapsed again and went back to treatment."

He's 23 now. He's hurt people close to him and his criminal record, fueled by his drug addiction, is long. By Louie's count, he has been through eight inpatient rehabs. Louis says his stays have ranged from about 18 to 45 days.

"I did 30 days, and after that I came here," he concludes, talking about his latest visit.

A month's stay can be pretty typical among people who go to an inpatient facility.

But why?

"As far as I know, there's nothing magical about 28 days," says Kimberly Johnson, director of the Center for Substance Abuse Treatment at SAMHSA, the federal agency that studies treatment services.

Anne Fletcher, author of the book Inside Rehab, agrees.

"It certainly is not scientifically based," she says. "I live in Minnesota where the model was developed and a lot of treatment across the country really stemmed from that."

She says the late Daniel Anderson was one of the primary architects of the "Minnesota model," which became the prevailing treatment protocol for addiction specialists. At a state hospital in Minnesota in the 1950s, Anderson saw alcoholics living in locked wards, leaving only to be put to work on a farm.

To find a path for them to get sober and leave the hospital, he came up with the 28-day model.

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Marvin Ventrell, executive director of the National Association of Addiction Treatment Providers, has studied the model's history. He says the month-long standard comes from the notion that when "someone is suffering from addiction — and in the days that this began, we're pretty much talking about alcoholism — it made sense to people that it took about four weeks to stabilize somebody."

And then, Ventrell says, "It became the norm because the insurance industry was willing to pay for that period of time."

Now the model has spread to treatment for opioid addiction, even though recovering from addiction to those powerful drugs may require a different method.

Ventrell admits there isn't enough research about the most effective length for an inpatient stay for opioid addiction.

"Treatment centers have to step up and say, 'Just like cancer or heart disease, we're going to measure our outcomes and show them to you,' " he says.

The federal government estimates spending on treatment for all substance abuse will hit a high of $42 billion by 2020. Some people pay tens of thousands of dollars, desperately hoping inpatient treatment will work.

But there's increasing evidence that medication assisted treatment with the synthetic opioids methadone or suboxone can help those addicted by helping to relieve symptoms of withdrawal and reduce craving, especially when paired with strong outpatient counseling and other support.

Shots - Health News Doctors Who Treat Opioid Addiction Often See Very Few Patients

Fletcher says it's important for treatment to move away from the default month-long model.

That may be enough for some people, she says, but it "isn't the case for most people. It's like any other chronic disorder, it waxes and wanes."

After his inpatient stays, Casanova is still trying to break his addiction. While he says recovery largely depends on the person, he preferred longer stays because it gave him more time to learn from other patients in a supportive environment. But Casanova is just one person; others prefer inpatient stays that are shorter than a month, followed by intensive outpatient programs.

Casanova relapsed in February, before I talked to him, and recently had to serve some jail time. But he's back in the recovery house, and hoping to soon make the leap to the next stage — a house with even more independence.

This story is part of a reporting partnership with NPR, WITF's Transforming Health and Kaiser Health News.

Copyright 2016 WITF-FM. To see more, visit WITF-FM.
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CDC Tells Men At Risk Of Zika To Put Off Procreation For 6 Months

Fri, 09/30/2016 - 1:40pm

Men who may have been exposed to the Zika virus should wait at least six months before trying to conceive a child with a partner, regardless of whether they ever had any symptoms, federal health officials are recommending.

The Centers for Disease Control and Prevention had previously recommended that only men with Zika symptoms had to wait that long. Those who may have been exposed to Zika but never developed any symptoms were told to hold off on trying to conceive for just eight weeks.

But on Friday the agency published revised recommendations based on new evidence indicating the Zika virus can remain in semen longer than had been thought and can be spread by men even if they don't have symptoms.

"The updated recommendations incorporate what's been learned since the previous guidance was released," the CDC said in a statement announcing the change.

"The new time period for couples to wait to attempt conception when the man has possible Zika exposure but no symptoms [is] expected to minimize the risk of sexual transmission around the time of conception and prevent possible early fetal exposure to the Zika virus," the CDC said.

The Zika virus can cause a variety of birth defects when women get infected while pregnant. The most serious birth defect that has been linked to Zika is microcephaly, which causes babies to be born with abnormally small heads and badly damaged brains.

For couples planning to conceive who do not live in a place where the virus is actively spreading, the CDC recommends that men who may have been exposed to the virus by traveling where the virus is being transmitted wait at least six months before trying to conceive.

The virus has spread through Latin America, especially Brazil, and the Caribbean, including Puerto Rico. It has also been spread by mosquitoes in Pacific islands such as Fiji.

For couples who live in a place where the virus is spreading, the CDC recommends that women and men should be tested if they develop any symptoms. Men who test positive should wait at least six months to try to conceive. Women who test positive should wait at least eight weeks. Those who test negative should talk to their doctor about what to do.

The guidelines are less specific for couples who live in a place experiencing an outbreak, such as Miami, but who don't have any reason to believe they may have been infected.

The guidelines recommend that those couples talk to their doctors about what they should do, weighing factors that "might influence pregnancy timing," such as their age, whether they had problems getting pregnant and their fertility.

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The agency stressed that its guidelines could continue to change as new information about Zika becomes available.

The virus has repeatedly surprised health authorities. At first they thought the virus was transmitted only by mosquitoes. Then researchers discovered men could spread Zika to women through sexual contact. The CDC was surprised again when doctors determined women could also spread the virus to men.

The Food and Drug Administration also recently recommended that all blood donations be screened for the virus to minimize the chances that pregnant women could get infected from a transfusion, or sex with someone who had a transfusion.

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

Infection Outbreak Shines Light On Water Risks At Dentists Offices

Fri, 09/30/2016 - 12:03pm

Mimi Morales recovers in Children's Hospital of Orange Country in late September after surgery for a dental infection she contracted at Children's Dental Group in Anaheim, Calif. She had three permanent teeth, one baby tooth and part of her jawbone removed.

Mindy Schauer/Courtesy of The Orange County Register

When people go to the dentist, they generally expect to leave in better health than when they walked in.

But the water that dentists use to rinse teeth sometimes carries infectious bacteria.

The Orange County Health Care Agency in California says that nearly two dozen children who received so-called baby root canals, or pulpotomies, are thought to have developed dangerous bacterial infections. Dentists perform pulpotomies to remove infected pulp inside a baby tooth so the rest of the tooth can be spared.

The infections were caused by Mycobacterium abscessus, which the health department traced back to the water at Children's Dental Clinic of Anaheim.

"The reason we're so concerned is this infection is very hard to treat with antibiotics," says Dr. Eric Handler, health officer with the Orange County Health Authority. Instead, the tissue is surgically removed. "Treatment can be very traumatic and deforming."

As of Sept. 27, three confirmed and 19 probable infections have been linked to the clinic. In each case, the children had to be hospitalized. In an email to Shots, Children's Dental Group CEO Sam Gruenbaum said, "I am currently devoting all of my time and energy to making certain our patients are taken care of."

In a Sept. 23 letter to patients, Gruenbaum asked the families of patients who had received pulpotomies since April 1 at the Anaheim clinic to come in and be examined for signs of infection. The letter said that the Orange County Health Care Agency had found abnormal levels of microbes in the water, and the clinic is no longer using office water for patient procedures.

Deepa Bharath and Courtney Perks at The Orange County Register report that several children have had surgery to treat infections, including a 7-year-old girl who had "three permanent teeth, a baby tooth, and a part of her jaw bone" removed.

Although infections like these are rare, this isn't the first time Mycobacterium abscessus has been traced to a dental office. In Georgia in 2015, more than 20 children who had pulpotomies were later hospitalized with confirmed or suspected mycobacterium infections.

Still, according to the federal Centers for Disease Control and Prevention, the Georgia outbreak of dental mycobacterium infections is the only other one on record. The investigation into Georgia cases found that 1,386 children received pulpotomies and were potentially exposed to the bacteria. But only about 1 percent of them got sick.

"Infections from mycobacterium are very rare," said Dr. Melissa Tobin-D'Angelo, a medical epidemiologist with the Georgia Department of Public Health who investigated the 2015 outbreak. "We don't want to discourage parents from having their children see their dentists two times a year as recommended. The reason children had to have this procedure is because they had decay to begin with."

Investigators learned that the water supply to the building wasn't contaminated. Ultimately, they traced the infection to the dental unit waterlines — the flexible plastic tubes that carry water to the hoses that rinse your mouth.

The researchers weren't surprised that the tubes turned out to be the source of the problem. Keeping waterlines clean can be a challenge for dentists.

A bacterial incubator

Dental unit waterlines are very good at growing bacteria, says Dr. Nuala Porteous, an associate professor of dentistry at University of Texas Health Science Center Dental School in San Antonio. In her research, she looks at how to control infection risks in dental offices, including the microbes that live in waterlines.

Mimi Morales says she's "flabbergasted" that her granddaughter, Mimi, 7, ended up in the hospital with an infection following a pulpotomy in July.

Mindy Schauer/Courtesy of The Orange Country Register

"If you think about the last time you went to the dentist, they only use the water sometimes," Porteous says. "It's very start and stop. They work and then they rinse, so there's a lot of stagnant water."

And bacteria love to grow in stagnant water. How prevalent they are is hard to say. A study of dental waterlines in the U.S. found harmful bacteria 68 percent of the time. Still, another study was reassuring, barely finding any contamination in dental offices in London and Northern Ireland.

Mycobacterium isn't the only kind of germ that can thrive in waterlines. Pseudomonas and legionella can, too. Both types of bacteria can cause pneumonia-like illnesses. Despite studies showing that dentists are more likely to have antibodies for legionella than the general population, very few actual illnesses have been directly linked to dentistry.

"These are organisms that are typically found in water and groundwater, things like that," says John Molinari, a microbiologist and professor emeritus at the University of Detroit Mercy School of Dentistry. "They wouldn't normally get you sick. It's when you have high concentrations in a certain person that illness happens." The elderly and people with an underlying illness are most at risk.

"With legionella, you're more likely to get sick when there's a lot of bacteria, like when you get biofilms," says Molinari.

Fighting biofilms

A biofilm is a group of microorganisms — typically bacteria, fungi or a mixture of microbes — that live in a colony. These microbes communicate with each other and even feed and protect each other. And that can make them very hard to remove.

"Think of the plaque that grows on your teeth," says Molinari, "That plaque is a biofilm. At first you can wash it off with water, but after 24 hours you need to brush your teeth and use chemicals to remove it. Even mouthwash alone isn't enough."

The biofilms in waterlines do the same thing. The outer layers might die as cleaning chemicals rush through the pipes, but the inner layers can survive.

A paper published online Sept. 13 in the journal Pathogens and Disease looked at dental practices using industry-standard sterilization techniques. "We found fungi, bacteria, viruses, and protozoa in dental unit waterlines. In our study, decontamination procedures worked but not completely," Damien Costa, at the University of Poitiers in France and the lead investigator on the study, told Shots in an email.

Costa says there aren't any set procedures for sterilizing waterline units in France, where his research was conducted. He hopes his study will provide data that will help the government create guidelines.

In the United States, the CDC says dentists should "consult with the dental unit manufacturer for appropriate methods and equipment to maintain the recommended quality of dental water." Waterlines vary depending on the dental equipment, so a one-size-fits-all approach wouldn't be effective, a CDC spokesman told Shots.

Generally, dental offices use a combination of chemicals. Some are added continuously to the water in low concentrations, while other, stronger disinfectants are used intermittently. Filters and disinfectant cartridges can be added to the ends of lines, and the ADA recommends occasionally draining and purging the waterlines with air.

Dentists should be able to tell if the bacteria-killing maintenance for their equipment is working. Porteous says chairside kits that check for bacteria are available. Dentists can also send water samples to testing companies to make sure bacterial counts fall within CDC guidelines.

The CDC says that the water dentists use should meet the same quality standards as drinking water. But the CDC and the American Dental Association don't say how often dentists should test their water.

"Without water testing, it's impossible to tell if your treatment works," says Mark Frampton, owner of ProEdge Dental Products, a manufacturer of disinfectants for dental lines. Frampton's company also analyzes water quality for dentists. "In our experience, about a third of the time people that have maintenance programs will still fail our tests because they don't always follow the treatment instructions. People don't always do everything perfectly."

Frampton recommends that dentists check their water quality at least quarterly, or more often depending on the treatment product they use.

University of Texas Health Science Center's Porteous recommends dentists check the water coming out of dental lines at least weekly. "I would hope that all dentists take note of these cases that have been occurring recently in Georgia and under investigation in LA," she says. "It's very sad, and I hope that it makes all dental institutions sit up and take note."

Back in California, the dental clinic linked to the mycobacterium infections isn't taking any chances. It will replace its entire water system.

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

FDA Approves The First Automated Insulin System For Type 1 Diabetes

Fri, 09/30/2016 - 5:00am

The MiniMed 670G hybrid closed loop system is the closest thing yet to an artificial pancreas for people with Type 1 diabetes.


The Food and Drug Administration's approval of a new insulin delivery system for people with Type 1 diabetes is a big deal.

With Type 1 diabetes, the pancreas makes little or no insulin so people have to replace it with either multiple daily injections or a pump. In either case, that process involves constant error-prone adjustments, particularly around food and exercise. Over the long term, high blood sugar levels can lead to organ damage, but over-correcting by giving more insulin can cause dangerous low blood sugars that can lead to unconsciousness.

The device, Medtronic's MiniMed 670G hybrid closed loop system, is made up of an insulin pump and continuous glucose monitor (CGM), both of which are already on the market separately. The new part involves the communication between the two devices.

Medtronic's previous system already had a feature that would shut down the insulin pump if the wearer's blood sugar dropped too low. But the 670G predicts when a person's blood sugar is dropping and prevents the low in the first place, and also corrects high blood sugars.

This is the first such machine in the world with that level of automation, and thus it is informally being called the first "artificial pancreas" system.

However, it's called a hybrid rather than a fully closed-loop system because users will still need to signal that they're about to eat and estimate the carbohydrate count of the food so the device can calculate the additional amount of insulin needed. That means there's still the possibility of mistakes. But now if that count is off, the 670G will correct the error automatically.

For people with Type 1 diabetes, the new capabilities mean they can both sleep through the night without worrying about their blood sugars dropping too low and can go through their day without having to think about their diabetes all the time, according to Aaron Kowalski, chief mission officer for the JDRF, the organization that funds much of the "artificial pancreas" research.

"You get almost normalized overnight blood glucose. For people with Type 1 diabetes, that's massively important," he said, adding that the overall 24/7 burden reduction means better quality of life. "The diabetes isn't gone, but [wearers] can think about it less ...This is a historic milestone."

And more systems like this are coming.

Shots - Health News Diabetes Technology Inches Closer To An Artificial Pancreas

Medtronic, via the MiniMed division that it acquired in 2001, was the first to market because it's still the only company that manufactures both the insulin pump and CGM technology. But at least five other partnerships between other manufacturers are now developing closed-loop systems, some using already-available pumps and CGMs, others creating new devices. The systems will likely differ from one another in form, user interface and in the algorithmic approaches embedded in the communication software, "so people with diabetes will have more choices," Kowalski says, noting that JDRF is "celebrating Medtronic because it's the first commercial system, but we're supporting the entire field."

Of course, the field still faces challenges. One of the major technological problems is that insulin deposited just under the skin takes too long to begin working; that's why people still need to signal ahead that they're about to eat. The JDRF is currently funding several initiatives working on making faster-acting insulins.

"The faster the insulin works, the more closed the loop will be," Kowalski notes. "It's not easy, but there's a lot of work going on."

Wearability is another issue. Some people simply don't want to be strapped to devices, even if it means better diabetes control. So, the JDRF has recently announced new funding for miniaturization of the devices.

And of course, there's the problem of access. While insurance coverage for insulin pumps is widely established, this is not the case for the CGM component. Medicare doesn't cover CGM technology, meaning that people now must give up those devices or pay out of pocket when they reach age 65. The JDRF is one of several organizations lobbying to change that, as well as to make sure that all payers recognize both the health and economic advantages of new diabetes technologies.

"This is a priority for us," Kowalski says. "We need to make sure people have access. Not just rich people, but anybody who will benefit."

For now, the 670G, which the FDA gave the nod on Wednesday, is approved only for people ages 14 years and older. Medtronic is studying it in children ages 7 to 13 with the aim of making it available for them, too.

Copyright 2016 NPR. To see more, visit NPR.
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Are Golden Tickets That Speed Drugs Through FDA Worthwhile?

Thu, 09/29/2016 - 2:16pm

Sarepta Therapeutics was awarded a voucher for a fast-track drug review by the Food and Drug Administration when the company's medicine for Duchenne muscular dystropy was approved Sept. 19. Now Sarepta is looking to sell the voucher to the highest bidder.

Mick Wiggins/Ikon Images/Getty Images

Drugmaker Sarepta Therapeutics won a big victory when its $300,000 muscular dystrophy drug was approved Sept. 19, despite questions about its effectiveness.

But the company had other reasons to celebrate. It was also awarded the pharmaceutical industry's version of a Willy Wonka golden ticket.

The ticket, known as a priority review voucher, was created by Congress in 2007 to encourage the development of drugs for neglected tropical diseases and was expanded in 2012 to rare pediatric disorders. A company that gets a qualifying drug approved can be awarded a voucher that can be redeemed for a fast-track government review of one of its future drugs. Or the voucher holder can sell the golden ticket to the highest bidder.

A voucher can help a drug company leapfrog a rival.

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"The only people who would buy a priority review voucher would be someone who had something that wouldn't merit its own priority review but they want the priority review," says Dr. Tim Coté, a former FDA official who now runs a consulting firm for rare disease drugs.

A voucher guarantees a company that its drug will be reviewed within six months, as compared with the standard 10. But approval isn't assured, just a speedier decision.

The sale of a voucher can earn a lot of money for a small company like Sarepta. Last year, a voucher sold for a record $350 million when AbbVie Inc. bought one from United Therapeutics. AbbVie hasn't disclosed its plans for the voucher.

Members of Congress, the pharmaceutical industry and rare-disease advocates have passionately supported vouchers as a way to spur development of drugs for rare and neglected diseases. But skeptics, including FDA officials and some academics, have questioned whether the program is paying off.

Nancy Goodman, executive director of Kids v Cancer, is a champion of vouchers. She created her foundation after her son died seven years ago of medulloblastoma, a type of brain cancer that often affects children.

There were no drugs available for her 10-year-old son, she said. "I believe and hope we will see a whole crop of pediatric disease drugs because of the program," Goodman said.

Legislation extending the pediatric voucher program through early December passed the House and Senate by unanimous consent and awaits action by President Obama, who is expected to sign it. The program was set to expire Oct. 1.

Advocates are fighting to keep the program authorized until Dec. 21, 2018, as part of the 21st Century Cures Act, which has passed the House and has stalled in the Senate, where backers hope it will be taken up after the elections.

But officials at the FDA, which must implement the vouchers, are at odds with industry and advocates.

Dr. John Jenkins, director of the office of new drugs in the Center for Drug Evaluation and Research at the FDA, has said he supports the overall goal of providing incentives to promote drug development but that the voucher program is wrong.

In December, Jenkins told the industry publication Pharmaceutical Executive that vouchers raise safety concerns because the program requires the FDA to give any drug accelerated review – even when reviewers have to address complex issues. "We're not making pizza here," he said.

Jenkins declined interview requests for this story. FDA spokeswoman Sandy Walsh said, the "FDA has not seen evidence that the program is effective."

Walsh also said the agency is concerned that the voucher program "adversely affects the agency's ability to set its public health priorities" and "the additional workload from the program strains the agency's resources."

The voucher program does require companies to pay an additional user fee of nearly $3 million on top of the standard fee to review a drug, in order to help the agency pay for the program.

Shots - Health News Price Rises For Ticket To A Quicker Drug Review By FDA

But the additional money may not be sufficient.

In March, a Government Accountability Office report on pediatric vouchers said FDA officials complain there is too little time to use the money to hire and train additional employees to do accelerated reviews and that the one-time fee does not enable hiring of long-term staff.

The GAO's report said it was too early to say whether the program is stimulating development of drugs for rare childhood disease. Of the seven pediatric review vouchers that have been awarded, four have been sold to other drug companies.

Drugmaker Sanofi has redeemed two pediatric vouchers. For the first, it paid $67.5 million to BioMarin, developer of a treatment for Morquio A syndrome, a rare, inherited disorder, and used it to expedite review of the cholesterol drug Praluent. Later, Sanofi spent $245 million for a pediatric voucher from Asklepion Pharmaceuticals, maker of treatment for a rare childhood metabolic disease. Sanofi said in February it would be used to speed up the FDA's decision on a Type 2 diabetes treatment.

Vouchers don't expire. If a voucher isn't used, it can be sold an unlimited number of times.

Sarepta plans to sell its voucher. Chief Financial Officer Sandy Mahatme told Wall Street analysts the company has already reached out to "a bunch of potential buyers." He said the proceeds would help finance other drugs in its pipeline, pay to scale up its manufacturing capacity and support the company's entry into European markets.

Kaiser Health News is an editorially independent news service supported by the nonpartisan Kaiser Family Foundation. Follow Sarah Jane Tribble on Twitter: @sjtribble.

Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
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CDC Urges Americans To Get A Flu Shot As Soon As Possible

Thu, 09/29/2016 - 1:23pm

Luz Barajas took her son Carlos Cholico to get his flu shot at Crawford Kids Clinic in Aurora, Colo., last year. Health officials say there is some evidence the flu shot is more protective than the nasal flu vaccine.

Brent Lewis/The Denver Post via Getty Images

Federal health officials are urging all Americans to get their flu shots as soon as possible, and are especially concerned that too few elderly people are getting vaccinated.

"Flu is serious. Flu is unpredictable," Dr. Thomas Frieden, the director of the Centers for Disease Control and Prevention, told reporters during a joint briefing Thursday with the National Foundation for Infectious Diseases. "Flu often does not get enough respect."

While the influenza virus causes relatively mild illness in most people, the disease can lead to tens of thousands of deaths during severe flu seasons, Frieden noted. About 100 children die each year from the flu.

The CDC and other infectious disease specialists are concerned by a recent drop in seasonal flu vaccination. About 45 percent of the U.S. population got vaccinated against the virus last year, which was down 1.5 percentage points from the previous year.

The largest decrease was among people ages 50 and older. There was a 3.4 percentage-point drop among people ages 50 to 64, and a 3.3 percentage-point drop among those ages 65 and older. The elderly are among those most vulnerable to life-threatening complications of the flu.

As many as 168 million doses of flu vaccine should be available this year, and more than 93 million have already been distributed, according to the CDC.

"There's plenty for everybody," Frieden said.

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Although some questions have been raised about whether getting the flu vaccine too soon may diminish its effectiveness, federal officials recommended against anyone waiting. Similarly, some research recently questioned whether protection from the vaccine may wane more quickly among people who get vaccinated every year. But the CDC and other infectious disease specialists still advocate annual vaccination.

The nasal spray vaccine, which many parents have preferred for their children, is not being recommended this year because recent research has questioned its effectiveness. Researchers are still trying to confirm if and why the nasal version might be less effective than the shot.

But two new flu vaccines are available this year. One protects against four strains of flu instead of just three. The other contains a substance known as an "adjuvant," which boosts the vaccine's effectiveness.

Health officials recommend that most people simply get whichever version of flu shot is most readily available to them rather than wait for a specific version.

Copyright 2016 NPR. To see more, visit NPR.
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Rats That Reminisce May Lead To Better Tests For Alzheimer's Drugs

Thu, 09/29/2016 - 12:04pm
Rats That Reminisce May Lead To Better Tests For Alzheimer's Drugs Listen · 1:55 1:55 Toggle more options
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September 29, 201612:04 PM ET Heard on All Things Considered

Rats are great at remembering where they last sniffed the strawberries.

Alexey Krasaven/Flickr

What rats can remember may help people who forget.

Researchers are reporting evidence that rats possess "episodic memories," the kind of memories that allow us to go back in time and recall specific events. These memories are among the first to disappear in people who develop Alzheimer's disease.

The finding, which appears Thursday in Current Biology, suggests that rats could offer a better way to test potential drugs for Alzheimer's. Right now, most of these drugs are tested in mice.

"We need to have a way to study the exact type of memory that we think is impaired in Alzheimer's disease," says Bruce Lamb, a professor of medical and molecular genetics at Indiana University in Indianapolis. He was not involved in the study.

Shots - Health News Genetically Modified Rat Is Promising Model For Alzheimer's

The lack of an adequate animal model of Alzheimer's disease may be one reason drugs that seemed to work in mice have failed when given to people, Lamb says.

Loss of episodic memories, especially recent ones, is a key sign of Alzheimer's, says Jonathon Crystal, an author of the study and director of the neuroscience program at Indiana University in Bloomington.

"So if you visit your grandmother who has Alzheimer's, [she] isn't going to remember that you were visiting a couple of weeks ago and what you described about things that are going on in your life," he says.

Crystal and a team of researchers thought rats might have some form of episodic memory. So they began doing studies that relied on the animals' remarkable ability to recognize a wide range of odors, like basil and banana and strawberry.

The latest study, led by graduate student Danielle Panoz-Brown, tested the animals' ability to remember whether they had detected a particular combination of odors, and, if so, where that event had occurred.

"And what we find is that the rats are really adept at this," Crystal says. The animals remembered more than 30 odor events, a finding that suggests their brains can handle a large number of episodic memories.

So far, mice have been used for most animal research on Alzheimer's. That's because they are cheaper and because of the wide availability of lab mice that have been genetically altered to develop brain diseases similar to Alzheimer's.

But there's evidence that rat brains have more in common with human brains. And researchers are developing rat models of Alzheimer's that seem to do a better job mimicking the human disease.

So it may be time to give rats another look, says Lamb, who is co-leading a $25 million, government-funded effort to develop better animal models of Alzheimer's.

"We're going to initially focus on mice," he says, because they are so widely used by researchers. "But we hope to expand this to rats."

Copyright 2016 NPR. To see more, visit NPR.
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Flawed Research Tool Leads To Faulty Medical Findings

Thu, 09/29/2016 - 5:00am

A multi-million dollar effort to produce a test to guide treatment for a potentially lethal skin cancer recently fell apart after the scientific investigator discovered that the commercial antibodies he was using were unreliable.

Cultura RM Exclusive/Peter Mulle/Getty Images

Researchers trying to understand diseases and find new ways to treat them are running into a serious problem in their labs: One of the most commonly used tools often produces spurious results. More than 100 influential scientists met in California this week and agreed on a strategy to address the troubling issue.

The tool in this case is a process — the use of custom-built antibodies. Like the antibodies in your body that help fight off disease, these customized research antibodies are also designed to home in on a specific target, this time to help scientists decipher the invisible workings of a cell.

Dozens of companies around the world produce more than 2.5 million varieties of these antibodies. It's a billion-dollar industry.

The antibodies may be genetically engineered, or they may be produced by injecting a substance into an animal, and then filtering and purifying (from the animal's blood) antibodies produced in reaction to that injected substance.

Unfortunately, these commercial antibodies often don't work as advertised. One common and serious problem is that they latch onto the wrong target — fooling the researchers who are putting them to use.

In one iconic case, a multi-million dollar effort to produce a test to guide treatment for melanoma fell apart, after the researcher conducting the cancer study discovered that his antibodies were utterly unreliable.

Scientists are becoming increasingly aware of this problem and increasingly concerned. A surprisingly large share of research conducted in one lab can't be reproduced elsewhere, and "antibodies are a very large contributor to the problem," says biochemist and biophysicist Dr. Joshua LaBaer, who heads the Biodesign Institute at Arizona State University.

LaBaer was among the scientists gathered in Asilomar, Calif., this week to talk about ways to make the antibodies more reliable, and the research more rigorous.

Last year, some researchers concerned about iffy antibodies came up with a set of guidelines for how companies can validate their antibodies to make sure they perform as advertised.

These ideas were "very much supported at the conference," says microbiologist Mathias Uhlen from the Royal Institute of Technology in Stockholm, who chaired last year's international working group and also helped organize the conference in California.

Scientists from academia, industry and government agreed at the conference that what's needed is a specific set of standards that antibody production companies should all use to test their products. Those ratings would allow customers to make head-to-head comparisons between competing products before buying antibodies.

Though complying with such standards would be voluntary, Uhlen argues that they would encourage companies to produce higher grade products and to compete on quality. It's an open secret in this field that many smaller companies in this billion-dollar industry produce cheaper but inferior products.

This is not a quick fix. Tests to validate antibodies are time-consuming and expensive, and sorting through the more than 2 million antibodies on the market today would be a Herculean task.

The National Institutes of Health, which provides $30 billion a year to support biomedical research, is reluctant to insist that scientists use only validated antibodies.

"NIH clearly views themselves as a funder, not a regulator," says Leonard Freedman, a molecular geneticist who runs a nonprofit called the Global Biological Standards Institute, which organized the Asilomar meeting.

Part of the problem also lies with poor training of young scientists working in university research labs, Freedman says. GBSI surveyed scientists about their use of antibodies in preparation for the meeting and discovered that 31 percent of young scientists didn't even think it was necessary to validate the antibodies they rely on in their labs, even though bad antibodies could completely invalidate their findings.

"It was pretty shocking," Freedman says.

Email Richard Harris at

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

Congress Ends Spat, Agrees To Fund $1.1 Billion To Combat Zika

Wed, 09/28/2016 - 3:56pm

A health department microbiologist looks for mosquitoes carrying Zika virus in Hutchins, Texas.

LM Otero/AP

After nearly seven months of bickering and finger-pointing, Congress on Wednesday agreed to allocate $1.1 billion to help fight the spread and effects of the Zika virus.

The deal is part of a broader agreement to continue to fund the government after the fiscal year ends on Friday and the current budget expires.

It brings to an end a partisan fight that has had the unusual effect of delaying funding to deal with what all sides agree is a public health emergency. The delay came out because of disagreement over side issues like funding for Planned Parenthood and whether the money should be considered "emergency" spending.

Wednesday's deal drops language barring the money from going to Planned Parenthood clinics. The Senate passed the measure Wednesday afternoon; the House passed it Wednesday night.

"Women's health should never be treated like a political football," said Sen. Patty Murray, D-Washington, who is the ranking member of the Senate's Health Education Labor and Pensions Committee. "I am glad that Republicans finally agreed to set aside the extreme provisions that would have specifically blocked Planned Parenthood health care providers from accessing critical funding."

More than 23,000 people in the mainland U.S. and Puerto Rico have contracted the Zika virus, according to the Centers for Disease Control and Prevention. That includes more than 2,000 pregnant women, which is especially troubling because the virus can cause birth defects.

The CDC estimates that 20 babies in the mainland U.S. and 1 baby in Puerto Rica have been born with birth defects related to Zika.

The Zika virus can cause microcephaly — a condition where a baby's head and brain are undersized and underdeveloped — in as many as 13 percent of babies born to women who get infected while pregnant. It is also linked to several other types of birth defects, and to Guillain-Barre syndrome in adults.

The deal reached in Congress includes $394 million to help control Zika-carrying mosquitoes and another $397 million to help develop a vaccine against the virus and better tests to help diagnose cases of Zika.

There is also $66 million allocated to health care for people affected by Zika in Puerto Rico and other U.S. territories.

President Obama asked for $1.9 billion in emergency federal funding back in February to fight Zika. The administration has been using money shifted from other accounts, including money that had been specified for studying and fighting Ebola, and for state-level emergency preparedness, to address the Zika threat.

Earlier this month Dr. Tom Frieden, director of the Centers for Disease Control and Prevention, warned that his agency would run out of funds to fight Zika by Friday. Health and Human Services Secretary Sylvia Burwell issued a similar warning in August.

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

A Look At How The Revolving Door Spins From FDA To Industry

Wed, 09/28/2016 - 10:48am

A job reviewing drug applications at the Food and Drug Administration can be the springboard for a career in industry.

Andrew Harnik/AP

More than a quarter of the Food and Drug Administration employees who approved cancer and hematology drugs from 2001 through 2010 left the agency and now work or consult for pharmaceutical companies, according to research published by a prominent medical journal Tuesday.

Dr. Vinay Prasad, a hematologist-oncologist and assistant professor at Oregon Health and Science University, sought to understand the so-called "revolving door" between the FDA and the pharmaceutical industry, which he said is often discussed but hadn't been quantified.

"We all know about these anecdotal cases" of a person who was "often a major player at the FDA, someone in an important role — and then they leave the FDA and go and work for industry," Prasad said, but he couldn't find anyone who knew whether this happened "5 percent or 60 percent" of the time.

Prasad and his colleague Dr. Jeffrey Bien, an internal medicine resident also at OHSU, tracked 55 FDA reviewers in the hematology-oncology field from 2001 through 2010, using LinkedIn, PubMed and other publicly available job data. The researchers found that of the 26 reviewers who left the FDA during this period, 15 of them, or 57 percent, later worked or consulted for the biopharmaceutical industry. Put another way, about 27 percent of the total number of reviewers left their federal oversight posts to work for the industry they previously regulated.

Prasad and Bien published their findings as a research letter in The BMJ, formerly The British Medical Journal.

Going to work for industry after leaving the FDA isn't inherently bad, but it does raise some questions.

"If you know in the back of your mind that your career goal may be to someday work on the other side of the table, I wonder whether that changes the way you regulate," Prasad said. "Are you more likely to give [companies] the benefit of the doubt? Are you less likely to beat them up hard over [using bad comparisons in drug studies]?"

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Prasad focused his research on his own field — hematology-oncology — because it spawns a large number of new drugs and reviewers have a lot of autonomy, he said.

"There's a lot of room for interpretation in deciding whether or not a cancer drug should be approved," he said, because so many studies of cancer drugs rely on what's called a "surrogate endpoint," meaning that something other than survival or quality of life was measured to determine whether a drug worked. For example, shrinking a tumor may be a stand-in for survival. But according to one of Prasad's previous studies, there isn't always evidence that surrogate endpoints are linked to better health outcomes for patients, suggesting that some approved drugs aren't as beneficial as they appear.

"Sometimes, the public needs [the FDA reviewers] to be firm. If they're not, no one else in the health care sector is going to be," Prasad said, adding that once the agency approves a drug, the Centers for Medicare & Medicaid Services has to cover it and can't negotiate prices under current laws. "The FDA is often the only real wall between ineffective, harmful drugs and patients."

He and Brien tracked reviewers instead of higher ranking officials because reviewers provided a larger sample size, Prasad said. They would have liked to include reviewers named on denials as well, but the denial documents are secret, making it impossible to identify the reviewers.

Although Prasad said FDA reviewers have a lot of power over approvals, Dr. Joshua Sharfstein, the FDA's principal deputy commissioner until 2011, disagreed.

"There are just so many checks and balances within the review process that it's really not up to one person by and large," said Sharfstein, now an associate dean at the Johns Hopkins Bloomberg School of Public Health in Baltimore. "Key regulatory decisions are looked at from many different angles. I think it would be very difficult for an individual to do something inappropriate and not have that caught."

Sharfstein said he has met with companies to offer advice, but wasn't compensated for it.

The revolving door is a fair topic to study, he said, but having former FDA officials on the pharmaceutical industry payroll can have a public health benefit. Former FDA employees with deep knowledge of the approval process can help make it go smoother by ensuring all the relevant research is complete and that the latest pathways to approval are understood.

FDA spokesman Jason Young said employees leave the government to work for industry at various agencies, not just the FDA.

"The FDA has a strong set of rules in place to ensure that our employees are working in the public interest, not to advantage any company, organization or individual," he said, adding that these include protecting confidential information they learned at the FDA and a cooling-off requirement for senior officials before they can work for industry.

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Follow Sydney Lupkin on Twitter:@slupkin.

Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
Categories: NPR Blogs

These Women Discovered It Wasn't Just Fat: It Was Lipedema

Wed, 09/28/2016 - 5:00am

Marlene Simpson of Sacramento, Calif., wears compression bandages daily to help reduce the swelling in her legs. She is getting fitted for compression bandages for her arms to prevent swelling there.

Lesley McClurg/KQED

Judy Maggiore remembers looking in the mirror in college, perplexed by her body's disproportion.

"I was skinny. I was a stick. The upper part of my body was really, really thin. You could see my ribs!" exclaims Maggiore. "But from the waist down, it was like there were two of me or something."

Tree-trunk-like legs and a slim upper body are the signature characteristic of a lipedema patient. You can starve yourself and exercise for hours a day and the fat will not regress. But Maggiore didn't know that at the time. She swore off bathing suits and hit the gym fanatically.

Even though she was mystified by her body, she didn't consider going to the doctor. "Clearly, there was something wrong with me. I wasn't eating the right things. I wasn't exercising correctly."

She tried every diet imaginable, from Atkins to Weight Watchers to Jenny Craig. Nothing worked.

Judy Maggiore eats a salad every day for lunch in the hope of preventing more fat deposits.

Lesley McClurg/KQED

Finally, last year — when she was 68 years old — a lymphatic specialist shocked her with a diagnosis of lipedema.

"I was like, 'Whoa!' " exclaims Maggiore. "I've never heard that before. They have a name for it and it's not my fault!"

Lipedema is a lymphatic disease that is thought to affect 10 million to 17 million people in America, mostly women. Exact patient estimates are not available because it's hard to diagnose. In fact, many lipedema patients don't even know they have it. Neither do their physicians, who often assume their patients are obese. Plus, doctors often confuse lipedema with lymphedema — a prevalent lymphatic disease that presents similar symptoms. Maggiore says every doctor she saw throughout her life told her she needed to lose weight.

There isn't a standard exam like a blood or urine test for lipedema. Instead, doctors use physical clues, like the unusual texture of the skin. It starts to feel like sand, then pebbles, and then small stones. The fat cells keep enlarging and increasing.

"It's like being wrapped in bubble wrap," says Maggiore.

The causes are mysterious too, although early studies suggest lipedema is a genetic condition in women. It seems the disease is hormonally triggered, as the onset is usually around puberty, and symptoms worsen during childbirth and menopause.

"We just have the earliest clues about where to look and what to think about," says Dr. Stanley Rockson, a professor and researcher at Stanford University.

Usually fat cells expand when you overeat, and then shrink when you diet — but something goes awry in lipedema patients. Rockson uses the metaphor of a bank to illustrate how cells in lipedema patients work.

"They're a very unusual bank, because they accept deposits but no withdrawals," says Rockson. "So once they accumulate material, it never comes out again."

Rockson is one of only a handful of lipedema specialists in the world trying to understand the disease's pathology. In a current study, he is analyzing tissue samples from the legs and abdomen to better understand why subcutaneous fat accumulates primarily in the lower body. He is also testing anti-inflammatory drugs that have worked on other lymphatic diseases to reduce pain.

And he is one of the founders of an international registry collecting the medical records of patients who suffer from lymphatic diseases. He hopes the research will eventually lead to treatments for the disease. As of now, doctors have few options for patients.

The only long-term treatment is liposuction, and Maggiore is terrified of surgery. But some women felt like it was their only choice.

When Marlene Simpson's scale topped 300 pounds, she was desperate for thinner legs. She wasn't sleeping, which led to exhaustion and made functioning at work nearly impossible.

She tried complete decongestive therapy, compression stockings, wraps, night garments, manual lymph drainage therapy (by a therapist and self), weight-loss diets, swimming, walking, deep breathing exercises and daily use of a compression pump before she chose to undergo liposuction.

But her initial appointment with a plastic surgeon was devastating. The physician denied her self-diagnosis. "He told me that I shouldn't believe what I see on the Internet," says Simpson.

Marlene Simpson's legs before surgery (left) and one month after.

Courtesy of Marlene Simpson

But she didn't give up. More Internet research led her to Dr. David Amron, a dermatologic surgeon in Beverly Hills who specializes in lipedema. She booked a flight from her home in Sacramento, Calif., as soon as she could. After two surgeries, Simpson's legs were 24 pounds lighter.

When she returned home, she felt like a new person.

"It wasn't until I had surgery that I just realized that I was in a lot of pain," says Simpson.

Simpson's pain was caused by all the extra weight pressing on her nerves and lymph vessels. Over time, lipedema can be debilitating because blood clots, skin ulcers and recurrent infections can develop.

But the relief set Simpson back $21,000 because her insurance denied the procedure. The company claims that liposuction is a cosmetic procedure, and it is not a recognized treatment for lipedema.

Amron says liposuction does work. If patients continue to diet and exercise, he swears the fat should not come back.

Ninety percent of Amron's clientele have lipedema. They come to him for liposuction.

"They found their way to me about 10 years ago when I started doing lipedema patients, and I'd never even heard of the condition," says Amron.

In fact, most doctors haven't heard of lipedema. A 2004 Stanford University study showed that most U.S. medical schools spend less than 30 minutes teaching the entire lymphatic system.

"So, not surprisingly, doctors don't know a lot about these diseases or the underlying conditions," says Rockson. "If you poll 100 physicians off the street, you might find one that knows the term lipedema, and that one might not have much to say about it other than a recognition of the name."

One of his patients, Maggiore, hopes to someday benefit from his research. In the meantime, her daily lunch is a bowl filled with vegetables, and even though she usually skips dinner, the fat on her legs continues to thicken, causing chronic pain. She savors each bite slowly, in hopes of keeping fat cells at bay.

Copyright 2016 KQED Public Media. To see more, visit KQED Public Media.
Categories: NPR Blogs

Would California's Proposed Tobacco Tax Hike Reduce Smoking?

Tue, 09/27/2016 - 3:13pm
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Backers of California's Proposition 56 hope to hit people hard enough in the wallet that they quit smoking.

Paul Sancya/AP

Each time New York state increased its tobacco tax — now at $4.35 per pack of cigarettes — calls to the state's Quitline spiked.

In New York City, then-Mayor Michael Bloomberg hiked the tax even more.

"I was so angry with him, I could hardly afford it," says Elizabeth Lane, a Harlem resident who paid $12 a pack. "I had to beg, borrow and steal to get money to buy cigarettes."

At first, Lane cut down to four packs a week from seven. But even so, she sometimes didn't have money to buy laundry detergent or toilet paper. Then in 2013, after smoking for 40 years, the price tag, her doctor's warnings and her daughter's guilt trips all came together.

She quit.

"I said, 'Lord, I've been waiting a long time for this. When will you answer my prayer?' " she says. "And he answered this time."

Four states will vote on whether to raise their tobacco tax in November: California (by $2), Colorado ($1.75), North Dakota ($1.76) and Missouri (15 cents). California currently has one of the lowest cigarette taxes in the country: 87 cents per pack. If voters pass Proposition 56 in November, the tax would go up to $2.87 a pack. Backers of the measure, including the American Cancer Society and the American Lung Association, hope to hit people hard enough in the wallet that they quit smoking, or never start.

Studies support the goal. For every 10 percent increase in the price of cigarettes, smoking goes down 4 percent, according to a 2014 report on smoking by the U.S. surgeon general.

"Part of that is people quitting. Part of that is people cutting down," says Stanton Glantz, a professor of medicine at University of California, San Francisco and director of the Center for Tobacco Control Research and Education.

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In New York City, smoking rates declined from 22 percent of adults to 13 percent in the 12 years after the tax, and a ban on smoking in restaurants and bars, was implemented.

California's smoking rate is about 12 percent, the second lowest in the country after Utah. Most people in California who do smoke, Glantz says, don't smoke that much.

"It may be that a price increase that will follow Prop. 56 will be enough to just get these light, intermittent smokers to just say, 'Forget it,' " he says.

Behavioral economist Justin White, a colleague of Glantz's, says the vast majority of smokers wish they could quit. They know it's bad for them. But addiction is a powerful force.

"There's this universal tendency toward immediate gratification," White says.

The craving for a cigarette right now easily overwhelms fears of heart disease or lung cancer in the future. But, White says, a cigarette tax that is high enough can flip that. A tax evident at the time of purchase has the power to compete with the desire for a cigarette.

"Increasing taxes is a way to really bring that back to equilibrium, the cost in the future versus the benefits now," White says.

The question is, how much. He says a $1 or $2 tax is enough to sway smokers with a mild self-control problem. But for smokers with a strong addiction, the tax needs to be between $5 and $10 to work.

Either way, White says, a tax is most effective when paired with support from a cessation program.

And this is where opponents have been digging into Proposition 56. The "No on 56" campaign, backed by tobacco companies R.J. Reynolds and Philip Morris, has raised $56 million to defeat the measure. Supporters have raised $17.5 million.

Opponents are investing in radio ads that say proponents "are telling us Proposition 56 is all about helping people stop smoking. But follow the money, and you'll find out that only 13 percent of the new taxes would actually help people quit."

This is true. Of the $1.4 billion that Proposition 56 is expected to raise from the tax, 13 percent would go to the state's cessation programs. The rest of the tax money would go to Medi-Cal, the state's low-income health care program, which covers care for one in three Californians.

But UCSF professor Glantz says that $100 million for smoking-cessation programs is enough money to fully serve all would-be quitters who need help.

Opponents ultimately reject the tax, no matter how the revenues would be spent.

"I'm opposed to every manner of taxing," says Steven Greenhut, Western Region director for the R Street Institute, a free market think tank that promotes limited government. "Let people make their own choices."

He doesn't like that Proposition 56 would tax e-cigarettes, too.

"Vaping is not entirely safe," he says. "But it's pretty clear that vaping is far less harmful than smoking."

Early studies suggest that e-cigarettes may have fewer health effects than cigarettes. Still, in a proposal to regulate e-cigarettes that became effective in August, the Food and Drug Administration said that some studies have found toxic material in e-cigarette liquid and the exhaled vapor. But, the agency said, "we do not have sufficient data to determine what effects e-cigarettes have on public health at the population level."

In any event, Greenhut says it's premature to tax e-cigarettes.

For Elizabeth Lane in New York, the nicotine patch was her ticket to quitting. Now, she no longer huffs and puffs when she walks.

"I can walk up stairs. I don't cough," she says. "And the circulation in my legs has improved."

She says now she saves the money that she used to spend on cigarettes so she can buy birthday and Christmas presents for her daughter and granddaughter.

"Instead of being on the receiving end all the time, you know, give me, give me, give me," she says, "I can give now."

This story is part of a reporting partnership with NPR, KQED, WNYC and Kaiser Health News. WNYC's Fred Mogul contributed to this report.

Copyright 2016 KQED Public Media. To see more, visit KQED Public Media.
Categories: NPR Blogs

Expansion Proposed For Women's Health Services Without A Copay

Tue, 09/27/2016 - 5:00am

The range of preventive health services covered without a copay could be extended to include condoms and vasectomies.

Media for Medical/UIG via Getty Images

The list of preventive services that women can receive without paying anything out of pocket under the health law could grow if recommendations from a group of mostly medical providers are adopted by federal officials later this year.

The draft recommendations, which are open for public comment until Sept. 30, update the eight recommended preventive services for women. The list was developed by the Institute of Medicine (now called the National Academies of Sciences, Engineering, and Medicine) to build on existing recommendations and fill in gaps that weren't addressed in the health law. Under the IOM list, which took effect in 2012, most health plans are required to cover well-woman visits, screening and/or counseling for sexually transmitted infections, domestic violence and gestational diabetes as well as breastfeeding support and supplies.

In addition, most health plans must cover, without cost sharing, all methods of contraception that have been approved by the Food and Drug Administration. That controversial requirement led to numerous lawsuits by religious institutions and employers that object to providing such coverage, including several cases that reached the Supreme Court.

When it developed the initial list, the IOM advised that the guidelines be reviewed and updated at least every five years in order to stay current with scientific evidence. This year, the review panel also weighed in on breast cancer screening, coverage of follow-up testing or procedures as part of the preventive services and male methods of birth control.

The proposed new recommendation would allow women at average risk for breast cancer to begin screening as early as age 40 and receive a mammogram every one or two years. That is a more liberal standard than the guidelines that insurers rely on for free screening from the U.S. Preventive Services Task Force, which recommends women generally be screened every other year starting at age 50.

"We have really confused the heck out of women," said Dr. Hal Lawrence, executive vice president and chief executive officer of the American Congress of Obstetricians and Gynecologists. "Do I start at age 40, do I start at 50, do I do it every year or do I do it every other year? We wanted to get some uniformity."

ACOG was awarded a five-year grant to manage the review process, working in conjunction with a steering committee of nearly two dozen provider groups from different women's health disciplines.

In addition to the breast cancer screening itself, the ACOG working group proposes that if imaging tests, biopsies or other interventions are required to evaluate the mammogram findings that those be considered an integral part of the screening, which would mean they would be provided without charge to women.

Such follow-up care emerged as a theme from the panel: If additional testing or procedures are necessary following a preventive service, it should be covered as part of the service. The recommendations also clarify that some of the preventive services may require more than one visit and provide other specifics on coverage requirements.

"It's critically important for plans and people to recognize that the well-woman visit [required under the current guidelines] could happen in multiple places and require multiple visits," said Mara Gandal-Powers, senior counsel at the National Women's Law Center, which participated in the ACOG working group. "If you're a woman who needs a Pap test and a colonoscopy, you're probably not getting them from the same providers and you're hopefully not getting them at the same time."

The recommendations' specificity is important: The original IOM guidelines left implementation details vague, leading to scuffles between patient advocates and insurers over precisely what was covered, and that ambiguity required ongoing guidance from the federal government. For example, if a plan covers oral contraceptives without cost sharing, could it charge for other hormonal methods such as the contraceptive patch? Answer: No.

"It's helpful to get the real-world piece," said Dania Palanker, assistant research professor at Georgetown University's Center on Health Insurance Reforms. "For insurers, what do we mean when we say you have to cover a service?"

A spokesperson for America's Health Insurance Plans said that the trade group will likely submit comments on the proposed recommendations and declined to comment before then.

The working group recommended expanding the scope of what's covered without cost sharing in some important ways. The contraceptive coverage requirement, for example, would cover over-the-counter methods of birth control without a prescription and allow women to receive a full-year supply of contraceptives all at once, which has been shown to improve adherence.

The ACOG group also proposes covering contraception methods used by men, including condoms and vasectomy.

"The best contraceptive method for a woman at a particular time may be her partner," said Adam Sonfield, a senior policy manager at the Guttmacher Institute, a reproductive health research and policy organization.

The working group will submit its final recommendations to the Health Resources and Services Administration, part of the Department of Health and Human Services, by Dec. 1, and HRSA will make the final decision on adoption of the recommendations. If adopted before the end of the year, they would go into effect for most plans at the beginning of 2018.

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Michelle Andrews is on Twitter: @mandrews110.

Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
Categories: NPR Blogs

Walking Fends Off Loss Of Mobility, And It's Not Too Late To Start

Mon, 09/26/2016 - 5:18pm
Zing Images/Getty Images

People who have reached their later years may think it's primarily a time to relax, not to increase their physical activity. Not so. Previous research has suggested that exercise can improve memory and reverse muscle loss in older adults, among other benefits. And a study out Monday finds that a regular program of physical activity reduces the time spent with mobility-limiting disability.

Researchers took more than 1,600 sedentary people between 70 and 89 years old who had some functional limitations, but who could walk about a quarter of a mile in 15 minutes or less, unassisted by another person or a walker. (Canes were OK.)

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Half of the participants got a health education program involving regular in-person sessions and some stretching exercises, while the other group was told to aim for 150 minutes of aerobic activity as well as strength, flexibility and balance training both at the study's facilities and at home. "Walking was the cornerstone of the program," says Thomas Gill, a professor of geriatrics at the Yale School of Medicine and an author of the study, which appears in Annals of Internal Medicine.

The study followed participants for about 2.7 years, and found that the physical activity program cut the amount of time that people spent with a "major mobility disability" — defined as being unable to walk a quarter mile — by 25 percent compared to the education program. Previous findings from the same study showed that the exercise program lowered the risk of becoming disabled in the first place; this one showed that it sped recovery from an episode of disability and lowered the risk of subsequent episodes.

"They've done a really nice job of showing the incredible power of physical activity," says Bradley Cardinal, a professor of kinesiology at Oregon State University who wasn't involved with the study. "It's the secret ingredient to successful aging in terms of quality of life." An editorial accompanying the study, by the University of California, San Francisco's Patricia Katz and the University of South Carolina's Russell Pate, also noted that people who engage in physical activity have a lower risk for heart disease, diabetes, certain cancers, depression, cognitive impairment and functional decline.

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The exercise program pretty closely followed the government's recommendations for all adults, including older ones: 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity exercise per week, plus two strength sessions that hit all the major muscle groups.

But most Americans don't get that much exercise, and that becomes increasingly true as people age. According to statistics from the Centers for Disease Control and Prevention, just 28 percent of those 75 and up meet the recommendation for aerobic activity, and only 8 percent also did the suggested amount of strength training.

Cardinal says older adults need to realize that exercise can greatly improve their quality of life by maximizing function as long as possible. But he says that many believe that older age is for relaxing and that physical activity is somehow dangerous or unnatural. That belief "is pervasive among older adults," he says, even though for many of them, meeting the minimum requirements "is doable."

Semantics can help. "We try to frame this as more physical activity than exercise," says Gill. "We talk with older folks and many say, 'I can't exercise, but maybe I can become more physically active.' " Study participants were advised to "start low and go slow," and some were even able to get rid of their canes after six months of exercise, which Gill says they found particularly rewarding.

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Physicians can also help. "Prescribing exercise may be just as important as prescribing medications — perhaps even more important in some cases," the editorial said. The authors called on medical schools to "start preparing students to prescribe exercise as effectively as they prescribe statins, and for health systems to support physicians in addressing inactivity just as they provide support in addressing other health risks." (The American College of Sports Medicine has an "Exercise is Medicine" initiative to help physicians integrate exercise recommendations into their treatment plans.)

There are also some basic behavioral strategies for getting yourself to get moving, no matter your age, including giving yourself an incentive to change and engineering your environment to encourage the activity.

Katherine Hobson is a freelance health and science writer based in Brooklyn, N.Y. She's on Twitter: @katherinehobson

Copyright 2016 NPR. To see more, visit NPR.
Categories: NPR Blogs

Medications Can Help People Stop Abusing Alcohol, But Many Don't Know That

Mon, 09/26/2016 - 2:54pm

Public health officials want doctors to consider treating alcohol abuse with medications that have a track record of success.

Hero Images/Getty Images

Two often-overlooked medications might help millions of Americans who abuse alcohol to quit drinking or cut back.

Public health officials, building on a push to treat people who abuse opioids with medications, want physicians to consider using medications to treat alcohol addiction. The drugs can be used in addition to or sometimes in place of peer-support programs, they say.

"We want people to understand we think AA is wonderful, but there are other options," says George Koob, director of the National Institute of Alcohol Abuse and Alcoholism, a part of the federal National Institutes of Health.

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It is still rare for a person struggling with alcohol to hear that medication therapy exists. This partly reflects the tradition of treating addiction through 12-step programs. It's also a byproduct of limited promotion by the drugs' manufacturers and confusion among doctors about how to use them.

A key study funded by the federal government reported last year that only 20 percent people who abuse alcohol will ever receive any form of treatment, which ranges from seeing a counselor or doctor to entering a specialized treatment program.

The same is true for opioid addiction — about 80 percent of people dependent on opioids will never receive treatment.

The NIAAA, in an effort to give patients and doctors more choices, has launched programs to develop medications and support drug trials. NIAAA and the Substance Abuse and Mental Health Services Administration also asked a panel of outside experts to report on drug options.

"Current evidence shows that medications are underused in the treatment of alcohol-use disorder, including alcohol abuse and dependence," the panel reported last summer. It noted that although public health officials and the American Medical Association say alcohol dependence is a medical problem, there continues to be "considerable resistance" among doctors to this approach.

Naltrexone and acamprosate are the two drugs on the market for patients with alcohol cravings. "They're very safe medications," said Koob. "And they've shown efficacy."

One of the drugs, naltrexone, is also used to treat opioid abuse.

For one North Carolina woman eager to get sober, naltrexone provided that help. Dede, who wishes to remain anonymous, says she went to hundreds of AA meetings. She spent time in two different rehabilitation facilities, one of which cost her $30,000 out of pocket. But she still struggled.

"The self-loathing was the worst thing about it," she says. "I hated myself as an alcoholic, but I could not stop."

Eight years ago, during a meeting for people who had drinking problems with counselors at the University of North Carolina, Chapel Hill, she first heard about Dr. James Garbutt, a psychiatrist who uses naltrexone to treat patients with alcohol-use disorders. She tried to get an appointment to see him, but was told it would take weeks to fit her in. She wouldn't wait that long. Instead, she showed up in the doctor's waiting room and stayed until he was able to see her.

"I begged. I really begged to get to see him," she says.

With the help of naltrexone and one-on-one counseling, Dede says she has consumed no more than two sips of wine since that visit.

Shots - Health News New Medications For Treating Opioid Addiction Are On The Horizon

A third drug is also available, but it does not work against alcohol cravings. Disulfiram, also known by the brand name Antabuse, makes people violently ill when they consume alcohol. It has been found to be less effective in helping stem alcohol abuse than the other two drugs.

Naltrexone comes in both an oral and injectable form and has few side effects. It was approved for use in alcohol addiction in 1994. Acamprosate was approved in 2004 to treat only alcohol problems. It comes as a tablet.

When naltrexone came on the market, many misunderstood how and for whom the drug worked. Naltrexone's makers stopped marketing the drug in 1997. Acamprosate was plagued by many of the same marketing problems. Misunderstanding still persists today.

Naltrexone's history of opioid treatment also hurt its image. The drug blocks the effects of opioid receptors in the brain, so opioid users who take it without first having completely detoxed experience agonizing withdrawal.

But naltrexone doesn't have the same effect on patients with alcohol-use disorders. A patient who drinks while taking the drug will still experience the effects of alcohol that impair coordination and judgment, but not get the opioid-induced reward to reinforce the behavior. That makes the idea of drinking less appealing.

Garbutt, who was on the expert panel last year, encourages complete abstinence for his patients, but also supports patients who would rather set a goal of harm reduction.

"If we can reduce your intake 80 percent and reduce your heavy drinking days a lot, that's also very positive," he says. "Some people just aren't ready. The idea of sobriety is just too big of a concept for them to wrap their head around."

In fact, explains Garbutt, while naltrexone does help patients remain abstinent, "the effect of reducing heavy drinking is the most prominent effect of naltrexone."

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Emma Yasinski is on Twitter: @EmmaYas24

Copyright 2016 Kaiser Health News. To see more, visit Kaiser Health News.
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War Studies Suggest A Concussion Leaves The Brain Vulnerable To PTSD

Mon, 09/26/2016 - 4:39am
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September 26, 20164:39 AM ET Heard on Morning Edition

Charles Mayer, 30, of San Diego survived an IED attack while serving in Iraq in 2010, but has suffered from complications including PTSD.

Stuart Palley for NPR

There's growing evidence that a physical injury to the brain can make people susceptible to post-traumatic stress disorder.

Studies of troops who deployed to Iraq and Afghanistan have found that service members who have suffered a concussion or mild traumatic brain injury are far more likely to develop PTSD, a condition that can cause flashbacks, nightmares and severe anxiety for years after a traumatic event.

And research on both people and animals suggests the reason is that a brain injury can disrupt circuits that normally dampen the response to a frightening event. The result is like "driving a car and the brake's not fully functioning," says Mingxiong Huang, a biomedical physicist at the University of California, San Diego.

Scientists have suspected a link between traumatic brain injury (TBI) and PTSD for many years. But the evidence was murky until researchers began studying troops returning from Iraq and Afghanistan.

What they found was a lot of service members like Charles Mayer, an Army sniper from San Diego who developed PTSD after finishing a deployment in Iraq.

In 2010, Mayer was on patrol in an Army Humvee near Baghdad when a roadside bomb went off. "I was unconscious for several minutes," he says. So he found out what happened from the people who dragged him out.

The blast fractured Mayer's spine. It also affected his memory and thinking. That became painfully clear when Mayer got out of the Army in 2012.

Charles (right) gets tutoring from his brother David on the GRE test at their parents' home. The couch in the living room bears a blanket with images of the three Mayer brothers.

Stuart Palley for NPR

"Two weeks later, I started school," he says. "And a simple math equation like 120 times 7, where I previously would do that in my head very easily, I all of a sudden couldn't do that."

And Mayer had a bigger problem. His time in Iraq had left him with an uncontrollable fear of improvised explosive devices, or IEDs.

"When I would walk down the street, I would walk away from trash piles because that's often how they would hide IEDs," he says. "I stayed away from large crowds."

Mayer's fear was not only disturbing, it was disabling. "I would get severe panic attacks to the point where I would have to go to the hospital," he says. "I would feel like I'm actually having a heart attack."

Eventually, Mayer went to a Veterans Affairs hospital for help. An exam confirmed that he had PTSD.

The wars in Iraq and Afghanistan have produced thousands of Charles Mayers. First they got a concussion from a bomb blast. Then they got PTSD.

"We had people who were looking very miserable when they came back," says Dewleen Baker, a psychiatrist at UCSD and the VA San Diego Healthcare System.

Baker kept asking herself: Was the PTSD just from the emotional trauma of combat? Or did a concussion alter the brain in a way that amplified fear and anxiety?

"I could easily diagnose the PTSD," she says. "But I found it very, very difficult to tease apart the contribution of traumatic brain injury."

Mayer in Iraq in 2010, where he served as a sniper and was injured in a roadside explosion.

Courtesy of Charles Mayer

So Baker and a team of researchers began studying more than 1,600 Marine and Navy service members from Camp Pendleton, in San Diego County, Calif. The service members had been assessed before deploying to Iraq or Afghanistan, and then again three months after returning.

"At one point we got this battalion that went to Helmand province in Afghanistan, and literally 50 percent of them were complaining of blast exposures and symptoms," Baker says. "I got concerned."

Baker had reason to worry. The study found that troops who experienced a traumatic brain injury were twice as likely to develop post-traumatic stress disorder.

But why? There was no easy way to answer that question in people. But several years ago some answers began to emerge from animal studies.

In one experiment, a team of scientists at the University of California, Los Angeles compared healthy rats with rats that had experienced a traumatic brain injury. All of the rats received a type of behavioral conditioning known to induce fear.

They found that fear response learned by the animals that had experienced a TBI was much greater than it normally would be, says Michael Fanselow, a psychology professor at UCLA and an author of the study.

Next, the team looked at cells in the amygdala, a part of the brain that takes sensory information and decides whether to be afraid. They found changes that would amplify the animal's response to a frightening experience.

"And we think that that's the way TBI has of increasing your susceptibility to post-traumatic stress," Fanselow says.

If brain injuries really do change the brain's fear circuitry, there should be some way to detect that change in people, says Baker.

So Baker teamed up with her colleague Mingxiong Huang, the biomedical physicist. Huang has been using a technology that measures electrical activity in the brain. It's called magnetoencephalography,or MEG.

Huang and a team of researchers used MEG to scan the brains of 84 people who had experienced a brain injury. Some of the participants were service members, some were civilians.

Those scans found abnormal signals coming from the brains of people who'd had a concussion. And the location of those abnormal signals suggested that there was too much activity going on in the amygdala and not enough in an area that normally tempers emotional reactions.

The result is a brain that is "like a car with no brake," Huang says.

After leaving the Army and starting school, Charles discovered he could no longer do simple math equations in his head.

Stuart Palley for NPR

To learn more about the brain circuitry involved in both TBI and PTSD, Dewleen Baker is expanding her earlier study of Marines. She plans to scan the brains of about 200 combat veterans, including some with both TBI and PTSD.

And Baker will have help from a researcher with a personal stake in the project: Charles Mayer, the former soldier whose college career was interrupted by PTSD.

After getting treatment, Mayer was able to finish his undergraduate degree in December. Then Mayer, who is now 30, started looking for a job that would let him study the problems that had affected his own brain.

"I looked up the psychiatrists that were doing research that I really cared about, and Dr. Baker was definitely up there," he says. And Baker hired him.

Their research will focus on veterans. But the findings could also help identify civilians who've suffered a brain injury that could make them vulnerable to PTSD.

Copyright 2016 NPR. To see more, visit NPR.
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Deadly Opioid Overwhelms First Responders And Crime Labs in Ohio

Sun, 09/25/2016 - 8:35am
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September 25, 20168:35 AM ET Heard on Weekend Edition Sunday

From Side Effects Public Media

Bob Topmiller, chief of toxicology at the Hamilton County Coroner's Office, holds a small vial containing carfentanil extracted from a sample of blood.

Jake Harper/Side Effects Public Media

Jamie Landrum has been a police officer for two years in District 3 on the west side of the Cincinnati. In late August, the city was hit by 174 overdoses in six days. Landrum says officers were scarce.

"We were literally going from one heroin overdose, and then being on that one, and hearing someone come over [the radio] and say, 'I have no more officers left,' " Landrum says. Three more people overdosed soon after that.

Heroin isn't new in Cincinnati, but the recent surge in overdoses is being blamed on an even more potent drug called carfentanil. It's 100 times stronger than fentanyl, a more common synthetic opioid that is itself much stronger than heroin. Carfentanil is used to sedate elephants. It can be dangerous to even touch it without gloves.

City and county agencies in the Cincinnati area — from law enforcement to the county coroner — are straining to respond to the carfentanil wave.

Shots - Health News An Even Deadlier Opioid, Carfentanil, Is Hitting The Streets

Carfentanil is part of a shift to synthetic opioids in Cincinnati and around the country. Last year in Hamilton County, Ohio, there were more deaths attributed to fentanyl than to heroin.

Suspected carfentanil cases were first reported in the U.S. in July in Ohio. The rate of overdoses has dropped since that shocking 174 in six days, but not by much. There are currently 20 to 25 overdoses a day, on average, reports Hamilton County's heroin task force. Police are calling it the new normal.

About an hour into a recent shift, Officer Landrum gets a call. A man has overdosed at an apartment building on the outskirts of town. His girlfriend found him and called 911.

By the time we get there, there's a crowd outside. The man is unconscious in the back of the ambulance, and EMTs have given him three doses of Narcan, an antidote for opioid overdose. For a heroin overdose, one round of Narcan is usually enough.

EMTs clap and shout his name, trying to wake him up, but something's wrong. They turn off the music blaring in the ambulance and continue working. After a few minutes, Officer Landrum gives me an update.

"This is the most I've ever seen," she says. "He's gotten four Narcans so far, and he's still not awake."

The EMTs decide to take him to the hospital. We follow, not knowing if the man will make it. "Whatever he got ahold of, it's really bad," Landrum says.

For first responders, the arrival of carfentanil can be summed up with one word: More. More overdoses, more Narcan, more time spent on each call.

And when the efforts to save someone's life fail, more work gets passed on to the Hamilton County Coroner's Office.

"The caseload keeps getting larger and larger," says Bob Topmiller, who heads the toxicology section at the coroner's office, where they test blood and urine. "We may have had a 100- or 150-case backlog a year ago, and it's almost doubled." The time it takes to process a sample has also doubled, from one month to two.

Evidence of the deluge is all over the lab: Equipment spills into the hallways, envelopes cover the intake desk, and everyone seems to be busy.

And it's more than the number of cases causing the flurry of activity. It's the fact that the drug was never meant for people.

"It's what we don't know about this drug that scares us," says Dr. Lakshmi Sammarco, the coroner for Hamilton County. "We don't have any human testing data. We don't know what the lethal level really is. There is no therapeutic level — it's not meant for human use."

Dr. Lakshmi Sammarco, the coroner for Hamilton County, Ohio, worries about the paucity of information about how carfentanil, an animal drug, affects humans.

Jake Harper/Side Effects Public Media

That means Sammarco's team is using the samples coming in to try to extrapolate some important information, like the lethal dose per kilogram of body weight, or how long carfentanil stays in someone's system — things that could help the people treating the overdoses.

Sammarco says this process is part of a pattern they've dealt with before, playing catch up with the suppliers as new drugs appear.

"However, in the spectrum of opiates, this is about max," she says. "Out of all of them, carfentanil really is the most potent."

For now, Sammarco can only say that there have been eight deaths in which carfentanil might be the cause. Her office is working to test samples dating back to July, when the drug first showed up in Ohio.

At the hospital, Landrum follows the overdose victim into the emergency room. After about half an hour, doctors and nurses stabilize him.

We leave after that. The man didn't have any drugs on him, so he wasn't charged with any crime. His girlfriend wouldn't say where the drugs came from, though she did mention that the two of them had overdosed the week before.

"Believe it or not, we'll probably be responding out for her here shortly," says Landrum. Even after close calls, people keep using. Addiction is too strong.

What's worse, the danger of carfentanil seems to act as an advertisement: People seem to equate near death with a really good high, and the problems in Cincinnati are attracting customers. Landrum says recently she met a couple from Indianapolis in town to buy drugs. Another officer talked to people from central Kentucky.

So far, the DEA says carfentanil has only been confirmed in Ohio and Kentucky. Other states are starting to test for it, bracing for its arrival.

This story is part of a reporting partnership with NPR, Side Effects Public Media and Kaiser Health News.

Copyright 2016 Side Effects Public Media. To see more, visit Side Effects Public Media.
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Controversy Continues Over Muscular Dystrophy Drug, Despite FDA Approval

Sat, 09/24/2016 - 8:47am
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September 24, 20168:47 AM ET Heard on Weekend Edition Saturday

Duchenne muscular dystrophy patients Jack Willis (center), Nolan Willis (right) and Max LeClaire, attended the opening of Sarepta Therapeutics new headquarters in Cambridge, Mass., in 2014.

Boston Globe via Getty Images

When 15-year-old Billy Ellsworth stepped up to the microphone at a Food and Drug Administration public meeting in April, he had no way to know he was part of a historic shift in how the government considers the desires of patients and their advocates in evaluating new drugs.

Ellsworth has Duchenne muscular dystrophy, a muscle-wasting disease, that mainly affects boys. And he was taking an experimental drug that the FDA was trying to decide whether to approve.

"I'm going to beat this bloody disease but I need your help," Billy told the scientists weighing the evidence about the drug. "So please help me and my friends and do the right thing. FDA, please don't let me die early."

Applause swelled from the overflow crowd.

His testimony and other pleas like it during the 10-hour hearing clearly affected some of the scientists sitting in judgment of the experimental drug called eteplirsen. But when the scientists turned their attention to the slim evidence before them, they ultimately voted that drugmaker Sarepta had not shown that the experimental drug was effective.

Just 12 boys had been involved in the key study, and just about everybody agreed that the research was deeply flawed. But parents of some of those boys were convinced that the drug was in fact helping delay the progression of a disease that ultimately proves fatal.

"We came away really heartbroken in many ways," said Pat Furlong, a longtime advocate who founded Parent Project Muscular Dystrophy and who had lost two sons to the disease.

One similar drug had previously been rejected by the FDA, and two others were turned away before they could even get through the door. There was no approved drug to stop the progression of this disease.

But that wasn't the end of the story.

Times are changing at the FDA and other federal agencies. In recent years, legislation and regulation has pushed for a greater patient voice in decisions. The FDA's job wasn't simply to look at the science, as it has done for many years. They have "to look to what is meaningful benefit on the part of the patients," Furlong said. "What do the patients value?"

In this case, the parents saw real promise in this drug, despite the results from the flawed study. They also noted that the drug appears to be safe, so there wasn't much risk. And the research did show that boys on the drug were producing a small amount of a potentially helpful protein called dystrophin, which could be a sign that the drug provides some benefit.

That was all part of the FDA's thinking when on Monday it approved eteplirsen, brand name Exondys 51, on a provisional basis. A letter written by FDA Commissioner Robert Califf laid out in remarkably frank terms the heated internal debate at the agency, which may have led to the departure of one key scientist who was opposed to approving the drug.

"It is inevitable that in some of these situations, highly qualified experts will disagree," Califf wrote, and he praised Dr. Janet Woodcock, the head of the FDA division that reviews new drugs, who made the call "in the face of profound changes in science and social interactions related to drugs."

Califf said Woodcock ultimately made a scientific judgment call, anchored on the observation that the drug does prompt patients to produce at least a small amount of dystrophin.

Yet the role of advocacy here was inescapable. It is, after all, the patients who face the risks and the benefits.

"You can look at this as being a potentially damaging precedent, and on the other hand you can look of this as being an innovative precedent, that could bring good things and earlier access to medicines," Eric Hoffman told NPR.

Hoffman and Louis Kunkel discovered the dystrophin gene in 1987. Hoffman is now CEO of ReveraGen, a company working on a drug for the disease, as well as associate dean of research at the University of Binghamton's pharmacy school in New York.

The FDA decision approves the drug on an accelerated basis, but that approval is contingent on follow-up studies and it can be withdrawn. In other diseases, provisional approvals have been reversed after follow-up studies failed to show the drugs were effective. (Avastin for advanced breast cancer is a notable example, despite pleas from patient groups to keep the approval intact).

The Sarepta drug addresses just one genetic mutation in muscular dystrophy, and that particular flaw only affects about 1,500 boys in the entire United States. Drugmaker Sarepta plans to use the same approach now to target other mutations related to the disease, and to use those study results to comply with the FDA's requirement for more and better studies.

In the meantime, Sarepta can start charging $300,000 per patient per year for treatment with eteplirsen.

"Yes, there was a lot of pressure," Dr. Edward Kaye, CEO of Sarepta said, "but I think the FDA demonstrated the flexibility they are allowed under the law. It took a lot of courage for them to do this. It's always easy to take the safe path and say, just give us more data."

Advocate Pat Furlong agreed. "I think the important aspect of this is maybe a new social contract," she said. Since the drug is apparently safe and possibly useful, parents wanted to make the drug available while the questions about usefulness and value are fully answered. "And at the end of five years we can reevaluate whether this really hits its mark in terms of the healthcare cost and the benefit to patients," she said.

More than a dozen potential drugs for this disease are in the pipeline now, and at the very least they now have a standard against which they can be judged.

The decision about eteplirsen would have been considerably easier, for patients and scientists alike, if the company had conducted its trials carefully and rigorously.

"Considering that a substantially flawed development program contributed to the difficulty of coming to resolution in this case, we must redouble our efforts to ... use methods that will produce high-quality evidence from the outset," Califf wrote.

Copyright 2016 NPR. To see more, visit NPR.
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This Doctor Is Trying To Stop Heart Attacks In Their Tracks

Fri, 09/23/2016 - 1:25pm
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September 23, 20161:25 PM ET Heard on All Things Considered

Dr. Harry Selker, a cardiologist, works on collaborations to improve delivery of medical care.

M. Scott Brauer for NPR

When Harry Selker was working as a cardiologist in the 1970s, clot-busting drugs were showing great promise against heart attacks. But their lifesaving properties were very time sensitive. "If you give it within the first hour it has a 47 percent reduction of mortality; if you wait another hour, it has a 28 percent reduction; another hour, 23 percent. And people were taking about 90 minutes to make that decision," he recalls. "So they were losing the opportunity to save patients' lives."

Selker envisioned a predictive tool, a kind of calculator that would help make the decision faster. He knew the data to create such a tool were already out there, from research on drugs that dissolve blood clots. "We made mathematical models and they kind of represented that comparison from those data, and that helped us make these predictive instruments. We built them into electrocardiograms," Selker says. That helped physicians make better decisions.

The EKG-based predictive instruments have helped doctors prescribe clotbusters within the hour, increasing the use of the therapy within one hour, and getting more people treated with either clotbusting drugs or angioplasty.

Building on this success, Selker and colleagues at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center in Boston, where he is executive director, have gone on to develop other predictive tools, in areas from knee replacement therapy to opioid addiction treatment.

Selker grew up in a household in the Seattle area where he was encouraged to tinker. In his office, he proudly shows off the first automobile shock absorber, invented by his grandfather.

And while Selker's own list of patents will attest to his passion for innovation, he's equally passionate about working to ensure those innovations will have an impact.

One medical treatment Selker is pursuing right now has never delivered on its early promise for saving lives. It's a cocktail of glucose, insulin and potassium, known by its chemical initials GIK. In studies with baboons and rabbits more than 50 years ago, GIK seemed to actually prevent heart attacks. "They would clamp off these coronary arteries simulating coronary thrombosis, but keep infusing them with glucose and insulin, then potassium," Selker says.

When the researchers unclamped the arteries, they found no signs of cardiac arrest, as would be expected. The simple concoction had protected heart muscles against damage. Selker says: "So it was very encouraging. It was extraordinary, really."

But there was a problem in translation: In human studies, GIK didn't seem to do much of anything to prevent heart attacks or damage. The research sat on the shelf. But when Selker learned about the research from a colleague and they started to discuss it, he became convinced there were fatal flaws in the human studies, including administering the GIK too late to have an effect. Selker and his colleagues designed a study to test GIK in humans.

Paramedics in 13 cities gave people who appeared to be having a heart attack either GIK or a placebo. The GIK didn't keep people from having heart attacks, but those given it were less likely to suffer cardiac arrest or death in the hospital. It also reduced the amount of heart damage by 80 percent. The results were published in JAMA in 2012.

Selker is testing whether a simple, cheap combination of three drugs can help reduce the damage caused by a heart attack.

M. Scott Brauer for NPR

Selker says that if additional research supports these findings, many lives could be saved with a simple therapy that costs less than a hundred bucks. But he soon discovered that knowing what needed to be done wasn't enough.

"I thought, pretty much, my work was done and people call me up and say you know, 'when would we get this GIK stuff?' And I realized nobody's making it, nobody's selling it. And so I started talking to the pharmaceutical companies saying, 'You know, would you make this stuff?' And they basically weren't interested."

GIK is a cocktail of existing off-the-shelf ingredients. A company could invest in the additional research and work to get it out to patients, but there'd be no big payoff. But Selker refuses to be deterred.

He is now in dialogue with the Food and Drug Administration about the details of a definitive clinical trial to determine the effectiveness of GIK in acute coronary emergencies. And like so many times before, he's continuing to reach across professional boundaries, working with policy experts, statistical modelers, anyone who can push the process forward.

Shots - Health News Are We Reaching The End Of The Trend For Longer, Healthier Lives?

"If you're going to try to improve things, you have to work on all angles, you have to work in all disciplines," Selker says. "You can't just work in biology; that would never get you anywhere."

His happiest moments in research, he says, have been sitting down with people who have ideas he never could have imagined, where he gets to push and prod, challenging them to figure out how to put those ideas to use.

"So working across disciplines and personalities and in different perspectives; that's the good stuff for me. Now really that makes a great day."

Selker is hopeful that the next clinical trial for GIK will take place by early next year, moving one step closer to a tested treatment that could save lives.

Copyright 2016 NPR. To see more, visit NPR.
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Doctor Confesses: I Lied To Protect Colleague In Malpractice Suit

Fri, 09/23/2016 - 5:00am

Dr. Lars Aanning, seen at his home outside Yankton, S.D., said he lied to protect a colleague in a malpractice case. Now, Aanning is a patient safety advocate.

Jay Pickthorn/AP for ProPublica

Almost two decades ago, Dr. Lars Aanning sat on the witness stand in a medical malpractice trial and faced a dilemma.

The South Dakota surgeon had been called to vouch for the expertise of one of his partners whose patient had suffered a stroke and permanent disability after an operation. The problem was that Aanning had, in his own mind, questioned his colleague's skill. His partner's patients had suffered injuries related to his procedures. But Aanning understood why his partner's attorney had called him as a witness: Doctors don't squeal on doctors.

The attorney asked the key question: Did Aanning know of any time his partner's work had been substandard?

"No, never," Aanning said.

Now, Aanning, in a stunning admission for a medical professional, has a blunter answer: "I lied."

While it's impossible to know to what extent Aanning's testimony influenced the outcome, the jury sided in favor of his colleague — and, ever since, Aanning said, he has felt haunted by his decision.

Now, 77 and retired, he decided to write about his choice and why he made it in a recent column for his local newspaper, The Yankton County Observer. He also posted the article in the ProPublica Patient Safety Facebook group. Aanning, who is a member, called it "A Surgeon's Belated Confession."

"From that very moment I knew I had lied — lied under oath — and violated all my pledges of professionalism that came with the Doctor of Medicine degree and membership in the [American Medical Association]," Aanning wrote.

Aanning, who has become an outspoken patient advocate, now assists the medical malpractice attorney who represented the patient in the case in which he lied for his partner.

There's no way to tell how often doctors lie to protect their colleagues, but ProPublica has found that patients frequently aren't told the truth when they are harmed. Studies also show that many physicians do not have a favorable view of informing patients about mistakes and that health care workers are afraid to speak up if things don't seem right. Many doctors and nurses have told ProPublica that they fear retaliation if they speak out about patient safety problems.

ProPublica spoke to Aanning about his unusual column and why he decided to confess all these years later. The interview has been edited for clarity and length.

Why did you tell the lie?

I did it as a matter of course. And I did it because there was a cultural attitude I was immersed in: You viewed all attorneys as a threat, and anything that you did was OK to thwart their efforts to sue your colleagues. I just accepted that as normal. It wasn't like, "I'm going to lie." It was, "I'm going to support my colleague."

Did you feel pressure from your peers to never criticize a colleague?

Pressure is the prevailing attitude of the medical profession. The professional societies like the AMA and the American College of Surgeons say you should be a patient advocate at all times. But that goes out the window because here you are, banding together with your peers. Because if you don't, you'll be like a man without a country.

Why are you telling the truth now?

I'm retired now. The big benefit is they can't hurt me, but I can't go to the clinic for any help. All my doctors are out of town. I came to America from Norway in '47 and grew up in New York. I've always been a rabble-rouser. This testifying falsely at this trial was not like me, so it stands out. It's not how I do stuff.

I also told the truth about my lie because I have been helping some of these plaintiffs' lawyers with their cases. It seems that the courtroom is not the arena for adjudication of medical right or wrong. I shared my story to give an explicit example of why you can't always rely on physician testimony in court. I think that's the big reason. There's got to be a different way to help people who have been medically harmed. Looking to the legal system is like mixing oil and water.

Do you feel like it's your fault the patient lost the case?

I haven't touched on that question. It would make it painful for me. I would be moved to tears if that whole case revolved around just my testimony. I was on the stand so briefly. But cumulatively between what I said and the other testimony — it was never a level playing field for the plaintiff. People don't recognize it. How the judges don't recognize it and the system doesn't recognize it is beyond me. It's something I'm coming to grips with.

Have you thought about talking to the patient's family?

The attorney said something about meeting the patient's widow in his office, or something like that. I worry about whether my testimony weighed on the final verdict or not. It's something that you just have to face up to. It's too late to deflect it.

Do you feel any better or worse now that you've gone public with your moral failure?

I'm not altruistic. I'm not a crusader. I got into writing this column accidentally, so I just kind of find myself in this position. I get a great satisfaction out of defining what I see and writing about it. I hope nobody's going to come back at me and accuse me of bad conduct. Although that's what it was. I felt bad about it.

ProPublica is interested in hearing from patients who have been harmed while undergoing medical care, through its Patient Harm Questionnaire and Patient Safety Facebook Group. You can follow Marshall Allen on Twitter: @marshall_allen.

Copyright 2016 ProPublica. To see more, visit ProPublica.
Categories: NPR Blogs