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Credit Agencies Agree To Wait Before Adding Medical Debt To Ratings

Fri, 03/13/2015 - 12:22pm
Credit Agencies Agree To Wait Before Adding Medical Debt To Ratings March 13, 201512:22 PM ET

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Too many consumers have learned the hard way that their credit rating can be tarnished by medical bills they may not owe or when disputes delay insurer payment. That should change under a new policy agreed to this week by the three major credit reporting agencies.

The agencies say they will establish a 180-day waiting period before medical debt is added to someone's credit report. In addition, the agencies agreed that when an insurer pays a bill, the debt will be promptly removed from the consumer's credit report, unlike certain debts that remain for years.

The changes are part of a settlement between the credit rating agencies — Equifax, Experian and TransUnion – and the New York Attorney General's office that aims to improve accuracy and enhance procedures for disputing credit report errors. The agreement covers consumers across the country.

Credit Rating Agencies Agree To Change Process For Reporting Errors 3 min 5 sec  

The three agencies gather information from banks and collection agencies about consumers' credit — such as payment history and how much someone owes — to create a credit score for more than 200 million individuals throughout the country. A person's credit score is used as a measure of credit-worthiness, and can influence people's ability to get loans and the interest rates they're charged, among other things.

"This is going to help millions of people access more affordable loans," says Mark Rukavina, a principal at Community Health Advisors in Chestnut Hill, Mass. "People will no longer be penalized for having a medical bill slip past them and get on their credit report even though the bill gets paid."

Insurers sometimes wrangle with patients and providers for months before paying a bill. The new six-month waiting period will give consumers time to resolve such disputes, Rukavina noted.

Medical debt accounts for more than half of the collection items on credit reports, according to a report by the Consumer Financial Protection Bureau. Among people facing collection for only medical debt, about half have otherwise clean credit reports with no sign of past debt collection problems.

Copyright 2015 Kaiser Health News. To see more, visit http://www.kaiserhealthnews.org/.
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Feds Knew About Medicare Advantage Overcharges Years Ago

Fri, 03/13/2015 - 9:15am
Feds Knew About Medicare Advantage Overcharges Years Ago March 13, 2015 9:15 AM ET Fred Schulte

Carol Berman, of West Palm Beach, Fla., makes the case for policymakers to protect Medicare Advantage benefits during the Coalition for Medicare Choices' Medicare Advantage Food Truck stop in Washington, D.C., on Monday.

Bill Clark/CQ-Roll Call/Getty Images

Federal health officials were advised in 2009 that a formula used to pay private Medicare plans triggered widespread billing errors and overcharges that have since wasted billions of tax dollars, newly released government records show.

Privately run Medicare Advantage plans offer an alternative to standard Medicare, which pays doctors for each service they render. Under Medicare Advantage, the federal government pays the private health plans a set monthly fee for each patient based on a formula known as a risk score, which is supposed to measure the state of their health. Sicker patients merit higher rates than those in good health.

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The program is a good fit for many seniors. Some 16 million people have signed up — about a third of people eligible for Medicare — and more are expected to follow. Supporters argue that Medicare Advantage improves care while costing members less out of pocket than standard Medicare. The Medicare Advantage industry is lobbying hard to block budget cuts sought by the Obama administration.

Medicare Advantage plans are "clearly an important force to be reckoned with when it comes to making public policy," said Dr. Robert Berenson, a former government health official, who is now at the Urban Institute.

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But overspending tied to rising risk scores has cost taxpayers billions of dollars in recent years, as the Center for Public Integrity reported in a series of articles published last year. And concerns that some health plans overstate how sick their patients are date back years, according to records recently released to the Center for Public Integrity under the Freedom of Information Act.

The documents include an unpublished study commissioned by the agency that runs Medicare and the Centers for Medicare and Medicaid Services, and dated Sept. 29, 2009; the study tracked growth in risk scores starting in 2004, the year after Congress created the billing tool.

The study found that risk scores for Medicare Advantage enrollees grew twice as fast between 2004 and 2008 as they would have had the same person remained in standard Medicare. The study said it was "extremely unlikely" that people who enrolled in the plans actually got sicker and noted that coding inflation "results in inappropriate payment levels."

The lead author was Richard Kronick, then a researcher at the University of California, San Diego. Kronick now heads the federal Agency for Healthcare Research and Quality, a research arm of the Department of Health and Human Services. He had no comment. Other authors listed included three CMS employees.

A CMS spokesman said on Thursday that the agency sought to publish the findings on a government run research site, but was told it needed to be "substantially shortened" to be considered. "Given competing workload demands we were not able to revise and resubmit the article," the official said in a statement.

The study cited diabetes as an example of the billing problem.

The private Medicare Advantage health plans reported rates of diabetes with medical complications more than twice as often as for people in standard Medicare. "It seems extremely unlikely that the actual distribution of diabetics changed substantially in MA plans ... and almost surely reflects MA efforts to more fully document members' diagnoses," the study said.

The authors noted that "a number of companies have successfully marketed services to help MA plans increase their risk scores." They also said that the problem was worsening over time.

The study said that a number of large Medicare health plans, which were not named, raised risk scores far above their peers. But the agency chose not to ferret out the worst offenders and discipline them. Instead CMS cut rates industrywide in 2010 by 3.41 percent to offset the jump in risk scores.

Berenson, of the Urban Institute, said cutting rates across the board was a kind of "rough justice."

"It seems to me that they need to identify the plans that are bending the rules," Berenson said. "It's not so easy to focus in on plans that are overly aggressive [in billing]," he said.

Medicare Advantage plans are currently mounting an aggressive lobbying effort to stave off proposed new federal budget cuts. Fifty-three senators signed a recent letter opposing the cuts. The Coalition for Medicare Choices, run by the health insurance industry, even rolled out a "Medicare Advantage"-themed food truck that parceled out free cookies and coffee near the U.S. Capitol. Utah Sen. Orrin Hatch was among those who stopped by.

Separately, an advocacy group called the Better Medicare Alliance on March 10 unveiled a pair of advertisements arguing any cuts would cause seniors to pay more for their medical care.

Clare Krusing, a spokeswoman for America's Health Insurance Plans, said in a statement:

"Seniors enrolled in Medicare Advantage have already faced year-over-year cuts to the coverage they rely on. Now, CMS is proposing another cut at a time when beneficiaries, policymakers, providers are all calling for stability in the program. Preventing any further cuts to Medicare Advantage will ensure seniors can continue to rely on this critical lifeline."

Though Medicare Advantage has built formidable support in Congress, the risk-based payment system has critics in other areas of government.

Earlier this week, the Government Accountability Office, the audit arm of Congress, cited more than $12 billion in improper payments to Medicare Advantage plans among a total of nearly $60 billion in misspent Medicare funds for 2014. A broader GAO audit of how well federal officials have monitored the industry to curb overbilling is underway; it's due to be released later this year.

The industry has a good track record when it comes to building the political support to silence its critics. For instance, an ad campaign run by the industry in 2013 turned a proposed 2 percent cut in rates into a 3 percent rate hike. In backing down, CMS officials said the revised rates would give patients "more value in the care they receive and greater protections against increasing costs."

President Obama's proposed 2016 budget seeks more than $36 billion in Medicare Advantage cuts over the next decade, mainly by taking aim at risk scoring.

A final decision on the payment rates for 2016 is due in April.

This piece comes from the Center for Public Integrity, a nonpartisan, nonprofit investigative news organization. For more, follow the center on Twitter @Publici, or sign up for its newsletter.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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Before The Gas Is Passed, Researchers Aim To Measure It In The Gut

Thu, 03/12/2015 - 12:04pm
Before The Gas Is Passed, Researchers Aim To Measure It In The Gut March 12, 201512:04 PM ET Angus Chen

Feces contain digested food residue and a wide variety of microorganisms, mostly bacteria, that are adapted to life in the intestines. The gases the microbes produce could help doctors and scientists track and understand changes related to health.

Scimat Scimat/Photo Researchers/Getty Images

Electrical engineer Kourosh Kalantar-Zadeh calls the stinking mixture puddled in jars inside his laboratory "fecal inocula."

The jars of fresh poop are instrumental to his research at the Royal Melbourne Institute of Technology in Australia to develop ways to scientifically analyze people's farts, something that the researchers believe could help them more easily track the activity of the human gut microbiome.

Kalantar-Zadeh and his colleagues propose in a paper in Trends in Biotechnology online Thursday two new devices that could keep a vigilant eye, or a nose in this case, on what's going on deep in the gut. He hopes that someday medical doctors could use the devices to diagnose certain gastrointestinal diseases without having to do an invasive procedure like a colonoscopy.

Swallowable Gas Capsule

The pill uses a sensor to identify the gas in the gut and beams the information out of the body through a tiny antenna. The pill itself follows a few hours or days later.

Credit: Nam Ha

The jar is pretty straightforward. A spoonful of poop goes in and a technician squeezes on a lid containing a sensor that detects the molecules of gas fuming inside and at what concentration. "I love that system," Kalantar-Zadeh says. It's cheap and reusable, but he's most excited about their other invention.

It's a robotic pill that sniffs its way along a craptastic voyage through the gut. As the pill tumbles through, a membrane on the pill lets gasses pass onto a small molecular sensor inside that serves as its nose. The membrane blocks the other stuff sloshing around in the gut.

The pill notes the gasses that gut microbes produce, including oxygen, methane, hydrogen and hydrogen sulfide, which smells like rotten eggs. The pill's sensor figures out how much of each gas is present, and beams the information out of the patient's body through a tiny antenna. The pill itself follows after a few hours or days.

The researchers aim to detect changes in gas content. As people's health waxes or wanes because of stress or disease their intestinal ecosystems change too. Certain microbes may thrive in the new conditions while others struggle. As the populations shift, so will the concentrations of their distinctive gassy waste products. "They're fantastic biomarkers that tell about the state of our health," Kalantar-Zadeh says.

But others aren't quite blown away. "I don't think we know enough about it at this point," says Ilseung Cho, a gastroenterologist at New York University School of Medicine who conducts research on the gut microbiome. "The problem is that you have hundreds of species of bacteria in your gut, and their waste products are all fairly similar."

Cho, who isn't involved in the sensor research, says that changes in methane concentration in people's flatulence have been linked to diseases like irritable bowel syndrome. But it's impossible to tell whether that methane is coming from a disease-causing bacteria or a benign species.

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The pill and the sensing jar can't identify the species of bacteria that are present. They only smell the gas. "That's it," Cho says. "That's all the data you have, you don't have any other data to suggest that there's a mechanistic link between this bacteria and that ... gas measurement," Cho says.

Cho says the stool samples are more interesting. By grinding up poop, doctors can run tests that reveal the species of bacteria that are present in the gut and see other bacterial byproducts that aren't gas. But Cho also says that poop contains a mixture of bacteria from each part of the gastrointestinal tract. "We don't know how much comes from the colon versus the small bowel, all the way up to the stomach," he says. The nice thing about the pill is it tests each part of the gut one at a time.

Knowledge about the microbiome's gas could be helpful to patients someday, Cho says, but it will take time. "The field is really young, so there's not much we can bring to the clinical realm right now." He says neither device could be used as a diagnostic tool just yet, unlike the pill camera approved by the Food and Drug Administration as an alternative to endoscopes.

But Cho says people could use them to do research on something like irritable bowel syndrome – maybe. The paper, he's quick to add, is just a concept at this point — not a presentation of results from actual experiments.

The data are coming, Kalantar-Zadeh says. His team already has the jars running with human feces and is testing if there's a link between gas and human health in those. "One of the samples is actually myself," he says. "The results are amazing." They're getting ready to start testing the pill in humans as well, and the intrepid engineer is hungry to try one himself.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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When Life Overwhelms, This Group Lends A Healthy Hand

Thu, 03/12/2015 - 4:26am
When Life Overwhelms, This Group Lends A Healthy Hand March 12, 2015 4:26 AM ET Listen to the Story 5 min 19 sec  

Ella Barnes-Williams visits the thrift shop associated with Martha's Table, a nonprofit social services organization in Washington, D.C.

Anders Kelto/NPR

Ella Barnes-Williams is dealing with a lot right now.

For starters, her government-subsidized house in Northeast Washington, D.C., leaks when it rains. She points at a big brown splotch on the ceiling.

"It's like mold, mold, mold all over," she says. "I've got to clean that now 'cause that just came back."

"I connect low-income families at the hospital with different resources in the area."

Barnes-Williams is 54 and lives with her 30-year-old daughter and three young grandchildren. All three grandkids have severe asthma, which makes the mold a serious problem. And she and her daughter are diabetic.

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On top of the housing and health problems, Barnes-Williams hasn't had steady work for more than a decade. At the end of most months, the family runs out of food.

As if all that weren't enough, their house was recently robbed — twice. "They, like, went shopping in my house," Barnes-Williams says. "They even stole the kids' school uniforms."

But she isn't the type of person to give up. Though she dropped out of high school as a teenager, she went back to school and got her diploma at age 46. She now attends community college, attends career training workshops and volunteers on political campaigns.

There's also a steady stream of visitors to her house because she's a notary public. She receives $2 per stamped document, which she says helps with small costs around the house.

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But, despite being hardworking and well-connected in her community, Barnes-Williams didn't know about a wide range of social programs that are available to help her family — until she met a young man named Phung Tran.

Tran grew up in Washington, D.C., and is a senior at the University of Maryland. Two days a week, he comes to a small office in the Children's National Medical Center to make phone calls through a program called Health Leads.

"I connect low-income families at the hospital with different resources in the area," Tran says.

He first started working with Barnes-Williams a few months ago. She had about 10 specific needs, he discovered — many related to food, clothing and housing. "It was kind of overwhelming at first," he says.

So they made a list and started working through the items, one by one. Her top priority was food; Tran referred her to a local food pantry that now provides the family with free groceries once a month.

Next was furniture: Tran found an organization that gave Barnes-Williams a couch, shelves, lamps, a drawing board and puzzles for the grandkids.

Now he's helping address the mold problem, by connecting Barnes-Williams with an organization called Breathe DC, which provides air purifiers, vacuum cleaners and specific advice on how to stop mold.

Phung Tran is an advocate with Health Leads, based at the Children's National Medical Center in Washington, D.C.

Anders Kelto/NPR

Tran is also lining up summer activities for Barnes-Williams' grandkids, including a camp geared toward kids with asthma.

Health Leads operates in seven cities across the U.S. and has more than a thousand volunteer advocates, the vast majority of whom are college students. It was founded by Rebecca Onie. Now the organization's CEO (and recipient of a MacArthur Foundation Fellowship in 2009) Onie came up with the idea as a college sophomore in the 1990s. While volunteering at a hospital in Boston, she often asked doctors this question: If you had unlimited resources, what's the one thing you would give your patients?

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The answer that came back over and over again, she says, was food, transportation, or a better place to live, because those were the real problems — and the underlying cause of many patients' health problems.

This led Onie to imagine an entirely different kind of health care system — "one in which a physician or nurse could prescribe basic resources that a patient needs to be healthy, like heat in the winter or access to healthy food," she says.

And that's exactly what Health Leads does. It trains doctors to ask patients about their social needs and then connects patients with organizations that can meet those needs.

Onie says the long-term goal is to show that providing patients with better food, housing, transportation and so on not only improves patients' health, but also reduces the cost of health care. She and her team are collecting data to try to make that case.

"Then we can work closely with health care systems across the country," she says, "to really make [addressing social needs] an integral part of how they deliver care."

Since Ella Barnes-Williams began working with Health Leads a few months ago, she has been making regular trips to Martha's Table, a food pantry in Washington, D.C. She had no idea how much help was out there, she says. She just needed someone to help her find it.

This story is part of the NPR series, What Shapes Health? The series explores social and environmental factors that affect health throughout life. It is inspired, in part, by findings in a recent poll by NPR, the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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Results Of Many Clinical Trials Not Being Reported

Wed, 03/11/2015 - 5:41pm
Results Of Many Clinical Trials Not Being Reported March 11, 2015 5:41 PM ET Listen to the Story 4 min 37 sec  

Glenn Lightner in 2012 at age 13. His father searched clinicaltrials.gov for years, to no avail, hoping to find a promising experimental cancer treatment that might save his son's life.

Courtesy of Lawrence Lightner

"We were really surprised to find that very few people are following the law."

Many scientists are failing to live up to a 2007 law that requires them to report the results of their clinical trials to a public website, according to a study in Thursday's New England Journal of Medicine.

The website is clinicaltrials.gov, which draws 57,000 visitors a day, including people who are confronting serious diseases and looking for experimental treatments. A study from Duke University finds that five years after the reporting law took effect, only 13 percent of scientists running clinical trials had reported their results.

"We were really surprised to find that very few people are following the law," says Dr. Monique Anderson, a cardiologist and the study's first author.

There are many exceptions in the law, so many of those who have not reported results are at least temporarily exempt from doing so. But Dr. Anderson says researchers should also feel an ethical obligation to make data generated by human volunteers available promptly.

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"Any patient who participates in clinical research should expect to see that their participation is going to be used effectively," she says.

People desperate for cures and treatments who are searching these results are also being shortchanged.

Larry Lightner found himself on clinicaltrials.gov after his then 9-year-old son, Glenn, developed a rare brain cancer in 2009.

Lightner, from Long Valley, N.J., says Glenn's initial radiation treatment worked for a while, but the treatment itself had a serious side effect. Glenn "developed a second cancer, which was far more aggressive than the first cancer. One of the oncologists at NYU suggested that we look into clinical trials, because they knew they had nothing to cure this cancer with."

Night After Night, Year After Year, 'No Results Posted'

Lightner is a transportation manager, not a scientist, but he spent four hours a night, every night, on clinicaltrials.gov, looking for something that could help Glenn.

"Every time I clicked on the results tab, it always said 'no results posted,' night after night, year after year."

That's only a mild overstatement, considering that the 13 percent reporting figure from the Duke study excludes many studies that don't fall under the reporting law. There's a complicated list of exemptions, and it's impossible to tell by looking at a study on clinicaltrials.gov whether the scientists have neglected to report their results or simply don't have to.

Anderson's study found that experiments sponsored by the pharmaceutical industry had a much better track record than university experiments funded by the National Institutes of Health or other agencies.

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About half of the missing reports from industry-sponsored research were temporarily exempt. Companies are allowed to sit on their data at times to preserve a competitive advantage if they're trying to develop a new drug.

That is not the case for studies funded by the NIH or other agencies, "who are just lagging," Anderson says.

Even counting the late entries and allowable exceptions, only about 50 percent of taxpayer-funded research has been reported back to the taxpayers on clinicaltrials.gov, she says.

The study doesn't assess why universities are frequently failing to post their results. As it happens, Duke University is considered a good example of what a university needs to do to comply with the law.

"It was extremely difficult," says Dr. Mark Stacy, a neurologist and vice dean for clinical research at Duke. He says the university had a team working for months to develop a compliance system, and Duke has kept two full-time staffers to parse the complicated rules — and to remind and cajole Duke scientists to fill out the forms.

"These are very busy people and this represents a new step in workflow, and we don't always do well when we add a step in workflow," Stacy says.

Some Scientists Avoid Publishing Bad News

But one worry is that the scientists who aren't complying aren't simply busy. Dr. Mark Helfand, a professor of medicine at Oregon Health and Science University says scientists are generally more likely to publish good news and ignore bad news, which skews the scientific record. He's concerned that may be occurring on clinicaltrials.gov as well.

What's more, Dr. Helfand has found that what's published in medical journals doesn't necessarily match what was reported in clinicaltrials.gov.

"In a significant proportion of cases, the results on cliniclaltrials.gov were reported more thoroughly than the results in corresponding journal articles," he says.

Serious side-effects in particular were more likely to be reported online than in a published study.

Universities who don't report their studies on time can face fines of $10,000 a day. Scientists can even lose NIH research grants. But even though the law was passed in 2007, the government is still trying to finalize the precise rules. And in the meantime, no transgressors are being punished.

Larry Lightner, whose son had brain cancer, is rallying patient-advocates to support disclosure rules with no exceptions. He has put out the call both from his popular Facebook page and his website, FixCancerNow.

"There are a lot of parents who have asked for the results of a clinical trial that their child was in, and they will not get an answer," he says. The scientists "refuse to give them the results."

And as for Glenn: He died December 12, 2012. He was 14.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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Would A Pill To Protect Teens From HIV Make Them Feel Invincible?

Wed, 03/11/2015 - 5:32pm
Would A Pill To Protect Teens From HIV Make Them Feel Invincible? March 11, 2015 5:32 PM ET

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Truvada can dramatically reduce the risk of HIV infection when taken as a preventative medicine — if taken every day. Studies are underway to determine if young people are likely to take the pill consistently.

Justin Sullivan/Getty Images

Leon Richardson is 18 years old and tall, charismatic and thoughtful about his sexual health.

He understands that as a young, gay black man, he is in the demographic with the highest rate of HIV infections in the country. But when Richardson learned that he could be part of an HIV prevention pill research study for young people, he was skeptical.

"I was scared. I had to really think about it, 'What is this drug going to do to me?' " he says.

The regimen, called pre-exposure prophylaxis, or PrEP, can reduce the risk of HIV infection by more than 85 percent when a pill called Truvada is taken daily. In a first, the Food and Drug Administration approved Truvada for prevention of the infection in 2012. Truvada had been used previously to treat HIV infection.

But the Centers for Disease Control and Prevention recommends caution when prescribing PrEP to adolescents. CDC is waiting for final results from the trials being conducted on young people in cities across the country.

Initially, Richardson's mom stoked his concerns. "She was saying the medical industry tried to sterilize some people; they were trying to do it again," he remembers. But he found encouragement from another family member: his grandfather, who is HIV-positive.

"We had a long discussion about this drug and what the side effects could be, and he overall supported me totally," Richardson says. "And it was kinda like, why not? Let me just try it."

Now, Richardson is part of CRUSH, an HIV-prevention project in Oakland, Calif. CRUSH offers PrEP to participants.

Daniel Zeh is part of a PrEP study being conducted by the Adolescent Trials Network with young people between the ages of 15 and 22, based at John H. Stroger Jr. Hospital in Chicago. He was 17 when he started taking the pill as part of a daily regimen that was sometimes hard to explain, he says.

"I guess it was kind of weird during high school, popping it before lunch, trying to make sure nobody sees," Zeh chuckles. "People are like, 'What are you taking?' 'Nothing, you know, just a sugar pill.' "

Zeh first heard about the Stroger Hospital study on Facebook. Outreach coordinators also turned to gay hook-up apps, like Grindr and Jack'd, to recruit possible subjects. It's a clever strategy, even if it's awkward to run into a researcher when you're looking for a date.

Psychologist Sybil Hosek, the lead researcher for the study, funded by the National Institutes of Health, offered to pay participants $50 per visit to the clinic. When enough guys said yes, she got to work.

"What we wanted to do was design a study where they could try to take this pill every day," Hosek explains. "And see whether, one, they were interested in taking it; two, if it was hard for them to take it; and three, how it impacted their sexual behavior." For instance, would being on the pill encourage more risky sexual activity?

Inside a conference room at the hospital, a group of the guys in the study share stories about what it's like to be on PrEP. Dexter Canty is also enrolled in the Chicago PrEP study, and says people have a lot of misunderstandings about the pill and individuals who take it. They're often asked, "Are you HIV positive?" But, in fact, they're taking the drug to prevent getting infected.

Canty compares the reactions he's experienced to people's perceptions when he goes to the drugstore to buy condoms or when a woman goes to Planned Parenthood and gets birth control. "You're automatically looked at as being promiscuous instead of safe," he says.

The idea is that PrEP would be used in combination with condoms. But critics worry that the pill will make users feel invincible, increasing the likelihood that they won't use condoms or follow through on taking the pill every day. And when you miss doses, the pill becomes less effective.

Andrew Weinstein, President of the Los Angeles-based AIDS Healthcare Foundation, is against PrEP use, especially by young people. "Young people have unstable lives. They're sleeping on someone's couch. They're out for the weekend," he says. "That's not to stigmatize them, it's just the nature of youth. It's a carefree time. Expecting people to take a pill every day is not realistic," says Weinstein.

It's enticing to imagine a magic pill that could bring about the end of AIDS. But a recent study of young adults taking PrEP shows that they take it, at best, 60 percent of the time.

This story was produced by outLoud, a project of Youth Radio.

Copyright 2015 Youth Radio. To see more, visit http://www.youthradio.org/.
Categories: NPR Blogs

The Boss Can Force You To Buy Company's Health Insurance

Wed, 03/11/2015 - 12:32pm
The Boss Can Force You To Buy Company's Health Insurance March 11, 201512:32 PM ET

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Michelle Andrews

Under the health law, large employers that don't offer their full-time workers comprehensive, affordable health insurance face a fine. But some employers are taking it a step further and requiring workers to buy the company insurance, whether they want it or not.

Many workers may have no choice but to comply.

Some workers are upset. One disgruntled reader wrote to Kaiser Health News: "My employer is requiring me to purchase health insurance and is automatically taking the premium out of my paycheck even though I don't want to sign up for health insurance. Is this legal?"

The short answer is yes. Under the federal health law, employers with 100 or more full-time workers can enroll them in company coverage without their say as long as the plan is deemed affordable and adequate. That means the employee contribution is no more than 9.5 percent of the federal poverty guideline and the plan pays for at least 60 percent of covered medical expenses, on average.

"If you offer an employee minimum essential coverage that provides minimum value and is affordable, you need not provide an opt out," says Seth Perretta, a partner at Groom Law Group, a Washington, D.C., firm specializing in employee benefits.

If a plan doesn't meet those standards, however, employees must be given the opportunity to decline those company plans, under the health law. They can shop for coverage on the health insurance marketplaces and may qualify for premium tax credits if their income is between 100 and 400 percent of the federal poverty level.

Those premium subsidies aren't available to workers whose employer offers good coverage that meets the law's standards.

Not that many employers are expected to strong arm their workers into buying health insurance. Those that do may be confused about their responsibilities under the health law, mistakenly believing that in order to avoid penalties they have to enroll their workers in coverage.

"That is just dead wrong," says Timothy Jost, a law professor at Washington and Lee University who's an expert on the health law.

"Nothing in the Affordable Care Act directs employers to make their coverage mandatory for employees," says a Treasury Department spokesperson. The law requires large employers "to either offer coverage or pay a fee if their full-time workers access tax credits to get coverage on their own in the marketplace."

Employer penalties for not offering insurance that meets the health law's standards can run up to $3,000 per employee.

For employers, forcing coverage on their workers could be counterproductive. "Do you really want to limit employees' ability to select whether they get this coverage?" says Amy Bergner, managing director at human resources consultant PwC. "What impact does that have from talent management perspective?"

Copyright 2015 Kaiser Health News. To see more, visit http://www.kaiserhealthnews.org/.
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Documents Detail Sugar Industry Efforts To Direct Medical Research

Wed, 03/11/2015 - 10:45am
Documents Detail Sugar Industry Efforts To Direct Medical Research March 11, 201510:45 AM ET

from

Lisa Aliferis Pink Sherbert Photography/Flickr

Back in 2007, Christin Kearns attended a conference for dentists like herself to learn about links between diabetes and gum disease.

She was handed a government pamphlet titled, "How to Talk to Patients about Diabetes," and was surprised to find that the diet advice didn't mention reducing sugar intake. She said it made her wonder if the sugar industry "somehow impacted what the government can or cannot say about diet advice for diabetics?"

Kearns, now a fellow at the University of California, San Francisco wanted to answer that question. She went on a hunt for industry documents that might yield clues.

After months of online searches, she started uncovering some documents which ultimately led to an archive at the University of Illinois, 1,551 pages of documents that show how closely the sugar industry worked with the federal government during the 1960s and early 1970s, when dentists were trying to find a way to prevent cavities in children.

In an analysis of the documents published Wednesday in the journal PLOS Medicine, Kearns and her collaborators concluded that industry influence starting in the late 1960s helped steer the National Institute of Dental Research, part of the National Institutes of Health, away from addressing the question of determining a safe level of sugar.

"What this paper has shown is that our [NIH] was working toward potentially answering that question," Kearns said. "The sugar industry derailed them from doing the research to help to answer that question, so we're still debating [it] here in 2015."

The Salt How Much Sugar Is Too Much? A New Tool Sheds Some Light

The documents show that the sugar industry formed an expert panel using all but one member of the government panel that set research priorities, Kearns said. Ultimately, the industry group submitted a report to the government panel and that report became the foundation for research going forward.

"Seventy-eight percent of the sugar industry submission was incorporated into the NIDR's call for research applications. Research that could have been harmful to sugar industry interests was omitted," the authors note in the study.

"What this shows is that sugar interests were running science manipulation in as sophisticated a manner as 'Big Tobacco' was back in the 50s and 60s," said Stanton Glantz, a professor at UCSF, coauthor of the study and longtime anti-tobacco advocate.

The paper "makes it clear that the sugar industry systematically and deliberately adopted strategies to make sure that federal research agencies did not urge the public to cut down on sugar intake as a means to prevent tooth decay," says Marion Nestle, a nutrition professor at New York University who was not involved in the analysis. "I can attest that the sugar industry is especially aggressive in defending itself against any suggestion to eat less and is following the tobacco industry's playbook."

In a statement, the Sugar Association said it "questions the relevance of attempts to dredge up history when decades of modern science has provided answers regarding the role of diet in the pathogenesis of dental caries."

The statement also says that the authors' "use of attention-grabbing headlines and scare tactics that liken consumption of all-natural sugar ... to a known carcinogen is a 'textbook' play from the activist agenda."

The authors admit their analysis is limited because it "provides a narrow window into the activities of just one sugar industry trade association" and that they could not "interview key actors."

Kearns says there are more documents to be found; she just needs the time and money to do it. And with an eye toward the history of tobacco litigation, she believes litigation is "certainly a possibility" in this case as well. "We've only just begun to scratch the surface of understanding some of the tactics the sugar groups have implemented," she says.

Copyright 2015 KQED Public Media. To see more, visit http://www.kqed.org/news.
Categories: NPR Blogs

States Aim To Restrict Medically Induced Abortions

Wed, 03/11/2015 - 3:36am
States Aim To Restrict Medically Induced Abortions March 11, 2015 3:36 AM ET Listen to the Story 5 min 10 sec  

A view of the eastern entrance to the Ohio Statehouse.

Bob Hall/Flickr

Of the million or so women who have abortions every year in the U.S., nearly a quarter end their pregnancy using medications. But just as states have been passing a record number of restrictions on surgical abortion, more are trying to limit this option as well.

One of the country's strictest laws is in Ohio. To understand it, a little history helps.

The Food and Drug Administration first approved mifepristone, or RU-486, for abortion back in 2000. It laid out guidelines: women must see a doctor to take mifepristone, then come back two days later to take another drug, misoprostol. And the drugs must be taken within the first seven weeks of pregnancy.

But doctors kept experimenting. Lisa Perriera, a Cleveland obstetrician, says researchers found that women can actually take just a third of the dosage and at up through nine weeks' gestation. They also deemed it safe for women to take the second drug on their own, without making another trip to a doctor.

"RU-486 isn't just an aspirin, take one and call you in the morning."

"We made it better by making it less costly, by making it easier to use for women," says Perriera. "We know it's just as effective, probably actually safer with fewer side effects."

Chrisse France of Preterm Clinic in Cleveland says a lot of women preferred drugs to surgery "because they could do it in the privacy of their home."

"It was more comfortable; they could have their partner with them," she says, "[It] felt more natural to them."

That's how it works in all but three states.

But the law in Ohio, like those in Texas and North Dakota, says providers must follow those original FDA guidelines: more doctor visits, more drugs and the earlier cutoff. Preterm Clinic and others fought, but lost. A U.S. appeals court ruled the restrictions don't pose an undue burden.

"Medical abortion has the potential to be a real disruptive technology and change the way women access and experience abortion."

Chrisse France disagrees. In Ohio, combined with other laws that mandate in-person counseling and a 24-hour waiting period, women seeking a medical abortion must make four trips to a clinic. And with a number of clinics closing, some must travel a greater distance.

"We give them the second medication and often they'll start cramping and bleeding in their car on the way home," she says. "And our legislators have determined that this is good medicine."

The law's supporters say it is in the best interests of women's health.

"RU-486 isn't just an aspirin, take one and call you in the morning," says Mike Gonidakis, the president of Ohio Right to Life. He says requiring a woman to see a doctor for both rounds of medication also helps foster the doctor-patient relationship.

"The FDA is the gold standard in our country," he says. "The FDA could change the guidelines on RU-486, but they haven't."

Actually, it's up to the drug manufacturer to apply for new guidelines. That's a lengthy and expensive process. Medical experts also say it's totally unnecessary, since the FDA expects doctors to use approved drugs in other ways.

Last year the U.S. Court of Appeals for the Ninth Circuit struck down another law just like Ohio's. In that case, the state of Arizona also argued the FDA guidelines were better for women's health. But the court said the basis for that claim was "nonexistent."

If Ohio has some of the toughest restrictions on medically induced abortion, the other end of the spectrum is Iowa. Planned Parenthood of the Heartland used to have doctors drive hours to remote clinics to provide abortion drugs to women in rural parts of the state. But chief clinical officer Penny Dickey says that in 2008, they started using telemedicine.

"The physician and the patient connect via a HIPAA-compliant video conferencing system," Dickey says. The doctor reviews the woman's ultrasound online and they talk about her medical history. Then, Dickey says, the doctor clicks in his or her computer to open a locked drawer where the patient is sitting.

Additional Information: Shots - Health News Abortion Restrictions Complicate Access For Ohio Women States Fund Pregnancy Centers That Discourage Abortion Shots - Health News States Continue Push To Ban Abortions After 20 Weeks

"It will say, are you sure you want to do this?" she says. "And they'll click again, and the drawer will open."

Inside are the two medications. The woman takes the mifepristone in view of the doctor. A clinic staffer sitting with her confirms instructions on taking the second drug at home.

Iowa's telemedicine program has not increased the overall number of abortions in Ohio, but a study found it has shifted more of them to the first trimester of pregnancy. That's good, say public health experts, because the earlier an abortion takes place, the safer and cheaper it is.

In 2010 Iowa's Board of Medicine reviewed the program and decided it could continue. But in 2013, after a Republican governor appointed all new members, the board ordered it stopped. Executive Director Mark Bowden declined an interview with NPR. But in a written statement, the board stressed the importance of the doctor-patient relationship. "The physician's in-person medical interview and physical examination of the patient are essential to establishing that relationship," the statement read.

Planned Parenthood of the Heartland has sued. The case is now before Iowa's Supreme Court. Meanwhile, 16 other states have proactively banned telemedicine for abortion, with a flurry of more bills expected this year.

"Medical abortion has the potential to be a real disruptive technology and change the way women access and experience abortion," says Dan Grossman, an obstetrician and vice president of research at Ibis Reproductive Health, a nonprofit that promotes access to safe abortion. He says medication abortion is so safe and so easy, you can imagine not needing to visit a clinic at all.

"It would really be quite easy for women to actually use this on their own," Grossman says, "and potentially access this medication directly from a pharmacy. It could almost be eligible for the kind of medication that could be available over the counter."

To be clear, Grossman does not expect that to happen in the U.S. anytime soon. But he does think the possibility helps explain abortion opponents' big rush to restrict these drugs.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
Categories: NPR Blogs

States Aim To Restrict Medically-Induced Abortions

Wed, 03/11/2015 - 3:36am
States Aim To Restrict Medically-Induced Abortions March 11, 2015 3:36 AM ET Listen to the Story 5 min 10 sec  

A view of the eastern entrance to the Ohio Statehouse.

Bob Hall/Flickr

Of the million or so women who have abortions every year in the U.S., nearly a quarter end their pregnancy using medications. But just as states have been passing a record number of restrictions on surgical abortion, more are trying to limit this option as well.

One of the country's strictest laws is in Ohio. To understand it, a little history helps.

The Food and Drug Administration first approved mifepristone, or RU-486, for abortion back in 2000. It laid out guidelines: women must see a doctor to take mifepristone, then come back two days later to take another drug, misoprostol. And the drugs must be taken within the first seven weeks of pregnancy.

But doctors kept experimenting. Lisa Perriera, a Cleveland obstetrician, says researchers found that women can actually take just a third of the dosage and at up through nine weeks' gestation. They also deemed it safe for women to take the second drug on their own, without making another trip to a doctor.

"RU-486 isn't just an aspirin, take one and call you in the morning."

"We made it better by making it less costly, by making it easier to use for women," says Perriera. "We know it's just as effective, probably actually safer with fewer side effects."

Chrisse France of Preterm Clinic in Cleveland says a lot of women preferred drugs to surgery "because they could do it in the privacy of their home."

"It was more comfortable; they could have their partner with them," she says, "[It] felt more natural to them."

That's how it works in all but three states.

But the law in Ohio, like those in Texas and North Dakota, says providers must follow those original FDA guidelines: more doctor visits, more drugs and the earlier cutoff. Preterm Clinic and others fought, but lost. A U.S. appeals court ruled the restrictions don't pose an undue burden.

"Medical abortion has the potential to be a real disruptive technology and change the way women access and experience abortion."

Chrisse France disagrees. In Ohio, combined with other laws that mandate in-person counseling and a 24-hour waiting period, women seeking a medical abortion must make four trips to a clinic. And with a number of clinics closing, some must travel a greater distance.

"We give them the second medication and often they'll start cramping and bleeding in their car on the way home," she says. "And our legislators have determined that this is good medicine."

The law's supporters say it is in the best interests of women's health.

"RU-486 isn't just an aspirin, take one and call you in the morning," says Mike Gonidakis, the president of Ohio Right to Life. He says requiring a woman to see a doctor for both rounds of medication also helps foster the doctor-patient relationship.

"The FDA is the gold standard in our country," he says. "The FDA could change the guidelines on RU-486, but they haven't."

Actually, it's up to the drug manufacturer to apply for new guidelines. That's a lengthy and expensive process. Medical experts also say it's totally unnecessary, since the FDA expects doctors to use approved drugs in other ways.

Last year the U.S. Court of Appeals for the Ninth Circuit struck down another law just like Ohio's. In that case, the state of Arizona also argued the FDA guidelines were better for women's health. But the court said the basis for that claim was "nonexistent."

If Ohio has some of the toughest restrictions on medically induced abortion, the other end of the spectrum is Iowa. Planned Parenthood of the Heartland used to have doctors drive hours to remote clinics to provide abortion drugs to women in rural parts of the state. But chief clinical officer Penny Dickey says that in 2008, they started using telemedicine.

"The physician and the patient connect via a HIPAA-compliant video conferencing system," Dickey says. The doctor reviews the woman's ultrasound online and they talk about her medical history. Then, Dickey says, the doctor clicks in his or her computer to open a locked drawer where the patient is sitting.

Additional Information: Shots - Health News Abortion Restrictions Complicate Access For Ohio Women States Fund Pregnancy Centers That Discourage Abortion Shots - Health News States Continue Push To Ban Abortions After 20 Weeks

"It will say, are you sure you want to do this?" she says. "And they'll click again, and the drawer will open."

Inside are the two medications. The woman takes the mifepristone in view of the doctor. A clinic staffer sitting with her confirms instructions on taking the second drug at home.

Iowa's telemedicine program has not increased the overall number of abortions in Ohio, but a study found it has shifted more of them to the first trimester of pregnancy. That's good, say public health experts, because the earlier an abortion takes place, the safer and cheaper it is.

At first, Iowa's Board of Medicine agreed the telemedicine program worked well. But in 2013, after a Republican governor appointed new members, the board ordered it stopped. Executive Director Mark Bowden declined an interview with NPR. But in a written statement, the board stressed the importance of the doctor-patient relationship. "The physician's in-person medical interview and physical examination of the patient are essential to establishing that relationship," the statement read.

Planned Parenthood of the Heartland has sued. The case is now before Iowa's Supreme Court. Meanwhile, 16 other states have proactively banned telemedicine for abortion, with a flurry of more bills expected this year.

"Medical abortion has the potential to be a real disruptive technology and change the way women access and experience abortion," says Dan Grossman, an obstetrician and vice president of research at Ibis Reproductive Health, a nonprofit that promotes access to safe abortion. He says medication abortion is so safe and so easy, you can imagine not needing to visit a clinic at all.

"It would really be quite easy for women to actually use this on their own," Grossman says, "and potentially access this medication directly from a pharmacy. It could almost be eligible for the kind of medication that could be available over the counter."

To be clear, Grossman does not expect that to happen in the U.S. anytime soon. But he does think the possibility helps explain abortion opponents' big rush to restrict these drugs.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
Categories: NPR Blogs

FDA Decision Signals New Competition For Some Of The Costliest Drugs

Tue, 03/10/2015 - 4:50pm
FDA Decision Signals New Competition For Some Of The Costliest Drugs March 10, 2015 4:50 PM ET

from

Elana Gordon Listen to the Story 3 min 43 sec  

A look inside the factory in Kundl, Austria, where Sandoz, a unit of Novartis, makes biosimilar drugs.

Novartis

Mark McCamish spent more than five years preparing for a presentation he gave this winter.

McCamish is in charge of biopharmaceutical drug development at the Sandoz division of Switzerland's Novartis. He and his colleagues made the case to a panel of 14 cancer specialists and a group of Food and Drug Administration regulators that a company drug codenamed EP2006 should be approved for sale in the U.S.

The drug, brand name Zarxio, is similar to but not quite identical to Amgen's Neupogen, a medicine approved by the FDA back in 1991 to fight infections in cancer patients.

Industry representatives, patient advocates and investors paid close attention to the evidence under review. Some came in for the day from Europe, their suitcases propped against the wall. That's because Novartis' drug application represented uncharted territory.

The FDA approved Zarxio on Friday, and it's the first time the agency has approved a so-called biosimilar, or close copy of an existing biotech medicine.

Dr. Jay Siegel, chief biotechnology officer at Johnson & Johnson and a former FDA regulator, says biosimilars are a little like the generic drugs we're used to. The key difference is that they're copycats of more complex medicines called biologics, made with living cells.

"In a simplistic sense, biologics are typically much larger molecules, usually made by living organisms," Siegel says. "They can be antibodies whereas most drugs are smaller chemical entities that can be synthesized in the laboratory," he explains.

It is difficult to make exact copies of biotech drugs because they are manufactured differently than tablets or syrups.

Think of it a little like drinks. If you want to copy the cocktail you had at your local bar, you buy the ingredients and faithfully follow the steps and proportions laid out in the bartender's recipe. Voila! A generic cocktail mixed more cheaply (probably) at home than at the bar itself — and just as good.

Now, let's say you fell in love with the glass of Bordeaux you had with your meal. Want to copy that? Good luck. At the least, you've got to account for the grapes and their unique character, the fermentation and the aging process. Making wine is a biological process that's more complicated than simply combining ingredients in a cocktail shaker.

OK, back to the medicine.

Many biologics are approved for sale in the U.S. to treat conditions ranging from anemia to multiple sclerosis. The medicines make up a small but costly portion of the U.S. drug market. Amye Leong is a patient advocate who came in for the FDA hearing from California. Leong has rheumatoid arthritis. She was in a wheelchair for five years. No more, thanks in part to biologics. But she says it's important to approve biosimilars because biologics are so expensive that they're often out of reach for patients.

For example, she says, to treat some forms of autoimmune inflammatory arthritis, the medicine costs at least $1,800 a month.

"Now you want to pay rent food, get child through school or do you want the drug that will hopefully make a difference in your disease and life, it should not have to be about that," she says.

The hope is that like generics, biosimilars could offer cheaper options for patients like Leong that are just as effective.

The copycat drugs have been on the market in Europe for nearly a decade and led to a 20 to 30 percent reduction in some prices for some biologics. An estimate from Express Scripts, a drug benefit manager, projects Zarxio alone could save the health system nearly $6 billion over the next decade.

But while Europe passed a law establishing an approval pathway for biosimilars a decade ago, that didn't happen in the U.S. until the Affordable Care Act took effect. Specifically, there's a 40-page section called the Biologics Price Competition and Innovation Act. Like the Hatch-Waxman Act which paved the way for generics in the '80s, this law established the framework for the FDA to assess and approve biosimilars.

The legislation "was anticipated to save money," says Gillian Woolette, a consultant at Avalere Health who attended the meeting. "So therefore, if you put it in the Affordable Care Act, both the timing was right but also the CBO estimate was a savings of $14 billion [over the next 10 years]," which helped offset other costs in the health law.

Other estimates put the savings even higher.

Everyone at the meeting knew cost is a huge issue, but the FDA panel's task was to examine whether this drug is similar enough to the original one to be given to patients. It's a higher standard than is required for traditional generics and requires makers of biosimilars to submit some clinical data. After a brief, anticlimactic back and forth, all 14 advisors recommended that the FDA approve the drug, which it did last week.

Dr. Scott Waldman, a clinical pharmacologist from Thomas Jefferson University in Philadelphia, was on the panel. He says the Zarxio application, unlike others in the pipeline, had it easy because the drug has been used in Europe for years and there's a lot of data to support its use.

"I think this is a pretty high bar to set and that other compounds that come through are going to have to leap over this bar," he says.

This story is part of a reporting partnership with NPR, WHYY and Kaiser Health News.

Copyright 2015 WHYY, Inc.. To see more, visit http://www.whyy.org.
Categories: NPR Blogs

FDA Decision Signals New Competition For Some Of The Costliest Drugs

Tue, 03/10/2015 - 4:50pm
FDA Decision Signals New Competition For Some Of The Costliest Drugs March 10, 2015 4:50 PM ET

from

Elana Gordon Listen to the Story 3 min 43 sec  

A look inside the factory in Kundl, Austria, where Sandoz, a unit of Novartis, makes biosimilar drugs.

Novartis

Mark McCamish spent more than five years preparing for a presentation he gave this winter.

McCamish is in charge of biopharmaceutical drug development at the Sandoz division of Switzerland's Novartis. He and his colleagues made the case to a panel of 14 cancer specialists and a group of Food and Drug Administration regulators that a company drug codenamed EP2006 should be approved for sale in the U.S.

The drug, brand name Zarxio, is similar to but not quite identical to Amgen's Neupogen, a medicine approved by the FDA back in 1991 to fight infections in cancer patients.

Industry representatives, patient advocates and investors paid close attention to the evidence under review. Some came in for the day from Europe, their suitcases propped against the wall. That's because Novartis' drug application represented uncharted territory.

The FDA approved Zarxio on Friday, and it's the first time the agency has approved a so-called biosimilar, or close copy of an existing biotech medicine.

Dr. Jay Siegel, chief biotechnology officer at Johnson & Johnson and a former FDA regulator, says biosimilars are a little like the generic drugs we're used to. The key difference is that they're copycats of more complex medicines called biologics, made with living cells.

"In a simplistic sense, biologics are typically much larger molecules, usually made by living organisms," Siegel says. "They can be antibodies whereas most drugs are smaller chemical entities that can be synthesized in the laboratory," he explains.

It is difficult to make exact copies of biotech drugs because they are manufactured differently than tablets or syrups.

Think of it a little like drinks. If you want to copy the cocktail you had at your local bar, you buy the ingredients and faithfully follow the steps and proportions laid out in the bartender's recipe. Voila! A generic cocktail mixed more cheaply (probably) at home than at the bar itself — and just as good.

Now, let's say you fell in love with the glass of Bordeaux you had with your meal. Want to copy that? Good luck. At the least, you've got to account for the grapes and their unique character, the fermentation and the aging process. Making wine is a biological process that's more complicated than simply combining ingredients in a cocktail shaker.

OK, back to the medicine.

Many biologics are approved for sale in the U.S. to treat conditions ranging from anemia to multiple sclerosis. The medicines make up a small but costly portion of the U.S. drug market. Amye Leong is a patient advocate who came in for the FDA hearing from California. Leong has rheumatoid arthritis. She was in a wheelchair for five years. No more, thanks in part to biologics. But she says it's important to approve biosimilars because biologics are so expensive that they're often out of reach for patients.

For example, she says, to treat some forms of autoimmune inflammatory arthritis, the medicine costs at least $1,800 a month.

"Now you want to pay rent food, get child through school or do you want the drug that will hopefully make a difference in your disease and life, it should not have to be about that," she says.

The hope is that like generics, biosimilars could offer cheaper options for patients like Leong that are just as effective.

The copycat drugs have been on the market in Europe for nearly a decade and led to a 20 to 30 percent reduction in some prices for some biologics. An estimate from Express Scripts, a drug benefit manager, projects Zarxio alone could save the health system nearly $6 billion over the next decade.

But while Europe passed a law establishing an approval pathway for biosimilars a decade ago, that didn't happen in the U.S. until the Affordable Care Act took effect. Specifically, there's a 40-page section called the Biologics Price Competition and Innovation Act. Like the Hatch-Waxman Act which paved the way for generics in the '80s, this law established the framework for the FDA to assess and approve biosimilars.

The legislation "was anticipated to save money," says Gillian Woolette, a consultant at Avalere Health who attended the meeting. "So therefore, if you put it in the Affordable Care Act, both the timing was right but also the CBO estimate was a savings of $14 billion [over the next 10 years]," which helped offset other costs in the health law.

Other estimates put the savings even higher.

Everyone at the meeting knew cost is a huge issue, but the FDA panel's task was to examine whether this drug is similar enough to the original one to be given to patients. It's a higher standard than is required for traditional generics and requires makers of biosimilars to submit some clinical data. After a brief, anticlimactic back and forth, all 14 advisors recommended that the FDA approve the drug, which it did last week.

Dr. Scott Waldman, a clinical pharmacologist from Thomas Jefferson University in Philadelphia, was on the panel. He says the Zarxio application, unlike others in the pipeline, had it easy because the drug has been used in Europe for years and there's a lot of data to support its use.

"I think this is a pretty high bar to set and that other compounds that come through are going to have to leap over this bar," he says.

This story is part of a reporting partnership with NPR, WHYY and Kaiser Health News.

Copyright 2015 WHYY, Inc.. To see more, visit http://www.whyy.org.
Categories: NPR Blogs

A Sheriff And A Doctor Team Up To Map Childhood Trauma

Tue, 03/10/2015 - 3:33pm
A Sheriff And A Doctor Team Up To Map Childhood Trauma March 10, 2015 3:33 PM ET Laura Starecheski Listen to the Story 8 min 15 sec  

Alachua County Sheriff Sadie Darnell (left) and Dr. Nancy Hardt, University of Florida.

Bryan Thomas for NPR

The University of Florida's Dr. Nancy Hardt has an unusual double specialty: She's both a pathologist and an OB-GYN. For the first half of her career, she brought babies into the world. Then she switched — to doing autopsies on people after they die.

"I want to prevent what I'm seeing on the autopsy table. ... A lot of times, I'm standing there going, 'I don't think this person had a very nice early childhood.' "

It makes perfect sense to her.

"Birth, and death. It's the life course," Hardt explains.

A few years ago, Hardt says, she learned about some research that changed her view of how exactly that life course — health or illness — unfolds.

The research shows that kids who have tough childhoods — because of poverty, abuse, neglect or witnessing domestic violence, for instance — are actually more likely to be sick when they grow up. They're more likely to get diseases like asthma, diabetes and heart disease. And they tend to have shorter lives than people who haven't experienced those difficult events as kids.

"I want to prevent what I'm seeing on the autopsy table," Hardt says. "I've got to say, a lot of times, I'm standing there, going, 'I don't think this person had a very nice early childhood.' "

Back in 2008, Hardt was obsessing about this problem. She wanted to do something to intervene in the lives of vulnerable kids on a large scale, not just patient by patient.

Hardt's Map Of Medicaid Births

The deep blue and red spot on the left shows the Gainesville area's most dense concentration of babies born into poverty — to parents on Medicaid.

Credit: Courtesy of Dr. Nancy Hardt

So, by looking at Medicaid records, she made a map that showed exactly where Gainesville children were born into poverty. Block by block.

Right away she noticed something that surprised her: In the previous few years, in a 1-square-mile area in southwest Gainesville, as many as 450 babies were born to parents living below the poverty line.

It just didn't make sense to her — that was an area she thought was all fancy developments and mansions.

So Hardt took her map of Gainesville, with the poverty "hotspot" marked in deep blue, and started showing it to people. She'd ask them, "What is this place? What's going on over there?"

Eventually she brought the map to the CEO of her hospital, who told her she just had to show it to Alachua County's sheriff, Sadie Darnell.

So Hardt did.

And, to Hardt's surprise, Sheriff Darnell had a very interesting map of her own.

What Shapes Health Shots - Health News Poll Explores Our Perception Of How Factors Large And Small Shape People's Health

Darnell had a thermal map of high crime incidence. It showed that the highest concentration of crime in Gainesville was in a square-mile area that exactly overlaid Hardt's poverty map.

"It was an amazing, 'Aha' moment," says Darnell.

"We kind of blinked at each other," Hardt says. "And — simultaneously — we said, 'We've got to do something.' "

The hotspot is dotted with isolated, crowded apartment complexes with names like Majestic Oaks and Holly Heights. The first time she visited, on a ride-along with Sheriff Darnell's deputies, Hardt tallied up all things that make it hard for kids here to grow up healthy.

Dr. Nancy Hardt's free "clinic on wheels," parked in December at an apartment complex in Gainesville, Fla., gets about 5,000 visits from patients each year.

Bryan Thomas for NPR

There's a lot of poorly maintained subsidized housing. Tarps cover leaky roofs. Mold and mildew spread across stucco walls. Sherry French, a sergeant from the sheriff's office, says lots of families here have trouble getting enough to eat.

Hardt added hunger to her list and substandard housing. And she noticed something else: almost a total lack of services, including medical care.

She mapped it out and determined that the closest place to get routine medical care if you're uninsured — which many people here are — is the county health department. It's almost a two-hour trip away by bus. Each way.

This was a problem a doctor like Hardt could tackle. She would bring medical care to the hotspot, by rustling up a very large donation: a converted Bluebird school bus, with two exam rooms inside.

Hardt organized a massive crew of volunteer doctors and medical students from the University of Florida, where she teaches, and raised the money to hire a driver and a full-time nurse.

The "clinic on wheels" first made it out to the hotspot in 2010, parking right inside one apartment complex there. Patients could walk in without an appointment and get treatment free of charge, approximating the experience of a house call. Today, the mobile clinic gets an average of 5,000 visits from patients per year, in under-served areas all over Gainesville.

Physician assistants and undergraduate care coordinators treat patients in the mobile clinic parked at Majestic Oaks, a low-income apartment complex in Gainesville.

Bryan Thomas for NPR

But the clinic is really just one piece of the puzzle.

Because after the day that Hardt and the sheriff matched up their maps, they kept digging into the data. And, a few years later, Hardt made some new maps. They showed that the crime in the hotspot included the highest concentration of domestic violence, child abuse and neglect in Gainesville.

Childhood Trauma Maps

The reddish pink spots on these maps of the Gaineseville area, indicate an increased density of reports of child abuse and neglect (top map) and domestic violence (bottom). Deep blue indicates the highest concentration.

Source: (Top) Alachua County Department of Children and Families; (Bottom) Gainesville Police Department, Alachua County Sheriff's Office

Credit: Courtesy of Dr. Nancy Hardt

That revelation brought Dr. Hardt back to her original mission — to head off bad health outcomes in the most vulnerable kids. So she teamed up with Sheriff Darnell and other local groups and grass-roots organizers from the neighborhood. They collaborated to create the SWAG (Southwest Advocacy Group) Family Resource Center, right in the Linton Oaks apartment complex.

The SWAG Center opened in 2012. Kids can come play all day long. There's a food pantry, free meals, a computer room, AA meetings. A permanent health clinic is slated to open up across the street next week.

All the resources here are designed to decrease the likelihood of abuse and neglect by strengthening families.

"I think we knew it intuitively — that health issues are associated with crime, [and] crime is associated with health issues and poverty," Darnell says. "But seeing that direct connection literally on a map ... it helped to break down a lot of walls."

Child abuse and domestic violence are still serious problems, but there has been a small drop in the numbers of such calls over the past few years, according to the data.

Hardt says that investing in families and health now can help kids grow up healthy — and save money in the future.

Shots - Health News To Head Off Trauma's Legacy, Start Young

"Conservatives or liberals, everybody gets that," she says. "That we have limited resources and we need to really spend them wisely. I think the maps — the hot spot maps — just tell us policywise, where we need to be going and what we need to be doing."

Hardt's next goal is to make more people aware of the links between health and early education. Last summer, the county got a new superintendent of schools. Hardt has been to visit him three times already — maps in hand.

This story is part of the NPR series, What Shapes Health? The series explores social and environmental factors that affect health throughout life. It is inspired, in part, by findings in a poll released this month by NPR, the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
Categories: NPR Blogs

A Sheriff And A Doctor Team Up To Map Childhood Trauma

Tue, 03/10/2015 - 3:33pm
A Sheriff And A Doctor Team Up To Map Childhood Trauma March 10, 2015 3:33 PM ET Laura Starecheski Listen to the Story 8 min 15 sec  

Alachua County Sheriff Sadie Darnell (left) and Dr. Nancy Hardt, University of Florida.

Bryan Thomas for NPR

The University of Florida's Dr. Nancy Hardt has an unusual double specialty: She's both a pathologist and an OB-GYN. For the first half of her career, she brought babies into the world. Then she switched — to doing autopsies on people after they die.

"I want to prevent what I'm seeing on the autopsy table. ... A lot of times, I'm standing there going, 'I don't think this person had a very nice early childhood.' "

It makes perfect sense to her.

"Birth, and death. It's the life course," Hardt explains.

A few years ago, Hardt says, she learned about some research that changed her view of how exactly that life course — health or illness — unfolds.

The research shows that kids who have tough childhoods — because of poverty, abuse, neglect, or witnessing domestic violence, for instance — are actually more likely to be sick when they grow up. They're more likely to get diseases like asthma, diabetes and heart disease. And they tend to have shorter lives than people who haven't experienced those difficult events as kids.

"I want to prevent what I'm seeing on the autopsy table," Hardt says. "I've got to say, a lot of times, I'm standing there, going, 'I don't think this person had a very nice early childhood.' "

Back in 2008, Hardt was obsessing about this problem. She wanted to do something to intervene in the lives of vulnerable kids on a large scale, not just patient by patient.

Hardt's Map Of Medicaid Births

The deep blue and red spot on the left shows the Gainesville area's most dense concentration of babies born into poverty — to parents on Medicaid.

Credit: Courtesy of Dr. Nancy Hardt

So, by looking at Medicaid records, she made a map that showed exactly where Gainesville children were born into poverty. Block by block.

Right away she noticed something that surprised her: In the previous few years, in a 1-square-mile area in southwest Gainesville, as many as 450 babies were born to parents living below the poverty line.

It just didn't make sense to her — that was an area she thought was all fancy developments and mansions.

So Hardt took her map of Gainesville, with the poverty "hotspot" marked in deep blue, and started showing it to people. She'd ask them, "What is this place? What's going on over there?"

Eventually she brought the map to the CEO of her hospital, who told her she just had to show it to Alachua County's sheriff, Sadie Darnell.

So Hardt did.

And, to Hardt's surprise, Sheriff Darnell had a very interesting map of her own.

What Shapes Health Shots - Health News Poll Explores Our Perception Of How Factors Large And Small Shape People's Health

Darnell had a thermal map of high crime incidence. It showed that the highest concentration of crime in Gainesville was in a square-mile area that exactly overlaid Hardt's poverty map.

"It was an amazing, 'Aha' moment," says Darnell.

"We kind of blinked at each other," Hardt says. "And — simultaneously — we said, 'We've got to do something.' "

The hotspot is dotted with isolated, crowded apartment complexes with names like Majestic Oaks and Holly Heights. The first time she visited, on a ride-along with Sheriff Darnell's deputies, Hardt tallied up all things that make it hard for kids here to grow up healthy.

Dr. Nancy Hardt's free "clinic on wheels," parked in December at an apartment complex in Gainesville, Fla., gets about 5,000 visits from patients each year.

Bryan Thomas for NPR

There's a lot of poorly maintained subsidized housing. Tarps cover leaky roofs. Mold and mildew spread across stucco walls. Sherry French, a sergeant from the sheriff's office, says lots of families here have trouble getting enough to eat.

Hardt added hunger to her list and substandard housing. And she noticed something else: almost a total lack of services, including medical care.

She mapped it out and determined that the closest place to get routine medical care if you're uninsured — which many people here are — is the county health department. It's almost a two-hour trip away by bus. Each way.

This was a problem a doctor like Hardt could tackle. She would bring medical care to the hotspot, by rustling up a very large donation: a converted Bluebird school bus, with two exam rooms inside.

Hardt organized a massive crew of volunteer doctors and medical students from the University of Florida, where she teaches, and raised the money to hire a driver and a full-time nurse.

The "clinic on wheels" first made it out to the hotspot in 2010, parking right inside one apartment complex there. Patients could walk in without an appointment and get treatment free of charge, approximating the experience of a house call. Today, the mobile clinic gets an average of 5,000 visits from patients per year, in under-served areas all over Gainesville.

Physician assistants and undergraduate care coordinators treat patients in the mobile clinic parked at Majestic Oaks, a low-income apartment complex in Gainesville.

Bryan Thomas for NPR

But the clinic is really just one piece of the puzzle.

Because after the day that Hardt and the sheriff matched up their maps, they kept digging into the data. And, a few years later, Hardt made some new maps. They showed that the crime in the hotspot included the highest concentration of domestic violence, child abuse and neglect in Gainesville.

Childhood Trauma Maps

The reddish pink spots on these maps of the Gaineseville area, indicate an increased density of reports of child abuse and neglect (top map) and domestic violence (bottom). Deep blue indicates the highest concentration.

Source: (Top) Alachua County Department of Children and Families; (Bottom) Gainesville Police Department, Alachua County Sheriff's Office

Credit: Courtesy of Dr. Nancy Hardt

That revelation brought Dr. Hardt back to her original mission — to head off bad health outcomes in the most vulnerable kids. So she teamed up with Sheriff Darnell and other local groups and grass-roots organizers from the neighborhood. They collaborated to create the SWAG (Southwest Advocacy Group) Family Resource Center, right in the Linton Oaks apartment complex.

The SWAG Center opened in 2012. Kids can come play all day long. There's a food pantry, free meals, a computer room, AA meetings. A permanent health clinic is slated to open up across the street next week.

All the resources here are designed to decrease the likelihood of abuse and neglect by strengthening families.

"I think we knew it intuitively — that health issues are associated with crime, [and] crime is associated with health issues and poverty," Darnell says. "But seeing that direct connection literally on a map ... it helped to break down a lot of walls."

Child abuse and domestic violence are still serious problems, but there has been a small drop in the numbers of such calls over the past few years, according to the data.

Hardt says that investing in families and health now can help kids grow up healthy — and save money in the future.

Shots - Health News To Head Off Trauma's Legacy, Start Young

"Conservatives or liberals, everybody gets that," she says. "That we have limited resources and we need to really spend them wisely. I think the maps — the hotspot maps — just tell us policywise, where we need to be going and what we need to be doing."

Hardt's next goal is to make more people aware of the links between health and early education. Last summer, the county got a new superintendent of schools. Hardt has been to visit him three times already — maps in hand.

This story is part of the NPR series, What Shapes Health? The series explores social and environmental factors that affect health throughout life. It is inspired, in part, by findings in a poll released this month by NPR, the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
Categories: NPR Blogs

Playing The Odds With Statins: Heart Disease Or Diabetes?

Tue, 03/10/2015 - 1:55pm
Playing The Odds With Statins: Heart Disease Or Diabetes? March 10, 2015 1:55 PM ET Wendy Wolfson Katherine Streeter for NPR

Last year my cholesterol shot up despite living nowhere near a decent barbeque joint. I was totally stressed. I wasn't overweight. But I was pretty sedentary. My doctor prescribed a high dose of Lipitor, a powerful statin.

For women of a certain age, statins are supposedly the best thing since Lycra for keeping wayward bodies in check. Statins interfere with the synthesis of low-density lipoprotein, the "bad" cholesterol. LDL is a prime suspect in heart disease, the top killer of women.

The statin cut my cholesterol like buttah.

Heart trouble and diabetes run in my family. Was I trading a heart attack for diabetes?

But statins can also increase the risk of developing Type 2 diabetes, muscle and/or liver damage. Heart trouble and diabetes run in my family. Was I trading a heart attack for diabetes?

"We give statins to people with diabetes," was all my doc said.

That didn't answer my question. I knew from an unrelated test that I did not currently have coronary artery disease, so I decided to investigate the statin situation.

In 2012 the Food and Drug Administration slapped a black box warning on statins, saying that they could raise blood glucose levels in people at high risk of Type 2 diabetes. That meant an increase of anywhere from 9 to 27 percent in relative risk – in absolute terms about 0.3 excess cases of diabetes for every 100 people who are treated for a year with high-intensity statins (which lower cholesterol by 50 percent or more) and 0.1 excess cases of diabetes for every 100 people treated with moderate-intensity statins (which lower cholesterol by 30 to 50 percent.)

Shots - Health News Genetic Disorder May Reveal How Statins Boost Diabetes Risk

Because doctors disagree on who should get statins, in 2013 the American College of Cardiology and the American Heart Association issued guidelines advising doctors not to treat to a cholesterol target, but to prescribe statins if patients fit into one of four risk categories and had an estimated 10-year heart disease risk greater than 7.5 percent.

I didn't fit any category, and based on their calculator my 10-year risk of a heart attack was only 2.9 percent. But my father had a heart attack before age 55. That meant medicating was up to my doctor.

Shots - Health News Cholesterol Drugs May Raise Risk Of Diabetes A Little

That dumped me right back into the slush pile of uncertainty. Comparing clinical studies was frustrating because populations and measures varied, error margins were squishy and effects were small and murky over large populations.

I hit pay dirt with the Statin Diabetes Safety Task Force 2014 Update, which stated that statins lower the relative risk of heart attack, stroke and death by 25 to 30 percent. They increase diabetes by a relative risk of 10 to 12 percent compared to placebo or usual treatment. So if you are at high risk for diabetes, a statin will get you there faster. Boiled down: one excess case of diabetes in 255 people who took a statin, balanced against 5.4 heart events avoided over an average of 4 years.

Lipitor, a blockbuster drug used by millions, went generic in 2011 but is still big business. It had $631 million in U.S. sales in 2013, down from a peak of $7 billion in 2006. That meant Lipitor must have a track record.

Shots - Health News Side Effects Prompt Patients To Stop Cholesterol Drugs

Clinicial trials don't give a full picture of risk because they are conducted on a limited population, according to Brian Overstreet, CEO of Adverse Events, a Healdsburg, Calif., data-mining company. Things get far messier in real life. His company cleans up data from FAERS, the FDA Adverse Event Reporting System on consumer-reported side effects, and sells it to health care systems like the one where my doctor practices. In the company's report, out of almost 50,000 consumer-reported complaints of Lipitor side effects, about 4 percent were for diabetes.

For a sanity check, I emailed Dr. Naveed Sattar, a professor of metabolic medicine at the University of Glasgow who writes for Diabetes Update. He tactfully confirmed that my diabetes fears were overblown. Sattar is younger and far fitter than me. He told me that his risk of diabetes is far higher than mine because his immediate family members already have it. But he reassured me that while exercise does not directly lower cholesterol, it helps prevent heart disease in other ways.

Maybe reading all those studies had fanned my incipient hypochondria, but going for a walk was like slogging through mud. Forget running. And my liver was squawking.

After four months on statins, my blood glucose still tested normal, but I was feeling increasingly seedy, wobbly-kneed and weak. Maybe reading all those studies had fanned my incipient hypochondria, but going for a walk was like slogging through mud. Forget running. And my liver was squawking. My liver enzyme level was only a few points above normal, but it had almost tripled since last year.

My husband, an engineer in a semiconductor foundry, observed that that kind of change would shut down the assembly line and require statistical process control. Go for it, I told him.

Using our daughter's pink calculator, The Cartoon Guide to Statistics and study data, we calculated conditional probability scenarios like Las Vegas bookies. Given high cholesterol, my personal probability of getting heart disease in 10 years unmedicated was about 12 percent. Taking a statin, about 10 percent.

So marginal benefit versus a whiff of real side effects; was the statin worth it? I ditched the statin. The weakness evaporated. I could run again.

The correlation between my blood cholesterol level and the chance of getting heart disease was weak, but my personal risk was statistically driven up because 30 percent of American women my age (early 50s) have heart disease.

So marginal benefit versus a whiff of real side effects; was the statin worth it? I ditched the statin. The weakness evaporated. I could run again.

On reflection, maybe the reason I got statins was not medical but economic. My health plan rates its doctors by their efficiency in taming patient numbers. Taking a pill is easy and gets quick results. Regular cardiovascular exercise, repeated blood tests and doctor's visits is more uncertain and expensive.

Shots - Health News I Thought It Was Just Stress, Until It Broke My Heart

I finally got in to see my doctor last week. She didn't remember repeatedly insisting that I take the highest dosage of Lipitor, but after I briefly reviewed with her my risks and side effects, based on real research and experience this time, she agreed I could drop the statin.

My victory was in finally figuring out the right questions to ask. I'm still shaken because she had prescribed to formula but not to me as an individual. We both missed things in the risk conversations we should have had. Next time I hope to do better at asking questions like "Why?" and "What happens in people like me?" and "What are the alternatives?"

And of course, "Where can I look this up?"

Wendy Wolfson is a science writer in Orange County, Calif.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
Categories: NPR Blogs

Playing The Odds With Statins: Heart Disease Or Diabetes?

Tue, 03/10/2015 - 1:55pm
Playing The Odds With Statins: Heart Disease Or Diabetes? March 10, 2015 1:55 PM ET Wendy Wolfson Katherine Streeter for NPR

Last year my cholesterol shot up despite living nowhere near a decent barbeque joint. I was totally stressed. I wasn't overweight. But I was pretty sedentary. My doctor prescribed a high dose of Lipitor, a powerful statin.

For women of a certain age, statins are supposedly the best thing since Lycra for keeping wayward bodies in check. Statins interfere with the synthesis of low-density lipoprotein, the "bad" cholesterol. LDL is a prime suspect in heart disease, the top killer of women.

The statin cut my cholesterol like buttah.

Heart trouble and diabetes run in my family. Was I trading a heart attack for diabetes?

But statins can also increase the risk of developing Type 2 diabetes, muscle and/or liver damage. Heart trouble and diabetes run in my family. Was I trading a heart attack for diabetes?

"We give statins to people with diabetes," was all my doc said.

That didn't answer my question. I knew from an unrelated test that I did not currently have coronary artery disease, so I decided to investigate the statin situation.

In 2012 the Food and Drug Administration slapped a black box warning on statins, saying that they could raise blood glucose levels in people at high risk of Type 2 diabetes. That meant an increase of anywhere from 9 to 27 percent in relative risk – in absolute terms about 0.3 excess cases of diabetes for every 100 people who are treated for a year with high-intensity statins (which lower cholesterol by 50 percent or more) and 0.1 excess cases of diabetes for every 100 people treated with moderate-intensity statins (which lower cholesterol by 30 to 50 percent.)

Shots - Health News Genetic Disorder May Reveal How Statins Boost Diabetes Risk

Because doctors disagree on who should get statins, in 2013 the American College of Cardiology and the American Heart Association issued guidelines advising doctors not to treat to a cholesterol target, but to prescribe statins if patients fit into one of four risk categories and had an estimated 10-year heart disease risk greater than 7.5 percent.

I didn't fit any category, and based on their calculator my 10-year risk of a heart attack was only 2.9 percent. But my father had a heart attack before age 55. That meant medicating was up to my doctor.

Shots - Health News Cholesterol Drugs May Raise Risk Of Diabetes A Little

That dumped me right back into the slush pile of uncertainty. Comparing clinical studies was frustrating because populations and measures varied, error margins were squishy and effects were small and murky over large populations.

I hit pay dirt with the Statin Diabetes Safety Task Force 2014 Update, which stated that statins lower the relative risk of heart attack, stroke and death by 25 to 30 percent. They increase diabetes by a relative risk of 10 to 12 percent compared to placebo or usual treatment. So if you are at high risk for diabetes, a statin will get you there faster. Boiled down: one excess case of diabetes in 255 people who took a statin, balanced against 5.4 heart events avoided over an average of 4 years.

Lipitor, a blockbuster drug used by millions, went generic in 2011 but is still big business. It had $631 million in U.S. sales in 2013, down from a peak of $7 billion in 2006. That meant Lipitor must have a track record.

Shots - Health News Side Effects Prompt Patients To Stop Cholesterol Drugs

Clinicial trials don't give a full picture of risk because they are conducted on a limited population, according to Brian Overstreet, CEO of Adverse Events, a Healdsburg, Calif., data-mining company. Things get far messier in real life. His company cleans up data from FAERS, the FDA Adverse Event Reporting System on consumer-reported side effects, and sells it to health care systems like the one where my doctor practices. In the company's report, out of almost 50,000 consumer-reported complaints of Lipitor side effects, about 4 percent were for diabetes.

For a sanity check, I emailed Dr. Naveed Sattar, a professor of metabolic medicine at the University of Glasgow who writes for Diabetes Update. He tactfully confirmed that my diabetes fears were overblown. Sattar is younger and far fitter than me. He told me that his risk of diabetes is far higher than mine because his immediate family members already have it. But he reassured me that while exercise does not directly lower cholesterol, it helps prevent heart disease in other ways.

Maybe reading all those studies had fanned my incipient hypochondria, but going for a walk was like slogging through mud. Forget running. And my liver was squawking.

After four months on statins, my blood glucose still tested normal, but I was feeling increasingly seedy, wobbly-kneed and weak. Maybe reading all those studies had fanned my incipient hypochondria, but going for a walk was like slogging through mud. Forget running. And my liver was squawking. My liver enzyme level was only a few points above normal, but it had almost tripled since last year.

My husband, an engineer in a semiconductor foundry, observed that that kind of change would shut down the assembly line and require statistical process control. Go for it, I told him.

Using our daughter's pink calculator, The Cartoon Guide to Statistics and study data, we calculated conditional probability scenarios like Las Vegas bookies. Given high cholesterol, my personal probability of getting heart disease in 10 years unmedicated was about 12 percent. Taking a statin, about 10 percent.

So marginal benefit versus a whiff of real side effects; was the statin worth it? I ditched the statin. The weakness evaporated. I could run again.

The correlation between my blood cholesterol level and the chance of getting heart disease was weak, but my personal risk was statistically driven up because 30 percent of American women my age (early 50s) have heart disease.

So marginal benefit versus a whiff of real side effects; was the statin worth it? I ditched the statin. The weakness evaporated. I could run again.

On reflection, maybe the reason I got statins was not medical but economic. My health plan rates its doctors by their efficiency in taming patient numbers. Taking a pill is easy and gets quick results. Regular cardiovascular exercise, repeated blood tests and doctor's visits is more uncertain and expensive.

Shots - Health News I Thought It Was Just Stress, Until It Broke My Heart

I finally got in to see my doctor last week. She didn't remember repeatedly insisting that I take the highest dosage of Lipitor, but after I briefly reviewed with her my risks and side effects, based on real research and experience this time, she agreed I could drop the statin.

My victory was in finally figuring out the right questions to ask. I'm still shaken because she had prescribed to formula but not to me as an individual. We both missed things in the risk conversations we should have had. Next time I hope to do better at asking questions like "Why?" and "What happens in people like me?" and "What are the alternatives?"

And of course, "Where can I look this up?"

Wendy Wolfson is a science writer in Orange County, Calif.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
Categories: NPR Blogs

Genetic Disorder May Reveal How Statins Boost Diabetes Risk

Tue, 03/10/2015 - 1:54pm
Genetic Disorder May Reveal How Statins Boost Diabetes Risk March 10, 2015 1:54 PM ET

Lipitor and other statin drugs are commonly prescribed to lower cholesterol.

Paul J. Richards/AFP/Getty Images

Millions of people take statins to lower their cholesterol and reduce the risk of cardiovascular disease. But taking statins does slightly up the risk of Type 2 diabetes. Figuring out whether that means "No statins for you" isn't always easy, despite a proliferation of guidelines intended to help.

Here's in interesting wrinkle: If you've got a hereditary form of high cholesterol you're much less likely to get Type 2 diabetes, according to a study published Tuesday in JAMA, the journal of the American Medical Association.

Shots - Health News Playing The Odds With Statins: Heart Disease Or Diabetes?

That's good news for those people, who often have high levels of LDL cholesterol starting in childhood and face a high risk of heart disease and stroke. And it offers intriguing hints as to a possible link between cholesterol receptors in the body and Type 2 diabetes.

To find that out, researchers in the Netherlands delved into an amazing database that has tracked people for familial hypercholesterolemia since 1994. The large number of people tested — 63,320 — made it possible to not only identify people with genetic mutations that caused the high cholesterol, but to show how it runs in families.

The people with familial hypercholesterolemia had a 51 percent lower risk of Type 2 diabetes than their relatives without the disorder. But the diabetes risk for both groups was low: 1.75 percent versus 2.93 percent. It varied based on the particular genetic mutation involved. That difference makes for a nifty demonstration on how genes affect risk, and confirms a link that doctors who treat patients with the disorder have long observed.

And it also may explain why taking statins boosts the risk of Type 2 diabetes in some people.

Shots - Health News Shift In Cholesterol Advice Could Double Statin Use

One theory on how statins work is that they encourage cells to hoover up the bad LDL cholesterol by turning on LDL receptors. That's good for lowering cholesterol levels in the blood, but the study authors said it may also end up damaging the pancreas, which has lots of LDL receptors and controls blood sugar.

"They're speculating that this LDL receptor may be important in some way in determining the risk of diabetes in a statin," says David Preiss, a metabolic physician at the Glasgow Cardiovascular Research Center at the University of Glasgow who wrote an editorial accompanying the JAMA study. "The data they show is quite strongly supportive of that."

Shots - Health News Statins Might Not Cause Aching Muscles, But Diabetes Risk Is Real

"Of course this is very intriguing," says Kees Hovingh, a vascular medicine specialist at the Academic Medical Centre in Amsterdam and a co-author of the study. He and his colleagues are already looking at the cellular level to see how LDL receptors and cholesterol could affect other organs, including the liver and adrenal glands. The research might someday lead to better treatments for diabetes, he says.

The vast majority of people with high cholesterol don't have familial hypercholesterolemia or a genetic mutation that protects them from diabetes. But Hovingh and Preiss both say that doesn't mean people should fear statins. Taking high-dose statins raises the risk of diabetes by 0.3 per every 100 people.

Shots - Health News Taking Statins May Make People Less Physically Active

"People who get diabetes in those large clinical trials are the ones who are actually already on the doorstep of diabetes," Hovingh tells Shots. "They're already overweight, obese, have a little bit of hypertension; they're already in the metabolic state." The increased in cholesterol uptake caused by statins might be enough to push them over the edge, he speculates.

"For people who are at borderline risk of getting diabetes, some would say that these are the people who should be cautious about statin therapy," says Preiss, a researcher who also treats patients with high cholesterol. "I don't share that view myself. People at high risk of diabetes are also likely to be at high risk of cardiovascular disease. If I were in that situation I would take statin treatment and just be sure to be screened for diabetes as well."

And figuring out whether statins are right for an individual isn't determined by studies like this; it comes down to the person and a doctor. One persistent woman deployed her daughter's pink calculator to figure it out for herself.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
Categories: NPR Blogs

Genetic Disorder May Reveal How Statins Boost Diabetes Risk

Tue, 03/10/2015 - 1:54pm
Genetic Disorder May Reveal How Statins Boost Diabetes Risk March 10, 2015 1:54 PM ET

Lipitor and other statin drugs are commonly prescribed to lower cholesterol.

Paul J. Richards/AFP/Getty Images

Millions of people take statins to lower their cholesterol and reduce the risk of cardiovascular disease. But taking statins does slightly up the risk of Type 2 diabetes. Figuring out whether that means "No statins for you" isn't always easy, despite a proliferation of guidelines intended to help.

Here's in interesting wrinkle: If you've got a hereditary form of high cholesterol you're much less likely to get Type 2 diabetes, according to a study published Tuesday in JAMA, the journal of the American Medical Association.

Shots - Health News Playing The Odds With Statins: Heart Disease Or Diabetes?

That's good news for those people, who often have high levels of LDL cholesterol starting in childhood and face a high risk of heart disease and stroke. And it offers intriguing hints as to a possible link between cholesterol receptors in the body and Type 2 diabetes.

To find that out, researchers in the Netherlands delved into an amazing database that has tracked people for familial hypercholesterolemia since 1994. The large number of people tested — 63,320 — made it possible to not only identify people with genetic mutations that caused the high cholesterol, but to show how it runs in families.

The people with familial hypercholesterolemia had a 51 percent lower risk of Type 2 diabetes than their relatives without the disorder. But the diabetes risk for both groups was low: 1.75 percent versus 2.93 percent. It varied based on the particular genetic mutation involved. That difference makes for a nifty demonstration on how genes affect risk, and confirms a link that doctors who treat patients with the disorder have long observed.

And it also may explain why taking statins boosts the risk of Type 2 diabetes in some people.

Shots - Health News Shift In Cholesterol Advice Could Double Statin Use

One theory on how statins work is that they encourage cells to hoover up the bad LDL cholesterol by turning on LDL receptors. That's good for lowering cholesterol levels in the blood, but the study authors said it may also end up damaging the pancreas, which has lots of LDL receptors and controls blood sugar.

"They're speculating that this LDL receptor may be important in some way in determining the risk of diabetes in a statin," says David Preiss, a metabolic physician at the Glasgow Cardiovascular Research Center at the University of Glasgow who wrote an editorial accompanying the JAMA study. "The data they show is quite strongly supportive of that."

Shots - Health News Statins Might Not Cause Aching Muscles, But Diabetes Risk Is Real

"Of course this is very intriguing," says Kees Hovingh, a vascular medicine specialist at the Academic Medical Centre in Amsterdam and a co-author of the study. He and his colleagues are already looking at the cellular level to see how LDL receptors and cholesterol could affect other organs, including the liver and adrenal glands. The research might someday lead to better treatments for diabetes, he says.

The vast majority of people with high cholesterol don't have familial hypercholesterolemia or a genetic mutation that protects them from diabetes. But Hovingh and Preiss both say that doesn't mean people should fear statins. Taking high-dose statins raises the risk of diabetes by 0.3 per every 100 people.

Shots - Health News Taking Statins May Make People Less Physically Active

"People who get diabetes in those large clinical trials are the ones who are actually already on the doorstep of diabetes," Hovingh tells Shots. "They're already overweight, obese, have a little bit of hypertension; they're already in the metabolic state." The increased in cholesterol uptake caused by statins might be enough to push them over the edge, he speculates.

"For people who are at borderline risk of getting diabetes, some would say that these are the people who should be cautious about statin therapy," says Preiss, a researcher who also treats patients with high cholesterol. "I don't share that view myself. People at high risk of diabetes are also likely to be at high risk of cardiovascular disease. If I were in that situation I would take statin treatment and just be sure to be screened for diabetes as well."

And figuring out whether statins are right for an individual isn't determined by studies like this; it comes down to the person and a doctor. One persistent woman deployed her daughter's pink calculator to figure it out for herself.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
Categories: NPR Blogs

With Medicare Pay On The Line, Hospitals Push Harder To Please Patients

Tue, 03/10/2015 - 4:20am
With Medicare Pay On The Line, Hospitals Push Harder To Please Patients March 10, 2015 4:20 AM ET

Partner content from

Jordan Rau Listen to the Story 3 min 53 sec  

Carl Denham was hospitalized at Rowan Regional Medical Center in North Carolina in December. Denham, seen with his daughter Benicia, said his second visit to the hospital was much better than his first one two years before.

Michael Tomsic/WFAE

Lillie Robinson came to Rowan Medical Center for surgery on her left foot. She expected to be in and out in a day, returning weeks later to the Salisbury, N.C., hospital for her surgeon to operate on the other foot.

But that's not how things turned out. "When I got here I found out he was doing both," she said. "We didn't realize that until they started medicating me for the procedure." Robinson signed a consent form and the operation went fine, but she was in the hospital far longer than she'd expected to be.

"I wasn't prepared for that," she said.

Disappointed patients such as Robinson are a persistent problem for Rowan, a hospital with some of the lowest levels of patient satisfaction in the country. In surveys sent to patients after they leave, Rowan's patients are less likely than those at most hospitals to say that they always received help promptly and that their pain was controlled well. Rowan's patients say they would recommend the hospital far less often than patients elsewhere.

Feedback from patients like Robinson matters to Rowan and to hospitals across the country. Since Medicare began requiring hospitals to collect information about patient satisfaction and report it to the government in 2007, these patient surveys have grown in influence. For the past three years, the federal government has considered survey results when setting pay levels for hospitals. Some private insurers do as well.

In April, the government will begin boiling down patient feedback into a five-star rating. Federal officials say they hope that will make it easier for consumers to digest the information now available on Medicare's Hospital Compare website. The hospital industry says judging a hospital on a one-to-five scale is too simplistic.

Nationally, hospitals have improved in all the areas the surveys track, including how clean and quiet their rooms are and how well doctors and nurses communicate . But hundreds of hospitals have not made headway in boosting their ratings, federal records show.

"For the most part, the organizations that are doing really wonderfully now were doing well five years ago," said Deirdre Mylod, an executive for Press Ganey, a company that conducts the surveys for many hospitals. "The high performers tend to continue to be the high performers and the low performers tend to be low performers."

Some hospitals have made great gains. The University of Missouri Health System created a live simulation center at its medical school in Columbia to help doctors learn to communicate better with patients. The simulations use paid actors. Instead of having to diagnose the patient, doctors must respond to nonmedical issues, such as a feuding teenager and mother or a patient angry that he was not given information about his condition quickly enough.

Shots - Health News What's A Patient To Do When Hospital Ratings Disagree?

"My scenario was I was late to the appointment and the patient's husband was upset," said Kristin Hahn-Cover, a physician at Missouri's University Hospital. In 2013, the most recent year that the government has provided data for, 78 percent of patients at University Hospital said doctors always communicated well, a 10 percentage-point jump from 2007. Other scores rose even more.

Nudging up scores has been a frustrating endeavor elsewhere, such as at Novant Health, a nonprofit hospital system that runs Rowan Medical Center and 13 other hospitals in North Carolina, South Carolina and Virginia. While some Novant hospitals have excellent patient reviews, Rowan's scores have remained stubbornly low since Novant took over the hospital in 2008.

Last fall, Rowan's president, Dari Caldwell, replaced the physician group that ran the emergency room because the doctors had not reduced wait times. ER waits are down to half an hour, a spokeswoman said. Doctors and nurses also are being coached on their bedside manner, like being advised not to stare at their computer when a patient is talking.

Rowan's nurses now spend 70 percent of their time with patients, swinging by every hour. Even the president makes rounds once a day. The hospital has made lots of small improvements to provide a warmer environment, such as putting white poster boards in each room where nurses can list a few personal details about their patients.

"I can go in there and say 'Oh, you have three dogs' or 'You have a grandchild, that's great, great,'" said Jennifer Payne, a nurse manager. "And they can talk for hours about that."

Patient perceptions have been tough to change at Rowan Regional Medical Center in Salisbury, N.C.

Joanna Serah/Wikimedia

Payne said she pores over patient comments and surveys, passing around the good ones and tackling complaints. "We're very driven by what these patients say," she said. "Everything I do is based around how these patients come back [in comments in the surveys] and say, 'Hey, is this working?' or 'This isn't working.'"

Rowan executives fear scores may not be going up because patients still harbor bad memories from previous hospitalizations.

"I was treated like a dog," Carl Denham, 76, said about a stay two years ago. He said the hospital was doing loud construction work that kept him awake, and it took nurses all day to deliver an oxygen tank his doctor ordered.

Admitted again in Rowan in December, Denham said that visit was different. "It is fantastic from what it used to be if you want my opinion," he said as he lay in his hospital bed a few days after he came back. "I've been both ways and the way it is now, it is great. No waiting and the doctors are all pleasant. I never thought I'd see it like this." He said he would give the hospital top marks.

His daughter Benicia said that in the last visit she had to nag the nurses to get her dad his medication. This time, it has not been an issue. "It's like a totally different hospital," she said. "I had to say, 'Did I come to Rowan Regional?'"

Despite the unexpected operation on both feet, Robinson also said nurses have been attentive to her pain. "They do the best they can," she said. "At times it gets so bad I'm crying because it's overwhelming to me."

But "the best they can" is not good enough for Medicare. In determining how much to pay hospitals, the government only gives credit when patients says they "always" got the care they wanted during their stay, such as their pain was "always" well-controlled. If a patient says that level of care was "usually" provided, it does not count at all. Likewise, the surveys ask patients to rank their stays on a scale of 0 to 10; Medicare only pays attention to how many patients award the hospital a 9 or 10.

"Sometimes what we see and hear from our patients doesn't show up on their surveys," Caldwell said.

Copyright 2015 Kaiser Health News. To see more, visit http://www.kaiserhealthnews.org/.
Categories: NPR Blogs

With Medicare Pay On The Line, Hospitals Push Harder To Please Patients

Tue, 03/10/2015 - 4:20am
With Medicare Pay On The Line, Hospitals Push Harder To Please Patients March 10, 2015 4:20 AM ET

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Jordan Rau Listen to the Story 3 min 53 sec  

Carl Denham was hospitalized at Rowan Regional Medical Center in North Carolina in December. Denham, seen with his daughter Benicia, said his second visit to the hospital was much better than his first one two years before.

Michael Tomsic/WFAE

Lillie Robinson came to Rowan Medical Center for surgery on her left foot. She expected to be in and out in a day, returning weeks later to the Salisbury, N.C., hospital for her surgeon to operate on the other foot.

But that's not how things turned out. "When I got here I found out he was doing both," she said. "We didn't realize that until they started medicating me for the procedure." Robinson signed a consent form and the operation went fine, but she was in the hospital far longer than she'd expected to be.

"I wasn't prepared for that," she said.

Disappointed patients such as Robinson are a persistent problem for Rowan, a hospital with some of the lowest levels of patient satisfaction in the country. In surveys sent to patients after they leave, Rowan's patients are less likely than those at most hospitals to say that they always received help promptly and that their pain was controlled well. Rowan's patients say they would recommend the hospital far less often than patients elsewhere.

Feedback from patients like Robinson matters to Rowan and to hospitals across the country. Since Medicare began requiring hospitals to collect information about patient satisfaction and report it to the government in 2007, these patient surveys have grown in influence. For the past three years, the federal government has considered survey results when setting pay levels for hospitals. Some private insurers do as well.

In April, the government will begin boiling down patient feedback into a five-star rating. Federal officials say they hope that will make it easier for consumers to digest the information now available on Medicare's Hospital Compare website. The hospital industry says judging a hospital on a one-to-five scale is too simplistic.

Nationally, hospitals have improved in all the areas the surveys track, including how clean and quiet their rooms are and how well doctors and nurses communicate . But hundreds of hospitals have not made headway in boosting their ratings, federal records show.

"For the most part, the organizations that are doing really wonderfully now were doing well five years ago," said Deirdre Mylod, an executive for Press Ganey, a company that conducts the surveys for many hospitals. "The high performers tend to continue to be the high performers and the low performers tend to be low performers."

Some hospitals have made great gains. The University of Missouri Health System created a live simulation center at its medical school in Columbia to help doctors learn to communicate better with patients. The simulations use paid actors. Instead of having to diagnose the patient, doctors must respond to nonmedical issues, such as a feuding teenager and mother or a patient angry that he was not given information about his condition quickly enough.

Shots - Health News What's A Patient To Do When Hospital Ratings Disagree?

"My scenario was I was late to the appointment and the patient's husband was upset," said Kristin Hahn-Cover, a physician at Missouri's University Hospital. In 2013, the most recent year that the government has provided data for, 78 percent of patients at University Hospital said doctors always communicated well, a 10 percentage-point jump from 2007. Other scores rose even more.

Nudging up scores has been a frustrating endeavor elsewhere, such as at Novant Health, a nonprofit hospital system that runs Rowan Medical Center and 13 other hospitals in North Carolina, South Carolina and Virginia. While some Novant hospitals have excellent patient reviews, Rowan's scores have remained stubbornly low since Novant took over the hospital in 2008.

Last fall, Rowan's president, Dari Caldwell, replaced the physician group that ran the emergency room because the doctors had not reduced wait times. ER waits are down to half an hour, a spokeswoman said. Doctors and nurses also are being coached on their bedside manner, like being advised not to stare at their computer when a patient is talking.

Rowan's nurses now spend 70 percent of their time with patients, swinging by every hour. Even the president makes rounds once a day. The hospital has made lots of small improvements to provide a warmer environment, such as putting white poster boards in each room where nurses can list a few personal details about their patients.

"I can go in there and say 'Oh, you have three dogs' or 'You have a grandchild, that's great, great,'" said Jennifer Payne, a nurse manager. "And they can talk for hours about that."

Patient perceptions have been tough to change at Rowan Regional Medical Center in Salisbury, N.C.

Joanna Serah/Wikimedia

Payne said she pores over patient comments and surveys, passing around the good ones and tackling complaints. "We're very driven by what these patients say," she said. "Everything I do is based around how these patients come back [in comments in the surveys] and say, 'Hey, is this working?' or 'This isn't working.'"

Rowan executives fear scores may not be going up because patients still harbor bad memories from previous hospitalizations.

"I was treated like a dog," Carl Denham, 76, said about a stay two years ago. He said the hospital was doing loud construction work that kept him awake, and it took nurses all day to deliver an oxygen tank his doctor ordered.

Admitted again in Rowan in December, Denham said that visit was different. "It is fantastic from what it used to be if you want my opinion," he said as he lay in his hospital bed a few days after he came back. "I've been both ways and the way it is now, it is great. No waiting and the doctors are all pleasant. I never thought I'd see it like this." He said he would give the hospital top marks.

His daughter Benicia said that in the last visit she had to nag the nurses to get her dad his medication. This time, it has not been an issue. "It's like a totally different hospital," she said. "I had to say, 'Did I come to Rowan Regional?'"

Despite the unexpected operation on both feet, Robinson also said nurses have been attentive to her pain. "They do the best they can," she said. "At times it gets so bad I'm crying because it's overwhelming to me."

But "the best they can" is not good enough for Medicare. In determining how much to pay hospitals, the government only gives credit when patients says they "always" got the care they wanted during their stay, such as their pain was "always" well-controlled. If a patient says that level of care was "usually" provided, it does not count at all. Likewise, the surveys ask patients to rank their stays on a scale of 0 to 10; Medicare only pays attention to how many patients award the hospital a 9 or 10.

"Sometimes what we see and hear from our patients doesn't show up on their surveys," Caldwell said.

Copyright 2015 Kaiser Health News. To see more, visit http://www.kaiserhealthnews.org/.
Categories: NPR Blogs