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Did A Study Overreach When It Said A Vaccine Prevents Leukemia?

41 min 1 sec ago
Did A Study Overreach When It Said A Vaccine Prevents Leukemia? May 27, 2015 9:32 AM ET Tara Haelle

Controversy over childhood vaccines may make it too easy to embrace what appear to be new vaccine benefits.

Dmitry Naumov/iStockphoto

Sometimes a story takes odd turns as you report it. Every once in while it goes off the rails. That's what happened as I reported on a new study purporting to explain how a childhood vaccine helps prevent leukemia. The experience reaffirmed the lessons I've learned in my years of reporting on vaccines and other scientific research: be wary of grand claims, get outside perspectives on new research and never, ever rely only on the press release.

Of course, the press release headline was captivating: "Study Explains How Early Childhood Vaccination Reduces Leukemia Risk." Multiple news stories were already sharing how the Hib vaccine — which prevents a horrific, often fatal disease known as Haemophilus influenza Type b — could help prevent childhood cancer. It's always thrilling to come across a new way that existing vaccines can benefit people, such as using the tetanus vaccine to enhance immunotherapy for brain tumors. So I eagerly dove into reporting on this development.

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Yet something confused me: The press release stated that "the cancer protection offered by the Hib vaccine has been well established in epidemiological studies." I had never heard that vaccines reduced leukemia risk, despite having read hundreds of studies on vaccines. But I'm also a journalist, not a researcher or clinician. My expertise is in finding the right experts to talk to me about research, not knowing the whole research base. I expected the experts would shed some light.

First I spoke to the study author, Dr. Markus Müschen, a professor at the University of California, San Francisco. The way he explained the mechanism made sense: early exposure to slight challenges to the immune system, such as vaccines and minor infections from daycare, keep the immune system in check, he said. Without that, the immune system can kick into high gear with a major infection, such as Hib, and cause two enzymes in particular to overreact.

And it just so happens that these two enzymes also apparently play a role in the development of acute lymphoblastic lymphoma, or ALL, one of the most common childhood cancers. Müschen's experiments in mice showed that these enzymes, when activated by repeated inflammation, might cause pre-leukemic cells to develop into leukemia.

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But when Müschen said it was "common knowledge that vaccines protect against cancer and leukemia," a "fact had been known for many years," alarm bells rung in my head. Only two vaccines are clearly known to prevent cancer. The HPV vaccine prevents cervical and other cancers, such as oral and anal cancers, caused by human papillomavirus infections, and the hepatitis B vaccine can prevent liver cancer by preventing hepatitis B, one cause of liver cancer. And I wasn't aware of any vaccine that prevented leukemia.

Further, a quote from Müschen in the press release said his "experiments help explain why the incidence of leukemia has been dramatically reduced since the advent of regular vaccinations during infancy." But I couldn't find evidence of this dramatic reduction in government health statistics.

When I turned to outside experts, I discovered my confusion was justified. I asked Dr. Walter Orenstein, associate director of the Emory Vaccine Center, if he could help or recommend others. He sent me to Dr. Art Reingold, head of epidemiology at the University of California, Berkeley, School of Public Health, and Dr. Martha Arellano, an oncologist specializing in leukemia at the Winship Cancer Institute of Emory University. Arellano also suggested I speak with Dr. Edmund Waller, an immunologist and oncologist also at Emory's Winship Cancer Institute.

Every one of them conveyed the same message: nothing in this paper proves that the Hib vaccine reduces leukemia risk, much less helps prevent ALL. In fact, the word "vaccine" appears only once in the entire paper, to cite a handful of observational studies that have shown a correlation between Hib vaccination and lower leukemia rates. But the first rule of science journalism (and science) is that correlation does not equal causation.

"I think this research is very interesting and thought-provoking, but I can't connect the data they're presenting to how Hib vaccine may reduce the risk of childhood leukemia."

"I think this research is very interesting and thought-provoking, but I can't connect the data they're presenting to how Hib vaccine may reduce the risk of childhood leukemia," Arellano said. "I think it's a jump."

Reinhold said something similar and pointed out another limitation: Müschen's experiments involved mice, and, well, mice aren't humans. "People have raised increasing doubts about whether mouse immunology, however elegant, is representative of human immunology," he told me. The study did test leukemia-infected human tissue for the gene expression caused by the two enzymes, but again, that's only an association.

Reingold also confirmed that the HPV and hepatitis B vaccines were the only vaccines known to reduce risk of specific cancers. "Those are infectious agents that we know produce chronic infection and that does result in cancer in some people," Reingold said. "But if one is making a statement beyond that, that is highly dubious and it wouldn't hold up to scrutiny among people who study vaccines. I think this is an instance where one should be more cautious in making a connection."

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Waller concurred with Arellano and Reingold: "What I see from the paper does not prove a causal or protective relationship of the Hib vaccine in preventing ALL because I don't see the data that would support that." While we were on the phone, he pulled up the supplementary materials for the paper to be sure we weren't missing something. Nope.

I also asked Dr. Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia and an outspoken supporter of childhood immunizations, if he had heard of the leukemia-preventing powers of the Hib vaccine. If anyone knew of a side benefit of vaccines that might improve their public image, it would be Offit. But nope — he, too, had not heard that vaccines reduce leukemia risk.

So I returned to Müschen and told him of the skepticism I had heard from others. "As we had discussed," he told me, "the protective effects of the Hib vaccine were shown in many previous studies, not ours. Our study provides a potential mechanism of how the protective effect can work" — the mechanism driven by those two enzymes. But the press release contains no ambiguity on this point. It clearly suggests that Müschen's findings prove Hib vaccines prevent childhood leukemia, and he appeared to confirm this idea in our initial interview.

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Most news organizations reported that the prevention occurs because a Hib infection stimulates the overreaction of these enzymes, so preventing Hib prevents that overreaction. But Reingold told me the characterization of Hib as chronic in the study is inaccurate. It's an acute infection: "You're only infected for a few days before you get better or die," he said.

In short, this study's press release greatly oversold the findings, and in my first interview with him, Müschen did not discourage this conclusion. Was the research interesting? Yes. Does it add to our understanding about how leukemia begins? Yes. Can other researchers build on what Müschen and his colleagues demonstrated? Yes. Does it show that the Hib vaccine helps prevent cancer? Absolutely not.

Then why all the media attention? I suspect it has something to do with the huge public attention on vaccine refusal, especially after this year's measles outbreak in unvaccinated people. That might make people too eager to embrace what appear to be new vaccine benefits. "We all support vaccination, and we as physicians from various specialties believe they're one of the greatest advances of medicine in the 20th century," Waller said. "To see that being rolled back in the 21st century is very concerning."

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A Neurosurgeon Reflects On The 'Awe And Mystery' Of The Brain

Tue, 05/26/2015 - 2:30pm
A Neurosurgeon Reflects On The 'Awe And Mystery' Of The Brain May 26, 2015 2:30 PM ET Listen to the Story 37:12
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Thomas Dunne Books

Henry Marsh was the subject of the Emmy Award winning 2007 documentary The English Surgeon, which followed him in Ukraine, trying to help patients and improve conditions at a rundown hospital.

Thomas Dunne Books

Neurosurgeon Henry Marsh has opened heads, cut into brains and performed the most delicate and risky surgeries on the part of the body that controls everything — including breathing, movement, memory and consciousness.

"What is, I think, peculiar about brain surgery is it's so dangerous," Marsh tells Fresh Air's Terry Gross. "A very small area of damage to the brain can cause catastrophic disability for the patient."

Over the course of his career, Marsh, a consulting neurosurgeon at Atkinson Morley's/St. George's Hospital in London since 1987, has learned firsthand about the damage that his profession can cause. While many of the surgeries he has performed have been triumphs, there is always a risk of leaving the patient severely disabled.

In the memoir Do No Harm, Marsh confesses to the fears and uncertainties he's dealt with as a surgeon, revisits his triumphs and failures and reflects on the enigmas of the brain and consciousness. Despite his decades on the job — or perhaps because of them — Marsh says that much of the brain remains beyond his grasp. He likens the mystery of the brain to that of the big-bang theory. "We're all sitting on an equally great mystery within ourselves, each of us, in this microcosm of our own consciousness, and I find that a quite nice thought," he says.

Interview Highlights Additional Information: Do No Harm

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On the danger of brain surgery

You can nick the liver, you can remove bits of the lung, you can remove bits of the heart and the organ goes on working. But with the brain, although some areas can suffer some damage without terrible consequences for the patient, in general terms, it's very dangerous. Which means the decision-making is very important and ... in my experience over the years, when things have gone wrong, it's not because of [we] cut the wrong blood vessel or dropped an instrument or something like that. The mistakes made — the mistakes are in the decision-making — whether to operate or when to operate.

On the computer navigation system used in brain surgery

One of the ways brain surgery is different from surgery elsewhere is you can't explore the brain. If you do an abdominal operation you actually put your hands — nowadays a lot of it is done visually ... but when I trained many years ago in abdominal surgery you actually put your hands into the patient's abdomen and feel around. You feel for the abnormality. You clearly can't do that with the brain and [that's] why brain surgery was very limited until the modern era — we didn't have brain scans. It wasn't exactly guesswork as to where to go, but it was very difficult. Now with so called computer navigation there's not a real-time method but it's a way you can see on the brain scan done just before the operation where you are with your instruments in the patient's brain.

On how the brain creates pain

A lot of what we think is real and obvious, in fact, is, well you could call it an illusion in a way. If I got pain in my hand the pain is not actually in the hand, the pain is my brain. My brain creates a three-dimensional model of the world and associates the nerve impulses coming from the pain receptors in my hand with pain in the hand and it create this illusion that the pain is actually in the hand itself, and it isn't. The more you look into neuroscience the more strange and confusing it becomes.

On patients watching their own surgery

I'll ask my patients, "Do you want to see your own brain?" and some of them say, "Yes," and some say, "No." If they say "Yes," I'll say, "Well, now you're going to be one of the few members of the human race who has ever actually seen their own brain." It's a strange, strange thing to experience. I've actually had an operation on the visual areas of the brain, with the patient awake, at the back of the brain. I've had some of my patients — the visual cortex looking at itself on a television screen — and you feel there should be a philosophical equivalent of acoustic feedback.

On the mysteries of human consciousness

My thoughts don't feel like electric chemistry, but that is what they are. I find it quite a consoling thought that our modern scientific view of the world which has explained so much, we can't even begin to explain how consciousness, how sensation arises out of electric chemistry, but the fact of the matter is it does. ...

"If you don't have conventional religious belief, as I don't, I think in a way thinking about the mystery of one's own consciousness and the universe is a sort of compensation for that in some ways."

The sense of awe and mystery, for some reason, has gotten greater as I've got older. I'm not sure why. Maybe because many of us, as we get older, we start thinking more about the fact our life is going to come to an end, and we become a bit more religious and philosophical. If you don't have conventional religious belief, as I don't, I think in a way thinking about the mystery of one's own consciousness and the universe is a sort of compensation for that in some ways.

On being open about his mistakes

The public need to understand that medicine actually is often a very uncertain process. It's not like going to a car dealer and buying a car or getting things fixed. It's very uncertain. It's very difficult, and there's a lot of talk in this country as there is in the States about duty of candor and guilt-free culture and transparency, and I thought, "Well, I'm going to write a book," (which is based on a diary I've kept all my life) "which says what it's really like with no holds back, the good things and the bad things." Again, some of my operations are great triumphs and tremendous, but they're only triumphs because they're also disasters. If all operations were easy and safe and straightforward there'd be nothing very special about them.

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Delayed Umbilical Cord Clamping May Benefit Children Years Later

Tue, 05/26/2015 - 12:06pm
Delayed Umbilical Cord Clamping May Benefit Children Years Later May 26, 201512:06 PM ET Tara Haelle

The World Health Organization has endorsed waiting to clamp the umbilical cord for at least one minute after a baby is born.

Sebastien Desarmaux/Godong/Science Source

A couple of extra minutes attached to the umbilical cord at birth may translate into a small boost in neurodevelopment several years later, a study suggests.

Children whose cords were cut more than three minutes after birth had slightly higher social skills and fine motor skills than those whose cords were cut within 10 seconds. The results showed no differences in IQ.

"There is growing evidence from a number of studies that all infants, those born at term and those born early, benefit from receiving extra blood from the placenta at birth," said Dr. Heike Rabe, a neonatologist at Brighton & Sussex Medical School in the United Kingdom. Rabe's editorial accompanied the study published Tuesday in the journal JAMA Pediatrics.

Delaying the clamping of the cord allows more blood to transfer from the placenta to the infant, sometimes increasing the infant's blood volume by up to a third. The iron in the blood increases infants' iron storage, and iron is essential for healthy brain development.

"The extra blood at birth helps the baby to cope better with the transition from life in the womb, where everything is provided for them by the placenta and the mother, to the outside world," Rabe said. "Their lungs get more blood so that the exchange of oxygen into the blood can take place smoothly."

Past studies have shown higher levels of iron and other positive effects later in infancy among babies whose cords were clamped after several minutes, but few studies have looked at results past infancy.

In this study, researchers randomly assigned half of 263 healthy Swedish full-term newborns to have their cords clamped more than three minutes after birth. The other half were clamped less than 10 seconds after birth.

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Four years later, the children underwent a series of assessments for IQ, motor skills, social skills, problem-solving, communication skills and behavior. Those with delayed cord clamping showed modestly higher scores in social skills and fine motor skills. When separated by sex, only the boys showed statistically significant improvement.

"We don't know exactly why, but speculate that girls receive extra protection through higher estrogen levels whilst being in the womb," Rabe said. "The results in term infants are consistent with those of follow-up in preterm infants."

Delayed cord clamping has garnered more attention in the past few years for its potential benefits to the newborn. Until recently, clinicians believed early clamping reduced the risk of hemorrhaging in the mother, but research hasn't borne that out.

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Much of the research has focused on preterm infants, who appear to benefit most from delayed cord clamping, Rabe said. Preemies who have delayed cord clamping tend to have better blood pressure in the days immediately after birth, need fewer drugs to support blood pressure, need fewer blood transfusions, have less bleeding into the brain and have a lower risk of necrotizing enterocolitis, a life-threatening bowel injury, she said.

This study is among the few looking at healthy, full-term infants in a country high in resources, as opposed to developing countries where iron deficiency may be more likely.

The American Congress of Obstetricians and Gynecologists has not yet endorsed the practice, citing insufficient evidence for full-term infants. The World Health Organization recommends delayed cord clamping of not less than one minute.

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It is unclear whether the practice could harm infants' health. Some studies have found a higher risk of jaundice, a buildup of bilirubin in the blood from the breakdown of red blood cells. Jaundice is treated with blue light therapy and rarely has serious complications.

Another potential risk is a condition called polycythemia, a very high red blood cell count, said Dr. Scott Lorch, an associate professor of pediatrics at the University of Pennsylvania Perelman School of Medicine and director of the Center for Perinatal and Pediatric Health Disparities Research at Children's Hospital of Philadelphia.

"Polycythemia can have medical consequences for the infant, including blood clots, respiratory distress and even strokes in the worst-case scenario," Lorch said. Some studies have found higher levels of red blood cells in babies with delayed cord clamping, but there were no complications.

Lorch also pointed out that this study involved a mostly homogenous population in a country outside the U.S.

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"We should see whether similar effects are seen in higher-risk populations, such as the low socioeconomic population, racial and ethnic minorities and those at higher risk for neurodevelopmental delay," Lorch said.

So far, studies on delayed cord clamping have excluded infants born in distress, such as those with breathing difficulties or other problems. But Rabe said these infants may actually benefit most from the practice.

These babies often need more blood volume to help with blood pressure, breathing and circulation problems, Rabe said. "Also, the placental blood is rich with stem cells, which could help to repair any brain damage the baby might have suffered during a difficult birth," she added. "Milking of the cord would be the easiest way to get the extra blood into the baby quickly in an emergency situation."

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Second Opinions Are Often Sought, But Their Value Isn't Clear

Tue, 05/26/2015 - 10:23am
Second Opinions Are Often Sought, But Their Value Isn't Clear May 26, 201510:23 AM ET

Partner content from

Michelle Andrews

Actress Rita Wilson arrives at the premiere of the documentary Fed Up in West Hollywood, Calif., in May 2014.

Gus Ruelas/Reuters/Landov

Actress Rita Wilson, who was diagnosed with breast cancer and underwent a double mastectomy, told People magazine in April that she expects to make a full recovery "because I caught this early, have excellent doctors and because I got a second opinion."

When confronted with the diagnosis of a serious illness or confusing treatment options, everyone seems to agree that it can be useful to seek out another perspective. Even if the second physician agrees with the first one, knowing that can provide clarity and peace of mind.

A second set of eyes, however, may identify information that was missed or misinterpreted the first time. A study that reviewed existing published research found that 10 to 62 percent of second opinions resulted in major changes to diagnoses or recommended treatments.

Another study that examined nearly 6,800 second opinions provided by Best Doctors, a second-opinion service available as an employee benefit at some companies, found that more than 40 percent of second opinions resulted in diagnostic or treatment changes.

But here's the rub: While it's clear that second opinions can help individual patients make better medical decisions, there's little hard data showing that second opinions lead to better health results overall.

"What we don't know is the outcomes," says Dr. Hardeep Singh, a patient safety researcher at the Michael E. DeBakey VA Medical Center and Baylor College of Medicine in Houston, who co-authored both those studies. "What is the real diagnosis at the end? The first one or the second one? Or maybe both are wrong."

That doesn't mean second opinions are a bad idea. By some estimates, diagnostic errors occur in 10 to 15 percent of cases.

"There's no getting away from it, diagnosis is an imprecise thing," says Dr. Mark Graber, a senior fellow at RTI International who also co-authored the studies. Graber is the founder and president of the Society to Improve Diagnosis in Medicine.

Requests for second opinion were related to diagnosis questions in 34.8 percent of cases in the Best Doctors study. These included 22.5 percent of patients whose symptoms hadn't improved, 6.3 percent who hadn't gotten a diagnosis and 6 percent who had questions about their diagnosis.

In Wilson's case, she wrote that after two breast biopsies she was relieved to learn that the pathology analysis didn't find any cancer. But on the advice of a friend, she decided to get a second opinion, and that pathologist diagnosed invasive lobular carcinoma. Wilson then got a third opinion that confirmed the second pathologist's diagnosis.

Getting a second opinion may not involve a face-to-face meeting with a new specialist, but it will certainly involve a close examination of the patient's medical record, including clinical notes, imaging, pathology and lab test results, and any procedures that have been performed. Some people choose to have that second look done by physicians in their community, but other patients look for help elsewhere.

In addition to employer-based services like Best Doctors or Grand Rounds, medical centers such as the Cleveland Clinic and Johns Hopkins in Baltimore also offer individual patients online second opinions.

Cleveland Clinic's MyConsult service doesn't accept insurance. A medical second opinion costs $565, while a consultation with a pathology review costs $745.

Face-to-face meetings with specialists who provide a second opinion and review a patient's medical record are more likely to be covered by insurance than an online consult, but nothing is guaranteed.

"Usually it's not the second opinion where the hiccup is," says Erin Singleton, chief of mission delivery at the Patient Advocate Foundation, which helps people with appeals related to second opinions. "It may be that the MRI that they want to do again won't be approved." Many insurers won't pay for diagnostic or other tests to be redone.

Patients seeing an out-of-network specialist for a second opinion may encounter significantly higher out-of-pocket costs, particularly if they want to subsequently receive treatment from that provider. In those instances, the foundation can sometimes work with patients to make the case that no specialist in their network is equally experienced at treating their condition.

Of course, asking for a second opinion doesn't necessarily mean accepting the advice. In the Best Doctors survey, 94.7 percent of patients said they were satisfied with their experience. But only 61.2 percent said they either agreed or strongly agreed that they would follow the recommendations that they received in the second opinion.

Copyright 2015 Kaiser Health News. To see more, visit http://www.kaiserhealthnews.org/.
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Multiple Sclerosis Patients Stressed Out By Soaring Drug Costs

Mon, 05/25/2015 - 3:37am
Multiple Sclerosis Patients Stressed Out By Soaring Drug Costs May 25, 2015 3:37 AM ET Listen to the Story 6:55
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Maria Fabrizio for NPR

American medicine is heading into new terrain, a place where a year's supply of drugs can come with a price tag that exceeds what an average family earns.

Pharmacy benefit manager Express Scripts says last year more than half a million Americans racked up prescription drug bills exceeding $50,000.

Barbara Haedtke of Portland, Ore., knows this all too well. When she was diagnosed with multiple sclerosis in 2001 at the age of 35, she was prescribed Avonex, at a cost of around $10,000 a year. Her health insurance paid most of that, until she and her husband found themselves without jobs during an economic downturn. "We were in the hole, and so $10,000 was a lot of money," she says. "Under the best circumstances it's a lot of money, but then particularly it was really difficult."

Barbara Haedtke says she's grateful for a drug-company program that helps cover copays, but doesn't know how long she'll get that benefit.

Courtesy of Barbara Haedtke

The drug company gave her the medication at no charge until she once again had a job with insurance, and for that, she says, she's really grateful. But the story doesn't end there. Haedtke used Avonex for about a decade and watched with disbelief as the price more than tripled. She's now taking a new drug, Tecfidera, that's priced even higher — $66,000 a year, according to her pharmacy receipt.

The drug is supposed to help reduce the number of episodes that characterize multiple sclerosis, a disease in which nerve fibers gradually degenerate, causing muscle weakness, numbness, loss of balance and even paralysis. Haedtke describes these episodes as "terrifying," saying sometimes it feels like there's a cinder block on her leg when she tries to move. And she's had vision problems, too. It's hoped the new medication will also slow down the progression to permanent physical disability caused by the disease.

Still, Haedtke worries not just about the disease, but about the financial threat it poses. All the prescription medications for MS are extremely expensive.

A recent study from Oregon State University and the Oregon Health and Science University finds that the cost for MS drugs averages $60,000 a year, compared to $8,000 to $11,000 a year in the 1990s. The price for some climbed by an average of 30 percent per year for two decades, according to the report in the journal Neurology.

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Every time a new drug came onto the market, the price of all the drugs jumped, too, says Daniel Hartung, a pharmacist and associate professor who conducted the study along with Dr. Dennis Bourdette, Sharia Ahmed and Dr. Ruth Whitham.

"Despite more choices, prices just continue to rise, contrary to what you think would happen," Hartung says.

The standard economic principle that more choices will drive down prices doesn't always apply in the topsy-turvy world of drug economics, especially in the United States.

"We pay more, substantially more, than what is paid in Canada, Australia and the U.K., often two to three times more than what those countries are able to negotiate directly," Hartung says.

"We can get away with raising the price, because if a person has multiple schlerosis, what other choice do they have?"

Drug companies are acting much like a cartel such as OPEC, says Stephen Schondelmeyer, a pharmaceutical economist at the University of Minnesota. He says the companies must figure "if we all keep moving [our prices] up and nobody moves down, we can get away with raising the price, because if a person has multiple sclerosis, what other choice do they have?"

Last year, new drugs to treat hepatitis C at a cost of $80,000 or more also sparked an anxious discussion about high drug prices. At least those drugs cure the disease, and by so doing reduce future health-care costs. But that's not true for multiple sclerosis drugs.

"When the price of a drug doubles, does the patient get twice as much outcome?" Schondelmeyer asks. "No, it's the same drug."

Expensive new drugs are becoming increasingly common, not just for neurological diseases but for cancer as well. The federal government's Centers for Medicare and Medicaid Services estimates that drug costs in the U.S. will rise from $272 billion in 2013 to $406 billion at the end of this decade, driven in part by higher priced "specialty" drugs like the MS medications.

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"Sometimes the drug companies talk about a death spiral down if they compete on prices," Schondelmeyer says. "I think we've entered the period of the death spiral upward."

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The trade group Pharmaceutical Research and Manufacturers of America (PhRMA) disputes that. Lori Reilly, executive vice president for policy and research, says inflation for drugs has been about the same as medical inflation overall.

While new high-priced drugs are driving up expenses for some conditions, there are savings elsewhere, Reilly says, as consumers switch from brand-name drugs to generics.

Reilly also says the figures cited in the Neurology paper aren't a true reflection of the price of drugs because they are list prices. "When you're only looking at the list price and you're not looking at the significant rebates and discounts that go on," she says. "It's really not an apples-to-apples comparison."

Insurance companies cut deals with the drug companies, so it's hard to know what the manufacturers are actually charging. Reilly says the discounts can be 30 percent or more. Even then, they are still very expensive drugs.

"When you're only looking at the list price ... you're not looking at the significant rebates and discounts that go on."

Patients themselves don't often pay the sticker price. In fact, for drugs with the extreme price tags, drug companies may also let them off the hook for copays that could easily run into the thousands of dollars.

Instead, the price of these high-cost drugs is typically shouldered by the other people who are in a patient's health-insurance plan. The premiums go up for everyone. And for patients getting these drugs through government-sponsored health care plans, taxpayers pick up a lot of the tab.

The drug industry remains one of the most profitable businesses on the planet, but Reilly argues that the high prices are justified.

"The revenue that a company derives year in and year out is also paying for future research," she says. "Obviously we know in the MS space that the medicines that exist on the market today don't cure the disease. A lot of the companies that are currently in the MS space ... are using that revenue to reinvest for future innovation. And that innovation is costly."

Barbara Haedtke has heard that argument before, and she understands it. But still, "To have to think about costs continually going up so I can help fund the research — on the one hand I'm grateful, but on the other hand I'm upset."

She's also grateful to be in a drug-company program that lets her avoid what could be thousands of dollars in copayments for her medication. But that's not guaranteed.

"It's always a stress, because every year I also need to renew the copay program, and I don't know if they're going to continue to cover me."

And she says that stress surely can't be helpful as she tries to keep her MS under control.

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The Future Of Cardiology Will Be Shown In 3-D

Fri, 05/22/2015 - 3:41pm
The Future Of Cardiology Will Be Shown In 3-D May 22, 2015 3:41 PM ET

from

Christina Farr

A 3-D simulation of a human heart created by The Living Heart project.

Courtesy of Dassault Systèmes

How can you tell ­the difference between a good surgeon and an exceptional one?

You could start by looking for the one who has the rare ability to visualize a human organ in three dimensions from little more than a scan.

"The handful of the top surgeons in the world are like sculptors," said Dr. Deepak Srivastava, a director at the Gladstone Institute of Cardiovascular Disease in San Francisco.

"When cardiovascular surgeons go in to repair a defect in the heart, their success is so often dependent on an ability to see the anatomy in 3-D in their minds," said Srivastava. "That's more difficult for younger, less experienced surgeons."

But recent advancements in the field of computer-based modeling may make it easier someday for good surgeons to be great.

One such technology comes from Dassault Systèmes, a French company that specializes in 3-D software to help engineers who design cars and planes avoid potentially fatal outcomes.

Earlier this week, Dassault released its highly realistic digital model of the human heart, which it calls the "Living Heart Project." Doctors wear 3-D glasses and use a joystick to zoom in to a ventricle or valve, while listening to every heartbeat.

"We take a [patient's] scan, reconstruct it into a 3-D model, and test all the possibilities before a heart surgery," said Dr. Steve Levine, chief strategy officer and director for the Living Heart Project.

The technology hasn't received regulatory approval for doctors to use it in making medical decisions. But hospitals can buy it for research and educational purposes, such as exploring triggers that cause heart attacks.

Dassault hopes that medical device makers will also use the Living Heart Project's technology for research and development. The software is free to organizations that agree to conduct research and share their findings with the project. Otherwise, licenses start at $15,000 a year for commercial use, with educational licenses starting at $500 per year.

Recruiting Partners in Health Care

For the Living Heart Project, Levine has so far recruited 45 partners, including the Mayo Clinic, Stanford University and the University of Oxford.

Levine said the Food and Drug Administration initially wanted to take a "watch and wait" approach when told about the project. "I told them, you can't sit on the sidelines as nonparticipants. You have to get involved."

In 2014, the agency agreed to work with Dassault on a five-year research project that will focus on the reliability of pacemaker leads (the thin wires that carry an electrical impulse from the device to the heart.) But the agency said that it won't necessarily endorse any of the computational models that are developed as part of the research.

"Challenges to greater adoption of computer-modeling include a lack of data for some medical conditions, which makes realistic predictions difficult," said Donna Lochner, a senior scientific advisor in the FDA's Office of Science and Engineering Laboratories.

A Hammer Looking for a Nail?

At the University of California, San Francisco, a team of researchers in the cardiology division are hoping to use the Living Heart Project to figure out the best time to replace patients' heart valves.

Surgeons have to strike the right balance between swapping out too early, when a valve is still working reasonably well, or waiting too long, when heart function has already deteriorated.

Dr. Jeffrey Olgin, the division's chief, has been following the project's progress. But he isn't convinced it will transform how are surgeries are performed. "Is this a hammer looking for a nail?" he asked. "Or will this change how we practice medicine?"

He said he hopes advanced technology can fill some gaps, where surgeons are still making educated guesses, such as the timing of valve replacements. But he also said he hasn't seen a convincing study yet that proves the simulation can improve patient outcomes.

Unlike simulations involving manmade objects such as cars and planes, it's very difficult to predict how the human heart will respond to stress in the real world. Olgin said he fears that doctors could come to rely too heavily on this technology and medical device makers could pull the plug on promising research if the simulation shows a negative result.

"The technology doesn't offer the same level of evidence as [medical research on] animals or small pilot human trials," he said.

Christina Farr is the editor and host of KQED's Future of You blog, which explores the intersection of emerging technologies, medicine and health care. She's on Twitter: @chrissyfarr

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

Your Roommate In The Nursing Home Might Be A Bedbug

Fri, 05/22/2015 - 11:14am
Your Roommate In The Nursing Home Might Be A Bedbug May 22, 201511:14 AM ET Angus Chen

Hospitals seem to be doing a better job than nursing homes of keeping bedbugs at bay.

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If you're in the hospital or a nursing home, the last thing you want to be dealing with is bedbugs. But exterminators saying they're getting more and more calls for bedbug infestations in nursing homes, hospitals and doctor's offices.

Nearly 60 percent of pest control professionals have found bedbugs in nursing homes in the past year, according to an industry survey, up from 46 percent in 2013. Bedbug reports in other medical facilities have gone up slightly. Thirty-six percent of exterminators reported seeing them in hospitals, up from 33 percent. Infestations seen in doctors' offices rose from 26 percent to 33 percent in the past two years.

"Nursing homes would be difficult to treat for the simple reason you don't use any pesticides there," says Billy Swan, an exterminator who runs a pest-control company in New York City. That and the fact that there's a lot more stuff. "Somebody's gotta wash and dry all the linens, you know, and all their personal artifacts and picture frames."

Shots - Health News The Creepy, Crawly World Of Bedbugs And How They Have 'Infested' Homes

Those personal belongings might help account for the big disparity in infestations between nursing homes and hospitals, according to Dr. Silvia Munoz-Price, an epidemiologist at the Medical College of Wisconsin who studies infection control in health care facilities. "The more things you bring with you, the more likely you're bringing bedbugs, if you have a bedbug problem... and you live in a nursing home, so all your things are there."

By contrast, "When bedbugs are located in a hospital, they're usually confined to a couple of hospital rooms," Munoz-Price says.

And it may be easier for hospital staff to spot bedbugs.

"Hospital cleaning staff, nurses, doctors are extremely vigilant," says Jim Fredericks, chief entomologist for the National Pest Management Association, which conducted the survey along with the University of Kentucky. "[Bedbugs] don't go unnoticed for long."

Shots - Health News Buzz Off: Bedbugs Unfazed By Ultrasonic Devices

And hospitals are typically brightly lit, routinely cleaned places. It's just much easier to find pests in this setting than in a dark movie theater, where only 16 percent of pest professionals report seeing bedbugs, according to the survey.

Fredericks says the recent multiplication of bedbug reports in medical facilities is just a part of a larger trend. Exterminators have been finding more of the bugs everywhere the parasites are most commonly found like hotels, offices, and homes, where virtually 100 percent of pest control professionals have treated bedbugs in the past year. And they've been popping up in a few unexpected places, too, like a prosthetic leg and in an occupied casket.

"There are a lot of theories as to why they've made a comeback," Fredericks says. It could be differences in pest management practices, insecticide resistance, or just increased travel. "Bottom line is nobody knows what caused it, but bedbugs are back." He falters for a moment. "And they're most likely here to stay."

Shots - Health News Bedbug Infestations Are A Family Affair

The good news is bedbugs aren't known to transmit any diseases, and a quick inspection under mattresses or in the odd nook or cranny while traveling can lower the risk of picking the hitchhiking bugs up. Swan says a simple wash or freezing will kill any bedbug. "If you came home, took off all your clothes, put 'em in a bag – you'd never bring a bedbug home," he says. "But who does that?"

At least one reporter might start.

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

Covered California Votes To Cap What Patients Pay For Pricey Drugs

Fri, 05/22/2015 - 10:46am
Covered California Votes To Cap What Patients Pay For Pricey Drugs May 22, 201510:46 AM ET

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April Dembosky

Retired California school teacher Mikkel Lawrence sits with his cat, Max. Lawrence has hepatitis C and has struggled to afford the medicine he needs to treat it.

April Dembosky/KQED

In recent years, expensive specialty medicines used to treat cancer and chronic illnesses have forced some very ill Americans to choose between getting proper treatment and paying their rent.

To ease the financial burden, the California agency that governs the state's Obamacare plans issued landmark rules Thursday that will put a lid on the amount anyone enrolled in one of those plans can be charged each month for high-end medicine.

The agency says its rules, set to take effect in 2016, "strike a balance between ensuring Covered California consumers can afford the medication they need to treat chronic and life-threatening conditions while keeping premiums affordable for all."

Mikkel Lawrence, a retired teacher in California, is the kind of patient lawmakers keep in mind when they're designing such policies.

Sometimes Lawrence gets up in the morning, eats breakfast, and then heads straight back to bed for a nap. "I get really bad tired spells," he says. "It's like you have to go to sleep."

This is one of the symptoms of hepatitis C, a virus that can damage the liver. Most people who have the virus don't have any symptoms, sometimes for decades. But for some people like Lawrence, waves of intense fatigue hit several times a day.

"It takes away probably three or four hours of my waking day," he says.

There's also an increased risk of liver cancer or liver failure. So when Lawrence heard last year that there was a new drug regimen that could cure his disease, he went straight to his insurance company.

"The first thing they did, of course, was deny it," Lawrence says.

But the real problem, once he did get approval, was the price tag. Each pill costs $1,000.

"The first quote I got was $140,000 — and I would be responsible for $14,000 of it," he remembers.

Lawrence now lives on Social Security. There was just no way he could come up with $14,000 on his own.

"I went to everybody I knew of and fussed and fumed and all that stuff," he says.

Eventually, Lawrence got financial aid from a nonprofit to help him cover his out-of-pocket costs. Every morning at 10 a.m., he stood over his bathroom sink and swallowed two capsules.

"I'd go to take my pills and I'd go, 'There's one thousand.' " Before swallowing his second, he'd tell himself: "And there's another thousand."

Health advocates hear scenarios like this all the time from patients with a range of chronic conditions, including hepatitis C, HIV, multiple sclerosis, and rheumatoid arthritis.

"We've heard stories of people who've emptied their retirement savings to cover their drug needs," said Betsy Imholz, special projects director at Consumers Union, an advocacy group. "It's a really frightening, wild west situation for people who need these specialty drugs."

She and other advocates took their concerns to Covered California, the agency that implements the Affordable Care Act in the state. The advocates argued there should be a limit on how much consumers have to pay for these drugs.

The agency agreed, and Thursday the board voted to cap the monthly out-of-pocket costs for specialty drugs. Starting in 2016, most people will only have to pay a maximum of $150 or $250 per prescription, per month. These caps are for Covered California's so-called silver and platinum plans. Bronze plans will have caps of $500.

This policy will only apply to the 2.2 million people who buy coverage on the individual market. A bill under consideration in the California Legislature would extend that protection to many people with employer-based plans, as well.

Several other states are considering similar caps, some as low as $100.

"We're better than most, but not the absolute top of the heap," Imholz says.

Health insurance companies involved in meetings with Covered California tried to negotiate for higher caps — closer to $500 for all plans, Imholz says. Still, she adds, insurers did support the overall idea of caps.

Nicole Kasabian Evans of the California Association of Health Plans, says insurers see a correlation between the cost of a drug and adherence. Patients who can't afford what they're prescribed will sometimes split pills, or not take them at all.

"If you ultimately have to go back and take a second round, because you didn't take it right the first time, or you never took it and you develop a more serious health condition, it's not good for the consumer," Kasabian Evans says. "And it costs the health care system more money."

She says the root of the problem lies with the pharmaceutical companies that set the high drug prices. More than a half-million patients in the U.S. had medication costs that exceeded $50,000 in 2014, according to a recent report from Express Scripts, a company that manages prescription benefits.

"This is unsustainable, and it's going to have a major impact on the price of health care," Kasabian Evans says.

Even as the new rules require insurers to cap the co-pays for patients who take specialty drugs, the price the insurers pays will stay the same. Eventually, the insurers say, the only way to balance the books will be to raise monthly premiums for everyone in the health plan.

"So, if we really want to make sure consumers can afford prescription drug coverage," says Kasabian Evans, "then we need to deal with the root price of the drug."

Drugmakers defend their drug prices, citing the lengthy and expensive process of developing new medicines, and the many failed attempts that often precede a final success.

Such debates aren't helping Mikkel Lawrence right now. His battle over hepatitis C drugs continues. Turns out that $140,000 regimen he took last year didn't work. He fell into the 5 percent of patients who don't respond.

But now he's caught wind of a new drug that's coming through the pipeline. And he's already drafting a series of emails and letters to get it approved by his insurance plan — and to find the money to pay for the pills.

"As soon as they're out, I'm taking them," he says.

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

Coded Talk About Assisted Suicide Can Leave Families Confused

Thu, 05/21/2015 - 3:14pm
Coded Talk About Assisted Suicide Can Leave Families Confused May 21, 2015 3:14 PM ET

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April Dembosky Listen to the Story 4:22
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Hope Barrone-Falk and J.D. Falk on their wedding day in 2009.

Kelly Dunsford/Courtesy of the family

Physician-assisted suicide is illegal in most states in the U.S. But there are gray areas where doctors can help suffering patients hasten their death. The problem is nobody can talk about it directly.

This can lead to bizarre, veiled conversations between medical professionals and overwhelmed families. Doctors and nurses want to help but also want to avoid prosecution, so they speak carefully, parsing their words. Family members, in the midst of one of the most confusing and emotional times of their lives, are left to interpret euphemisms.

Shots - Health News Terminally Ill California Mom Speaks Out Against Assisted Suicide

That still frustrates Hope Arnold. She says throughout the 10 months her first husband J.D. Falk was being treated for stomach cancer in 2011, no one would talk straight with them.

"All the nurses, all the doctors, everybody we ever interacted with, no one said, 'You're dying,' " she recalls.

Until finally, one doctor did, she says. That's when J.D., who was just 35, started to plan. He summoned his extended family and Hope made arrangements for him to come home on hospice.

The day he was discharged from the hospital, Hope was dropping off some paperwork at a medical office when she bumped into one of J.D.'s doctors.

"He hugged me and asked me how I was holding up," she says. "And then he handed me a bottle of liquid morphine. He said, 'You might need it.' "

Shots - Health News Doctors With Cancer Push California To Allow Aid In Dying

Hope says she handed the bottle back. She told the doctor the hospice was going to drop off a machine that would administer J.D.'s pain medication automatically.

"And he looked at me," she says, "and he held my gaze for a second. And he put it back in my hand and he said, 'You might need it.' "

She slipped the vial into her purse.

"When I got home, it hit me like a ton of bricks," Hope remembers. "And I said to J.D., 'I think he may have given this to me so I can give you an overdose.' And he said, 'Maybe.' And then we didn't talk about it anymore."

When J.D. Falk was dying of stomach cancer in 2011, his wife says doctors would only talk about death in euphemisms.

Hope Arnold

Over the next couple days, J.D. deteriorated quickly. Hope worried that J.D. was in a lot of pain but she couldn't tell. She was afraid that if she asked the nurse, it would betray the thoughts she was having about that extra vial of morphine.

"I couldn't ask the nurse that," Hope says. "I couldn't ask anybody anything."

If Hope had asked Stanford medical ethicist David Magnus, he would have explained what assisted suicide is – and what it isn't. It is legal for people to take or give large doses of narcotics to relieve pain, even if a known side-effect is that it may hasten death.

"The difference really has to do with intent," Magnus says. "And that's a tricky thing because it has to do with what's going on in the mind."

He and others say this kind of situation is a symptom of a much bigger problem: Doctors are just plain bad at communicating about death.

"Across the board with end-of-life care clinical interactions, they're full of misunderstandings," he says.

He suggests that what some people interpret as hints on how to hasten someone's death, maybe aren't.

Just over 3 percent of U.S. doctors say they have written a prescription for life-ending medication. Almost 5 percent of doctors reported giving a patient a lethal injection.

Shots - Health News How A Woman's Plan To Kill Herself Helped Her Family Grieve

"Those practices are undercover; they are covert," says Barbara Coombs Lee, president of Compassion and Choices, an advocacy group. "To the degree that patients are part of the decision-making, it is by winks and nods."

Coombs Lee's organization helped tell the story of Brittany Maynard, a 29-year-old woman who moved from California to Oregon to be able to end her life legally after she was diagnosed with a brain tumor. Now the organization is backing legislation in California to make it legal for doctors to prescribe lethal medication to terminally-ill patients who request it.

Coombs Lee's group guides dying patients on current law.

"We talk with people about how they might broach the subject with their physicians," she says, "and quite frankly, how to play the wink-and-nod game in a way that doesn't jeopardize their physician."

In the end, Hope didn't do anything with the extra vial of morphine. Her husband died within days of coming home on hospice.

"J.D. never told me, 'I do want you to give me too much morphine,' " Hope says. "Actually, I don't know whether or not he wanted that. That's not the point. The point was nobody could talk about it."

This story is part of a reporting partnership that includes NPR, KQED and Kaiser Health News.

Copyright 2015 KQED Public Media. To see more, visit http://www.kqed.org.
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You And Yeast Have More In Common Than You Might Think

Thu, 05/21/2015 - 2:06pm
You And Yeast Have More In Common Than You Might Think May 21, 2015 2:06 PM ET Listen to the Story 2:35
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This fungus among us — baker's yeast, aka Saccharomyces cerevisiae — is useful for more than just making bread.

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Rip open a little package of baker's yeast from the supermarket, peer inside, and you'll see your distant cousin.

That's because we share a common ancestor with yeast, and a new study in the journal Science suggest that we also share hundreds of genes that haven't really changed in a billion years.

Edward Marcotte, a biologist at the University of Texas at Austin, knew that humans and yeast have thousands of similar genes. But, he wondered, how similar are they?

"Humans and yeast are doing not only the same thing as each other, but the same thing that their last common ancestor a billion years ago was doing. It's changed remarkably little over all of that time."

"We've been separated by a billion years of evolution," notes Marcotte. "Do those genes really work the same way?"

He figured the best way to answer that question would be to try swapping out the genetic material – basically, disable a gene in yeast, then replace it with the human version of that gene, and see if the yeast can survive.

Scientists had done this already with some individual genes, but Marcotte wanted to test a lot more — about 500 key genes that yeast need for life.

"There's a postdoc in my laboratory named Aashiq Kachroo who was willing to tackle this slightly insane project," says Marcotte. It was a brute force effort, he says, that took about three years.

What they found was that roughly half of these yeast genes could be readily replaced with the human version.

"The yeast were just fine," says Marcotte.

The Human Edge Un-Natural Selection: Human Evolution's Next Steps The Two-Way How Bird Beaks Got Their Start As Dinosaur Snouts

The researchers next looked to see if they could figure out some rules that explained why some genes were interchangeable between people and yeast and others weren't. They noted that genes tend to belong to sets that are related to specific jobs or processes in the cell — and genes in the same set tended to be either all replaceable, or not.

For example, the researchers looked at a whole bunch of genes involved in manufacturing cholesterol, which cells need to keep their shape. Almost all of the human genes for that job worked perfectly in yeast.

"Humans and yeast are doing not only the same thing as each other, but the same thing that their last common ancestor a billion years ago was doing," says Marcotte. "It's changed remarkably little over all of that time."

But this work isn't just a reminder of our deep evolutionary past, says Marcotte. Each yeast strain that's been modified to contain a human gene allows scientists to test the function of that gene. They'll be able to see if it's related to disease, and perhaps develop drugs that could affect it.

"Say somebody is born with mutations in that gene," Marcotte says. "We might be able to test that specific genetic variant in this yeast system and make a fairly educated guess about whether that would lead to a clinical outcome or not."

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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People In Poor Communities Are More Likely To Lose Eyesight

Thu, 05/21/2015 - 1:10pm
People In Poor Communities Are More Likely To Lose Eyesight May 21, 2015 1:10 PM ET $(function() { var pymParent = new pym.Parent( 'responsive-embed-map-poverty-vision-20150520', 'http://apps.npr.org/dailygraphics/graphics/map-poverty-vision-20150520/child.html', {} ); });

Vision loss and blindness can be devastating, isolating people and increasing their risk of illness and death. And that burden falls hardest on people in poor communities, especially in the South.

More than three quarters of the counties with the highest rates of severe vision loss are in the South, according to an analysis published Thursday in Morbidity and Mortality Weekly Report. It's the first analysis of severe vision loss at the county level.

Nationwide, 2.6 percent of adults said they had severe vision loss, but the prevalence by county varied from less than 1 percent to 18 percent.

More than half of the counties with high rates of severe vision loss also had high rates of poverty.

Cataracts, diabetic retinopathy, glaucoma and macular degeneration are the most common causes of vision loss in adults. Some, like cataracts, are easily treated once they're diagnosed. Others, like macular degeneration, can be managed but not cured.

Regular eye exams would identify problems early on, before people start losing vision, the report notes. And in many cases, people can't see well just because they don't have the right glasses. But vision care isn't covered in many insurance plans. Medicare provides eye exams only for people with diabetes or at high risk of glaucoma.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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Overnight Contacts Can Help Kids' Sight During Day, But Also Carry Risks

Thu, 05/21/2015 - 11:52am
Overnight Contacts Can Help Kids' Sight During Day, But Also Carry Risks May 21, 201511:52 AM ET Barbara Feder Ostrov

The sales pitch for contact lenses that help kids see better by reshaping their corneas sounds futuristically appealing. Sleep overnight in the lenses, pop them out in the morning and experience perfect or near-perfect vision for an entire day.

Beth Levenson of Williamsburg, Va., thought the lenses, even at a price of $2,000, seemed ideal for her son Logan, then 9, who played on several sports teams.

"It was pretty amazing, actually," Levenson said. "He'd sleep in them at night, and when he woke up in the a.m. he could see. It was going beautifully, then one morning he woke up and said, 'My eye hurts.' "

A week and several misdiagnoses later, Logan underwent an emergency cornea transplant for a fungal infection that threatened to perforate his cornea and destroy his eyesight. Now 10, Logan no longer can play team sports, and he will need to take anti-rejection eye drops for the rest of his life.

Levenson said her family's optometrist never told them about possible risks associated with the lenses.

Logan Levenson had a cornea transplant to repair an eye after a fungal infection.

Courtesy of Beth Levenson

"I had no idea, none whatsoever, that any of this could have happened," Levenson said. "As far as I was concerned, it was completely safe." She said she never knew the brand of lens that had been prescribed to her son.

The practice of using contact lenses to shape the cornea in an attempt to prevent the progression of myopia (nearsightedness) has been around for decades. In the 1990s, better contact lens materials and technological improvements in measuring patients' corneas made it possible for the lenses to be used overnight to correct daytime vision.

The Food and Drug Administration approved the first orthokeratology contact lenses, as they're called, for overnight wear in 2002. Some studies have shown that the lenses may help slow the progression of myopia, which is increasing among children worldwide.

Today, orthokeratology lenses are primarily marketed by optometrists to children and teens with mild to moderate myopia. Typically, patients wear the rigid, gas-permeable lenses overnight and remove them during the day. But their effect is temporary, and the lenses need to be worn regularly at night to maintain clear daytime vision. The lenses, also known as ortho-k lenses, can cost between $800 to $2,000 and typically aren't covered by insurance.

Ophthalmologists and cornea specialists have raised concerns about ortho-k lenses, citing several studies and their own experiences treating children and teens who developed serious eye infections after wearing them.

Lens manufacturers and optometrists who prescribe them say that ortho-k lenses are as safe as any contact lenses approved for overnight wear, as long as young patients practice proper hygiene and lens care.

Newer lens materials have improved safety and manufacturers require providers to undergo training and pass a test before prescribing ortho-k lenses, said Harue Marsden, a professor at the Southern California College of Optometry at the Marshall B. Ketchum University in Fullerton, Calif.

While infections can occur with any type of contact lens, sleeping overnight with contact lenses in can significantly raise the risk of infection, eye specialists say. In 2008, the American Academy of Ophthalmology issued a report citing more than 100 case reports of ortho-k related infections and called for more research into complications from the lenses, particularly among children.

An FDA-required postmarketing study completed in 2010 found that six cases of "corneal infiltrate" — a sign of infection — were found in 661 children wearing ortho-k lenses for at least three months over a period of two years. But the study's authors noted that the study's sample size was small. Also, their survey of contact lens providers was voluntary, and providers who didn't respond might have been "motivated not to report," the authors wrote.

One manufacturer, Paragon Vision Sciences, said that of an estimated half-million of its Paragon CRT lenses prescribed to children worldwide, there had been only nine FDA medical device reports of problems with the lenses since 2002, and none caused vision loss. "Paragon's highest priority is the safety of the patients that use our products and we are proud of Paragon CRT's safety record," said company president and CEO Joe Sicari in a written statement.

But Dr. Chris Rapuano, chief of the Wills Eye Hospital Cornea Service in Philadelphia, says the benefit of the lenses for children isn't worth the risk.

Rapuano, who performed Logan Levenson's cornea transplant, said he's recently treated two other patients like Logan who experienced serious infections after wearing ortho-k lenses.

"I'm not saying these lenses are evil, that no one should use them, but they do have risks," Rapuano said, "and each of these patients was not told of the risks."

Barbara Feder Ostrov is a freelance health journalist based in San Jose, Calif.

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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Heart Risk Factors May Affect Black Women More Than White Women

Thu, 05/21/2015 - 10:34am
Heart Risk Factors May Affect Black Women More Than White Women May 21, 201510:34 AM ET

African-American women may be more sensitive to metabolic abnormalities like high triglycerides or low good cholesterol.

iStockphoto

African-American women can be at risk of heart disease even if they don't have metabolic syndrome, a study finds.

That's a problem, because the current thinking is that metabolic syndrome — defined as high triglycerides, bad cholesterol, abdominal fat, high blood pressure and impaired glucose metabolism — is the big risk factor for heart attacks and strokes.

The picture with women appears to be a lot more complicated, especially when you compare women in different racial or ethnic groups.

Shots - Health News Younger Women Hesitate To Say They're Having A Heart Attack

This study, published Wednesday in the Journal of the American Heart Association, found that having just having two metabolic abnormalities raised heart disease risk in African-American women. Being overweight or obese with two or three metabolic factors almost doubled their heart disease risk.

That wasn't true for white women. For them, being overweight or obese didn't boost their risk unless they had full-on metabolic syndrome, too.

"The metabolic health concept has has only been investigated in the white population," says Dr. Michelle Schmiegelow of Copenhagen University Hospital Gentofte in Denmark. She led the research while at Stanford University. "We found that it cannot be directly applied to black individuals."

Looking just at metabolic syndrome will underestimate risk in African-American women and overestimate it in white women, Schmiegelow says.

Shots - Health News Women Having A Heart Attack Don't Get Treatment Fast Enough

This study looked at data from 14,364 postmenopausal women who participated in the Women's Health Initiative, tracking their health for 13 years. Hispanic women were included, but there weren't enough of them to come to any firm conclusions.

"There's a lot we don't know," says Dr. Robert Eckel, a professor at the University of Colorado's Anschutz School of Medicine who was not involved in the study. "Does culture or race, environmentally or genetically, have impacts that we can't quite assess accurately?"

It also raises the question of how the health effects of race and culture vary around the globe, Eckel says.

And it shows that a one-size-fits-all approach to health risks doesn't cut it.

"You have to make an individual risk assessment," Schmiegelow told Shots. "I'm really hoping this study will motivate other groups to see if they can replicate our finding in men or in other races and ethnicities."

Copyright 2015 NPR. To see more, visit http://www.npr.org/.
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Maine Bill Aims To Make Abuse-Deterrent Painkillers More Affordable

Wed, 05/20/2015 - 4:58pm
Maine Bill Aims To Make Abuse-Deterrent Painkillers More Affordable May 20, 2015 4:58 PM ET

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Sales of prescription opioid painkillers have quadrupled since 1999, according to the Centers for Disease Control and Prevention.

Rich Pedroncelli/AP

The problem of opiate addiction in Maine is one that state Rep. Barry Hobbins knows something about. "One of my family members has been struggling with this dreaded addiction of opiates for six years," he says.

So when pharmaceutical company Pfizer — which makes opioids that have abuse-deterrent properties — asked Hobbins to sponsor a bill that would require insurance companies to cover these more expensive drugs at the same level as other opioids, he agreed.

Shots - Health News As Pain Pills Change, Abusers Move To New Drugs

Abuse-deterrent opioids are designed to be harder to crush, cut, or dissolve. Some transform into a gel when mixed with water, so are harder to inject than versions that readily dissolve. "The bill that I sponsored was, I think, one step to address the problem that we have," Hobbins says.

Last year, Massachusetts became the first in the nation to pass a similar law, which will take effect this October. This year, states from Vermont to California may follow suit.

Some physicians say such legislation is well-meant, but question how much of a dent it will put in the addiction problem. Insurance companies, meanwhile, say that if the bill becomes law, it will only drive up the cost of monthly premiums for all policyholders.

Hobbins' bill initially sought to require insurance companies to cover all abuse-deterrent opioids as "preferred drugs." It's been amended to allow insurance companies to choose whether or not to cover the more expensive opioids. If they do, the co-pay level that patients pay must be the same as for traditional versions of the pain pills.

But there are only three prescription opioids approved as abuse-deterrent by the FDA, and they're all name brands, says Katherine Pelletreau, executive director of the Maine Association of Health Plans, which represents four insurance carriers.

Shots - Health News Brand-Name Medicines Dominate Medicare's $103 Billion Drug Bill

"We have concerns about requiring that a name brand drug — which can be significantly more expensive — be subject to the same cost-shares as a generic," Pelletreau says. Tamper-resistant opioids can cost hundreds of dollars more than versions of opioids that don't have those properties.

Some doctors aren't keen about Maine's bill, either. Dr. Mark Publicker, a psychiatrist and past-president of the Northern New England Society of Addiction Medicine, says the bill has good intentions, but "I'm not sure it's going to have the desired impact."

These new opioids are not abuse-proof, Publicker says. An HIV outbreak in Indiana has been linked to the opioid drug Opana, which, Publicker points out, "is alleged to be tamper-resistant, and people with opiate addiction fairly quickly figured out how to extract the drug." Sales of prescription opioid pain relievers have quadrupled since 1999, according to the Centers for Disease Control and Prevention, and overdose deaths have shot up, too.

Shots - Health News Indiana Struggles To Control HIV Outbreak Linked To Injected Drug Use Shots - Health News Indiana's HIV Spike Prompts New Calls For Needle Exchanges Statewide

If lawmakers really want to put a dent in the addiction problem, Publicker says, they should increase access to treatment.

Dr. Noah Nesin, chief medical officer at Penobscot Community Health Center in Bangor, says the current problem with opioid addiction has largely been driven by misguided prescribing practices. Making abuse-deterrent opioids more available, he says, could lead to more lax prescribing — exacerbating the addiction problem instead of easing it.

"Creating a dynamic in which we think, 'Oh, here's a safer alternative,' is an extremely relative comparison," Nesin says.

The FDA announced in April that it considers the development of opioids that deter abuse "a high public health priority," and says it is committed to supporting their development.

Nesin says he's wary of lawmakers dictating medical care. Rep. Barry Hobbins counters that increasing access to abuse-deterrent opioids may not be a silver bullet, but is one factor that could help prevent opiate addiction in the first place. His bill is expected to reach the floor of Maine's House of Representatives this week.

A version of this story first appeared on MPBN.net, NPR's Maine affiliate.

Copyright 2015 Maine Public Broadcasting Network. To see more, visit http://news.mpbn.net.
Categories: NPR Blogs

Terminally Ill California Mom Speaks Out Against Assisted Suicide

Wed, 05/20/2015 - 4:40pm
Terminally Ill California Mom Speaks Out Against Assisted Suicide May 20, 2015 4:40 PM ET

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Stephanie and Brian Packer make lunch with their children, Brian, 11, Savannah, 5, Scarlett, 10, and Jacob, 8.

Stephanie O'Neill/KPCC

Stephanie Packer was 29 when she found out she had a terminal lung disease.

Shots - Health News Contemplating Brittany Maynard's Final Choice

That's the same age as Brittany Maynard, who last year was diagnosed with terminal brain cancer. Last fall, Maynard, of Northern California, opted to end her life with the help of a doctor in Oregon, where physician-assisted suicide is legal.

Maynard's story continues to garner support for right-to-die legislation moving through legislatures in California and several other states. Now, Packer, another young California woman, is stepping up to share her story, but she wants people to draw a different conclusion.

On a recent spring afternoon, Packer, 32, is in her kitchen, preparing lunch with her four children.

"Do you want to help?" she asks the eager crowd of siblings gathered tightly around her at the stovetop.

"Yeah!" yells 5-year-old Savannah.

"I do!" says Jacob, who is 8.

Calmly managing four kids as each vies for the chance to help make chicken salad sandwiches can be trying, but Packer cherishes these moments.

Shots - Health News California Faith Groups Divided Over Right-To-Die Bill

In 2012, after suffering a series of debilitating lung infections, she went to a doctor who diagnosed her with scleroderma. The autoimmune disease causes hardening of the skin and (in about one-third of cases) other organs. The doctor told Packer that it had settled in her lungs.

"And I said, 'OK, what does this mean for me?' " she recalls. "And he said, 'Well, with this condition you have about three years left to live.' "

Packer is on oxygen full time and she takes a slew of medications.

She says she has been diagnosed with a series of conditions linked to or associated with scleroderma, including lupus, gastroparesis, Raynaud's phenomenon, interstitial cystitis and trigeminal neuralgia.

The Two-Way As Planned, Right-To-Die Advocate Brittany Maynard Ends Her Life

Packer's various maladies have her in constant, sometimes excruciating pain, she says. She also can't digest food properly and feels extremely fatigued almost all the time.

Some days, Packer says, are good. Others are marked by low energy and pain that only sleep can relieve.

"For my kids, I need to be able to control the pain because that's what concerns them the most," she says.

But Packer says physician-assisted suicide isn't something she is considering.

"Wanting the pain to stop, wanting the humiliating side effects to go away — that's absolutely natural," Packer says. "I absolutely have been there and I still get there some days. But I don't get to that point of wanting to end it all, because I have been given the tools to understand that today is a horrible day, but tomorrow doesn't have to be."

She and husband Brian, 36, are devout Catholics. They agree with their church that doctors should never hasten death.

"We're a faith-based family," he says. "God put us here on earth and only God can take us away. And he has a master plan for us, and if suffering is part of that plan, which it seems to be, then so be it."

Stephanie Packer, 32, is terminally ill with the autoimmune disease scleroderma.

Stephanie O'Neill/KPCC

They also believe if California legislation called SB 128 passes, it would create the potential for abuse. Pressure to end one's life, they fear, could become a dangerous norm, especially in a world defined by high-cost medical care.

Instead of fatal medication, Stephanie says she hopes other terminally ill people consider existing palliative medicine and hospice care.

"Death can be beautiful and peaceful," she says. "It's a natural process that should be allowed to happen on its own." Even, she says, when it poses uncomfortable challenges.

Brian has traded his full-time job at a lumber company for weekend handyman work so he can care for Stephanie and the children. The family downsized, moving into a two-bedroom apartment they share with their dog and two pet geckos.

Brian says life is good.

"I have four beautiful children. I get to spend so much more time with them than most head of households," he says. "I get to spend more time with my wife than most husbands do."

Shots - Health News A Busy ER Doctor Slows Down To Help Patients Cope With Adversity

And it's that kind of support — from family, friends and people in her community — that Stephanie says keeps her living in gratitude, even as she struggles with her terminal illness and the realization that she will not be there to see her children grow up.

"I know eventually that my lungs are going to give out, which will make my heart give out," she says. "And I know that's going to happen sooner than I would like — sooner than my family would like. But I'm not making that my focus. My focus is today."

Stephanie says she is hoping for a double lung transplant, which could give her a few more years. In the meantime, this month marks three years since her doctor gave her three years to live. So every day, she says, is a blessing.

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

Copyright 2015 Southern California Public Radio. To see more, visit http://www.kpcc.org/.
Categories: NPR Blogs

Looks Good Enough To Smoke: Marijuana Gets Its Glamour Moment

Wed, 05/20/2015 - 12:52pm
Looks Good Enough To Smoke: Marijuana Gets Its Glamour Moment May 20, 201512:52 PM ET
  • Hide caption GDP (Granddaddy Purple). Smell/taste: grape, creamy, berry. Common effects: euphoria, relaxed, body buzz. Top medicinal uses: appetite and pain. Previous Next Courtesy of Chronicle Books
  • Hide caption Blue Kush. Smell/taste: floral, berry, spicy. Common effects: body buzz, relaxed, alert. Top medicinal uses: pain and muscle tension. Previous Next Courtesy of Chronicle Books
  • Hide caption Black Cherry Soda. Smell/taste: cherry, creamy, berry. Common effects: relaxed, euphoria, lazy. Top medicinal uses: stress and pain. Previous Next Courtesy of Chronicle Books
  • Hide caption Skunk #1. Smell/taste: skunky, pungent, acrid. Common effects: uplifting. Top medicinal uses: stress and anxiety. Previous Next Courtesy of Chronicle Books
  • Hide caption Sour Amnesia. Smell/taste: spicy, fuel, skunky. Common effects: energetic, uplifting, cheerful. Top medicinal uses: fatigue and mood enhancement. Previous Next Courtesy of Chronicle Books
  • Hide caption Strawberry Cough. Smell/taste: strawberry, cedar, earthy. Common effects: sociable, cheerful, focused. Top medicinal uses: fatigue and mood enhancement. Previous Next Courtesy of Chronicle Books
  • Hide caption Sugar Daddy. Smell/taste: peppery, lemon, earthy. Common effects: relaxed, mellow, lazy. Top medicinal uses: stress and nausea. Previous Next Courtesy of Chronicle Books

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When Erik Christiansen started smoking pot, he became fascinated by the look of different marijuana strains. But the photographs of marijuana he saw didn't capture the variety.

So he went to the hardware store and picked up two lights and a cardboard box. "I didn't even have a macro lens — I was shooting through a magnifying glass," he says.

High-Def Views

Christiansen has created high-resolution 360-degree views of some strains of marijuana, including this one of Platinum Bubba.

Credit: Courtesy of Erik Christiansen

The California-based photographer tinkered with his macro technique until he had created a consistent way to capture highly detailed images of marijuana.

Then Dan Michaels, a cannabis aficionado and strategist for the growing legal pot industry, contacted Christiansen about collaborating on a field guide. The result is Green: A Field Guide to Marijuana (Chronicle Books, $30). The high-end coffee table book documents over 170 strains of cannabis, explaining their medicinal and recreational attributes. (Though it's worth noting that the medicinal benefits are based on subjective reports rather than randomized clinical trials.)

The book is meant to appeal to the growing artisanal marijuana industry, describing each bud's tasting notes and effects much like a sommelier would describe a vintage wine.

We asked Christiansen about becoming a professional weed photographer, and what we can tell about a marijuana bud's effects by looking at it. The conversation has been edited for length and clarity.

How did you source all of these buds?

I had a library of probably 300 to 400 strains that we were able to pull from. There's your popular strains that most people who enjoy cannabis have heard of, like your Blue Dreams and your Girl Scout Cookies. But we also wanted to include the rare ones. I searched through hundreds of dispensaries in San Diego, L.A., and the Bay Area to try and track down all of them.

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Seeing the buds close up accentuates the variations — some have these wiry golden threads and others are tightly coiffed, like beehive hairdos. They seem to take on personalities. What does this tell us about the plants?

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You can take the same plant and give a clone to six different growers and at the end of that grow cycle each will be unique in its own way, based on the nutrients that the growers us, the CO2 content of the air and the temperature of the room. Being able to get up close and see those differences is important.

If you look at any of the pictures, there are these little balls on the end of each plant— that's where the THC is stored. The more little balls, or trichomes, that are present on the buds, the more potent it can be. The color will also tell you a lot about the effect it will deliver. More amber-color trichomes will deliver a more body effect, where lighter-colored trichomes will be more of a head-y effect.

Do you have any favorites?

My favorite in the book is the strain called the Shire. I've only been able to find it once. The effect was so uplifting. It's the only strain that's ever given me the stereotypical effect where you're just sitting there laughing. I went back to that dispensary trying to get it again and was never able to find it again.

There's a certain legitimacy to field guides, or any reference book that documents variations of a species. Was legitimacy the intention?

Absolutely. It's not this stoner druggie culture anymore; it's becoming a real industry.

It's like the wild, wild West. Or craft beer. It's a bunch of little guys tinkering and creating new strains. Some of them totally take off and blow up and you see them all over the place.

What happens to the buds after you've shot them?

I usually get to sample them. Not all the time, but that's a perk of the job.

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

Grassley To Justice Department: Crack Down On Medicare Advantage Overbilling

Wed, 05/20/2015 - 11:57am
Grassley To Justice Department: Crack Down On Medicare Advantage Overbilling May 20, 201511:57 AM ET Fred Schulte

Sen. Chuck Grassley has questions about what the feds are doing to investigate allegations of Medicare Advantage fraud.

Drew Angerer/Getty Images

Senate Judiciary Committee Chairman Chuck Grassley has asked Attorney General Loretta Lynch to tighten scrutiny of Medicare Advantage health plans suspected of overcharging the government, saying billions of tax dollars are at risk as the popular senior care program grows.

In May 19 letters to Lynch and Andrew M. Slavitt, acting administrator of the Centers for Medicare and Medicaid Services, Grassley wanted to know what both agencies have done, together and apart, to stamp out overcharges that have plagued the privately run insurance program for years.

Shots - Health News How Medicare Advantage Investors Profited From Loose Government Lips

"Safeguards become all the more important as Medicare Advantage adds more patients and billions of dollars of hard-earned taxpayer money is at stake," the Iowa Republican wrote.

Medicare Advantage plans have gained popularity as an alternative to the government-run Medicare program in recent years, and the plans now cover some 16 million people.

Grassley cited the Center for Public Integrity's investigative reporting, which found that CMS made more than $70 billion what the agency itself deemed "improper" payments to Medicare Advantage plans between 2008 and 2013.

The concerns revolve around the accuracy of a billing tool called a "risk score," which is supposed to pay insurers higher rates for taking sicker people and less for those with few medical needs.

But federal officials have struggled for years to track overspending tied to inflated risk scores. A 2009 agency study found that some plans had exaggerated how sick patients were to boost their payments, for instance. CMS also has acknowledged that faulty risk scores remain a costly problem, as the Center for Public Integrity first reported last year.

"With the reported increase in risk score gaming, and the monumental cost that the taxpayer will shoulder for such wrongdoing, it is imperative that CMS implement safeguards to reduce risk score fraud, waste and abuse. Moreover, if the reports of abuse are true, CMS should increase its auditing practices," Grassley wrote.

Neither CMS nor the Justice Department had any immediate comment on the letters.

Shots - Health News Feds Knew About Medicare Advantage Overcharges Years Ago

Grassley also cited a 2015 report by the Government Accountability Office , the watchdog arm of Congress, that found CMS "could save billions of dollars by improving the accuracy of its payments to Medicare Advantage programs." The watchdog noted that CMS had estimated "improper payments" to Medicare Advantage plans at more than $12 billion in 2014 alone.

Grassley additionally referenced Center for Public Integrity reports on "an increasing number" of whistleblower lawsuits targeting Medicare Advantage. The suits argue that some insurance companies that offer Medicare Advantage "are allegedly engaging in billing abuse by altering patient records in order to claim patients are sicker than they actually are ... . News reports indicate that some insurance companies are wrongfully claiming sicker patients, leading to inflated risk scores and reimbursements," Grassley wrote.

Medicare Advantage often resonates with many seniors because of its low out-of-pocket costs. It's also winning favor with some health policy wonks who argue these managed care plans can offer higher quality care than standard Medicare, which pays doctors and hospitals on a fee-for-service basis.

Medicare Advantage plans also have proven to be a formidable lobbying force in Washington able to repeatedly beat back any efforts by the government to cut payment rates, most recently in April.

At the time, Karen Ignagni, chief executive officer of America's Health Insurance Plans, the industry's trade group, noted: "Millions of seniors across the country have made their voices heard in Washington, and more than 340 members of Congress have stood in support of Medicare Advantage."

Shots - Health News More Whistleblowers Say Health Plans Are Gouging Medicare

But the whistleblower cases and government audits suggest that it's far too easy for health plans to gouge the government.

Grassley asked Lynch for a "detailed explanation" of what steps the Justice Department "has taken, and is currently taking, to ensure that insurance companies are not fraudulently altering" risk scores.

Government investigations of Medicare Advantage plans rarely spill out into public view. One exception was a 2009 Justice Department lawsuit against the owners of America's Health Choice Medical Plans Inc. in Vero Beach, Fla. The government accused the health plan of bilking Medicare out of millions of dollars by reporting "as many diagnosis codes as possible without regard to their truthfulness."

The health plan denied the accusations. The case was settled in 2010 when the plan's owners agreed to pay the government $22.6 million. The HMO is defunct.

At least one other Justice Department probe into whether exaggerated risk scores are jacking up costs is believed to be widening.

Humana Inc., based in Louisville, Ky., which counts more than 3 million seniors in its plans, wrote in a March Securities and Exchange Commission filing that "a number of Medicare Advantage plans, providers and vendors" have come under scrutiny.

On April 14, DaVita Healthcare Partners Inc., headquartered in Denver disclosed that Justice Department investigators had subpoenaed Medicare Advantage billing data and other records from January 2008 through the end of 2013.

Grassley asked both Justice and CMS to tell him how many risk-score fraud investigations had been conducted over the past five years and their outcome. He asked for a reply no later than June 3, 2015.

Grassley also wants to know how many risk score audits CMS has conducted, how much money was recovered and how much CMS spends attempting to collect overpayments.

This piece comes from the Center for Public Integrity, a nonpartisan, nonprofit investigative news organization. To follow CPI's investigations into Medicare and Medicare Advantage waste, fraud and abuse, go here. Or follow the organization on Twitter: @Publici.

Copyright 2015 The Center for Public Integrity. To see more, visit .
Categories: NPR Blogs

Map Reveals The Distinctive Cause Of Death In Each State

Wed, 05/20/2015 - 10:42am
Map Reveals The Distinctive Cause Of Death In Each State May 20, 201510:42 AM ET

There's no getting around the strangeness of a map that shows the most distinctive cause of death in each of our 50 states and the District of Columbia.

In Texas, it's tuberculosis. In Maine, it's the flu. And in Nevada, it's the ominous "legal intervention."

But what does it mean to label a cause of death distinctive?

I asked Francis Boscoe, a researcher with the New York State Cancer Registry, who came up with the analysis and the map published last Thursday by Preventing Chronic Disease, an online journal from the Centers for Disease Control and Prevention. Since then, the map has gone, well, viral.

"To be honest, I was seeing these maps about a year ago," he tells Shots. One he points to is a state-by-state map of distinctive musical artists based on the online listening habits of people across the country. In other words, which artist was listened to far more often in one state than the others.

"I wondered what it would look like if you applied this to something more serious, like mortality data," he says. He took advantage of a standardized list of causes of death — 113 in all — that are used across the country and a national database of the underlying causes of death collected between 2001 to 2010.

Boscoe calculated the mortality rates for all 113 causes of death in each state and compared them with the rates for the same causes nationwide. On the map, each state and Washington, D.C., then got labeled with the local cause that was, essentially, the largest multiple of the corresponding national rate.

If you'd like to try it, here's the formula for standardized mortality rate that he used:

The biggest of the outliers was Oklahoma, where the rather vague death cause "other acute ischemic heart diseases" was used 19.4 times more often than it was nationally.

Boscoe says the most distinctive death cause in about half the states, including Oklahoma, says more about how people there are classifying deaths than the actual health of people. There are "a few different flavors of heart disease," Boscoe says. "Oklahoma, for whatever reason, is putting them in the other, unspecified category. If you're interested in heart attacks vs. chronic heart disease, you're not going to get a good read on that there, whereas in most states you would."

Other top causes are clearly on the money, he says, such as tuberculosis in Texas and black lung disease, or pneumoconiosis, in the coal-mining states of West Virginia and Kentucky. Those causes are straightforward to diagnose and make sense in context.

The map has limitations. "Some states deserve to have more than one color," he says, because there are a couple of causes that rise above the rest. In Nevada, for instance, he says, atherosclerosis and legal intervention (which is a death in the context of a crime scene and could be either someone in law enforcement or a civilian) were both quite high.

In general, he says, the most distinctive cause of death in each state is at least double the corresponding national rate. He plans on looking at that doubling rule of thumb in more detail.

Boscoe says the map has already sparked conversations with public health officials in some states about how to improve the classification of deaths. And he's been deluged with calls from reporters interested in the prime causes where they work.

While he acknowledges a certain cartoonishness to the map, he says that he doesn't think the work was frivolous: "It obviously works better than sending out a 16-page report that no one would open."

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

Dense Breasts Are Just One Part Of The Cancer Risk Calculus

Tue, 05/19/2015 - 1:06pm
Dense Breasts Are Just One Part Of The Cancer Risk Calculus May 19, 2015 1:06 PM ET

Almost half the states now require doctors to tell women if they have dense breasts because they're at higher risk of breast cancer, and those cancers are harder to find. But not all women with dense breasts have the same risks, a study says.

Those differences need to be taken into account when figuring out each woman's risk of breast cancer, the study says, and also weighed against other factors, including family history, age and ethnicity.

The researchers looked at the records of 365,426 women who had a normal mammogram, then looked to see which ones were diagnosed with breast cancer within a year — a cancer that may have been missed by the mammogram.

All told, 47 percent of the women in the study had dense breasts. But just half of those women had a higher cancer risk. The women who got cancer were more likely to be older and white, have a family history of breast cancer, and to have "heterogeneously" or "extremely" dense breasts, the top two categories of breast density.

Shots - Health News Letters About Dense Breasts Can Lead To More Questions Than Answers

The results were published Monday in Annals of Internal Medicine.

Breast cancer advocates have been pushing for state and federal laws requiring that women be told if they have dense breasts, so they can get extra screening with ultrasound or MRI. That screening can find more cancers in dense breasts, but it can also lead to more false positives and needless surgery.

This study makes the point that women need to know not just about breast density, but what kind of breast density, and other risk factors, too.

Sounds complicated. So we called up Dr. Karla Kerlikowske, a professor of medicine at the University of California, San Francisco and lead author of the study, to help us figure this out. The conversation has been edited for length and clarity.

Your study looks at breast cancer risk using not just breast density but also family history, age and ethnicity. Why is that?

About 45 percent of women have dense breasts; that's a large number of women. But the sensitivity of mammograms is such that we're not missing 45 percent of cancers. So can we narrow it down to women who are at higher risk of cancer, and especially women at higher risk of advanced cancer? Then if we did supplemental imaging of women in that group, it might help them.

How would I figure out the other risk factors besides breast density?

Shots - Health News Federal Panel Revisits Contested Recommendation On Mammograms

You can use our Breast Cancer Surveillance Consortium Risk Calculator; it looks at age, race, family history, history of biopsy and breast density. Ours is the only risk calculator that has breast density in it. We actually validated it in another mammography population. And it's an app; just type in "BCSC Risk Calculator" and download.

I looked at the calculator, and even though I've been told I have dense breasts I realize I have no idea if they're heterogenous or extremely dense, which are the higher-risk categories. How do I find that out?

The provider who ordered the test will get that information. You'd have to ask the provider; it's in the mammography report. My understanding from the bills in Congress is that you'd actually be told what your density is; if you're fatty or scattered or heterogenous or extremely dense. All women would be informed, and they would know the category. If I have fatty breasts I'd like to know that, too, because then I'm at really low risk.

Are you telling your patients that?

It sort of depends. If I don't think they're at high risk of an interval cancer I tend not to worry them too much. If they're at high risk then I have a discussion with them. If they have fatty breasts I let them know, wow, you're really at low risk for cancer.

It feels like we're still struggling with who really needs the extra scans. How will we figure that out?

Now that we know who these high-risk groups are, we need to know how supplemental screening works in those high-risk groups. If we add ultrasound, do we miss less cancer? If we add MRI, do we miss less cancer? We have data on both of them, and we're in the process of analyzing them.

When will we find out?

I'm hoping sometime this summer.

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

How Medicare Advantage Investors Profited From Loose Government Lips

Tue, 05/19/2015 - 10:54am
How Medicare Advantage Investors Profited From Loose Government Lips May 19, 201510:54 AM ET Fred Schulte

On Wall Street, Feb. 3, 2011, was mostly a ho-hum day. But not for companies that sell Medicare Advantage plans.

Several of those that offer the privately run Medicare coverage option hit the jackpot, tacking on billions of dollars in new value after federal officials signaled they might go easy on health plans suspected of overcharging the government.

Shots - Health News More Whistleblowers Say Health Plans Are Gouging Medicare

The stocks took off after the federal Centers for Medicare and Medicaid Services advised the plans in a memo that it was rethinking a move to ratchet up audits. Some of these plans are run by publicly traded insurance companies whose fortunes can rise and fall on a whiff of change in Medicare policy.

At the time, health insurers were bracing for tougher audits, fearing they could wind up owing the government millions of dollars as a result.

The memo was sent to Medicare Advantage plans, but wasn't available to the general public.

A CMS spokesman said the two-paragraph memo was routine and that officials did nothing wrong in sending it out. But the advisory appears to contradict CMS regulations that urge officials to wait until after markets close to disclose information that could move stocks. The episode also raises fresh questions about the security and timing of so-called market-sensitive disclosures — and just who gains access to the information.

"When the memo was released by people at the agency, they had to be brain dead if they thought it would not quickly make its way into the hands of those who influence stock prices," said Lynn E. Turner, a former Securities and Exchange Commission official and expert on financial reporting requirements.

Big Jump

CMS said it began sending out the memo on an internal message system at 9:30 a.m. on Feb. 3 and it took "several hours" to reach all of the 6,500 health plan recipients.

By mid-afternoon, a CMS official in Washington noted that shares in three major Medicare Advantage insurers had "shot up" as a result.

"There's also an incredible volume — an atypical number of buyers and sellers," CMS official Misha Segal wrote in an email to several agency higher-ups at 2:37 p.m. (See the email traffic below.)

UnitedHealth Group, the nation's biggest Medicare Advantage company, rose 4 percent, which "is nearly $2 billion in 'newly created equity' for the company," according to Segal. "This is a big jump."

The huge stock rally — and the role CMS played in sparking it — is disclosed in agency emails and other records obtained by the Center for Public Integrity through a Freedom of Information Act lawsuit.

CMS officials, in a statement, said nothing was amiss.

The memo "was routine, appropriate and did not contain sensitive information. This standard memo was simply a reminder that CMS would thoroughly evaluate all the comments received and that we anticipated potential future changes based on the input we received. No non-public information was provided in this message."

Yet even the suggestion of an upcoming Medicare policy shift can trigger a stampede of buying or selling of health care stocks — and raise questions about how closely agency officials followed CMS regulations written to prevent this sort of Wall Street windfall.

The rules say officials should "strive to err on the side of caution" by waiting until after markets close at 4 p.m. Eastern Time to make announcements "because it is sometimes difficult" to predict what will roil stock prices.

The wait is to "allow the investment community broad access to the information and time to fully analyze the announced change before reacting to it," according to a September 2010 CMS policy statement. CMS also regularly cautions employees to keep market-sensitive deliberations under wraps. (See the policy statement below.)

Additional Information:

Signaling changes

But the February 2011 memo from Cheri Rice, acting director of the Medicare Plan Payment Group, stated that CMS "anticipates making changes" to the much-feared audit process. The memo arrived at a time when the industry — and stock market analysts — were worried that the audits could hurt the companies' bottom lines.

Indeed, the memo brought a strong reaction. Justin Lake, then an analyst at UBS Investment Bank, flagged the memo as "breaking news from CMS" in a research note sent via email at 1:33 p.m.

"We have been reading CMS notices for 10 years now and don't EVER remember the agency indicating explicitly that there were changes coming in between publishing preliminary and final rules such as this. Very interesting indeed," Lake wrote.

Lake speculated that it could signify a "kinder/gentler CMS" that would be less aggressive about clawing back widespread overpayments to Medicare Advantage plans. Such a stance would be "very bullish" for Medicare Advantage stocks, he said.

It's not clear how the UBS analyst obtained the memo. Lake, who recently joined a hedge fund in Connecticut, declined comment through the firm.

At 2:07 p.m., a second CMS official remarked that Lake's analysis "is generating huge amounts of interest from the markets. Bank of America just called me too," he wrote.

In his 2:37 p.m. email, Segal cited Lake's note as the biggest driver of the market: "The sales team at UBS must have gotten on [the] phones and convinced a bunch of analysts and traders that this was a big deal," Segal wrote.

Much of the other chatter within CMS as the stocks gained ground was redacted from the volley of emails released to the Center for Public Integrity.

Still, it's clear that agency officials were caught off guard. Stock in Humana Inc., the country's second biggest Medicare Advantage plan, rose by 5 percent. HealthSpring, also a Medicare insurer, was up 4 percent. It all happened on a day when the Standard & Poor's 500 index was roughly flat, according to the CMS mid-afternoon analysis.

CMS spokesman Aaron Albright said the memo was a "standard communication" and suggested the markets had overreacted. "We can't control how people react to a memo like this," he said.

While investors may have welcomed CMS easing up on Medicare Advantage audits, taxpayers, both then and now, have much less cause for applause.

The audits that the industry was hoping to scale back assess the accuracy of a billing tool called a "risk score," which is supposed to pay insurers higher rates for taking sicker people and less for those with few medical needs.

By 2011, CMS officials had been struggling for years to track overspending tied to inflated risk scores. A 2009 agency study found that some plans had exaggerated how sick patients were to boost their payments, for instance. And by the agency's own account, "improper" payments to Medicare Advantage plans cost taxpayers billions of dollars annually, as the Center for Public Integrity first reported last year.

Despite growing losses from improper billing, CMS officials have repeatedly caved in to pressure from the industry to scale back the consequences of these audits, which are known as Risk Adjustment Data Validation — or RADV.

CMS posted a draft regulation on Dec. 20, 2010, that outlined how the audits would be conducted and asked for comments. In the Feb. 3 memo, CMS official Rice wrote: "We are thoroughly evaluating all comments and anticipate making changes to our draft, based on input we received."

The amount of money in dispute could be growing along with the Medicare Advantage program, whose annual cost now exceeds $150 billion.

More than four years after the February 2011 memo was sent, CMS still hasn't finished even the first round of the RADV audits. "These audits are underway. CMS is auditing 30 contracts and we do not have a specific timeframe for completion," agency official Albright said.

CMS has come under fire in recent years over how it releases policy information — and to whom. In Dec. 2011, Sen. Chuck Grassley, R-Iowa, criticized the agency for conducting briefings on behalf of hedge funds and so-called "political intelligence brokers" who seek to profit as a result. The SEC also has regulations on disclosure.

CMS also is at the center of an ongoing probe into whether 2013 Medicare Advantage rate information was leaked in advance of the public announcement.

This piece comes from the Center for Public Integrity, a nonpartisan, nonprofit investigative news organization. To follow CPI's investigations into Medicare and Medicare Advantage waste, fraud and abuse, go here. Or follow the organization on Twitter: @Publici.

Copyright 2015 The Center for Public Integrity. To see more, visit .
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