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FDA Cracks Down On Fake Ebola Cures Sold Online

NPR Health Blog - Thu, 10/23/2014 - 4:22pm
FDA Cracks Down On Fake Ebola Cures Sold Online October 23, 2014 4:22 PM ET

fromKERA

Listen to the Story 3 min 20 sec  

The problem isn't just that fake cures are worthless, doctors say. Fraudulent claims also give some people the false sense that the product can protect them from getting sick.

iStockphoto

Snake venom, vitamin C, Nano Silver and herbs have all been pitched online as a treatment or cure for Ebola. None has the backing of the FDA.

"Unfortunately during public health threats such as Ebola, fraudulent products that claim to prevent, treat, cure disease often appear on the market almost overnight," says Gary Coody, the FDA's national health fraud coordinator. In particular, the FDA wants consumers to beware Ebola "cures" peddled online.

“ It's like storm-chasing roofers, who go and try to defraud people after a big storm. Some of them may be making an honest mistake; other companies are trying to rip people off.

The problem isn't just that such products are worthless. "Consumers who are misled by false claims may delay seeking the medical care they need, such as proper diagnosis and supportive care," Coody says. Or they may have a false sense that the product will protect them from the virus.

Goats and Soda Fake Cures For AIDS Have A Long And Dreadful History

The FDA has sent warning letters to three companies it says are making fraudulent claims about Ebola cures. The letters threaten property seizure and even criminal prosecution if the firms don't respond appropriately.

The strategy amounts to "public shaming," says Nathan Cortez, who teaches law at Southern Methodist University in Dallas. "It's one mechanism that the FDA uses to lean on companies in a very public way. It's also meant as a warning to other firms, he says, "to say we know companies are trying to defraud the public with fake Ebola tests and treatments and we're on the case."

Two of the firms that got the FDA warning letters didn't respond to my emailed messages. But Ralph Fucetola of the New Jersey-based company Natural Solutions Foundation says he heard the FDA's message loud and clear. Natural Solutions received the warning for its claims that a product known as Nano Silver can effectively kill Ebola.

Shots - Health News Banned Drugs Still Turning Up In Weight-Loss Supplements Shots - Health News How To Sell Bogus Health Cures In 5 Easy Steps

"We understand that there is no approved treatment for Ebola," Fucetola says. "Since we are in the middle of negotiating with the government with regard to how we can best describe what we believe is a very important health breakthrough, we are not using the legal term of art 'treatment of disease.' "

Even if the company doesn't explicitly say that Nano Silver "treats" Ebola, it has claimed on its website, Twitter and Facebook that Ebola has a cure — a statement not borne out by the evidence so far, according to the FDA, CDC and other health officials.

While there are experimental drugs and vaccines being tested in the current Ebola outbreak, nothing yet has been proved to work.

Online, other companies tout clove oil, oregano and homeopathic treatments to prevent the virus. There's even a tutorial that was up on YouTube for a do-it-yourself vaccine.

Some businesses, Cortez says, take advantage of fear.

"It's like storm-chasing roofers, who go and try to defraud people after a big storm," he says. "Some of them may be making an honest mistake; other companies are trying to rip people off."

Mistake or not, the FDA says Ebola cures advertised on the Internet are misleading and dangerous. The agency encourages consumers who have seen such claims to report them.

Copyright 2014 KERA Unlimited. To see more, visit http://www.kera.org/.
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What To Do When The CDC Orders You To Check For Ebola Symptoms

NPR Health Blog - Thu, 10/23/2014 - 3:53pm
What To Do When The CDC Orders You To Check For Ebola Symptoms October 23, 2014 3:53 PM ET

Travelers from Guinea, Liberia, and Sierra Leone will receive a CARE (Check And Report Ebola) Kit when they arrive in the United States, starting Monday.

CDC

Now that the United States is asking people arriving from West Africa to monitor their health in an effort to identify those infected with Ebola virus, the natural question is: How would I do that?

With your Ebola CARE Kit, of course.

On Thursday the Centers for Disease Control and Prevention unveiled the Check and Report Ebola Kit, which it will be handing out starting Monday to travelers from West Africa who arrive at U.S. airports. Think of it as a swag bag for epidemic time.

Though about 150 people arrive in the U.S. each day from these countries, the CDC says that at first they'll be monitoring people going to just six states — New York, Pennsylvania, Maryland, Virginia, New Jersey and Georgia. Those states account for about 70 percent of travelers from Liberia, Sierra Leone and Guinea end up. The goal is to eventually ramp up to include every state.

If you get a temperature reading of 100.4°F (38°C) or higher, it's time to call the health department.

CDC

The packet includes a thermometer, because people will have to take their temperature twice a day. And they will have to call the health department daily to report those temperatures.

Those being monitored must also have to provide contact information so that they can be tracked down if they don't comply.

The packet includes illustrations of symptoms you don't want to have, including a fever of 100.4°F (38°C) or more, diarrhea, vomiting, headache and red eyes. And there's a tracking log to record symptoms and temperatures.

The symptom card tells what to watch for, and the log sheets are for recording temps and symptoms, twice a day.

CDC

Wait, there's more! A wallet card makes it easy to know how to call your health department.

Once the 21 days have passed, the kit notes, "if you have no symptoms or fever, you are no longer at risk of Ebola."

"We hope you find this kit useful," the welcome letter that accompanies the kit says. "Please use it to keep yourself safe and help others around you to stay safe too. "Together, we can protect everyone from Ebola."

A wallet-size version of what do to when.

CDC Copyright 2014 NPR. To see more, visit http://www.npr.org/.
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How To Sell Bogus Health Cures In 5 Easy Steps

NPR Health Blog - Thu, 10/23/2014 - 1:55pm
How To Sell Bogus Health Cures In 5 Easy Steps October 23, 2014 1:55 PM ET

Wouldn't it be great if this stuff really did cause quick painless weight loss?

iStockphoto

I'm bummed that the green coffee weight-loss cure touted by Dr. Oz doesn't work. It could have been the perfect painless antidote to my habit of lying on the sofa eating Russian chocolate.

"My job is to be a cheerleader for the audience when they don't think they have hope," Dr. Mehmet Oz told a congressional panel that blasted him for promoting supplements.

Brad Barket/Getty Images

But the one flimsy bit of research that suggested that green coffee extract might speed weight loss was retracted this week, putting an end to a supplement saga that made serious coin for the purveyors of the stuff — and got the telegenic heart surgeon scolded by Congress in June for promoting snake oil.

Now there's nary a mention of green coffee extract to be found on the Dr. Oz website.

But if it's adios green coffee extract, it's hello to the next dubious cure, on that site and so many others. Enzymes are big. Fraudulent Ebola "cures" are being hawked online. The Federal Trade Commission recently forced manufacturers to reimburse $1.5 million to customers who bought caffeine-infused underpants that allegedly melted fat. And the Food and Drug Administration's ever-growing warning list of scams also includes phony treatments for diabetes, autism and concussion.

The Salt Sorry, Dr. Oz, Green Coffee Can't Even Slim Down Chubby Mice

If I'd succumbed to Dr. Oz's promises, I would have been out some bucks, but probably not harmed. But many fake cures not only distract people from getting effective care, they can be dangerous. And fraudsters typically target people who are overweight, have a serious disease like cancer, or something without a cure, like arthritis, multiple sclerosis, or HIV/AIDS.

Here's how to market your own dubious cure (or avoid them), with a hat tip to the FDA and Mayo Clinic:

  • Miracle cure! Dr. Oz promised that green coffee extract was a "miracle cure that can burn fat fast." Who doesn't love a good miracle?
  • "It worked for me." Journalists love a story, and you probably do, too. But heartfelt anecdotes do not an evidence-based treatment make.
  • Burns fat fast! Speed is of the essence when hawking a dubious cure. It's much more fun than going to months of Weight Watchers meetings and measuring your serving sizes. Alas, the only time I achieved quick weight loss was when I had giardia.
  • It's all natural. So is arsenic. And Ebola. Reassuring though it may sound, but being natural is no guarantee of safety or efficacy, the two things you want in a medical treatment.
  • It's scientific! Bad science abounds in scam land. Sciency claims like "boosts the immune system" or "detoxifies" are common, as are references to irrelevant or out-of-date studies. Or, as with green coffee extract, false ones.

"Most people rely on experts to summarize the science for them, which they should," says Steven Salzberg, a researcher in computational biology at Johns Hopkins University who tracks supplement hype. "Dr. Oz puts himself out there as one of those people, but unfortunately he's just a terrible scientist."

Shots - Health News Banned Drugs Still Turning Up In Weight-Loss Supplements

Most people assume that medical doctors like Oz know their way around research, Salzberg told me, but that's not always the case. "Unfortunately, he believes stuff that's just wrong."

So what's a person in search of a miracle to do? Be skeptical, Salzberg says; "always be skeptical. When someone's selling you something, ask, 'Well, what's in it for them?"

For Oz, it may be that it's much more satisfying to talk about miracles than it is to admit the less glamorous part of health. "There is no miracle weight-loss cure," Salzberg says. "The way to lose weight is to consume fewer calories. But nobody wants to hear that. If he went on his show every day and eat less, nobody would watch."

Copyright 2014 NPR. To see more, visit http://www.npr.org/.
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Scientists Fight For Superbug Research As U.S. Pauses Funding

NPR Health Blog - Thu, 10/23/2014 - 8:58am
Scientists Fight For Superbug Research As U.S. Pauses Funding October 23, 2014 8:58 AM ET Listen to the Story 3 min 47 sec  

A rogues gallery of the viruses (left to right) that cause MERS, SARS, and influenza.

Niaid; 3D4Medical; Niaid/Science Source

An unusual government moratorium aimed at controversial research with high-risk viruses has halted important public health research, scientists told an advisory committee to the federal government on Wednesday.

“ This is potentially the worst time for this type of pause to occur.

Shots - Health News U.S. To Temporarily Halt Funding For Controversial Virus Research

The White House Office of Science and Technology Policy said Friday that the federal government will, for now, not fund any new research proposals that might make three particular viruses more virulent or contagious. The three viruses are those that give rise to influenza, severe acute respiratory syndrome, and Middle East respiratory syndrome.

The White House also said it would encourage "those currently conducting this type of work — whether federally funded or not — to voluntarily pause their research while risks and benefits are being reassessed."

Some researchers who study these germs say they received "cease-and-desist" letters from their funder, the National Institutes of Health.

The moratorium has hit efforts to develop a small-animal model for MERS, the troubling virus that's recently emerged in the Middle East, says Kanta Subbarao, a biologist who studies influenza, SARS, and MERS at the National Institute of Allergy and Infectious Diseases.

She notes that currently scientists have no rodent models to use for testing drugs or other treatments for MERS. Her group developed such a model for SARS by creating a form of the virus that makes mice sicker, and she wants to do the same for MERS.

"This moratorium will stop that research," Subbarao told members of an advisory committee called the National Science Advisory Board for Biosecurity, at their Wednesday meeting on the NIH campus in Bethesda, Md. "I have concerns about whether that's the wisest thing to do in the face of an ongoing outbreak without a small animal model."

"This is potentially the worst time for this type of pause to occur," agreed Matthew Frieman of the University of Maryland School of Medicine, a MERS researcher who notes that over the last several weeks a dozen more cases of the illness have occurred.

What's more, a flu researcher named Stacey Schultz-Cherry of St. Jude Children's Research Hospital told the committee that her cease-work order from NIH inexplicably told her to stop work on projects that included surveillance of circulating flu viruses. "And that really concerns me from a public health standpoint," she said.

The chair of the NSABB said the committee would relay these issues to higher-ups; one official noted that waivers could be granted under the temporary moratorium.

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All of this is the latest twist in a long, stormy debate that began about three years ago, after two teams of government-funded scientists created mutant forms of the bird flu virus H5N1. This type of research has polarized the scientific community, with biologists lining up on opposing sides.

Proponents of so-called "gain-of-function" experiments say the work is vital to understand what these viruses are capable of, because of the risk that they might mutate in the wild and cause a natural pandemic.

Critics say the experiments effectively create super-germs that could wreak havoc and potentially kill millions of people if they got out of the lab.

In January of 2012, flu researchers voluntarily agreed to a moratorium that ended up lasting about a year. The government adopted new policies to give certain high-risk flu experiments extra oversight.

But then came the recent lab accidents at the Centers for Disease Control and Prevention that involved anthrax and a deadly flu virus.

Suddenly government officials worried about lab safety and decided they had to temporarily stop research that could create more dangerous pathogens, as they began a year-long public process to look at the risks and benefits.

“ I agree that risk assessment of this work is needed. I think the risks are potentially extraordinary.

The NSABB will be weighing in, as will the prestigious National Research Council. The government will also be hiring outside experts to do risk analyses.

The final goal is a new policy to guide decisions about what should get funded.

"I think the moratorium is long over-due," says epidemiologist Marc Lipsitch of the Harvard School of Public Health. "I would have preferred to have the risks and benefits weighed before these experiments started. But I think it's very important that we pause now and evaluate them in light of the increased concern over laboratory safety and the possibility of an accident that could lead to a pandemic."

Lipsitch notes that the issue is not work with dangerous pathogens in general, but rather research that could create novel, virulent, and transmissible agents that might spark a pandemic in people.

"I was pleased to see the pause announced," says Dr. Thomas Inglesby, director of the University of Pittsburgh Medical Center's Center for Health Security. "I agree that risk assessment of this work is needed. I think the risks are potentially extraordinary."

But others say they think halting this research is counterproductive. "I'm disappointed. I think it is a knee-jerk reaction to a very complex problem," says Dr. Arturo Casadevall, a microbiologist at the Albert Einstein College of Medicine.

Virologist Paul Duprex of Boston University also opposes the ban. "People don't completely understand what is allowed and what is not allowed," he notes.

But Duprex thinks starting this deliberative process is reasonable. "They have outlined a time-restricted process for consultation," he says. "That's good for the people who are vested in the experiments because they at least know there is a process which is not open-ended."

After all, the flu research community has already gone through one year-long pause.

"After the voluntary moratorium on H5N1 transmission studies, new regulations and policies were issued," flu researcher Yoshihiro Kawaoka of the University of Wisconsin-Madison noted in an email. "I do not know what else is needed. We will never be able to satisfy critics who call for 'zero risk.' "

He had government approval for additional H5N1 transmission studies, but says they will now be paused. "There are other projects for which we need guidance from NIH to determine whether they are subject to the pause," Kawaoka wrote, adding that continued pauses to influenza virus research will delay progress in science and have long-term effects on public health such as slowing improvements in vaccines and antivirals.

Copyright 2014 NPR. To see more, visit http://www.npr.org/.
Categories: NPR Blogs

Poll: Broad Support In U.S. For Ebola Travel Ban

NPR Health Blog - Wed, 10/22/2014 - 3:53pm
Poll: Broad Support In U.S. For Ebola Travel Ban October 22, 2014 3:53 PM ET

A passenger wearing a face mask arrives at Los Angeles International Airport Friday. Federal officials now require people traveling from West Africa to enter the U.S. at one of five airports equipped to screen them for signs of Ebola.

Mark Ralston /AFP/Getty Images

How do Americans feel about Ebola and the U.S. response to the outbreak so far?

NPR and our partners at Truven Health Analytics asked more than 3,000 adults in a poll conducted online and by phone (mobile and landline) Oct. 1-15.

NPR-Truven Health Analytics

Nearly everyone — 97 percent — knew about the Ebola outbreak in West Africa, and a slim majority of those people, or 53 percent, believe the U.S. government has taken a leadership role in response.

A clear majority of Americans are worried about Ebola. Fifty-six percent of people are either "very concerned" or "somewhat concerned" about the spread of the Ebola virus to this country.

The level of worry "is a little lower than I would have guessed given the media play over the last several weeks," Dr. Michael Taylor, Truven's chief medical officer, tells Shots. He says there's no reason for panic. "The big concern is that if it can't be managed in Africa it's going to spread," he says.

People were split pretty evenly on whether the U.S. response has been adequate: 49 percent said yes; 51 percent said no.

About three-quarters of people aware of the Ebola outbreak say the U.S. should take steps such as banning travel to and from the affected part of Africa.

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Things got a little more complicated when we asked whether U.S. citizens who become infected with Ebola while performing humanitarian work should be brought back to this country for treatment.

Shots - Health News Ebola In The United States: What Happened When

Overall, 40 percent of people oppose that idea; 60 percent are in favor. But sentiment varied quite a bit by age, education and income. There is support for bringing people back for treatment among nearly three-quarters of people who are 65 or older, have at least a college degree or whose annual household income is $100,000 or more. Among people under 35, there is an even split on whether infected people should be brought to the U.S. for treatment.

While the poll questions were in the field, Thomas Eric Duncan became the first person to die from Ebola in the U.S. and less than a week later Nina Pham, a nurse who helped care for Duncan, became the first person to become infected with Ebola in this country.

We asked while events were unfolding how Americans see the country's preparedness? A slim majority — 51 percent — believe the U.S. health care system has the resources and trained personnel to deal with Ebola here.

The poll's margin for error is plus or minus 1.8 percentage points. The full results, including the text of the questions, can be found here.

Copyright 2014 NPR. To see more, visit http://www.npr.org/.
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A 45,000-Year-Old Leg Bone Reveals The Oldest Human Genome Yet

NPR Health Blog - Wed, 10/22/2014 - 2:39pm
A 45,000-Year-Old Leg Bone Reveals The Oldest Human Genome Yet October 22, 2014 2:39 PM ET Listen to the Story 2 min 56 sec  

Researcher Svante Pääbo, was able to extract a complete genome from this ancient human leg bone.

Bence Viola/Max Planck Institute for Evolutionary Anthropology

Researchers have successfully decoded the genes of a 45,000-year-old man from Siberia. The results offer clues about early human life outside of Africa as well as how humans interacted with Neanderthals and other groups around at the time.

The complete set of genes is the oldest genome of its kind, according to Svante Pääbo, a director at the Max Planck Institute for Evolutionary Anthropology in Leipzig. "It's almost twice as old as the next oldest genome that has been sequenced."

The work of Pääbo and his colleagues was published Wednesday in the journal Nature.

The bone was found along the Irtysh River in Siberia, which was pretty far north to live 45,000 years ago.

Bence Viola/Max Planck Institute for Evolutionary Anthropology

The DNA came from a human femur found in 2008 by a collector scouring the Irtysh River in western Siberia. The femur was handed over to a local paleontologist who in turn gave it to Pääbo's team in Leipzig.

When the age of the bone was revealed, the team couldn't believe it. "We were actually so amazed, we actually had it dated even twice, to make sure," Pääbo says.

Pääbo's team specializes in extracting ancient DNA from bones like these. They carefully set to work retrieving genetic material from bone cells in the femur. Because the bone came from a modern human, they had to take precautions to ensure it wasn't contaminated with their own genetic material.

The results provide a window into an unusual period in human existence.

The DNA in the man's femur shows that he had some Neanderthal ancestors.

Bence Viola/Max Planck Institute for Evolutionary Anthropology

Modern humans evolved in Africa around 200,000 years ago. They left the continent around 100,000 years ago. But researchers now know that other human-like people were already living in Europe and Asia. These included Neanderthals, large, muscular hominins that lived in the caves of Europe.

"What's exciting about this paper is that it's looking at a very ancient modern human who would have lived around the same time as Neanderthals," says Sarah Tishkoff, a geneticist at the University of Pennsylvania who was not involved with the work.

The bone shows that the Siberian man's DNA contained a tiny amount of Neanderthal genes. In other words, he had some Neanderthal ancestors. It's the latest in a series of papers showing that humans and Neanderthals bred.

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Modern Asians, Europeans and Native Americans also have Neanderthal genes, but the Neanderthal gene sequences of the Siberian man were longer, indicating that interbreeding had taken place in the relatively recent past, between 50,000 and 60,000 years ago.

"They actually mixed with each other and did have children," Pääbo says.

As intriguing as the bone is, it leaves many questions about what happened next.

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We know that humans thrived and that Neanderthals eventually went extinct, but we still don't know why, says Janet Kelso, a computational biologist at the Max Plank Institute in Leipzig, and a co-author on the paper. "The genetics just doesn't tell us anything about that."

Just as big a mystery is what happened to the Siberian man and his descendants.

MayPreviously it was thought ancient humans hadn't lived so far north 45,000 years ago. And venturing into the region may have been a bad move, Pääbo suspects. The Siberian man's genetic code is distant from other groups of humans, suggesting his family may have gone extinct even before Neanderthals died out.

Copyright 2014 NPR. To see more, visit http://www.npr.org/.
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Quick Facts About Ebola

NPR Health Blog - Wed, 10/22/2014 - 10:43am
Quick Facts About Ebola October 22, 201410:43 AM ET

Basic information about Ebola isn't as clear as it probably could be.

Additional Information:

A recent poll by the Harvard School of Public Health, for instance, found that 38 percent of Americans are worried that Ebola will infect them or a family member in the next year, despite assurances from officials that the U.S. will stop Ebola in its tracks.

We've put together a primer on what you need to know. We'll update it as new information develops.

Copyright 2014 NPR. To see more, visit http://www.npr.org/.
Categories: NPR Blogs

Banned Drugs Still Turning Up In Weight-Loss Supplements

NPR Health Blog - Wed, 10/22/2014 - 8:49am
Banned Drugs Still Turning Up In Weight-Loss Supplements October 22, 2014 8:49 AM ET Listen to the Story 3 min 22 sec  

Even versions of Zi Xiu Tang Bee Pollen labeled "genuine" and "anti-counterfeit" have been found to contain the drug sibutramine, which was supposed to come off the U.S. market in 2010 for safety reasons.

Food and Drug Administration

Americans spend about $4 billion a year on weight-loss supplements. And the Food and Drug Administration spends a lot of effort policing distributors who market fraudulent products that are tainted with unsafe, banned drugs.

But a study published Tuesday finds that buyers should beware: Just because the FDA recalls a product for containing dangerous substances doesn't mean the product disappears from the market.

Researchers from the Cambridge Health Alliance, a health care network affiliated with Harvard University, got a list of 274 dietary supplements that the FDA recalled between 2009 and 2012.

Then, they analyzed 27 products (including supplements marketed for weight loss, sexual enhancement and sports performance enhancement) that were still being sold months after being recalled. They found that two-thirds of the products still contained banned ingredients.

"I was so disheartened to see that manufacturers would have the chutzpah to sell the exact same product" even after it had been recalled, says Harvard's Dr. Pieter Cohen, a Cambridge Health Alliance researcher and internist. His findings are published in the current issue of JAMA, the Journal of the American Medical Association.

Consider, for example, a weight-loss product called Zi Xiu Tang Bee Pollen Capsule.

Shots - Health News Recalls Of Dietary Supplements Highlight Mystery Ingredients

The FDA took action to recall the product in October 2012. But when Cohen and his colleagues purchased the product in July 2013, it still contained sibutramine — the banned drug that led to its recall in 2012.

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Sibutramine, once marketed as the diet drug Meridia, was pulled from the market in 2010 after research linked it to an increased risk of heart attack and stroke. (Six of the 27 recalled products analyzed in the JAMA study contained sibutramine.)

And, despite warnings by the FDA, Zi Xiu Tang Bee Pollen is still marketed on the Internet.

It's possible that the manufacturer has changed the formulation since the JAMA study testing was conducted, but we were unable to reach the distributor for comment. Our email was returned as undeliverable.

"People selling these products should be enforced against to the fullest extent of the law," says Daniel Fabricant, CEO of the Natural Product Association, a nonprofit trade association that represents supplement-makers and other companies.

Fabricant points out that products adulterated with drugs are not considered to be supplements, so he chafed at the use of the term "dietary supplements" to describe the products analyzed in the JAMA study.

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"The products analyzed in this study aren't supplements," Fabricant told NPR. "People selling these products online don't represent the industry."

The Salt Philadelphia Children's Hospital Bars Herbs And Supplements

In a written statement, the FDA told NPR that the agency has pursued civil and criminal enforcement against people who illegally market these products, but it's tough to crack down.

"The supply chain for these products is extremely fragmented," an FDA spokesperson said in an email. "One product manufactured by an unknown company overseas may be sold by dozens of different distributors in the United States."

In the case of the Zi Xiu Tang Bee Pollen capsules, for example, even if one distributor is detected and shut down, many more may still be selling the product.

And it can be tough for consumers to know which products might pose dangers.

Given the uncertainty, Candy Tsourounis, a professor of clinical pharmacy at the University of California, San Francisco, says her advice is to steer clear of all weight-loss supplements.

"I think what's most striking about [the findings of the study] is that these supplements pose a significant health risk," Tsourounis says.

And even when weight loss products don't contain banned substances, she says, they're unlikely to help.

"None of these supplements," Tsourounis says, "has been adequately tested to demonstrate that it will work" to help sustain weight loss over time.

Copyright 2014 NPR. To see more, visit http://www.npr.org/.
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Ebola Vaccine Could Start Testing In Africa By January

NPR Health Blog - Tue, 10/21/2014 - 6:08pm
Ebola Vaccine Could Start Testing In Africa By January October 21, 2014 6:08 PM ET Listen to the Story 3 min 53 sec  

The World Health Organization says that efforts are on track to distribute an experimental Ebola vaccine in West Africa in January.

Two potential vaccines are now being tested for safety in people, and Russia is developing another one. While quantities will be limited, scientists say even a relatively small supply of vaccine can help bring the epidemic under control.

“ Some vaccines are also in development in Russia. So we are in contact with Russians to see when they could be available for testing in Africa.

There's no guarantee that any vaccine will be effective, so it's good that several are in the pipeline. That includes an Ebola vaccine being developed by GlaxoSmithKline, which has already been tested in a small number of volunteers in the U.S., Europe and Africa.

Marie-Paule Kieny, assistant director-general for health systems and innovation at the World Health Organization, says a Canadian vaccine licensed to NewLink Genetics in Ames, Iowa, is now being tested in people as well, at the Walter Reed National Military Medical Center and the National Institutes of Health, near Washington, D.C.

Next month, those trials will be expanded to include several hundred volunteers in Europe. Those tests will involve 250 doses of each of these two front-running vaccine candidates, "and these data are absolutely crucial to allow decision-making on what dose level should go into the testing in Africa," Kieny says.

That's a critical question at the moment, because nobody now knows whether a tiny dose or a large dose would be required to protect someone from the Ebola virus. The largest dose in these tests will be nearly 1,000 times larger than the smallest dose.

Goats and Soda Ebola Researchers Have A Radical Idea: Rush A Vaccine Into The Field

"Everybody would like to have the lowest dose because, of course, you could have so much more vaccine than if it's the highest dose," Kieny says.

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Health officials are hoping to have tens of thousands of doses available starting in January. But that could present a major manufacturing challenge, especially if each shot needed to contain a huge dose of the vaccine.

And while these two potential vaccines are the farthest along, they aren't alone. Three others are in earlier development stages at U.S. companies, and "some vaccines are also in development in Russia," Kieny told a WHO news conference in Geneva on Tuesday. "So we are in contact with Russians to see when they could be available for testing in Africa, and what type of doses, in terms of quantity, could be available in the months to come."

She says it's not clear whether the Russian scientists have already started safety testing in people.

Until quite recently, public health officials figured that a vaccine would come along too late to be of any use in controlling the current Ebola outbreak. But that attitude is changing.

"We could use a strategy similar to the ring vaccination strategy that was used in the smallpox eradication program," says Stephen Morse, an epidemiologist at Columbia University's Mailman School of Public Health.

Patients in a clinic line up to get a smallpox shot on Feb. 24, 1962, in Leopoldville, Congo. Health workers used vaccination campaigns to finally eradicate smallpox by 1980.

AP

The concept of ring vaccination is that you wouldn't need to immunize the many millions of residents in the affected West African countries. Instead, if health officials can see where the disease is heading next, they can focus on immunizing people who will soon be in harm's way.

That of course includes health care workers, who are at highest risk right now.

"That would not require large amounts of vaccine," Morse says, "but it probably would limit the spread of the epidemic considerably."

Using this strategy, the vaccine wouldn't have to be perfectly effective, and you wouldn't even need to vaccinate all people who are at risk in order to put brakes on the epidemic.

Drugs to treat Ebola would help as well.

Kieny says the French government plans to test a Japanese antiviral drug called Favipiravir in Guinea. And there's an international partnership coordinated by England's Oxford University to bring a half-dozen other potential drugs into the region as well.

She says the partnership is now visiting sites in the three African countries to identify which treatment centers would be adequate and would also be willing to participate in the testing of drugs.

Of course, public health officials responsible for stopping Ebola are still relying most heavily on the tried-and-true method: finding people who are sick and isolating them so the disease stops spreading.

Copyright 2014 NPR. To see more, visit http://www.npr.org/.
Categories: NPR Blogs

Hospitals Struggle To Beat Back Serious Infections

NPR Health Blog - Tue, 10/21/2014 - 4:05pm
Hospitals Struggle To Beat Back Serious Infections October 21, 2014 4:05 PM ET

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An official at the University of Michigan Health System in Ann Arbor says its mix of patients helps explain the infection rates.

Scott C. Soderberg/Courtesy of University of Michigan Health System

While Ebola stokes public anxiety, more than 1 in 6 hospitals — including some top medical centers — are having trouble stamping out less exotic but sometimes deadly infections, federal records show.

Nationally, about 1 in 25 hospitalized patients gets an infection. Some 75,000 people die each year from them — more than from car crashes and gunshots combined. A Kaiser Health News analysis found 695 hospitals with higher than expected rates for at least one of the six types of infections tracked by the federal Centers for Disease Control and Prevention. In 13 states and the District of Columbia, a quarter or more of hospitals that the government evaluated were rated worse than national benchmarks the CDC set for at least one infection category, the Kaiser analysis found.

The missteps Texas Health Presbyterian Hospital made this month in handling an Ebola patient echo mistakes hospitals across the nation have made in dealing with homegrown infections. Dr. Kevin Kavanagh, a patient safety specialist from Kentucky, said hospitals often fail to strictly follow protocols to deal with infectious diseases, and the government's standard responses aren't specific enough. "Right now there are too many recommendations on how to handle infectious diseases, too much leeway," he said.

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A 2011 study in the New England Journal of Medicine underscored the problem. While hospitals have reduced the frequency of many infections over the last decade, they could do better if staff complied fully with recommendations. Those include diligent attention to hand-washing and using stringent barrier protection when tubes are being inserted, such as covering patients from head to toe with a sterile drape and wearing sterile caps, masks gowns and gloves.

"The percentage of time that health care providers do all of the things they are supposed to do when caring for a patient with a contagious disease can be pretty low," said one of the authors, Dr. Don Goldmann, chief medical and science officer at the Institute for Healthcare Improvement, a nonprofit in Cambridge, Mass. "There's a lot of room for improvement."

Goldmann said that hospitals tend to become more focused on following procedures when facing novel, highly publicized outbreaks such as Ebola. "When [an infection risk has] been around for a long time, it kind of becomes part of the background," he said.

Since 2012 the federal government has been analyzing and publishing the CDC rates for specific hospitals on Medicare's Hospital Compare website. Starting this fall, Medicare is considering infection rates when deciding how much to pay hospitals.

The CDC reports six categories of infections: those from flexible tubes inserted into veins to deliver medicines or nutrients; infections from catheters that drain bladders; two antibiotic resistant germs, Clostridium difficile and Methicillin-resistant Staphylococcus aureus; and two surgical site infections after hysterectomies and colon operations.

States with more than a quarter of hospitals having at least one high infection rate in the CDC data were Arizona, California, Colorado, Connecticut, Florida, Massachusetts, Montana, Nevada, New Jersey, New York, Rhode Island, South Carolina and Utah, according to the Kaiser analysis of the most current CDC records.

Three highly regarded institutions — New York-Presbyterian Hospital in Manhattan, Geisinger Medical Center in Danville, Pa., and the University of Michigan Health System in Ann Arbor — were among seven hospitals the CDC rated as having worse rates for four of the six infections, Kaiser found.

The CDC data, based on reports hospitals submit, are considered the most reliable assessments that exist. Still, many hospitals the CDC judged as having worse rates disputed those verdicts. They said that they look bad because they are more vigilant in identifying and reporting infections, or because they handle very sick patients who are more prone to catching a bug.

For instance, Dr. Darrell Campbell Jr., chief medical officer at the University of Michigan Health System, said hysterectomies are performed on cancer patients at four times the rate than at other Michigan hospitals that compare information with each other. Because cancer surgeries take longer than regular hysterectomies, often involving removal of pelvic lymph nodes, the chances of infection are greater, he said.

"When you adjusted for the cancer, we don't look different from any of the hospitals," he said. Campbell said none of Michigan's infection rates deserved being rated poorly. "Eventually, we'll get where we are more comfortable with this data, but we're not there now," he said.

New York-Presbyterian said in a statement it has made "significant improvements." Geisinger said in a statement that its infection rates have dropped since 2012 and that its MRSA rate appeared high because the hospital made a "data entry error" when it reported cases to the government. Geisinger also noted that many patients who test positive for C. diff never develop any symptoms, but hospitals still must report it as an infection.

Some major teaching hospitals, like Denver Health Medical Center, Duke University Hospital in Durham, N.C., and Mayo Clinic's hospitals in Rochester, Minn., have been able to maintain low infection rates, the KHN analysis shows.

Others are succeeding in controlling some infection types but not others, according to the CDC data. Yale-New Haven Hospital had lower rates of bloodstream infections caused by central lines, but higher rates of infections from catheters inserted into the bladder to remove urine. Since one of the main ways to avoid such infections is to remove the catheter as soon as it isn't essential, the hospital now allows nurses to take them out without a physician's order under certain conditions, said Dr. John Boyce, the hospital's director of epidemiology and infection control. "Busy physicians sometimes forget their patient has a catheter in, but the nurses know," he said.

Nationally, surgical site infections dropped by a fifth and central-line infections decreased by 44 percent between 2008 and 2012. MRSA decreased by a third during that period.

Battling C. diff is very different than fighting Ebola and in some ways harder, because it requires hospitals to restrain use of the antibiotics necessary for so many patients. When those drugs eliminate weaker bacteria from the intestines, C. diff is able to prosper. Patients can get massive diarrhea and, while C. diff can be treated, the worse cases may require surgery to remove the infected part of the intestines.

Other infections for which the CDC tracks but doesn't yet publish hospital-specific rates, known as gram negative, are impervious to nearly all antibiotics.

Reducing the frequency of C. diff and these kinds of infections requires hospitals to become more judicious in deploying antibiotics. But only about half of hospitals have established stewardship programs that help doctors use the appropriate antibiotics in the most effective doses without overdoing it, researchers say.

"We have increasing amounts of data that 30-50 percent of the antibiotics we are prescribing are inappropriate," said Dr. Kavita Trivedi, a consultant and former infection control official for California. "It sounds crazy to people who are not in medicine: Why would a patient be prescribed an antibiotic they don't need? But it happens frequently because we don't know what they need."

Copyright 2014 Kaiser Health News. To see more, visit http://www.kaiserhealthnews.org/.
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When The Economy Goes Down, Vasectomies Go Up

NPR Health Blog - Tue, 10/21/2014 - 1:04pm
When The Economy Goes Down, Vasectomies Go Up October 21, 2014 1:04 PM ET

Did worries about financial stability get more men to say no to fatherhood?

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The number of men getting vasectomies spiked during the Great Recession, rising one-third from 2006 to 2010, a study finds.

In 2006, 3.9 percent of men said they had had a vasectomy; in 2010, 4.4 percent reported having the surgery. That means an additional 150,000 to 180,000 men per year had vasectomies in each year of the recession.

That squares with earlier research that showed birth rates dropped during the recession, falling 4 percent between 2007 and 2009.

After the recession, man were making less money, were less likely to be working full time, and were less likely to have health insurance, according to the National Survey for Family Growth, which researchers at Weill Cornell Medical College used to come up with the vasectomy numbers.

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They reported their results Monday at the American Society for Reproductive Medicine conference in Hawaii.

OK, so what were women up to? The Weill Cornell researchers didn't look at this, but the survey did ask recession-era women about birth control, and there was no increase in the number of women who got birth control or had sterilization surgery from 2002.

Men typically aren't nearly as apt to embrace sterilization as a form of birth control as are women.

For women who use contraception, 26.6 percent chose tubal sterilization, which is permanent, compared to 27.5 percent for the pill, according to 2010 numbers from the Guttmacher Institute.

But just 10 percent of women said they're relying on their partner's vasectomy to avoid pregnancy, according to Guttmacher.

We'll have to stay tuned to see if guys' seeming embrace of vasectomy was just a recessionary blip, or if they really are saying no (or no mas) to fatherhood.

Copyright 2014 NPR. To see more, visit http://www.npr.org/.
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More Insurers Put Spending Limits On Medical Treatments

NPR Health Blog - Tue, 10/21/2014 - 10:14am
More Insurers Put Spending Limits On Medical Treatments October 21, 201410:14 AM ET

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The California Public Employees' Retirement System has capped how much it will pay for some common medical procedures and tests.

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To clamp down on health care costs, a growing number of employers and insurers are putting limits on how much they'll pay for certain medical services such as knee replacements, lab tests and complex imaging.

A recent study found that savings from such moves may be modest, however, and some analysts question whether "reference pricing," as it's called, is good for consumers.

The California Public Employees' Retirement System (CalPERS), which administers the health insurance benefits for 1.4 million state workers, retirees and their families, has one of the more established reference pricing systems.

More than three years ago, CalPERS began using reference pricing for elective knee and hip replacements, two common procedures for which hospital prices varied widely without discernible differences in quality, says Ann Boynton, who helps set benefits policies at CalPERS.

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Working with Anthem Blue Cross, the CalPERS set $30,000 as the reference price for those two surgeries in its preferred provider organization plan.

Members who get surgery at one of the 52 hospitals that charge $30,000 or less pay only their plan's regular cost-sharing. If member choose to use an in-network hospital that charges more than the reference price, however, they're on the hook for the entire amount over $30,000, and the extra spending doesn't count toward their annual maximum out-of-pocket limit, Boynton says.

"We're not worried about people not getting the care they need," says Boynton. "They have access to good hospitals; they're just getting it at a reasonable price."

In two years, CalPERS saved nearly $6 million on those two procedures, and members saved $600,000 in lower cost sharing, according to research published last year by James C. Robinson, a professor of health economics at the University of California, Berkeley, and director of the Berkeley Center for Health Technology. Most of the savings came from price reductions at expensive hospitals.

The agency recently set caps on how much it would spend for cataract surgery, colonoscopies and arthroscopic surgery, Boynton says.

Those who have studied reference pricing say it is most appropriate for common, non-emergency procedures or tests that vary widely in price but are generally comparable in quality. Research has generally shown that higher prices for medical services don't mean their quality is higher. Setting a reference price steers consumers to high-quality doctors, hospitals, labs and imaging centers that perform well for the price, proponents say.

Others point out that reference pricing doesn't necessarily save employers a lot of money, however. A study released earlier this month by the National Institute for Health Care Reform examined the 2011 claims data for 528,000 autoworkers and their dependents, both active and retired. It analyzed roughly 350 high-volume and/or high-priced inpatient and ambulatory medical services that reference pricing might reasonably be applied to.

The overall potential savings was 5 percent, the study found.

"It was surprising that even with all that pricing variation, reference pricing doesn't have a more dramatic impact on spending," says Chapin White, a senior policy researcher at RAND and lead author of the study.

Even though the results may be modest, a growing number of very large companies are incorporating reference pricing, according to benefits consultant Mercer's annual employer health insurance survey. The percentage of employers with 10,000 or more employees that used reference pricing grew from 10 percent in 2012 to 15 percent in 2013, the survey found. Thirty percent said they were considering adding reference pricing, the survey found. Among employers with 500 or fewer workers, adoption was flat at 10 percent in 2013, compared with 11 percent in 2012.

This spring, the Obama administration said that large group and self-insured health plans could use reference pricing.

The health law sets limits on how much consumers have to pay out of pocket annually for in-network care before insurance picks up the whole tab — in 2015, it's $6,600 for an individual and $13,200 for a family plan. But if consumers choose providers whose prices are higher than a plan's reference price, those amounts don't count toward the out-of-pocket maximum, the administration guidance said.

Leaving consumers on the hook for amounts over the reference price needlessly drags them into the battle between providers and health plans over prices, says White.

"You expect the health plan to do a few things: negotiate reasonable prices with providers, and not to enter into network contracts with providers who provide bad quality care," White says. "Reference pricing is kind of an admission that health plans have failed on one or both of those fronts."

Copyright 2014 Kaiser Health News. To see more, visit http://www.kaiserhealthnews.org/.
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When Reassuring Isn't: The Rush To Test Cruise Passenger For Ebola

NPR Health Blog - Mon, 10/20/2014 - 5:47pm
When Reassuring Isn't: The Rush To Test Cruise Passenger For Ebola October 20, 2014 5:47 PM ET

The cruise ship Carnival Magic floats behind a catamaran off Cozumel, Mexico on Oct. 17. The ship skipped a planned stop there Friday, the cruise line says, after Mexican authorities delayed granting permission to dock.

Reuters/Landov

Here's a question about the fine line between a prudent response and worrisome overkill: Is the sight of a U.S. Coast Guard helicopter hovering over a cruise ship to pick up a blood sample (which is to be tested for Ebola) a sight that should inspire feelings of reassurance, or a nagging sense that something is not quite right?

The question is still in the air after the weekend's effort to airlift a few milliliters of blood from a passenger who was on board what is now being called the Ebola Cruise.

"I understand the motivation to do as much as we can to reassure the public," says Dr. Thomas Inglesby, director of the University of Pittsburgh Medical Center's Center for Health Security. But when people act with an excess of caution, he says, "that can lead us to do things that are inadvertently making people more frightened."

"It's not clear to me why, for an asymptomatic person coming into port, we would need to get that test before docking," says Inglesby, who was not involved in making the decision.

“ We knew a cruise ship full of passengers would be concerned, and we wanted to reassure them that there was no risk.

The passenger on the ship was a lab worker who had handled clinical specimens from Thomas Eric Duncan, the Liberian man who died of Ebola in Dallas. She departed on the cruise before officials said they did not want people who might have been in close contact with Duncan to travel.

She had no symptoms of Ebola and had isolated herself in her cabin.

Previously, health officials such as Tom Frieden, director of the Centers for Disease Control and Prevention, have said that diagnostic tests of people with Ebola are not reliable until those people develop symptoms. And people who have no symptoms are not contagious, experts say.

The ship was on its way back to Galveston on Saturday when Carnival Cruise Lines learned that "the local health authorities in Galveston [not Texas state officials] were requiring a blood test," Jennifer De La Cruz, Carnival Cruise Lines noted in an email to Shots.

“ While such testing is 'reassuring,' it sets a bad precedent that grants too much credibility to the panic.

She explained that the U.S. Coast Guard provided the helicopter to bring the testing kit to the ship and bring the blood sample back to shore, "but it was local health authorities in Galveston who mandated the test. I need to refer you to them for an explanation as to why they felt it was necessary, as well as the timing."

Kurt Koopman, a spokesperson for the Galveston County Health District, told Shots by email that officials knew when the efforts to get a test began that the results might not come in before the ship's arrival.

"Had the patient remained asymptomatic she would have still been allowed to disembark," he noted. "The test was requested after careful consideration by local, state and federal officials who felt it could be reassuring to other passengers and crew."

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A spokesperson with the Texas Department of State Health Services, Carrie Williams, told Shots that the test was not required of the passenger; she agreed to it.

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"We wanted to test to give passengers that reassurance — given the anxiety and reaction we have been seeing across the country with regards to Ebola," Williams says. "We knew a cruise ship full of passengers would be concerned, and we wanted to reassure them that there was no risk."

But some say the series of events were a total — and emblematic — overreaction.

"A generalized panic is occurring worldwide and is largely disproportionate to the risk," says Dr. Amesh Adalja, a representative of the Infectious Diseases Society of America.

He says the facts that the passenger was tested while at sea and that the ship was refused entry by Mexico are "definitely part of that panic."

"While such testing is 'reassuring,' it sets a bad precedent that grants too much credibility to the panic," Adalja points out. "I also wonder how much scarce public health resources are being diverted to deal with these incidents, when they would be better-employed combating the epidemic at its source."

After all, around 9,000 people have fallen ill with Ebola in West Africa — and the death rate there from this disease is around 70 percent.

Oh, and the result of the Ebola test on that helicopter-delivered blood sample? Negative. There was no sign of Ebola.

Copyright 2014 NPR. To see more, visit http://www.npr.org/.
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Parkinson's Drugs Can Be A Gateway To Sin

NPR Health Blog - Mon, 10/20/2014 - 4:16pm
Parkinson's Drugs Can Be A Gateway To Sin October 20, 2014 4:16 PM ET

Drugs that are commonly prescribed to help people cope with Parkinson's disease have been linked to bizarre changes in behavior that patients and doctors should be on guard against, researchers say.

The disturbing side effects include compulsive gambling, uncontrollable shopping and a sudden obsession with sex.

The problems with the drugs, called dopamine agonists, are serious enough that the researchers say the Food and Drug Administration should require the medicines to carry what's called a black-box warning, one of the most prominent and serious cautions used for prescriptions drugs.

Some of the drugs are also prescribed for restless leg syndrome and hyperprolactinemia, a hormonal condition that can trigger milk production.

While the problems with the dopamine agonists have been noted in the past, the recommendation for a more prominent warning comes come after researchers sifted through 2.7 million reports of drug reactions submitted to an FDA database between 2003 and 2012.

The researchers from the Institute for Safe Medicine Practices, Harvard and the University of Ottawa found 1,580 adverse drug events involving impulse control disorders. A little less than half, or 710 reports, were associated with dopamine receptor agonist drugs.

The link was strongest for pramipexole, brand name Mirapex, and ropinirole, brand name Requip. The instructions for doctors who are thinking about prescribing Mirapex already carry a warning that says patients taking the medicine "may experience compulsive behaviors and other intense urges." Requip, a treatment for restless leg syndrome.

The results were published online Monday by JAMA Internal Medicine.

Back in 2005, doctors from the Mayo Clinic reported 11 cases of patients who became compulsive gamblers after taking dopamine agonists. A 52-year-old man lost $100,000 in casinos after previously gambling only once in his life. He also became fixated on pornography and obsessed with sex, carrying on extramarital affairs. A month after stopping the drug, he was his old self.

Doctors and patients may have overlooked the problems. In a commentary accompanying the latest findings, two Johns Hopkins doctors wrote that nausea, dizziness and other physical side effects are more typical parts of the conversations between doctors and patients about drugs. "During an office visit, a patient is unlikely to spontaneously mention, 'By the way, doctor I lost $250,000 in casinos last week' or 'I spend all night on Internet pornography sites and am soliciting prostitutes,' " they wrote.

Neurologist Howard Weiss, a co-author of the commentary, tells Shots that these drug-related compulsive behaviors haven't gotten the attention in the medical community that they deserve. A heightened warning in the drugs' instructions could help make the risk clearer, Weiss says. The behavioral problems, he says, "are more important than 99 percent of the other side effects that are being listed."

Weiss says he's had at least three patients who have lost their homes because of bankruptcy after taking the drugs.

When he asked an elderly patients taking one of the drugs if she ever gambled, she replied, "Gambling is the work of the devil." But it turned out she had been buying hundreds of dollars' worth of lottery tickets a week, a habit she didn't consider to be gambling.

Weiss says the behavioral problems usually go away after patients stop taking the medicines. He also says the drug combination carbidopa-levodopa, another Parkinson's treatment, works better and doesn't increase the risk for impulsive behavior.

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Eye Phone? Your Next Eye Exam Might Be Done With Your Phone

NPR Health Blog - Mon, 10/20/2014 - 2:46pm
Eye Phone? Your Next Eye Exam Might Be Done With Your Phone October 20, 2014 2:46 PM ET

Smartphones can now capture high-quality images of the front and back of an eye.

Courtesy of David Myung

A researcher shows a woman in Nepal how to use a visual field test on an iPad. It's used to diagnose glaucoma.

Dr. Suman Thapa/Courtesy of University of Iowa

Getting an eye exam typically involves big complicated machines. But eye doctors are trying to get the big and complicated out of the equation by using smartphones and tablets instead. That way, they figure, eye exams can be done just about anywhere — even a village in Nepal.

That's where Dr. Chris Johnson and his colleagues are using iPads to test people for glaucoma, a disease that often has no symptoms until it has irreversibly damaged eyesight. That's because it nibbles away at vision at the periphery of the visual field.

Finding that out usually involves sitting in front of a big machine and staring at a screen while gray dots appear and disappear.

Instead, Johnson tested an off-the-shelf free app called Visual Fields Easy to screen about 200 patients in Nepal. "I was skeptical at first; we did some tests and calibrated it."

The app was very good at identifying people with moderate to severe disease, less so at screening out people with normal vision. "It works much better than I expected," Johnson, who specializes in developing diagnostic tests, told Shots. He and his colleagues are now expanding the tests to India, with the aim of refining it. "I know I can make it better."

Visual field testing usually requires an expensive machine. This man in Nepal helped test an iPad app.

Dr. Suman Thapa/Courtesy of University of Iowa

Johnson presented his data Monday at the meeting of the American Academy of Ophthalmology in Chicago, and he was far from the only one tinkering with mobile tech. A number of researchers presented devices that clip onto iPhones to turn them into diagnostic tools.

Dr. David Myung, chief resident at Stanford University Hospital, wanted to come up with an easy way to photograph an eye inside and out. A big ophthalmology practice would have a machine that does that beautifully, but it costs tens of thousands of dollars and requires specialized training. Myung wanted something that a harried ER doctor or nurse could use on the fly.

"We wanted to find a low-tech way to do it," Myung told Shots. So he and his colleagues came up with a plastic arm that snaps onto an iPhone, holding an ophthalmology lens in front of the camera at just the right distance. "The plastic arm is about as low-cost as it gets."

To get around the fact that the photographer isn't an ophthalmologist, it's designed so that people take videos or multiple photos. "It's a little like trying to take pictures of your kids, and they're moving around all the time. If you take 10 or 15 photos, one of them going to be in focus."

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The gizmo is also being tested to see if it can reliably screen people at a public hospital for diabetic retinopathy, and Myung and colleagues are applying for FDA approval, since it's a medical device. "We originally developed this for ophthalmology work in developing countries," Myung says. "People do have smartphones and digital capability. We think it could be very useful there."

And maybe closer to home, too.

Since the goal is cheap, simple tests using available technology, couldn't I just do my eye exam at home skip the two hours sitting in the waiting room with my eyes dilated? There are plenty of eye tests apps ready for download right now. But it's complicated, Johnson says.

"Did they get a bad result because they didn't do the test right, or is there a change in their visual status?" Johnson says. He's worried that people will skip an eye exam, then get frightened by a false negative result to a home test. "I think having that as a screen that's available for people who don't have good access to health care is the first thing. Home testing will require some additional things to make it bulletproof."

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Halting Schizophrenia Before It Starts

NPR Health Blog - Mon, 10/20/2014 - 4:23am
Halting Schizophrenia Before It Starts October 20, 2014 4:23 AM ET Listen to the Story 8 min 45 sec  

Meghan, 23, began experiencing hallucinations at 19. "Driving home, cars' headlights turned into eyes. The grills on the cars turned into mouths and none of them looked happy. It would scare the crap out of me," Meghan says.

Marvi Lacar for NPR

The important thing is that Meghan knew something was wrong.

When I met her, she was 23, a smart, wry young woman living with her mother and stepdad in Simi Valley, about an hour north of Los Angeles.

Meghan had just started a training program to become a respiratory therapist. Concerned about future job prospects, she asked NPR not to use her full name.

Five years ago, Meghan's prospects weren't nearly so bright. At 19, she had been severely depressed, on and off, for years. During the bad times, she'd hide out in her room making thin, neat cuts with a razor on her upper arm.

Meghan had been depressed off and on for years, but the hallucinations signaled a subtle shift in her symptoms.

Marvi Lacar for NPR

"I didn't do much of anything," Meghan recalls. "It required too much brain power."

"Her depression just sucked the life out of you," Kathy, Meghan's mother, recalls. "I had no idea what to do or where to go with it."

One night in 2010, Meghan's mental state took an ominous turn. Driving home from her job at McDonald's, she found herself fascinated by the headlights of an oncoming car.

"I had the weird thought of, you know, I've never noticed this, but their headlights really look like eyes."

To Meghan, the car seemed malicious. It wanted to hurt her.

Kathy tried to reason with her.

"Honey, you know it's a car, right? You know those are headlights," she recalls pressing her daughter. "You understand that this makes no sense, right?"

"I know," Meghan answered. "But this is what I see, and it's scaring me."

In other words, Meghan had insight, defined in psychiatry as the ability to understand that one's unusual experiences are attributable to a mental illness.

What Meghan saw did not fit with what she believed. She knew she was hallucinating.

Meghan keeps a photo of her cat, Boo, on the wall in her bedroom. "She would stay in her room and keep to herself," Kathy, Meghan's mother, says. "Sometimes that was a good thing because her depression just sucked the life out of you."

Marvi Lacar for NPR

It's the loss of insight that signals a psychotic break. This can lead to several different diagnoses, but in people ultimately diagnosed with schizophrenia, the break signals the formal onset of the disease. Typically, a first psychotic break occurs in a person's late teens or early 20s. In men, the range is 15 to 24; in women, 25 to 34.

That first psychotic break can lead to a series of disasters: social isolation, hospitalization, medications with sometimes disabling side effects, and future psychotic episodes.

So, what if you could intervene earlier, before any of that? Could you stop the process from snowballing?

At 19, Meghan hadn't had a psychotic break. She still had insight. That made her eligible for a new type of program taking shape in California that aims to prevent schizophrenia before it officially begins.

The program draws on research suggesting that schizophrenia unfolds much more slowly than might be obvious, even to families.

"You start to see a decline in their functioning," says Dr. Daniel Mathalon, who studies brain development in the early stages of psychosis at the University of California, San Francisco.

"They were doing better in school, now they're doing worse," he says. "Maybe they had friends but they're starting to be more isolated."

Eventually, these subtle behavioral shifts may take on a surreal quality. A young person may hear faint whispers or hissing, or see flashes of light or shadows on the periphery.

"They lack delusional conviction," explains Mathalon. "They're experiencing these things; maybe they're suspicious. But they're not sure."

"I valued my ability to think and learn," Meghan says. "To know that the one thing I valued so highly was dissolving away, that I was losing chunks of my sanity with every hallucination. ... That was more terrifying than the monsters that I saw could ever be."

Marvi Lacar for NPR

Psychiatrists have a word for this early stage: prodromal.

Meghan took a screening test developed at Yale University Medical School that identified her as possibly within the prodromal stage of psychosis. That is, her symptoms could be indicative of early psychosis, but weren't predictive.

She was referred to a clinic in an office park about an hour from her house called Ventura Early Intervention Prevention Services, or VIPS, operated by Alameda-based Telecare Corp.

VIPS is one of a handful of programs that have sprung up in California in recent years, based on a model developed in Maine by psychiatrist Dr. Bill McFarlane.

McFarlane believes that psychosis can be prevented with a range of surprisingly low-tech interventions, almost all of which are designed to reduce stress in the family of the young person who is starting to show symptoms.

McFarlane cites research done at UCLA suggesting that certain kinds of family dynamics — families that don't communicate well, or are overly critical — can make things worse for a young person at risk of schizophrenia.

Meghan's family credits the VIPS program for her transformation. "She's not the broken little girl that she was three years ago," Meghan's stepfather, Charlie, says.

Marvi Lacar for NPR

"Our theory," says McFarlane, "was that if you could identify these young people early enough, you could alter some of those family patterns. Then you could work with the family to start behaving not just normally, but in a way that was smarter."

McFarlane's programs bring families in for twice-monthly multifamily group therapy sessions, where participants take a nuts-and-bolts approach to resolving disputes at home and softening their responses to what the young person is going through.

"We assume parents can't figure this out alone," says McFarlane.

In some cases, participants are also prescribed antipsychotic drugs, especially one called Abilify, which McFarlane and others believe can stem hallucinations.

McFarlane himself is careful about recommending antipsychotic medications.

The drugs, he says, should be used cautiously, at lower doses than would be prescribed for full psychosis, and even then only in young people who aren't responding to other treatments.

But in programs inspired by his model, the drugs appear to be widely prescribed, including in clients as young as 10 or 13. This fact has become a flashpoint in the conversation around schizophrenia prevention.

"No one is harder to diagnose than a child or a teenager," says Dr. Allen Frances, a former chair of the psychiatry department at Duke University and chair of the task force that produced the fourth revision of the Diagnostic and Statistical Manual, or DSM-IV, the standard reference for psychiatric diagnoses.

"There are rapid developmental changes from visit to visit," he says. "The tendency to overdiagnose is particularly problematic in teenagers."

Frances points to studies showing that if you take three kids, all experiencing those surreal early symptoms, only one will get schizophrenia.

So what about the other two?

“ We have to be careful of any new fad in psychiatry. The field has been filled with fads in the past, and often we learn in retrospect that they've done much more harm than good.

Frances says these kids are wrongly labeled and stigmatized. Their parents are terrified. And in many cases, they will be prescribed antipsychotic drugs, which can have serious side effects and haven't been studied well in children.

"We have to be careful of any new fad in psychiatry," says Frances. "The field has been filled with fads in the past, and often we learn in retrospect that they've done much more harm than good."

But what Frances calls a fad is to others a model for mental health care.

To see these programs in action, the best place to go is California, where over the past few years a handful of programs have sprung up based on McFarlane's PIER model.

One, in San Diego, is called Kickstart. Like the others, it's paid for by a state tax on millionaires, passed by voters in 2004, that funds mental health. Services — everything from homework help to family therapy and outings such as kite-flying expeditions — are offered for free.

Joseph Edwards, Kickstart's assistant program director, says for teenagers who might be developing schizophrenia, just being outside, with friends, is a kind of therapy.

"They'll want to isolate," says Edwards. "There's sensitivity to a lot of stimulation. And a lot times we'll see what we call day/night reversal, where they'll stay up all night and go to sleep in the daytime."

Edwards says if a teenager is really isolating, a Kickstart worker will drive to his or her house and cajole the person out. Anything, he says, to keep them engaged, with friends in school or at work.

Tony, 13, spends an afternoon at an arcade with Ashley Wood, his occupational therapist in the Kickstart program in San Diego.

Marvi Lacar for NPR

At an arcade in a strip mall, we meet Ashley Wood, one of Kickstart's occupational therapists. Wood brought her client, 13-year-old Tony, here as a reward for being cooperative in therapy.

We aren't using Tony's full name because he's a minor, at the request of his parents.

Wood has an easy laugh and teases Tony gently to pull him out of his shell.

"When we first met, he was so quiet," she says, laughing. "He's like, 'Who is this chick?' "

"Nah," says Tony, smiling shyly. "I was being a jerk."

Tony had been getting in fights. He was angry at his mom, angry in school. And there was something else.

"I used to see stuff and hear [stuff]," he tells me.

"Like what?" I ask him. "Like ... weird objects," he responds. When I press him for more details, he shakes his head.

Are Tony's symptoms the beginning of schizophrenia? Or just the routine weirdness of a teenage brain taking shape?

No one — not Wood, not his therapists — can say for sure.

Wood says what she's teaching him will be helpful either way: "When he's frustrated at school or at home, instead of immediately responding, kind of finding a way to communicate. So we're trying to work on the impulse control as well."

Impulsive, unruly, prone to angry outbursts, Tony sounds like a lot of 13-year-old kids.

That's one reason that last year, the American Psychiatric Association opted to exclude the idea of "psychosis risk syndrome" from the DSM-5, the latest version of the manual of mental disorders. The screening test is generally considered to be only 30 percent accurate.

In 2011, a review of prodrome intervention programs called the idea of intervention in pre-schizophrenia "inconclusive."

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"This is an experiment far before its time," says Allen Frances.

McFarlane believes the benefits of these programs are borne out in the work done at his clinic and others based on his model. In July, he published the results of a two-year study of two groups of young people at risk for, or in the early stage of, schizophrenia, which showed better functional outcomes for those who went through treatment.

TED Radio Hour Is It Possible To Live With The Voices In Your Head?

He and other proponents say schizophrenia's early window may be too precious to miss.

"We're running up against the limits of what we can do for patients who develop schizophrenia, once it goes to chronic stages," UCSF's Mathalon says. "I think this is a direction we have to go in, but we have to do it carefully."

When you talk to people who have been through these programs and ask them what helped them, it is not the drugs, not the diagnosis. It's the lasting, one-on-one relationships with adults who listen, like Ashley Wood.

“ I thought she'd forever be marginal, forever be medicated. I thought we'd just have to get used to it.

Tiffany Martinez, an early client of Bill McFarlane's in Maine, chokes up when asked to describe what she thinks helped her climb out of an incipient mental health crisis that began when she was in college.

"To share such personal intimate details, you know? To have these people working so hard on it and so devoted and invested in the work," Martinez, now age 26, says, "it's like getting a chance. Just the program, what the program stands for alone, is hope."

That same relief is palpable when you talk to Meghan's mom, Kathy, and stepfather, Charlie.

"I thought we were going to have to take care of her for the rest of her life," says Kathy. "I thought she'd forever be marginal, forever be medicated. I thought we'd just have to get used to it."

Today Meghan is off all her medications. She's animated, playing board games with her family, excited about being back in school.

Her family credits the VIPS program.

"We were blessed to have this for her," Charlie says. "We really were. It saved her life."

Copyright 2014 NPR. To see more, visit http://www.npr.org/.
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U.S. To Temporarily Halt Funding For Controversial Virus Research

NPR Health Blog - Fri, 10/17/2014 - 4:44pm
U.S. To Temporarily Halt Funding For Controversial Virus Research October 17, 2014 4:44 PM ET

Avian influenza, or bird flu, causes an infectious and contagious respiratory disease. In the lab, several scientists have made the H5N1 strain more contagious, a controversial line of research.

James Cavallini/ScienceSource

The federal government will temporarily stop funding any new studies that could make three high-risk infectious diseases even more dangerous. The government is asking all scientists involved in this research now to voluntarily halt their current studies.

The unusual move comes after a long controversy over experiments with mutant forms of a bird flu virus.

The White House Office of Science and Technology Policy said that the government will launch a review of the potential risks and benefits of certain experiments with three viruses: SARS, MERS and influenza.

The concern is that so-called gain-of-function studies would probe how these viruses work by altering them in ways that could make them more pathogenic or contagious.

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Scientists have been arguing about the wisdom of doing such experiments ever since two studies of the H5N1 bird flu virus created mutant forms that could potentially spread between people and cause a pandemic, if they ever got out of the lab.

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The prestigious National Research Council will be involved in the government's new deliberations, as will a government advisory committee called the National Science Advisory Board for Biosecurity, which is meeting October 22 after not meeting for over a year.

"It sounds like very good news," says Marc Lipsitch of the Harvard School of Public Health, who has been critical of experiments that could create new pathogens with the potential to cause human pandemics. "I was pleased to see they are at least asking the existing projects to pause."

Until officials adopt a final policy on these experiments, which they expect to do next year, new proposals won't be funded by the National Institutes of Health.

"Public involvement in this deliberative process is key, and the process is thus designed to be transparent, accessible, and open to input from all sources," NIH Director Francis Collins said in a statement.

"NIH has funded such studies because they help define the fundamental nature of human-pathogen interactions, enable the assessment of the pandemic potential of emerging infectious agents, and inform public health and preparedness efforts," Collins noted. "These studies, however, also entail biosafety and biosecurity risks, which need to be understood better."

Updated at 5:25 p.m.:

Yoshihiro Kawaoka, a virologist at the University of Wisconsin-Madison whose lab has done studies with influenza, told NPR by email that he would initiate no new projects and would consult with NIH officials on projects that have experiments underway.

"I hope there will be an eventual resolution of the issues that surround research that is important to protecting public health and advancing influenza virus research," Kawaoka wrote, adding that he would participate in the upcoming NSABB meeting and looked forward to constructive discussions.

Copyright 2014 NPR. To see more, visit http://www.npr.org/.
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Why Won't The Fear Of Airborne Ebola Go Away?

NPR Health Blog - Fri, 10/17/2014 - 4:18pm
Why Won't The Fear Of Airborne Ebola Go Away? October 17, 2014 4:18 PM ET

Audio for this story from All Things Considered will be available at approximately 7:00 p.m. ET.

Ebola Virus, Transmission Electron Micrograph Of The Ebola Virus, Rna Virus, Cause Of Hemorrhagic Fever.

BSIP/UIG via Getty Images

Experts keep saying Ebola can't spread through the air but some Americans seem deeply skeptical.

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Why Won't The Fear Of Airborne Ebola Go Away?

NPR Health Blog - Fri, 10/17/2014 - 4:18pm
Why Won't The Fear Of Airborne Ebola Go Away? October 17, 2014 4:18 PM ET Listen to the Story 4 min 12 sec  

The Ebola virus as seen under an electron microscope.

BSIP/UIG via Getty Images

How many times do top officials have to say that the Ebola virus is not airborne?

A lot, apparently.

Here is President Obama Thursday: "This is not an airborne disease. It is not easy to catch."

And the day before: "It is not like the flu. It is not airborne."

And Friday, a reporter asked the inevitable question about airborne Ebola when Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, held a press briefing about nurse Nina Pham's transfer to the National Institute of Health.

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"There is no evidence whatsoever that this virus is airborne-transmitted," said Fauci emphatically. "Everything we know about this virus is that it is direct contact with bodily fluids."

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This gets said over and over. It's backed up by epidemiological studies of past outbreaks. Yet the possibility of Ebola spreading through the air keeps being raised.

At a hearing Thursday, for example, lawmakers grilled Dr. Thomas Frieden, the director of the Centers for Disease Control and Prevention.

"You've already said a couple of times that you don't believe that this is airborne," said Republican Congresswoman Renee Ellmers from North Carolina. And yet, she noted, the two nurses still got sick. "They followed precautions, I am sure, and now we are having this conversation and I'm very concerned about that."

Frieden responded that the investigation is ongoing but the nurses treated the Ebola patient when his vomit and diarrhea contained a lot of virus: "We are confident this is not airborne transmission."

When government officials keep saying this isn't airborne, it seems like what they're really trying to tell the public is, "Don't worry about catching this virus in the course of your normal daily activities."

"I think that what they are trying to convey with the idea that 'it's not airborne' is that you likely need to be relatively close to the person where there are some bodily fluids present," says Rachael Jones, who studies infectious disease transmission at the University of Illinois at Chicago.

She says if someone down the hall from you had Ebola and threw up vomit that contains the virus, "those particles are not going to travel hundreds of feet or hundreds of meters to cause an infection."

But if a health care worker or a family member gets very close to someone who has a lot of symptoms, which is when people with Ebola are most contagious, Jones says droplets of body fluid could potentially travel through the air for short distances.

"If you vomit there are projectile droplets that could spray up," she notes.

And she says there's reason to be concerned that an Ebola patient might produce even smaller droplets that someone in close quarters could inhale and get sick from — during medical procedures like putting in a breathing tube.

"A lot of these medical processes that health care workers perform produce small aerosols," says Jones. This is why she and a colleague recently wrote a commentary saying this needs to considered when protecting health care workers.

So even though Jones takes issue with the White House's flat statement that the Ebola virus cannot spread through air, she says this is really not a concern for the public.

"There is not epidemiological evidence that community-based exposure, such as being at a shopping mall or walking down the street or riding a bus, is associated with disease transmission," she notes.

Still, what if the Ebola virus mutates? That's another fear that keeps surfacing. The chairman of the Joint Chiefs of Staff, Gen. Martin Dempsey, spoke about that on CNN this week.

"I'm worried about it because we know so little about it," he said. "You'll hear different people describe whether it could become airborne." He said that scientists did not agree. "I don't know who's right. I don't want to take that chance. So I'm taking it very seriously."

It's true that researchers can't absolutely rule out the idea that mutations might change how the virus spreads, but this seems unlikely, says Alan Schmaljohn, a virologist the University of Maryland School of Medicine. He said the chance of that is "very low, probably in the range of winning the multi-state lottery."

On Capitol Hill, the CDC's director said his team has been on the lookout for any significant genetic mutations. "What we've seen is very little change in the virus," Frieden told lawmakers. "We don't think it is spreading by any different way."

Chances are that's not the last time he'll have to say that.

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California Nurses' Union Pulls Ebola Into Contract Talks

NPR Health Blog - Fri, 10/17/2014 - 4:04pm
California Nurses' Union Pulls Ebola Into Contract Talks October 17, 2014 4:04 PM ET

fromKQED

Listen to the Story 2 min 23 sec  

Members of the California Nurses Association rallied in Sacramento, Calif., in May, in anticipation of contract negotiations with Kaiser Permanente that began in this fall.

April Dembosky / KQED

The powerful California Nurses Association has put Ebola on the bargaining table in its negotiations for a new contract with Kaiser Permanente.

Contract talks have been going on for months, and the nurses' most recent demands are focused on Ebola — better training, more staffing, protective gear that goes beyond what's recommended by federal officials and even a special life insurance policy.

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"We'd like to have an extra supplemental coverage, for specifically Ebola, if we were to contract Ebola while we're at work," says Diane McClure, a nurse at Kaiser Permanente's hospital in Sacramento, where a patient suspected of having Ebola was treated in August. He later tested negative for the virus.

She says even a month after the Ebola scare at her hospital, nurses hadn't received any meaningful hands-on training.

"They felt that all they had to do was pull up some [Centers for Disease Control and Prevention] information online and put some flyers on the tables and in the bathroom and that was it," says McClure, who is a member of the nurses' bargaining team.

Leaders from California's union and its partner in lobbying, National Nurses United, are quick to label the problems with training as a symptom of the country's fragmented health care system. The CDC issues guidelines, state departments of public health pass them on, then it's up to each hospital to take it from there.

The unions say fragmentation and a lack of protocols are the reasons two nurses at Dallas' Texas Health Presbyterian hospital were infected with Ebola. They've hosted several rallies for the nurses at the Dallas hospital, while noting that it isn't unionized.

Shots - Health News California Nurses Union Braces For Contract Battle

Joanne Spetz, an economics professor at the nursing school of the University of California San Francisco, says National Nurses United is doing what any other group that's looking to gain membership would do.

"Of course it's opportunistic," says Spetz, but "Texas is a state that has had virtually no union representation for registered nurses. So NNU may view this as an opportunity to demonstrate to nurses in the state what the value of their representation might be."

Kaiser Permanente has yet to respond to all of the California Nurses Association's demands. In a statement, Kaiser Permanente said that it is rolling out new training this week, including videos and simulation exercises. And it is supplying protective gear that is consistent with current CDC guidelines.

This story is part of a reporting partnership that includes KQED, NPR and Kaiser Health News. Kaiser Health News is not affiliated with Kaiser Permanente.

Copyright 2014 KQED Public Media. To see more, visit http://www.kqed.org.
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