Tag Archives: npr

Days numbered for UK’s arbiter of comparative effectiveness

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

While comparative effectiveness research in the United States is booming thanks to the stimulus, a United Kingdom bastion of the discipline may be on the way out. Over at the NPR health blog, Joanne Silberner reports that the National Institute for Health and Clinical Excellence (NICE), which publishes guidelines on treatments and medical devices based on their cost and effectiveness, could be gone by 2013.

At a drug industry trade group meeting in London earlier this week, Health Minister Lord Howe, Under Secretary of State for Quality, said NICE has become “redundant,” and that it should focus on setting quality standards rather than evaluating individual drugs.

Meanwhile, the Cameron administration has disregarded NICE advice on several cancer drugs, and Howe reports that the government is working on a new “value-based pricing system.”

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For more European health news, see AHCJ’s Covering Europe initiative.

Everyone reacts to Avandia roller coaster

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

First, the background: Avandia, also known as rosiglitazone, is an anti-diabetes drug that helps patients control their blood sugar. It made billions of dollars for GlaxoSmithKline until it became associated with higher risks for cardiovascular issues. On Sept. 23, the FDA and European regulators issued their verdicts on the drug. In America, it will still be available, though with much stronger restrictions than before. In the European Union, regulators are looking to stop sales entirely and steer patients toward alternatives.

If you’re looking for the official lines and basic news, start with CardioBrief, where Larry Husten recapped a few of the highlights and then provided each agency’s press release, as well as the official take of Avandia maker GlaxoSmithKline.

Then, it’s time for the reactions. On the NPR health blog, Richard Knox examined the dueling story lines that have emerged since yesterday’s announcements. This larger framework makes all subsequent reactions a little easier to contextualize.

Speaking of other reactions, The Hill‘s health blogger, Julian Pecquet, rounded up the thoughts of some Washington heavy hitters involved in the Avandia debate, from the omnipresent Sen. Max Baucus to the consumer group Public Citizen. Another key player, cardiologist and Avandia critic Steven Nissen, spoke to The Wall Street Journal‘s Alicia Mundy.

In terms of the big regulatory picture, Avandia is the 30th drug which has been restricted under the FDA’s risk evaluation and mitigation strategy provisions since they began in 2007. Merril Goozner says that the FDA has created a new class of drugs. “They are not exactly safe, but not so dangerous that we would deny them to physicians or patients who really want to have them,” he wrote. Five years ago, he said, Avandia would have been pulled from the market. Now, it just gets restricted. It remains to be see how effective those restrictions really are.

Finally, Pharmalot’s Ed Silverman brings us the thoughts of cardiologist and Yale professor Harlan Krumholz, who you might remember from his recent star turn in Forbes. His take emphasized a principle well-known to health journalists: Marketing matters, and often it matters even more than regulation does.

“The company has announced it will no longer promote the drug,” Krumholz wrote, “and the practical result in Europe and the US may be a lot more similar than the decisions at first appear. Usage will stop in Europe and new use should virtually stop here.”

That said, Krumholz raises some interesting questions, any one of which could form the basis of a follow-up story or two. I’ll paraphrase:

  • A long series of fortunate coincidences lined up to produce the evidence that led to Avandia’s delayed near-demise, which begs the question: Why are we relying on luck when it comes to spotting danger in major pharmaceutical products?
  • “Why does the FDA believe that the barriers to prescription in new users should be stronger than those for current users? There are no studies that indicate that the excess risk dissipates over time.”
  • Will the FDA really be able to effectively implement the regulations and guide physician/patient behavior, especially when it comes to a blockbuster such as Avandia?
  • Have we done anything to prevent the next Avandia? How do we even go about doing that?

Update: The European Association for the Study of Diabetes weighs in

Military slow to treat mild traumatic brain injury

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

ProPublica‘s T. Christian Miller and NPR‘s Daniel Zwerdling have found unpublished military documents which indicate that tens of thousands of soliders who suffer from mild traumatic brain injury have gone undiagnosed.

dentistPhoto by isafmedia via Flickr

These are in addition to the 115,000 soldiers known to suffer from such injuries, many of which are inflicted by shock waves caused by roadside bombs. They write that the lack of concern shown by top brass for mild traumatic brain injuries was “a reflection of ambivalence about these wounds at the highest levels.”

“It’s obvious that we are significantly underestimating and underreporting the true burden of traumatic brain injury,” said Maj. Remington Nevin, an Army epidemiologist who served in Afghanistan and has worked to improve documentation of TBIs and other brain injuries. “This is an issue which is causing real harm. And the senior levels of leadership that should be responsible for this issue either don’t care, can’t understand the problem due to lack of experience, or are so disengaged that they haven’t fixed it.”

After a thorough review, one not helped by a top medical official’s early attempts to prevent local medical commanders from responding to the reporters, the duo distilled their findings into three bullet points:

  • From the battlefield to the home front, the military’s doctors and screening systems routinely miss brain trauma in soldiers. One of its tests fails to catch as many as 40 percent of concussions, a recent unpublished study concluded. A second exam, on which the Pentagon has spent millions, yields results that top medical officials call about as reliable as a coin flip.
  • Even when military doctors diagnose head injuries, that information often doesn’t make it into soldiers’ permanent medical files. Handheld medical devices designed to transmit data have failed in the austere terrain of the war zones. Paper records from Iraq and Afghanistan have been lost, burned or abandoned in warehouses, officials say, when no one knew where to ship them.
  • Without diagnosis and official documentation, soldiers with head wounds have had to battle for appropriate treatment. Some received psychotropic drugs instead of rehabilitative therapy that could help retrain their brains. Others say they have received no treatment at all, or have been branded as malingerers.

Read the full investigation at ProPublica or NPR. It’s some of the deepest work on the subject we’ve seen thus far, and includes incredible quotes such as “What’s the harm in missing the diagnosis of mTBI?” as well as graphics and an explanation of why the numbers are so fuzzy.

Medical groups voluntarily tighten ethics rules

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

Writing for NPR’s health blog, Maggie Mertens reports that while recently passed reform legislation includes the “Physician Payments Sunshine Act” (PDF) that will require companies to report any payments or gifts to physicians over $10 in value starting in 2012 (and reported and made available in a public database in 2013), some groups are getting a jump on the rules and voluntarily tightening their own conflict of interest policies.

Take, for instance, the recent decision by a bunch of medical specialty groups to stop taking industry money when coming up with guidelines for treatment. The Council of Medical Specialty Sciences, representing groups like the American College of Physicians, the American College of Cardiology and the American Society of Clinical Oncology, unveiled new rules on conflicts of interest last week. Thirteen of the member groups have adopted them so far, with the others saying they aren’t far behind. The rules also require that all funding from pharmaceutical and device-making companies to board members or groups will be publicly disclosed. Swag at medical conferences becomes a no-no, although big drugmakers had said a few years back they were going to stop the giveaways of medicine-branded pens, logoed tote bags and that sort of thing anyway.

For a discussion of the challenges reporters face when investigating conflicts of interest, read Elizabeth Bahm’s AHCJ article about a related panel at the recent Health Journalism 2010 conference, and this related article by John Fauber.

Hensley explores HIT-related privacy breaches

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

NPR health blogger Scott Hensley writes that the HHS’ running list of “breaches of unsecured protected health information affecting 500 or more individuals” reads like a sort of police blotter for health wonks, and explores a few of the more interesting cases.

Related: FDA committee recommends anonymous HIT error database

As expected, the FDA’s Health IT Policy Committee endorsed a database to confidentially record reports of HIT-related errors. A few months, another committee and the Office of the National Coordinator still sit between the recommendations and action.

Little recent progress on foodborne illnesses

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

The CDC’s Morbidity and Mortality Weekly Report contains some early numbers on foodborne illness rates in 2009. The data, NPR health blogger Scott Hensley writes, aren’t promising, and it looks like most infection rates haven’t really improved since 2004. A transcript and audio of the April 15 media briefing is available.

The report comes with data for the 10 states monitored by the CDC’s Foodborne Diseases Active Surveillance Network; they’re also broken down by age. To demonstrate just how variable the infection rate is, we’ve pulled numbers for two of the most common foodborne illnesses, salmonella and campylobacter.

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