Smooth Pebbles

Rumblings and worries about Obama's FDA options

As Obama solidifies his teams on science, education, and environment, attention -- and not a little worry from the drug industry -- is turning toward his hunt for a new FDA commissioner. The WSJ Health Blog reports that the FDA Commissioner Coalition, which is heavy with groups financed by the drug industry, appears increasingly concerned that Obama will appoint outspoken critics of drugmakers and the FDA, such as Cleveland Clinic cardiologist Steven Nissen or Baltimore health commissioner Joshua Sharfstein, who is heading Obama's FDA assessment team.

While the coalition prominently talks about the need for an FDA chief who can withstand some kinds of outside pressure, there’s no mention of an ability to withstand pressure from industry. Yet undue industry influence is at the heart of concerns from both parties in both houses of Congress, from FDA officials, from doctors and many medical researchers.

A copy of the Coalition's letter (to Secretary of Health Designate Tom Daschle) can be found at Pharmalot.

6 medical myths debunked - just in time for the holidays

Scientificblogging, drawing on apparently credible medical expertise, deflates six common med myths.

My wife will love this. I've cited #4 to her a million times.

6 Medical Myths Debunked For Christmas:

1. Sugar makes kids hyperactive.

2. Suicides increase over the holidays.

3. Poinsettias are toxic.

4. You lose most of your body heat through your head.

5. Eating at night makes you fat.

6. You can cure a hangover with%u2026

Great fodder for Christmas parties.

Is Obama for real on health-care reform?

It appears Obama is going to make a health-care system overhaul a top priority in his first year.

from the Tribune:

"The time is now to solve this problem," Obama said at a Chicago news conference where he announced that former Senate Majority Leader Tom Daschle would head his health-care team. "It's not something that we can sort of put off because we're in an emergency. This is part of the emergency."

And as many have pointed out, his selection of Tom Daschle as Secretary of Health and Human Services shows serious intent as well.

This should be quite interesting to watch. As Obama pointed out, the current recession, which can seem an argument not to take on health-care reform, is also a good argument for doing so. People are losing health-care access along with their jobs, and runaway health-care costs are adding extra strain, and more by the year. Probably just as important is Obama's recognition that the first year is the time to get big things done -- and his seemingly sincere conviction that the combination or rising per-capita expenditures and a growing number of un- and underinsured is a deadly serious problem and a blight on the country. Yet to get something done that is both truly reforming -- in the sense of a recognizable reshaping -- may well be the most difficult and ambitious thing he hopes to accomplish.

Except for maybe education reform ... on which more later.

More pebbles: items I (wanted to but) didn't get to

Boing boing spots Virgin Mary in MRI

Bird flu round-up, from Great Beyond touches a few stories reporting some unsettling human deaths from bird flu. I think people are scared to cover bird flu these days: There was so much about it 2-3 years ago, then the epidemic didn't come (we're so impatient!), and now a lot of journalists feel they were out shouting wolf. Maybe wolf is still out there.

Jonah Lehrer on Governor "Show Me the Money" Blagojevich, greed, and a version of the ultimatum game called -- I love this -- the dictator game. "When the dictator cannot see the responder - they are isolated - the dictator begins acting with the kind of unfettered greed expected by economists." (Special bonus: Andrew Sullivan's Quote of the Day is also about Blagojevich.)

Daniel Carlat on "It's not about Goodwin. It's about disclosure."

The Extensible Obama: How the POTUS-elect will use web tools to power his next presidency. From MIT's Technology Review.

The Great Beyond: Far East top in science subjects

From The Great Beyond

Far East top in science subjects

Researchers in the US have released the latest figures comparing the maths and science abilities of 4th- and 8th-grade students in countries across the globe.

Far Eastern countries dominate the top tens, with Singapore top for science in both 4th and 8th grade. In maths, Hong Kong tops the 4th grade scores, with ‘Chinese Taipei’ leading the 8th. (Image right shows the percentage of fourth-grade students who reached the TIMSS advanced international benchmark in science in the top ten countries. See full graph.)

As the New York Times points out, this should worry the US as these subjects “are crucial to economic competitiveness and research”.

“It was good to see that the United States has made some progress in math, but I was surprised by the magnitude of the gap between us and the highest performing Asian countries, and that should cause us some concern,” Ina Mullis, of the International Study Center at Boston College that directs the study, told the paper.

Say that again.

More at the Great Beyond

Why we still need newspapers

From Knight Science Journalism Tracker:

Phil. Inquirer: Four part series disembowels the Bush White House version of the EPA

Many reporters have dived pretty deep into the legal and regulatory changes wrought at the EPA in the last eight years and into the scientist-administrator Stephen Johnson who imposed them at the behest of the George W. Bush administration... But no other newspaper that the Tracker knows of has torn into the agency with as thorough, focussed and full-hearted a pummeling as seen in the Philadelphia Inquirer for four days this week. ....

Sometimes it’s good to let one’s anger show and these reporters do. The pace, enthusiasm, and rhythm of the prose is like that of a flogging of a misbehaving crewman in an old Royal Navy sailing ship.

Oh, that Lucky Jack should have such luck.

Survey the Slippery Slope of Cognitive Enhancement

There's been a lot of buzz on the Net* about the Nature commentary on cognitive enhancement I blogged about yesterday, in which I noted that you need only think about coffee to realize what a slippery slope the cog enhancement issue presents.

If you want to experience first-hand just how slippery, take this survey, which reader Michael Lanthier kindly drew my attention to. It starts with a question about coffee and pulls you inexorably, um, downhill from there.

It's hard to take that survey without concluding the issue of enhancement offers no bright lines. if someone knows of a rigorous argument to the contrary, please chime in.

*NB this one from a chess site.

Obama to bring cheaper meds, universal coverage, pharma nightmares?

So says the Wall St. Journal's Health Blog:

Obama Presidency Could Bring Cheaper Medicines, Universal Coverage

Disclosure of interest: I spent about $10,000 this year on health insurance, $6000 out of pocket; owe $1200 to doctors and hospitals; and still haven't gone through my deductible.

Psych Problem #2: Cooking the Books

Lisa Bero

Critics of the FDA drug-trial process have often complained that the drug companies are free to publish only the trials that are flattering to their cause (that is, only those that show effects above placebo and relatively low side-effects). As explained in Wired Science, UC San Francisco health policy expert and Cochrane Collaboration co-director Lisa Bero has been picking this process apart:

The difference between what drug companies tell the government and doctors suggests that they're cooking the books, which could mislead doctors making prescriptions.

Of 33 new drugs approved by the Food and Drug Administration in 2001 and 2002, one-fifth of supporting clinical trials were not published in medical journals, according to a new study. And those results that were published were often more positive than what companies presented to the FDA in their applications. As a result, potentially unreliable data is being used to promote drugs on which billions of dollars and thousands of lives may ride.

"Some studies aren't published at all. Then, when they are, there are little changes that make the papers look more favorable towards the product," [said Bero].

Among the things Bero found:

Among the differences between results submitted to medical journals and to the FDA were trials that didn't favor a company's product, Bero found. Only half of 43 such outcomes were reported in the literature. More subtly, but just as importantly, key pieces of trial data vanished.

"The main thing that jumped out at me was the addition and deletion of primary outcomes. Those are the most important outcomes of a trial. To find that one disappeared from a paper, or just appeared in a paper, is pretty amazing to me," said Bero.

How to fix this? The FDA does things this way partly because the drugs companies are paying for the studies, and so get to control them. But there is a healthier model:

Bero calls for the FDA to be overhauled to run clinical studies itself, as is done by comparable agencies in Italy and Spain.

"The Italian FDA collects money from every drug company that sells drugs in Italy, pools that, and funds drug trials. They fund the sort of head-to-head drug comparisons that companies don't like to fund. And they have independent people peer-reviewing the trials. It's a great model," she said.

Bero's study is at PLOS Medicine.

Who's Driving the Psych Bus? [was 'Psychiatry at a crossroads']

Sen. Charles Grassley, R-Iowa

As the Times reported Friday, Senator Charles Grassley's pharma-money sweep has taken down another huge player in psychiatry: Grassley revealed that Fred Goodwin, a former NIH director who has long hosted the award-winning NPR radio show "The Infinite Mind," which frequently examined controversies about psychopharmacology, had taken in over $1.3 million consulting and speaking fees from Big Pharma between 2000 and 2007 and failed to report that income to the show's listeners and, apparently, to its producers. (For rundowns on this, see Furious Seasons, Huffington Post, WSJ's Health Blog, PsychCentraol, and PharmaLot

The expansion of Grassley's investigation into journalism throws a new kind of light on the lines through which Big Pharma seeks to shape opinion about powerful psychopharmaceuticals. And the mounting body count from Grassley's campaign -- and the fear in psych departments across the country -- adds to the sense that psychiatry stands near some sort of crisis point.

A Bit o' Background

Goodwin's reported $1.3 million in pharma income is an iceberg the tip of which was exposed in May in a Slate article by Shannon Brownlee and Jeanne Lenzer; I wrote about that article -- and about the counterattack it produced from Pharma and Infinite Mind producer Bill Lichtenstein - in an article at Columbia Journalism Review's science blog. As I noted then, Lichtenstein's counterattack, which seemed to treat failure to disclose conflicts as a hassle that is optional, ignored that drug-industry-related conflicts of interest in psychiatry have have become so big a problem that they are central and relevant to any discussion of any psychiatric disorder.

If journalists like Lichtenstein want the information they present to the public to be taken as credible, they need to err on the side of transparency, presenting not only the voices, but also the relevant financial interests of the experts they feature. Failing to do so only damages message and messenger alike. In the wake of the repeated scandals about drug-company concealment of drug-trial data, it’s strange that I have to spell this out.

Not Getting It

This same tone deafness saturated Goodwin's reported response to Grassley's revelations. If the Times quoted Goodwin accurately, he argued that he suffered no conflict of interest because the various payments from different drug companies "cancelled each other out" -- as if the only concern was whether a particular company, rather than an entire industry, might win his favor.