Pharma
ddobbs | January 18, 2009Virginia Postrel says
It's the worst regulatory news I've heard in a long time--and it predates the new administration by a half year. Sidney Wolfe, who seemingly never met a new drug or device he thought should be legal, has been named to four-year term on the FDA's Drug Safety and Risk Management Committee. He's got the "consumer" slot. Well, I'm a big-time pharmaceutical consumer, and this man does not speak for me.
His philosophy: "If there were any question, they would take the drug off the market."
Postrel also posts a nice admiration of a Freeman Dyson lecture (availabe via pdf…
ddobbs | January 15, 2009The price drug companies pay for illegally marketing drugs for off-label (tnat is, non-FDA-approved) uses just got higher. Such off-label pushing has been a growing problem the past few years, as drug companies sought to expand the use and thus the profit from established drugs. Doctors are free to prescribe drugs for off-label uses -- but companies aren't allowed to recommend or urge such use, as such use hasn't, by definition, been vetted at the FDA and so should be a doctor call, not the drug companies. Nevertheless, companies have indulged heavily in the practice.
This fine might be…
ddobbs | January 13, 2009Rolling deadlines have kept me from the blogging desk, but I can occupy it long enough now to call out a few items that either haven't received as much coverage as they might have -- or that have gotten several interesting hits.
⢠At Huffpost, Jeanne Lenzer and Shannon Brownlee offer the FDA a three-step program:
Step One: Admit that you are currently powerless over the industry you are supposed to be regulating. You have let Big Pharma take over your life. You have become dependent on drug company money that comes from the Prescription Drug Fee User Act (PDUFA) of 1992, and over the…
ddobbs | January 8, 2009
This post by Science's Jennifer Couzin at ScienceInsider suggests how much serious overhaul the FDA needs.
Looks like some scientists at the Food and Drug Administration are doing what they can to influence president elect Obama's choice of their new boss. Nine scientists have written to Obama's transition team pleading with him to restructure the agency and lamenting manipulation of scientific data there. The biggest worry cited in the letter is around review of medical devices. Obama reportedly has his eye on some candidates who would likely shake up the FDA, including agency critic…
ddobbs | January 5, 2009Ezra Klein relays Jim Manzi's worry that public funding of drug trials
exposes you to the inverse problems of the current system. Namely, "bureaucrats and politicians tend to have enormous career risk from an unsafe drug introduction, but almost none from a rejected drug that would have been effective had it been introduced...[it] would likely result in fewer new drugs being brought to market."
There's a bit to this. But it misses something important: The biggest problem with the present system may not be that deeply unsafe drugs are approved but that too many drugs that carry modest safety…
ddobbs | December 18, 2008As 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…
ddobbs | December 17, 2008
Other deadlines bar elaboration, but I wanted to draw attention to some worthwhile reading:
A good Wired Science story explores how "Free Range Research Could Save Chimps, the notion that Oil is Not the Climage Change Culprit -- It's All About Coal, and the Christmas Tree Cluster (of stars).
The Sterile Eye posts a video of a total gastrectomy.
World of Psychology has a particularly good "Mental Health Year in Review" article that reviews research highlights, the flaps over conflicts of interest and disclosure, the controversy over the legitimacy of the pediatric bipolar disorder…
ddobbs | December 15, 2008As time goes on, it seems the benefits offered by modern antidepressants seem to drop while the downsides seem to expand. A story in today's Boston Globe -- excerpted below -- suggests that up to half of people who take SSRIs suffer significant sexual side-effects.
Sexual "numbness." Lack of libido. Arousal that stalls.
Such sexual symptoms have long been known side effects of the popular Prozac class of antidepressants, but a growing body of research suggests that they are far more common than previously thought, perhaps affecting half or more of patients....
Current warnings on the labels…
ddobbs | December 10, 2008
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…
ddobbs | December 9, 2008
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…
ddobbs | December 8, 2008A few that rolled away with the tide ...
PsychCentral not impressed with Outliers
Look Who's in the Operating Room
From the Deutches Museum, tractors as core culture
And from Boing Boing, a Studley tool chest. And I was all excited to get my little canvas toolbag yesterday.
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Technorati Tags:Malcolm Gladwell, Medtronics, Deutsches Museum, Wildlife
ddobbs | December 2, 2008A few that keep slipping out of my hands:
It's All in Your Head -- Sally Satel, in the Wall St Journal, on a recent study showing about half of American doctors use placebos in practice. Satel, who wrote an interesting piece NY Times Magazine piece a while back on her search for a kidney donor, also has an interesting piece on a Senate bill designed to allow states to reward organ donors.
PhamaLot on Pharma's Influence on the Media.
On a related note, a Columbia Journalism Review piece on Science Reporting by Press Release
Andrew Sullivan on The AP's Cowardice.
Hospitals Fail to Take Basic…
ddobbs | November 28, 2008
Jerome Kagan, a highly prominent developmental psychologist, weighs in the Dana Foundation's Cerebrum on the roots of the skyrocketing rates of diagnosis of childhood bipolar disorder, autism, and ADHD. "[it] is important ... to ask," he writes
whether this troubling [increase] reflects a true rise in mental illness or is the result of changes in the definition of childhood psychiatric disorders. The latter explanation is likely because the concept of psychopathology is ambiguous, and physicians have considerable latitude when they classify a child as mentally ill. Because a diagnosis of…
ddobbs | November 26, 2008Lisa 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…
ddobbs | November 25, 2008More wheels coming off the bus.
Research Center Tied to Drug Company - NYTimes.com:
By GARDINER HARRIS
Published: November 24, 2008
When a Congressional investigation revealed in June that Dr. Joseph Biederman, a world-renowned child psychiatrist, had earned far more money from drug makers than he had reported to his university, he said that his interests were "solely in the advancement of medical treatment through rigorous and objective study."
But e-mail messages and internal documents from Johnson & Johnson made public in a court filing reveal that Dr. Biederman pushed the company to…
ddobbs | November 24, 2008Sen. 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,…
ddobbs | November 21, 2008
This one hits close to home, as I live in Vermont. As Daniel Carlat notes, Vermont is one of the few states to actually require drug companies to disclose drug-company payments to MDs, but the state allowed exception for payments related to 'trade secrets.' The companies apparently made the most of this.
The Carlat Psychiatry Blog: How Drug Companies Hid Millions in Physician Payments in Vermont:
Vermont is one of a handful of states that requires drug companies to disclose their payments to physicians. But the law contains a loophole as big as the Ritz%u2014companies are allowed to…
ddobbs | September 9, 2008The evidentiary landscape regarding antidepressant efficacy seems to grow ever more slippery. Now comes a study, drawn to my attention by the busy-eyed Philip Dawdy at Furious Seasons, that finds that the beneficial effects of placebo treatment of depression last longer than generally thought.
As the study's authors note, "The assumption that the placebo response in depression does not endure is widely held and often stated in writing." In particular, many seem to assume that placebo effects fade while effects of actual medications persist -- another argument for antidepressants.
The point…
ddobbs | May 26, 2008
A Chopin Nocturne...
from Derek Bownds' MindBlog by noreply@blogger.com (Deric)Bownds blogs on neuro matters -- and, each week, posts a video of him playing a bit of classical music on his piano. Gotta like it.
FDA To Mine Big Databases For Safety Problems
from Pharmalot
The effort, called Sentinel Initiative,will be the first time the FDA will have an opportunity to monitoralmost immediately how drugs are affecting the public. To do so, theagency will mine databases of more than 20 million patients who receivetheir drugs through Medicare. The idea, of course, is to catch sideeffects…
ddobbs | May 26, 2008A couple weeks ago Slate ran a piece asking "Are doctors shilling for drug companies on public radio?", which I took brief note of in a previous post. Now I've written up a longer reaction (actually a reaction to the reaction to the Slate story) for Columbia Journalism Review's "Observatory" blog, which covers science journalism. The gist: If journalists ... 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…