Science Policy
ddobbs | January 27, 2009
Close on the heels of Lilly's $1.42 billion penalty for off-label marketing comes the news that Pfizer paid out $2.3 billion to settle similar allegations.
From FiercePharma
News of the Pfizer-Wyeth merger this morning drowned out some not so good news for the company. Just after announcing its $68 billion buyout of Wyeth, Pfizer published its 2008 fourth quarter earnings report. In it, Pfizer reveals a $2.3 billion charge to end investigations into allegations of off-label promotions of the company's COX-2 meds, including Bextra. That settlement caused a 90 percent reduction in Pfizer's…
scientificactivist | January 26, 2009Last Friday the British Minister of Science, Paul Drayson, visited the science area of Oxford University to give a short speech and take questions. The audience was a fairly random assortment of a couple of hundred academics and students, mostly from the sciences. I was invited to fill one of ten graduate student slots granted to the Department of Biochemistry. It was a nice gesture by Drayson, and I think he was legitimately interested in hearing from scientists. Based on what I witnessed, though, I hope that he took some of it in.
Drayson spoke and took questions about his role and the…
ddobbs | January 20, 2009One theory about antidepressants is that they relieve depression by encouraging neurogenesis -- the creation of new neurons. Neuroskeptic reviews a study that argues against this idea.
the neurogenesis hypothesis has problems of its own. A new paper claims to add to what seems like a growing list of counter-examples: Ageing abolishes the effects of fluoxetine on neurogenesis.
The researchers, Couillard-Despres et. al. from the University of Regensburg in Germany, found that fluoxetine (Prozac) enhances hippocampal neurogenesis in mice - as expected - but found in addition that this only…
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…
revere | December 21, 2008Maybe the biggest science story of 2008 is that science will be back in government in 2009. In a way it is a commentary on how far we have fallen that the appointment of distinguished scientists to important posts in government is a story at all. It should be a given. But for eight years -- and more -- it has been the exception, and scientists who have been in government have been marginalized. Even worse, whatever they have done in private, they have been compliant public faces -- the word stooges comes to min -- for the Bush administration's contempt for any science not consistent with…
evolgen | December 20, 2008John Hawks points out that Eric Lander has been appointed to co-chair Obama's Council of Advisers on Science and Technology along with science adviser John Holdren and Nobel Laureate Harold Varmus. Here's how the AP article describes Lander:
Lander, who teaches at both MIT and Harvard, founded the Whitehead Institute-MIT Center for Genome Research in 1990, which became part of the Broad Institute in 2003. A leading researcher in the Human Genome Project, he and his colleagues are using the findings to explore the molecular mechanisms behind human disease.
Wait, Eric Lander teaches? Really?…
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 18, 2008Scientificblogging, 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.
ddobbs | December 18, 2008Atop other Obama appointments, this is one I suspect America's scientists will welcome. From the Washington Post:
Report: Holdren to Lead White House Science Policy
By Joel Achenbach
President-elect Obama will announce this weekend that he has selected physicist John Holdren, who has devoted much of his career to energy and environmental research, as his White House science adviser, according to a published report today.
The Obama transition office would not confirm Holdren's selection. Last night, asked by The Post to comment on the science adviser search, Holdren responded by e-mail that…
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…
sb admin | December 17, 2008Larry Moran points to a couple of posts critical of microarrays (The Problem with Microarrays):
Why microarray study conclusions are so often wrong
Three reasons to distrust microarray results
Microarrays are small chips that are covered with short stretches of single stranded DNA. People hybridize DNA from some source to the microarray, which lights up if the DNA hybridizes to the probes on the array.
Most biologists are familiar with microarrays being used to measure gene expression. In this case, transcribed DNA is hybridized to the array, and the intensity of the signal is used as a…
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 10, 2008From 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…
ddobbs | December 10, 2008From 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…
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 1, 2008So 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.