Latest Drugwonks' Blog
Hoosier daddy?
David Graham's latest black helicopter theory about the fact that an FDA advisory committee recommended keeping Avandia on the market (with additional warnings) with editorial comments from Steve Nissen:
Silver Spring, MD - Accusations of bias among the FDA advisory committee that voted on the fate of rosiglitazone (Avandia, GlaxoSmithKline) earlier this summer have been made by two members of the FDA's Office of Surveillance and Epidemiology [1].
In a letter to BMJ published online September 7, 2010, Drs David Graham and Kate Gelperin point out that half the members of the July 2010 advisory panel had previously voted in favor of allowing rosiglitazone to stay on the market at an earlier FDA advisory committee in 2007. They write: "In an unprecedented move, the FDA's Center for Drug Evaluation and Research (CDER), which originally approved rosiglitazone and has defended its continued marketing, invited not only the current members of these committees [the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee] but also all members from the 2007 meeting, even though they were no longer active members of either committee. Of the 32 advisers who voted at the 2010 meeting, 16 (50%) attended the 2007 meeting, and 15 of them had voted that rosiglitazone remain on the market (one attendee was a temporary nonvoting invitee)."
Graham and Gelperin say this biased the vote at the 2010 meeting. They calculate that members voting for the first time were 4.4 times more likely to vote that rosiglitazone be withdrawn from the market than were members who had voted previously to keep it on the market. "Had these former members not been included, the vote would have been 10 out of 17 (59%) in favor of rosiglitazone withdrawal, with an additional three in favor of severely restricted distribution," they add.
Panel "loaded"?
Commenting on this for heartwire, Dr Steve Nissen (Cleveland Clinic, OH), the coauthor of the meta-analysis at the center of the rosiglitazone safety concerns, who has been leading the campaign to get rosiglitazone withdrawn, said it was obvious that the 2010 panel was "loaded."
They have rigorously defended rosiglitazone again and again, and obviously they feel they cannot be seen to have made such an error.
He added: "The outcome of FDA advisory panels is significantly influenced by who is on the panel. When I saw the roster, I knew it was going to be an uphill struggle. I was very surprised that they had invited back people who had already voted to keep the drug on the market in 2007. Once you have opined publicly, it is very difficult to turn around and admit you made a mistake." Nissen said it would have been the leadership at the CDER that decided who to invite to this panel meeting, and this is another demonstration they do not want to act against this drug. "They should have acted much earlier on, when the first negative data were reported. But they have rigorously defended rosiglitazone again and again, and obviously they feel they cannot be seen to have made such an error."
Here are my questions:
Why does BMJ feel compelled to help Graham and Nissen peddle their fearmongering? And where is the opportunity to provide an opposing (and more balanced) view?
Why are the two launching an attack on FDA's integrity now? Does it have anything to do with yet another campaign to pressure the agency to overturn the Ad Comm decision?
Does Nissen actually believe that the composition of the Ad Comm is part of a CDER coverup? That is a very serious accusation. Did St. Steven the Pure wear a wire when talking to CDER officials?
www.theheart.org/article/1121701.do
Oh, and one more question: What about the recent observational study showing no difference in heart risks between Avandia and Actos. No comment or BMJ editorial yet from Nissen or Graham, a study that, uniike Graham's did not use data dredging to squeeze out an 18 percent additional risk of heart problems associated with Avandia compared to Actos..
circoutcomes.ahajournals.org/cgi/content/short/3/5/538
Agenzia Fides, the missionary press agency of the Vatican, has spoken out against counterfeit drugs
and the approximated 700,000 people expected to die annually due to their pervasiveness.
Fake tuberculosis and malaria drugs alone are estimated to kill 700,000 people a year. A large part of these victims are African. The World Health Organization (WHO) estimates that up to 30 percent of the medicines on sale in many African countries are counterfeit and have found that nearly half of the drugs sold in Angola, Burundi, and the Congo are substandard.
In 2003, Interpol conducted a survey on the quality of drugs available in Lagos, sub-Saharan Africa's most populous city and found that 80 percent of the drugs available were fakes. In 2008, more than 80 children in Nigeria died after being given medicine for teething pain that was laced with antifreeze.
Fake medicines can be missing key ingredients, use the wrong ingredient, or have insufficient or too much of the active ingredient. In some cases, use of these medicines can increase drug resistance. When there is not enough of the active ingredient, the drug kills some of the parasites or viruses, but the pathogens that are not killed adapt. As time goes on, even if a patent was to be treated with the correct medication, he or she would not be cured.
Agenzia Fides states, “The development of germs resistant to antibiotics and other treatments is a problem that affects all humanity, not just Africans. It is therefore in the best interest of all concerned that smuggling of counterfeit drugs be fought against.”
Which brings us to the FDA and the future of medical innovation.
A few years ago I had the honor of discussing both topics with Nobel Prize Laureate Joshua Lederberg. Actually, to be accurate, I mostly listened and took notes at the feet of the great man.
When I asked him about FDA's role in 21st century medical science, Dr. Lederberg responded that the real question should be, "Is innovation even possible?"
To that end, have a look at this very interesting and challenging cover story from this week's edition of BioCentury. Titled, "Regulatory Innovation," it makes some keen observations and offers some siginificant food for thought.
Is innovation even possible? Let's hope so.
In an upcoming position paper the Infectious Diseases Society of America suggests that overuse of antibiotics could be controlled via a REMS-like approach – or even an actual REMS.
Interesting idea, because something new must be done. The problem of antibiotic resistance is a real, urgent, and relatively silent public health crisis. For those who rant about the influence of DTC advertising on the doctor/patient dialogue -- it doesn't even hold a candle to a parent's plaintive plea for a prescription when their child has an ear ache.
In the past, FDA has worked with the CDC on consumer education programs such as “Cough, Sniffle, Sneeze – No Antibiotics, Please." But such efforts have met with only modest success (and that’s being generous).
If it takes a REMS to drive the safe and appropriate use of antibiotics, then so be it. Burdensome on docs, yes – but they have nobody to blame but themselves.
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TO BE FOLLOWED BY CMPI'S OWN SEMINAR: TIPS ON HOW TO DATE A DRUG REP
Counterfeit medicines are a real problem – and quantifying that problem is, well, a real problem. How do you estimate criminal activity in ways other than a body count? “Show me the dead Canadians” (as Senator Bernie Sanders is so fond of saying) is not an excuse to do nothing. And purposely derailing the international fight against the false profits of fake medicines via the spanner of "definition" is unconscionable.
Here are four excellent new articles (two from the Wall Street Journal, one from USA Today and the fourth from the Washington Post) that remind us that counterfeit medicines are an important public health issue here at home and around the world.
The first WSJ piece can be found here, the next here, the USA Today story here and the Post’s take here.
While counterfeits are tough to measure, it doesn’t mean that we can ignore the problem. To belittle the problem because we cannot substantiate the volume is unwise. If we wait to count the bodies – we have only ourselves to blame.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
