However, in the August 26, 2010 issue of The New England Journal of Medicine, which is one of the most prestigious medical journals in the world, Dr. Clifford J. Rosen, who was the Chair of the 2007 advisory committee, and also served on the committee that met last month, wrote an article discussing the advisory committee process, and suggesting strong action. Dr. Rosen writes that there are three lines of evidence which have emerged since 2007 suggesting that Avandia’s “cardiovascular risk is significant and that major federal action is now required.” He states that the medical evidence shows that the risk of heart attack is 30-80% higher for patients with diabetes who take Avandia compared to those who do not, that Medicare data shows further evidence of this increased risk and that the risk of a cardiovascular event or death is nearly 25% higher for a patient taking Avandia than for a patient taking a competitive drug known as Actos.

Dr. Rosen concludes his article by stating that the clear risk demonstrated by this research “…calls for serious measures.” Dr. Rosen suggests that the FDA has only two choices left, one is to make the warnings on the drug stronger than they already are and in addition, to require a specific informed consent form to be signed by a patient before taking the drug or that the drug be removed from the marketplace.

This article, by a doctor who is in a position to know more about Avandia than most other researchers in the world, not only serves to illustrate the risks attendant to use of this medication, but also causes one to question just how vigilant the FDA is in protecting the health of medical consumers. If you or a member of your family has been injured by use of this drug, please call one of the lawyers at the Locks Law Firm to discuss your legal rights.

The recall came after at least 2 years of complaints to J&J and FDA about these devices. DePuy issued a statement and a Recall Guide which details the actions patients should follow. DePuy has said that it would pay for replacements and the costs of surgery in patients whose devices have failed. Despite assurances from DePuy that “most” surgeries with the implants had been “successful” some orthopedic surgeons have said that between 12 and 13% of patients who had the DePuy devices implanted required revision surgery. Problems with these devices had been reported previously by The New York Times.

David Floyd, president of DePuy, said in a statement that the recall would be a concern for patients and their family members and for surgeons. “We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the costs of doctor visits, tests and procedures associated with the recall,” he said.

Harvard also reduced by half (to ten thousand dollars) the amount of money a faculty member may accept for studying a product or drug. Harvard is one of the few universities to impose such a cap. The changes resulted from an analysis of a 34 member review panel. They were accepted this week by the dean of the medical school and will go into effect over the next year.

This is yet another step toward the emancipation of medical education from industry money and influence. Are we seeing a trend, perhaps?

Dr. Steven Nissen, whose 2007 study sounded the alarm about Avandia, was quoted in the New York Times today as saying he believed that the Panel’s findings about Avandia would eventually lead to suspension and abandonment of the study altogether. Nissen noted: “There was really no other action they [FDA] could take. Now the challenge is, if that trial is unethical, how can Avandia stay on the market?”

Stay tuned.

One wonders how Dr. Capuzzi got on the panel in the first place.

When it comes to the health and safety of Americans, we don’t need the fox guarding the henhouse. Big Pharma already has a large impact on the FDA—we don’t need paid drug spokesmen on FDA panels. Surely there are doctors out there as qualified as Dr. Capuzzi who do not take drug company money that FDA could call upon.

The Panel of 33 members took six votes, the critical vote coming toward the end of the 2 day hearing. 12 members of the Panel voted that the drug should be withdrawn from the US market; 10 members voted that its use should be restricted and that warnings enhanced on the label; 7 voted for enhanced warnings only; 3 voted that the drug should be sold without change; 1 member abstained and there were no votes to weaken the warnings on the label.

Reactions to the vote were mixed. Glaxo, through its’ chief medical officer Ellen Strahlman said “Following today’s recommendations, we will, of course, continue to work with the FDA in the best interest of diabetes patients who face this chronic and serious disease. Patients taking Avandia should speak with their physician about their treatment and any questions they may have regarding the safety of the medicine.” Glaxo’s press release makes for interesting reading and is spin at its finest.

Dr. Steven Nissen of the Cleveland Clinic whose 2007 study linked Avandia with heart attacks said that the vote was the best one could hope for. “Effectively, this drug is gone.” FDA Drug Director Janet Woodcok said FDA would review the Panel’s findings and come to a decision on whether to pull Avandia or restrict its use. No timeline was set for a decision from FDA.

The New York Times reports today that the University of Michigan Medical School has become the first medical institution to no longer accept industry money to fund physician education programs. Dr. James O. Wolliscraft, Dean, cited the school’s desire to have education that is “free from bias” and based on the best scientific evidence. The school’s policy announcement was greeted with support, howls of dissent and calls that the move was still insufficient to remove the taint of Big Pharma and Medical Device money from physician education.