Concerns rise on NEMJ report on Avandia and cardiovascular problems

Senator Chuck Grassley of Iowa, Made a statement from the floor of the House on Monday (21/5/07) "About the safety of Avandia"

" ....today, Dr. Steven Nissen, the Chairman of Cardiovascular Medicine at the Cleveland Clinic and the immediate past president of the American College of Cardiology, and his colleague Ms. Kathy Wolski reported in the New England Journal of Medicine that there is a serious problem with Avandia. Avandia, according to Dr. Nissen and Ms. Wolski is increasing the likelihood that a diabetic will have a heart attack and maybe even die. I want everyone to pay attention to the fact that the New England Journal of Medicine accepted this analysis of Avandia on a “fast track” review. The New England Journal of Medicine did that because it was requested by the authors and because in its opinion, the analysis of adverse effects related to Avandia suggests serious patient health risks. "

"Around 1pm today, the FDA told the American people that they intend to call for an advisory board meeting to discuss Avandia and that they could not yet reach a “firm conclusion” on what to recommend to people taking Avandia. It was interesting to listen to the call because Dr. Dal Pan, who is the head of the Office of Surveillance and Epidemeology, didn't say a word, although he is in charge of post-marketing surveillance. I guess the FDA thinks that
the decision to go to an advisory committee meeting takes the heat off what looks like another failed decision-making process. We'll see. "

"There have been many clinical trials involving Avandia over the years and there have
been numerous post-marketing changes to Avandia's label. I also understand that FDA has known about the possibility of problems with this drug since about October 2005.
That's about 19 months ago.

"The article appearing today in the New England Journal of Medicine raises a lot of serious questions for me about the real story behind the safety of Avandia. When I couple that article with the FDA conference call that ducked lots of questions I become very suspicious."

"My question today is: do we have another Vioxx on our hands with Avandia? I am not sure, but I intend to find out. In fact, today Senator Baucus and I sent out several ocument requests including one to the FDA and one to the drug sponsor. We want to understand what did FDA know about this drug, when did it know it, and what did it do about it? "

"The authors of The New England Journal of Medicine article report a 43 percent increase in the risk of myocardial infarction/heart attack and potentially a 64 percent increase in the risk of cardiovascular death. I need the FDA to tell me why a diabetic would take a drug that may increase the risk of the very thing they are trying to avoid-a heart attack. I also want to know why the FDA did not require the drug sponsor to conduct long-term safety studies instead of small, short-term trials that resulted in few adverse cardiovascular events or death. I want to know what the FDA has been doing for the last 18 months. We want to know the same from the drug sponsor."

"Interestingly, in an editorial that accompanied the study, two other veterans of the Vioxx controversy-Dr. Bruce Psaty of the University of Washington and Dr. Furberg of Wake Forest University-write: “…the rationale for prescribing rosiglitazone at this time is unclear.”

"Additionally they call for the FDA to take regulatory action and note that bigger and better long-term studies of long-term treatments for conditions such as diabetes should be completed as soon as possible after a drug is approved."

"Drs. Psaty and Furberg also said in their editorial, “On May 10, 2007, the Senate passed the Food and Drug Administration Revitalization Act. Although the Senate bill has many strengths, including the allocation of new authority to the FDA, none of its provisions would necessarily have identified the cardiovascular risks of rofecoxib or rosiglitazone in a timely fashion.”

"The drug industry has brought us miracle drugs. These drugs have vastly improved the lives of millions throughout the world. At the same time, we all know that drugs have risks and benefits. Each of us tries to consider those risks and benefits when we consult with our doctors to make the best decision for ourselves or our family members as to whether or not we will take a particular drug. But we can't do what is best for ourselves or our family members if we don't know all the relevant information in a timely manner."

Lord Patel is neither a lawyer or a physician , but he has diabetes and he takes Avandia 3 mgm tablets daily. Anyone with the similiar habit should consult their physician pronto - me, I've stopped taking them. Period.