Avandia Reax From Congress, Wall Street
7 CommentsBy Ed Silverman // May 21st, 2007 // 2:24 pm
Can you guess what they’re saying?
Prudential Equity’s Tim Anderson:
“The news “is likely to have a material impact on sales. The meta-analysis revisits an issue that has been known for awhile, which is that Avandia and other drugs in the class impactd the cardiovascular system adversely…We believe adverse product labeling for Avandia could be en route. We think it is unlikely that either Glaxo or FDA removes the product from the market.”
“Eli Lilly and Takeda have a competing drug in the same class, Actos, but one differentiating factor in its favor is much less of an impact on LDL cholesterol levels…Merck stands to benefit from Glaxo’s woes, having launched Januvia in 2006 that appears to have placebo-like safety.
Senator Max Baucus, a Democrat who chairs the finance committee:
“What we are learning about the handling of Avandia by both GlaxoSmithKline and the FDA is appalling and unacceptable. Both the drug company and the FDA have some major explaining to do about what they knew about Avandia, when they knew it, and why they didn’t take immediate action to protect patients. The number one priority for drug manufacturers and the FDA must be patient safety. Medicare and Medicaid patients - and all Americans - must never be put at risk like this again.”
Sen. Chuck Grassley, a Republican and ranking finance commitee member:
“We need to know if this is another Vioxx, where the FDA sat on its hands and endangered lives. The FDA has talked a good game about how it’s beefed up post-market surveillance over the last two years, but a case like this undermines that claim. It’ll take more than administrative reforms to fix the system within the FDA.
Congress ought to take advantage of the opportunity that we have right now with the FDA funding bill to make a real difference for public safety. Study after respected study has said that the FDA office responsible for post-market review of drug safety ought to have equal footing with the FDA’s drug approval office. It’s hard to understand how there’s any resistance to this kind of reform if you care about public safety and public access to the never ending flow of new information about pharmaceuticals. I won’t stop making the case for giving the post-market review office real clout.â€
Sid Wolfe, Public Citizen:
“The New England Journal of Medicine study…should come as no surprise either to the FDA or to Glaxo. In animal studies done prior to its approval, one of the most constant findings was damage to the heart, and within the first six years of approval there have been 689 cases of heart failure reported to the FDA in patients using the drug. In addition, there have been reports of anemia which, along with heart failure, increases the risk for a heart attack.
“Despite prior knowledge of serious cardiac problems, the FDA has failed to require Glaxo to adequately warn about the dangers of this drug that should be, at best, a last-choice treatment for type II diabetes. In addition to the accumulating evidence of its risks, it is not even as effective as other diabetes drugs in lowering blood sugar or hemoglobin A1C, a measure of glucose control.”
[tags]Avandia, GlaxoSmithKline[/tags]
Lew
Congressional oversight is one thing…but when does it start to become micromanagement that impedes access to needed medications. Does Congress know that every drug has side effects and some sort of risk/benefit ratio? Will we reach a point that new products have to receive both FDA and Congressional approval?
Lisa Van Syckel
Our Senators had more BARK than BITE when it came to drug safety legislation.Senator Kennedy who is Chairman of the HELP Committee,treated the safety of our nation’s drug supply in the same callous manner in which he left a young woman to drown to death in a lake,just another blatant disregard for human life!!
Melody
Whether you speak of Avandia, Vioxx, Fen-Phen or others . . . the pharmaceuticals indeed have unfair playing field. When the drugs they push cause harm and/or death, they ultimately succeed (to a very large degree) in blaming the disease. Doctors, who certainly do not want to be in the mix, have the pulpit whereby they can blame both the disease (diabetes kills … it WASN’T the drug) or the drug company did it (they didn’t tell me about harmful side effects. And both pharma and doctors complain about litigious patients–always hoping to “win the medical lottery.”
Sorry–I like the least amount of government we can manage. But self-policing by both pharma and the medical profession obviously does not work. How sad that lawyers and/or government afford the patient with the only avenue of addressing misconduct and encouraging both pharma and docs to “do the right thing.”
Laurie
“Does Congress know that every drug has side effects and some sort of risk/benefit ratio?”
So how do you suppose a doc or patient should make a decision of risk vs benefit, if the risk has been suppressed, and not reported?
No, Congress shouldn’t have to be involved..if the FDA did their job, Congress wouldn’t be involved. Until that time, then it’s up to Congress to act for the citizens of the U.S.
Les
It is known by the pharmaceutical companies CEOs, etc. that advancing paternal age is associated with an increased risk of non-familial cases of type 1 diabetes, autism, schizophrenia, prostate cancer, Alzheimer’s disease, MS, etc. The current epidemics of type 2 diabetes and obesity are problably related also to genetic mutations that occur sporadically in the offspring of fathers over the age of 33. The studies have not been done on these disorder and the results of studies that do show that increasing paternal age is causal for de novo schizophrenia, and Alzheimer’s are not publicized. The public and any interested citizens groups need to become acquainted with these studies and paternal age needs to come down if we are to prevent these chronic disorders.
http://how-old-is-too-old.blogspot.com/
Thank you for your excellent blog.
Bob
Having taken this drug for almost 4 years you can not imagine the rage I feel today toward the FDA and this drug giant! A few years I was taking Baycol for high cholestereol only to learn on a tv report that it had been pulled from the market. Now I read that the FDA and Glaxo knew this was a “killer drug” in 2002. What confidence can we have that our medications will not kill us?
James F
Most Senators know very little about the regulatory environment for approving pharma and biotech products. All of their “noise” is paving the way for McClellan’s post-market surveillance program.