Who Hearts Avandia?
Well, I guess the FDA advisory panel does. Well, not exactly. They just don’t dislike it enough to pull it off the market.
In a remarkable 22-1 decision, the advisory panel voted to allow Avandia (the multi-billion dollar drug from Glaxo for Type-II diabetes). I find this remarkable because I wasn’t sure the Agency had the cajones to stem a rapidly swelling tide against the drug.
Much hay was made in May when a NEJM article described a meta-analysis of thousands of patients and found an increase in myocardial ischemia (a loss of bloodflow usually caused by a blockage) which can offer be a pre-cursor to a heart-attack.
A meta-analysis is performed by combining results from several studies to form a database with a large number of patients. And that's the problem -- because the combined trials were all run differently, its really hard to extract statistically meaningful data – and so such analyses are used to guide specifically designed clinical trials that WILL yield statistically significant data – if there’s anything to find.
And here’s the kicker – Glaxo’s been DOING THAT TRIAL. They know they need this answer. The damn thing is Avandia has always had a “heart disease” issue, and is contra-indicated in people likely to have congestive heart failure. They think their compound is safe (enough) and that the trial will show it. But suddenly, there were ascending cries to remove the compound from the marketplace right now.
And I’m glad it wasn’t. The FDA can not let media feeding frenzies dictate the nation’s health policy.
That said – if I was diagnosed as a Type II diabetic, would I want to take Avandia? No. Not because of the heart risk (if its there), but because Avandia is hell on your liver, causes edema AND there are new medicines that take advantage of a different mechanism that has a good chance of being way better than Avandia. I would choose to take Amylin’s Byetta or Merck’s Januvia.
But that’s just me – if you’ve got questions, go talk to your doctor – better yet get your PCP to recommend an endocrinologist and get the real deal from someone that knows.
(end of rant -- back to travel and music and books and movies...)
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Props to you for getting the word out to us voxers...
The FDA's in a really tough place. On the one hand, they get criticism for not giving people answers fast enough. When you submit something to the FDA it takes at least 6 months to get an answer - that's in the biologics world anyway, and for minor changes to things like the blood donor questionnaire. I'm sure in the drug world, and with a whole new drug, it takes much, much longer. While I don't doubt that the old government ineffeciency is alive & well at the FDA, I like to believe that they at least try to look for the risks vs. benefits.
On the other hand, you have certain media on the lookout for an "expose," and guys like the Law Offices of Robert J. Sokolove who, once a new drug hits the market, are just waiting for someone to succumb to the side efffects that may or may not have been listed in the package insert, had anyone bothered to read it. People want their lives saved but with no risk - which I guess is the heart of the drug industry.
And don't even get me started on all those commericals that market prescription drugs to the general public. Makes me wonder how many doctors prescribe this or that drug to their patients even when they know it's not the best choice for them because the patient threatens to "take his business elsewhere."
I don't know what the answer is, all I know is I sure wouldn't want to work for the FDA. You're the bad guy if you do, and you're the bad guy if you don't.
Sorry, Steve, I wasn't intending to write such a long comment! I think you're right on.
Jen -- yeah, I've never been a big fan of this mechanism (PPAR-gamma agonists), but for nearly a decade they've been the best thing out there for people that have failed on metformin. That might not be the case now.
As for celebrex, its taken a huge hit from the vioxx withdrawl. Cardiovascular risks have been investigated for these selective cox-2 inhibitors for a long time (sound familiar?) -- I've never known anyone that's taken it, though I've heard it works pretty well.
Mello -- no apologies necessary -- you're absolutely right about the no-win situation that the FDA is in, and the combination of instantaneous litigation and sensationalized media scrutiny creates a very toxic atmosphere. (one could write whole posts on those, too!)
I think you're right that the public is poorly informed about the risk-reward profiles of drugs these days -- and direct-to-consumer advertizing with sunny days and happy people don't do anything to help.
Additionally, drug companies themselves have hurt their own cause by becoming "shareholder-driven" entities that have to beat-the-street. The discovery cycle for a new drug takes 5-8 years. That really doesn't work in a business that's over-emphasizing quarterly returns.
sage advice. Don't go to your doctor; they get kickbacks. Go to the specialist; he still gets kickbacks, but he is more likely to RX what is right for you.
huh. stuff like this makes me glad i'm on straight insulin.
and that it's far less hell on the body than it used to be.