Lancet: "Don't Panic on Avandia"
Thursday May 24, 2007
The British journal Lancet yesterday published an online editorial (available here) urging the FDA, doctors and patients not to panic over the recent report that Avandia may produce an increased risk of heart attack and cardiovascular death. There are potential flaws in the methodology used to reach this conclusion, says Lancet. And while there is certainly enough there to produce "a signal of concern," they say, everyone should just calm down, keep taking their medicine, and wait for the results of the RECORD trial, which ought to be available in a mere two years. Then, one supposes, Lancet will report on whether patients who followed their advice in May of 2007 have done themselves any good, or whether all the good accrued to GlaxoSmithKline.
This is certainly one approach to the new information on Avandia. For another approach, see DrRich's take, here.
Comments
I looked at the original data supplied to the FDA for licence approval. There was some small evidence in these figures that Avandia showed some anomolous events in the small study supporting the application.
Its rival, Actos, was not squeaky clean either, but had far fewer events associated. Most of these deaths were from Heart Failure, not Heart attack.
The immediate live trials following approval also showed these tendancies, and hence the warning not to continue taking it if edema is present or increases was added.
I can understand that increased fluid retention can increase risk of heart failure. What I did not see, and what this new report is showing, is that heart attack risk is also shown to increase. This is the aspect that worries me, as a patient, since I am already at significant risk already due to other factors. The increase in cholesterol that I have experienced since starting Avandia is also a concern. This is why I am asking my doctor to consider a change in my prescription.
I suspect that there is a class effect in play. However, I may consider Actos as a suitable alternative, and accept the reduced risk.
I am already a heart patient w/ a-fib and CHF and take a slew of meds daily for these and other medical problems as well as for diabetes. Avandamet is the fourth drug in the past few years that I have been given and that has been either the cause of concern or out and out removed from the market. I think it’s irresponsible to publish ’studies’ that are incomplete, biased, too few participants involved, etc. The only thing accomplished is the scare tactic hurts and confuses the patients. We are already at the mercy of doctors, insurance companies, and pharmaceutical companies. Nameless, faceless studies of dubious origin are not very helpful, no matter who prints them.