Glaxo's Avandia Drama

Yesterday I wrote about how the fallout from a recent study that found Glaxo' Avandia has potential to increase heart attack and death. Yesterday i came out this nice coverage of the Avandia drama at BioHealth Investor, on how the media overdramatized the case. I think this has a potential for the Vioxx/Cox2 case redux. That dramatically changed the modd and behavior of the FDA. FDA's approval rate dramatically declined after that, mostly because of public outcry blaming the regulatory body for approving the drug and well, public's sad mastery of statistics. I am for public disclosure of all information but not mis-information.

Even the author of the Avandia study, Dr. Nissen cautiouned the public, “I do not want our study to lead to a public panic... Patients should not stop taking the drug on the basis of a news report.” in a CBS coverage.

The study found that 0.44% of the 10 thousand people from various Avandia clinical trials developed heart attacks compared to 0 .33% taking placebo, and death resulting from cardiovascular causes was 0.38% in Avandia group compared to 0.19% for the placebo group. After crunching the numbers, the authors came up with the odds ratios that taking Avandia has 1.43 times the odds of developing heart attack and 1.64 of dying (the confidence interval was a little broad). So as you can see the odds of dying and getting heart attack despite being significantly elevated, was still relatively small. All drugs have side effects and elevates risk of developing something. Some of these risks might show up during trials, some won't until the drug is widely used. Hell, I don't have hard data, but I guess French Fries might have similar effect to Avandia.

A lot of people are panicking, a family member asked if it's true that taking Avandia will give him 43% chance of developing heart attack and death. This is serious matter, and I think Avandia patients should discuss with their doctors if taking the drug is still worth the drug's increased risk. But there is no need to panic and stop taking the drug for no reason. I think instead of spreading uncontrolled wildfire, the media might be better off giving the public (and probably capitol hill) statistic 101 refresher before oversimplifying and misinterpreting the facts.

The sad part is that I think this will make the FDA less efficient in performing its duties. No FDA official will want to face congressional hearings or public outcry for his/her head in the future ifor a drug being approved today ended up having have unknown side effects/risk. The Vioxx case have made the FDA slower and being overly conservative in approving drugs. I won't be surprised if in the future the FDA won't approve any new drugs at all because of this fear.

I think the FDA is only a front line gate for drugs. Ultimately it is the patients and physicians' (well and payors, etc.) decision whether a drug's benefit outweighs its risk to be prescribed in case by case basis. I think it is better off that patients and doctors are given the chance to use as much choice of arsenal in fighting diseases and improve quality of life.