Dr. Ross essentially argues that the senators have completely misinterpreted the Avandia data, whether intentionally or not, in order to fulfill their objective of creating an independent drug safety division within, but separate from, the FDA. Perhaps Dr. Ross thinks that’s a bad thing—it’s not clear from his commentary. It seems to me that erecting another level of safety in regulating drugs can only be a good thing. But that’s another blog post.
The criticism boils down to the fact that these are senators—mere politicians—who are sticking their noses where they don’t belong—in areas of science of medicine. Unfortunately, we don’t have a separate job for “scientist politicians” who can this job, so our political system is left having to deal with it as it is. Also, the senators criticizing the FDA’s handling of Avandia are undoubtedly relying on the opinions and conclusions of doctors and scientists, mainly because Dr. David Graham, employed by the FDA (the commentary paints him to be an anti-Pharma crusader—perhaps this is true, but perhaps he just puts patient safety a little higher on his list than others do).
One other attack I have to comment on:
The charges in this compendium undoubtedly will launch a torrent of litigation against GSK, to the delight of trial lawyers, despite the fact that the senators’ assertions are unsupported by the data.
As a trial lawyer, I will tell you that drug litigation is no joke. It’s expensive. Very expensive. No lawyer in his right mind would be “delighted” to start drug lawsuits without having a sound factual basis for doing so. If the data really doesn’t support the lawsuits, lawyers who invest in that litigation stand to lose a lot of money. And, sometimes, lawsuits have to be started before the science is fully developed. The reasoning is often based on the statute of limitations. Right now, we are hearing that Avandia has problems. If lawyers wait four or five years to bring the lawsuits after all the studies have been done and scientists have made their opinions, many patients may have lost their chance to bring a lawsuit—in many states, the deadline to file a complaint is 3 years or less from the time a reasonable person should have known about a possible connection between the drug and their injury. Of course, if the drug companies are comfortable joining trial lawyers to extend the statute in all states to something like ten years, perhaps lawyers will have time to wait for the science. But that’s just my two cents.
The end result is, the Senators have looked at the documents and heard the testimony, and we, the public, haven’t. So, we rely on them to start the process, start the investigation, and in time, everything will become evident.