The Doctor Doth Protest Too Much, Methinks
Today The New York Times, which dutifully fanned the flames of the 2007 "prescription drug crisis" started by those pushing for greater FDA powers and fewer new drugs, published "Caustic Government Report Deals Blow to Diabetes Drug". In essence it reports Dr. Thomas Marciniak's criticism of the RECORD study which in 2007 led the FDA, despite congressional histrionics, to vote 22 - 1 to keep Avandia on the market. What the NYTimes is talking about is this.
What sets off the alarms, to a mass tort lawyer anyway, is slide 22. Why, asks the good doctor, should you believe his numbers? After all he declares that he has "nothing to hide" and that "[n]either my job nor (for me) $100,000,000's are riding on the results." The other slides evidence an effort to dig, but not too much, into the data and upon finding seeming errors to imply, without saying so, that the manufacturer somehow managed to beguile honest researchers from around the world into signing off on bad science. It's the kind of drama you'd expect to see from a certain sort of expert witness testifying at the courthouse in Jefferson County; but hardly the sort of presentation typical of scientific gatherings. Then again the FDA has been hyper-politicized so maybe this is the new normal.
Anyway, the implication that this is the "Government Report" is highly misleading. It is in fact but one of many government reports (if by that we agree to mean presentations generated by government employees/contractors). Indeed, another "Government Report" addresses Dr. Marciniak's claims. You'll find it here.
Dr. Marciniak did the easy thing. Post hoc he rummaged around for evidence of errors that would undermine the RECORD study. When examining the outcomes of thousands of people based on many times that number of documents he found a few seeming inconsistencies. Anyone who does mass tort litigation knows that if a bad data point or two were enough to refute any study then we wouldn't have much to talk about down at the courthouse.
What's also interesting is the fact that throwing in the extra assumed heart attack episodes (even the ones for which there were no biomarkers confirming same) the study still only shows a small increase (1.38) that is statistically significant by the barest margin (C.I. 0.99 - 1.93) (i.e. "not") and still it does not support the Nissen hypothesis (to say nothing of the study of 227,000 Medicare patients that rejects it).
But most interesting of all is the data on the only question we really, ultimately, want answered. Do the people taking the medication live longer, or die sooner, than those who don't? By that measure, the protesting doctor's numbers still show that patients on Avandia were 14% less likely to die than those who weren't. By this most critical measure, even considering the data cherry picking of Dr. Marciniak, the results for Avandia are "reassuring" - according to that other government report.
