If you have been following the trials and tribulations of the diabetes drug Avandia, you might be surprised to have learned that after all the grim prognostication in the media, all the haughty criticism of the state of drug regulation by newspaper op-eds, the warnings of death-tolls exceeding 9/11, and of medication that was useless for all but lining Big Pharma's coffers, the expert panel commissioned by the Food and Drug Administration to investigate whether to pull the drug from the market not only *didn't* recommend doing so (by 22 to one), they didn't even recommend the toughest regulatory warning for the drug - a so-called black box.
What happened? Take several critics of the way the FDA ensures the safety of drugs, rush a flawed study into print, characterize the results as catastrophic, rope in drug regulation warriors on Capitol Hill, rant about the evils of Big Pharma, talk to a credulous, statistically-illiterate media, and voila - you have Vioxx II, except the data ultimately got in the way of the story.
Lessons
The key lesson for politicians, journalists and doctors is that if you are treating an epidemic with a popular drug, you shouldn't warn the public about that drug unless you have reliable evidence that it's unsafe. The 43% increased risk of heart attack touted endlessly in the media was, from the get go, statistically fragile; it might well have been an artifact of the way the data was mined and analyzed, as might the other meta-analytic results reported by the FDA. When weighing the reliability of studies, randomized control trials signify greater reliability than meta-analyses (also known as pooled data).
Read the Studies Before Reporting
The campaign against Avandia was driven by poor data and questionable statistical methods, but the press failed to catch on to that fact - or if they did, it had little more than the status of a digression in the coverage. It's not that Avandia's critics tried to cover the fragility of their case up: Steve Nissen and Kathy Wolski were frank about the limitations of their analysis in the conclusion to their study published in the New England Journal of Medicine even if Nissen was much more bullish in talking to reporters; moreover, there was a series of analyses, submissions and commentaries on Nissen and Wolski published afterwards in medical journals that rang out like a five alarm fire on the problems of their analysis; and yet, these were largely ignored by the media, which continued - and still continues -- to talk up the 43 percent increased risk.
In one of the most devious pieces of reporting, the New York Times characterized Nissen's critics as "Republicans on Capitol Hill and others." How many New York Times readers just read "Republicans" and automatically dismissed the idea that Nissen's data was impeachable? Shouldn't readers have been told that the "others" consisted of leading medical experts?
If The Problem is Diabetes, Talk to Endocrinologists (At Some Point in the Story)
One of the bizarre aspects of the media coverage of Avandia is the second-tier status given to endocrinologists. Hello! These are the people who are managing the diabetes epidemic, doing the research, and prescribing the drugs; and yet, their voices were subordinated to a handful of critics, none of whom appeared to be involved in the clinical treatment of the disease. It should have given reporters some pause for thought that the doctors who denounced Avandia were not endocrinologists - and that pause should have raised questions such as, if this drug is as useless, as the FDA's associate director for science and medicine in the office of surveillance and epidemiology, David Graham, claims, why has it been so widely prescribed? Is the entire field of endocrinology either in the greedy maw of Big Pharma or so stupid as to require board recertification en masse, or did Graham ignore or fail to grasp the way diabetes is treated in clinical practice?
The media needs to be skeptical of drug-safety warriors.
We need a calmer debate about drug safety, and that isn't going to happen unless the media starts treating those who relentlessly hammer the FDA from within and without with a little more skepticism. The panel vote amply demonstrates that there is, at the very least, a massive dispute between drug safety advocates, such as David Graham and the rest of the FDA along with many clinical practitioners.
The key question here is whether Graham et al are reasoning from a standard of safety so extreme, so governed by an inflexible protocol of precaution, that the effectiveness of powerful but inherently risky medications becomes an afterthought. Answer this question and you, at least, have the terms under which there can be a meaningful discussion of how the FDA should be reformed. Should safety always over-rule efficacy? If, for example, a diabetes drug raises the risk of heart attack for four out of 100 diabetics but prevents blindness in 10 and amputations in 20, do we still remove it from the market? Do we say that cardiac risk trumps all other risks?
These kinds of questions were never raised by the media, even though they are at the heart of the safety versus efficacy debate; and their answers, for good or ill, will determine the future of medicine. Hand the media soapbox over to the drug-safety warriors, or reflect their arguments in editorials, and you deprive the public of the means to really understanding the full ramifications of this debate, which is important given --
The toll from diabetes each day in the United States
4,100 new cases
810 people die
230 amputations are performed
120 people experience kidney failure
55 people go blind
(Source, MedStar Research Institute.)
Until we get serious about preventing diabetes as a disease that is largely driven by lifestyle, we will be dependent, whether we like it or not, on drugs, and the pharmaceutical industry, and the FDA to manage a massive public health problem.