The American Medical Association has long been known as a bastion of conservative thought (though by today’s standards it is actually quite moderate). Therefore, when its journal, the Journal of the American Medical Association (JAMA) comes out with a scathing editorial against the corporatization of a federal agency, that is a clear sign that things have gone way too far. And indeed they have.
Dr. Howard Markel’s editorial, “Why America Needs a Strong FDA”, in the most recent issue of JAMA, drives this point home. I can’t provide a link to it, since the article is only available on-line to subscribers – but I will summarize it here, while quoting some of the most critical parts.
Since I have worked as an FDA scientist since shortly before Bush took office I can tell you that Markel’s editorial is right on target, or if anything under-states the problem. The repeated substitution of political considerations in what is supposed to be a scientific organization is demoralizing to many of us who work in the FDA. And it is symptomatic of what is happening in our country as a whole.
Markel begins with a tribute to the need for the FDA:
One critical American idea that garners too little credit for a century of arduous public health surveillance, regulation, and scientific inquiry is the Food and Drug Administration (FDA), the federal government's first regulatory agency dedicated to protecting the health and welfare of the individual citizen.
He talks about the origins of the FDA, how Theodore Roosevelt, our last liberal Republican President
justified his decision to enlarge the role the government played in a citizen's life in the form of federal regulation and oversight of food and drugs. The Rough Rider understood the distinct, but often uneven, tug of war between his sworn allegiance to expanding business interests and his credo of a "fair deal" for all Americans, and on June 30, 1906, he signed the Pure Food and Drug Act into law.
Describing the current era, initiated in 1981 with the Reagan revolution, Markel notes how the FDA was the first target of the Reagan Administration’s craze for deregulation because:
The FDA represented everything despised by the modern conservative movement. The FDA was a science-based policymaking agency, but its logic and evidence often failed to resonate with ideology-based policymakers and leaders. The FDA also was quite good at confronting businesses and reigning in their profit-seeking behavior if their interests conflicted with the public interest.
He notes how the Reagan Administration severely cut FDA budgets, canceled legal investigations, and developed policies meant to weaken consumer protections against industry, under the ideological and false argument that those consumer protections were too expensive, reduced business profits and thereby inhibited research and development.
After noting that the deregulation craze was somewhat curtailed under the Clinton Administration, and discussing some important successes during that period – most notably the battles against the tobacco companies under the leadership of FDA Commissioner David Kessler – Markel comes to the current Administration:
But the agency's direction during the last 25 years and especially over the past 5 years has been one of downward transformation from a sterling, albeit very human, regulatory agency into one much more tarnished, politicized, and increasingly disputed by the very people it was designed to protect.
He notes some recent scandals, which he says “suggested an uncomfortably cozy relationship between the FDA and the pharmaceutical companies at the expense of the American consumer”. He talks here about various drugs, such as Vioxx, which were recently approved by the FDA without sufficient consideration of their lethal hazards, and consequently resulted in numerous deaths. And he mentions the recent resignations of two top FDA officials, including Assistant Commissioner for Women's Health Susan F. Wood, who recently resigned in protest over the high level decision to not approve the Plan B contraceptive, without even a full scientific review, based on ideological grounds alone.
And he concludes with this sad but all too accurate assessment of today’s FDA:
In a very real sense, it is the FDA's proud tradition of service that is fueling the public outcry over its recent bad decisions and foul-ups. Whether US citizens consciously consider the FDA to be one of the crown jewels of the American system or not, most have grown rather accustomed to the idea that somewhere, someone in the federal government is watching over to make sure that the foods and beverages consumed, the medicines prescribed, and the medical instruments applied are safe and effective.
Among the many reasons for founding the FDA a century ago was that industries and businesses that had profound effects on the nation's health were placing profits over consumer safety. Sadly, that blind, and often careless, dash toward financial or political gains is again dominating the business-government nexus today. And all recent events suggest that the FDA, as it was originally conceived and allowed to develop is needed more than ever.
A recent personal experience of mine says it all IMO. Can you believe that the FDA would squelch a scientific article that discusses a fatal complication of a medical device simply because a powerful manufacturer complained about the article? Well consider this:
Not very long ago I participated in an assessment of the post-market performance of a medical device that was supposed to prevent the rupture of abdominal aortic aneurysms – a usually fatal event. My research suggested some problems with the safety of the device, which I wrote up and submitted to a medical journal for vascular surgeons. The journal accepted our article for publication (after having gone through the normal FDA clearance process). The manufacturer of the device found out that the article was about to be published, and they complained about it to the Commissioner of the FDA. The FDA subsequently ordered the journal to withdraw the article, which it did. But then, someone leaked the story to the Wall Street Journal, which published the whole sordid story on their front page. Here is the Wall Street Journal story:
http://www.ahrp.org/infomail/04/07/09.php
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