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.
This is a personal and serious matter to me because I have worked as an FDA scientist since the late Clinton Administration. So I can tell you that I was very happy and somewhat amazed to see this editorial.
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 then begins to recount 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 he mentions the recent resignations of two top FDA officials:
Assistant Commissioner for Women's Health Susan F. Wood, who quit the agency in early September in protest of what she considered to be the politically motivated decision to delay a clear decision on the Plan B contraceptive despite the drug's proven safety and efficacy at the expense of the health of American women. Then there was the abrupt "retirement" of FDA Commissioner Lester Crawford in September, after only two months on the job, because of what now reportedly appears to be financial interests in companies regulated by the agency.
Then Markel goes on to talk about the origins of the FDA. Setting the stage by recounting how badly our country needed an organization to protect consumers against dangerous foods and drugs, he discusses the roles of various journalist and scientist heroes in creating the political climate that allowed the birth of that organization. And how President Roosevelt, after wrestling with a myriad of political obstacles finally
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.
Then he comes to the current era, initiated in 1981 with the Reagan revolution. He 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 argument that those consumer protections were too expensive, reduced business profits and thereby inhibited research and development. But Markel notes that:
Ironically, the historical record strongly refutes this claim. For nearly a century, under the watchful eye of the FDA, the pharmaceutical, medical device, biologic, and food industries have blossomed as instruments of profit and discovery.
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 finally 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.
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.
Having worked for the FDA through the past 5 years of the Bush Administration I can only say that Markel is right on target, or if anything he understates the extent of the problem. So I will now conclude this discussion with a personal observation, which I feel serves as a kind of metaphor for much of the problem discussed in Markel’s editorial:
Not very long ago I led 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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