This is the seventh posting in a series in which I present evidence about the ill effects of some drugs and medical devices, the ways these Sickening Meds are pushed by those who profit from them, and the reasons the FDA is neglecting its regulatory duties. (Check back next Monday for the final installment. See previous postings here: Part I: Zyprexa, Part II: Baycol, Part III: Guidant, Part IV: Posicor, Part V: Redux, Part VI: Vioxx) If you agree that this is an issue that deserves attention in short order—please consider passing the word on to others. Maybe together we can put it on the national agenda. In the process we are sure to discover who keeps the politicians mum and how the drug companies are able to continue in this nefarious business.
At first glance it is hard to imagine an issue that politicians would seem more likely to raise than the scandalous marketing of Sickening Meds—medications that cause numerous casualties. One would surely expect elected officials and those who seek to be elected or reelected to raise Cain every time a drug company violates the law by failing to report to the FDA adverse findings about the meds they peddle, and continuing to sell these meds to millions of ill people even after they prove to be harmful or even fatal. The issues raised by these Meds scandals seem, on the face of it, God’s gift to an aspiring politician. Yet, not one of the presidential candidates has raised this issue; it was not featured in the last Congressional elections; and neither party is addressing this outrage.
A cure or -- painkillers for the FDA?
The fact that many drugs that are marketed and promoted are not safe has not gone completely without reaction. Several reforms have been suggested, some even enacted. However, these reforms are limited in scope and largely allow the pharmaceutical industry to roll on as before.
A key case in point involves the ‘expert advisory committees’ that help determine whether or not a drug is safe enough for the market. It sounds like a promising safeguard until one finds out that a considerable number of these experts have financial ties to the drug companies whose drugs they are supposed to be reviewing. According to a 2006 Public Citizen study, published in the Journal of the American Medical Association, twenty-eight percent of advisory board members disclosed a financial conflict. In these cases, the experts are supposed to recuse themselves from the committee. Instead, the FDA has been allowed to make exemptions from this recusement—to grant waivers to committee members with conflicts of interest. Thus, when a committee approved Vioxx in 1999, four of its six members had been granted waivers from the conflict–of-interest rule.
A recent reform bill, enacted in 2007, could have closed this giant loophole in the meds safety net. Indeed, the version of the bill that passed in the House included a requirement that no more than one such waiver could be granted per committee. But, a similar amendment was voted down in the Senate, and is not included in the final legislation. No new restrictions on FDA committee members with conflicts of interest is contained in the new law. Other reforms are similarly anemic.
To give but one more example: Direct to consumer advertising, especially of new drugs, has long been opposed and is still banned in Britain and many other nations. Meds differ from paper towels, washing machines and cars, whose merits consumers can judge easily. Urging consumers to pressure their beleaguered and rushed doctors to prescribe new drugs, for real and imagined illnesses, is a counterproductive and costly business.
Although there was some support for amendments proposed in both the House and Senate which would have put a two year moratorium on consumer advertising of new drugs, both versions were voted down. No restrictions on advertising are contained in the new law. And so it goes.
Why no voice? Why do our elected representatives—and those who rise to replace them—have so little to say on this subject? Why is their voice so mute?
According to the non-partisan Center for Responsive Politics, the pharmaceutical industry has outspent just about everyone else on lobbying Congress in in 2007—only the US Chamber of Commerce and General Electric have spent more. The industry is also one of the top contributors to congressional election campaigns; they dropped about $20 million in the 2006 election cycle.
Also, a significant and growing part of the FDA budget is provided by "user fees" paid by the drug companies to the agency (to the tune of about two hundred million dollars annually). To antagonize the industry, and to slow down the approval process of new drugs, would mean cut-backs in everything the FDA draws on, from staff to labs.
No attempt to wean the FDA away from pharmaceutical funding is contained in the new law. In fact, the law calls for an increase in the amount pharmaceutical industry money to fund the FDA’s drug regulation.
Frankly, given the vital and emotive nature of the issue at hand, all this still does not quite explain the silence. It is hard to understand why not a single presidential candidate has made Sickening Meds a major campaign issue. This is not an abstract or highly complicated issue, nor does it take place on the other side of the ocean or affect only one class of citizens. People die needlessly, others get sick, we all cannot trust the drugs prescribed to us. Someone should speak up for them. Loud and clear.
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Amitai Etzioni is University Professor at the George Washington University and, most recently, the author of Security First: For A Muscular, Moral Foreign Policy (Yale, 2007).
www.securityfirstbook.com