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This is the sixth 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)  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.

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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.


Case VI: “Tens of Thousands” victims: The Vioxx Case

Over the course of its four years on the market, an estimated 80 million people worldwide took Vioxx, an anti-inflammatory developed by Merck. In September of 2004, amid a torrent of scrutiny and mounting questions over the safety of the drug, Merck announced that it would voluntarily withdraw Vioxx from the market. As the evidence coalesced to show that Vioxx indisputably raised the risk of heart attack and stroke, a sobering fact became clear: of the 80 million patients who took Vioxx, “tens of thousands” died or suffered serious medical problems because of the drug.  (1) In the words of Eric Topol, a prominent cardiologist and expert on the case, neither Merck nor the FDA “fulfilled its responsibilities to the public.” (2)

In the aftermath of Vioxx’s withdrawal, the medical community came to realize that these deaths were largely preventable.

When it withdrew Vioxx, Merck cited internal research and supplemental data from the FDA pointing to increased risk of heart attack and stroke for Vioxx users. The withdrawal announcement claimed that “new, three-year data” from an in-house study had shown that patients taking Vioxx had an elevated risk of suffering cardiovascular events.

Merck’s in-house study did indeed find troubling results, but that is not the whole story. Four years earlier, the Vioxx Gastrointestinal Outcomes Research (VIGOR) study found significantly higher instances of heart attack in test subjects. When the VIGOR trial was published, Merck took exception to the conclusion that Vioxx had caused the increase in heart attacks; it proposed a different explanation for the heart attacks. Between the publication of the VIGOR study in 2000 and the withdrawal of Vioxx in September, 2004, at least four additional studies—enlisting tens of thousands of patients—argued that correlated use of Vioxx with increased risk of stroke and heart attack. At each instance, Merck explained the results by pointing to an intrinsic flaw in the study, and staunchly defended Vioxx’s safety record. Nor did the FDA step in until 2004; it considered the extant studies to provide insufficient data, and justified its inaction by reasoning that it could not take Vioxx off the market until it saw conclusive proof.

Several post-facto meta-analyses have confirmed that Merck and the FDA had access to enough factually sound data to justify withdrawing Vioxx far sooner than late 2004. A November 2004 analysis performed by The Lancet concluded that, “rofecoxib [Vioxx] should have been withdrawn several years earlier.” (3) A 2006 retrospective published in the Journal of the American Medical Association, which tabulated the results of 114 randomized trials comprising 116,094 patients, also found that Vioxx uniquely raised the risk of renal and cardiac problems. Because of the number of patients who took Vioxx, the medical uncertainties involved in heart attacks and strokes, and numerous other mitigating variables, it is impossible to tell how many people died or suffered serious illness due to Vioxx. The best estimate, however, is probably in the “tens of thousands.” (4)

(1) Topol, E. “Failing the Public Health – Rofecoxib, Merck, and the FDA.” New England Journal of Medicine 2004; 351;17: 1707-10.
(2) Ibid.
(3) Juni, P. et al. “Risk of cardiovascular events and rofecoxib: cumulative meta-analysis.” The Lancet 2004; 364: 2021-29.
(4) Karha, J. and Topol, E. “The Sad Story of Vioxx, and What We Should Learn From It.” Cleveland Clinic Journal of Medicine 2004; 71;12: 933-39.

**

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   

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Originally posted to Amitai Etzioni on Mon Nov 19, 2007 at 01:57 PM PST.

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