This is the fifth 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 next installment. See previous postings here: Part I: Zyprexa, Part II: Baycol, Part III: Guidant, Part IV: Posicor.) 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.
Case V: Redux And The Fen-Phen Catastrophe
In the wake of two major internal studies, the makers of the diet pill Redux, Wyeth-Ayerst Laboratories, withdrew the drug from the market in September 1997, along with Pondimin, a related drug. The withdrawal came as it was becoming clear to the FDA and doctors nationwide that patients (mostly women) taking Redux were developing serious – and often fatal – medical problems. Today these drugs have become synonymous with lethal – and legal – prescription drugs.
In April 1996 the FDA approved a diet pill for sale in the United States. It was the first time in decades that such a drug was made available in the U.S., and demand was enormous. Redux, as the drug was called, was often paired with another weight-loss drug, and the resulting cocktail was known as "fen-phen."
When Redux came to the FDA for approval, it had already triggered safety concerns several years prior in Europe. In 1992 the U.K. Committee on Safety of Medicines advised doctors not to prescribe dexfenfluramine [Redux] for more than three months, due to the risk of primary pulmonary hypertension (PPH), a lethal and incurable condition of the heart and lungs. (1) Similarly in 1992, a letter in The Lancet linked PPH and dexfenfluramine. (2) In 1996, shortly after the drug’s approval, the New England Journal of Medicine reported a French study that showed a 23-fold increase in the likelihood of developing PPH when fenfluramine was taken for more than three months. (3) And in a lawsuit brought in the aftermath of the fen-phen crisis, the plaintiffs charged that Wyeth knew, as early as 1994, of 41 cases linking PPH and Pondimin, but disclosed only 4 in the drug’s warning label. After Redux and Pondimin were pulled from the market, extensive studies confirmed their causative role not only in PPH, but also in potentially deadly heart valve defects.
Given the uncertainty that surrounded Redux, a September 1995 FDA advisory panel voted 5-3 not to recommend Redux, citing its safety which was "not sufficient to warrant approval," noted David Willman in the Los Angeles Times. (4) In a highly unusual move, the FDA scheduled a second meeting two months later, where the drug was approved 6-5. The FDA subsequently rejected a proposal to "black box" Redux, which would have given it a prominent warning label advising of its possible side effects. Dr. Leo Lutwak, the chief FDA medical officer in charge of reviewing Redux, accused the FDA of ignoring his warnings and accepting at face value Wyeth’s assurances that the drug was safe. (5)
In a notice to the public explaining the recall, the FDA pointed to a July 1997 Mayo Clinic report that strongly linked fen-phen with heart valve damage. Using language like "recently" and "within the last several weeks," the FDA withdrawal memo pointed to concerning studies that called into question Redux and Pondimin’s safety. (6)
Yet the evidence compiled by the scientific and legal community in follow-up studies, ongoing investigations, and tens of thousands of class-action suits against Wyeth overwhelmingly shows that fenfluramine (Pondimin) and dexfenfluramine (Redux) had raised red flags on numerous occasions in the past, primarily in several European studies and field observations (Alfred Fishman noted in Circulation that the first linkages of fenfluramines and dangerous side effects dated back to the 1980s.) (7) Equally troubling, the FDA approved Redux over the objections of several of its own experts using an unusual second advisory panel.
How many people died as a result of these drugs? To date, Redux has been directly implicated in 123 deaths, but the real – and uncounted – total is certainly far higher. It is estimated by Wyeth that before their recall, over 6 million Americans took Redux or Pondimin. Although the FDA initially stated that Redux and Pondimin accounted for a 1 in 25,000 chance of developing PPH, subsequent studies have suggested that number may be higher, possibly as great as 1 in 3,500. A 1998 study published in the New England Journal of Medicine found that 22.7% of patients exposed to these diet drugs developed heart valve abnormalities. (8) Between the PPH and the valvular heart defects, it is possible that hundreds – and possibly thousands – of people have died as a result of these drugs.
(1) Sukkari, S. "Weighing Benefits and Risks of Drug to Treat Obesity," Canadian Medical Association Journal, 156(6), March 1997, 768.
(2) Roche, N. et al. "Primary Hypertension and Dexfenfluramine," The Lancet 339;8790, February 1992, 436.
(3) Abenhaim, L. et al. "Appetite-Suppressant Drugs and the Risk of Primary Pulmonary Hypertension," The New England Journal of Medicine, 335;9, August 1996, 609-616.
(4) Willman, David. "Redux: Unheeded Warnings on Lethal Diet Pill," The Los Angeles Times, 20 December 2000.
(5) Ibid.
(6) U.S. Food and Drug Administration, Center for Drug Evaluation and Research, "Questions and Answers about Withdrawal of Fenfluramine (Pondimin) and Dexfenfluramine (Redux), accessed at <http://www.fda.gov/cder/news/phen/fenphenqa2.htm> 4 April 2007.
(7) Fishman, Alfred P. "Aminorex to Fen/Phen: An Epidemic Foretold," Circulation, 99, 1999: 156-161.
(8) Khan, Mehmood A. et al. "The Prevalence of Cardiac Valvular Insufficiency Assessed by Transthoracic Echocardiography in Obese Patients Treated with Appetite-Suppressant Drugs," New England Journal of Medicine, 339;11, 1998: 713-719.
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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