This is the fourth 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) 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 IV: Posicor, A Deadly and Unneeded Drug
When Roche Laboratories withdrew Posicor in June 1998, the hypertension and chest pain medication had been on the market for just under a year. Beginning with an FDA warning in late 1997 (1) and culminating with a stark study published in June in the Journal of the American Medical Association (JAMA) (2), mounting evidence pointed to Posicor as the culprit in hundreds of adverse drug interactions. From cardiac problems to kidney damage to muscle death, Posicor caused other drugs to be retained in the liver, where they built up to deadly concentrations. In all, a total of 26 drugs were found to have potentially lethal interactions with Posicor.
Prior to its approval by the FDA, two major problems presented themselves in the case of Posicor. The first, and most serious, was that Posicor’s effects on the liver were already known and documented. Upon its release to the FDA, as staff writer Ruth SoRelle documents in Circulation, Roche informed the FDA that Posicor could not be used in conjunction with three other medications. (4) Roche knew this from preliminary reports from a 2,400 patient study that was in progress. (5) According to David Willman of the Los Angeles Times, the FDA had a choice: it could wait a year until the completion of the study, or it could begin the approval process. It chose the latter over the objections of several of its most senior scientists, troubled at findings from the study so far, as well as at the drug’s rejection by Swedish authorities due to its perceived risks. Even in 1996, Dr. Shaw Chen, the FDA medical team leader, wrote that existing studies "cast a shadow of potential risk for serious arrhythmias." (5) Similarly, Dr. Lemuel Moye, a member of the FDA’s Cardiovascular and Renal Drugs Advisory Committee, was quoted in 1998 by the New York Times as having been extremely troubled by the extant data. "I could not justify voting for this drug in the presence of a finding which may be a harbinger of danger," he said. (6) "Patients will be taking this in fairly uncontrolled situations in combinations of drugs which have ramifications yet unknown." (7) Chen and Moye were in the minority; the advisory committee voted 5 to 3 to recommend approval of the drug, which the FDA did on 20 June 1997. (The committee’s chairman, following the vote, was hired by Roche to be a public spokesman for the drug.)
On top of the drug’s potentially deadly interactions with other drugs (which, Wellman notes, were buried on the 278th line of the warning label when it was approved), it was not a unique or groundbreaking medication. In fact, it did nothing that other blood pressure or chest pain medications could not already do. A later JAMA study concluded that, "mibefradil [Posicor] could demonstrate no definite additional benefit over existing treatments." (8)
In all, 142 patients who participated in the study to examine Posicor’s effects on congestive heart failure suffered "sudden death," as did a patient in another chest pain study, according to the record from the Cardiovascular and Renal Drugs Advisory Committee meeting in February 1997. (9) Amazingly, this was known even at the time of Posicor’s approval. Outside the studies there are no estimates as to Posicor’s effects. A reporter for the Chicago Sun-Times estimated after Posicor’s withdrawal that 400,000 people worldwide took the drug, including 200,000 Americans. (10)
In a "Dear Doctor" letter circulated by Roche at the time of withdrawal of Posicor from the market, Roche did not note the fatalities, but issued rather general wording on the drug’s safety. It held that the new data made wording of warning labels unduly difficult. To wit: "complexity of such prescribing information [on warning labels] would make it too difficult to implement." (11)
(1) Food and Drug Administration. "FDA Talk Paper: Warning Labeling Changes for New Heart Drug Posicor." 19 December, 1997.
(2) Mullins, Michael E. et al. "Life-Threatening Interaction of Mibefradil and beta-Blockers With Dihydropyridine Calcium Channel Blockers," Journal of the American Medical Association, 280;2, July 1998: 157-158.
(3) SoRelle, Ruth. "Withdrawal of Posicor From Market," Circulation, 98, 1998: 831-832.
(4) Willman, David. "Posicor: 143 Sudden Deaths Did Not Stop Approval," The Los Angeles Times, 20 December 2000.
(5) Ibid.
(6) Stolberg, Sheryl Gay. "Heart Drug Withdrawn as Evidence Shows It Could Be Lethal," The New York Times, 9 June 1998.
(7) Wellman, ibid.
(8) Friedman, Michael A. et al. "The Safety of Newly Approved Medicines: Do Recent Market Removals Mean There Is a Problem?" Journal of the American Medical Association, 281;18, May 1999:
(9) Food and Drug Administration, Center for Drug Evaluation and Research. "Eightieth Meeting of the Cardiovascular and Renal Drugs Advisory Committee." 28 February, 1997.
(10) Neergaard, Lauran. "Heart Drug is Pulled Off Market," Chicago Sun Times, 8 June 1998, 1.
(11) Roche Laboratories. "Voluntary Market Withdrawal All Lots: Posicor 50 mg and 100 mg Tablets." 8 June, 1998.
****
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