This is the second 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) 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 it peddles, and continues 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 II: Baycol, risking kidney failure
Bayer withdrew Baycol from the market in August of 2001. At least 1,600 injuries and 52 deaths are linked to this pill treating high cholesterol.(1) Baycol has been found to lead to rhabdomyolysis, the breakdown in muscle fibers leading to their release into the blood. This causes joint pain, fatigue, and muscle weakness, but the key danger is to the kidneys—rhabdomyolysis can lead to kidney failure and death. Seven hundred thousand Americans were among the six million people worldwide who had taken Baycol. By late 2006 Bayer had settled more than 3,000 lawsuits regarding Baycol, costing $1.2 billion. Over 2,000 cases were still pending.
Bayer continued to market Baycol, although it had received warning about its ill effects as early as 1999. In the spring of 2000 Bayer compared adverse event reports of Baycol to those of the industry leader, Lipitor. Bayer found that in Baycol cases there were 20 times more reports of rhabdomyolysis than with Lipitor. (2) Baycol also compared unfavorably with its peers Mevacor, Zocor, Lescol, and Lipostat (3) ; this spring 2000 study, highlighting the risks of rhabdomyolysis associated with Baycol, was in line with reports the company had received in 1999. (4)
Bayer did not disclose the results of the spring 2000 study to doctors or to the FDA; instead Bayer decided the issue needed further study. (5) Bayer would later argue that the spring 2000 study was based on unreliable data and that it was unscientific. Bayer made these arguments, questioning the reliability of their own study, despite the fact that their internal memos from mid-2000 indicate ongoing concerns about the incidences of rhabdomyolysis caused by Baycol.
Bayer also continued to seek FDA approval for the marketing of an even higher Baycol dosage, 0.8 milligrams (Bayer began selling Baycol in 1997 with doses of 0.3 milligrams, and in 1999 Bayer received FDA approval for a 0.4 milligram pill). Bayer’s goal was to move from 5% to 15% of the market with this higher 0.8 milligram Baycol dose. (Bayer had found higher dosages of Baycol garnered better cholesterol reduction results in comparisons with competitors’ drugs.) Baycol was a key component of Bayer’s strategy for the cholesterol-lowering drug market. They that hoped Baycol sales would exceed $1 billion a year, making it a "blockbuster" drug in industry terminology. In July of 2000 the FDA approved the stronger pill.
In November 2000, Bayer’s analysis of reported side effects of Baycol showed 5-10 times more likelihood of rhabdomyolysis in Baycol than its competitors. Again, Bayer decided the issue needed further study. By the spring of 2001, the FDA had seen a rapid increase in Baycol-related deaths. (6) Bayer responded with a study that, minimized the problems with Baycol, as the FDA found. (8) Bayer withdrew Baycol in August 2001.
In 2003 an FDA official explained, "When a company becomes aware of a specific problem with their drug, they come to us; that’s our expectation." Also in 2003, Dr. Leo Lutwak, a former FDA drug reviewer, described the system:
"The FDA is wholly dependent on trust, on trusting that the company is providing all the truth, all the time, that the company is not hiding information, the company is not covering up information, the company is not changing information."
(1) Melody Petersen and Alex Berenson "Papers Indicate That Bayer Knew of Dangers of Its Cholesterol Drug" New York Times, February 22, 2003
(2) "Dangerous Prescription" Frontline (Link)
(3) Scott Williams, "The cholesterol drug Baycol—an example of the Drug industry (Link) (accessed 8/1/2007)
(4) Melody Petersen and Alex Berenson "Papers Indicate That Bayer Knew of Dangers of Its Cholesterol Drug" New York Times, February 22, 2003; Melody Petersen "Bayer Official Offers Defense in Texas Trial of Drug Suit" New York Times, March 1, 2003
(5) Melody Petersen "Bayer Official Offers Defense in Texas Trial of Drug Suit" New York Times, March 1, 2003
(6) Melody Petersen and Alex Berenson "Papers Indicate That Bayer Knew of Dangers of Its Cholesterol Drug" New York Times, February 22, 2003
(7) "Dangerous Prescription" Frontline (Link)
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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