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Ed Silverman, Pharmalot.com, April 25th, 2008

Whistleblower Lawsuit Filed Over Baycol Fraud

The suit was brought by Laurie Simpson, a former Bayer strategic research analyst who joined the drugmaker just after the controversial cholesterol pill was launched in 1998, and she accuses Bayer of violating the federal and state False Claims Act. The suit was initially filed in 2006 in US District Court in Newark, New Jersey, and was just unsealed. (WHOOPS: We initially wrote the feds joined the suit, but in fact, the US Attorney has declined to do so.)
The lawsuit alleges that over a three-year period, prior to its withdrawal from the market, Bayer engaged in illegal and deceptive marketing practices in selling the Baycol cholesterol pill, which was later withdrawn due to side effects, predominantly rhabdomyolysis, a severe weakening of the muscles. Numerous death and 1,600 injuries were linked to the drug.
The lawsuit alleges Bayer exaggerated Baycol’s efficacy and safety, downplayed its risks, and concealed info about the drug’s dangers from doctors, the federal government and consumers. The lawsuit claims that Bayer paid kickbacks to doctors and other providers to influence them to prescribe the pill, and alleges that these scrips would never have been written and or paid for by the government had everyone been properly informed. Here is the lawsuit.
Among the evidence cited: A 1997 report by a consulting firm noted that one drug interaction “only kills the drug: ‘Asking for Liabilities,’ ” and that multiple drug interactions would be a ” ‘Competitive Vulnerability (Suicide if it happens).’ ” Then there was a September 1998 meeting in which Simpson noted that Bayer Healthcare ceo David Ebsworth suggested push Baycol more aggressively ‘the legal area is grayer than we treat it,” he allegedly said. And he also said Baycol should be promoted as comparable to Lipitor, which clinical data didn’t support. Don’t stop, there’s more…
There were also key graphs with responder data, some of which was omitted because some patients didn’t respond well to the drug. These were given to sales reps to distribute as non-approved sales material, or ‘homebread bread,’ the very same practice that company policy – written by Ebsworth – prohibited, according to the suit. And sales aids containing risk info was minimized in hard-to-read small type. Bayer execs discussed the possibility the material violated FDA regs, but proceeded anyway because it would take awhile for the agency to find out and new aids could then be in place. An FDA warning letter was issued later.
As part of her job, Simpson gathered adverse events reports for Baycol and other statins and, in her report, noted that Baycol garnered much larger numbers, but she was ordered to remove that info before the report was distributed internally “in case of litigation.” Simpson also alleges Bayer orchestrated a ghostwritten article in the American Journal of Cardiology to allay fears over rhabdomyolysis and that Bayer reorganized its safety team to better control the flow of information about Baycol side effects. There was also a misleading press release and a Dear Doctor letter that downplayed the side effect.
Let’s not overlook an alleged ’switching seed trial,’ in which Bayer budgeted millions of dollars to pay some 3,900 docs to attend seminars in hopes they would boost their Baycol scrip writing. The suit labels these as kickbacks. One of the links below, by the way, has a list of all the docs who attended.
The list of alleged fraudulent moves is lengthy. Feel free to read the lawsuit to soak in the details.

see the complete charge