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At its core, the 55-page whistleblower lawsuit unsealed Friday in U.S. District Court in Philadelphia makes one stunning allegation – that pharmaceutical giant Merck traded children’s health to protect monopoly profits, and engaged in a systematic, elaborate, and ongoing fraud to do so.
If the charges – which Merck denies – are true, a 12-month-old child getting a recommended shot containing the mumps vaccine at their pediatrician’s office this morning would not be adequately protected from the disease, and could face serious health complications down the road as a result.
The alleged fraud: a multi-year effort to hide the fact that the mumps vaccine is no longer anywhere near as effective as Merck claims. The project was widely known and approved within the company’s vaccine division and even had a name, Protocol 007, according to the two former Merck scientists who filed the suit more than two years ago under the federal whistleblower statute. Virologists Stephen A. Krahling and Joan A. Wlochowski claim they witnessed the fraud firsthand when they worked at the Merck vaccine laboratory in West Point, Pennsylvania, between 1999 and 2002, and were pressured to participate...
...The suit describes Merck’s allegedly no-holds-barred effort to protect its market position. “Merck set out to conduct testing of its mumps vaccine that would support its original efficacy finding. In performing this testing, Merck’s objective was to report efficacy of 95 percent or higher regardless of the vaccine’s true efficacy. The only way Merck could accomplish this was through manipulating its testing procedures and falsifying the test results. … Krahling and Wlochowski participated on the Merck team that conducted this testing and witnessed firsthand the fraud in which Merck engaged to reach its desired results. Merck internally referred to the testing as Protocol 007.”
the medical literature related to Vioxx suggests an even more onerous possibility, which is that Merck intentionally designed its studies to avoid discovering the truth about the potential C.V. risks of Vioxx. I have not been privy to the company’s private staff meetings and internal documents. But it has been my experience that undertaking any major research study involves extensive consultation between experts in all pertinent fields, including pharmacologists, epidemiologists, statisticians and business managers. Given the enormous intellectual investment in the design of a drug like Vioxx, it is reasonable to presume that all potential outcomes were seriously entertained. I must presume that Merck would factor in what might happen to Vioxx sales with each study result. And so it’s hard to escape the sadly cynical conclusion that the company consciously crafted its tests to avoid exposing the risks of Vioxx to the public.