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Strategies & Market Trends : John Pitera's Market Laboratory

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To: mad_one who wrote (19465)6/26/2017 2:27:22 PM
From: mad_one4 Recommendations

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John Pitera
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Vioxx may have set records!

“Merck has agreed to pay $950 million and has pleaded guilty to a criminal charge over the marketing and sales of the painkiller Vioxx,” the New York Times reported Nov. 23 …

? ?The FDA had initially approved Vioxx (after a hasty “priority review”) in May, 1999 to treat osteoarthritis, acute pain, and menstrual cramps. By September 30, 2004, when Merck announced its “voluntary recall,” some 25 million Americans had been prescribed the widely hyped drug. Evidence that using Vioxx doubled a patient’s risk of suffering a heart attack or stroke —based on a review of 1.4 million patients’ records— was about to be published in Lancet by David Graham, MD, an FDA investigator. The FDA director’s office, devoted valet of Big PhRMA, had contacted the Lancet in a futile effort to stop publication of their own scientist’s findings.


? ?Graham’s data indicate that 140,000 Americans suffered Vioxx-induced heart attacks and strokes; 55,000 died, and many more were permanently disabled. The Merck executives’ real crime was conspiracy to commit murder … An early clinical trial had alerted them to the fact that Vioxx caused coronary damage. Their response was to exclude from future trials anyone with a history of heart trouble!

? ?Once Vioxx was approved, Merck spent more than $100 million a year advertising it … Sales hit $2.5 billion in 2003. And when brave Dr. Graham first presented his irrefragable evidence to an FDA advisory committee in February 2004, Merck argued that the “unique benefits” of Vioxx warranted its remaining on the market. The FDA committee voted 17-15 to keep it available with a black box warning. Ten of the 32 committee members had taken money from Merck, Pfizer or Novartis (which were pushing drugs similar to Vioxx) as consultants. If these MDs had declared their conflicts of interest, Vioxx would have been pulled from the market by a vote of 14-8. By buying an extra seven and a half months, Merck made an extra billion or two, and killed 6,000 more Americans.

? ?Worldwide, Vioxx was used by 80 million people. Assuming their dosages were similar to the 1.4 million Kaiser Permanente patients whose records Dr. Graham analyzed, the death toll exceeds 165,000.” (Merck Pays a Pittance for Mass Deaths, Fred Gardner, CounterPunch)
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