As Whitehouse Station, NJ-based Merck announces its purchase of Kenilworth, NJ-based Schering-Plough who remembers that it was a Merck/Schering-Plough combo that brought us Vytorin?
No one outside the scientific community had heard the term "surrogate endpoint" before Vytorin--a cholesterol drug that combined Merck's statin drug Zocor (simvastatin) with Schering-Plough's anti-hyperlipidemic drug Zetia (ezetimibe)--was marketed in 2004.
But it soon came to mean "the sun-was-in-my-eyes" as Merck/Schering-Plough sat on a Vytorin efficacy study for over a year tampering with its endpoints until Congress said time's up in 2008. Surprise! Vytorin was no better at unclogging arteries than generic simvastatin at a fifth of the cost.
In fact Vytorin was so worthless, Sen. Chuck Grassley (R-Iowa) asked the General Accounting Office to investigate why the FDA would approve a drug to reduce artery-clogging plaque that doesn't reduce artery-clogging plaque.
Congressmen Bart Stupak (D-MI) and John Dingell (D-MI) asked why Schering-Plough executive VP Carrie Smith Cox unloaded $28 million stock between the end of the stonewalled study and release of its results. (Maybe her stint at fen phen and HRT plagued Wyeth taught her when to head for the exits.) And why the brat pack drug reps on Cafepharma seemed to know about the study's results before the government!
States had questions of their own--especially as Schering-Plough paid $31 million to Missouri in 2008 for bilking Medicaid with a different drug three years earlier. Who can say incorrigible?
And New York Attorney General Andrew Cuomo wondered whether the $21 million his state paid for Medicaid Vytorin prescriptions in only two years was Vioxx all over again as he sought to recoup $100 million from the first Merck scandal.
And it got worse. A second Vytorin study testing the drug's effectiveness in aortic stenosis showed Vytorin worthless in preventing aortic-valve and cardiovascular events but with a macabre dividend: it increased the chances of getting and dying from cancer.
When the study results were integrated with two others trials, Vytorin only increased the risk of dying of cancer not getting it--whew!--and the FDA sounded an all-clear. But the New England Journal of Medicine (NEJM) said a cancer risk could not be discounted in a Sept. 2008 editorial.
The Vytorin scam came less than four years after the Vioxx scam in which Merck's superaspirin taken by 20 million was withdrawn from the market for doubling heart attack and stroke risk in 2004.
Court documents show that Merck researchers were well acquainted with Vioxx's "cardiovascular events" when they supplied the NEJM with phony heart attack data for the 2000 article that led to led its popularity and medical credibility. Oops
No wonder the NEJM filed a supporting brief in the recent Supreme Court Wyeth v. Levine case,
Who realizes today that up to 139,000 people had heart attacks and strokes on Vioxx and 50,000 died? Think ten Iraqs or one Vietnam.
Nor did Fosamax (alendronate) Merck's bone wonder drug have a happy ending.
Despite Merck's "awareness" campaign which increased the diagnosis of osteoporosis sevenfold thanks to bone density measuring machines planted in doctors' offices, Fosamax was found to cause esophageal cancer, osteonecrosis (jaw bone death) and the very fractures it was supposed to prevent. It was listed on the FDA's second quarterly Potential Signals of Serious Risks list. (See: forgiveness easier than permission)
Singular, Merck's asthma drug is also on the ropes for suicidal side effects and parents are saying you want us to vaccinate our daughter with WHAT about its $400 cervical cancer drug Gardasil. (Who do you think paid for all the HPV "awareness" campaigns?)
Many are saying the drug companies need a new business model, having dealt themselves out of the game with their crash-and-burn blockbusters and with third party and Medicaid benefits managers saying "you've got to be kidding" about extravagant patent drugs.
Nor will they be shielded from law suits because they have FDA approval thanks to March's Wyeth v. Levine ruling.
Will patients pay hundreds for the vaccines and biologics which drug companies hope will become their new gravy train? If they say Trust Us?