US Regulators Reject New Merck Drug
US Regulators Reject New Merck Drug and Impose Restrictions on Future Marketing
By Martha Rosenberg
Even as Merck seeks closure on its Vioxx nightmare by paying $4.85 billion to tens of thousands of plaintiffs who took the painkiller--not that it did anything wrong--the bad ink continues.
Articles about Vioxx, withdrawn from the market in 2004 for doubling stroke and heart attack risk, in the April 16, 2008 JAMA charge Merck disguised mortality data it submitted from Vioxx trials to the FDA and wrote the scientific papers itself it claimed were penned by doctors.
Merck transposed its own clinical study results of 34 deaths in the Vioxx group and 12 in the placebo group to 29 deaths in the Vioxx group and 17 in the placebo group when it submitted data to the FDA write Bruce Psaty, MD, PhD; and Richard Kronmal, PhD, professors at the University of Washington in JAMA. Worse, Merck knew as early as 2001 that participants in Vioxx trials who had Alzheimer's disease were dying at three times the rate of those taking placebo.
Articles extolling Vioxx as the new, Super Aspirin were also a product of Merck machinations says another article in JAMA. They were actually ghostwritten from Merck's own research with doctors' "guest author" names attached as an afterthought write Joseph S. Ross, MD, MHS, Kevin P. Hill, MD, MHS and two other authors on the basis of 250 court documents they examined.
In fact this week Merck's ghostwriting was actually banned as part of a new, $58 million multistate settlement over deceptive Vioxx marketing--in addition to the $4.85 billion it is paying to plaintiffs--that also requires Merck submit future TV commercials to the FDA before airing.
Merck marketing, with Schering-Plough, of Vytorin, the cholesterol drug exposed as no more effective than generics in January, is also under scrutiny in a House Energy and Commerce Committee investigation.
In fact it was the investigation, begun in December 2007, that pried loose the results of the Enhance study which Merck and Schering-Plough were sitting on since April 2006-- despite clearance from their consultant Michiel Bots--while they tried to change end points apparently to spin the data and unloaded Schering-Plough stock, say published reports.
"I would like for the companies to explain why they didn't proceed with data analysis after Dr. Bots' independent consultation report indicated the data were 'fine,'" Rep. John Dingell (D-Mich.), chairman of the committee, said to The Star-Ledger.
In May, a House Energy and Commerce subcommittee hearing into deceptive drug industry marketing also looked at Merck's multimillion dollar Vytorin campaign--the drug targeted "cholesterol from two sources: food and family" claimed the ads--in light of the suppressed Enhance study results.
"Many consumers may not have taken Vytorin had they been aware of the study results," said Rep. Bart Stupak (D-Mich.) to Deepak Khanna, senior vice president of the Merck and Schering-Plough joint venture, according to The Star-Ledger.
Nor are other Merck drugs doing well.
Fosamax, Merck's osteoporosis drug, was already facing more than 100 suits for causing osteonecrosis of the jaw or jaw bone death--added as a warning to its label in 2005--when a new wrinkle emerged. Women who took Fosamax were twice as likely to have atrial fibrillation, a chronically irregular heartbeat, as those who didn't says an article in the April 28, 2008 Archives of Internal Medicine, echoing a New England Journal of Medicine article last year.
And Singulair, Merck's allergy and asthma pill, is under FDA review for possible suicide side effects.
But even as jokes appear about the number of Merck staffers required to change a light bulb--10 to call it a breakthrough, 10 to conference call Wall Street, 10 to suppress evidence it's been done before and more safely and one to change the bulb--Merck is repeating its mistakes.
In April, it tried to launch a new cholesterol drug, Cordaptive, that combines niacin, a B vitamin which raises HDL but causes facial flushing with laropiprant, an anti-flushing drug, without waiting for study results, like it did with Vytorin.
Not only did the company want to start marketing before safety studies were completed and while admitting "theoretical" safety concerns about the drug’s effect on liver according to the The Star-Ledger, this week Merck abruptly halted a 900 patient laropiprant study altogether and many are asking why.
"I am concerned whether the reasons for terminating this trial are commercial or scientific," said Dr. Steve Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, according to the Associated Press.
Nor is the science behind Cordaptive--that raising HDL, or good cholesterol will result in fewer heart attacks and strokes--reliable, says The Star-Ledger's George E. Jordan.
"The utility of biomarkers was turned on its ear in a study of GlaxoSmithKlein's diabetes pill Avandia, which found it lowered blood sugar in patients but resulted in elevated heart risks," he writes. "Vytorin dramatically reduced LDL, but it worked no better at clearing clogged arteries than a generic drug five times less expensive."
No wonder the FDA rejected Cordaptive out of hand, in April causing Merck to cut 1,200 sales jobs and add to its anti-fan club.
Merck didn't even do simple market research. Vitamin and drug stores have been selling flush free niacin for years. A bottle costs about $9.95. END