GlaxoSmithKline Plc (GSK) agreed to plead guilty and pay $3 billion to resolve criminal and civil allegations that it illegally promoted prescription drugs and failed to report safety data, the U.S. said.
The settlement, the largest-ever in a health-care fraud case in the U.S., includes a criminal fine of $956.8 million, the Justice Department said today. London-based Glaxo will also forfeit $43 million, the U.S. said.
GSK will plead guilty to marketing the drugs Paxil and Wellbutrin for uses not approved by the U.S. Food and Drug Administration and for failing to report clinical data on Avandia, federal prosecutors said. The company has agreed to admit to the charges, which are misdemeanors, according to filings today by the U.S. in federal court in Boston…read more
Martin Winn’s cholesterol level was inching up. Cycling up hills, he felt chest pain that might have been angina. So he and his doctor decided he should be on a cholesterol-lowering medication called a statin. He was in good company. Such drugs are the best-selling medicines in history, used by more than 13 million Americans and an additional 12 million patients around the world, producing $27.8 billion in sales in 2006. Half of that went to Pfizer (PFE) for its leading statin, Lipitor.
Statins certainly performed as they should for Winn, dropping his cholesterol level by 20%. “I assumed I’d get a longer life,” says the retired machinist in Vancouver, B.C., now 71. But here the story takes a twist. Winn’s doctor, James M. Wright, is no ordinary family physician. A professor at the University of British Columbia, he is also director of the government-funded Therapeutics Initiative, whose purpose is to pore over the data on particular drugs and figure out how well they work.
Just as Winn started on his treatment, Wright’s team was analyzing evidence from years of trials with statins and not liking what it found….read the rest
Posted in Diet and Nutrition, Diseases, Drugs, Health & Fitness, Medicine, Survival
Tagged cholesterol, drug companies, lipids, lipitor, Merck, mevacor, zocor
By LAURAN NEERGAARD, AP Medical Writer
WASHINGTON – The government is questioning if too many of the wrong people will take cholesterol-lowering Mevacor if it’s sold without a prescription, days before Merck & Co. makes its third try to move the drug over the counter.
Merck says selling a low dose of this long-used medication on drugstore shelves, next to the aspirin, could get millions of people at moderate risk of heart disease important treatment that they otherwise may miss.
A preliminary Food and Drug Administration review released Tuesday agreed that nonprescription Mevacor would be “a reasonably safe and effective” option — if consumers used it as directed.
But when Merck tested if consumers could judge who was a proper Mevacor candidate, only 20 percent answered all the questions completely correctly — 50 percent if researchers counted people who said they’d check some things with their doctor before purchasing, concluded FDA‘s lead medical reviewer.
Moreover, about 30 percent of people who already were diagnosed with heart disease, diabetes or had had a stroke wanted to purchase over-the-counter Mevacor, people who need a doctor’s care, the FDA documents say.
The studies “have not convinced this reviewer that there is adequate consumer comprehension of the proposed product label to ensure safe and effective use of this product,” the preliminary assessment concluded.
Merck argues that most people made the right decision on whether they should buy OTC Mevacor even if they missed some answers.
On Thursday, Merck will present its case to the FDA’s independent scientific advisers, hoping they will recommend that Mevacor become the first in the family of cholesterol-lowering “statin” drugs to be sold in this country without a prescription. Twice before, FDA has said no.