Back in the mid-1990s, pharmaceutical giant Merck tried to grab a “multi-billion-dollar share of the arthritis and pain-relief market” with its drug Vioxx. You may have heard of it? You probably know of Vioxx not for the billions of dollars it made for Merck but because five years after gaining FDA approval, Merck pulled it off the market because of overwhelming evidence that the drug increased the risk of heart attack and stroke. This was evidence that the company had known about for years but consistently and strenuously fought or downplayed. By the time it was withdrawn, an estimated 1.3 million Americans were taking the drug, as many as 140,000 had experienced serious heart problems, and up to 55,000 people may have died from heart attacks or strokes.
So, what is this now, 2012? Plenty of time for the lessons of Vioxx to sink in. One would think. But apparently, not so much. Today, Merck just agreed to settle a 4-year-old lawsuit brought by Merck shareholders because the company “delayed releasing results on a study of cholesterol drug Vytorin [which] showed the blockbuster pill was no better at reducing plaque buildup in arteries than a cheap generic drug.”
Vytori, vytorin, where have we heard this before? Oh yeah, back in 2009, we told you that Merck and Schering-Plough agreed to a $41.5 million settlement (without admitting any wrongdoing), resolving 140 claims brought by insurers and consumers “who bought, used, or paid money toward the purchase of Vytorin and Zetia” because the companies buried (for about two years) an unfavorable study that showed the companies’ jointly marketed cholesterol drugs, Vytorin and Zetia “were no more effective in unclogging arteries than a pre-existing and less expensive cholesterol treatment[s].” And this settlement came on the heels of a $5.4 million settlement with “attorneys general of 35 states and the District of Columbia for costs incurred in investigating consumer-protection cases involving” Vytorin and Zetia.
Meanwhile yesterday, it was reported that Merck “may face fines after being almost a year late with a post-market study of its diabetes drugs Januvia and Janumet to determine if the pills inflame the pancreas.” Reports Bloomberg,
A letter posted today on the Food and Drug Administration’s website warned a subsidiary of the Whitehouse Station, New Jersey-based company that the diabetes medications are considered misbranded because Merck hasn’t completed a 3-month pancreatic safety study in rodents. Merck agreed to the study to gain expanded approval of the drugs and committed to completing it by March 15, 2011, according to the letter dated Feb. 17.
Back to today’s Vytorin settlement. This one requires Merck’s research division “to report any significant delay in publicly disclosing results of patient studies to the research committee of Merck's board of directors. The committee could then investigate or raise the issue with the full board.”
Yet once again, Merck denies any wrongdoing. Ever, apparently. So we'll see if Merck does better next time, or whether this settlement becomes yet another in the unending “non-teachable” moments contained in the hallowed annals of Merck history.
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