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› $4.85 Billion settlement in drug case
The U.S. Food and Drug Administration announced today that it found no clear link between Merck’s blockbuster cholesterol drug Vytorin and increased risk of cancer, but it could not rule out the possibility that such a link exists. The agency reviewed data from three Vytorin trials, including the controversial SEAS trial results, which Merck had withheld from the public for 18 months as it aggressively marketed the drug.
Merck and Schering-Plough, the pharmaceutical giants whose joint venture produced the blockbuster cholesterol drug Vytorin, agreed to pay $41.5 million to settle 140-plus New Jersey lawsuits lodged against the manufacturers for misleading and improper marketing of the drug and for withholding the results of a clinical trial that showed Vytorin to be a dud.
Remember those Vytorin commercials with the split screen, comparing people to food? Aunt Barbara on the left and some tacos on the right? Mildly entertaining though they were, those ads underscore a big problem with the promotion of new pharmaceuticals. Evidence suggests that Vytorin’s manufacturers, Merck and Schering-Plough, promoted and sold the anti-cholesterol drug for nearly 2 years despite known clinical trial results that strongly suggested Vytorin to be no more effective than cheap, generic statin drugs.
For a while it seemed as if sales of Merck’s blockbuster anti-cholesterol drug Vytorin would plummet into oblivion. Unfavorable and botched ENHANCE trial results, harrowing SEAS trial results, lawsuits filed on behalf of individuals and government, congressional inquiries, and so on plagued Merck and co-creator Schering-Plough because it looked as if Vytorin was at best a dud and at worst a cancer-inducing danger.
Controversy surrounding the cholesterol-fighting drug Vytorin continues to escalate as federal and state prosecutors investigate Merck and Schering-Plough’s marketing of the drug. According to an article in the Wall Street Journal, many government officials suspect that the companies’ marketing of Vytorin was misleading and improper.
Cholesterol-fighting medicine may fail some people, as the controversial and embattled drug Vytorin illustrates, but now medical technology provides a solution for those who just can’t lower their cholesterol any other way: a low-density lipoprotein (LDL) apheresis machine.
Clinical trials haven’t been kind to Vytorin, Merck and Schering-Plough’s cholesterol brainchild. The first blow was dealt by the ENHANCE study, which showed Vytorin to be no more effective than much cheaper generic statins. Next came results of the SEAS trial, which indicated a link between Vytorin and risk of cancer and death by cancer. A flurry of disputed interpretations, accusations, and controversy followed in the wake of the trials.
Should municipalities be allowed to reclaim the money it spent on expensive prescriptions if the prescribed drug turns out to be a dud? For the city of New Haven, CT, the answer is yes. According to a report in the New Haven Independent , the city’s top lawyer, John Ward, wants more than $400,000 back from Vytorin manufacturers Merck and Schering-Plough.
Does Vytorin increase the risk of cancer death? The question seems like it would be simple to answer, yet finding the answer requires navigating through a murky labyrinth of botched test results, apparent cover-ups, possible payoffs, and a whorl of conflicting interpretations that sometimes resemble self-interest, sometimes truth, depending on whom you ask.
The cholesterol-fighting drugs Zetia and Vytorin, blockbuster drugs that once represented multi-billion dollar sales for Schering-Plough and Merck, now seem to be squeezing the pharmaceutical giants.
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