Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

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.

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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.

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Many Americans assume that the Food and Drug Administration adequately tests new drugs for safety before they go on the market and become available to the general population. If your doctor prescribes a new drug to help you lower your cholesterol or help you quit smoking, then that drug must be safe, right?

The answer is a surprising, and disconcerting, NO.

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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.

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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.

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Global sales of Vytorin fell 18 percent, while sales of Zetia dropped by 12 percent in the third quarter. The loss of sales revenue from the two drugs, combined with difficult economic conditions worldwide, have led drug maker Merck to announce that it will cut its workforce by 12 percent.

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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.

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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.

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Following Vytorin’s recent fall from its blockbuster status, Merck is ratcheting up studies of its new cholesterol fighting drug, The Washington Times reported.

MK-0524A, as the new drug is called, is the subject of a study based in Oxford University in England. Merck submitted the drug to the FDA for approval, but it was rejected last April. The FDA wanted results from the study known as THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) before it made another ruling.

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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.

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