› $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.
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.
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.
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.
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.
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.
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.
Today in Munich, Germany, researchers presented all of the data from the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) study to the European Society of Cardiology. The SEAS study roused concern back in July when researchers revealed a possible link between cancer and the Zetia half of Vytorin.
