Assignment

Discovered in a Merck lab in 1994, the drug was one of a new class of painkillers called COX-2 inhibitors, which reduce pain and inflammation without the side effects-ulcers and gastrointestinal bleeding-that painkillers such as ibuprofen can cause. Vioxx worked beautifully in clinical trials with arthritis patients and was approved by the FDA in 1999. Edward Scolnick, president of Merck Research Labs, even let it be known that he was taking Vioxx himself for back pain.

But in September 2004, Merck removed Vioxx from the market after a study found a higher rate of heart attacks and strokes in patients taking the drug. Vioxx, on the market for five years, had been marketed in 80 countries with worldwide sales totaling $2.5 billion in 2003. When it was pulled from the market, 2 million Americans were taking Vioxx.

The pharmaceutical industry was astonished that the well-respected company had marketed a drug known to cause higher rates of cardiac events. Almost 20 years earlier Merck established a reputation for social responsibility by donating a treatment for river blindness to patients in developing countries.

Still more shocking was the admission that as far back as 1998 Merck knew the drug had problems. Even before FDA approval, researchers outside Merck had found evidence that it might increase the risk of a heart attack. In 1998 a group at the University of Pennsylvania discovered that COX-2 inhibitors interfere with enzymes thought to ward off cardiovascular disease. A 2001 study testing the drug against nonprescription naproxen showed that Vioxx was safer than naproxen, but it also found that Vioxx doubled the risk of cardiovascular problems. Merck put a positive spin on the data, highlighting the lower risk of side effects, not the cardiac complications.

The FDA mandated that Merck note a possible link to heart attacks and strokes on Vioxx's label. At the time, Merck was spending more than $100 million a year on direct-to-consumer advertising building the "blockbuster" status of the drug.

Merck continued to minimize the problems up until a month before withdrawing the drug. The deathblow to the drug was the results of APPROVe, a database analysis of 1.4 million patients. Ironically, this study was designed to test whetherVioxx reduced the risk of colon polyps. Instead, it showed that patients who took the drug for at least 18 months had double the risk of heart attacks and strokes as those who took the placebo. For a few weeks, Merck focused on the fact that it took 18 months for Vioxx to cause problems. However, Merck researchers continued crunching the data and concluded that the safety window might be as little as three months.

The researchers who told Merck CEO Ray Gilmartin about the APPROVe results pointed out that the company was under no obligation to recall the drug. Merck could take the data to the FDA and have the labeling changed. In fact, the majority of outside clinicians whom Merck consulted in the first few days suggested it do just that, since there were millions of people who were benefiting from Vioxx and not getting heart attacks. But Gilmartin decided that withdrawing the drug was the responsible thing to do.

Since the drug was withdrawn, investigators have linked Vioxx to more than 27,000 heart attacks or sudden cardiac deaths nationwide from the time it came on the market in 1999 through 2003. Over 11,000 lawsuits have been filed against Merck.[i]

Questions

1) If Merck can donate $50 million in free doses of ivermectin, what does that say about the amount of revenue the company generates in the drug research and distribution industry?

2) In the case of Vioxx, known serious side effects were being reported and yet the company was slow to suspend or remove the drug from the market. What does this say about the approval process of drugs to the market and why companies would be reluctant to give up the revenue stream for a commonly used drug like Vioxx?

3) Merck finally pulls Vioxx from the market and has 11,000 lawsuits to handle. How would you feel if you were the company president and you were a known name and face of a company that was responsible for the stroke or heart attack of a past user of the drug?