Through the late 1990’s a number of major pharmaceutical companies, including Merck and Pfizer, began to develop a new kind of pain relief drug. At the time, the only drugs available to deal with arthritis and other similar kinds of pain were drugs like aspirin or ibuprofen. The problem with these drugs is that they had serious side-effects, including causing stomach problems such as ulcers and bleeding. Essentially these older drugs worked too indiscriminately by going after two enzymes in the body: one of these enzymes causes swelling and arthritis (COX-2), but the other one, COX-I, protects the lining of the stomach. Research was focused on finding a new drug which would attack the problematic enzyme (COX-2) without negatively affecting the beneficial properties of COX-I in protecting the stomach. The race was on to develop and patent a COX-2 inhibitor for pain relief.
By 1999, both Pfizer and Merck had independently developed separate but similar COX-2 inhibiting drugs, and had spent the millions of dollars necessary to fund the extensive serious clinical trials which had led to government approval in the U.S (and approval of the various equivalent bodies in nations around the globe, including Health Canada approval in Canada). In fact Pfizer was able to bring its COX-2 inhibitor, which it called “Celebrex” to market first. By this point, both companies had spent millions in developing their drugs, and both then began spending millions more in advertising the drug directly to the public.
(In Canada, advertising prescription drugs directly to the public is illegal; however, since Canadians watch American television broadcasts, they too see such advertisements.)
Although Pfizer had an initial head start in marketing, both Merck’s Vioxx and Pfizer’s Celebrex, have subsequently sold extremely well since. In 2003, Vioxx sold US $ 2.5 billion world-wide, representing 11% of Merck’s revenue. Similarly Celebrex sold US $2.3 billion.
Between 1999 and 2003, both drugs had been subject to a number of Adverse Drug Reaction (ADRs) reports from physicians whose patients were using these COX-2 inhibitors. Many of the reports focused on increased risk of heart-attack. Merck funded studies of these side-effects from Vioxx. It’s September 2004 and you, R. Gilmartin, have just received the results of a study of long-term side effects, specifically increased risk of heart-attack, from Vioxx use. It seems that after 18 months of use, there is substantial increase in the risk of heart attack and stroke for Vioxx users, compared to a control group. Vioxx appears to have caused up to 140,000 additional
cases of serious heart disease in the U.S. alone, of which 44% were fatal. This gives you serious concern about continuing to market the drug. After all, there are other (older) therapies for arthritis-like pain such as aspirin, and patients may well be much better off with the more benign side effects of aspirin, such as risk of damage to the stomach lining, than they are with the side effects of the COX-2 inhibitors, which includes risk of heart attack and stroke.
One consideration is the nature of the study which showed Vioxx-users with increased risk. It could be possible to argue that the increased risk of heart attack and stroke is NOT caused by Vioxx, since the study was not carefully controlled for other factors such as high blood pressure, smoking and raised cholesterol. You have the option of repeating the study with more careful controls, and this could buy you at least another profitable 18 months with Vioxx on the market. However, your own conviction is that leaving Vioxx on the market would probably lead to more heart attacks and strokes among Vioxx users during those 18 months. However you also know that Vioxx has been a much more successful pain killer for millions of arthritis victims than any other alternative, and that taking Vioxx off the market will cause great additional suffering for these
individuals. In addition, the label on Vioxx already indicated that there was a slight cardiovascular (heart) risk in taking the
medication.
Another consideration is what Pfizer will do with Celebrex. Since the study in question was specific to Vioxx, Pfizer may take
the position that there’s no evidence that Celebrex leads to increased risk of heart attacks and strokes. If you take Vioxx off
the market, and Pfizer does not follow suit with Celebrex, Pfizer will likely gain windfall profits as many of your current
customers, switch to Celebrex. You know that these two COX-2 inhibiting drugs are very similar, and that it’s very likely
Celebrex will ultimately be shown to have exactly the same side effects as Vioxx.
What will be the rations choice decision? Which will be the bounded rational decision? Provide an overall moral
judgment based on your own personal opinion.
