Vioxx Example Vioxx: Ethical Questions

Vioxx Example

Vioxx: Ethical questions

Vioxx was a drug originally marketed to patients suffering from chronic pain, often as a result of arthritis. It was designed to be more effective than traditional remedies, such as the non-steroidal anti-inflammatory (NSAID) ibuprofen. Ibuprofen is often found marketed under the brand names of Motrin or Advil. Initial results suggested that Vioxx was only mildly more effective than NSAIDs, although responses to different drugs' palliative effects can be highly individualized. Vioxx was one of a number of drugs which were known as COX-2 inhibitors. They were widely marketed not just to physicians, but also directly to consumers through magazine and television advertisements.

The mechanisms behind the COX-2 inhibiter drugs were as follows: "The most commonly prescribed class of drugs that includes aspirin, ibuprofen and other NSAIDs (non steroidal anti-inflammatory drugs) work by blocking an enzyme called cyclooxygenase (COX). There are two forms of the enzyme, COX-1 and COX-2. COX-1 is expressed in lots of cells all the time, notably the lining of the stomach, where it regulates acid production. COX-2, on the other hand, was thought responsible for the bad effects of this enzyme, and is not present in most cells normally, only appearing when things are going wrong" (Gitlin 2004). To reduce the NSAID-induced gastrointestinal damage drug makers created a drug that only blocked the bad enzyme (COX-2) and left the one in the stomach (COX-1) alone. However, "it turns out that COX-2 isn't just bad. In addition to its role in inflammation, it also plays an important part in controlling the cardiovascular system" and "stopping platelets from forming thrombi" (Gitlin 2004). Initially, Merck though that the experimental group's higher rates of heart disease in drug trials comparing NSAID and COX-2 drugs had to do with the heart-protecting effects of NSAID, but gradually it emerged that COX-2 drugs did raise a patient's risk of heart complications. "An FDA advisory committee suggested that the increase in cardiovascular side effects warranted a new clinical trial to determine the risk, especially given that the target patient group (osteoarthritis) frequently had coexisting cardiovascular disease," but Merck did not disclose this to the public and continued to market Vioxx to consumers without warnings about its potentially lethal side effects (Gitlin 2004).

However, the question remains of the need to balance the patient's desire for an active life with the risk of heart disease. What if the patient wishes to take the risk, given a relatively minor family history of heart complications? What if NSAIDs are too upsetting to his or her stomach to be bearable, or if he or she has a better response to COX-2 inhibiting drugs? So long as Merck openly disclosed the risk to consumers, it could be considered ethical. However, someone could counter that since heart attack is a 'silent' killer, but the less dangerous but more uncomfortable stomach discomfort and pain could deter individuals from substituting Advil or Motrin, leaving Vioxx as a dangerous option is still ethically tenuous, especially given the vigorous and effective marketing campaign of the corporate drug giant.