Harris, Gardener (17 Feb 2005) \"Medical Panel

¶ … Harris, Gardener (17 Feb 2005) "Medical Panel Poses Pointed Questions to Drug Makers Over Risks of Painkillers." The New York Times. Sunday Edition. Retrieved 19 Feb 2005 at http://www.nytimes.com/2005/02/17/health/17fda.html?pagewanted=

Perhaps the some of the most infamous research studies conducted in recent years were the ones currently undergoing FDA scrutiny, regarding the safety of the once-popular COZ-2 inhibitor drugs such as Vioxx and Bextra and Celebrex. An early Vioxx study found that patients taking the medication had more than four times the risk of undergoing a heart attack as those individuals in the control group. Those patients in the control group were taking Naproxen, another common pain pill but not a COX-2 inhibitor. The Merck Company has since stated it believed that the difference might have resulted because Naproxen protected against heart problems in a manner similar to aspirin.

This raises an important question validating the hypothesis of the research study -- what should constitute a control group? In this case, the human control group consisted of a patient population likely to be in need of painkilling medication. The control group was given another painkiller that chemically different than the drug being tested, to validate the hypothesis that COX-2 inhibitors were more effective in treating pain and giving patients with chronic pain a more normal life. However, because no drugs are without side effects, the improved cardiovascular health of the control group relative to the test group was inaccurately attributed to the drug being used by the control group, according to Merck.

Also, because the studies consisted of elderly or ailing patients with many health concerns, it was often different to isolate the variables of the hypothesis being tested, namely if the COX-2 inhibitor drugs were effective (which they were) in controlling pain and if they had any dangerous side effects that other painkillers did not (which they also did)

The company was taken to task for its surmise about Naproxin's similarity to aspirin, as aspirin has been, in previous research studies shown to reduce the risk of heart attacks by about twenty percent, a fraction of the suggested protection of Naproxen in the research study. Naproxen would have been even more effective than aspirin to explain the greater number heart complaints of the group taking the COX-2 inhibitors vs. The Naproxen group.