Lancet Article Implicates Merck, Known Vioxx Side Effects
On November 5, 2004, The Lancet, a world-renowned British medical journal, published an editorial commentary stating that Merck knew about "the unacceptable cardiovascular risks of Vioxx (rofecxib)" as early as 2000 – a full four years before the drug was finally withdrawn from the market by its manufacturer.
The commentary was based on the results of cumulative analysis of Vioxx data available from a wide range of studies and trials that compared Vioxx to other COX-2 inhibitors and to non-selective pain relievers types or a placebo. The goal of the analysis published on the same date as the editorial was to establish "whether the drug should have been withdrawn earlier."
The study indicated that "an increased risk of myocardial infraction was evident from 2000 onwards. At the end of 2000, the effect was both substantial and unlikely to be a chance finding." One of the studies that raised red flags about the potentially deadly side effects of Vioxx in 2000 was the VIGOR study. It compared Vioxx to another COX-2 drug, Celebrex, and found that Vioxx increased the risk of heart attacks by four times when taken in high dosage and by 1.5 times when taken in standard dosage.
It becomes clear that given the high incidence of heart attack and other side effects shown in the studies that followed, Merck should have directly studied Vioxx for cardiovascular side effects by comparing patients taking Vioxx to patients taking no drug.
Such a study might have uncovered the potentially severe cardiovascular effects of Vioxx earlier, and the drug could have been recalled from the market well before September 2004. Such a study would have demonstrated a great responsibility by Merck to protect patients taking Vioxx. At a minimum, the physicians dispensing the drug would be more aware of the potential side effects and would not recommend the drug to all patients, regardless of their cardiovascular health. Merck did not initiate such a trial.
The company finally recalled Vioxx after an internal study showed a high percentage of heart attacks or other cardiovascular side effects in colon cancer patients compared to those not taking the drug. This internal study was one of the few studies that directly compared Vioxx to no drug (placebo). The only drug being taken was Vioxx, so there was no escaping the obvious severe side effects. (Almost all of the previous studies compared patients taking Vioxx to patients taking other COX-2 drugs or patients taking other types of pain relievers.)
Harsh Criticism
The editorial harshly criticized "astonishing failures by Merck's internal systems of post-marketing surveillance" and "lethal weaknesses" in the U.S. Food and Drug Administration, who should ensure the ongoing safety of drugs approved for routine use.
"Why clinical investigators studying Vioxx did not do more to raise concerns is a fair question that needs to be answered. But in doing so, we must not diminish the importance of the covenant of trust that society has established with powerful commercial and governmental institutions. For with Vioxx, Merck and the FDA acted out of ruthless, short-sighted, and irresponsible interest."