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REVIEW & OUTLOOK (Editorial): The Trials of Merck
Wall Street Journal, 11-18-04

The Journal notes that there are two distinct accusations against Merck, “the first broad and fallacious and the second narrow and possibly true.” The broad charge is that Vioxx and other Cox-2 drugs are virtually identical to older, cheaper drugs like aspirin and ibuprofen, and that “bringing them to market after even a hint that they increase cardiovascular risks is irresponsible.” This is manifestly untrue, since the older drugs, which are taken long term by many arthritis sufferers, cause “16,000 deaths every year from gastrointestinal bleeding.” So much for generic safety. Cox-2s do prevent those gastrointestinal effects, and for a “sizable minority” of patients with disabling pain, Vioxx and other Cox-2 drugs were a valuable addition to the nation's medicine chest.

However, if Merck knew about the heart risks “much earlier than it let on, yet inappropriately marketed the drug too widely as if it was just easy on the stomach aspirin”, then Vioxx crossed the line and should pay the penalty – for “marketing fraud, not for producing an inherently unsafe drug”. Only time will tell if the second, narrower accusation is true or not. All-in-all, the Journal opines that the best course of action would’ve been to leave Vioxx on market with a very stringent label recommending use only in patients without heart disease and with a history of gastrointestinal problems.

No matter what happens to Merck, the most troubling facet of the case is that it will “lead to longer drug approvals and new liability standards that will wreck havoc throughout the whole industry.”

Project FDA.
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