Editorial: Drug makers’ wake-up call

Wednesday, Aug. 24, 2005 | 9:16 a.m.

In November of last year the U.S. Senate conducted hearings on the pain-relieving drug Vioxx, made by Merck & Co. The hearings were held two months after the drug, which had been recording sales of $2.5 billion a year, was pulled from the market because of studies linking it to heart problems after prolonged use. Sen. Charles Grassley, R-Iowa, said on CNN before the hearing started: "My investigators have come up with information that both before Vioxx went on the market and even after Vioxx went on the market there were various red flags coming up within the organization of Merck that raised these legitimate questions about the safety of the drug."

This was a point driven home at trial by attorneys representing Texas resident Carol Ernst, whose husband, Robert, a produce manager at a Wal-Mart store, died suddenly in his sleep four years ago after months of taking Vioxx. This past Friday a Texas jury found that Merck was liable. In a New York Times story on the six-week trial, it was reported that jurors were shown internal Merck documents in which Vioxx's potential link with heart risks were discussed as early as 1997 -- more than two years before the drug went to market.

The jury awarded Robert Ernst's family $24.5 million for suffering and $229 million as punishment against Merck for obscuring the drug's risks in its advertising. Texas law caps punitive damages at $1.6 million. But the jurors symbolically awarded the enormously higher amount as a way of telling drug makers that they had better start being more honest. "We expect accountability, we expect them to be open with us, we expect them to be honest with us," the jury's forewoman told The New York Times.

Although Merck vigorously defended itself and plans to appeal the verdict, it appears as though its day of reckoning -- for years of being less than forthcoming in its advertising aimed directly at consumers -- is coming soon. It faces a trial next month in New Jersey in the case of a former postal worker who a had heart attack in 2001 after taking Vioxx. Altogether, more than 4,000 Vioxx-related lawsuits have been filed against Merck.

We see the downturn in Merck's fortunes -- its stock dropped almost 8 percent Friday after the verdict was announced -- as a message to both the drug industry and the federal government. If drug ads are to continue to target consumers directly, they need to forthrightly disclose the risks. And the Food and Drug Administration needs to become more serious about its role in protecting the public. In March 2000 results of a clinical study of Vioxx clearly showed the drug's potential for causing heart problems. But it wasn't until September 2001 that the FDA ordered Merck to warn doctors of the problem and it wasn't until April 2002 that Merck was required to warn consumers, on labels, about Vioxx's risks. Sen. Grassley, in his CNN appearance last fall, said the relationship between drug makers and the FDA is "far too cozy." The consequences of such a relation ship are beginning to unfold.

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