Despite Warnings, Drug Giant Took Long Path to Vioxx Recall

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Despite Warnings, Drug Giant Took Long Path to Vioxx Recall

By THE NEW YORK TIMES

 

Published: November 14, 2004

 

his article was reported and written by Alex Berenson, Gardiner Harris,

Barry Meier and Andrew Pollack.

 

In May 2000, executives at Merck, the pharmaceutical giant under siege

for its handling of the multibillion-dollar drug Vioxx, made a fateful

decision.

 

The company's top research and marketing executives met that month to

consider whether to develop a study to directly test a disturbing

possibility: that Vioxx, a painkiller, might pose a heart risk. Two

months earlier, results from a clinical trial conducted for other

reasons had suggested such concerns.

 

 

But the executives rejected pursuing a study focused on Vioxx's

cardiovascular risks. According to company documents, the scientists

wondered if such a study, which might require as many as 50,000

patients, was even possible. Merck's marketers, meanwhile, apparently

feared it could send the wrong signal about the company's confidence in

Vioxx, which already faced fierce competition from a rival drug, Celebrex.

 

" At present, there is no compelling marketing need for such a study, "

said a slide prepared for the meeting. " Data would not be available

during the critical period. The implied message is not favorable. "

 

Merck decided not to conduct a study solely to determine whether Vioxx

might cause heart attacks and strokes - the type of study that outside

scientists would repeatedly call for as clinical evidence continued to

show cardiovascular risks from the drug. Instead, Merck officials

decided to monitor clinical trials, already under way or planned, that

were to test Vioxx for other uses, to see if any additional signs of

cardiovascular problems emerged.

 

It was a recurring theme for the company over the next few years - that

Vioxx was safe unless proved otherwise. As recently as Friday, in

newspaper advertisements, Merck has argued that it took " prompt and

decisive action'' as soon as it knew that Vioxx was dangerous.

 

But a detailed reconstruction of Merck's handling of Vioxx, based on

interviews and internal company documents, suggests that actions the

company took - and did not take - soon after the drug's safety was

questioned may have affected the health of potentially thousands of

patients, as well as the company's financial health and reputation.

 

The review also raises broader questions about an entire class of

relatively new painkillers, called COX-2 inhibitors; about how drugs are

tested; and about how aggressively the federal Food and Drug

Administration monitors the safety of medications once they are in the

marketplace.

 

The decisions about how to test Vioxx were made in a hothouse

environment in which researchers fiercely debated how the question

should be pursued, and some even now question whether the drug needed to

be withdrawn. It also took place amid a fierce battle between Vioxx and

Celebrex in which federal regulators said marketing claims ran ahead of

the science.

 

Today Merck faces not only Congressional and Justice Department

investigations, but also potentially thousands of personal-injury

lawsuits that could tie the company up in litigation for years and

possibly cost it billions to resolve.

 

In late September, more than four years after that May 2000 meeting,

Merck announced that it was pulling the drug off the market because a

long-term clinical trial showed that some patients, after taking the

drug for 18 months, developed serious cardiovascular problems. The data

that ultimately persuaded the company to withdraw the drug indicated 15

cases of heart attack, stroke or blood clots per thousand people each

year over three years, compared with 7.5 such events per thousand

patients taking a placebo.

 

But the company never directly tested the theory that it used to explain

the worrisome results of the clinical trial in 2000. Merck was

criticized for what some charged was playing down the drug's possible

heart risks; in one case, it received a warning letter from the Food and

Drug Administration for minimizing " potentially serious cardiovascular

findings.'' And when outside researchers found evidence indicating Vioxx

might pose dangers, Merck dismissed their data.

 

 

 

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