quinta-feira, 7 de setembro de 2006

WSJ: Merck se auto-absolve do caso Vioxx.

Segue abaixo, reportagem do The Wall Street Journal sobre a auto-absolvição da Merck Sharp Dohme no caso Vioxx. Apresentei em negrito, o único parágrafo onde o relatório pago pela própria empresa se auto-recrimina e, cita comportamentos pouco aceitáveis em relação aquilo que chamou de médicos "anti-Vioxx" ou "anti-Merck". Lembro que quando a análise do braço cardiovascular do Vioxx foi publicado, os médicos brasileiros "pró-Vioxx" e "pró-Merck" não perderam tempo em defender o produto.

By JOHN CARREYROU and HEATHER WON TESORIEROSeptember 7, 2006; Page D3 Copyright The Wall Street Journal.
An outside investigation ordered by Merck & Co.'s board largely exonerated the drug maker's management of any wrongdoing in developing and marketing the painkiller Vioxx, citing much of the same evidence that critics say shows Merck acted irresponsibly.
Plaintiffs' attorneys dismissed the investigation as a whitewashing exercise. Merck faces more than 14,200 lawsuits alleging that Vioxx caused heart attacks and strokes. So far, the company has won four cases that have gone to trial and lost four.
Summarizing the results of a 20-month investigation, retired U.S. District Judge John S. Martin Jr. took up 27 allegations that critics have leveled against Merck, ultimately rejecting the central elements of each one. Mr. Martin is with the law firm Debevoise & Plimpton LLP.
Merck's management believed Vioxx was safe until the company withdrew the drug from the market in September 2004 and never intended to mislead the Food and Drug Administration or the public, Mr. Martin's report says.
"Critics contend that senior officials at Merck knowingly put patients at risk of cardiovascular events rather than jeopardize the profits that Merck generated from the sale of Vioxx," the report says. "We have concluded that there is no basis for such a claim."
Plaintiffs' attorney Christopher Seeger called the report "a legal brief on behalf of the company." He added: "If law firms like Debevoise said anything negative about the companies that hire them to do these reports, they'd never be hired by a big company again."
At a news conference to present his findings, Mr. Martin said the report was "positive because that's what we found."
Investigations commissioned by companies' boards of directors have a mixed record of credibility, says Edwin Stier, a partner at the law firm Stier Anderson LLC, who has conducted several such probes and used to head the criminal division of the U.S. attorney's office in New Jersey.
"This report should be scrutinized with a great deal of skepticism," Mr. Stier says. But, "I think it's a mistake to automatically assume that an investigation is a whitewash because there's so much money at stake."
Analysts have projected Merck could face legal liability on Vioxx of anywhere between $4 billion and $30 billion. If Mr. Martin's report had laid blame on Merck's management, it would have been sure to feed the litigation frenzy.
Mr. Martin was assisted in his investigation by a team of lawyers and paralegals from Debevoise. The firm spent a collective 53,000 hours reviewing tens of millions of documents and interviewing dozens of Merck scientists and executives, as well as outside experts. However, none of the interviews were recorded and notes were taken by hand. The interviews aren't included in the report's appendices. Merck said it would pay the law firm $21 million for its services.
Mr. Martin's investigation found that some of Merck's sales tactics were overly aggressive, but it pinned the blame on individual employees and said upper management was either not aware of or didn't condone those practices.
One of them involved "neutralizing" physicians that sales representatives had identified as "anti-Vioxx" or "anti-Merck" with payments, support for their clinical studies, trips to "elegant" locations such as New York or Hawaii, and medical-school grants. The report says these were merely recommendations and there is no evidence they were ever acted upon.
The report also noted that a promotional aid called "the Cardiovascular Card" used by Merck sales representatives to pitch Vioxx to doctors didn't include data from a 2000 clinical trial that showed a higher incidence of heart attacks and strokes among patients who took Vioxx. But it excused this by saying that Merck provided a separate letter describing that trial to doctors who asked about it.
The report accepted Merck scientists' explanation that, at the time, they believed the higher rate of heart attacks and strokes detected among Vioxx patients in that clinical trial was due to the beneficial effects of the drug Vioxx was being compared to, rather than any negative effects of Vioxx itself. Outside scientists have frequently rejected that theory.
The report says an email that former Merck research head Edward Scolnick sent to colleagues in March 2000 after learning of the results of that trial, in which he acknowledged the cardiovascular data and called it "a shame," was merely an initial reaction. Subsequent emails show Dr. Scolnick changed his mind upon further reviewing the data, and he became convinced that Vioxx was safe, the report says. At the news conference, Mr. Martin called Dr. Scolnick "brilliant

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