Journal editors to be deposed ahead of next Vioxx trials

TRENTON, N.J. - A current editor and former editor of the New England Journal of Medicine, which last month criticized drug maker Merck & Co. for withholding data from a published study on its withdrawn painkiller Vioxx, will be grilled next week by the company's lawyers.
The depositions, ahead of the next round of product liability trials over Merck's former blockbuster arthritis pill, will be held next Tuesday and Wednesday, Paul Shaw, an attorney representing the editors, said Wednesday.
The depositions are to center on a December editorial in the journal, one of the world's most respected medical publications, that said Merck concealed three heart attacks suffered by patients in a large study published in the journal in November 2000. Whitehouse Station, N.J.-based Merck has said those heart attacks happened after the study's cut-off date for side effects, but journal editors say such data is routinely added until a study's publication.
The editorial also alleges the study's authors deleted some relevant data before submitting their article.
"There was no material deleted from the submission to the journal," but some was moved from a graph into the body of the text, said Kent Jarrell, a spokesman for Merck's outside counsel.
The 2000 study, known by the acronym VIGOR, has been a key part of Vioxx product liability trials so far, with both sides using it in their arguments over whether Merck promptly disclosed the drug's cardiac risks. Merck pulled the drug from the market in September 2004 after research showed Vioxx doubled the risk of heart attacks and strokes after 18 months' use.
Merck has won one state case, in New Jersey, and lost one, in Texas. The first federal case ended in a hung jury last month.
After the journal's editorial was widely reported, attorneys for Merck subpoenaed multiple NEJM editors and sought information on its "peer reviewers," independent scientists who critique studies before publication. The editors subpoenaed include editor in chief Dr. Jeffrey M. Drazen and executive editor Dr. Gregory D. Curfman.
"The court should prohibit Merck from engaging in these retaliatory tactics because they run afoul of the protection journalists enjoy under the First Amendment," Shaw wrote in a motion seeking to block the subpoenas.
On Tuesday, U.S. District Judge Eldon Fallon of New Orleans, who is overseeing thousands of consolidated federal lawsuits over Vioxx, ruled that Merck can depose Curfman but not Drazen.
Curfman said Wednesday that he had been subpoenaed and will comply.
In addition, Merck can depose a second person, a former New England Journal editor involved in handling of the VIGOR study, Shaw said. That person has not been publicly identified, and Shaw would not do so.
Fallon rejected Merck's bid to get information on the identities of the journal's peer reviewers.
"He's protecting the integrity of the peer review process," said lawyer Chris Seeger, co-lead counsel for the consolidated federal suits. He said the subpoenas continue Merck's "history of intimidating scientists who question anything on the safety of Vioxx."
Seeger said information from the two editors' depositions can be used by both plaintiff and defense lawyers in all future Vioxx cases. Merck faced at least 9,200 lawsuits around the country, including about 4,000 in New Jersey, as of Nov. 30.
"We're very happy with Judge Fallon's ruling," Seeger said, adding he believes the depositions will hurt Merck more than any plaintiffs.
Among the next cases slated for trial is the retrial of the federal case. It is scheduled to begin Feb. 6 in New Orleans.
Merck shares fell 18 cents to close at $33.03 Wednesday on the New York Stock Exchange.

'Vioxx like' drugs may still be best option for arthritis write scientists

Scientists believe that despite the current concerns around anti-inflammatory drugs like Vioxx, they may still be the best option for treating some forms of arthritis.
In a Nature Reviews of Drug Discovery article this month the researchers from Imperial College London and Queen Mary, University of London examine the use of selective inhibitors of cyclo-oxygenase-2 (COX-2).
They argue that although this class of drugs, which includes Vioxx, has been associated with an increase in the risk of cardiovascular events such as heart attacks and strokes in some patients, the same may be true for traditional non-steroid anti-inflammatory drugs (NSAIDs).
All NSAIDs, including COX-2 inhibitors, work by blocking the actions of both COX-1 and COX-2 enzymes. Blocking COX-2 relieves inflammation and pain, but blocking COX-1 can increase the risk of gastric ulcers and bleeds. For this reason COX-2 selective drugs were developed with the simple aim that they would retain the therapeutic actions of NSAIDs (linked to inhibition of COX-2) but lose the gastric side effects (linked to inhibition of COX-1).
The researchers reviewed over one hundred papers on the subject and looked at the latest recommendations from organisations such as the American Federal Drugs Administration on the use of COX-2 inhibitors and NSAIDs.
The researchers point out that the calls for the removal of COX-2 inhibitors, and a return to using NSAIDs, may cause additional problems. Although NSAIDs have been marketed for a number of years, they have never been required to meet the clinical trial standards now set for COX-2 inhibitors, meaning they may not be any safer.
Professor Jane Mitchell , from Imperial College London, and one of the reviews authors, said: "Although some COX-2 drugs have been reported to increase the risk of heart attack and stroke, they may still remain the best option for treating arthritis in some patients without cardiovascular risk factors who cannot tolerate traditional NSAIDs because of gastric side effects."
Professor Mitchell added: "This review shows us that despite the large scale use of NSAIDs and COX-2 inhibitors for a number of years, we still need more information on their benefits and potential risks and that more research needs to be done in this area. Looking at existing evidence, however, it would seem COX-2 inhibitors may be the best option for some patients. They are as effective as traditional NSAIDs, but with less gastric side effects than some older drugs."

Pfizer quarter beats forecasts

LONDON (SHARECAST) - Pfizer was in demand today after the drug giant said cost cutting helped it top Wall Street’s expectations for the fourth quarter, although generic competition sent profits lower. The New York based group reported earnings of $2.73bn, or 37 cents per share, versus $2.83bn, or 38 cents, a year ago. Revenue was down 9% to $13.6bn, but beat forecasts of £13.27bn. Ignoring one-time items, group earnings were 51 cents, trumping forecasts of around 42 cents per share. Cholesterol drug Lipitor remained the world's top-selling prescription drug with sales up 3% to $3.36bn during the period, with annual sales up 12% to $12.19bn. Cheaper generic drugs ate away at sales of the group’s drugs that have lost patent protection, sending total sales for 2005 2% lower to $51.3bn. Epilepsy treatment Neurontin saw sales slump 71%, hypertension drug Accupril sank 74%, while sales of arthritis treatment Celebrex tumbled 53% following the recall of Merck’s similar drug Vioxx in 2004. Pfizer is due to release new financial forecasts for 2006 in February.