Merck Vioxx News and Press Releases - News Menu

Source: Reuters
By Kim Dixon

CHICAGO, Dec 17, 2004 (Reuters) - Doctors writing in a prominent medical journal on Friday recommended that physicians stop prescribing Pfizer Inc.'s <PFE.N> Bextra painkiller, just as a large study found the drug maker's sister drug, Celebrex, doubled risk of heart attacks. Both drugs are members of the so-called COX-2 inhibitor class of painkillers, which recently gained notoriety when Merck & Co. Inc. <MRK.N> withdrew Vioxx in September after a study found it doubled the risk of heart attack and stroke.

A letter by three top doctors published in The New England Journal of Medicine said that in light of Vioxx and negative signs on Bextra, Bextra should be avoided. "We believe the doubts raised about the safety of valdecoxib (Bextra), constitute a potential imminent hazard to public health" and thus they should be prescribed only in "extraordinary circumstances," editorial writers at The New England Journal of Medicine wrote in an issue dated Dec. 23, but released early.

Earlier on Friday, Pfizer, the world's No. 1 drug maker, said a government-sponsored trial of Celebrex was halted after patients taking the medicine had more than twice as many heart attacks as patients taking a placebo. The developments are rekindling debate over the merits and safety of the entire class of painkiller drugs, doctors interviewed by Reuters said.

"I'm a cardiologist and I take note of these findings from this trial, which say there is harm, and I am supposed to 'do no harm,'" said Marc Pfeffer, a doctor at Brigham and Women's Hospital in Boston, who advised researchers on the Celebrex study on the heart effects. Pfeffer and other top doctors said they will not be prescribing the drugs for their patients.

NO TO COX-2s

Pfizer, for its part, has aggressively defended Bextra and Celebrex since Vioxx's withdrawal and questions about safety arose. A spokesman at Pfizer said the company had not seen the medical journal letter and could not comment. The company has put out at least four press releases defending the safety of Bextra and Celebrex since the Sept. 30 recall of Vioxx by Merck. Chief Executive Hank McKinnell again defended the drug class and said in a Friday television interview that there should not be a rush to judgment because of the findings.

The authors of The New England Journal of Medicine letter are doctors at the Vanderbilt University School of Medicine. They said they made the recommendation in light of the long lag time between when evidence emerged on Vioxx and its withdrawal, coupled with two negative studies suggesting Bextra boosts heart problems in bypass patients by a factor of three. Older cheaper painkillers such as aspirin are as effective as the COX-2s, but can upset some stomachs.

Jonathan Kay, associate clinical professor at Harvard Medical School and a rheumatologist at Massachusetts General Hospital, uses painkillers as a cornerstone treatment for his rheumatoid arthritis patients. He said the key advantage of using COX-2 inhibitors -- protecting the stomach in patients with gastrointestinal problems -- can be avoided by prescribing a separate medication to prevent stomach upset. "This data about Celebrex certainly raises enough concern that all physicians should be very cautious," Kay said.

Doing the unthinkable

Bob Martin, Editor & Publisher
May 13, 2005 - Notwithstanding the possibility that Vioxx may eventually be placed back on pharmacy shelves, what Merck &Co. (MRK) did to push the sale of the drug to doctors and consumers was unthinkable.

Merck's own documents, released by a Congressional Committee last week, detail how its sales force aggressively pushed the drug before it was pulled from the market last fall because of risks relating to heart attacks.

The Washington Post reported Monday that instructions to the sales force of 3,000 were as detailed as how long to shake a physicians hand...three seconds...and how to eat bread when dining with doctors... "one small bitesize at a time."

The sales representatives were offered $2,000 bonuses to meet sales goals even as regulators were about to increase warnings on the drug's label according the Post. A Dec. 9, 2001 memo which was released warns... "Don't bring up the heart risks."

The documents show that when doctors did ask about the risks, sales reps were told to refer to a "cardiovascular card" with data suggesting that Vioxx could be safer than other anti-inflammatory drugs. However, the card released to the House Government Reform Committee didn't include the very study that raised the first warning signals about Vioxx.

The reward for Vioxx was that sales of the drug soared to $2.5 billion in 2003.

With this kind of deception for profit by the drug industry, coupled with the fraud and outright corruption in many major corporations, it is little wonder that the public is becoming fed up and disgusted with America's "corporate culture?" It is understandable why the major corporations worldwide are cleverly trying to immunize their bad behavior toward consumers and small businesses by using their huge stockpiles of cash to place restrictions on our civil jury system, one of the few remaining places where citizens and small businesses can obtain a degree of justice. These multinational giants won't police their own activities and so much of government is in their hip pocket that regulation of their abusive tactics is almost nil.

AND SPEAKING OF SUCH THINGS AS corruption, a Montgomery Grand Jury is back in session this week, continuing its probe of possible corruption in state government, particularly during the administration of Don Siegelman.

Whether or not the jury will pin any blame on Siegelman for what happened on his watch, we do not know. But hopefully, the federal prosecutors, now that they have their chief songbird, Lanny Young, back in a mood of cooperation, will soon wrap up this investigation. If Siegelman is not indicted he will, although somewhat damaged politically, no doubt move his gubernatorial campaign into full throttle. If he is charged, he will immediately become past history politically in Alabama.

THE STATE LEGISLATURE WILL return May 16th for its final gasp of the 2006 regular session. Who knows what will happen when the final dust settles. Will Gov. Bob Riley veto the education budget?...likely. Will the legislature override his veto and keep the teacher pay raise at six percent? Perhaps. Or will there be a compromise?...Who knows.

The entire session has been a disaster, filled with rancor and dissent, not just between political parties, but within them as well.

The Mobile Register credits last week's "quote of the week" to Montgomery's own Sen. Larry Dixon, as follows: "Do any more Democrats want to go kiss a--?" The comment was stated loudly on the Senate floor, the paper writes, as a stream of legislators exited the chamber last Thursday, headed to the gallery to greet AEA's Paul Hubbert, who returned to the capitol after recovering from heart surgery to see the state's education budget pass.

The Franklin Resources Group, one of the premier lobbying players in the capital city, suggests in its most recent newsletter that besides the general fund budget, there are a few other bills being watched closely as the final day approaches. They include a bill to distribute Alabama's national tobacco settlement dollars which support Medicaid and child welfare programs, two economic development bills, one for state docks construction and the other appropriation designed to meet the state's site prep grants for new and expanding business.

But for all but a few bills adjournment "sine die" has already sounded.

Thursday, May 12, 2005

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