Gov't OKs Vioxx, Celebrex, Bextra

COX-2 inhibitor pill, tablet, CELEBREX, vioxx, bextra, arthritis
A Food and Drug Administration advisory panel narrowly voted Friday to recommend that Merck & Co. be allowed to resume sales of its painkiller Vioxx, which the company removed from the market last year because it increased patients' risk of cardiovascular problems.

The panel said that all three scrutinized Cox-2 drugs — Bextra, Celebrex and Vioxx — pose cardiovascular risks, but still voted 17-15 to keep Vioxx on the market.

The news sent Merck shares skyrocketing.

The decision, which surprised many analysts, came the same day that the panel voted to recommend allowing both of Pfizer Inc.'s painkillers Celebrex and Bextra to remain on the market, as long as Celebrex has a stronger warning label, CBS News Medical Correspondent Elizabeth Kaledin reports.

The one thing panel members almost unanimously agreed on is that these drugs must be used under the strictest warnings and tightest supervision, pushing for black box warning labels that let the people know that these drugs can help but can't be taken lightly, Kaledin reported.

The vote for Bextra was 17-13 with two abstaining. While the Vioxx decision was the closest, 17-15, Celebrex passed the panel's approval easily, 31-1.

Merck spokesman Christopher Loder said the company looked forward to discussing the issue with the FDA. The FDA typically follows the recommendations of its advisory panels, but it was unclear Friday what Merck would need to do to resume selling the drug. If the drug is reintroduced, it seemed likely what's called a black box warning about its cardiovascular risks would be required.

"If there is going to be a black box warning now, why did it sell it without one before?" asked plaintiff lawyer Peter Kaufman, who remains confident about the company's liability.

He also noted that the close vote was hardly a ringing endorsement of the drug.

The FDA panel's actions came during a three-day meeting to discuss the safety of pain relievers. Analysts had anticipated that studies linking Celebrex to greater risk of heart attack and stroke might lead the panel to recommend a so-called black box warning, the highest level of warning at the FDA, for the Pfizer drug. Since Celebrex sales have already fallen dramatically since the risk emerged, analyst don't believe the warning will have a big effect on its revenue.

Bextra already has a black box warning.

"Pfizer has escaped. Nothing awful has happened," said Ira Loss, a vice president at Washington Analysis.

Pfizer spokeswoman Susan Bro said the company would work with the FDA on Celebrex's new label. The company also plans long term studies about the cardiovascular safety of both Celebrex and Bextra.

"The key concern of patients and doctors going into this meeting was that there would be choices available to treat pain and the FDA affirmed that," Bro said.

Vioxx, Celebrex and Bextra are Cox-2 inhibitors, a category of painkiller medication. When Merck voluntarily recalled Vioxx in September 2004, it was the only one in the group that showed cardiovascular risks. Since then, several studies have linked Celebrex and Bextra to the same risks.

Cox-2 inhibitors were developed to be gentler on the stomach than older pain relievers, though only Vioxx received FDA permission to include that claim on its label. That benefit is one reason doctors still like the drug.

"I could see prescribing it to patients with a high risk of gastrointestinal problems," said Dr. John Sundy, a rheumatologist at Duke University Medical Center. "But I wouldn't give it to people with cardiovascular problems."

Dr. Eric Matteson agreed. "I wouldn't blithely prescribe it," said the rheumatologist at Mayo Clinic. "But it will definitely have a limited market."

At the meeting, some of the panelists expressed concerns their treatment options might be unwisely curtailed. There was also was debate over whether older pain relievers carry the risk of heart problems — prompting committee members to question whether Cox-2 inhibitors should be held to a higher safety standard.

"I can't treat patients with just Tylenol, ibuprofen and Aleve," said Dr. John J. Cush, a panelist who is chief of rheumatology and clinical immunology at Presbyterian Hospital in Dallas.

Tylenol is sold over the counter as nonprescription medications by Johnson & Johnson while Aleve is made by Bayer AG.

The panel's recommendation came despite some strong words against Cox-2 inhibitors, and Vioxx in particular, from prominent critics. FDA whistleblower Dr. David Graham said: "there doesn't appear to be a need for Cox-2" inhibitors.

Graham authored a study published in Lancet, which said Vioxx caused an estimated 88,000 to 140,000 excess cases of serious heart disease in the U.S. while it was on the market.

Meanwhile, meeting chairman Alistair J. J. Wood of Vanderbilt University Medical School said, "The data are very compelling, Vioxx is substantially worse than the others."

Last year, Celebrex sales leapt 75 percent to $3.3 billion. In December, during the week when word of its cardiovascular risk became public, Celebrex claimed 44 percent of prescription pain killer sales in the retail market with revenues of $44 million. By the week ended Feb. 11, Celebrex's share fell to 23 percent with sales of $24 million, according to Verispan, which tracks prescription drug information.

In trading Friday, Merck shares surged $3.76, or 13 percent, to close at $32.61 on the New York Stock Exchange, while Pfizer shares gained $1.74, or 6.9 percent, to finish at $26.80.

Bert Hazlett, an analyst at SunTrust Robinson Humphrey, upgraded Merck to a buy from a neutral because he believes Vioxx will return to the market for use in a limited population.

And while Vioxx sales my be relatively small, he predicted the resurrection of the drug may help limit the company's legal liability. Hundreds of lawsuits have been filed against Merck over Vioxx and some have estimated the company's liability could go to $30 billion.

"I wouldn't want to be a plaintiff's lawyer right now," said Hazlett.

While the warning could further dampen Celebrex sales, analysts don't think it will be extreme.

"Celebrex will still be a blockbuster," said Hazlett.