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FDA Will Scrutinize Disputed Drugs

Hearings will air risks of Vioxx-class pain medications

Feb 15, 2005 | Boston Globe After months of heightened concerns about the safety and effectiveness of Vioxx and similar best-selling painkillers, and intense criticism of how the Food and Drug Administration has handled them, the agency will launch critical meetings beginning tomorrow on what to do next.

Two FDA advisory panels holding three days of hearings in Gaithersburg, Md., will weigh the risks, benefits, and future of the disputed class of painkillers that includes Arcoxia, Bextra, Celebrex, and Prexige. The outcome is eagerly awaited by patients, doctors, and others who hope the agency will finally sort out the series of frightening, but largely inconclusive studies made public since last fall linking the drugs to heart risks.

''We don't really know the absolute risks of these drugs, and we don't really know which patients are at highest risk," said Jonathan Coblyn, director of the Center for Arthritis and Joint Diseases at Brigham and Women's Hospital in Boston.

The federal panels will study the most detailed analysis to date, potentially voting to add safety warnings to drugs like Celebrex. Products that wait in the wings could face lengthy safety studies or severe restrictions on sales, transforming a potential blockbuster into a niche remedy.

The advisers will hear testimony from drug company representatives and FDA drug safety specialists, including details of the bleeding problems older painkillers caused and theories explaining why newer drugs designed to avoid stomach risks instead imperiled hearts. Patient representatives a sliver of the tens of millions of Americans who took the drugs have signed up to speak, painting emotional testimonies of the drugs' hope and harm. While the FDA has not yet released an agenda, typically panels vote on the final day guiding later agency action.

Much rides on the group's advice: Consumer confidence in painkillers, prescribing habits for doctors, and the credibility of the FDA itself, under constant fire for bungling its drug safety oversight mission.

The debacle, however, did not imperil Lester M. Crawford, the agency's acting commissioner. President Bush yesterday, nominated Crawford as the agency's permanent leader.

Many of the drugs could survive, as well. Some doctors are expected to testify that the drugs should stay on the market to treat people with severe arthritis and other ailments.

But the agency faces mounting pressure from the personal losses like those of Sharda Ramlackhan. Her 72-year-old mother, Morni Bhatia, died from a pair of strokes Ramlackhan blames on Vioxx.

Merck & Co. removed Vioxx from the market on Sept. 30 after a study indicated long-term use doubled the risk of heart attacks and strokes. But similar painkillers like Bextra and Celebrex are still available.

''They should take them off the market," Ramlackhan said. The link between heart risks and those painkillers may be anecdotal, but she added, ''it's there."

The panel will face lobbying on safety issues raised by other painkillers.

Seven-year-old Sabrina Brierton Johnson will explain how Children's Motrin weakened her immune system and caused a rare infection that robbed her of sight. Testifying through a face mask, the girl is going to tell the FDA ''she doesn't want this to happen to any other kid," said Kathy Pinckert, a spokeswoman for the Santa Monica, Calif., law firm representing her.

The girls' parents want a warning label added to the over-the-counter product.

''As the maker of Children's Motrin, we are deeply concerned about all matters related to our products and we are investigating the situation," said Kathy Fallon, spokeswoman for Motrin's maker, McNeil Consumer and Speciality Pharmaceuticals, a division of Johnson & Johnson.

But the bulk of testimony is expected to focus on cox-2 painkillers. From the drugs' ballyhooed start, agency officials have balanced what were expected to be the drug's life-saving benefits vs. the emerging evidence of life-ending risks.

The new class of drugs target the cox-2 enzyme, which is linked to pain and swelling. Their selling point to bone-weary Americans was that the class of drugs, named cox-2, eased pain relief without causing gastrointestinal troubles of earlier, cheaper painkillers.

One by one, however, Vioxx, Bextra and Celebrex were linked to higher odds of suffering heart attacks and strokes.

Arcoxia and Vioxx, produced by Merck, and Pfizer's Celebrex cause a ''somewhat greater" elevation in blood pressure compared with sugar pills and older painkillers, says today's Archives of Internal Medicine. Researchers spotted the trend by analyzing 19 clinical trials published before May 2004 and also noticed possible bias in industry-financed studies. Pfizer-sponsored studies showed Celebrex less likely to cause high blood pressure than Vioxx. Merck studies, however, showed the two products had similar impacts on blood pressure.

''The new analysis supports the concept that blood pressure elevation, especially pronounced with Vioxx, is in part responsible for the excess in heart attacks and strokes," said Dr. Eric J. Topol, chair of the Cleveland Clinic's department of cardiovascular medicine.

Such worries have tarnished hopes of drugs awaiting FDA approval.

Arcoxia, a product given a tentative approval last fall by the FDA, causes more deaths and heart problems than other painkillers and a placebo, according to a reviewer's report that is part of a thick stack of documents provided to the committee. Novartis' drug candidate Prexige poses the same heart risks as Vioxx in one study.

If any of the drugs remain safe enough to sell, the panel will decide to whom.

Doctors say such patients exist: People who have cycled through scores of ineffective painkillers, or who are at risk of suffering ulcers with older drugs or who have low risk of heart problems. Specialists also view the painkillers as a promising way to reduce cancer risk. Those niche markets, however, are much smaller than the tens of millions of people prescribed cox-2 drugs when they hit the market with massive advertising campaigns that, after FDA pressure, have been curbed by the companies.

IMS Health, a healthcare information company, said the number of prescriptions for Celebrex and Bextra filled in December 2004 fell to 2.72 million from 4.73 million prescriptions filled for those painkillers plus Vioxx in March.

Even if Celebrex, the nation's most popular cox-2 painkiller, can still be sold, a simple question remains: Are any Americans brave enough to take it?

Dr. Kathy S. Albain, a professor of medicine and director of the breast research program at Loyola University Health System in Illinois, sees patients whose advanced cancer has infiltrated their bones. The pain is so intense that a simple painkiller no longer works. Adding a cox-2 inhibitor boosts pain-reliving power of narcotic-based painkillers.

Her petrified patients, whose remaining life span may number in the months to years, say no.

''They've seen and heard this in the news. They've read things in the newspaper. They come in with clippings," Albain said. ''And they're scared of heart attacks."

By contrast, premenopausal women with minimal heart risks testing Celebrex as a possible cancer remedy hope that clinical trials, halted due to the safety fears, will proceed.

Some people who found relief for the first time from arthritis pain and suffered ulcers on other painkillers, appear willing to gamble on cox-2s.

''I'm hopeful at least Celebrex may be left alone," said Dr. Elizabeth Tindall, a clinical professor of medicine at Oregon Health and Science University in Portland, who sees up to 100 patients with arthritis weekly.

Tindall, president of American College of Rheumatology, is scheduled to testify at the FDA hearing.

If the FDA does not act ''they are going to be viewed as ineffectual and weak," Tindall said. ''That would certainly be the easiest thing for them to do, just say 'Well, the heck with this, we did fine without these drugs.' But I don't think it would be the right thing to do."

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