This comes on the eve of a three-day hearing on the risks and benefits of non-steroidal anti-inflammatory drugs, which include Vioxx and Celebrex.
Health and Human Services Secretary Michael Leavitt told the FDA staff Tuesday the agency would try to improve transparency in the drug approval and post-approval surveillance processes through creation of an independent Drug Safety Oversight Board.
The board, to be made up of FDA staff and medical experts from HHS and other governmental departments, will monitor drug safety issues and provide information about drug risks and benefits to physicians and patients. It will resolve disagreements over approaches to drug safety and oversee development of FDA's drug safety policies.
"The public has spoken and they want more oversight and openness," Leavitt told the staff. "They want to know what we know, what we do with the information and why we do it."
In a statement following the announcement, Rob Schneider, legal counsel for Consumers Union, said, "This is a symbolic first step, but until drug companies are required to make all their information on potential safety problems public, this board can't ensure consumers will know about possible harmful drug side effects."
The oversight board's goal is to share information about drug safety sooner and to a broader audience. That is one of the questions asked about Vioxx and Celebrex: Did FDA respond soon enough to clinical trial data suggesting a link between long-term use of these drugs and cardiovascular side effects such as heart attack and stroke?
FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will hold a public hearing Wednesday into NSAIDs, including COX-2 medications. The meeting should attract a wide range of interested parties, from patients or families of patients who took the drug to the pharmaceutical industry, Congress and, of course, attorneys. After the hearings, the committees will make recommendations to the FDA about what actions should be taken.
"I think we are at risk of losing the class of drugs," Dr. Robert Bresalier of M.D. Anderson Cancer Center in Houston told reporters during a conference call Tuesday.
Bresalier, who also is professor and chair of the Department of GI Medicine and Nutrition at the University of Texas, is the leader of the APPROVe study -- which stands for Adenomatous Polyp Prevention on Vioxx. It is the longest test -- three years -- of Vioxx, a drug Merck pulled from the market last September. The adverse side effects appearing in APPROVe trial, which looked at whether Vioxx could prevent the reoccurrence of pre-cancerous colon polyps, did Vioxx in. Patients who had taken 25 milligram doses of the drug daily after 18 months had almost a twofold increased risk for heart attack and stroke.
The study's safety-monitoring board noted the adverse events data and halted the study several months before it was to have ended. Shortly thereafter, a clinical study involving Celebrex also showed an increased risk of cardiovascular events, but Pfizer continues to sell the drug, albeit without advertising.
What is interesting about the study is it did show Vioxx -- effective at reducing arthritis pain and inflammation -- helped prevent polyps. This issue is at the heart of the upcoming meeting: Do the potential benefits of taking Cox-2 drugs outweigh the risks in certain populations? Or are the drugs simply too risky for any patients to take?
Bresalier, who presents his study results in this week's New England Journal of Medicine, said he did not know.
"We've tried to look at whether we could identify the components that went into this increased risk," he said, "and at this point we have not really been able to come up with something that will stratify patients into high-risk or low-risk groups."
Since September, other studies have been released that both substantiate the risks found in the APPROVe trial and suggest the COX-2 drugs could be used to treat or prevent other diseases, such as Alzheimers and cancer. Studies also have shown other NSAID drugs, such as naproxen, have cardiovascular risk factors.
"These things are being looked at and scrutinized very carefully," Bresalier said, adding that the evidence is mounting so it "appears to suggest it may indeed be a class effect."
It would be unlikely for the FDA to pull the entire class of drugs, but not impossible if the evidence is overwhelming, which at this point it is not. More likely, FDA will place a black-box warning to consumers on containers of the drugs.
There still is much research to be done on NSAIDs, however, and though Merck's Vioxx is out of the game, Pfizer's Celebrex and Bextra remain players.
Pfizer's data will come under scrutiny during the hearing, but Merck could be the big loser as attorneys for patients or families of patients who took Vioxx pay close attention to the evidence presented. Merck's estimated liability for Vioxx-related lawsuits could run into billions of dollars.
MEDCO WANTS TO BE NATIONWIDE DRUG SPONSOR
Pharmacy benefit manager Medco Health Solutions said Tuesday it will bid to become a nationwide drug-plan sponsor for traditional, fee-for-service beneficiaries in the new Medicare prescription drug program in 2006.
"This is just to say we are applying to be a national PDP (prescription drug plan) in all 34 regions," Medco's Jennifer Leone told UPI's Health Biz.
Beyond that, Medco also will apply to provide PBM prescription-drug services for health plans participating in Medicare Advantage's managed-care option. The company said it will work with employers who choose to continue providing prescription-drug coverage to their retirees, so they comply with all Medicare regulations tied to a subsidy that businesses can receive for maintaining retiree benefits.
Medco already has about 1 million Medicare beneficiaries enrolled in its Medicare prescription-drug discount cards, which phase out next year when the permanent Part D benefit begins.
The Department of Health and Human Services will approve which PDP sponsors will participate, but the agency hopes to have two plans per Medicare region. If two plans are not available in each region, HHS will establish a fallback plan to provide the drug benefit for seniors in that area.
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