Pfizer Defends Painkiller Despite Federal Warning
The head of the pharmaceutical company that produces the controversial arthritis painkiller Celebrex argued Sunday that the drug still had an important role to play in medical treatment despite a federal warning that its use could promote heart attacks.
“We need to put the cardiovascular risk in perspective here,” Pfizer Inc. Chairman and Chief Executive Hank McKinnell said on ABC’s “This Week.” “For millions of patients, Celebrex is the best option, or in some cases, the last option to live a normal life with the pain and inflammation of arthritis.”
The company is leaving the drug on the market, he said, noting that a series of large studies had shown the risk presented by Celebrex was less than other treatment options.
McKinnell’s comments came two days after the Food and Drug Administration issued a warning to doctors that the drug doubled the risk of heart attack and stroke.
The FDA urged physicians to consider prescribing alternative medications and said it was contemplating tougher action against Celebrex, including more stringent warnings or banning its sale.
Speaking on the same program, the FDA’s acting director of drug safety, Dr. David Graham, reaffirmed the agency’s stand on Celebrex, calling it “a serious signal.”
“I would be very concerned,” Graham said. “Indeed, I don’t think I would prescribe Bextra or Celebrex to my mother-in-law.” Bextra is a similar medication also produced by Pfizer.
Pfizer said Sunday that it would stop advertising Celebrex to consumers, Associated Press reported.
Last week’s federal warning on Celebrex came three months after another pharmaceutical company, Merck & Co., withdrew its painkiller Vioxx from the market after the FDA issued a similar finding.
The problems with both drugs have raised questions, both about the entire class of painkilling medications, known as Cox-2 inhibitors, and about the FDA’s ability to protect the public from potentially harmful side effects of new drugs.
Also appearing on “This Week,” White House Chief of Staff Andrew H. Card Jr. praised the FDA as doing “a spectacular job.” But his comments drew an immediate and caustic response from a leading critic of the agency.
In response to Card’s comments, Sen. Edward M. Kennedy of Massachusetts, the senior Democrat on the Senate Health, Education, Labor and Pensions Committee, issued a statement Sunday saying that the agency’s “record on protecting us from harmful prescription drugs is a catastrophic failure.”
“We need an FDA that looks out for the health of patients and not just the health of the pharmaceutical industry,” Kennedy said. He called for a replacement of the agency’s leadership who would begin to reform the process of drug certification.
Kennedy’s statement followed a suggestion made Friday, after the warning on Celebrex was announced, by Sen. Charles E. Grassley (R-Iowa), who called for “a 9/11-type commission of scientific experts” to review drug safety issues. Grassley held hearings on Vioxx last month.
