The federal drug safety agency is doing a “spectacular job” of protecting the public, the White House chief of staff said Sunday. The assessment drew an immediate outcry from a Senate critic who charged that government oversight under the Bush administration has proved “a catastrophic failure.”
The debate about the effectiveness of the Food and Drug Administration comes days after the agency began advising doctors to consider alternatives to Celebrex, the leading arthritis painkiller, for their patients. A study had shown that the Pfizer Inc. medication increased the risk of heart attack and strokes at high doses.
Pfizer said Friday it will leave Celebrex on the market, although the same problems led Merck & Co. in September to withdraw from the market its painkiller Vioxx, a Celebrex competitor.
“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,” Pfizer’s chairman and chief executive, Hank McKinnell, said Sunday.
Later Sunday, Pfizer said it would immediately stop advertising Celebrex to consumers. The move covers television, radio, newspaper and magazine advertising.
The FDA’s acting commissioner, Lester Crawford, said Friday the agency has “great concern” about Celebrex and a group of similar medications, called cox-2 inhibitors.
The National Institutes of Health, which halted a study testing Celebrex for cancer prevention, ordered a full review of studies involving cox-2 drugs.
President Bush’s chief of staff, Andrew Card, said, “I don’t know that we need a commission. I would like the FDA to continue to do the job they do.”
Appearing on ABC’s “This Week,” Card said, “I support the FDA. They do a spectacular job. When you think about all of the new technologies and the new drugs that are coming into the marketplace, and they have to review them all to make sure that when they come into the marketplace, they live up to the expectation of improving health care.”
That the public is learning about drugs on the markets that “may not live up to those expectations is a testament to the FDA in how they do their job,” Card said.
But the top Democrat on the Senate Health, Education, Labor and Pensions Committee charged that the administration’s record “on protecting us from harmful prescription drugs is a catastrophic failure.”
Sen. Edward Kennedy of Massachusetts said in a statement: “We need an FDA that looks out for the health of patients and not just the health of the pharmaceutical industry. Lives are at stake, and the president should put an FDA leadership team in place right away, with no ties to the industry it regulates, and that’s committed to reform.”
An internal FDA survey made public last week found that about two-thirds of agency scientists are less than fully confident in the FDA’s monitoring of the safety of prescription drugs now being sold. Also, more than one-third of those scientists had some doubts about the process for approving new drugs.
The chairman of the Senate Finance Committee, GOP Sen. Charles Grassley of Iowa, has suggested that an independent board of drug safety may be needed to ensure the safety of medications after FDA approval.
Pfizer’s McKinnell defended the extensive research on Celebrex and said several studies showed “the risk with Celebrex is less than any other treatment option and is even less than people not being treated at all.”
He added, “I’m not sure we really understand yet the relevance of this new data.”
But David Graham, a whistle-blower who works in the FDA’s office of drug safety, said, “The fact that the FDA says now that it’s concerned about Celebrex to me is a serious signal. I would be very concerned.”
Graham, who appeared with the Pfizer executive on ABC after Card’s interview, contended the agency is “more concerned with getting drugs onto the market than it is with getting safe drugs onto the market. And so rather than dealing with issues such as cardiovascular safety with Celebrex or Vioxx or Bextra before approval, the FDA is willing to allow the experiment to occur after approval.”
Bextra is Pfizer’s other cox-2 inhibitor.
Graham testified before a Senate committee last month that the FDA fumbled in its handling of Vioxx and had mishandled safety problems with five other widely used drugs.