Ads for Arthritis Drug Celebrex Were Misleading, Claims Unsubstantiated, FDA Says
FDA in a letter Monday asked Pfizer to immediately halt all advertisements for its COX-2 inhibitors Celebrex and Bextra because the ads were inaccurate and inconsistent with federal law, the AP/Long Island Newsday reports (Meckler, AP/Long Island Newsday, 1/12). After a national study in December found that high doses of Celebrex tripled patient risk for cardiovascular events compared with a placebo, Pfizer officials said that they agreed to an FDA request to end all direct-to-consumer advertisements for Celebrex but would not remove the medication from the market. FDA, which also asked Pfizer officials to revise how the company markets Celebrex to physicians, said at the time that it may soon take other actions, including stronger warnings or withdrawing the drug from market. Pfizer spokesperson Mariann Caprino said at the time that the company would immediately and indefinitely suspend all DTC ads for Celebrex, which include television, radio, newspaper and magazine ads. Caprino said that Pfizer will continue to send thousands of sales representatives to market Celebrex to physicians (Kaiser Daily Health Policy Report, 12/20/04). Pfizer's voluntarily removal of its Celebrex ads in December was "in advance" of FDA's letter this week, the AP/Newsday reports. FDA in its letter asked Pfizer to detail any other similarly misleading ads and remove them from the air as well. Caprino said Pfizer had received the letter but had no other comment.
Letter
The letter cited five ads for Celebrex and/or Bextra that appeared on television, in print, on TV infomercials and in direct-mail brochures. According to FDA, the ads wrongly claimed superiority, made unsubstantiated efficacy claims and omitted facts, including side effect information. The ads cited by FDA include:
- A television "reminder ad" that mentioned the name of the drug but not the condition it is intended to treat. The ad suggested Celebrex provided better movement and flexibility but did not include information about side effects.
- A television ad cited by FDA that opened with, "Celebrex presents, arthritis tips," and then provided information about the disease, with the drug's name repeated at the end of the ad. FDA said the ad "clearly suggests that the drug is the arthritis treatment" and can treat "crippling disability," although Celebrex has only been shown to relieve signs and symptoms, not modify the disease itself, the AP/Newsday reports. FDA stated in the letter that the ad "greatly overstates the proven benefits of Celebrex."
- A 27-minute infomercial that included testimonials and statements from health providers about Celebrex producing dramatic effects and complete pain-free relief. The program repeatedly mentions Pfizer and directs consumers to the company for more information but omits information about Celebrex's safety and risks (AP/Long Island Newsday, 1/12).
Commentary
Two recent opinion pieces addressed patient safety and recent FDA actions. Summaries appear below.
- Ellen Goodman, Boston Globe: The recent, sometimes conflicting, news reports about the safety and benefits of Celebrex and other COX-2 inhibitors, which some studies have shown raise cardiovascular risks and others have found reduce cancer risks, "is the medical equivalent of a triple axel" where researchers do "complete 360-degree swirls ... without ever falling on the ice," columnist writes in a opinion piece. According to Goodman, "We, the sole owners of used bodies, are the last living generalists. We are left to supervise our own personal risk assessment plans, balancing every ulcer and polyp, while we overdose on this week's information that may be next week's misinformation" (Goodman, Boston Globe, 1/13).
- Russell Roberts, NPR's "Morning Edition": "The search for perfect safety is a mistake" and it is "ludicrous to demand" that FDA establish an "arbitrary standard of risk, arbitrarily labeled as safe," Roberts, a professor of economics at George Mason University and a research fellow at Stanford University's Hoover Institution, said in a commentary Tuesday. According to Roberts, "there's no such thing as a safe drug" and patients and their physicians must be allowed to make their own decisions on the trade-offs between safety and effectiveness and between pain and risk. Although making FDA approval more difficult to obtain could increase the safety of medications, it could also mean "losing the drugs that we won't discover because it is simply too expensive to go looking for anything other than a blockbuster," according to Roberts. "We're heading in the wrong direction, demanding that the FDA become even more cautious and careful in protecting us from harm," Roberts said (Roberts, "Morning Edition," NPR, 1/11).
The complete segment is available online in RealPlayer.
