Pfizer’s Decision To Continue To Sell Celebrex Could Pose Risk for Company

Pfizer's decision to continue selling the arthritis medication Celebrex -- which, based on the results of a national study announced on Friday, can triple patient risk for cardiovascular events compared with a placebo -- "puts the company on a risky legal path" that could "backfire" in the event FDA removes the medication from the market, the Wall Street Journal reports (Martinez/Hensley, Wall Street Journal, 12/21). Pfizer officials on Sunday said that they have agreed to an FDA request to suspend all direct-to-consumer advertisements for Celebrex but will not remove the medication from the market. FDA acting Commissioner Lester Crawford said that physicians should consider alternatives to Celebrex, a COX-2 inhibitor taken by 27 million patients worldwide since 1998.

FDA officials, who also asked Pfizer officials to revise how the company markets Celebrex to physicians, said that it could take other actions related to the medication in the near future. Celebrex is similar to the COX-2 inhibitor Vioxx, which Merck in late September withdrew from the market because of safety concerns.

In addition, FDA recently announced that Bextra, a second COX-2 inhibitor manufactured by Pfizer, could increase patient risk for heart attack and stroke. In response to the Celebrex study, which was sponsored by the National Cancer Institute, NIH on Friday ordered a review of more than 40 clinical trials that involve COX-2 inhibitors and told researchers to inform participants about potential safety concerns (California Healthline, 12/20).

Liability Issues

Most attorneys agree that lawsuits against Merck over Vioxx are "much stronger" than expected cases against Pfizer over Celebrex, but additional negative information on Celebrex "would translate into a much greater liability problem," the Journal reports. In the event that FDA does not remove Celebrex from the market, Pfizer likely would face limited liability because "a drug still approved for sale on the market makes it much more difficult to prove in a court of law that it is unsafe," the Journal reports. According to the Journal, disclosure of all information about the safety risks of Celebrex by Pfizer to allow physicians and patients to decide whether to continue to prescribe and take the medication "could save Celebrex" and provide a "helpful defense to the company."

However, physicians and patients "don't always follow directions," and such a move also could "be construed as some admission of guilt," the Journal reports. A Pfizer spokesperson said, "Product liability concerns don't dictate our decision-making. Rather, it's the health and well-being of patients along with the guidance that we receive from the FDA that inform our decisions." Joseph Capobianco, a partner with Reisman Peirez & Reisman, said, "From a liability and lawsuit view, my advice would be to pull the drug off the market. That's the safest course." Paul Rheingold, an attorney who plans to file Celebrex lawsuits, said that the decision by Pfizer to suspend DTC ads for Celebrex indicates the company is "admitting something." Rheingold added, "What are they saying, 'It's only half dangerous'? It's certainly encouraged us to get going on these cases."

Paul Argenti, a professor at the Tuck School of Business at Dartmouth College, said, "If their strategy is to minimize legal ramifications by keeping the product on the market, that's a short-term gain that will have long-term repercussions," adding that patients "see these drug companies are taking advantage of people with expensive advertising and then trying to rationalize about things that are emotional -- like the sense of danger. Pfizer will be lumped together with Merck" (Wall Street Journal, 12/21).

Financial Issues

Although Pfizer has lost almost $35 billion in market value since the Celebrex announcement, some analysts said that "the sell-off appeared to have gone too far" because FDA has not decided whether to remove the medication from the market, New York Times reports. According to the Times, many scientists and analysts prior to the announcement said that the market for Celebrex would "shrink quickly" because the medication had "shown little benefit" over older and less-expensive treatments (Berenson, New York Times, 12/21).

Other analysts said that the market for Celebrex would "dry up in response to stiffer government warnings, posing a significant threat" to Pfizer, the Newark Star-Ledger reports (Schwab, Newark Star-Ledger, 12/21). Celebrex and Bextra this year likely will have sales of $4.2 billion, which will account for about 8% of total Pfizer sales. Sanford C. Bernstein analyst Richard Evans on Monday said that sales for Celebrex and Bextra in 2007 would decrease to $775 million, which would cause total Pfizer sales to decrease from an estimated $51.1 billion this year to $46.5 billion in 2007 (New York Times, 12/21).

Pfizer spokesperson Mariann Caprino called the estimates "highly speculative" (Newark Star-Ledger, 12/21). However, analysts said that investor "panic" over potential Celebrex lawsuits prompted the decrease in the value of Pfizer stock, rather than "a careful calculation of the real impact of the Celebrex problems on Pfizer," the Times reports. David Katz, chief investment officer of Matrix Asset Advisors, which manages $1.5 billion and owns 2.2 million Pfizer shares, said that based of the size and financial position of Pfizer, "the stock is at a great price under every scenario" (New York Times, 12/21).

Additional Coverage

New York Times, "Madison Ave. Sharing Drug Makers' Pain": Although "plenty of other drugs are still being pitched to consumers in major advertising campaigns," the decisions by Pfizer to suspend DTC ads for Celebrex and Merck to withdraw Vioxx from the market have left the market for prescription drug ads "not looking nearly as healthy as it seemed earlier this year," according to the Times (Ives, New York Times, 12/21).

Wall Street Journal, "Making Sense of Side Effects": Patients should remain aware that alternatives to Celebrex and Vioxx also have safety risks, according to the Journal (Petersen, Wall Street Journal, 12/21).

Wall Street Journal, "Celebrex Moratorium Threatens To Chill Some Drug Marketing": DTC ads for prescription drugs -- one of the "hottest areas" in the ad market in recent years - likely will face a "chill" as a result of the decision by Pfizer to suspend such ads for Celebrex, according to the Journal (Steinberg, Wall Street Journal, 12/21).

Wall Street Journal, "Patients Weigh Pain vs. Risk": FDA officials and patients face the challenge of "how to weigh the risks of side effects from a particular medicine against its benefits," and some Vioxx patients maintain that Merck should have informed consumers about the safety risks but left the medication on the market, according to the Journal (Won Tesoriero, Wall Street Journal, 12/21).

Wall Street Journal, "Drug-Stock Ills Are Hard To Cure": Although pharmaceutical industry stocks have "held up reasonably well" in recent years, the "snarled" pipeline for new medications and safety concerns about treatments on the market have caused investors to reconsider "the entire pharmaceuticals business," according to the Journal (Zuckerman/Hensley, Wall Street Journal, 12/21).

Broadcast Coverage

Several broadcast programs reported on the effect of the Celebrex announcement on Pfizer:

APM's "Marketplace": The segment includes comments from Kenneth Baron, a cardiologist at United Hospital; Meredith Rosenthal, assistant professor of health economics and policy at the Harvard School of Public Health; and an attorney for Celebrex patients (Tong, "Marketplace," APM, 12/20). The complete segment is available online in RealPlayer.

CBS' "Evening News": The segment includes comments from Dr. Peter Bruno of Lennox Hill Hospital and Pfizer CEO Hank McKinnell (Kaledin, "Evening News," CBS, 12/20). The complete segment is available online in RealPlayer.

NPR's "All Things Considered": The segment includes comments from Evans; McKinnell; and Eric Topol, chief academic officer and provost of the Cleveland Clinic (Prakash, "All Things Considered," NPR, 12/21). The complete segment is available online in RealPlayer.

NPR's "All Things Considered": The segment includes comments from Dr. Robert Schmerling, a rheumatologist at Beth Israel Deaconess Medical Center (Norris, "All Things Considered," NPR, 12/21). The complete segment is available online in RealPlayer.

NPR's "Day to Day": The segment includes comments from Lisa Napoli of APM's "Marketplace" (Chadwick, "Day to Day," NPR, 12/20). The complete segment is available online in RealPlayer.

NPR's "Talk of the Nation": The program on Tuesday will include a discussion on pain medications (Conan, "Talk of the Nation," NPR, 12/21). The complete segment will be available online in RealPlayer at 6 p.m. ET.

WBUR's "On Point": Guests on the program included Dr. John Abramson of Harvard Medical School; Donald Kennedy, a former FDA commissioner, president-emeritus of Stanford University and editor in chief of Science magazine; Arthur Levin, director of the Center for Medical Consumers; and Rita Rubin, a medical reporter for USA Today (Ashbrook, "On Point," WBUR, 12/20). The complete segment is available online in RealPlayer, Windows Media and Quicktime media formats.

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