Hank McKinnell, Pfizer; FDA officials should go to jail

You can bet it's going to continue. Statins next anyone?

Pfizer Says Celebrex Study Showed Risk to Heart (Update5)
Dec. 17 (Bloomberg) -- Pfizer Inc. said its Celebrex painkiller more than doubled the risk of heart attacks in a study. Shares of Pfizer, which has defended Celebrex's safety since Merck & Co.'s withdrawal of Vioxx, tumbled as much as 24 percent.

There are no plans to withdraw Celebrex, and the findings from the U.S. National Cancer Institute study were unexpected and inconsistent with other research, Pfizer, the world's largest drugmaker, said today. More than 27 million people in the U.S. have been prescribed Celebrex since 1999.

The share decline, which wiped out as much as $41 billion in market value, reflects concern that New York-based Pfizer, like Merck, may lose one of its biggest drugs. Celebrex was Pfizer's sixth-largest medicine last year, generating $1.88 billion in sales. Pfizer chief Hank McKinnell has repeatedly said Celebrex is safe, including during a Dec. 6 interview.

``It's going to bring up the same issues as Merck with Vioxx, litigation risk and all the rest,'' said Sena Lund, an analyst with Cathay Financial in New York, who has an ``outperform'' on shares of Pfizer and owns them. ``It's definitely not positive for the company, especially if they have to pull the drug.''

Pfizer shares fell $3.43, or 12 percent, to $25.55 at 2:44 p.m. in New York Stock Exchange composite trading, after dropping as low as $21.99. At its worst, Pfizer's share decline was the biggest in almost two decades.

The Study

The U.S. National Cancer Institute had been studying whether Celebrex might aid in preventing growths known as polyps that put people at risk for colon cancer. The heart risk was discovered during one of the trials. Patients taking 400-milligram and 800- milligram doses of Celebrex daily had a 2.5 fold increase in their risk of a cardiovascular event compared with those on placebo, Pfizer said in a statement. The institute suspended dosing of Celebrex in the study.

Another study, also intended to see if Celebrex can prevent some growths, found no increased heart risk for patients taking a 400-milligram dose of Celebrex compared with a group taking placebo, Pfizer said.

Celebrex is approved for use in the U.S. for the treatment of Arthritis and pain, at recommended doses of 100 milligrams to 200 milligrams daily for osteoarthritis, and 200 milligrams to 400 milligrams a day for Rheumatoid Arthritis .

Regulators

Pfizer officials couldn't immediately comment on details of the study beyond the information contained in the statement, spokesman Paul Fitzhenry said. He did say in an interview that ``Pfizer has no plans to withdraw Celebrex from market.''

The U.S. Food and Drug Administration and cancer institute declined immediate comment.

Regulators in the U.S. and Europe already were taking a closer look at the Cox-2 class of painkillers after Merck pulled Vioxx off the market Sept. 30 in the biggest withdrawal ever of a prescription drug. The FDA plans to hold an advisory committee meeting next year to review the safety of the Cox-2 painkillers.

The Vioxx recall prompted Congress to examine how the FDA monitors the risks of medicines. The Senate Finance Committee held a Nov. 18 hearing where FDA reviewer David Graham said the agency is incapable of protecting the U.S. against another drug with risks such as Vioxx.

Public Citizen, a consumer group that monitors the FDA, has been preparing a petition asking the FDA to take Celebrex and Pfizer's Bextra, which is in the same class of drugs, off the market.

``They should come off the market and our petition will be filed in the next several weeks to ban both of these drugs,'' said Sidney Wolfe, the director of the Washington-based organization's Health Research Group.

Cox-2's Claims

Vioxx and Celebrex were supposed to be gentler on the stomach because they targeted the Cox-2 enzyme that is involved with pain. Older painkillers can cause stomach irritation by interfering with Cox-1, a related enzyme.

That difference was intended to justify the cost, sometimes more than $2 a pill, of these drugs, while generic painkillers sell for pennies each. Neither Merck nor Pfizer was able to prove that their painkillers were substantially different from older medicines, Wolfe said.

``We have clear evidence from placebo-controlled trials of Vioxx, Celebrex, and Bextra that there is an increased cardiovascular risk,'' said Garret FitzGerald, director of the University of Pennsylvania's Institute of Translational Medicine and Therapeutics in Philadelphia. ``You'd need to be a devotee of flat earth to believe that this was a series of horrible coincidences. They've conclusively ended the conversation about whether it's a class effect.''

Liabilities

Pfizer has litigation risk from Celebrex, although not as much as Merck has said, said Victor Schwartz, a partner with Shook, Hardy & Bacon in Washington and general counsel of the American Tort Reform Association. His firm has represented Pfizer in the past. He hasn't spoken to anyone on the case.

``From a pure product liability point of view, when you have one study that shows an increase in risk and one study that says there's none, you have nothing,'' said Schwartz, whose firm has represented Pfizer in the past. ``Pfizer is a big company, they're big boys, they have much more experience with liability than Merck. They may be more ready to deal with this, with the plaintiff's lawyer sharks that see the raw meat.''

Merck said this week that 475 product-liability lawsuits have been filed so far by 1,100 Vioxx users or their family members. Merck's Vioxx-related liabilities could reach $18 billion, Merrill Lynch & Co. has estimated. Lawmakers, trial lawyers and doctors say Merck should have known as early as 2000 that Vioxx was dangerous, an argument the company rejects.

Bextra

Pfizer's other Cox 2 painkiller, Bextra, has been linked to an elevated risk of blood clots and heart attacks and strokes in cardiac-surgery patients. The company announced plans Dec. 9 to warn doctors of the increased risk. Bextra was one of five drugs that FDA reviewer Graham identified as unsafe at the Nov. 18 hearing.

Upcoming patent expirations on top-selling drugs, safety concerns in wake of the Vioxx recall and pressure from lawmakers and the public to reduce drug prices have weighed on shares of drug stocks, including Pfizer. The Standard & Poor's 500 Pharmaceuticals Index has fallen 11 percent this year, compared with a 7.5 percent increase in the S&P 500 Index.

Among the other drug companies releasing bad news today was AstraZeneca Plc and Eli Lilly & Co. AstraZeneca said its Iressa lung-cancer treatment didn't help patients live longer in a study, the second research setback this year to cost Europe's No. 3 drugmaker a potential $1 billion product. Eli Lilly said it's adding a safety warning to the label of its attention-deficit drug Strattera after two people taking the medicine suffered severe liver damage.



To contact the reporter on this story:
Kerry Dooley in Washington at kdooley@bloomberg.net.

To contact the editor responsible for this story:
Robert Simison at rsimison@bloomberg.net.
Last Updated: December 17, 2004 14:48 EST

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