[IP] Celebrex in same boat with Vioxx]
Pfizer Finds Celebrex Heart Attack Risk
[quote]By THERESA AGOVINO, AP Business Writer
NEW YORK - Pfizer Inc. said it found an increased risk of heart attacks and
strokes for patients taking high dosages of its top-selling arthritis painkiller
Celebrex, the same problem that led to the withdrawal of its one-time competitor
The company said it has no plans to remove Celebrex from the market, but the
disclosure on Friday sent Pfizer's shares tumbling because of fears that it
could cripple sales of what had been the most-prescribed drug for treating
Acting FDA (news - web sites) Commissioner Lester Crawford said the government
is advising physicians to consider prescribing drugs other than Celebrex to
"We're leaving open all regulatory decisions as we move forward. But we do not
have a decision on the fate of the product," said Crawford, during a press
briefing. "We do have great concern about this product (Celebrex) and the class
But doctors have already been inundated with phone calls from worried patients
and say they will curtail writing prescriptions for the drug. Shares of Pfizer,
a member of the Dow index and the world's largest pharmaceutical maker, plunged
$3.23, or 11.15 percent, to $25.75 in late afternoon trading on the New York
Stock Exchange (news - web sites). The decline wiped out almost $25 billion of
Pfizer's market value.
The drug industry has already been under fire for numerous high profile
debacles: Merck & Co.'s withdrawal of Vioxx, the failure of Chiron Corp. to
deliver half the country's flu vaccines, and disclosures that drug companies had
stifled negative clinical trial data from studies examining anti-depressant use
Both Celebrex and Vioxx are a type of drug called cox-2 inhibitors, which have
become popular because of their effectiveness in treating the pain of arthritis
and other ailments. Vioxx was pulled from the market in September because it
doubled patients' risk of heart attack and strokes.
National Institutes of Health (news - web sites) director Dr. Elias Zerhouni
said that he ordered a full review of the more than 40 agency-supported studies
involving cox-2 inhibitors.
News of the increased heart risk for patients using Celebrex came in one of two
long-term cancer prevention trials.
The National Cancer Institute (news - web sites), which was conducting the
study for Pfizer, said patients in the clinical trial taking 800 milligrams of
Celebrex had a 3.4 times greater risk of cardiovascular events compared to a
placebo. For patients in the trial taking 400 milligrams of Celebrex the risk
was 2.5 times greater. The average duration of treatment in the trial was 33
In the 2,000 patient study, 15 individuals taking 400 mgs, 20 patients taking
800 mgs and 6 patients on placebo suffered either a cardiac-related death, heart
attack or stroke.
The study was intended to show whether Celebrex could prevent precancerous
growths called polyps in patients that had already had at least one such growth.
A separate cancer study done by Pfizer found no increased heart risk with
patients taking 400mg of Celebrex per day.
Dr. Joseph Feczko, president of worldwide development for Pfizer, noted that
the results in the trial finding increased risk of heart attacks were not
consistent with either the other cancer prevention trial or with a "large body
of data" that the company had collected.
Feczko said in an interview later in the day that sales of Celebrex will
continue because "it has not shown in totality that it increases the risk of
heart attacks." He said Pfizer still hadn't seen the data from the NCI study so
he couldn't speculate on how the two trials could have such different outcomes.
He added that the company was still planning to go ahead with a previously
announced study to see if Celebrex could actually help patients at high risk of
Finding patients to participate in such a study will be challenge because
doctors are now saying patients at high risk of heart attacks should avoid
Dr. Garret A. FitzGerald, who has been critical of cox-2 inhibitors, said he
doesn't believe Pfizer should take Celebrex off market but has to work hard to
find the appropriate patient population for the drug. Cox-2s were developed to
be gentler on the stomach than older pain relievers called nonsteroidal
anti-inflammatory drugs, such as naproxen, that are associated with
gastrointestinal problems. But unlike Vioxx, Celebrex was never statistically
proven to decrease the risk of ulcers. It also doesn't reduce pain better than
"The challenge for Pfizer now is to show why this drug should be chosen," said
FitzGerald, a cardiologist at the University of Pennsylvania.
FitzGerald said Pfizer's huge marketing push behind the drug accounted for its
dramatic use. Last year, Pfizer spent $87.6 million to advertise Celebrex. It
recently launched a new campaign for the drug and placed full-page ads in
newspapers touting Celebrex's safety in the wake of the Vioxx recall.
FitzGerald said he believed the news has implications for cox-2 inhibitors such
as those under development at Merck and Novartis.
"I think the trial concludes the controversy about whether there is a class
effect of these drugs. Now there is clear evidence of it," said FitzGerald. "You
would need to believe the earth is flat if you thought this was just a
For the first nine months of the year, worldwide sales of Celebrex more than
doubled from a year earlier to $2.3 billion, accounting for 6 percent of
Pfizer's total sales of $37.6 billion during that period.
Barbara Ryan, a managing director at Deutsche Bank said she expects Celebrex's
sales to fall by 50 percent next year and has dropped her Pfizer 2005 earnings
estimate to $2.10 a share from $2.35 a share.
"In this environment people are hysterical," said Ryan, who said all the
headlines would scare people even though the drug's problem manifested itself at
Moody's Investors Service revised its outlook on Pfizer to negative from stable
because it believes Celebrex use may decline as the controversy about the class
increases. Moreover, it said the likelihood that the drug could be pulled from
the market may have risen and Pfizer's litigation may increase.
Moody's points out that this is happening when Pfizer is facing high exposure
to patent expirations, with 30 percent to 35 percent of its revenues coming off
Patent through 2007. The combination means Pfizer may not be able to maintain
its triple A rating, Moody's said.
Dr. Marie Griffin, an epidemiologist and drug safety expert at Vanderbilt
University, said concerns may only apply to patients taking Celebrex at high
She noted that the halted study was testing a 400 to 800 milligram dose. The
highest recommended dose for Celebrex to treat rheumatoid patients is 400
milligrams a day while the dose for osteoarthritis patients is 200 milligrams a
Still, some doctors are concerned about the drug at lower doses because
different patients metabolize drugs at different rates.
"You can't say as a result of this study that doses under 400 milligrams are
absolutely safe," said Dr. Eric Matteson, a professor of medicine in the
division of rheumatology at the Mayo Clinic in Rochester, Minn.
Matteson said his office has been besieged with calls and that he plans to
review his patients' records and take some of them off the drug. Some have
specifically asked to be given something else.
The withdrawal of Vioxx has been a financial and public relations disaster for
Merck. Its legal liabilities are estimated at up to $18 billion, and its shares
have dropped by nearly one-third since the recall announcement in late
Vioxx had been a blockbuster drug for Merck, its No. 2 earner with annual
global sales of $2.5 billion, amounting to 11 percent of the company's $22.49
billion in revenue last year.
Earlier this month, the Food and Drug Administration (news - web sites) said it
was adding a warning to the labels of another Pfizer drug, Bextra, noting a risk
of potential heart problems associated with the use of Bextra in people who have
recently had heart bypass surgery. Bextra is also a cox-2 inhibitor type of
Griffin and two other Vanderbilt epidemiologists also raised fresh concerns
about Bextra, in a letter to be published Thursday in the New England Journal of
Medicine (news - web sites). Doctors should not prescribe the drug "except in
extraordinary circumstances," they recommend.
Last month, in testimony before Congress an FDA official said that Bextra was
one of five drugs whose sales should be halted or curtailed because it is
AP writers Mark Sherman and Marilyn Marchione contributed to this story.
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