Pfizer Celebrex Lawsuits - 1500 and Counting
The first Celebrex trial, originally set for June 6, 2006, has been delayed indefinitely, reportedly to give attorneys
more time to gather information. Although no new trial date has been set, legal analysts now predict that Celebrex
trials will begin in early 2007.
The delay was requested by a federal judge in San Francisco, where Pfizer is facing around 1,500 lawsuits related to its
painkillers Celebrex and Bextra, according to Bloomberg News. In light of the studies on Celebrex that have surfaced
over the past year, any media update should say 1,500 lawsuits and counting.
The lawsuits filed actually list defendants involved in the development, manufacturing and distributing of Celebrex as
Pfizer Inc, Pharmacia Corp, Monsanto Co, and GD Searle & Co.
On August 30, 2006, Health Day News doused Pfizer's last hope of ever finding a reason to justify the over-prescribing
of Celebrex when it reported that the "final word on whether the cox-2 painkiller Celebrex might be used to prevent
colon cancer is a definite "no," according to the long-awaited results of two major studies."
"Both of the three-year trials found that the drug reduced the occurrence of precancerous polyps called adenomas in
people at risk for colon cancer," Health Day wrote, "but it more than doubled patients' risk for heart attack and other
serious cardiovascular events."
"The message is that celecoxib has no role as a chemotherapeutic agent -- in people with adenomas or in people among the
general population," said Dr Bruce Psaty, a professor of medicine, epidemiology and health services at the University of
Washington in Seattle, who co-authored an editorial on the two studies, published in the August 31, 2006, New England
Journal of Medicine.
According to Dr Psaty, the take home message is that the cardiovascular risks "far outweighed even the most optimistic
projections about the drug's cancer-prevention properties."
More bad news was reported a week earlier on August 24, 2006, by MedPage Today, in the results of a Canadian study that
found women who take NSAIDs (nonsteroidal anti-inflammatory drugs), such as Celebrex, during the first trimester of
pregnancy have twice the risk of having babies with congenital anomalies, particularly cardiac septal defects,
researchers reported.
Of 1,056 women who filled prescriptions for NSAIDS during the first trimester of pregnancy, 8.8% had infants with
congenital abnormalities, compared with 7% of 35,331 women who did not use NSAIDs, said Anick Berard, PhD, of
Sainte-Justine Hospital, and colleagues, in the September 2006, issue of Birth Defects Research Part B.
And a few months ago on March 1, 2006, the Scotsman reported: "In a study involving more than 4,000 patients, Celebrex,
which is the most commonly used Cox-2 inhibitor, was found to increase the risk of heart attacks by 2.26 times."
The leader of the study, Professor Richard Beasley, from the Medical Research Institute of New Zealand, warned that,
"Given the popularity of this in the treatment of arthritis, drug regulators must undertake an up-to-date risk
assessment based on the findings presented here."
The study was published in the Journal of the Royal Society of Medicine and reported that in addition to the increased
risk when compared to a placebo, the use of Celebrex also had a 1.88-fold increase in the risk of heart attacks when
compared with other painkillers.
According to a November 16, 2005, study conducted in Denmark, presented to the American Heart Association, people who
have survived a previous heart attack and take Celebrex are at an increased risk of death, especially if they take
Celebrex at higher doses.
The lead researcher, Dr Gunnar Gislason, stated that people with heart disease or history of heart attack should not use
Celebrex. The study showed that heart disease patients who take 200 mg of Celebrex a day are more than four times more
likely to die.
The first Celebrex trial that was delayed involves the case of Rosie Ware, an Alabama woman who alleges that a stroke at
age 53, in February 2005, was caused by Celebrex and that the stroke has resulted in medical, hospital, and after-care
costs of "substantial sums of money."
Ms Ware is represented by the law firm of Beasley, Allen, Crow, Methvin, Portis & Miles, in Montgomery, AL. On February 28, 2006, Attorney Jere Beasley told the Wall Street Journal that his client, a
nonsmoker whose health was “very good” before her stroke, took Celebrex for back pain and was left disabled and unable
to work after the stroke.
Mr Beasley also told the Journal that he is undeterred by the fact that Celebrex has been deemed safe by federal
regulatory agencies. “I don’t think that makes much difference,” he said. “The FDA is just an extension of the drug
industry.”
Ms Ware alleges in her lawsuit that had it not been for Pfizer's overly aggressive marketing campaign with misleading
claims about the safety and efficacy of Celebrex, she would never have taken it to begin with.
This allegation is pretty much verified by a study published on January 24, 2005, in the Archives of Internal Medicine,
titled, "National Trends in Cyclooxygenage-2 Inhibitor Use Since Market Release," which concludes that the "aggressive
marketing techniques to patients and physicians" caused a growth not only in use of COX-2 inhibitors but also in overall
market demand, resulting in the use of such drugs by patients who did not need them.
The study in Archives found that 63% of patients who received COX-2 inhibitors were at a low risk for developing the
ulcers and gastrointestinal problems that the drugs were supposed to prevent, and that the marketing campaign played a
significant role in the over-use of COX-2 inhibitors for this type of patient.
In both the non-risk and at-risk population, the study found, Celebrex was neither more effective or safer than NSAIDs,
meaning that there was a small population for which it might be a superior product, but for the vast majority of users,
its use was excessive.
According to Merrill Goozner in the new best-selling book, "The $800 Million Pill:"
"Sales exploded the instant the FDA gave the okay for the drugs’ makers to rev up their marketing machines. Commercials
featuring frisky seniors flooded the airwaves. Detailers inundated doctors with free samples. Millions of people
pestered their physicians to give them prescriptions for the new drugs, requests that fell on receptive ears."
Mr Goozner states that, "Wall Street’s stock analysts considered the rollouts of Celebrex and Vioxx the most successful
drug launches in pharmaceutical industry history."
"Within a year of its launch," he notes, "Celebrex was generating more than $2 billion a year in sales for Pharmacia and
its comarketer Pfizer.
"Arthritis pain relief medicine that had once cost pennies a day," he says, "was now costing millions of patients and
their insurers nearly three dollars a pill."
Celebrex in fact, has no proven superiority over other NSAIDs and yet it sells for anywhere between $2.50 to $6.50 per
day depending on the dose, while NSAIDs sell for $0.21 to $0.31 per day which means Pfizer has made billions of dollars
off Celebrex by charging an outrageous price for a drug that in reality is not even better than over-the-counter drugs
that cost pennies per pill and have been on the shelves for years.
Had the truth been known about the drug's lack of safety and efficacy, critics says, Celebrex would have sold for a
price similar to other NSAIDs and would not have become a standard in the treatment of arthritis and other forms of pain
relief.
In 2004, Pfizer spent $117 million promoting Celebrex and sales reached $3.4 billion worldwide, according to the April
28, 2006, New York Times. The following year, after advertising of Celebrex ceased, sales dropped 48% to $1.73 billion
in 2005, the WSJ reports.
Although scrutiny over marketing practices intensified following the Vioxx recall, violations of advertising regulations
have been getting worse, according to Tom Abrams, director of the FDA's Division of Drug Marketing, Advertising, and
Communications, speaking in an interview for Pharmaceutical Executive on December 1, 2005.
FDA regulations require drug companies to submit promotional materials to the FDA at the time of first use which means
Mr Abrams and his staff of 35 receive an average of 53,000 promotional pieces a year, he estimates.
He says the biggest public misconception is that the FDA screens and approves all ads before they are released but that
most ads are launched without the agency reviewing them first. "We get complaints from consumers and physicians who call
us up and say, 'Tom, how can you allow that TV ad to be on?'" Mr Abrams said during the interview.
"They're flabbergasted," he says, "when we say, 'We didn't approve it before it went on TV.' Often, we're seeing it at
the same time as the American public. DDMAC has limited resources and we use our limited resources as effectively as we
can to do our job."
He told Pharmaceutical Executive that competing marketing campaigns within the pharmaceutical industry have become
fierce. "Currently, industry spends $25 billion a year on promotion," he said in the interview.
"I think it is going to continue to increase," he added.
When the FDA determines that ad is violating regulations, it sends the drug company either a notice of violation letter
or a warning letter. Notice of violation letters are untitled and are issued for the least serious offenses. "They
pretty much tell companies, 'Stop what you're doing and don't do it again," says Mr Abrams.
Warning letters, he explains, request that the drug company stop the promotion and disseminate corrective messages, and
are issued for more serious or repetitive violations.
Over the years, the misleading and deceptive ads for Celebrex have led to regular correspondence between Pfizer and the
FDA.
Since its arrival on the market, Celebrex has been promoted as having the ability to improve the quality of life with
ads in which patients go from not being able to work or do much of anything, to being able to work and do everything
else pain-free.
In one infomercial, Celebrex patients talk about being able to “do anything,” “do as much as I want to do,” being “back
to doing what I do,” and such. They talk about “enjoying life” again, how the drug improved their “quality of life,” and
how the drug “gave them back their lives.”
One person states that “you can be free,” and another says that Celebrex “brought new vitality in life.”
Such claims portray Celebrex as a superior pain relief drug when in fact, the FDA has stated that, “none of the
comparative studies with naproxen, ibuprofen, and diclofenac to-date has been designed to demonstrate superiority or a
specified degree of similarity in a rigorous way.”
Typical of the phony "improve the quality of life" commercials is a TV ad that promotes the use of Celebrex for
osteoarthritis or rheumatoid arthritis, with a woman playing a guitar. The visuals focus on her hands and fingers and
playing ability with a voice-over saying, “With Celebrex, I will play the long version.”
Combined, the image and voice-over imply that there is a direct benefit to the woman's wrist, hand, and finger joints so
that she can now play the long version and that prior to taking Celebrex she could not.
This misleading ad earned the drug maker the most serious FDA "warning letter" stating: While the Guitar TV ad suggests
a direct benefit to this patient’s wrist/hand/finger joints related to movement and flexibility, it fails to state the
actual approved indication (e.g., relief of signs and symptoms of osteoarthritis).
It also fails to include any risk information about Celebrex, the FDA said, thus omitting the major side effects and
contraindications (including warnings and precautions). Omission of this information, the warning letter said, implies
that there are no risks to the patient who takes Celebrex which overstates the drug’s safety.
The Canada's regulatory agency were also keeping a close watch on Celebrex and apparently so were consumers. On November
4, 2004 a class action lawsuit was filed in Canada alleging that Celebrex caused cardiovascular related side effects and
on November 28, 2004, Canada's Adverse Drug Reaction Monitoring Program confirmed 14 Celebrex related deaths.
About 2 weeks later in mid-December 2004, the announcement came that a clinical trial investigating a new use of
Celebrex to prevent colon polyps, conducted by the National Cancer Institute and Pfizer, was discontinued because of an
increased risk of cardiovascular events in patients taking Celebrex versus those in the group taking a placebo.
Patients in the trial who were taking 400 mg of Celebrex twice a day were found to have a 3.4 times greater risk of
cardiovascular events compared to patients taking a placebo and patients taking the 200 mg dose had a risk that was 2.5
times greater.
The news of this study came a mere 10 weeks after Merck's recall of Vioxx, when a study found that Vioxx doubled the
risk of heart attack and stroke among patients taking the drug to prevent colon polyps.
In fact, on September 30, 2004, in response to Merck's announcement, Pfizer issued a press release bragging that over 27
million patients in the US had been prescribed Celebrex since it was approved and said people should use it instead of
Vioxx.
"Because of its outstanding long-term safety profile and broad indication base including osteoarthritis, rheumatoid
arthritis and acute pain, Celebrex is an appropriate treatment alternative," said Dr Joe Feczko, Pfizer's president of
worldwide development.
The press release claimed that a recent FDA sponsored study of 1.4 million patients, found that those patients who
received Celebrex demonstrated no increased risk of cardiac events. "Pfizer is confident in the long-term cardiovascular
safety of Celebrex," Dr Joe Feczko stated.
Well, that glory was short-lived because in January 2005, following a sharp decline in new prescriptions for Celebrex
after the December 2004 study was revealed, Pfizer investors filed a federal class action lawsuit against Pfizer in
Connecticut alleging that the company misled investors about the safety of Celebrex.
A former Vice President of Pfizer turned whistleblower, Peter Rost, says shareholders were rightfully upset and
estimates that the fiasco probably cost Pfizer $3-4 billion.
As for the potential damages to the company from all the lawsuits filed, Mr Rost states companies like Pfizer usually
carry some insurance but says, "Most comes out of shareholders pockets."
He predicts that more hidden studies and documents will pop up during litigation.
And that too seems likely being Pfizer has been forced to acknowledge that a study that was testing Celebrex as a
treatment for Alzheimer's disease between 1997 to 1999, showed patients taking Celebrex quadrupled their risk for a
heart attack compared to those patients taking a placebo.
The study found patients on Celebrex had a 3.6 times greater occurrence of a serious heart event compared to those on a
placebo, according to an analysis of the data by the patient advocacy group, Public Citizen.
On January 24, 2005, Public Citizen petitioned the FDA to immediately remove Celebrex from the market and a week later
on January 31, 2005, Citizen accused Pfizer of burying the study. Sidney Wolfe, director of Public Citizen's Health
Research Group, said "there is no excuse for this study not being made more public."
Critics say this study proves that the drug makers knew that Celebrex was a total fraud before the drug even hit the
shelves.
According to Merrill Goozner, author of the $800 Million Dollar Pill, the only legitimate selling point for the Cox-2
inhibitors was the claim that they would eliminate the ulcers and deaths that on rare occasions resulted from the
prolonged use of generic painkillers.
"Yet the FDA didn’t allow them to claim that in their advertising or literature," he points out, "since the clinical
trials failed to turn up evidence that the new drugs were safer than NSAIDs."
"The package insert, which goes out with every prescription," he notes, "contained the same warning label as all the
other NSAIDs."
Critics predict that Vioxx, Celebrex and Bextra will go down in history as a shining example of the danger posed by
allowing the unbridled promotion of prescription drugs to both doctors and patients.
Experts blame the doctors for over-prescribing and being so gullible to trust the information in promotional materials
furnished by drug companies. On June 22, 2000, Dr Marcia Angell, wrote in the New England Journal of Medicine:
"Unfortunately, many doctors do indeed rely on drug-company representatives and promotional materials to learn about new
drugs, and much of the public learns from direct-to-consumer advertising. But to rely on the drug companies for unbiased
evaluations of their products makes about as much sense as relying on beer companies to teach us about alcoholism. The
conflict of interest is obvious."
"The fact is," she said, "marketing is meant to sell drugs, and the less important the drug, the more marketing it takes
to sell it."
"Important new drugs do not need much promotion," she wrote.
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For more information for injured parties go to Lawyers and Settlements.com
Evelyn Pringle
evelyn.pringle@sbcglobal.net
(Evelyn Pringle is a columnist for OpEd News and an investigative journalist focused on exposing corruption in
government and corporate America)