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.
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.
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.
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