Pfizer Celebrex Lawsuits - 1500 and Counting

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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.

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