The FDA also noted that the ad fails to disclose any risk information and omits the major side effects and contraindications, including warnings and precautions, which implies that there are no risks to the patient who takes Celebrex, thus overstating its safety.
In the same letter the FDA warmed that a Celebrex print advertisement also made unsubstantiated claims with respect to less expensive alternative drugs. The print ad features the headline "Strength They Can Stay With" and shows a chart comparing Celebrex, Ibuprofen and Naproxen, titled "6-Month Patient Persistency Rate."
Over the chart is the statement, "In a study of approximately 1 million patients, persistency rates of different OA/RA treatments were assessed at 6 months." The line below the Celebrex logo says, "Proven strength that lasts."
The FDA said these claims imply that Celebrex is more effective (i.e., stronger) than ibuprofen and naproxen for treatment of osteoarthritis or rheumatoid arthritis and that
patients "stay with" or are more compliant with Celebrex therapy than with the other products. "We are not aware of substantial evidence or substantial clinical experience to support these claims," the FDA wrote.
The cited retrospective retail pharmacy database analyses by NDC Health, the FDA advised, do not contain any data or information demonstrating that patients found Celebrex to be more effective than the other products, or that patients will be more "persistent" or compliant with Celebrex therapy.
Moreover, the agency said, the information did not note the indication for which the drug was prescribed, so the suggestion that these rates reflect specifically OA/RA patients is misleading.
In addition, the FDA said, the analyses do not account for factors that affect persistence or compliance such as cost insurance coverage, side effects, dosage regimen, and ease of use.
"Therefore," the agency wrote, "the analyses do not constitute substantial evidence or substantial clinical experience demonstrating that OA/RA patients are more compliant with Celebrex or stay on Celebrex longer because it is more effective than other products for the treatment of OA or RA."
Experts say these overly aggressive promotional campaigns are causing great harm to consumers. Former FDA commissioner, David Kessler, told the San Francisco Chronicle, February 27, 2005, that the rapid adoption of new drugs -- fueled by heavy promotional campaigns -- is an inherent threat to the public.
"The way it used to be, if a drug got approval, its use would increase gradually over time,'' said Mr Kessler, who is dean of the UCSF School of Medicine. Thus, when unexpected side effects surfaced, he said, relatively few people had been exposed to the risk.
In recent years, though, he said, new medicines explode into widespread use before they build up a safety track record. Mr Kessler is credited with preventing the widespread use of drug TV commercials when he was commissioner.
"Many more people are going to be exposed," he warned in the Chronicle. "That's the nightmare.''
Patients who suffer from chronic pain, like Sandy Lambrecht, say Pfizer and other drug companies take advantage of their suffering. "Excruciating relentless pain is indeed a strong motivator," she states.
"That's why so many of us finally give in and take drugs that may indeed harm us even further," she explains, "we are that desperate."
Sandy says chronic pain sufferers keep up with the news about pain drugs like Celebrex but when the doctor says take it or go without, they take it. "We are not stupid," she states, "we know that we are being coerced into taking drugs pushed by these unconscionable criminals."
Her medicine cabinet still has half-empty bottles of Vioxx, Celebrex and Bextra. Last month she found out that she has heart problems, but has no way of knowing if its related to one of those drug or all 3. "And it's not likely I'll ever find out," she says.
In the same letter the FDA warmed that a Celebrex print advertisement also made unsubstantiated claims with respect to less expensive alternative drugs. The print ad features the headline "Strength They Can Stay With" and shows a chart comparing Celebrex, Ibuprofen and Naproxen, titled "6-Month Patient Persistency Rate."
Over the chart is the statement, "In a study of approximately 1 million patients, persistency rates of different OA/RA treatments were assessed at 6 months." The line below the Celebrex logo says, "Proven strength that lasts."
The FDA said these claims imply that Celebrex is more effective (i.e., stronger) than ibuprofen and naproxen for treatment of osteoarthritis or rheumatoid arthritis and that
patients "stay with" or are more compliant with Celebrex therapy than with the other products. "We are not aware of substantial evidence or substantial clinical experience to support these claims," the FDA wrote.
Moreover, the agency said, the information did not note the indication for which the drug was prescribed, so the suggestion that these rates reflect specifically OA/RA patients is misleading.
In addition, the FDA said, the analyses do not account for factors that affect persistence or compliance such as cost insurance coverage, side effects, dosage regimen, and ease of use.
"Therefore," the agency wrote, "the analyses do not constitute substantial evidence or substantial clinical experience demonstrating that OA/RA patients are more compliant with Celebrex or stay on Celebrex longer because it is more effective than other products for the treatment of OA or RA."
Experts say these overly aggressive promotional campaigns are causing great harm to consumers. Former FDA commissioner, David Kessler, told the San Francisco Chronicle, February 27, 2005, that the rapid adoption of new drugs -- fueled by heavy promotional campaigns -- is an inherent threat to the public.
"The way it used to be, if a drug got approval, its use would increase gradually over time,'' said Mr Kessler, who is dean of the UCSF School of Medicine. Thus, when unexpected side effects surfaced, he said, relatively few people had been exposed to the risk.
In recent years, though, he said, new medicines explode into widespread use before they build up a safety track record. Mr Kessler is credited with preventing the widespread use of drug TV commercials when he was commissioner.
"Many more people are going to be exposed," he warned in the Chronicle. "That's the nightmare.''
Patients who suffer from chronic pain, like Sandy Lambrecht, say Pfizer and other drug companies take advantage of their suffering. "Excruciating relentless pain is indeed a strong motivator," she states.
"That's why so many of us finally give in and take drugs that may indeed harm us even further," she explains, "we are that desperate."
Sandy says chronic pain sufferers keep up with the news about pain drugs like Celebrex but when the doctor says take it or go without, they take it. "We are not stupid," she states, "we know that we are being coerced into taking drugs pushed by these unconscionable criminals."
Her medicine cabinet still has half-empty bottles of Vioxx, Celebrex and Bextra. Last month she found out that she has heart problems, but has no way of knowing if its related to one of those drug or all 3. "And it's not likely I'll ever find out," she says.
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