Dr Garret Fitzgeral criticized Pfizer, the Times said, for not making the information public more quickly since the company had completed the study in the spring.
Pfizer claimed it could not release the results sooner because it had to analyze the information.
On December 23, 2004, the New England Journal of Medicine reported that Bextra increased the risk of serious cardiovascular outcomes by a factor of approximately three.
And less than 2 months later, on February 14, 2005, the Associated Press announced a "new study has linked pain killers Vioxx, Celebrex and Bextra to increased cardiovascular risk, reinforcing findings of other trials that have already sparked concern over the safety of a popular category of drugs."
The study was conducted by WellPoint Inc, the nation's largest provider of health benefits and began after Vioxx was taken off the market. Researchers examined records for the period of January 2001 through June 30, 2004, on patients who were on the drugs for at least 18 months.
They studied the records of 7,232 patients over the age of 40 who were taking one of the three drugs and compared them with records of 629,245 people in the same age group who were not taking the drugs.
According to the AP, Bextra increased the risk of heart attack and stroke by 50 percent, and WellPoint reported finding no increase in cardiovascular events in patients taking traditional anti-inflammatory medications.
A little over a month later, on March 17, 2005, the New England Journal of Medicine published the results of a Pfizer clinical trial, confirming the 3-fold risk of stroke and heart attack.
In addition to heart, stroke and other problems listed above, Pfizer's 2004 third quarterly report filed with the Securities and Exchange Commission, said that a few patients treated with Bextra developed Stevens Johnson syndrome, which results when the immune system rejects a drug.
In October 2004, Pfizer sent a letter to doctors warning about the risks of SJS and said skin reactions had led to hospitalizations and deaths in a small number of patients.
As it turns out, the word "few" in the SEC report is a gross understatement. By November 2004, the FDA had already received 87 reports of cases of severe skin reactions associated with Bextra. Of the 87 patients, 36 required hospitalization and four patients died. Twenty involved patients with a known allergy to sulfa.
As always, it is important to consider that reports to the FDA on adverse events represent only one to 10% of the actual number of adverse reactions that occur.
In addition, seven people in Canada had reported severe skin reactions before Bextra was removed from the market, according to the December 17, 2005 Toronto Star.
Moreover, the word "severe" is much too mild an adjective to describe SJS. The disorder is more accurately described by Kristian Rasmussen and Amanda Slevinski Levin, Papantonio, et al P.A. who say: "Imagine a medical disorder where the body burns from the inside out. The skin scalds black and rots away. Sensitive area of the body, the eyes, mouth, anus and genitalia are massacred beyond function. The pain is so intense and uncontrollable, patients are medicated into an artificial coma for months at a time as the only means of relief. Welcome to Stevens-Johnson Syndrome, courtesy of you family medicine cabinet."
SJS warnings were placed on Bextra in November of 2002, approximately one year after the drug gained FDA approval, and stronger SJS warnings were issued by the FDA in February of 2003, and again by recommended label changes in August of 2004.
Despite Pfizer's knowledge of the SJS problem, the company never placed a black-box warning on the label until the FDA ordered one in December 2004, critics say because it would have killed direct to consumer marketing which would have been required to show the warning.
Pfizer claimed it could not release the results sooner because it had to analyze the information.
On December 23, 2004, the New England Journal of Medicine reported that Bextra increased the risk of serious cardiovascular outcomes by a factor of approximately three.
And less than 2 months later, on February 14, 2005, the Associated Press announced a "new study has linked pain killers Vioxx, Celebrex and Bextra to increased cardiovascular risk, reinforcing findings of other trials that have already sparked concern over the safety of a popular category of drugs."
They studied the records of 7,232 patients over the age of 40 who were taking one of the three drugs and compared them with records of 629,245 people in the same age group who were not taking the drugs.
According to the AP, Bextra increased the risk of heart attack and stroke by 50 percent, and WellPoint reported finding no increase in cardiovascular events in patients taking traditional anti-inflammatory medications.
A little over a month later, on March 17, 2005, the New England Journal of Medicine published the results of a Pfizer clinical trial, confirming the 3-fold risk of stroke and heart attack.
In addition to heart, stroke and other problems listed above, Pfizer's 2004 third quarterly report filed with the Securities and Exchange Commission, said that a few patients treated with Bextra developed Stevens Johnson syndrome, which results when the immune system rejects a drug.
In October 2004, Pfizer sent a letter to doctors warning about the risks of SJS and said skin reactions had led to hospitalizations and deaths in a small number of patients.
As it turns out, the word "few" in the SEC report is a gross understatement. By November 2004, the FDA had already received 87 reports of cases of severe skin reactions associated with Bextra. Of the 87 patients, 36 required hospitalization and four patients died. Twenty involved patients with a known allergy to sulfa.
As always, it is important to consider that reports to the FDA on adverse events represent only one to 10% of the actual number of adverse reactions that occur.
In addition, seven people in Canada had reported severe skin reactions before Bextra was removed from the market, according to the December 17, 2005 Toronto Star.
Moreover, the word "severe" is much too mild an adjective to describe SJS. The disorder is more accurately described by Kristian Rasmussen and Amanda Slevinski Levin, Papantonio, et al P.A. who say: "Imagine a medical disorder where the body burns from the inside out. The skin scalds black and rots away. Sensitive area of the body, the eyes, mouth, anus and genitalia are massacred beyond function. The pain is so intense and uncontrollable, patients are medicated into an artificial coma for months at a time as the only means of relief. Welcome to Stevens-Johnson Syndrome, courtesy of you family medicine cabinet."
SJS warnings were placed on Bextra in November of 2002, approximately one year after the drug gained FDA approval, and stronger SJS warnings were issued by the FDA in February of 2003, and again by recommended label changes in August of 2004.
Despite Pfizer's knowledge of the SJS problem, the company never placed a black-box warning on the label until the FDA ordered one in December 2004, critics say because it would have killed direct to consumer marketing which would have been required to show the warning.
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