Pfizer New Zealand Response To The IMMP Assertions

Pfizer New Zealand Response To The IMMP Assertions.

Pfizer New Zealand today strongly disagrees with the statement issued by the IMMP, Pfizer General Manager Mark Crotty said.

“The assertions contained in the press release are incorrect, misleading and as such extremely irresponsible.”

“They go against the large body of data comparing cardiovascular risk between Celebrex and Vioxx,” he said.

“The ‘study’ referred to by the IMMP is a simply an adverse events monitoring system and does not take into account individual cardiovascular risk. It is not a clinical trial, and its results should be treated with extreme caution.”

“In additional, the IMMP data is not collected in a controlled fashion, and is dependent on the vigilant reporting of a medical practitioner,” stated Pfizer Australia and New Zealand Medical Director, Dr Bill Ketelbey.

“The statement from the IMMP that this is the first ‘study’ to compare cardiovascular risk of the two medicines is blatantly incorrect and misleading to the public.”

“The FDA in the United States recently published a ‘real life’ observational study designed to assess the cardiovascular risk of all NSAIDS (including Celebrex and Vioxx) and found there was no increased risk associated with Celebrex, whereas there was a significantly increased risk associated with Vioxx use. This study involved over 1.3 million people. In addition, three further independent studies (Ray et al; Solomon et al; Mamdani et al) involving over 570,000 patients have again illustrated an increased cardiovascular risk associated with Vioxx, and shown no increased risk with Celebrex. The results of these studies have been submitted to Medsafe as part of its review of the COX -2 class,” Dr Ketelbey said.

"The IMMP data involved only 11,000 people and, as admitted by the author, lacked the statistical power to detect a difference between these medicines that have repeatedly been shown to have different safety profiles. The inability of the IMMP data to detect a known difference between these two medicines merely adds support to the New Zealand government's decision to cease funding it." ENDS

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