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Sunday, October 16, 2005

The Case of the Missing Study of Depo Provera and Osteoporosis

The mystery of the osteoporosis problems associated with Depo Provera goes back many years.

Depo Provera was approved by the FDA in 1992. This approval took place after many years of denial of approval and great concern over the impact on bone density. Thus, part of that approval process was a requirement (or agreement) that Upjohn (which then became Pharmacia & Upjohn, then became Pfizer) was to do additional studies of the long term affects on bone mass density loss as a result of long term use of Depo Provera.

A review of the research publications does not reveal such a study. Note, I say, a review of the published research does not reveal this study.

In digging for the answer to the study that is missing, I able to find an FDA publication of the CV (resume) of a Dr. Diane F. Merritt. And as it turns out, on Dr. Merritt's CV is a mention of just the sort of study that was promissed to the FDA in 1992.

Dr. Merritt's 2004 CV lists "Assessment of Bone Mineral Density in Women Receiving Depo-Provera Contraception Injection." 1995-2002. So it appears that in 1995 a study was begun, and in 2002 it was concluded. This was not something that was not completed, because it is listed on a 2004 CV of Dr. Merritt.

Thus, Dr. Merritt did a study and the study was finished 2 years before the label was changed on Depo Provera. A label change was made by Pfizer in November 2004, telling women (and doctors) that long term use of Depo Provera might not be advisable, as it could be causing long term and possibly non-reversible bone loss -- osteoporosis.

But there has been no publication of the results of Dr. Merritt's study. The only thing is a mention in the package insert for Depo Provera that a 7 year long study showed that there could be long term and permanent losses of bone mass as result of usage of Depo Provera.

Why has Pfizer not released the actual results of Dr. Merritt's study? Where is the data? What does it show? How much does it make clear what is so clear to so many women who used this drug long term. That is can cause very serious and very permanent damage to their bones.

by Michael Monheit, Esquire


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