Merritt not alone in studying Depo Provera and Bone Density Loss
October 1, 2005 11:47

Melanie Ariane Gold, D.O. was managing a study under a research grant from Pharmacia & Upjohn/Pfizer totalling $1,087,783.

The research, she directed on site was called, "Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent Depo-Provera Users and Matched Controls" and took place from 1998-2005.

Where are the results of this research?

I am trying to contact any women who participated in a clinical trial or study of the side effects of Depo Provera. In particular, the studies I am interested in are:

Doctor Study Name Start End

Diane F. Merritt, M.D. "Assessment of Bone Mineral Density in Women Receiving Depo-Provera Contraception Injection." 1995 2002

Diane F. Merritt, M.D. Cyclo-Provera Contraceptive Injection: A Comparative Study of Safety, Patient Acceptability and Efficacy to Ortho-Novum 7/7/7, 28 Tablets 1997 1999

Melanie Ariane Gold, D.O. Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent Depo-Provera Users and Matched Controls 1998 2005

Melanie Ariane Gold, D.O. Cyclo-Provera and Depo-Provera versus Ortho-Novum 7/7/7: a comparative study of the safety and acceptability in adolescents 1999

Barbara A. Cromer, M.D. Evaluation of bone mineral density and total body calcium in adolescent DP150CI (Depo-Provera) users and matched controls. 1998

Barbara A. Cromer, M.D. Depo-Provera and Bone Mineral Density in Adolescents. National Institutes of Health 1999 2004

Dilip R. Patel, MD Cyclo-Provera Contraceptive Injection and Depo-Provera Contraceptive Injection versus Ortho-Novum 7/7/7, 28 tablets : A comparative study of safety and patient acceptability in adolescents ( 18 years or less ) who desire contraception 1999 2000 (cut short!)

LAURA BARCHRACH, MD Depo-Provera: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP 150CI Users and Matched Controls 1998 2004

Simon Kipersztok, M.D. - USA Cyclo Provera Contraceptive Injection: An Open-Label Continuation Protocol for Patients Successfully Completing M/5415/004 or M/5415/0009

Simon Kipersztok, M.D. - USA A comparative study of safety, patient acceptability and efficacy to Ortho-Novum 7/7/7, 28 tablets 1997 1999

Simon Kipersztok, M.D. - USA Assessment of Bone Mineral Density (BMD) in Women Receiving Depo-Provera Contraceptive Injection 1994 2002

If you have information on the above research, please contact me at: Michael Monheit, Esquire

Pfizer says, "Since the U.S. approval of DEPO-PROVERA in 1992, the prescribing information has included a warning that use of the product may be considered among the risk factors for development of osteoporosis. Additional clinical research was initiated in the 1990s to clarify the effects of DEPO-PROVERA on bone mineral density in women aged 25 to 35 and in adolescents. The results of these studies were recently submitted to the FDA and are reflected in the revised labeling for DEPO-PROVERA."

But I wonder... why now? Why does the disclosure/label change come in November 2004? The following questions and research results from this inquiry:

• When was the drug going to become generic? 3 months after they changed the label. Does that mean that Pfizer waited until the market share was going to drop anyway before they warned? Or is this merely a coincidence?
  
• When was research to be done? Some of it was completed in 2002. Does that mean that the studies were never published, even though they were finished in 2002?
  
• How many studies sites were there It appears that there were 15 sites for one study. And there was more than one study being done. For example: March, 1998: Cromer BA (contractual, principal consultant): Evaluation of bone mineral density and total body calcium in adolescent DP150CI (Depo-Provera) users and matched controls. Pharmacia & Upjohn Co.; $409,500 over 5 years as site 1 and $460,000 for site 2 (of a total of 15 sites). See: http://www.metrohealthresearch.org/pdf/Cromer_cv.pdf
  
• How many doctors studied the BMD effects? We have already found at least 6 doctors who list having done these studies between starting on or after 1994 and finishing on or before 2005. Some were completed in 2002.
  
• How long did the studies last? Some lasted as long as 8+ years. Others 7 years. Others 5 years. There are many studies that were done to measure the long term effects of Depo Provera on BMD.
  
• How much was spent on studies of BMD?: There appears to be over $5,000,000 that went into these sorts of studies.
  

What needs to be disclosed, and what has been disclosed by Pfizer are two different things.

While Pfizer now will admit that Depo Provera shots can be very dangerous especially with long term use, resulting in fractures and Osteoporosis, they won't show the test results that lead to that conclusion.

In 1992, there were to be studies done of the long term side effects with respect to bone density.

The FDA, on 10/29/1992, in Press Release P92-31, Depo Provera, said, "Recent data have also demonstrated that long-term use may contribute to osteoporosis. The manufacturer will conduct additional research to study this potential effect. "

Where is the "additional research"? It was conducted. Dr. Diane F. Merritt for Upjohn (Pfizer) according to her CV. Her CV states that she received RESEARCH SUPPORT as "Principal Investigator. Upjohn "Assessment of Bone Mineral Density in Women Receiving Depo-Provera Contraception Injection. (1995-2002)"

Again, there is no evidence of publication of Dr. Merritt's 7 years of research. However now Pfizer says, "Women who use Depo-Provera Contraceptive Injection may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if use of Depo-Provera Contraceptive Injection during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk of osteoporotic fracture in later life."

And the package insert refers to a 7 year study that showed bone loss that was not reversible.