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Get new male contraceptives faster

None of the experimental male contraceptives reported on here are currently on the market. These contraceptives are in various stages of development, and the actions you can take to help bring them to market faster vary accordingly. In general, pharmaceutical companies need to be reminded of the size of the market for new male contraceptives. Contact the companies working on hormonal male contraceptives and pharmaceuticals based on Nifedipine or Zavesca to encourage their research.

In general, national policymakers need to know that the public wants them to prioritize financial and institutional support for the male contraceptive research community. Long-range support of basic science research, the development of an Andrology specialty recognized by the American Medical Association, and the addition of a male contraceptive research agenda to the proposed Office of Men’s Health would all benefit the male contraceptive research community.

Male hormonal contraceptives 

Some pharmaceutical methods are accessible through clinical trials as they are prepared for a broader market. This is the case with male hormonal contraceptives. Pharmaceutical company policymakers are researching the market potential of male hormonal contraceptives. Their sociological surveys show broad support for such products. You can add your voice to those of others who support the timely development of hormonal male contraceptives.

Two large pharmaceutical companies, Schering and Organon, are in Phase II clinical trials of a male hormonal contraceptive in Europe. Schering has developed new formulations of androgens for hypogonadism patients, while Organon manufactures a progestin that has proven potent in male contraceptive formulations. Both of these companies are based in Europe, but both have identified the growth of their United States market as a major objective. You can contact them and tell them that men in the US are awaiting a male hormonal contraceptive product.

Schering executive officer responsible for new product development within the andrology division:
Dr. Marc Rubin
Vice Chairman of the Board of Directors
Schering Berlin, Inc.
P.O. Box 1000
Montville, NJ 07045-1000
Organon executive officer responsible for new product development:
David Nicholson
Executive Vice President Global Research
Organon International, Inc.
56 Livingston Avenue
Roseland, NJ 07068

You can also contact the US Food and Drug Administration – the regulatory body responsible for oversight and approval of new contraceptive drugs – and ask them to create a set of guidelines for the assessment of new male contraceptives. Such guidelines could speed the regulatory process. The Advisory Committee for Reproductive Health Drugs makes recommendations to the FDA Center for Drug Evaluation and Research (CDER), while the CDER staff make final regulatory decisions.

FDA Advisory Committee for Reproductive Health Drugs Chair:
Dr. Arthur Burnett
Department of Urology
JHU School of Medicine
600 N. Wolfe Street
407 Marburg Building
Baltimore, Maryland 21287
FDA Center for Drug Evaluation and Research, Office of New Drugs, Office of Drug Evaluation III, Division of Reproductive and Urologic Products Director:
Dr. Dan Shames
US Food and Drug Administration
Center for Drug Evaluation & Research (HFD-580)
5600 Fishers Lane
Rockville, MD 20857

Nifedipine and Zavesca  

Intriguingly, some potential male contraceptives are drugs already approved in the US and elsewhere for other treatment purposes. This is the case with both Zavesca and nifedipine. Because these drugs have already received FDA approval, they can be prescribed to men willing to participate in a clinical trial of their contraceptive effectiveness. This makes the process for assessing them as possible male contraceptives much simpler. These tests would technically be Phase IV clinical trials, which are after-market assessments of a product’s performance.

However, the manufacturer of such drugs must be willing to develop their product as a contraceptive. In the case of nifedipine, because its patent has expired, several drug companies manufacture it generically. If these pharmaceutical companies were assured of the market for nifedipine as a male contraceptive, they would have an incentive to pursue its development.

Licensee of Aventis’ Cardizem:
Dr. Douglas Squires
Chief Executive Officer
Biovail Corporation
7150 Mississauga Road
Mississauga , Ontario L5N 8M5
CANADA
Makers of Adalat:
Dr. Udo Oels
Bayer AG
51368 Leverkusen
GERMANY
Makers of Procardia:
Dr. Michael Brown
Science & Technology
   Committee Chair
Pfizer, Inc.
235 East 42nd Street
New York , NY 10017
 

In the case of Zavesca, the manufacturer is willing to explore the development of the drug as a male contraceptive. Zavesca is currently priced at the maximum allowable European Union limit: nearly $7000 US for 20 pills. Presumably if the drug is a viable male contraceptive, its market would be exponentially larger than its current Gaucher patient market, and the drug price would drop proportionally. Contact Actelion to voice your support for their exploration of Zavesca as a male contraceptive, and let them know what you might be willing to pay for such a product.

Licensee of Celltech’s Zavesca:
Jean-Paul Clozel
Chief Executive Officer
Actelion
Gewerbestrasse 16
4123 Allschwil
SWITZERLAND

 

Supporting valuable basic science research 

American Society of Andrology

The work of male contraceptive researchers is built upon the scientific community’s understanding of the male reproductive system as a whole. New information about the way the male reproductive system works provides not only improvements to existing experimental male contraceptives, but also completely new approaches toward the control of male fertility. Scientists working as infertility specialists, endocrinologists, urologists, anatomists, biochemists, proteomic researchers, and molecular biologists are sharing this type of information through the American Society of Andrology (ASA). The ASA endowment is used to create real advances in the field by funding training sessions for researchers. They are also working to receive recognition from the American Medical Association for an Andrology specialty. You can make a donation to the ASA to support this work.

Send a tax-deductible donation to the ASA:
American Society of Andrology
1111 N. Plaza Dr.
Suite 550
Schaumburg IL 60173

National Institute of Child Health and Human Development

Another way to support basic science research is to advocate for increased funding from the government. University research programs across the country are supported by funding from the National Institute of Child Health and Human Development (NICHD), USAID’s Contraceptive Research and Development program (CONRAD), and the World Health Organization’s Department of Reproductive Health and Research. These organizations are, in part or in whole, funded by the US government. Congressional appropriations committees create legislative language that designates funding for specific goals within these organizations. Write to the Chairmen of the House and Senate Appropriations Committees for Health and Human Services to ask for earmarked male contraceptive research funding for NIH and CONRAD.

US Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies Chairman:
Senator Arlen Specter
711 Hart Building
Washington , DC 20510
(202) 224-4254
US House of Representatives Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies Chairman:
Congressman Ralph Regula
2306 Rayburn House Office Building
Washington , DC 20515
(202) 225-3876

In addition to direct funding for the NICHD, the Director of the National Institutes of Health has the discretion to allocate Roadmap funds to each constituent Institute. The Director takes public comments into account when making decisions about calls for Roadmap grant applications. Ask the Director to use Roadmap Interdisciplinary Research Initiative funding to further male contraceptive research. Here is a sample letter to the Director, Dr. Elias Zerhouni.

Dr. Elias Zerhouni
Office of the Director
National Institutes of Health
9000 Rockville Pike
Bethesda , Maryland 20892

The proposed Office of Men's Health

The Men’s Health Network, along with various US Senators and Congresspeople, has worked toward the establishment of a national Office of Men’s Health within the Department of Health and Human Services. The proposed Office would work to educate “men, their families, and health care providers about the importance of early detection of male health problems” such as prostate and testicular cancer. Encourage the bill’s sponsors to broaden their support base by including a health issue important to many men: reproductive self-determination. A better understanding of the functioning of the male reproductive system will lead to both innovative cancer therapies and potential male contraceptives.

Office of Men’s Health Resource Center
c/o Men's Health Network
P.O. Box 75972
Washington , D.C. 20013



 


To write a letter advocating the development of male contraceptives

Personal letters are the most effective advocacy tool. They get policymakers’ attention and, in the case of public officials, can be entered into the public record. Some points you might want to cover in a letter include:

• The origin of your interest in the experimental male contraceptive

• Why you find the method you are advocating worthy of your support

• How soon you would like to see it on the market

Click here for a sample letter to the Director of the National Institutes of Health.