Breaking news on RISUG, the vas-based contraceptive that lasts ten years or more: Manufacturing difficulties have been resolved, and the Phase III trial can be restarted next month!
The Indian Council for Medical Research worked with India’s Central Glass and Ceramic Research Institute to produce a glass syringe designed specifically for RISUG. The syringes have been manufactured for the trial, and the private company Marksans Pharma has manufactured RISUG and gotten the special syringes filled.
Researchers are planning to restart the Phase III trial of RISUG in March. (The study on 140 men begun in 2001/2002 is now being called a “preliminary” Phase III trial, and this new part is being called the “extended” Phase III trial.) The study design includes 10 centers throughout India with 50 men at each center. (The first 4 of the centers have their paperwork done or nearly done and will start in March, and the other 6 will be a second round.) The research team estimates that the recruitment phase will take about 2 years. They plan 3 to 5 years of follow-up after administering RISUG, so the total study duration will be up to 7 years.
What does the resumption of the Phase III clinical trial mean for men who live outside India? Don’t book your plane ticket to India yet! This study is limited to local men, because regulatory agencies require standardized follow-up visits overseen by the same doctor. However, this is a good time to express your support for research collaborations with scientists in your country – particularly in Canada and the United States where there are already nascent collaborations. If you haven’t already, be sure to fill out the survey and sign the petition – and tell your friends!
We don’t have details yet on which Good Manufacturing Practice (GMP) standards Marksans Pharma followed while manufacturing the RISUG. Thanks for all your letters on this issue, which we’ve passed on. (See the September and November 2006 editions of the Male Contraception Update for the background on this story.) Check back next month for an update.
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The International Male Contraception Coalition, which runs MaleContraceptives.org, is about to release the first issue of a quarterly report for policymakers. The report makes the case that men and women around the world are ready for new male contraceptives.
Its centerpiece is an analysis of the online survey, signatures of the men and women who signed the letter to policymakers, and personal stories explaining why signatories care about this issue. Seven hundred and thirty-four folks participated in the survey in its first quarter, and 584 folks signed the letter. The names and quotes fill 6 pages!
The quarterly reports will be ongoing, and the IMCC will keep a running tally of survey participants and signatories. As the numbers grow, so does the case for increased support for the work of male contraceptive developers. Keep spreading the word about the survey.
We especially appreciate the articulate comments and personal stories we got from men and women around the globe, from Hawaii to Texas to Canada to Germany. They help remind policymakers that real people and their lives are at stake.
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In MaleContraceptives.org’s survey, 96% of men said that they would go to a doctor to get a new male contraceptive. Yet aside from their general practitioner, men don’t have many options. For men in Manchester, England, that has changed.
The Manchester Royal Infirmary (MRI) has opened Britain ’s first Centre for Andrology, which will provide “a range [of services for male] infertility, hormonal and sexual conditions.” Dr. Fred Wu explained the impetus for creating the center: “Traditionally, women have accessed health care for female disorders through contraception and baby care services, but the equivalent male services don't exist - so their problems tend to be worse before they get help.” Dr. Wu hopes that providing services specifically for men will lead to faster diagnosis and treatment. Dr. Wu has coordinated studies of hormonal male contraceptives at the MRI and knows the new center will be a perfect place to provide new male contraceptives. Let’s hope this clinic inspires more of its kind!
Read more:
First 'just for men' health centre opens
Manchester Evening News, January 31
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In an editorial for an upcoming issue of the academic journal Fertility and Sterility, Drs. Jerry Strauss and Gautam Chaudhuri chronicle the recent trend of pharmaceutical companies backing out of their reproductive health research programs. They cite Ortho-McNeil and Wyeth’s quiet discontinuation of their contraceptive R&D programs, and an uncertain future for Schering’s programs. “As a consequence of these changes, a generation of reproductive scientists with skills in product development will evaporate, and the expertise to train new scientists in this area will be gone…”
“What’s to be done? We will have to place our trust in the existing [National Institutes of Health]-supported contraceptive development and infertility research centers, and committed individuals, including those recently released from companies that are eliminating their reproductive-health discovery programs, to keep on target. Even with the long time horizon, academic obstetrics and gynecology has got to get moving and produce researchers with expertise in this area. Small pharma and biotech need to step up to the plate. Moreover, what is likely to be the salvation of the field of family planning and fertility treatments should be considered: a concerted effort to outsource research and development and product development to countries such as Brazil, China, and India, which have contraceptive and reproductive health needs and emerging biotech and pharmaceutical industries.”
Translation: Let’s hope government and family foundation-funded programs have enough support to hire the researchers who are losing pharma company jobs. Otherwise there will not be jobs in the U.S. and E.U. for contraceptive developers, and it will become a self-perpetuating cycle as the scientists qualified to train the next generation of researchers leave the country or leave the field.
For many years, the National Institutes of Health (NIH) created a “brain drain” in other countries as scientists seeking steady funding and interesting work moved to the US for NIH jobs. If NIH and USAID’s funding continues to suffer cuts, those scientists may reverse course, and it will be the U.S. experiencing the “brain drain.”
Read more:
The accelerated pace of pharma abandonment of research and development in family planning and fertility – will reproductive health technology be frozen in time?
By Drs. Jerome Strauss III and Gautam Chaudhuri
Fertility and Sterility, Epub ahead of print on January 12, 2007
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A discussion Dr. John Herr’s work on sperm tail proteins and the new home sperm checks his company has developed, which may be useful post-vasectomy and for men using heat methods. He is hopeful that the tests will be on the market within the next year.
University researchers work toward developing male contraceptive drug
Cavalier Daily, February 19
“This week a new study will reveal how much ignorance surrounds contraception in Britain. Here Lucy Fairford tells how, after suffering years of mood swings, she found the pill might be to blame.” A compelling story of how different individuals react differently to formulations of the Pill.
I quit the pill and got my life back
The Observer, February 11
A college woman’s thoughts on male birth control.
A hard pill to swallow: Male birth control a mixed promise of things to come
The Breeze, January 25
A discussion of last month’s news about British work on a potential nonhormonal male pill. The Nigerian men interviewed are skeptical and ask: Why would I be a guinea pig when I can use condoms?
Male contraceptive pill promises heaven on earth
The Nigerian Tribune, January 31
Thoughts on men’s and women’s attitudes on contraception in Vietnam.
Condoms, considerate men prove best bets
Vietnam News Agency, January 28
To end, a humorous look at hormones and how they affect our experience of being in love.
The science of love
The Daily Mail, February 12
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Editors
Elaine Lissner, Director of the Male Contraception Information Project (MCIP)
Email: info@NewMaleContraception.org
MCIP is entirely nonprofit and works in three areas: raising public awareness of promising nonhormonal male contraceptives, advocating increased and expedited government research, and serving as a resource for journalists who wish to write about the subject.
Kirsten Thompson, Director of the Male Contraception Coalition (MCC)
Email: info@MaleContraceptives.org
The Coalition’s objectives are to speed the development of new male contraceptives through increased legislative and institutional support, to raise funds for applied male contraception research and development, and to educate the public about the work of the research community.
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