This Tuesday members of a House subcommittee will choose how much money to give to the U.S. Agency for International Development (USAID). The Senate will review the House recommendations a week or two later. What they decide can make or break contraceptive research.
Why does this matter so much? Because USAID is one of only two funding sources for contraceptive development in the US. Last year, an external review stated that USAID’s departure from this field would have devastating impacts; yet influential officials have advocated getting USAID out of the research business entirely.
If you live in California, Florida, Hawaii, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, or Wisconsin, your congressperson has an important vote on this issue.
Take a moment to send a message to your congressperson. The time to act is now: once the appropriations language is written, it will be hard to change. The 2008 budget – which will be written by mid-July – will determine whether USAID can finish the contraceptive development it has started.
It’s official: The new Phase III study of RISUG has started! The first men now have gotten their RISUG. In previous studies RISUG -- short for “Reversible Inhibition of Sperm Under Guidance” -- has been an effective contraceptive for at least 10 years, and in animal studies it has been reversible.
The first two men to get their RISUG injection as part of this study were in the central Indian city of Ludhiana. Investigators are not having any trouble finding volunteers, with 150 men already lined up at the New Delhi site and a couple dozen at a third site.
Because men in clinical trials must have multiple follow-up visits with the same doctor, men from outside India are not allowed to participate in this study. However, RISUG’s inventor and the Indian government are now expressing interest in international collaborations.
If RISUG studies make it to the US, they will need a funding source. Don’t let US contraceptive development funding dry up; if you haven’t already, send a letter to the Congressional subcommittee that is writing next year’s budget (see above for details).
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Recently ExpressIndia.com featured a story on RISUG with some misleading inaccuracies. For those who read the story, here are a few clarifications:
- The planned market price the article gives for India is an old number and shouldn’t be relied on; the price hasn’t been set yet. The eventual price of RISUG will depend on whether government and nonprofit interests fund its development or a deal is made with a pharmaceutical company.
- The article describes it as a 1-year study; but with follow-up, the total study time will be 7 years.
- The article says men are kept under observation for 2 to 3 weeks. This doesn’t mean they stay in the hospital; it just means they are interviewed after several days and give a semen sample after 3 weeks. They can get up and go home pretty much right after the procedure.
- Though no men in previous studies suffered serious side effects, it isn’t correct to say that there have been no side effects at all. About a third of the men in previous studies experienced painless swelling which resolves on its own within two weeks. Since a tiny hole is made in the scrotal skin before the injection, it isn’t correct to say that it is a nonsurgical procedure; however, no stitches are required.
- RISUG is not removed with a magnet. The reversal procedure is an injection of sodium bicarbonate (baking soda) solution, which dissolves the RISUG and flushes it out. The team researching RISUG has proposed a possible future generation of RISUG that could include a metallic substance which would make the RISUG visible during a body scan and might allow the use of a magnet to aid in its removal. However, in this study plain RISUG is being used.
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The Cochrane Collaboration is a respected nonprofit that gathers and reviews the evidence on healthcare issues. In April they published a review of 30 studies of hormonal contraception for men. Their conclusion: “The percent of men who achieved no sperm varied widely. We found a few major differences and describe them briefly below: implants plus injected testosterone worked better than a [progestin] pill plus testosterone patch; adding a hormone pill improved the effect of injected testosterone; a lower dose pill did not work as well as a higher dose when testosterone was put under the skin; when used with implants, a lower dose of injected testosterone led to no sperm more often than a higher dose; an injected hormone plus injected testosterone led to no sperm more often when given every 8 weeks versus 12 weeks; four implants of [MENT testosterone] worked better than two implants.
“Several trials showed good results for percents with no sperm. Five studies compared [desogestrel, etonogestrel, or levonorgestrel progestins] with testosterone. Most trials were small pilot studies trying out different hormone treatments. Larger trials with better methods are needed to find good leads in this area.”
Read more:
Grimes D, Lopez L, Gallo M, Halpern V, Nanda K, Schulz K. Steroid hormones for contraception in men. Cochrane Database System Review.
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Bayer has dropped out of a joint research project on a hormonal contraceptive for men, following Organon Pharmaceuticals’ departure in September. Schering, the remaining partner, says it will continue the research alone.
Bayer wouldn’t say exactly why it has dropped out of the research. Some speculate that the company considered the drugs’ delivery method of injections plus an implant too unpopular to develop further.
This decision underscores the difficulty of relying upon private enterprise to fund male contraceptive research. Contraceptives, which are essentially drugs for healthy young people, have inherent liability issues. Pharmaceutical companies have so far invested in “me too” versions of existing contraceptives, such as new variations on the Pill for women, rather than risking developing something truly new.
Like vaccines and drugs for tropical diseases, contraceptive development depends on public and nonprofit funding. With yet another pharmaceutical company program closing, it is more crucial than ever to maintain public funding sources. If you haven’t already, send a letter to make sure contraceptive development funding stays in the 2008 US budget.
Read more:
Bayer Breaks-Up With Male Contraceptive
Forbes.com, 8 June 2007
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Who will provide new contraceptives to men once they reach the market? Your federally funded clinics and private practices are one possible venue. Some of you already offer reproductive health care services specifically for men. Title X training centers have begun to train more providers, expanding both the number of venues offering these services and the range of the services provided. The Family Planning Male Training Center (FPMTC) is collecting information and coordinating training for Title X funded clinics.
The 4,700 US family planning clinics receiving Title X funding from the federal government are eligible to participate in the FPMTC’s annual meeting. The meeting offers clinical training and management tracks and draws nurses, outreach coordinators and Title X regional trainers who want to learn how to include men, the other half of the equation.
The FPMTC and affiliated doctors are working to create standard curricula for clinicians learning how to do a male reproductive health exam. In the US, there is currently no consensus on what training or qualifications are required to offer family planning services for men. As we move toward new birth control options for men, putting such guidelines in place will speed the introduction of these products.
Read more:
Office of Family Planning, Title X male involvement initiatives
Family Planning Male Training Center ’s statement of purpose
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The Family Planning Council of Philadelphia, PA, has developed a great resource for your male clients. In the “Men’s Health” section of their website is a primer for first-time male clients. The primer describes what a man can expect while his medical history is taken, and what a typical exam consists of. This information has been generalized and formatted as a PDF for any clinic to use.
There are more fact sheets at the new Male Contraception Coalition website.
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If you work for a Planned Parenthood Federation of America (PPFA) affiliate, you'll soon have a great new resource in the PPFA Manual of Medical Standards and Guidelines (MS&Gs): a new section on men’s reproductive health care services. The standards and guidelines have been developed by the national office staff in collaboration with several affiliate medical directors and the PPFA National Medical Committee, which includes Dr. David Bell of the Columbia University Young Men's Clinic. Topics covered include the management and treatment of balanitis, epididymitis, erectile dysfunction, penile skin lesions, benign prostatic hyperplasia (BPH), and many others. The 2007 MS&Gs will be available to all PPFA affiliates on the PPFA extranet in late June.
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Bayer Pharma decides to drop out of a joint study of hormonal injections plus implants; only Schering is left.
Bayer Breaks-Up With Male Contraceptive
Forbes.com, 8 June
Long interview and profile of Joseph Tash, the University of Kansas researcher who recently received a multi-million-dollar NIH grant to continue his team’s work on Gamendazole and other potential male contraceptives.
Sperm: The Final Frontier
The Pitch, 31 May
Coverage of the re-starting of the RISUG clinical trial, and interviews with researchers at one of the sites. We enumerate some corrections and clarifications above.
A shot that works for 10 years
Indian Express- Chandigarh Newsline, May 20
The city of Pune in India starts a campaign to popularize vasectomy and address myths.
With just 174 vasectomies, bureau plans PMT campaign
Indian Express- Pune Newsline, May 3
The Indian state of Tamil Nadu is elated to have achieved its population goals. But why does so much of the burden fall on women, with many women believing that an IUD is mandatory after their first child and female sterilization after their second? And why is use of condoms and vasectomy so abysmally low? This well-written opinion piece asks tough questions and isn’t afraid of uncomfortable truths.
Planning for the future
Newindpress on Sunday, April 27
Men’s and women’s views — and concerns — about the “male Pill” idea, such as this quote from Adam Wroblewski, age 29: "It's just another option… If both people are taking the pill, that's doubly safe."
Male pill idea may prove hard to swallow
Milwaukee Journal Sentinel, 26 April
Coverage of Adjudin, male hormonal contraception and RISUG.
A birth control 'pill' for men?
Jamaica Gleaner, 15 April
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Planning to attend a family planning event that's not listed here? Let us know so we can post it and alert your colleagues to interesting upcoming events.
June 22 |
Creative Methods for including Males in Clinic Services and Contraceptive Decision-making for Region VI Oklahoma Title X Grantees; Multisite videoconference |
July 21-25 |
40th Annual Meeting of the Society for the Study of Reproduction; San Antonio, Texas, USA |
September 26-29 |
Joint meeting of the Association of Reproductive Health Professionals and the Planned Parenthood Federation of America, Reproductive Health 2007; Minneapolis, MN |
September 27-28 |
2nd Future of Male Contraception conference; Seattle, WA, USA |
Oct 13-17 |
American Society for Reproductive Medicine; Washington , DC |
November 3-7 |
American Public Health Association 2007 Annual Meeting “Politics, Policy & Public Health”; Washington, DC |
2008 |
January 1 |
Deadline for European Society of Contraception abstract submission |
April 30 - May 3 |
10th Congress of the European Society of Contraception; Prague, Czech Republic |
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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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