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 [between different regimens]… Several trials showed good results for percents with no sperm… 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 a plain-English summary of the study:
Hormones for contraception (birth control) in men.
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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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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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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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