In this last in a series on the current state of male contraceptive research, Gregory S. Kopf Ph.D., Director of Research and Development, FHI 360, Durham, NC, issues a call to action.
Increasing numbers of men and women want new male options as part of their contraceptive method mix. While this demand could open new markets for the pharmaceutical industry, to date, Big Pharma has shown little to no interest in capitalizing on the opportunity. Fortunately, a steadfast and devoted group of non-industry scientists, clinicians and advocates—with a desire to bring new and innovative male contraceptive options to market—continues to move the idea forward. Slow and steady progress is being made, but important challenges still need to be addressed before new male contraceptives become a reality.
As noted in one blog in our series on male contraception, a number of hormonal approaches are currently in clinical trials while several non-hormonal targets and long-acting, nonsurgical, reversible vas deferens occlusion devices are being explored. In my opinion, the large number of unique and often highly expressed genes and proteins in the male reproductive tract—and in sperm cells themselves—present the best opportunity for developing a novel male method over the long term. In fact, the number of genes/proteins that may be unique contraceptive targetsappears to be higher in the male reproductive tract than in the female.
The availability of several genetic approaches (e.g., gene knock-outs and knock-ins; RNAi) enables scientists today to identify the function of specific genes. In addition, the increasing popularity of CRISPR-Cas9 gene editing techniques permit more rapid assessment of gene function. Once assessed, the unique character and function of these genes and proteins could be exploited, using both classic high throughput/content screening paradigms of chemical libraries or with the use of newer chemical compound screening approaches, such as DNA-encoded libraries. Together, these technologies may afford a more rapid identification of compound structures that target unique and critical processes in male reproduction that could ultimately result in contraceptives with few to no side effects.
While these new technologies bring excitement to new male contraceptive prospects, without a fuller understanding of what users (and their partners) want and would find acceptable, we are bound to fail. The few acceptability studies that have been conducted, as noted in another blog in this series, show that men want to be in control of their fertility and are willing to be active participants in family planning. Moreover, their partners trust them to take on this responsibility. As with women, unwanted pregnancy poses emotional and financial tolls on men, which adds to their desire for individual control of fertility.
Additional behavioral and acceptability research is needed to refine product preferences and delineate the market. Limited assessments conducted to date indicate a significant global market for new male contraceptive options and that some new products could command prices that would be profitable for the pharmaceutical industry. Understanding how different pricing scenarios align with current and evolving healthcare paradigms in both developed and developing markets will also be critical. Clearly, all of these factors need further systematic evaluation to strengthen the investment case.
Raising awareness about the need and demand for new male contraceptive options is also critical. Advocacy organizations (Male Contraceptive Initiative; International Consortium for Male Contraception; non-governmental research-based organizations (Guttmacher Institute; Population Council; FHI 360), and scientific societies (American Society of Andrology) all play key roles in keeping this important area of men’s health front and center. Along with the power of social media, efforts to promote the need, acceptability, market, and scientific cases for new male contraceptive options must increase if we are to be successful.
Here in the U.S., the nexus of these exciting early development activities lies with the National Institutes of Health, currently the chief funder of male contraceptive research. However, to advance product development through to commercialization, additional funding (e.g. USAID, Bill & Melinda Gates Foundation and the Parsemus Foundation) needs to be tapped. Perhaps even more importantly, new partnerships with industry must be forged. This call comes at a time when pharmaceutical companies continue to undergo seismic shifts in their business strategies, including a reduction and de-emphasis of research and development, and outsourcing of R&D activities once performed internally. Given their substantial resources, capacity to perform clinical trials, and ability to market and distribute products, pharmaceutical companies are indispensable partners for future male contraceptive development.
We must create new models of collaboration in which all parties view their engagement and investment as winning propositions. Therein lies our biggest challenge to bringing a new male contraceptive method to market. Considerations related to intellectual property and patent rights, investment costs, market demand, product liability and profitability must all be addressed. For the risk-adverse pharmaceutical industry, venturing into a new therapeutic area sets the bar for success that much higher.
While the challenges outlined here seem daunting, development of innovative and safe new products that appeal to a large number of individuals is at the core of private sector investment. We should be optimistic that society will continue to demand such innovation. Think about the innovations mentioned in this list of top 10 inventions that changed the world; contraceptives are # 2! Working in partnership, industry, research organizations, advocacy groups and funders could make new male contraceptives a top 10 invention of the 21st century.