Male Contraception - The Profit Factor

The hype about encouraging male responsibility in reproductive health and contraception notwithstanding, male sterilization accounts for less than three per cent of all sterilizations in India. And when it comes to male contraceptives, many factors - not least the pharmaceutical industry's concerns about profits - come into play.

Globally too, the overall scene is skewed in the direction of female contraception. The reason for this is not hard to find. It is a common perception -- shared by the public and policy makers alike -- that reproduction, and therefore contraception, are the responsibility of women. And if condoms are registering their presence, it is more because of the growing fear of HIV-AIDS and other sexually transmitted diseases.

In India only 34.42 people have shown interest in any form of family planning as per the Annual Report (1999-2000) of the Ministry of Health and Family Welfare. A total of 4.18 million sterilization operations were reported during 1998-99, of which tubectomy acceptors (women) formed the bulk at 97.6 per cent. Fear of impotence, decrease in libido and apprehension of general weakness are reported to be deterrents to acceptance of vasectomy.

In fact, only five per cent of the world's married couples opt for vasectomy - but some countries have a better record in this respect. The percentage of contraceptive-using married couples opting for vasectomy is as high as 13 to 15 per cent in Korea, Australia and the Netherlands. It is 17 per cent in the United States and Great Britain, 31 per cent in New Zealand and 41 per cent in Nepal. Says Professor GP Talwar, Founder Director of the National Institute of Immunology (NII) and the Director of Talwar Research Laboratory, "No Indian man really cares about male contraception, and methods like vasectomy are avoided due to fear of surgery."

Yet, men are not totally averse to accepting responsibility for contraception. As far back as 1985, a World Health Organization study found that between 41 and 75 per cent of the men interviewed would welcome a safe, reversible, convenient, non-surgical male contraceptive. And if recent developments are any indicator, scientists are responding to this need. Dr Sanjoy Guha, professor at the Indian Institute of Technology, New Delhi, announced a breakthrough in reversible male contraception.

This method, called Reversible Inhibition of Sperm Under Guidance (RISUG) earlier known as Styrene Malic Anhydride (SMA) made news in late April when it was clinically proved that one injection into the vas deferens could cause membranes or sperm heads to rupture and thus make them incapable of fertilizing the egg.

One of the main advantages of this method is its reported reversibility. Although the method has a lot of potential to gain popularity, most drug companies have not found it a profitable venture since one 60 mg injection would last 10 years. Phase III clinical trials on the method are currently underway.

Other methods like the Medical-Grade Polyurethane (MPU) plug and the Medical-Grade Silicon Rubber (MSR) plug to block sperm have reportedly gained popularity in China. Since 1983, an estimated 300,000 Chinese men have used this contraceptive method. However, even in China, no interest seems to have been shown from the pharmaceutical industry to mass manufacture these products.

"Most of these indigenous methods do not get industry recognition due to vested interests," explains Dr Anup Dhir, Senior Andrologist, Ashlok Hospital. It is true that till a drug gets approval from the US Food and Drug Administration (FDA), worldwide manufacturing and marketing of these drugs does not usually take off. While India has its own monitoring body -- the Drugs Controller of India, whose approval is necessary for any manufacturing or marketing of drugs, approval in India is often linked to FDA approval.

Another factor that has an impact on drug research and manufacture, is the profitability factor among pharmaceutical companies. To quote one instance, Nifedipine, a drug used to treat high blood pressure and migraine, was also being tested for its contraceptive effect since 1992. In 1999, Dr Susan Benoff, associate professor at the New York University School of Medicine reported its contraceptive effects. Studies indicate that the drug blocks the calcium channels in sperm cell membranes, makes the sperm membranes rigid and prevents them from binding with the outer layer of the ova.

Yet, this pill has never hit the market as a male contraceptive. The drug, which is manufactured by major pharmaceutical giants like Pfizer, Hoechst, Marion Roussel and Bayer has been available in the market for the last 20 years as a drug to treat hypertension. For obvious reasons, drug companies are reluctant to make public the findings about the drug's contraceptive effects, since they fear loss of their share in the market for anti-hypertensive drugs. Moreover, the patent on Nifedipine is about to expire, which means other drug companies too can manufacture the drug with
price cuts, thus cutting into the profits of the larger companies.

Another product that is at the research stage is the sugar pill, developed by Dr Joseph Hall of Norfolk State University after 15 years of research. This pill is believed to disrupt the binding of sperm with the outer layer of the egg. His team found the efficacy rate to be as high as 98 per cent and it was announced that clinical trials on human beings would start sometime in 2002. Although holding considerable potential, not much has been heard about his research.

"The sugar pill has a very promising future compared to other drugs as it does not have side effects," says Dr SK Wangnoo, Senior Consultant (Endocrinology), Indraprastha Apollo Hospital, New Delhi.

While some male contraceptives face road-blocks due to vested interests in the pharmaceutical industry, others are abandoned due to lack of reversibility. For instance, Nofertil, a proposed male contraceptive made out of the non-hormonal fertility-inhibiting molecule gossypol (extracted from cottonseed oil) created a stir when researchers in China and Brazil recognized its contraceptive effects. But its lack of reversibility forced the World Health Organization to abandon clinical trials on Nofertil in 1998.

Similarly, most of the drugs that hormonally suppress sperm production are not readily acceptable to the user. Doctors as well as the industry feel that these drugs have systemic effects on the human body, which may not be desirable. "Using testosterone and progestin, the synthetic form of the female hormone progesterone, can have a contraceptive effect in a male. However, if such a drug leads to loss of libido and hot flushes or even development of breasts in men it is less likely to get accepted," says Dr Subramanian, Senior Urologist and Andrologist, Indraprastha Apollo Hospital.

Most researchers, funders and doctors believe that the "male pill" will take a few more years to formulate and many more years to get approval. Even if certain drugs manage to get approval, it is a moot question whether the pharmaceutical industry will be convinced enough about marketability to jump into the fray.


More by :  Sudeshna Banerjee

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