Injecting doubt

There's nothing new about new drugs running into a controversy. But there certainly is a need to cap alarmist claims, emotional demands, uni...

There8217;s nothing new about new drugs running into a controversy. But there certainly is a need to cap alarmist claims, emotional demands, uninformed debates and allow a free and fair appraisal by independent and unimpeachable medical bodies of the drug in question. The latest controversy concerns the indigenously-developed RISUG, or Reversible Inhibition of Sperm Under Guidance. This May, the Union health ministry had claimed it as the world8217;s first male injectable contraceptive. RISUG is the product of research 8212; spanning 25 years 8212; by the biomedical engineering division of the Indian Institute of Technology in collaboration with the Indian Institute of Medical Research and the All India Institute of Medical Sciences.

Clinical trials during Phase I and II had shown that a single shot injection into the scrotum resulted in the destruction of the fertilising ability of sperms without any adverse impact on male sexuality. An important aspect was that the reversibility factor was not dependent on surgery 8212; a radical and user-friendly departure from other surgical contraceptive procedures. The working of the injectable was also different and innovative. It generated a small electrical charge on the sperm leading to enzyme changes and disintegration of sperms.

The new controversy over RISUG is over scrotal swelling and the presence of albumin in the urine in the trail subjects. The scrotal swelling is not a new development because it was reported and documented in the Phase I and II trial stages and was a temporary reaction that subsided after three weeks. The albumin angle needs further probe as it involves kidney functioning. These side reactions are not very alarming to warrant a ban. They demand, instead, long term observational studies. The clinical trial studies on RISUG were done by premier hospitals in India which have given the injectable a clean chit and there is no reason to doubt this. The charge that the drug is being targeted by multinational lobbies also needs a closer look because of the large interest that RISUG had generated in China, Malaysia, Thailand and other countries struggling to cope with their population numbers. Clearly, it would be too early, harsh and unwise to abort the RISUG.