Letters to the Editor

Indian Pediatrics 2002; 39:894-895

Viagra Neonatal Experimentation - The Pandora’s Box!

The news is full of the successful experiment with Viagra in three neonates with Persistent Pulmonary Hypertension. This report followed a publication in a magazine and featured on a television news interview (Star News) where it was justified as a desperate and successful attempt to save lives. This methodology, using the lay press, echoes numerous announcements like a similar Bangalore transplant team’s decision to ‘permit’ a mentally retarded sibling to donate a kidney for a brother on similar grounds.

There is evidence that Viagra (Sildenafil) may have potential. Intravenous Sildenafil is a selective and highly effective pulmonary vasodilator, which is at least as effective as inhaled nitric oxide, in a model of neonatal persistent pulmonary hypertension. The models were pulmonary hypertension induced in 18 piglets(1). The randomized controlled study on Sildenafil concluded that it has a beneficial pulmonary hemodynamic effect in adult humans and mice(2). There are no human neonatal studies available.

The issue is not the above claimed success, but that the Pandora’s box has been opened in tolerating such clinical research. Innovative treatment would be difficult to differentiate from clinical research/human experimentation especially since the drug has never undergone adequate human studies especially in children. Health research plays a pivotal role in addressing inequities in health and human development, but to achieve these objectives the research must be based on sound scientific and ethical principles(3). Research involving patients as per guidelines of the ICMR can be undertaken, provided ethical considerations are borne in mind(4). If we are all allowed to proceed with similar clinical research we would be on the ‘slippery slope’ and we would not be able to check any further "research", including the attempted pig heart xenotransplant. The fact that this was announced on a National Television News broadcast does not assist the case since there was no attempt at first peer review and medical publication of the facts, yet another common trend in fashion today. Another question that could be asked was whether this was a yet another simple attempt at publicity to invite attention to self or achievements in contraindication to the MCI’s article 6.1 on Unethical Acts - Advertising(5).

.

References

1. Shekerdemian LS, Ravn HB, Penny DJ. Intravenous sildenafil lowers pulmonary vascular resistance in a model of neonatal pulmonary hypertension. Am J Respir Crit Care Med 2002; 165: 1098-1102.

2. Zhao L, Mason NA, Morrell NW et al. Sildenafil inhibits hypoxia-induced pulmonary hypertension. Circulation 2001; 104: 424-428.

3. Bhutta ZA. Ethics in international health research: a perspective from the Developing world. Bull World Health Organ 2002; 80: 114-120.

4. The Indian Medical Council Research. The Indian Medical Council Regulations 2002 Article 7.22. Part III Section 4 Gazette of India 6 April 2002.

5. The Indian Medical Council Advertising. The Indian Medical Council Regulations 2002 Article 6.1. Part III Section 4 Gazette of India 6 April 2002.