http://bmj.com/cgi/content/full/325/7357/181
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A doctor who gave the anti-impotence drug sildenafil (Viagra) to three newborn babies with pulmonary hypertension has caused a controversy over the unauthorised use of the drug.
In what may be the first such case in India, the babies were given Viagra orally at the Amrita Institute of Medical Sciences and Research Centre, a private charitable trust, at Kochi, Kerala, in May and June.
Standard intensive treatment had failed, and Viagra was given in a situation described as "life threatening" by APS Krishnan, vice president and spokesman for the Amrita Institute.
"There were children dying in my presence, and I was expected as a responsible physician to use all available methods to save my patients," Dr Parapurath Kovummal Rajiv, head of newborn services at the institute, said. "So, I used sildenafil citrate," he added. All three babies lived.
The doctors were using the drug to dilate the blood vessels supplying the babies' lungs, in the hope of reducing pulmonary hypertension.
Dr Rajiv was criticised by local non-governmental organisations and the national media for unethical and illegal administration of the drug. Such a use is not authorised by the drugs controller of India; Viagra is authorised under medical supervision only for male erectile dysfunction. The institute discounts ethical concerns in this case. "The question of ethics arises in the case of clinical trials," said Mr Krishnan.
"Using the drug on three patients acquires the form of a planned experiment," said a WHO expert, who did not want to be named. Such persistent unlicensed use cannot be acceptable, he added. If something went wrong, the doctor could be held responsible.
Dr Weerasuriya, regional adviser on essential drugs for WHO's south east Asia region, said the next step should be to take all the available data and evaluate the new use scienti-fically. "Maximum benefit can be derived by thoroughly investigating it under controlled clinical trials," he said.
Dr Mira Shiva of the Voluntary Health Association of India, a leading non-governmental health organisation, was concerned that other doctors may adopt this treatment.
"India has acquired the potential of becoming a fertile ground for non-transparent or even clandestine drug trials by Indian and foreign companies without accountability, compensation, surety, or safety of patients," she cautioned.
However, she added: "My sense of ethics allows using sildenafil citrate as a life saving drug for children."
Faced with hostile reactions in sections of the media, Mr Krishnan would say
only that it would depend on the medical condition of the patient and
the judgment of the doctor concerned whether they would repeat the
treatment.
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Collections under
which this article appears:International
health Heart
Failure Infants
Neonates
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