Use of letrozole for inducing ovulation justified: Kerala IMA

R Baby Manoj - Thiruvananthapuram

Letrozole is approved for marketing for the treatment of advance/metastatic breast cancer in post menopausal women. However, the Indian Medical Association’s (IMA) Kerala branch is of the view that the use of letrozole for inducing ovulation is perfectly justified. According to a letter by IMA, Kerala Branch (ref/no.IMA/KSB/SS/371 dated 23.12.2003, addressed to the then Health Minister, a copy of which was made available by this paper), held the view that the drug was widely used by infertility specialists as a second line of treatment for infertility, the first being ’clomiphene citrate.’ In order to corroborate their argument, the association cited data appearing in peer review journals like Fertility and Sterility, claiming that letrozole was used not on experimental basis, but as an accepted safe drug for inducing ovulation.

However Gopinathan argued that without clinical trials to ascertain any possible side effect, prescribing this drug for infertility is unethical and illegal. IMA Kerala branch office bearers Dr N V Markose (president) and Dr Jose M Malana (secretary) contend that ‘‘Since this drug is used for short course of five days and it is short acting, the side effects are minimum or practically nil. Since the drug is administered before ovulation and fertilisation, there is no question of terratogenicity (malformation of the foetus). Injectible gonado tropins used in the treatment for infertility is costly and raises several concerns including the need for intensive monitoring and higher incidence of multiple pregnancy.’’

With regard to the right of the drugs controller for attempting to dissuade the doctors from prescribing or patients from consuming a particular medicine, the association holds the view that ‘‘the drug controller can introduce a new drug for marketing, or ban a particular drug from being sold. We believe that the drug controller does not have the right to designate a particular drug for a particular disease, to be prescribed by a particular section of doctors. The practice of medicine is regulated by Medical Council of India, and not by the Drugs Controller. It is up to the doctors to decide the indication of a particular drug. For example, methotroxate marketed as an anti-malignant drug is widely used safely in the treatment of rheumatoid arthritis, psoriasis and ectopic pregnancy.’’

The Kerala Drugs Controller’s argument is that Letrozole could be prescribed only for treating breast cancer and not for inducing ovulation as per the permission given by the Drugs Controller General of India (DCGI). However he agrees that he can’t ask the doctors not to prescribe it. Instead it is within his powers to ask the drug store owners not to honour any prescriptions violating existing norm stipulated by the Drugs Controller’s office and hence this action.

It is learnt that Dr R Rajan, a medical practitioner in the Kottayam district of Kerala had conducted clinical trials for letrozole on women for the treatment of infertility without their consent and knowledge and not obtaining prior formal permission from DCGI’s office. In this regard, DCGI had already sought clarification from Dr Rajan. Dr Rajan could not be contacted for comment.

Dr Ramanand of ’A cure for incurable,’ a city based hospital specialising in oncology and women’s diseases opines that, ‘‘use of letrozole in a healthy women if used for ovulation may lead to developing cancer of ovary, breast or any other part of the body and the chance is one in every one thousand cases.’’ He feels that homeopathic medicines are better alternatives for inducing ovulation as they do not have any side effect.

Dr Ajith of Panacea hospital is of the view that letrozole is very effective in inducing ovulation and no significant side effect is reported so far. Clomiphene citrate is the preferred choice in the initial stages of treating infertility by inducing ovulation. If this is not effective a combination of clomiphene and letrozole is used. Still if the effect is not up to the desired level, letrozole alone is prescribed, he explained. He is of the view that the advantages of using letrozole far outweigh the disadvantages.

rbmanoj@express2.indexp.co.in