Doctors in India have been
accused of prescribing women a drug that has been illegally promoted and
marketed for infertility treatment by a major drug company in the country.
In an editorial in its September edition, the drug industry journal, the Monthly Index of Medical Specialties India, has accused Sun Pharmaceuticals in Bombay of promoting an anticancer drug, letrozole, for infertility treatment in women.
Letrozole has been approved globally for the treatment of breast cancer in post-menopausal women, but it is not approved for any other use in any country. But Sun Pharmaceuticals has allegedly been promoting letrozole to gynaecologists across India for several months as an alternative to conventional drugs for inducing ovulation. This has apparently been done through visits to gynaecologists and infertility clinics and through seminars for doctors conducted in several Indian cities.
Drug industry analysts say that the case highlights the ease with which pharmaceutical companies in India can violate drug laws. "Promoting a drug for an unapproved use is illegal and punishable with fine and prison sentences," said Chandra Gulhati, publisher of the Monthly Index of Medical Specialities India.
"And it is unethical on the part of doctors to prescribe this drug to patients for infertility," said Dr Gulhati. Infertility specialists contacted by the BMJ said they did not realise the company had not obtained approval from the Drugs Controller of India for promoting letrozole to treat infertility.
Several countries, including the United States and India, had cleared letrozole two years ago for the treatment of breast cancer exclusively. The drug lowers levels of oestrogen—an effect that some researchers in the United States have tried to exploit to induce ovulation in women with infertility.
At least three studies have shown a positive effect of letrozole on ovulation. But an editorial in the Monthly Index points out that even researchers involved in these studies have cautioned that the drug has not undergone controlled trials and is not ready yet for being approved for routine infertility treatment.
Sun Pharmaceuticals has said it is investigating the circumstances under which its marketing division promoted letrozole for infertility treatment. "It is possible that some marketing people went overboard on the basis of published scientific papers and interactions with gynaecologists and infertility specialists," it said.
One doctor told the BMJ that she had to take panic calls from patients who read leaflets with the drug that said it is intended for breast cancer. "We assume that a drug being marketed has the required approvals," said Dr Indira Hinduja, medical director at the Inkus in vitro fertilisation centre in Bombay.
A spokesperson for Sun Pharmaceuticals said off-label application of drugs for indications not mentioned on its label is a widespread practice around the world.
Dr Gulhati said doctors who
felt that they just had to prescribe letrozole should have obtained
permission from hospital ethics committees and informed the patients that
they were being given a drug that has not been approved.