[india-drug] Unapproved letrozole trials

[Sunitha Srinivas <s.srinivas@ru.ac.za>]

Unapproved letrozole trials conducted on 300 women by doctors in
clinics
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Monday, December 22, 2003 08:00 IST 
Joe C Mathew, New Delhi

Three hundred women in India were subjected to unapproved clinical
trial for the infertility use of letrozole by Sun Pharmaceuticals
during the last couple of years, it is learnt. The trials were carried
out by a handful of doctors at private clinics in various parts of the
country.

The doctors have clearly stated that the objective of their study was
to "examine the efficacy of letrozole for ovulation", "to study the
role of rosiglitazone, metformin and letrozole combine therapy to
estimate the success in ovulation induction, conception and maintenance
of pregnancy" etc. It is known that none of them were part of any
approved clinical trial over the new usage of the drug. 

When contacted, the doctors informed that they were never aware of the
regulations involved in carrying out such trials for this use. Some of
them admitted that representatives of Sun Pharmaceuticals had asked
them to undertake such studies. The company also suggested the
protocols, they informed. 

While the doctors admit that they had informed the patients about the
"new drug" that are being administered to them, none of them were in a
position to assert that they had informed the patient about the
"dangerous side effects" of the drug. Neither they felt the need for a
prior approval from the regulatory authorities for conducting such
trials. 

It should be noted that the records submitted by the innovator of the
drug to both US FDA and British Medicines and Healthcare products
Regulatory Authority (MHRA) have labeled letrozole as embryotoxic,
fetotoxic and teratogenic at miniscule doses. 

If the published reports are to be believed these half a dozen
self-styled researchers have subjected over 300 unsuspecting women to
the trials. The fact that they were willing to get their "research
findings" published and circulated by Sun Pharmaceuticals reveal their
ignorance of the illegal nature of the act that they had done. 

Legally all clinical trials require the permission of the Drugs
Controller General of India and approval by the concerned hospital
ethics committees. Research can only be conducted at recognized centres
by duly qualified and experienced investigators. Unfortunately the
companies are encouraging the doctors to take up clinical trials
without any such permission. 

The clinicians had presented their findings in foray like Indian
Congress on Gynecologic Endoscopy, Infertility and ART Jodhpur, ISAR
2003 Indore and AICOG, Banglore. The clinics where the trials were
conducted are Institute of Reproductive Medicine, Kolkata, Nagpur Test
Tube Baby Center, Nagpur, Hyderabad Fertility & Research Centre,
Hyderabad, Civil Hospital, Ajnala, Amritsar, Fertility Research Centre
Jodhpur etc. 

The doctors who had substantiated their claims in various medical
conferences are likely to be in trouble as the companies who had
prompted them to take up the trials have publicly admitted their
mistake in promoting the drug for unapproved use and have also
announced to withdraw all letrozole brands that were targeted at
infertility patients from the market. This was after the office of the
DCGI, responding to media reports on the illegal use of letrozole,
threatened the companies of grave action.



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