[india-drug] Illegal drug trials in India

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(Source: Edrug. Thanks?.SS)

Illegal drug trials in India
------------------------------------

The following editorial has appeared in the latest
issue of MIMS INDIA (Vol. 23, Number 12; December
2003)

Illegal trials on letrozole:
Hundreds of Women Used as Guinea Pigs

Over 430 unsuspecting young women have been used as guinea pigs by
self-styled researchers in India to test if an anti-cancer drug
Letrozole can be used to induce ovulation. The clinical trials have
been
conducted illegally without permission from the Drugs Controller
General, India (DCGI) predominantly at private clinics not recognized
as research centres. At least one ?investigator? with just a diploma in
gynaecology could hardly claim to be qualified or competent enough to
try untested drugs.
Curiously enough, based on documents submitted by the innovator of the
drug Novartis, both the U. S. Food and Drug Administration (USFDA) and
the British Medicines and Healthcare products Regulatory Authority
(MHRA) have labelled Letrozole as embryotoxic,fetotoxic and teratogenic
at minuscule doses of one-tenth to one-hundredth of human dose. The
drug is contraindicated for use in pre-menopausal women, the
sole candidates for infertility treatment. Its other serious side
effects include: ovarian tumours, liver cancer, angina, myocardial
infarction, life-threatening pulmonary embolism, hemiparesis, loss
of libido and stroke.
Being an anti-cancer drug, letrozole belongs to Schedule G of the Drugs
and Cosmetics Rules and therefore can only be sold against
prescriptions from cancer specialists. This warning is clearly printed
on every strip of the medicine. In violation of this rule, unauthorised
practitioners have been prescribing and retailers selling the drug.
It may sound incredible but animals subjected to experiments in the
United States enjoy more protection than human subjects in India. Any
trial done on any animal without permission from the Ethics Committee
carries a mandatory fine of Rs. 120,000 (US$ 2,500) under Animal
Welfare Act. In India, hundreds of young women have been treated worse
than animals in America.
When contacted, the ?researchers? claimed that a Mumbai-based company
marketing letrozole had requested them to undertake clinical trials.
Unlawful trials were conducted at the following places:
? Dr. Anoopkumar Gupta, at a private clinic called
?Delhi IVF Centre?. Number of women in the trial: 35
? Dr. Sadhna Patwardhan and Dr. Mangala Ketkar, at a
private clinic called ?Nagpur Test Tube Baby Centre."
Number of women in the trial: 10.
? Dr. B. N. Chakrabarty at the Institute of
Reproductive Medicine, Kolkata. Number of women in the
trial: 45.
* Dr. Vandana Batra and Dr. Sanjay Makwana at a
private clinic called ?Vasundhara Hospital & Fertility
Research Centre?, Jodhpur. Number of women in the
trial: 60.
? Dr. S. S. Chawla at District Hospital, Ajnala
(Amritsar Dist.). Number of women in the trial: 40.
? Dr. G. Padmasiri, at a private clinic called
Hyderabad Fertility and Research Centre. Number of
women in the trial: 111.
? Dr. Mandakini Parihar. Number of women in the trial:
not disclosed.
? Dr. Konkan Mitra, Dr. B.K.Mitra. Number of women in
the trial: 75.
? Dr. S. Krishna Kumar. Number of women in the trial:
59.
(Source: Booklet of Sun Pharmaceutical Industries Ltd,
Mumbai).

The "results" of these illicit trials have been extensively used by
pharmaceutical manufacturers to illegally promote letrozole for
ovulation induction. 
As per ORG-MARG data, the annual sale of letrozole exceeds Rs. 6 crores
with a growth rate of 430 per cent in the case of just one company
alone. Such illegal trials are conducted without any fear
because regulatory authorities, either by design or default, fail to
take suitable action. A couple of years ago, totally untested new
chemical entities (NCEs) called M4N and G4N discovered in the United
States were unlawfully tested on 26 oral cancer patients at the
Regional Cancer Centre (RCC) in Thiruvananthapuram. Under unrelenting
pressure from the media and NGOs, an unwilling Government was
literally dragged to take action. Instead of penalizing the guilty,
further research on untested substances was temporarily suspended for
six months.
The law provides for three months imprisonment for the guilty.

All clinical trials in India require prior permission from DCGI and
approval by the concerned Hospitals? Ethics Committees. Drug trials can
only be conducted at recognized centres by duly qualified and
experienced investigators As per Section 122 (E) of the Drugs and
Cosmetics Rules, all drugs are considered new if they are to be
tested for an unapproved indication. Clinical trial of ?New Drugs? is
governed by Schedule Y of the D&C Rules. There are a large number of
pre-conditions but important ones are: submission of Protocol,
Investigator?s Brochure, Case Report Forms (CRFs), draft of Informed
Consent documents in English and local language by the sponsor to DCGI
to obtain approval. Insurance or similar arrangement have to be
made to compensate patients in case of trial-related injury including
loss of wages and income. Once DCGI approval is received, an
application has to be made to the Ethics Committee of the recognized
research hospital. Trials can begin only after the Ethics Committee's
permission is received. Patients have to be specifically informed that
they are being subjected to a trial and there could be risks
involved. Their written consent is legally mandatory. Progress reports
on all clinical trials have to be submitted periodically to the Ethics
Committee and finally to the DCGI.

Most of the clinical trials in India are conducted without any
arrangement for compensation in case of study-related injury,
disability or even death. Indian Council of Medical Research (ICMR)
Guidelines specifically require that each research ?shall include
in-built mechanism for compensation for the human subjects?to cover all
foreseeable and unforeseeable risks.?

The investigators for clinical trials, particularly when drugs are to
be tested, are chosen by sponsoring companies. Naturally, all
manufacturers want that their products should be found to be safe and
effective. There cannot be a better way to ensure positive results than
to select friendly, obliging and ever willing investigators to do the
bidding. Many investigators that conduct clinical trials are, or
have been, beneficiaries of largesse from the pharmaceutical
manufacturers. The financial ties include paid speaking engagements,
shares of the sponsoring companies, expensive gifts such as cars,
refrigerators, air conditioners, medical equipment, attendance at
sponsored scientific conferences, paid consultancy work, authoring
?ghostwritten? scientific articles and travel grants for domestic and
foreign travel. Last year a Mumbai-based foreign company
marketing erythropoietin had obliged some 300 senior most nephrologists
to visit Singapore on an expense paid jamboree, an effective strategy
not only to garner more prescriptions but ensure positive results
of future clinical trials.

Neither the regulatory authorities nor the Ethics Committees seek
conflict of interest information from investigators.

Unless laws are fairly and firmly implemented, the current
unsupervised, unethical and often illegal trials will pave the way for
similar tests in gene therapy that may leave many Indians diseased,
deformed or even dead.

=====
Dr. Chandra M. Gulhati
Editor, MIMS INDIA
(Monthly Index of Medical Specialities)
503 Mansarovar,
90 Nehru Place,
New Delhi 110019.

Tel: 26433115
Fax: 26424016/26463720
seeemgee@yahoo.co.uk


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