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Oct-Dec2001-9(4)
EDITORIAL
Research : history repeats
itself
Sandhya Srinivasan,
Sanjay A Pai
The news that patients at the Regional Cancer
Centre (RCC) in Trivandrum were administered an experimental drug without their
knowledge should not surprise us. However, the very fact that this trial took
place is a reflection on the inadequacy of existing mechanisms to protect
participants from unethical research.
Between November 1999 and April 2000, 25 oral
cancer patients at the RCC had their tumours injected with tetra-O-methyl
nor-dihydro-guaiaretic acid (M4N) or tetraglycinyl nor-dihydro-guaiaretic acid
(G4N), an experimental chemical in an attempt to evaluate the anti-tumour
properties of the chemical.The study was initiated by Professor Ru Chih C Huang
of the Johns Hopkins University (JHU), USA, with funding from JHU.
Patients had not been informed of the chemical's
risks and were exposed to the toxic effects of an untested drug. (In US studies
the chemical was found to stimulate human cancers.) The trial was also conducted
without the prior approval of the Drug Controller General of India
(DCGI).
A breach of trust
The trial represented a serious breach of trust -
the very basis of the doctor-patient relationship. People with cancer went to
the RCC for treatment - and were used as experimental subjects. The chemicals
had earlier been tested on mice at JHU, but no human trials had been done Thus,
patients were exposed to a potentially dangerous chemical without their
knowledge. In the belief that they were undergoing standard, life-saving
procedures, they signed what they thought were routine consent forms in English,
a language they did not understand well. They certainly had no idea that they
were helping the RCC develop a drug from which it planned to earn royalties.
Finally, Indians were used as guinea pigs to test a drug that could not be
tested in the US. Thus, all principles of medical ethics - patient autonomy,
beneficence, non-maleficence and justice - were flouted. How did this trial take
place at all? Sanction from the Drug Controller-General of India (DCGI) was
given only in February 2001, almost a year after the trial's completion. (It is
not clear how approval for this phase II trial was obtained, since reportedly
phase I trials were not done.) The RCC ethics committee okayed the study -
despite its evident flaws, and without confirming that it had obtained DGCI
approval. JHU released funds even though its ethics committee had not cleared
the project.
A failure of institutional monitoring
mechanisms
If two respected institutions could ignore the
ICMR's ethical guidelines, international guidelines such as the Helsinki
Declaration, as well as the DGCI's legal requirements, one can only speculate on
what is happening in the thousands of medical research projects in public and
private institutions all over India. How many unethical studies go unreported
because no one steps forward to complain?
Health authorities recently enquired into how
patients in a private New Delhi hospital received an experimental treatment for
coronary artery disease - developed in the US but not tested there. But such
action is the exception not the rule. Women's and health groups had to go to
court before the DCGI agreed to ban the unapproved testing of quinacrine as a
'chemical sterilising agent'. By that time, thousands of poor rural Indian women
had been sterilised, with unknown consequences, and the court did not sanction a
follow-up of the women who have been experimented on.
Further, the ICMR does not have the machinery to
effectively monitor the research it does fund; it has no authority over studies
funded by other organisations. In fact the RCC plans to continue its work and
the trial is scheduled to continue in three other hospitals. In effect, there is
nothing to protect Indians from unethical research.
The situation is all the more frightening as India
becomes the site for increasing amounts of collaborative drug research,
especially for multinational drug companies. We have competent medical
professionals, the technical facilities - and thousands of poor patients. A
trial in India costs a fraction of what it would in the US.
Such horror stories only contribute to the bad
press that the medical profession has been getting in recent years. Dr V N
Bhattathiri's petition to the Kerala state human rights commission -- which
exposed the trial in the first place -- has sought a review of all trials in the
RCC. While this is a start, we have much more to do. An open enquiry followed by
punishment of all those found guilty, and an evaluation of the problems and
their solutions, are required immediately. The ICMR's finalised guidelines for
medical research must be translated into more than just guidelines. Unless
justice is done and seen to be done, history will repeat itself, again.
References:
1. Krishnakumar R. Ethics on trial. Frontline
August 4-17, 2001.
2. Sharma Dinesh C. Johns Hopkins and RCC face
drug trial allegations. The Lancet Oncology 2001, accessed athttp://oncology.thelancet.com/journal/vol2/iss9/full/lonc.2.9.newsdesk.17519.1( 19-9-2001)
4. Anonymous. Supreme Court of India bans
import, manufacturing, sale and distribution of quinacrine in pellet form for
use as a contraceptive. The Hindu, August 17, 1998.
5. Special correspondent: Foetal tissue
transplant: ICMR clarifies. The Hindu, January 2, 1997.
6. Anonymous: Clinical trials in India: patient
capital. The Economist January 29, 2000.
Sandhya Srinivasan, 8 Seadoll, 54 Chimbai Road,
Bandra (W), Mumbai 400 050.sandhya@medicalethicsindia.org.
Dr Sanjay A Pai, consultant pathologist, Manipal Hospital, 98 Rustom Bagh,
Airport Road, Bangalore 560 017. Email:s_pai@medicalethicsindia.org.