The Dark Side

• In a country like India, there are allegations  that the poor, illiterate and sometimes even the mentally-challenged are being used for clinical trials.
• It is  more than likely that these individuals do not fully understand the implications of the procedures involved.
• Sometimes clinical trials can carry a lot of risk. A glowing example comes from a clinical trial conducted by Pfizer on the  cholesterol-reduction drug - Torcetrapib.The trial came to a grinding halt due to the  high death rate recorded among the 15,000  candidates, in three continents.
• Negligence during the trial, from undertrained /unskilled staff is a possibility in India.
• In case of damage, the  trial victims may not be able to claim any damages if the clause of indemenity is not framed in favor of the patient. If a foreign insurance company is involved the claim process may not take place in India. This would make it difficult for the patient to make the claim.
• Lack of  vigilance or  timely enforcenment of laws is likely to make India a ‘hotbed of risks and controversies’.

Ethical Issues

There are several ethical issues concerning clinical trials in India.

• If the drugs are too expensive it will be of little benefit to the majority of people in India.
• These trials are being conducted in India because of the larger number of candidates who are available and who can be convinced and recruited. This is not possible in a developed country, like the USA, with its good health care system. So are Indians the guinea pigs?

Making Clinical Trials safe for Indian Patients

Three scientific bodies - Drug Controller General of India (DCGI), Department of Biotechnology (DBT) and Indian Council of Medical Research (ICMR) are looking at the possibility of liaising with the US ‘Food and Drug Administration’ (FDA) to enforce regulations with regard to clinical trials and research in India.

With regard to patient benefit the following measures should be followed-

• There should be no element of coersion when recruiting patients for clinical trial.
• The subject should clearly understand the advantages and disadvantages. Informed consent should be available in all the local languages, besides English, and the patient being taken on the trial should be a given a copy of the consent form. They should be made to read all sections and sign all the page of the consent form.
• There should be no monetary inducements to the patients to join the trial and this should be clearly stated in the consent.
• Insurance certificate covering the clinical trial should be from an Indian Insurance company and  any indemnity clause should be part of the agreement document. The insurance cover should be adequate and this should be reviewed from time to time. Currently, the recommended cover is about Rs.1 crore.

As far as possible the trial agreement should be signed between the investigator/hospital along with the principal company and an ‘Indian Clinical Research Organisation’ (if involved in the trial).

Being poor or illiterate does not qualify a person to serve as a guinea pig. The way we treat our citizens, especially the under privileged, will definitely lay the foundation to the manner in which foreigners will regard us- as a people. Therefore, let us hope that government bodies put up a regulatory mechanism in place that ensures the safety of the patients besides addressing the issue of the disadvantaged, like the minors, illiterate or mentally challenged.

Let them strive to be uncompromising when it comes to upholding the common man’s interests, and, never hesitate to address the fears of the Indian public. 

India has a huge number of patients who can help to contribute to the advancement of medical sciences. By using India, the multinational pharma companies were hoping to tap into this rich resource and to fast forward their turn-round time for the trials; but this should not mean any compromise on safety standards. It is important for all parties involved in these clinical trials to get this message loud and clear.

Source-Medindia
Dr. REEJA THARU/S