Concern over irregular drug trials on patients

By M. Dinesh Varma

THIRUVANANTHAPURAM, JULY 15. Lack of standardised ethical guidelines to dictate drug trials on patients in hospitals is raising serious concern over the subjugation of patient rights in collaborative ventures with foreign institutions.

Several senior doctors when contacted by The Hindu pointed out that though drug experimentation on humans and the ethical and moral issues that it raised are a relatively recent facet to the quest for improved drugs, globally, the pressure from pharmaceutical industry for testing new drugs on human beings has been increasing in the recent past.

Medical experts also point out that consequent on the tightening of drug trial procedures on patients in developed societies, the search for volunteers has shifted to developing countries, where lack of adequate ethical controls provides foreign institutions with a much-cheaper and less-cumbersome alternative.

``The slackness of developing countries in evolving ethical trial norms potentially provides prime movers in establishing global protocol trends across countries to determine drug trials with institutions it perceives as lesser partners on a set of terms that remain unchallenged,'' says Dr. G. Vijayaraghavan, former Head of the Department of Cardiology, Thiruvananthapuram Medical College.

It may be recalled that in 1997, the prestigious Johns Hopkins University had to abandon a proposal for a joint public health venture with Kerala in the face of intense pressure from critics of the project. While there is still a section of scientists which believes that the State had missed out on an "omnibus opportunity" to rise in research, it is pertinent that there was sufficient lack of contractual transparency that ultimately led to the project being abandoned.

Assuming significance in this context is a complaint recently lodged with the State Human Rights Commission by the senior clinical radiobiologist at the Regional Cancer Centre, about alleged unethical drug trials on patients at the cancer hospital.

In his petition, Dr. V.N. Bhattathiri, Head of the RCC's Radiobiology section, alleges that patients were subjected to trials that exposed them to toxicity from drugs which stood banned by the Federal Drugs Administration (FDA) in the United States.

According to him, the tetra methyl form of Nor Dihydro Guaretic Acid (NDGA), the M4N developed by the Johns Hopkins University as one the drugs which was being used for human trials at the RCC in spite of their being removed from FDA'a ``Generally Regarded As Safe'' category.

``It is not known how many patients suffered any of these. No blood level study has been done in any of them. More significantly, it was not done either as a Clinical Research study nor as a non-Clinical Biomedical study (as required by the Helsinki Declaration)", the petitioner alleges.

Dr. Bhattathiri also cites the use of a drug developed by a U.K. firm as another instance of violation of patients' human rights as well as physicians' ethics at the RCC. The petition states that the drug was used on patients who could have been given standard treatment in violation of ethical and moral convention of administering experimental medication only on patients after exhausting available therapeutic modalities.

According to the petitioner, it was probably due to the post- medication progression of disease, which proved fatal for some patients, that the FDA of USA and European Medicine Evaluation Agency denied approval for this drug.

However, it is learnt that the trials had the approval of the Government of India. According to the State Drugs Controller, Dr. S.S. Venkatakrishnan, permission of clinical trial procedures on new drugs as per the Drugs Rules require only a formal application by a competent researcher in an institution.

It is not necessary for a drug which is banned by the U.S. FDA to be automatically banned in India. Problem drugs are regularly re-evaluated by the review panel of the Drugs Controller General of India, on the basis of recommendations by the World Health Organisation, or review appeals of members on the panel.

He points out that it is routine for drugs which are withdrawn from distribution due to various factors in one country to be considered safe in another country. For instance, analgin is banned in several European countries while it continues to be used in many others, Dr. Venkatakrishnan says. The quality, ethics and moral issues governing such clinical trials are completely vested with the researchers involved.

There is, meanwhile, as much concern over the compromises made by researchers (read hospitals) to fall in line with the sponsoring institutions, as over the grim prospects of patients, mostly from the poor strata, becoming ill-informed targets of drug trials that are designed for pharmaceutical advantage.

``The kind of collaborative research being conducted in the country is blatantly mercenary research where patient rights are completely overwhelmed by pharmaceutical interests,'' says Dr. C. R. Soman, chairman of the Health Action by People (HAP), a city- based NGO.

Serious doubts are also being raised over the content, or lack of it, of the information provided to the patient who volunteers for a trial. More often than not, it is "ill-informed" consent that is secured from the patient. And, even if drug tests succeed in formulation of an improved protocol, the newer drugs are only beneficial for the developed countries and are hardly accessible for the common man in a developing nation, points out Dr. V. Raman Kutty, executive director, HAP.

Moreover, while in the developed countries, the patient is the all-important focus of the trial and set norms guarantee handsome compensation for participating in a research exercise, patients here are not only taken for granted, but, in some cases, made to pay as well, says Dr. Soman.

The ethical guidelines being evolved by the Indian Council for Medical Research is expected to address the complex issues involved in drug trials on patients.

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