New US rules to free clinical trials of ethics
it is alleged that Johnson and Johnson carried out clinical trials of its anti-psychotic drug, Risperdal, in Gujarat three years ago without the informed consent of patients. The study also used placebos despite drugs being available for treatment. Both these actions flout the Helsinki Declaration, adopted in 1964 by the World Medical Association. Numerous such examples exist (see box: Clinical trials gone awry).
The declaration, considered the cornerstone of medical ethics, states that the well-being of the human subject takes precedence over the interests of science and society. It is against the use of placebos in clinical trials if proven drugs are available for comparison.
All this may change for the worse as new rules on conducting clinical trials are in the offing in the us. The Food and Drug Administration (fda) is planning to abandon the declaration. Concerns about the new rules encouraging substandard research with disregard to safety of human subjects, especially in trials conducted in the developing world, are high. The new rules, says an editorial published in the May 22 issue of Nature, are being rewritten with an emphasis on methodology rather than ethics.
Pharmaceutical companies conduct trials, mostly in developing countries, and send data to the fda with an application to allow for sale of drugs in the us. The fda assesses the data before approving a drug. Over 500 trials conducted outside the us come to the fda for approval annually.
In spite of criticism that having both the declaration and new rules are not counterintuitive, the fda is firm on dropping the declaration. It has shrugged off concerns saying that its new rules, called Good Clinical Practice (gcp), does address ethical issues and human rights. It says that gcp will be defined as "a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials in a way that provides assurance that the data and reported results are credible and accurate, and that the rights, safety, and well-being of trial subjects are protected". It also says that the trial data will be vetted by an independent ethics committee.
Portraying the revision as essential to avoid pharmaceuticals getting confused between standards of the declaration and its own laws, fda officials say they are redefining standards since the declaration does not come under their jurisdiction. Besides, the declaration does not elaborate the correct method to conduct clinical trials, they add.
Vasantha Muthuswamy, director of the Indian Council of Medical Research (icmr), says national laws should be stringent. "As long as developing nations ensure strong national legislation, our populations are safeguarded. India's laws are based on the declaration," says Muthuswamy. C M Gulhati, editor of the Monthly Index of Medical Specialities, agrees. "Though it is not a good sign, it is according to their national laws so we have no say in it," he says.
The question remains though whether developing countries are up to the task of monitoring clinical trials to ensure the safety of the subject. "This is a problem. We have icmr guidelines and several bills pending in Parliament, but our ability to monitor is questionable," says Gulhati.
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