More bureaucracy in medical research

The recent proposal by the U.S. National Academy of Sciences' Institute of Medicine for more government oversight of clinical trials of new drugs on human subjects should make plaintiffs' lawyers happy, critics say. But it is bad news for sick people who are hanging on in the hope that a cure for their ills will be developed before they die.

The Institute claims that patients participating in the testing of new drugs deserve greater protection. But protection from what and by whom? The implication is that the patient-participants must be protected by bureaucrats from their own doctors.

Those familiar with the process of medical experimentation report that no reliable data exists on how much harm occurs now in clinical trials – with fears being whipped up by only a very few highly-publicised incidents.

Advocates of greater regulation promise that the changes they want won't interfere with research -- but sceptics question how they can be sure.

There are already perhaps 4,000 Institutional Review Boards at American universities monitoring thousands of experiments.

The cost of bringing a new drug to market is already $800 million (R8.36 billion) – mainly due to the need for massive clinical trials.

Experts say the debate simply illustrates the continuing disintegration of the status of physicians in U.S. society and the ascendancy of lawyers and bureaucrats to the place of trust physicians formerly held.

Source: Daniel Henninger, Wonder Land: Medical Research Falls Deeper into Bureaucracy, Wall Street Journal, October 11, 2002.

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FMF Policy Bulletin\15 October 2002