Tuesday, May 20, 2008

The Helsinki Syndrome, or "Ethics? We Don't Need No Steenking Ethics!"

According to Integrity in Science Watch, the United States Food and Drug Administration is changing the rules on clinical trials to allow drug companies to compare new medications with placebos instead of current standard treatment. The Bush Administration is siding with Big Pharma again.

It sounds like a small change, but it contravenes the 1989 Declaration of Helsinki, which established an international standard set of ethical guidelines for human experimentation. The declaration is not binding international law but is considered "a guiding statement of ethical principles for doctors involved in medical research".

The current text of the Declaration, as amended five times, says:

The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists

At Embo, Howard Wolinsky explains:

This [FDA] decision, triggered by the 2000 update to the DoH, is the latest move in an increasingly heated debate over medical research ethics. The FDA is reacting in particular to the addition of two controversial paragraphs, which, if adopted in their own regulations, would limit the use of placebos in drug trials and increase the responsibilities of trial sponsors towards research participants.

The heart of the distinction / dispute comes back to an ancient precept commonly taught in medical school: primum non nocere, "first, do no harm". Not part of the Hippocratic Oath, it may be a Latin paraphrase of a Hippocratic aphorism. It may be from Epidemics, Bk 1, Sect V, "...to help, or at least to do no harm".

In order to "do no harm", medical researchers testing a new drug (for example) must compare the drug with the current standard of care (if any). Only if there is no current standard treatment can researchers compare an experimental new drug with a placebo. In other words, researchers cannot deny treatment to someone just because they've entered a drug trial.

The FDA wants to change that. The FDA wants to make it legal for medical researchers to deny treatment to research subjects. The FDA wants to make it legal for medical researchers to let people die instead of giving them the best current treatment.

How's that for a "culture of life"?