Are Ethics Rules Setting Back Medical Research?

Maybe. But I have my doubts, at least after reading Sally Satel's op-ed piece in today's New York Times.

Dr. Satel, a psychiatrist and resident scholar at the conservative American Enterprise Institute, claims that "the oversight system has fallen short of the ethical standard it purports to uphold: that the benefits of medical research exceed the costs."

That's the final sentence of her essay, although it doesn't have much to do with the rest of the article, which argues only that federal ethics regulations (oh, no!) and "overbearing federal boards" are impeding research.

She appears not to have completely forgotten why strict ethics regulations were put in place -- "No one denies the need to shield human subjects from undue risk."

But that statement isn't strictly correct: the reason we need strict ethics regulations for medical research is not that human subjects might be subject to excessive risk, but that they would be uninformed about the risks (as a prospective participant, if I'm fully informed at the project, I might choose to take on risks that seem "excessive" to others).

And Dr. Satel's final sentence is really just an economics-happy cost-benefit analysis. Strict regulations are needed not because research costs might otherwise exceed the benefits, but because it isn't about the costs and benefits.

Ethics regulations are about treating human beings as ends in themselves, and not as means to an end. For all I know -- this is not my area of research expertise -- the infamous Tuskegee syphilis experiments might have been "successful" by Dr. Satel's standard, with research benefits exceeding costs. Instead, those experiments are rightly vilified today because the study, which ran for 40 years, deliberately kept nearly 400 black men uninformed and untreated. (In 2002, Alex Chadwick produced a brief but excellent summary for National Public Radio website, here.)

Satel's essay is awash in similar sloppy thinking and slippery writing. Another example: "Stanford University researchers have estimated that it cost them about $56,000 in administrative wages, 18 months of delay and 10,000 pages of paper to make a small change to an already-approved research program..." Define "small change" for me, please. (She doesn't.)

Another: "Before a 43-center study of hypertension could begin at Veterans Affairs medical centers, ...a year and a half was spent getting all 43 boards to approve the same protocol. Each time a single board required a change to the protocol, the others had to review it and agree as well." Um... don't you think that's the way a multi-center study should be run? If the protocols aren't identical, how will you know which variables have affected any differences in results?

Enough! I expect better thinking on the op-ed page of the Times. But not necessarily from the increasingly-rabid conservative sector.