Ready for Values Regulations?

Science is no longer enough for left and right.

Sometimes a bad idea is so attractive that it appeals to both ends of the political spectrum.

Recently, some on the political Right—specifically elements of the religious Right—have been trying to smuggle their moral concerns into the U.S. Food and Drug Administration's (FDA) regulatory process. Most infamous is the FDA's continued dawdling over the approval of the emergency contraceptive Plan B as an over the counter medication. Two FDA scientific advisory committees overwhelmingly voted that the Plan B should be sold right next to the condoms in drug stores. However, one advisory committee member, Dr. W. David Hager, a Kentucky gynecologist who advises women to pray for relief from PMS, wrote an opposition minority report that seems to have stymied that approval for now. His concern is that easy availability of this safe and effective medication could lead to consensual out of wedlock sex.

Now an interesting article in the Baltimore Sun suggests that some left-wingers are also hinting that ethical concerns should be included in FDA regulatory decisions. In a poll last fall, the Pew Initiative on Food and Agriculture found "a strong majority (63 percent) of Americans believe government agencies should include moral and ethical considerations when making regulatory decisions about cloning and genetically modifying animals, with 53 percent feeling that way strongly."

Liberal bioethicist, Daniel Callahan, co-founder of the Hastings Center in Garrison, N.Y., says that he is leery of having the FDA rule on moral issues, but thinks that it might want to consider the financial impact of approving new drugs on the health care system. Presumably, the regulators might decide that a drug is too expensive and refuse to approve it although it is safe and effective. The problem is that deciding to withhold a drug from patients because regulators think it's "too expensive" is a moral judgment. If the government doesn't want to pay for an expensive drug that's OK, but why should regulators forbid consumers, who might want to pay for it on their own, access to drugs that are safe and effective?

Carol Tucker Foreman, director of food policy at the Consumer Federation of America, points out that the FDA has already taken into account non-scientific concerns in some of its regulatory system. For example, she notes that the FDA requires that irradiated food be labeled even though there is no scientific evidence that irradiation harms human health. The reason for the labels is that activist groups like Public Citizen managed to scare some consumers into demanding them in the early 1990s. Now the question is should the FDA be pushed further down this slippery slope of non-scientific regulation?

Let's consider the case of an agency that already has an explicit authority to impose its moral judgments in making regulatory decisions, the Human Fertilisation and Embryology Authority (HFEA) in Britain. In 1999, Louise and Alan Masterton lost their 3 year old daughter Nicole in a fire. Although the Masterton's fully realized that Nicole was irreplaceable, they felt that her tragic death had left an aching void in their family of four healthy boys. They decided they would like to use pre-implantation sex selection of embryos to try to have another girl. The Masterton approached the HFEA for permission to do this at one of Britain's five in vitro fertilization clinics and were refused in 2000. Suzi Leather, head of the HFEA, explained, "The HFEA has to balance the potential benefit of any technique against the potential harm. We are not persuaded that the likely benefits of permitting sex selection for social reasons are strong enough to outweigh the possible harm that might be done." The HFEA reaffirmed its ban on sex selection in 2003 declaring| that "sex selection for non-medical reasons should not be permitted."

The Masterton's traveled to an IVF clinic in Italy where they were able to produce only a single male embryo which they decided to donate to another couple. In the meantime, other Britons have gotten around the HFEA ban by similarly seeking sex selection services abroad. For example, Nicola Chenery, mother of four sons, gave birth to twin girls by means of sex selection treatments she received at a Spanish IVF clinic. One can easily imagine a future in which Americans must go abroad for a new medicine because the FDA has banned it on the grounds that it is too expensive.

Ethical debates are often a mask for public unease about new technologies, the famous "yuck factor." If it's new, ban it. However, all sorts of technological advances of which the public was ethically suspicious, like oral contraceptives, organ transplants, and IVF, were later found to be moral. It's hard enough for the FDA to figure out if a drug or a medical treatment is safe or not. Leave the moral judgments of what to do them up to individuals.