Main

Home brews are a major portion of the genetic testing market. They are a vibrant means of converting genomic correlations into innovative and prototypic genetic tests offered directly to consumers. And they are run by researchers and clinicians whose grasp of the predictive power and utility of the methods is sound and who generally have the best interests of patients (consumers) at heart. Their methods evolve and improve rapidly as new findings come forth and as the use of the home brew methods become more widespread.

At the same time, some home brew genetic tests are unreliable and uninformative. In a 2006 report, the US Government Accountability Office (GAO) looked at websites of companies selling designer cocktails of nutritional supplements based on a genetic profile and concluded that these companies “mislead consumers...by making predictions that are medically unproven and so ambiguous that they do not provide meaningful information.” The main purpose of some of these tests appeared to be to persuade those who had been tested to buy proprietary brands of 'personalized' nutritional supplements costing over $1,000 a year.

Unfortunately, the conclusion being drawn in US political circles from these examples seems to be that “all home brews are unreliable and informative” and that the FDA should step in and fix the problem. Senator Edward Kennedy, for example, recently announced that he will introduce legislation establishing a role for the FDA in regulating genetic tests. Kennedy wants the FDA to be responsible for giving a 'seal of approval' to all genetic diagnostics.

This is muddled thinking. First, as its name suggests, the FDA is largely involved in the regulation of substances that interact directly with the human (and animal) body and that clearly raise safety issues. If its remit were extended to home brews because of questionable utility, then surely it should also look hard at the cosmetics market as well. The FDA is, in fact, charged with ensuring that cosmetics do not contain “any poisonous or deleterious substance [except for hair dyes],” do not consist of any “putrid or decomposed substance” and have not been “contaminated with filth.” In short, the FDA is concerned with safety.

The broader criticism is simply that the major impact of increased FDA regulation will be to stifle useful innovation rather than target the charlatans. Genetic snake-oil peddlers will always find a way around the rules, and credulous consumers will always seek them out. And the involvement of the FDA in a heavy-handed way will ensure that some useful, if not entirely perfect, genetic diagnostics never see the light of day.