Unauthorized medicine: Leave important clinical testing to the professionals

Misuse of direct-to-consumer genetic tests doesn't just result in wasted money -- it also can harm patient health.

Posted March 21, 2011.

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Science has made great strides in the development of clinical genetic testing, putting yet another potent weapon in the arsenal against illness and chronic disease. But when used improperly, such a weapon might end up hurting some of the very patients it is intended to help.

Direct-to-consumer genetic testing kits have become more commonly available in recent years, and some patients might see them as an attractive option for determining their risks for disease, hereditary problems or bad reactions to certain drugs. But while such information can be useful to patients, it does them little good if the results are inaccurate or misinterpreted. In fact, it can do great harm.

That's why the Food and Drug Administration needs to regulate these consumer genetic tests to ensure that patients conduct screenings only under the guidance of a physician, genetic counselor or another type of genetics specialist. Without such expert supervision, patients will not be able to know the correct course of action to take if they obtain test results that they consider bad news -- or to know whether a given test is even worth taking in the first place.

The possible harm that can come from misinterpreting genetic tests is cause for great worry. Being considered at high risk for a condition does not necessarily mean one will develop the disease. And receiving one good screening does not mean a patient is necessarily in the clear.

Patients might alter their behavior in ways that prove worse for their health than the conditions they are trying to avoid. Only a professional will be able to tell patients with any surety what their screening results mean and what, if anything, they should do about it.

Manufacturers of direct-to-consumer tests will tell consumers that their products are meant to be informational and not diagnostic in nature. But the results that the companies send their customers often include predictions of whether they will develop a certain disease. This isn't just unwise; it's the unauthorized practice of medicine.

And then there is the fact that consumers of genetic tests might not even be getting good information in the first place. Benefits of the screenings are routinely touted while test limitations are discounted or ignored altogether. A recent government watchdog report by the Government Accountability Office found that genetic testing companies gave inconsistent and inaccurate results for some of their tests. In some cases, unqualified employees of the companies dispensed what amounted to medical advice, in clear violation of the rules. If there were ever a compelling reason for the FDA to regulate this industry closely, this report is it.

Under more scrutiny than ever, some consumer genetic testing companies have started sharing screening results with the consumers' physicians. This is a good start, but such a practice should be mandatory for any vendor selling a product that, if misinterpreted, poses a risk to patients. All tests also must be put into a national genetic testing registry that will allow patients and their doctors to find out if a given product is clinically authentic before they even consider buying it.

Only when these steps are taken and when tests are regulated in the same way as medical devices will patients be able to have any confidence that they are putting their health concerns in the right hands.

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