Should consumers have easy, direct access to genetic tests? So asked a recent survey on MedPage Today. After nearly 1,000 people voted, the tally was: Yes 37%; No 30%; it depends on the test 32%.
Of course this survey is “unscientific,” meaning anyone who sees it may (or may not) vote so there is obvious selection bias. Nonetheless, since the number voting is hefty, it is worth looking at.
I am impressed that the wisdom of the aggregate is split almost exactly three ways. Very interesting. I can agree with all 3 groups.
For the group that voted “yes,” there is strong support for patient autonomy. After all, who owns your genes and why should you not have the right to learn about them without someone interfering?
For those who voted “no,” there is strong support for the competing ethic of physician autonomy and protecting patients from confusion or harm that may come to them from data that they may not be able to deal with.
For those who voted “it depends on the test,” I agree.
Basically, these genetic tests are lab tests. Their performance is technically difficult and the interpretation can be confusing. Quality assurance seems in its infancy.
Some companies that do the tests recently tried to mass-market them to American consumers by direct-to-consumer advertising and pharmacy sales. The companies obviously liked the “yes” votes. The FDA seemed shocked by the speed and market penetration of this development and said NO, wait a minute, let us take a look and decide whether the tests are “safe and effective.”
My Pontification: You should never order a lab test unless and until your know in advance that the results will be “interpretable,” and what action the physician and patient will take if the results are high, low, in-between; positive, negative, indeterminate, and that any action taken will likely benefit the patient.
With that standard, no way should consumers get these tests done on their own at this level of the development of the science. Maybe some day?
George Lundberg is a MedPage Today Editor-at-Large and former editor of the Journal of the American Medical Association.