*The Presidential Commission for the Study of Bioethical Issues held a public meeting on August 19-20 in Philadelphia.
The Bioethics Commission advises the President on bioethical issues arising from advances in biomedicine and related areas of science and technology. It seeks to identify and promote policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner.
So you wonder why should you care about this?
Well, what caught my attention during the brief time I spent during one day of the meeting, was the growing phenomenon of “direct-to-consumer” testing.
More and more companies are offering direct to consumer (DTC) genetic tests that let you check your genetic predisposition for diseases without a doctor’s order. This means you can walk into a drug store, or go online, and purchase a kit that allows you to send a sample (hair, urine, saliva, etc.). The company will then run an analysis, and inform you of how much you are at risk for a particular disease or condition. One popular test currently, is the one that identifies your genetic ancestry.
There is no health-care provider or ‘gatekeeper’ to prevent inappropriate test ordering or misinterpretation of test results. For example, a patient informed of his or her genetic profile for depression, might decide, on their own, to change the dose of antidepressant medication – with some unpleasant health outcomes. Antidepressants have been associated with suicidal thoughts and suicide attempts, among other adverse effects, and physicians are warned to carefully monitor their patients, particularly when adjusting dosage, which may prove difficult with increased patient access to DTC testing.
The promise of the millions of newly insured Americans, which includes countless people of color, has yet to show indications that it is impacting health disparities. At no time in history has the state of health disparities, particularly in communities of color, been more dismal than today. As we see an inevitable expansion of the types of tests offered, history tells us that underserved and poor communities of color will gravitate towards them in disproportionate numbers. Basically left to fend for themselves, at the mercy of the marketing by these companies (many of them created or run by medical doctors). So, needless to say, this could represent yet another area where inequities and disparities are reflected in poor communities of color.
Discussion among the Commissioners at the meeting looked at whether this lack of “gatekeeping” raises questions about whether federal agencies with the authority to do so, like the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), need to step in and enact measures to ensure that consumers are not making inappropriate, perhaps even dangerous, decisions based on their DTC test results. Unless appropriate measures are taken, scientists argue, DTC testing could actually backfire, by causing consumers to lose their trust in the information provided by such services.
Some recent studies and research raises the concern on this dilemma.
An in-depth analysis and comparison study conducted by investigators at Emory’s Rollins …read more