glenn ellis

Glenn Ellis

*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 School of Public Health showed that the predicted disease risks by companies that offer direct-to-consumer personal genome testing can vary widely, and even provide false-negatives, as can happen in a normal clinical setting. But in a clinical setting, the patient’s care and testing is supervised by a medical doctor, and there is some degree of recourse for counseling and education.

The purpose of most DTC tests is simply to provide individuals with information about their risk of developing a disease or some other trait, or their odds of responding in a particular way to a certain drug. For the vast majority of these tests, there is no way to definitively determine whether an individual will actually ever develop the disease in question or respond in a certain way to a drug.

Adding to further concern for me is the unanswered question of what happens to your genetic sample after testing?

Imagine this? (no pun intended):

A dentist who bought one of the teeth of former Beatle, John Lennon, at an auction for $30,000, has sent it to a US laboratory to attempt to extract and sequence Lennon’s genetic information. With researchers working on ways to clone animals, the same technology certainly could make human cloning a reality.

So, we’re talking about a guy who wants to make a clone of John Lennon by using DNA from one of his teeth?

Does mean that a homogenously white community can create a community of immigrants, or people of color? Or how about a house staff for a wealthy couple? Might sound like a bit of a stretch of the imagination, but without proper standards and ethical guidelines, this is a possibility.

It is also not clear whether people who receive positive genetic test results are, in fact, taking a more active role in maintaining their health and preventing disease. And even if they are, there remain questions about whether these individuals are more careful with their health because of the DTC test results, or because those people who sign up for DTC testing are typically more careful about their health anyway. Perhaps the more serious question is whether or not DTC testing could be harmful.

This particular concern was pointed out by Commission Chairwoman, Dr. Amy Gutmann, who stated, “So consider the most well known recent testing that yielded life-saving results; that of Angelina Jolie… testing for a rare form of breast cancer that has a high probability – if not prophylactically treated – of being fatal. The test is costly. The greatest inequalities, however, are not connected to the testing per se, but to the quality counseling as to it whether, and what test is high quality… what woman is likely to be at high enough risk to make it worthwhile, being tested… and what to do with the information gathered…”

The work of this Commission is critically important to all who are touched by clinical and medical research. As stated in its Charter, “The Bioethics Commission advises the President on bioethical issues arising from advances in biomedicine and related areas of science and technology.”

The government funds only about 15 percent of trials for new drugs and treatments. Private pharmaceutical industry funds 85 percent. So it is vitally important that the Government sets policies, and ethical considerations in genetic research to be a barometer of sorts for industry.

Bioethics is full of difficult ethical questions for everybody: families, hospitals, governments and our whole civilization. Inevitably, there will be ongoing collisions, requiring a commitment to sound ethical insights and judgments, among these various stakeholders in every aspect of health, medicine, and research.

Dr. Anita Allen, Vice-Provost at the University of Pennsylvania, and member of the Commission, Chair of the Direct-to-Consumer sub-committee, brilliantly conveyed the Commission’s resolve towards consideration of this key issue. “We don’t know, of course, what will be the best path for people of different economic classes, races, and situations to get the testing and the healthcare they need. One of the reasons I raise inequity, is because we are hearing that some people may be turning to alternative direct to consumer modalities, and we must be therefore especially concerned about the quality of those modalities because if they are not good, people who turn to them will be harmed.”
Dr. Allen’s statements mirrored the general conscious of the Commission’s ongoing deliberations, assuring the public that their final recommendations will reflect the impact of bioethical issues in genetic research on the well-being and safety for all Americans.

Remember, I’m not a doctor. I just sound like one.

Take good care of yourself and live the best life possible!

Glenn Ellis, is a Health Advocacy Communications Specialist. He is the author of Which Doctor?, and Information is the Best Medicine. A health columnist and radio commentator who lectures, nationally and internationally on health related topics, Ellis is an active media contributor on Health Equity and Medical Ethics.

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