Over-the-Counter Genetic Tests: A Good Idea?

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A few months ago, Americans were very close to being able to purchase relatively affordable genetic tests at drugstores across the nation. The tests, which are currently available for purchase online from Pathway Genomics, are designed to detect genetic predisposition for more than 70 common diseases and conditions ranging from obesity to Alzheimer’s.

It would have been the first inexpensive, mass marketed, “over-the-counter” genetic test available in the U.S., if Walgreens (the largest drugstore chain in the country) had gone ahead with its plans to sell it. Just before the testing kits were due to hit store shelves, however, the FDA raised questions about their safety, effectiveness and legality, and Walgreens decided not to sell them. In June, the FDA sent letters to several companies that sell such direct-to-consumer genetic tests, warning them that they, like other medical devices, might soon be subject to regulation. This action sparked debate about whether or not consumers should, in fact, have direct access to genetic tests.

Should the FDA Regulate Access to Genetic Information?

On one side of the debate, people argue that the FDA should prevent direct consumer access to all genetic tests, allowing them to be administered only by certified health care professionals.

A major concern is that the tests may not be accurate or reliable. The biology of how DNA variations actually lead to certain diseases is still poorly understood, though the field of genetic research is rapidly evolving and advancing.

Consumers Need Protection

According to a study published online earlier this month in the New England Journal of Medicine, consumers need to be protected from unrealistic claims about what genetic tests can offer. Researchers from the University of North Carolina at Chapel Hill School of Medicine say that there is “little or no evidence of the clinical validity of tests developed from genetic technologies,” and that “consumers must be protected from unrealistic claims and the misinterpretation of complex and dynamic genomic information.”

Their concern, which is shared by others, is that the average consumer might not be able to interpret the results of a genetic test on their own, and could end up confused or unnecessarily fearful based on what they learn about their genes. Some worry that people might make decisions that could put their health at risk as a consequence.

For example, genetic risk for breast cancer can only be assessed by screening for a few of the known genetic mutations associated with increased risk for the disease. The test does not take into account other genetic mutations or non-genetic lifestyle factors that may lead to breast cancer development. The fear is that women who don’t understand all of this and receive a result suggesting an increased risk for breast cancer could subject themselves to unnecessary tests and treatments. Conversely, those who find out that breast cancer is not coded in their genes may forgo important preventive measure and screenings.

There is also the potential for discrimination based on genetic test results. Some worry that insurers could use genetic information to limit access to health care coverage.

Who Owns Your Genes?

On the other hand, should the government be able to restrict your access to information about your own genes? After all, your genes are yours, and if you want to know more about them, shouldn’t you have the right to do so without someone interfering?

The FDA is notoriously slow to enact change and is under pressure from many competing interest groups. The influence of lobbying groups and individuals who may represent interests other than those of the average American consumer holds unknowable power over policymakers. Many fear that heavy FDA regulation of genetic testing will bog down the rapid pace of genetic research and innovation. And as a result, genetic tests could become excessively expensive and inaccessible to the majority of the population.

Many of the concerns voiced by those who oppose easy access to genetic tests rely on a few basic assumptions that are worth looking at critically.

First of all, the assumption is that the average American will not be able to “handle” getting a glimpse at their genetic information. Those who fear that consumers will become confused or behave irrationally based on their test results assume that the average American is unable to take control of his or her own health. For the most part, Americans are already almost entirely dependent on health care practitioners and the media for information about their own health and wellness. And maybe the FDA — maybe Big Pharma — would like to keep it this way.

Could Genetic Testing Be a Tool for Health Empowerment?

What would happen if consumers suddenly became empowered by the knowledge that they could use information about their genes to take appropriate preventive measures to stay healthy?

Another assumption made by many of those in favor of strict FDA regulation is that prevention, in many cases, is not practical or probable. Of course, there are some genetic conditions which are not preventable, based on current medical knowledge. But there are volumes of research showing that there are ways to prevent some of the diseases most prevalent in the U.S., such as heart disease, certain cancers and Alzheimer’s. If you desire to know whether you are at greater risk for a disease known to be largely preventable, shouldn’t you have easy access to that knowledge?

Some people may have no interest in taking a genetic test, and that’s just fine. Ultimately, regardless of your genes, striving to live a healthy, balanced lifestyle may be your best bet for avoiding disease and achieving a long, healthy lifespan.

Is There a Middle Ground?

Earlier this month, in an opinion essay which appeared in the journal, Nature, genetics policy expert Gail Javitt proposed the idea that genetic tests be regulated based on the type of test and the level of risk they pose to the consumer.

Because the genetic tests currently available range from those with clear mutation-disease risk correlation to those with more “gray area,”  Javitt argued that tests should be regulated accordingly. She says that simple, clear-cut tests could be sold over-the-counter. More complex tests should be administered by a health care professional who can properly interpret the results, and accompanied by counseling.

What Do You Think?

Should over-the-counter genetic tests be widely available to consumers looking to protect their health? Or should the FDA prevent direct access to such tests, in order to protect consumers from unnecessary confusion and anxiety?

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Tags: Alzheimer’s, FDA, genetic testing, genetics, heart disease prevention, heart health, obesity