Brown: Context necessary for genetic information

We’ve seen genetically modified foods are a controversial topic in news so what if there were to be genetically modified humans? That would surely raise a contentious debate simply due to the questionable ethics and medical implications. 

We’ve seen genetically modified foods are a controversial topic in news so what if there were to be genetically modified humans? That would surely raise a contentious debate simply due to the questionable ethics and medical implications. 

Phil Brown

“And ye shall know the truth, and the truth shall make you free.”

Some ISU alumni and students will recognize this biblical verse from their days on the ISU campus, as it adorns the eastern side of our very own Parks Library. It is entirely appropriate that here, at a place of higher learning, we would emphasize the benefits of knowledge, but there remain some instances where greater access to information does not necessarily help you.

For instance, there is currently a fairly contentious debate over potential regulations on the ways in which an individual can access their genetic information. Some find the idea of government inserting itself between you and your genes a disturbing thought, while others contend that genetic information can be extremely difficult for the average person to interpret.

In addition to being simply difficult to understand, personalized genetic information can actually mislead those who request it. For example, if someone were to find out that they possess no known genes that increase their risk for breast or prostate cancer, they might be led to believe that they do not need to receive examinations. Even worse, the testing itself may provide false results and then intentionally downplay the possibility of such events.

23andMe is an at-home genetic testing company that recently has been told by the Food and Drug Administration that it must stop sales of its genetic tests. The Personal Genome Service offered by 23andMe has already been used by hundreds of thousands of consumers and can be purchased for less than $100.

The FDA, in a letter that later became public, scolded 23andMe for failing to provide information regarding the testing its product underwent to make sure it works as advertised. This lack of information comes despite more than a dozen in-person meetings between the testing company and the FDA.

With the status of “medical device,” an at-home genetic testing kit is required to undergo experimental trials and be sanctioned by the government for personal use. So instead of big government bringing down the regulatory hammer on 23andMe for giving people useful information, it is actually under fire for not proving to anyone outside of its company that its tests — and, more importantly, the interpretations provided — are accurate.

That interpretation, even when accurate, is exactly what makes genetic tests prime targets for regulation. Far from being simply a list of “your genes”; what companies like 23andMe are actually selling is the information that accompanies your genetic makeup.

There is nothing in your DNA that says in plain English, “I’m a gene that makes you more likely to develop diabetes,” or “I might give you digestive problems if you eat gluten.” Those explanations come exclusively from someone else. In the case of a medical doctor, the usual purveyor of such information, their expertise is known.

Beyond that, one would hope that a physician would not suggest or endorse useless yet expensive treatments and preventative measures. This is an expectation that we hold of physicians due to their elevated status and the rigorous licensing they undergo to practice their craft.

A simple, for-profit business does not have these restrictions. Without FDA intervention, there would be nothing to stop a group that provides genetic tests from providing deliberately confusing or misleading results and then offering access — for a fee — to certain supplements or medications that might not be needed at all.

To be fair, many of the companies that are already offering personalized genetic tests do not seem to be engaging in these kinds of shady dealings. David Kaufman, director of research at Johns Hopkins University, categorized the recently sanctioned 23andMe as a company that is “trying to do [genetic testing] the right way.”

However, one business doing things the right way does not mean others will. The nature of genetic tests and their interpretations means that they will sometimes be wrong, and they could be misrepresented for profit.

In order to protect consumers, scientific scrutiny and other regulations will need to be enforced on companies that seek to give what is essentially medical advice. So despite common sense arguments to the contrary, we might very well need an arbiter between us and our own genetic information.