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FDA Stopping the Genetics Revolution

FDA Stopping the Genetics Revolution

4 Mins
December 11, 2013

Entrepreneurs look to limitless possibilities while government regulators look to limit possibilities.

That’s the stark contrast we see between 23andMe , a company that makes and markets genetic test marker kits, and the Food and Drug Administration, which has forced them to stop selling their potentially life-saving product.


Linda Avey (L) and Anne Wojcicki, founders of 23andMe

Since 2006, 23andMe has been selling $99 kits that allow individuals to send a saliva sample to company labs. 23andMe analyzes the sample to find out whether individuals are predisposed to several forms of cancers and other diseases, to determine possible responses to certain types of drug treatments, and to glean other information about individuals from their genetic material.

The FDA was established to certify the safety, efficacy, and health claims of medicines and medical devices. And the FDA’s authority is broad. It covers not only what is considered a “device”—everything from heart valves to tongue depressors—but also how “efficacy” is defined.

23andMe does not claim that the results of their analyses are accurate 100 percent of the time. Few medical tests are. And to be sure, 23andMe has not jumped through all the time-consuming FDA hoops that might secure for their product the government seal of approval. But the key reasons that the FDA gives for being concerned are also key reasons why the FDA has outlived any usefulness it might ever have had.


In its “cease selling” letter to 23andMe, the FDA asserted that if an “assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery … or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.” Similarly, “assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies…”

In other words, individuals are just too stupid and irresponsible to handle information about their own bodies and health.

In point of fact, were 23andMe to make a positive finding for cancer risk, the individual would do like every single individual does now in such cases: go for a second opinion and more tests. In the case of a false negative, this is not a negative for having the ailment—which many FDA-approved tests can fail to find in the early stages. It's a failure to find the genetic propensity for the ailment. Vigilance is always advised. Similarly, a finding that suggests better treatments for some condition would certainly lead a patient to inquire further into the best way to ensure his or her health.


And the FDA’s concern that individuals might “self-manage” treatment reveals an issue in its war on 23andMe that’s so fundamental that it’s missed by many. Your life is your life! Your body is your body! You have a right to “self-manage” yourself! The benefit of living in society with others is that through the production and voluntary exchange of goods with others you can better preserve and improve your own life.

23andMe and companies like them are the vanguard of a revolution in medical treatments and life extension.

Politicians and government bureaucrats don’t own you. You are not a child to be abused by these negligent paternalists.

To be fair, the FDA was started earlier in the last century in reaction to concerns about hucksters pushing phony snake oil “cures” to an uneducated and uninformed population. But if there ever was a problem, the communications and information revolution obviated it. Adults can and should be allowed to make their own decisions about their own lives. As to fraud, that's what we have law courts for.


The other big issue that many are missing is that 23andMe and companies like them are the vanguard of a revolution in medical treatments and life extension similar to the revolution in communications and information made by companies like Apple and Microsoft. The latter revolution was made by entrepreneurs, operating in a free market with virtually no government regulation, producing undreamt-of goods and services.

Genetic science offers the possibility of tailored therapies for individuals. It offers a future from which Alzheimer’s, Parkinson’s, and so many other afflictions will have been banished.

Some people might fear a dystopian “Brave New World” and, thus, want the FDA and, more generally, government oversight of this emerging revolution. That guarantees that the revolution will be smothered in the crib. By attacking 23andMe, the government has shown that it is a roadblock to progress in this field. Imagine if Apple had received a “cease and desist” letter for creating the iPhone. That's how medical advances are being treated today.

Those who fear the future should get out of the way of those who embrace it. And this means getting the FDA out of the way of the entrepreneurs who will help give us all longer, healthier tomorrows.
Hudgins is director of advocacy and a senior scholar at The Atlas Society.

For further information:

*Edward Hudgins, “It’s Getting Better All the Time: Reviews of Abundance and Merchants of Despair.” April 24, 2013.

*Edward Hudgins, “Government Medicine's Prejudice Against Innovation.” October 20, 2004.

*William Thomas, “Transhumanism: How Does It Relate to Objectivism?”

Edward Hudgins
About the author:
Edward Hudgins

Edward Hudgins, former director of advocacy and senior scholar at The Atlas Society, is the founder of the Human Achievement Alliance and can be reached at ehudgins@humanachievementalliance.org.

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