“It can’t be true!”
I was on the phone with my mother, and she was on the verge of tears.
“Relax,” I said. “It’s not the end of the world.”
“But you can’t be part Neanderthal.”
“Listen, I’ve got more Neanderthal DNA than most of my friends.”
“Oh, my God!”
“Calm down. It’s not a bad thing!”
“You must have gotten it from your father.”
“The latest findings in genetics have revealed that most people have 2-4 percent Neanderthal DNA. My test results indicate that I have 3 percent.”
“But the Neanderthals . . . they were . . . they were cavemen!”
“You’ve got the wrong idea about them. It turns out that having Neanderthal DNA confers numerous benefits on modern humans. Neanderthals were in Europe hundreds of thousands of years before Homo sapiens entered the region, and they developed a strong immune system to cope with the cold weather. Having Neanderthal DNA actually boosts your immune system. And contrary to the common misconception that they were of low intelligence, Neanderthal’s had a highly developed visual cortex, so there is some speculation that their DNA helps people do advanced mathematics.”
“But you aren’t good in math.”
“Yes, I am. In fact, I was in advanced placement calculus in high school.”
No matter what I said, it was hard for my mother to accept the fact that her son had Neanderthal DNA. But it didn’t bother me. In fact, I was proud of it.
The way I found out was that I spit into a plastic tube and mailed my saliva to 23andMe, which performed ancestry and health-related tests for a $99 fee. I also found out hundreds of medical risks that I can now take aggressive steps to avoid. As a salve to my inherent narcissism (yes, there’s a gene for that, too!) I discovered many genetic strengths, such as the fact that I possess one working copy of alpha-actinin-3 in fast twitch muscle fiber. I share this trait with many world-class sprinters and Olympic athletes. I also have a variant of the FADS2 gene that increases IQ on average by 6 or 7 points, provided an individual was breastfed, which I was.
I also found out fun facts about myself, such as that if I’m a coffee drinker (which I am) I’m likely to drink more cups of coffee per day than average. This rings true because when I go out to lunch, I’ll typically order between four and six cups of espresso. And I also learned, to my great amusement, that I have a highly superior ability to avoid errors and learn from mistakes, based on genes for dopamine neurotransmitter signaling.
The fact is that a revolution is in the making. Recent advances in genetic testing are allowing consumers to find out things about themselves and take control of their own health in a way that has never been possible before. The problem is that doctors are being left in the dust. Over 850,000 people have received their DNA test results from 23andMe, which was founded by Sergey Brin, the co-founder of Google, and his then wife, Anne Wojcicki. But when people show their results to their doctors, there are some reports of physicians reacting in a hostile manner or, more often, simply not knowing how to deal with the data.
As some analysts, such as Larry Downes and Paul Nunes, have pointed out “when technologies improve exponentially, many industry incumbents – and the regulators who oversee them – are kept constantly off-balance.” 23andMe is a startup hoping to give people more information so that they can help themselves, but the status quo is unfortunately acting as if it’s not ready for this extremely useful information.
Believe it or not the FDA has stopped 23andMe from making genetic reports available, although consumers can still get raw data (which most laymen can’t interpret) and ancestry data (which is fascinating in itself; I now know the names of 396 cousins worldwide!). The FDA’s reasoning is that doctors didn’t order the tests and laymen might jump to erroneous conclusions. For example, a woman who learned that she had a BRCA mutation might rush to have a mastectomy. It’s a valid concern, but it shouldn’t cause the FDA to shut down the tests. It’s unlikely that anyone would elect to have major surgery based on a single consumer test like 23andMe, and no doctor that I know would allow it to be done without more rigorous tests. The irony is that most doctors don’t understand the genetic results when patients bring them to their attention anyway. And it is paternalistic for the FDA to assume that people can’t figure out how to use the test results. The FDA is essentially treating the American people as if they were unintelligent.
As David Kroll writes in Forbes, “Personal genomics information is here to stay and is getting cheaper by the day. While DNA sequences don’t tell us everything about disease risk, they can ultimately help people live healthier lives by pointing to preventive interventions in their diet or in early screening for diseases at increased likelihood to pop up. We will soon be walking around with our complete genome sequences on a flash drive, or maybe in an implantable subdermal chip.”
In my view, and in the view of nearly a million people who have already opted to buy the service, genetic testing is the future of medicine. Even more importantly, your DNA is yours. It is not the government’s. You have a right to look at it, to read it – and to have it analyzed.
In an interesting twist, a 2013 story in The New Yorker by David Dobbs, and one on genomeweb.com by Turna Ray, suggest that 23andMe may have provoked a contest with the FDA on purpose to attempt to prove that direct-to-consumer genetic testing is permissible. And as Berin Szoka, president of TechFreedom, reminds us, “Government agencies rarely reverse course unless sued.”
Another explanation of the rift between the genomics company and the FDA, as Dobbs points out, is that 23andMe’s general counsel left the company in the summer of 2013 and maybe no one else kept in contact with the FDA to provide the agency with information.
One last point for attorneys. We have an ethical obligation to participate in activities for improving the law. The Model Rules of Professional Conduct articulates this obligation in Rule 6.1(b)(3), indicating that “every lawyer has a professional responsibility” to do public service work, including “participating in activities for improving the law.” The FDA’s actions in this case are, in effect, a law which genetics companies must follow. Many believe that the FDA’s position is in need of reform. Unfortunately, it is unlikely that anything we can do as individuals will change the FDA’s policy, so for the time being new customers can only get raw genetic data and ancestry information from 23andMe. Still, some clever lawyers may find ways to join the fight against the FDA’s regulation and lead to a future which will make direct-to-consumer genetic tests available again. I sure hope so.
Meanwhile, I’m going to think about brushing up on my calculus and have another cup of coffee.