23ANDME AND YOU IN THE DATABASE
That’s because the FDA’s decision will help the company collect yet more DNA to feed its database, already said to be the world’s largest. It’s the database, not direct-to-consumer gene testing, that is 23andMe’s real business–a fact that the media reporting on the FDA decision largely chose to ignore. Mystifying.
Lots of folks will now spit in a tube and send their DNA-containing saliva (and $199) off to 23andMe to be tested for genes that contribute to the risk of developing 10 diseases, some quite rare.
(At one point the company was selling genetic testing for risk of 240 medical conditions, but the FDA called an irritated halt to those services in 2013 partly on the reasonable grounds that the tests were not accurate.)
Why is the new testing kit limited to 10 diseases? Because the FDA permission for which tests to include in the kit is based on how reliable the current tests are. The FDA is requiring the company to include only tests that are known to be 99% accurate, according to Jessica Hamzelou at New Scientist.
What the test selection is not based on is how useful the results might be to individual patients and their health care.
Some of the tests make medical sense. Knowing that you’re genetically at risk for the autoimmune disorder celiac disease could prompt you to avoid gluten, which triggers attacks. A good friend of mine was finally diagnosed fairly late in life as suffering from celiac disease. Getting that diagnosis much earlier would have saved him many years of misery. Being alerted to his genetic risk before he was seriously symptomatic might have gotten him to change his eating habits in time to prevent the worst.
The healthcare utility of some of the other tests is not at all obvious. They violate a basic principle of medical testing: a test is pointless if nothing can be done about preventing or treating the disease.
What, for instance, is the point of testing for risk of late-onset Alzheimer’s disease by looking for the APOE4 gene mutation? There are as yet no preventive measures or treatment for the devastating brain disorder. “For Alzheimer’s, carrying two copies of the ApoE4 variant (one from each parent), as 1 to 2 percent of the population does, raises the lifetime risk of the disease to as much as 87 percent, for instance, compared to about 9 percent in the general population,” Sharon Begley tells us at STAT.
But what use would knowing your risk of Alzheimer’s is 87% be to you–besides clinging to the hope that you’ll be among the 13% who escape their predicted genetic fate?
I can’t imagine that carrying such a burden would improve your life–except maybe prompting you to buy long-term care insurance. (And hope that the insurance company you buy it from doesn’t insist on a genetic test of its own. Or that your employer doesn’t disclose the genetic test results it has insisted on. That is a real possibility given new legislation Congress is considering, as I wrote here at On Science Blogs a couple weeks ago.)
Consult Sharon Begley’s post at STAT for a rundown about what each of the tests in 23andMe’s initial lineup can–but, more important, can’t–tell you.
It seems odd to me that almost no media accounts of the FDA decision and its likely impact on big increases in direct-to-consumer genetic testing mentioned the real reason why 23andMe wants to look for your risk genes for Alzheimer’s and, eventually, all other diseases. It fell to a law school blog to make the connection. Here’s illumination from Kayte Spector-Bagdady and Michele Gornick at Harvard Law’s Bill of Health blog:
“Despite the inspiring enabling consumers with their information-kind of rhetoric, this is about research. 23andMe’s bio/databank, the largest of its kind in the world, is a major component of its $1.1 billion valuation. Not that 23andMe is hiding the ball. 23andMe participant data (note it has a research consent process) has been used for several recent high profile genetic breakthroughs including for depression and skin cancer. The more tests 23andMe can offer, the more consumer interest—the more consumer interest, the more donors and data for its bank. The more donors and data for its bank, the more interest from industry and other researchers.”
So consumers are paying $199 (and up) not so much for information about their own health. They are paying so that 23andMe can sell their data. And the company is even using this customer data to develop their own pharmaceuticals; 23andMe’s drug lab opened last year. Antonio Regalado explored the business of 23andMe’s genetic database at Tech Review.
THE FUTURE OF DIRECT-TO-CONSUMER GENETIC TESTING
The 23andMe decision is only the beginning. The FDA has also loosened its rules for getting a new genetic test approved for marketing. This “throws the door wide open to dozens of other companies to run out their own versions of at-home genetic risk-analysis products,” says Dave Gershgorn at Quartz.
Media reports about the FDA decision tended to focus on how gene-testing results could be misinterpreted. Doc Michael Joyner’s post at HealthNewsReview echoed a common theme: genes are not destiny. A test may give you a risk estimate but cannot tell you whether you will develop the disease.
But the fact that genes are not destiny provides an excellent marketing ploy for genetic testing companies–selling the idea that the tests help people make lifestyle choices to reduce their risks.
Would that it were so. Joyner points out that research has so far shown that knowing their genetic risks does not prompt people to change their behavior.
He argues that your bathroom scale will predict your risk of future disease better than most genetic testing will. Yet people ignore what their scales are telling them. Why should we expect genetic testing to be more effective?
MARCH FOR SCIENCE COMING UP APRIL 22
At LiveScience, Mindy Weisberer’s post is a rundown on the basics of the March for Science April 22, a topic that has appeared here at On Science Blogs a number of times (for example, “Is the March for Science in trouble?“) It’s taking place not just in Washington DC but in nearly 500 other locales. Her post covers the March’s brief history, its organizers, and logistics.
Saul Elbein has a longer profile of the organizers at Undark. At Grist, Brian Kahn reports that the organizers say that, after the March, they plan to transition “to a global organization focused on science education, outreach, and advocacy.”
The Climate Science Legal Defense Fund has a free PDF pamphlet of advice for marchers. Get it here. Among the advice: When marching, don’t wear work paraphernalia; do bring cash, ID, and medication; memorize essential phone numbers; Be prepared for the improbable (encounters with law enforcement.)
At the SciComm Blog, my PLOS Blog Network colleague Victoria Costello has compiled what’s being tweeted and written about the upcoming March for Science. She says, “Check it out for evidence-based scicomm resources (for your local use) and for a good dose of team spirit as we approach the April 22nd global demonstration of our resolve to STAND UP FOR SCIENCE.”
As is only appropriate, at least four research groups are gearing up to study the March for Science. Jeff Mervis describes their plans at ScienceInsider, adding “The challenge for researchers is to understand what is driving people to act now and what their actions say about the status of science in today’s fractious political culture.”
The path to the March has not been smooth. In “Is the March for Science in Trouble?” I described some of the disputes, especially about diversity and partisan politics. These issues have not gone away.
Azeen Ghorayshi of BuzzFeed described the fracas after Bill Nye the Science Guy, who is not only a guy, but a white guy, was appointed honorary co-chair of the March. You can imagine what followed. And what followed after that was the appointment of two other honorary co-chairs, both women of color: “Mona Hanna-Attisha, the pediatrician who first exposed dangerous lead poisoning among the mostly poor black kids in Flint, Michigan, and Lydia Villa-Komaroff, a molecular biologist famous for helping to figure out how to get bacteria to make insulin.”
Another continuing argument is about whether science should be political. Steven Novella recently tackled that one at Neurologica, concluding that, while science is inevitably political in some sense (for example because it depends on government funding dispensed by politicians), it should strive to be non-partisan.
“The March is overtly political. It is a public demonstration of support for science in various ways, and meant to put pressure on politicians,” he says. “However, I do not think the Science March should be either a “liberal” or “conservative” event. It should be non-partisan.”
The plans Trump has for dispensing with science don’t make it easy to be high-mindedly non-partisan. At NASA Watch, Keith Cowing describes a tweet trolling Trump from the edge of space. The tweet was sent by the Autonomous Space Agency Network (ASAN), which describes itself as “the first branch of a global network of community based space exploration programs.”
The ASAN project was a “protest in space” against President Trump, in solidarity with the March for Science. ASAN sent a weather balloon into space with a printed-out anti-Trump tweet attached to it.
What the tweet said was LOOK AT THAT, YOU SON OF A BITCH.
Cowing kindly explained to those of us lacking in space literacy that the tweet was not just an expletive. It was a historical reference, a comment from Apollo 14 astronaut Edgar Mitchell: “From out there on the moon, international politics look so petty. You want to grab a politician by the scruff of the neck and drag him a quarter of a million miles out and say, ‘Look at that, you son of a bitch.'”