News of the California Health Department’s mailing of cease and desist letters to 13 direct-to-consumer genetic testing firms, such as 23andMe, Navigenics and DeCodeMe, has sparked intense debate over balancing regulations to guarantee quality and individual rights to genetic data.
Here on THCB, Matthew Holt called the move the "first establishment challenge of Health 2.0."
"This is a case where the regulations are running way behind the technology, and the trade protection organizations of health care providers are, I’m sure, whispering in the ear of the regulators," Holt wrote.
Why all the fuss now?
CA regulators say doctors must be involved in ordering and deciphering the genetic tests, which currently are offered directly to consumers. Currently, customers pay about
$2,500 at Navigenics for an initial one-year membership — and then an
annual fee of $250.
23andMe and DecodeMe both charge about $1,000 for permanent access.
Thomas Goetz, a blooger at Wired and Epidemix, wants doctors to stay uninvolved. He compared the genetic tests to pregnancy tests and thinks the state shouldn’t meddle with his DNA.
"The assumption that there must be a layer of ‘professional
help’ is exactly what the new age of medicine bodes — the automation
of expertise, the liberation of knowledge and the democratization of
the tools to interpret and put to use fundamental information about who
we are as people. Not as patients, but as individuals. This is not a
dark art, province of the select few, as many physicians would have it.
This is data. This is who I am. Frankly, it’s insulting and a
curtailment of my rights to put a gatekeeper between me and my DNA."
Murphy over at Gene Sherpa,
however, argues that doctors must be involved and for more regulation
to ensure the quality and integrity of genetic testing. "Medical
Genetic testing will and should fall in the realm of health care and
practitioners," Murphy wrote.
The California officials’ move was predictable, Murphy says, and points out research from Burrill & Co.
that found “makers of these tests might have more success penetrating
the market by working through doctors rather than trying to make the
case for their products directly to the consumer.”
Murphy felt bombarded by commentators with strong opinions on the subject and wrote several follow-up posts defending his position. Murphy is a clinical genetics fellow at Yale University and founder of a personalized medical practice. He says his opinions that the average person and many general physicians cannot understand genetics is not arrogance but merely the truth.
"I am just shocked and awed that some in the public think that they can do this on their own without professional help. Do you build your own home? What about fight your own court cases? Some do their own taxes … but only when it isn’t complicated. Trust me, this IS COMPLICATED!"
On his blog, Murphy provides a helpful timeline for genetic testing, going back to 1994 when JAMA published an article discussing the psychological implications of genetic testing.
State regulators gave the testing companies two weeks to prove they are in compliance with state law. Stay tuned for the outcome.
So much for Web 2.0 “revolution” in healthcare.
That’s what I don’t understand….
You get some regulations and you quit? Where in the world would medicine be if it had that attitude. Healthcare is the most tightly regulated field in the nation. Why in the heck would anyone playing with tech in this space assume that the government would treat them like tech but NOT treat them like healthcare. I think the tech industry needs to look deep in side itself and be thankful for all the years of carte-blanche….now they have some hard work to do. Welcome to the world of healthcare. Don’t quit, work hard to make it better and play by the rules. That’s what we at Helix Health do everyday!
Good luck making a case that these tests stay unregulated.
On one end you have vendors arguing their right to make a buck. On the other you have regulators claiming to protect the public and established healthcare groups giving them the ammo.
Guess who is going to win.
If you have any doubts, try making an argument that drugs should be sold without doctors and pharmacists. You know, like you should be able to buy crack at every gas station, because it is your right.
This is a rehearsal of how regulation will be imposed on the rest of “Health 2.0”. As soon as anyone starts making money you will hear safety concerns first, followed by cease-and-desist orders later.
So much for Web 2.0 “revolution” in healthcare.
” He says his opinions that the average person and many general physicians cannot understand genetics is not arrogance but merely the truth.”
I support his statement. I am not only a physician but a laboratory physician and I do not understand these tests, although I could with some more education and study. The average physician, be he/she generalist or specialist (other than this specific field) would be in the same boat as me.
Every, and I mean EVERY laboratory test has false positives and false negatives. Even that over-the- counter pregnancy test. Finding the setpoint to call a test “positive” or “negative” is thus critical and requires professional expertise. It’s just the facts, folks.
Having said that, I agree that a person has a right to his/her results, if accompanied by a proper written explanation of the confidence level in their accuracy. One shouldn’t have to make an appointment with their physician, who knows little more than they do, to get these results.