On June 9, 2008, the California Department of Public Health sent cease and desist letters to 13 companies that offer genetic testing. According to the letters, the companies are in violation of certain sections of the Business and Professions Code of California, including offering “a clinical laboratory test directly to the consumer without a physician order” since such tests “must be ordered by a physician or surgeon” (according to these officials). Copies of the letters are available here. The companies receiving letters are:
- CGC Genetics
- deCODEme Genetics
- DNA Traits
- Gene Essence
- HairDX LLC
- New Hope Medical
- Sciona Inc
- Smart Genetics
- Suracell Inc
I’m entering this discussion late, although I’ve been watching with great interest. What I’ve noticed is that much of the discussion, both in the blogosphere and the media, is confusing or ignoring the fact that there are actually two questions involved here.
The first question is solely a legal one: are these companies actually in violation of the California statutes? Ultimately, this question won’t be decided by the California DOH or the genetic companies; it will be up to the courts to decide (if it gets that far). It is important to note that just because officials at the California Dept of Health have interpreted these statutes this way doesn’t mean (1) that their interpretation is correct, or (2) that this type of testing is what the statute was meant to protect or defend against. Craig Manson at GeneaBlogie raises the same point:
The other point is that there is not necessarily a violation of state law simply because a mid-level bureaucrat says there is. There are questions about how the statute was intended to be interpreted and even some constitutional questions here.
Since at least a few of these companies have decided to ignore the cease and desist letters, they must believe that their testing is outside the prohibitions of the statutes, or that the statutes are unconstitutional (e.g. they impinge on an individual’s constitutional rights).
The second question is a matter of opinion: SHOULD genetic testing by these companies without a physician be illegal? This is a question that involves personal philosophy, ethics, and beliefs, and we should each answer this question for ourselves. I know what I believe, and I know what many of my fellow bloggers believe. But I hesitate to force my answer on anyone else. I would rather see a system where people can answer this question for themselves and then order from the appropriate company (i.e. a company with a physician, or a company without a physician).
What About the Uninsured?
And finally, there is one other point that I haven’t seen discussed anywhere else. Although genetic testing is expensive right now, it won’t be for much longer. In the next 5-10 years I’ll be able to send off my DNA and receive my entire sequence for much less than $1000. However, if a company is forced to employ geneticists and physicians to order tests and then interpret them for the customer, the price of testing will remain higher than it otherwise could be. Alternatively, an individual might be forced to visit a doctor who will then order the test for them, and then they’ll have to visit again when the results are returned. In either scenario, the expense of sequencing might be beyond the reach of most low- to middle-class Americans (as it is now). To compound this problem, many of these people do not have health insurance.
I agree completely that people who are uninsured should spend money on proper doctor’s visits rather than genetic testing, but in a few years – as we learn more – that will change. In the future genetic sequencing could have a huge impact on a person’s health and medical care. What happens if the uninsured can’t afford genetic testing because of these potentially expensive regulations? It might be a little far-fetched, and I don’t have an answer, but I thought I’d at least raise the concern.
Here are some blogosphere reactions:
- The Gene Sherpa – Do you hear that sound Mr Anderson?; Streets of Philadelphia; R’Uh-R’Oh Shaggy!!!; DNA Traits among the 13; Daniel is a Great Guy!; Let’s Just Say…..; ABC, Misinformation and Government Regulation. Unfortunately, many comments left on Steve’s posts have been less than civil, which is very disappointing. Although I don’t agree 100% with his opinion, leaving rude comments (often anonymously) on his blog is not the way to let him know. Additionally, Steve is all for genetic testing and patient empowerment, and I’m certain that he isn’t proposing more doctor involvement just for a few extra billing events.
- Genetic Future – Cat-fight over California; Some surrender, some fight on: genetic testing companies respond to the California letter; Gene Essence: what bad personal genomics looks like; The market for personal genetic testing. As usual, Daniel at Genetic Future writes interesting and timely posts. The Gene Sherpa and Genetic Future have been discussing some of the issues back and forth on their blogs, which has been very interesting to follow.
- Genome Boy – Itâ€™s my duck in a box!
- Epidemix – Attn, California & NY: DNA is Data; The Public Health Case for Direct-to-Consumer Personal Genomics
- Adaptive Complexity – Getting Your DNA Sequenced: Should Regulators Crack Down on Genetic Testing Companies?
- Pimm – Future stop: California health officials against personal genetics risk-takers; Innovation stop: â€œAll theyâ€™ve done is created an extra billing event for the doctorâ€
- bbgm – The right to get yourself genotyped; Your SNPs are your information
- TechCrunch – Cease And Desist: California Tries to Unravel 23andMeâ€™s Genetic Testing
Here are some articles about the dilemma in California and New York:
- Wired.com – When’s a Gene Test Not a Gene Test? – Navigenics’ response to California’s cease and desist letters.
- Wired.com Blog – Are Internet Genetic Testing Services Really Illegal? – An actual analysis of the legal issues, something that very few others are actually doing.
- Wired.com Blog – Two More DNA Testers Shutter California Operations; 23andMe to California: We’re Not Ceasing or Desisting; Top 10 Reasons that Regulators Should not Hinder Genetic Testing; Attention, California Health Dept.: My DNA Is My Data; Exclusive: DNA Testers Reveal Cease-and-Desist Letter; Meeting Reveals California’s Hardline Stance on DNA Testing
- New York Times – Gene Testing Questioned by Regulators
- TechNewsWorld – Genomics Meets Sacramento
- MIT Technology Review – Genetic-Testing Fight Continues
- Reason.com – California Public Health Bureaucrats Attack Your Genetic Liberty
- The Huffington Post – California’s Misguided War on Self-Knowledge
- The Mercury News – Genetic-testing business all but unregulated
- San Francisco Chronicle – Genome testing firms defy state order to stop
- Portfolio – DNA Testers Scramble to Meet Deadline
- The Guardian – California clamps down on genetic testing industry
- TechDirt – Why Do You Need A Doctor’s Note To Get A Genetic Test?
- Forbes.com – California Orders Stop to Gene Testing
Thanks for these cogent insights, Blaine. I agree with you that people ought to have a choice. Your point about the uninsured is right on target.
Craig Manson’s last blog post..Saturday at the Jamboree
Thanks for amassing all of this in one convenient place, Blaine. You are a gentleman and a scholar.
Misha’s last blog post..Coming soon to a SNP panel near you?
My barber as a kid used to say that to me….
Blaine, excellent round up. Thank you for not blasting me…… BTW the uninsured thing is a stretch. There are tons of minute clinics, Npt For Profit hospitals with clinics and doctors doing pro bono work for the indigent and uninsured. This would apply here as well.
Steven Murphy MD’s last blog post..Good Morning America and Our CliniCast(TM)
In requiring a doctor’s referral, aren’t people overlooking the fact that there’s lots of non-disease related information revealed by SNP profiling? Why would you want to put an overworked doctor who isn’t a genetic testing expert(and doesn’t want to be) in charge of this?
I understand the point about protecting people from being taken advantage of by unregulated practitioners and scared by dubious information, but I don’t see how requiring a doctor’s permission will help this.
Mr. Gunn’s last blog post..Thompson Scientific has a closed science search engine.
Thank you for the nice comments everyone. Steve, I hope you’re right about the uninsured finding ways to get tested.
Mr. Gunn, I think that the doctor’s permission requirement would help weed out non-scientific genetic testing, but I also believe there are more efficient ways of ensuring quality.
My opinion is that GGists should stick to tests which do not allow for the positive identification of the persons tested but only of their patrilineage and matrilineage. Haplo tests serve just that purpose. GGists do not need in their work of simple genealogy/ancestrology the use of tests relying on diploid information which permit individual identification.
If the aim is to do genealogy, then there is no need for tests which are normally reserved to the medico-legal domain or to biomolecular genome research.
Their use poses at least a deontological problem.
If people get tested in order to gain knowledge about their atavisms, about their genetic makeup and especially about their susceptibilities to certain “maladies”/behavioral tendencies, then their motivation is not genuinely that of Genetical Genealogy.
I would prefer that test results relying on diploid information not be considered nor discussed by GG which is after all a scientific hobby, but be left to another discipline which remains to be given a name.
We cannot fully imagine for the moment the societal consequences of letting ordinary people (wrongly) cultivate the impression of knowing their own genome and that of others.
I don’t think it would, Blaine. CLIA certification and validated reporting methods would do that. Making people get a doctor’s permission to get the test done would make doctors the decision makers regarding which services are high quality and which aren’t, but they’re clearly the wrong people for the job. The average GP is way too busy treating patients. Some would categorically deny permission so they don’t potentially expose themselves to liability, and some would simply rubber stamp the form for whatever service was recommended by the AMA or their state’s health board or whoever the buck gets passed to. That doesn’t protect consumers any better than requiring CLIA certification, it just changes who’s taking responsibility for protecting consumers. Why shouldn’t this continue to be the FDA’s job?
Nobody wants profiteers selling dubious results to a credulous public, but there are good players and bad players in the field. Simply requiring CLIA certification should be enough to run off the bottom-feeders without creating a suffocating layer of bureaucracy.
Mr. Gunn’s last blog post..Thompson Scientific has a closed science search engine.
I believe genetic testing is wrong unless a doctor approves it. There are probably several other ways to improve the quality of testing without causing problems.
HR Blog’s last blog post..Employee Handbook Essentials
Thanks for the informative sharing information. I think that GGists should stick to tests which do not allow for the positive identification of the persons tested.
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