As I had postulated before, in order to move towards a profitable direction the DTC companies would have to choose "Medically Relevant" or "Novelty Testing" From this recent email sent to me by a reader it is clear, 23andME is Choosing to become a clinical service, without accepting the clinical responsibility.
Hello Patient X,
There's a wealth of new information in your 23andMe account. Our scientists have recently added a number of new articles to our Personal Genome Service, including two that may be of special interest.
If you take cholesterol-lowering statin drugs, be sure to check the new article for Statin Response, which deals with rare but serious side effects that may be influenced by genetics.
And for our members who have the data> from our v2 chip, we've added important information about BRCA1 and BRCA2 -> genes with variants having a quite rare but significant correlation to breast and ovarian cancer - in BRCA Cancer Mutations (Selected).
You can read these or any of our other recently published reports here.
And check out the expanding list of topics being added by your fellow community members here. Please join the conversation!
Best Wishes,
The 23andMe Team
So there you have it! BRCA1 testing on the V2 chip from 23andMe. I never, ever, ever thought that they would lay this stake so quickly. Yes, it is clear. 23andMe wants to report, directly to the consumer BRCA1 genetic test results! It is a variant and it is being reported.
Do they have medical malpractice coverage?
Are they covered by HIPAA?
Do they have the HHS Certificate of Confidentiality? They are doing research on genomics!
NO.
Rest assured, I have forwarded this information on to the California Department of Public Health as well as EGAPP. People do deserve to know results of these tests, there is no doubt about that. But people also deserve to have the legal protections afforded to all others who do genetic testing through a provider. These protections include significant regulations mandated of labs as well as ordering providers.......
I said last month that we would know which way these companies will go in 6 months. Looks like it took 23andMe only 1 month.......
The Sherpa Says: Pharmacogenomics and BRCA testing is in the realm of Clinical Medicine my friend.......so shall end your punch line of "Testing for Fun" I look forward to you taking medical responsibility for your actions. I hope you do too.......
9 comments:
Since you've pointed to a single snp, I thought you and your readers might find it useful to look at
http://www.snpedia.com/index.php/BRCA1_and_BRCA2
which shows just how many BRCA1&2 snps are on the various platforms. Customers of deCODEme and Navigenics are also tested for these snps.
Yeah Navi and DeCode crossed that clinical line already and freely admitted it.....not 23andMe.
Snps in BRCAs that increase disease risk.....sounds like cancer genetics to me.
-Steve
Thanks for the Link Mike. You have done a ton of work on your site....great stuff!
-Steve
Steve, you are fighting a losing battle.
As Daniel MacArthur says, you have strong financial interest in 23andMe staying as far away as possible from the area of clinical diagnostics. You do not want Helix Health of Connecticut to compete with DTC companies. Maybe because they can do the same thing (or better) Helix Health of Connecticut does.
Even Andrew, your friend and employee at your company Helix Health of Connecticut says that he likes 23andMe. He even recommends 23andMe tests to patients...
I think you are getting alone in this battle induced by your strong financial interest. Just money...
Listen, you are a doctor, not a businessman. Do your job and enjoy life with your family. You will never become a successfull businessman. Remember, you are a doctor and it is very unlikely that you have the capabilities needed to become a successfull businessman.
@ Anonymous,
How does 23andMe's success....or lack thereof affect my bottom line?
It doesn't, just like it doesn't affect my patients' health. It is a shiny bobble and if it were to produce a clinically useful tool which could help me.....that's fantastic....provided it doesn't steal my patients' genomic data...
How come all of these 23andMe fans don't understand how medicine works, yet think they can learn something amazing from this snp scan? Tell me anonymous.....will you do your own rectal exam or Prophylactic mastectomy?
We never lose.....
We are doctors....
That's why we went to medical scool for over 100 thousand dollars of debt....
We don't get downsized....and will never be replaced by google.....ever.
So, I maintain, if 23andMe can make a clinically useful test which can help my patients, I would order it...provided they don't steal my patients' genomic data....
Thanks,
-Steve
The anonymous is Daniel MacArthur himself. The writing style is the same. If Andrew recommends 23andMe tests to patients, I'm very disappointed in him.
N/A
Drew cannot make recommendations on clincal matters to patients as he is not a clinician.
However, If he wants to tell someone on his OWN FREE time that he thinks 23andMe tests are Da' Bomb.....He is more than welcome to. His opinions and those of his blog are not in anyway reflective of Helix Health of Connecticut, just as my blog is not representative of Helix Health of Connecticut policy.
-Steve
Good. I don't see why that other poster said patients.
I'm a mutation carrier.
I find this new development terrifying. While I certainly agree that your genetic information belongs to you, offering these services without medical insight (especially not through a genetic counselor) is irresponsible at least and criminal at worst. When you learn that you have an up to 80% risk of early cancer, you need medical professionals to help you understand that risk in the context of your own particular family history as well as help you learn about your options for surveillance or prophylactic action. The average person may not be aware of the numerous academic centers that specialize in this area, nor the fact that the consequences of this information in a health record have become innocuous, and that insurance and medical professionals are supportive of learning how to manage one's risk.
Regardless of the ethical considerations of these tests (does a parent have the right to the child's information for a disease that has onset as an adult, for example), it disgusts me that something like this is part of a business model for a fast-moving genetic company. Too bad, 23andme, I thought there was hope for you.
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