The argument maybe defused. Quacksalvers?

Ok,

So what happened in the DTC market was a fractionating of services with different "legal" arguments for what they were doing in attempts to avoid regulations which comes with all sorts of health care practice.

At that time I argued that these firms WERE DOING healthcare and should be regulated as such.

Astute legal times from Navigenics and 23andME said.....we aren't doing medicine. We are only using algorithms to process results of biospecimens .....Despite receiving cease and desists

They even said, we don't NEED CLIA because we aren't doing clinical testing.......

Yes, in hindsight these arguments did seem silly......they seemed silly to me at the time as well. But then these businesses fell in line, sort of..... Paired with CLIA labs and then we all moved on. But what they didn't do is submit their algorithms to regulation as well. We now see this problem getting larger. Especially as Muin Khoury and the CDC argue for complete transparency of what these "algorithms" are.

Why? Because the CDC, like me feels that they are providing some sort of healthcare service. One that will likely exist in the future as well. So much so that it needs to be regulated now, to prevent all sorts of shenanigans like those that existed even in 20th century healthcare.....

Cocaine for headaches and depression?

Traveling medical shows where women all sat in a train car and......

Mercury to sure mania? We saw that all of these things were used without regulation or guidance, exposing people to significant harm.....

Like the financial industry, the argument that regulations will prevent us from being the world leader in genomic technology is pure B.S. Just like it was with Finance

In fact, I do remember all of these money making brokers saying the exact same things I hear now from Genomicists mouths......

Scary, if you ask me.

So what about these "algorithms"?

Well, a few people confirmed that in California we have some new drafted legislation which could affect all players in this DTC and lab space.....

• This bill would require an entity that provides post-CLIA bioinformatics services, as defined, to contract with a licensed clinical laboratory to process biological specimen collection kits, except as specified.


• The bill would require an entity that provides post-CLIA bioinformatics services to employ a specified expert for approval of the algorithms used in the interpretation of the biological data of a customer.


• The bill would further impose on an entity that provides post-CLIA bioinformatics services specified privacy, recordkeeping, disclosure, and audit requirements, and would impose specified duties on the State Department of Public Health in that regard.


• The bill would also subject those entities to specified provisions of existing law prohibiting unearned rebates, refunds, and discounts, a violation of which constitutes a crime.


• Because the bill would expand the scope of a crime, the bill would impose a state-mandated local program. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.


• This bill would provide that no reimbursement is required by this act
  for a specified reason.

We will see if this bill passes. But if it does, it may mean the end of Auctioning Off Genome Scans......

Which puts this technology right in line with the rest of healthcare, where it is ILLEGAL/Ethical Violation to discount, rebate, guarantee or refund.

The Sherpa Says: In my mind, this argument seems to be: "You are healthcare or you are Novelty. You cannot chose both" If this law passes it would be in line with the government of California as well as New York......

23andMe says "We have no use for YOUR laws"

In an age where no one trusts anyone and we see defiance of laws for the sake of profit I am still shocked and awed that companies that are formed to "Not be Evil" or to "Benefit Mankind" choose to ignore laws.


In healthcare, imagine if your doctor was found to be breaking the law. Stole from Medicare? Non-Compliance with State regulations? Spousal Abuse? Selling Drugs?



Most of these are career killers. In fact in CT we just had a large group of GI doctors who are now not doing so well because one of their partners was just charged with endangering a minor.


Why is it so vital that physicians, nurses and others in the healthcare field try to stay above the law? Because patients lose trust in the system. They begin to think that their care givers are reckless criminals. And WHO would trust their life to a criminal???



Apparently, this stream of thought doesn't even phase a company like 23andME. You see, they are blatantly breaking the law in several states. Why? They are on a mission. Destroy the current healthcare system, shatter the current ethical way that we currently practice research!


Why? They think that the cavemen currently practicing healthcare aren't in tune with their goofy Singularity!



How do we know that they don't care about the rules? 2 ways.


1.) They are actively doing research without abiding by the international "rules" for ethical research. They have no IRB and are coercing their participants by charging them money.



2.) They have said F~c& you to New York State by flaunting loopholes in their laws governing labs. In fact, NYS had asked them to destroy the samples which they had collected ILLEGALLY at a Fashion Show Spit Party.........In fact they post the loophole on their website



23andMe is currently unable to process saliva samples collected in or mailed from the state of New York. The New York Department of Health considers our Personal Genome Service a test requiring a lab license and direct physician involvement.


"If you or the recipient of the Spit Kit intends to collect your sample and mail it from outside the state of New York, please select the 'Ship to New York' button. … Upon receipt of your Spit Kit, you or the Spit Kit recipient will be required to affirm under penalty of law that the sample for the Spit Kit has not been collected in or mailed from the state of New York."


I watched the NY State presentation at the Recent SACGHS meeting. The woman seemed pretty pissed off at 23andMe's flaunting of these rules. In addition, she said that if they wanted to have any more spit parties, they could come up to Connecticut.....


But what she doesn't know, is that CT's laws are pretty clear about DTC testing as well......



IT IS NOT ALLOWED..........But that's not stopping the criminals at 23andME......



According to a 2007 survey by the Johns Hopkins University's Genetics and Public Policy Center, Connecticut, Pennsylvania, and New Jersey do not allow or limit DTC marketing of genetic tests and require tests to be ordered by a doctor.


23andMe offers its DTC service in these four states neighboring New York.

I guess they don't care about Connecticut's laws either..........or California's or Pennsylvania's of New Jersey's. I could go on and on here.



I have a big issue with companies looking to play doctor without going through the process of being a doctor. Or playing clinical laboratory without taking any of the responsibility of being a laboratory.


The Sherpa Says: DTC genomics companies in this current form are breaking the law and could care less. Why did I point out the insurance fraud going on at major academic centers? The same reason I warn state governments about the flagrant disrespect of these laws. You cannot effectively practice medicine when the "Chain of Trust" has been broken......

23andMe enters the Clinical Medicine Realm!!!

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.......