In an obvious move California has taken their stance. This was the sound of inevitability. I find it funny that the same journalist hyping these tests 1 year ago is now reporting on how California has sent cease and desist letters to the genome firms. This week, the state health department sent cease-and-desist letters to 13 such firms, ordering them to immediately stop offering genetic tests to state residents.
As I sat near Dietrich Stephan, Joanna Mountain of 23 and Me, Ryan Phelan and the number 2 from deCode it was evident on their faces. I knew they had received the letters (Well maybe not Ryan, she was ebullient)*. Their faces showed what I already knew to be true. Medical Genetic testing will and should fall in the realm of healthcare and practitioners.
* It turns out Ryan Didn't get a letter!
According to the article from Forbes
23andme did not immediately return calls Friday afternoon. Navigenics confirmed it had received a letter. Navigenics Chief Executive Mari Baker said her company continues to process orders from California residents because "to the best of our knowledge, we are in compliance" with state law. Navigenics uses a doctor to transit orders and review results, and it relies on a state-certified lab testing company to do the gene tests, Baker said.
This strategy is ok for now. But I have the inside scoop. This little loophole is going bye-bye soon enough. That's right, in order to test, you are soon going to have to document informed consent and evaluation by physician or extender. So anyone not doing what Helix Health of Connecticut is doing will soon find themselves on the wrong side of the law....again. Don't believe me? Just investigate the Medi-Spa industry. Think you will win the lawsuits? Yeah.....Napster did too.
From the Mercury News
......It added that the businesses were told to submit a plan of correction within 14 days to the California Department of Public Health, showing "how the businesses will prevent further violation of California state laboratory law."
"Businesses that fail to comply with the order are subject to civil and/or criminal sanctions," the statement noted. Brooks said those fines could be up to $10,000 a day per violation.
Hey Guys. Got 5 million to spare? I can make all your problems go bye-bye.....
The Sherpa says:
The Matrix and Neo finally combine forces to beat Agent Smith.....remember?
37 comments:
Hey Steve. Read your site regularly. Definitely appreciate what you're doing. However, everytime I end up here every post you make has either an undertone or (as here) a complete focus on how much you want the government to further regulate.
I find it absolutely appalling that the government could step in and prevent people from freely finding out information about themselves. California can't put a decent school together, I'll be damned if I let them prevent me from sequencing my own DNA.
My only solace is that I expect Google...sorry, 23andMe, to fight this. I suppose we'll see how successful they are against the healthcare lobby....probably not very.
Does this affect DNA Direct?
Eco,
No one is banning anyone from getting genetic testing. I appreciate your comments. I just think you may need a Sherpa to help guide your discovery process, that's all. If you do have the genetic education and training to interpret these tests on your own....then by all means, get a CA state license and obtain your test. Or go to a trained professional to help you. This information isn't like your taxes or a binary pregnanc test. It is complicated stuff.
Google will lose, just like Napster did. But you won't lose, I promise
-Steve
Something tells me that documenting informed consent and physician evaluation isn't going to be that hard, but why are you so against genetic screening as a stand-alone industry?
Is it really just your own narrow self-interest in providing interpretive services?
I am so confused by Ananoymous' comments that I can't comment.
As for those of Mr Gunn,
What this amounts to is "Shame on you Doctor, for wanting to practice medicine!"
This is an industry argument which is disnigenuous. I thanf you for reading Mr Gunn. But you would be singing a different tune if you knew what I know. Trust me....that's why I am a Sherpa.
Hell with it. You can go ahead and practice surgery on your self too.. Maybe you can write a perscription for your
anti-arrythmics and blood thinners too?
I think that I am through. Do you really think so little of medical genetics that it is NOT considered medicine.....That's pretty bad....I don't blame you though. I blame the medical geneticists who never portrayed themselves as doctors.
-Steve
Quote: "Something tells me that documenting informed consent and physician evaluation isn't going to be that hard, but why are you so against genetic screening as a stand-alone industry?"
This is NA. I also make postings on EyeOnDna. I thought I would post my thoughts.
- Genetic testing is a medical test. You are testing for a health condition. A random consumer should not order a test. Should I order a surgery to see if I have any scar tissue in my left knee because it hurts at times and do the surgery myself?
- Clinical tests require certain regulations.
- Genetic counseling is needed pre and post testing. A genetic mutation for a condition does not mean you will get the condition. You need to take into account the medical history, family history, environmental exposures, phenotype, and so forth. Only a person trained in the area of medical genetics should provide these services (this can include doctors, PA's, nurses, genetic counselors).
- Some of these Internet based companies (well, not really Internet based...but tests can be ordered online) didn't offer any pre or post counseling and a consumer could randomly order any test.
- These companies were founded upon a published finding of a SNP to disease relationship. Genetics is much more complicated than this.
- Consumers should not be purchasing a $1,000 test to only be told “this is not a medical test, but only an informational test.” If you want to be tested for a health condition, go to a local genetic counselor and/or clinical geneticist and speak with a person that is trained in this area. You could save yourself $1,000, or you may find out that you actually could benefit from a different type of test then the one you wanted to order.
Anonymous but commenting on Eye on DNA,
Well Said.
-Steve
well, I am a geneticist (though not a human one) so I guess that makes me not a typical customer but I can only say that my experience talking genetics with MDs has been appalling. 23andME and these other *dedicated* services do a much better job of explaining genetics - especially on a genomic scale - to people than doctors, who are only really comfortable prescribing antibiotics.
the other anonymous is correct -- this is blatant rent seeking and will greatly harm the public interest. People must be allowed to learn for themselves not be obliged to hand over money in fear to a vested interest only to be handed down "expert" judgements. association studies are going to be coming in faster and faster. how often should I go back to my GP for another fee and another opinion? the public might be lazy but they are not stupid. let them learn.
Anonymous,
As I sit in the Union League, preparing for the ICOB meeting at the Coriell Personalized Medicine Collaborative......I have now seen the arrogance with which these companies were launched. Your arrogance and sneering down the nose at physicians is precisely why you WILL be regulated.
I am deeply saddened that you think so little of people who have a doctorate degree in something that you do not have.
"23andME and these other *dedicated* services do a much better job of explaining genetics - especially on a genomic scale - to people than doctors, who are only really comfortable prescribing antibiotics."
Ouch....this is obviously why you feel the way you do. You would have no idea what a physician is comfortable doing. I am not saying they are perfect, but they are easier to educate than the public. That being said, we need to educate both. I think you have given me great fodder to post on tomorrow. Thank you
-Steve
Such arrogant responses for someone who purports to educate people, do you talk down to your customers too?
I see two different pro-regulation people making a major straw man equating consumer genetic testing to surgery. Not to mention the strong undertone of urging regulation of what the consumer can and cannot do.
Mr. Gunn hits the nail on the head...there is a tired business plan in place here that is threatened by those who innovate. If CA regulates them, they will move. If the US regulates them, they'll move. You can't stop interested people from FedEx'ing saliva to Fiji.
Ever consider rolling with the times? Offer 23andMe consultations or something similar? It could only bring you more customers if more customers are out there interested and getting tested.
A straw man argument is an informal fallacy based on misrepresentation of an opponent's position
Have you heard of people committing suicide after finding out they tested positive for Huntington's Disease?
I have. That is just a serious as surgery. If not more so.
I don't mean to be arrogant. I just get frustrated with the whole DIY gang!. I went to medical school for an extra 4 years and then on to residency for 5.
9 Extra years....maybe I am upset that readers such as yourself think what we do is so easy that they can download a report and assume it is correct.
This is not arrogance, it is frustration and disbelief. As for the business plan......the price point is too high and the services too little.
-Steve
Steve, I am a medical geneticist and physician. I don't think you get what Navigenics et al have to offer. They are building the interpretation, communication and education interfaces that we need to really put this stuff into practice. We need them to be successful and the sooner the better. I don't favor regulation at this stage ... their results are relatively harmless (prove otherwise) and regulation is just going to slow things down and more expensive.
Counseling is not the most important point in the genomic profile strategy. The problem is to efficiently use the new information about a person to effectively improve their care. This is not going to be a manual gene by gene process. It is already too complex to follow the same paradigm as that used for Mendelian diseases.
Steve,
why are you so arrogant that you think people do not have the right to investigate their own DNA? All 23andMe/deCODEme... do is to provide the service. With your, i.e., most physicians, arrogant attitude of wanting to be a gate-keeper between people and their ability to know about themselves, and the politics of NY and CA a new industry and development will not be destroyed. Rather, these companies will just move out of the USA and only market their tests over the internet independently of government regulations. The only result of your and the government's actions: more jobs move out of the USA! Congratulations on your contribution to destroying the economy of Western countries!
Hi Steve. Nice site and insightful commentary. However, I'm with ECO, on the topic of your rent-seeking stance and also when he says:
"If CA regulates them, they will move. If the US regulates them, they'll move. You can't stop interested people from FedEx'ing saliva to Fiji."
Substitute Dr. Martin Whittle of Genomic in Sao Paulo, Brazil (www.genomic.com.br) for Fiji and you have a reliable destination for your DNA sample.
Hey Steve,
Apologies if I came off harsh, "government knows best" is a peeve of mine.
I _in no way_ think your job is easy, nor am I (nor are most consumers) qualified to analyze the information given by 23andMe,etc to the level where I would diagnose myself and start ordering prescription drugs from Fiji.
However, the position that "personal information is dangerous" is not compatible with my version of personal freedom.
Best,
Eric
To the Doctor from Navigenics,
I too agree that you are doing some wonderful things. You are to be lauded for this. We just debated the merits of releasing data at the Coriell Personalized Medicine Collaborative today. Follow up, education and more education is the order of the day. Which is why I think Navigenics would do well partnering with Helix Health of Connecticut.
-Steve
ECO,
I just have seen too many bad outcomes with limited data. This is very much the case with the patient who you tell aspirin can cause bleeding, so they won't take it when they have a heart attack. I have actually seen this. What's to say that someone who tests negative for fgfr2 won't stop undergoing mammography? Information without context is just plain garbage and unfortunately can be dangerous...Sorry.
-Steve
"Rather, these companies will just move out of the USA and only market their tests over the internet independently of government regulations. The only result of your and the government's actions: more jobs move out of the USA! Congratulations on your contribution to destroying the economy of Western countries!"
Aren't you changing the topic. Medical testing needs to be regulated not someone running away from the regulation. One may ask "Why run away?" "Why not comply?" is there something to hide.....like clinical validity.
-Steve
Speck,
Who should pay for false goods? What value do you place on gibberish? I am just so sad that the public feels that they are so smart that they don't need physicians. It just speaks to the sad state of our healthcare system. How sad that in order to avoid seeing a trained professional we have to send our samples to Brazil. Thanks for reading Speck.
-Steve
A recent Times article gives some insight into the distress and worry that can be caused by a dtc health test.
"As I stood in my hall with the opened envelope, I felt as if I'd been punched in the face. Staring at me was a large rectangle consisting of coloured blocks, with green (good) at one end, followed by yellow, amber, then red (very bad) at the other. My liver, said the impersonal letter, was in the red zone. “Your overall LiverCheck score is RED,” it informed me. “This means that your liver health is less than optimal. Even mild liver- test abnormalities may be an early clue to the presence of liver disease.” I felt sick."
In this case, it looks like the results were wrong but I think this illustrates just how upsetting and unsettling this was.
Who do you think should regulate these companies? The FDA?? Are they not already unable to keep up with monitoring clinical trials and keeping our food safe? The USA does not have the resources to regulate in the current fiscal climate.
I think we're getting to the root of the issue here.
Steve, your education was long and arduous, and your expertise is to be respected. However, you don't want to be like Thomas Edison, dismissing the virtue of alternating current because you've got so much invested in DC. Change happens, man. The respected and valuable skill of one generation becomes the commodity of the next. The only thing regulation does is to slow this down, and it's always pushed for by the people who don't want their skills to become devalued.
Your earlier mention of Napster is telling. The recording industry has fought MP3s and digital distribution tooth and nail, but it's now commonplace, and they missed out on their chance to get a piece of it.
Whose side do you want to be on, Steve? You have an enormous amount of expertise. I totally understand how you feel insulted by these companies deciding they just don't need you. Here's my question to you: Do you think the total worldwide market for skilled interpretation of genetic information will be greater or smaller if everyone is getting their profiles done? Do you really think there will be no place for you in all that?
The consumer is purchasing data, not a consultation of opinion of what the data means. It's the same paradigm as a pregnancy test or blood pressure measurement. Like a prior poster noted, services will just be available outside of the U.S. if they are regulated here. As the internet has demonstrated countless times, it's much harder to regulate the commerce of information than a physical product or service. If you have any doubts about that, consult a recording industry executive...
Re: " I am just so sad that the public feels that they are so smart that they don't need physicians."
Are you not part of "the public?" I think several of those commenting on your blog are trying to help you understand that your tone is not helping your argument.
I would seriously distrust a physician who has such poor pattern recognition skills that he can't see when he's shooting himself in the foot. Of course, in your opinion, I'd need a doctor tell me if that was actually a foot.
Most of the people who oppose your position do so not from a disdain of professional medicine, but from the position of individual liberty. I would get the government out of the business of medicine altogether if it were up to me. Let the free market handle things, instead of the monstrosity that has been shoved down our throats in America for the last 100 years.
And please don't use the tired argument that our "system" has been the cause of improvements in medicine. The improvements that have taken place have done so in spite of the system, because individual human beings used their own wit, creativity, insight, and hard work to improve health care for others. The government has at EVERY turn impeded this process, increased the cost, and lessened our liberty as a bonus.
You sir, are playing for the wrong team and your inimitable arrogance is preventing you from seeing it.
Quite frankly, I find your attitude on this matter utterly disgusting. If my own doctor said something of the sort to me, then I'd drop the use of his services there and then.
Your assumption that people are ignorant fools who must be handheld and guided by professionals is, quite frankly, evil. People can be intelligent and smart without large amounts of education and training, thank you very much.
Furthermore, the idea that genetic testing is a "medical test" is ludicrous. Is spitting on the sidewalk a "medical test" as well? It has exactly the same health ramifications, after all.
My professional opinion is that your opinion is highly unprofessional and unfitting for a person in the medical fields. It is unethical to support withholding of a patient's own information from them, under any circumstances. My genetic data is MINE. Not yours. If I want to interpret it myself, then it is not the right of the doctors or the state to stop me.
This blog will ultimately eat this post. The issue falls within the domain of multiple advocacy groups and it will definitely be taken to court. The state will lose, even if it has to go to the SCOTUS.
Not only curious individuals, but large companies (including Google financially, and perhaps the EFF for advocacy) have a vested interest in seeing that genomic data is made as widely available as possible. On top of that, it is only a matter of time before home tests are made available to consumers, nullifying the issue. Finally, there is nothing stopping individuals from sending their saliva to companies in other countries or states whose laws are not so draconian as to try and stop them from offering the services.
However complicated this MD thinks my genomic data is, they are wrong. We are all armed with search engines and whatever it is that we need to know can be more readily obtained (and for free) in this medium than from a know-it-all doctor.
All of this is an aside. I simply have a right to my own data. There is no other way to slice it. If I am comfortable with the knowledge that I may have Huntington's, then it's my prerogative.
Why do I need to pay extra to have my own genome tested. In your view we are but little children who need the Big Nanny State to protect us from ourselves (and so that members of the medical industry can stick their hands in our pockets).
Do you really see no difference at all between the risks and consequences of:
a) Performing surgery without medical assistance
b) Acquiring information about my genes
In my simple minded (and clearly not medical opinion) I would argue that you are not seeing the point of a lot of the comments.
The risks related to case (a) are acknowledged by everyone (I think). However, it can be argued that the risks in the case (b) are of a different nature.
This can be seen in your example, in terms that you are not concerned that the 'patient' will be harm in the 'procedure' involved on getting the information; you said that you were concerned about how people might react when they receive information about their potential future.
I might be wrong, but what I think the point of several previous comments is that prohibiting access to certain types of information for its possible consequences is a very complicated position.
Just to illustrate the point allow me to use an extreme example: under that rationale someone could decide to regulate access to medicine books because people without 'the proper background and preparation' might misinterpret them and act based on those misconceptions.
If you ask me, human beings are actually unprepared to deal with a lot of the relevant information we are offered on a day to day basis...
Just a thought... an important number of people does not 'really' understand statistics and fail to understand probabilities (e.g. gambler's fallacy), but for some reason, we do not test whether they are prepared to deal with the relevant information before they enter a casino. I am pointing out this because a lot of people ruins its life gambling, and I think that is also a very serious threat to their well being... but I am not sure that the right thing to do would be to forbid them to play.
By the way, sorry for the messy writing. I am not an English native speaker.
Since the sample collection is as harmless as having a photo taken, and the interpretation is equally as harmless, I can see no case for a regulation. You can buy over the counter medications that are much more dangerous than this test all on your own personal judgment that you are sick. (If you can point to one single case of harm caused by a cheek swab I will eat my words)
If some people are too stupid (too bad they haven't found the genes that are linked to that hideous disease) then I'll be damned if I should have my options limited for their sake. Any fool with a computer can easily find information on any disease tested for by these services and even an article on the math used to interpret them.
I asked my doctor about this test and he said that he doesn't think it's worth the ~$1000 but there's no harm in getting it, and he would give the permission necessary free of charge. Good thing he said that, because if he had given me some condescending bs about how I should not be allowed to know my own genome for my own good, I would go find a better doctor.
You are all entitled to information. The big question is what portal will you have to access to get this information. Is it such a bad thing to go see your physician, get your cholesterol and blood pressure checked, get a physical....and maybe get a SNP scan? I say no. In fact in a public health play, this could actually reduce a significant amount of disease. So why are you all pissing and moaning about having to go see a physician?
-Steve
Steve
This is information. It is your right to get access to this information. If there are decisions to be made then you need to consult your physician.
I still don't understand your logic. None of these companies is saying, you need to take x drug for y SNP. And to say that the people there are not qualified is absolutely untrue. People at DeCode have more genetic cache than most people in the world. Dietrich Stephan has been in the middle of the genetics world, esp for medical applications for years. The internal team at 23andme are not a bunch of hacks. They are all qualified individuals.
They have a business model that you don't like and think that people should no more. You believe you should collaborate with them. Equally fair. But to say that they should be forced to get yourself genotyped only in consultation with a physician is just turf protection. I know you feel strongly about this and respect your opinion, but you have to accept that my SNP information is my SNP information.
And by the way, you can dump your SNP info from any of these services and open it up in any genome browser of your choice, so it's not locked in. They're just the content management system in a way.
Deepak,
You and the people at these companies are absolutely brilliant. I would never doubt that. But to say that SNPs with interpretation is just information is dead wrong. It IS medicine. End of story. Give the SNPs.....no interpretation......not medicine. Interpret.....medicine. Medical genetics to be precise....the 24th medical specialty.
I respect you tremendously, but humbly disagree with your statement.
-Steve
Because you don't have a right to make money off of my desire for information when you aren't the one providing the service. If I get the test, decide I need to see a physician, I will see one, but I won't pay you to get results I can get without you.
I can buy cold medicines without your help, and those are actually put into my body. This does nothing but analyze my body and give me information. No, I don't need you, and just because you are a Dr. does not mean you are qualified to interpret the results for me. It merely means you went to school, got a degree, and have a license to extort money from me and the system.
You want to give out free checkups? I didn't think so. So don't expect me to give you money when I don't want your input.
Why don't I want to do this through my doctor?
Because with a 20% co-pay and the prices we've had to pay for other tests, I expect that the first visit to a GP, the referral to a specialist, the 2 month wait for the specialist to have an opening, the 5 minute first visit, the test and the 15-minute after visit might cost $2000.
And then they'll charge $.25/page for the printout, because I don't think they'll put it on a CD. I wish I was being funny, there.
And yes, I do know my HDL, LDL, etc.
"So why are you all pissing and moaning about having to go see a physician?"
Steve, this is not moaning about having to "go see a physician". This is about the LAW requiring the CONSENT of a physician.
The word "consent" implies that the physician is capable of saying "no". Why should I need the explicit approval of a doctor just to have my DNA tested? Why should I need anybody's approval?
I'm pissed about having to get anybody's "consent" to find out more information about my own genetic structure and my own body. It is NOT within yours nor anybody else's rights to withhold that information from me, and by making it a requirement for me to get *consent*, then you are doing exactly that.
THAT is why your opinion is wrong. Not because you want people to see a doctor, but because you want the doctors to have any sort of say in how much those people are allowed to know about themselves.
With knowledge from my AP biology high school class, I could chat with some family members about their medical histories, construct a family pedigree, and find out all kinds of things about the diseases that I may be facing in the future.
So by your argument I need permission from an MD (oh, I'm sorry, a "Sherpa") in order to talk to my own family about whether or not Grandpa had heart disease.
I am absolutely disgusted by your paternalism, Dr. Murphy. I guess you think I need to be protected from myself, but I think I need more protecting from the likes of you. And please don't call yourself a Sherpa, you insult the skilled mountaineers.
p.s. you better call the local Borders Bookstore and tell them to stop stocking the DSM-IVs and Merck Manuals... Information is only for the self-proclaimed Experts!
This is a perfect example why non-doctors should war down the Medical Guild.
They are a key player in the economic destruction of America; not as bad as bankers, but pretty damn close.
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