Friday, February 20, 2009

I am not a man.......


As I post in the "southern command" I want to announce.....

I AM Not a Man.

I repeat.

I Am Not a Man.

I know, I have man parts.

I may have a hairy chest like a man.

I may have an X and a Y.

But I repeat, "I Am Not a Man!"

I am dead serious. I AM NOT A MAN.

In a statement to Pharmacogenomics Reporter, 23andMe stressed that offering BRCA testing does not mean the firm is moving into the medical genetic-testing space.

It sounds just as silly, doesn't it?


BRCA testing is NOT A MEDICAL GENETIC TEST.......

BRCA testing is NOT A MEDICAL GENETIC TEST......

I think Myriad will beg to differ. A whole bunch of Geneticists and Counselors would as well......Just ask Ellen Matloff CGC, Research Scientist at Yale......


"Only a doctor can provide a medical diagnosis and we report information that the current state of genetic research and our technology allows. "


Last time I checked, Genetic Counselors, Nurse Practitioners, Physicians Assistants AND Doctors report medical genetic test results,...........SO DOES 23andME! But unlike 23andME the others do so in the supervision of a licensed physician. But it doesn't change the fact that presentation of genetic testing results is making a diagnosis.

Hey Linda, have you ever heard of a V84.01 or V84.02? No? Why should we expect you to? You aren't a doctor, but your company IS PERFORMING MEDICINE everytime they tell a patient they have a BRCA mutation. In essence you are reporting that the patient is a V84.01 or V84.02.


Well..........


What this shows is a true lack of accountability in a lame attempt to:


I view this act in the same light I view AIG's CEO saying everything was ok, 2 days before AIG's collapse

Or when A-Rod was asked "Have you ever used steroids, human growth hormone or performace enhancing drugs"..........."NO"

Where is the accountability today?


The Sherpa Says: Linda, Anne, Sergey, Eric....admit your mistakes, accept your regulations and become a medical testing company. Because if you don't, if you try to play a "Definition of Is" on the public, then the chain of trust between patient and testing laboratory as well as between physician and testing laboratory will likely be broken. That is a risk, healthcare cannot afford........Because of your arrogance, we may need to once again ask the law to repair our chain of trust. To practice medicine, you need that chain of trust. It is essential to medicine! And you make a mockery of it.

38 comments:

Vincent said...

I trust 23andMe to tell me whether I have a A,G,C, or T at a certain location in my genome. That's not "practicing medicine", even though my genome may influence my medical state.

I check my weight on the bathroom scale every morning: that's not practicing medicine either, even though my weight is a pretty good predictor for many medical conditions.

If Steve Murphy were selling bathroom scales instead of genetic counseling services, I wonder if he'd be equally outraged that Target and Walmart sold bathroom scales?

Steve Murphy MD said...

Vincent,
It's not that you have a A at position x....it is that the A now makes you a deleterious BRCA carrier.....That is a very important distinction. I have no problem with the telling you about your As, Gs, Cs and Ts......just not what it means when it gives you an established medical disease/risk.

Get it?

-Steve

Anonymous said...

"But it doesn't change the fact that presentation of genetic testing results is making a diagnosis."

Just curious, but what exactly is the diagnosis. Obviously, it is not "ductal carcinoma in situ" or any disease state. Please clarify. Thanks.

Oh, and as a reference, please refer to the following:

diagnosis - the process of determining by examination the nature and circumstances of a diseased condition. [1]

Also, please tell me that physicians are not trying to expand the practice of medicine into the realm of statistics.

[1] http://dictionary.reference.com/browse/diagnosis

Anonymous said...

Many people are who 23andMe supporters (or consumer based genetic testing) don't get and never will.

N/A

Vincent said...

It's not that you have a A at position x....it is that the A now makes you a deleterious BRCA carrier.....That is a very important distinction.

That's no distinction at all, in my opinion. It's the same thing: an A is an A is an A.

I have no problem with the telling you about your As, Gs, Cs and Ts......just not what it means when it gives you an established medical disease/risk.

Either way, 23andMe is not making a diagnosis of any disease. They are not telling me I have breast cancer (something I think most reasonable people would want a doctor to do). They are telling me what my DNA says, which I think only a doctor would want a doctor to do.

Further, I'm don't think there is any good reason that 23andMe should avoid (or be prohibited from) discussing particular SNPs on their website when a search of Google Scholar or a trip to the public library would turn up the same information. They are providing a useful service to their customers (in essence, it is nothing but an effectively indexed and annotated libary of research papers).

Do we really want a world in which only medical doctors have the right to read the NEJM?

Some people can't find the distinction between a non-medical revelation of risk and a medical diagnosis of condition. I guess I'm just not one of those people.

I know I'm being contrary, and a little disagreeable. But I am> glad you write about these issues. It provokes discussion, which ultimately benefits us all regardless of what our own opinions are.

VV

Anonymous said...

VV, you speak with many errors.

I will leave it up to Steve to correct you.

Steve Murphy MD said...

Vincent,
I am glad you appreciate the dialogue. As for your comments.....

"Either way, 23andMe is not making a diagnosis of any disease. They are not telling me I have breast cancer (something I think most reasonable people would want a doctor to do). "

The medical diagnosis of genetic increased risk of breast cancer is coded for by medical diagonosis code called V84.01

the one for genetic increased risk of ovarian cancer is V84.02. You should look these up prior to making such a definitive statement about what a diagnosis is.

Take it from a doctor who knows what a diagnosis is.

They ARE making diagnoses by reporting what these As, Cs, Gs and Ts do......

Especially with BRCA!

These ARE now clinical tests.....in some states you can have a clinical test done without a doctor. In others you cannot. If you have a problem with that, then lobby your legislature and change the law.....but right now, the law is what it is.....

-Steve

Steve Murphy MD said...

@ Anonymous,
Read the comments I just posted

V84.01 is a CPT code (Diagnosis Code) for genetic increased risk of Breast cancer. This code was developed specifically to denote the pre-disease state BRCA carrier.

DCIS is also a pre-disease state, it is the predisease for Ductal Carcinoma......

BOTH are considered diagnoses and Disease.....

Take it from the doctor. THEY ARE DIAGNOSING customers.....

-Steve

Devilboy said...

Steve

Are you saying that just because those test have now become diagnostic, 23andMe should stop doing them? Are you still happy for 23andMe to sequence human DNA, just not the parts that can be used diagnostically?

Matthew Markus said...

@Steve

You state that:

"V84.01 is a CPT code (Diagnosis Code) for genetic increased risk of Breast cancer. This code was developed specifically to denote the pre-disease state BRCA carrier."

Fortunately, I know a little about medical coding and I can tell you the following:

1.) CPT codes are "Current Procedural Terminology" codes for procedures. V84.01 is not a CPT code.

2.) V84.01 is an ICD code.

3.) The V01-V86 codes fall under the heading of "Supplementary Classification Of Factors Influencing Health Status And Contact With Health Services". These codes do not deal with diseases.

4.) Within these supplementary codes, there is a branch known as V85 - "Body mass index (bmi)." According to your logic, gym teachers are making diagnoses and practicing medicine when they compute and use BMIs as part of a health class.

5.) DCIS has an ICD code of 233.0, which falls under the heading of "Neoplasms", a topic area that only physicians are qualified to handle.

6.) ICD codes are not legal diagnoses.

7.) 23andme, as far as I know, does not intend on assigning ICD codes to customers.

So, again, are physicians trying to expand the practice of medicine into the realm of statistics?

Vincent said...

The medical diagnosis of genetic increased risk of breast cancer is coded for by medical diagnosis code called V84.01

The fact that a doctor can me for a certain item does not necessarily mean that only a doctor has the right to administer that item. There is an HCPCS billing code for bandages, but that doesn' prevent Rite-Aid from selling me Band-Aids.

The billing code exists largely so doctors can document and get paid for the work they do. Your right to be paid for your work doesn't entitle you to a monopoly on every tiny piece of data related to MY health.

Frankly, I'm more worried about protecting myself from the government on this issue than on protecting myself from 23andMe.

Besides, I'm sure that 23andMe have lawyers who know the law better than you or I do. If they think they are on safe legal ground with their current BRCA reporting, I wouldn't bet against them.

VV

Steve Murphy MD said...

Vincent,
Yes, my mistake. I mistyped....these V84 codes were recently added....and interestingly enough, they are considered diagnoses......

In my post in September I cover it.....is predisease disease....

To get certain treatment you may be required to have these diagnosis codes.....

These are not HCSPCS modifiers....that is a tricky thing you did.....and probably just as forked tongued as what 23and Me is doing.

-Steve

p.s. In what world is a BRCA test not clinical?

-Steve

Steve Murphy MD said...

To be clear
V84.X is NOT a diagnosis ICD9 code it is a category of V codes.....which according to page 19 of my ICD-9 code book , the subcodes V84.01, .02, .03 etc CAN be used to establish and indicate diagnosis.....

This is all minutia compared to the bigger picture, which is

23andMe now has a clinical test on their hands and they have to treat it as such......

They WILL move into the clinical diagnostics space OR face lawsuits.......

Plain and simple. Sorry Vincent, you better go get your "non-clinical" BRCA test.

As a clinician I wonder if we will have to retests your BRCA multisite to "Prove" your carrier status.

-Steve

Vincent said...

p.s. In what world is a BRCA test not clinical?
This world, as far as I can see.

I'm not a patient of 23andMe. They don't think I am one, and I don't think I am one. Therefore our relationship is not clinical.

You are trying to expand the definition of "clinical" beyond any current definition to include anything a doctor might potentially discuss with a patient. I don't think it's going to work. I certainly hope it doesn't.

VV

Vincent said...

To get certain treatment you may be required to have these diagnosis codes.....

I'm fine with that, actually. 23andMe are NOT making a diagnosis and are NOT prescribing any treatment. I wouldn't want them to do either.

In fact, no one - as far as I can tell - is lobbying for DIY chemotherapy based solely on a 23ndMe genome scan: that line of argument is nothing but a strawman.


If someone tells me that I have cancer and recommends a specific treatment for that cancer, that person better be a doctor (and a good one, if I'm going to agree with her).

But that scenario is a world away from an arrangement in which someone tells me that my genotype at rs6983267 is GG, GT, or TT.

VV

Matthew Markus said...

@Steve

I am curious, why you are so monomaniacal when it comes to genetics? Are you telling me that there is no difference between the following statements?

"You have N/N at position rsX in your genome, and this has been associated with an increased risk for Y. Please consult with your physician for more details."

"I have taken your family history, conducted a physical exam, and conducted a specific genetic test. Unfortunately, based on all of this information, you have an increased risk for Y. I propose that we take the following steps (e.g. surgery, drug regimen, lifestyle modification) for prophylaxis."

The first statement is from the realm of community medicine. This is no different than the screening/referral programs typically done by public health departments and pharmacies. This is where 23andMe resides in the new healthcare landscape. The second statement is one made by a physician treating a specific individual. There is a world of difference between the two statements. Are you telling us that public health departments are "practicing medicine" and conducting "clinical diagnostics"?

P.S. You state:

"As a clinician I wonder if we will have to retests your BRCA multisite to 'Prove' your carrier status."

Of course you will have to retest since you plan on making a diagnosis and recommending a course of treatment! That is your job. Similarly, you would retake a blood pressure measurement before moving on to a diagnosis of hypertension even if the person was referred to you by a pharmacy taking blood pressure measurements.

Steve Murphy MD said...

@ Devilboy

23andMe is NOW medical diagnostics and should be regulated as such. If they decide to give up the clinical part, then they can go ahead and keep on with the same regulations atht any "novelty" lab would have.

That was teh risk they took by testing DNA in the first place. Sooner or later, some of the tests will have clinical meaning.....

-Steve

Steve Murphy MD said...

@ Matthew,
Have you ever diagnosed someone? Have you ever presented results to a BRCA patient? I have. Guess what, BRCA results are given such as
"You have a 6714delT mutations in your BRCA2 gene located on chromosome 13"

Sound familiar?

"In addition, you are at x risk for breast cancer and y risk for ovarian cancer"

"there are many options you can take"

If this is a counselor, they usually don't even direct which option to take (Much like 23andMe)

So I ask again? Isn't testing for BRCA mutations and then presenting the data non directively, EXACTLY what a counselor does?

Listen,
23andMe has 3 choices
1. Give up the lab and turn into a prometheus program plus social network
2. Become a clinical diagnostics lab
3. Partner with physicians and present them a new clinical test.

Otherwise, they are practicing medicine without a license.

I am done with this argument.

-Steve

Steve Murphy MD said...

Vincent,
Thank you for reading my blog.

By denying the clinical utility and applicability of the BRCA testing, you have disqualified yoursself from being able to have a clinically competent discussion.

"p.s. In what world is a BRCA test not clinical?
Vincent-This world, as far as I can see."

Not thinknig you are a patient doesn't prevent the practice of medicine being carried out on you.

We can agree to disagree, but as a physician who knows clinical utility and how to make diagnoses, I am afraid to say....you have demonstrated that you don't.



-Steve

Dirk said...

I agree with Vincent.

> Steve:
> 23andMe is NOW medical
> diagnostics
> and should be regulated as such.

Steve, there is no logical reason why a gate-keeper (read physician) should exist between a person and the knowledge of his/her genome.

23andMe is telling its customers which bases/deletions/insertions are present at a specific position, and what is public knowledge about them, i.e., has been published in "peer-reviewed" journals.

The role of a physician/medicine is then to treat any corresponding disease.

> Steve: the chain of trust
> between patient and testing
> laboratory as well as between
> physician and testing laboratory
> will likely be broken.

As you said, we customers trust 23andMe/deCODEme to give us scientifically correct results.

Funny, that you don't mention any 'trust' between patients/customers and physicians!

I am glad I already have my 23andMe/deCODEme data, and wish in the future they will include more known-to-be-disease-associated SNPs on their chips.

Dirk (Ph.D. in Chemistry)

Matthew Markus said...

@Steve

I know that you have unilaterally declared that this argument is over, but I am still trying to figure out what your true objection to 23andMe is other than the fact that you mistakenly believe that you are in competition with them.

You state:


Listen,
23andMe has 3 choices
1. Give up the lab and turn into a prometheus program plus social network
2. Become a clinical diagnostics lab
3. Partner with physicians and present them a new clinical test.


If I am not mistaken, 23andMe runs a CLIA-certified lab and hosts a "prometheus" like program online (along with a social network). What more do you want them to do? Are you saying that one must have a prescription to have any genetic work done, but after that, the raw data may be released to the patient for use with something like prometheus? Are there any circumstances under which you would not give a patient a prescription to, say, have their genome sequenced? Or, would you always write such a prescription? I mean, I can envision a situation in which you would not prescribe an X-ray even if the patient wanted one. Likewise, you would be right to refrain from prescribing narcotics to a pain-free patient. Yet, I cannot think of a single reason not to grant a whole-genome or even partial genome (SNP) scan. If you would never deny such a prescription to any patient in your practice under any condition, then why is there a need for prescriptive authority?

Vincent said...

By denying the clinical utility and applicability of the BRCA testing, you have disqualified yoursself from being able to have a clinically competent discussion.

Be careful.

I never said that BRCA testing doesn't have any clinical utility or applicability. I only said that its utility is not EXCLUSIVELY clinical.

It doesn't take a doctor to see that. In fact, maybe being a doctor clouds your vision on issues like this.

Listen,
23andMe has 3 choices
1. Give up the lab and turn into a prometheus program plus social network
2. Become a clinical diagnostics lab
3. Partner with physicians and present them a new clinical test.


Option number 4 is, of course, to continue doing what they are doing and demonstrate that Steve Murphy is barking up the wrong tree.

VV

Steve Murphy MD said...

The reason I declared this over is because neither of you has stopped to ask yourselves "What if this is medicine? What if Steve is right?"

I have actually done that.

What if offering X-Rays up to people is not medicine?

Do you know of anyone doing that?
I don't. Because it is medicine?

Do you know anyone offering LDLs up? I do, and it IS considered a clinical test and is regulated. In some states you can order a clinical test without a doctor. In others, like NY and CT you cannot.

Do you know anyone offering a blood pressure screening? I do, and it is not a medical test per se......until it is interpreted....

You don't need treatment to practice medicine. The tag line often goes: To prevent, diagnose OR treat with the intent cure or palliate.....in this case it is the diagnosis that qualifies it.

Just because you say so doesn't make it right, just like because I say so doesn't make it so......

However, the laws of most states are pretty clear and it is only a matter of months before they are onto this little scheme.....

Just watch.

Genomes without interpretation is not medicine. However, who would want a company who just gave you a base pair read out? That's not worth 399....

So, these companies will likely be forced into splitting into a lab side and an interpretation side. It is the only way to get around the law without looking like a pack of idiots fighting lawsuits.

If you are cool with granting 23andME a worldwide, unrestricted, NONREVOCABLE, license on everything you do on that site AND are cool with them selling your data to who ever the "F" they want to, then there is no way a doctor practices medicine is going to convince you otherwise......

Just like the idiot drinker who gets cirrhosis or the smoker who gets lung cancer......you never stop to think it could happen to you.....that's why it hits you so hard when it does. Especially after I had been begging you to quit for years.

Just open your ears guys.....come one.....is a BRCA test anything OTHER than clinical. What person would do that test without an intent to do something if they were a carrier?

Hey, you might get cancer.....That's fun and entertaining.......Join the conversation ;>

If you guys are right, then the laws will have not been enforced, or they really did manage to redefine what the meaning of IS is....and if that is the case, watchout for all the other kooks that follow behind 23butNotMe

-Steve

Anonymous said...

Vincent,

Please tell me you are not some business hack coming around tell doctors how things should be done for genetic testing.

While we are at it, tell us what your specific job is and we will tell you how it should be done from this second on.

Vincent said...

Please tell me you are not some business hack coming around tell doctors how things should be done for genetic testing.

I am not a business hack coming around telling doctors how to do their job.

It should be said, though, that medicine is not strictly the purvue of doctors. Patients have rights, and in fact society sees great value in protecting patients from doctors. Much more so than the converse. Surely, no one sincerely believes that only doctors should be involved in the regulation of doctors?

My objection, in point of fact, is to the notion that I should not have access to my own DNA. I also object to the fact that some government agencies are acting to prevent that access already.

Some doctors and some bureaucrats are currently (and in some cases vociferously) misconstruing the laws, and I (as a patient and a citizen) am motivated to point that out.

Vince

Steve Murphy MD said...

@Vincent

"It should be said, though, that medicine is not strictly the purvue of doctors. Patients have rights, and in fact society sees great value in protecting patients from doctors. Much more so than the converse. Surely, no one sincerely believes that only doctors should be involved in the regulation of doctors?"

You are correct, the same should hold true for companies giving medical scientific data.....Clearly you agree with this but are just being pejorative and have not taken that into account. This recent statement just disqualifies all that you have said about 23andME being free from regulations......

Obviously you have a double standard....That's a shame Vincent, a real shame.

-Steve

Vincent said...

This recent statement just disqualifies all that you have said about 23andME being free from regulations.....
Be careful.

I never said that 23andMe should be "free from regulations" nor do I think they should be. I'm not an anarchist.

I am fine with the FDA exerting regulatory authority over the manufacture of ibuprofen. I am not fine with the government requiring me to see a doctor to obtain ibuprofen. For example. There are some drugs (e.g. morphine) that I agree should require a prescription. That doesn't mean I operate with a "double standard". It just means that I have the ability to distinguish between two situations that are not identical.

And what's with all the strawmen, Steve? Don't they teach reasoning skills in medical school?

Vince

Matthew Markus said...

@Steve

I have considered your point of view and find some merit in it. I still think that an organization should not be subject to FDA regulation if it makes statements like:

"We looked at [SNP1], [SNP2], and [SNP3] in conjunction with papers [PMIDx], [PMIDy], and [PMIDz]. Overall, individuals with your genotypic composition at these markers appear to have a greater risk (quantify) of developing [Disease] according to [Algorithm]. Consult with your physician for more details."

since such statements are relatively transparent, backward-looking, and talk about population risk, not individual risk. However, 23andMe seems to be moving in the direction of making deterministic and patient, not population, directed statements like:

"...you are a carrier for Breast/Ovarian Cancer."

I would say that an organization that makes such statements should probably fall under the purview of the FDA.

This has been a great conversation and it has helped me to clarify my thoughts on the matter. Thanks.

Vincent said...

@Matthew

The statement you highlight (""...you are a carrier for Breast/Ovarian Cancer.") is ludicrous on its face. They clearly need an editor. How can one be a "carrier" for cancer? It's not exactly what I would call a contagious disease. It's a false statement, and if we need the FDA to step in and correct them then I'd be comfortable with that.

In their actual report to customers, though, their language is much more sane. E.g.

Carrier for the 6174delT BRCA2 mutation. Lifetime risk of breast cancer for women is increased from 13% to 85% and risk of ovarian cancer is increased from less than 2% to 23%. May significantly increase risk of prostate cancer in men. There is also an increased risk for breast cancer in men.

That an accurate (as best as I can tell) statement of fact, and one that does not cross the line into the area of clinical diagnosis.

When and if they start telling me I HAVE cancer (or am a carrier for cancer?), I'll agree they've undertaken a clinical diagnosis and should be subject to laws that regulate such things.

Vince

Steve Murphy MD said...

@ Vincent,
You are correct. They need an editor, and FDA regulation. That does not change the fact that this is computer generated content which is on THEIR site!

However. What you said is in their report is EXACTLY what a genetic counselor would tell their patient.......

BTW, the rate is only as low as 13% in one report of a non-enriched family history study. which is why we very rarely use that low a number for breast cancer.

This IS clinical medicine. No one who practices medicine would disagree with me. Most sane people wouldn't wither, unless they were a shill for these companies.

Not everything in medicine is black and white. A diagnosis is not necessarily a disease.

I will continue to publish your arguments, but will cease to respond. May we agree to disagree.

-Steve
p.s. Thank you for reading my blog

Vincent said...

However. What you said is in their report is EXACTLY what a genetic counselor would tell their patient.......

A doctor or genetic counselor would take the conversation much further, however, and that is the key point I think. A licensed practioner has the ability and obligation to go far beyond the purely statistical and into the truly clinical. Family history, behavioral factors, prevention options, treatment options, and so forth.

A company like 23andMe does not have that obligation, and it seems like that is part of what drives you bonkers. You see that lack of complete obligation as a necessarily bad thing, while others like me see it differently. As long as they are not actually diagnosing or prescribing, I'm fine with merely being informed. And yes, entertained.

Don't get me wrong. I'm aware that there IS a line between the non-clinical and the clinical. The line may be a little blurry - and perhaps worthy of public policy debate - but I am quite confident that line isn't currently where you think it is.

Vince

Anonymous said...

Quote: "A licensed practioner has the ability and obligation to go far beyond the purely statistical and into the truly clinical."

That is not always the case. It depends on the patient population that the GC works with. I know of some GCs who work in prenatal care and about all they do with the patients is explain the tests and give stats so the patient can decide what they want for a test.

Steve Murphy MD said...

@ Frank,
Ok. You got me......physicians CAN DO MORE, Genetic Counselors often do not, and in fact are supervised by physicians.

This sounds exactly like the case with 23andME. They are acting as genetic counselors.

In that case, guess what? The law should recognize that as in need of physician oversight.

My guess is that will be the happy medium here. Physician backup and supervision for each of these companies.....

Don't believe me? Just wait and see.

-Steve

Matthew Markus said...

@Steve,

My guess is that will be the happy medium here. Physician backup and supervision for each of these companies.....

You are probably right, although I would imagine that they would want physicians on staff as is. Also, I think I can finally see exactly where we differ on this issue:

You see 23andMe as an automated genetic counseling service counseling individuals on genetic tests while I see 23andMe (caveat: ideally and not in its present ambiguous form) as an automated newspaper reporting on scientific publications relevant to an individual's genotypes. I think that 23andMe has a strong 1st Amendment case against further regulation if it conforms to the latter model.

Steve Murphy MD said...

Matthew,
I agree with you. But it may be like a health newsletter. If that is the case, they could summarize the scientific findings. However, it is still a very gray line when that newspaper is actually ordering the tests on you.....

-Steve

Anonymous said...

You can NOT stop this. Canada or Bermuda or Mexico will legalize it an 60% of USAians can drive a few hours or hop on a $95 round trip flight and get the test. There is going to be no censoring of the encrypted website results.

Seriously, does a couple need mandatory counseling and interpretation help from a pregnancy test?

Aaron said...

I've read this entire comment thread. And carefully, too.

I just still don't see what I, as a potential customer of 23andMe, am supposed to be so afraid of. What risk am I exposing myself to, beyond paying $400 for something that isn't worth $400?

This recent point from Steve, I really don't get:

However, it is still a very gray line when that newspaper is actually ordering the tests on you.....

If I decide to be a 23andMe customer, am I not ordering a test on myself? And maybe a doctor would think that is bad, too. But honestly, if I decide I want a cholesterol test, I can call my doctor and schedule it. She won't say no. If I want a hearing test, I can go to countless clinics and get one on my own initiative.

This is bigger than a hearing test, of course. Breast cancer is far more impactful than high cholesterol or tinnitus. But if the 23andMe test suggests I'm at higher risk for cancer, I would probably contact a physician and ask for more advice. On the other hand, I believe that a genetic counseling session with a doctor is going to cost me more than $400, so I am much less likely to start there.

As a potential customer, please explain to me what I have to fear from 23andMe.

Full disclosure: I've only recently learned about 23andMe because I'm writing a paper on them for a business strategy class. I'm in business school, pursuing my MBA. Suspect my perspective, if you will, but I have no interest in this company beyond an academic one.

Anonymous said...

I am a BRCA carrier. I come from a family with multiple cancers, sometime in the same individual, in multiple generations. I am the first women out of my mother, my grandmother, and my grandmother's 5 sisters, to live past 40.

I can't tell you the legalities of 23andme's choice, and although I do think at this point it sounds a lot like practicing medicine, I also recognize that technology is making us look at these things again, and I do believe that your genetic information belongs to you.

At the same time, though, while it might be legal, or make business sense, or be just part and parcel of letting you know your own specific genetic code, I am disappointed by this choice.

You can't know what this information may mean, nor the ethical questions it may raise, without having gone through the process. Having access to genetic counseling of some sort is crucial for understanding what your results mean in your particular family and what your options are for management. Yes, a company is allowed to give information without this, but personally I think it is a copout.

Legal: possibly. But moral: definitely not.