Thursday, November 8, 2007

The Sherpa's Leash

Well, after the nitroglycerin I had to take for the angina my last post gave me (and I am sure many others) I have decided to ask my readership a question, I am hoping that we could start a dialogue. I know the last time I went at a certain GENEDTC company, a certain CEO asked an unnamed and famous friend of mine to put a leash on me. Next time, I ask the CEO to find my contact info on the Helix Health of Connecticut site and ask me nicely.

So I ask you all.

Why do you think it is illegal to Direct To Consumer genetic test in New York and Connecticut?

Please comment and lets get to the heart of why the DNA sandbox is such a contentious place.


Matthew Markus said...

Why do you think it is illegal to Direct To Consumer genetic test in New York and Connecticut?

The proximate cause underlying the illegality of DTC genetic testing in New York and Connecticut is probably due to the American Medical Association (AMA) House of Delegates Resolution 904 [1]. This resolution states, in part, that:

"non-physician laboratory personnel and PhD scientists are advocating for expansion of their scope of work into independent practice in the clinical setting and recognition through payment under the physician fee schedule..."

Of course, such an encroachment by non-physician laboratory personnel and PhD scientists represents a direct threat to the economic interests of physicians. Therefore, Resolution 904 authorizes the AMA to:

"pursue all appropriate legislative, regulatory and legal actions through the Scope of Practice Partnership to counter expansions of the scope of work by PhD scientists and other non-physician laboratory personnel..."

To the layperson, the AMA's stance may seem shocking even though it is couched in the language of public health and safety. A careful review of the AMA's history, though, reveals the likely distal cause behind the illegality of DTC genetic testing in New York and Connecticut.

The AMA was founded in 1847 as an organization designed to elevate practitioners of allopathic medicine (i.e. MDs) above all other medical providers including homeopaths, naturopaths, and osteopaths (i.e. DOs) [2]. One way in which the AMA advanced its agenda was by repeatedly declaring its competitors to be quacks and charlatans. Simultaneously, the AMA championed the "scientific" nature of allopathy, which, at the time, endorsed heroic treatments such as bloodletting and mercury-based medicines to evacuate the bowels [3]. By 1910, the AMA, through licensing requirements and regulations, had obtained substantial power over the medical system. Around this time, the AMA supported a series of recommendations made by the educator Abraham Flexner in a report known as the Flexner Report. The subsequent implementation of the Flexner Report's suggestions resulted in [4]:

1.) The rigid standardization of medical education.
2.) The closure of more than half of all American medical schools.
3.) The domination of American medicine by upper middle-class white males.
4.) Dramatic increases in income for these physicians.

In the end, then, both the proximate and distal cause of the illegality of DTC genetic testing in New York and Connecticut is seemingly of a financial nature. More specifically, DTC genetic testing represents the first challenge to the AMA-induced cartelization of medicine in approximately one hundred years. It is essential that history not repeat itself; therefore, New York and Connecticut should change their laws and regulations to ensure that genetic testing is safe and efficacious and not a state-sponsored sop to allopathic physicians.


Steve Murphy MD said...

Just so I am clear. What you are saying is

1. It is ok for PhD's who likely never have touched a human being as part of their training or gave them medications, to diagnose and treat

2. The AMA has forced down D.O.s Who happen to have their own lobbying organization called the AOA. Last time I checked the D.O. physicians salaries are on par with that of M.D.'s In addition most naturopath's these days are making way more than the M.D. Notably as they sell remedies in their offices. Something M.D.'s would get crucified for.

3. Is the AMA is a racist organization currently? Don't think so

4. The flexner report was a bad thing. Ummm. how about the dramatic increase in our lifespan since 1910?

Steve Murphy MD said...

Is a blood sugar as complex as a genetic test?
By the way, you make excellent points.

Matthew Markus said...

Is a blood sugar as complex as a genetic test?

This is a good question. It is always hard to quantify complexity. Assaying blood glucose is invasive (i.e. requires a finger stick) and any "diagnostic interpretation" must be made relatively quickly in order to prevent an episode of hypoglycemia. On a conceptual, level, though, the results of a blood glucose test are easier to understand and interpret than a typical genetic test. Of course, a genetic test may be less invasive (i.e. buccal swab) and individuals have more leeway when it comes to educating themselves, making "diagnostic interpretations", and/or consulting with physicians.

It will be interesting to see how this plays out. My guess, though, is that this is not a zero sum game and that there is room for both DTC genetic companies and Sherpa-esque medical practices. In fact, in some ways, they complement each other. It will be interesting to see how these services evolve. I just hope that DTC genetic companies are not prohibited from adding value by legislative fiat since that would drain a lot of potential innovation out of a very promising field of human endeavor.

Steve Murphy MD said...

Here's the shocker. I agree with you. A partnership between service and product provider is what's key here...Uh wait. Isn't that what Big Pharma already does with us? Well, it's not the same. I think we need both. But the diagnostic interpretation for diagnosis and treatment of human disease should probably be left to the trained. Aided by the product companies....

Hercules said...

Matthew Markus said "I just hope that DTC genetic companies are not prohibited from adding value by legislative fiat since that would drain a lot of potential innovation out of a very promising field of human endeavor." and the Sherpa agreed with him! but I said the same thing in simpler language a few posts ago and got held up as a bad example by the Sherpa. The bottom line for me is always freedom. My genome is mine, and if I want to pay someone to allow me to take a look at it, I don't want big government telling me I can't, no matter what harm I might bring to myself (worry? panic? change of lifestyle?) -- authoritarians like to control others, and (like Steve), rationalize this into being for the good of other people (which he is trained to do), and libertarians dislike being controlled -- there is s lot of psychology involved between these two positions.

Steve Murphy MD said...

Ok, Ok. I just re-read our comment string The Shmoopies. Fine....I am torn on this one. Sequence your genome? Feel free. Promote it to you as a panacea or a longevity elixir or to guide your own self-medication with potentially harmful substances? Should not be legal. Just like advertising to children for cigarettes. The children do not understand the potential dangers but think Joe Camel is cool. Do I think adults are children? No, absolutely not. You can make your own decisions, but should it be falsely advertised to you? Can't say I agree with that one. But if you got the scratch then spend away. This is why I partially agree with Navigenics plan. I just think everyone could use a sherpa when sifting through this data.

Anonymous said...

A patient should have the right to have their genome sequenced if they chose to do so, but the information needs to be read by a trained professional and a trained counselor should be the only person to give the results to the person. I feel that we are starting to miss the boat in regards to the purpose of a genetic test. Genetic testing should not be allowed to be marketed for profit, but to be used as a diagnostic tool. I personally think there needs to be new regulations and policies developed in the area of genetic testing. A physician should not be the only person allowed to order a genetic test (which I don't think is the case anyways), but the approval from a physician should still be needed to catch for mistakes.

Prevention is the best way to treat a disease.

As a prospective undergraduate genetic counseling student, I will try to help develop and change policies that are already in place to try and help the policies make sense, protect the consumer, and not allow companies to exploit genetic testing for profit gain (i.e., offering BRCA1 and BRCA2 testing to any female that thinks they would benefit from this information).

I personally think there should be a genetic counselor hired in every clinical department in every clinic in the United States. We need to analyze our family history and know what mutations are clinically significant before physicians go off on a rampage and offer a genetic test for every patient that has breast or colon cancer.

How should we deal with the shortage of genetic specialists? Should a genetic counselor be allowed to do physical exams and diagnose patients since there is such a huge shortage of clinical geneticists?

Steve Murphy MD said...

If genetic counselors are up to doing physical exams, I say go for it. There are PAs and NPs leveraging physicians' efforts every day. I would love them to be trained as counselors too! Diagnosing requires licensure and malpractice. So if the NSGC is willing to add at a minimum 1-2 years to the CGC program for training in physical diagnosis and medicine, I would wholeheartedly support that!