Tuesday, November 18, 2008

Not Intended to Diagnose or Treat


Andrew at ThinkGene comments on something that I have not been able to effectively explain.

We trust health assets like “medical advice” to exist. That is, we trust that public medical information describes reality such that it may be applied to measurably improve health. This is a challenge because medical advice, especially preventative medical advice like genomics, is a trust asset: an abstract idea with value applied to the indefinite future.


This is a very precise explanation. We pay for medical advice.......which may include diagnosis or treatment.......We trust trained health professionals to give that advice. We trust that they are capable of giving that advice......Why?


Well, we have a licensing system in this country that helps us assure that quality. In addition to that licensing we have things such as Board Certification or eligibility which also let us know that the practitioner has a certain set of skills, verified by a specialty.


These hurdles are required. Why? They are required to help establish "trust" in the system...

Andrew goes on to say

However, that trust is under attack, and as the immediately profitable but eventually catastrophic erosion of the term “insurance” now jeopardizes the financial industry, the meaning of term “medical advice” is now being eroded by greedy companies.


This system had been under attack for a very long time.....It had appeared that things such as "Alternative Healthcare" or "Nutriceuticals" had carved their own niche and it was Understood by the lay public that this system existed "Outside of the trusted practice of medicine" Thus the DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994 opening the field wide open for alternative care.....Prior to this the FDA regulated nutritional supplements.


The public knew that these systems existed in parallel tracks and that the quality of care by alternative systems would likely need to be "backed up" by standard medical care....a very small few, swore off western medicine, but these were the patients who would often present to an Emergency room with some "Morning Report" type case of undiagnosed diabetes, heart disease or cancer. Morning Report cases are often tales of very bad diagnoses (Bad for the patient, incredibly instructive for the resident)


But what is happening now is the replacement and possible erosion of the trust in medical advice. Why? Science or perhaps PseudoScience has evolved. Reporters relying on press release have adopted "Newly Published Results in Nature Science" as the Truth......Despite this not always being the case....even Russ Altman commented on this the other day.


The public is now understanding that Genomics is part of healthcare.....and with good reason, it IS healthcare. But the layperson doesn't have such a nuanced view and can't understand limitations of Non-Medical Medical Advice when it comes to genomics.


I Repeat "But the layperson doesn't have such a nuanced view and can't understand limitations of Non-Medical Medical Advice when it comes to genomics."


A gene is a gene, and to convince them of otherwise takes quite a bit of effort. The string of though goes something like this: "Genes are medicine, thus a genetic test is medicine.....and genetic advice, must be medical advice....

Thus, I implicitly trust the genomic testing advice....which in disclaimer is not for "Diagnosis or Treatment"


Andrew has reported on precisely this confusing thing on a DTC genomic website and press release. It can be easily viewed as confusing when a company tells you "Helps the patient make informed personal health decisions" Despite Andrew highlighting the "state of the art medical advice and services" he should have high lit "Helps the patient make informed personal health decisions"


This is the crux of this argument. When a patient usually wants advice about personal health where do they normally go?


The Doctor....Despite WebMD being the first link for Medical Advice on google, we eventually end up at the doctor's office...BTW the web tools for genetics in medicine are woeful, with over 1/3 having wrong answers or misinformation...


So what is personal health? In my opinion it is the realm of medicine. Health can be viewed in many ways, but protecting health and restoring health has always been viewed as a medical trait. Ever heard of preventative medicine?????


So Andrew is correct, the line is getting awfully blurry. When companies start making claims which blur that line while hiding under the legal nomenclature "This Service is not intended to Diagnose or Treat" it can be very confusing for the public....and with fantastic PR and being named as the invention of the year, we can be certain that the public is starting to lose sight of that line.....


But I say, isn't this what these companies want anyways? They want to replace modern care with "Wiki-Style" care.....I think we have seen that already...


This may or may not be a good thing.....Personally I think it is a horrible thing, but the scientist in me accepts the null hypothesis "There is no relationship"


So when would it be a bad thing? If the replacement of current medical advice takes place without the same licensing and regulatory guidelines that exist in current medical advice, then we may see a true erosion of trust in Medical Advice, which when it happens will lead us right back to where we began, with skilled professionals giving us the trusted advice we sought in the first place....


The Sherpa Says: "Genetic/Medicinal Advice" could be placed back in the dark ages if we start allowing it to be sold without the stringent regulations or to be able to jump the turnstyle through legal jargon and avoid regulations that are placed on it currently. This is one of those dangerous shortcuts that the Sherpa avoids.....you won't jump start the system by cutting the climbers off at the knees simply because you don't have enough crampons to climb the mountain....

2 comments:

Anonymous said...

Come on Steve,...

You are a loser, just start a personal genomics company, earn money and not waste your time saying stupid things.

Navigenics, like 23namde, is a great company. Learn from them.

Anonymous said...

what a good post by the other "anonymous." lame!