Wednesday, November 4, 2009

Change IS Needed. I agree with William, sometimes.

Over the past day or so I have been engaged with one of my fiercest critics. No a critic of me per se, but a critic of my opinions in the space of Personalized Medicine.

We may have a "truce", maybe......

William Gunn PhD is a pretty amazing guy and if you read his CV you can see he is very involved in the space and an excellent scientist.

Yesterday he and I exchanged emails and he posted a letter to the medical community. I think it is a great letter. He expresses some of the EXACT SAME frustration I have.

"I believe, as does pretty much everyone, that medicine is on the cusp of great changes and that personalized medicine holds great promise. I believe that an informed patient is an empowered patient, and ultimately a healthier one. Every good doctor should want this, and every below-average doctor should pray this day never comes."

I love his opening lines, but there are some problems that I see.

First let me state I agree with most of what he says, but:

1. There are a whole bunch of people who think personalized medicine is a pipe dream created while chilling with the caterpillar and Alice. Namely, doctors, scientists and politicians

2. I think most doctors try to help people, even the less than average ones. An empowered patent would be a benefit to them, but it depends on what the definition of empowered means.....

That is the major league difference between doctors and "super early adopters" in the DTC genomics space.

What is the difference?

The definition of empowered patient.

I have heard it described broadly such as

"Patient empowerment in the health care context means to promote autonomous self-regulation so that the individual’s potential for health and wellness is maximised."

This could be just about anything, including diagnosis and treatment. Which is interesting because in all states of the US you need a medical license to do that.

I also have heard it stated specifically in the Patients Bill of Rights as

The providing of information regarding therapeutic options so that a Patient can actively participate in the decision on whether to undergo a diagnostic or therapeutic procedure, or pursue alternatives." See Patient Bill of Rights

This is obviously more specific and falls in the realm of, you have a disease, now you can be empowered to actively participate in the discussion. I have always thought that if you don't have the terminology of medicine, this part puts you as a one legged man at an ass kicking contest.

The ideal place for patient empowerment is not sick in the hospital, by that time it is too late. You are sick and not likely to be able to learn as well as if you were healthy.

Which is why the empowerment piece should come in at the doctor's office or even at home in your underwear on your MacBook. I agree. I love when patients come in having read stuff. Just recently a patient came in knowing just about everything about a familial disease....the consult was super awesome and we had a great discussion. But again, this was a motivated subject.

But I ask, is that what the DTC Genomics coummunity thinks empowerment is? Is empowerment education? That is what the health community thinks.

But, William think it is more than that. They think it is access to biometric data AND interpretation of that. In some aspects, this could be considered education......

I agree, it is education of a sort. When it is from your doctor it is called good medical care.

But often it is through an Apomediary.

What's an apomediary? Well, 23andME considers themselves such.
even I consider myself an apomediary in things for which I am not licensed for (golf, start ups, etc). I.E. a self defined expert providing guidance to information about their "expert subject"

But for medicine, I am a licensed, board certified physician who has worked long and hard to stand by my expertise (8 years of work after my undergraduate work). Unlike DTC genomics companies, who are neither regulated, nor accredited to give expert medical opinion.

Thus, they are apomediaries. Is patient empowerment, unregulated access to apomediaries? Well, maybe. But I argue that DTC genomics are more than just Apomediaries.

They test human biologic samples and provide a diagnostic result, despite stating they are not providing diagnosis. Think BRCA carrier status here. Which BTW is a medical diagnosis. With a medical test.

So, is patient empowerment the ability to obtain diagnoses from a non licensed diagnostician?

I would argue that this is precisely what I am opposed to. This can lead to all sorts of danger. Last time I checked, laudanum was not FDA approved, nor were the apothecaries.......

The Sherpa Says: We have come a long way since then and going back there would put us squarely into the stone ages for quality of care. Which is why I am so vehemently against a company that tests your human biologic sample and provides a diagnosis without being licensed to do so. Change is Needed William, I agree.

1 comment:

Danny said...

From what I understand you can make your final "Sherpa" statement even more specific, no?

It seems like you would agree with allowing DTC companies to aid with empowerment if they were "licensed" to do so and they based their interpretations of the genotyping (which has shown to be accurate) on more sound requirements? Do you want the DTC companies to stay purely in the recreational (ancestry/hair color etc.) and completely get out of what you call the clinical realm (which I agree with)? Or would you just like to see stricter standards?

In that case, if that were to ever happen, it would be just like sending a sample to a lab and the doctor relaying/believing those results?