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April 23, 2008

Personalized Medicine: Back to the Future

Personalized Medicine
  1. The type of sing molecular analysis to achieve optimum medical outcomes in the management of a patient’s disease or disease predisposition,
  2. Right treatment for the right patient at the right time.

As I have mentioned in several of my posts, I have been working on a couple of health care finance reform initiatives over the last six months. After banging away now for awhile, I am starting to see some emerging ideas that are starting to bring out that old revolutionary feeling of doing something that can have an industry changing impact. The opportunity lies in the ongoing pace of innovation, with new forms of health care delivery, with new models of health care financing, and that fact that eh American public and politicians are slowly waking up to the fact that our health care system is headed toward radical surgery (not the cosmetic kind).

So lets start this out by talking about the personalization of medicine. This is typically thought of in a genetic sense, wherein people are customizing medications and therapies based on your individual genetic profile. Said in other words, the “Right treatment for the right patient at the right time”. However, most consumers already assume Right/Right/Right is happening, and more likely consider personalized medicine as a type of practice delivery style. This is where the physician knows the patient intimately, their social and demographic context, and the correct diagnostic or therapeutic approach given the patient’s preferences that have been learned throughout the relationship. The only physician I have ever had whom I had this type of relationship with was Dr. Richard Jones who took care of me from age 6-21 (when the front office lady finally told me that I “really should find another doctor“).

Dr. J, as he was affectionately called, had a personal interest in our family. Not only did I play football with his son throughout my school years, but he was always available to to see us at a moments notice. He was larger than life in our home - he expertly took care of coughs, earaches, nosebleeds, annual physicals, immunizations, concussions, and nearly every other ailment we could bring to him`. He was an excellent diagnostician, compassionate clinician, and very efficient with his time and practice. As our team physician, I got to know him as a second coach, a counselor, and someone who could console in times of defeat and share the joy of championships. In fact, more than any single factor, Dr. J influenced me to go into medicine because of the significant impact that he had in my life. I looked up to him as a role model, as an advisor, and as a friend. The relationship was time-tested, absolutely trusted, and he represented someone and something that I aspired to be.

However, that was not the world that I would find years later when going to medical school. The late nineties represented the first major backlashes against both nationalization of health (aka “HIllaryCare v1.0″) as well as the oppressive managed care regimes. The physicians that trained me and my classmates were angry, bitter, decrying the loss of the “golden era”, and just plain burned out. The Dr. J’s of the world were being forced onto a 7-10 minute treadmill, procedure focused, and RUC enhanced schema that perverted the primary care practice style that has been shown to increase health care value. The entire E&M coding concept, the fee for service, “do more get paid more” delivery model supported by RUC reimbursement methods (and its 24 out of 29 specialist committee members) has led to a dramatic DECREASE in VALUE (outcomes/price) by dramatically driving up the “price” part of the equation. In addition to driving up price, (which was initially combatted and later retracted through the managed care “spasm”) the problem has been that even with all the increasing costs there has been very little change the overall health outcomes. Research by Wennberg, and books like Overtreated and Crisis of Abundance effectively make the case against the specialist and procedure intensive “Premium Medicine” currently practiced in America.

But all that is beginning to change. Just as data drives discovery, medical evidence can and should drive medical practice. The evidence is showing that our current cultural expectations, third party payment misincentive system, and malpractice litigation environment are creating the perfect storm for healthcare reform. The winds of revolution are being buoyed up by the pioneers of health care delivery reform, and a return to when becoming a primary care provider delivering true health care (preventive care and wellness) versus “disease care” (what is currently practiced) is actually cool. Its the “going green”, renewable wave as applied to health care. I have documented the first wave of hip new doctors, now better equiped through technology to deliver highly personalized care (personal health records, predictive practice analytics, and evidence based treatment sensitive to individual cultural, demographic, and contextual preferences) who are reinvigorating the entire field of primary care which has unfortunately languished for decades (not for a shortage of solid physicians!). When added alongside payment reform (initially beginning as cash payment for services), and ultimately the realignment of incentives (through market forces supported by an appropriate regulatory environment) and reassignment of work tasks (appropriate utilization of physicians and other trained healthcare providers (RN’s, NP’s, etc), primary care has an opportunity to survive in a modified form.

So we are back to where we started 50 years ago. Trusted primary care physicians using technology to delivery highly personalized and effective medicine that their patients value and are willing to pay for - now that’s a future Dr. J could be proud of.

Scott Shreeve is a physician and entrepeneur based in Laguna Beach, California. After a long career in medicine, Scott founded the open source electronic medical record company MedSphere. He currently serves as entrepreneur in residence at Lemhi Ventures. If you enjoyed this piece you may also enjoy his earlier piece examining the potential impact of Long Tail economic theory on the healthcare industry. Scott is a frequent contributor to both THCB and the Health 2.0 Blog.

He blogs regularly at CrossOver Health.   

April 23, 2008 in Personalized Medicine, Scott Shreeve | Permalink

Comments

In the case of personalized cancer medicine, significant hurdles do need to be overcome to help physicians tailor treatments to individuals and their disease.

Uncovering the genetic differences that determine how a person responds to a drug, and developing tests, or biomarkers, for those differences, is proving more challenging than initially hoped. As a result, cancer patients are still being prescribed medicines on a trial-and-error basis, and adverse drug reactions remain a major cause of injury and hospitalizations.

In the new paradigm of requiring a companion diagnostic as a condition for approval of new targeted therapies, the pressure is so great that the companion diagnostics they've approved often have been mostly or totally ineffective at identifying clinical responders (durable and otherwise) to the various therapies.

If you find one or more implicated genes in a patient’s tumor cells, how do you know if they are functional? Is the encoded protein actually produced? If the protein is produced, is it functional? If the protein is functional, how is it interacting with other functional proteins in the cell?

All cells exist in a state of dynamic tension in which several internal and external forces work with and against each other. Just detecting an amplified or deleted gene won’t tell you anything about protein interactions. Are you sure that you’ve identified every single gene that might influence sensitivity or resistance to a certain class of drug?

Assuming you resolve all of the preceeding issues, you’ll never be able to distinguish between susceptibility of the cell to different drugs in the same class. Nor can you tell anything about susceptibility to drug combinations. And what about external facts such as drug uptake into the cell?

More thought "outside the box" needs to implemented before substantial realization of "personalized" cancer medicine.

Posted by: Gregory D. Pawelski | Apr 23, 2008 8:25:35 AM

Me too! That is, our family physician when I was a kid, the late Dr. Alexander Smith of Rochester, NH, actually knew us as individuals and a family.

In my much more recent experience of a never-diagnosed disease, I experienced eleven years of shuttling myself around from specialist to specialist, with my sister and I doing all the research, to finally end up too fragile to leave the house as of the last four years and therefore without access to relevant medical care.

When I think of the personalized care I knew as a child and the "care" I've experienced as an adult, it feels like I must have grown up overseas, in some different country.

Posted by: Paul Maurice Martin | Apr 23, 2008 12:02:26 PM

I could not agree more with Scott's focus on the important role a consistent primary care physician can play in enabling an individual to stay healthy throughout their life. It is promising to see individual physicians and entrepreneurs push against the system we know today to help facilitate change.

It really does feel as if the time is ripe for change and hopefully once again the United States can become a leader in healthcare.

Posted by: Doug Rogers | Apr 23, 2008 6:21:56 PM

Take a look at Interleukin Genetics, Inc. They have been on point with personalized medicine. Why have the managed care companies embraced this?

Posted by: Rob Fitz | Apr 24, 2008 5:25:53 AM

When Doc sent Morty back to the future in a deLorean, he forgot more than just the law of physics... he forgot that its already been done !

MYCIN: http://en.wikipedia.org/wiki/Mycin
Statistical models outperformed Stanford faculty at 69% back in the 70s. Reasons cited for lack of implementation was hardware. In the age of mobile computing or supercomputers that can be built for a couple of thousand dollars with off the shelf components, what we need is a webserver with some really hardcore scripts (think Adam Bosworth new startup Keas) that can classify disease states better than human diagnosis. Statistical models can be created for the top ten diseases. They can optimize for diagnosis based on the cheapest available tests OR more advanced imagine or marker data, and it can tell you the accuracy of a classification base on data available.

Consider the common scenario of being un/underinsured with high blood pressure. Rather than dealing with the inefficiency of people, simply get lab test run for $100 http://online.wsj.com/public/article_print/SB115076935218484812.html

Then have test analyzed by a statistical model that outperforms a human. Extend this to the top ten diseases- from diabetes to heart arrythmia... now that would be a disruptive business model!

Finally, for those of you are interested in yet another engineering milestone, last week machine learning defeats human in Go.
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/04-09-2008/0004789446&EDATE=
http://query.nytimes.com/gst/fullpage.html?res=9c04efd6123af93aa15754c0a961958260


Ultimately, would I want to sit back with the family Doc, marty, and talk about flux capacitors over a couple of beers. Sure, but not as a beholden patient made to wait hours contemplating the similarities between medieval trade guilds and 20/21st century medical licensing regimes. Besides, any statistical model could easily incorporate my psychological profile, remember my favorite color and song, and create a better user experience than a licensed human. (see articles on Halo3 programming team hiring a pyschologist to analyze players to create a better game)

-i wish i was born in the future !

Posted by: anoni | Apr 25, 2008 12:37:14 AM

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