Wednesday, June 13, 2007

Personalized Medicine since 1986???

First I would like to apologize for the lack of postings on interesting topics lately. I am glad that others have picked up my slack. Notably Hsien and Bertalan's interesting posts this week. Or for an in depth post on the politics of health care and the reform movement check out VentureBeat

What I want to pay attention to today is the question I inevitably get asked when I speak to other physicians. "Is what you say feasible in a 7 minute consult world?" The answer is inevitably NO. I do not feel in my heart of hearts that we will ever be able to practice personalized medicine in a 7 minute consult world.

What's needed is a Revolution. We need a place where the patient has access to their records and their physicians 24/7. We need a place where the patient is given the skills to understand and manage their disease. My friend's 12 year old son can quite effectively manage his diabetes, how come a 45 year old venture capitalist cannot? Support is the key and learning is the motion required to open the lock. How do we make these things easier? How can we get doctors to teach their patients? What ever happened to true continuity of care? These are big questions that need answers. I don't have them all. But I am working with some great people who will find those answers.....

So the next question is "How can we have the knowledge to practice these things?" I often tell physicians to go back to college or read a book on genetics. If you don't have the time to do that, then you will fail your patients. This often meets an uproar of disbelief......I am pretty good at pissing people off. Just ask Lisa Lee at DNADirect ;)

In all honesty, we need some clinics who offer personalized medicine consultations. These specialists need to guide care in collaboration with PMDs. I am building this model in NYC! We will be seeing patients in July. Give me a call and we can arrange to start the relationship.

But there has been someone doing this since 1986!!!! Wha??? The HGP was only 3 years in and they were providing these services. Yes that is correct. Greats such as David Rimoin and Maren Scheuner helped form and develop this practice. It goes by the "trademarked" name GenRISK Adult Genetics Program. It has been in practice since 1986 offering several tests that you can see on their site. I have been critical of predisposition tests unless clinically indicated. This is an example of how a personalized medicine practice can be run.

The Sherpa Says: Genomic and Personalized Medicine need to be given in a continuity of care. Family history changes, medical history changes. A one time consultation cannot deliver that kind of service. Oh and what about pharmacogenomics?


Brian Meshkin said...

Dear Steve -
Thank you for your post. I read your recent post with interest. I have been involved with personalized medicine for several years and my colleagues have been involved in actually "reducing to practice" the concept. At our former company, we brought to market and built to blockbuster status TPMT Genotyping and Enzymology testing for the purposes of identifying those at risk for myelosuppression on thiopurines, as well as to guide initial dosing. We then also built to blockbuster status thiopurine therapeutic drug metabolite monitoring to measure efficacy and compliance. We brought these products to market in gastroenterology where thiopurines are used to lessen IBD patients' use of steroids, specifically in severe Crohns' patients. Whereas the "standard of care" was to start with a low dose and titrate up until a side effect was present (pancreatitis, myelsuppression, etc.), we offered a personalized medicine alternative of being able to predict the moderate and high risk patients to make more educated dosing decisions, and then truly understand how a patient was metabolizing the drug upon commencing therapy. Though these therapeutics are used off-label by gastroenterologists, we built a valuable relationship with them. We had 79% of GI's in the U.S. using the technology and 30% of all new Rx's on thiopurines receiving the test up front and ongoing (annual basis) TDM. We were able to not only get most GI physicians to use the technology, but since many IBD patients are diagnosed between 15 and 29 years of age, it was a welcome advance for the parents of these children and young adults who want only the best for their children. This was such an accomplishment that despite not having prospective data, only restrospective analyses, we were able to get the FDA to approve amendments to the package inserts of all thiopurine drugs to mention the availability of such testing - without the tests being FDA approved.

So yes, personalized medicine has been around and we had been doing it since the late 1990's. Our team has experience getting physicians to order it, patients to ask for it, parents of patients to demand it, insurance companies to pay for it, and the FDA to include it in package inserts without formal FDA pre-market review.

Today, some of the persons responsible for this huge accomplishment have joined forces to bring many of these technologies to market to address personalized medicine - both from a conventional medicine (pharmaceutical) and complementary and alternative medicine (nutraceutical) standpoint. That company is Salugen, Inc. Check us out sometime, I'd love to discuss it with you.

Best of luck with your clinic in The City.

Steve Murphy MD said...

I appreciate your work. I personally had a patient in my emergency room who missed his "blood draws" while on 6MP. He had no white blood cells and was septic. The cost of his stay 120k, the costs of TPMT testing prior would have been priceless. He has absent enzyme activity. Send me an email. I would love to chat.