[ExI] Article: Realizing the Promise of Personalized Medicine
Max More
max at maxmore.com
Wed Dec 5 18:12:30 UTC 2007
I recently wrote this commentary on/review on a
Harvard Business Review article that will be of interest to many on the list:
Realizing the Promise of Personalized Medicine
Mara G. Aspinall, Richard G. Hamermesh
Thalidomide, a drug sold and prescribed during
the late 1950s and early 1960s, became perhaps
the most reviled medical drug ever. Primarily
prescribed to pregnant women, between 1956 and
1962, around 1,000 children were born with severe
malformities to mothers who had taken thalidomide
during pregnancy. Despite its horrible
reputation, subsequent research has indicated
significant potential benefits of the drug as an
anti-inflammatory that provides relief to leprosy
sufferers, as a treatment for multiple myeloma,
and perhaps for arachnoiditis, Crohns disease,
and several cancers. About the only people who
should not take Thalidomide, it appears, are
pregnant women. The Thalidomide experience
underscores the vital importance of carefully
targeting treatments based on individuals
particular physiologies oras this article considerstheir particular genome.
Not so very long ago in human history, for almost
all medical conditions and all people, doctors
would prescribe a course of blood-letting. Now,
more than ever, doctors are able to customize
therapy for individuals. Mara Aspinall, the
president of Genzyme Genetics, and Richard
Hamermesh, chair of a Harvard Business School
initiative to improve leadership in health care
organizations, argue that explain that adoption
of personalized medicine has been painfully slow,
being held back by the trial-and-error treatment
model. That dominant model governs how the health
care system develops, regulates, pays for, and
delivers therapies. In this article, they detail
the four main barriers to personalized medicine
and suggest ways to overcome them.
If we could accelerate the adoption of
personalized medicine, we would save both lives
and money in abundance. Several scientific
advances seem to make the eventual triumph of
personalized medicine inevitable. The inevitable
could be far too slow in arriving since the
transition from trial-and-error medicine to
personalized medicine is being held back by four
barriers: The pharmaceutical industrys
historically successful blockbuster model; a
problematic regulatory environment; a
dysfunctional payment system; and physician
behavior that is firmly attached to trial-and-error medicine.
The authors point to several signs that the
industrys blockbuster model is failing. They
recommend that big pharmaceutical companies
abandon the blockbuster business model in favor
of one based on a larger portfolio of
targetedand therefore more effective and
profitabletreatments; forge alliances with
diagnostic companies; and step up efforts to
communicate the safety and efficacy advantages of
targeted therapies. They cite several reasons to
believe that the targeted model would increase
sales and profits in the intermediate and long
terms. The current regulatory environment also
needs overhauling. It overemphasizes large-scale
clinical trials of broad-based therapies and
neglects monitoring and assessment after approval
is won. The authors recommend fast-tracking the
review of all new drugs that include a diagnostic
test as part of the patient-selection process and
urge the FDA to craft appropriate standards to
ensure the accuracy and integrity of diagnostic tests.
To improve the economics of the payment system
(which currently rewards physicians for activity
rather than for early diagnosis and prevention),
regulation and reimbursement must be coordinated
to create the right incentives for the right
outcomes. The authors make some specific
suggestions for achieving this. Medical schools
can help overcome the final barrier of physician
behavior rooted in trial-and-error medicine, such
as through education about genomics, diagnostic
testing, and targeted therapies. Employers in the
United States can do their part to hasten the
triumph of personalized medicine by pushing
insurers to cover targeted therapies, including
diagnostics and insisting that providers
routinely offer them to their employees; and by
demanding that cost-conscious insurers focus on
the overall expense of treatment during the
entire course of a disease, not just the cost of the initial procedures.
Max More, Ph.D.
Strategic Philosopher
www.maxmore.com
max at maxmore.com
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