The tools for personalized medicine are hitting the mainstream market, including tissue microarrays, commercial tests for DNA analysis and
pharmacogenetics. Drug companies have long resisted the move to personalized medicine, fearing that individualized care would destroy the blockbuster
drug market. As pharmacogenetics prepares to celebrate its 50th anniversary, the FDA is backing efforts by the National Institutes of Health to
promote the paradigm shift. Personalized medicine focuses on disease prevention, rather than treating symptoms.
"The biggest news these days in tissue microarrays (TMAs) may be that this former "next big thing" has become a standard tool for molecular
profiling of disease."
...Also see ATS: DNA Analysis to Become Household Item
Personalized Medicine and the Death of Blockbuster Drugs
"I think that in the future the health care model will de-emphasize acute care and start emphasizing preventive care. People will know their
predisposition to disease and their likelihood of becoming ill, and the health care provider will need to build a strategy with the patient that will
focus more on disease prevention than symptom relief. That is an opportunity for drug market expansion. Consumers will be more likely to act upon this
advice, because they will know in a very intimate way what their own likelihood of disease is.
I’m not so sure that pharmacogenomics spells the end of the blockbuster. I think that you will have blockbusters and multibusters—a number of very
good drugs that are very efficacious and very safe in subpopulations."
From pharmacogenetics to personalized
medicine: a vital need for educating health professionals and the community.
" The field of pharmacogenetics will soon celebrate its 50th anniversary. Although science has delivered an impressive amount of information in
these 50 years, pharmacogenetics has suffered from lack of integration into clinical practice. There are several reasons for this, including the unmet
need for education at medical schools and the lack of awareness about the impact of genetic medicine on healthcare in the community. Recently, the FDA
announced that it considers pharmacogenomics one of three major opportunities on the critical path to new medical products. This notion by the FDA is
filling the regulatory void that existed between drug developers and drug users. However, in order to bring pharmacogenetic testing to the
prescription pad successfully, healthcare professionals and policy makers, as well as patients, need to have the necessary background knowledge for
making educated treatment decisions. To effectively move pharmacogenetics into everyday medicine, it is therefore imperative for scientists and
teachers in the field to take on the challenge of disseminating pharmacogenetic insights to a broader audience."
Please visit the link provided for the complete story.
We all know that different people react differently to the same drugs, and some "side effects" are fatal. Other drug reactions speed disease
progression and cause chronic illness. Testing to predict drug reactions always has been possible - drugs are targeted to specific proteins and it's
relatively simple to test for the presence of the target protein. Such tests are part of "pharmacogenomics" or "pharmacogenetics."
However, insurance plans don't cover the tests and doctors are not taught about them in medical school. As a result, patients become guinea pigs,
forced to "try" one drug after another to find one that "works" and doesn't have debilitating side effects.
The new tests and techniques make testing fast, cheap and easy - and lead the way to creating drugs tailored to each individuals' very specific
In the past, pharmacogenetic science and techniques focused on race-specific bioweapons - the military and drug industry both had a stake in keeping
pharmacogenetics and genomics out of the public domain.
Now, after 50 years, the science has gone mainstream and promises to benefit ordinary people. Granted, pharmacogenetics still has the potential to be
abused but overall, the benefits seem to far outweigh the risks to civil liberties and privacy.
Also of interest:
Predictive Pharmacogenomics: Revolutionizing Health Care
Personalized Medicine - Scientific and Commercial Aspects
Note: This report and others like it cost $2,000 and up, but the table of contents is informative.
11thAnnual FDA Science Forum
[edit on 10-4-2005 by soficrow]