A lot of people might think that the term "personalized medicine" means medicine that is tailored and fashioned for your particular needs – a drug made to fit you. In fact, it is the other way around – it is testing to determine whether you fit the drug. Pharmacogenomics is a combination of genetic testing (genomics) with drugs (pharmacology).
Right now, most drugs are a "one size fits all" medication. A drug is formulated and tested in a population and some respond really well while others may suffer adverse events. If there are more benefits than risks, generally the drug gets approved. Once out in the general population, that profile will repeat itself – many will benefit and many will not.
However, a growing number of drugs come with a more analytic approach to the patient. Genetic testing may predict whether a patient is a good candidate for treatment with a particular medication – that is "personalized" part of personalized medicine. Good examples of drugs whereby genetic testing makes their use more effective include Herceptin and Tarceva and even anti-virals used to fight HIV, where genetic testing can tell you if the virus you harbor is resistant to certain drugs. And there are many benefits in the future that can be realized in the broader application of pharmacogenomics.
The FDA has outlined the promise of pharmacogenomics in many public statements, including the so-called "critical path initiative" and there are several backgrounders and primers on pharmacogenomics on the FDA Web site.
But right now on the Hill, there is a bill introduced before Congress that is key any real future for personalized medicine called S. 358 – the Genetic Information Nondiscrmination Act of 2007, introduced by Senator Olympia Snow (R-Maine) which would prohibit discrimination in employment and health insurance based on genetic
information.
Imagine that there were a promising therapy for you but that to find out which one best suited you, you underwent genetic testing. That testing will reveal information about you that a health insurer or employer might find unappealing. You are then faced with a choice – do you take the test or do you forgo the therapy in the interest of preserving your job and your health insurance. It isn’t a choice you should have to make and moreover, key to the future of personalized medicine is an umbrella of protection that makes sure that is a choice you don’t have to make.
This is but one of many examples of how public policy can directly promote or impede medical progress. Let’s hope this one ends up in the right place. You can track the progress by using GovTrack in the column at the right on the blog. Cheers.
You raise interesting points on the ethical/legal issues.
But one of the more fundamental is the FDA approval process these drugs go through (1o vs. adjuvant therapy and in combination with what gold standard and measured against what endpoints). Dendreon has been to hell and back (a few times) with Provenge. I used to think we would never see a cancer vaccine from the FDA. After Gardasil, I have to wonder if that day is coming.