Late last month, the National Health Policy Forum published a background paper called Pharmacogenomics: A Primer for Policymakers written by Leslie Tucker. It is a really excellent overview of the state of the state on pharmacogenomics and as the title indicates, outlines what must occur from a policy point of view to set the stage that would make it possible for the full promise of pharmacogenomics to be realized.
Pharmacogenomics potentially may yield a great deal for patients in the future. Put over-simplistically, the genetic variations in the population can be tested and people who will respond to medications will be identified from those who won’t. There will be no "number needed to treat" factor. In addition, companies can discover what genes respond to which therapies. Needless to say, there are a whole host of considerations and challenges that are presented by this promise. For example, will companies only develop therapies for conditions where the majority of people can respond to a compound, leaving the minority out of luck?
Another example is found in the challenge to an individual in taking a genetic test. It almost reminds me of the early days of the AIDS epidemic when people were encouraged to take an HIV test, even when there was no treatment for HIV. It became more than a medical test, it was a marker for discrimination. The New York Times on Sunday ran an article from a series called The DNA Age about the fact that many people will avoid genetic testing because they fear that in finding the information they want, they may be deprived of the insurance coverage they will need. It is one of the many examples who the age of pharmacogenomics cannot be ushered in without some effort by policymakers, in this case, to enact anti-discrimination laws.
But that is only the tip of the iceberg. There are other barriers as well, many of which are economic and some of which are ethical.
The only problem is that when one reads it, as I did, one might be left with the sinking feeling that there is no way policymakers can possibly get their act together to do what must be done. And, even worse, that there is no way the FDA, at least in its current state, can step up to the challenge. It is but one more of the many, many reasons that the FDA needs to pull itself together and once again assume a leadership posture and leave the status quo behind. The current rudderless nature of the agency not only seems to call into question current safety practices, but promises for the future as well.