Tuesday, August 22, 2006
Putting the "me" in "medicine"
An article appearing in Scientific American discusses the unrealized potential of a new field called ‘Pharmacogenomics’, defined as ‘applying genetics to medicine’. The idea is that we are all a bit different on a genetic scale, and if we could figure out some of the ways we are different, we could begin to prescribe medicines based on those differences. For example, maybe only one in ten people will benefit from a particular drug but we have no way of separating the people who will benefit from those who will not. But what if we had a test for a biomarker that would tell us who would benefit? The problem is these biomarkers are not that easy to find, we are left with reams of data explaining our genetic differences with little ability to connect that to how we would respond to
One of the reasons the field has not matured as we would hope is because for a long time the FDA did not explicitly outline how companies might go about getting approval based on their tests for biomarkers. But this past March they came out with such guidelines, so now the onus falls back onto the companies.
And they have little to no incentive to move to this pharmacogenomic model, as it would severely limit their customer base for a given medicine. For example, imagine how drug commercials would change- would they disappear? Why market to everyone when people will be going to the doctor for a genetic screen to decide which drug to take?
But on the other hand, the system would decrease the number of people with adverse effects as well. Suppose a genetic screen could have outlined who would and wouldn’t benefit from Vioxx? That would not only have saved money but also lives.
So what is the reason for the lack of realization of this potential? Is it lack of international cooperation among scientists? Is it because drug companies believe they stand to lose money if we move to this more personalized model? It may be necessary for governments to offer incentives to pharmaceutical companies to make this major change.
One of the reasons the field has not matured as we would hope is because for a long time the FDA did not explicitly outline how companies might go about getting approval based on their tests for biomarkers. But this past March they came out with such guidelines, so now the onus falls back onto the companies.
And they have little to no incentive to move to this pharmacogenomic model, as it would severely limit their customer base for a given medicine. For example, imagine how drug commercials would change- would they disappear? Why market to everyone when people will be going to the doctor for a genetic screen to decide which drug to take?
But on the other hand, the system would decrease the number of people with adverse effects as well. Suppose a genetic screen could have outlined who would and wouldn’t benefit from Vioxx? That would not only have saved money but also lives.
So what is the reason for the lack of realization of this potential? Is it lack of international cooperation among scientists? Is it because drug companies believe they stand to lose money if we move to this more personalized model? It may be necessary for governments to offer incentives to pharmaceutical companies to make this major change.