Evidently the new FDA guidelines about moving toward using genetic profile data to differentiate drug development and prescription has kicked-off some heated discussion. A Forbes article describes a debate between a cardiologist and a drug company exec that got pretty ardent. The cardiologist said genetics-based diagnostics will be important in medicine, and the pharma exec said it won’t happen because it’s not economically feasible for them to absorb additional development costs, especially if it leads to narrowing of markets.
The pharmaceutical industry really doesn’t want to go there. The business model that made them very profitable in recent years is not based on targeted, niche drugs. They’re interested in the blockbusters, side effects and all. That’s why at BIOSILICO speakers predicted that the big pharmaceuticals either will have to figure out a new business plan or they will go away. The drug execs want to say, “It’ll never happen.”
It seems to me a case can be made that, not only will the pharmaceutical companies have to deal with emerging genetic diagnostics, but doctors and patients will too. The use of genetic diagnostics will prevail for the several reasons:
The FDA is not going to ignore studies suggesting genetic differences affect drug effectiveness and side effects.
Doctors can’t ignore it either. Better diagnostics will become part of best practices in medicine.
The lawyers surely won’t ignore it. Malpractice avoidance will eventually drive everybody to use the best information they can get.
So the question that will come up eventually is: how will patients deal with all of this? The public has been leery of genetic testing because they might find they’re at risk of something for which there’s no treatment and because genetic privacy and discrimination issues are still far from resolved. But if genetic testing progresses from checking for things such as birth defects to refining diagnoses and to determining if a chemotherapeutic agent will work, genetic testing will broaden quickly. The social, counseling, and personal decision making issues could be upon us sooner than expected.