The phrase “Take two aspirin and call me in the morning” may soon be a thing of the past, according to Food and Drug Administration Commissioner Andrew C. von Eschenbach.
During a U.S. Senate hearing held on campus last Friday at the Eccles Institute of Human Genetics, von Eschenbach, Utah Sen. Bob Bennett and a panel of medical professionals discussed how to better treat patients based on their individual characteristics and genetic makeup.
Through the use of genetic information, the panel members hope researchers can predetermine who will benefit from certain drugs and who shouldn’t take certain drugs.
By taking the guesswork out of medical care, the right drug gets to the right person, side effects are minimalized and drug benefits are maximized, Bennett said.
The hearing focused on the FDA’s Critical Path Initiative, which centers on the safe, effective and timely development of medical products.
According to a 2001 report by the Tufts Center for the Study of Drug Development, it costs pharmaceutical companies, on average, $802 million and takes 10 to 15 years for a drug to become available to patients. This arduous process is one of the contributing factors to the declining number of new medical products over the past several years.
Also contributing to the decline, said David Jones, senior director of early translational research at the Huntsman Cancer Institute, is the “blockbuster mentality” of pharmaceutical companies that if a medication is not a cure-all wonder drug, it’s not worth the time and money.
By developing drugs to work well with individual DNA types rather than the public as a whole, the FDA hopes to fight the blockbuster mentality.
“We can?create a system of health care that is predictive, preemptive and much more personalized,” von Eschenbach said.
Sen. Bennett described the drug Vioxx as the “poster child” for the new initiative. Originally intended to treat symptoms associated with arthritis, Vioxx was recalled after it was found to increase the risk of heart attacks and strokes in some patients. Bennett noted that roughly 6 percent of those who took Vioxx were found to have an increased risk, while 94 percent benefited from the treatment. After the recall, no one was able to benefit from Vioxx, he said.
“The old paradigm is the doctor prescribes a drug based on how it works in the large population,” Bennett said. “Now, the prescription written for you will be based upon your own genetic makeup.”