When Raju Kucherlapati, the Paul C. Cabot Professor of Genetics at the Harvard Medical School and chair of the organizing committee for the conference, “Personalized Medicine: The Time is Now,” summed up the defining annual event on November 18-19 in Boston, he noted that the time for personalized medicine is not only now but that personalized medicine is here.
Five years ago the Personalized Medicine Coalition helped organize the first international conference at Harvard entitled, “Personalized Medicine: Promises and Prospects.” One third of the size of this year’s conference, which brought together over 600 high level executives from across the healthcare spectrum, it made the case that the accelerating pace of discovery was rapidly making one-size-fits-all, trial and error medicine obsolete. We argued that it was important, if not critical, to realign our regulatory, reimbursement, and educational systems to harness the power of new insights and new technologies for the benefit of patients who want safer and better drugs as well as for society, which can no longer afford the inefficiencies of 20th century medicine.
Five years ago we were struggling to define personalized medicine while the Royal Society, the United Kingdom’s independent academy of science and technology, issued a troubling report on the future of personalized medicine that may be summed up in a single phrase: Don’t hold your breath.
Today, as Dr. Kucherlapati pointed out, we see evidence of personalized medicine’s potential impact on millions of people. Not only is the list of widely prescribed drugs targeted for specific populations growing for many different kinds of cancer, heart disease and other disorders, it is being adopted in the United States by large institutions whose programs have the capacity to touch millions of people.
DNA Direct, a company that provides guidance and decision support for genomic medicine, and Humana, an insurance company that covers 11 million people, have announced a program to help physicians understand how genetic counseling can assure better outcomes and avoid unnecessary expenses. Generation Health, a new genetic testing health benefit management company, is partnering with CVS Caremark, a pharmacy benefit manager for 50 million subscribers, to analyze more than a dozen drugs with associated diagnostic tests to determine the best prescriptions for patients with selected diseases including cardiovascular disease, cancer and HIV. The two companies think that they can also improve patients’ health, reduce adverse events, and save costs by not prescribing drugs to non-responders. And Medco, the largest pharmacy benefit manager in the United States, has created a program to help advise physicians when to prescribe a diagnostic test to improve patients’ health and lower costs of care for their members. Medco has invested heavily in its own research, for example, to test the hypothesis that genetic testing can improve warfarin dosing. Warfarin is the second most widely prescribed drug in the United States and also, according to FDA, the second leading cause, after insulin, of drug-related emergency room visits.
In a sign of the times, Pfizer and Abbott, two large pharmaceutical companies, have formed a partnership to develop a drug and companion diagnostic test for non-small cell lung cancer, based on the knowledge that some 6 to 7 percent of patients with these tumors have the genetic markers that make them good candidates for the drug in development. According to Stafford O’Kelly, president of Abbott Molecular, “What’s happening is that [once] the understanding of the molecular basis for disease is validated, it’s increasingly important to get these tests.”
To be sure, we have a long way to go before all therapies are linked to molecular diagnostic tests of one sort or another. But, as Mr. O’Kelly’s comment suggests, we are on the right road because the science points in that direction.
By Edward Abrahams, Executive Director, Personalized Medicine Coalition.