The Time is Now, and the Rest is Up to Us

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 20^th 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.

Personalized Medicine: The Time is Now

Five years ago the Harvard-Partners Center for Genetics and Genomics, an organization that was a joint enterprise of Harvard Medical School and Partners HealthCare in Boston, held a conference on Personalized Medicine (PM).  As the subtitle of that first meeting, “Promises and Prospects,” indicated, the conference sought to examine the status of personalized medicine and to bring together different stakeholders in this emerging field. 

A newly founded organization, the Personalized Medicine Coalition (PMC), joined the effort.  The PM conference in 2005 focused on the scientific and medical basis of PM.  Two themes emerged from that meeting.  One was that a conference organized by a not-for-profit organization, together with an entity whose mission is to educate different societal constituencies about different facets of PM, was a welcome addition.  The second theme to come out of that meeting was that the implementation of personalized medicine requires collaborations between academic medical centers, government and its regulatory agencies, businesses, pharmaceutical companies, payers, doctors and patients. 

Personalized medicine has evolved significantly during the past five years.  In 2005 few people knew about PM and some who did know about it felt that it represented a futuristic view of medicine that may be implemented in 10-15 years.  In the ensuing years there has been a significant change in the awareness and attitude about PM.  Many influential people in the national administration and Congress have embraced PM as an important component of healthcare future.  President Obama, while he was a Senator, introduced PM legislation in the Senate.  Michael Leavitt, while he was the Secretary of HHS, embraced PM, and the current Secretary, Kathleen Sebelius, is very supportive. 

Many pharmaceutical executives are speaking of the importance of personalized medicine in their drug development efforts.  An electrifying moment in our 2007 conference was a talk by John Lechleiter, the current CEO of Eli Lilly, championing how a pharmaceutical company can develop excellent drugs based on the principles of PM while maintaining profitability.  Today most, if not all, pharmaceutical companies are developing many drugs based on these principles.  

At that first meeting in 2005 the payer community did not believe that PM was ready for implementation and there was inadequate evidence to support payer attention.  We are pleased that since then examples of personalized medicine and their success have caught the attention of payers and that this is an important topic in the boardrooms and executive offices.

A major development during the past five years is the development and availability of technologies that enable rapid and low cost DNA sequencing.  In 2003 when the first human genome sequence was completed it was estimated to have cost nearly two billion dollars.  A few months ago a company announced that it has sequenced human genome for less than $10,000 a genome.  Many believe that the $1,000 genome is just around the corner.  This cost of sequencing has important implications for diagnostics and handling the large data sets. 

It also has implications for consumer genetics companies that raised excitement in some quarters and concerns in others.  Several thought leaders argue that the involvement of consumers in healthcare decisions augurs well for our future and the consumer genetics companies have the potential to predict and therefore prevent disease in our population.  The role of information technologies in medicine in general and personalized medicine in particular cannot be overemphasized.  It is important to assess the current status and future of all these features.

Based on the feedback from that first meeting all of the subsequent meetings have been a collaborative effort between the Center, now renamed the Partners HealthCare Center for Personalized Genetic Medicine (PCPGM), Harvard Medical School and the Harvard Business School.  The PMC continues to be an active partner in these meetings.  Past conferences attracted speakers and participants from many walks of life and the discussions inside and the outside the conference auditorium have been lively. 

This year we are hosting the 5th annual Personalized Medicine Conference.  It is going to bring together the largest group ever to celebrate the discoveries and success stories of personalized medicine and explore new ways to bring the power of PM to our healthcare.  We believe that the implementation of personalized medicine will result in better outcomes for the patient population at a reduced cost to the society.  Such implementation would indeed revolutionize the practice of medicine.

This year’s meeting is attracting a more diverse audience than previous years and we expect that there will be many interesting discussions at the meeting.  We welcome you to our conference.  I am sure you will find something of interest at our meeting.  It is also a great opportunity to meet new people.

By Raju Kucherlapati, Ph.D., Paul C. Cabot Professor of Genetics, Professor of Medicine, Harvard Medical School

Aligning CER and PM – Progress on the Hill

The debate on comparative effectiveness research (CER) policy in the House of Representatives took two interesting turns over the last few days.  First, the House released its health reform bill (H.R. 3962) that combined three separate versions.  In the section related to CER, research on genetic and molecular sub-types was added to the scope of work for the Center for Comparative Effectiveness Research, some independence was added to the organization, and some patient protections were outlined. 

PMC sent a letter to House leadership on the bill.  In it, we laud their inclusion of language on genetic and molecular subpopulations as an important step forward for personalized medicine, and ask them to take the additional step of combining this language with a CER bill (H.R. 2502) introduced by Rep. Kurt Schrader (D-OR-5th) as the best approach to aligning PM and CER. 

In addition, Rep. Schrader sent a letter to colleagues stating his intention to continue pursuing his CER bill as an alternative to the House bill’s CER section.  His letter also highlighted the importance of aligning CER and PM. H.R. 2502 has a similar approach to CER as outlined in the Senate Finance version that recognizes personalized medicine throughout its structure. 

While the CER section is only a small part of a very big bill, the extent to which it aligns with personalized medicine could have a huge impact on continued progress in our field.

By Amy Miller, Public Policy Director, Personalized Medicine Coalition