Adriana’s Dying Wish

“I am dying. We all die someday, but my expiration date is sooner than most. At age 41 I am facing my second recurrence of cancer. I was first diagnosed with an advanced and rare type of breast cancer in 2001. This led to a large tumor in my brain last year. Now the cancer has spread to my spinal fluid, which will likely seal my fate within weeks.”

So writes Adriana Jenkins in a column Forbes will publish next week called “A Dying Wish.” It already appears online, here, and is a must-read for anyone in the field of personalized medicine.

Unfortunately, Ms. Jenkins died on February 9th, just before the piece was published, though I am told that she did see it in print, which made her very happy.

She had sent us her draft ten days earlier. I was very moved by her essay, and recognizing the power of her argument, told her that PMC would like to publish it in our next newsletter, which, with Forbes’ permission, we will. She was very pleased.
 
In her article, Adriana notes that she participated in the original Herceptin trial, a drug she credits with extending her life by nearly a decade. As she describes it: “A targeted cancer drug kept me alive for nine years. Congress must ensure that future patients get the same chance to live.”

She asks why there are not more personalized medicines on the market, and pointed to some of the business model challenges inherent in discovering and developing targeted treatments linked to advanced diagnostic tests. She calls for better incentives to speed the development of personalized medicine, pointing to the Orphan Drug Act (which grants longer market exclusivity and other incentives for drugs targeting small populations) as one potential model.

Concluding her article, Adriana wrote, “I am so grateful for the extra time a PM drug gave me. My hope is that future patients have the same chance to benefit from personalized medicine.”

Adriana’s struggle, and her dying wish, should be a rallying point for all of us involved in the field of personalized medicine. Hers is a call for renewed commitment to stimulate more investment in the development of personalized medicine products, in particular through the creation of public policy incentives, such as those outlined in the Orphan Drug Act and elsewhere in other laws.

This year PMC will redouble its efforts to advance the understanding and adoption of personalized medicine concepts and products for the benefit of patients like Adriana.

We owe it to her and to ourselves.

Health IT and Personalized Medicine: Making the Connection

In his recent blog entry, Darrell West, Ph.D., of the Brookings Institution discussed the importance of health information technology (HIT) for the advancement of personalized medicine.  He argues that HIT can serve as the bridge enabling the flow of information between the researcher’s lab and the clinician’s office, helping to realize the full potential of personalized medicine: patient care guided by an understanding of disease at the molecular level, resulting in health system savings as we move away from a trial-and-error approach to medical care.

Taking a more in-depth look at the need for synergy between personalized medicine and HIT, the Brookings Institution published Enabling Personalized Medicine Through Health Information Technology, a paper by Dr. West outlining public policy changes needed to ensure that HIT facilitates innovation and clinical adoption of personalized medicine.  While I won’t summarize all eight of the policy recommendations highlighted in the paper, a couple have particularly important ramifications for personalized medicine.

Better Data-Sharing Networks. With proper policy in place, HIT can help to facilitate the connectivity, integration, and data analysis that is necessary to help researchers understand what types of therapies will work for what types of people, and provide a platform for health care providers to use this information in clinical practice. However, as suggested in a report last year from the President’s Council of Advisors on Science and Technology (PCAST), connecting data across the nation’s 650,000 doctors and 5,800 hospitals is one of the most significant challenges in achieving the necessary exchange of health information that can better inform research and patient care. As Dr. West rightfully points out, HIT policy must facilitate the creation of a system that not only improves the accounting and administrative aspects of health care, but also facilitates the tracking of information on treatment guidelines, medical tests, and clinical outcomes – helping to achieve greater value in health care. Furthermore, we can only realize the full benefits of our improved understanding of disease when new genomic and other personalized information is included in a patient’s electronic health record and can be connected and compared to clinical outcomes data from other patients to allow researchers to spot trends and build knowledge.

Of course improved data sharing capabilities will require a balance between protecting the privacy of personal health information and enabling appropriate access to aggregate data and analyze results.  Dr. West offers additional insight in the paper as to what this may look like.

Ending the Catch-22 of Reimbursements. As discussed in the Personalized Medicine Coalition’s issue brief The Adverse Impact of the U.S. Reimbursement System on the Development and Adoption of Personalized Medicine Diagnostics, diagnostic tests play a pivotal role in the practice of personalized medicine, but as of yet, coding systems have not been updated to reflect the multitude of tests available and reimbursement does not adequately reflect test value or interpretation costs. Dr. West expounds on this in his discussion of the CMS Coverage with Evidence Developmental (CED) system. In 2009, CMS rendered a CED for warfarin diagnostics where they could only cover the cost of the test for participants in two specific research studies.  Though CED could help demonstrate the value of genetic tests in improving clinical outcomes, it also creates a catch-22 in that insurers are reluctant to cover “experimental” diagnostics. Without updates to the coding and reimbursement system, and HIT-driven pathways to capturing information, innovative test developers will not be able to gather the level of evidence required to qualify for reimbursement. Speaking at Brookings, David Brailer, M.D., Ph.D., Chairman of Health Evolution Partners and the former National Health Information Technology Coordinator suggested, “We should develop the reimbursement coding schema [for personalized medicine technologies…[The lack of a reimbursement coding framework] has had a more adverse effect than any other aspect on the development of these technologies.”   

As advances in science transform our understanding of disease, we must also adapt our policies and perspectives on how medicine is practiced.  We have the opportunity to leverage HIT to enable a new era in medicine – one that can integrate research findings into treatment guidelines by applying what we know about disease to more effectively and efficiently direct research, treat patients, and reduce costs in our overburdened health care system.

For more in depth examination of the policy recommendations in the Brookings paper, the full report is available for download at: http://www.brookings.edu/papers/2011/0128_personalized_medicine_west.aspx.  A transcript and audio recording of the release event featuring Dr. Brailer, and a panel discussion including Paul Billings, M.D., Ph.D., of Life Technologies Corp., Mark Boguski, M.D., Ph.D., of Harvard Medical School’s Center for Biomedical Informatics, Emad Rizk, M.D., of McKesson Health Solutions, Inc., and Donald Rucker, M.D., of Siemens Medical Solutions USA is also available for download at http://www.brookings.edu/events/2011/0128_personalized_medicine.aspx.