By Jan A. Nowak, MD, PhD e-mail: jan@nowaks.org

Musing about AMP’s fifteenth year, I looked back to the Tenth Anniversary Issue of the AMP Newsletter (Vol 10, Number 4, 2004).  Amidst the many reminiscences in that issue, I focused on then President Angie Caliendo’s message.  “Today,” she wrote, “it is impossible to imagine the practice of medicine without molecular methods.”  The trendy catch phrases of today touting a new world of personalized medicine, with targeted therapies directed to specific patients identified with laser directed precision by pharmacogenomic  testing using companion diagnostics were yet to be hatched, but as an organization we knew that the future of medicine lay with molecular biology.  Angie warned that in the ensuing decade, we would be challenged to ensure “the appropriate use of molecular testing, adequate availability of testing”, and the “development of high quality products”.  "[It] is essential," she wrote, “that AMP take the lead in educating healthcare providers, government officials, including those setting public health policies, as well as the general public.”

How have we done, now that we are half way through the second decade of our existence?  Reading through the reports in this Newsletter, there is little doubt that the members of this organization are meeting the challenges that we envisaged.  I am particularly struck, however, with the growth of AMP‘s advocacy efforts in the last few months.   In late March, AMP sent a letter to the Institute of Medicine Committee on Comparative Effectiveness Research Priorities, identifying those issues that we see as critical.  In the last few months, AMP representatives attended the FDA Oncology Drug Advisory Committee (ODAC) hearing on KRAS, and provided comments at the recent Medicare Payment Advisory Committee (MEDCAC) hearing on evidentiary issues related to genomic testing.  In March and April AMP members and staff visited the offices of key US Senators and Congressmen, meeting with their respective health policy aides, informing them of who we are and offering  our expertise and assistance. The offer was immediately accepted by an aide to Senator Enzi (Wyoming) who invited AMP to comment on legislation being prepared by that office. We will continue to make similar visits to the “Hill” accompanied by our government relations consultants at HealthFutures. 

Our Clinical Practice and Professional Relations Committees (CPC & PRC) have been working jointly to respond vigorously to the Genentech petition to the FDA on regulation of laboratory developed tests.  PRC will also be responding to the recently released Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) draft on gene patents, their affect on patient care, and on our laboratories.  Did I mention that PRC and the recently renamed Economic Affairs Committee (formerly the CPT coding committee) were successful in bringing about the retirement of a flawed Medicare local coverage policy for molecular tests with at least one Medicare contractor, and are working on others?  The EAC also developed and sponsored a new coding proposal for microbial identification by sequencing methods before the Pathology Coding Caucus (PCC) and is optimistic that the new codes will be accepted by the AMA CPT Editorial Panel for 2010. A continued dialogue with MEDCAC on evidentiary issues surrounding genetic screening tests is also in the works.

I cannot overlook the efforts of Rick Press and Helen Fernandes and the new Membership and Professional Development Committee to initiate efforts to develop international chapters in India and elsewhere.  Our members populate various committees in other professional organizations and I can vouch from personal experience that it is not uncommon for someone to ask “what is AMP doing about that?” or “can someone post a message on CHAMP to see what the molecular community thinks…”  These are just sampling of the advocacy efforts in which AMP has been involved.  

Five years ago our leadership saw what AMP needed to do.  Looking back, I think Angie would agree that we have accomplished a lot.  Most importantly, AMP has been successful in establishing itself as a creditable authority with other laboratory professional organizations, with regulatory agencies, and with policy makers.  This reputation was not easily earned, but certainly well deserved.  It leaves us in good position for the future.