News and Events: Congressional

BEFORE THE UNITED STATES HOUSE OF REPRESENTATIVES

COMMITTEE ON ENERGY AND COMMERCE

SUBCOMMITTEE ON INVESTIGATIONS

STATEMENT OF PETER J. LEVINE

PRESIDENT, CORRELOGIC SYSTEMS, INC.

JUNE 22, 2004

Mr. Chairman and Members of the Subcommittee:

My name is Peter J. Levine.  I am President of Correlogic Systems, Inc.  I do not want to take the Subcommittee’s valuable time this morning reading my testimony, but I would ask that my written statement be entered into the record.  I would however, like to make a few brief observations and then take the Subcommittee’s questions. 

Correlogic is a clinical proteomics company based in Bethesda, Maryland, that specializes in the development of tools and processes that can assist with the early detection of various cancers and other diseases.  The focus of Correlogic’s energies has been the development of a complete diagnostic system based in part on the use of pattern recognition for the early detection of cancer.  Our technologies and processes have a wide range of applications and can be used in the creation of disease diagnostic models, biomarker discovery, and new drug discovery processes.  We are also a clinical laboratory regulated under the Clinical Laboratory Improvement Amendments of 1988 and are currently working with the nation's two premier diagnostic laboratories, Laboratory Corporation of America and Quest Diagnostics, to provide an ovarian cancer testing service.

I wish I were testifying today only about the accomplishments of Correlogic and the results of our most recent research, because I believe we are at the brink of translating significant research progress into the ability to provide more accurate and earlier detection of certain diseases, such as ovarian cancer.   Quite frankly, we would not be at this critical and exciting juncture without the considerable talent and resources of the National Institutes of Health, the National Cancer Institute, the Food and Drug Administration, and the Public Health Service.  I hope my comments today will not be taken as a broad criticism of the life-saving mission of these agencies or as justification for reducing our nation’s financial commitment to them.  I also ask that my testimony not be misconstrued as a critique of the vast majority of men and women who work there. They have dedicated their professional lives, often at great personal sacrifice, to the advancement of medical science and the health of our nation.  Because of their work, hundreds of thousands of lives have been saved, and they give hope to a brighter future for millions of others. 

All is not well, however at NIH, and the experience of Correlogic these past two years has revealed what I believe are some very serious flaws in the manner in which the agency implements its licensing, CRADA and conflict of interest policies.   Simply put, Correlogic entered into both a research CRADA and a licensing agreement with the National Cancer Institute, the Food and Drug Administration, and the Public Health Service to develop a diagnostic testing system for ovarian, prostate, breast cancer and other cancers.   These agreements, for which we paid and continue to pay significant royalties, were designed to facilitate the development and commercialization of a diagnostic testing system for the benefit of patients. 

We have met all of our obligations and entered into contractual relationships with other well-established industry players, that have been approved by the Public Health Service, to satisfy the government’s requirements.  Unfortunately, since our work first became known to the public in 2002, what started as a cooperative, constructive, research and business relationship has clearly deteriorated.  Only now, under the light shed by this Subcommittee, and with the full perspective of hindsight can we see what was really going on.   As the balance of my written testimony describes in more detail, we have been caught up in a morass of conflicting interests, unilaterally changed agreements and a failure of an agency to abide by the letter, much less spirit of a critical research and licensing agreement.   

While preparing for my testimony today, I struggled to find a starting place to address the focus of the Subcommittee’s interest.  But when I think about all that has happened, the concept of “good faith” is the recurring theme.  The agencies of our government must act in good faith.  As the Subcommittee continues its work, I would ask that each and every issue under review be evaluated from the perspective of this fundamental concept: were these actions, these decisions, made in good faith, or were facts and legal interpretations made to support outcomes that were inconsistent with the spirit and the clear intention of the pre-existing agreements and relationships? 

Mr. Chairman, I appear here today with great reluctance.  I am concerned about the impact my testimony may have on my company’s ability to continue to do business with the various branches of the Public Health Service.  Obviously, there are policy changes that need to be made at NIH.  I only hope, that when the dust has settled and attention shifts elsewhere, that Correlogic is not penalized for cooperating with the Subcommittee’s inquiry.

I would happy to answer any questions that the Subcommittee may have.