AAMC Reporter: June 2005

Peter G. Traber, M.D. President and CEO Baylor College of Medicine

Viewpoint: "Who Owns Our Science?"

Science may be defined on many levels, from individual experiments and methodological advances to the broad principles and concepts that define how we describe and understand the world. Ownership of the various components of scientific discovery may be legally defined through intellectual property, but ownership of scientific advancement and principles is fleeting and generally communal.

Throughout history, increased understanding of the world around us led to great advances. Scientific discoveries result in innovations that improve quality of life and drive the advancement of civilization. Of course, human health and prosperity rely directly on biomedical research advances. Thus, from a broad perspective, science must be "owned" by all of society because our civilization is dependent on scientific progress.

While society may collectively own biomedical science, three groups are responsible for the management of scientific progress and the development of useful innovations. In the United States, the tri-partite partnership between academic health centers (AHCs), industry and government guides and oversees biomedical advances. This partnership is vital for the development of safe and effective treatments for the public.

Academic health centers represent the research and development arm of the nation's health system. The activities of AHCs effectively integrate the missions of education, research and patient care, providing a fertile environment for the generation of ideas and fundamental breakthroughs in scientific concepts. This environment, and the inquisitive minds it attracts, promotes creative solutions to medical problems and the validation of those solutions in application to human populations. In short, AHCs are the engine behind medical innovation and, it can be argued, are responsible for virtually all of the breakthroughs in biomedicine of the last century. Innovations that occurred primarily in industry were developed by scientists who received their education, post-graduate training and employment in academic health centers.

Private sector entrepreneurial enterprises ensure that scientific discoveries are translated into marketable products that add value to the practice of medicine and human health.

Government functions to develop policy and ensure that regulatory agencies provide ethical and systematic processes in which both industry and AHCs can operate. The federal government provides the major funding for biomedical research in academic medicine.

These three groups must work together to ensure the public receives the greatest benefit from biomedical advances while it is protected from harm that new therapies may inadvertently cause. There are natural conflicts at the working interfaces between these groups, but a functioning partnership is critical for progress.

Societal conditions that have caused a growing public distrust of all three partners provide obstacles to building a more stable partnership. Increasingly, the patients are more willing to pursue solutions independently-especially with the advent of the Internet-rather than relying solely on what their physician may tell them. This "individual determinism" is coupled with a diminishing scientific knowledge base, relative to the mass of advancing scientific knowledge and a desire for simple answers to complex questions. Add to this some major ethical breakdowns by all three partners, and it is becoming clear that the public expects more accountability for those who manage science.

Public concerns have a basis in facts and events. Academic medicine is under intense economic pressure that may lead to an increased focus on revenue generation at the expense of its research and education missions. Scandals-from Medicare fraud to conflict of interest-have added to the erosion of public confidence. In several widely publicized cases, the pharmaceutical industry has withdrawn drugs following adverse events, some of which may have been avoided. The industry is also experiencing a prolonged drought of innovative drug development. Government is viewed as overly bureaucratic, slow to respond and not up to the task of protecting the public. In the face of these pressures, however, it is vital that the partnership remains strong and grows effectively to ensure medical innovations.

How do we manage biomedical science so that the real "owners," the public, are assured of a good return on their investment? How do we overcome growing public concerns that hinder a more effective partnership? Although clear policies, contracts and regulations are important ingredients, I believe the critical component lies in the relationship between the three partners and the transparency of those relationships. Key components of a principled relationship between the partners should include:

• An agreement to work together through a social contract.
• A clear definition of individual missions and how a balance can be achieved that takes into account what is best for the public versus what is best for only one of the partners.
• Clarity and consistency of internal processes in academic medicine and industry to provide transparency to the government.
• An agreement to promote transparency through open communication with the media.

By following these principles the partners most responsible for medical innovation can begin to restore the public trust and smooth the path to the application of scientific discovery in improving health.

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