PerspectivesAre you interested in submitting a Perspective Article? Be sure to read The Science Advisory Board's Editorial Guides for Perspective Articles. Click here. NIH Rules by Wim D’Haeze, Ph.D. In the beginning of February 2005, the Department of Health and Human Services and the Office of Government Ethics launched the adjusted and new restrictive ethics rules applicable to all approximately 17,000 employees of the National Institutes of Health (NIH), one of the country’s largest intramural biomedial research institutions and extramural funding organizations. So far, the new amendments initiated substantial worry and controversy among the NIH employees and scientists, and lead to major organizational changes within the NIH with presumably more to come in the near future. Briefly, the new ethics rules prohibit NIH employees from engaging in activities of conflicting interest with organizations that include pharmaceutical and biotechnology companies. Activities such as compensated or uncompensated employment (e.g. consulting and scientific and other board service) with affected organizations such as pharmaceutical or biotechnology companies, supported research institutions, health care providers and insurers, and similar professional organizations; compensated teaching, speaking, writing or editing for the above mentioned organizations; and self-employed business activities that involve the sale or promotion of products or services of those organizations. Thus, the new regulations basically prohibit consulting by NIH employees with pharmaceutical, biotechnology, and other companies involved in the research, development, or manufacture of medical devices, equipment, treatments, preparations, or product, grantee institutions, health care providers and insurers, and related trade, professional and similar organizations. Ongoing activities should be disrupted within a period of 30 days of the date on which the regulations became effective unless an extension granted by the NIH has been obtained. Receiving compensations for teaching, speaking, writing and editing is still allowed, but only if the compensation is meant to cover the expenses. Teaching a course at a university is still possible if the course is part of the established curriculum of an institution of higher education and prior approval by the NIH has been obtained. Furthermore, the new ethics rules prohibit NIH employees from owning stocks in pharmaceutical and biotechnology companies. In case the individual files a public or confidential financial disclosure, the filer together with spouse and children, must not own stocks in the type of companies mentioned above. In case the person is a non-filer, it is allowed to own a combined total of up to $15,000 in stock in any such company. As non-senior employee, it is not allowed anymore to accept gifts or awards with a value of more than $200. Soon after the new NIH rules were made available to the public, an assembly of prominent NIH researchers formulated a response requiring changes to make the regulations less stringent. After careful consideration, the assembly of scientists came to the conclusion that the regulations will severely and irreparably compromise the mission of the NIH. The new rules are thought to discourage talented, innovative scientists from remaining at or being recruited to the NIH and preclude scientists already at the NIH from participating as full members of the scientific community. The rules are overbroad and will make fruitful collaborations impossible since they do not only apply to pharmaceutical and biotechnology companies but also to a larger variety of scientific organizations including institutions of higher education. The new restrictions may deliberately inhibit the exchange of ideas and thoughts between scientists at NIH and researchers at other professional organizations. In addition, the prohibition of holding major stocks by any NIH employee, including those who have no decision making authority for grants or funding and their families, may cause unexpected but detrimental financial impacts. And, if the NIH will fulfill its newly chosen responsibilities in a proper manner, additional employees will need to be appointed to figure out whether all employees obey the rules which will undoubtedly increase the administrative burden and initiate extra costs that will significantly weigh on the annual NIH budget. As of shortly after the new regulations became effective, pressure continued to build on the NIH, not only by the assembly of scientist, NIH employees, and senators wording their protest and concerns, but also because of recent decisions made by forefront (NIH) scientists. A couple of prominent NIH scientists have decided to retire or leave the organization because of the introduction of the stringent regulations. One individual appointed to become a director of a major institute within the NIH has postponed his plans. It is expected that more withdrawals as those mentioned above may appear and, besides the fact that the reputation of the NIH became badly sullied during the past year because of embarrassing revelations about conflicts of interest among NIH scientists, the current situation created by launching the new ethics regulations is also rather demanding for the impeccable reputation of the NIH. In my point of view, it is totally understandable that the NIH as one of the major governmental scientific organizations wishes to protect itself by adding more restrictive rules to its repertoire. It is pivotal for the well-functioning of the NIH to avoid that knowledge and experience generated within the NIH is transferred to for instance pharmaceutical and biotechnology companies as part of relatively cheap deals (some consulting or advisory board member fees) and that, as a consequence, tens (or maybe hundreds?) of NIH employees enrich themselves with outrageous consulting fees as high as tens of thousands of dollars within a few years. For sure, most pharmaceutical and biotechnology companies are even better encapsulated by even more stringent regulations to prevent the leakage of valuable information. However, the NIH rule makers may not ignore the fact that it is just important for the NIH as well as for its senior scientists and researchers to serve as members of scientific advisory boards of companies or other research institutions, to engage in collaborations with other laboratories (within an academic or industrial setting), and to provide answers to tough biological questions that cannot be dealt with within for instance a particular pharmaceutical company. In addition, there will always be a dichotomy in the way academic scientists and industry scientists think and perform their research. The former have commonly more time and freedom to pursue open-ended questions whereas the latter are often forced to pursue proof-of-concept studies using validated methodologies within a tight timeline. On the one hand, academic pursuits can provide drug companies with unconventional solutions in areas of research where not much is known; on the other hand, the discipline and urgency demanded by industry may help to structure the research environment in academia. Thus, those interactions broaden the scientist’s knowledge and polish their professional performance which is mutual beneficial, also for the NIH as an institution. Furthermore, the main goal of most, if not all, fundamental biomedical research performed in an academic setting is to contribute to our understanding of processes and pathways in humans and to unravel molecular mechanisms that lead to disease to eventually engineer drugs that are commercially available to all of us. Consequently, links with pharmaceutical and biotechnology companies are not only inevitable but also needed. And what about the stock options? Is it really cumbersome for an organization as the NIH that a scientist has a $30K stock in a pharmaceutical company? The latter does not necessarily imply that the scientist is going to influence the company in any way, provide scientific information to the company which should not be provided, or be prejudiced for the interpretation of his own research. Maybe the scientist does welcome the extra income to his relatively low NIH salary in order to run a family while living in one of the major US cities where living is expensive. As of to date, the new NIH regulations are operational and have led to the departure of prominent NIH scientists, to withdrawals of new scientists’ candidature to start serving the NIH, and in addition many NIH employees are grumping. Obviously, ethics regulations are required to protect the NIH, foster public trust and promote the NIH scientific missions. Nevertheless, the NIH should have conducted an in-depth survey among all levels of employees in order to obtain a strong basis for rule making. An NIH-independent external committee should have previewed the regulations before making them available to the public. In my opinion, consulting for a company, acting as a member of a company’s advisory board, or collaborating with research groups at universities and/or pharmaceutical or biotechnology companies are most often healthy and fruitful practices. However, one must not ignore that the experiences and knowledge required to do so are, at least in part, obtained while employed by the NIH, and thus, it is not at all unreasonable to inquire to report about consulting, advisory board memberships, collaborations and other related activities to a specialized NIH committee, and to share the benefits if applicable (e.g. a consultant fee) with the NIH as an organization. This may not only diminish the taste of competition of today’s scientific research but may also lead to more fruitful and stronger collaborations between academia and industry which will be mutual beneficial for the NIH and its employees, researchers within a pharmaceutical or biotechnology company, and the patients. ### Wim D’Haeze is Bio-Engineer in Chemistry and received his Ph.D. in Biotechnology at the Ghent University (Belgium) in June 2001. His doctoral thesis work was focused on the understanding of several early steps of the symbiotic interaction between the Gram-negative soil bacterium Azorhizobium caulinodans and the tropical legume Sesbania rostrata. The initial steps require the production of bacterial compounds including signal molecules and complex surface polysaccharides, that are pivotal for invasion of the plant tissue and the formation of new organ tissues. In the three subsequent years, he performed post-doctoral research at the Complex Carbohydrate Research Center at the University of Georgia (Athens, GA) dealing in part with the structural and functional characterization of azorhizobial extracellular polysaccharides. Currently, Wim D’Haeze is employed at The Scripps Research Institute (La Jolla, CA) as Science Writer and focuses on a new horizon regarding the molecular basis of devastative neurodegenerative diseases, such as Alzheimer’s and Parkinson’s diseases, in order to screen for and develop new therapeutics. He has been a member of the Science Advisory Board since November 2002. E-mail: wim.dhaeze@sbcglobal.net ### << Previous Next >> [ View All Perspectives ] |
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