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October 2011
Core Principles Concerning
Corporate Funding for tobacco, Nicotine, and Alternative Product
Harm Reduction Research
A product of the
University of Virginia/Institute for Environmental Negotiation
Forum for a Civil Dialogue on tobacco, Nicotine and Alternative Product Harm Reduction*
Held March 14-15, 2011
Corporate Funding for tobacco, Nicotine, and Alternative Product
Harm Reduction Research
A product of the
University of Virginia/Institute for Environmental Negotiation
Forum for a Civil Dialogue on tobacco, Nicotine and Alternative Product Harm Reduction*
Held March 14-15, 2011
In spite of the fact that 'harm reduction' is practiced in many areas of our society, the issue of tobacco, nicotine and alternative products harm reduction remains to date guided more by emotion, rhetoric and past history than by good science.
Accordingly, in an effort to reduce disease and death caused by the use of tobacco products, we call upon corporations, public health and other organizations, academic institutions, researchers, producers, and policy makers to embrace, support, adopt, and in some cases implement the following principles concerning the scientific research, development and marketing of reduced risk tobacco, nicotine and alternatives products. These principles are being recommended in part as a guide for academic institutions and others who may choose to accept corporate funding and who recognize that the advent of governmental regulation has changed the environment of research and policy. These principles are meant to serve as a basis for further dialogue and discussion on a number of levels.
We recognize that various academic institutions may use their prerogative to accept or not to accept certain types of corporate funding. Such decisions should be respected.
Therefore, be it resolved:
- That it is recognized and accepted that it should be a shared goal (both domestically and internationally) to reduce disease and death caused by the use of tobacco. In addition to well-established strategies of preventing initiation of tobacco use by young people and helping those who want to quit smoking, this also includes supporting the research, development, responsible labeling, and marketing of significantly lower risk, scientifically verified, tobacco, nicotine and alternative products;
- That science should be used to assist a regulatory body in setting the standards on how a spectrum of low risk products should be labeled, sold and marketed. Such standards of science (which would and should be multi-tiered) should seek to set labeling and marketing requirements based on the risks, relative risks and intended uses of the various products;
- That an independent third party regulatory authority such as the Food and Drug Administration is essential for overseeing and setting fair, workable, and effective regulations designed to achieved the goals of the first bulleted principle. Under such authority it will be the manufacturer of the reduced risk product who bears the primary responsibility to submit to the agency the necessary data and scientific evidence to support the approval of a product, whether the research is internally or externally conducted;
- That academic research institutions have in place and promote publicly available conflict of interest policies that prevent or limit the funder, the research institution and the researcher from misusing or distorting the purposes for which the funds for the research have been allocated; that the research have a public health benefit and objective; that the principle investigator and/or academic research institution retain a reasonable, but limited time period of control over the time, place and manner of the publication of the research (after which patent rights etc. can be sought); that the funding of a research project be determined following an independent peer-reviewed process that includes internal scientists; that contact between the researcher and the funder is monitored; that the research institution receiving the funding is not portrayed as approving or endorsing any method, procedure, or product developed by the funder;
- That, recognizing constraints involving proprietary information and trade secrets, entities which provide harm reduction research funding to the private sector (including pubic sector academic research institutions) do so transparently and in such a way as to ensure the independence and integrity of the research; its further is recommended that each institution accepting such funding consider forming a board to oversee the research and assure that the work was conducted entirely independently without unwarranted input from the funder;**
- That manufacturers of conventional combustible products be given incentives (as recommended by the Institute of Medicine, in its landmark report, Clearing the Smoke) to develop science based, consumer acceptable, lower risk tobacco, nicotine and alternative products. As the marketplace changes and realigns itself towards allowing science- based significantly lower risk products into the market place, companies should simultaneously make both short term and long term demonstrable commitments to reducing the production and marketing of higher risk products such as conventional combustible products;
- That an independent tobacco, nicotine and alternative products clearing house be established that will give researchers, manufacturers, public health organizations, policy makers, medical professionals, regulators, the media, academic journals, the public, and others access to information about tobacco, nicotine and alternative products harm reduction, designed to assist them in the development of policies, stimulate civil discussion, and identify potential areas for new research etc. Such functions might also include monitoring both domestic and international research funding activities related to lower risk tobacco, nicotine and alternative products;
- That consideration should be given to the development of models that can be used by research institutions to establish the necessary safeguards that will ensure the highest integrity of the research being conducted;
- That corporate research funding is not the only source of potential funding for research on reduced risk products but that other sources such as Master Settlement funds, users fees, and governmental funding be considered as well;
- That all interested parties, stakeholders, policy makers and experts should strive to enhance scientific knowledge, to promote open and reasoned dialogue that address differences and conflict directly, to provide greater understanding, to resolve the inevitable conflicts that will arise from this new regulatory environment, and to seek solutions that achieve stated goals and objectives for reducing the disease and death caused by use of tobacco products.
** As was noted in the Summary Notes from the March 2011 meeting from which these Core Principles have been developed, it was pointed out that there were three areas of research to take into account: 1. basic research 2. applied research and 3. research submitted to regulators in support of specific products and their claims. For (2) it was suggested that this would likely involve IPR which will potentially restrict wider oversight and transparency (at least initially) and that (3) would be the primary responsibility of the manufacturer although independent research (e.g. additional post market surveillance, product analysis, consumer behavior etc.) could (and probably should be) conducted by independent third parties post launch.
* * * *
* These Core Principles were developed following a civil dialogue sponsored by the University of Virginia's Institute for Environmental Negotiation held March 14-15 at a retreat site (Morven) just outside of Charlottesville, Virginia. The meeting which consisted of approximately 20 individuals with diverse backgrounds and perspectives, was held to determine whether and how corporate funding (particularly tobacco industry funding) could be managed with appropriate safeguards in a rapidly changing regulatory environment. These Core Principles are not intended to necessarily represent the views or positions of any individual or their organization but instead serve as the basis for continuing dialogue and discussion. Copies of the Dialogue's Summary Notes can also be obtained by contacting Frank Dukes (Director), ed7k@virginia.edu), or Tanya Denckla Cobb (Associate Director), td6n@virginia.edu of the Institute for Environmental Negotiation, or Scott Ballin (Project Advisor) at ScDBa@aol.com .
The participants*** in the dialogue, all who came as individuals included: Karl Fagerstrom, David Sweanor, Jed Rose, Richard Bonnie, Delon Human, Brad Radu, Thomas Eissenberg, David Smith, Richard Tubb, Jim Solyst, Patricia M. Terekerz, David O'Reilly, Michael Falk, Todd Walker, Susan Winckler, Curtis Wright, Alex Hearn, Jeff Walker, Frank Dukes, Tanya Denckla Cobb, Scott Ballin
*** RobertO'Keefe, Cheryl Healton and Abby Dilly had committed to attend but had unexpected unavoidable conflicts.
