A conflict of interest (COI) occurs when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in another.
Technology Incubators / Academic ties between physicians or medical researchers and pharmaceutical, medical device, and biotechnology companies can benefit society – most notably by promoting the discovery and development of new medications and medical devices that improve individual and public health. However some of these financial interests have raised concern about conflicts of interest which may present the risk of undue influence on professional judgments and thereby may jeopardize the integrity of scientific investigations, the objectivity of medical education, the quality of patient care, and the public’s trust in clinical trials and medicine.
The risk is that these conflicts could adversely affect the quality of research, possibly harming human subjects and anyone who relies on the research, including patients. It is difficult to prove that financial interests have caused researchers or their institutions to waiver in their commitment to producing quality studies, and there is considerable disagreement over which financial interests might inappropriately influence whom and under what circumstances. But studies of academic biomedical researchers have found troubling correlations between financial relationships with industry and problems with research, including a tendency to produce pro-sponsor results, increased secrecy, and poor study design.
Studies suggested that financial interests between academic researchers and industry are common, and are correlated with both results that favor sponsors and increased secrecy—scientists refusing to share data with colleagues, withholding negative data from publication, and delaying publication of research results.
Few examples:
- A 2007 survey found that nearly 60% of respondents had personal relationships with industry.
- A 2003 review article, found studies suggesting that between 23% and 28% of academic investigators received research funding from industry, over 40% received research-related gifts, and about 33% had personal financial ties with industry sponsors.
- A 1999 survey conducted by the Association of University Technology Managers, found that 68% of academic research institutions held equity in companies that in turn sponsored research there.
History of research ethics already witnessed two most outrageous studies where conflicts of interest in research caused suffering and loss of life: the Tuskegee Study of Syphilis in the Negro Male (1932-1972) and the Willowbrook Hepatitis Studies (1963-1966). Even though recent studies uncover “strong and consistent evidence” that industry-sponsored research tends to draw conclusions favoring industry, often uses an inactive control, and sometimes administers a higher dose of the sponsor’s drug than of the comparison drugs or uses comparison drugs that are poorly absorbed. Industry sponsorship of research, as well as involvement with start-up companies and other commercial relationships, were significantly associated with delaying publication or withholding data.
Academic researchers may also have a strong reluctance to give their time, expertise, or resources – including inventions – to industry without being compensated, even if compensation risks creating a conflict of interest. In 2005 one commentator proposed a principle of “no conflict, no interest” in NEJM, according to which a financial stake increases an individual’s commitment to a project and, therefore, its chances of success. This attitude may also reflect a belief that it is unfair to prevent individuals from profiting from their effort and that restrictions are intrusions on privacy and freedom of association.
Society traditionally has placed great trust in physicians and researchers and protecting the rights and well-being of the research subjects remains the most important duty. The Helsinki Declaration 1 (principle 6) and various other ethics guidelines clearly recognize this. The obligation does not necessarily clash with researchers’ commitment to conduct good research. Very often patients do better when enrolled in a clinical trial. Yet, research also involves risks. It exposes patients to unknown side effects and to the risk of receiving inferior therapies. When the interests of subjects and the interests of research collide, the obligation toward subjects must takes priority.
Campbell EG, Weissman JS, Ehringhaus S, Rao SR, Moy B, Feibelmann S, & Goold SD (2007). Institutional academic industry relationships. JAMA : the journal of the American Medical Association, 298 (15), 1779-86 PMID: 17940234
Campbell EG, Rao SR, DesRoches CM, Iezzoni LI, Vogeli C, Bolcic-Jankovic D, & Miralles PD (2010). Physician professionalism and changes in physician-industry relationships from 2004 to 2009. Archives of internal medicine, 170 (20), 1820-6 PMID: 21059976
Brockway LM, Furcht LT, & FASEB (2006). Conflicts of interest in biomedical research–the FASEB guidelines. FASEB journal : official publication of the Federation of American Societies for Experimental Biology, 20 (14), 2435-8 PMID: 17142792
For More Information: www.iom.edu/conflictofinterest
Dr. Michael Ward commented (comment on http://goo.gl/O9TmHO)
I would almost suggest that you are scare-mongering with this suggestion of tainted research. I would not deny that research bias and research fraud exits. It is not exclusive to industry though. I have personally witnessed a researcher in an North Carolina academic center who fabricated all his animal data in what were deemed to be critical and important cancer findings.Though I do not dispute that under the table influences exist, it is nowhere near to the degree your reference implies. First, all the references provided were old and they were pre-Health Care Compliance (HCC) laws that are enforced today. Industry is scrutinized right down to the pens and key chains that are given to all Health Care Providers (HCPs). I would suggest that violation of these laws comes with harsh penalties and companies are obliged to provide annual reports to state and federal agencies of all the “gifts” they have given HCPs.As one involved in clinical research, I do know that all payments to a hospital for industry-sponsored studies is limited to functions and responsibilities and no more. And, these payments are very transparent. Relationships between physicians and industry are also well documented through financial disclosures given at public presentations or in publications or in industry-sponsored studies. Every employee in industry, regardless of job title, is required to take and pass a training on HCC-related topics as well as other illegal financial transactions, such as bribery and fraud. FDA inspections include checking the training records of industry employees.I admit that training does not guarantee compliance in all cases, no more than a law or medical student passing a course in ethics assures future ethical behavior. But, the combination of training, required annual reporting, and government scrutiny make it very difficult to assure investigator bias through gifts of any kind.We have come a long way from the days (1980s) where I witnessed a well-regarded g-I surgeon asking for and receiving $1 million annually from each company with a presence in the clinical nutrition market for “research purposes”. The money was essentially in exchange for testimonials. Public ethics and compliance with laws will always be present. But I submit it will not be in the manner to which your referenced article alludes.
Dear Dr. Ward
I do agree with the facts that rule and regulations are now stringent and transparent “if only when seen through the Americanised FDA lenses”. However, looking though generic glass most of the clinical trial in developing countries suffer with medical imperialism. Regions like South America and South and South East Asia where most of the clinical trial thrives with less stringent policies and law.
Recently (on 16 Sept 2013), Ministry of Health and Family Affair, Gov of India, constituted a expert panel to reform drug regulations and clinical trials, so from here it’s seems like a long road to develop something substantial like FDA / NIH. There are many loop holes and pitfalls in the system of developing countries.
Research seems to be a luxury not necessity in third world countries, among several factors: poor institutional organisation, lack of funding through government bodies, unpredictable career structure may drive researchers to lucrative clinical trials.
And as you said, still there are retraction in account for falsified data, I consider that is a breach of trust. Patient got worse but data shows significant improvement ? Though personal experience, I would like to mention that many of the investigators / physicians don’t really inform the subjects about the potential risk vs benefits of the drugs. Not all but many drug trial don’t consider the facts like 1. Is the disease is similar in different countries 2. Is the trial relevant to the country: eg. Are the risk factors the same, is treatment relevant and are the outcomes approx the same ?
I don’t imply that, ties between industry and academia are bad, but I want to point out the fact that conflict of interest should not cloud the outcomes which aims toward the advancement of technology and patients care.