Conflicts of Interest: A Framework of Empowerment

In a framework designed to highlight bias, conflicts of interest, and promote transparency around the reflexivity inherent in some research, some conflicts of interest can be managed while others should be avoided. The fundamental issues and analysis surround who holds power and how the consumer of health-related goods and services can empower themselves and harness the tools of deliberative democracy and courts to level the playing field by highlighting and resolving conflicts. Recognizing the people whose health, well-being, or rights are affected or could be affected by the conflict are the stakeholders whose stake is generally bodily or personal, and secondarily financial. The stake of the corporation or government varies, is not bodily, and is usually foremost financial, making ethical claims arguably weaker. Both the degree and the type of stake matter.

Research and Clinical Care Financial Conflicts of Interest

Shutting down every financial relationship for the inherent conflict could have ancillary problematic results. Some research would not be performed if not for the collaboration between clinicians, researchers, and pharmaceutical companies. Sometimes disclosure could be enough. In other circumstances, disclosing a large profit motive only serves to highlight the conflict.

The research itself and the sanctity of the data is always going to be challenged or disputed when a financial interest exists. Independent research would be the best solution but in the research landscape, partnerships are becoming more prevalent. Disclosure is not always enough and is unlikely to foster additional public trust. Examples of fraud or cover-ups like Vioxx or Purdue Pharma’s opioid research are heavily publicized yet most pharmaceutical research is valid. It becomes difficult to argue for disentanglement if innovation were stifled. Measuring public distrust of pharmaceutical research is also difficult with so many consumers of pharmaceuticals who maintain their trust and need medications. Those lacking trust in the data are generally welcome to avoid pharmaceutical products with exceptions like vaccination requirements. Building public trust would help so that public health authorities interact with more respect and integrity in their advocating or requiring vaccination.

Conflicts of interest at the doctor-patient level that spring from relationships to pharmaceutical companies can be approached many ways. The upstream considerations include the role of large academic medical centers. I am not convinced that having doctors do both research and clinical care is beneficial to the person seeking care. Yet the systems grew and there is now a prevailing pattern of doctors who have a lab as well. As researchers, they collaborate directly with pharmaceutical companies or medical device manufacturers. (The ACA promoted transparency by reporting requirements when accepting anything ($10 or more) from manufacturers of most drugs, biological agents, medical devices, or supplies.)

Financial conflicts of interest when a clinician recommends a pharmaceutical brand or product is an ongoing concern, especially because disclosure of the relationship is the general requirement but might not be enough. Ways to assess financial interests and how the investment might grow help evaluate the enormity of the conflict. (A little stock in a company or payment for a speaking engagement is different from a lot of stock in a company whose drug sales are likely to take off.)

Hospitals as a Business; Fee for Service Physicians

Within the care structure, conflicts of interest can arise at many levels. The hospital inherently has a conflict due to its desire to provide care and operate as a business. Should they discharge a person if the same bed is needed for a more expensive person? These conflicts seem like distant hypotheticals in the current ethics landscape, and are an on-the-ground concern that must be handled personally (physician’s moral code), locally, and rigorously.

Hospital Ethics Committees and Mediators

Conflicts of interest are inherent in ethics committee and patient representatives. There are not policies requiring ethics boards to be comprised of only non-employees or to be majority non-scientists. All people have a stake in ethics regardless of education, background, or specific degrees. Overvaluing the stature of doctors, the dual degree in public health, or an MD with an MS in bioethics can undermine the value of simply the voice of the patient, the parent, the surrogate, the social workers, and lawyers who also sit on ethics committees. A medicalized viewpoint can be prevalent. Ethics serves as a check on the power of some professionals. The asymmetry in medical knowledge should not drown out other valuable opinions.

Inhouse mediators are avoidable and should be managed by a model that prohibits the conflict of interest. Outside independent mediators may be helpful as long as mediation is entered freely by both parties.

Fear of Liability

The role that protection from potential liability plays in person-centered care and autonomy creates an inherent conflict sometimes, especially when the person disagrees with a doctor about the choice of care. If the lingering issue of whether the doctor will be held responsible for not giving the treatment that was refused, the doctor’s interest in protection from liability can obscure clinical judgment.

Government Conflicts

In some areas, it would be easy to eliminate conflicts, for example, by not allowing those who work for universities that profit from medical research to sit on the Presidential Commission or other seemingly unbiased organizations meant to promote ethics. There are conflicts at every level of government. In the United States, many elected representatives hold pharmaceutical and medical device stock. The revolving door between industry and government causes constant conflict, especially when the government agency has a role in industry oversight. A prohibition on government or upstream conflicts would be easily achieved with the political will to do so.

There are policies that were intended to create a check on pharmaceutical industry projects seeded by NIH funding.  The safety nets like march-in rights (that would take away the patent holder’s exclusivity) and other fair price initiatives have not really been used. (See Zimmerman, below). The pure financial incentives of pharmaceutical corporations conflicts with the government role in incentivizing affordable solutions. The financial interests align if enough people in Congress own stock, and that leads to the more serious conflict of interest: in neoliberal society, government could be more aligned with corporate interests than with individuals’ interests when the two conflict. 

Other Applications

The framework of empowerment to address conflict of interest applies to corporate behaviors that affect health. For example, nutrition research is often financed by food manufacturers or sellers and the policies surrounding food are influenced by lobbyists. Corporate free speech allows advertising of pharmaceuticals, giving power to corporations that refutes consumer empowerment.

Non-Financial Conflicts of Interest

A doctor’s personal ambitions (like wanting to become famous for a novel approach or having a medical risk reward threshold that differs from the standard) or religious beliefs may compete with what is best for the person receiving care. Subtle biases may also stem from receiving gifts even when a physicians sees themselves as unswayable and the gift is not of much value.

The Framework

A person-, consumer-, or population-centered empowerment approach to conflicts of interest covers broad considerations. First, the ethically required and best practice should put the person receiving care first and act in that person’s interest. The responsibility stems from old oaths, philosophical notions of doing the right thing for someone in need, altruism, and that the moral goods associated with medical care run to the patient. The landscape has changed with increasing financial complexity and an open door to relationships with pharma, etc. Legal changes encouraged relationships that drive innovation, but come with the risk of abuse of position or power. Doing the right thing has become increasingly challenging because now it is a weighing process where generating data by encouraging use of a drug can be a public good, arguably (to some) justifying some financial gain for the physician, researchers, and company. Second, trust and integrity run from the patient to the doctor, clinicians, and the system. There is a give and take where the system of big medicine must be trustworthy.

Anne Zimmerman, “Who really funds early pharmaceutical research? Taxpayers, and they deserve fairness in both pricing and policy,” Zimmerman, A., Unpublished Report, 2019. WhoReallyFundsPharma

Patient Outcomes Research Teams (PORTS): Managing Conflict of Interest (1991) Chapter: 5 Managing Conflicts of Interest: General Models and Approaches, page 61. Managing Conflicts of Interest Article

Matt Lamkin, “Conflicts of Interest at the President’s Bioethics Commission,”
December 20, 2011, Law and Biosciences Blog, Stanford Law School Lamkin Article (concerns who was on the commission and their conflicts in objectively contributing to the commission’s report on research subjects)

Josephine Johnston, “Conflict of Interest in Biomedical Research,” Bioethics Briefings, The Hastings Center, September 21,  2015 Johnston Article (Overview of conflicts of interest)

Christopher Mayes, Ian Kerridge, Roojin Habibi & Wendy Lipworth (2016) Conflicts of interest in neoliberal times: perspectives of Australian medical students, Health Sociology Review, 25:3, 256-271, DOI: Conflicts of Interest in Neoliberal Times

DuBois JM, Kraus EM, Mikulec AA, Cruz-Flores S, Bakanas E. A humble task: restoring virtue in an age of conflicted interests. Acad Med. 2013 Jul;88(7):924-8. A Humble Task

Brody H. Professional medical organizations and commercial conflicts of interest: ethical issues. Ann Fam Med. 2010 Jul-Aug;8(4):354-8.  Brody Article  (Coca-Cola corporate donation to fund obesity research and other commercial conflicts.)

Greenberg RD. Conflicts of Interest: can a physician serve two masters? Clin Dermatol. 2012 Mar-Apr;30(2):160-73. PMID: 22330659.  Greenberg Article (regulation vs improved physician ethics)

Schofferman J. The medical-industrial complex, professional medical associations, and continuing medical education. Pain Med. 2011 Dec;12(12):1713-9. doi: 10.1111/j.1526-4637.2011.01282.x. Epub 2011 Dec 6. PMID: 22145759.The Medical Industrial Complex

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