Selected resources from The Hastings Center.

Bioethics Briefings:

Conflicts of Interest in Biomedical Research and Clinical Practice

Financial relationships can create conflicts of interest between researchers’ obligations to abide by scientific and ethical principles and their desire for financial gain. The Bayh-Dole Act of 1980, which encourages technology transfer from universities to industry, has facilitated financial relationships between academic biomedical researchers and the biotechnology industry. Studies have found conflicts of interest correlate with results benefiting sponsors, poor study design, withholding negative data from publication, and other problems. Read our briefing to consider: How should financial conflicts of interest by addressed, managed, and regulated?

From Hastings Bioethics Forum:

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  #MeToo and Health Research Ethics
  As a public health researcher interested in brain injuries in sports, I was searching for peer-reviewed literature that examined cultural pressures that cause athletes to…
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  Let the Sun Shine into the Medical Ivory Tower
  In 2012, I coauthored a case report about the successful use of dietary supplements in treating a case of male infertility in the American Family…
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  Rounding Up Scientific Journals
  Scientific journal publishing reached a low point in November, when the journal Food and Chemical Toxicology retracted a study by Gilles-Eric Séralini and colleagues at Caen University in…
• U.K.’s Landmark Case on Withholding Treatment Affirms the Importance of Patients’ Values
  Family Lose Right-to-Life Case at U.K.’s Highest Court.” “Judges ‘Right’ to Allow Man to Die.” “Widow Loses ‘Withdrawn Treatment’ Case.” These were the headlines on…
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  Getting By with a Little Help from Your Friends
  If the mutilated body of one of your research subjects is discovered in a blood-soaked bathroom, who should investigate the death?  If you want to…
• Shame and Guilt in Minnesota
  Over the past month, a petition asking the governor of Minnesota to investigate a research scandal at the University of Minnesota has been steadily gathering momentum.  The…
• Walk it Off, Crybaby
  On a recent installment of This American Life, Ira Glass asks this pressing question. Why are rich and powerful people so often the world’s biggest…

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From Hastings Center Report:

Financial Conflicts of Interest at FDA Drug Advisory Committee Meetings

First published: 28 March 2018

Abstract

The U.S. Food and Drug Administration’s drug advisory committees provide expert assessments of the safety and efficacy of new therapies considered for approval. A committee hears from a variety of speakers, from six groups, including voting members of the committee, FDA staff members, employees of the pharmaceutical company seeking approval of a therapy, patient and consumer representatives, expert speakers invited by the company, and public participants. The committees convene at the request of the FDA when the risks and harms of novel products are not immediately clear, and their final decisions carry significant weight, as most therapies that receive advisory committee approval are subsequently approved by the FDA. In recent years, across a series of diverse publications, the financial conflicts of interest of each category of participants in the meetings have been investigated. Here, we summarize these findings and their ethical implications, focusing on the FDA Oncologic Drugs Advisory Committee, and we suggest ways to move toward more transparent and impartial advisory committee meetings.

Closed Financial Loops: When They Happen in Government, They’re Called Corruption; in Medicine, They’re Just a Footnote

First published: 24 May 2017

Abstract

Many physicians are involved in relationships that create tension between a physician’s duty to work in her patients’ best interest at all times and her financial arrangement with a third party, most often a pharmaceutical manufacturer, whose primary goal is maximizing sales or profit. Despite the prevalence of this threat, in the United States and globally, the most common reaction to conflicts of interest in medicine is timid acceptance. There are few calls for conflicts of interest to be banned, and, to our knowledge, no one calls for conflicted practitioners to be reprimanded. Contrast our attitudes in medicine with public attitudes toward financial conflicts among government employees. When enforcement of rules against conflict of interest slackens in the public sector, news organizations investigate and publish their criticism. Yet even when doctors are quoted in the media promoting specific drugs, their personal financial ties to the drug maker are rarely mentioned. Policies for governmental employees are strict, condemnation is strong, and criminal statutes exist (allowing for corruption charges). Yet the evidence that conflict is problematic is, if anything, stronger in medicine than in the public sector. Policies against conflicts of interest in medicine should be at least as strong as those already existing in the public sector.

Implicit Cognition and Gifts: How Does social Psychology help Us Think Differently about Medical Practice?

First published: 06 May 2016

Abstract

This article takes the following two assumptions for granted: first, that gifts influence physicians and, second, that the influences gifts have on physicians may be harmful for patients. These assumptions are common in the applied ethics literature, and they prompt an obvious practical question, namely, what is the best way to mitigate the negative effects? We examine the negative effects of gift giving in depth, considering how the influence occurs, and we assert that the ethical debate surrounding gift-giving practices must be reoriented. Our main claim is that the failure of recent policies addressing gift giving can be traced to a misunderstanding of what psychological mechanisms are most likely to underpin physicians’ biased behavior as a result of interaction with the medical industry. The problem with gift giving is largely not a matter of malicious or consciously self-interested behavior, but of well-intentioned actions on the part of physicians that are nonetheless perniciously infected by the presence of the medical industry.

Substantiating this claim will involve elaboration on two points. First, we will retrace the history of policies regarding gift giving between the medical profession and the medical industry and highlight how most policies assume a rationalistic view of moral agency. Reliance on this view of agency is best illustrated by past attempts to address gift giving in terms of conflicts of interest. Second, we will introduce and motivate an alternate view of moral agency emerging from recent literature in social psychology on implicit social cognition. We will show that proper consideration of implicit social cognition paints a picture of human psychology at odds with the rationalistic model assumed in discussions of COIs. With these two pieces on the table we will be able to show that, without fully appreciating the social-psychological mechanisms (both cognitive and affective) of implicit cognition, policy-makers are likely to overlook significant aspects of how gifts influence doctors.

Sea Change on Financial Conflicts of Interest in Health Care?

First published: May 2009

Abstract

For the last quarter century, members of the medical and scientific communities have detailed the corrosive influence of industry payments to clinicians and biomedical scientists. Groundbreaking studies have repeatedly revealed how drug company gift-giving influences prescribing practices, how corporate sponsorship biases research, and how compensation from industry leads people to suppress research results, downplay harmful side effects, and put their name on papers to which they have made little or no contribution. Since none of this influence could occur without the participation of the health care providers and scientists themselves, professional bodies—including academic institutions, journals, and professional societies—have placed certain conditions on relationships with industry. One of these is that individuals don’t get to keep these financial relationships secret.

Clinical Ethics Consulting and Conflict of Interest Structurally Intertwined

First published: March 2007

Abstract

Clinical ethical consultants are subject to an unavoidable conflict of interest. Their work requires that they be independent, but incentives attached to their role chip relentlessly at independence. This that they be independent, is a problem without any solution, but it can at least be ameliorated through careful management.

The Curious Saga of Congress, the NIH, and Conflict of Interest

First published: March 2005

Abstract

Depending on who you read, either the campus of the National Institutes of Health will soon be a ghost town as staff flee in the great Bethesda brain drain of’ 05, or Congress is finally teaching the research cowboys a lesson in respect for the American public. Lost in most analysis of the NIH’s new conflict of interest rules, though, is an instructive story about how policy (at least sometimes) takes shape.

Conflicts of Interest at the NIH: No Easy Solution

First published: January 2005

Abstract

On February 2, 2005, the National Institutes of Health changed course on conflicts of interest and prohibited its scientists from owning stock in or working as consultants with pharmaceutical or biotechnology companies. The following essay, sent to press before the new policy was announced, recommends a very different approach. The author stands by the recommendations.

Piercing the Veil of Corporate Secrecy about Clinical Trials

First published: September 2004

Abstract

In the last three decades, the pharmaceutical and biotechnology industry has burgeoned into one of the most profitable industries. With profit has come power. Backed by unprecedented financial means and pressured by stockholders’ demand for investment returns, pharmaceutical companies have taken a much larger stake in all stages of medical research. Corporate contributions to research and development in academia have risen by 875 percent between 1980 and 2000.¹ Over this time, the industry has extended its influence into all aspects of the process of creating and regulating scientific knowledge and health care products.

Bioethics, Conflicts of Interest, the Limits of Transparency

First published: July 2003

Abstract

The movement in bioethics toward disclosure of financial conflicts of interest is well and good, most of the time. But in some cases, disclosure is not only unnecessary but destructive. When bioethicists advance arguments whose premises and logical moves are open to scrutiny, disclosure—far from clearing the air of bias—introduces bias.

Science, Bioethics, and the Public Interest: On the Need for Transparency

First published: May 2002

Abstract

As in science, so in bioethics: if prohibiting conflicts of interest is not feasible, rigorous requirements for disclosure can at least manage them.

Managed Care, Conflicts of Interest, and Quality

First published: September 2000

Abstract

The Supreme Court case of Pegram v. Herdrich, decided in June 2000, refocused the debate on the nature of the managed care system in America. The legal issue before the Court was whether beneficiaries of an employer-sponsored health care plan can sue the plan on the theory that, in failing to provide adequate health care to its members, the plan breached its fiduciary duty under the Employee Retirement Income Security Act (ERISA). The facts of Pegram highlight the extent to which managed care organizations (MCOs) provide economic incentives for physicians to provide less care. In particular, physicians may receive greater compensation for fewer hospitalizations, diagnostic tests, and referrals to specialists.

Special Reports

NFL Player Health: The Role of Club Doctors

November/December 2016, Volume 46, Issue S2

Abstract

How can we ensure that players in the National Football League receive excellent health care they can trust from providers who are as free from conflicts of interest as realistically possible? NFL players typically receive care from the club’s own medical staff. Club doctors are clearly important stakeholders in player health. They diagnose and treat players for a variety of ailments, physical and mental, while making recommendations to the player concerning those ailments. At the same time, club doctors have obligations to the club, namely to inform and advise clubs about the health status of players. While players and clubs share an interest in player health—both of them want players to be healthy so they can play at peak performance—there are several areas where their interests can diverge, and the divergence presents legal and ethical challenges. The current structure forces club doctors to have obligations to two parties—the club and the player—and to make difficult judgments about when one party’s interests must yield to another’s. None of the three parties involved should prefer this conflicted approach.

We propose to resolve the problem of dual loyalty by largely severing the club doctor’s ties with the club and refashioning that role into one of singular loyalty to the player-patient. The main idea is to separate the roles of serving the player and serving the club and replace them with two distinct sets of medical professionals: the Players’ Medical Staff (with exclusive loyalty to the player) and the Club Evaluation Doctor (with exclusive loyalty to the club). We begin by explaining the broad ethical principles that guide us and that help shape our recommendation. We then provide a description of the role of the club doctor in the current system. After explaining the concern about the current NFL player health care structure, we provide a recommendation for improving this structure. We then discuss how the club medical staff fits into the broader microenvironment affecting player health.

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From Hastings Center Bioethics Timeline

1999: Case of Jesse Gelsinger

Jesse Gelsinger, age 18, develops respiratory failure and dies after receiving experimental new gene therapy. In a wrongful death lawsuit against the researchers, the University of Pennsylvania and Children’s Hospital of Philadelphia, numerous problems are identified. The Gelsinger case leads to efforts to promote ethical conduct of clinical research and to better protect patient safety in trials. The case highlights the uncertainty of genotoxicity as a risk that needs to be communicated in the informed consent process and the possible introduction of bias in presenting information about a research trial when an investigator or institution has a conflict of interest.

https://www.nytimes.com/1999/11/28/magazine/the-biotech-death-of-jesse-gelsinger.html/

https://www.nature.com/news/gene-therapy-trials-must-proceed-with-caution-1.20186/

2005: NIH and Conflict of Interest

Prior to 2005, NIH policies allow senior employees to consult and receive money, stock, and stock options in return for their advice. This is intended to facilitate recruitment of well-qualified investigators to conduct federally funded research. However, after media attention to possible conflicts of interest, Congress pressures the U.S. Department of Health and Human Services (the source of NIH budgets) to publish new regulations on conflicts of interest. The new rules prohibit all NIH employees (and in some instances, their spouses) from activities and investments such as receiving any compensation from the private sector or from research institutions that receive NIH grants, and from holding stock in biopharmaceutical companies. Although the reactions to the new rules are mixed and a few prominent NIH researchers leave the NIH for positions at major U.S. universities, open discussion is proposed to extend the conflict-of-interest rules to universities and other public institutions.

Department of Health and Human Services. Supplemental standards of ethical conduct and financial disclosure requirements for employees of the Department of Health and Human Services: interim final rule with request for comments.

Fed Reg 2005;70:5543-65

https://pubmed.ncbi.nlm.nih.gov/15690579/

http://portal.unesco.org/en/ev.php-URL_ID=31058&URL_DO=DO_TOPIC&URL_SECTION=201.html