Life Science Compliance Update

October 07, 2015

Study Looks At How Many Industry Boards of Directors Have Academic Affiliations


Conflict of interest rules for the medical community have been in the spotlight lately, though they typically center around rules that prohibit or restrict physicians from enjoying lunch on behalf of a pharmaceutical company or stocking their office with pens. A new study conducted by researchers from the University of Pittsburgh School of Medicine and published in the British Medical Journal recently decided to look at conflicts of interest from a different perspective: they looked at how many for-profit healthcare company positions were occupied by people with academic affiliations.

These researchers analyzed public disclosures of all publicly traded United States healthcare companies listed in the NASDAQ and NYSE in January 2014 that specialized in pharmaceuticals, biotechnology, medical equipment, and providing healthcare services. The researchers defined an academic medical or research affiliation as “a formal position at a US medical school, affiliated teaching hospital, or health system; overseeing research university; or medical research institute with a medical school partnership” and they further classified individuals with academic affiliations as either leaders, professors, or trustees, as each group holds a different set of responsibilities to their academic institutions that pose unique conflicts with their obligations as for profit company directors.

The study found that 41% of the companies surveyed had one or more academically affiliated board of directors members in 2013. Several of those board of directors members held positions on more than one company’s board of directors: the study found that 279 academically affiliated directors held a total of 309 healthcare directorships, which is less than 10 percent of all total healthcare directorships.

Over half of academically affiliated directorships were held by individuals with clinical training, predominately in internal medicine or related subspecialties, the most common of which were general internal medicine, cardiology, and oncology.

The compensation these academically affiliated board of directors members received for their board of director position varied widely, ranging from zero dollars to over one million dollars, with the median compensation being $193,000. In addition to their monetary compensation, many board of directors members received major stock in their company.

After looking at all of the data, study co-author Timothy Anderson, MD, does not believe that the existence of academically affiliated board of directors members is necessarily a problem in and of itself. Instead, he thinks that it simply poses legitimate questions for initiating a discussion about conflict of interest with academic institutions, healthcare companies, and their interrelationships.

When questioned about the link and possible problems, Dr. Anderson stated, "Our view is not to pass judgment. We wanted to paint that landscape of how diverse these sorts of relationships are. Some may be quite beneficial and some might be quite concerning, but until we really understand what relationships exist, it is hard for the medical and academic community to have a good discussion about what we should do to minimize the risks and maximize the benefits of these collaborations." He continued on, noting that a one-size-fits-all approach will not work to manage all of the relationships, but instead, a more open approach is warranted to avoid losing the public’s trust.

Anderson thinks that the way the Sunshine Act solely focuses on physicians and attempts to expose their minute financial interests might be misguided and results in oversight of academic professionals and their loyalties. The study focused on the fact that academics who sit on the board of a for-profit company have duties of loyalty both to the academic organization that employs them, as well as to the shareholders of the company whose board they sit on. The concern of the study and the researchers behind it are that those loyalties have the opportunity to conflict at times, placing the academic board member in a precarious position.   

The study acknowledged that “there is no doubt that collaboration between academic institutions and industry has led to profoundly important clinical trials, drug development, and translational research initiatives, although the role and necessity of academically affiliated directors in facilitating these projects is unclear and undocumented” and that academic institutions can benefit from having their staff members and faculty as representatives in corporate board rooms, forging fundraising or research partnerships.

The study further recognized that one of the difficulties in developing guidelines to monitor the competing interests is that the potential harms vary depending on the individual’s primary academic duties. Certain academics may be in a position, both academically and professionally as a board of director, to balance the potential conflicts of interest and will successfully benefit both organizations with their knowledge and expertise.

However, because the end result of the study advocates for “additional review, regulation, and, in some cases, prohibition when conflicts cannot be reconciled,” it is worth keeping an eye on potential movement in this area. It is likely only a matter of time before someone, or a group of people, speak up and ask for more strict regulation on academics who serve as a member of the board of directors for for-profit companies.   This would be unfortunate as both organizations can benefit from the other in expertise and developing much needed cures.

October 05, 2015

Conflict of Interest Rules in Medical School Might be Changing


Harvard Medical School has been known to have some of the most stringent conflict of interest rules in the nation. Several faculty members, however, have not been shy about questioning whether stricter rules could be damaging innovation, one professor noting, “If there were conflict-of-interest policies so that Thomas Edison couldn’t be involved in the company he formed to create the electric light, we’d still have gas lamps.”

In light of faculty discontent, changes in the medical field, and additional research on conflicts of interest and how they affect physicians, Harvard Medical School is starting to take some steps back from the strict conflict of interest rules they set out five years ago. The school has started to discuss with faculty some changes that can be made to protect the integrity of the medical field while also promoting new innovation and creativity. One of the policies they are reviewing is the “research support rule,” which bars faculty from receiving research grants or contributions from a company they hold equity in. Another strict rule under review, which is believed to be unique to Harvard, is the “clinical research rule,” which prohibits faculty from conducting clinical trials on products if the faculty has equity or earns at least $10,000 in income from the company who produces the product.

The viewpoint Harvard has held for the last several years gives credence to the thought that if you have a financial stake in a particular product, it is hard for you to accurately evaluate it. They believe that these rules protect patients against self-serving doctors who are solely focused on making as much money as they can with disregard for patient health and safety.

However, it has been found that while small gifts may influence the activity of physicians, it does not necessarily follow that greater financial stakes have a large impact on the activity and decisions physicians make. Dr. Lisa Rosenbaum has done some research on the topic and believes that conflict of interest rules have been so entrenched in the medical field that at this point, keeping them is a matter of indignation, not a matter based in reality. She believes that a shift toward a conversation that “better accounts for the diversity of interactions, the attendant trade-offs, and our dependence on industry in advancing patient care“ will be a more beneficial way of looking at things for all parties involved.

Dr. Rosenbaum also has concerns about the accuracy, reliability, and relevance of the data that has been considered to be the impetus behind the strict conflict of interest rules around the country. She does believe that while patient health should never be compromised by a physician’s desire for financial gain, “the extent to which physicians’ primary and secondary interests actually conflict, under what circumstances, and at what cost are unknown.” She also highlights the fact that neither the benefits, nor the harms, of these regulations attempting to expose or mitigate these conflicts are clear.

In her research, Dr. Rosenbaum poses several questions about the suggestive data that has been relied upon to create these conflict of interest rules. Some of these studies have been somewhat self-serving, in that they specifically go out to find instances of potentially negative industry influence and wind up successful. However, just because industry influence exists, that does not mean it is harmful to the patient. Just because a doctor attends a symposium funded by a drug manufacturer and ends up prescribing that drug to a patient does not mean the patient is harmed. Just because a doctor receives drug samples or a lunch from a drug representative and then goes on to prescribe that medicine does not mean the patients who receive that medicine are harmed by those interactions between the physician and the pharmaceutical industry.

In all, while there have been many studies done on the relationships between physicians and the pharmaceutical industry, there have not been many studies done on the effects of those connections to patient health. There are two sides to this coin, but if conflict of interest rules prevent physicians and others from creating the next “big thing” in medicine, that could very well be doing more harm to patients than a doctor who has contacts with a pharmaceutical company.

It will be interesting to keep up with the progress of this Harvard Medical School review and see if any changes are made to their policies, and consequently, to any other medical schools who may have similar rules. 

September 28, 2015

“Confluence, Not Conflict of Interest: Name Change Necessary”


Last week, the Journal of the American Medical Association (JAMA) released an editorial entitled “Confluence, Not Conflict of Interest: Name Change Necessary.” In it, the authors make a number of important points about certain problems with the “conflicts of interest” label that they feel has been misused. Anne Cappola and Garret Fitzgerald, both of the Institute for Translational Medicine and Therapeutics (ITMAT) at the University of Pennsylvania, note that their editorial reflects themes that emerged from a recently convened international meeting on conflicts of interests.

The authors’ first disagreement stems from the phrase itself—“conflict of interest is pejorative” they write, and “confrontational and presumptive of inappropriate behavior.” The authors argue that better terms would be “confluence of interest,” and “the focus should be on the objective, which is to align secondary interests with the primary objective of the endeavor—to benefit patients and society—in a way that minimizes risk of bias.” The term “confluence of interest” expands the individuals who could be liable to bias beyond just the investigator and sponsor to include departments, research institutions, universities, and out to nonprofit funders, the National Institutes of Health, and journals, which the authors state “generate advertising revenue from sponsors.”

Their second point is that up to now, clinical research disclosure policies have focused on financial disclosure. The authors provide their views that money is only one part of the picture. “[I]n academia, the prospect of fame may be even more seductive than fortune,” they write. Bias may be stronger for a researcher who may benefit from the outcome of a study by having the study published in a prestigious journal, receiving invitations to speak at conferences, and even enjoying promotions or higher salary. “Even though an investigator may publicly eschew any direct financial reward from a sponsor, such fiscal and professional benefits may accrue to them indirectly from the institution, if they attract clinical trials with their attendant indirect costs,” the authors write.

They offer an idea on how to potentially track this: “Much like a heat map of gene expression, a dashboard would express and give weight to elements of fame and fortune on the y-axis, charted against individuals and entities on the x-axis that are likely to gain from the endeavor,” they write.

The authors next discuss another theme that emerged during their Conflicts of Interest meeting—that inventors of medicine or devices may have “a highly restricted skill set necessary to advance translation of the discovery from ‘bench to bedside.’” Despite the potential for bias, the authors note that there has been “a move away from blanket exclusion to permitting engagement by the inventor in clinical development, conditional on additional oversight, to assure the public and to mitigate bias.”

The article also notes that despite the benefits of public private partnership, the interests of these parties may sometimes diverge. “Just as universities foster relationships of their faculty with industry, their responsibility to the public interest behooves them to protect and ensure the independence of their faculty to disseminate the full spectrum of their discoveries, even when they may include uncomfortable truths for the sponsor,” the authors write. “Institutions also have an obligation to be governed by their mission, rather than profit, and maximizing profit may not always serve that mission.”

Finally, the authors place a high level important on education. “Education of trainees, investigators, administrators, funders, publishers, politicians, and the public—is essential for progress,” they state. “Academic institutions have a particular responsibility to inculcate, promote, and reward intellectual honesty in ways more imaginative and effective than in the past.”

 “Confluence of interest represents a complex ecosystem that requires development of a uniform approach to minimize bias in clinical research across the academic sector,” the authors conclude. “Such a policy must be at once simple and accessible, capturing the complexity of the relationships while being sufficiently flexible at the individual level not to intrude on the process of innovation.”

This article gives us a hint that there may be a change in the editorial direction at JAMA, earlier this year a competing journal the New England Journal of Medicine also ran a series of articles questioning the burden that the conflict of interest movement has had on medicine.

View the article in JAMA here


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