Category: Conflicts of Interest

Twitter Round-Up (12/9-12/15)

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By Casey Thomson
This week’s round-up looks at the problems of substandard drug prevalence abroad, NIH’s possible push for an anonymous grant-awarding process, and the Liverpool Care Pathway investigation. Check it out below!
  • Dan Vorhaus (@genomicslawyer) included a link to a report on the recent launch of Personal Genome Launch Canada. The post includes links to help navigate the content and learn more about the intricacies of this project. (12/9)
  • Frank Pasquale (@FrankPasquale) shared a post on the benefits and detriments of raising the age of Medicare eligibility from age 65 to 67 – an idea that has recently gained sway in the political arena. The author ultimately concludes that the move would only be a matter of cost shifting rather than cost saving, and thus harm the disenfranchised 65-66 year-olds that would front the cost. (12/10)
  • Frank Pasquale (@FrankPasquale) also included this article on Dr. Oz’s wrongful diagnosis on organics. While concerns about finances must indeed be taken into consideration when families decide what foods to purchase, families must also be concerned about the presence of pesticides in their food. Organic food, while more expensive, avoids this health hazard. (12/10)
  • Frank Pasquale (@FrankPasquale) additionally linked to this report on the preponderance of substandard (and oftentimes, consequentially lethal) drugs particularly in emerging markets. Efforts to crackdown on substandard drugs have thus far focused largely on counterfeit drugs, rather than those that are the result of “shoddy manufacturing and handling…or deliberate corner cutting,” which constitute an arguably much greater public health threat. (12/10)
  • Daniel Goldberg (@prof_goldberg) shared this post on the prevalence of worthless clinical practice guidelines. The article notes the need to distinguish the guidelines that meet much of the Institute of Medicine (IOM) quality criteria from the rest. (12/10)
  • Alex Smith (@AlexSmithMD) linked to a blog post on advance care planning and the gap between the needs of the healthcare system and those of patients. Currently, much of the paperwork required for advance directives is given without providing families and patients concrete skills needed for both identifying their desires and communicating such desires to direct their own medical care. This article calls for refocusing on providing direct patient empowerment in addition to the existing efforts to improve clinician communication in order to facilitate the ability of advance care planning to reflect the patient’s wishes. (12/11)
  • Michelle Meyer (@MichelleNMeyer) retweeted an article about the NIH’s consideration of introducing anonymity into the grant-awarding process in order to alleviate some of the concerns with bias that have long-plagued the agency. (12/12)
  • Dan Vorhaus (@genomicslawyer) also posted a report on BGI, a world-leading DNA sequencing organization based in China, and their commercial expansion efforts into the healthcare, agriculture, and aquaculture sectors. The question of whether BGI is more a research institute or commercial enterprise comes into question in the article. (12/12)
  • Stephen Latham (@StephenLatham) included a link to his own blog post on the recently renewed controversy concerning the Liverpool Care Pathway for the Dying Patient (LCP), particularly as to whether patients put on the LCP had a discussion with their care providers prior to the decision and whether hospitals were wrongly putting patients on the pathway. The talk of scandal sparked an independent investigation into the LCP; Latham’s article expressed his hope for thoroughness in the investigation and for serious consideration on how to renew the LCP effectively. (12/12)
  • Arthur Caplan (@ArthurCaplan) posted a link concerning the implications of 23andMe, a personalized genomics company, and their launch of the $99 genetic test in the hopes of inspiring greater numbers to get tested. The article’s author reflects on how the real benefit will likely not be immediate for individuals, but will rather depend on the chance that greater data will lead to more breakthroughs in understanding the human genome. (12/14)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

The Risk of Revictimization and the Ethics of Covering School Shootings: What Journalists Can Learn from IRBs

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By Michelle Meyer

Updated below

Like most parents, after learning about the latest mass school shooting this morning, my thoughts immediately went to my own kindergartener. And of course, like most reading this blog, I thought about how poorly we handle guns and mental illness. Before too long, though, I couldn’t help but make a less direct connection between today’s events and my scholarly interests. I’m thinking of the way journalists cover school shootings as compared to how we regulate human subjects research.

As I write in The Heterogeneity Problem, 65 Admin. L. Rev. __ at 14-16 (forth. June 2013):

Studies on sexual abuse and assault, grief, war, terrorism, natural disasters and various other traumatic experiences are critical to better understanding and addressing these phenomena. But exposure to trauma — whether as a survivor or as a first rescuer or other third party — often causes substantial psychological morbidity. . . . Given their potentially fragile state, IRBs understandably worry that “questioning [or otherwise studying] individuals who have experienced distressing events or who have been victimized in any number of ways . . . . might rekindle disturbing memories, producing a form of re-victimization.”

IRBs — local licensing committees who operate according to federal statute and regulation and must approve most studies involving humans before researchers can even approach anyone about possibly participating — sometimes impose burdensome requirements on the way trauma research is conducted in order to protect adult subjects from the risk of revictimization. And they do so in addition to applying regulations that require that researchers disclose that risk (and others) to subjects.

Contrast this with the way journalists cover trauma. Read More

Extreme COI: The Named Beer University Studying the Health Effects of Beer?

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The Petrie-Flom Center recently co-hosted a conference with the Safra Center on Institutional Financial Conflicts of Interest in Research Universities (fCOI), exploring situations where universities get cozy with industry.  My friend, Jonathan Marks, is doing some really interesting work (see e.g., this) on conflicts of interest in the field of food-health research in particular.  And, Michael Sandel also has a new book out called, What Money Can’t Buy, wherein he covers everything from organ sales to stadium naming rights, lamenting the commodification and loss of truly public spaces. (For example, a certain university near me has given their stadium name to Wells Fargo, along with dozens of other universities that have done likewise.)

In that light, this HuffPo story caught my eye:  “Beer May Have Anti-Virus Properties, According To Study Funded By Sapporo Breweries.”  Not only is the study on Sapporo beer funded by Sapporo Breweries, but it was conducted at “Sapporo Medical University.”  That looks like extreme COI, almost as bad as this, one of my favorite New Yorker cartoons, where the physician is actually wearing ads like a race-car driver.

Seriously, “Sapporo Medical University?”  Is this an instance of a company department simply calling itself a university, like McDonald’s Hamburger U?  Or, did the brewery actually buy the naming rights to the entire university?  Alas, the answer is no:  “Sapporo” is the name of a large city in Japan, where the public “Sapporo Medical University” is located.

WaPo on Industry Influence of Clinical Trials

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By Christopher Robertson

The Washington Post has an extensive story about the drug and device industry’s influence on the outcomes of clinical trials, which are published in leading medical journals and which then shape the prescribing decisions of physicians everywhere.  Below the fold, I share some of my own thinking on this issue, and link to some of my relevant publications.   Read More

Open Access to Health Research: Highlights from the NIH Public Access Policy panel

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By Adriana Benedict

As of 2008, the NIH Public Access Policy requires “that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication.”  Four years later, approximately 80% of NIH-funded research articles make their way into PubMed Central.  Institutional Open Access resolutions such as Harvard’s Open Access Policy have helped accommodate the NIH Public Access Policy requirements, but Harvard Medical School and Harvard School of Public Health have yet to adopt it.

In May, the Harvard Library Faculty Advisory Council issued a public letter calling on faculty to promote open access scholarly publishing, noting that “Many large journal publishers have made the scholarly communication environment fiscally unsustainable and academically restrictive”.  In a Petrie-Flom Center-sponsored Open Access Week panel (moderated by Open Access Liaisons Scott Lapinski and June Casey), Peter Suber, Amy Brand, Winston Hide and Patrick Taylor discussed the challenges and opportunities for progress towards achieving open access to health research.  Highlights from the panel are presented below, and the video should be available on the Petrie-Flom website shortly.

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It’s the End of the University as We Know It?!!? On MOOCs and Attestation

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I am writing this from Malaysia where I am touring hospitals as part of my book in progress on medical tourism. I may try to blog on the trip a bit next week, but for now I want to continue my thoughts from my last blog post prompted by our conference on Financial Conflicts of Interest In Research Universities.  Shortly after my post the New York Times ran a long story on Massive Open Online Courses (MOOC)s, such as Coursera, EdX and the like which enroll thousands of students in online courses that incorporate, among other things, recorded lectures in bite sized portions. Full disclosure, I teach in a MOOC of sorts: I teach NY and MA Civil Procedure for the bar-prep company Themis, although this is not as a substitute for university courses. Bar prep has long beem MOOC-y.

MOOCs are, I think, a major form of disruptive innovation for  universities. Suppose I taught the first-year introduction to economics course at my local university. Suppose we have five professors lecturing in that course, as we did at the University of Toronto where I did my undergraduate education (and took such a course). The course is a lecture course. Why have five faculty members teach it? Why not merely record *the best* lecturer of the group and have him record the course and make it available to all the students, ready to be scaled up? But why stop at my faculty? Why not find the best introductory economics lecturer in the U.S., record her, and license it to all faculties across the country?

One answer is the importance of the 1 on 1 faculty engagement. However, once these introductory courses get beyond a certain size (say 150) how different is the MOOC in this regard, do students really access those profs? Moreover, universities offering MOOCs might remedy this downside the same way they do for large bricks and mortar classes through discussion sessions taught by teaching assistants, often graduate school students. I fondly remember being a Teaching Fellow while at law school for Michael Sandel’s Justice course which packed hundreds of students in Sanders Theater (although to Sandel’s credit he was able to make it feel interactive even in those huge numbers). Office hours with *the* professor might be a problem, although again perhaps the other faculty members in the department *not* teaching these large classes anymore would have *more* time to meet students.

To be sure I am not arguing that MOOCs would be as good or better than the bricks and mortar classes  (although interestingly the NY Times’ stories’ report that some students that took the MOOC version of one of the courses featured in the article preferred it to the bricks and mortar version). Instead, the claim is that the resources saved by offering the MOOC and the lower pass-through costs might outweigh diminutions in quality, especially if one could find the very best lecturers.

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Should Researchers Have a Professional Code of Ethics?

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by Suzanne M. Rivera, Ph.D.

I was giving a workshop presentation at the annual meeting of the National Council of University Research Administrators and my co-presenter raised an interesting idea. Tommy Coggins of the University of South Carolina was talking about the importance of integrity for preserving the public’s trust in the research enterprise, and he pointed out that, unlike physicians, attorneys, and accountants, researchers do not have a unifying professional code of ethics.  Instead, they are subject to a patchwork of regulations, policies and laws, most of which were promulgated by grant funding agencies and therefore are enforceable only in cases where tax payer dollars are involved.  Although discipline-specific societies, such as the American Psychological Association, have their own ethics codes, researchers as a profession are not asked to adhere to a shared set of standards for their conduct.

And it’s true— there is no unifying code that all researchers (spanning the range of disciplines from anthropology to zoology) must swear to uphold.  And maybe it’s not realistic to expect that people whose jobs entail such a variety of different activities (working with data sets, lasers, yeast, mice, human participants, super colliders, etc.) could find sufficient common ground on which to cobble together a code.  But I wonder if it’s worth a try.  Given the current atmosphere of distrust that has resulted in new rules for increased transparency and oversight of researchers’ financial interests, perhaps the time is right to think explicitly about ethical standards for research.  Not merely avoiding “FFP” misconduct, but an affirmative duty to behave with integrity.

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Institutional Corruption, Conflicts of Interest and Commitment, and Online Courses

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I am writing this post from a terrific conference on Institutional Financial Conflicts of Interest In Research Universities, hosted at Harvard Law by the Petrie-Flom Center and the Edmond J. Safra Center for Ethics.

One set of fascinating questions that has been raised is when the university should reign in the ability of faculty members to take on directorships and other outside activities. While these issues have been well-known in the sciences and medicine, increasingly it has come home to roost in the law and other faculties. The Harvard Law School  recently adopted a new conflicts of interest policy, as part of a Harvard-wide revision of its policies.

Here is a question that has received less discussion from what I have seen, though it may become more pressing given Coursera, EdX, and other online teaching venues.  The New Yorker profile of my Harvard Business School colleague and world-renowned teacher Clayton Christensen reported that he has recorded videos lectures (complete with good-looking young men and women actors playing students and laughing at the right moments, what a perk!) for the University of Phoenix’s lecture series, for significant remuneration. Imagine that this series (or one of these other non-Harvard platforms) were to offer to pay half a million dollars to me to teach a 4-hour Civil Procedure (or health law or bioethics and the law course) that would in part mirror the teaching I do of the course at Harvard Law School. Should Harvard have a veto right over me doing so? Should it demand “a piece of the action” and revenue sharing agreements as a condition of letting me participate? After all, I am in some ways trading on my capitol for teaching at Harvard, and potentially also diluting the reputational value of Harvard instruction (the informercial would go “You don’t need to go to Harvard to get a lecture from a Harvard Prof! Only $9.99!”) How can the rules governing patent and other IP ownership in the  life and other sciences help us develop a sensible policy? Would or should things be different if I gave these lectures for free on YouTube rather than selling them? [Disclosure: Harvard DOES have a policy on conflicts of commitment, though I am unaware of it speaking specifically to these issues about online lectures, but happy to be corrected].

Reminder: Tomorrow, Institutional Financial Conflicts of Interest in Research Universities

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Friday, November 2, 2012
8:30am – 6:30pm (reception to follow)
Milstein Conference Rooms, 2nd Floor
Wasserstein Hall
1585 Massachusetts Avenue
Cambridge, MA

The Petrie-Flom Center and the Edmond J. Safra Center for Ethics will be co-sponsoring a day-long symposium organized by Dr. David Korn on institutional financial conflicts of interest in research universities. The speaker line-up is incredible, including Derek Bok and Zeke Emanuel, among other experts from academia and government.

For more information, and to register (attendance is free), check out the symposium webpage.  We hope to see you there!

Conflicting Interests in Research: Don’t Assume a Few Bad Apples Are Spoiling the Bunch

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by Suzanne M. Rivera, Ph.D.

In August of 2011, the Public Health Service updated its rules to address the kind of financial conflicts of interests that can undermine (or appear to undermine) integrity in research.  The new rules, issued under the ungainly title, “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors,” were issued with a one-year implementation period to give universities and academic medical centers sufficient time to update their local policies and procedures for disclosure, review, and management (to the extent possible) of any conflicts their researchers might have between their significant personal financial interests and their academic and scholarly activities.

The rules were made significantly more strict because a few scoundrels (for examples, click here, and here) have behaved in ways that undermined the public’s trust in scientists and physicians. By accepting hundreds of thousands, even millions, of dollars from private pharmaceutical companies and other for-profit entities while performing studies on drugs and devices manufactured by the same companies, a few bad apples have called into question the integrity of the whole research enterprise.  This is a tremendous shame.

Having more than one interest is not bad or wrong; it’s normal.  Everyone has an attachment to the things they value, and most people value more than one thing.  Professors value their research, but they also want accolades, promotion, academic freedom, good parking spots, and food on their tables.  Having multiple interests only becomes a problem when the potential for personal enrichment or glory causes someone (consciously or unconsciously) to behave without integrity and compromise the design, conduct, or reporting of their research. Read More