ASSIGNMENT: Profile the University of Maryland Medical System COI challenge.
DISCLOSURE. I am a member and Interim Chairman of the IRB* at Stevens Institute of Technology.
“There are many varieties of conflicts of interest, and they appear in different settings and across all disciplines. While conflicts of interest apply to a “wide range of behaviors and circumstances,” they all involve the use of a person’s authority for personal and/or financial gain. Conflicts of interest may involve individuals as well as institutions. Furthermore, individuals, in certain circumstances, may have conflicts occurring on both an individual and an institutional level, as may be seen among members of an Institutional Review Board (IRB).
Conflicts of interest are broadly divided into two categories: intangible, i.e., those involving academic activities and scholarship; and tangible, i.e., those involving financial relationships.” (A)
“In an article in the May 2014 issue of Compliance Today, Bill Sacks, Vice President and co-founder of HCCS, a HealthStream company, describes how new NIH regulations are forcing academic medical centers (AMCs) to examine and update their conflict-of-interest policies. He lists the 15 best practices for management of conflicts of interest that have been proposed by the Pew Charitable Trust and discusses how some of these recommendations are enjoying wide acceptance, as others are being met by serious objections. The Pew “Best Practice” recommendations are summarized below.
1. No gifts or meals should be accepted from industry sales representatives…
2. Faculty must disclose all conflicts of interest. All academic medical centers must have a process in place to manage conflict of interest (COI) disclosures.
3. Industry-funded speaking should not be allowed…
4. Industry-funding of continuing medical education (CME) should be severely limited or prohibited…
5. Faculty, students, and trainees should not attend industry-supported promotional or educational events…
6. Limit or prohibit pharmaceutical sales representative access in academic medical centers…
7. Limit medical device representative presence in academic medical centers to what is necessary…
8. Conflict-of-interest education should be required for all clinical staff and students
9. Conflict-of-interest policies should apply to everyone with a relationship to the academic medical center—paid, volunteering, affiliated, etc…
10. Industry-supported clinical fellowships should be available for scientific training only…
11. Ghostwriting and honorary authorship are strictly prohibited…
12. …Consulting arrangements must require written contracts with clear deliverables, to ensure that inappropriate payments are not involved…
13. Consulting relationships for marketing purposes are prohibited.
14. Pharmaceutical samples can be accepted and used only when they don’t become marketing tools.
15. Members of pharmacy and therapeutics committee cannot vote on formulary or treatment changes involving a company or product in which they have a financial interest… (B)
“Open Payments gives the public more information about the financial relationships between physicians and teaching hospitals and applicable manufacturers and GPOs. Specifically, the program:
Encourages transparency about these financial ties
Provides information on the nature and extent of the relationships
Helps to identify relationships that can both lead to the development of beneficial new technologies and wasteful healthcare spending
Helps to prevent inappropriate influence on research, education and clinical decision making. (C)
“Community Catalyst offers this Policy Guide to Academic Medical Centers and Medical Schools to assist leaders, faculty, staff and medical students in successfully adopting and improving policies to address conflicts of interest and interactions with the pharmaceutical and device industries. Policies such as these and their effective implementation are of critical importance to the integrity of medical education and patient care…
Toolkit on Transparency and Disclosure. Toolkit on Relations with Sales Representatives. Toolkit on Promotional Speaking. Toolkit on Continuing Medical Education. Toolkit on Ghostwriting and Name-Lending. Toolkit on Samples. Toolkit on Pharmaceutical and Therapeutics Committees. Toolkit on COI Policy Implementation. Conflict of Interest Curriculum Toolkit (D)
“Papers in medical journals go through rigorous peer review and meticulous data analysis.
Yet many of these articles are missing a key piece of information: the financial ties of the authors.
Nearly two-thirds of the 100 physicians who rake in the most money from 10 device manufacturers failed to disclose a conflict of interest in their academic writing in 2016, according to a study published Wednesday in JAMA Surgery.
The omission can have real-life impact for patients when their doctors rely on such research to make medical decisions, potentially without knowing the authors’ potential conflicts of interest…
They did this by sampling 10 large surgical and medical device manufacturers. This list includes Medtronic, Stryker Corp., Intuitive Surgical, Covidien, Edwards Lifesciences Corp., Ethicon, Olympus Corp., W.L. Gore & Associates, LifeCell Corp. and Baxter Healthcare.
The researchers also pinpointed the 10 physicians who received the highest compensation from each company. They then searched for articles published by these physicians between Jan. 1 and Dec. 31, 2016, and reviewed the full text of each article for COI disclosure.
According to their findings, those 10 companies paid more than $12 million in 2015 to the 100 doctors included in the study. The median payment to these physicians was $95,993.” (E)
“Memorial Sloan Kettering Cancer Center launched a conflict of interest task force in the wake of the resignation of its chief medical officer, Dr. José Baselga, who failed to disclose connections to medical industry…
The Manhattan-based cancer center said the task force will assess its internal policies and processes for reporting and managing outside activities and industry-supported clinical trials.
The task force was announced by President and Chief Executive Officer Dr. Craig Thompson. It will be chaired by Debra Berns, MSK’s Senior Vice President and Chief Risk Officer.
Among its objectives, the task force will: Review MSK’s policies, procedures, and training on conflicts of interest; Identify best practices in COI, including monetary and commitment limits; Assess new or improved processes to support timely and thorough disclosure; Identify medical societies and journals with whom to partner in improving public disclosure at meetings and in publications. (F)
“One of the world’s top breast cancer doctors failed to disclose millions of dollars in payments from drug and health care companies in recent years, omitting his financial ties from dozens of research articles in prestigious publications like The New England Journal of Medicine and the Lancet.
The researcher, Dr. José Baselga, a towering figure in the cancer world, is the chief medical officer at Memorial Sloan Kettering Cancer Center in New York. He has held board memberships or advisory roles with Roche and Bristol-Myers Squibb, among other corporations; has had a stake in start-ups testing cancer therapies; and played a key role in the development of breakthrough drugs that have revolutionized treatments for breast cancer.
According to an analysis by ProPublica and The New York Times, Baselga did not follow financial disclosure rules set by the American Association for Cancer Research when he was president of the group. He also left out payments he received from companies connected to cancer research in his articles published in the group’s journal, Cancer Discovery. At the same time, he has been one of the journal’s two editors in chief.
At a conference this year and before analysts in 2017, he put a positive spin on the results of two Roche-sponsored clinical trials that many others considered disappointments, without disclosing his relationship to the company. Since 2014, he has received more than $3 million from Roche in consulting fees and for his stake in a company it acquired.” (G)
“Dr. José Baselga, the chief medical officer of Memorial Sloan Kettering Cancer Center, resigned on Thursday amid reports that he had failed to disclose millions of dollars in payments from health care companies in dozens of research articles…
Thompson echoed comments he made to the hospital staff on Sunday, saying that the cancer center had “robust programs” in place to manage employees’ relationships to outside companies, but that “we will remain diligent.” He added, “There will be continued discussion and review of these matters in the coming weeks.” (H)
“An artificial intelligence start-up founded by three insiders at Memorial Sloan Kettering Cancer Center debuted with great fanfare in February, with $25 million in venture capital and the promise that it might one day transform how cancer is diagnosed.
The company, Paige.AI, is one in a burgeoning field of start-ups that are applying artificial intelligence to health care, yet it has an advantage over many competitors: The company has an exclusive deal to use the cancer center’s vast archive of 25 million patient tissue slides, along with decades of work by its world-renowned pathologists.
Memorial Sloan Kettering holds an equity stake in Paige.AI, as does a member of the cancer center’s executive board, the chairman of its pathology department and the head of one of its research laboratories. Three other board members are investors…
Hospital pathologists have strongly objected to the Paige.AI deal, saying it is unfair that the founders received equity stakes in a company that relies on the pathologists’ expertise and work amassed over 60 years. They also questioned the use of patients’ data — even if it is anonymous — without their knowledge in a profit-driven venture.” (I)
“…The AAMC is continuing to work with member institutions, other associations and societies, journals, and the continuing education community to develop tools and resources to help institutions and individuals manage the disclosure of conflicts of interest.
Institutions looking for immediate steps to take could:
Remind faculty of the importance of full disclosure, not only to your institution, but in other writing, speaking and teaching situations, as well as grant applications.
Use relevant current events as an opportunity to recommit to the institution’s obligation to facilitate transparency about the ways in which faculty and industry may be collaborating, and the processes that are in place to review and manage those relationships.
Encourage faculty to review the information posted about them publicly on the Open Payments website, and to ensure its accuracy as well as consistency with complete disclosures in all aspects of their professional responsibilities.” (J)
* “Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.” (K)
(B) 15 Conflict-of-Interest Best Practices for Academic Medical Centers, https://www.healthstream.com/resources/blog/blog/2014/06/04/15-conflict-of-interest-best-practices-for-academic-medical-centers
(C) Open Payments Data in Context, https://www.cms.gov/OpenPayments/About/Open-Payments-Data-in-Context.html
(D) Conflict of Interest Policy Guide for Medical Schools and Academic Medical Centers, https://www.communitycatalyst.org/initiatives-and-issues/issues/prescription-drugs/conflict-of-interest-policy-guide
(E) Financial Ties That Bind: Studies Often Fall Short On Conflict-Of-Interest Disclosures, by Rachel Bluth, https://khn.org/news/financial-ties-that-bind-studies-often-fall-short-on-conflict-of-interest-disclosures/
(F) Memorial Sloan Kettering launches conflict of interest task force after CMO’s resignation, by David Robinson, https://www.lohud.com/story/news/health/2018/09/21/memorial-sloan-kettering-conflict-interest-task-force/1381042002/
(G) Top Cancer Researcher Fails to Disclose Corporate Financial Ties in Major Research Journals, by Charles Ornstein and Katie Thomas, https://www.propublica.org/article/doctor-jose-baselga-cancer-researcher-corporate-financial-ties
(H) Top Official at Memorial Sloan Kettering Resigns After Failing to Disclose Industry Ties, by Charles Ornstein, and Katie Thomas, https://www.propublica.org/article/memorial-sloan-kettering-official-jose-baselga-resigns-after-failing-to-disclose-industry-ties
(I) Sloan Kettering’s Cozy Deal With Start-Up Ignites a New Uproar, by Charles Ornstein, and Katie Thomas, https://www.propublica.org/article/sloan-kettering-cozy-deal-with-start-up-paige-ai-ignites-new-uproar
(J) Conflicts of Interest and Transparency Initiatives, https://www.aamc.org/initiatives/research/coi/
(K) Institutional Review Boards Frequently Asked Questions – Information Sheet, https://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm
(L) Facing Crisis, Sloan Kettering Tells Exec to Hand Over Profits From Biotech, by Katie Thomas and Charles Ornstein, https://www.propublica.org/article/facing-crisis-sloan-kettering-tells-exec-to-hand-over-profits-from-biotech(M)
“A vice president of Memorial Sloan Kettering Cancer Center has to turn over to the hospital nearly $1.4 million of a windfall stake in a biotech company, in light of a series of for-profit deals and industry conflicts at the cancer center that has forced it to re-examine its corporate relationships…
The move to hand over his stake is one of several steps now underway as the cancer center tries to contain a crisis that has already led to the resignation of its chief medical officer and a review of its conflict-of-interest policies. Several board members and some executives of the nonprofit institution have maintained close ties to the health and drug industries at a time when stunning cancer breakthroughs are generating excitement among investors and spawning a flurry of biotech startups.
At other cancer centers and research institutions, employees are barred from accepting personal compensation when they represent their institution on corporate boards. But Memorial Sloan Kettering had no such prohibition until now.” (L)