FEATURE
Conflict Resolution
Continued from page 73
“ There are now-entrenched cultural biases against industry that create barriers to appropriate collaborations that are in the best interest of patients and scientific progress .”
— MICHAEL ROSENBLATT , MD , and SACHIN H . JAIN , MD , MBA , in Harvard Business Review
“ Most clinical applications of discovery are made by the pharmaceutical and medical device industries ,” he wrote in a Surgery editorial last year . 8 “ Partnering with these industries not only affords research funding , but also a share of the market value of new discoveries .”
He cited the marked advances in health care over the last half-century as a justification for the existing system . “ These improvements are due to partnerships between physicians , academics , and industry ,” he wrote . But , because the “ COI instigators , enablers , and enforcers ” have so maligned the relationship between industry and innovators (“ guilty until proven innocent ”), he suggests , innovators have been hamstrung and innovation hampered , in some cases likely to fatal effect .
Dr . Stossel isn ’ t alone in his thinking . In a Harvard Business Review article published in June 2017 , Michael Rosenblatt , MD , chief medical officer of Flagship Pioneering , and Sachin H . Jain , MD , MBA , president and chief executive officer of CareMore Health System and a former senior adviser to the administrator of the Centers for Medicare & Medicaid Services under the Obama administration , contend that COI rules are “ holding back medical breakthroughs .” 9
“ We must recognize … that there are nowentrenched cultural biases against industry that create barriers to appropriate collaborations that are in the best interest of patients and scientific progress ,” they stated .
The authors , who have worked in industry , academia , clinical medicine , and government during their respective careers , continued : “ It is time for all parties to revisit those policies and replace them with rules that recognize both true conflicts and true confluences of interest . They are essential to forging the strong collaborations that are worthy of society ’ s trust .”
They suggest , among other things , that institutional COI policies be reworked to serve as frameworks for collaboration , rather than as tools “ solely for policing .”
Academia also needs to accept COI related to careerism and other non-financial motives , they write . For example , “ since many faculty members rely in part or fully on grants for their salaries , they are highly motivated to report data that supports grant applications .” This can have the unintended side effect of compelling researchers to design careers around supporting theories .
Their argument , essentially , is that one bad apple shouldn ’ t spoil the bunch . “ Clearly , some unacceptable past industry practices [ have ] driven continuous efforts to strengthen policies ,” they write , urging “ continued prudence ” to prevent unlawful and egregious behavior .
But policies that are created to punish an outlier may have downstream adverse effects , like the establishment of advisory committees that , in compliance with restrictive rules , are forced to staff themselves with “ conflict-free ” individuals who may not be true experts .
Value-Added Abstracts
The medical world continues to make rules and policies aimed at managing conflicts and avoiding the perception of bias . One such change was heralded widely last year , when the National Library of Medicine ( NLM ) announced that COI statements would be displayed on the front page of an article ’ s abstract on PubMed . 10 Traditionally , COIs were absent from indexed abstracts and only readers with access to the full-text article could view the disclosures and funding sources . The new policy places a COI statement at the bottom of the abstract in an expandable text box , alerting readers to any possible industry influence .
The COI field is indexed and searchable , just like other PubMed fields . A user searching “[ hascois ]” will find all citations that contain COI statements . Conversely , the field tag “[ cois ]” can also be used to restrict a search . For example : “ merck [ cois ]” will limit the search to abstracts that include the pharmaceutical company Merck as a sponsor or that are authored by researchers with relationships to the company .
The change was “ a congressionally mandated feature to improve the transparency of research ,” according to NLM Technical Information Specialist Marie Collins , MS . 11
Since the change was implemented , nearly 160,000 COI-containing abstracts have been indexed , but participation among publishers has been sporadic . “ We rely on the publishers to include COI information when they submit the rest of the information about the citation ,” NLM Librarian Sarah Helson , MLIS , told ASH Clinical News . “ While some consider including COI statements in the publication a best practice , NLM does not provide any incentive to publishers to include this data .”
“ It is up to the publishers to include this field ,” Ms . Helson explained . “ It is up to the publishers to determine if they require the authors to include COI information with their publication .”
So far , it is unclear how , why , and which publishers have opted to provide COI information to date . The lack of information prompts other questions , such as how disclosures are made , whether individuals with COIs are permitted to contribute editorial comments , and whether journal editors and publishers are under the influence of industry money .
Less attention has been paid to payments by industry entities to medical journal editors . In a recent study published in The BMJ , investigators found that industry payments to U . S . -based journal editors ( identified using publicly available government data ) are common , can sometimes be substantial ( mean general payment = $ 28,136 ; mean research payment = $ 37,963 ), and are infrequently disclosed or readily apparent . 12
The Disappearing Trust in Medicine
At the extreme end of each side of the COI argument , people sound , well , extreme . So-called “ pharmascolds ” insist that researchers whose work is funded by industry money are untrustworthy , while others retort that COI rules have gone too far . Is compromise possible ?
Take this example to judge for yourself : A recently published , industry-funded study had two co-principal investigators ( PIs ). One holds the patent on the assay used in the trial and most likely stands to gain financially from the trial producing positive results . The other PI has had an illustrious career in academic medicine and has received continual funding from the National Institutes of Health for decades . She took the company ’ s money to run the study but has , throughout her career , avoided taking industry money for consulting , speaking , food , travel , etc . All COIs were clearly disclosed in the publication of the study findings .
Is the first PI protecting his patent ? Is the second protecting her grants ? Or , can we trust that both physician-scientists are , despite competing interests , mostly driven to advance medical knowledge that will save lives ? — By Debra L . Beck ●
REFERENCES
1 . Lo B , Field MJ . Conflict of interest in medical research , education , and practice . National Academic Press , 2009 .
2 . International Committee of Medical Journal Editors . “ Author Responsibilities — Conflicts of Interest .” Accessed January 7 , 2018 , from www . icmje . org / recommendations / browse / roles-andresponsibilities / author-responsibilities--conflicts-of-interest . html .
3 . Steinbrook R . Disclosing the conflicts of interest of US Food and Drug Administration Advisory Committee members . JAMA Intern Med . 2017 ; 177:919 .
4 . Larkin I , Loewenstein G . Business model-related conflict of interests in medicine . Problems and potential solutions . JAMA . 2017 ; 317:1745-6 .
5 . Zuger A . What do patients think about physicians ’ conflicts of interest ? Watching transparency evolve . JAMA . 2017 ; 317:1747-8 .
6 . Lundh A , Sismondo S , Lexchin J , et al . Industry sponsorship and research outcome . Cochrane Database Syst Rev . 2012 ; 12 : MR0000033 .
7 . Lundh A , Lexchin J , Mintzes B , et al . Industry sponsorship and research outcome . Cochrane Database Syst Rev . 2017 ; 2 : MR000033 .
8 . Stossel TP . A guide to the anti-innovation “ pharmaphobia ” narrative for the aspiring innovator . Surgery . 2017 ; 161:305-7 .
9 . Rosenblatt M , Jain S . “ Conflict-of-Interest Rules Are Holding Back Medical Breakthroughs .” Harvard Business Review . Accessed January 12 , 2018 , from https :// hbr . org / 2017 / 06 / conflict-of-interestrules-are-holding-back-medical-breakthroughs .
10 . Collins M . PubMed updates March 2017 . NLM Tech Bull . 2017 ; 415 : e2 .
11 . Collins M . “ PubMed : Redesigned Citation Management to Better Serve PubMed Users .” Accessed January 12 , 2018 , from www . nlm . nih . gov / bsd / disted / video / mla _ 2017 / pubmed . html .
12 . Liu JJ , Bell CM , Matelski JJ , et al . Payments by US pharmaceutical and medical device manufacturers to US medical journal editors : retrospective observational study . BMJ . 2017 ; 359 : j4619 .
76 ASH Clinical News February 2018