Plastic and Reconstructive Surgery Advance Online Article DOI: 10.1097/PRS.0000000000000072 Letters to the Editor re: Conflicts of Interest
U. Tennessee Health Science Center
TE D
Edward A. Luce, M.D.
Financial Disclosure: "None of the authors has a financial interest in any of the
A
C
C
EP
products, devices, or drugs mentioned in this manuscript."
Copyright © American Society of Plastic Surgeons. All rights reserved.
Thank you for the opportunity to respond to Dr. Lineaweaver’s comments on “Financial conflicts of interest”1. He and I have engaged debate on this topic recently in the Annals of Plastic Surgery. Dr. Lineaweaver’s position2, provocative of my response3, is that full disclosure of financial conflicts of interest (COI) including the monetary amounts paid to the disclosure is not feasible, as proposed
TE D
in the original piece1, and; secondly, the exclusion of individuals with financial
conflict of interest from full participation in the process of scientific research and the peer review of same would be censorship.
In order, consider the purpose of disclosure: to enable the reading or listening
audience to judge the presence of bias and the degree of bias, if present, or in Dr.
Lineaweaver’s words, “With disclosures, academic presentations and publications
EP
should be considered on their merits, and the professional audience be allowed to
weigh the value of the material against presumption of bias based on disclosures”. That standard would dictate full disclosure, not qualified as “The authors have no financial interest to declare in relation to the content of this article.” or “The
C
authors have no sources of funding to report related to this submission”. Full disclosure would, by logic, if the audience is to judge degree of bias, include a quantitative (monies paid) yardstick of magnitude of such a conflict. To do so,
C
would not require a reductio ad absurdum objections of filed IRS returns, notarized statements, etc. but a statement of income accrued since, after all, the
A
reporting system for disclosures in general is honor based4. The standard of requirement of full disclosure on each and every occasion eliminates the potential for qualification by the author and should be adopted by our journals tout suite.
The second element of discussion that “extreme disclosure requirements” equates to censorship begs the question of implementation of appropriate exclusion of individuals with a defined financial COI from participation in the process of
Copyright © American Society of Plastic Surgeons. All rights reserved.
development of scientific literature either as Editor, Editorial Board membership, peer-review, publication of papers or discussion of same. Censorship, if the objective is suppression of information, is anathema to scientific investigation, publication for scrutiny, and discussion of same. What is proposed is protection of that scientific process from bias induced by financial conflicts of interest not
TE D
censorship. Nor what is under discussion here is a broad definition of “conflict”
generated by, for example, fee for medical care or a desire to climb the academic
ladder but rather the necessity for a full definition of financial conflicts of interest. Certainly, paid consultancy, part-or full-time employee of a member of industry, and service as member of the corporate governing structure would qualify.
Finally, the letter cites four examples of innovation from the past in hand and
EP
plastic surgery, three from 45 years or more. We can not ascertain at this juncture the relationship of those three investigators with industry. Conceivably, all three
collected royalties and the innovators of the vacuum-assisted device currently does so. Personally, this writer does not have moral or ethical concerns with the accrual
C
of financial rewards by individuals or their universities secondary to innovation. Regardless, as outlined in the piece1, industry-sponsored research could be
C
accomplished with maintenance of scientific integrity intact by utilization of an independent vehicle as the repository of industry funds and establishment of an
A
“arms-length” relationship with the investigators. Our focus should be directed towards assurance that the increasing incorporation of plastic surgery into a variety of forms of industry employ does not result in erosion of public confidence in a premier specialty.
Copyright © American Society of Plastic Surgeons. All rights reserved.
REFERENCES:
1.
Luce EA, “Financial conflicts of interest in plastic surgery: Background, potential for bias, disclosure, and transparency”, Plast. Recon. Surg., (2015); 135(4):1149-1155. Lineaweaver W, “Conflicts of interest, disclosures, CME credits, censorship”,
TE D
2.
Ann. of Plast. Surg., (2015); 74(1):1-2. 3.
Luce EA, “Conflicts of interest”, Ann. Plast. Surg., (2015); 74(4):387
4.
Luce EA, “Discussion: Financial conflicts of interest in plastic surgery:
Background, potential for bias, disclosure, and transparency”, Plast. Recon.
A
C
C
EP
Surg., (2015); 135(6):1067e-1069e.
Copyright © American Society of Plastic Surgeons. All rights reserved.
U. Tennessee Health Science Center
TE D
Edward A. Luce, M.D.
Financial Disclosure: "None of the authors has a financial interest in any of the
A
C
C
EP
products, devices, or drugs mentioned in this manuscript."
Copyright © American Society of Plastic Surgeons. All rights reserved.
Thank you for the opportunity to respond to Dr. Lineaweaver’s comments on “Financial conflicts of interest”1. He and I have engaged debate on this topic recently in the Annals of Plastic Surgery. Dr. Lineaweaver’s position2, provocative of my response3, is that full disclosure of financial conflicts of interest (COI) including the monetary amounts paid to the disclosure is not feasible, as proposed
TE D
in the original piece1, and; secondly, the exclusion of individuals with financial
conflict of interest from full participation in the process of scientific research and the peer review of same would be censorship.
In order, consider the purpose of disclosure: to enable the reading or listening
audience to judge the presence of bias and the degree of bias, if present, or in Dr.
Lineaweaver’s words, “With disclosures, academic presentations and publications
EP
should be considered on their merits, and the professional audience be allowed to
weigh the value of the material against presumption of bias based on disclosures”. That standard would dictate full disclosure, not qualified as “The authors have no financial interest to declare in relation to the content of this article.” or “The
C
authors have no sources of funding to report related to this submission”. Full disclosure would, by logic, if the audience is to judge degree of bias, include a quantitative (monies paid) yardstick of magnitude of such a conflict. To do so,
C
would not require a reductio ad absurdum objections of filed IRS returns, notarized statements, etc. but a statement of income accrued since, after all, the
A
reporting system for disclosures in general is honor based4. The standard of requirement of full disclosure on each and every occasion eliminates the potential for qualification by the author and should be adopted by our journals tout suite.
The second element of discussion that “extreme disclosure requirements” equates to censorship begs the question of implementation of appropriate exclusion of individuals with a defined financial COI from participation in the process of
Copyright © American Society of Plastic Surgeons. All rights reserved.
development of scientific literature either as Editor, Editorial Board membership, peer-review, publication of papers or discussion of same. Censorship, if the objective is suppression of information, is anathema to scientific investigation, publication for scrutiny, and discussion of same. What is proposed is protection of that scientific process from bias induced by financial conflicts of interest not
TE D
censorship. Nor what is under discussion here is a broad definition of “conflict”
generated by, for example, fee for medical care or a desire to climb the academic
ladder but rather the necessity for a full definition of financial conflicts of interest. Certainly, paid consultancy, part-or full-time employee of a member of industry, and service as member of the corporate governing structure would qualify.
Finally, the letter cites four examples of innovation from the past in hand and
EP
plastic surgery, three from 45 years or more. We can not ascertain at this juncture the relationship of those three investigators with industry. Conceivably, all three
collected royalties and the innovators of the vacuum-assisted device currently does so. Personally, this writer does not have moral or ethical concerns with the accrual
C
of financial rewards by individuals or their universities secondary to innovation. Regardless, as outlined in the piece1, industry-sponsored research could be
C
accomplished with maintenance of scientific integrity intact by utilization of an independent vehicle as the repository of industry funds and establishment of an
A
“arms-length” relationship with the investigators. Our focus should be directed towards assurance that the increasing incorporation of plastic surgery into a variety of forms of industry employ does not result in erosion of public confidence in a premier specialty.
Copyright © American Society of Plastic Surgeons. All rights reserved.
REFERENCES:
1.
Luce EA, “Financial conflicts of interest in plastic surgery: Background, potential for bias, disclosure, and transparency”, Plast. Recon. Surg., (2015); 135(4):1149-1155. Lineaweaver W, “Conflicts of interest, disclosures, CME credits, censorship”,
TE D
2.
Ann. of Plast. Surg., (2015); 74(1):1-2. 3.
Luce EA, “Conflicts of interest”, Ann. Plast. Surg., (2015); 74(4):387
4.
Luce EA, “Discussion: Financial conflicts of interest in plastic surgery:
Background, potential for bias, disclosure, and transparency”, Plast. Recon.
A
C
C
EP
Surg., (2015); 135(6):1067e-1069e.
Copyright © American Society of Plastic Surgeons. All rights reserved.
