Date Submitted: Thursday, February 6, 2020 - 09:02
It is easy to understand what the ICMJE Disclosure Form is asking to be disclosed.
Yes
Comments: January 29, 2020
On the ICMJE Disclosure Form , comments from a reader and contributor.
Dear Committee Members:
I believe that entirely too much energy is being devoted to defining disclosure and conflict of interest, and not enough is being dedicated to the more important issue of defining and dealing with misconduct or wrongdoing.
Wrongdoing has been my recent focus: I have made a major effort over the past two years, at the start of my emeritus professorship, toward the dissection of a small set of papers reporting a clinical study of a new drug for a fatal disease, a drug that according to my interpretation of the papers shows no efficacy, yet it received rave reviews in major journals and was approved by the AMA and the EMA. The study was led by an academic and supported by the drug maker. Approval, in my estimation, resulted from shrewd obfuscation of the results such that the basic information was unavailable to any except the most assiduous reviewer, of whom I think there were none. I succeeded by sheer tenacity. Thus, the wrongdoing in this case was of two sorts; one, the drug’s lack of efficacy was hidden; two, the papers were written in a manner that not only disguised the drug’s shortcomings from the scrutiny of reviewers but embellished benefit.
I have just recently published my analysis in manuscript form (Doubts about the efficacy of tolvaptan for polycystic kidney disease. doi: 10.5414/CN109927Letter. e-pub: January 30, 2020)(manuscript attached). Preparation and submission of my manuscript encountered severe resistance. Virtually none of my colleagues (at a large research university) were willing to read, analyze, or critique my paper after I briefly summarized its contents. Submissions to ten (mostly kidney) journals were met with rejections after reviews from experts with obvious conflicts of interest, who likewise, were unwilling to comment on the substance of my criticisms. I have no explanation for the acceptance by Clinical Nephrology, although multiple submissions and revisions had vitiated my paper.
My overall inference from this experience, consistent with my impressions after forty years as an NIH R01 award-funded principle investigator, is that dishonesty permeates the academy, especially when Pharma is involved. I concur with Donald Kennedy, former editor of Science, who said many years ago in discussing scientific misconduct, that a persistent substratum of mendacity infuses our society. Further, I believe that the tolerance for misconduct is high; misconduct is met with silence unless the offences are so gross as to fulfill NIH definitions.
My recommendation to deal with the wrongdoing that I describe above is to force immediate publication of papers that describe perceived dishonesty. My paper would thus have been published early, before it was rejected by my peers. Every reader would have had the opportunity to consider the merits of my criticisms. Were my critical comments baseless, such would have become clear immediately and the issues would have been dropped. Were the criticisms substantive, patients and their physicians would have been forewarned as they considered use of the drug.
I intend my comments to apply to a specific form of wrongdoing that fits my example. Let this solution serve as a prototype for dealing with other forms of wrongdoing.
Sincerely yours,
Clark L. Anderson
Clark L. Anderson
2536 Canterbury Road
Upper Arlington, OH 43221
614-421-6947 home
614-530-8900 cell
anderson.48@osu.edu
www.andersonlab.com
https://en.wikipedia.org/wiki/Clark_L._Anderson
The information collected by the ICMJE Disclosure Form is appropriate.
Yes
Alessia Mariacher
Istituto Zooprofilattico Sperimentale Lazio e Toscana
Role(s):
An author who publishes work in medical journals
A reader of medical journals
Date Submitted: Tuesday, February 4, 2020 - 09:23
It is easy to understand what the ICMJE Disclosure Form is asking to be disclosed.
Yes
The information collected by the ICMJE Disclosure Form is appropriate.
Yes
Susanne Saussele
UMM Mannheim, Germany
Role(s):
An author who publishes work in medical journals
A health care professional
A reader of medical journals
Date Submitted: Tuesday, February 4, 2020 - 07:43
It is easy to understand what the ICMJE Disclosure Form is asking to be disclosed.
No
Comments: As a non native english speaker it is not absolutely clear what topically means and why this difference is made. as other I fully support the suggestion to distinguish 2 sections: related disclosures and all other
The information collected by the ICMJE Disclosure Form is appropriate.
No
Comments: I agree with othr comemnts that it is most propably a big difference in the amount of support reveived from any institution /Comany so this sould be categoriezed in different levels.
Paul Axelsson
Nordsjællands Hospital Hillerød, Denmark
Role(s):
An author who publishes work in medical journals
A health care professional
A reader of medical journals
Date Submitted: Monday, February 3, 2020 - 13:28
It is easy to understand what the ICMJE Disclosure Form is asking to be disclosed.
Yes
The information collected by the ICMJE Disclosure Form is appropriate.
No
Comments: You have not considered religious beliefs, and if they can affect the conclusions of the paper. E.g. papers regarding male circumsision - do the authors hold religious beliefs where this is considered normal?
Or even other personal convictions: If I were to publish a paper regarding vegetarian diet, I would feel I was not disclosing conflicts of interest, if I did not report my own dietary preferences.
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Displaying 91 - 95 of 129 commentsIt is easy to understand what the ICMJE Disclosure Form is asking to be disclosed.
The information collected by the ICMJE Disclosure Form is appropriate.
It is easy to understand what the ICMJE Disclosure Form is asking to be disclosed.
The information collected by the ICMJE Disclosure Form is appropriate.
It is easy to understand what the ICMJE Disclosure Form is asking to be disclosed.
The information collected by the ICMJE Disclosure Form is appropriate.
It is easy to understand what the ICMJE Disclosure Form is asking to be disclosed.
The information collected by the ICMJE Disclosure Form is appropriate.
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