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“A Process-Based Approach to Conflicts of Interest”
  • David Birnkrant,
  • Jane Black,
  • John Carter
David Birnkrant
Case Western Reserve University School of Medicine

Corresponding Author:dbirnkrant@metrohealth.org

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Jane Black
Case Western Reserve University School of Medicine
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John Carter
Case Western Reserve University School of Medicine
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Abstract

The current system for disclosing financial conflicts of interest (COIs) can be traced back to the “Uniform requirements for manuscripts submitted to medical journals,” published in 1997. Meanwhile, new molecular and genetic therapies are transforming clinical medicine and these therapies have radically altered the financial landscape of drug development. The average price of new drugs has risen sharply, and in niche areas like rare diseases, the cost of new therapies can be stratospheric. Now, even rare or “orphan” diseases are funded by private investment. With high profitability, there is a new pathway for drug development involving unprecedented ties between industry and academia. The potential for COIs has greatly expanded and decisions that were once science-driven have become profit-driven. As a result, the risk that marginally effective, ineffective and even hazardous treatments will make their way to patients has greatly increased. In this editorial, we propose a system built on process-based COIs. This new system would trace the developmental journey of a drug from the lab to patients. All financial ties that institutions and individuals have to the drug would be disclosed at each developmental step. The goal would be to create a healthy skepticism and debate over the studies behind new drugs, restoring a scientific focus to the assessment of drug efficacy. When society’s limited resources are used to pay for drugs whose excessive cost primarily benefits investors and corporations, it derails scientific objectivity, harms patients, and threatens the financial stability of our health care systems.
02 Nov 2022Submitted to Pediatric Pulmonology
02 Nov 2022Submission Checks Completed
02 Nov 2022Assigned to Editor
02 Nov 2022Review(s) Completed, Editorial Evaluation Pending
04 Nov 2022Reviewer(s) Assigned
27 Dec 2022Editorial Decision: Revise Major
31 Jan 20231st Revision Received
31 Jan 2023Submission Checks Completed
31 Jan 2023Assigned to Editor
31 Jan 2023Reviewer(s) Assigned
31 Jan 2023Review(s) Completed, Editorial Evaluation Pending
12 Mar 2023Editorial Decision: Accept