More Than Half of Physician Guideline Authors for Expensive Medications Have Undeclared Conflicts of Interest

MedicalResearch.com Interview with:

Samir C. Grover MD, MEd, FRCPC Division of Gastroenterology Program Director Division of Gastroenterology Education Program  University of Toronto

Dr. Grover

Samir C. Grover MD, MEd, FRCPC
Division of Gastroenterology Program Director
Division of Gastroenterology Education Program
University of Toronto

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We know that physician-industry interactions are commonplace. Because of this, there has been a movement to make the presence of these relationships more transparent. For clinical practice guidelines, this is especially important as these documents are meant to be objectively created, evidence based, and intended to guide clinical practice.

The standard in the US come from the National Academy of Medicine report, “Clinical Practice Guidelines We Can Trust”, which suggests that guideline chairs should be free of conflicts of interest, less than half of the guideline committee should have conflicts, and that guideline panel members should declare conflicts transparently.

Other studies, however, have shown that some guidelines don’t adhere to this advice and have committee members who don’t disclose all conflicts. We thought to look at this topic among medications that generate the most revenue, hypothesizing that undeclared conflicts would be especially prevalent in this setting.

We found that, among 18 guidelines from 10 high revenue medications written by 160 authors, more than (57%) had a financial conflict of interest, meaning they received payments from pharmaceutical companies that make or market medications recommended in that guideline. About a quarter of authors also received, and didn’t disclose payments from one of these companies. Almost all the guidelines did not adhere to National Academy of Medicine standards.

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Oncologist-Authors Often Do Not Fully Disclose Financial Relationships with Pharmaceutical Companies

MedicalResearch.com Interview with:

MedicalResearch.com Interview with: Cole Wayant Oklahoma State University Center for Health Sciences ‐ Analytical and Institutional Research Tulsa, OK MedicalResearch.com: What is the background for this study? What are the main findings? Response: New FDA-approved oncology drugs are essential to oncology practice. These drugs may immediately change clinical care by offering better treatments for common, lethal forms of cancer. But, new FDA-approved oncology drugs are expensive and have been shown to have variable efficacy. Given the importance of new FDA-approved oncology drugs to patients and physicians, the trials that underpin the FDA-approval of these drugs must be free from bias and transparent. Therefore, we investigated the financial relationships between oncologist-authors of clinical trials that underpin FDA-approvals. MedicalResearch.com: What should readers take away from your report? Response: The key takeaway from our study is that oncologist-authors often do not fully disclose their financial relationships with pharmaceutical companies. Financial disclosures are important for the reasons of transparency and trust between physicians and other stakeholders, such as patients. Disclosing conflicts of interest helps readers interpret the findings of a research study, especially given the fact that drug companies finance their own drug trials. MedicalResearch.com: What recommendations do you have for future research as a result of this work? Response: In the future, beyond recommending that authors fully disclose all financial relationships with the sponsor of the trial, I recommend that journals use the Open Payments Database to verify the accuracy and completeness of author disclosure statements. Doing so is a small first step toward mitigating the potential for financial bias in the oncology literature.” Disclosures: I do not have anything else to add. None of the authors have conflicts of interest - financial or otherwise. Citation: Financial Conflicts of Interest Among Oncologist Authors of Reports of Clinical Drug Trials  <span class="last-modified-timestamp">Aug 30, 2018 @ 5:06 pm</span> The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

Cole Wayant

Cole Wayant BS
Oklahoma State University Center for Health Sciences ‐ Analytical and Institutional Research
Tulsa, OK

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: New FDA-approved oncology drugs are essential to oncology practice. These drugs may immediately change clinical care by offering better treatments for common, lethal forms of cancer.

But, new FDA-approved oncology drugs are expensive and have been shown to have variable efficacy. Given the importance of new FDA-approved oncology drugs to patients and physicians, the trials that underpin the FDA-approval of these drugs must be free from bias and transparent. Therefore, we investigated the financial relationships between oncologist-authors of clinical trials that underpin FDA-approvals. 

MedicalResearch.com: What should readers take away from your report?

Response: The key takeaway from our study is that oncologist-authors often do not fully disclose their financial relationships with pharmaceutical companies. Financial disclosures are important for the reasons of transparency and trust between physicians and other stakeholders, such as patients. Disclosing conflicts of interest helps readers interpret the findings of a research study, especially given the fact that drug companies finance their own drug trials.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: In the future, beyond recommending that authors fully disclose all financial relationships with the sponsor of the trial, I recommend that journals use the Open Payments Database to verify the accuracy and completeness of author disclosure statements. Doing so is a small first step toward mitigating the potential for financial bias in the oncology literature.” 

Disclosures: I do not have anything else to add. None of the authors have conflicts of interest – financial or otherwise.

Citation:

Wayant C, Turner E, Meyer C, Sinnett P, Vassar M. Financial Conflicts of Interest Among Oncologist Authors of Reports of Clinical Drug Trials. JAMA Oncol. Published online August 30, 2018. doi:10.1001/jamaoncol.2018.3738

Aug 30, 2018 @ 5:06 pm

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

 

Medical Textbooks Riddled With Undisclosed Conflicts of Interest

MedicalResearch.com Interview with:

Brian J. Piper, PhD, MS Department of Basic Sciences Geisinger Commonwealth School of Medicine Scranton, PA 18509

Dr. Piper

Brian J. Piper, PhD, MS
Department of Basic Sciences
Geisinger Commonwealth School of Medicine
Scranton, PA 18509

MedicalResearch.com: What is the background for this study?

Response: The authors of this study are biomedical scientists, health care providers and educators who teach medical and pharmacy students. It is a standard practice in reputable medical journals like the New England Journal of Medicine to disclose conflicts of interest (CoI). Reputable sources like the Cochrane Library also disclose CoIs and analyze for their potential impact on the evidence base. Unfortunately, textbooks, which can be highly influential in the training of medical professionals, usually do not disclose their conflicts of interest.

A prior study in this quantitative bioethics area found that more than one-quarter of a team-authored pharmacology textbook, Goodman and Gilman’s Pharmacological Basis of Therapeutics, had an undisclosed patent (PLoS One, 2015; 10: e0133261).  The goal of this investigation was to determine whether there were undisclosed CoIs in textbooks used in the training and as a reference for allopathic physicians, osteopathic physicians, dentists, pharmacists, nurses and other allied healthcare providers.  Continue reading

Financial Ties of Principal Investigators Associated With Positive Outcomes

MedicalResearch.com Interview with:
Salomeh Keyhani MD
Associate professor of general internal medicine
San Francisco VA Medical Center and University of California
San Francisco, CA 94121, USA

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Randomized controlled trials are the foundation of the evidence base. We examined the prevalence of financial ties in randomized controlled trials and also examined the relationship of financial ties of principal investigators (PI) with trial outcome. We defined a financial tie as the direct compensation (e.g., consulting fees) of a PI by the drug manufacturer of interest. Although there have been past studies that have examined this relationship, many did not separate financial ties from funding source for the trial and many were focused on one specialty, journal, or type of drug.

This study identified a random sample of RCTs published in 2013 that were focused on assessing drug efficacy. Both the disclosure section of the paper and several online databases (Medline, Google, Propublica’s Dollars for Doctors, and the US Patent Office) were searched for evidence of financial ties. Principal investigators financial ties with industry were independently associated with positive study outcomes.

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Conflicts of Interest in Peer Review of Biomedical Research Funding Studied

Stephen Gallo, Ph.D. Technical Operations Manager American Institute of Biological Sciences Scientific Peer Advisory and Review Services Reston, VA  20191MedicalResearch.com Interview with:
Stephen Gallo, Ph.D.
Technical Operations Manager
American Institute of Biological Sciences Scientific Peer Advisory and Review Services
Reston, VA  20191

Medical Research: What is the background for this study? What are the main findings?

Dr. Gallo: Peer review is an evaluation process widely used to help research funders identify the best projects to support. A cornerstone of the process is the independence and integrity of the review panel, which includes a fair and non-conflicted evaluation of the proposed research. Despite the importance of the process, there are few research studies  investigating the frequency and type of conflicts that occur, particularly with regard to the independent peer review of basic science research proposals.

To improve our understanding of conflict of interest in the peer review process, the American Institute of Biological Sciences (AIBS) conducted a retrospective analysis of conflict of interest data from the independent peer review of 282 biomedical research applications.

The overall ‘conflicted-ness’ of these panels was significantly lower than that reported for regulatory review panels, which have been studied by others. This might be explained by the fact that no direct financial conflicts were identified; the majority of identified conflicts were institutional or collaborative in nature.

The analysis revealed that 35 percent of conflicts were self-reported by review panel members. Importantly, peer review panel managers identified 65 percent of conflicts. These results underscore the important role administrators who organize review panels play in identifying conflicts of interest.

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