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Medical treatment guidelines are rife with undisclosed conflicts of interest

REUTERS/Jim Bourg
Only 1 percent of the 290 clinical practice guidelines examined in the study disclosed financial relationships between the organizations and biomedical companies.

Despite recent efforts to eliminate or, at least, be more transparent about financial conflicts of interest, many medical organizations continue to produce clinical practice guidelines — official treatment recommendations for doctors and other health-care professionals to follow — that are rife with such conflicts, according to a troubling study published online Monday in the journal PLOS Medicine.

In fact, only 1 percent of the 290 clinical practice guidelines examined in the study disclosed financial relationships between the organizations and biomedical companies (ones that make and sell drugs, medical devices and other health-related products).

The study also found that only half of the guidelines included financial disclosure statements about the individuals who served on the committees responsible for creating the guidelines.

This lack of transparency undermines public confidence in the guidelines, as a commentary that accompanies the study point outs.

“When guideline recommendations are controversial — and that’s often — suspicion quickly turns to financial conflicts of interest,” notes the commentary’s author, Hilda Bastian, an Australian who has worked internationally as a health consumer advocate and who is currently on the editorial board of PLOS Medicine. “The perception of conflicts can call the reliability of a recommendation into question, and even more so if there was no disclosure. This new study adds fuel to those concerns.”

Quite a lot of fuel. The study also found that organizations with weaker conflict-of-interest policies are more likely to make positive recommendations about the use of prescription drugs and other biomedical products.

A widespread problem

For the study, a team of Canadian researchers from the University of Calgary collected information about funding sources, conflict-of-interest policies and conflict-of-interest disclosures for 95 organizations (professional associations and disease/condition interest groups) that produced 290 clinical practice guidelines published on the National Guidelines Clearinghouse website in 2012.

The researchers collected the information by reviewing the organizations’ websites and by sending surveys to a representative of each organization. (Thirty of the organizations declined to complete the surveys.)

Most of the guidelines (65 percent) were produced in the United States.

The guidelines on the Clearinghouse’s website are considered to be among the most authoritative ones in use. But, as the authors of this study found, they are riddled with conflicts of interest.

Those conflicts start with the organizations themselves. Biomedical companies helped fund 63 percent (60/95) of the organizations producing the clinical practice guidelines analyzed in the study. Yet, only four of the organizations’ 290 guidelines, or about 1 percent, provided disclosure statements regarding these financial relationships.

The lack of transparency didn’t stop there, however. Only 147 of the guidelines (51 percent) included disclosure statements for the individual committee members who wrote them.

Even when organizations reported having a policy for managing conflicts of interest (and 80 percent said they did), the groups often failed to follow those policies.  For example: 

  • Of the organizations whose policies stated that a majority of the members of each guidelines committee must be free of conflicts, 61 percent (25/41) had produced at least one guideline that had a majority of committee members with such conflicts.
  • Among the 47 organizations that said their industry partners were not permitted to directly fund the development of their clinical practice guidelines, three (6 percent) produced a guideline that was directly funded by one of those partners.
  • And of the 92 percent of organizations that specifically stated they published committee member disclosure statements within their guidelines, 18 percent published at least one guideline with no committee member disclosures.

A common influence

Perhaps not unsurprisingly, the researchers also found a significant relationship between the organizations’ policies regarding conflicts of interest and how positive the guidelines were about recommending patented drugs and other products sold by biomedical companies.

Guidelines produced by the groups with the most comprehensive conflict-of-interest policies included 9 percent fewer positive and 32 percent more negative recommendations regarding such products.

“Financial relationships between organizations that produce clinical practice guidelines and the biomedical industry appears to be common,” the researchers conclude. “These relationship are important because they may influence, through guideline usage, the practice of large numbers of healthcare providers.” 

“We believe that to effectively manage conflicts of interest, organizations that produce clinical practice guidelines need to develop robust conflict of interest policies that include procedures for managing violations of the policy, make the policies publicly available, and disclose all financial relationships with biomedical companies,” they add. 

FMI: You can read both the study and the editorial in full on the PLOS Medicine website.

Comments (3)

  1. Submitted by Steve Titterud on 06/02/2016 - 11:43 am.

    Without disclosure of conflicts of interest,…

    …can a patient give a truly informed consent??

    • Submitted by Albert Vierling on 06/04/2016 - 08:28 am.

      Yes you can

      at the cost of visiting multiple doctors for other opinions outside the HMO your suppose to be using. There is also doing your research. In other words take charge of your own care cause to them you are just another person in the 9 to 5 grind.

  2. Submitted by Claire Neely on 06/09/2016 - 10:04 am.

    Guidelines & COI

    The Institute for Clinical Systems Improvement (ICSI), a Minnesota-based independent, nonprofit health care improvement organization, greatly appreciates Susan Perry’s recent Second Opinion article, “Medical treatment guidelines are rife with undisclosed conflict of interest.” For over 20 years, ICSI and its members have developed evidence-based guidelines used by clinicians in Minnesota, nationwide, and in over 180 other countries.

    ICSI guidelines require the disclosure of all real or potential conflicts of interest by everyone who serves on and supports the work groups and review committees that develop, approve and maintain its scientific documents. ICSI’s board-appointed Conflict of Interest (COI) Review Committee reviews all conflict of interest declarations and determines whether or not an individual is eligible to participate. ICSI’s Board of Directors maintains ultimate responsibility for any actions or limitations related to COI declarations.

    Transparency about COI is a key component of the Institute of Medicine’s Clinical Practice Guidelines We Can Trust, and ICSI agrees that it is an essential component of trustworthy guideline development. Clinicians who rely on ICSI guidelines understand and appreciate the paramount importance of a robust and transparent COI policy.

    Thank you for calling attention to this important issue.

    Claire Neely, MD, Chief Medical Officer, ICSI
    https://www.icsi.org

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