Clinical practice guideline authors fail to disclose all industry payments

Authors of several American Academy of Dermatology (AAD) clinical practice guidelines have received sizable payments from industry that were often not completely disclosed, according to authors of a cross-sectional, descriptive study published in JAMA Dermatology.

Moreover, the proportion of authors receiving payments appeared to exceed the allowed threshold stated in AAD guideline administrative regulations, according to the authors of the study, which focused on three guidelines developed between 2013 and 2016: acne, atopic dermatitis, and office-based surgery.^2-4

The analysis included 49 physician authors, of whom 40 received any industry payments. Financial payments to those authors averaged $157,177 over the 3-year period, with 24% receiving more than $100,000, according to the published results.

More than half of the authors receiving payments from industry (22 out of 40) did not disclose them correctly, based on a comparison of the authors’ self-reported disclosures with what was reported in years 2013-2015 in the Open Payments database established via the Sunshine provisions of the Affordable Care Act.

“More than 70% of [guideline] authors received payments in all clinical practice guidelines” under evaluation, suggesting a potential lack of enforcement of AAD administrative regulations, according to the researchers.

Work groups for guidelines “must minimally include 51% of experts without relevant financial conflict of interest,” according to AAD Administrative Regulations, current as of April 10, 2017, that were cited in the JAMA Dermatology report.

AAD RESPONSE

Henry W. Lim, M.D., president of the AAD, responded to the study, saying in a prepared statement that the organization stands by the accuracy of its clinical practice guidelines and its regulations in place to “minimize the influence of potential conflicts of interest” in the guideline development process.

“While we maintain the guidelines studied in this paper were created in compliance with those regulations, we take seriously this issue, and continue to evaluate and refine our guidelines process to address both real and perceived potential conflicts of interest,” Dr. Lim said in the statement.

Dr. Lim said the AAD does not consider research activities to be conflicts when evaluating guidelines authors, since those activities are “vital in advancing clinical knowledge and fueling dermatologic innovation.”

The study by Checketts and colleagues used the four classifications used in Open Payments data, which include general payments such as consulting fees and honoraria, research payments, associated research payments where the physician is named as a principal investigator, and ownership or investment interest.

“As the authors of this paper acknowledge, there is no way to determine how these reported payments influenced physicians in the development of AAD guidelines - or indeed, whether these payments had any influence at all,” Dr. Lim added.

In his statement, Dr. Lim noted that Checketts and colleagues did not assess the “potential relevancy” of the payments data beyond noting that the companies made products related to the topics of the guidelines. “In doing so, they make the assumption that the physicians’ relationships are connected to those products, when those relationships could in fact be completely unrelated,” he said.

POTENTIAL FOR IMPROVEMENT?

In an interview with Dermatology Times, lead study author Jake X. Checketts, BS, said changes in guideline panel composition and disclosure policies that might improve transparency and minimize potential bias stemming from industry conflicts of interest.

“My biggest recommendation would be to construct guideline groups where the majority of the authors have no industry conflicts,” said Checketts, a medical student at the Oklahoma State University Center for Health Sciences, Tulsa.

That approach might avoid the discussion over whether or not a particular conflict of interest is “relevant” to a particular guideline.

“There's no reason why you shouldn't be able to find enough dermatologists who aren't heavily conflicted in industry to help efforts in making these guidelines,” Checketts added. “I think that's an easier route, rather than looking at whether or not the payment's relevant-look for people who don't have any conflicts at all, so then you don't have to make that decision.”

To assess relevancy, Checketts and colleagues evaluated whether or not the industry payments they identified came from companies that manufactured products related to guideline topics.

For the acne guideline, all of the top 5 companies that made payments to guideline authors had products relevant to the guideline available or in development, study authors reported.

For the atopic dermatitis guideline, 4 out of the top 5 companies that payment to the authors had relevant products, and likewise, 4 of the top 5 companies making payments to authors of the office-based surgery guideline had relevant products, the report says.

EDITORIAL REACTION

In a related editorial also published in JAMA Dermatology⁶, Kenneth A. Katz, MD, of Kaiser Permanente, San Francisco, Calif., said the study is “a reminder that physicians and other stakeholders should continue to guard against the potential for ties to industry … to inappropriately influence the way we care for our patients.”

However, he said it was “not clear” the results of the study were valid, questioning how the authors evaluated relevance of a manufacturer’s product to a guideline, and criticizing several other aspects of the study.

For example, he said the authors assessed payments made up to the date of publication for each clinical practice guideline, which means the study “likely” included payments made after guidelines were developed but before they were published.

“Given concerns about time frames and determination of relevance of products to clinical practice guidelines, it is not clear in fact that AAD violated its administrative regulations, at least in this regard,” Dr. Katz wrote in his editorial.

Nevertheless, Dr. Katz in his editorial called upon the AAD to review their processes and incorporate emerging best practices in guideline development.

“Given the questions that Checketts et al raise,” Dr. Katz wrote, “AAD should itself audit its adherence to its administrative regulations, report the findings, and implement changes, if needed.”

REFERENCES

1. Checketts JX, Sims MT, Vassar M. Evaluating Industry Payments Among Dermatology Clinical Practice Guidelines Authors. JAMA Dermatol. 2017;153(12):1229-1235. doi:10.1001/jamadermatol.2017.3109.

2. AAD Atopic Dermatitis Clinical Practice Guideline. American Academy of Dermatology. https://www.aad.org/practicecenter/quality/clinical-guidelines/atopic-dermatitis. Accessed January 9, 2017.

3. AAD Office Based Surgery Clinical Practice Guideline. American Academy of Dermatology. https://www.aad.org/practicecenter/quality/clinical-guidelines/office-based-surgery. Accessed January 9, 2017.

4. AAD Acne Clinical Practice Guideline. American Academy of Dermatology. https://www.aad.org/practicecenter/quality/clinical-guidelines/acne. Accessed January 9, 2017.

5. American Academy of Dermatology responds to JAMA Dermatology article on industry payments to guidelines authors. https://www.aad.org/media/news-releases/aad-responds-to-jama-dermatology-article-on-industry-payments-to-guidelines-authors. Accessed January 8, 2018.

6. Katz KA. Industry Influence in Dermatology Clinical Practice Guideline Development. JAMA Dermatol. 2017;153(12):1219-1220. doi:10.1001/jamadermatol.2017.4323.