Expanding Disease Definitions in Guidelines and Expert Panel Ties to Industry:A Cross-sectional Study of Common Conditions in the United States

BACKGROUND: Financial ties between health professionals and industry may unduly influence professional judgments and some researchers have suggested that widening disease definitions may be one driver of over-diagnosis, bringing potentially unnecessary labeling and harm. We aimed to identify guidelines in which disease definitions were changed, to assess whether any proposed changes would increase the numbers of individuals considered to have the disease, whether potential harms of expanding disease definitions were investigated, and the extent of members' industry ties. METHODS AND FINDINGS: We undertook a cross-sectional study of the most recent publication between 2000 and 2013 from national and international guideline panels making decisions about definitions or diagnostic criteria for common conditions in the United States. We assessed whether proposed changes widened or narrowed disease definitions, rationales offered, mention of potential harms of those changes, and the nature and extent of disclosed ties between members and pharmaceutical or device companies. Of 16 publications on 14 common conditions, ten proposed changes widening and one narrowing definitions. For five, impact was unclear. Widening fell into three categories: creating “pre-disease”; lowering diagnostic thresholds; and proposing earlier or different diagnostic methods. Rationales included standardising diagnostic criteria and new evidence about risks for people previously considered to not have the disease. No publication included rigorous assessment of potential harms of proposed changes. Among 14 panels with disclosures, the average proportion of members with industry ties was 75%. Twelve were chaired by people with ties. For members with ties, the median number of companies to which they had ties was seven. Companies with ties to the highest proportions of members were active in the relevant therapeutic area. Limitations arise from reliance on only disclosed ties, and exclusion of conditions too broad to enable analysis of single panel publications. CONCLUSIONS: For the common conditions studied, a majority of panels proposed changes to disease definitions that increased the number of individuals considered to have the disease, none reported rigorous assessment of potential harms of that widening, and most had a majority of members disclosing financial ties to pharmaceutical companies. Please see later in the article for the Editors' Summar

Expanding disease definitions in guidelines and expert panel ties to industry: A cross-sectional study of common conditions in the United States

Background: Financial ties between health professionals and industry may unduly influence professional judgments and some researchers have suggested that widening disease definitions may be one driver of over-diagnosis, bringing potentially unnecessary labeling and harm. We aimed to identify guidelines in which disease definitions were changed, to assess whether any proposed changes would increase the numbers of individuals considered to have the disease, whether potential harms of expanding disease definitions were investigated, and the extent of members' industry ties. Methods and Findings: We undertook a cross-sectional study of the most recent publication between 2000 and 2013 from national and international guideline panels making decisions about definitions or diagnostic criteria for common conditions in the United States. We assessed whether proposed changes widened or narrowed disease definitions, rationales offered, mention of potential harms of those changes, and the nature and extent of disclosed ties between members and pharmaceutical or device companies. Of 16 publications on 14 common conditions, ten proposed changes widening and one narrowing definitions. For five, impact was unclear. Widening fell into three categories: creating "pre-disease''; lowering diagnostic thresholds; and proposing earlier or different diagnostic methods. Rationales included standardising diagnostic criteria and new evidence about risks for people previously considered to not have the disease. No publication included rigorous assessment of potential harms of proposed changes. Among 14 panels with disclosures, the average proportion of members with industry ties was 75%. Twelve were chaired by people with ties. For members with ties, the median number of companies to which they had ties was seven. Companies with ties to the highest proportions of members were active in the relevant therapeutic area. Limitations arise from reliance on only disclosed ties, and exclusion of conditions too broad to enable analysis of single panel publications. Conclusions: For the common conditions studied, a majority of panels proposed changes to disease definitions that increased the number of individuals considered to have the disease, none reported rigorous assessment of potential harms of that widening, and most had a majority of members disclosing financial ties to pharmaceutical companies

Different ways to expand disease definitions.

<p>Different ways to expand disease definitions.</p

Companies with highest proportions of ties, and drugs in therapeutic area.

a<p>Analysis not possible for Cholesterol 2002, diabetes, GERD panels.</p><p>CKD, chronic kidney disease; n/a, not available.</p

Nature and extent of disclosed ties, by panel.

a<p>Individual members can disclose ties to more than one company.</p>b<p>Other = stock, employee, travel, royalties.</p>c<p>Non-industry ties include ties to public agencies, non-government organizations, and publishers; some disclosure sections did not include non-industry ties.</p>d<p>Disclosure sections lumped some categories together.</p><p>CKD, chronic kidney disease; IQR, interquartile range; MI, myocardial infarction; MS, multiple sclerosis; n/a, not available; RA, rheumatoid arthritis.</p

Conditions and characteristics of the panels and publications included in the study.

a<p>The same Mood Disorders work group proposed separate changes to bipolar and depression.</p>b<p>The cholesterol 2002 panel publication was silent on disclosure.</p>c<p>The COPD panel did not separate speaker and consultant ties.</p>d<p>The diabetes panel disclosed no ties.</p>e<p>GERD panel disclosures only pertained to one company and did not include separate categories.</p>f<p>The myocardial infarction panel reported ties in a method that did not allow categorization of different forms of tie.</p>g<p>The rheumatoid arthritis panel did not separate all speaker and consultant ties.</p><p>MI, myocardial infarction; MS, multiple sclerosis; n/a, not available; RA, rheumatoid arthritis.</p

Flowchart identifying study conditions and panels reviewing definitions.

<p>Note: bipolar/depression was one panel.</p