Three-quarters of the members on guideline panels that proposed changes in disease definitions and diagnostic criteria had ties to drug companies, commonly working as consultants, advisers, and speakers to a median of seven companies, a study found.
Furthermore, 12 of the 14 panel chairs had financial ties to the pharmaceutical industry, according to the research, published Tuesday in PLoS Medicine.
"Companies with financial relationships with the greatest proportion of panel members were marketing or developing drugs for the same conditions about which those members were making critical judgements," Ray Moynihan, of Bond University in Robina, Australia, and colleagues wrote.
GlaxoSmithKline (GSK), for example, had financial ties to 20 of 24 members of a 2009 task force that developed new definitions for asthma control, severity, and exacerbations. GSK markets the asthma blockbuster treatment Advair (fluticasone propionate/salmeterol), which generated more than $3.9 billion in U.S. sales last year, according to the company's financial records.
Biogen, which makes the multiple sclerosis (MS) drug interferon beta-1a (Avonex), had ties to 13 of 18 members on a 2010 MS panel that widened the definition to simplify diagnosis, the study found.
Thirteen of 17 members on a panel about anemia tied to chronic kidney disease had ties to the biotech company Amgen, which makes the drug darbepoetin alfa (Aranesp) to treat the condition. The panel, however, narrowed the definition of disease.
Few studies have examined the financial ties of panels reviewing and changing the definition of common health conditions.
"Our aim was to identify guideline panels in the U.S. setting that have most recently made decisions about definitions or diagnostic thresholds for common conditions, and to report on any proposed changes and their industry ties," Moynihan and colleagues wrote.
The researchers looked at panels with broad U.S. recognition publishing decisions on disease definitions between 2000 and April 2013.
The authors limited their search to 14 common diseases where changes in the definition were made:
- Attention deficit/hyperactivity disorder
- Alzheimer's disease
- Anemia
- Asthma
- Bipolar disorder
- Hypercholesterolemia
- Chronic obstructive pulmonary disease
- Depression
- Diabetes
- Hypertension
- Gastroesophageal reflux disease (GERD)
- Myocardial infarction
- MS
- Rheumatoid arthritis
Diseases with no definitional changes -- HIV and osteoarthritis -- were excluded, and certain conditions and drug classes were excluded for being too broad such as cancer, hormonal contraceptives, and narcotics.
The study next looked at published disclosure sections to find financial industry ties such as speaker fees, research grants, stock, and royalties.
After reviewing the most recent panels that changed the definition of diseases, just one -- on type 2 diabetes -- stated its members had no conflicts of interest.
Among the 15 panels, 12 included members who had ties to multiple companies. Another panel, which chose to widen the definition of GERD, had ties to only one company.
"For the 12 panels for which ties were disclosed to more than one company, almost all companies with ties to the three highest proportions of panel members were also active in the market for that panel's condition, with at least one drug on the market or in the research pipeline," the authors wrote.
The Institute of Medicine in 2009 found physician-industry relationships were widespread and create significant risks. In 2011, a subsequent IOM report recommended guideline developers not have financial conflicts.
The current study is similar to a 2011 review in PLoS ONE which found 56% to 87% of clinical guideline writers had conflicts of interest.
Moynihan's study had several limitations, the authors noted. It lacked a comparison group to draw an association between industry ties and proposals to change disease definitions.
The study relied solely on disclosed ties, "likely leading to an underestimate of their extent," the authors said. The authors also excluded broad, common conditions like back problems, opening the potential for missing important examples.
"Finally, we note that while we tried to ensure an exhaustive and multilayered search strategy, we are unaware of any established method for identifying panel publications that review or propose changes to disease definitions," the researchers stated.
Disclosures
The study was funded by Austrialia's National Health and Medical Research Council's Screening and Test Evaluation Program Grant.
Primary Source
PLoS Medicine
Source Reference: Moynihan RN, et al "Expanding disease definitions in guidelines and expert panel ties to industry: A cross-sectional study of common conditions in the United States" PLoS Med 2013; DOI: 10.1371/journal.pmed.1001500.