BioPharma, Pharma

Many doctors writing clinical practice guidelines receive undisclosed industry payments, study finds

Greater transparency about conflicts of interest could curb punitive actions like MSKCC executive’s resignation last month, study author says.

Last month, controversy stemming from undisclosed financial relationships with the drug industry led to the resignation of one the top breast cancer doctors in the country. But two new studies have found that the issue of financial conflicts of interest in medicine goes beyond just one doctor.

Both studies were published Monday in the Journal of the American Medical Association, based on the assumption that financial conflicts of interests may affect the objectivity of clinical practice guidelines.

One study, by researchers at the University of Toronto, examined the prevalence of conflicts of interest among authors of clinical guidelines related to the drugs with the highest sales numbers in 2016. The other, by researchers at Oklahoma State University in Tulsa and Baylor Scott & White Health in Temple, Texas, did the same, but focused on gastroenterology, a specialty in which they said little research on the topic had been conducted relative to others, like oncology and dermatology.

Last month, Dr. Jose Baselga, chief medical officer of New York’s Memorial Sloan Kettering Cancer Center and a leading breast cancer expert, resigned after an investigation by The New York Times and ProPublica found that he had omitted financial relationships with drug companies in journal articles, including more than $3 million in payments from Swiss drugmaker Roche. Still, an expert said that despite the focus on disclosure, that alone will not solve the problem of bias.

The Canadian study, which focused on clinical practice guidelines written by 160 US physicians, found that 79 of them declared receipt of a payment in the guidelines or supplemental materials, with 50 declaring payments from companies marketing one of the drugs included in the analysis. However, 41 of the authors were found to have received, but not disclosed, receipt of payments marketing one of the drugs. At the same time, the researchers cautioned that the study was limited by lack of access to guideline voting records and also potential – and rarely corrected – inaccuracies in the source where they found conflict-of-interest declarations, the Centers for Medicare and Medicaid Services’ OpenPayments Database.

A way to resolve the issue would be for physicians and non-physicians with influence over clinical practice, including clinical practice guideline authors and authors of practice-changing research, should have a stringent process of not only disclosing industry payments but confirming them using open databases, said Dr. Samir Grover, lead study author and program director of the gastroenterology division at the university, in an email. “This should not be punitive, but rather this confirmation should be made protocol and should be publicly available,” he wrote, adding that greater transparency could prevent the need for punitive actions like Baselga’s resignation. For example, disclosures for manuscripts should include voluntary disclosures and those found in public databases.

The other study, which also used data from the CMS database, found that among 83 authors of 15 gastroenterology clinical practice guidelines, 44 received industry payments. But of the 83 authors, only 16 had both disclosed conflicts of interest in the clinical practice guidelines and were shown by the database to have received payments. Meanwhile, of 146 conflicts of interest disclosed by authors and 148 identified in the database, only 49 were both disclosed and evidenced by database payment records, the authors found.

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