Studies: Industry-Funded Research Produces Bias, and Is Not Always Disclosed
What should we know about medical researcher's financial ties, and when should we know it? Two new studies demonstrate the real risk of bias when industry pays for scientific studies, and the sad fact that much of these connections are never disclosed. The studies appeared in the latest Archives of Internal Medicine.
The first one, also reported by the Globe, evaluated the current level of disclosure provided to academic peer reviewed journals. As the article notes, transparency of academic articles are of great importance because they are “a permanent scientific record that is used by practicing physicians, guideline committees, purchasers, and patients to evaluate treatment options” and thus “[j]ournal editors, reviewers, and readers must be fully informed about authors' industry relationships to consider the potential for bias.”
What the investigators found is rather shocking. According to the study, more than half of the articles that were reviewed failed to disclose physician’s financial relationships with the analyzed sponsor medical device companies, Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer. This was a limited study and samples were limited to articles authored by recipients of more than $1 million in a single year, which ended up to be 40 orthopedic surgeons. It would be interesting to see what the disclosure rate would be for recipients of less than $1 million.
Despite all the discussions on conflicts of interest, there is still a pervasive problem where physicians’ financial conflicts are still undisclosed to the public, including patients. This is exactly why we passed the gift ban and disclosure law in Massachusetts. Massachusetts residents deserve better and we are fortunate to have benefited from the foresight and thoughtfulness of our legislature so all of these conflicts will be made publicly available this fall.
The second article is a good representation of why financial conflicts must be fully disclosed.
The Archives also published a study on the association between pharmaceutical support and basic science research on Erythropoiesis-Stimulating Agents (ESAs). ESAs are the most common drugs used to treat anemia by stimulating the natural process for making red blood cells. There have been concerns that ESAs in patients suffering from chemotherapy-associated anemia may potentially stimulate cancer. The scientific community has been performing research to evaluate the concerns. What the authors in this study decided to do was to evaluate the correlation between study results and pharmaceutical industry support.
The authors’ quantitative results show that investigators who did not receive industry funding included the potentially harmful effects of ESAs on cancer cells in 57% of the reports, whereas none of those who received funding made such reports. On the other hand, whereas only 14% of the scientists who did not receive funding from ESA manufacturers identified potentially beneficial antitumor effects of ESAs, 60% of those who received funding discussed potential benefits.
Scientific articles published in peer reviewed journals are building blocks to patient treatment. These two articles clearly support why financial conflicts need to be disclosed to the public, most importantly because industry funding by sponsoring medial device of pharmaceutical companies have the potential to affect the substantive contents of academic articles. It seems only reasonable that such financial relationships are fully disclosed.
We are grateful knowing that Massachusetts has enacted one of the strictest gift ban and disclosure law in the country. Our law mandates pharmaceutical and medical device companies to fully disclose any fee, payment, subsidy or other economic benefit with a value of at least $50 made to any physician, medical institution or other person authorized to prescribe, dispense, or purchase prescription drugs or medical devices. Consumers will also be able to view this information through a publicly available website and we thank DPH for making strong efforts to put the website together.