Researchers With Financial Interests Show Bias Toward Favorable Conclusions
Researchers With Financial Interests Show Bias Toward Favorable Conclusions
February 23, 2010 (Crystal City, Virginia) — An analysis of published reports on the antidiabetic drug rosiglitazone (Avandia, GlaxoSmithKline) shows that researchers with ties to industry were more likely to conclude that the drug did not increase risk for myocardial infarction (MI) than those with no industry ties, according to a study presented here at the Preventive Medicine 2010: the Annual Meeting of the American College of Preventive Medicine.
The new analysis — presented as a poster by Mohammed Hassan Murad, MD, from the Mayo Clinic in Rochester, Minnesota — comes in the midst of a media maelstrom over a senate report, released on the weekend, which concluded that there are serious health risks associated with rosiglitazone that were not appropriately handled by the US Food and Drug Administration or the manufacturer.
In the case of rosiglitazone, there is an ongoing debate over a possible association between the drug and the risk for MI; many articles have been published on both sides of the issue. The debate provided an ideal scenario from which to compare researchers' conclusions and their associations with companies involved in the manufacturing of antihyperglycemic drugs.
Dr. Hassan Murad and colleagues conducted a review of 202 articles contributing to the controversy for a possible association between the risk for myocardial infarction and the use of rosiglitazone in patients with diabetes.
The objective of the Mayo Clinic team was to examine the extent to which study findings could be explained by the researchers' financial relationships.
Articles that were selected for review addressed the findings of 2 studies — a meta-analysis of small trials and a subsequent larger trial, which largely contributed to the rosiglitazone controversy. The aim of the study authors was to characterize the prevalence and effects of conflicting relationships and to examine the extent to which the position taken in the report could be explained by the researchers' conflicting relationships.
Two reviewers who were blinded to the financial relationships of the researchers evaluated each article and classified it as being favorable (supporting the argument that the drug does not increase the risk for MI), neutral, or unfavorable.
Among the 202 reports that were evaluated, 107 (53%) had a conflict of interest statement and 90 (45%) had a conflicting financial relationship. Importantly, among researchers who concluded that rosiglitazone does not increase risk for MI, 91% had financial relationships with antihyperglycemic agent manufacturers and 86% had relationships with rosiglitazone manufacturers.
Among articles representing unfavorable reviews, only 25% of researchers had financial relationships with antihyperglycemic agent manufacturers (odds ratio, 32; 95% confidence interval [CI], 8.7 - 117.2) and 18% had relationships with rosiglitazone manufacturers (odds ratio, 41.5; 95% CI, 10.9 - 157.4).
"Disclosure rates of conflicted financial relationships were misleadingly low, despite their clear and strong linkage with [researchers'] expressed views," the study authors write. "These findings underscore the need for further progress in reform for the scientific record to be trusted. The quality of care that patients receive is clearly affected by these findings."
The study demonstrates the problematic pairing of researchers with financial interests in a company and studies involving that company's product, said David L. Katz, MD, director of the Yale University Prevention Research Center in New Haven, Connecticut.
"If the reseacher has a direct financial interest in the item being studied, the reseacher — who, unlike the funder, is responsible for interpreting the data, will share the funder's bias," said Dr. Katz, who was not involved in the meta-analysis. "The trend in the literature indicates that most people do not adequately resist this inclination."
When the study is backed by high-quality methodology, however, the facts borne out from the methods should be solid enough to speak for themselves and override any researcher biases, Dr. Katz told Medscape Public Health & Prevention.
"The stronger the methodology, the more potential bias on the part of the researcher it can bear, because one measure of strong methodology is its capacity to overcome and minimize any influence of bias."
Dr. Katz noted, however, that the driving motivation behind most research is to test some kind of theory or conclusion, and that in itself could constitute a bias.
"There is always some bias. I would not waste my time doing a study, no matter who funded it, where I had no 'preference' regarding the outcome," he said. "Another name for that preference is . . . bias."
The study received no funding. Dr. Murad and Dr. Katz have disclosed no relevant financial relationships.
Preventive Medicine 2010: the Annual Meeting of the American College of Preventive Medicine (ACPM): Poster abstract 212694. Presented February 19, 2010.
February 23, 2010 (Crystal City, Virginia) — An analysis of published reports on the antidiabetic drug rosiglitazone (Avandia, GlaxoSmithKline) shows that researchers with ties to industry were more likely to conclude that the drug did not increase risk for myocardial infarction (MI) than those with no industry ties, according to a study presented here at the Preventive Medicine 2010: the Annual Meeting of the American College of Preventive Medicine.
The new analysis — presented as a poster by Mohammed Hassan Murad, MD, from the Mayo Clinic in Rochester, Minnesota — comes in the midst of a media maelstrom over a senate report, released on the weekend, which concluded that there are serious health risks associated with rosiglitazone that were not appropriately handled by the US Food and Drug Administration or the manufacturer.
In the case of rosiglitazone, there is an ongoing debate over a possible association between the drug and the risk for MI; many articles have been published on both sides of the issue. The debate provided an ideal scenario from which to compare researchers' conclusions and their associations with companies involved in the manufacturing of antihyperglycemic drugs.
Dr. Hassan Murad and colleagues conducted a review of 202 articles contributing to the controversy for a possible association between the risk for myocardial infarction and the use of rosiglitazone in patients with diabetes.
The objective of the Mayo Clinic team was to examine the extent to which study findings could be explained by the researchers' financial relationships.
Articles that were selected for review addressed the findings of 2 studies — a meta-analysis of small trials and a subsequent larger trial, which largely contributed to the rosiglitazone controversy. The aim of the study authors was to characterize the prevalence and effects of conflicting relationships and to examine the extent to which the position taken in the report could be explained by the researchers' conflicting relationships.
Two reviewers who were blinded to the financial relationships of the researchers evaluated each article and classified it as being favorable (supporting the argument that the drug does not increase the risk for MI), neutral, or unfavorable.
Among the 202 reports that were evaluated, 107 (53%) had a conflict of interest statement and 90 (45%) had a conflicting financial relationship. Importantly, among researchers who concluded that rosiglitazone does not increase risk for MI, 91% had financial relationships with antihyperglycemic agent manufacturers and 86% had relationships with rosiglitazone manufacturers.
Among articles representing unfavorable reviews, only 25% of researchers had financial relationships with antihyperglycemic agent manufacturers (odds ratio, 32; 95% confidence interval [CI], 8.7 - 117.2) and 18% had relationships with rosiglitazone manufacturers (odds ratio, 41.5; 95% CI, 10.9 - 157.4).
"Disclosure rates of conflicted financial relationships were misleadingly low, despite their clear and strong linkage with [researchers'] expressed views," the study authors write. "These findings underscore the need for further progress in reform for the scientific record to be trusted. The quality of care that patients receive is clearly affected by these findings."
The study demonstrates the problematic pairing of researchers with financial interests in a company and studies involving that company's product, said David L. Katz, MD, director of the Yale University Prevention Research Center in New Haven, Connecticut.
"If the reseacher has a direct financial interest in the item being studied, the reseacher — who, unlike the funder, is responsible for interpreting the data, will share the funder's bias," said Dr. Katz, who was not involved in the meta-analysis. "The trend in the literature indicates that most people do not adequately resist this inclination."
When the study is backed by high-quality methodology, however, the facts borne out from the methods should be solid enough to speak for themselves and override any researcher biases, Dr. Katz told Medscape Public Health & Prevention.
"The stronger the methodology, the more potential bias on the part of the researcher it can bear, because one measure of strong methodology is its capacity to overcome and minimize any influence of bias."
Dr. Katz noted, however, that the driving motivation behind most research is to test some kind of theory or conclusion, and that in itself could constitute a bias.
"There is always some bias. I would not waste my time doing a study, no matter who funded it, where I had no 'preference' regarding the outcome," he said. "Another name for that preference is . . . bias."
The study received no funding. Dr. Murad and Dr. Katz have disclosed no relevant financial relationships.
Preventive Medicine 2010: the Annual Meeting of the American College of Preventive Medicine (ACPM): Poster abstract 212694. Presented February 19, 2010.
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