Monday, March 30, 2009

Journal editorials fuel unfounded brand-name bias

Medical Tribune Unpublished
David Brill

Medical opinion leaders are adding to unnecessary spending by promoting the misperception that generic cardiovascular drugs are inferior to brand-name versions, a recent study suggests.

In a thorough systematic review and meta-analysis comprising 47 studies, researchers from Harvard Medical School, US, found that generic cardiovascular drugs were equivalent to brand-name drugs in almost all clinical outcomes.

They also observed, however, that more than half of the relevant journal editorials and commentaries published over the same period expressed negative views about the substitution of these medications.

“Unfortunately, in general, generic drugs are relatively under-used because there are a lot of misperceptions out there that they might somehow be inferior to brand-name drugs,” said Dr. Aaron Kesselheim, lead author of the Journal of the American Medical Association paper. [2008 Dec 3;300(21):2514-26]

“The best way to combat these misperceptions is by looking at the data so that’s what we tried to do. There was no evidence that brand-name drugs are superior to generic drugs,” he said, adding that the study is the first to his knowledge to take such a comprehensive approach to summarizing the literature in this field.

The rising cost of brand-name drugs is not only creating a financial burden but also directly contributing to poor health outcomes, the researchers wrote, citing a study which found that the promotion of generic or preferred medications improved adherence. [Arch Intern Med 2006 Feb 13;166(3):332-7]

Kesselheim called on both the authors and publishers of editorials to take greater responsibility for ensuring that opinion pieces have a reasonable evidence base and present both sides of the argument when the data are conflicting.

“Doctors look to these journals as a source of medical information and that can influence a lot of prescribing practices. It seems that that the general message of a lot of these editorials was not in concert with what the data show,” he said.

The research did not address the reasons underlying these negative attitudes but Kesselheim speculated that physicians may have “fallen into the same cognitive trap” as patients, who tend to naturally associate the word generic with meaning lower quality.

“Another alternative is that some of the physicians who are writing these editorials might have financial relationships with brand-name drug companies that color their opinion of brand-name drugs as compared to generic drugs,” he added.

The meta-analysis included 38 randomized controlled trials (RCTs) and nine retrospective studies addressing the clinical equivalence of nine different cardiovascular drug subclasses. Only FDA-approved brand-name medications were assessed.

Clinical equivalence was observed in all seven RCTs of beta-blockers, five out of seven RCTs of calcium channel blockers and 10 out of 11 RCTs of diuretics. All of the remaining RCTs – covering statins, antiplatelets, alpha-blockers, angiotensin-converting enzyme inhibitors, class 1 antiarrhythmics and warfarin – demonstrated the clinical equivalence of generic medications.

“The implications are that physicians can feel confident prescribing generic drugs for their patients with cardiovascular disease when appropriate for their condition … and patients can be confident that they’ll be getting the same clinical effects that they might be getting with a brand-name drug,” said Kesselheim, who is an instructor in medicine at Harvard Medical School.

The literature review and content analysis included 43 editorials, 23 of which were deemed to have a negative stance towards generic drug substitution. Twelve articles were in favor of the practice and eight were neutral.

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