According to a new review of randomized controlled trials, editorials and commentaries published in today's issue of the Journal of the American Medical Association (JAMA), patients who spend extra cash on brand name heart meds do no better than patients who go the generic route. Interestingly, the reviewers found significant discrepancies between the randomized controlled trials and the editorials and commentaries published in the literature.
Aaron S. Kesselheim, M.D., J.D., M.P.H., of Brigham and Women's Hospital and Harvard Medical School, Boston, and colleagues looked at studies published between 1984 and August of 2008 and identified 47 data-driven articles and 43 editorials and commentaries.
The researchers looked at angiotensin converting enzyme (ACE) inhibitors, anti-platelet medications, alpha- and beta-blockers, calcium-channel blockers, diuretics, statins, narrow therapeutic index (NTI) anti-arrhythmic meds and warfarin, and found no evidence that expensive brand name heart medications are better than generic equivalents.
Of the 47 research articles, 81 percent were randomized controlled trials. The studies found clinical equivalence in 100 percent of studies looking at beta-blockers (seven trials), antiplatelet agents (three trials), statins (two trials), ACE inhibitors (one trial), alpha-blockers (one trial), and for the NTI drugs - class I anti-arrhythmics (one trial) and warfarin (one trial). They found clinical equivalence in 71 percent of calcium-channel blockers (five of seven trials) and in 91 percent of diuretics (10 of 11 trials).
According to the FDA, "A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use," but patients and clinicians alike have had doubts about their equivalency and safety.
In fact, the reviewers found 43 editorials and commentaries that met their criteria and over half of those expressed negativity about switching to generics from brand name products, less than 30 percent were positive about substituting with generics and the rest did not reach a conclusion on the topic. When it came to the NTI meds in particular, about two-thirds of the articles discouraged generic substitution and less than one-fourth supported making the switch.
The discrepancies between the randomized controlled trials and the editorials and commentaries could be due to the authors' personal experiences or due to undisclosed financial ties with the industry, which about half of the former--and none of the latter--disclosed.