Analysis of Generic and Brand-Name Cardiovascular Drugs Finds No Evidence of Brand-Name Superiority
Boston, MA – In a study of trials comparing generic and brand-name drugs used to treat cardiovascular diseases, researchers at Brigham and Women’s Hospital (BWH) found that brand-name drugs are not clinically superior to their generic counterparts. After also looking at editorials written on the topic, they were surprised to find that a substantial number cautioned against widespread substitution of generic drugs for brand-name drugs in the treatment of cardiovascular disease. The findings will be published in the December 3 issue of the Journal of the American Medical Association.
“Generic prescription drugs can help improve patient adherence to treatment plans by reducing spending on needed drugs. And though generics must be approved by the FDA, there is still widespread concern among physicians and patients that generic drugs are somehow inferior to brand-name drugs,” said Aaron S. Kesselheim, MD, JD, of the Division of Pharmacoepidemiology and Pharmacoeconomics at BWH and lead author of the study. “We found that head-to-head trials do not support this notion.”
The authors performed a systematic search of studies published in health care-related journals between 1984 and 2008 that compared clinical outcomes of generic and brand-name drugs used to treat cardiovascular disease. They identified 47 such studies, and a meta-analysis combining the results of clinical trials demonstrated no evidence for the superiority of brand-name drugs.
In addition, the authors reviewed all relevant editorials and commentaries from the same time period and found that about half expressed a negative view of the use of generic drugs to treat cardiovascular diseases, while only about a quarter supported the practice of substituting low-cost generics for brand-name drugs.
“We were surprised that so many editorials expressed a negative view of the interchangeability of generic and brand-name drugs, contradicting the available evidence on this point,” said Dr. William H. Shrank, MD, MSHS, of the Division of Pharmacoepidemiology and Pharmacoeconomics at BWH, and one of the co-authors of the study.
“It is possible that the disconnect between the data and opinions expressed stems from physicians’ personal experiences, anecdotal reports, and even popular media coverage of cases in the community,” said Dr. Kesselheim. He also commented that another possible explanation could be undisclosed financial relationships held by the editorialists, noting that nearly half of the trials and almost all of the editorials did not disclose funding sources or conflicts of interest.
The research was funded by a grant from the Attorney General Prescriber Education Program and investigator-initiated grants from the National Heart, Lung and Blood Institute, the National Institute on Aging, and the Agency for Healthcare Research and Quality.
Brigham and Women's Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomens.org.
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