Posted on behalf of Meera Swami
In 2009, the US Congress pledged $1.1 billion to improve comparative effectiveness research, a field dedicated to side-by-side evaluations of how drugs perform. The key question is whether new medicines really offer any improvements over the current standard of care at their time of approval. Without this information, are clinicians equipped to make the best treatment decisions?
Such concerns are reinforced by a study published yesterday in the Journal of the American Medical Association indicating that over the past decade approximately half of the new drugs approved by the US Food and Drug Administration (FDA) did not have publically available information on their comparative effectiveness when they were approved.
The authors of the study, Nikolas Goldberg and his colleagues at Brigham and Women’s Hospital and Harvard Medical School in Boston, suggest that increasing the proportion of drugs with this data and improving the accessibility of this information are crucial for making informed decisions. “Strategies are needed to enhance the accessibility of, and ultimately the use of, this information, particularly in the early marketing experience, when comparative effectiveness data from other sources are scarce or nonexistent,” they conclude.
Notably, these findings come a time when the future of the National Institute for Health and Clinical Excellence (NICE) — a UK agency that decides how best to allocate the country’s health spending — is under threat. So clearly this push for comparative effectiveness data has received a pushback. Given these cuts, and the situation revealed by Goldberg’s paper, those who believe comparative effectiveness data is a good thing need to make their voices better heard. Pouring money into the field doesn’t mean that the comparative effectiveness information it produces will necessarily be evaluated by regulators.