The government could save lives and cut costs if it made it more difficult to launch a new medication, according to a new study.
The study, conducted by Duke University and published August 5 in Health Affairs, said medication errors - or adverse drug events -could be prevented if the Food and Drug Administration required pharmaceutical companies to conduct larger pre-approval clinical trials.
Drug safety has been a much-discussed topic recently, but most of the attention has focused on post-marketing surveillance, not on determining how likely the drugs are to cause adverse effects, authors of the study said.
"Clinical trials are currently designed to get drugs approved," said lead author Shelby Reed, an associate professor in medicine at the Duke Clinical Research Institute. "Detection of adverse drug events, if it happens at all, occurs as a by-product."
Reed said the ability to detect adverse events should be "an explicit factor" in designing clinical trials.
"Pre-approval trials can't be the whole story when it comes to drug safety, but they can be a crucial part of an overall strategy," she added.
Reed and her co-authors said the FDA should require drug makers to increase the number of patients used in trials of drugs with greater odds of an adverse event. Pre-approval trials can then be designed with enough patients to be able to "reliably detect" the odds of adverse drug effects, she said.
Researchers said adverse drug events might outweigh a given drug's benefits depending on the severity of the disease being treated, the number of people suffering from the condition, and the availability of alternative therapies. The authors said the ability of clinical trials to detect potential medication errors could be strengthened by including patients at high risk for the adverse effects, as well as increasing the size of the trials.
Alan Garber, MD, a staff physician at the Veterans Affairs Palo Alto Health Care System and director of the Center for Health Policy and Center for Primary Care and Outcomes Research at Stanford University, said the best strategy for evaluating new therapies should vary from drug to drug. He called the Duke University study "a step toward the comprehensive, formal analysis needed to make rational decisions about drug safety."
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