With new drugs being reviewed by regulatory agencies and then released onto the market faster than ever before, patients' safety is being compromised, according to an analysis published online Dec. 2 in the British Medical Journal.
David Kao, MD, a cardiovascular medicine fellow at the University of Colorado Health Sciences Center in Aurora, Colo., said that while drug regulatory bodies are under pressure to make new drugs available more quickly, there are concerns that the deadlines for approving drugs have shifted the focus away from safety.
Kao reviewed trends in drug approval times in the U.S. and suggested how drug-marketing techniques could be used to improve the way new drugs are monitored.
Previous research has shown that drugs approved in the U.S. during the two months before the mandated deadline were more likely to be withdrawn for safety reasons or to carry a warning.
Today's marketing techniques are so sophisticated, said Kao, that once a drug has been approved the products can be released on websites within 90 minutes. He cited the example of Merck's new treatment (sitagliptin) for hyperglycemia. Within 14 days of approval, 188 million patients, or 73 percent of the insured U.S. population, had been targeted by the marketing campaign.
The danger with so many people trying a new drug very quickly, he said, is that it can expose large numbers of patients to unknown risks. When Merck's anti-inflammatory drug Vioxx (rofecoxib) was withdrawn from the market for safety reasons, it had been available for five years and 20 million patients had been exposed to it.
Regulatory agencies have been criticized for their dependence on drug companies for funding. The agencies often collect fees from drug companies so that they can hire staff to review the drugs more quickly.
The European Agency for the Evaluation of Medicinal Products receives 75 percent of its funding in this way, 43 percent of the FDA budget is similarly derived, and the U.K.'s Medicines and Healthcare Products Regulatory Agency is completely funded by drug companies.
The author said that the systems for reporting adverse drug reactions must be improved and suggests using the very same effective drug marketing techniques to do this. For example, laws in the U.S. already compel TV advertisements to instruct patients experiencing negative side effects to report their symptoms to the FDA. This could be expanded to include campaigns dedicated to drug safety monitoring.
Kao concluded by saying that the only drug monitoring system that will minimize unknown risks must involve all the key players in healthcare, including doctors, regulatory bodies, drug companies and patients.