The Massachusetts Institute of Technology has joined forces with the US Food and Drug Administration as part of a large-scale attempt to pick up drug safety issues more rapidly after several high-profile drug safety scares in recent years, most notably Merck & Co’s painkiller Vioxx (rofecoxib), which was pulled from the market after showing a doubling in the risk of heart attack in patients given the drug for 18 months or longer. Recent enormous advances in medical treatment mean that more must be done to monitor new medicines’ safety, according to Scott Gottlieb, US Food and Drug Administration deputy commissioner for medical and scientific affairs.
The kinds of side effects that eventually emerge with new drugs are often rare and cannot be predicted or unearthed with any reasonably-sized clinical trial, but this is no reason to delay access to effective new medicines for patients who can safely benefit from them, he told the Massachusetts Institute of Technology Center for Biomedical Innovation’s second annual Biomedical Innovation Forum.
Also, if something is learnt about a drug’s safety after approval, this does not mean the system failed, that someone was wrong or the drug should never have been approved, he said. Nevertheless, the “culture of blame,” which focuses too much on assigning fault when medical problems surface rather than trying to learn from them, is claimed as a reason why too many hospital medical errors go unreported, he added.*
“Across medicine, we need to focus less on finger-pointing and more on working collaboratively to find facts sooner,” said Dr Gottlieb.
He also noted that systems for unearthing side effects can help to discover new benefits. For “dozens” of medicines approved over the last decade – eg. tumour necrosis factor inhibitors but also common drug classes such as ACE inhibitors and statins – initial approved indications have been dwarfed by subsequent discoveries about the drugs and the indications for which they were then approved.
While the FDA is now taking many new steps to improve its post-approval monitoring systems, which “have too often remained old school,” he said, this is not a question of “adding new hammers to FDA’s toolbox” or finding more ways to restrict the decisions made by doctors and patients.
Rather, improving current approaches will require working together to improve the information on which the agency relies, and its tools and resources for gathering this data. The agency also needs to do more to collect this information actively, and not just rely on passive databases that may report information months or years after the events occurred.
In one such initiative, announced at the Forum, the CBI will work with the FDA to develop a computerized system based on key tools used by government departments in the fight against bioterrorism and pandemic influenzas. “The group plans to leverage what we have learned from biosurveillance methods developed over the past eight years to help detect outbreaks and track influenza and SARS and applying them to the problem of post-marketing surveillance,” said Dr Gottlieb.
Added CBI director Dr Frank Douglas: “We will have real, adjudicated data that provides the best guidance for decision-making, and create a model that will hold great promise for the future.” According to an Associated Press report, the system will automatically search reams of government and health insurance data to throw up unusual patterns that could suggest a safety problem. The current system is reliant on manual reporting by patients and health professionals, which can often lead to a significant time lag to the problem being identified and the drug being restricted for use, or pulled off the market.
* A study reported in the Archives of Internal Medicine August 14-28 issue blames doctors’ “culture of perfectionism” rather than fear of lawsuits for their failure to disclose medical errors to patients. “Disclosure standards and training are necessary to meet public expectations and promote professional responsibility following errors,” say the researchers. Arch Intern Med. 2006;166:1585-1593 By Lynne Taylor
