Talking to Different Audiences: Mini-Sentinel, precursor to the FDA's long-awaited Sentinel drug safety surveillance system, may soon reap benefits for insurers and patients.
Year: 2011
Type: article
Abstract: By all accounts, the proposal that the United States should create a nationwide drug surveillance system to track adverse effects was considered a great idea. After years of discussion, heated political debate, and nitty-gritty processing work, the first leg of the long journey to establish this therapeutic radar system — known as the Sentinel system — is almost complete. And once it’s in place, lengthy, and possibly discordant, discussions on the system’s full potential are sure to follow.
Richard Platt, MD
As the system was originally conceived, the U.S. Food and Drug Administration was to start with Medicare data, then add in data from private insurers. The idea was to help regulators scan a haystack of healthcare data to find that thin needle of information needed to identify, say, the nation’s next rofecoxib (Vioxx) — a blockbuster drug that passed regulatory muster only to trigger dangerous side effects that didn’t emerge until years after marketing approval. Ineffective drugs that were simply wasting dollars also could be flagged and sidelined.
Mike Leavitt, Secretary of Health and Human Services under President George W. Bush, asked the FDA to start exploring how to set up such a therapeutic alert system back in 2005. In 2007, lawmakers passed a bill requiring the agency to do it.
Then, in early 2010, the FDA contracted with a consortium of organizations led by the Harvard Pilgrim Health Care Institute to create a “Mini-Sentinel” program that would pool data from millions of Americans, offering a scaled-down but fully functioning surveillance system that would demonstrate what the data had to offer and how the larger system could be implemented.
“Once operational, the Sentinel system will help us find answers to important drug safety questions, leading to stronger safeguards for public health while still protecting the privacy and security of individual health information,” said Janet Woodcock, MD, director of the FDA’s Center of Drug Evaluation and Research, when the pilot project was set up.
Mini-Sentinel is “intended to be a laboratory to develop methods and resources and to fulfill the FDA’s mandate to use electronic health information” for a safety-surveillance program, says Richard Platt, MD, who leads the 20 people who are beavering away at Mini-Sentinel’s command center. “It will be more than a roadmap — it will be a set of electronic data resources and tools” that can provide “a viable program of active surveillance.”
“The FDA is asking us to create the system’s capabilities and to implement them,” says Platt, who is professor and chair of the Department of Population Medicine at Harvard Medical School and executive director of the Harvard Pilgrim Health Care Institute. Now two years into the contract, Platt says that his team is getting close to its target — access to the health data of 100 million people. The team has already reached the 90-million mark and is on track to have the first big segment of the program operational by the July 2012 deadline.
“It’s important to understand that the FDA doesn’t have the data,” Platt emphasizes. His team at the operations center is the hub in a complex web of spokes that link to some 30 organizations, including academic centers, that are assisting in the project. Central to that effort are 17 organizations — including large health plans like Kaiser Permanente, Humana, WellPoint, and Aetna — that are converting their own data sets into a common format. The FDA could then pitch a question and the central group could pool responses to analyze the threat level.
As an example of what Mini-Sentinel is being programmed to do, Platt cites the diabetes drug rosiglitazone (Avandia), which has been linked to thousands of heart attacks. With Mini-Sentinel, regulators could have asked how many people taking rosiglitazone had heart attacks, and the system could have checked the data for comparator drugs to provide some perspective on the numbers.
Source: PubMed Central
Author: John Carroll
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W329585987