No one likes it when a new drug in people’s medicine cabinets turns out to have problems — just remember the Vioxx debacle a decade ago, when the painkiller was removed from the market over concerns that it increased the risk of heart attack and stroke.
To do a better job of spotting unforeseen risks and side effects, the Food and Drug Administration is trying something new — and there’s a decent chance that it involves your medical records.
It’s called Mini-Sentinel, and it’s a $116 million government project to actively go out and look for adverse events linked to marketed drugs. This pilot program is able to mine huge databases of medical records for signs that drugs may be linked to problems.
“This is a new science, and much work needs to be done to develop and continue to improve the methods behind this,” says Troy McCall, who is managing the project for the Reagan-Udall Foundation.
The foundation does get some money from the FDA, but supports its research with other funds. And so far, all the money for this particular project has come from pharmaceutical companies like Merck, Pfizer, Novartis, Johnson & Johnson, GlaxoSmithKline, AstraZeneca and Eli Lilly.
McCall says he doesn’t think it’s seen as an “‘industry project,” because the work is so important. “Clearly at the end of the day this is all to benefit patients and ensure that drugs that are on the market are safe,” he says, adding that patients also benefit when safe drugs are not unnecessarily removed from the market.
Drug companies do have a big interest in what stays on or off the market. But Woodcock sees no problem with industry funding the development of the scientific methods that will then be used to help make regulatory decisions.
“It would be very difficult to develop a method that was going to favor your drug when you’re developing a general method, I think,” Woodcock says. “But what I would say is, OK, who is going to develop these methods? We need them developed.”
Officials at the Reagan-Udall Foundation say it operates transparently and has different stakeholders represented on its governing boards. But one board member who represents consumers says she finds the lack of independent funding troubling.
“I think that creates an appearance of a conflict of interest and potentially a real conflict of interest,” says Diana Zuckerman, president of the nonprofit National Center for Health Research. “If all the money is coming from the pharmaceutical companies whose livelihoods are going to be affected by what the project finds, I just think that’s an untenable situation.”
Zuckerman says she worries that industry funding might influence the methods that eventually get used for finding signals in big data that drugs are unsafe — and that could potentially limit what this new approach will reveal about the medicines Americans take every day.
Listen to the interview here!