Posted On: July 31, 2014 by Patrick A. Malone

FDA Initiative Finds Drug-Related Problems Through Medical Record Review

Earlier this week, we wrote about a Senate subcommittee hearing on patient safety, and how one major form of harm comes from adverse reactions to drugs. A new program within the FDA hopes to reduce those problems by finding drug-related problems by searching medical record databases.

As explained on NPR.org, the effort is supposed to identify problem drugs, such as Vioxx, a painkiller that was pulled from the market 10 years ago because it increased the risk of heart attack and stroke even though the FDA had approved it.

The program, called Mini-Sentinel, is proactive — it seeks adverse events linked to marketed drugs by reviewing medical records for signs that drugs may be linked to problems, even if the affected patients and their doctors never filed reports of a problem.

Mini-Sentinel is supposed to address a huge deficiency in MedWatch, the current system for recording problems with marketed drugs, which is strictly voluntary. Doctors, pharmacists and consumers are welcome to report bad drug outcomes, but there’s no systematic, trackable effort to ferret out drugs whose dangers might not present fully until they’ve been approved and on the market for some time.

"We get about a million reports a year that way," Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, told NPR. "But those are random. They are whatever people choose to send us."

You can’t necessarily tell from those reports if a drug is responsible for a problem. And if the side effect is common (such as a rash), there might be no reports because doctors might not connect a patient's symptoms to the drug.

Mini-Sentinel gets information from 18 data partners, such as health plans. It has access to health records for nearly 180 million Americans. According to Dr. Richard Platt, principal investigator for Mini-Sentinel and a professor at Harvard Medical School's Department of Population Medicine, if you have insurance through a private health plan, the chances are "pretty good" that your data may have been used in one of their studies.

The data mostly comes from billing records, not your doctor’s chart notes. Analysts use the billing codes to identify diagnostic tests and procedures, and all the data is anonymous to preserve patient privacy.

This kind of comparative analysis is an excellent measure of what might be going wrong, but like all good science, it takes time. It took five years to build Mini-Sentinel from scratch and now it’s making hundreds of queries a year, according to Platt.

For example, Mini-Sentinel ran a search when the FDA got some troubling reports possibly linking intestinal problems to a blood pressure drug called olmesartan. (See our blog, “Benicar Users Are at Risk of Serious Intestinal Side Effects.”)

After Mini-Sentinel found no connection between the problems and the drug, the FDA asked for a second search focusing on people who took the drug for an extended period. It found a link, and now there’s a warning on the drug's label. (The problems with olmesartan, however, have prompted many lawsuits.)

Mini-Sentinel is experimental, and its contract ends in September. The FDA will decide if the effort to analyze huge amounts of patient data is a roadmap to better harm reporting. Some observers are skeptical. Although he supports the FDA’s initiative, Thomas Moore, a senior scientist at the nonprofit Institute for Safe Medicine Practices, told NPR, "The problem is, I think, they have underestimated how far they have to go."

He questions how well billing data can disclose side effects from drugs, and is concerned that “people will get a false reassurance about safety."

He cites the example of dabigatran, a blood-thinning medicine that has sparked reports of serious bleeding. (See our blog, “Pradaxa Manufacturer Settles Cases Over Uncontrolled Bleeding.”) Moore noted that "the FDA published an article in a leading medical journal, basically discounting all that — saying that, using Mini-Sentinel, they had seen no unusual risk for this drug."

The agency is looking more closely at dabigatran because of questions about how well it designed the original Mini-Sentinel study.

It’s an evolving process, the feds say. How you set up the question in your drug investigation can affect the answer, so if the program continues, no doubt it will be refined. And the interest in poor drug outcomes doesn’t stop with Mini-Sentinel: Woodcock pointed to another FDA initiative to examine potential drug effects run by the Reagan-Udall Foundation, a foundation set up by Congress. Its major effort is research on how to use large databases to study the safety of medicines on the market.

But questions about conflicts of interest have been raised because in addition to FDA funding, the foundation gets money from pharmaceutical companies.

Troy McCall, manager for the project, said focusing on the funding is narrow-minded because it’s important to keep safe drugs on the market, just as it’s important to yank the risky ones. And 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 told NPR that she’s troubled by the lack of independent funding.

"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," said Diane Zuckerman.

She’s also concerned that industry funding could influence what methods are used to identify the signals of unsafe drugs, which could limit what the initiative discloses about the medicines Americans consume.

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