In order for there to be a functioning and reliable system of noting adverse events and side effects from drugs, manufacturers must report that information to the FDA. In fact their reports account for 97 percent of that information. But many of them might be leaving out some data here and a little data there.
A study, by the Institute for Safe Medicine Practices, a nonprofit that looks at drug safety issues, examined what info is coming into the FDA and found that only about half of reports of serious side effects submitted by manufacturers met basic standards for completeness – meaning they included a patient’s age, sex and the date the event took place. On the contrary, the FDA met those standards with reports collected itself 85 percent of the time.
Those standards are clearly important because they can indicate things like whether a drug affects women different than men or across different age groups. The study looked at 847,000 case reports received by the FDA for the 12-month period that ended in March of 2014.
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The New York Times pointed out where some of the bigger drug makers fall into this issue:
Thomas J. Moore, the senior scientist at the institute and the lead author of the report, noted that some companies — including Vertex Pharmaceuticals, Biogen Idec and Amgen — consistently submitted high-quality reports. Others, including Par Pharmaceutical, a generic drug manufacturer, and Cubist Pharmaceuticals, which was recently acquired by Merck, performed well below average. “We know it is feasible to do reasonably complete reports,” he said. So the main reason for the low quality in other cases, he said, “is lack of due diligence by the manufacturers.”
Spokespersons for the different drugs generally stood by their current practices, despite some of the numbers. Not really surprising.
Some of the reason data can get skewed is for reasons like when a manufacturer finds out that a patient died, they are required to report to the FDA but don’t include whether or not the drug was involved.
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Mr. Moore said this could be changed easily if drug makers were required to ask some simple questions before reporting such cases, like whether the drug was suspected in the patient’s death. “Large amounts of money are being spent collecting essentially worthless data,” Mr. Moore told The Times. “There’s really no reason not to fix it.”
