Blood glucose meters and test strips made by the Johnson & Johnson subsidiary LifeScan accounted for the largest number of adverse-event reports that were filed without public disclosure in a U.S. Food and Drug Administration program that has since been closed down.
An initial review of data released Friday by the FDA shows LifeScan filed 2.3 million secret adverse event reports regarding its SureStep Flexx glucose meter and related diabetes products intended to be used in hospitals between 2006 and 2018.
That was more than 20 percent of the entire dataset released Friday. Spread over 21 different spreadsheets, the previously undisclosed FDA data trove included nearly 6 million reports covering more than 100 different products made by dozens of different companies.
The second-highest total was for dental implants and supplies made by Nobel Biocare, a subsidiary of Washington-based conglomerate Danaher Corp., which logged more than 700,000 adverse event reports between 1999 and 2018.
Analysis of the data is ongoing. Federal law requires the makers of medical devices to file reports with the FDA in situations where the device caused or may have caused health problems in a patient, or when a device malfunctions in a way likely to happen again. The filing of a report is not a definitive conclusion that the device caused the underlying problem.
However the FDA quietly gave out more than 100 exemptions since 1999, covering between 7 events and 2.3 million events each, in situations where the agency said the problems were already well-known. The exemptions allowed manufacturers to file spreadsheets of events through a program known as Alternative Summary Reporting (ASR).
For example, the FDA in 2014 allowed Medtronic to file summaries of more than 1,000 reports of patient harm following the use of its controversial Infuse bone-growth product. Although the filings were more than five years late, and included four patient deaths, the FDA decided the potential risks described the reports were already known to the medical community by the time they were submitted. The deaths were viewed as unrelated to the procedures.
The FDA also allowed the makers of surgical staplers to file more than 56,000 adverse events between 2011 and 2018, though the agency is now considering moving the devices to a higher risk category based partly on a review of the entire dataset.
And the agency has collected more than 350,000 reports of problems since 2009 following the use of breast implants, which have come under increasing scrutiny after years of complaints about health problems that critics say have been ignored by authorities.
Although they're public information, ASR filings were previously only available through Freedom of Information Act requests, which can take a year or more to process. All 6 million or so files were released at the same time on Friday.
Taken as a whole, the data show that the ASR program grew gradually between 1999 and 2005, and then spiked in 2006 with the approval of the LifeScan exemption. The program peaked in use in 2016, with more than 528,000 adverse event reports filed that year by 68 manufacturers and their subsidiaries.
The FDA said the decision was made in 2017 to phase out the program, and it was formally ended this month with the revocation of the 13 ASRs that were still active, covering dental implants, implantable cardiac defibrillators and pacemaker electrodes.
All of the ASR data can be accessed, via CSV files, at an FDA web page.
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On Wednesday, FDA spokesman Michael Felberbaum provided the following statement for this blog post:
"The ASR program was intended to address high volume reports of well-known, well-understood adverse events, such as those reported for blood glucose meters and dental implants. The program allowed the FDA to more efficiently review reports of such events so that we could focus more resources on identifying and taking action on new safety signals and less understood risks. Where reporting volumes were low, the ASR program would not provide these same benefits.
"Of note, both of these products are commonly-used medical devices, and therefore it is expected that reported events for those devices would represent a larger portion of the events than those for devices that are not commonly used.
"DZE [the FDA product code for dental implants] -- The number of dental implant companies and marketing submissions for dental implants have increased over the past 20 years. Likewise, the use of, and number of patients receiving dental implants has also increased each year during this same time period and continues to go up. We attribute the counts observed in the data largely to increases in both product availability and use.
"NBW [the code for blood glucose tests] -- In general, the FDA sees a high volume of events associated with glucose meters in MAUDE. Approximately 10% of the U.S. population has diabetes and most rely on these devices several times a day. The events for NBW submitted as part of the ASR program were for two companies, LifeScan and Roche. For example, at the time FDA granted their exemption in 2006, the LifeScan meters were widely used by people with diabetes at home and the volume of events reported through the ASR program was expected to be large."
