Product News and Recalls

FDA Tracking: What Good is a Database if the Data is Inaccurate?

fda drug side effect database outdated and inaccurateA new report out of the Milwaukee Journal Sentinel calls attention to the fact that the FDA’s tracking of drug side effects; many of them dangerous, has been out of date, underreported, and inaccurate for upward of 60 years.

Created in 1960, the system was devised as a way of tracking adverse drug events once the products received their clearance and made it to market. Based largely on the honor system and a large degree of self-reporting, the database was supposed to be used to spot trends and frequently occurring events while calling attention to them for further investigation.

As early as two years into the system’s inception, then-president John F. Kennedy saw the potential for abuse and under-reporting of vital data used to keep Americans safe. “These new drugs present greater hazards as well as greater potential benefit than ever before,” he said, “for they are widely used, they often are very potent and they are promoted by aggressive sales campaigns that may tend to overstate their merits and fail to indicate the risks involved in their use.”

In 1974, an audit conducted by the U.S. General Accounting Office found that up to six million adverse drug events were occurring each year, but the number reflected in the FDA’s database was not reflective of such a problem. One expert estimated that 5% of patients admitted to the nation’s hospitals were there because of an adverse drug reaction and 10% of the hospitalized population would experience an adverse drug event while they were in the hospital.

The next 40 years would read much the same, even as technological advances made it easier than ever to get pinpoint accurate data that could be read and tracked in ways that would have bewildered Kennedy and the FDA analysts of the 60s. By 2016, a Tufts Medical School study conducted in conjunction with drug maker Amgen would find that over half of the doctors, nurses, and pharmacists surveyed hadn’t filed an adverse reaction report with the FDA in the past five years.

Who would have thought that a database that relied primarily on self-reporting could become so wildly inaccurate when left to its own devices for decades on end?