In 1993, Dr. David Aaron Kessler, commissioner of the FDA from 1990 to 1997, told the Journal of the American Medical Association that only 1% of serious adverse events are reported. This means that the true number of deaths from FDA-approved drugs and devices is 100 times higher than reported.
Hospitals have had strong incentives not to identify too many of these adverse drug events. Reporting large numbers of adverse events and any serious preventable event brings intense scrutiny from regulators and the public. Thus, most hospitals have relied on spontaneous reporting, which only identifies about 1 in 20 adverse reactions and leads to the perception that injuries from ADRs are less common than they really are.
Jerry Phillips, associate director of the Office Of Post-Marketing Drug Risk Assessment at the FDA, put it this way:
These reports, however, are generally believed by experts to grossly understate the actual situation, Phillips said. In the broader area of adverse drug reaction data, the 250,000 reports received annually probably represent only 5% of the actual reactions that occur.
The FDA itself says only 10% of adverse events are reported, and no one in medicine or government suggests anything higher than 20%. This means the true figure is five, twenty, or even 100 times higher than those reported by the FDA Adverse Event Reporting System (FAERS). One team of researchers wrote:
As few as 5% and no more than 20% of iatrogenic acts are ever reported (Barczak et al., 1997; Bates et al., 1995; Leape, 1994; Starfield, 2000a; Starfield, 2000b; Thomas et al., 2000b). A study conducted in two obstetrical units in the UK found that only about one-quarter of adverse incidents were ever reported, to protect staff, preserve reputations, or for fear of reprisals, including lawsuits (Bates et al., 1995).
An analysis by Wald and Shojania (2001) found that only 1.5% of all adverse events result in an incident report, and only 6% of adverse drug events are identified properly. The authors learned that the American College of Surgeons estimates that surgical incident reports routinely capture only 5-30% of adverse events. In one study, only 20% of surgical complications resulted in discussion at morbidity and mortality rounds (Vincent et al., 1999). From these studies, it appears that all the statistics gathered on medical errors may substantially underestimate the number of adverse drug and medical therapy incidents. They also suggest that our statistics concerning mortality resulting from medical errors may be in fact be conservative figures.
Standard medical pharmacology texts admit that relatively few doctors ever report adverse drug reactions to the FDA. The reasons range from not knowing such a reporting system exists to fear of being sued. Yet the public depends on this tremendously flawed system of voluntary reporting by doctors to know whether a drug or a medical intervention is harmful.
If hospitals admitted to the actual number of errors for which they are responsible, which is about 20 times what is reported, they would come under intense scrutiny (Vincent et al., 1999). Jerry Phillips, associate director of the FDA’s Office of Post Marketing Drug Risk Assessment, confirms this number. “In the broader area of adverse drug reaction data, the 250,000 reports received annually probably represent only 5% of the actual reactions that occur.”(Bates, 1998)
FAERS reports that between 2005 and 2015, there were 2.5 million adverse events from FDA-approved drugs that required hospitalization, threatened the patient’s life, or resulted in death. If the true figure is five or twenty times higher, there were between 12.5 and 50.2 million serious adverse events. If, as Dr. Kessler says, only 1% of adverse events is reported, then in the last decade there were 250.9 million serious adverse events from FDA-approved drugs, resulting in 72.6 million deaths.
The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, and medical devices, among other products. If the FDA approves drugs that are correlated with as many as 7.3 million deaths every year, how many are necessary before we can say the drugs are causing the deaths?
The Costs of Underreporting
In 1992, J. Lazarou et al. analyzed records for prescribed medications for 33 million US hospital admissions. They discovered 2.2 million serious injuries due to prescribed drugs; 2.1% of inpatients experienced a serious adverse drug reaction, 4.7% of all hospital admissions were due to a serious adverse drug reaction, and fatal adverse drug reactions occurred in 0.19% of inpatients and 0.13% of admissions.
The authors estimated then that 106,000 deaths occur annually due to adverse drug reactions. Using a cost analysis from a 2000 study in which the increase in hospitalization costs per patient suffering an adverse drug reaction was $5,483, costs for the Lazarou study’s 2.2 million patients with serious drug reactions amounted to $12 billion. Adjusted for inflation, the per-incident cost in 2016 would be $7,546.
The FDA acknowledges that between 2005 and 2015, 2,509,488 people were hospitalized after taking FDA-approved drugs, with 725,871 deaths. At a per-incident cost of $7,546, serious adverse events from FDA-approved drugs cost $18.9 billion.