Study: Up To 95 Percent of Serious Adverse Reactions To Drugs Go Under-Reported

Mass amount of prescription bottles, horizontal

In Brief

  • The Facts:
    • Multiple studies have found that many adverse reactions to prescription drugs are not reported, or are under-reported.

    • The amount of under-reporting is very significant.

  • Reflect On:

    Why aren't there proper adverse events reporting systems? How would proper systems and accurate numbers change health policy? What would it do to the reputation of big pharmaceutical companies if more people knew about this?

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Drug reporting systems designed to capture adverse events amongst the population have been known to be unreliable. With the rollout of COVID vaccines, adverse reactions have become a hot topic as well, mainly due to the fact that injury reporting systems for vaccines, are also known to be unreliable.

How common is it for mild, severe or death related adverse reactions for drugs or vaccines to go unreported? An important question because without reports, researchers cannot relay important cost benefit analysis of pharmaceutical products to the general population.

A study published in 2006 in the Journal Drug Safety poured over 37 studies using a wide variety of surveillance methods from 12 different countries.

They found evidence of widespread and significant under-reporting of Adverse Drug Reactions (ADRs). This includes very serious ADRs.

The median under-reporting rate across the 37 studies was 94% (interquartile range 82-98%). There was no significant difference in the median under-reporting rates calculated for general practice and hospital-based studies. Five of the ten general practice studies provided evidence of a higher median under-reporting rate for all ADRs compared with more serious or severe ADRs (95% and 80%, respectively). In comparison, for five of the eight hospital-based studies the median under-reporting rate for more serious or severe ADRs remained high (95%). The median under-reporting rate was lower for 19 studies investigating specific serious/severe ADR-drug combinations but was still high at 85%.

This is concerning given the fact that prescription drugs are the third leading cause of death after heart disease and cancer in the United States and Europe. 

A study published in 2018 in the International Journal of Research in Medical Sciences tried to answer the question of why this is happening. Again, it’s a well known issue among those who research it, and the data is quite similar across the board via multiple publications.

The 2018 study found that there is simply “a very low level of awareness about ADR reporting” found among doctors. They found that 32.8 percent of those surveyed did not know if or that the reaction was caused by the drug, while 46.3 percent felt that there is no need to report recognized reactions. Overall, “a very poor level of awareness of pharmacovigilance was seen among doctors” and the researchers stressed the need to improve awareness among doctors. Proper and accessible reporting systems should be in place for them to improve reporting.

What about vaccines? The CDC and FDA’s Vaccine Adverse Reporting System (VAERS) “is the nation’s early warning system that monitors the safety of vaccines after they are authorized or licensed for use by the FDA”. It is a self-reporting system that does not prove causality but rather is designed to help identify adverse events signals (i.e., COVID-19 vaccine thrombotic events and myocarditis). “VAERS scientists look for unusually high numbers of reports of an adverse event after a particular vaccine or a new pattern of adverse events”

Doctors are required to report vaccine adverse reactions to VAERS, but since it is a self reporting system, it has been criticized due to the fact that anybody can report a vaccine reaction. The CDC has made it clear that just because an event is reported and correlated with vaccine administration, this does not mean that the vaccine actually caused the adverse reaction.

That being said, it is concerning that adverse reactions during 1997-2013, VAERS received 2149 death reports and “no concerning pattern” was observed. But as Senator Ron Johnson wrote on August 22, 2021: “the 12,791 deaths related to COVID-19 vaccines reported on VAERS over the period of 8 months, compared to 8,966 deaths related to all other vaccines reported on VAERS since the inception of VAERS – a period of 31 years”. He continues, “VAERS is also reporting 16,044 permanent disabilities, 51,242 hospitalizations, and 571,831 total adverse events related to the COVID-19 vaccines.” Anyone can verify these numbers and read individual case stems, as I have previously done, on the VAERS website.

As of today there are approximately 17,000 deaths and 25,000 permanent disabilities, and 80,000 hospitalizations reported to VAERS regarding the COVID vaccines in the United States alone.

As far as vaccine underreporting goes, in a grant final report titled “Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS)” from 2011, Harvard medical professors Ross Lazarus, Michael Klompas, and Steve Bernstein report that:

Preliminary data were collected from June 2006 through October 2009 on 715,000 patients, and 1.4 million doses (of 45 different vaccines) were given to 376,452 individuals. Of these doses, 35,570 possible reactions (2.6 percent of vaccinations) were identified. This is an average of 890 possible events, an average of 1.3 events per clinician, per month. These data were presented at the 2009 AMIA conference.

In addition, ESP:VAERS investigators participated on a panel to explore the perspective of clinicians, electronic health record (EHR) vendors, the pharmaceutical industry, and the FDA
towards systems that use proactive, automated adverse event reporting.

Adverse events from drugs and vaccines are common, but underreported. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events
and 1-13% of serious events are reported to the Food and Drug Administration (FDA).

Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed.

It’s not like VAERS hasn’t been used before, for example, consider that on July 16th, 1999, the CDC recommended that healthcare providers suspend the use of the licensed, RotaShield – a rotavirus vaccine – after only 15 cases of intussusception were reported to VAERS.

There is clearly a way for researchers to use VAERS properly, and although vaccine adverse events may be grossly underreported, you have to factor in the number of reports in there that are probably not connected to the vaccine at all, but who knows? Either way you look at it, the numbers in VAERS regarding COVID vaccines is quite concerning and staggering.

The question is, how likely is it for a doctor to report a suspected adverse reaction to the vaccine? If a patient comes in with some sort of ailment three days after the vaccine, will most doctors even consider the idea that the event could be related to the vaccine?

Even severe adverse reactions may be ignored and unreported. A great example comes from a 12 year old girl named Maddie De Garay, who was injured during the Pfizer clinical trials. If you listen to her experience with doctors, as told by her mother Stephanie De Garay, it’s quite disturbing.

Doctors may have a bias that has them believe serious vaccine injuries are extremely rare. The CDC claims it’s 1 in a million, yet how can they claim such a number if proper adverse event reporting systems aren’t in place? Why don’t they provide any sources or data for their claim?

It’s also important to consider that proper reporting systems would not be something that pharmaceutical companies would openly advocate for. It would be bad for business, and as far as business goes, Pfizer has paid one of the largest criminal fines in history. They have numerous criminal convictions and have been found to falsify information about their drugs, including efficacy. 

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