The People's Perspective on Medicine

Why Can’t We Trust the FDA’s Adverse Events Database?

When a doctor tells you that you need a heart valve or a knee replacement you assume she has great data. But can you rely on the FDA's adverse events data?
FDA Approved words on an orange pill or medicine bottle with long shadow

Health professionals rely upon the FDA’s adverse events reporting systems to assess the safety of drugs and devices after they have been on the market. Because of faster approvals, these postmarketing data are more critical now than ever.

Faster Access to Drugs and Devices!

The Food and Drug Administration has been under intense pressure for years to allow manufacturers to bring drugs and devices to market faster. Obviously, the companies desire this. The sooner they can market their products the faster they can improve their bottom line.

Patients want access to the latest and greatest treatments. They assume that the FDA is all wise and all knowing. If a new heart valve gets FDA approval many people, including a lot of health professionals, assume it must be better.

Because of such pressure the FDA has been approving drugs and devices faster than ever. They even brag about the quicker turnaround. 

Should We Trust the FDA’s Adverse Events Monitoring Systems?

A new study in JAMA Internal Medicine (Oct. 7, 2019) suggests that the FDA’s adverse events databases may not be as accurate as most health professionals think. A team of researchers reviewed reports on interventional cardiology devices.

First, they point out that:

“Even for high-risk implanted devices, premarketing trials are usually small and have short-term follow-up. The process of reporting adverse events is cumbersome, and reporting rates are low.”

They report that there is substantial misclassification and underreporting of patient deaths in the FDA database.

Next, the authors note:

“Our findings raise concerns about the accuracy of adverse-event reports for high-risk devices. The results complement recent news reports that the FDA allowed device manufacturers to file reports of malfunctions in a hidden database, known as alternative summary reporting. Both the miscategorization of deaths in FDA adverse-event reporting and hidden adverse-events reports can lead to inaccurate public and physician perception of the safety of medical devices and can compromise informed decision-making.”

Why This Matters!

For patients and health professionals to make sound decisions about heart valves or other “high-risk devices,” they need highly accurate information. If FDA’s adverse events data are inaccurate, that becomes far more difficult.

Consumer Reports routinely reports on the reliability of things like cars, televisions, lawn mowers and microwave ovens. Shouldn’t patients have at least as much information about devices that are put in their bodies?

The Medical Device Scandal:

We have had the privilege of interviewing Jeanne Lenzer about her book, The Danger Within Us.  In it she reveals the underbelly of the medical device industry and problems with the FDA’s approval process. You can listen to the free podcast at this link:

Show 1123: What Are the Unexpected Dangers of Medical Devices?

You can click on the green arrow under Jeanne’s photo to listen to the streaming audio or download the free MP3 file by clicking at the bottom of the page. It’s just above “Rate this Article” and “View Comments.”

Share your own thoughts about the FDA’s adverse events reporting system in the comment section at the bottom of this page.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
Show 1123: What Are the Unexpected Dangers of Medical Devices?
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The FDA does not require clinical trials before it approves most medical devices. The consequences can be frightening. What should be done?

Show 1123: What Are the Unexpected Dangers of Medical Devices?
  • Meier, L, et al, "Miscategorization of Deaths in the US Food and Drug Administration Adverse Events Database," JAMA Internal Medicine, Oct. 7, 2019, doi:10.1001/jamainternmed.2019.4030
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The FDA adverse effects database accepts reports from patients as well, although the process is cumbersome and apparently not well known, and there’s no confirmation or acknowledgement from the FDA. I submitted a report on what I believe was a statin-induced neuromuscular condition, but do not know what happened to it after I sent it in.

The problem with high-risk medical devices is just one wrinkle in the FDA’s adverse event reporting. Prescription statin drugs that have been on market for decades were approved through questionable clinical trials, and the resulting data of those trials were never made public. The adverse effects of these common drugs are also under-reported. Doctors often don’t link the AE to the drug and don’t have the time to provide all the details that the FDA report requires. While patients may file adverse effect reports themselves, they aren’t given the same weight as those filed by medical professionals. At this rate, many dangerous drugs and medical devices will never be taken off the market, and hundreds of thousands if not millions of patients will be harmed, sometimes fatally. Manufacturers, however, continue to profit and also avoid liability.

Well, regarding PROCEDURES, it took the FDA much longer than TEN YEARS after the Europeans were using it to OK ultrasound destruction of prostate tumors. At least one smarter-than-your-average-bear urologist moved to Florida and set up a clinic in the Bahamas to do it.

Medication Roflumilast was FDA approved in March 1, 2011 but was opposed by an advisory panel. The Lancet publised Article on Feb. 25 2012 that drug was borderline at best. The need to update side-effects from any drug in my opinion has not met the criteria for the american public.

I found out yesterday that the “silicone” breast implants they put in me 10 years ago were known by Allergan, the manufacturer, to leak the contents (siloxane—a concrete water sealant and solvent, which is highly volatile) from a completely intact shell. I was told it was “completely safe,” “medical-grade silicone.” They were called “gummy bear implants”. I started having health problems 1 year after implantation, but every doctor I have ever seen since then has said my illnesses could not be related to the implants. They said it was “an inert substance”.

They are Allergan Style 20 – a non cohesive “silicone” gel. Now, there is a 6-month wait to get a surgeon to remove them, and it will cost around $13,000. Further, the health issues may never go away. Many people die of cancer from breast implants. In fact, the FDA recalled another implant from the same line as mine on August 7th, 2019. The FDA recalled it, not the manufacturer. I

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