Researchers: Drug Side Effect Reporting Systems Lack Thorough Safety Measures

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Many severe side effects of prescription drugs are not reported, according to new findings from JAMA Internal Medicine.

Moreover, the researchers who completed the study comment that current FDA regulatory practices need reform, especially the process used to report harm caused by medical devices.

“Over the last 4 decades, the approval and regulation processes for pharmaceutical agents have evolved and increased in complexity as special programs have been added and as the use of surrogate measures has been encouraged,” the researchers write. “The FDA funding needed to implement and manage these programs has been addressed by expanding industry-paid user fees. The FDA has increasingly accepted less data and more surrogate measures and has shortened its review times.”

What are the Issues?

The study shows that regulatory measures to ensure the safety of pharmaceuticals and medical technology have worsened — principally due to growth in those markets.

This isn’t a new issue, according to Dr. Ben Goldacre, a researcher at Oxford University, who led a similar study about underreported drug side effects.

“We’ve known about this problem for at least three decades,” Goldacre told Reuters. “It took us 25 years to get to the point of passing the law in 2007. It took another 10 years to have the final rule implemented. After all of that time, we now see that law is being very, very widely ignored.”

The JAMA study noted five specific drugs, which are:

• Mobic, a painkiller
• Celebrex, another painkiller
• Eliquis, a blood thinner
• Humira, a rheumatoid arthritis treatment
• Risperdal, an antipsychotic

The FDA has not yet addressed the fact that certain substances can cause a condition known as Toxicant-Induced Loss of Tolerance (TILT), according to Dr. Claudia Miller, a professor emeritus of Environmental Medicine at the University of Texas and leader of the Hoffman TILT program.

“Every health professional needs to be aware of TILT and ask patients about potential initiating exposures and the plethora of chemicals, foods, and drugs they no longer tolerate,” Miller writes. “The underlying cause may not be inflammation; inflammation is most likely the result of our exposures to myriad synthetic chemicals, foods, and drugs for which people lose tolerance.

“They may need to avoid certain exposures, e.g., home extermination or off-gassing of new construction materials. Physicians owe it to their patients to understand this disease mechanism so they can explain it to them.”

Commonly reported TILT symptoms include:

• Difficulties with attention, memory
• Irritability and depression
• Digestive problems
• Allergy-like symptoms
• Migraines, headaches
• Fatigue, muscle pain

Those interested in learning more about TILT can take the Quick Environmental Exposure and Sensitivity Inventory (QEESI) or The Brief Environmental Exposure and Sensitivity Inventory (BREESI) assessment.

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What do the Numbers Say?

Over the past forty years, the median number of generic drugs approved each year has increased:

• By 136 from 1970 to the enactment of the Hatch-Waxman Act in 1984
• By 284 from 1985 to the enactment of the Generic Drug User Fee Act in 2012
• By 588 from 2013-2018

“Worldwide, growing numbers of patients report adverse reactions to medical and dental procedures, implants including breast implants, and multiple medications,” Miller said.

Overall, the state of pharmaceuticals oversight presents one glaring truth: regulatory measures are not doing enough to ensure safety.

Editor’s Note: This article is part of a collaboration between Salud America! and the Hoffman Toxicant-Induced Loss of Tolerance (TILT) program at UT Health- San Antonio. To find out if you are TILTed due to exposure to everyday foods, chemicals, or drugs, take a self-assessment or learn more about TILT.