The Argument for a Second Independent Organization Dedicated Solely to Investigating Drug Safety

A recent article by Joe Graedon compares the FDA and the way the US investigates drug safety to the Federal Aviation Administration (FAA) and the National Transportation Safety Board (NTSB). In essence, Graedon works to demonstrate the need for an additional agency which focuses solely on evaluating drug safety, letting the FDA focus solely on drug approval. The addition of such an agency could ultimately save human lives.

Startling Statistics

Between October of 2018 and March of 2019, 346 people lost their lives during airline crashes while riding the Boeing 737 Max 8. During that same time period, approximately 38,860 people lost their lives as a result of adverse drug reactions (ADRs). That’s 290 people each day, and it’s probably an underestimate.

The estimated statistics regarding death by ARDs are equal to a jumbo jet crashing every day. What’s crazy is these statistics only account for patients in the hospital meaning those who pass in their homes, ambulances, retirement communities, and nursing homes aren’t included in the number. Annually there are  2,216,000 serious ARDs documented in the hospital,106,000 ARD related deaths in the hospital, and 350,000 estimated ARDs in nursing homes.

“ADRs are the 4th leading cause of death—ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents, and automobile deaths.”

Many of these deaths could be prevented.

The above statistics are from the FDA, but the organization doesn’t take responsibility for the problem themselves.

The Aviation Industry

In the aviation industry, the FAA approves aircrafts and the NTSB responds to airplane crashes and other safety concerns. The advantage of this system is that those who approve aircrafts never have to evaluate their own mistakes.

Even so, the system isn’t perfect. After the second Boeing Max 8 crash, it took two days for the aircrafts to be banned in the US. China grounded the planes the day of the crash, and other countries responded soon after that. The US was criticized for taking so long. The situation was publicized everywhere. Headlines regarding the aircraft were across websites, newspapers and the like.

You just don’t see that type of publicity for ARDs. And it’s a problem.

Moving Slowly

The FDA has been known to move much more slowly in response to ARDs than the FAA and NTSB ever have for airplane crises. Below are just a few examples.

  • Rezulin: Approved in 1997 despite an objection from a FDA safety officer. The drug was found to cause harm to the heart and the liver. Britain pulled the drug the same year. The FDA pulled it in 2000.
  • Avandia: Approved in 1999 to treat Type 2 Diabetes. The drug was found to cause heart attacks and ultimately death, resulting in 11,000 lawsuits. While other countries pulled it, the FDA decided not to.
  • Phenylpropanolamine (PPA): Approved for over 50 years before it was pulled for causing strokes (approximately 500 each year it was on the market). A study proving the association was published in 2000. The drug was not pulled until 2005.

A New Organization

Graedon argues that the addition of a second, independent organization focusing on drug safety would help to protect from ARDs. He also says that this organization should not receive funding from the pharmaceutical industry. There’s clearly an issue if safety officers doing their job are being overruled by management, which is exemplified in the Rezulin case noted above.

The author of this article explains that it’s time to one- admit our system is flawed, and two- discuss and implement remedies to improve it. It’s for the sake of patient lives.

You can read more about this take on the FDA here.

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