A World Made of Pillows

When risk aversion kills

J.K. Lund MS

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The FDA, it could be argued, is responsible for tens of thousands of deaths every year. Such a statement may sound outlandish or hyperbolic, but the case can be made. In the latter half of the 20th Century, the relentless expansion of regulation and bureaucracy was justified by specious claims of reducing safety and environmental risks. However, some level of risk is necessary for progress to occur, and progress itself reduces long-term risk to humanity. Our attempt to build a perfectly safe world made of soft pillows suffocates progress in the process.

Deadly Risk Aversion

The FDA was originally created to prevent unscrupulous food and drug producers from hawking products that were unsafe, if downright deadly. The overarching goal was to prevent harm to the public. But as these things tend to go, its power gradually expanded to become, arguably, the very thing it was intended to prevent.

In 1906, Congress passed the Food and Drug Act, creating the precursor to the modern FDA. Importantly, at that time, the new agency had no power to review or approve new drugs before they went to the market. It merely had police powers to enforce the law after a violation had taken place, and the law primarily was concerned with truth in advertising/labeling.

This changed in the late 1930s when a company called S. E. Massengill began marketing one of the first antibiotics, known as “Elixir Sulfanilamide.” In its liquid form, the drug was prepared with a solution of diethylene glycol, a toxic chemical akin to antifreeze. Many died, not from the drug itself, but from the preparation solution.

In response, Congress passed the 1938 Food, Drug, and Cosmetic Act, which catapulted the FDA into a regulator with the power to review and approve drugs before they could be sold. Crucially, however, the law gave the FDA just 60 days to vet drugs. Should the timeline not be met, it would automatically be approved…

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J.K. Lund MS

Risk Manager/Author | I research Human Progress and how to build a better future.