Science in the News: Why the FDA Matters

 

The Headline, 5 February 2017, New York Times // Trump’s F.D.A. Pick Could Undo Decades of Drug Safeguards

 

New and Startling Beauty to the Skin Thru Radium!

Tho-Radia, Méthode Scientifique de Beauté

Exciting Public Demand for Amazing Beauty Discovery

The active Radium which forms the basis of Artes Cream clears the skin in a magical way, and the complexion grows lighter, smoother and more refined of texture under its steady, all-stimulating action.

Radium Chocolate manufactured by Burk & Braun was sold in Germany from 1931 to 1936, advertised for its powers of rejuvenation. Image via Annabella Carter.

These are some lines taken from advertisements in the 1920s and 1930s for beauty products containing the radioactive element radium. Discovered in 1898 by Marie Curie, radium was believed to have amazing health benefits and could be used to treat many different medical ailments: hair loss, impotence, high blood pressure and cancer (among others). While low-dose radiation can still be seen in cancer treatments today, the idea of applying a skin cream every day with radium in it, or eating chocolate with radium inside, or using radium toothpaste is frightening. Continued exposure to radium is ultimately what led to Marie Curie’s death, though radiation poisoning was not well understood at the time when radioactive elements were first identified and scientists began working with them in the lab.

Fast forward a few decades to the late 1950s, when thalidomide was available as an over-the-counter remedy for sleeplessness and manufacturers touted the safety of the drug, claiming it was even safe for pregnant women and children to take. By 1960, sales of thalidomide worldwide were equivalent to those of aspirin. Merely two years later, thalidomide was banned in most countries because of severe birth defects linked to thalidomide use.

Today (and since the 1960s), the US Food and Drug Administration (FDA) has been the gold standard of drug safety worldwide. The US regulations are notoriously strict, meaning that when a pharmaceutical company can have a product with FDA approval, the drug is widely considered to be safe.

Understanding the Drug Discovery Process. Image via Compound Interest.

The process from discovering a possible pharmaceutical therapy and FDA approval is a necessarily long one. The hurdles that a company must leap over to demonstrate the safety are vital as a way to limit as much as possible situations like what occurred with radium and thalidomide. When regulations are bent or broken for popular opinion, the public bears the brunt of the damage. It is true that FDA approval is a very expensive process, and that those costs are often passed on to consumers (or used as a reason for high drug costs), but deregulation is not the best way to drive down drug costs. Instead, deregulation of the FDA will cause the US to lose its standing in worldwide drug safety research. It will lead to the approval of some compounds that should never be brought to market. Sure, it will streamline the process for some drugs that really are safe, but is it worth the risk of introducing a product with unforeseen effects to the general population? Is a lower cost of new medications worth the increased risk?

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