This is why we have the FDA

In a note of sad irony, I am finishing a chapter in Thomas Hager’s excellent, The Demon Under The Microscope, on the elixir of sulfanilamide deaths in the US in 1937. A specific formulation of this truly miraculous antibiotic at the time was associated with over 100 deaths from renal failure.
This formulation had used as a vehicle the solvent diethylene glycol, a relative of ethylene glycol used in antifreeze – a great solvent, but one that is metabolized to insoluble oxalate crystals that accumulate in the kidneys, causing virtually-irreversible renal failure and death.
In this oft-told story in pharmacy and the pharmaceutical sciences, the deaths led to new legislation and an amendment to the 1906 Federal Food and Drugs Act: the 1938 Food, Drug, and Cosmetic Act that some claim was the defining establishment of the US Food and Drug Administration (although it had existed in some form for decades previously).
The legislation also correct many abuses in the food industry and in the marketing of poorly-characterized “patent medicines,” the forerunner to today’s dietary supplements.
What is sad is the new story that came across the wires yesterday that first saw light of day in October from Panama: the death toll in a modern diethylene glycol medicine debacle has reached 48.
The US FDA and pharmaceutical industry have taken a great deal of heat lately for mismangement and/or withholding of crucial safety data related to Vioxx (rofecoxib) and Trasylol (aprotinin) (see Dr Jerry Avorn’s, “Dangerous Deception – Hiding the Evidence of Adverse Drug Reactions,” in the 23 Nov 2006 NEJM (free full text). In no way do I make apologies for the unethical activities associated with these episodes; the article points out just why some players in certain pharmaceutical companies (usually at management levels well above my highly-principled bench scientist colleagues) have brought well-deserved mistrust across the entire industry.
However, just as with public health initiatives, the public rarely thinks about the lives saved as a result of processes already in place to assure some degree of drug safety. The lesson of the current Panamanian episode is a reminder that, while much can still be improved at FDA, our nation dealt with this one set of drug safety issues nearly 70 years ago.

One thought on “This is why we have the FDA

  1. Thanks for the thoughtful post. I am possibly a DES daughter, and definitely a sister of a DES daughter. So far as I know, my only health problem is a cancer that does not yet seem to be related to DES (ovarian; the DES-linked cancers as far as I know are breast for mothers and vaginal/cervical for daughters). The part about the DES thing that really did me in was that it turned out that there was never any real evidence that DES worked. I was born at 32 weeks back when that was quite the big deal, survival-wise, and given my mother’s pregnancy experiences she might well have been willing to accept the risks of DES, had they been known, in order to stay pregnant long enough. (She had no idea what they were giving her in those pre-informed-consent days.) The fact that DES appears to have had no actual benefit just makes it all the more brutal. I guess my point is that some of us are conditioned not only to “mistrust” drug safety reporting; we have a high (I hope not too high) degree of skepticism regarding drug effectiveness reporting.

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