Oh, wait, phew, it's just Uncle Sam, aka, FDA man, aka, the Prince of Purity.
Because that ideal – ensuring purity – is the starting proposition of the FDA, or the Food and Drug Administration: the purity of products we willingly put into our own mouths and swallow. (Tobacco and veterinary products are also on that list).
So, hooray for the FDA, because it certainly cleaned up one kind of mess. Originating in the Teddy Roosevelt era, the agency racked up a darn good track record of heading off crooks, con men and incompetents who were hawking meat that had gone bad, medicines that killed people, and even, legend has it, a mascara that caused blindness. Impurity indeed.
But now, a century later, is this same FDA creating another kind of mess?
Next Wednesday, May 8th, we're putting on a debate centered on this motion: “The FDA's Caution Is Hazardous To Our Health” – the premise being that the world has changed since Teddy Roosevelt, and that the FDA's ways and means of ensuring drugs are safe and work as promised actually get in the way, slowing availability of new pharmaceuticals and devices that could be saving lives sooner. In other words, its caution turned into over-caution, and is actually doing harm.
To be blunt, the argument goes, you could die waiting for a drug that could have saved you had the testing regimen not been so unreasonably, and fatally, high.
There are, as ever, two sides to that argument, and we'll be bringing them both, with two teams of articulate and passionate debaters. Preview some of what they've said already in the column on the right, and be there in person next Wednesday. It's your medicine cabinet we'll be opening that night, in front of the world. Join us.
In the meantime, meet the debaters:
Changing The FDA's Culture
by Dr. Scott Gottlieb
“The current regulatory regime is a major barrier to better therapies — and thus to better lives for many suffering Americans.” Read More
by Peter Huber
“Arm in arm, the FDA and its wards tracked diversity into a quagmire of human trials that never stop growing, take forever, and cost the earth.” Read More
FDA Standards—Good Enough for Government Work?
by Dr. Jerry Avorn
New England Journal of Medicine
“There is one area of biomedicine in which the government allows — even defends — a minimal standard that would be unacceptable anywhere else in research. It is the set of evidentiary requirements maintained by the FDA for the approval of new drugs.” Read More
The IOM Report on the FDA's 501(k) Process
with David Challoner
“We basically say that the 510(k) emperor has no safety and effectiveness clothing, and that the public interest requires a paradigm shift.” Read More
John Donvan, Moderator
Intelligence Squared U.S. Debates