David R. Henderson  

The FDA's Power Grab

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But if the FDA gets its way, nitroglycerin will not be obtainable for pennies. The situation was stable until Pfizer went through the time and expense required to test its particular version of nitroglycerin, Nitrostat, which the FDA approved in 2000. Once the FDA did that, other versions became officially "unapproved." In 2010, the FDA sent warning letters to two companies, Glenmark and Konec, ordering them to cease marketing their versions of nitroglycerin, known as sublingual nitroglycerin tablets, leading to the New York Times headline above. The article quotes Dr. Harry M. Lever, a cardiologist at the Cleveland Clinic, who said, "If it's not approved and no one has tested it, we can't be sure that it's safe and effective." He added that if patients with angina took substandard or ineffective nitroglycerin tablets, their pain might not subside and the problem could potentially progress to a heart attack.

His statement is false. The unapproved versions have been tested in three important ways: the companies that manufacture these drugs thoroughly vet them to make sure that they are pure and offer a consistent dose of nitroglycerin; these marketed drugs have been tested in the bodies of millions of Americans in regular medical practice over many years; and many different organizations have tested nitroglycerin in countless clinical trials.

One of the manufacturers, Konec, has regularly conducted its own lab tests to ensure that its nitroglycerin pills have the same potency and stability as Pfizer's Nitrostat, the FDA-approved brand-name drug. In the world of medicine, this is basic stuff. Nitroglycerin is used to treat acute episodes of angina--chest pain. The benefit that nitroglycerin provides is not theoretical; if patients didn't feel relief from their pain, they wouldn't have continued taking it, and doctors wouldn't have continued prescribing it for the last 130 years. (emphasis added)


This is from David R. Henderson and Charles L. Hooper, "The FDA's Power Grab," Defining Ideas, September 8.

Read the whole thing. Charley and I wrote this in August but as you can see from my previous post about Scott Alexander, it's quite a propos.


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COMMENTS (4 to date)
mobile writes:
Doug T writes:

This is nuts. Nitroglycerin has been around forever. From Wiki:

"Its use began with the experiments of William Murrell, which were reported in 1879. It is on the WHO Model List of Essential Medicines, a list of the most important medications needed in a basic health system."

There's a touching scene at the end of "On Golden Pond" (1981) where Katherine Hepburn puts a nitroglycerine pill under Henry Fonda's tongue when he has an angina attack. As she holds him up, he gradually recovers and asks, "Do you want to dance, or just 'suck face'"?

I guess here I'd ask, is the FDA dancing? Or are they just helping big pharma to suck our dollars?

Thomas Nagle writes:

At one point I worked for a med products client that faced a similar absurd FDA restriction. The company had sold its product for many years, spot testing the output of final proudcts immediately before packing. If any failed, then that batch would be destroyed and the source of the problem corrected. This worked, as the company had an excellent reputation.

But at one point in the 1990s, the FDA changed the rules and ordered that testing of all manufacturing had to occur at each stage in the production process, not just at the final stage. When the company resisted this unnecessary additon to its costs in court, the FDA shut them down. The resulting shortage of their product caused huge market disruption, including shortages for awhile of an essential product, and enabled competitors to raise their prices as they rushed to increase output.

The lesson to everyone in the market: don't question the logic of the FDA's rules, Obey them.

AntiSchiff writes:

Dr. Henderson,

I would strip the FDA's power to control which drugs are on the market if I had my way, but have a problem with your statement about patients experiencing pain relief after taking certain nitroglycerin formulations. I assume I'm not telling you anything new by mentioning the placebo effect.

I think the FDA should play an advisory role solely and only have the power to label medication as approved or not and to insist on certain warnings on labels.

In general, I favor total drug legalization, meaning only drugs like antibiotics would require prescriptions, given the obvious need to ration them to maintain their effectiveness. Ditto for the flu vaccines, for example, during periods of shortage.

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