Tuesday, September 29, 2009

Part Three: The Relationship Between the Level of Regulation under the FDCA and the Health Status of a Product’s Targeted Population

[From BioLaw/AgLaw]

An Introduction to the History of Quack Medicine

In the late nineteenth and early twentieth centuries there was a remarkable growth in the marketing of sham products to treat and cure disease.

At that time, the rate at which quack medicines were being introduced into the market far outpaced the development of the science necessary to establish the efficacy and identify the risks associated with each new product. This scientific lag time created a period when there was an information void that
predatory commercial interests were quick to use to their advantage. As the FDA carried the burden of proof to show that a product did not work or was unsafe in order to remove the product from the market, during this lag time predatory commercial interests were able to profit from scientific uncertainty to the detriment of public health.

During this long period in U.S. history, the curative claims of the predatory sham medicine salesmen were limited only by the gullibility of their targets. In many cases, the degree of gullibility was proportional to the level of desperation of the individual for a cure. The more dire the condition, the more vulnerable an individual was to the ‘flim flam’ of the greedy snake oil salesman. And the more dire the condition, the greater the degree of harm when the sham medicine did not work, causing injury over and above the original illness and/or causing a delay in seeking effective medical treatment. Thus, this lag time between initial marketing of a sham product and the development of the science necessary to resolve uncertainties over the new product’s safety and effectiveness was very costly in terms of human suffering and loss of life. Slaying the Hydra: The History of Quack Medicines
In 1962, after a series of highly publicized public health crises, legislation was passed to close this ‘space between’ created by scientific uncertainty by switching the burden of proof for safety and effectiveness from the FDA and onto product manufacturers.

Read the rest here...


  1. Once again, I'm glad you're posting this series from the agricultural law blog. The word needs to be spread about these predatory practices.

    In an unrelated comment, I wanted to share an article with you that I thought you might find interesting. I thought it was incredibly informative and thought-provoking, thorough and well-written.

    The article is fairly long, but it's pertinent to your current place of residence (Cali). If you have any time to read it, I'd love to know your response to the article and opinions about legalization of marijuana - Should it happen? Will it happen? Has it happened (as the article insinuates)?


    (Don't feel any obligation to read/respond to this...just thought I'd put it out there for ya)

  2. Really great article, Ryan. Pretty much sums up the entire situation.

    I can tell you that it most certainly has already happened here in California, much like the author describes. People are about as scared of getting caught with pot as they are of getting caught jaywalking. Lots of very successful people smoke pot and you never hear people say they want to but don't because it's illegal like you do in other states. I think some of the best and brightest in the country are in the Bay Area and thriving at life all while getting high while not at work.

    This really gives me hope that I may one day live to see legalization.