Think Freely Media presents Common Sense with Paul Jacob

You’re sick and need medicine that has proved its benefits to you. Will the Food and Drug Administration let you use it?

The FDA recently extracted $600 million from Allergan, makers of Botox, for promoting uses for Botox different from those for which it was approved. It’s not illegal to use the drug for unapproved uses; it’s just illegal, sometimes, to tell you about those other uses. This, despite the fact that the First Amendment doesn’t exclude members of the pharmaceutical industry.

Now we’re hearing that the FDA has flip-flopped about letting people use midodrine, which quells dizziness. Back in 1996, midodrine was approved under “an abbreviated process,” one too brief to determine whether it really helps with dizziness. So, recently the agency outlawed sales of midodrine until its effectiveness could be shown. But — oops! — during the intervening 14 years, patients have come to depend on it. These patients swamped the FDA with complaints. So now the agency, in good-cop mode, says, okay okay, you can use it.

Thus, if you can persuade bureaucrats to let you medicate yourself as you and your doctor see fit, you get to do so. If not . . . sorry.

The New York Times talks about the “tough choices” facing the FDA, since banning a drug can mean “stranding desperate patients.” Congress should represent patients by stripping the agency of any power whatever to dictate when and how we may act to improve our own health.

This is Common Sense. I’m Paul Jacob.

By: Redactor

6 Comments

  1. Dennis Weber says:

    You are not correct about the use of drugs that are not part of the original approved FDA application. It is illegal for a pharmaceutical company to advertise or sell one of their products for any indication or purpose that was not part of the companies original FDA application. However, any knowledgable pnysician may use the drug for a purpose or in such a manner that is NOT in the original FDA approved application. The reason for this is that the physician has the knowledge of the condition, patient, etc. that no pharmaceruifcal company has. The pharmaceutical Industry in the first half of the 20th century had a well thought out and succesful operating arrangemnt with physicians.
    The flip-flop by the FDA is in respone to politicians and public who wanted to get to a new drug before ALLl the research was done. The U.S. drug industry is damaged by ignorant politicians. I can send a copy of what happened if you wish.

  2. Dennis Weber says:

    The Kefauver Commision in the late 1950s held hearings about the EFFIACY of drug products. Many of the over-the-counter roducts did not work or had claims that were not proven and were eliminated from the market. However, those products eliminated lobbied the politicians to force the drug companies to give, FREE all the recipes and research needed to make and sell the drug. Ignorant politicians, lawyers and the public have destroyed the best pharmaceutical industry in the world. I have written the story if anyone is interested.

  3. “If — at no time in your life — it has never crossed your mind that you need to go to a doctor to get a permission slip in order to buy a product that you will use on your own body, then it’s my sad duty to report to you that reading this sentence, right now, is the very first time you have ever encountered the concept of freedom.”
    –from Chapter 10 of Unchaining the Human Heart — A Revolutionary Manifesto, http://jneilschulman.rationalreview.com/2009/12/unchaining-the-human-heart-%E2%80%94-a-revolutionary-manifesto-high-times/

    And likewise from Paul Jacob’s excellent commentary.

  4. Vic Justes says:

    If you strip the FDA of the power to dictate when and how we medicate ourselves, you have effectively removed its reason for existence. Careful, Paul, some one might just begin to think you are promoting Libertarian ideas.

  5. Drik says:

    Congress should represent patients, and other Americans. What a great idea. Next time we set up a country, make sure they get the memo.

  6. ForFreedom says:

    The FDA exists because the pharmaceutical companies want the government to prevent competition, and it also drives up the costs of drugs to meet the stringent requirements to get a drug approved. Politicians like it because it means pharmaceutical companies now bribe the policians (I mean give them campaign contributions). It doesn’t serve consumers.

    Some call this “regulatory capture” I call it capture of the industry by politicians.

    The FDA has also approved drugs that have turned out to be harmful!

    I much prefer leaving this to the free market, ourselves and our doctors. If you disagree, where do you draw the line on the government protecting us from ourselves? We’re heading towards federal regulation and approval of the food we eat. And that may mean you can grow your own vegetables, they haven’t been approved.

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