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English: Logo of the U.S. Food and Drug Admini...

English: Logo of the U.S. Food and Drug Administration (2006) (Photo credit: Wikipedia)

{Published in the Colorado Springs Gazette, September 1, 2010}

Score one for the Nanny State. After two years and millions of dollars, three entrepreneurs and wealth creators formerly associated with Spectranetics in Colorado Springs are going to jail. Their crime? Importing medical devices not approved by the Food and Drug Administration.

People who break the law should be held accountable. I get that. But when good people break a bad law, the discussion shouldn’t end with who gets jail time. We ought to be asking if there isn’t something fundamentally wrong with the system. In this case, there most certainly is.

The FDA is in charge of making sure drugs and medical devices are “safe” and “effective”. This is like being in charge of motherhood. Who could possibly be against safety and efficacy? The devil is in the details.

It is true that the monopoly power of the FDA saves some lives. But does it save more lives than it kills? As far as I can tell, the answer is no. Not just no, but a clear and obvious no. It’s all a matter of how you do the counting.

Regulation of drugs and medical devices can err in one of two ways. A “Type I” error occurs when a dangerous and/or ineffective product comes on the market. That type of error is tragic and visible: It generates headlines, Congressional hearings, and plenty of media attention. But regulation can also err by keeping a safe and effective product off the market. That’s a “Type II” error.

Deaths caused by Type II errors are just as tragic as [[thalidomide]] babies and [[Botox]] victims. The only difference is that we will never know who they are. But here are some numbers to get you thinking, based on academic and medical studies (some of which use the FDA’s own data) that dare to ask how many people die from regulatory excess:

  • 119,000 Americans dead due to the seven-year FDA delay in the approval of beta blockers.
  • 25,000 Americans dead due to the three and a half year FDA delay in the approval of Interleukin-2.
  • 30,000 Americans dead due to a four year FDA delay in the approval of the clot-busting drug TPa.
  • 7,000 Americans dead for each year that the AmbuCardioPump (used in most industrial nations) is not approved by the FDA.
  • 10,000 Americans unnecessarily infected with HIV due to a five year FDA delay in approving an in-home HIV test.

The list goes on and on. For these victims, no reporter will tell their story, no hearings will ever be called, and none of their families will ever appear on Oprah. Is it any wonder that the FDA, and perhaps society in general, simply doesn’t care?

What’s the solution? Must we choose between a system that kills people through inaction, and one that permits drugs that poison you and pacemakers that cause heart attacks? Of course not. There are tons of other options out there.

If abolishing the FDA is too much for you, how about repealing its monopoly? Why not let anyone who wants to opt [out] of the FDA approval process? The only legal requirement should be full disclosure: “This product has not been approved by the FDA.” People who still want FDA certification can have it, people who prefer other approaches can exercise their right to do so. Over time, letting competing standards emerge for safety and efficacy is much more likely to get that crucial societal balance right.

Here’s another insane idea: Let the FDA still issue standards, but leave it up to private firms to certify compliance. Oh wait a minute, that’s not crazy at all. It’s what most industrialized countries already do.

But not here. In America, the Nanny State has run amok.

Spectranetics should be a Colorado Springs success story, enjoying multimillion dollar profits and employing hundreds of residents with good paying jobs. Instead, it’s still struggling, trying desperately to bring a quality, life-saving product line to market while jumping through the most burdensome regulatory process on the planet.

They deserve better. We all do.

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