Slowing Progress at the FDA

Econlog tells the story of how the FDA is blocking a drug for Restless Leg Syndrome because massive doses caused cancer in a few rats.  Millions of humans have taken the drug with no ill effect, but let a few rats dies, and the FDA refuses to approve it for a new use.

This reminded me of a story I meant to point out from the winter Olympics.  I think many people saw the US Bobsled team win the gold, piloted by Steve Holcomb.  Perhaps you heard the story of how Holcomb would have had to give up the sport several years ago due to a vision disorder until a new operation restored his sight.  But note the clause I have bolded:

Traditional corneal surgery would have left his eyes susceptible to damage from a jarring bobsled run. So last March he underwent a radical procedure, yet to be approved by the FDA, in which doctors implanted a lens behind each iris. When he woke from the surgery, Holcomb immediately noticed the detail of the palm trees in one of the posters on his doctor's wall. "An hour before, I didn't even know there were posters," he says. "It was a new world."

I wonder how many hoops he had to jump through to get the operation, and whether average people who are not on the Olympic team would have been able to get the same benefits.

  • sch

    Implantable lens have been available since the '70s in ever improving variants and with ever improving
    procedures and tooling. The typical cataract surgery takes about 30min with present techniques. Not
    knowing the details of the Holcomb surgery or underlying problem it is hard to comment further, but
    one should note that although the implanted device (lens) must be approved by the FDA, the FDA does
    not vet the surgical procedure(s) themselves at the present. In fact "no one" vets surgical procedures.
    They are developed, tried and fail or pass based on animal and/or human testing. Sounds irrational but
    that is the way it is and would be even if the FDA had the authority or will to give its imprimatur
    to procedures, which it does not. They do cover devices, vaccines and drugs.

  • Jamie

    I think the article is confusing FDA approval of a medical device, and FDA approval of a device for an alternative use.

    Holcomb has Vision ICL. See http://www.boxerwachler.com/usatoday/index.htm

    The FDA approved ICL in 2005 for myopia.
    http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm078356.htm
    I know this because my Optometrist keeps wanting me to have ICL (I can't get Lasik).

    Holcomb has Keratoconus, for which ICL is apparently not an approved treatment. But I don't think the FDA gets involved in an MD's medical judgment about whether an approved device can be used for something else. The restrictions are mainly on how much marketing the device manufacturer can do to doctors. Generally they can't market off-label uses.

  • sch

    Basically all Holcomb had to do was find someone willing to do the surgery, and perhaps fund it somehow
    as health insurance is a bit vague about non-standard procedures, though many companies will cover
    such if it is not on the bleeding edge, which as my other comment suggests, the surgery itself is not.
    My ophthalmologist would be happy to remove my lens and replace it with a new one that would get rid of
    my minimal cataracts AND correct my life long high myopia. Likely I would have to pay for it myself
    as Blue Cross would not, just as they don't cover Lasik procedures.

  • Chris K.

    Intra Ocular Lens, not uncommon. Doesn't distract from the truth of the rest of the post that the FEDGOV has no interest what I put in my body.

    Any more than they have any interest in what I put in my head (read: First Amendment)

  • Gil

    I presume if there was no FDA then you'll be signing a liability waiver every time you have an operation, buy medicine or buy medical equipment.

  • Dr. T

    I am not a defender of the FDA (far from it), but I do wish to point out that this story is absurd. The FDA does not regulate medical care or surgical procedures. There is no such thing as an “FDA-approved” operation. The FDA regulates food, drugs, and medical devices. The implanted lenses are medical devices that were approved for use in patients whose lenses no longer transmitted light correctly due to cataracts. The implanted lenses were never tested in patients with less common lens disorders, but there is no requirement for surgeons to get FDA approval for such an obvious “non-approved” use of the implants.

    The real story is simply: Surgeons correct rare lens disorder in young man by using artificial lenses that were created for treating cataracts.

    It's not as dramatic as the news reports, but it's far more accurate.

  • Chris K.

    Gil,
    for operations you already do that.

    And yes I would be fine with signing waivers.

  • frankania

    SCH, I had a double-cataract operation recently at a large, first-class hospital that specializes ONLY in eye problems.
    Cost only $1300 cash for both ops, all tests, German lenses, hospital stay etc.--everything.
    It is in Mexico City near the historic district.
    check it out.