May 18, 2009

  • I'm not FDA approved


    Well, I guess it was time I got off another medication anyway, right?  I'm already allergic to nearly everything out there, got off all the rest but two that aren't even really used for lupus directly, and the dosages are so small a child couldn't even overdose on them, and NOW my insurance company has stopped paying for one of them.  $15 ballooned into $115, per month.  Geez.
    I went through a lot of withdrawal last year getting off muscle relaxers and lyrica and nonsteroid anti-inflammatories, on top of one of the most severe viral infections I've ever had in my life and a gadolinium contrast reaction during an MRI because the drugs wiped out my immune system and the viral infection swelled my liver and spleen.
    So you can imagine, after ALL that, all I want to know is-- why?  Why is my insurance provider no longer paying for one of the final two drugs that I ~can~ still take?  LIBRAX ROCHE Pill Identification  
    I started asking this from inside a Walgreens, who had been trying to get my prescription to run through my insurance for a solid week without any explanation of why it wasn't going through.  I called my rep on my cell phone, and for 27 minutes, she, I, and the registered pharmacist at Walgreens jumped through every conceivable hoop trying to get *anything* remotely related in that drug family to run through the insurance.  The rep finally dug up something about the FDA issuing some kind of statement about those drugs, but there was no reason given, nothing indicating what in the world this had to do with the insurance company...  And it had nothing to do with the drug being pulled because Walgreens had no problem selling it to me full price.
    So I came home and called back, got another rep, wanted an answer.  I was nice, I know that people who answer the phones have protocols and don't have all the answers to the million questions that pop up.  After 36 minutes, a supervisor, and a pharmacy team, all I got was that the FDA hadn't made any kind of statement on this drug having any adverse effects.  Yes, I know that, I actually bought it... full price.  They suggested I call the main office.
    All I got with the main office was 16 minutes and a sort of promise that THEIR pharmacy staff, which sits in on all the meetings about coverage changes, will call me back.  Hold your hand up if you really think they'll call me.
    In the meantime, you know me, google queen.  There is ~nothing~ online (yet?) about this FDA hooplah that somehow has impacted my insurance coverage.  Or IS there...?
    It's not public.  You have to pay for this article from ScienceDirect - International Journal of Law and Psychiatry, but I will quote the public abstract.
    International Journal of Law and Psychiatry
    Volume 31, Issue 2, March-April 2008, Pages 126-135
    The Liberal State and Mental Health
    Copyright © 2008 Elsevier Inc. All rights reserved.

    The liberal state and the rogue agency: FDA's regulation of drugs for mood disorders, 1950s–1970sstar, open

    References and further reading may be available for this article. To view references and further reading you must purchase this article.

    Edward ShorterCorresponding Author Contact Information, a, E-mail The Corresponding Author

    aHistory of Medicine Program, University of Toronto, 88 College Street, Toronto, Canada M5G 1L4

    Available online 17 March 2008.


    The theory of the liberal state does not generally contemplate the possibility that regulatory agencies will turn into “rogues,” regulating against the interests of their clients and, indeed, the public interest. In the years between circa 1955 and 1975 this seems to have happened to one of the prime regulatory agencies of the US federal government: the Food and Drug Administration (FDA). Intent upon transforming itself from a traditional “cop” agency to a regulatory giant, the FDA campaigned systematically to bring down some safe and effective drugs. This article concentrates on hearings in the area of psychopharmacology regarding several antianxiety drugs, namely meprobamate (Miltown), chlordiazepoxide (Librium) (which is in my librax) and diazepam (Valium). In addition, from 1967 to 1973 this regulatory vengefulness occurred on a broad scale in the Drug Efficacy Study Implementation (DESI), an administrative exercise that removed from the market almost half of the psychopharmacopoeia. The article explores possible bureaucratic motives for these actions.

    Article Outline

    1. Introduction
    2. Muscle-flexing
    3. Taking down meprobamate
    4. DESI
    5. Conclusion

    star, openI should like to thank Leonard V. Kaplan for his comments on an earlier version.

    Corresponding Author Contact InformationTel.: +416 978 2124; fax: +416 971 2160.
    Hmmm...  That's interesting.  A witch hunt.  A lot of upset doctors.  Bureaucratic motives.  Rogue FDA officials.  Angry clients.  Wow.
    Since I found this before the second two calls I made, I asked my reps directly if the FDA was leaning on them not to pay for these drugs.  I knew they couldn't answer that, I'm not stupid.  And I was still nice, but persistent.  I only want to know WHY.  Why is my insurance company suddenly refusing to pay for a well established drug that I've been using off and on for 2 decades?  Like the pharmacist said today, in her own incredulity at this surprise, you can get ANY of these generics "dirt cheap" and you don't even have to get them off the street for that.  I asked her if I decide to get their Walgreens generics plan, would it be covered.  To her astonishment-- no.
    Lupus and fibro aren't fun to live with, especially once your nervous system and organs get involved.  My digestive tract is ~alive~ in there.  Plus I've been on anti-spasmodics since I was a baby, I was *born* this way (possibly related to being a CF carrier, validated by an endocrinologist who seems surprised I'm still alive *without* handfuls of medications).  And now my insurance company is saying I've gotta come up with $1380 a year for a prescription after we've already paid them beaucoup bucks to pay it ~for~ us.  Hey, just pro-rate that back off, and I'll buy my own pills, thanx.  My copays and expenses are already so high that I'm worth $500 a month out of pocket, AFTER insurance, and from the bills we get on the side after tests are run, we're thinking we really got screwed.  The loopholes we keep discovering in the policy (which can be changed quarterly without warning) have been a bit of a nightmare.  Our first experience with this mess when Scott's work first switched to this insurance was nearly losing his daughter between two hospitals and a botched 'routine' surgery.  Took years to pay off all the loopholes, may as well have just paid cash for the surgery in the first place.
    But I learned something else from the pharmacist.  There used to be a lot of drug companies who manufactured this drug.  Now there aren't, thanx to 'regulation' by the FDA.
    "FOR IMMEDIATE RELEASE -- Morristown, NJ, August 1, 2008 -- Actavis Totowa LLC, a generic drug manufacturer, is announcing a voluntary recall, to the retail level, of all drug products manufactured at its Little Falls, New Jersey facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.
    This action is not prompted by product complaints or health hazards associated with the products, which are all prescription medications. Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk."
    Not sure who worded that last sentence, but I'm sure they get paid more than I've ever made.
    Kinda reminds me of all those tomatoes getting thrown out before they figured out it was jalapenos...
    And how about this one?
    I think I'm starting to get the picture about insurance not wanting to cover something the FDA is really jumpy about.
    So all you have to do is freak out a little and call that 800 number right at the top of the page (which, incidentally is pretty sparse for a drug reaction page), and there you go, the FDA has JUST CAUSE for making everyone else's lives miserable.  Have you guys SEEN the drug reaction board for benadryl?  People are so stupid that they don't read the label, take it on TOP of their other OTC cold and allergy meds, and then freak out that they ~nearly~ ~died~.  You wanna know why the FDA has so much power to lean on everybody and their dog?  Because so many idiots out there can't be bothered to READ THEIR PRINTOUTS.
    So the witch hunt is on.  One of the last two drugs I can take has had a spotlight on it for a long time, and I'm sure more people die of alcohol poisoning every year than 'nearly' die from this drug.  I've used it for a long time, like millions of people have for some very severe health problems, and I'm still here, despite being quite the little guinea pig in the pharmaceutical industry.
    You know, I'm more surprised there isn't an iron warning on cereal boxes.  I once ate an entire box of cereal one day before I realized there was a whole day's worth of iron in every bowl.  They put warnings on vitamin bottles, why not cereal boxes?  Possibly because no one's ever died from eating cereal...?
    Sometimes you've just gotta dump it all out onto a blog.
    Oh, and all you *happy* people out there who think Obamacare is going to fix this.  Who do you think the FDA ~answers~ to?  Yeah.  NOT ~you~, or your needs.  And they're not infallible or omnipotent.
    Scroll down to the "Generic drug scandal" section, and then further down to "Criticism".  I'm not against someone making sure my milk is pasteurized properly, and that my vitamins don't contain toxic metals, and stuff like that.  But when a rep slips up in a giant insurance company and tells me the FDA is linked to a decision they made over whether to discontinue coverage on a drug they've supported previously for years, but everyone confirms 'nothing is wrong with the drug'... you *gotta* wonder what's up, perhaps maybe "regulating against the interests of their clients"...
    And then, if your interest has been piqued, you can move on to Criticism of the Food and Drug Administration.  I think "Cheerios" will make a nice subsection in that one.
    For all my fellow chronics and terminals out there, I salute you, and wish you well.  Just another day in our lives, eh?

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Apologies for the missing vids, another upgrade during the server migration swept through like a scan sweeping through the Enterprise. I'll fix those later, kinda busy...

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