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Off-Label Drug Marketing Is 'Free Speech,' Court Rules

Discussion in 'Other Health News and Research' started by MishMash, Dec 6, 2012.

  1. MishMash

    MishMash

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    This may sound a little wonky and technical. But it is incredibly important to patients of murky, hard-to-define illnesses like ours. Basically the US Supreme Court has ruled that any doctor can prescribe any drug he wants to off label. The drug companies are allowed to do off-label promotions. A doctor could prescribe Prozac for bad breath, or anti-retrovirals for the flu. That's not an exaggeration. (Although, I suppose he would still be bound by possible malpractice, and maybe ethical charges by medical associations.)

    There is a new class of mostly MS drugs coming on the market now which may benefit ME/CFS sufferers. Science has not come to a stop. It just pulled off the road for a 20 year nap. I'm optimistic for a change. I've been more frustrated and desperate than any patient on this forum. My oft-mentioned BG-12, neuro-anti-inflammatory, is scheduled to be on the market early 2013. If you go ask Lapp, Klimas, or Kogelnik to prescribe it, there are no rules whatsoever stopping him. The highest court in the land has ruled on this.

    This was the case that ended in the ruling. The drug rep and the doc were exonerated.

    http://abcnews.go.com/Health/Drugs/...ing-free-speech-court-rules/story?id=17883930
     
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  2. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    Why valcyte is prescribed for cfs and has been affective for so many but its time its indications are widened to includes this as it would make the drug alot cheaper for us if it was directly indicated.
     
  3. taniaaust1

    taniaaust1

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    Im not sure how I feel about this.. it could be a quite dangerous thing drug companies sales reps making all kinds of claims to our doctors etc and being protected over making UNPROVEN claims. Drug Reps are out to SELL their products so they saying whatever they like.. proven or not.. is a conflict of interest.

    Actually the more I think about it.. the more I think very bad consequences could come out of this. Sales people should have to stick to the truth.
     
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  4. Sushi

    Sushi Senior Member Albuquerque

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    I don't think drug companies can advertise unproven claims in the US. I remember recently that one company was fined for doing this. But, yes, docs can prescribe at their own discretion though insurance companies may not pay for off-label use.

    Sushi
     
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  5. MishMash

    MishMash

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    Xyrem is a so-called "orphan drug," which means the original company dropped development half way through. Jazz pharmaceutical is trying to spread it beyond narcolepsy to treatment of other illnesses like FM. The FDA stopped them when they tried to market for other illnesses. And of course it is going to be expensive:

     
  6. Kina

    Kina

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    The article says that 'How wide-ranging the decision becomes likely will depend on whether it gets to the U.S. Supreme Court, attorneys said.' and 'Once the Food and Drug Administration approves a drug, physicians are free to prescribe that drug as they wish -- but the drug makers can only market the drug for the FDA-approved marketing indication.'.

    So it would seem that the US Supreme Court hasn't made any ruling yet. It would also seem that once the FDA approves a drug Doctors can prescribe it 'off-label' but the drug companies can not market/promote the drug for off-label reasons. That's how I read the article but I could be misreading it.
     
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  7. MishMash

    MishMash

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    Kina
    No, sorry, I got it wrong.

    But this is the Supreme Court that said "money = speech". Which just lead to our billiion dollar election. So the commentary (at least on this side of the border) has been that the SC will not interfere with any free speech issues.

    But I could be wrong. I was totally wrong when they let Obama's health care pass.
     
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  8. MishMash

    MishMash

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    It's a fine line. The FDA has to regulate for safety and efficacy. But that is extremely hard to prove with highly complex illnesses which drugs work, and which don't. Peer review does not always work out. And the peers sometimes miss simple but important discoveries. I was hoping we could take advantage it, either individually or collectively. But I don't know..
     
  9. AFCFS

    AFCFS Senior Member

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    Might be interesting to follow up where this guy (Gary) left off:

    Fumaderm in the US - Biogen's response to me
    Granted by the time you got doc, script, pharmacy in place, it might be early 2013, but it may be worth a try. At least a query might show status or might give one more option.

    Some people on msconnection.org discuss it here: http://www.msconnection.org/app/ren...75&signature=c458e0b6065a053e43ed19b20e5f4cf9
     
    MishMash likes this.
  10. MishMash

    MishMash

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    AFCFS
    With ME/CFS, always keep track of what the MS people are up to. I think their angle is going to be much more salient to our condition than anything else i've heard.

    If there was a physician I knew of in Germany, I could always fly there, get the script, fill it there, then fly home. I'll bet it would much cheaper than paying cash for off-label BG-12 when it first comes out. I wonder if they have it in Mexico? It is not a controlled substance. I'm sure our government would slap some kind of penalty on it, should somebody try and import DMF drugs. Starting to look a little scandalous.
     
  11. AFCFS

    AFCFS Senior Member

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    I think it is a bit of a middle ground between the FDA, Supreme Court and other legal suggestions noted, but biased toward the SALE. Just listen to drug reps talk to a doctor. They typically do not have much time and learn to talk in sound bytes like a truncated tv commercial. They are not talking FDA.

    What they do, is not so much lie, but just highlight convenient truths. Every time you are highlighting a positive, you are also downplaying a negative, because it does not even come into discussion. I believe the TV med commercials are now required to spend 50% of the time on side effects, so they do not have that leeway - notice thought hey do not put it first in the ad.

    They did not formerly have that constraint, but now they do. It has had some effect to come back and bite them in the butt. The hype may be fine, but when the average user sees a side effect of something like "possible instant death," they may rethink asking their doc about it or even become squeamish when a doc then brings the med up.

    I have had a doc tell me this has happened on many occasions - they have to deprogram the patient from the negative side effects on TV, before they can get them to the free sample the nice drug rep has delivered.
     
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  12. MishMash

    MishMash

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    I know everybody hates malpractice attorneys in this country. They are the vultures and parasites of our medical system. But, in seeing some of the medical mistakes made by doctors treating friends and family members, I'm glad they are around. And if the pharma companies are now allowed to do unrestricted advertising, then things like class-action lawsuits are the only counter-balance. Litigation can be both the bane and boon of any health care system.
     
    AFCFS likes this.

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