Avistan Update 5: NIH Considers Trial Comparing Lucentis to Avistan

Discussion in 'Optometry Archives' started by Irv Arons, Aug 29, 2006.

  1. Irv Arons

    Irv Arons Guest

    Just to let those of you with age-related macular degeneration, or know
    someone with this disease, I have published an update on the status of
    Avastin for treating AMD.

    The latest information is that the NIH is considering sponsoring a
    trial to compare the costly Lucentis with the much less expensive
    Avastin to see if there is any significant difference in the clinical
    outcomes. As shown, if Avastin is used, the approximate yearly cost
    goes down to under $1000 compared to $10,000 to $14,000!

    The update is titled: Avistan Update 5: NIH Considers Trial Comparing
    Lucentis to Avastin.

    The link:

    Irv Arons
    Irv Arons, Aug 29, 2006
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  2. Irv Arons

    LarryDoc Guest


    1. NIH sponsoring/ funding a study that sucks the $$$ out of Genetech
    and Novartis, two of the largest and most powerful pharm corps on the
    planet? Sure. Never happen.

    2. The ophthalmologist-retina specialist community is quite aware of the
    effectiveness of Avastin compared to Lucentis (the same) and the cost
    scam. At more than one conference I attended the sentiment was to use
    Avastin off-label and save the patient (and the health care system) what
    could amount to $100,000 per patient over time. Times a few million
    patients a year. But then there are lawyers, eh?

    3. Lucentis was just approved in at least on EU country (Switzerland)
    and will likely be approved throughout the EU in the weeks/months to
    come. When it becomes the standard of care at any cost worldwide, what
    power do you think a poorly funded little NIH is going to have?

    And why do you post your stuff here, anyway?

    --LB, O.D.
    LarryDoc, Aug 30, 2006
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  3. Irv Arons

    Don W Guest

    Lucentis has gone through the FDA trials. Avastin has not. When
    unforseen side effects occur with the use of Avastin, how will you explain
    it to your patient?

    Don W.
    Don W, Aug 30, 2006

  4. Yes, it has. Not for mac. degen, so far as I know, but off-label use is
    not illegal.
    Scott Seidman, Aug 30, 2006
  5. Irv Arons

    Don W Guest

    Lucentis has gone through the FDA trials. Avastin has not.
    Not talking about approval for some other illness. Comparing it's use
    for "mac. degen" vs. Lucentis. Hmmm. How far off does off-label use have
    to go to be illegal?

    Don W.
    Don W, Aug 30, 2006
  6. So long as it's approved for use in humans, its OK. It's VERY illegal,
    however, for a pharmaceutical company to promote ANY off-label use.
    Scott Seidman, Aug 30, 2006
  7. Irv Arons

    Irv Arons Guest

    And, there have been several hundred, or perhaps thousands, of people
    with wet AMD treated and improved with the lower costing Avastin. So
    far, to my knowledge, there have been no side effects.

    Irv Arons

    PS Check out the rest of my postings on Avistan to see the results.
    Irv Arons, Aug 30, 2006
  8. Irv Arons

    Irv Arons Guest

    I rechecked the numbers -- I was wrong, there have been more than
    10,000 patient treatments with Avistan!

    Irv Arons
    Irv Arons, Aug 31, 2006
  9. Irv Arons

    LarryDoc Guest

    Then tell us the number of Lucentis patient treatments and compare the
    effectiveness and side effects. Then explain the how and why Lucentis
    got approval and Avastin was not even considered. Go ahead. You opened
    the can now clean up the mess.

    And do tell us why you post your stuff here, in this forum primarily for
    non-docs to query information on eye care, and when no one is asking for
    the info

    LB, O.D.
    LarryDoc, Aug 31, 2006
  10. Irv Arons

    Irv Arons Guest


    I post on this Usenet because its devoted to questions and answers
    about vision.

    Age-related macular degeneration is certainly a vision problem, and
    Lucentis and Avastin appear to be good answers. By posting on this
    site, I hopefully am informing the public about potential new
    treatments for this disease.

    Yours respectfully,

    Irv Arons
    Irv Arons, Aug 31, 2006
  11. Irv Arons

    Don W Guest

    So what you are saying is that so long as Drug A is approved for
    Symptom/Disease B, then it is "legal" to use it for Symptom/Disease C??

    Don W.
    Don W, Sep 1, 2006
  12. Essentially, once the FDA says a doctor can prescribe a drug, a doctor
    can prescribe a drug. All the warnings about when the drug might pose a
    danger and all the side effect info is already determined.

    It is not legal to market the drug for off-label use, though.


    Practically no Country in the World has formal legislation forbidding the
    off-label use of drugs by clinicians, nor are there measures to monitor
    and control such uses. However, if a manufacturer promotes a drug for an
    indication for which there is no approval from the drugs control
    agencies, it would be violative of the provisions under the Drugs and
    Cosmetics Act of that Country. Pfizer was reprimanded by FDA for
    promoting unlicenced indications for some of their drugs by executives
    and detailing representatives. The drugs concerned included Ziprisidine
    (anti-psychotic), Atorvastatin , Sildenafil and Gabapentin. It is thus
    clear that the controls on the manufacturer are very different from those
    on the Clinicians. In fact, according to FDA, if a drug maker knows that
    it's drugs are used for off-label indications, it is required to inform
    the agency of such use even if the Company had no role in the promotion
    for that use.. According to FDA officials this rule has never been
    strictly enforced so far. In one of the few litigations on the issue, a
    former employee of Warner-Lambert filed a law suit against the Company
    for promoting Neurontin, a drug approved for epilepsy for being promoted
    for treatment of bipolar disorder, pain etc.
    Scott Seidman, Sep 1, 2006
  13. Irv Arons

    Don W Guest

    Thanks for the link. Very informative. But I think Avastin falls into
    it's own unique class (i.e., the drug company denied the off-label use in
    such a fashion (OK, for obvious reasons)). I have a problem on how this all
    comes about. The maker designs the drug for disease A. So the users notice
    that it's use also improves macular degeneration. Great side effect!! But
    the primary treatment (usage) becomes problematical (those prescribers back
    off). What the heck, we'll water it down and inject it directly into the
    eye. Should not expect that "other bad side effect". Real low systemic
    effect. Now we'll tell the drug company they must keep producing the drug
    for this usage, sans clinical trials, backed up by a multitude of anectodal
    evidence (where is that data base??), and in competition with it's
    clinically proven drug.

    Don W.
    Don W, Sep 1, 2006
  14. Lucentis appears to be a form derived from Avastin tweaked for AMD
    treatment. Both drugs act upon the same mechanism-- VEGF inhibition.
    It's not unreasonable to believe that Avastin would work. To claim
    efficacy of Lucentis for AMD, however, Genentech claims that they would
    have to start over again at the pre-clinical trial stage, and that its
    not worth the expense because Lucentis has proven efficacy.


    Now, Genentech insist that this has no financial motivation (though the
    whole idea about not doing trials again is clear financial motivation--
    but I guess they're claiming that their reason is not because they can
    make more money selling the more expensive Lucentis!). But, they can't
    deny that they have a large investment in Lucentis.

    Apparently, though, there is a real live clinical trial for Avastin in

    The evidence for Avastin is largely anecdotal, in that the study doesn't
    seem to be done, but docs see their patients improve. AMD does not just
    get better by itself. Remember, the drug is an anti-VEGF, just like

    Try http://www.revophth.com/index.asp?page=1_991.htm
    Scott Seidman, Sep 1, 2006
  15. Irv Arons

    Don W Guest

    To me it boils down to this. For instance. As a producer of a certain
    product (say any product), I have the right to say how it will be used.
    Truth? As a user of said product, you can modify and use it for some other
    purpose. Good luck. But it seems (maybe for a moment, skipping profit,
    ethics, need and all other misc things), do you really have the right to
    tell me I must keep on producing this product solely for the need you have
    derived? Even when I say you shouldn't do this.

    Don W.
    Don W, Sep 2, 2006
  16. Not when it comes to drugs, in which case the FDA needs to approve any
    claim you make.
    Nobody, so far as I can tell, has claimed this as a right. There may or
    may not be orphan drug laws that apply-- I wouldn't know. If you can cite
    cases where someone has tried legal paths to try to make Genetech keep
    producing this drug, feel free to post them.
    Scott Seidman, Sep 4, 2006
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