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Medical Forum / General / Vision / September 2006Avistan Update 5: NIH Considers Trial Comparing Lucentis to Avistan
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: http://irvaronsjournal.blogspot.com/2006/08/avistan-update-5-nih-considers-trial.html Irv Arons > 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! ROFLOL! 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 $100,000 per patient over time. Times a few million patients a year. But then there are lawyers, eh? 3. Lucentis was just approved in at least on EU country (Switzerland) and will likely be approved throughout the EU in the weeks/months to come. When it becomes the standard of care at any cost worldwide, what power do you think a poorly funded little NIH is going to have? And why do you post your stuff here, anyway? --LB, O.D. Lucentis has gone through the FDA trials. Avastin has not. When unforseen side effects occur with the use of Avastin, how will you explain it to your patient? Don W. "Don W" <dwilgus@prodigy.net> wrote in news:Y3iJg.4442$yO7.1075 @newssvr14.news.prodigy.com: > Lucentis has gone through the FDA trials. Avastin has not. Yes, it has. Not for mac. degen, so far as I know, but off-label use is not illegal.  SignatureScott Reverse name to reply >> Lucentis has gone through the FDA trials. Avastin has not. > > Yes, it has. Not for mac. degen, so far as I know, but off-label use is > not illegal. 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. >>> Lucentis has gone through the FDA trials. Avastin has not. >> [quoted text clipped - 7 lines] > > Don W. 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. SignatureScott Reverse name to reply 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. > >>> Lucentis has gone through the FDA trials. Avastin has not. > >> [quoted text clipped - 10 lines] > 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. I rechecked the numbers -- I was wrong, there have been more than 10,000 patient treatments with Avistan! Irv Arons > And, there have been several hundred, or perhaps thousands, of people > with wet AMD treated and improved with the lower costing Avastin. So [quoted text clipped - 18 lines] > > 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. > I rechecked the numbers -- I was wrong, there have been more than > 10,000 patient treatments with Avistan! 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. Larry, 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 > > I rechecked the numbers -- I was wrong, there have been more than > > 10,000 patient treatments with Avistan! [quoted text clipped - 9 lines] > > LB, O.D. > 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. 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?? Truth?? Don W. "Don W" <dwilgus@prodigy.net> wrote in news:zJOJg.5165$yO7.2358 @newssvr14.news.prodigy.com: > 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?? > Truth?? > > Don W. 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. From http://www.pharmabiz.com/article/detnews.asp?articleid=24106§ionid=46 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. SignatureScott Reverse name to reply >> 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?? [quoted text clipped - 7 lines] > > It is not legal to market the drug for off-label use, though. 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. >>> 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 [quoted text clipped - 25 lines] > > Don W. 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. http://www.mdsupport.org/library/avastin.html 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 AMD. 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 Lucentis. Try http://www.revophth.com/index.asp?page=1_991.htm SignatureScott Reverse name to reply > 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 > Lucentis. 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. > 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? Not when it comes to drugs, in which case the FDA needs to approve any claim you make. > 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. 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. SignatureScott Reverse name to reply >Lucentis has gone through the FDA trials. Avastin has not. Avastin was FDA approved in 06/2006 (<http://tinyurl.com/ogjzu>) -- [scroll to bottom of page]. FDA approved drugs typically go thru "FDA trials". >When unforseen side effects occur with the use of Avastin, how will >you explain it to your patient? You mean "If", not "When". I have no problem using medications or medical devices "off label" and have done so routinely throughout the years. I do so only when the potential benefits outweigh the potential risks. |
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