![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 15 of 15. This is the beginning of the thread.
Posted by OldSchool on March 30, 2002, at 9:02:56
Well folks, its official. The much hyped "MAOI Patch" was rejected by the FDA. It aint gonna happen. I predicted this...it sounded too good to be true. I knew it would get rejected and turns out, I was right. Why? I have no real idea but can only speculate. Probably the SSRI companies had too much political pull and tried to get it blocked as an MAOI patch might eat into SSRI sales too much. Or maybe the FDA really honestly believed the patch was not effective or unsafe. Also, remember this patch would have been used by people with parkinsons, not just with depression.
All I can say is...what a bunch of shit.Somerset says FDA turns down depression-drug patch
Wednesday March 27, 8:59 PM EST
TAMPA, Fla., March 27 (Reuters) - Somerset Pharmaceuticals Inc., a joint venture of generic drugmakers Mylan Laboratories (MYL) and Watson Pharmaceuticals Inc. (WPI), said on Wednesday that U.S. regulators have rejected its application to market a skin patch for treatment of depression.
Somerset, based in Tampa, Florida, said the U.S. Food and Drug Administration decided that the company's Emsam skin patch, containing the drug selegiline, is not approvable unless there is more data showing that it is effective.
Somerset said it had scheduled a meeting with the FDA to review and clarify the comments and, subject to the meeting, will prepare a response to the agency.
Shares of Mylan, which is based in Pittsburgh, rose 3 cents to close at $30 on the New York Stock Exchange, while shares of Corona, California-based Watson fell 37 cents to close at $30.74.
©2002 Reuters Limited.
Posted by Elizabeth on April 4, 2002, at 19:22:58
In reply to Selegiline MAOI patch rejected by FDA, posted by OldSchool on March 30, 2002, at 9:02:56
I wouldn't worry about it. This just says that they might need to do some more research to demonstrate that the patch is effective (it doesn't mention any safety concerns). It doesn't mean that the FDA has decided, finally, once and for all, that it will never approve the patch!
Anyway, anyone who wants to take selegiline can still take the tablets. It's a well-tolerated drug, even in the higher doses typically required for depression.
-e
Posted by Adam on April 6, 2002, at 12:59:27
In reply to Re: Selegiline MAOI patch rejected by FDA, posted by Elizabeth on April 4, 2002, at 19:22:58
This does not suprise me at all.
My understanding of the results of some of the clinical trials is that STS efficacy for MDD, in the larger studies, was less easily and/or spectacularly demonstrated as it was in the earlier, smaller studes. Still, if I recall correctly, there was statistically significant improvement overall in depressive symptoms in these studies. None of us have seen all the data, though; but I very much doubt it could be argued that the STS would not have helped many people.
Elizabeth may be right, and more time and more studies will lead to approval. My guess is there were still safety concerns, given that selegiline is a non-specific MAOI when delivered transdermally at 10 and 20mg/patch. No new MAOI of that type could get approval these days, with the alternatives now available, unless there were something special about it. In the case of the STS, that something special was the lack of dietary restrictions, at least up to 20mg per patch per day, and rapid onset of effect. However, the potential for deadly drug interactions remains. There is also little flexibility, as the purported protection of alimentary MAO-A may be compromised at doses higher than 20mg/day, transdermally.
Anyway, that's my guess: Selegiline, after all, performs no better than any other antidepressant, and because it has some troubling safety issues, the FDA decided it wasn't worth the risks. The hurdle is just higher for the STS, and unless it can get over that, it's simply out of the running.
It's too bad. From my own personal experience, the STS can work wonders. That it isn't for everone is not all that startling. Neither are the other MAOIs, which, overall, perform no better than other antidepressants. I bet if trials could be designed more intelligently, the STS would look like the knock-'em-dead medicine the earlier, optimistic claims, made it out to be. If my experience is at all representative, perhaps many people who tried the STS and experienced great benefit had nearly exhausted the other options. An MAOI was the next step. To me, this looks like a self-selecting pool poised for success. For larger "better" designed studies, maybe the pool is more representative of the "general" depressive population. In such a pool, the effect of near-outliers like myself on the statistics can be diluted considerably.
Imagine giving tamoxifen to someone with prostate cancer. Wouldn't make a lot of sense, would it? Imagine giving selegiline to someone with the "wrong kind" of depression. If only we knew how to administer psycophamacoligic treatments more selectively, like we can for some cancers.
There may still be hope: The STS is being tested for other indications. If it gets approved for one of those, it may be possible to use it off-label for depression. That has seemed to me for some time to be the most likely scenerio, if it gets approved at all.
Posted by djmmm on April 6, 2002, at 14:56:51
In reply to Re: Selegiline MAOI patch rejected by FDA, posted by Adam on April 6, 2002, at 12:59:27
It is still in phase 3 for cocaine dependence
http://clinicaltrials.gov/ct/gui/c/a1r/show/NCT00007553?order=1&JServSessionIdzone_ct=jcle5vzj71
and, phase 2 for "Decreased mental function" in HIV patients
http://clinicaltrials.gov/ct/gui/c/a1r/show/NCT00013585?order=2&JServSessionIdzone_ct=jcle5vzj71
Posted by Elizabeth on April 7, 2002, at 21:11:14
In reply to Re: Selegiline MAOI patch rejected by FDA, posted by Adam on April 6, 2002, at 12:59:27
> My understanding of the results of some of the clinical trials is that STS efficacy for MDD, in the larger studies, was less easily and/or spectacularly demonstrated as it was in the earlier, smaller studes.
That still surprises me. I thought that high-dose selegiline was about as effective as the other nonselective, irreversible MAOIs (although it didn't do anything for me). It's hard to imagine that a large clinical trial (or a whole bunch of small ones) of selegiline for MDD wouldn't have clear-cut positive results. Does anyone have a clue what caused this result? A fluke seems unlikely....
> My guess is there were still safety concerns, given that selegiline is a non-specific MAOI when delivered transdermally at 10 and 20mg/patch.
Do you know what the ratio of oral dose to equivalent transdermal dose is?
> No new MAOI of that type could get approval these days, with the alternatives now available, unless there were something special about it.
Yeah, if the FDA had existed when the first MAOIs were discovered, they probably wouldn't have been approved. Kind of sad; they're really safe drugs as long as you take a few simple precautions.
> In the case of the STS, that something special was the lack of dietary restrictions, at least up to 20mg per patch per day, and rapid onset of effect.
The rapid effect is the part that has me interested. About how fast did it work, typically? And how long did the trial last?
> There is also little flexibility, as the purported protection of alimentary MAO-A may be compromised at doses higher than 20mg/day, transdermally.
Why would it?
> Anyway, that's my guess: Selegiline, after all, performs no better than any other antidepressant,
AFAIK, *no* antidepressant performs any better than any other antidepressant (overall, that is). The point of offering different options -- really different ones, not Just Another SSRI -- is to give a few more people the chance of finding something that works and is tolerable, IMO.
> and because it has some troubling safety issues, the FDA decided it wasn't worth the risks.
That is a good point; the FDA is very, uh, conservative about approving new drugs. (It's also very corrupt, of course.)
> The hurdle is just higher for the STS, and unless it can get over that, it's simply out of the running.
That would be unfortunate. It's had a lot of publicity, and a lot of people have been hoping for it. Still, oral selegiline is always an option. (That's why I was wondering about the relative dose.) It's always a shame that so many people have these (mostly irrational) fears of food-drug interactions. The drug-drug interactions are more dangerous, but they're easy to avoid too (thanks to poor Libby Zion, doctors are well aware of them).
> That it isn't for everone is not all that startling. Neither are the other MAOIs, which, overall, perform no better than other antidepressants.
I'm puzzled by that, actually. I'd expect them to have higher success rates than the other ADs.
> If my experience is at all representative, perhaps many people who tried the STS and experienced great benefit had nearly exhausted the other options. An MAOI was the next step.
I think it's pretty absurd how people think MAOIs are a last resort -- a lot of doctors, not just patients. When I was in college, I was informed by the student health center that they "don't use MAOIs." I knew several other students who were taking Nardil or Parnate, so it's not as if college kids don't need them. A lot of patients are scared of MAOIs, too -- often because they've been misinformed about potential interactions. A lot of doctors and pharmacists tell patients that they can't eat chocolate or drink any alcoholic drink, which naturally doesn't sound too great to some patients. Some people go to extreme lengths to avoid trying an MAOI, even trying things that aren't likely to work (obscure augmentation strategies, TCAs for atypical depressions, etc.). There's really no reason to avoid MAOIs so desperately...unless you're addicted to banana peels.
> To me, this looks like a self-selecting pool poised for success. For larger "better" designed studies, maybe the pool is more representative of the "general" depressive population. In such a pool, the effect of near-outliers like myself on the statistics can be diluted considerably.
That's not a very representative sample! I'm surprised they set it up that way -- if all the subjects are people who deliberately sought out a clinical trial, a lot of them are bound to be "treatment-resistant." The designers of the study must have known this.
> Imagine giving tamoxifen to someone with prostate cancer. Wouldn't make a lot of sense, would it?
I have trouble just imagining what tamoxifen would do to a man.
> Imagine giving selegiline to someone with the "wrong kind" of depression. If only we knew how to administer psycophamacoligic treatments more selectively, like we can for some cancers.
...but we don't. Even weirder, nobody seems interested in solving this problem.
-elizabeth
Posted by Adam on April 8, 2002, at 20:25:08
In reply to Re: Selegiline MAOI patch rejected by FDA » Adam, posted by Elizabeth on April 7, 2002, at 21:11:14
Hi, Elizabeth,
>
>I thought that high-dose selegiline was about as effective as the other nonselective, irreversible MAOIs...That's just the point I was making. In Bodkin's Phase II study, I think the STS looks more impressive still (http://www.mhsource.com/pt/p010525.html).
>
> Do you know what the ratio of oral dose to equivalent transdermal dose is?
>
All the references I have seen point to a big difference. In this study, they say it's about 1:50, for instance: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9089426&dopt=Abstract
>
>
> The rapid effect is the part that has me interested. About how fast did it work, typically? And how long did the trial last?
>
I don't have any concrete numbers. The time oft quoted to me has been as little as a week for full remission. Bodkin mentions rapid onset of effect in this hearbreakingly optimistic article: http://www.news.harvard.edu/gazette/1998/12.10/depression.html
>
> Why would (higher doses of transdermal selegiline lead to loss of MAO-A protection in the gut)?
>
I don't know, that's just what I was told. In reality, nobody really knows how MAO-A in the gut is protected in the first place, which makes it hard to know what would cause the loss of protection at higher doses with any certainty. My guess (and this is only a guess) is that active drug exclusion (maybe P-glycoprotein or some similar culprit) keeps circulating selegiline out of the gut lining. I mean, there's obviously a directionally-selective membrane somewhere in there or lots of stuff would just leak out of you by simple osmosis. Maybe at higher doses this barrier is overwhelmed.
>
> AFAIK, *no* antidepressant performs any better than any other antidepressant (overall, that is). The point of offering different options -- really different ones, not Just Another SSRI -- is to give a few more people the chance of finding something that works and is tolerable, IMO.
>
Well, that's what sucks about this. I don't think selegiline is on an even footing with other AD's though, for the reasons I mentioned.
>
>(The FDA is) also very corrupt, of course.
>
I'm not at all disputing this, I just wonder if you know of some specific examples of this corruption, for my own curiosity.
>
>I'd expect (MAOIs) to have higher success rates than the other ADs.
>
The way some doctors talk, they do. However, when I read about them, I inevitably come across the statement "MAOIs are no more effective than other antidepressants..." yadda, yadda. I guess it's safest to be agnostic on that point. One might use the logic that since they seem to work for some people who are refractory to all other drugs, AND they are also likely to work for a good portion of the people who aren't so refractory, hence they are better overall. This line of thinking can't be completely right; however, I don't know how wrong it is.>There's really no reason to avoid MAOIs so desperately...unless you're addicted to banana peels.
>
Well, I found my own banana-peel addiction difficult to overcome, and would hate to trivialize the plight of the banana-peel addict. However, as a recovering banana-peelaholic, I can personally say giving them up made me a better man.
>
> That's not a very representative sample! I'm surprised they set it up that way -- if all the subjects are people who deliberately sought out a clinical trial, a lot of them are bound to be "treatment-resistant." The designers of the study must have known this.
>
I'm speculating wildly here. However, from my own experience, and from posts I've seen on this board, it's clear that some people who entered an STS study did so because they had exhausted many other options and it was time to give an MAOI a try (the STS being a relatively pain-free way to do this). I think it's generally true that a good percentage of the people who want to get into a clinical trial do so because they've not found success with the proven options and are willing to take some risks. I imagine after Phase I and Phase II studies, when good safety info. is available, and efficacy is already demonstrated, risk aversion is diminished; a wider pool of candidates presents. Perhaps this is also a less "self-selecting" pool. Plus your n is bigger, and that certainly can lead to changes in the numbers.
Posted by Elizabeth on April 10, 2002, at 11:18:01
In reply to Re: Selegiline MAOI patch rejected by FDA, posted by Adam on April 8, 2002, at 20:25:08
> >I thought that high-dose selegiline was about as effective as the other nonselective, irreversible MAOIs...
>
> That's just the point I was making. In Bodkin's Phase II study, I think the STS looks more impressive still (http://www.mhsource.com/pt/p010525.html).I just didn't see any reason why it'd be *less* effective. I guess that both Nardil and Parnate have some "extra" effects in addition to MAO inhibition -- Nardil a GABA effect, Parnate an amphetamine-like one -- but I don't know about other MAOIs like Marplan, Marsilid, nialamide, etc. (I'm not convinced that there's anything useful about the L-amphetamine metabolites of selegiline.)
I seldom have trouble tolerating medications, but I got a bad case of the jitters from high-dose selegiline (p.o.) so it does surprise me that so many people completed the study. OTOH, I wasn't doing too well in general when I tried selegiline (I'd recently discontinued Nardil and was experiencing protracted withdrawal), and that could have made a difference. Something to consider if I ever have to ditch the Effexor. (I hope very much that I don't; I really dislike the medication merry-go-round.)
> > Do you know what the ratio of oral dose to equivalent transdermal dose is?
> >
> All the references I have seen point to a big difference. In this study, they say it's about 1:50, for instance: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9089426&dopt=AbstractHuh. I wonder what the ratio is for producing equivalent AD effects. If it's anywhere close to that, then oral selegiline isn't such a viable AD after all! But we know that some people do respond to oral selegiline without the pressor effects becoming a problem, so maybe the metabolites do contribute something -- other than side effects, that is. On the other hand, MAO-A and -B inhibition has to be about 100% with the 20 mg/day patch, but how high are they at various oral doses? There are lots of things going on with this -- it's pretty confusing.
> I don't have any concrete numbers. The time oft quoted to me has been as little as a week for full remission. Bodkin mentions rapid onset of effect in this hearbreakingly optimistic article: http://www.news.harvard.edu/gazette/1998/12.10/depression.html
Yeah, a week or so was what I heard, too. I wonder how long the trial lasted -- was it the usual 6-8 weeks? Hmm....
> My guess (and this is only a guess) is that active drug exclusion (maybe P-glycoprotein or some similar culprit) keeps circulating selegiline out of the gut lining. I mean, there's obviously a directionally-selective membrane somewhere in there or lots of stuff would just leak out of you by simple osmosis. Maybe at higher doses this barrier is overwhelmed.
That seems reasonable. Lots of things are like that: effects at high concentrations become very unpredictable. (Heck, at a high enough concentration, anything will bind to any receptor! So it's not hard to imagine that high enough concentrations of a drug can reach places that lower concentrations don't get to in significant amounts. Of course, I'm waving my hands here.)
> Well, that's what sucks about this. I don't think selegiline is on an even footing with other AD's though, for the reasons I mentioned.
Probably not. Still, I think that if the patch offers the capacity for much higher serum concentrations than are possible with oral selegiline, that's very significant and ought to be considered.
> >(The FDA is) also very corrupt, of course.
> >
> I'm not at all disputing this, I just wonder if you know of some specific examples of this corruption, for my own curiosity.Not off the top of my head, no. It's basically a revolving door, though: the FDA employs people who have ties to the drug industry, and people working for the FDA often move on to work in the drug industry.
> >I'd expect (MAOIs) to have higher success rates than the other ADs.
> >
> The way some doctors talk, they do. However, when I read about them, I inevitably come across the statement "MAOIs are no more effective than other antidepressants..." yadda, yadda. I guess it's safest to be agnostic on that point.That's how I feel too. And yet...well, you know.
> One might use the logic that since they seem to work for some people who are refractory to all other drugs, AND they are also likely to work for a good portion of the people who aren't so refractory, hence they are better overall. This line of thinking can't be completely right; however, I don't know how wrong it is.
My thought is, they work especially well (better than TCAs, at least) for "atypical" depressions; and they work for other depressions about as well as other ADs (as far as I know); therefore they should work better overall. This should work if atypical depressions constitute a significant proportion of all depressions (refractory depressions may be much rarer). Of course, there's also the possibility that MAOIs work less often in non-atypical depression, but there has been very little research on this subject. (It's certainly not consistent with my experience or impressions, although I think most people who have "classic" depression never reach the point of trying MAOIs.)
> Well, I found my own banana-peel addiction difficult to overcome, and would hate to trivialize the plight of the banana-peel addict. However, as a recovering banana-peelaholic, I can personally say giving them up made me a better man.
Hmm. Perhaps we should try and start a BPA group? Or maybe selegiline can be used to treat banana peel addiction?
> > That's not a very representative sample!
>
> I'm speculating wildly here. However, from my own experience, and from posts I've seen on this board, it's clear that some people who entered an STS study did so because they had exhausted many other options and it was time to give an MAOI a try (the STS being a relatively pain-free way to do this).I think that's often true in clinical trials, yeah. It's a problem, although I don't really know how to solve it (without screwing up the whole system of clinical drug research, that is). The fact is that people for whom other things haven't worked are a great source of research subjects, and I'd hate to deny them access to experimental drugs. Yet a subject pool consisting mostly of refractory subjects is unlikely to do much better than placebo. Of course, the placebo arm would also consist of refractory depressives -- a group with a notoriously low placebo response rate. Also, it's true that a study of selegiline, a drug with more potential risks than numerous available ADs, might be expected to attract mainly refractory depressives. It might get a better response rate for the other indications; cocaine addiction, in particular, is something that has proven practically impossible to treat reliably, and it probably won't be hard to do better than placebo there (assuming the stuff actually works).
> I think it's generally true that a good percentage of the people who want to get into a clinical trial do so because they've not found success with the proven options and are willing to take some risks.
I don't doubt it. Of course, I've been in that situation and I was never willing to take the risk! (The risk I was worried about was the risk of being stuck in the placebo arm, not the risk of adverse effects. Also, a lot of the time, the researchers require you to be off all other medications in order to participate in a clinical trial.)
> I imagine after Phase I and Phase II studies, when good safety info. is available, and efficacy is already demonstrated, risk aversion is diminished; a wider pool of candidates presents. Perhaps this is also a less "self-selecting" pool. Plus your n is bigger, and that certainly can lead to changes in the numbers.
But these were Phase III studies, no? (I wonder how many sites there were and what the n was.)
-elizabeth
Posted by Adam on April 11, 2002, at 18:58:44
In reply to Re: Selegiline MAOI patch rejected by FDA » Adam, posted by Elizabeth on April 10, 2002, at 11:18:01
>
>(I'm not convinced that there's anything useful about the L-amphetamine metabolites of selegiline.)
>
I think the possibility that they have a clinically significant effect must be allowed. There's about zero information addressing this possibility, though. However, from what I've read, it's not 100% correct to say that "l-methamphetamine is ten times less potent than d-meth" or whatever. L-meth is actually a pretty good potentiator of norepinephrine, but less so for dopamine. For this reason, it's used instead of d-meth in Vick's inhaler decongestants. However, apparently, you can get high on enough l-meth, if the anti-drug literature is any guide. I think either isoform of meth is also a weak MAOI-inhibitor. Since it's known that drugs like desipramine and reboxatine, which are pretty specific for NE-reuptake inhibition, have antidepressant effects, it's not that much of a stretch to think that l-meth couldn't have mood altering effects as well at the relevant doses.However, just as you suggest, l-meth is a mixed bag, as far as pros and cons go. Because of the reduction in metabolites when using the STS, selegiline may have significantly altered pharmacodynamics. Does this mean that it has reduced efficacy, pound for pound? I don't know. Nothing about the trials leads me to believe that, though. I always thought the changes were ultimately a plus.
>
> Not off the top of my head, no. It's basically a revolving door, though: the FDA employs people who have ties to the drug industry, and people working for the FDA often move on to work in the drug industry.
>
The whole drug-approval process is rife with conflicts of interest. A very significant number of trials are run by investigators who have a financial stake in the companies producing the drug or other therapy. I wonder if a corrupt investigator running a trial would be cancelled out by a corrupt regulator on a competator's meal ticket. It would be nice to get rid of all these conflicts of interest. I'm not sure there would be anyone left to do the work, though.
>
> I don't doubt it. Of course, I've been in that situation and I was never willing to take the risk! (The risk I was worried about was the risk of being stuck in the placebo arm, not the risk of adverse effects. Also, a lot of the time, the researchers require you to be off all other medications in order to participate in a clinical trial.)
>
The thing that hooked me into the STS trial was the promise, after completing the six-week blinded portion, of six months on the 20mg patch. It was a suprisingly tough six weeks, but I could see how such a promise kept others like myself going. I have wondered quite often what such an incentive might do to the "placebo effect". There's been recent work published suggesting a good portion of the placebo effect can be chalked up to the patient's willingness to please the doctor. Is one more or less willing when the promise of the real thing awaits? And do people who know they are now getting the real thing suddenly respond, even when they were getting the real thing all along?I'm very interested in seeing the results of all the studies. I'll be waiting with interest.
Posted by Adam on April 11, 2002, at 22:01:03
In reply to Selegiline MAOI patch rejected by FDA, posted by OldSchool on March 30, 2002, at 9:02:56
I read with some suprise a previous thread, where a Dr. Kramer seems to have some knowledge of the results of the PhaseIII trials for the STS. He states that it did no better than placebo. This is pretty amazing to me, but I don't dispute it. If true, this would of course negate all of my speculation above (except the potential means of availability), and would also negate everything I have heard word-of-mouth about the PhaseIII trials.
I have tried like crazy to find information about this on the web, but have yet to, other than the link Oldschool provided.
Does anybody have any other specific information? I wonder how Dr. Kramer knew. I know you don't post here often, Dr. Bob, but have you heard anything, or do you know where I might find some specific info.?
Posted by Jodeye on April 12, 2002, at 1:45:31
In reply to Re: Does anyone know more?, posted by Adam on April 11, 2002, at 22:01:03
> I read with some suprise a previous thread, where a Dr. Kramer seems to have some knowledge of the results of the PhaseIII trials for the STS. He states that it did no better than placebo. This is pretty amazing to me, but I don't dispute it. If true, this would of course negate all of my speculation above (except the potential means of availability), and would also negate everything I have heard word-of-mouth about the PhaseIII trials.
>
> I have tried like crazy to find information about this on the web, but have yet to, other than the link Oldschool provided.
>
> Does anybody have any other specific information? I wonder how Dr. Kramer knew. I know you don't post here often, Dr. Bob, but have you heard anything, or do you know where I might find some specific info.?Not in answer to your question... I have a holistic MD and he prescribed transdermal selegeline gel. I tried 5 and 10mg per day without effect. Any doctor can prescribe it, but it is only available at a compounding pharmacy. I suppose this would work similar to the selegeline patch.
--Jodeye
Posted by djmmm on April 12, 2002, at 11:55:18
In reply to Re: Does anyone know more?, posted by Adam on April 11, 2002, at 22:01:03
I don't think that there is any conspiracy behind the FDA's decision to not approve the Selegiling Patch (for depression) at this time. The facts are, apparently, the outcome of the study shows that it isn't effective, and that the FDA needs additional efficacy info to proceed with this protracted process.
The fact is, (and we all know) Antidepressants often perform no better than placebo...I have never believed that this was due to a lack of efficacy on the part of the antidepressant, but simply due to the power of the placebo effect.
Bodkin's study was promising, this isn't, but this is almost typical of current research. A recent St Johns Wort study using Zoloft and a placebo found that Zoloft was no better than placebo...as we all know, Zoloft has been proven in numerous studies to be effective, and significantly better than placebo.
As far as web info goes...
I know Bodkin is (or was??) on staff at Harvard medical, you can try and search the Harvard site for something..
http://www.hmcnet.harvard.edu/psych/The Selegiline patch studies were conducted at McLean, here is that site... http://www.mclean.harvard.edu/index.html
I don't know if you will find anything, but it's worth a shot.
Posted by AnnieDonia on April 15, 2002, at 23:03:30
In reply to Re: Selegiline MAOI patch rejected by FDA, posted by Adam on April 8, 2002, at 20:25:08
I guess everything happens for a reason. I used to be a regular here but haven't been back in about a year. I've been trying in "hold on" until the Selegiline patch was approved. I was a participant in the first trial and it was the first treatment that ever helped me. For 6 months out of the last tee years I felt human.I have tried oral Selegiline and it didn't work for me. I have tried virtually every oral treatment available with very limited success. I have been told it is because of the way I metabolize medication. I've tried other treatments. I was in the first TMS study and while I saw it significantly improve others, for me it was almost useless. I even had ECT last year in desperation. Now I'm depressed AND have serious memory problems and cognitive impairment. There is no purpose to this post other than to keep from thinking. What is there to hold on for now? I'm sorry.
Posted by IsoM on April 16, 2002, at 1:09:12
In reply to Re: Selegiline MAOI patch rejected by FDA, posted by AnnieDonia on April 15, 2002, at 23:03:30
Annie, the way pharmaceutical companies are set up & operate is the same with just about everything else in this corrupt world - the bottom line is 'will the profit be large enough'?
The fact the Selegiline patch works very well for some isn't reason enough for them. I guess they figure there's not a big enough profit margin in it to proceed. One thing that's hopeful is it may be picked up by another company instead.
Another post mentioned a drug study being done on a substance P antagonist labelled MK-869. Merck jumped on it & got to stage III (I think) testing before they realised that people were responding just as well to the placebo & dropped it. They didn't take other factors into consideration &, in my opinion, stopped it prematurely. Some other companies such as Pfizer & Eli Lilly have taken it up instead & are working further with it.
Maybe the same will happen with the Selegiline patch. There's bound to be a few researchers involved who'll note that it did work wonderfully with some & spread the idea or cross over to the competition & they'll decide they don't have a big new winner & will go at it. I really wouldn't be surprised to see it come up with another company. The competition to come up with new or improved ADs is intense & very political too.
Posted by djmmm on April 16, 2002, at 9:29:36
In reply to Re: Selegiline MAOI patch rejected by FDA » AnnieDonia, posted by IsoM on April 16, 2002, at 1:09:12
> Annie, the way pharmaceutical companies are set up & operate is the same with just about everything else in this corrupt world - the bottom line is 'will the profit be large enough'?
I just don't agree with this...I bet If you were to take a poll of both currently depressed people not responding on meds, and those who are on meds and consider themself recovering or responding, you would find a great majority of *all* of them willing to try this patch.I take an oral MAOI, and consider myself cured, I would be willing to try the Selegiline patch in a second...*IF* it was as effective as the early Bodkin studies show.
The fact remains, We are disparate for new treatment options, the drug co's know that, and the FDA knows that. The FDA is not the corrupt superpower it is made out to be.
If there is any concern about letting a drug on the market, you should be concerned about drugs that are released that truely perform poorly in tests, or have undisclosed dangerous side-effects. This information is held back by the drug co's not the FDA.
All we can do is wait until Somerset Pharm. tweaks their research methods, so they can present an adaquate statistical difference (vs placebo).
If several studies can show St johns Wort a "safe and effective antidepressant" Somerset should have no problem
> The fact the Selegiline patch works very well for some isn't reason enough for them. I guess they figure there's not a big enough profit margin in it to proceed. One thing that's hopeful is it may be picked up by another company instead.
>
> Another post mentioned a drug study being done on a substance P antagonist labelled MK-869. Merck jumped on it & got to stage III (I think) testing before they realised that people were responding just as well to the placebo & dropped it. They didn't take other factors into consideration &, in my opinion, stopped it prematurely. Some other companies such as Pfizer & Eli Lilly have taken it up instead & are working further with it.
>
> Maybe the same will happen with the Selegiline patch. There's bound to be a few researchers involved who'll note that it did work wonderfully with some & spread the idea or cross over to the competition & they'll decide they don't have a big new winner & will go at it. I really wouldn't be surprised to see it come up with another company. The competition to come up with new or improved ADs is intense & very political too.
Posted by Elizabeth on April 16, 2002, at 20:55:17
In reply to Re: Does anyone know more?, posted by djmmm on April 12, 2002, at 11:55:18
> Bodkin's study was promising, this isn't, but this is almost typical of current research.
>
> As far as web info goes...
> I know Bodkin is (or was??) on staff at Harvard medical, you can try and search the Harvard site for something..
> http://www.hmcnet.harvard.edu/psych/The page to look at if you're interested in research is the "Redbook" listings (http://www.hmcnet.harvard.edu/psych/redbook/). Unfortunately, this site hasn't been updated in quite a long time.
> The Selegiline patch studies were conducted at McLean, here is that site... http://www.mclean.harvard.edu/index.html
The McLean web site has recently been redesigned, and it may be difficult to find what you're looking for there as well. I'd try checking the site for patients interested in participating in clinical trials -- unless it's been updated already (highly unlikely), it should still have the contact information for the selegiline patch study.
Incidentally, I would expect that there would be other sites involved in clinical trials of the selegiline patch besides McLean. To the best of my knowledge, you usually need more than one study to back you up if you're trying to get a drug FDA-approved for a particular indication.
-elizabeth
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