Developmental drugs & treatments - Still in trial or not approved for Peyronies

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ComeBacKid

Howcanthisbe,

When wil they be out?  Thats the million dollar question, I don't think anyone knows for sure, just estimates, people have been saying next year sometime, maybe like springtime.  The thing I don't understand is why do they need to go through FDA trials, PDLabs was selling their product TV without going through FDA trials and still hasn't, probably mainly cause then the documented efficacy will be shown to be 0(since there are not other studies than the one done by Dr. Fitch).  

However, J has stated that if the injections see good results for other things such as dupuytren's contracture, or frozen shoulder, they may move ahead and do off label use on peyronies patients.  

Does anyone know when they will start the trials or is there a way for us to find out? ???

One guy stated he talked to the company but I don't know how much they will tell you over the phone.

ComeBackid

Hawk

I think their website will give the most optomistic projections.  Here is a blip and a link to more info.

http://www.peyroniessociety.org/news.htm
Prostatectomy 2004, radiation 2009, currently 70 yrs old
After pills, injections, VED - Dr Eid, Titan 22cm implant 8/7/18
Hawk - Updated 10/27/18 - Peyronies Society Forums

ComeBacKid

"Their initial level II trials used 9 injections and they hope to reduce that number in their IIb trials."

So it seems that they have done some studies already, then my source could be right in that he talked to the doctor running this.  Perhaps the new protocal is just another study or the study with "less" injections.

ComeBackid

j

My understanding is that once a drug like verapamil is FDA-approved for certain uses, it can also be prescribed for certain other conditions and this is called "off-label".  That's how PDL can sell verapamil for Peyronie's, and urologists can inject it. Whether this might apply to injectable collagenase, I don't know. But clearly it would require some urololgist to be willing to push the envelope a bit.

I think one drawback of this is that insurance companies may not cover off-label prescriptions.

There are probably some big gaps in my understanding here. We need someone with more understanding of the drug business to really explain this.


ComeBacKid

J,

Now that you mentioned it your right, and I remember reading this on the literature PDL labs sent me. Actually most of the drugs used in psychiatry are off-label drugs and covered by insurance companies.  However with something like this I'm sure most places would try and deny coverage, I know for me MEDCO has done everything they can do to deny me coveage, changing their ridiculous excuses, and I've continued to fight them and finally got coverage.

Heres some information on off-label use.

Off-label

ComeBackid

dcaptain

hey wantitstr8,

i'm sure everyone would be interested in learning more about this "end of the year" advancement!  thanks for the info.

dcaptain

wantitstr8

I asked him about it at my last visit...posted it somewhere...I can't remember where.  Anyways, he confirmed that the end of the year treatment is the AA4500 collagenase treatment.  He said the treatment showed real promise in the early 80's but the patent was owned by a Company that did not pursue the development.  He really thinks the treatment may be viable.  He is working with several other Uro's on developing the protocols for the trials...I'll keep everyone informed...

j

wantitstr8 - I don't understand how a urologist could say that AA4500 could be available at the end of this year. Phase III trials haven't even started, and Auxilium is telling their own investors to expect it in 2009.


ComeBacKid

J,

I agree with you, but once again if its coming from Dr. Levine there must be some kind of truth behind it.  Kind of like with the traction devices, if Dr. Levine didn't have some faith in the things he wouldn't be doing a study with them.  My source told me Auxillium is purposely not releasing any info on the product cause they dont' want any speculation.  But as for what Dr. Levine says that is very puzzling, I just hope your dead wrong J!  ;D

ComeBackid

Hawk

Maybe he was talking about trials not general availability to the public.
Prostatectomy 2004, radiation 2009, currently 70 yrs old
After pills, injections, VED - Dr Eid, Titan 22cm implant 8/7/18
Hawk - Updated 10/27/18 - Peyronies Society Forums

j

Yes that could be it.   IF those trials actually happen, AND the stuff obviously works, AND word gets out, the situation could get interesting.  While our condition isn't life-threatening, it has -arguably - no effective non-surgical treatment, so urologists would have patients banging on their doors asking for AA4500.  I wonder if there's any way to make a drug like this available, outside of the trials themselves,  before formal FDA approval. Previous trials have already established its safety.  


ComeBacKid

One thing I'm still pondering is that it seems like verapamil injections don't work that well.  And a lot of people point out that injections will cause more scar tissue or more plaque nodules.  So while we all are getting a little excited and hoping the collaganese injections work, what about the fact that they will be delivered through injection method and could make more plaque, or aggravate previous plaques if the drug doesnt work.  Also even if it does work on the original plaque one has, what if the injections create more plaque?  Although they are trying to reduce the number of injections down to less than half a dozen, so I suppose that could prove to be helpful in not creating anymore plaque.

ComeBackid

wantitstr8

As far as the end of the year, I'm not sure what he meant...maybe I get to be one of the guinea pigs.  I know he said a viable treatment may be available by the end of this year...when I visited two weeks ago, I asked again and he confirmed it was the AA4500...that's all I really know.

kenm

As i stated in an earlier post if the drug becomes available for another indication urologists will be free to use it off label for peyronie so it might be prior to 2009.

Hawk

Quote from: pudder135 on June 20, 2006, 10:31:33 PM
a lot of people point out that injections will cause more scar tissue or more plaque nodules.  So while we all are getting a little excited and hoping the collaganese injections work, what about the fact that they will be delivered through injection method and could make more plaque, or aggravate previous plaques if the drug doesnt work.  Also even if it does work on the original plaque one has, what if the injections create more plaque?  

ComeBackid,

Assuming AA45oo breaks down collagen scar tissue, it seems a needle delivery system would not be a huge concern.  if it can't prevent collagen scar tissue in the needle trail, it sure isn't going to break down or prevent established scar tissue adjacent to the the injection.  
Prostatectomy 2004, radiation 2009, currently 70 yrs old
After pills, injections, VED - Dr Eid, Titan 22cm implant 8/7/18
Hawk - Updated 10/27/18 - Peyronies Society Forums

ComeBacKid

Ok assuming it is used off-label for peyronies does that mean most insurance companies won't pay for the injections?  What would be a good estimate of a price of a series of 5 injections of collaganese done by a doctor ?  I would want to go to a doctor who is well trained in injecting into the penis itself.

ComeBackid

Liam

http://www.clinicaltrials.gov/ct/search?term=collegenase&collagenase.ID=term&collagenase.badWord=collegenase&collagenases.ID=term&collagenases.badWord=collegenase&collegiate.ID=term&collegiate.badWord=collegenase&collagens.ID=term&collagens.badWord=collegenase&colleges.ID=term&colleges.badWord=collegenase&I+meant+collagenase.x=6&I+meant+collagenase.y=8

Found this and thought I'd pass it on.

Liam
"I don't ask why patients lie, I just assume they all do."
House

j

See the 'investor relations' section on www.auxilium.com.  There's an announcement today that I think is mostly good news. As I interpret it, it says they've concluded that AA4500 works well on Dupuytren's and they've decided to spend more money on building up a manufacturing capacity.  

Speculating a little further, I think this is good news, and bad.  The good news is they're going ahead with Phase III trials for Dupuytren's and Peyronie's, and those involve a lot of patients, so they'll need more AA4500. The bad news might be that they really hadn't comitted to those trials before now, so they don't have the necessary supplies of the drug yet.

The bottom line has to be good news, because they're talking about spending millions on actually producing the drug itself, not just more PR. Spending those millions is going to increase their financial losses for the year.




ComeBacKid

Well like I said, my source told me they were seeing results in the testing of the drug, so despite the fact that some doctors(including Dr. Levine) are planning a future protocol as we speak, they must have done previous tests to show the drug worked, probably in a small group of patients.  I'd say this is only good news, finally they are going to advance foward with this thing.  Seems like Dr. Levines prediction of the drug being available by the end of the year may happen.  

Now the real question is will my insurance cover the injections and just how expensive will they be.  

ComeBackid

Hawk

Could a doctor just try out a drug on "small numbers" without FDA approved and monitored drug trials?  I think that is the point of the FDA and trials, to prevent doctors from experimenting on patients.  That why we have such a long approval process because they have to jump through hoops until the FDA is satisfied that the trial format meets their guidelines for patient safety and accurate reporting of data.

Or so i thought
Prostatectomy 2004, radiation 2009, currently 70 yrs old
After pills, injections, VED - Dr Eid, Titan 22cm implant 8/7/18
Hawk - Updated 10/27/18 - Peyronies Society Forums

j

If AA4500 had FDA approval for any use, I believe that would open up the possibility of "off label" use for other conditions at the discretion of a physician. That's how urologists are able to inject verapamil.  Insurance coverage might be an issue. But hey, I'll pay.


BSTC got essentially the same results 10 years ago in a trial at SUNY, using collagenase on Dupuytren's contractures. It's not clear to me why Auxilium is making a big deal about this latest demonstration of already established facts.  If I were a cynic, I'd say that they're just running another cycle of announcing how "promising" this drug is, pumping the stock price and bringing in new investment. But, I'm not a cynic.  

If they're putting money into production, that's good. Whatever else happens, we can't get the treatment if there's no supply of the drug.

The other good thing is that there's now simply no doubt that AA4500 can safely break up this tissue. Dupuytren's is a good condition on which to test this stuff because results are clear and unambiguous.  No nonsense about "erection quality", "plaque reduction" or patients being asked to evaluate their own improvement. You inject AA4500 and put force on the contracture, snapping it if possible. Then you straighten the finger as far as it will go and measure the angle. No smoke, no mirrors.

What we don't know is how this drug would be applied to Peyronie's, which is similar tissue but a very different situation mechanically.  However, it seems to me that there should be a way to make it work.

Hawk

J, anybody,

Am I correct in saying that at this point there is no FDA approval for general use of this drug so it could not have been administered to anyone for any reason without a detailed FDA approved clinical trial in place for that specific use?
Prostatectomy 2004, radiation 2009, currently 70 yrs old
After pills, injections, VED - Dr Eid, Titan 22cm implant 8/7/18
Hawk - Updated 10/27/18 - Peyronies Society Forums

j

As far as I know, BSTC's 'injectable collagenase' has no approvals.


ComeBacKid

Here is a link to Clinical trials and what happens in each phase.  On that clinical trials I noticed that some ot he experiments using injectable collaganese are in phase II and even phase III trials, meaning there could have been some smaller studies that showed it was working in the phase II trials previously.  I don't think my source would of made this up as they are very credible and repubatle in the Peyronies Disease community.  

FDA Trials

ComeBackid

Hawk

ComeBackid,

This topic is getting exasperating.  Either there were FDA trials for AA4500 on Peyronies Disease, or there were not.  If there were, surely someone has the link since it would be a matter of public record and something the company would hype.  If there were not FDA clinical trials, then it has never been used on Peyronies Disease, at least ethically and legally.
Prostatectomy 2004, radiation 2009, currently 70 yrs old
After pills, injections, VED - Dr Eid, Titan 22cm implant 8/7/18
Hawk - Updated 10/27/18 - Peyronies Society Forums

kenm

Not necessarily.  The drug could have been first investigated oversees.  Secondly in the early 80's when the trials apparently were first performed there was much less oversight.  I dont know whether this company is a typical NASDAQ pump and dump or not but the good news is it does have real earnings with its testim product.  I agree it appears someone has seen that the drug works.  If the drug appears to be working in phase IIB or III clinical trials for peyronies but has not yet gotten aproval for that condition but has gotten approval for some other condition then it certainly could be used off label.  Insurance companies would not pay for the treatment however.  That probably would be small price to pay for a legitimate cure.

j

Hawk, 'exasperating' also describes my feelings after 10 years of trying to figure out what BSTC/Auxilum are actually doing with this drug, the efficacy of which has never really been questioned.  Our nation's intellectual property laws are often praised as being a big factor in our success, but these laws cut 2 ways. The holder of a patent has no responsibility to actually do anything with it or allow the rest of mankind to benefit from it.  The 'invention' of injectable collagenase might have been a stroke of geniius, or just an obvious, incremental improvement to something that already existed, but once someone is able to get a patent on it, the bottom line  is - nobody gets well until somebody gets rich.

The extremely lengthy and expensive FDA approval process was intended to prevent another catastrophe like Thalidomide.  But today, in many cases, it's just an out-of-control bureaucracy that impedes progress. There's no realistic possibility that injections of small amounts of collagenase would pose any systemic health risks.  

Having said all that, let's treat this announcement as basically the best news we've had in quite a while.






ComeBacKid

Hawk,

Sorry to exasperate you... I'm just trying to sort through the facts, and no one really seems to have a clear cut answer.  I believe my source as he had no reason to lie, as I said before I will requestion, still waiting for a reply via email.  It exasperates me that I've had this disease for 7 years and they've only recently gotten into high gear in trying to come up with a solution for peyronies.  I think we are all expaserated and getting a bit grouchy, and rightly so!

J, I agree with you about the intellectual property laws going both ways.  As tim has previously pointed out look what PDLabs did.  They took verapamil which already had FDA phase I approval for safety and got a patent on the delivery mechanism itself.  As tim has pointed out they've just sat on this patent and haven't allowed anyone else to experiment with the drug, or prescribe it.  Meanwhile PDLabs themselves haven't even started Phase II trials yet.  I believe that phase I trials are just done to prove the drug is safe.  So basically PDLabs has not forked over any money at all for any kind of FDA approval because verapamil was already deemed safe before they created their "patented delivery system," which doesnt work(not to mention they only have a utility patent, no such special delivery patent or special mixture patent).  The more and more I think about it the PDLabs thing was a total scam.  They filed the patent on purpose, paid off the doctor and never plan to ever release any new information, cause they aren't gathering.  They realized it would be a long time before anyone came up with anything to treat us desperate peyronies patients and we'd just keep trying their product.  Once someone comes up with something effective, PDLabs will probably just disappear off the map never moving into phase II trials or ever defending their product, they know it doesnt work.  As I said in my report they had members of their own company online claiming to have used the product and saying it worked, I simply don't trust them at all.  Been using the crap now for over two months with absolutely no softening of my plaque....

The FDA process clearly was made to do well but needs reformed like so many things in government. We need to reform into "smart regulation," as I call it and throw out cumbersome processes and rules for dumb things that only require common sense to figure out.  

ComeBackid

howcanthisbe

If this is a "cure" will the length and grith we lost return to normal, I mean will our penises be just like they were before Peyronies Disease or what? I really hope for a cure, but this has been around for 250 years so I start thinking what makes the next few years special? You guys think this injection could be the answer?

ComeBacKid

Howcanthisbe,

I've had two theories on the loss of length and girth.  Either A. the plaque wraps around the corpus Cavernosum, and as the plaque shrinks its squeezes the corpus cavernosum smaller and smaller. or B. The plaque and fibrosis spreads into the corpus cavernosum, making for less elastic tissue to expand.  I would say that if the injections really do work and dissolve the plaque and calcifications then if A. is the case one might see a return of some length and girth, however if B is the case, now that the healthy tissue was turned into plaque and you dissolved that plaque, you will see no return of lost length and girth.

Just my thoughts, I may be wrong on both of those theories so who knows.  I think there could be somewhat of a return of length and girth, but more so elasticity, if the drug works and if it is ever made available to the public...

ComeBackid

j

I shouldn't be offering my theories on this becaus I'm not a doctor, much less one of the AA4500 researchers. But since Auxilium won't tell us anything, here's what I think I know.

AA4500 aka Collagenase will break up, digest, metabolize, dissolve - whatever you want to call it - certain types of collagen, including the tangle of misplaced, interlinked collagen molecules responsible for our problem. But it isn't something that will just spread out into an area and get rid of all the collagen in its path. That would be bad, because collagen makes up many structures in your body.  

To release a Dupuytren's contracture they inject a small amount of AA4500 into the center of the band. Not enough to dissolve the whole band, or even to sever it - just enough to weaken it but stay confined inside the band. Then they try to snap the band by straightening the finger. This is often fairly easy to do - but the band, now broken in 2, remains in your hand.

For Peyronie's it's going to be more complicated as obviously that simple strategy won't apply. The results will probably vary a lot depending on the distribution and amount of the fibrotic tissue. Maybe they'd have to do many injections of very small amounts - I don't know. Apparently it's been tried by Auxilium and they had enough success to go forward with it.  I don't think it will be a 'cure' by any means but in time, as urologists get skillful in using it, it may do a lot of good for many cases of Peyronies Disease.

ComeBacKid

J,

If what you say is true, and I don't think anyone really knows, perhaps they will need to do injections in small amounts in different places.  Perhaps the random injections at different places putting weakening holes into the collagen, combined with an effective VED workout could cause the corpus Cavernosum to be strong enough, and the collagen to be weak enough (from the injections) to break the plaque apart.

What about tissue atrophy with this medication?  Will it damage healthy tissues like the corpus cavernosum or other skin membranes?

ComeBackid

j

The Dupuytren's study that I saw made no mention of any side effects, like the atrophy that can result from steroids.  However I think bad things could happen if this stuff weren't injected carefully and in the right amounts.  It's not clear to me how general its effect might be - what types of tissue it might attack.

Maybe at some point we'll be able to see a published study that answers some of these questions.


soxfan


Hi All,

This aa4500 sounds very interesting. But, I am still wary of injecting my penis for fear of more scarring. Would it be possible to use this compound with dmso or phlojel to administer it transdermall to avoid the trauma of injections? Does anyone know the molecular weight of this compound?

Cheers.

j

DMSO isn't a safe or effective way to deliver a drug as you have no control over how far it penetrates. And collagenase would have to be delivered very accurately.  

ComeBacKid

Now that it is proven that TV simply doesn't work, I'd say there is no effective way to deliver collaganese transdermally.

Even if the injections give you a little scar tissue, if the drug works you'll be dissolving most of the scar tissue, even if you create a little new scar tissue you'll have less than when you started, and perhaps the collaganese will break down the scar tissue you create upon injection.

All this is assuming that injections will give you scar tissue, if done properly I don't think they will give you scar tissue from a minimal amount of injections.

ComeBackid

ComeBacKid

I found some information off the wikipedia on stocks, pricing, and what makes a stock price go up and down.  This information could be useful to some on here who don't totally understand the Auxillum stock and why it goes up and down, I'd encourage everyone to check out this information for a good read, and a refresher on how profits will be needed to be shown eventually for Auxillum to survive.

I'm no finance major but I've read a few books, invest myself, and followed Warren Buffet closely.  The simplest explanation is to buy a stock when it is low and hold onto it until you think its reached its potentil and sell, sounds very simple, it isnt.  Auxillium will not be able to post loses forever, they will have to produce products that work to posts profits (or will they, PDLabs has been earning huge profits, with useless products).  If one believe that Auxillium really has had success and will eventually come out with collaganese that works on many conditions including peyronies, they would want to buy this stock immediately at the low price it is and hold it for awhile!  They may have a patent on their product eventually and be turning huge profits... or I guess they could turn out to be a PDLabs...

Stocks

Stock Price Fluctuation




Tim468

Just a dash of cold water.

I remember when an active enzymatic degradation of a disk seemed like a great idea. An enzyme derived from papaya was injected into herniated disks and led to resorbtion of material and decompression of herniated disk against adjacent nerves. Basicly an "easy" discectomy surgery with an injection.

But later it turned out that the areas thus treated were far more prone to arthritic changes.

I would love for a collegenase to be a panacea for this problem - it makes sense that it could. But lots of therapies that make sense turn out to cause harm, or to not work. And the incredible number of false positive results reported from inadequate initial studies in the area of Peyronies Disease research are just amazing. I worry that this may be the same.

Tim
52, Peyronies Disease for 30 years, upward curve and some new lesions.

Blink

I thought I'd share a little something that I learned Tuesday, July 11th. About two weeks ago I got a phone number from Auxilium's web site. I called that number, and explained to the person who answered that I wanted to find out if Auxililum would be doing more clinical testing. I was transferred to another extension. Naturally, when I got an answering machine, I figured I was getting blown off. On Tuesday I received a phone call from a guy named Gary Nevin, who works for Auxilium. He told me that testing on AA4500 would resume in a couple of months nationwide. He asked if I was still interested in participating in the study. I said yes. He then told me that he would put my name on a list of others who had called him. He only wanted to know my name, phone number, and town that I live in. He told me that there where no guarantees I would be chosen for the testing, but that he would be able to give me "a heads up" on the start date, and location nearest to me, that would be testing. I do know that the testing will be done on patients who have Peyronies and/or  Dupuytrens. I can't guarantee that anyone else who calls will get the same response, but I felt that I needed to share this info with all of you. This is Gary's office number: 1-732-223-7321. I did not get any approval from Gary to give out this number, nor did I tell him I was connected to this forum. When I talked to him, he told me that he could not take too much information from me, because he could not appear to be biased towards me in any way. I hope that some of us will try to help with this testing. Hopefully we can help to find that "silver bullet" that we are all looking for. If we don't find it, at least we tried. Keep the faith, brothers and sisters....Blink
We are not specialists, but we are special for what we know.

mark501

Today, July 12, Auxilium filed Form 8K with SEC. See page 20 thru 23 for info on AA4500 used for Dupuytrens. There are before & after color photos of both surgery & injection with AA4500. I don't believe these have ever been seen by the public before. They state pivotal phase III trial to be initiated this year for Dupuytrens & target BLA filing is 2007.  As for peyronies see pages 26 thru 29. There are photos of before & after surgery but I did not see any photos of AA4500 use. They state Phase IIb to be initiated for peyronies this year & target BLA filing following approval of Dupuytren's BLA.  

Liam

Blink,

Thanks for the heads up.  I placed a call and left a message.  I'll post any response I get.


Mark,

Thanks.  I'm going to their site now.

Here is a direct link to that presentation.

http://library.corporate-ir.net/library/14/142/142125/items/204739/auxlpres706.pdf

Page 4 says 2008/2009 as the AA4500 for Peyronies Disease "maturing" timeline
"I don't ask why patients lie, I just assume they all do."
House

Hawk

Quote from: Blink on July 12, 2006, 08:52:42 AMBlink

Guys,

I hope it is not lost that a man that is hoping for the the luck of draw on these trials selflessly posted the information for other members even though he knew it would lessen his chanches of selection.

Blink, I salute you!
Prostatectomy 2004, radiation 2009, currently 70 yrs old
After pills, injections, VED - Dr Eid, Titan 22cm implant 8/7/18
Hawk - Updated 10/27/18 - Peyronies Society Forums

Liam

Truly an unselfish act Blink!

I got a call back this afternoon.  Gary said he would put my name on a list and would give me a heads up when and where the trials would start.  I felt like he was being honest.  I mentioned I was near New Orleans and Dr. Helstrom was at Tulane.  He said he did not know if that would be a center for the trials.  
"I don't ask why patients lie, I just assume they all do."
House

ComeBacKid

I wanted to make everyone aware that I've been contacted and in touch with a guy named Travis Strong via email from John Hopkins. He had initially made a post on the BTC calling for funding and showing a huge interest in peyronies research and stem cell research. Apparrently he has been corrobarating with some medical professionals and may start a research project in the near future on the tunica albuginea graft materials and stem cells. Not much more information beyond this is available but it is certainly some positive news to hear.


Steve

Promising contact!   ::) Please keep us all informed of any developments with Mr (Dr?) Strong.

Steve
Topical Verapamil,
12 Verapamil shots (ouch!),
Now VED - Too many Weeks,
Still 70 Degrees :(

Liam

"I don't ask why patients lie, I just assume they all do."
House

Blink

Quote from: Blink on July 12, 2006, 08:52:42 AM
I thought I'd share a little something that I learned Tuesday, July 11th. About two weeks ago I got a phone number from Auxilium's web site. I called that number, and explained to the person who answered that I wanted to find out if Auxililum would be doing more clinical testing. I was transferred to another extension. Naturally, when I got an answering machine, I figured I was getting blown off. On Tuesday I received a phone call from a guy named Gary Nevin, who works for Auxilium. He told me that testing on AA4500 would resume in a couple of months nationwide. He asked if I was still interested in participating in the study. I said yes. He then told me that he would put my name on a list of others who had called him. He only wanted to know my name, phone number, and town that I live in. He told me that there where no guarantees I would be chosen for the testing, but that he would be able to give me "a heads up" on the start date, and location nearest to me, that would be testing. I do know that the testing will be done on patients who have Peyronies and/or  Dupuytrens. I can't guarantee that anyone else who calls will get the same response, but I felt that I needed to share this info with all of you. This is Gary's office number: 1-732-223-7321. I did not get any approval from Gary to give out this number, nor did I tell him I was connected to this forum. When I talked to him, he told me that he could not take too much information from me, because he could not appear to be biased towards me in any way. I hope that some of us will try to help with this testing. Hopefully we can help to find that "silver bullet" that we are all looking for. If we don't find it, at least we tried. Keep the faith, brothers and sisters....Blink
We are not specialists, but we are special for what we know.

myrddin

I wonder, if a person is chosen for this AA4500 testing, is there a chance they'd unknowingly get assigned to the "control" group who think they're getting AA4500, but are really getting a placebo?

Testing sounds tempting to participate in, but not if there's a chance I'll spend months taking a placebo and experiencing no improvement.

Hawk

Myrddin,

I know people well that have been in blinded control studies at major research centers.  In fact they do not know until the end of the study which group they were in.  In fact the doctors do not know if it is a double blind study.  At the end of the study they are given the test drug for free.  It does involve more travel however.  If it is not double blinded and you have to travel a long distance you can hope for some consideration.

Since I am not sure that the AS4500 studied are blinded, or if they even have a control group, this may not be an issue.  I think injecting a placebo into ones penis my have serious ethical prohibitions but they could use a control like Verapamil.
Prostatectomy 2004, radiation 2009, currently 70 yrs old
After pills, injections, VED - Dr Eid, Titan 22cm implant 8/7/18
Hawk - Updated 10/27/18 - Peyronies Society Forums

Tim468

The surrent standard of care for the ethics of such studies is that the control group gets current standard of care therapy (and a placebo, if it is needed), and the intervention group gets the same PLUS the study drug. For those studies that cannot be blinded (ie a surgical intervention versus what?), then the comparisons are usually made to either historical controls or a similar group followed conservatively.

The advantage of participating is such a study is that one should get a lot of close evaluations. If one is seen to be getting worse, we will often break out of study mode, and treat them with more aggressive therapy and to hell with the control crap. A recent study of mine was discontinued because all the patients were doing so well that we felt it was unethical to continue to give placebo. We aborted the study and put everyone on therapy, and just wrote it up.

Tim
52, Peyronies Disease for 30 years, upward curve and some new lesions.