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

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jon


Iceman

The Xiaflex trials have been going for quite a while now - surely surely surely there must be someone out there with some feedback on how its working - hasnt anyone gone back a second time and can report on some improvement - surely this MUST be a priority for ourselves here???? shouldnt we focus on this?

Going on holidays now....

wayne999

Iceman:

Please reply to my PM. Thanks

ComeBacKid

I kind of agree with you that we should hear from people who are in the study.  On the other hand I don't  want us to disrupt the study and have it be deemed non - scientific for some dumb reason.  If people on here starting talking about what region they are in and what doctor they have etc... this could influence the study, or someone could accuse the forum of influencing members in the study.  I know it is tough to stay patient but hey at least we know the trials are under way!  

Comebackid

Tim468

Iceman,

If the study is a randomized double blinded study, that means that neither the investigators or the subjects know if they are getting placebo or study drug. If for some reason we get a bunch of guys here who ended up with placebo, then we are going to get some bad reports (or vice versa). We just have to wait.

When I have done drug studies, we usually do an interim analysis to be sure that nothing bad is going on, but even then we do not break the code for who is getting the drug. I have been fooled completely by thinking that a guy got drug, when he did not. Another kid had a "probable" adverse event who got placebo. So it goes. So again, we are going to wait, for we have no choice!

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

Ticker

Hey guys,Just a short note to let you know that I am in the Xiaflex study.I will be going in on Jan 14th for my second series of injections.I have posted in the past that I was one of the ones in the study.I really have not posted too much because i am really not sure if i got the drug or not.I am still sore at times and it does lead me to believe that I got the drug but other times I think I might not have.I feel that the plaque got softer but my curve is the same(so it seems)I will be going in on the 5th for measurements then back on the 14 for the 2nd series of injections.I really don't have a lot of positive info to share but don't want to discourage anybody either.I will post after my second series.Thank You,Ticker

G.

Just a short note along the lines of the one just posted by Ticker:

No progress to report so far - the bruising from the second injection (of the first set) went away after four or five days, but there's no difference in my curve.  I figure I may have gotten the placebo but not drawing any conclusions.  I'll get re-measured and then a second set of injections in mid-January - will post back after that.

G.

George999

Sometimes it is helpful to get an additional perspective on a deal like the Pfizer/Auxillium thing.  I just picked up this interaction that demonstrates an investor/outsider perspective:

Quote from: CNBC

Pfizer's 40 Year Run Of Hiking Dividend Ends

Funtleyder says Pfizer's standing pat can be viewed two ways. On the one hand he writes, "The dividend is still above seven percent which makes the company seem almost distressed." But on the other hand Funtleyder says, "Despite the company's (approximately) $27 billion in net cash...they might be penalized for using any cash. The longer the cost of capital stays high, the more cash on a balance sheet becomes a competitive advantage. Should we be in for a prolonged lull in the capital raising cycle, PFE may be able to buy its way out of some of its pipeline deficiency."


Note that Pfizer apparently has a "pipeline deficiency".  This means that they are desperate at this point to find new products to continue to generate profits into the future.  Much of this desperation is due to their Lipitor patent expiring soon.

Quote from: CNBC

Pfizer's Pipeline Envy

There are so many partnerships like this being struck here and there that normally I wouldn't blog about it. PFE's paying AUXL $75 million up front and if everything goes according to plan another $410 million over time.  So what makes this so unusual? Well, it's the drug AUXL is developing. It's a two-in-one for a rare disease that causes fingers to curl toward the palm and--and, no, I'm not making this up and it's not a joke--for penises that curve. The "problem" is called Peyronie's disease and it reportedly affects one to four percent of men. I'd never heard of Peyronie's until I read the press release.


Here we get a perhaps typical reaction from an investor perspective regarding Pfizer's new investment.  Does anyone else see the potential for a little education to be going on among the general public regarding Peyronie's?

And this whole discussion IS being followed in the blogosphere, here is one example:

Quote from: Rx Recruiting

How Will Pfizer Spend Their Cash?

Mike Huckman of CNBC reported earlier this week here that Pfizer's streak raising dividends ended after 40 years. What does this signify for Pfizer?  ...  Late this week we got an answer. Pfizer signed a drug development partnership with Auxilium Pharmaceuticals and is paying $75 million up and and up to $410 million over time if additional milestones are met. But as Huckman writes....this is not your "typical" drug partnership  ...  I don't know about you...but if I still owned Pfizer stock...I think I would rather that they just gave me the dividend.


So here may be a typical reaction from someone who knows nothing about this Peyronie's thing.

But there is more:

Quote from: Rx Recruiting

Update re: Pfizer and Peyronie's Disease

And in my post, I was somewhat critical of Pfizer's decision.  However, a reader was able to provide me with additional information re: Peyronie's Disease. It turns out that that the number of men suffering from Peyronie's Disease is not 1-4%, The percentage of men afflicted by the diesease is 9%. ... Nevertheless this drug will improve the lives and health of a significant percentage of people. And, when it comes down to it, improving the lives and health of people is the real purpose of the Pharmaceutical Industry.


So you see what I mean about this Pfizer acquisition bringing Peyronie's prime time exposure and offering educational opportunities!

Quote from: Rx Recruiting

Additional Information on Peyronie's Disease

I have had the good fortune to have been communicating with Stan Hardin who is the head of The
Association of Peyronie's Disease Advocates. Stan reached out to me after I had written a post that was questioning Pfizer's decision to partner with Auxilium to develop a drug for Peyronie's Disease.  ...  You can read more about both Peyronie's Disease and Stan's organization at their website here.  The site is extremely well done and informative.  And best of luck to both Pfizer and Auxilium in their quest for a cure.



We may have our occasional minor differences of opinion with APDA.  But if anyone doubts the good work they are doing for us, I offer the above as just one example of the good work they ARE doing.  These are just the kinds of interactions that can bring real potential to the Pfizer deal for all of us here.  - George

ComeBacKid

George,

Your right that is the typical reaction to peyronies, most people don't know what the hell it is.  Yes lets hope that there is a good education campaign and stockholders believe the "sales pitch," on why this is a good move.  If they are seen as desperate and buying into a company that researches "bent dicks," this could be bad if shareholders don't buy their theory that there is money to be made here.  If they don't we could see a sell off and a decline in stock price for pfizer.  

" And, when it comes down to it, improving the lives and health of people is the real purpose of the Pharmaceutical Industry. "

Yeah if it is financialy worth it and a profit can be made.... sounds like this blogger wants to sound politically correct now, if it didnt make a profit he wouldnt hold the stock....  

I must say before I got peyronies I never heard of a bent dick or even thought about it.  I think more people have peyronies or some form of bend in their penis than we think, one look at pornography and you will notice this...

Pfizer

George,  there is no doubt in my mind that the APDA is working hard for peyronies sufferers.  However it is my longstanding view that we'd be better off combined.

Comebackid

Hawk

I have no doubt that Aux and Pfizer will try to draw in investors and as a result they will surely have to sell the need.  That is hard to do without some education and some light being shown on Peyronies Disease.  Hopefully it will surpass the Peyronies Disease's only other moment of limelight when a President was allegedly showing his allegedly bent penis as an educational aid (or to an aide, I forget).

How can Aux and/or Pfizer NOT promote this product if it tests out?  hopefully it will be like the ads we all see for "ask you doctor about..." products all over TV.

Auxillium has funded some things for the APDA so there is a pretty cozy relationship between Aux. and the doctors sitting on the board at the APDA.  I think we can all rest assured, that if this product works, those to benefit financially will use every innovative ad campaign possible to draw Peyronies Disease sufferers out of the closet and into the market.  Pharmaceutical reps will as well, surely be educating doctors on the fallacies of Peyronies Disease and the ineffectiveness of other treatments.

All of this is a plus EVEN on the off chance the actual product later failed the test of time.
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

JPRHenry

Hopefully,... Xiaflex will come close to hitting the marks.  I think we all have that wish on this years Christmas list.  Regarding education, that is the duotask of the marketeers.  To both education, create the need and demand for the product. My mother, a brilliant business "lady" use to say: "If we communicate, we may succeed, it we don't, it's assured we won't.  While I think many of us have become appalled, embarassed and totally turned off to many of the ads out there (i.e. Viagra,  bladder control, male enhancement, and female self pleasuring devices),.. I feel comfortable in believing the marketing giants can approach, create and educate the public and medical professionals alike, of the features and benefits of the product we all hope Xiaflex will prove to be.  Yes,.. please put all of this under the tree for me this year, Merry Christmas!

Hawk

If any product does go to market, we know that it is a given that there will be a marketing campaign to have everyone with possible Peyronies Disease symptoms ask their doctor about "ABC" or whatever.  A possible ad would go something like:

"Did you know that Peyronies Disease can cause penile deformity, loss of length and girth, ED, painful erection and lumps or nodules called plaque on the penis.  If left untreated Peyronies Disease often leads to deformity significant enough to prevent intercourse.  Did you also know that some studies suggest that as many as one out of ten may be affected. Early intervention is critical! Ask your doctor about Peyronies Disease if you have symptoms such as painful erection, onset of deformity, nodules, or loss of size.  Xiaflex is the only clinically proven treatment and it can stop and often reverse these symptoms."  

OK, I'm no ad man but you get the point.

With the value men place on their organ, it will start an avalanche of weekly penis measuring.  It will also likely result is some hypochondria and obsession.  It may not be far fetched to say that it may well even spin off VED or traction ads trying to ride the wave.

ED is a widespread common term because Viagra made it so.

Xialeflex is still a long way from hitting the market.  There is no general ad campaign, and already it is starting a small ripple of education and discussion.
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

Hawk,

Not to mention all the literature given out to doctors by pharmacutical reps who will come out in droves to push the product.  Did any of you older fellows ever have a routine checkup and have the doctor just bring up viagra or ask you about your sexual health?

Comebackid

Humorous3

I ran across a new study "H-22411: BOTOX® for Peyronie's Disease" at this link:
http://clinicaltrials.gov/ct2/show?term=peyronies&rank=2

"This study is not yet open for participant recruitment.  The sponsors are Baylor College of Medicine and Allergan.  Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque."  The location is Houston, TX.

The MedLinePlus link says "Botox injections work by weakening or paralyzing certain muscles or by blocking certain nerves. The effects last about three to four months."  Given that, and with my limited medical knowledge, I don't understand how that will affect the plaque which causes the bending.  Obviously the people conducting the study believe this will be helpful.  Any ideas, opinions, or comments?

One of the side effects of Botox injections in the face is that it may cause temporary drooping eyelids.  Does that mean injections in the penis may cause "droopy dicks"?  (I just couldn't resist adding that.)

Humorous3

Attica!

   20-30 injections with a 20 gauge needle? Sounds to me like torture and in my humble, not-a-doctor opinion, it would most likely make the plaque worse. Where is the common sense behind this study?  

Old Man

Note to all:

Before embarking on any therapy/treatment involving needles, do your homework. And, realize that with 20 to 30 injections into the shaft that it can and will cause more trauma to the penis. It is not one of the better approaches to any form of therapy for Peyronies Disease IMHO.

The verapamil injections results can be read in that thread/topic elsewhere on this forum. So, cruise through that one and judge for yourself if you would care to get that many injections.

Old Man
Age 92. Peyronies Disease at age 24, Peyronies Disease after
stage four radical prostatectomy in 1995, Heart surgery 2004 with three bypasses/three stents.
Three more stents in 2016. Hiatal hernia surgery 2017 with 1/3 stomach reduction. Many other surgeries too.

jackp

Old Man
I agree 100%!!! Do Not Stick A Needle In Your Penis.
I tried trimix injections for about a year with little to no help. The result was corporal fibrosis and more shortening of the penis that was not recoverable.
The VED is the best exercise you can do for you and your penis. Your penis is a prized possession do not abuse it.
Jackp

George999

Guys, we also have to remember that, while it is impossible to get a real study done on something like Pentox because of the huge cost, the manufacturers of stuff like Botox have huge sums of cash to throw around, and if they see any possibility of a new market for their product, there WILL be a study.  Personally, I like the posters below, would avoid it like the plague EVEN if they turn up with some short term 'benefit'.  Xiaflex at least makes sense, this one does not!  Who knows, now that the world is discovering Peyronie's, the next great treatment to get promoted might be acupuncture.   ???  - George

Tim468

Interesting - the other day I was imagining that Botox might be worth studying, and someone else is interested in doing just that!

The contractile nature of the lesions is that of a "myofibrobolast" that is transformed into more of a fibroblast and then the lesion contracts. Thus, in a plaque, it is not just that it fail to stretch out properly, but that it has contracted down (note that scar tissue often contracts also). So, if the lesion's contracting is facilitated by the contraction of smooth muscle that serves as a "ratchet", then preventing that might help.

I also wonder if those who are "grow-ers, not show-ers" would have a larger flaccid "hang" to their penis if the smooth muscle that leads to tightening up were blocked with Botox. Doesn't make much practical difference, but I bet that a lot of egotistical men would love to have a larger flaccid penis. And I bet that if someone showed this to be true (a larger flaccid penis with a simple injection once every three months!) that we would then find a whole new crew of men with Peyronie's Disease.

So, in my mental ramblings, I came to the conclusion that Botox might help, but might hurt. I will wait to see what the data show!

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

George999

Quote from: Tim468 on December 26, 2008, 05:31:55 PMSo, if the lesion's contracting is facilitated by the contraction of smooth muscle that serves as a "ratchet", then preventing that might help.

Tim,  There are certainly ways to do that short of injecting something like Botox and creating more tissue trauma in the process.  There are drugs that achieve the same end in terms of relaxing smooth muscle.  But you know as well as I do that the root of the problem biologically is altered tissue in the tunica albuginea and NO AMOUNT of smooth muscle relaxation is going to fix that.  AND injections will most certainly run the risk of exacerbating it.  Certainly, I wish for the best with this study, as with any study, but it really doesn't look very promising to me and I certainly would not be trying to get at the head of the line as a candidate.  If I was really wanting to pursue this strategy (which in fact, I have already pursued to some degree) I would be taking Forskolin regularly since it is a fairly potent smooth muscle relaxant.  But when I have used it in the past over a long time period, it produced no real significant benefit.  So I just really doubt this whole approach and I really abhor the concept of injections to treat Peyronie's, the exception being something like Xiaflex that actually addresses the inflammation factor directly and would thus seem to have a *potentially* built in way to mitigate the damages it inflicts.  Botox on the other hand would seem to hold the potential of itself being an inflammatory agent.  No thank you!  - George

stopthismadness

Don't know if this has been posted before or if this is the right section, but seeing as peyronie's is a fibrotic condition I found this to be very interesting. If they can do this to stop cirrhosis and scarring in the liver perhaps they could do the same to the scarring associated with peyronie's.


December 27, 2007
Liver Fibrosis Stoppable In Mice

Lots of liver diseases kill by causing accumulation of scar tissue. Well, at least in mice the scarring process can be stopped and partially reversed with an inhibitor peptide.

   University of California, San Diego researchers have proven in animal studies that fibrosis in the liver can be not only stopped, but reversed. Their discovery, to be published in PLoS Online on December 26, opens the door to treating and curing conditions that lead to excessive tissue scarring such as viral hepatitis, fatty liver disease, cirrhosis, pulmonary fibrosis, scleroderma and burns.

   Six years ago, the UC San Diego School of Medicine research team discovered the cause of the excess fibrous tissue growth that leads to liver fibrosis and cirrhosis, and developed a way to block excess scar tissue in mice. At that time, the best hope seemed to be future development of a therapy that would prevent or stop damage in patients suffering from the excessive scarring related to liver or lung disease or severe burns.

   In their current study, Martina Buck, Ph.D., assistant professor of medicine at UCSD and the Veterans Affairs San Diego Healthcare System, and Mario Chojkier, M.D., UCSD professor of medicine and liver specialist at the VA, show that by blocking a protein linked to overproduction of scar tissue, they can not only stop the progression of fibrosis in mice, but reverse some of the cell damage that already occurred.

We have been watching bioscience and biotechnological advances for many years. Isn't it about time this progress starts to translate into a whole bunch of disease cures? It is all well and good to watch the progress and marvel at the cleverness of the researchers who find ways to tease out the secrets of biological systems. But getting down to some curing treatments would be great. You might want to see cancer or heart disease cured first. But I'd be happy to see an end to death by liver cirrhosis as a starter.

Inhibition of a protein that actives growth of a type of cell involved in collagen production did the trick.

   In response to liver injury – for example, cirrhosis caused by alcohol – hepatic stellate cell (HSC) activated by oxidative stress results in large amounts of collagen. Collagen is necessary to heal wounds, but excessive collagen causes scars in tissues. In this paper, the researchers showed that activation of a protein called RSK results in HSC activation and is critical for the progression of liver fibrosis. They theorized that the RSK pathway would be a potential therapeutic target, and developed an RSK inhibitory peptide to block activation of RSK.

   The scientists used mice with severe liver fibrosis – similar to the condition in humans with cirrhosis of the liver – that was induced by chronic treatment with a liver toxin known to cause liver damage. The animals, which continued on the liver toxin, were given the RSK-inhibitory peptide. The peptide inhibited RSK activation, which stopped the HSC from proliferating. The peptide also directly activated the caspase or "executioner" protein, which killed the cells producing liver cirrhosis but not the normal cells.

   "All control mice had severe liver fibrosis, while all mice that received the RSK-inhibitory peptide had minimal or no liver fibrosis," said Buck.

Researchers probably had to spend many years teasing out the connection between the RSK protein, hepatic stellate cells, collagen production and scar tissue accumulation. But now they have something really powerful to show for it. Hurray.

But how many years will it take for a human treatment to make it to market?
By Randall Parker at 2007 December 27 09:09 PM  Biotech Therapies | TrackBack


http://www.futurepundit.com/archives/004886.html

McNally

I recently overheard (just before the holidays) that Dr. Levine's office at Rush University Medical Center in Chicago is still looking for study subjects for the Xiaflex Phase 2b study for Auxilium Pharmaceuticals.

Check out the NIH Clinical Trials website for details on the study. (search on peyronies if the link I tried to insert does not work - look for study referring to AA4500)

http://clinicaltrials.gov/ct2/show/NCT00755222?cond=%22Peyronie+disease%22&rank=1

btw, I don't believe this whole issue about placebo subjects not being able to get Xiaflex in the future is true, in fact I "thought" that placebo subjects might well be asked to participate in Phase III studies & there was some suggestion, assuming the drug is released for Peyronies, it would be offered to placebo subjects, possibly even at no cost

Tim468

In every Phase 2 or 3 study I have ever done on a drug, drug was offered to those who got placebo when the study was nearing completion. There is either an "open label" phase, where everyone gets drug, or there is a cross over design, where those getting drug are moved to placebo and those getting placebo are moved to drug (this effectively eliminates potential bias selection, and increases the N that helps give a study power).

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

joe

I wanted to let everyone know that I will be participating in the Xiaflex trial.  They told me the deadline was the end of December, so all I did was sign the consent so far.  I have a penile doppler scheduled for this week.  I'll keep everyone informed.  I just pray that I won't get the placebo.  

ComeBacKid

Joe,

I to would be concerned about the placebo.  If you look at our old poll on verapamil injections you will see very little people got better, and quite a few got worse.  I have to think that just sticking a needle into the penis will make it worse. There was a technique going on in europe for awhile, leriche or lariche, I forget the name that was supposed to be so effective where the doctor would take a needle and just stab it into the penis.  Funny how we havent heard anything about this lately?  Personally I think the placebo should be tossed out, you can still determine the effectiveness without it.  Considering we are dealing with a very important body organ, there is no reason to play games with placebos that involve sticking a needle in it.  This is not a placebo sugar pill, its more than that and could cause damage.  Personally I wouldn't sign up myself for any trials until I saw a study showing the drug was effective.  With that being said someone has to go through the trials and I wish you the best luck my friend.

Comebackid

Tim468

ComeBacKid

Can't show a drug is effective until it has been studied. Can't study it without a placebo. It's that simple.

Peyronie's Disease is tough, and we all need to be tough to deal with it. That includes taking risks.

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

j

I understand that inclusion of a placebo in the trials may be required, but in a technical sense I don't see the point. The effect of this treatment is, or should be, objectively measurable following an induced erection.  There have already been far too many useless studies of Peyronie's "treatments" where success was determined by the results of a questionaire, i.e. "patient satisfaction".   The use of a placebo implies that the evaluation of the results will be weak and subjective.  In my opinion the question is not whether the patient's sexual activity or satisfaction improves, it's whether a mechanical/hydraulic problem has been alleviated.

As always - just my opinion.

ohjb1

I do agree with J concerning the low value of patient satisfaction surveys. I am in the Xiaflex study and  in addition to surveys ( a waste of time in my opinion), the dr does inject me with a chemical to produce an erection and then measures to determine the degree of curvature.  Even with this "objective" measure there can be some degree of variation depending on the amount of chemical injected and the patient's reaction that day.

Both before and after the first set of injections, there curvature has remained exactly the same. No change, at least it did not get any worse.  


George999

Regarding the issue of placebo use.  I understand the value of using a placebo in trials, but I also think its value is significantly over rated.  After all, we are not evaluating relief from headache pain here.  I think if one believes that the placebo effect can straighten penises one would have to buy into a whole new dimension in terms of the power of the mind.  This would be like going beyond Uri Geller for crying out loud.  Unless they are looking for more subjective benefits.  In that case why use something as invasive as Xiaflex when we have Pentox?  Its sort of like testing cancer surgery by using a placebo candidate and checking them with imaging afterward to make sure that the tumor is not gone as opposed to the one who got the real surgery.  The hoped for results are so obvious and physical, I guess I just don't get it.  - George

ohjb1

yes, i agree with you George, but I suspect that a placebo is required by the FDA or some similar government organization.  As we all know, gov't rules and regulations often make no sense.  

joe

I understand why the placebo is needed, for example say the way in which the study doctors injected the drug they were coming close to the lariche technique mentioned.  You might see improvement because of that and not necessarily the drug (although that is a stretch in this case there could be similar mechanisms going on).  I will ask the Dr this week to clarify if the real drug will be available at the end of the trial for those who've received the placebo.  

Also I forgot to mention that the paperwork said there would be 4 groups: drug, placebo, drug with modeling, placebo with modeling.  I'm guessing modeling is synonymous with tugging or stretching.  They said there was a 3:1 chance of receiving the drug vs placebo.  

ohjb1

modeling is some stretching and mostly bending. You may want to ask your dr if you can see the DVD by Dr. Jordan. It is for the Dr and tells him how to explain and then demonstrate the modeling for patients.  There is no good reason for not letting you see the DVD and it goes into some detail about the modeling.

j

I suppose the placebo could be a sort of reverse logic.  If bad effects result from the treatment, and they also result from the placebo, then they're just caused by the injections and not Xiaflex.    

Tim468

My favorite placebo story is from Pitt. To train surgeons in technique, they practiced on dogs, and did some reaserch for good measure. Thus, lungs were taken fro mone dog and transplanted into another. In fact, lungs were taken a "moved" in a domino-like series of surgeries were all the dogs served as donors and as recipients. They then got state of the art care in recovery and were started on study drug for immunosuppression.

The placebo group got "sham surgery" (something we do not do with people!!). They were open and shut (BTW, I think this is where the term "it was an open and shut case" comes from - meaning you open up a person and shut them up because there is nothing to do surgically) and so everything was done to the placebo group as with the other dogs, except they did not have lungs removed and replaced.

Interestingly, the sham operation group developed an asthma like condition. If the surgeons (aho also learned technique) had not done the "pointless" sham surgery, we would have thought that the drug caused the asthma like condition.

The point of a placebo is that it gives you a reference point. In a disease like Peyronie's, it is usually not "nothing" (ie a sugar pill) but the standard of care. I do not know if the control group in the Xiaflex study is getting Verapamil, but that would be an example of someone comparing new treatment B to standard treatment A.

The NIH does not make rules regarding this (though there are federal guidelines regarding research), but a study without a control group of some sort will not get funded, and usually not published. Except in this miserable field of research, where there are multiple studies of 15 or so men, without a control group, in paper after paper. Most of those papers I wouldn't use to wipe my ass.

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

Hawk

Quote from: Tim468 on January 05, 2009, 05:03:58 PMI do not know if the control group in the Xiaflex study is getting Verapamil, but that would be an example of someone comparing new treatment B to standard treatment A.

Tim,

In your example of Verapamil possibly being used in the Xiaflex study.  Would it be proper for them to refer to Verapamil as a "placebo" group or would the proper term for that be a "control" group?
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

bodoo2u

I had the opportunity to participate in the Xiaflex trial study, but I turned it down because I already have a pronounced curve to the right, and I didn't want to take a chance on the needles worsening it. The participants who receive the placebo will be injected with Interferon, according to the literature I received.

Just thought I would let you know.

Bo

G.

I'm in the Xiaflex trial and my understanding is that the placebo contains no drug of any kind.  The written consent documentation states this in two different places, and additionally I asked the doctor and his study coordinator to confirm this, prior to my getting the first injection - they told me the placebo was essentially saline.  

I don't know anything about the design of drug trials, but it seems it would be ridiculous to give the control group some other active drug - except perhaps if there were any already-accepted standard treatment that it would be valid to test against (from what I read here, it doesn't seem that there is any proven, accepted standard treatment for Peyronie's) .  Anyway, in this case the consent documentation says that getting the placebo is like getting no treatment at all.

I also asked them, prior to getting the first injection, about potential harm if in the placebo group, just from the injection itself.  The doctor told me that in the earlier phases of the trials, there were no adverse outcomes seen in anyone in the placebo groups. Of course I remain skeptical about this, but in the end you have to decide either you're going to do it or not.

Having been through one round of injections, my curve is completely unchanged - neither better nor worse.  (which I'm not necessarily taking to mean I got the placebo, although that seems likely.  I figure after the second round of injections I'll have a better idea - we'll see)  (Also, as someone else mentioned here, the study is double-blind, so I don't think there's anything wrong with my posting limited comments like this, mid-study - no matter what opinion I state here, the fact is that I don't know which group I'm in)

G.

Hawk

I know little to nothing about the actual parameters of the Xiaflex trials but I think I know the meaning of the word "placebo" and how it is used in clinical trials.  A placebo is a substance that has no known therapeutic benefit or side effects.  It is used in trials as a control to guard against "placebo effect" in which a patients perception influences the outcome.  It also as Tim pointed out guards against some effect from the procedure (such as the injection) being credited to the drug.

As G. indicates, sometimes the control is an alternate standard of treatment rather than a placebo.  I would surely think the participants of this study had full disclosure on whether they were signing up for a placebo based study or a control study based on a specific control drug that has known benefit and side-effects.  I would even think this is a public information component of the study that we should all know by now.  The guessing should be over at this point.

Rather than guessing, can someone settle this issue with authoritative evidence?

Were participants given copies of signed releases which shed light?

Are there published study guidelines?
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

G.

Hawk,

I was given an Information and Consent Form to sign, which runs to 20 pages.  I was given a hard copy to keep, and also have it on my PC in PDF form.  I don't know whether or not this document is publicly available, therefore I don't know if it's appropriate for me to quote from it at any length, but here are the two relevant passages (by way of justifying my sharing them here, I'm assuming these are typical language for drug trials):

"As a participant in this study, you will receive either AA4500 or placebo (placebo looks like AA4500 but has no active drug) as injections into your penile plaque."

And later in the document, under the heading Placebo Risks:  "Receiving placebo is the same as not receiving anything for your Peyronie's Disease."

hth,
G.


mikesb

Quote from: Hawk on January 06, 2009, 04:06:29 PM
I know little to nothing about the actual parameters of the Xiaflex trials but I think I know the meaning of the word "placebo" and how it is used in clinical trials.  A placebo is a substance that has no known therapeutic benefit or side effects.  It is used in trials as a control to guard against "placebo effect" in which a patients perception influences the outcome.  It also as Tim pointed out guards against some effect from the procedure (such as the injection) being credited to the drug.

As G. indicates, sometimes the control is an alternate standard of treatment rather than a placebo.  I would surely think the participants of this study had full disclosure on whether they were signing up for a placebo based study or a control study based on a specific control drug that has known benefit and side-effects.  I would even think this is a public information component of the study that we should all know by now.  The guessing should be over at this point.

Rather than guessing, can someone settle this issue with authoritative evidence?

Were participants given copies of signed releases which shed light?

Are there published study guidelines?

Geez and all of this time I thought the "placebo" group was being forced to listen to the music of an overwrought tenor, truly an excruciating experience...

Sorry I could not resist.....

Hawk

Quote from: G. on January 06, 2009, 07:41:16 PM
"As a participant in this study, you will receive either AA4500 or placebo (placebo looks like AA4500 but has no active drug) as injections into your penile plaque."

And later in the document, under the heading Placebo Risks:  "Receiving placebo is the same as not receiving anything for your Peyronie's Disease."

Then it is conclusively answered.  It is a placebo -  a substance not known to have any treatment benefits or any side effects.  That would certainly not describe Verapamil or interferon.

Thank you G
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

rbwoodward

Also it should be pointed out that the Xiaflex trial is currently a phase 2B trial, in which there is no direct comparison to a standard treatment.  Therefore the placebo is a saline solution.  When an investigational drug reaches phase 3, a head-to-head comparison is made with an established drug.  In this case, it may very well be interferon or verapamil, but we are getting ahead of ourselves here.  Let's hope that Xiaflex makes it that far!  

Hawk

Thanks RB,

Another excellent point that we should have picked up on.  Comparisons to other treatments are only made in phase 3 trials.
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

It sounds like the Xiaflex study uses a true placebo for the control group. The terminology used is usually thus: the study drug group is compared to a control group. The control group may receive drugs (usually standard of care) or nothing (ie true placebo) if that is safe. In the case of Peyronie's, as many here have found out, doing nothing IS the standard of care and so doing nothing or a sham injection of saline is an ethical comparison group.

In other diseases (ie brain tumors) with some therapies available that are not good, then the control group usually gets the standard therapy, and the study group gets the study drug, or sometimes the standard therapy PLUS the study drug. The design of the study follows the available therapies, how dire the nature of the illness, and the risks of the study drug versus the risks of the control group therapy.

In Peyronie's Disease, some men here have reported having their Peyronie's triggered by injections, or made worse. But, in general, many men have had injections without problem. Also, given the questions raised by the hard-to-find reports about using the Leriche technique to treat plaque by loosening it up with a needle (I think they call it needle aponeurotomy, breaking up the plaque, in Dupuytren's Contracture), it is erasonable to hypothesize that the needle itself may have accounted for some of the improvement seen in Verapamil injections (and, I might add in the control group for that study).

Thus, it is reasonable that one have a small amount of saline injected into the plaque, in an identical manner as Xiaflex is injected, to allow the study docs to draw accurate and fair assessments of the drugs efficacy. It sucks to get placebo, but getting a good study done for a possible curative therapy (for some men) is worth the small risks some men face. Men given Xiaflex also face the possibility of worsening, or of nothing happening at all. If Xiaflex does one no more good than saline, then I would like to know it.

Tim

ps Phase 1 trials look at safety, and phase 2 studies look at dosing to help design a larger study. Phase 2 studies may include a control group and placebo.
52, Peyronies Disease for 30 years, upward curve and some new lesions.

G.

Tim and RB,

Thanks for your posts - now I have a much better idea as to how these studies are designed.

Now let's just hope this stuff works!

G.

barky

new to this forum...I have had two injections of xiaflex this week...hurts like h**l.....entire penis is black and blue...i can tell from the reaction that i got the real thing (i think the placebo is saline solution...).  so - 2 injections this week.  no idea what is happening to the plaque as i hurt too much to even think about touching it to find out.  will post more as developments proceed...

Ted Williams

Hey Barky,

Thanks for keeping us posted.  I appreciate it.  I am excited to hear what your experience is like.  

Regards,

Ted

barky

ted, you are welcome. one other thought - this stuff will be app'd for dupuytren's before it is approved for Peyronies Disease. doctors can use drugs "off-label" so probably some urologists will start using this once it get the app'l for dupuytren's.

Ted Williams

Hey Barky,

Xiaflex can be used off-label.  Insurance won't cover it... but I don't care.  There are videos on google that show a woman's experience with Dupuytren's contacture and her result is AMAZING!  She goes from crippled to functional.  She was actually short of complete cure but she stopped because it hurt.  The big difference is the degree of "manipulation."  The doctors really, really, REALLY try to force the hand open.  I guess it is hard to force the penis to that extent.

Keep us posted.

Ted

ohjb1

Is there anyone on this forum who is in the Xiaflex study who has noticed any improvement?

FYI - the fact that your penis is bruised is not an indication that you received the actual drug vs the placebo. Bruising is a result of the needle, not the medication.