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

[rcrj]

I keep reading about Harvard scientists and Dr. Anthony Atala at Wake Forest creating rabbit penises from their own cells, but they seem content to experiment on other animals instead of conducting human trials.  How would subjects be chosen for any future human trials, and have prominent Peyronies Disease docs like Lue, Levine, Mulhall, etc. shown any interest in this field?  Finally, what is a realistic guess as to when a human penis will be grown, and which biotech companies might jump in to give the whole thing momentum?

Robert


An exact duplicate of this post under "Urologists and other Doctors" was deleted as a duplicate post.  
Hawk

[Rico]

auxl CEO will be on a conference call on the Feb 8th and there will be another(earning report) on the 15th.... the 8th will be replayed for a week on the auxl site on Yahoo finance.....  

[Tim468]

The Harvard scientist was Anthony Atala - and then he moved to Wake Forest.

The penile recontruction was a "proof of priniciple" experiment that he conducted to demonstrate that it could be done. He has focused more of his attention on simpler organs that are more devastating to people when they malfunction (or so they think!). He has been creating artificial bladders, and may contruct an artificial uterus that could carry a fetus to term. This is all big stuff and is out of the league of scientists like Lue, Levine etc. When he gave a talk recently here he gave no indication that he intended to do any more work with penis surgery. But he has a big lab, and some eager trainee will probably pick up the ball and run with it.

Tim

[Rico]

Dear forum members,

I just listen to the CEO from AUXL... Mr. Armando Anido.... he address the company and different applications for the aa4500... he address the peyronies and said at this time the FDA is having them do a study with animals to see if the aa4500 misses the plaque when the doctor injects it into the penis, what happens to normal tissue.... once this study is done and FDA lets them move forward then they do the two b phase which is to see if 6 or 9 injections are needed.... then a questionaire filled out by clients and they feel they should be able to license the product to the public after this...

The drug aa4500 is not in the clinics now since it was pulled in december for manufactoring problems.... they are working with the FDA to correct this for they can go back to phase three with the frozen shoulder and hand trials....

It was nice to hear the call and peyronies brought up to the financial community and that someone is working on it a least..... he did say that after phase 11b and the questionaire that the FDA should let it go to the public.... so with luck it could be a year or so..... I still don't know if it will help with lost size or waisting, but it should help with bend....

Rico

[Hawk]

Rico,

Good update thanks.

One issue - If they have not yet started with animals; they will never do the animal studies, plus the human trials, and questionairs, and be done in anything close to one year.

[ComeBacKid]

Hawk,

Good point, it could still be awhile.  I listened in on the conference call for a bit, only part of it was spent on peyronies.  It seems they are looking to try a new format for the shots, 2 per week, then a 6 week break until the next shots.  I'd encourage everyone to listen in on auxilliums webpage.  It does seem positive that they are moving forward at least and aren't giving up on the drug. They seem to think that after the animal study which really needs to be done for safety(we don't want to inject this medicine and destroy healthy erectile tissue) as much as we grip about it, and after the next phase studies, this product will be at market.  

ComeBackid

[Rico]

Hawk when I listen to the call it sounded like the animal studies where in process... hard to say for sure.... one has to remember that share holders and funds are listening to this call and of course they want to put a positive spin on the company and products coming to market....

The most positive part of the whole thing in my opinion is that they are working with peyronies and bringing it to the attention of more people.... as far as a year, I shouldn't of said that, I have nothing to base that off of other than wishful thinking:)...

Rico

[Rico]

Someone asked when the aa4500 would be on the market on the auxl message board, don't know how accurate this answer is but it was 1st quarter of 2009....two years out:(...

[Power]

Today there was a documentary on History Channel about sex and technology-Modern Marvel (airing right now as I type). Dr. Atala and his gene therapy research was featured in a segment and it was stated that it should be availble by 2010 to the public.

Keep on Fighting this crap
Power

[rcrj]

It will be interesting to see what form that takes, whether there will be human trials for a full replacement or if a scaffolding approach to grow new tunica cells over the damaged will be tried first, and how the existing scarring and fibrosis will be dealt with in that case.  I'm just wondering if there's some way for this forum, the APDA or someone with clout acting as a representative to access a contact there at Wake Forest to alert us if there are to be trials, or at least how the preliminary research is progressing other than the infrequent press releases/conferences.  

Robert

[ComeBacKid]

Thats a neat idea RCRJ, to grow new tunica cells over the damaged ones, perhaps they could be injected into the penis?  But yeah we should think about contacting Dr. Atala, he seems to be really on our side, and interested in this stuff.  Perhaps he doesn't realize just how many guys out there have peyronies, and how desperate we are.  We do have a director of advocacy but hes been inactive for awhile, I hope everything is ok with Blink, perhaps someone new should fill in for him that has the energy to run with the ball?  

[Rico]

AUXL just had there earning call and the CEO talked about peyronies and aa4500, he said that phase two B should be in place by fourth quarter of this year and then the bla study for the fda in fifteen months followed by fda approval in another 12 months, so 2010 looks like when it would be ready for market.... the formation or melt back of aa4500 and the need to learn how to extend drying to reduce moisture set it back a good year:).... the animal studies are not complete yet for the fda on what happens to normal tissue also if it misses the plaque...

[Power]

Received an email from Auxilium with some new information concerning their phase III trials on AA4500 for Dup.

http://phoenix.corporate-ir.net/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=964735&highlight=

Keep Frighting,
Power

[mark501]

Power, thanks for the info. It looks like there were enough patients who completed their treatment with AA4500 in Phase III prior to the early termination of trials to determine its effectiveness and safety. That's the good news. The bad news is that Auxilium predicts trials for peyronie's & dupuytrens will not begin again until Oct-Dec 2007. Keep the faith.

[Rico]

I agree that the conference call and reports are positive, but like mark501 said they aren't even going to start again till the fourth quarter of 2007 and the CEO said that it will be anouther two years for peyronies to be available to the market, and this is if the FDA approves it, they still have the animal testing to complete to see how it affects normal tissue... I guess three years from now is better than nothing:(...

[Steve]

I just got this news in a Google alert!...here's the link http://biz.yahoo.com/prnews/070221/nyw034.html?.v=84
As you can see in this quote from the story, BTC has close connections with Auxilium:

As a result of its research and development efforts BTC has also developed an injectable collagenase for treatment of various diseases or indications. BTC has a development and license agreement with Auxilium Pharmaceuticals, Inc. ("Auxilium") for injectable collagenase for clinical indications in Dupuytren's disease, Peyronies's disease and frozen shoulder (adhesive capsulitis).

[Rico]

Yes this is the aa4500.... it will be available with luck in 2010 for peyronies, this is if it gets passed by the FDA.

[roadblock]

I came across this article on pubmed where I periodically check for new articles...

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17325694&query_hl=1&itool=pubmed_DocSum

When I think about this disease process in general, I think the first big break will be the ability to pharmacologically inhibit TGF-beta to halt the abnormal disease process. Further down the road, gene therapy will allow for cells to be redirected to attack fibrotic tissue and increase elastic characteristics of the tunical tissue.

Just wanted to 1) highlight the fact that the disease process that currently is being proposed as being behind Peyronies Disease is generating interest for more research and 2) go on record with my theory so I can say "told ya so" when this stuff is just a thing of the past!

[hopeful]

This is Hopeful.. Please tell me what the drug (Pirfenidone)....is??- and how does it work with Peyronies Disease?-any studies that I can read, etc.. how is it administered,
Thank you,

Hopeful

Hmmm...
If Intermune actually does continue "squatting" on a very promising drug (Pirfenidone)....
...and...

http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=ITMN&script=2100

]

[Hawk]

Hopeful,

if you click on the SEARCH button (right next to "Help")
then type pirfenidone
put a check in front of SHOW RESULTS AS MESSAGES

You will find all the information you are requesting.  We have a great advantage on this forum having a search feature and it keeps members from having to type he same information over and over again.

If you have any problem just ask.  Many of us would be glad to help you with this option since it will help you greatly in researching topics.

[mark501]

REF: Journal Sexual Medicine March 2007 (477-84 & PubMed Abstract 17367443 / Title: Topical Verapamil HCI, Topical Trifluoperazine & Topical Magnesium Sulfate For the Treatment of Peyronie's - A Placebo Controlled Pilot Study //  Among the authors are William Fitch MD of Urology Consultants*, San Antonio & WJ Easterling RPH of Prescription Dispensing Laboratories** of San Antonio (this per Blackwell Synergy website). // They studied the same 3 drugs in a 2002 report (with a 3 month protocol). In this new study it was for 9 months: l. verapamil only for the full 9 months, 2. trifluoperazine (trade name: stelazine) for 3 months followed by 6 months of verapamil and 3. magnesium sulfate for 3 months followed by 6 months of verapamil. According to the abstract no patients were given a full 9 months on only trifluoperazine or magnesium sulfate. I wonder why not. Was this study sanctioned by the FDA? Was the FDA consulted before, during or after this study? The magnesium sulfate is the only one of the three available without a prescription. It might be a big challenge to obtain a patent on this inexpensive natural substance. I believe Peyronies Disease Labs & Assoc. holds patents on use of verapamil & stelazine for treatment of peyronie's.      This from the Peyronies Disease Labs website today referring to topical verapamil: "This medication provided only by a physician's prescription, is not FDA approved & no formal claims related to efficacy or safety are being made"     *Urology Consultants is an office of 5 urologists in the Medical Center area in San Antonio of which Dr. Fitch is the only one named on this study.    **Peyronies Disease Labs is a commercial compounding pharmacy located in the Falcon International Bank building in the Stone Oak neighborhood of San Antonio.

[scott]

This is certainly interesting.  Stelazine is an antipsychotic (for schizophrenia) taken orally.  It was applied topically in this study?  What is it thought to do for Peyronie's?

[j]

Fitch and Easterling are the guys that originally gave us transdermal Verapamil. From this abstract, it appears that the other compounds were given to the 'control' group basically as placebos.

I wouldn't be surprised if this new article is nothing but a rehash of the study they reported in 2002.  That study also claimed improvement in over 90% of the patients.  Based on my own experience and that of many posters to this forum, a number of 0% seems more accurate.  

[mark501]

j, yes this is somewhat similar to the 2002 study however it does have a different protocol. The conclusions they draw from their studies do not match the experiences of members on this forum. The abstract mentions 4 groups of patients. I take it from that statement to mean 3 different drugs plus l placebo. I don't feel that the magnesium sulfate & trifluoperazine could be considered placebos as they have both shown some effectiveness in treating peyronie's. I have used magnesium sulfate with good success & no side effects. I also used verapamil with bad side effects. This is a bit odd since both are calcium channel blockers. I think I would be cautious in using trifluoperazine (stelazine) even in topical form. It is a potent anti-schizophrenia & anti-anxiety drug. Peyronies Disease Labs did patent it's use in 2003 (issue date) for peyronie's. They call it a calmodulin blocker. In any case I would like to see offical FDA clinical trials on these 3 drugs separately. Until then I remain skeptical of the conclusions in their reports.

[Tim468]

Just a note of clarification. The FDA sanctions and controls study of experimental drugs that are new to the market. They thus make researchers do studies in phases that first dertermine that the drug is not unsafe, and then potentially helpful (for limited uses). Once a drug is approved it can be prescribed by anyone.

After a drug is approved (and some were never studied initially anyway - like aspirin), then one can design a study of it for other purposes. If one creates a new formulation (this might improve, say, drug delivery to tissue - but it might also be patentable!), then that formulation must also pass FDA muster. However, if one is studying an older drug in a novel way, then the FDA is not going to primarily control that study.

I could thus study the role of vitamin E on lung health. I would have to propose a study, find someone to fund it, and get it approved by my Institutional Review Board. If I were in private practice, then the rules are more slack. For instance, a local Homeopath may decide to "study" vitamin E, but not really do a randomized study, or get it to pass muster with an IRB. But that person might find it hard to get published in a peer reviewed journal.

I haven't looked at this journal (Journal Sexual Medicine) lately, but it is definitely second tier in terms of level of quality. It is the kind of place I might submit a paper less likely to be accepted in a "real" journal like Urology.

Tim

[j]

mark501, do you have access to the full text of the article?  If so, how many patients are they claiming were enrolled in the new study?

Is "Peyronie's Disease Labs" just a new name for their old front, "Prescription Dispensing Laboratories"?

I'll state the obvious question - why have none of these patients (94% of whom saw significant improvement) posted on this forum?  And I'll predict that none of them ever will.  As was the case with the 2002 study.

[mark501]

J & Tim, Thanks for your input on this subject. Sorry I don't have access to the full article. It does say in the abstract that there were 57 patients "randomized". On the company literature "PDLABS" is in large print & underneath in small print is "prescription dispensing laboratories". I spoke to one of the employees of this company years ago and they told me that to comply with FDA regulations of a clinical trial of their primary asset (topical verapamil) would cost them more than the bank building that they are housed in. The wording "two simultaneous, three armed, double blinded, placebo-controlled studies" sound very impressive at first glance however it does not address the role of each of the 3 topicals independently for a 9 month period. Their stated goal in the abstract is "to assess the efficacy of a 15% verapamil gel". What about the efficacy of the other 2 gels? Unstated at least in the abstract is the percentage (strength) in the magnesium sulfate gel & the trifluoperazine gel.

[Hawk]

I spoke to one of the employees of this company years ago and they told me that to comply with FDA regulations of a clinical trial of their primary asset (topical verapamil) would cost them more than the bank building that they are housed in.

My guess is that it would cost them more than that.  I suspect it would demonstrate the ineffectiveness of their product and cost them their business.  

[George999]

So Mark, please tell us what this magnesium sulfate preparation is.  The common form of magnesium sulfate is epsom salts, but I take it you are using something more concentrated?    So, please give us some information on what you are using and where you are getting it.  

Thanks,

George

[mark501]

George, I don't know how to make an exact strength comparison between epsom salt cream from www.kirkmanlabs.com & epsom salt granules from Walgreens. Perhaps you can help work the numbers.     Kirkman Labs cream: 113 grams in 4 oz. jar; 1 gram supplies 100mg of epsom salt USP (magnesium sulfate heptahydrate); suggested use on label: 1 gram 1-4X daily.     Walgreens epsom salt granules (magnesium sulfate USP) Total magnesium  - 9.8%, Total sulfur 12.9%. suggested use onl label: dissolve 2 cups of epsom salt (granules) per gallon of water. The label does not say how many mg are in each cup. Perhaps another brand would have this info on their product. My use of the Kirkman product has usually been 2 grams 3x daily.  

[George999]

Mark, I'm not sure strength is the important factor here.  Its efficacy can also be related to the formulation itself.  The fact, for example, that it is dissolved in a a fatty or oily base rather than in water can make a huge difference in its potential effectiveness.  And of course, convenience can be a factor as well.  Thanks for sharing the info.  This is interesting.

- George

[tdsc]

Does anybody know if epsom salts or this formulation could be irritating to the skin or whatnot over time?

[kenno]

Gee and this is the one I have been hoping for.  I'd volunteer for this one in a minute I think.  This is one reason I hesitate to have a graft or something.  I keep thinking that maybe a cure will be coming soon.  Looks like this one will be a while.

I agree that the conference call and reports are positive, but like mark501 said they aren't even going to start again till the fourth quarter of 2007 and the CEO said that it will be anouther two years for peyronies to be available to the market, and this is if the FDA approves it, they still have the animal testing to complete to see how it affects normal tissue... I guess three years from now is better than nothing:(...

[mark501]

Auxilium stated today that their "outside of plaque" animal study is to be completed this summer & the results forwarded to the FDA then. If I understand correctly they are saying that in Dupuytren's, a 5 degree variance from normal will be considered a success. A measurement of success for AA4500 in treatment of Peyronie's has not been determined yet. They mentioned today that answers from patient questionaires after treatment & consultation with FDA would help define success.

[kenno]

So does this mean human trials by end of the year?

Auxilium stated today that their "outside of plaque" animal study is to be completed this summer & the results forwarded to the FDA then. If I understand correctly they are saying that in Dupuytren's, a 5 degree variance from normal will be considered a success. A measurement of success for AA4500 in treatment of Peyronie's has not been determined yet. They mentioned today that answers from patient questionaires after treatment & consultation with FDA would help define success.

[Liam]

This may be of interest to some:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17419813&query_hl=2&itool=pubmed_docsum

[jon]

http://www.cnn.com/2007/TECH/science/05/17/baldness.study.reut/index.html

while completely unrelated to peyronie's there was this little nugget in there that may lend some application to peyronie's:

"Cotsarelis also envisioned treating wounds in a way that would leave skin with hair follicles, sweat glands and other normal attributes that would be functionally and cosmetically much better than a scar."

edit:
full text of the article below

WASHINGTON (Reuters) -- Mice with deep skin wounds can grow new hair, scientists said on Wednesday in a finding that offers hope for a baldness remedy for humans.

The mice regenerated hair at the site of the wound via molecular processes similar to those used in embryonic development, according to the research, published in the journal Nature.

The findings show mammals possess greater regenerative abilities than commonly believed. While some amphibians can regenerate limbs and some reptiles can regenerate tails, regeneration in mammals is far more limited.

Dr. George Cotsarelis, a dermatology professor at the University of Pennsylvania School of Medicine in Philadelphia who led the study, said the findings dispel the dogma that hair loss is permanent in people and other mammals, and that once they are lost new hair follicles cannot grow.

Cotsarelis said the findings could pave the way for remedies for male-pattern baldness and other types of hair-loss. He said the idea would be to apply compounds to get epidermal cells to turn into hair follicles.

The regenerated follicles functioned normally, cycling through the various stages of hair growth, and the hair was indistinguishable from neighboring hair with a key exception -- it lacked pigmentation and was white.

The otherwise brown-haired mice had patches of white hair marking the site of the wound.

Cotsarelis said the white-hair issue may not materialize in any baldness remedy in people because the human pigmentation system differs from that in mice.

The researchers made relatively large wounds on the backs of adult mice, and found that if a wound reached a certain size new hairs formed at its center, with the skin undergoing changes mimicking stages of embryonic hair-follicle development.

Dormant embryonic molecular pathways were activated, sending stem cells -- master cells able to transform into other cell types -- to the damaged skin.

The stem cells that gave rise to the regenerated follicles were not stem cells usually associated with hair-follicle development.

"They're actually coming from epidermal cells that don't normally make hair follicles. So they're somehow reprogrammed and told to make a follicle," Cotsarelis said.

The researchers also found a way to amplify the natural regeneration process, causing mice to grow twice as many new hairs by giving the skin a specific molecular signal.

Cotsarelis is involved with Follica Inc., a privately held start-up company that has licensed the patent on the process from the University of Pennsylvania. He said it probably would be more than five years before a treatment was possible.

Cotsarelis also envisioned treating wounds in a way that would leave skin with hair follicles, sweat glands and other normal attributes that would be functionally and cosmetically much better than a scar.

Dr. Cheng-Ming Chuong, a professor of pathology at the University of Southern California who was not involved in the study, said it proved the principle that hair can regenerate from adult skin, but cautioned that human skin differs from mouse skin.

"Repair and regeneration appear to be in competition," Chuong said by e-mail.

"Since fast-closing wounds help the survival of wild animals, repair often dominates regeneration. In the practice of medicine, physicians are trained to close wounds as soon as possible, thus leaving not enough time for regeneration to occur."

[Hawk]

Jon,

That link is worthy of discussion but you should probably summarize it.  CNN will move or delete the story and the link will go inactive on the CNN site.  No one will have a clue what you were in reference to.

[Power]

Hey Guys,

Seems like AA4500 will come to fruition (though its taking a while). Keep fighting and strive to keep the body as optimal as you can, so when the time does come around, the treatment can do what it does best..bye bye collagen!!!

Check the link out below:

http://www.chron.com/disp/story.mpl/ap/fn/4835578.html

God Bless,
Power

[Tim468]

I am personally quite suspicious of this company and their practices. I have seen more that is directed towards increasing market share value and less towards development of a genuine product. Buy now? I will pass and accept a loss gladly if I can see a product that works.

I am starting to wonder if this company is all hat and no cattle.

Tim

[Power]

Hey Tim,

Sorry you feel that way. Understandable though. I have some suspicions my self.. Suspicions that you may be one of the first in line to get it, if and when it does reach the market. ..I'll see you in line.. hahah.

But for real. They really need to get the whip cracking on this AA4500. I personally, prefer to keep hope alive, irregardless of the company's profit aspirations.

God Bless,
Power

[Steve]

Well, living in America, I don't mind a company trying to increase it's market share, but only if it's by bringing out a worthwhile product...not by bringing out promises only!  Time only will tell if/when AA4500 will be a savior to all of us or just to Auxilium.

[tdsc]

I posted earlier about taking borage oil and vitamin E.  While on Vitamin E, I was ramping it up to about 1000 IU and noticed a lot of fatique, mentally especially.  I took one borage oil capsule at night along with 400 IU of Vitamin E.  The next morning I took one more borage oil capsule.  I was studying for a test that morning.  About an hour after taking the borage oil, I noticed a very sudden increase in pressure (which can only be described as a once in a lifetime event of a mammoth increase in pressure that did not cause pain however) localized on the left side of my brain.  I stopped whatever I was concentrating on and the pressure went down.  The increase and the decrease was on the order of 3 or 4 seconds total.  It was nearly impossible to concentrate after this during the day on whatever I was studying.  During that day, on the very few times that I talked, there were popping sensations in my head, and I had fatigue.  I had a test 4 days later, and one where I could easily have concentrated before, it was literally like wading in quicksand in terms of thinking.  I could still think but it was very slow.  The left side of my head which would activate when I concentrated has only come back minimally.  I would have to say that my ability to concentrate, especially in terms of reading material or verbally, has diminished somewhat.  It is clear in my mind that I had a blood vessel burst in my head localized in the region that I used a lot, in fact which I was using at the time that it happened.  I still have the logical, mathematical abilities, it is just that I literally am disabled when it comes to reading and concentrating on verbal things.  It's like there is this blank or void spot in my head that never activates, when I could feel it activating before.  I don't mean to sound like I'm bitching, but this is what I believe happened.  I remember in the days afterward, when I tried to concentrate like I used to, that there was pain in this region of my head.  The only other explanation is that this increase in pressure was a drug effect that shut down this area of the brain, temporarilly, it is yet to see.  But I literally feel that I am somewhat disabled.

[Liam]

there were popping sensations in my head,

Man, I hate it when that happens!

I stopped whatever I was concentrating on and the pressure went down.

This I understand.

I still have the logical, mathematical abilities

I'm not sure about the logical part.  This is very very far fetched.  Check with your doctor!  

The only other explanation is that this increase in pressure was a drug effect that shut down this area of the brain, temporarilly, it is yet to see

That is the only thing that would explain nothing.  Vitamin E and Bosarge Oil are not drugs, they're supplements.  In low doses they are safe.  They're not going to cause your brain to bleed.  And if they did, you would not be here writing about it.  See your doctor and explain your theory.  See what he says.  Have you considered something like Meniere's Disease ( http://www.menieresinfo.com/start.html ).  Another alternative is chronic fatigue syndrome.  Lyme Disease and MS could produce those symptoms.  There are several psychiatric disorders which could be culprits.  Have you been tested for ADD?

I remember the good old days when kids would OD on real drugs and then have coversations with characters from "Through the Looking Glass".    

BTW, here's a good link on Aphasia:  http://en.wikipedia.org/wiki/Aphasia

Also check www.ASHA.org


Any other discussion on this...... Lets move to Oral Treatments topic.

Liam

[Tim468]

When you last checked in, you asked us if using the VED made our penises look like "beat up sausages", which challenges us to state publicly if we are insane or sane, for who on earth would use something that did that to our penises if we were sane?

Today, apparently unconvinced of our sanity (for no one admitted to having their penis look like a sausage after VED use), you are challenging us to believe something that is, um, unlikely and incredible.

I do think that this statement is probably truthful: "I literally feel that I am somewhat disabled."

There are other explanations for your symptoms (if they really happened and you are not simply an attention junkie here making crap up). Migraine headache is a good bet, as is a psychologic impairment of some sort. You could resolve such a question with a trip to a doctor - and one might wonder why a man who was convinced a blood vessel had burst in his head, rendering him disabled, did NOT go to a doctor.

If you genuinely want to learn about Peyronie's Disease, I think it is time to take the cotton out of your ears and stuff it in your mouth. Read here and learn, but such posts are beyond incredible.

Tim

[tdsc]

I can't say that it caused a disability.  I will try to describe what happened.  Do you know when you concentrate, you can sometimes feel the brain activating?  Well I was concentrating, and the usual feeling of just activation in the left area of my brain somewhat near the ears was occuring.  I'm concentrating, and then suddenly it's like that feeling starts to escalate and escalate and escalate, almost like a blow-out or something.  I can't be certain it was a blood vessel burst.  Perhaps what was happening was an increase in blood pressure in this area, and that either caused the brain in this area to shut down for safety reasons or there, and I'm speculating, that there was small amounts of blood leakage from capillaries due to the increased pressure.   That day, I was literally wiped out and could not probably do anything that required a great deal of thought if my life depended on it, and I don't know how vitamin E fatique could explain that.   For the next several nights, in bed, when I tried to concentrate like I used to, it wouldn't really activate and there was pain while trying to concentrate but not without.  I've had this area activate again in the past usually when I'm not trying to activate it, like when I am encountering a new situation, and it is somewhat coming back now.  Perhaps it is psychological to some extent.  But what I don't know is why it was so difficult for me to concentrate and finish the test, as if I had a really bad hangover.  I've had vitamin E in the past causing fatique, and making it difficult to concentrate, but nothing like this.  I stopped taking all vitamins after this, and yet for several weeks, it was still quite difficult to concentrate in comparision to previous times.  It has improved somewhat, though.

[tdsc]

I just looked up brain hemorrhage.  They say a brain hemorrhage is a sudden increase in pressure within the brain caused by leaking blood.  My question to anybody knowledgeable in this area, and I may see a doctor, is, can the increase in pressure be localized to one area of the brain or is the feeling of increase in pressure throughout the entire brain.  The feeling I had was in one localized spot in my head which the pressure went down after I stopped whatever I was doing.  The link I see says that if there is enough bleeding, it can be enough to cause unconsciousness, which I didn't have.  They also say that the bleeding can cause a massive headache, which I didn't have.  One of the main reasons I didn't see a doctor, was that I didn't have a headache.

[George999]

Tdsc, You might want to consider the fact that the pressure referred to in the case of brain hemorrhage is actual physical pressure within the brain.  The perceptions of that pressure are as stated in the definition which, as far as I know, do not include the perception of 'pressure'.  Simply 'feeling' pressure in the brain could probably be caused by a long list of things, most of them benign.  But there is simply no way that one can accurately diagnose one's own condition reliably because to do so takes a lot of objectivity and that is why even doctors see other doctors to diagnose their afflictions.  I once was told by a doctor that it is very common in medical school for even doctors to suddenly become convinced that they were experiencing some dread condition simply on the basis that it was something they had recently studied and, from their perceived symptoms, they just knew that they must have had that problem.  And it was equally common that they were completely misinterpreting their symptoms.  So Tim is right about this.  You should run it by your doctor and let him have a chance to be able to ask the right questions to help you understand whether or not this is serious, important or even diagnosable.  As you get older, you will find that you will suffer from all sorts of mysterious symptoms that come and go and usually, almost always, amount to nothing.  I am not trying to trivialize your concern, I have been in similar situations myself on more than one occasion.  But those experiences would indicate to me that you probably have very little to be concerned about.  All of our physical perceptions are sensed through the nervous system and the nervous system can and does play tricks on us.  That would be one of my first suspicions in your case.  Like you, I have felt a sensation of pressure in my head before on more than one occasion.  Other than being a bit weird and scary, no negative effects ever resulted from it.  When you need to become concerned is when you are experiencing such things as sudden vision problems, or unexplained nausea or dizziness, stiffness or numbness in the extremities, stuff like that.  But just to make sure you are not missing something, it is always good to mention these things to your doctor.  - George

PS - Trust me, you can die a thousand unnecessary deaths by trying to speculate on your symptoms and to diagnose your own condition.  People actually commit suicide simply because they are convinced they have some terrible disease which they don't (didn't) have.  So it doesn't pay to try to use the internet to come up with a diagnosis.  Do go see your doctor.  Its a lot less painful that way.

[Hawk]

TDSK - This is NOT a self-diagnosis forum.  It certainly is not a self-diagnosis forum for neurological problems.  These posts are both beyond the scope of any forum and totally unrelated to, and off topic to this forum.  I am certain that your perceived problems have nothing to do with the things to which you attribute them.  I am also certain that you need some up-close, hands-on, time with competent professionals.  

Please peruse this coarse rather than wasting time with these type of posts.

Good luck.  

[mark501]

Auxilium in an SEC filing yesterday are now calling AA4500 by the trade name "XIAFLEX" . In the filing they also restate clinical trials for Dupuytren's to begin 4th quarter of 2007 and for peyronie's Q1/Q2 of 2008. I didn't notice any info on results of out of plaque animal studies but perhaps it will be mentioned later today in their audio webcast. They have a 2d webcast this month; tuesday, July 31 at 9am CDT.