Open Letter To Auxilium - Breach of Obligations to a Clinical Trial Patient

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exo

Note: I am a member of this board, but I wanted to do this under a new name due to the personal details here.  I'm a PhD researcher myself, and I would never dream of treating people as deplorably as Auxilium has treated me in this trial.  And, they refuse to speak to me.  My own doctor refuses to give me the contact information of his Auxilium contact.  Nobody has called me back, despite 5 calls to their call center.  I am absolutely at the end of my rope after waiting over a year for the real drug, after receiving the placebo for a year in their trial.

I have tried contacting people at Auxilium to ask questions while I was in the trial 18 months ago, and I tried contacting them again recently.  Nobody from that company who is in a knowledgeable or decision making position will take the time to call me or email me, no matter who I have left messages with. Since I know for a fact that Auxilium staff read this board, I am going to post this here (and I have submitted it to them as well, which I am guessing will be ignored like all of my calls).  I have removed some personal information, but they know who I am and how to contact me.  I called the call center 5 times in the last week alone.  And they can contact me here as exo9400 (at) gmail.

Board members, please do not take this as an invitation to play Devil's advocate.  After everything I have been through emotionally by having this disease and being given the placebo for a year while worsening while being made to go off penotx for the trial  (and now denied the real drug), I am quite angry.  So, I can only imagine that if anyone sides with them, they are just employee shills or failed to read the entire thing.  I would also like people to see the kinds of behaviors that this company endorses.  Since I am a PhD myself, i have done quite a lot of digging into this trial over the last year (partially thanks to help from board members here), and I can post a lot more information about what is going on if you want to argue with me about their ethics.  I also know what they have been lying about (from a molecular biology standpoint and from a side effect standpoint) and I've been sent photos to prove it from other patients.  So, if you want to defend them, I'll be happy to respond with quite an arsenal of previously hidden information.  For now, I just want what was promised to me by wasting a year of my life by driving 2 hours each way to have my penis injected with saline and repeatedly examined - all with the promise that IF I got the placebo, THEN I would get the real drug.


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I was a participant in The Auxilium clinical trial for the use of AA4500 in the treatment of Peyronie's Disease during 2010 and 2011.  I enrolled in the study after signing an informed consent document which explicitly stated that if I turned out to be in the placebo group, I would receive the actual drug upon the completion of the study.  I attended approximately 20 visits to the urology office in XX for the trial.  Additionally, I had to cease all other treatments such as traction and pentoxifylline, allowing my condition to worsen while I was being injected with a placebo for this trial.  Furthermore, the XX office was two hours from where I lived, often requiring me to stay overnight in a nearby hotel at my own expense due to the long drive, physician scheduling, and wanting to be close in the event of adverse reactions.  I paid over $2000 of my own money in hotel bills and gas expenses.  I never missed the narrow time frames for a single visit.  I received approximately 20 painful and uncomfortable penile injections.  The injections included drugs to induce erection, eliminate erection, in addition to the placebo substance.  To qualify, I even underwent an x-ray of my penis to rule out calcification of the plaques, exposing my genital area to radiation.

Toward the end of the study, I moved to another area after completing my coursework in graduate school.  I asked if I could transfer to one of the offices of a principal investigator physician in that area (there are several doctors listed on clinical trials.gov for this study in those areas).  Although the informed consent NEVER stated that patients must stay with the same physician for the entire duration of the study, my request was refused.  Auxiluim requested that I fly back to the original site for two follow up visits at my own expense (over $1000 for the flight and hotel due to the timing).  Due to the significant costs of graduate school, I was not in the financial position to do that at the time.  However, Auxilium refused to provide any financial assistance, despite insisting that I visit the same physician (despite nothing about this in the informed consent).   Since I could not afford the trip, I was dropped from the study (despite having received all injections and only having 2 visits left) and never contacted about receiving the active drug.  

I was a researcher too – and we all, under federal law, have to list the reasons we would terminate someone from a trial in the informed consent document, per 45 C.F.R. § 46.116 (2005) for studies under HHS guidelines and 21 C.F.R. § 50.25 (2011) for FDA trials.  Failing to stay within the geographical area of the study doctor (and/or requesting to see another doctor in the study) was not one of the reasons for termination listed.  The document covered all of your bases 110% - so this "you can't switch doctors" thing was made up, verbally, and used to kick me out of the study.  If it was such an important thing to "control how I was measured," then it should have always been in the informed consent document from day one.  Also, it wouldn't be that complicated to have the two doctors speak to each other about how they are measuring things to ensure the consistency they were so worried about.  I technically "withdrew" because my office kept trying to schedule my next appointment as I tried to figure out if I could fly there, but I was effectively terminated (unjustly) – not withdrawn.  I offered to continue in my new location.

When I heard that patients were now getting the active drug from reading a message board online, I contacted Auxilium on March 18.  The people who responded at Auxilium told me to contact my  study site.  I contacted this site, and they confirmed with Auxilium that I was, in fact, excluded from receiving the active drug.  I was never even called or emailed to be told that I was in the placebo group (again, another breach of the informed consent – I had only assumed I was in the placebo group due to lack of any swelling or bruising which happens to 95% of patients – but I was never told for sure).    I again contacted Auxilium on the 18th and 21st, but I have not received a reply from them.  The people in the study site refuse to give me contact information of the person who has declined me request to get the active drug.  The call center at Auxilium (877-663-0412) initially insisted that someone from the "appropriate department" would "call me back within a few days, try your study center again for the right person" but nobody has called.  When I called the study center back, I was rudely told "there is nothing we can do for you – stop calling."  The person refused to give me any contact information so that I could reach Auxilium's representative directly.  I could only call the call center. The Auxilium call center rep was also increasingly rude and hostile toward my simple requests for a call back which is shocking, considering what I have been put through for your drug to go to the market.

As a PhD researcher at [X] University, I have done research on human beings and would never treat them in this way.  I am not a lab rat, and Auxilium's treatment of me has been unethical and in violation of their own informed consent document.  My personal research as a PhD candidate was never anywhere near as invasive as penile injections, yet I followed my informed consent to the letter in every study.  I have never ignored a study subject, lied to them, or failed to follow through with promises.  In this case, I received 20 penile injections and invasive physical examinations – yet I am ignored and being treated like a nuisance, simply because I was forced out of the study because I moved cities.  Auxilium has broken its obligations by (a) failing to inform me that I was in the placebo group and (b) failing to give me the active drug when they forced me out of the study.  They have also failed to speak to me in a year and a half.  I have attempted to contact them in a variety of ways, but nobody at the company will actually call me back or email me.  To treat someone who has been through what I have is absolutely disgusting.  This disease is very traumatic and taxing by itself, and using me solely as a lab rat so that Auxilium can profit is even worse.  I was promised the real drug, and despite completing 95% of the study, I have received 0% of the real drug because they did not let me continue.  This is not a black and white issue, despite what they have tried to argue (in a 2 line email sent by Auxilium to my study coordinator by someone who no doubt has ZERO understanding of the torture that goes along with this disease and how much of my life I had to rearrange to be in the trial).

Not only is this a highly unethical action to do to someone who volunteered nearly 100 hours of his time and spent over $2000, but it is also a violation of the agreement that was made.  Having a shrunken and deformed penis is bad enough, but what you are doing is even worse.  Again, there was no page of the informed consent that had any wording prohibiting transferring to another physician's office.  The office staff knew that I was in graduate school and would likely move out of the area toward the end of the study. I would have made other arrangements if the prohibition to switch physicians was in the informed consent document.  However, it was not.  Perhaps Auxilium is using my move as an excuse to avoid having to pay the costs associated with giving me the active drug. Everyone I talked to, including the practitioners in the office and even the CEO of another pharmaceutical company (a professor of mine who used to oversee trials) and the IRB at my own university agreed that the right thing to do would be to give me the active drug when it was available. Even the staff in the doctor's clinical trial office agreed that the RIGHT thing to do would be to give me the active drug, after I spent nearly a year in the study and only missed the final one or two visits due to circumstances that were never made clear to me by Auxilium's informed consent document.  

Thank you for your attention in this matter.  A prompt reply would be appreciated.  My understanding is that enrollment in the open label study is ending soon, but again, I do not think this is an appropriate excuse to deny me the active drug (again).  I was never even informed that I was in a placebo group or that the active drug was available by my PI.  I had to read it online.   Thank you for your time.

Skjaldborg

Hey Exo,

That sounds awfully dodgy what they did to you. Have you had a chance to discuss this with a lawyer? Auxillium may have failed in their obligations to you under the study. If you can, get together all your records for travel and any evidence you have that you attended all appointments as required by the study. Then, lawyer up. Sorry this happened to you and good luck. Keep us posted.

bummedout

More proof that Auxilium is in it for the money and that's all.  They will go to any extents necessary to make sure they make money off of Xiaflex.  They will hide what they have to hide and lie when they can get away with it.  I've called them up once only to talk with some woman who I can only describe as an arrogant robot.  She wouldn't answer any of my questions and wouldn't put me through to anyone else who could.  Unfortunately I've come to the conclusion that there is currently no fix, at least for me, who has a plaque deep in the base of my penis and one by the head.  I'm technically impotent know from it, and single at the age of 33.  I've read some of the stem cell postings  on here too, but it seems as if those people are being duped too.  Sorry to sound pessimistic, but I'm just trying to be realistic.
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Hawk

This is an unfortunate situation.  If I am anything, I am a straight shooter that speaks plainly and tells it how I see it.  My first reaction is to empathize with exo.  I don't like however when someone poisons the discussion by telling everyone in advance what they better think or they are in the pocket of Auxillium.  I refuse to let such a comment shackle what I think or what I say.

I feel like the decent thing to do would be for Auxillium to give him the drug.  It might also be the smart business thing to do, and if I can take one side of this argument it may or may not be their legal obligation.  That however should not be the only issue.

I also think the statement "that it shows they are only in it for the money" is kind of peculiar.  Why else would they be in it ???  That why we all work.  It would be pretty difficult for Auxillium to get investors to put up the millions necessary to get this to market if it was not focused on profit.  Certainly none of us would put in our life savings. Why would we expect others to do that?  That has little to do with this in my view.  Even from a money stand point however, I think it is in Auxillium's best interest to give him the drug, especially if Exo is as tenacious as I am when it comes to waging a battle when I think I am in the right.

If I read the posting correctly the one thing I would note is that the simple thing would have been for Exo to be up front and say "I likely will not be ale to complete this study at this location. Is that a problem"?  Unless i am wrong he did not complete all the injections before moving.  The fact that he never discussed the likelihood he would move and certainly never directly told them it was likely, suggests to me that he was afraid they would reject him for the trial on that basis so he figured he would take the chance and get far enough into the study that it would paint them into a corner.  That makes it seem that there might be some less than admirable conduct on both sides.

I want to conclude that it is situations just like these that are the reason we have always committed to remain free from drug companies.  If you have a forum or organization sponsored by or partnered with a company like Auxillium then you lose your freedom to give members both sides of the issue.
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

MattFoley

The only strategy left would be to keep pestering the hell out of Auxilium and hope they will relent. I mean, there's no apparent legal recourse since exo broke the terms of the agreement by dropping out of the study. Exo made a conscious decision to abandon the study so I don't know what he can do. Maybe find an advocate to help push things along. Maybe small claims court and get an order to compel or injunctive relief. Or, just wait until the FDA approves it and helpfully get healthy insurance that will cover the treatment.

I wish there was an easy answer but I hope exo gets the treatment somehow.
Got Testosterone?

exo

.
Note: this board posts the newest message on top (unless you changed your setting).  So, my letter is at the bottom of the thread, if you haven't read it already.

Hi everyone.  Thanks for the replies.  I can answer / clear up a few things up from your posts.  The original letter is at the bottom of the thread (if you are using the default setting).  I am waiting to get a reply from them before I go into more detail – but yes, I did get all of the injections.  Also, they knew I was in grad school and would most likely move.  When I was done with my coursework and my lease was up in my apartment - I moved.  I never even thought that moving would be an issue, since it is not mentioned anywhere in the consent form.  Nobody in the doctor's office thought it was an issue either, until I tried to do it.  The study had so many exclusion criteria and rules; it's hard to imagine they would miss anything.  And, if they did miss something – it's not my fault.  With a document that comprehensive, why would I assume that if I moved to another study doctor, I would be kicked out?  I was a researcher too – and we all, under federal law, have to list the reasons we would terminate someone from a trial per 45 C.F.R. § 46.116 (2005) for studies under HHS guidelines and 21 C.F.R. § 50.25 (2011) for FDA trials.  Failing to stay within the geographical area of the study doctor (and/or requesting to see another doctor in the study) was not one of the reasons for termination listed. There were at least 3 offices in my new area that were running this trial...and they would only have had to see me for 2 final checkups - not even injections.   The document covered all of their bases 110% - so this "you can't switch doctors" thing was made up, verbally, and used to kick me out of the study.  If it was such an important thing to "control how you are measured," then it should have always been in the informed consent document from day one.  Also, it wouldn't be that complicated to have the two doctors speak to each other about how they are measuring things to ensure the consistency they were so worried about.  I technically "withdrew" because they kept trying to schedule my next appointment as I tried to figure out if I could fly there, but I was effectively excluded – not withdrawn.

Also, like Bummedout said, Auxilium will NOT talk to patients beyond the call center.  My study doctor and office coordinator would not give me the name of the Auxilium person running the trial even though I've asked about 5 times (2 years ago and now).  They will only take what I say and then communicate a version of that to Auxilium.  So, things got lost in translation between what I said to them and what they said to Auxilium.  I actually don't even know if Auxilium is running the study or if it's a CRO (contract research organization) like many pharma companies use.  So, my doctor's office just emailed "can he move to another office?" and they emailed back "no."  It was never escalated or discussed with other people.

When my study coordinator asked recently if I could get the real drug - they wrote back in 2 hours with the answer being "no - he dropped out" - there was no consideration or review of the situation of how much I actually completed.  And, I didn't drop out - I was forced out (effectively terminated because I was not going to go to the last 2 visits anyway - I just gave them notice as a courtesy).  I offered to continue with doctors in my local area.  I explained that I gave up a year of my life to be off pentox and traction (only to get the placebo).  I explained how this disease basically ruined my life...and on and on.  Was that communicated to Auxilium?  No.  The research director at my site typed the email while I was on the phone – it probably just said "can we give him the drug" and they checked their excel file and said "no."  There was no consideration of the situation here.  I cannot contact them directly because my study center won't give me any of their names.

"I've called them up once only to talk with some woman who I can only describe as an arrogant robot.   She wouldn't answer any of my questions and wouldn't put me through to anyone else who could. "  -- Bummedout.  Yeah, this is exactly how they are in the call center.  I tried talking to them for over two years.  I called them when I was thinking about switching offices and for side effect questions.  They just ask you for your name, address, phone number, and some other stuff - then tell you that they can't help you and hang up.  And, they are rude about it most of the time.  It's useless to even call them.  I think they are only there because of a legal requirement to document adverse events.

I'll write more later.  There's a lot more to say - from other patient's too.  Thanks for keeping the forum sponsor free, Hawk.

Hawk

Exo,

I sent you a PM about some off topic issues.

Please clarify what part of the study they would not let you complete at another study site if you in fact received all the scheduled injections?

Hawk
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

Jonbinspain

Exo;

It probably won't get you much further with these call centre people, but you might want to ask them if they understand the meaning of the word Auxillium - it's Latin and means assistance - which they don't seem to be providing any of!.

exo

Quote from: Jonbinspain on March 25, 2013, 08:54:45 AM
ask them if they understand the meaning of the word Auxillium - it's Latin and means assistance - which they don't seem to be providing any of!.

lol - I didn't know that.  

Hawk - I missed the 42 and 52 week measurement and vital signs.   However, I was at the 24 and 33 week follow ups and also measured at the start of every cycle.  They collected plenty of data from me that can be used.

Hawk

I consider that an outrage on their part.  I have no idea what it would cost in effort or money to give you the injections after you gave yourself to be impaled with a placebo for their research but I would probably make it my new life's cause to see that I cost them far more in money and effort for not doing it.

In the meantime, I would also go post on the forum they sponsor.

Hawk
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

exo

I couldn't find their forum...can u send it to me on PM?  All I found were their employees talking about it... a little shocking

Auxilium - Cafepharma Message Boards

The letter I wrote is at the bottom of the thread (if you are using the default setting).  

MattFoley

exo, in the State of California, I can go into small claims court and instead of asking for money or in conjunction with asking for money, I can ask for "injunctive relief". Injunctive relief is an order compelling the defendant to do something. In your case, you could force Auxilium to give you the real injections. If it comes down to court, that is your cheapest strategy.

Check into that as an option.

Got Testosterone?

ComeBacKid

I think everyone is in it for the money, but there comes a point when your making lots of money and you have a choice to do the "right" thing, not keep taking more and more and more when it costs you little or nothing...  There are times when making money come in direct contradiction of doing business, like a health insurance denying a claim to show a bigger profit, these ethical decisions come up everyday, the best way to handle it is to put yourself in the other persons shoes, seems like a lot of egotistical people in our country can't seem to do that.  Auxilium should be more than willing to extend a hand to us and work with us, but of course they don't have to be nice...


funnyfarm

I was reading comments from employees posing on the forum exo linked to.   It sounds like a poorly managed company.  Here is a typical post:

"What a sleazy, lying, unethical organization this is. The FDA will get us eventually and we can all kiss our jobs good-bye. The products suck, the management sucks and so do most of the reps."

I make it a habit to avoid dealing with companies that have poor worker moral.   Disgruntled workers = bad service and poor products.   I hope I am proven wrong, but I don't think I will consider Xiaflex until it has a proven history showing it is safe and effective.

Exo I would hate to see you get stressed out about this to the point that it effects your health.  Do what you feel is right, but remember life is short and we have to choose our battles wisely.
When you are in tune with the unknown, the known is peaceful.

exo

I forgot to mention, in all of this, they switched doctors on me at the start of the study.  I was initially screened and measured by Dr. 1 and then a month later Dr. 2 took over.  So, there's yet another reason why this "switching doctors" excuse doesn't fly.  In fact, my initial consent form has the first doctor's name on it.  Then, they switched doctors.  When I had to move and asked to switch doctors, the rules changed.

Skjaldborg

At this point, your best bet is to explore legal options. There's not a whole lot we can do about it here on the forum. I can ask some of my attorney friends to recommend what type of attorney would handle this. I can PM you their answers.

Best,

Skjald

exo

Quote from: Skjaldborg on March 27, 2013, 02:31:39 PM
At this point, your best bet is to explore legal options. There's not a whole lot we can do about it here on the forum. I can ask some of my attorney friends to recommend what type of attorney would handle this. I can PM you their answers.

Best,

Skjald

The main point is to get a reply and to expose their behavior in this situation (not much different than most open letters) and I will expose some other information that they are not going to like if they continue to ignore me, as they have since since March 18.  I haven't replied to any of the posts about lawyers in the open board because I can't, but you can PM me about it.  I have information from molecular biologists and photos from other patients that are a far worse threat to them than a lawsuit anyway  (all non-confidential but conveniently hidden). All i want is a phone call which costs them nothing.  Being ignored and being denied the drug are two separate things - and right now, being ignored is far more inexcusable given the amount of time, money, and discomfort I went through to end up in the placebo condition.

MattFoley

exo, do you live in a state where "injunctive relief" is available? If so, you have your solution. Obviously going after these guys here or calling them all day long is a dead-end.

Got Testosterone?

DO

This study also restricts Gay men ...as if penis deformity is their own fault! It based on vaginal sex penetration response questions!
Well sex is sex and a penis does not know what it is in. It is so unfair. They maybe be working another trial with use of traction device...but it is still undecided as far as I know.
Big pharma rules... and they get away with it.  

exo

I want to update everyone on this.  I was contacted by the head of clinical trials (CC the head of compliance) - so I have gotten through to actual Auxilium employees for the first time in 2 years.  All I was told was that they would look into it in a letter that was very polite.  This contact was on April 1.  So, two weeks have gone by and I have not heard anything at all.  The good news is that human beings (other than their awful call center - which is outsourced to Medcomm and not AUXL employees - which finally explains why they are so awful) are looking into this situation.  However, I am not sure why nothing has emerged since I called initially on March 18.

The drug is FDA approved.  One thing I wonder is why they can't they just give 8 vials to a urologist who is properly trained, ask me to sign a waiver that I won't sue them if anything goes wrong, and then that's it.  It's just "off label" now - and many drug companies give their drugs away for free for a variety of reasons.  So, I am not sure what there is to look into.  If they do get my data from the clinical trial site I was at, they will see it is pristine - I never missed a session or was outside of a time frame.  Also, even if their open label trial enrollment for the placebo subjects is ending, they can still enroll me and just not use my data - since they want to end that study by the summer & analyze the data (and I would take longer to treat than the other placebo people who enrolled in the open label in the fall, that I didnt know about since my study center never called me).   I have given them data for 8-9 months in this trial - never missing an injection or being outside the window for a session.   These were very invasive & personally intrusive procedures that were carried out on me.  As people in the trial know, we had over 20 penile injections, x-rays, and ultrasounds. I also had numerous blood tests. So, this was not a trial for tylenol or even gleevec (and in the case of Gleevec, a chemo drug, patients in the "placebo" condition were put on the next best drug - which was NOT the case here.  We had to stop Pentox, which worsened my condition).  I know this isn't cancer, but I still think some people have lost sight of the proportionality here.  Did I miss the last two visits? Yes.  But, do you know what was done to me in the other 20 visits?  Things that I wouldn't do to my worst enemy.

DO - I will respond to you and make some other comments that this got me thinking about.  I think I read on here (or heard somewhere) that this restriction was due to the FDA.  Auxilium didn't have a problem with it, but the FDA required it to be considered "medical" since the only reason someone has an erection is to put it in a vagina and have kids.  Otherwise, it's just a cosmetic occurrence. (I'm being sarcastic - but this is how the FDA sees things...and potentially how insurance companies do too).  There were numerous surveys about sexual performance (vaginally) in the study, since that's the only government sanctioned use of an erection.  I wonder if gay men were excluded from the trials of viagra, etc... I wouldn't be surprised.

The bigger problem is that Auxilium excluded people with an hourglass deformity, which is extremely common, and my guess is that it will be used on plenty of patients with hourglass deformities (to unknown benefit but known risk).  By excluding people with hourglassing and calcification, it also stacks the results in their favor.  So, the improvement they saw was the improvement with the best possible patients...which is not necessarily the "average" Peyronies Disease patient.  

On the other hand, the injection technique used in the study was questionable, given the size of the molecules involved (both collagen and collagenase are huge).  When it is injected properly, collagenase will dissolve some collagen, but it does not go very far.  It certainly does not "spread through the plaque" as some doctors ("mistakenly") told their patients.  It cleaves the collagen molecules right next to where it was injected - and "dies out" (denatures) shortly.  Also, it is NOT selective for collagen in scar tissue (again, another bending of the truth I've heard over and over).  Plenty of patients had blood blisters due to their capillary walls being dissolved.  In one patient, this left a permanent scar - lighter than the surrounding skin.  I have his photos too (so I cannot be accused of lying or defamation).  Anyway, just wanted to give everyone an update.


exo

They said no - in a letter that was basically written by a lawyer and signed by a doctor, based on how it was worded.  No doctor writes "The North City Urology Center ("The Center")" in any context I have ever seen.  Also, they combed though all of my interactions (over 100 hours and 9 months and managed to find a single quote where I said I might not do the next trial.)  Then, they made up a number of things, including some fact that that I was offered to skip some of the final visits (I have no memory of this or email of it anywhere).  And, their final decision came down to "standard operating procedure" which is just BS.  They can just as easily give me the drug off label.  The person who signed it (James Tursi) makes 1.2 million a year - which is astounding given how awful the study was designed.  I don't have his email address, so my (totally sarcastic) reply is here.

-

Thank you from the bottom of my heart for your "kindest regards" expressed in your letter.  I have no doubt that you sincerely did everything you could possibly do to help me get this medicine, after your company was responsible for sticking 20 needles in my dick for 9 months filled with a placebo, while I worsened due to your study requiring me to be off pentoxifylline.  It was clear that every quote you selectively pulled out of the thousands of correspondences I had with [urology office] from 9 months of study participation was in-context and representative of actual events.  I can see you (and your legal staff) clearly worked hard to find a balanced view as to the circumstances around my study withdrawal, so you could deny me the drug with most ethical standards possible.  You even managed to save time by ignoring every single statement, fact, and suggestion I made in the several pages of letters I sent in.  Thank god you did not waste your time with any of the drivel I was spewing.   I am sure that someone who makes 1.2 million dollars a year (while virtually every field employee hates his job at Auxilium) must have the deepest regard for other human beings.  And, your concern is touching.  Also, never bothering to call me to work out any kind of other arrangement (e.g., partial enrollment in the study, off label use) speaks to your highly efficient use of time and deep concern for my telephone battery life – for which I again thank you sincerely.