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Author Topic: Report on PDLabs and Topical Verapamil  (Read 23838 times)

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ComeBacKid

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Report on PDLabs and Topical Verapamil
« on: June 13, 2006, 05:58:31 PM »

PDLabs Report

Introduction

I have used PDLab’s product Topical Verapamil myself as many of you guys have as well.  I have dealt with PDLabs now for months, and have tried both generic topical verapamil, and PDLab’s topical verapamil.  I’ve had many telephone conversations with PDLabs personnel, and with Will Sheppard.  I’m left with contradictory, and disturbing evidence, and lay out all the facts as I know them in this report. 

PDLabs

Let me first just say that I’ve tried both generic verapamil and verapamil compounded by PDLabs.  Verapamil will dialate your blood vessels causing increased blood flow, this can cause your penis to hang bigger in the flaccid state.  When this occurs your corpus cavernosum is spongier with blood, and may cover up your plaque more, this will make your penis feel soft, and lead some to believe their plaque is being broken down when in reality it’s just being covered up temporarily.  This is what topical verapamil will do most surely.

When I first ordered topical verapamil from PDLabs they sent along some literature that said after 30 days you should notice a softening of collagen.  Of course this never happened.  When I called and talked to Brad he informed me that it takes about 3 months before you see any real effect and softening of the plaque.  He also said curvature is the last thing to be cured.  Other people have stated they went 3 months with PDlabs and were told to double the dosage at the cost of PDLabs supplying the extra dosage.  This then turned into 6 months, and eventually a year.  So on PDLab’s original literature they say 30 days and a softening of the collagen should occur (Will Sheppard also states this).  However if you call them they will tell you that you need to be on the medicine at least 3 months before you see any results or softening of the collagen.  This is contradictory to their own studies, especially their first published study of 214 patients.  This study was only done for 1 to 6 months, meaning some patients in the study did 1 or 2 months of the medicine, some did 3, and some did 4,5, or 6 months.  71.4% saw reduction in curvature and 86.5% had an improvement in erection quality and rigidity.  The second study had very high results as well claiming to have gone on for 1 to 12 months.  In their comparison study, patients were treated for only 3 months and reportedly 90% saw improvement in curvature.  Plaque decreased in 91.7% of patients.  This study was done for only 3 months!  It definitely seems as if PDLabs changed their time frame for the drug to work. Keep in mind PDLabs states that a softening of the collage should occur after 30 days(well they used to state this now they changed it to 3 months), and a softening of the collagen is just the beginning of results, they claim that reduction of curvature takes longer.  So in the study done for 3 months those patients saw a a significant reduction in curvature, meaning they would of seen a softening of the collagen much sooner.  However now PDLabs is telling people and myself that a softening of the collagen only occurs after about 3 months, this contradicts their own study they have published.

During the course of my investigation I talked to two different people that didn’t know each other.  The first person told me he knew that there was a study done by a pharmaceutical company looking to buy the drug from PDLabs, the efficacy shown from the study was 0.  I talked to a second person who knew one of the doctors involved in the study, he informed me that the doctor who was involved in the study said the efficacy was 0 as well.  Upon questioning Brad from PDLabs he denied any knowledge of any study done by a pharmaceutical company looking to buy their product. I used PDLabs product for 9 weeks applying more than the recomended dosage religiously 2 times per day, in the end I saw absolutely no softening or reduction of my plaque. I also used generic verapamil for 6 months and saw no softening of the plaque or reduction of it.  It was also noted by Brad from PDL that Will Sheppard does not offer the same "formula," of topical verapamil that they do, and that he uses one of their old "formulas."  Basically they admitted to have changed their formula as time passes.

PDLabs Website-  http://www.pdlabs.net/

FDA Trials

When I first spoke to Dallas Dryden in April after first purchasing the product he told me PDLabs was involved in phase 2 trials for FDA approval.  After speaking to Brad on the phone just a few weeks ago he informed me that PDLabs is still trying to raise the $20 million dollars needed to begin phase 2 FDA trials.  There is definitely some conflict here with their stories.

The NIH maintains a website, www.clinicaltrials.gov to provide the public with information about clinical trials for FDA approval.  Section 113 of the FDA Modernization Act requires companies to submit information to clinicaltrials.gov for trials involving serious or life-threatening conditions.  A study can be exempted from this requirement if making it public would discourage patients from enrolling, which could be the case for peyronies disease.  Studies also must be registered with clinicaltrials.gov in order to be accepted for publication in medical journals.  There is no evidence, either on the NIH site or in a journal, that such a study was carried out or is in progress.  Is PDLabs really doing FDA trials?  No one can seem to find this information, it is left unknown.

Other Facts

This drug (Transdermal Verapamil) has been out for awhile now, all along PDLabs has claimed they are gathering information.  The real question is where is this information and why are they not making it available; they could easily do this on their website.  This leads us to another point, there website has not been updated in years, giving the impression they just put it out in the beginning to make sales, and then left it alone.  Other questions that come up is why won’t PDLabs license the product to other pharmacies so we can get our insurance plans to pay for it, they could still make a killing profit this way. There have also been some contradictions involving what exactly topical verapamil will do the to patient's peyronies plaque.  Dallas Dryden originally told me it will turn the plaque tissue into a healthy state, but other people were told it will dissolve the plaque itself. 

PDLabs Lawsuit against Will Sheppard and Dan Sheppard


The civil suit ruling was made by Judge Rebecca Simmons in the 408th judicial district court.  Many people have stated that Will has told them he won his lawsuit.  This is simply not true, indeed he did lose. The ruling was made on August 28th, 2003.  It should be noted that Will Sheppard used to work for PDLabs himself and was their employee.  Brad from PDLabs has stated Will was fired for “unethical behavior,” and “stealing patient records.”  He then went on to report to me he slipped up, and should have not released that information about Will.  Will has stated to me personally that he won the lawsuit against PDLabs.  He has also stated this to others, and after you read this lawsuit summary you will know the truth about Will Sheppard.  Can Will Sheppard be trusted at all anymore?  It should be noted that Will is not a licensed pharmacist.  Brad from PDLabs has told me that whatever Will is selling through Talon, it is not the same formula they have at PDLabs and that legally he is not allowed to sell any TV because of their utility patent.

Rulings

   Will and Dan Sheppard were ordered and commanded to desist and refrain from each and every of the following with respect to confidential information:

•   Using confidential information for his or their own account or purposes, or for the purposes of any other party, or for any purpose whatsoever
•   Disclosing or publishing any confidential information to any third party
•   Making, photocopying, or otherwise reproducing or disclosing any documents or copies of documents containing disclosures of any confidential information
•   Manufacturing, selling, distributing, offering to sell, offering to distribute, promoting, or advertising (by internet website, brochure, print media, electronic media, oral presentation, or mail) any product whose formula or compositions is derived from any confidential information

*It should be noted that “confidential information,” means “the proprietary information that was maintained in PDL’s pharmacy database and was removed on a disk, a copy of which was marked as "Ex.”

•   Audit prescriptions(formula specific) by formula within specified dates; patient profiles (including tax and medical records); prescription daily logs; formulas; prescriptions; single formula details with preparation information; patient lists; patient lists by doctor; patient lists with numbers of prescriptions filled within specified dates; vendor lists; prescriptions filled by date, including cost and selling price; total sales for any specified time periods (day, week, month, year, etc.) and sales-representative sales for any specified time period

   It was also ruled:

•   Will and Dan Sheppard where enjoined and compelled to deliver PDL’s trial counsel all originals and all copies of any confidential information in any and all mediums in which they exist, no later than September 5, 2003

   It was also ruled:

•   PDLabs can recover from and against the defendants the amount of $119,040.00 as the actual damages supported by the evidence

   It was also ruled:

•   PDLabs was also awarded to recover from the defendants an additional amount of $100 as statutory damages pursuant to section 134.005(1) of the Texas Civil Practices and Remedies Code

   It was also ruled:

•   PDLabs was also awarded to recover from the defendants prejudgment interest on the total of the foregoing damages calculated in conformance with the statutory provisions in effect as of the date of this judgment

   It was also ruled:

•   PDLabs was also awarded to recover from the defendants attorney fees in the amount of $130,000, and $40,000 if the event is taken on appeal to the Court of Appeals; and awarded a further $40,000 if the event is appealed up to the Supreme Court of the United States

   It was also ruled:

•   PDLabs was also awarded from the defendants all court costs

Mulhall Study

Dr. Mulhall did a study of patients before going through with penile prothesis surgery.  He had them apply topical verapamil (commercially available/40mg)  the day before the surgery, that night at 10pm, and the next morning at 5am.  Upon the conclusion of the study Dr. Mulhall found that no verapamil was detected in any tunica specimens.  Dr. Mulhal concluded the delivery system simply does not work, and one person has told me through my investigation that after talking to Mulahll in his office, he basically ripped the drug and said it won’t work at all.

Robert L. Talbert, Jerry Easterling and William Fitch III replied with a counter publication.  They basically said the study done by Dr. Mulhall does not provide definitive evidence of lack of verapamil penetration to the tunica, and further studies are needed.  They claimed it takes time to build up a high concentration of the drug. 

Robert L. Talbert’s email address is [email protected]

What will PDLabs tell you if you call them and report no results?

  • People that see results from their drug move on and don't hang out on these forums
  • You need to take the drug longer, if you've done 3 months they'll tell you 6, if you've done 6, they'll tell you 9, if you've done 9, they will tell you 12
  • Double the dosage at their expense
  • They will say the Dr. Mulhall study was not done using their "patented" version of TV, and that is why there was no absorption (they will forget to tell you that they've changed their formula over the years)
  • They will tell you generic verapamil is "crap," and won't work because they have a "patented" delivery system and that no one could know how to make their product like they do (I talked to a pharmacist who told me all the ingredients are on the patent and the formula is known because they only hold a utility patent, they hold no such special mixture patent
  • Your not applying the drug right or allowing it to soak in for long enough, PDLas states on their literature to allow 2-3 hours to soak in, however when I talked to them in person they said the medicine should be left on all day, Will Sheppard however states it only takes 1 hour for the drug to soak in

Conclusion

In conclusion it can be determined that there are many contradictions and unanswered questions in regards to PDLabs and Will Sheppherd and their verapamil products.  This report was meant to inform anyone who has used their product or might in the future, and give them an educated summary about the company and product.

*It should be noted that verapamil costs about $20 to make.  So if Will Sheppard tells you hes giving you a deal at his Talon price of $169 instead of the PDLabs price of $270 hes not, hes just not ripping you off as much as PDLabs.

*It should be noted I have finished my topical verapamil treatment from PDLabs, I was on the gel twice daily for just under three months, however each application I was using more than the recomended dosage, and about the last three weeks I was doing double doses! While on the topical verapamil I saw increased bloodflow and a gain in size, including better erections.  After stopping the topical verapamil gel, the bloodflow, size gain, and better erections, went away and my penis shrunk back to the normal size, the curve remained the same.  I saw the same exact thing happen when I was on the generic verapamil, in conclusion I can state that topical verapamil did absolutely nothing to my plaque, and its efficacy on myself was 0.

Compiled  by ComeBacKid
J also contributed to this report

Please take our topical veapamil survey, whether your supplier is PDLabs, Talon Pharmacies, or another generic brand, click here to take our survey!
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Hawk

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Re: Report on PDLabs
« Reply #1 on: June 13, 2006, 06:14:49 PM »

ComeBackid,

This is an example of what our organization can accomplish when members pitch in as you have done.  I think you have gone the extra mile to research your treatment, dig through the facts, and then make a significant contribution to the Peyronies Disease Community by taking the time and effort to share information.  You raise issues very worthy of our concern.  Though we have heard snipits on these issues, this report consolodates these facts in a significant way. 

As you point out, PDLabs and Will Shepperd of Talon clearly have some significant questions to answer.  I am sure that any reputable company would welcome this opportunity to inform their base and answer these legitimate concerns.

I salute you and J for one hell of a good job. 

Thanks ! ! !
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After pills, injections, VED - Dr Eid, Titan 22cm implant 8/7/18
Hawk - Updated 10/27/18 - Peyronies Society Forums

Kimo

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Re: Report on PDLabs and Topical Verapamil
« Reply #2 on: June 13, 2006, 07:20:26 PM »

ComeBackid,,,i agree with Hawk,,,you have done an excellent job on this..Thank you for all your work..Now maybe more things will fall into place to answer more of the questions that are unanswered.......

Good Job,,,,Kimo
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SteveW

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Re: Report on PDLabs and Topical Verapamil
« Reply #3 on: June 13, 2006, 08:02:03 PM »

Excellent !!!  Good work ComeBackid and J.  This really confirms my Uro's opinion on TV.  Even though he did prescribe it for me he did it ONLY cuz' my insurance would cover it for $30 copay.  Otherwise, he won't prescribe it.  I did a 90 days, twice a day blah, blah, blah.  It did exactly what he thought it would, nada.  Still cost me $90 total, but a hell of a lot cheaper than buying it at full boat.  Thanks again.
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It takes guts to deal with Peyronies Disease.  Almost a 90 degree curve, hourglass effect, VI series & lots of ??

Fighter

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Re: Report on PDLabs and Topical Verapamil
« Reply #4 on: June 14, 2006, 10:20:55 AM »

ComeBackid & J,
Wow! You really did your homework on this! But now you got me thinking if TV is worth the money? My insurance company pays for about 60% of it... I have been using it for about 2 1/2 months now and I really haven't seen that much improvement. There has been some improvement in the pain maybe about 60% from before treatment. That could be just Peyronies Disease running it's course? Not sure... No change in curvature... Maybe a little change in plaque? Hard to tell some days feel better than others? I also started ALC last week and have seen no change as of right now. My erection quality seems to be getting worst but again some days better than others. Lately in the past couple of weeks my Libido seems to be very low which in the past 10 months with Peyronies Disease it was fine. Not sure why this is happening now? Do you have any suggestions? I am going to be calling PDLabs next week and relating them my info and see what they tell me what to do as far as increasing the dose or keep on doing the same dose. I got a feeling they will be telling me to increase. Do you think I should mention your report to them or will they read it on this form? This disease is very confusing and frustrating and it seems that nobody can get a handle on it including the professionals.


Good Job!

PDLabs Report

Introduction

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zigwyth

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Re: Report on PDLabs and Topical Verapamil
« Reply #5 on: June 14, 2006, 10:26:37 AM »

Great Job ComeBackid and j. I wished I would have had this knowledge before I paid all that money out of pocket for TV. I will participate in the poll. I will however continue to use TV until I'm out of tubes. Have finished about 3 1/2 months so far. I will then contact my Urologist with my results and your findings. Again, I want to make it clear that my Urologist(the 3rd one) was the only one to admit lack of knowledge about this Peyronies Disease but was and is willing to try anything.
Thanks
Zig The Twig
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j

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Re: Report on PDLabs and Topical Verapamil
« Reply #6 on: June 14, 2006, 01:11:53 PM »

There do seem to be a lot of unanswered questions about TV and one of them certainly is - does it work at all, ever? I can't discount the possibility that it has worked for many guys who then simply moved on, forgot about Peyronies Disease and never posted on a forum.  That's what my urologist was saying when he prescribed it, but I came to doubt that claim.

Maybe a poll would, over time, arrive at the truth.  What we need is for guys to be participating in this forum before they start TV, then go on to post their results, good or bad, after a reasonable period of use.



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ComeBacKid

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Re: Report on PDLabs and Topical Verapamil
« Reply #7 on: July 02, 2006, 02:18:01 PM »

I got inspired to do this report after getting different stories everytime I called PDLabs to report no progress.  Also after reading so many guys posts on the BTC and on here who claimed to have no results.  My goal was to bring out the facts as we know them and I know them from phone discussions, and raise questions that are left unanswered. 

The TV survey is up and ready to go, if you've used TV make sure you take that survey!

ComeBackid
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ComeBacKid

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TV Survey
« Reply #8 on: August 05, 2006, 01:22:22 PM »

Hey guys,

The TV survey is up so make sure if you used TV from anyplace whether its PDLabs, Talon, or a generic kind, to take our survey so we can gather the facts and come to a conclusion on the product!  By sharing information with each other we can help weed out ineffective treatments and save $ for each other.

Also once you take our TV survey, please feel free to share your experiences with PDLabs or Talon, or about TV in general.  Did anyone else notice PDLabs changed their literature, the old literature used to state you should see signs of the collagen softening after 30 days, if you buy their product today it will say 3 months.

Check out our survey HERE if you've used topical verapamil!

ComeBackid 
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ComeBacKid

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Report on PDL Labs and topical verapamil survey
« Reply #9 on: February 15, 2009, 02:55:25 PM »

Here is the report on PDL Labs and also the survey topical verapamil.

Comebackid
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