My Letter To Pharma Medica...

[dbzfan]

Never doing a study HERE AGAIN!!!

...& telling everyone I know in the midwest to do the same.

To whom it may concern...

1st of all, I've been regularly doing 4-6 clinical trials a year for the past 14 years..
With that said, I understand that different facilities have different protocols; I'm used to it..this is why I have been successful at doing clinical trials for so long.
Every facility is going to have it own unique rules/modus operandi/etc but there are also things that are uniform with all the various facilities I've been to, with that said I was impressed with the screening process... but after that, the great staff, & excellent cuisine it all goes downhill from there...

This isn't a letter to complain about the TV stations or the bad internet, I don't care about that petty stuff... sure that stuff sucks... but I can deal with all that, I'm a professional.. the confinedness & lack of space SUCKED... being almost 40 years old (other facilities have a '35 & over get a priority bottom bunk' rule) & having to climb a top bunk SUCKED. Being waken up at 4:30am everyday to do ONE procedure & not being able to go back to sleep until 7am (the next procedure), that sucked too.. But I'm a professional & I can't deal with it... I'm not at home, I don't expect it to be comfortable like home... so I don't whine & cry, I'm there to do a JOB.. so I conduct myself like a professional... ask STEVE who works there, he said so.. several times!

My issue is THIS, I did a study there for $5500... I screened 3 times for the study... THREE. Passed ALL THREE SCREENINGS with flying colors. The reason for the multiple screenings was because the drug which came from Switzerland or Amsterdam or somewhere was held in customs for months allegedly. They told us to comeback & screen & had NO study drug but didn't tell us this... so I wasted my time & money screening... the 1st screening when they postponed the study they compensated us for travel... I did NOT get compensated for the 2nd trip... & the 3rd time (I was called last minute) was the very day BEFORE check in...

So I passed the screening OF COURSE & was admitted for check in the very next day. I stayed the 1st 10-11 days of the study & everything went as it should have; we received $1000 of the money we were owed. I check in the next week, right before dosing they tell me that they found some elevated enzymes & for that reason they could not dose me because THE DOCTOR didn't think it was safe. They said that the DRUG was KNOWN to do this.. Ben informed me I'd be compensated for TRAVEL, what I was owed for the 1st 10 days, & extra whatever... of course he refused to tell me what money I was going to get in an exact dollar amount (obviously for fear of me acting out or soing like that...) he kept avoiding it, then he said he'd tell me over the phone.. & of course when he called he conveniently left out the travel money that he originally spoke of. He was very snappy & condescending, acting as if I had no right to question the amount of money I was supposed to receive.

Now, this has happened to me on a couple of RARE occasions in the past; what USUALLY happens (in every other place except Pharma Medica that is) is that they keep you for observation to make sure you are 'ok' whether it's overnight or for a week. Of course you get your FULL COMPLETION money due to the fact that you complied with everything... YOU took the experimental drug that RAISED your enzymes & you are being COMPENSATED because their experimental drug did this to YOU. I screened 3 times... 4 times including check in... NOTHING is wrong with my enzymes.. I take the drug, check in & my enzymes have raised... by the way, no screening labs were taken at the 1st checkout.. fyi.

Two days later I screened at another facility & of course nothing was wrong with me... so I check in 2 & a half weeks later.. & I'm doing that study right now. NO PROBLEMS.
Now, I wasn't even going to write this letter.. but Ben had to make it personal: Last week he calls me & asks me to come back &/or waste time & money going somewhere doing some labs for him... because "we took your labs right after check in, so we need to make sure you're healthy..." or soing like that. What a JOKE! If you were concerned about that you would have kept me for observation & PAID me... it's THAT simple. But saving a few thousand dollars is obviously more important, so I'm discarded like a piece of garbage. So I told him 'NO'. Then I asked him again about my check... he told me it would be mailed on the 5th & that there was NOTHING I needed to do... he LIED.

I just called Pharma Medica, my check was NOT mailed... In fact they were told to HOLD it. I've already had to wait ALL this time for my check which is it's bad enough that it's $3000 short of what it should be ALREADY (in my opinion), now I have to wait EXTRA time... time that my BILLS are accumulating. Now, being a man of my life experience (especially in the study world), I confirmed with Ben on 4 to 5 different occasions that my check would be sent on October the 5th: the 1st time I did so FACE TO FACE after Paris & I tracked him down right before I was discharged. She was a witness! The 2nd & 3rd time when he called to tell me I was getting only $1800... at the beginning of the call & at the end, & then TWICE when he called me to request that I do labs again FOR FREE... I was going to let everything go, but BEN impeding my payment.. that's PERSONAL!!!

However, I had already decided I would NEVER do a study there EVER again, only a $3000 check & a written apology could change my mind, but that's not going to happen. I have friends who go there & want things to improve there for THEM, but they soon will probably disue doing studies there as well if this type of treatment keeps happening. If you want people like myself who Steve called "a model subject" & "courteous" & "a total professional" to not want to do studies at your facility... then turn a blind eye & let these shenanigans ue. But I act like a professional & feel like I should be treated that way. I'm not asking to be treated special... just treated with respect.

Sincerely...

[puntkicker]

Oct 13, 2016 14:14:02 GMT -5 dbzfan said:

Never doing a study HERE AGAIN!!!

...& telling everyone I know in the midwest to do the same.

To whom it may concern...

1st of all, I've been regularly doing 4-6 clinical trials a year for the past 14 years..
With that said, I understand that different facilities have different protocols; I'm used to it..this is why I have been successful at doing clinical trials for so long.
Every facility is going to have it own unique rules/modus operandi/etc but there are also things that are uniform with all the various facilities I've been to, with that said I was impressed with the screening process... but after that, the great staff, & excellent cuisine it all goes downhill from there...

This isn't a letter to complain about the TV stations or the bad internet, I don't care about that petty stuff... sure that stuff sucks... but I can deal with all that, I'm a professional.. the confinedness & lack of space SUCKED... being almost 40 years old (other facilities have a '35 & over get a priority bottom bunk' rule) & having to climb a top bunk SUCKED. Being waken up at 4:30am everyday to do ONE procedure & not being able to go back to sleep until 7am (the next procedure), that sucked too.. But I'm a professional & I can't deal with it... I'm not at home, I don't expect it to be comfortable like home... so I don't whine & cry, I'm there to do a JOB.. so I conduct myself like a professional... ask STEVE who works there, he said so.. several times!

My issue is THIS, I did a study there for $5500... I screened 3 times for the study... THREE. Passed ALL THREE SCREENINGS with flying colors. The reason for the multiple screenings was because the drug which came from Switzerland or Amsterdam or somewhere was held in customs for months allegedly. They told us to comeback & screen & had NO study drug but didn't tell us this... so I wasted my time & money screening... the 1st screening when they postponed the study they compensated us for travel... I did NOT get compensated for the 2nd trip... & the 3rd time (I was called last minute) was the very day BEFORE check in...

So I passed the screening OF COURSE & was admitted for check in the very next day. I stayed the 1st 10-11 days of the study & everything went as it should have; we received $1000 of the money we were owed. I check in the next week, right before dosing they tell me that they found some elevated enzymes & for that reason they could not dose me because THE DOCTOR didn't think it was safe. They said that the DRUG was KNOWN to do this.. Ben informed me I'd be compensated for TRAVEL, what I was owed for the 1st 10 days, & extra whatever... of course he refused to tell me what money I was going to get in an exact dollar amount (obviously for fear of me acting out or soing like that...) he kept avoiding it, then he said he'd tell me over the phone.. & of course when he called he conveniently left out the travel money that he originally spoke of. He was very snappy & condescending, acting as if I had no right to question the amount of money I was supposed to receive.

Now, this has happened to me on a couple of RARE occasions in the past; what USUALLY happens (in every other place except Pharma Medica that is) is that they keep you for observation to make sure you are 'ok' whether it's overnight or for a week. Of course you get your FULL COMPLETION money due to the fact that you complied with everything... YOU took the experimental drug that RAISED your enzymes & you are being COMPENSATED because their experimental drug did this to YOU. I screened 3 times... 4 times including check in... NOTHING is wrong with my enzymes.. I take the drug, check in & my enzymes have raised... by the way, no screening labs were taken at the 1st checkout.. fyi.

Two days later I screened at another facility & of course nothing was wrong with me... so I check in 2 & a half weeks later.. & I'm doing that study right now. NO PROBLEMS.
Now, I wasn't even going to write this letter.. but Ben had to make it personal: Last week he calls me & asks me to come back &/or waste time & money going somewhere doing some labs for him... because "we took your labs right after check in, so we need to make sure you're healthy..." or soing like that. What a JOKE! If you were concerned about that you would have kept me for observation & PAID me... it's THAT simple. But saving a few thousand dollars is obviously more important, so I'm discarded like a piece of garbage. So I told him 'NO'. Then I asked him again about my check... he told me it would be mailed on the 5th & that there was NOTHING I needed to do... he LIED.

I just called Pharma Medica, my check was NOT mailed... In fact they were told to HOLD it. I've already had to wait ALL this time for my check which is it's bad enough that it's $3000 short of what it should be ALREADY (in my opinion), now I have to wait EXTRA time... time that my BILLS are accumulating. Now, being a man of my life experience (especially in the study world), I confirmed with Ben on 4 to 5 different occasions that my check would be sent on October the 5th: the 1st time I did so FACE TO FACE after Paris & I tracked him down right before I was discharged. She was a witness! The 2nd & 3rd time when he called to tell me I was getting only $1800... at the beginning of the call & at the end, & then TWICE when he called me to request that I do labs again FOR FREE... I was going to let everything go, but BEN impeding my payment.. that's PERSONAL!!!

However, I had already decided I would NEVER do a study there EVER again, only a $3000 check & a written apology could change my mind, but that's not going to happen. I have friends who go there & want things to improve there for THEM, but they soon will probably disue doing studies there as well if this type of treatment keeps happening. If you want people like myself who Steve called "a model subject" & "courteous" & "a total professional" to not want to do studies at your facility... then turn a blind eye & let these shenanigans ue. But I act like a professional & feel like I should be treated that way. I'm not asking to be treated special... just treated with respect.

Sincerely...

Ben's last name must be "Dover", as he sounds like a jerk the way he treated you. Between this post and Vark's review, it sounds like this is a place to avoid!

I'm not an expert, but you may wish to copy and paste this epic post, edit as you see fit, and then send it to the review board and wherever else you think may make a difference either to you or to them. It would be nice if we could send a message that things like this will not be tolerated. I have half-jokingly mentioned "unionizing" in a post before. I hope I didn't put my name on a hit list(not to be confused with a simple blacklist, lol). Ive also shared my thoughts about the illegal IRS seeming even more out of place than the usual income tax(never ratified) by directly taxing human bodies. It's not the money with me but the principle.

I encourage folks to think big and not just accept what theyre first given. Hopefully someone else here can add some actions that may benefit you. I wonder if this is the type of discussion that happened before the Spaulding discussion area was banned, people simply speaking the truth to help fellow study participants? I wish if anyone is still alive from that time(I notice the half life of most members here is incredibly short!!) that they'd either post or PM me what the heck happened. I want to know what's so seedy about Spaulding.

Anyhow, thank you for contributing useful information to the site, we very much appreciate it! I hope others will reply to you as well.

[dbzfan]

Oct 13, 2016 21:12:56 GMT -5 puntkicker said:

Ben's last name must be "Dover", as he sounds like a jerk the way he treated you. Between this post and Vark's review, it sounds like this is a place to avoid!

I'm not an expert, but you may wish to copy and paste this epic post, edit as you see fit, and then send it to the review board and wherever else you think may make a difference either to you or to them. It would be nice if we could send a message that things like this will not be tolerated. I have half-jokingly mentioned "unionizing" in a post before. I hope I didn't put my name on a hit list(not to be confused with a simple blacklist, lol). Ive also shared my thoughts about the illegal IRS seeming even more out of place than the usual income tax(never ratified) by directly taxing human bodies. It's not the money with me but the principle.

I encourage folks to think big and not just accept what theyre first given. Hopefully someone else here can add some actions that may benefit you. I wonder if this is the type of discussion that happened before the Spaulding discussion area was banned, people simply speaking the truth to help fellow study participants? I wish if anyone is still alive from that time(I notice the half life of most members here is incredibly short!!) that they'd either post or PM me what the heck happened. I want to know what's so seedy about Spaulding.

Anyhow, thank you for contributing useful information to the site, we very much appreciate it! I hope others will reply to you as well.

Yeah... the next step is contacting the IRB.. & left my study info from Pharma Medica at home... I called them yesterday to get the IRB number & they basically used stalling tactics...taking my number saying a 'supervisor' will call me...BS. I still have NOT received my check... I'm going to get paid from THE study I'm NOW before I paid from the Pharma Medica study I finished WEEKS ago... SMH.

[puntkicker]

That sounds terribly unethical on their part. I can't say for certain, but if you keep calling enough to really annoy them, maybe they will get tired and take action?

Maybe I can get you an assist: Will someone who's done a study there give our friend the contact info for their IRB ASAP? Thanks

I'm not sure if soing as basic as better business bureau complaints would help as well, but if it were me I'd try to think of every angle possible of seeking justice with someone who refuses to play by the rules... especially knowing big pharma mints money and these clinics are raking in a portion of it.

Hopefully some more experienced people will weigh in. However, if you want a much larger audience, I'd suggest posting soing in the general or healthy studies areas, where the odds of a response would be better.

[travelingrat]

i'm at a library computer and don't have many minutes left, but I wanted to add that I think you should also send the letter on to the sponsor.

I know other volunteers who have contacted sponsors who DID respond, and actually helped, and were often shocked by what REALLY goes on in clinics. you can always say that the clinic treats volunteers badly and they should consider taking their business elsewhere, etc etc.

the IRB is a crap shoot but I also strongly recommend your contacting them. you will probably get the runaround but BE PERSISTENT. I have talked to a number of IRB's over the years. they are usually useless, but sometimes will help.

the contact info for the IRB should be on one of the back pages of your consent form.

I would also KEEP A WRITTEN LOG from this point on. every time you talk to someone on the phone, write down date and time and whom you talked with. if you still have the numbers and dates under "recent calls" or whatever in your phone memory, try to save those or at least write down dates and times.

i'm out of time. your letter brings up certain basic issues that come up time and again in our line of work. the cards are NOT stacked in our favor and there is really no reliable watchdog looking out for us.

again, I strongly urge you to contact the sponsor.

thank you so much for sharing this info with us, sad and outrageous as it is. I wish you the very best and my thoughts are with you (not that that is any help, but hey).

oh, and yes, I would contact the Better Business Bureau also as puntkicker suggested.....anyone you can think of, in fact. from traveling rat

[dbzfan]

Oct 15, 2016 12:50:18 GMT -5 travelingrat said:

i'm at a library computer and don't have many minutes left, but I wanted to add that I think you should also send the letter on to the sponsor.

I know other volunteers who have contacted sponsors who DID respond, and actually helped, and were often shocked by what REALLY goes on in clinics. you can always say that the clinic treats volunteers badly and they should consider taking their business elsewhere, etc etc.

the IRB is a crap shoot but I also strongly recommend your contacting them. you will probably get the runaround but BE PERSISTENT. I have talked to a number of IRB's over the years. they are usually useless, but sometimes will help.

the contact info for the IRB should be on one of the back pages of your consent form.

I would also KEEP A WRITTEN LOG from this point on. every time you talk to someone on the phone, write down date and time and whom you talked with. if you still have the numbers and dates under "recent calls" or whatever in your phone memory, try to save those or at least write down dates and times.

i'm out of time. your letter brings up certain basic issues that come up time and again in our line of work. the cards are NOT stacked in our favor and there is really no reliable watchdog looking out for us.

again, I strongly urge you to contact the sponsor.

thank you so much for sharing this info with us, sad and outrageous as it is. I wish you the very best and my thoughts are with you (not that that is any help, but hey).

oh, and yes, I would contact the Better Business Bureau also as puntkicker suggested.....anyone you can think of, in fact. from traveling rat

Thank you sir... I didn't think of that (sending this letter to the actual SPONSOR...) I will do that, thanks...
Thanks for the other helpful tips you gave.. I'll keep you guy updated as this situation develops.

[humanpincushion]

I screened for that one twice. So glad I passed up on the third invitation to screen.

[dbzfan]

Oct 17, 2016 7:40:54 GMT -5 humanpincushion said:

I screened for that one twice. So glad I passed up on the third invitation to screen.

Be glad...

Also if you don't like a bunch of animals acting overly aggressive, petty, & belligerent... you'll also be glad you passed this study up.



P.S.

I'm a young Black male from a gang banging family, BTW.
So yes... I know 'animals' because I grew up surrounded by them.

[dbzfan]

Several weeks ago I finally found the IRB contact info... today they just sent me a BS response:

"Re: Teva Pharmaceutical Works Private Limited Company, Protocol number 2016-4130

Dear Mr. ...... :
At the convened meeting held on 14 November 2016, the Board reviewed your correspondence dated 11 November 2016. Upon receipt of additional information from the Investigator, the Board has determined that the Sponsor has compensated appropriately for the portion completed as indicated in the Informed Consent Document (ICD), page 11, “If you do not complete the entire study for any reason (e.g. dismissed. cancellation of the study), your compensation will be reduced and you will be compensated only for the parts of the study you have completed”.
If you have questions, or if we can provide further assistance, please contact our office at [phone] or at [e-mail].
Sincerely, ..."

To which I replied:
"...right,
& you guys are just going to diegard my payment being withheld for over a month. Please don't contact me again."

[franz]

What do you actually think the clinic did that violated the terms of the consent? Are you able to state that concisely? Was your letter to the IRB as nuts as your first post in this thread? Did you tell them how awesome you are 50 times?

And people, the Better Business Bureau, a private organization mediating disputes between merchants & customers (& without much influence when the merchant isn't a paying BBB member), has no relevance to these situations at all. Please stop wasting people's time by telling them to go crying to the BBB.

[puntkicker]

It wouldnt take the person that long, and it obviously isnt the first line. I just figured hit in as many ways as possible. Many would take the same attitude as yours and say also skip the IRB who is paid by the clinic and cross your fingers with the sponsor or your religious leader. If it were me, I'd likely go for all of the above, and possibly more. However I am not telling anyone else what to choose to do, just what I'd consider if I felt wronged.

[travelingrat]

i did have a friend who had serious issues with the old New Jersey Celerion and contacted everyone under the sun. she did contact the BBB and a complaint was registered that showed up on the BBB website. since that clinic has been closed for over 2 years, i don't think you can access it any more.

but why not go full throttle? there are so few ways to call attention to our grievances.

if so many of us were not always struggling with money, clinics could not get away with all that they do, because we would do soing else. but now, there are always others willing to sign up if we don't.

[franz]

BBB pages for businesses allow "consumer reviews," which I doubt the BBB even reads. Spaulding, for example, has an A+ rating with the BBB, but as only one (very negative) consumer review has been left--by a study volunteer, not a "consumer"--they have a 100% negative consumer review rating. That rating is not even viewable unless you click on the A+ however, and as Spaulding is listed as having zero complaints against them, it obviously doesn't count as one. Leaving reviews like this is not "complaining to the BBB" in the usual, or in any meaningful, sense.

So if you want to give clinics some almost invisible negative publicity, sure, ignore that you aren't a clinic's "consumer" in your role as a volunteer and leave a review there. But all references to making complaints to the BBB that I've seen on this forum imply the BBB might take an interest in advocating for you against the clinics. Nope.

I love explaining the obvious...

[travelingrat]

in the past i have complained to IRB's and the FDA, to no avail. if i am going to complain to them, i figure, why not also complain to the BBB? at least i will have voiced my dissatisfaction in all ways that i can think of. maybe the BBB sends the clinic a notice that will irritate someone, who knows..

NO ONE seems to take an interest in advocating for volunteers.

my friend did have some luck complaining to sponsors, but that was after she had already left the clinic so it didn't help her much. but at least she got a good response. maybe it helped someone in the future.

i wish that the sponsor's phone numbers were on our consent forms instead of the IRB's. the sponsors seem to usually have very little idea what volunteers go through, yet everything rests on us..

[franz]

Study coordinators & many other clinic bureaucrats tend to be nurses. It's very easy to get the attention of a nurse.

www.ncsbn.org/filing-a-complaint.htm