questions during study screenings

[travelingrat]

in general, i have been very disappointed at screenings with the quality of info re side effects, their duration, etc., imparted by the staff.

a few months ago i screened at one of the celerions and asked about the rather severe side effects. the doctor did not even know what i was talking about. he said, "Shall i go find out?" well, duh! when he returned, he said, oh, those side effects were from the animal studies. but right on the forms, the side effects on humans in previous studies, were listed, and that is what i was referring to! one of the side effects listed was "Parkinsonism" and i wanted to find out how long the tremors etc lasted. i never did receive an answer.

recently i screened at one of the unmentionable clinics. there were numerous study side effects listed such as loss of taste, loss of hearing, abnormal hair growth, liver failure! when i asked the screening doctor, he made jokes, for ex., he said, "Oh yes, when you leave the study, you'll have hair on the soles of your feet."

needless to say, i did not sign up even though as usual i have very little money (thank God for good friends!).

i would like to know what other rats experience when you ask questions at the screenings. most rats i have talked to just say, "i don't ask questions, nothing will happen."

since there is no long-term tracking system to make sure we have not suffered side effects once the study has closed (for ex., what if a statistically significant number of participamts in a study developed similar forms of cancer over time), i think we should start asking many more questions. we are NOT expendable!

i would really like to know the views of others on this subject!

[labrat1]

Hi travelingrat
This is labrat1
We did a study together.

This is one thing that I have complained to certain clinics about.

You know what happened to me right? I got ousted for demanding better conditions at one clinic located way south of NJ .
I went as far as writing to the CEO of that entire CRO enterprise after my attempts to talk with the IRB and the management were unsuccessful, and though the CEO did not honor my request that she call me back and talk with me , it seems that the CEO did listen to some of what I said in my letter . She had to because she realized that I brought up some un-refutable points about the bad conditions in the NJ clinic.
Only a few weeks after sending my letter to the CEO did I notice that the website of the particular clinic say that the NJ facility had undergone renovations so as studies can be carried out more efficiently and so that volunteers have better living conditions.

Ultimately I can only find out if it is true if someone puts a post on JALR mentioning that NJ facility and if the facility had changed for the better from what it used to be .

I am still waiting to see some post here on JALR about that.

I am not allowed back in that NJ facility because I tried to tell the management that they have to shape up and stop running such a horrific clinic in which the volunteers are irresponsible because much of the staff allow it and don't care .

The thing is that there needs to be more of us rats contacting the clinic managers and/or study doctors and/or the IRBs and even the Chief Executive Officers of the clinics and letting them know that they do not provide sufficient information about risks of certain study drugs.

And yet, the clinics themselves are businesses and have no incentive to tell the volunteers anything that would result in a lack of rapid enrollment. The clinics essentially try not to answer a lot of questions about the high risks of certain studies.
It seems that certain agencies such as the FDA has to hear from a lot of research participants so that the FDA realizes that this is a wide-scale problem and tries to impalement regulations so that the CROs have to tell volunteers everything about the risks and not just do things like assign un-informed staff to talk with the volunteers so that those particular staff members don't give information because they themselves don't know and honestly cannot answer.

Too many rats complain about dumb things, such as they want to get paid without carrying out the study.

There is a need for intelligent, honest and dedicated rats to contact the people in charge of CROs and research cilincs and in a civilized, educated, but sincere way, let the people in charge know that lab rats are being taken advantage of by the very system and people who need the money are being made to be afraid of asking questions or they will be rejected for the study.



Of course I want to take opportunity here to say that there are certain clinics that say that they are accredited by the AAHRPP (Association for the Accreditation of Human Research Protection Programs (or soing like that)) . Well the AAHRPP is not a government organization and no clinic is required to be investigated by the AAHRPP and when any clinic says that they are accredited by the AAHRPP it is in hope that no one knows that the AAHRPP is like a fake-diploma mill.

Some person must have thought it up because s/he realized that s/he could make money making CROs and research clinics appear to have passed rigorous investigation and appear to have high ethical standards, excellent living conditions for volunteers, and highly efficient and ethical practices by the management and staff.

Ha Ha Ha phooey.

As far as my research into the matter a clinic has to pay the AAHRPP to "investigate" their facility and their practices.

A CRO or clinic has to contact and assign the AAHRPP to investigate their clinic and their procedures. The AAHRPP does not (repeat, does not) conduct un-announced , surprise investigations and investigate the clinic or CRO while the clinic, or CRO, is not expecting to be evaluated . Again, the clinic or CRO who assigns the AAHRPP to look into their operations also has to pay the AAHRPP to do so. Furthermore, (this is really a biggie) the CRO, or research site, or clinic, does not have to provide any information to the AAHRPP that it does not want to provide. The AAHRPP is not a government agency and hasn't the outright legal authority to make a CRO, or clinic, or research site surrender any kind of information that the CRO, or clinic, or research site does not want to surrender. Thus a clinic can "pass" inspection with the AAHRPP easily, essentially.
The AAHRPP is said to have accredited two big clinics.
One of those big clinics ( which has a location north of NJ) has been investigated by the FDA ( which is a government agancy) and had been found in the fairly-recent to have falsified study results. There is information about it on www.Pharmalot.com.


I will have more to say here on JALR when I get the chance.

I am actually one person who is going out on a limb and trying to make the system better.






www.pharmalot.com/2012/03/cro-files-for-bankruptcy-after-fda-alert/


www.pharmalot.com/2011/08/reevaluating-studies-a-cro-a-coincidence/

[labrat1]

I meant to say "South" of NJ

[vark]

it's good that you are asking tough questions. more of us should do that. what i suggest is when talking to recruiters or doing the consent interview, maybe tape it. that is, you can bring your laptop and have it recording into a sound file. that way you have a record of what was actually said. be careful if they have policies against that, but that shouldn't apply to screening? one of the many catch-22s is they ask on the screening form, were all your questions answered, and you have to write yes even when it was really no, or they won't let you in the study.

i was banned from [unmentionable] for asking that they follow their own rules, and i got the runaround from the IRB and the company president,and I'm still unhappy about it.

[travelingrat]

hi vark, good idea! also. i have started emailing IRB's with questions re some of the studies i have screened for. most studies seem run-of-the-mill but a few here and there have seemed actually dangerous. i have wondered why a clinic (in this case the unmentionable) is even being allowed to do a study when the consent form says, "Several persons with no prior liver disease have unexpectedly developed liver failure in the first 7 days of taking this drug, and one death was reported."

That level of risk seems unacceptable to me and i think such drugs should be used in patient studies only. why risk causing liver failure in a healthy person? and can you imagine what that person would go through trying to prove the study drug caused that?

the more i investigate, the more i believe that lab rats have little protection. there is almost no government oversight and most of the IRB's are a joke.

one email i received back from an IRB simply said, you do not have to participate unless you want to. wow, how's that for trying to answer my concerns!

anyway these days i pick and choose my studies veeeeery carefully.

[vark]

if the death was of a healthy volunteer, i think we would have heard about it. this was likely to have been a patient study. still yikes.
everybody has to make their own decisions about risks. most of us don't care too much, knowing that if it gets past the irb it's probably safe enough to do - i find being broke to be risky in itself. but it's still up to you. the irb that [redacted] uses seems to be entirely controlled by the industry, with no concern for the rats.

[travelingrat]

my main problem was that the doctor seemed to know little about the drug, did not answer my questions, and was flippant.

i looked up patient reviews of the drug being tested, Everidge (i may not be spelling this right). there were many reviews and numerous persons had lost their sense of taste and some of their hearing.

as far as the liver failure goes, it stated on the consent form that the drug was believed to have caused the problem and not the patients' condition. to me, 7 days is a very short amount of time for this to happen. since the trial was for 7 days, i wanted more answers than i was given.

i do still believe that we are not protected by the FDA. they leave it to the IRB's to monitor the trials but they are for-profit orgainizations. plus i have contacted IRB's and not gotten answers to specific questions.

as i said, i am fortunate to have friends i can stay with when necessary. but if i did not, i would rather "risk" a shelter than lose my sense of taste, my hearing, or go into liver failure. that is why i think this drug should not be used on healthy volunteers: too much unknown risk. and it was being paired with other drugs!

i go into the studies where the doctors will answer my questions and take me seriously.

[carmel]

Mar 13, 2013 13:03:43 GMT -5 travelingrat said:

a few months ago i screened at one of the celerions and asked about the rather severe side effects. the doctor did not even know what i was talking about. he said, "Shall i go find out?" well, duh!

It doesn't seem to matter what anyone says about Celerion. All the bad stuff that is written about them on this board (do deep searches, old posts, etc) and people still go there. I don't get it. AVOID Celerion! It is bad. Too many complaints. If they were listed on Yelp they'd get a 1-star rating. Would you go to a business you searched on Yelp that had a 1-star rating with 20 reviews? No.

[travelingrat]

Carmel, you make a very good point.

in my post, i was trying overall (in my convoluted way!) to find out how other rats feel about the consent form process. overall i have been very disappointed with the process. i have had trouble getting answers from most of the clinics i have been to.

i am hoping that more of us will ask more questions at the screenings. even if one has already decided to go into the study, the more we ask questions, the more the clinic staff will have to be ready with answers ... i hope anyway!!!!!

ours is a very strange job ... there are always persons who are having so many financial problems, they will do just about anything. and i understand! one of my long-term goals is to see if the FDA will exert more oversight of "healthy volunteer" studies. what is the point of making a healthy volunteer UN-healthy by subjecting him or her to dubious risks?

celerion: i have done studies that seemed relatively SAFE at celerion tempe and celerion NJ and i would go to either clinic again. i jsut will not do a study -- there or anywhere! -- that seems to be outright crazy with strange risks. i AGREE with you insofar as, if one has a choice, why not choose a clinic that has great labrat ratings!

so far my fave clinic from the jalr list is OCRC. the doctor there really cares, and most of the staff too. the food was awful, soooo bad, but most clinic food is .. why, i don't know. most clinics pay providers huge amounts PER PLATE yet the food is consistently bad in most clinics imo. oh well, topic for another day!

[carmel]

Mar 30, 2013 11:54:35 GMT -5 travelingrat said:

Carmel, you make a very good point.

in my post, i was trying overall (in my convoluted way!) to find out how other rats feel about the consent form process.

so far my fave clinic from the jalr list is OCRC.

Hi travelin. I don't think you took it this way, but just to be sure. I wasn't chastising you or anyone who goes to Celerion. Just making a point I guess, and hoping that maybe it does influence some random viewer's decision out there.

OCRC. Interesting. I think I saw you post about them in their own section. I've looked at their website when you updated it, but I don't see anything. I tried it again just now... and it still just lists studies for unhealthy subjects. All the studies listed now are for liver and hepatitis patients right now. This link right here correct?

[travelingrat]

oh gosh no, i did not take it in the wrong way! i actually think you make a very good point and worded it well too, why go to a one star clinic if we can go to a 5 star (or at least a 4 star!)? my thing is to really look closely at the risks, whatever the clinic ... although if we have side effects, we are probably much better off if we are not in the one star clinics!

OCRC: i actually never posted a review.... i was lazy. i will try to do one at some point. you are correct, they are mostly a patient clinic but they do have other studies from time to time. i think it is better to phone the recruiter and get in their database, then check back from time to time. personally i never trust any recruiter of any clinic to call me ... i have missed out on studies that way.

last year i did 2 healthy studies there, one for $1900 and one for $1250. they were short studies with no returns (yay). i met some labrats who have done 9 or 10 healthy studies there in the last few years. so far this year, nothing for me, but i am in the upper age range for studies so it is a bit harder for me to find them. hope this may help you.