Words getting around to other participants

[vark]

I agree you have identified an important problem. I've had that experience of reporting a side effect at celerion and getting paid half what I expected. "Pro-rated" didn't mean what you'd think it would mean.

Celerion isn't the only clinic where people are afraid to report adverse events out of fear of retaliation. Covaance and are particular offenders. And when lab rats don't feel safe to report adverse events, the study fails to do what it's supposed to; test to see if if there are adverse events that are a threat to safety. Under Obama, the impression I got was that the FDA didnt care. Under trump, I expecct that they will care less.

[sam9009]

I thought it was normal for some places to pay you less if you can't ue the study because of a side effect or soing else.

Is there a rule book or soing that every spot has to follow?

[antecubital]

Apr 19, 2017 21:36:30 GMT -5 vark said:

I agree you have identified an important problem. I've had that experience of reporting a side effect at celerion and getting paid half what I expected. "Pro-rated" didn't mean what you'd think it would mean.

Celerion isn't the only clinic where people are afraid to report adverse events out of fear of retaliation. Covaance and are particular offenders. And when lab rats don't feel safe to report adverse events, the study fails to do what it's supposed to; test to see if if there are adverse events that are a threat to safety. Under Obama, the impression I got was that the FDA didnt care. Under trump, I expecct that they will care less.

On the other hand, you could have people reporting fake adverse events just to get out of the study early with full pay. I've seen it happen, one guy in particular making it his modus operandi.

[tina]

Apr 19, 2017 21:36:30 GMT -5 vark said:

I agree you have identified an important problem. I've had that experience of reporting a side effect at celerion and getting paid half what I expected. "Pro-rated" didn't mean what you'd think it would mean.

Celerion isn't the only clinic where people are afraid to report adverse events out of fear of retaliation. Covaance and are particular offenders. And when lab rats don't feel safe to report adverse events, the study fails to do what it's supposed to; test to see if if there are adverse events that are a threat to safety. Under Obama, the impression I got was that the FDA didnt care. Under trump, I expecct that they will care less.

[FloridaGirl]

I was at Covance and had a known reaction caused by drug. It was a double blind study So maybe that is why they kept me but I knew from screening that a headache could occur so felt safe reporting it. But u are right sometimes they send you home with prorated pay so yes participants are afraid to say anything. I don't always say soing because I am planning on full pay if it soing like a headache or nausea I mean if I had a serious reaction that would be different would definitely report it.

[rapunzel]

This happens at PPD as well. The vets do not report anything. I had heart palpitations and almost passed out after the first dose and the advice was: "smile and show up on time, or you won't be welcome here anymore." I came upon one woman throwing up, doubled over in pain. She begged me not to go get help or say anything or they would send her home w(with less pay) and ban her as they had someone else. She was a single Mom trying to keep the rent paid. Her friends kept the admins away and made sure the got to the check-ins and vitals on time looking ok enough not to raise any flags.

I've experienced this elsewhere too.

This is an important issue for several reasons:
1- The sponsor and CRO want the drug to get approved
2- Adverse effects slow the process or can prevent that, and I've literally had the techs in more than one place complain about the paperwork involved (despite that it's one of the reasons they get a regular paycheck and benefits.)
3- There's huge money invested in getting drugs approved; corporations are all about the bottom line
4- NOT reporting effects is dangerous for everyone; for us and the multitudes it will be prescribed to later
5- This is a significant ethical issue we all have to live with

The prevailing point of view (politically and otherwise) seems more about short term profit than long term well being, and it is defeating the purpose of the trials and has the potential to create significant harm to many.

I see this as not much different than other "whiste blower" issues;
Things cannot change unless we say soing, and there is risk if we do, but if one person is willing to do it and others say "me too," it can change for the better.

Has anyone here contacted the IRB about a problem? If so, what was your experience and lasting impression?

[rapunzel]

I've also seen someone create an adverse effect t get out early with full pay, but not all places offer that. In fact, the majority of the contracts I've seen "prorate" for the number of actual days, period. It prevents fraud, but also screws those who legitimately have an effect that deserves attention.

[brat]

This is a good thread.

Over 2 years I've noticed soing. Some swear that is a golden child in this industry, but I'm seeing differently.

I was part of a phase I for a particular drug of theirs at a big warehouse style place in the southwest. It was awful, with badly trained staff, malcontent within the ranks, and AE's all over, even though most of the people with AE's refused to report. The staff whined an moaned about every AE reported, about the paperwork and delayed compensation for them, and actually coached people to report it in a certain way to decrease their...having to do their jobs. I did report, in full, and they discriminated against me for it while I was there...and even though my labs came back normal upon discharge, my final check arrived 6 months after the study ended.

The drug was more dangerous in higher doses, but that was not what was reported.

The same drug is being tested again now in other clinics. When I ask about the purpose of these studies, I'm told its about seeking more info on AE's. So, those who did NOT report their AE's in that initial study did impact the original results.

Drug companies have huge coffers. CRO's get a huge sum for these studies from sponsors and they want to spend as little of that as possible and "yes" the sponsor into going forward with the drug so the funds are liquid. They pay the people on the ground (including us) a pittance, which makes the drones want to keep every cent regardless of the consequences.

This industry is incredibly dysfunctional because of the greed at all levels, and the "do no harm" oath plays no part.