Safety of radiolabel studies

[puntkicker]

(EDIT: I wish one of our best safety advocates, TravelingRat, hadnt gone MIA.  I'd really like to hear what she has to say on this.  Vark may be the leading advocate at the moment, so I hope he has soing to say as well.  Really, I'd be grateful for anything informed, and/or to see if others had given this thought)

I'm curious if anyone has any good information about the safety of radiolabel studies.  For a moment I wanted to assume they were safe, but then I remembered the type of corporations we are dealing with.  I found this, which seems to imply there is a degree of safety concerns:

"In recent years, the use of substances enriched in the non-radioactive isotope 13C has become the preferred od, avoiding patient exposure to radioactivity.[10]".  Note how it says preferred, and not exclusive, or anything of the like.  Has anyone who has done radiolabel studies looked to see which isotope was used?  If this 13C weere to be safer but more expensive than the radioactive 14C, how much would you want to bet that big pharma would use the more dangerous/less expensive one?   I'm not saying that is the case, but I am just reminding folks of the bottom line with these people, and that it's not safe to assume anything.  I'm hoping what theyre using now isnt radioactive, and the label is just a misnomer.

I did read soing about it potentially getting into stomach and other tissue somewhere, and will post that if I can find it again.



I have another question which may not be related to safety like the regular washout period.  Why do radiolabel studies have a 1 year washout period?   It's not like it's just a half-life issue, being the half-life of 14C is over 5,000 years!   Any input is appreciated.  

[vark]

i personally have no trouble with radiolabel studies. i have done one, at covance, back in the day. i think the year washout is just to add a safety factor because people are scared of radiation and afraid of clinical trials.

[travelingrat]

this is certainly an interesting question. i know i have had many MRI's done in which they use a dye. i can't think of the name of it now. 2 years ago, columbia university in NYC notified me and another lab rat friend that that dye has been shown to linger in the brain. they know that from autopsies done on patients (not lab rats ha). so they said they were using a variation of that dye in the future. but it made me wonder how much they know about the one now being used and if somewhere down the road, it too will be found to linger on in the brain.

i am somewhat depressed about doing studies. the IRB's are useless. the FDA never responds. there should be an agency that puntkicker could pose his question to and get a response. it is useless to ask questions at the screening because if you don't sign and just move forward, you will miss out on the study while waiting for an answer.

i guess i either will give up on studies (not likely) or walk 100 % into the Dose Me, Pay Me category of lab rats. maybe an asteroid will hit and i won't have to think about it any more.

[puntkicker]

Mar 23, 2017 21:13:16 GMT -5 travelingrat said:

this is certainly an interesting question. i know i have had many MRI's done in which they use a dye. i can't think of the name of it now. 2 years ago, columbia university in NYC notified me and another lab rat friend that that dye has been shown to linger in the brain. they know that from autopsies done on patients (not lab rats ha). so they said they were using a variation of that dye in the future. but it made me wonder how much they know about the one now being used and if somewhere down the road, it too will be found to linger on in the brain.

i am somewhat depressed about doing studies. the IRB's are useless. the FDA never responds. there should be an agency that puntkicker could pose his question to and get a response. it is useless to ask questions at the screening because if you don't sign and just move forward, you will miss out on the study while waiting for an answer.

i guess i either will give up on studies (not likely) or walk 100 % into the Dose Me, Pay Me category of lab rats. maybe an asteroid will hit and i won't have to think about it any more.

Thank you for that, and welcome back, awesome to see you again!  I appreciate that information, because a lot of people just assume things are safe, with absolutely no scientific data to prove it.  I mean many folks still consume toxins like MSG(an exitotoxin that literally kills brain cells) and/or aspatame(has numerous ill effects) regularly, along with however many other things.  You're right, the IRBs are crap, and as I just pointed out, even federal agencies like the FDA are crap, and are about getting their pockets greased, or you dont get your things approved.  

What do you mean by stepping into the dose me/pay me camp?  Becoming despondent and/or a meathead like many poor folk and even people on here that will shove anything in their mouth or whatever orifice big pharma asks them to?  

Anyhow, thanks for responding.  I really hope to hear from a number of people on this.   Youre right that they dont really tell you JACK at the screenging/informed consent.  The person reading the sheet often has little more(if any) idea about what they are reading than any seasoned labrat, and even some newer ones!  Some places surprise you after a long journey with extra requirements such as having your entire genome mapped and saved for 20 years(or longer, if the government requests it!).  Again, that is soing most folks do not see the multiple potential problems with.

I actually have an idea that I think could change the game, TR.  Id be willing to talk to you about it in PM and see if you think it's worth pursuing.  Thank you again for adding to the discussion, I have missed having your realism around! 

[FloridaGirl]

I think what TR is saying is that like me I am wondering if I just need to read ,sign and do the study without asking too many questions because it all boils down to do you want to participate or not. If u want the stipend then the answer is yes.
I don't think TR means do any study no matter the drug but that in general we are kind of at the mercy of the drug companies in the sense that we need money and in to get paid we need to do follow the protocol in the numerous page consent forms. I have turned down studies before but in general I consent and hope/pray that I don't have a bad reaction or that the pk days don't have umpteen blood draws.
It is what it is and as I tell many people it is not for everyone. I am just at the point that I don't think I can work in the public sector , I enjoy my freedom and making my own schedule. Ah the joys of self employment. I like being my own boss.