The Genomic Repairman is currently a Ph.D. student who escaped from the deep south, and studies DNA damage and repair through biochemical and genetic approaches. He intends to use pine away about his scientific interests and rant about the things (and there are lots of them) that annoy him.
My posts are presented as opinion and commentary and do not represent the views of LabSpaces Productions, LLC, my employer, or my educational institution.
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So at some point in my not really too long or distinguished career I have had experience with clinical trials both working on them and being a subject in them. What many people don't know is that there is a section of our healthcare economy that purely relies upon transients doing Phase I clinical trials. This is the stage where Pharma R&D folks are trying to work out what the adverse effects (AE's), dosing some dose studies, and getting a grasp on the pharmicokinetics of their potential drugs. Sometimes this stuff is handled by universities but the vast majority of this research takes place in clinical research organizations (CRO's) which do the bidding of companies or "sponsors" as they can't be trusted to do it themselves. CRO's are pretty professional and each study goes through an IRB process and has an assigned PI who is an MD. Some of these poor souls work seven days a week and are on call ALL the time, but they are paid handsomely for their work. But enough about them, back to these CRO's. You would be surprised to find that there are at least a few CRO's operating in your city depending upon where you live. You may have even heard their radio commercials asking for "subjects" to take part in the clinical studies. And as a point of terminology for Phase I clinical trials, most CRO's use the term subjects because they folks that they bring in for these trials are usually healthy individuals so as a matter of legalese, they aren't sick and thus can't be classified as patients. So patients come in, get screened to see if they meet inclusion criteria and don't get bounced for exclusion criteria. They are given a date to report back to the clinic and here is the trick, not all of them are needed. A few of them are held as alternates in case others no show, because the usual sort of folks that do these studies are not the most responsible about showing up. In fact when some of them do show up, they are testing positive for drugs for which they know they will be tested, or are drunk or still tweaking, if they do show up, thus the need for backups. So you come in and do the study, they pretty much strip you of all your personal stuff and go through everything of yours looking for contraband. Cell phone with a camera? Good luck, getting that into the clinic.
So at the conclusion of the study you get paid, which compensation isn't based upon the value of your work, but merely your incovenience based upon how long you were in the clinic and how invasive the study was. Another factor controlling subject pay is if a sponsor is pushing to get a study done and the CRO is under the gun they will toss extra cash to fill a study. Fill a study you say? That's right, they have preset numbers of slots for each in order to make the study significant, and CRO's end up losing money by not filling a study and having to run what is called a "straggler group" or second study in order to get the requisite number of subjects. Not filling studies is huge because the cost of recruitment of more subjects and the extra man hours it takes to run the study, not to mention this occupies clinic space longer and prevents them from moving on to other studies.
My point of contention with CRO's and the FDA for that matter is there is no centralized or for that matter organized system to know who has been in what study, when they were in it, and what they have taken. A fair number of the subjects are broke college kids or folks who are professional subjects doing these studies to make ends meet. Most CRO's require a 30 or 100 day wash out period before you can come back and do another study, so that you don't have any active drug in your system. However, smarter subjects hop from study to study by simply going to different CRO's since they don't communicate with one another about who has been doing what. So a subject could literally be discharged from a anti-viral medication study on Friday and start a new study for cholesterol medication on Tuesday. And they do. That's why we go through all of there stuff, we have seen checks in their personal effects from other CRO's for studies that they just got out of. I sort of consider these folks to be a vulnerable population who would be willing to do a study for money even though it might possibly hurt them later because the rent money is due next week.
My eventual hope and its probably going to take a subject's death due to AE's from medication from two studies, is the creation of a national registry. The function of this registry would be to document a subject in these trials, which would not be hard because they have to show CRO's identification and a social security card. That way when someone is being screened for a study, you can see when they were last in a study and with what company. I understand not putting what drug to protect the pharmaceutical companies interest but you might be able to list possible AE's of their previous study. But so far, neither the FDA, CRO's, or Big Pharma are pushing for any of this, which is understandable. Its going to cost time, money, and subjects, thus making clinical research more difficult at the trade off of improving subject protection.
So lets discuss...
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I make one serious post without any fucking profanity and you assholes blackball me on comments. WTF?
Im not surprised there's no national registry TBH. Its a cottage industry, same as private IRBs, who wil generally pass any old shit through. I'm not pulling the "big pharma" is corrupt schtick, but...
...well, regulation costs money. Lots of money. Really, fucking huge amounts of money and takes a lot of time. Who is gonna do it? I know it's needed, but who pays?
It's gotten re-tweeted a lot on my end, so people are reading it :) I agree with you, GR. There really should be a tracking system. Who should pay? The drug companies. Who should run it? The FDA.
Thanks for the Twitter-Love B. You did your job man. Maybe I should have just ranted this one out. I guess you could create the registry and offer tax-based incentives for those that participate as you phase it into mandatory compliance. As far as costs, I'm assuming pharmaceutical companies would encumber them. I'm sure they'll bitch about them, just the way researchers first bitched about IRB's coming into fashion but its my opinion that these folks are a vulnerable population and we have to watch out for them. Plus, what if they need this information down the road for some health-related reason, a registry would make it easier and more organized to access it.
I used to do the MRI studies all the time. I didn't have to take anything, and all I had to do was lie in an MRI and do matching or math. MRI studies pay well (like $50 an hour) because there are so many people who are claustrophobic.
This whole thing, of course, reminds me of when Kramer had to fake clinical symptoms on Seinfeld.
When I was wrapping up my graduate work, and my boss was being a general pain in the ass, I had some massive anxiety. Fortunately for me, they were doing an anxiety study down the hall ... using an anti-seizure medication. It was double-blind, so no one on our end had any idea what we were being given (or taking) but they had a dosage phase where we (I) were given increasing doses. This was fine until they up'd my dosage to a point where I was as high as a kite. Thinking this could be placebo-effect, I waited three days before reporting it ... and simply enjoyed the ride. Once they brought me down from that dosage, things returned to normal. It kicked my anxiety's ass too.
God bless Gabitrol.
GR, you say the cost would be encumbered by industry. Nice plan but it won't get there without serious Federal oversight. The only reason they put up with IRBs is because of the Code of Fed Regs (CFR45 etc.). HIPAA and now HITECH carry nasty penalties for fucking with patient data, something similar needs to be put in place for patient tracking. But they'll see who is going to foot the bill and fight every step of the way. IT won't even make it to debate on the House floor...