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Post Archive
2017 (0)2010 (241)
December (20)

Have a little personality on Friday...
Friday, December 10, 2010

Thursday is going to be epic...
Thursday, December 9, 2010

Good Night, and Good Luck
Wednesday, December 8, 2010

Ask Genomic RepairMom...Child Birth
Wednesday, December 8, 2010

Wednesday is definitely a rollercoaster
Wednesday, December 8, 2010

12 Months of Blogging Meme
Tuesday, December 7, 2010

LabSpaces Fantasy Football Challenge: Week 13
Tuesday, December 7, 2010

Don't Run Around On A Tuesday
Tuesday, December 7, 2010

A rhetorical question and science fail...
Monday, December 6, 2010

Sue
Monday, December 6, 2010

It definitely doesn't feel like summer...
Monday, December 6, 2010

A Friday Recipe... Stuffed Jalapenos
Friday, December 3, 2010

A Friday morning haiku for you...
Friday, December 3, 2010

Friday better not be your time of dying...
Friday, December 3, 2010

Music Warz--Fuck all you emos--Punk is where its at...
Thursday, December 2, 2010

Is this a sign of things to come...
Thursday, December 2, 2010

Speaking to the next generation...
Thursday, December 2, 2010

Apparently we must have used hypocritical evangelical coders...
Thursday, December 2, 2010

Have an Unbelievable Thursday
Wednesday, December 1, 2010

Don't ge a Gigolo on Wednesday, its just not right.
Wednesday, December 1, 2010
November (44)

LabSpaces Fantasy Football Challenge: Week 12
Tuesday, November 30, 2010

It Might Get Loud On Tuesday
Tuesday, November 30, 2010

Do you know what the Spellcheck button is?
Tuesday, November 30, 2010

Update: I think I'm dying...Science in Motion...
Monday, November 29, 2010

Feel The Noise On a Monday
Monday, November 29, 2010

The jail story...
Wednesday, November 24, 2010

Don't be talking that shit on a Wednesday..
Wednesday, November 24, 2010

The dark danger and human cost of drug development
Tuesday, November 23, 2010

LabSpaces Fantasy Football Challenge: Week 11
Tuesday, November 23, 2010

Thrift Store T Shirt Tuesday
Tuesday, November 23, 2010

Request for Reprint...Should I put on my throwback jersey too?
Monday, November 22, 2010

Moving Boxes, we aren't going a damn place...
Monday, November 22, 2010

Does your brain feel like its going to Pop on a Monday?
Monday, November 22, 2010

Friday Wrap-Up and Links
Friday, November 19, 2010

Believe Me, Its Friday
Friday, November 19, 2010

An Open Letter To The Guy Who Tried To Mug Me...
Thursday, November 18, 2010

Who the hell said it was Thursday?
Thursday, November 18, 2010

Ask Genomic RepairMom...Retractions.
Wednesday, November 17, 2010

Are you in the house?
Wednesday, November 17, 2010

Pay me fuckers
Tuesday, November 16, 2010

LabSpaces Fantasy Football Challenge: Week 10
Tuesday, November 16, 2010

Don't Feed the Animals
Tuesday, November 16, 2010

A Tuesday Morning Book Review...
Tuesday, November 16, 2010

On which I make my return
Monday, November 15, 2010

One of the best discussions on Climate Change...Ever.
Monday, November 15, 2010

Guess who's back?
Monday, November 15, 2010

Lets keep on Rocking on a Friday...
Friday, November 12, 2010

Don't Rock the Boat on a Thursday
Thursday, November 11, 2010

Don't get too Hooked on Wednesday
Wednesday, November 10, 2010

Don't Wine on a Tuesday
Tuesday, November 9, 2010

Caribbean Monday
Monday, November 8, 2010

I'm out...
Monday, November 8, 2010

We call this a teachable moment...
Friday, November 5, 2010

Can't help that its Friday
Friday, November 5, 2010

A comparative study on pain medication reactions (n=2)
Thursday, November 4, 2010

Dear students applying for fellowships...
Thursday, November 4, 2010

Don't be Tempted on a Thursday...
Thursday, November 4, 2010

Ask Genomic RepairMom...Elections
Wednesday, November 3, 2010

Working it out from home on Wednesday...
Wednesday, November 3, 2010

LabSpaces Fantasy Football: Week 8
Tuesday, November 2, 2010

Hope you find Satisfaction on a Tuesday...
Tuesday, November 2, 2010

Tales of the Genomic Repairman: DNS
Monday, November 1, 2010

The fall of Agamemnon and the rise of Ajax: Is the PI being cheap?
Monday, November 1, 2010

Don't be Trippin on a Monday...unless you want to.
Monday, November 1, 2010
October (47)

Is the PI being cheap?
Friday, October 29, 2010

Friday Save
Friday, October 29, 2010

Nobel Prize Blunder...
Thursday, October 28, 2010

Don't be gray on a Thursday...
Thursday, October 28, 2010

Be a Wiz on a Wednesday
Wednesday, October 27, 2010

Ask Genomic RepairMom.... Vaccines
Tuesday, October 26, 2010

Things learned from my Society meeting...
Tuesday, October 26, 2010

LabSpaces Fantasy Football: Week 7
Tuesday, October 26, 2010

Attack my Site...I'm Gonna Knock You Out...
Tuesday, October 26, 2010

Write, write, write...
Monday, October 25, 2010

Hold on I'm Coming to play you some music on a Monday...
Monday, October 25, 2010

Get off this Friday...
Friday, October 22, 2010

Dear Graduate Student, let me list the reasons why I shall beat you with a stick...
Thursday, October 21, 2010

Slow down, you don't have to Run on a Thursday...
Thursday, October 21, 2010

Could you be loved on a Wednesday...
Wednesday, October 20, 2010

Ask Genomic RepairMom...Big Bang Theory...
Wednesday, October 20, 2010

It was only a matter of time before I got off my ass...
Tuesday, October 19, 2010

LabSpaces Fantasy Football: Week 6
Tuesday, October 19, 2010

Is Everything Zen on a Tuesday?
Tuesday, October 19, 2010

10 Commandments of Poster Presentations...
Tuesday, October 19, 2010

Shout it out on Monday
Monday, October 18, 2010

Pinch me its Friday...
Friday, October 15, 2010

Donor's Choose: Give me your lunchmoney!
Thursday, October 14, 2010

So I know I slagged off on a vendor but now its time to give one props...
Thursday, October 14, 2010

Did you see Fireflies on a Thursday?
Thursday, October 14, 2010

New Series: Ask Genomic RepairMom...Stem Cells
Wednesday, October 13, 2010

Make Wednesday A Magic Moment...
Wednesday, October 13, 2010

The Tribe of Science loses a Warrior
Tuesday, October 12, 2010

LabSpaces Fantasy Football: Week 5
Tuesday, October 12, 2010

Hey Man, quit Ramblin on a Tuesday
Tuesday, October 12, 2010

Cocaine is not a good way to start the week off...
Monday, October 11, 2010

Candidacy Exam: Last one out gets the lights...
Monday, October 11, 2010

Who would have ever thought that Gatorade was pro-evolution...
Sunday, October 10, 2010

Candidacy Exam: I think I'm qualified.
Friday, October 8, 2010

Giving you guys some culture...One Semester of Spanish, Spanish Love Song
Friday, October 8, 2010

I'm sorta Research Blogging...Insight into the function of PALB2
Thursday, October 7, 2010

Chances Are I'm bringing you old guy radio today
Thursday, October 7, 2010

You only knew it was a matter of time before I went off again...
Wednesday, October 6, 2010

Welcome to Wednesday
Wednesday, October 6, 2010

LabSpaces Fantasy Football: Week 4
Tuesday, October 5, 2010

What I'd be doing, if I wasn't doing this: A fishing story!
Tuesday, October 5, 2010

Keep Moving on Tuesday
Tuesday, October 5, 2010

A little Dave Holland recommendation for Tideliar
Monday, October 4, 2010

My mom reads my blog, Happy Birthday Genomic RepairMom
Monday, October 4, 2010

More than a feeling on Monday Morning: I rocked this song in Rock Band
Monday, October 4, 2010

Candidacy Exam: Fourth and inches...
Sunday, October 3, 2010

I'm running late because I got caught on the Radar Gun
Friday, October 1, 2010
September (45)

A man can only take so much bluegrass, time to rock!
Thursday, September 30, 2010

Don't be running down the street hungry as a hound on Wednesday...
Wednesday, September 29, 2010

How not to foster a scientific collaboration...
Tuesday, September 28, 2010

LabSpaces Fantasy Football: Week 3
Tuesday, September 28, 2010

In Spite of Tuesday
Tuesday, September 28, 2010

Candidacy Exam: Someone check his pulse
Monday, September 27, 2010

Stomp it out on a Monday
Monday, September 27, 2010

Update: To the coworker who saw me lose my shit tonight...
Friday, September 24, 2010

Hoping for No Rain on a Friday
Friday, September 24, 2010

Don't have a bad Thursday
Thursday, September 23, 2010

Don't be Greedy, enjoy your Wednesday
Wednesday, September 22, 2010

What is your opinion on reuse of a figure in a journal? Misconduct?
Tuesday, September 21, 2010

LabSpaces Fantasy Football Challenge: Week 2
Tuesday, September 21, 2010

Taking it back old school with The Tokens on a Tuesday
Tuesday, September 21, 2010

I've got a case of the Mondays...
Monday, September 20, 2010

A little Rebel Yell on Monday
Monday, September 20, 2010

An Open Letter to Bio-Rad...This is going to fuck up any chance of a sponsorship...
Sunday, September 19, 2010

A lawyer is calling stem cells outmoded?
Thursday, September 16, 2010

Happy Mexican Independence Day & Potential Darwin Award
Thursday, September 16, 2010

Is Science the Love of Your Life?
Thursday, September 16, 2010

Got it made in the shade on Wednesday?
Wednesday, September 15, 2010

Can you go the distance on Tuesday?
Tuesday, September 14, 2010

LabSpaces Fantasy Football Challenge: Week 1
Monday, September 13, 2010

Candidacy Exam: Damnit go away!
Monday, September 13, 2010

Don't break down on a Monday.
Monday, September 13, 2010

Good grief, its Friday!
Friday, September 10, 2010

Guest Post: The Easy Pub
Thursday, September 9, 2010

You don't know how it feels on a Thursday
Thursday, September 9, 2010

Funniest Comment Contest Part 2
Wednesday, September 8, 2010

Stay with me on a Wednesday
Wednesday, September 8, 2010

I wish I knew: A Tale of 2.5 stories...
Tuesday, September 7, 2010

Lets just be friends on a Tuesday...
Tuesday, September 7, 2010

In case you weren't signed up...
Monday, September 6, 2010

Come on ride that train on a Monday...
Monday, September 6, 2010

Candidacy Exam: Clocks ticking yo!
Monday, September 6, 2010

You want to guest post on LabSpaces?
Friday, September 3, 2010

Watch out for the small print on a Friday
Friday, September 3, 2010

Are you actually working with a neuronal line?
Friday, September 3, 2010

Groups
Thursday, September 2, 2010

Whats that smell and how should I mentor it?
Thursday, September 2, 2010

Travelling Riverside on a Thursday
Thursday, September 2, 2010

LFG...
Wednesday, September 1, 2010

Contest Winners!!!
Wednesday, September 1, 2010

Go Your Separate Ways on a Wednesday
Wednesday, September 1, 2010

My first (and best ever) conference...
Wednesday, September 1, 2010
August (75)

Mentoring a mentor?: Get it in writing.
Tuesday, August 31, 2010

Warning: Its Tuesday
Tuesday, August 31, 2010

I've survived a month of blogging.
Monday, August 30, 2010

New Yorker Article on Francis Collins and the Stem Cell Ruling
Monday, August 30, 2010

Crunch!
Monday, August 30, 2010

Can't Relate to a Monday
Monday, August 30, 2010

Female Science Bloggers...
Monday, August 30, 2010

Potential blogger drink err meet up?
Friday, August 27, 2010

Candidacy Exam: Scheduling, scheduling, scheduling
Friday, August 27, 2010

Friday morning special...
Friday, August 27, 2010

Dear IACUC inspector...
Thursday, August 26, 2010

The State of My Blog
Thursday, August 26, 2010

The Genomic Repairman's Book Club
Thursday, August 26, 2010

Wishing you were home on a Thursday
Thursday, August 26, 2010

Here is where you get to win the liquor
Wednesday, August 25, 2010

Epic Fail on a macroscale level.
Wednesday, August 25, 2010

Some recent big news in the DNA Repair field
Wednesday, August 25, 2010

Don't get caught asleep at the wheel on a Wednesday morning
Wednesday, August 25, 2010

Funniest comment, formerly most obnoxious contest...
Tuesday, August 24, 2010

Dear Trainee, the clock is ticking...
Tuesday, August 24, 2010

Cleanliness is next to...
Tuesday, August 24, 2010

Tuesday morning got you feeling numb
Tuesday, August 24, 2010

An Open Letter to Core Director
Monday, August 23, 2010

Conference Calls
Monday, August 23, 2010

Don't be blue on a Monday!
Monday, August 23, 2010

LabSpaces NFL Pick 'Em Challenge
Friday, August 20, 2010

Its Friday In Spite of Ourselves
Friday, August 20, 2010

The Genomic Repairman gets a pat on the back from the boss and a boot in the ass
Friday, August 20, 2010

Legit Science Question Here Folks
Thursday, August 19, 2010

Rise up on a Thursday Morning
Thursday, August 19, 2010

Dumping on technicians...
Thursday, August 19, 2010

Antibody Naming Contest Winners
Wednesday, August 18, 2010

Trying to find some music for tomorrow, like yesterday
Wednesday, August 18, 2010

ncRNA: Oh the splendor, oh the horror!
Wednesday, August 18, 2010

Still want in on Battle of the Science Blogs
Tuesday, August 17, 2010

Another twofer on a Tuesday morning.
Tuesday, August 17, 2010

Linked Out?
Tuesday, August 17, 2010

Data Embargos
Monday, August 16, 2010

I need a remedy for this sunburn
Monday, August 16, 2010

Cell culture question for the readers...
Monday, August 16, 2010

A letter to the other graduate student in my lab...
Friday, August 13, 2010

Friday morning groovin by the Fratellis
Friday, August 13, 2010

The Apprentice: The Finale!
Friday, August 13, 2010

Candidacy Exam: The Runaround
Thursday, August 12, 2010

Shake off them shoes if you got the Thursday morning blues...
Thursday, August 12, 2010

Update to the aged RO1
Wednesday, August 11, 2010

Candidacy Exam: The Series
Wednesday, August 11, 2010

Shameless product plug
Wednesday, August 11, 2010

Quality is when you...
Wednesday, August 11, 2010

Honestly I didn't think I'd make it to Wednesday
Wednesday, August 11, 2010

A LabSpaces Prayer
Tuesday, August 10, 2010

A two for Tuesday with the boys of Cracker and Camper Van Beethoven
Tuesday, August 10, 2010

You can hold an RO1 for 27 fucking years!
Tuesday, August 10, 2010

Name my antibody!
Monday, August 9, 2010

Antineoplastons? You gotta be kidding me!
Monday, August 9, 2010

Monday morning beats by Morcheeba
Monday, August 9, 2010

So I'm at work today so I figure I owe you a song...
Sunday, August 8, 2010

Well since I'm working on a Saturday
Saturday, August 7, 2010

So I got tagged in a damn meme
Friday, August 6, 2010

What are you doing to promote science to the public?
Friday, August 6, 2010

A chilled tune for Friday and an extra track
Friday, August 6, 2010

Say goodbye to film.
Friday, August 6, 2010

Long Lost Paper
Thursday, August 5, 2010

Feel alive with Live on a Thursday morning.
Thursday, August 5, 2010

A Forum For Discussion
Wednesday, August 4, 2010

Some Wonderful Music for a Wednesday Morning
Wednesday, August 4, 2010

Is this really elevating your science?
Wednesday, August 4, 2010

Helen Larson my ass!
Wednesday, August 4, 2010

2010 LabSpaces NFL Challenge & Banner Contest
Wednesday, August 4, 2010

Balance...You gotta be kidding me.
Tuesday, August 3, 2010

Feeling Stuck on a Tuesday?
Tuesday, August 3, 2010

A Note On Peer Review
Monday, August 2, 2010

Monday Morning Soothing Tunes and Moving Music
Monday, August 2, 2010

Candidacy Exam Blues
Monday, August 2, 2010

How do you balance the job and life?
Monday, August 2, 2010
July (10)
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Genomic Repairman

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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Tuesday, November 23, 2010

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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Genomic Repairman
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I make one serious post without any fucking profanity and you assholes blackball me on comments.  WTF?


Tideliar
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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?


Brian Krueger, PhD
Columbia University Medical Center
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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.


Genomic Repairman
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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.


Geeka
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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.


Thomas Joseph
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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.


Thomas Joseph
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That would be Gabitril by the way. 


Evie
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This is really interesting stuff dude, good to know.


Tideliar
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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...

 

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