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Subject Safety Problems – Not An Isolated Incident

Diane
Sometimes I wonder if NYU had any idea of how often the safety of their human research subjects was being placed at risk – but how could they not know? The FDA dinged them on multiple violations for the Pfizer drug trial (Protocol #B0541013), however that study wasn’t the only one in which NYU’s regard for subject safety is questionable. An earlier brain imaging study (S12-01521), a collaborative effort between NYU and Yale, had problems as well. As I mentioned in my open letter to NYU, one of the incidents that I believe jeopardized my safety was being put on a

Open Letter To NYU

Diane
Dear NYU, I am angry. I trusted the ethics and reputation of your institution implicitly, and in return I was misled, I was used, and my safety was disregarded by your researchers. And the more I think about some of the things that happened during and leading up to those studies, the angrier I get. I was told that my participation could possibly result in a delay of treatment for up to 60 days. However due to NYU’s delays and false-starts, that length of time was far exceeded, to the tune of several months. Do you know what it’s like to

To be honest…no, I’m not ok.

Diane
I have been debating on whether or not to share my current meltdown status here on my Facebook blog because I try to keep it as positive as possible, and don’t want to disappoint anyone by coming across as weak. So on the advice of a very dear, strong friend – I will be honest. I’m a fucking wreck. Since the New York Times story about the canned PTSD studies went to print I’ve been fighting off feelings of guilt, shame and fear. As more articles are published I keep seeing my name and the words “childhood sexual abuse” and

PTSD medical studies trashed, FDA investigates

Diane
Well…that didn’t go quite as expected. It’s been a while since I’ve posted, but there have been some changes in the studies that I’ve kept quiet about for quite some time. I wasn’t really ready to share my disappointment. I left with the hope of the drug trials getting further approval and extending. I had an offer of participation from Dr Neumeister in longer-term trials, should they become available. Unfortunately, that’s not what happened. Both drug trials are no longer active; Dr Neumeister no longer works for NYU; all data from ALL THREE studies is trashed; and there is a

The noose is loose…finally

Diane
My brain is finally starting to really loosen up from 13 days of hell. At one point I thought I was actually going to have a flashback, but fortunately that never happened…I’m so thankful that it didn’t. I wrote this on Thursday in an attempt to document what I was feeling emotionally, mentally and physically. It was not easy, and it ended up taking several hours to write. I’m feeling better, but I am exhausted. I’m getting back up on my feet. Now I just need to dust myself off and get moving again. Thursday 02/19/2015 When it first started

Not feeling well…at all

Diane
I have a practice on here of being pretty honest about how I’m feeling. Right now I’m in the middle of a big fat FUBAR event. I am certainly dissociating, and have been for several days now. At first I thought it was just going to be a little anxiety attack…nothing unusual. It kept going and growing, but still up until just a few minutes ago I thought it was going to pass. Now I think I might be headed into a full-blown flashback. I’m in a safe place, in contact with my therapist and medical professionals. I am going

NYU – Eli Lilly Drug Trial: Baseline, Dosing Challenge Study (Visit 1)

Diane
Just ONE. MORE. DAY. Today is what’s called the Dosing Challenge Study – based on the flip of a coin, one of the following happens: I receive a placebo I receive 40 mg of pomaglumetad methionil (the study drug) I receive 160 mg of pomaglumetad methionil About an hour before dosing, I have to participate in a behavioral task/triggering session. Electrodes are attached on my body to record muscle movements, mainly under my eyes to track my blinking. Sweating will also be measured. I will receive mild electric shocks to my wrist while listening to bursts of extremely loud white

NYU – Eli Lilly Drug Trial: Screening Visit

Diane
Rough Day. Rough Night. Getting up this morning was a little rough since I didn’t get to sleep until around 5AM! But I was up at NYU bleary-eyed and bushytailed at 8:30 AM as per schedule. Screening went smooth, I’m getting used to the drill by now. More assessments, blood work, ECG, physical, please pee in this cup, etc., etc., etc. It was just a couple of hours, then I was free to leave. Again I have to say that the staff there is truly amazing. They are understanding and gentle, and treat me with respect. But god I feel

Countdown to Drug Trial Two…

Diane
I really need to get some sleep…I have to be at the hospital for screening at 8:30. The past few nights my parents have been in my dreams again – not doing anything, not saying anything, just watching me and staring at me. It hasn’t been scaring me really; the best way I can describe it is that it has been creeping me out. I really wish I could get the hang of that lucid dreaming thing. Ah well…meditation time. Onward, onward, onward.

NYU – Eli Lilly Drug Trial: Back in NYC

Diane
Back in my hotel room after a long day and night! I flew in on a redeye and the flight here was crowded and I was squished in my seat by a rather large fellow with a robust snore. At least he slept well. 😉 It was 78 degrees when I left, 10 degrees when I landed. Freaking cold!! But I love it. I made my way to the hotel, got an early check-in with no problem, and after a good breakfast I popped over to NYU for my follow-up bloodwork and last official visit for the Pfizer drug trial. Easy

Time to Regroup

Diane
Taking a little time to regroup after this last round – and to gear up for the next study. It’s hard to believe that this time next week I’ll be back in New York! Once this is all over with I’ll be posting links to some news articles and other information about the science behind these trial medications. For now, some cuddle time with Cassidy. She’s as glad to have me home as I am to be home. 🙂

NYU – Pfizer Drug Trial: Day 8: Almost home (for now)

Diane
Heading in for my last fMRI and workup…then on to home this afternoon! Today will be a few hours of some final assessments, and I have to turn in my little medication cooler and dosing diary. There will be a final workup…ECG, vitals and another slew of paperwork to finish. I will have one more fMRI session, then I am homeward bound. I am so ready.

NYU – Pfizer Drug Trial: Day 7

Diane
So I had one of those crappy starts today. After deciding to sleep in just a little extra today I dreamt of my sister – not really a nightmare, but emotional. I woke up, made myself a couple peanut butter and jelly sandwiches, then proceeded to spill milk everywhere! Soggy sandwiches and (argh!!) SOGGY PHONE. The speakers stopped working on my phone, but luckily I was able to take it apart and dry it out with a hairdryer…and it works! Whew. So I said screw it and chucked the sandwiches in the trash and am enjoying a plateful of buttermilk

NYU – Pfizer Drug Trial: Day 6

Diane
Sleep. The Good Kind. And NYC Shuts Down I am becoming fully convinced that there is nothing quite as healing as a good night’s rest. The past few nights I’ve had the best sleep (and NO nightmares!!) I’ve had in years…I can’t even remember ever sleeping this well. It’s been a deep, restful sleep. Not the kind you get from a sleeping pill. Just a very natural feeling rest. Is it medication? Is it exhaustion? Again, only time will tell. I should find out if I am taking a placebo or medication by May. I know that in just a