“PanChol” clinical trial thread unroll

This is the room I'm trapped in for the next week while participating in a #clinicalTrial for a potentially revolutionary #cholera vaccine called #PanChol invented here at Brigham & Women's hospital (#BWH) in #Boston. I'll basically be doing my regular job all week while helping save lives.
I'm in isolation because if I were to shed the vaccine and somebody else picked it up from me it could cause a false cholera outbreak panic.
I'll be posting about my experience under #PanCholLiveToot. #AMA!

@jered Other than missing a few hours of work this morning during intake I expect to work a full week, so I'll make up those hours at some point during the week and therefore not require PTO or dispensation from work.
I work remotely so I can do my work from the hospital room as easily as anywhere else.
Well not "as easily" since I don't have my keyboard or multiple monitors, but it'll be good enough, for a week.
#PanCholLiveToot

@SeaFury It's very high tech. It's used among other things for sleep research, so the lights are very fancy (and controlled from outside; I have to ask them to turn off the lights at night!) and it has good soundproofing.
#PanCholLiveToot

@SeaFury oh yes, there's wifi, otherwise being trapped in here for a week would be intolerable and I wouldn't be able to do my job. 😉
#PanCholLiveToot

I just took the trial vaccine—or a placebo!—and now they're monitoring me to make sure there are no immediate adverse reactions. That's very unlikely, since 40+ people have already gone through this trial (and more through earlier ones) and none of them had reactions.
The vaccine is taken by drinking a small bottle of solution (about 4 oz I think). It tastes gross, but not so gross that you gag on it. Very salty. It took three tips of the bottle for me to get it all down.
#PanCholLiveToot

Alas, this hospital no longer screens everyone for #COVID upon admission. I asked them if they could test me specifically, since I'd just spent several days in and out of a different hospital helping my uncle after his surgery and I know at least one person I interacted with there was COVID+ (I was masked, of course). Not for my benefit, but for the benefit of the nurses taking care of me for the next week. She said she'd ask the doctor to put in a test order if possible.
#PanCholLiveToot

@eladnarra Isolation protocol means anyone who comes into the room needs to wear a yellow isolation gown and a mask; I checked on that before agreeing to participate in the study, since I don't want to have to mask for a week straight.
Also, people come into the room as infrequently as possible.
Also, there are lots of air vents in the room so I suspect it has independent air filtration.
Regarding other COVID precautions, it's… not great. See https://federate.social/@jik/113386031992291779.
#PanCholLiveToot

@stevegis_ssg Nope. It's a live attenuated vaccine which has been gene-edited to remove the negative effects of cholera while preserving characteristics of the bacteria that the immune system can learn how to resist.
I suspect they will do reactivity tests of my blood with real cholera in the lab, but I will not be exposed to real cholera.
(For those who are unaware, a "challenge study" is one where participants are infected with the disease being studied. This isn't one.)
#PanCholLiveToot

@eladnarra The clinical trials team does all mask when interacting with patients and study participants; their team made the decision to do that independently after the hospital as a whole eased its masking policy. Many other hospital staff members individually choose to mask as well. But yes, it's bad that the hospital policy doesn't require masking.
(FWIW Dana-Farber next door is still requiring masks for everyone, so it's obviously not impossible to do that.)
#PanCholLiveToot #CovidIsNotOver

This is the electric kettle I brought with me to the hospital because I drink a LOT of red rooibos tea and it will be easier for both me and the nurses if I don't have to keep asking them to bring me hot water throughout the day.
Today's nurse, who did my intake, said to me, "I don't think you're supposed to have that kettle in the hospital, but I won't tell anybody if you don't." Let's hope all the nurses for the next week are similarly chill.
#PanCholLiveToot

Another important (well, I think so, anyway) thing I brought with me to the hospital from home is my memory foam pillow. I don't know about y'all, but I am uber-picky about pillows, and hospital pillows tend to be particularly terrible. I can't say I'm looking forward to sleeping alone in a hospital bed for the next week, but at least I'll be doing it with a good pillow.
#PanCholLiveToot

@jklolling I'm being given complete privacy for most of the week. There are cameras in the room but they're turned off since they're not required for this study (they're typically used for the sleep studies). The nurses and doctors have to come in a few times a day, and they'll obviously come in if I push the call-button because I need something, but most of the time I'm left to my own devices.
#PanCholLiveToot

I'm usually pretty good with blood draws—I've been told I have "good veins"—but alas, today when they did the intake blood draw my vein decided to stop cooperating shortly before the end so they had to stick me again in the other arm to get the last two vials of blood they needed.
I think it's probably because I'm a little dehydrated right now (I'm behind on my red rooibos tea!).
Fortunately the mid-week and end-of-week blood draws are for much less blood.
#PanCholLiveToot

@onezetty This is the lowest-anxiety thing in my life right now. 😉
The clinical risk from this trial is exceedingly low; I carefully examined that before agreeing to participate.
I have people depending on me; I can't endanger my ability to live up to those dependencies by participating in dangerous research.
#PanCholLiveToot

@Beachbum Strictly speaking you're right, but I'm trapped by my own conscience. Having committed to participate in the trial, it would be dishonorable to unnecessarily leave prematurely.
Having said that, legally speaking they can't hold me here against my will, so if I wanted to just up and walk out, I could do that. That's not something I would do.
If there were a family emergency of some sort and I needed to leave, the people running the study would facilitate that.
#PanCholLiveToot

@APBBlue Ah, so, about that. Because they do a lot of sleep studies here, they need to be able to control the lighting and sound exactly, 24/7. So none of the rooms in this particular research facility have windows, and they all have raised floors and lowered ceilings to control noise.
Apparently they got some push-back about the lack of windows, which they responded to by putting up landscape prints. Here's the one in my room. Yeah, it's kind of silly.
#PanCholLiveToot

@onezetty The vaccine's researchers want to make it available worldwide to reduce avoidable cholera illnesses and deaths.
They are working on making it possible to ship it in shelf-stable, dry form, so that it can be reconstituted with distilled water for administration, which would make it much easier to deploy worldwide.
Also, early results suggest that it starts protecting against infection as soon as 24 hours after it is administered.
#PanCholLiveToot

So, @APBBlue asked elsewhere in the thread how the food is in the hospital.
It's not great so far.
For dinner I ordered pesto crusted whitefish, steamed broccoli, diet ginger ale, fruit cup, and tartar sauce.
What I got is shown below (for scale, note that the ginger ale is only 7.5oz, not a full-size 12oz can).
The steamed broccoli was fine. The chef apparently thinks the primary ingredient in pesto is salt. The cantaloupe in the fruit cup was not entirely fresh.
(continued)
#PanCholLiveToot

There's an old Jewish joke… Two yentes are eating dinner at a Borscht Belt hotel. One says, "The food here is terrible!" The second responds, "Yes, and the portions are so small!"
Although the portion sizes here are indeed small (I was warned about this by the nurse), I can apparently order essentially whatever I want to make up for it.
Food is ordered over the phone; ordering digitally on-screen in the room is not an option here like it is at some other hospitals.
#PanCholLiveToot

I don't want to be too overly dramatic about this, but if you open a new box of tissues, like, for example, the ones they give to patients in the hospital, and it's impossible to pull the first tissue out of the box without a big wad of tissues coming out with it, that's not an accident and it's not poor design, it's theft. The manufacturer has designed their packaging to encourage this wastage so they can sell more tissues.
Not speaking theoretically. Looking at you, #Medline.
#PanCholLiveToot

@zspeaking Good question! I don't expect to get much exercise this week. I could pace or jog in place or do jumping jacks, I suppose.
The researchers tried to borrow an exercise bike from the PT department to put in the room but it didn't work out.
Apparently an earlier study participant brought a manual treadmill with them for their week and left it behind when they were done, but the staff think it's so rickety that they're not comfortable letting other participants use it.
#PanCholLiveToot

Good morning, and welcome to day 2 of #PanCholLiveToot! I slept ok, despite the hospital bed, thanks mostly to the personal pillow I had the foresight to bring with me. Also, the temperature in the room is lovely.
Breakfast this morning was the same level of mediocre as dinner last night; enough said.
Apparently hospitals are just as bad at shower design as hotels. The hottest shower available in my room is obtained by turning the handle all the way around and pointing it at "C". *sigh*

It's the start of day 3 of #PanCholLiveToot! So far no reaction to the experimental vaccine (or placebo!).
#today I want to talk about why it's so important for people to volunteer to participate in clinical trials.
Simply put, medical advances save lives, and advances are often impossible without human trials.
Trials are designed to be extremely safe.
They usually even pay a bit of money (more on that later).
Please consider volunteering! See my blog for more info: https://blog.kamens.us/2023/03/27/the-easiest-way-in-the-world-to-save-lives-has-been-inside-you-all-along/

#Today is day 4 of my week in isolation while participating in a clinical trial for a new cholera vaccine.
I've complained in this thread about the hospital food, so I want to acknowledge that today's vegetarian smoky bean chili was excellent. Out of the 9 meals I've had here so far, this is the first I would say that about!
#PanCholLivetoot

If you haven't participated in a clinical trial before, you may not realize that participants are paid, and expenses are reimbursed.
For example, for this clinical trial, I will be paid $50 for each of my trips to the hospital preparing for the inpatient stay, and $200 for each day in the hospital during the isolation period. I'll also be reimbursed for my travel expenses.
I don't do it in the money, but the money makes it a bit more palatable.
#PanCholLiveToot

I don't actually have any reimbursable travel expenses for the three appointments before the isolation period, because I rode my motorcycle to/from those appointments and parked it at a bike rack so there were no parking fees. If I had driven they would have paid for my parking.
However, I didn't want to leave my motorcycle parked on the street for a week, so this week I took the bus to the hospital and will take the bus home at the end. Those bus fares will be reimbursed.
#PanCholLivetoot

The phone in my room, which I am supposed to use to order my meals from food service, randomly stopped working today some time between when I ordered breakfast and when I tried to order lunch. The nursing staff was not able to figure out what's wrong, so perhaps they've put in a ticket with IT. In the meantime I am going to have to give my food orders to the nurse for them to call in for me. D'oh!
#PanCholLivetoot

Friday evening I'll start antibiotics to purge the trial vaccine. I've already begun stockpiling extra snacks from food service to take with the antibiotics to avoid stomach upset.
Saturday they'll test to see if the vaccine has cleared my system. The test takes about a day. If it comes back ok, I'll go home Sunday. Otherwise, I'll go home Monday.
I'm hoping the side-effects from the antibiotics aren't too severe, because I need to work the polls for 15 hours Tuesday!
#PanCholLiveToot

Good morning! It's day 5 in the hospital as a guinea pig for a cholera vaccine. I'm feeling good. How are you?
My hospital phone is broken again, so again my nurse had to order my breakfast. I hope it's fixed in time for me to order lunch!
The entire time I've been here, I've had trouble reaching only one site on the guest wifi… https://xkcd.com. Did an xkcd strip piss off an administrator so he ordered IT to block the site hospital-wide? lol!
#PanCholLiveToot #xkcd #today

I'm no hero for participating in this trial. Hanging out in a comfortable room for a week, eating perfectly adequate food, playing on my laptop and phone, and doing my job, all while getting paid extra for it, really isn't a huge burden.
The real hero is my wife! She has a job, AND she's taking care of our two kids at home and our three cats one of whom is sick, AND she's listening to me complain on the phone every day about my difficult uncle and his difficult health problems.
#PanCholLiveToot

Apparently the hospital food service thinks "baked lentil shepherd's pie" means a pile of lentils with a scoop of mashed potatoes in the middle of it. #wtaf #smdh #yhgtbfkmwts #PanCholLiveToot

Well, I just took the first dose of antibiotics, which will clear the cholera vaccine from my system, hopefully within 24 hours, so that I can go home Sunday morning.
Which is kind of important since my wife called right before I took the medicine to tell me that one of our cats is in the hospital and not doing well and quite possibly won't make it through the weekend.
Please enjoy this photo of the noble #Lancelot who is not doing well. 😿
#PanCholLiveToot #CatsOfMastodon

Day 6 of cholera vaccine clinical trial isolation!
I took my 2nd dose of antibiotics this morning. The nurses were right: the antibiotics are making me feel worse than the vaccine (or placebo!) did. Quite a bit of nausea this morning. It took a couple of hours to pass.
In other news, I figured out why xkcd.com is blocked on the hospital wifi: it's misclassified as a porn site because it starts with "x" and ends with ".com". Don't ask me how I figured it out, I won't tell. 😂
#PanCholLiveToot

There's an aspect of this clinical trial I've hesitated to post about because it involves poop 😉, but it's significant, so I suppose I should spill. There will be no pictures of poop, I promise.
Cholera is a gut bacteria: it lives in people's intestines and is shed in poop. It spreads wherever people are exposed to raw sewage, ergo it's a big problem in refugee camps, disaster areas, etc. — anywhere without a reliable, working sewage system.
(continued)
#PanCholLiveToot

Because this trial involves a live, attenuated cholera vaccine, an important measure of success is, does the vaccine multiply and take up residence in the intestines of trial subjects?
This is important both because the bacteria need to multiply to give the immune system something to resist, and because one reasons this vaccine immunizes quickly is that once it populates the gut, it prevents "real" (unattenuated) cholera bacteria from doing so.
(continued)
#PanCholLiveToot

The way the study measures that is, as you might have guessed by now, by analyzing my poop to determine whether there is cholera vaccine in it.
To facilitate that, I have to poop in what the nurses call a "hat" (because it kind of looks like an upside-down hat if you squint at it) instead of directly into the toilet. This is what the "hat" looks like when it's not "deployed":
(continued)
#PanCholLiveToot

And this is what the "hat" looks like when it's ready to "collect" a sample:
(continued)
#PanCholLiveToot

For the first 5 days of the study, my samples went to a blinded lab for analysis, because researchers aren't supposed to know until the end of the study who got the vaccine vs the placebo.
However, they need to confirm that the vaccine is no longer in my system before I go home, so today's sample—after I started the antibiotics—will be tested by an unblinded lab.
Most people are clean by now; the few that aren't need to stay another day.
(continued)
#PanCholLiveToot

This means there is a small risk of "accidental unblinding" at this point in the study: if someone's sample tests positive for cholera on the sixth day after they've started the antibiotics, then the researchers know they got the real vaccine instead of the placebo! This is considered a necessary, acceptable trade-off, because of the public-safety aspect of making sure people are clean before they go home.
It's happened a small number of times out of all the study participants.
#PanCholLiveToot

In other clinical trial news, last night I finally used the TV provided in the room for the first time since I got here Monday morning: I binged the fourth and final season of #TheUmbrellaAcademy off of #Netflix.
No spoilers, but I enjoyed the episodes and found the ending satisfying.
Definitely worth staying up late to watch.
#PanCholLiveToot

Man, since I've been in isolation in the hospital all week participating in a clinical trial, #Trump's mic is getting more action than I am.
#PanCholLiveToot #politics #USPol

I've posted a lot about the hospital food this week, but something new occurred to me today that is worth commenting on.
One of today's entrée options, which I ordered, is "Indian potato and pea curry." The meal slip on my tray calls it "alu matar," which I looked up, and indeed that's what it was.
It was good, with a bit of a kick.
This is, literally, the only Indian cuisine item on the menu for the entire week.
(continued)
#PanCholLiveToot #food #cuisine #healthcare #hospital

This is what occurred to me as I was eating the alu matar: what if I'm an Indian-American, accustomed to eating Indian food, and I come into the hospital, and there is literally one food choice for the entire week which is familiar to me?
I've been able to find something on the menu to eat for every meal while I've been here, but the menu is SO AMERICAN. What if that's not the kind of food I eat? It would suck a whole lot, right?
(continued)
#PanCholLiveToot

It's not just about Indian cuisine; most cultures are not represented. E.g. there isn't a single Asian item on the weekly menu.
I asked the nurse, and she confirmed that it's a very negative experience for people who aren't accustomed to American food.
Some people have family bring in meals. Some order food delivery (the nurses will go downstairs and get it for you!). But what about people who don't have those options or are on restricted diets?
We need to do better.
#PanCholLiveToot

@samhainnight 🤷 I think they'd have tested if I had any symptoms.
Actually, I suspect they would have sent me home and rescheduled my trial week if I was feeling unwell in any way on the first day.
Note, btw, that I didn't end up getting tested even after asking for it.
In any case, the way these trials are structured and analyzed includes mechanisms for filtering out "irrelevant" symptoms.
#PanCholLiveToot

In most of the clinical trials I've done, I've found that the researchers LOVE to talk about their work.
When the doctor sits down with you to go over the consent form and answer questions, if you want to talk to them for an hour about the research, they will gladly do that.
If you're smart and curious, a trial isn't just an opportunity to help advance healthcare; it's also a chance to engage in fascinating discussions with experts about their work. Not something to sneeze at!
#PanCholLiveToot

The doctors doing this trial have been friendly and generous with their time with me, both before this week and while I've been here. A member of the team has stopped by my room to check in on me every single day.
The nurses have also all been friendly and generous with their time. I'd expect nothing less given that I'm trapped in a room that they're free to enter and leave 😉, but when it comes to hospitals, reality often doesn't match reasonable expectations.
#PanCholLiveToot

Not a single one of the nurses on the floor with me this week has been a man. It really is astounding how woman-dominated the nursing field is. I think that says something not-so-good about our society and something very good indeed about the women just trying to exist within it.
I've visited my uncle in the hospital 30-40 times in the past few months during his health woes, and I think I may have seen maybe two male nurses in all those visits.
#PanCholLiveToot

I have been cleared for departure. Heading home as soon as I finish posting this and packing up my stuff.
#PanCholLiveToot

A final update about the #PanChol cholera vaccine clinical trial which I participated in, spending a week in the hospital as described in the above thread…
This morning was my final appointment for the trial. I dropped off one last home-collected stool sample (ugh!), had a few vials of blood drawn, and was on my way. This was the last of three such visits after the inpatient stay.
#PanCholLiveToot
🧵1/3

They may ask me later to participate in a booster trial of the vaccine. Hopefully that one won't require an inpatient stay.
I am now free to resume blood donations, though I will probably wait to start doing that until after Passover when things are less hectic and I've had some time to settle into my new job.
🧵2/3
#PanCholLiveToot

On the way out of Brigham and Women's Hospital after the appointment, I took a moment to reflect in the empty Bornstein Family Amphitheater. I don't know why, but I find it immensely calming to walk into a dark, empty lecture hall, turn on the lights, and just sit and ponder for a few minutes.
If you've never participated in a clinical trial before, please consider it. I've written about it on my blog if you're curious: https://blog.kamens.us/2023/03/27/the-easiest-way-in-the-world-to-save-lives-has-been-inside-you-all-along/ .
🧵3/3
#PanCholLiveToot

Followup about the #PanChol clinical trial I participated in back in April: the study was just unblinded, so I now know that I was given the vaccine, not a placebo.
They want me to participate in a followup booster study, which will again involve an inpatient hospital stay albeit hopefully a shorter one. I told them I couldn't commit to that right now—feeling rather overwhelmed in general at the moment—but they should check back in September and things might be better then.
#PanCholLiveToot

They hope that the inpatient stay for the booster trial will be shorter because if the vaccine worked as intended then I now have immunity which means the booster won't be able to gain a foothold hold in my body. If so, then I'll test negative for the attenuated bacteria in the vaccine on the third day and they'll be able to let me go home.
Otherwise, if I test positive for the bacteria, they'll have to put me on antibiotics for 48 hours before they can let me go home.
#PanCholLiveToot