The Life of a Professional Guinea Pig
October 19, 2015 8:32 AM   Subscribe

What it’s like to earn a living as a research subject in clinical trials Today, Stone no longer relies on strangers in bars—instead, he’s a part of a small community that shares info about study opportunities. Stone says he sends mass texts whenever he sees a new study online. In exchange, the group does the same for him. The members of this group call themselves guinea pigs, or lab rats. They also call themselves professionals.
posted by sciatrix (33 comments total) 27 users marked this as a favorite
Interesting read. I had no idea there was a business in being a professional guinea pig. The complexity of the ethics of incentivising people to volunteer for drug testing is not one I'd thought about, and the notion that there should be more room for negotiation makes sense.

However, it feels to me like the high degree of competition for positions on trials as well as the presence of so many individuals who break (or at least seriously bend) the rules is creating a situation that will stifle reform in the clinical trial industry.

These guys might think there doing everyone a favour because they "know the ropes", but one day some of them will end up taking a really nasty, life-threatening drug and their lies about their medical history will be used against them and the status quo will remain unchanged.
posted by kisch mokusch at 9:15 AM on October 19, 2015

I've yet to read the article but it reminds me of the old Loompanics book "Sell Yourself To Science" which somebody I know used as inspiration to actually become a human guinea pig for a bit. It turned out okay.
posted by I-baLL at 9:16 AM on October 19, 2015

I didn't realize that phase 1 trials were not overseen in any regulatory way. That's terrifying. And if phase 2 and 3 trials are using people who falsify their records, then how much pharmaceutical research can be trusted at all?
posted by SecretAgentSockpuppet at 9:18 AM on October 19, 2015 [1 favorite]

These guys are just begging to get the Phase 1 process regulated more heavily.
posted by resurrexit at 9:33 AM on October 19, 2015 [1 favorite]

I certainly would not want to do anything involving needles, and the idea of Phase I trials- 1st time in humans- does not seem like anything I'd volunteer for, either.
However, I'm guess I'm glad that someone [else] does it.

I work in this industry, but far removed from the blood, urine and feces collections. I support programs that do electronic data capture.
(I have a T-shirt from one of the CRO's I worked with that says "Hello- my name is Guinea Pig", but I practically fainted looking at just a picture of a cannula in someone's arm.)
I do see patients (their numbers at least) who sign up for repeated trials. It doesn't strike me as the best way to make money, but I'm sure for some it might be worth it.

As far as Phase I not being regulated- I think that's about the CRO's themselves, not the drug results that come out of the trials. In the US, for example, the trials' results go through the FDA.
Also, the CRO's have to compete for business with the pharma companies. I think they have a big incentive to do whatever it is would be achieved by regulation.
On the other hand, tell us about the insanity that occurs.
posted by MtDewd at 9:34 AM on October 19, 2015

Odinsdream: tell us your stories!
posted by sciatrix at 9:36 AM on October 19, 2015 [6 favorites]

Hey, a topic related to my old job! You would not believe the level of insanity that occurs in clinical trials. It's a huge, huge issue.

I believe you have underestimated my credulity on the subject.
posted by Pope Guilty at 9:36 AM on October 19, 2015 [10 favorites]

Guy I knew did this. He was a perfect example of why one should carefully consider whether or not it's worth it. It depends on the trial, and your reasons, but I'm thinking no.

They did one where they sprayed some cold virus up his nose, then he spent the weekend playing cards with other volunteers and those folk had taken something that was supposed to prevent colds. No idea how that trial went, but the guy with the virus up his nose was hospitalized and nearly died.

Next trial was for an alzheimer drug. They had to halt that one because the recipients were having terrible seizures. Even after no longer using the drug he kept getting them to the point that he still has them to this day and can't drive for the rest of his life.

All for a fist full of dollars. No thanks.
posted by cjorgensen at 9:40 AM on October 19, 2015 [5 favorites]

This is my job. I regulate the ethics of clinical trials. If anyone thinks that they are un- or under-regulated, I invite you to sit in my chair for a week and answer some of the questions I get.

Phase 1 trials are heavily regulated. Just because they're not on means nothing about the degree of scrutiny these trials get. And they get a lot. And some of the scrutiny is great and makes things more ethical for the participants and some of the scrutiny is ridiculous and is someone showing off how powerful or smart they are, but to say that Phase I is unregulated is laughable.

The reams of paper I have wasted in the 17 years I've been doing this would speak otherwise.
posted by Sophie1 at 9:51 AM on October 19, 2015 [15 favorites]

In 2006 there was a disastrous drug trial in the UK where the research participants ended up in emergency care with organ failure and there was the loss of toes and fingers and all the recipients now have increased risk of cancers and autoimmune disorders.
posted by srboisvert at 9:54 AM on October 19, 2015 [6 favorites]

I thought this might be a double, but I was thinking of this from Wired: Drug Test Cowboys: The Secret World of Pharmaceutical Trial Subjects. The "guinea pig" community is fascinating, thanks for the post.
posted by Room 641-A at 10:11 AM on October 19, 2015 [1 favorite]

People get injured during clinical research. This is absolutely true. We talk to people extensively about the risks of being part of research. There is no way in hell I would be a professional research volunteer, and personally, I would never volunteer for a trial at a for-profit research center. I have no idea what the regulations are like at those places, but I have been a research volunteer as well as a regulatory person, I am enrolled in a trial right now at a university (Phase IIb).

Without research volunteers, we would have none of the medications we have to treat HIV right now, so I'm grateful that some people are willing to take the risks.
posted by Sophie1 at 10:16 AM on October 19, 2015 [5 favorites]

In 2006 there was a disastrous drug trial in the UK where the research participants ended up in emergency care with organ failure and there was the loss of toes and fingers and all the recipients now have increased risk of cancers and autoimmune disorders.

I remember around the time that story came out, my local cinema advertising for volunteers for drug trails at the nearby university (the really cheap looking ads that were part of a slide show before the proper pre-film filmed ads / trailers started).

I wonder how many people signed up?
posted by fearfulsymmetry at 10:38 AM on October 19, 2015 [1 favorite]

Without research volunteers, we would have none of the medications we have to treat HIV right now, so I'm grateful that some people are willing to take the risks.

Wouldn't those have been people who had HIV and presumably already had drastically reduced life expectation, so no worries?
posted by nevercalm at 10:47 AM on October 19, 2015

nevercalm, you're talking about the 'old way', where drugs were tested on sick people to see if they made them better. The 'new way' is to first give them to healthy people and see if they make them sick.
posted by kisch mokusch at 10:51 AM on October 19, 2015 [1 favorite]

Absolutely not, nevercalm. First, phase I trials are safety trials and occur in a small group of people who are healthy. Phase II trials are further safety and some efficacy and are larger trials. They would occur with people who may or may not need the drug. Phase III trials are the trials that occur in people who have the disease exclusively, though phase II may also.

With HIV, there are thankfully, still people volunteering for research trials, even though they may have a VERY long life expectancy. We have FAR better drugs than the first approved, or even the first approved protease inhibitors which extended one's life but had a huge host of side effects.

It is entirely the altruism of people who want better medications for the next generation who are testing these drugs. Without them, we'd still be back in 1999.
posted by Sophie1 at 10:56 AM on October 19, 2015 [12 favorites]

Did you read the article Sophie1? This idea that volunteering in clinical trials is driven out of altruism is misguided, and is doing a disservice to the industry.
posted by kisch mokusch at 11:00 AM on October 19, 2015

I read the article. I also work in the field. Most of our volunteers are doing this out of altruism. That might be different with diabetes medications or heart disease, but in HIV, that is the case.
posted by Sophie1 at 11:05 AM on October 19, 2015 [5 favorites]

Do you pay them? Seems to be the major point of difference between altruism and financially motivated.
posted by kisch mokusch at 11:11 AM on October 19, 2015

We absolutely pay our participants - it would be unethical not to. Many of them have to take time off work or make other sacrifices to participate. That said, we do not pay them enough to live on. I have been involved in many of these debates on a national level regarding the ethics of paying research participants. It is an incredibly hot topic and has been for the entire time I have been in the field but different fields of research have different variables, so one size is not going to fit all.
posted by Sophie1 at 11:15 AM on October 19, 2015 [6 favorites]

Thank you for that link, srboisvert.

The Wikipedia article on the drug in question, TGN1412, gives a more complete account, eminently suited for the Halloween season:
Originally intended for the treatment of B cell chronic lymphocytic leukemia (B-CLL) and rheumatoid arthritis,[3] TGN1412 is a humanised monoclonal antibody that not only binds to, but is a strong agonist for, the CD28 receptor of the immune system's T cells.[4] CD28 is the co-receptor for the T cell receptor; It binds to receptors on the interacting partner in the reaction through one of its ligands (B7 family).

In its first human clinical trials, it caused catastrophic systemic organ failure in the subjects, despite being administered at a supposed sub-clinical dose of 0.1 mg per kg; some 500 times lower than the dose found safe in animals.[5] Six volunteers were hospitalized on 13 March 2006, at least four of these suffering from multiple organ dysfunction. Tentative opinions from an as-yet uncompleted inquiry suggest that the problems resulted from "unforeseen biological action in humans", rather than breach of trial protocols, and the case therefore has had important ramifications for future trials of potentially powerful clinical agents.
All of the men were reported to have experienced cytokine release syndrome resulting in angioedema, swelling of skin and mucous membranes, akin to the effects of the complement cascade in severe allergic reaction. The patients were treated with corticosteroids to reduce inflammation, and plasma-exchange to attempt to remove TGN1412 from their circulation. The treating doctors confirmed in August 2006 that all six men had suffered from a cytokine storm, and that, paradoxically, the men's white blood cells had vanished almost completely several hours after administration of TGN1412.[5]

According to a press release from 5 July 2006 on the North West London Hospitals NHS Trust website, where the men were treated, the patients continued to improve and "five of them went home within a month of the incident, while one patient remained in hospital until 26 June, when he also went home."[22] However, Head of pharmacology at University College London Trevor Smart has suggested that the men may never fully recover, and may suffer long-term disruption to their immune systems.[19]

An article by The Sunday Times on 30 July 2006 reported lawyers' claims that the long-term damage to the patients may be worse than originally thought. Medical assessment by immunologist Professor Richard Powell were said to have revealed that the blood of the patients contained a low number of regulatory T-cells, below one percent compared to three to five percent for healthy male adults - although the clinical significance of any such finding are unknown. Powell also reportedly claimed that one of the patients has "definite early signs that a lymphoid malignancy is developing". Some of the men involved in the trial are said to have been told that they face "a lifetime of contracting cancers and all the various auto-immune diseases from lupus to MS, from rheumatoid arthritis to ME."[23]
A passage in the article seems to suggest that the men might have had most of their regulatory T cells, which keep the immune system from attacking the tissues of the body, each clone with a specific target it protects, converted into effector cells which instead attack those very same targets:
A new explanation for the trial mishap was suggested by the findings of a recent paper in Clinical Immunology. Pillai et al. found that all T cells that get activated using conventional TCR-mediated stimulation become regulatory for a brief time and express FOXP3. However, eventually most of these cells downregulate their regulatory capabilities and become effector cells. Thus, attempts to induce FOXP3+ T cells might also induce effector cells capable of causing tissue damage.[12]
posted by jamjam at 11:17 AM on October 19, 2015 [1 favorite]

Heh. I've worked in a few Phase III clinical trials and the patients didn't get paid then (except for taxi fares to and from the hospital). Is it unethical to not pay healthy people but ethical to not pay sick people?
posted by kisch mokusch at 11:21 AM on October 19, 2015

Again - it's still a debate. I feel it's unethical not to pay participants. Other people feel differently. Generally, healthy people are paid more than sick people. For instance, if you are on a phase IV cancer trial (post-approval), you are less likely to get paid than on a phase I trial for any drug because it is an approved drug that you need and you would probably be on the same medication were you not actually involved in the trial.
posted by Sophie1 at 11:36 AM on October 19, 2015

Phase IV has usually shown efficacy, so I can understand that. Phase IIb/III the jury is still out. I suppose one can make the case that the risk of harm is lower in a non-Phase I trial and therefore you don't need to be compensated.
posted by kisch mokusch at 11:40 AM on October 19, 2015

jamjam, that final reference is seriously dated. It's now well-appreciated that activated T cells express Foxp3 without being regulatory T cells. The explanation for the severe effect was most likely a systemic activation of the effector/memory T cells. This wasn't observed in the pre-clinical trials because the mice were grown in clean rooms and had relatively few memory T cells and they didn't have strong agonistic (i.e. comparable) antibodies for the other animals.

The interesting thing about TGN1412 is that it would probably make a great anti-cancer drug. Needs to be titrated down even further, but activating the immune system is doing wonders in melanoma. Wonder what the going price would be to participate in another Phase I trial at a 1/5000 dose...
posted by kisch mokusch at 11:41 AM on October 19, 2015 [2 favorites]

you know, I've seen (and probably participated in) poking fun at pretty much every major psychological finding, because the test subjects are press-ganged undergrads.. Now throw in folks like this, and, well, turtles all the way down.
posted by k5.user at 11:46 AM on October 19, 2015

The interesting thing about TGN1412 is that it would probably make a great anti-cancer drug. Needs to be titrated down even further, but activating the immune system is doing wonders in melanoma. Wonder what the going price would be to participate in another Phase I trial at a 1/5000 dose...

It actually recently managed to successfully make it through a redesigned Phase I trial! Sounds like going down to just a 1/20 dose was enough.
posted by un petit cadeau at 12:00 PM on October 19, 2015 [1 favorite]

It actually recently managed to successfully make it through a redesigned Phase I trial! Sounds like going down to just a 1/20 dose was enough.

I was just about to post this. Wikipedia cites an article I can't access saying they started at 1/1000. And its going into Phase II in Russia now.
posted by atoxyl at 12:07 PM on October 19, 2015

Wow, that I didn't know. And one of the comments in your link suggests I was wrong about the lack of comparable antibody in the non-rodent studies:

The failure of TGN1412 to trigger a CRS in cymolgus monkeys is NOT due to poor binding to cyno CD28 – in fact, binding is identical in humans and cynos, which is due to the 100% identity of the extracellular domain (see Lessons from TGN1412. Hanke T.Lancet. 2006 Nov 4;368(9547):1569-70). The alleged differences in amino acid sequence affecting binding are a myth that was introduced into the literature based on a mis-sequenced rhesus macaque CD28.
Rather, it was the unexpected absence of CD28 from cyno CD4 effector memory cells

I'd be surprised if it was good in arthritis (quite the opposite), but one of the great things about medicine is that once something is approved, it makes it easier to look at it's effectiveness in other conditions. And we know that drug is quite potent, so I'm sure there will be a disease or two it's good for.
posted by kisch mokusch at 12:14 PM on October 19, 2015

I tried to enter an HIV drug trial, back a dozen years ago, not for the money but because I wanted to do what I could to help. I was turned down because I had not had the common cold in which the drug (or placebo) was delivered. I was like, no seriously, that's not the reason. They insisted it was. I said, okay, I'll sign the waiver. The importance of this drug trial WAY outweighs the inconvenience to me of having a cold. Nope, they said. Can't do it. It would be unethical.

Skip forward a dozen years and I finally decided to pull the trigger and donate a kidney to a stranger. I figure my kidneys have worked fine so far so there's a pretty low likelihood of kidney failure, plus you get points for giving a kidney if you ever need one. Anyway, this time they didn't want me because I had cancer in 09. I'm like no you don't understand, No Evidence of Disease for more than five years! Recurrence of less than 2%! Almost 100% survival at 10 years! And they said, we are really glad for you but still can't accept your kidney. Even one cancer cell could spell curtains for the recipient.

So now I'm just grumpily filling in online surveys about my shopping habits and food consumption and what words come to mind when I think of "Citibank" or "Capital One" or what have you ._.
posted by janey47 at 1:23 PM on October 19, 2015 [3 favorites]

I probably made about $6-10K over the course of my grad school career doing occasional trials for generic equivalents of established drugs. I don't have any good stories; it was mostly like hanging out in a really low-budget college dorm. The diversity of the participants was pretty impressive. I would have kept doing it but I got screened out for some out-of-range blood tests at one point. Sadly that happened just when I was particularly in need of the extra cash; I was pretty unhappy about it.
posted by sevenyearlurk at 7:20 PM on October 19, 2015

I strongly agree with the bioethics professor on the point of looking at this as a labor issue.
Among other things, he argued that participants should be able to negotiate payment based on the discomfort they experience during a study. ... “You have to ask: Who has a month or three weeks to just check in to a trial site or live there for that amount of time?” he said. “Homeless people, undocumented people, people who are either temporarily or long-term unemployed, people who are out of jail who can’t get regular work.” Paying members of vulnerable groups to put experimental drugs in their bodies can seem dangerously close to coercion. ... But treating money as an afterthought rather than the main motivator also means that guinea pigs aren’t considered employees. “It’s work, but it offers none of the protections of work,” Elliott said. “You don’t have the right to minimum wage, you don’t have the right to unionize, you don’t have disability payments, you don’t even have regular health and safety inspections.”
Being a human test subject is work by any definition, and people who do this work absolutely should be able to organize. Like a lot of "paid volunteer" work, it is really vulnerable to worker exploitation.
posted by Aya Hirano on the Astral Plane at 7:58 PM on October 19, 2015 [2 favorites]

Funny thing - spoke to some friends of mine and discovered that the Robert Helms of this article was (maybe even still is) a Wobbly. Which explains the entire process described in the article of what is known as a "march on the boss", i.e., getting your co-workers together to agree on a set of demands to management, and then presenting said demands as one unit.
posted by Aya Hirano on the Astral Plane at 9:17 AM on October 20, 2015

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