Some web articles claim that there are actually people out there who get into one clinical trial that compensates participants, get paid, then move on to another trial, get paid, and then on to the next one, etc.
Of course the first and most obvious question that comes to mind is: how can they do that? Aren't there some kind of rules that would prohibit them from doing so?
And what about the risks to their own health that such behavior may subject them to?
"While the professional guinea pigs tended to believe that most clinical trials pose only a moderate health risk, Abadie (an investigator) contends that the hazards presented by continuous participation, such as exposure to potentially dangerous drug interactions, are discounted or ignored by research subjects in need of money. The risks to professional guinea pigs are also disregarded by the pharmaceutical industry, which has become dependent on the routine participation of experienced research subjects. Arguing that financial incentives compromise the ethical imperative for informed consent to be freely given by clinical-trials subjects, Abadie confirms the need to reform policies regulating the participation of paid subjects in Phase I clinical trials."
Source:
"The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects"
https://www.dukeupress.edu/the-professional-guinea-pig/
There are certainly ethical questions about what these people are doing, especially if clinical trial administrators know this is happening.
Here's an article describing these repeat trial participants generally:
"Professional 'Guinea Pigs Can Make A Living Testing Drugs"
https://www.npr.org/sections/health-shots/2016/05/08/476797735/professional-guinea-pigs-can-make-a-living-testing-drugs
From this article:
(From one participant): "We are selling our bodies, most definitely ... well. renting. " (He claims to have taken part in more than 80 drug tests in the past 11 years).
and
"He says he can make thousands of dollars in just a few weeks. "Generally, the more procedures, the more perceived risk in a study, the more it's going to pay."
and
"Every time you see a TV commercial for a drug and they rattle off all the reasons why you shouldn't take the drug — that's all information that they got from people like me."
Also from the article:
" ... there's no question that these early tests in humans help reveal the potential hazards of experimental medicines."
"And for some people, especially those with a history of incarceration, clinical trials are a rare opportunity. "I can't get a regular job because I have a couple of legal problems in my background," (one man) says. But when he signs up for a clinical trial, "They're only looking at what your body does, not what you did."
"The vast majority of participants are under-represented minorities. In the Northeast they're typically black men, and in the Southwest they're typically Hispanic men."
From another participant:
"This is easy. And I'm getting full medical checks. Where else am I going to go and get labs done, physicals done, ECGs done, MRIs looked at and people are going to look at my body and tell me what is wrong with me before something's even wrong? ... Every time someone picks up medicine from a pharmacy, or gets a prescription, they owe a debt to the human guinea pigs. If it wasn't for people like us you wouldn't get that medication."
Criticism of this practice:
"How Duplicate Subjects in Clinical Trials Can Cripple Research Efforts"
https://www.clinicalresearchnewsonline.com/news/2021/06/22/how-duplicate-subjects-in-clinical-trials-can-cripple-research-efforts
which tells us
"These individuals go by many names: “professional patients”, “professional study subjects”, and “duplicate subjects”, to name a few. However, their involvement and unscrupulous behavior greatly threaten the integrity of clinical trials."
"Lying (about previous clinical trial participation) is quite common to enroll in studies."
"There are many cases where patients exaggerate their conditions to get enrolled. These are common in research regarding anxiety, depression, schizophrenia, and similar conditions."
"One of the screening questions was whether or not she ever had Botox. A “yes” answer would have triggered her exclusion, so she replied “no,” despite the fact that she had received it in the previous trial. She also fudged her age and got away with it."
"Research for promising drugs, procedures, or medical devices is often halted prematurely or fails to make it past the initial phase when duplicate subjects participate in clinical trials."
"For Matthew, clinical trials are a key source of income. One trial earned him over $30,000."
"Even one of them (an unqualified participant) is enough to skew overall results and reduce the efficacy of trials or studies."
So how common is this kind of unethical repeat participation by some subjects? While I was unable to find even a general statistical estimate of the number of persons who may be doing this, there was some comment that "it's a larger number than many may suspect."
And worthy of note:
"While there are various ways to approach the “professional patient” problem, one of the best ways to eliminate their participation is by using a robust and centralized biometric patient identification platform. This can help to blacklist professional participants in clinical trials, protect the integrity of trial data, and save pharmaceutical companies and their CROs (contract research organizations) a ton of money in the process."
That is, a national database of "registered" available trial participants, with a chronology for each of what trials they have already been in. Consulting their participation histories would tell if they will qualify, or nor, for an upcoming trial.
And a further note on what kind of income can be had from being paid to be a professional repeat subject in various clinical trials, drug tests, etc. Quotes from some articles:
" ... thousands of dollars in just a few weeks."
" ... typically around $200 a night spent in a facility."
"the contract research organization ... can fork over $3000 for a patient’s body for a three-week trial."
Further reading indicates it is very much a market-driven activity. The drug testers are usually under pressure to get testing done and results, hopefully positive, available as soon as possible. They prefer experienced test subjects who have shown they are reliable, show up on time, cooperate and follow instructions, and already know the testing routine. The test subjects, OTOH, especially the experienced ones, are aware of the pressures the testers are under, and use this knowledge to their advantage to negotiate favorable compensation rates for themselves.
It's hard not to feel appreciation for these people, since it was through their actions as test subjects that probably all of the medications that we take for PCa, or other conditions, came to be approved for our use. But the ethics of their participation are questionable for many.
A couple of other related (and interesting) articles:
The FDA's position on protecting would-be trial participants in general:
https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection
and
Some facts about trial participant deaths during testing (they do occur) :
https://www.crs501.org/news/press-releases/53-after-150-plus-treatment-related-deaths-in-clinical-trials-since-2014-lawsuit-is-filed-against-fda-to-increase-protection-of-human-subjects
Finally, a short video on completing the NIH form that would-be trial participants must submit before entering a trial:
https://www.youtube.com/watch?v=fngohqmk0ry&list=ploeuwsnjvqbjehcb4yai7_fdnfzfpemqk&index=3
Perhaps to sum it all up:
"Those on both sides of the trial — those who need the subjects and those who need the money — do an elaborate dance around rules which are designed to protect the safety of the volunteer and the integrity of the data. An unspoken collusion permeates the relationships between the contract research organizations hired by the drug companies to conduct studies and the pliable cohort of professional test subjects, without whom no drug would get approved ... (it is) an ethically challenging terrain."
Source:
https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3168673/
Our hats should be off to those honest and rule-following clinical trial participants who do it the right way, and are a valuable part of the process to evaluate the drugs we may evenually use.
As for dealing with the bad actors discussed above, the suggestion voiced in the bold-faced paragraph above, may be pointing the way to go.
Age: 77
Chronic prostatitis (age 60 on)
BPH w/ urinary obstruction, 6/2011
TURP, 7/2011
Ongoing high PSA, 7/2011-12/2011
Biopsy, 12/2011: positive 3/12 (90%, 70%, 5%)
Gleason 6(3+3), T1c
No mets, PCa likely still organ contained
IMRT w/ HT (Lupron), 4/2012-6/2012
PSAs (since post-IMRT): < 1.0
The world of the repeat clinical trial participant: the professional guinea pig, in it for the money
Hats off to our "battle brothers" here who valiantly signed up to help, in the right way, for clinical trials for prostate cancer treatments and new medications.
Several of us here have ridden the "first wave" when new treatments or medications were approved.
At my clinic, I was the first prostate cancer patient to undergo the "early chemotherapy" protocol when it was approved, the first fellow to agree to two new state-of-the-art genetic tests, and the first patient to try ZYTIGA.
I also agreed ~ based on my medical needs ~ to try 3 different forms of ADT injections, over time, in the belief that one would be shown to work better for me.
My true and trusted oncologist JOKED that I was a "guinea pig" during that time frame. I continue to benefit from what we discovered ~ that best helped me.
Some treatment successes I have had DID help my local doctors, with other patients. My main oncologist shared that with me. That was really uplifting.
My treatment history and data ~ with my full endorsement ~ has been entered into a vast data pool at Mayo Clinic.
This collective data is studied, over time, to help guide future research ~ and to assess treatment sequencing and efficacy.
I was happy to participate, and sought no compensation, nor was any offered ~ thankfully!
I DID feel my health treatment data could provide some additional insight, amongst thousands of others who did the same.
I think all clinical trial participants need to be carefully screened. I can certainly understand if travel or lodging expenses might be covered for a trial participant.
But this notion of "frequent flyers" ~ who are simply chasing down medical trials to "earn a fast buck" ~ that's something I would never do ...
Again, I owe a debt of gratitude to other prostate cancer patients, who have truly helped the cause ~ by participating, in good faith, in clinical trials.
A few thoughts & experiences to share ~
CYCLONE ~ # Iowa State University
PSA At Diagnosis In Year 2013 : 138
Initial Diagnosis: Advanced Prostate Cancer, With Metastases In Both Lungs
Age At Diagnosis: 48 years
ADT Treatments: LUPRON, FIRMAGON, & currently ZOLADEX
Subsequent Treatments: Chemotherapy (TAXOTERE) & ZYTIGA & RADIATION
Additional Consultant - Dr. KWON - Mayo Clinic
Current PSA Level: < 0.10 - Undetectable Range - Treatments Ongoing
Several of us here have ridden the "first wave" when new treatments or medications were approved.
At my clinic, I was the first prostate cancer patient to undergo the "early chemotherapy" protocol when it was approved, the first fellow to agree to two new state-of-the-art genetic tests, and the first patient to try ZYTIGA.
I also agreed ~ based on my medical needs ~ to try 3 different forms of ADT injections, over time, in the belief that one would be shown to work better for me.
My true and trusted oncologist JOKED that I was a "guinea pig" during that time frame. I continue to benefit from what we discovered ~ that best helped me.
Some treatment successes I have had DID help my local doctors, with other patients. My main oncologist shared that with me. That was really uplifting.
My treatment history and data ~ with my full endorsement ~ has been entered into a vast data pool at Mayo Clinic.
This collective data is studied, over time, to help guide future research ~ and to assess treatment sequencing and efficacy.
I was happy to participate, and sought no compensation, nor was any offered ~ thankfully!
I DID feel my health treatment data could provide some additional insight, amongst thousands of others who did the same.
I think all clinical trial participants need to be carefully screened. I can certainly understand if travel or lodging expenses might be covered for a trial participant.
But this notion of "frequent flyers" ~ who are simply chasing down medical trials to "earn a fast buck" ~ that's something I would never do ...
Again, I owe a debt of gratitude to other prostate cancer patients, who have truly helped the cause ~ by participating, in good faith, in clinical trials.
A few thoughts & experiences to share ~
CYCLONE ~ # Iowa State University
PSA At Diagnosis In Year 2013 : 138
Initial Diagnosis: Advanced Prostate Cancer, With Metastases In Both Lungs
Age At Diagnosis: 48 years
ADT Treatments: LUPRON, FIRMAGON, & currently ZOLADEX
Subsequent Treatments: Chemotherapy (TAXOTERE) & ZYTIGA & RADIATION
Additional Consultant - Dr. KWON - Mayo Clinic
Current PSA Level: < 0.10 - Undetectable Range - Treatments Ongoing