Thus Spake Zuska

Is the current economy making more people want to participate in human research studies, asks Isis?

In this new study here at MRU, we began advertising online last Wednesday. By Friday, my study coordinator had received 300 responses…I can’t help but wonder if the current poor economy is driving more people to consider human research.

Probably – I wouldn’t be at all surprised. It seems possible to me, though, that is just an exacerbation of the situation that obtained previously – which is that poorer people have always been attracted to participation in clinical research trials either as a means of making money, or as a means of obtaining at least some sort of health care, even though clinical studies are most definitely not about providing health care to the participants. That may be the other motivator for Isis’s applicants. Many people don’t really understand that clinical trials are not really places to receive health care.

When I worked in the pharmaceutical industry, a few of my coworkers seemed to have fuzzy ethics around this point, too. At least one of my coworkers was explicit in his belief that it was an ancillary “benefit” for clinical trial participants to obtain the attentions of medical professionals during a clinical trial. He insisted on referring to participants as “patients” rather than “subjects” (which I think is the preferred and correct term).

If you are wealthy, or even reasonable well-off, you have access to the best already-tested and approved health care and treatments on offer. Or you can figure out how to work the system and get yourself into Phase III clinical trials if your medical situation is such that there are no good tested options available out there. What you most likely aren’t doing is saying to yourself, “Hey! I could make fifty bucks if I sign up for this Phase I clinical trial, AND I’ll be helping out science, AND maybe I’ll finally get my blood pressure checked by a real doctor, too!”

I appreciate Dr. Isis’s sense of unease over the recent recruitment phenomenon. But I think it is just foregrounding an issue that has been there all along.

Thought experiment: Sometimes I have imagined a society where everyone is eligible for, and required to, participate in clinical research, akin to jury duty, or maybe like military service in Israel. Only when you were called up, you’d be assigned to a research study that was a good “match” – if you are healthy, you go into a Phase I or II; if you have a medical problem, you go into some relevant Phase III. Spread the risks and responsibilities out across the society regardless of social glass, gender, race. Of course its unworkable, but what would be the pros and cons of such a system? What things would need to change radically to make it work? Would drug development research need to move largely out of the hands of private industry or could it stay pretty much as it is?

Note I am not advocating for such a system, just floating it as a thought experiment to examine how we do things now and how we might do them differently. I have participated in clinical trials – as a student, just to get the money; as a researcher, with the goal of bringing a new therapy for a disease to market; and as a patient, in the hopes of helping doctors come to a better understanding of my particular illness. I’ve helped someone else gain entry to a clinical research study because no other available therapies were helping this person and we hoped the study therapy (it was open label) would work (it did provide partial relief that has persisted over time). So I’ve seen them from a variety of perspectives. The best-planned study in the world can be left with misleading results if participants are overly motivated by money, or by the hope of obtaining medical treatment for illness.

Comments

#1 FrauTech
December 15, 2009

I think though it’s not THE place to receive healthcare, for many it is a means to SOME level of healthcare. I used to work in clinical trials and many patients were not precisely “poor” (I’m sure the $5 per visit we gave them meant almost nothing) but had no other means of obtaining the drugs we were able to treat them with. Our drugs were ones normally available in similar combinations through HMOs. Obviously you risk being in the placebo group. And we didn’t provide full medical treatment for these people. But we were able to give them the drugs, have nurses looking at their problems and reactions that week, and referring them to free or reduced price clinics in town that perhaps they otherwise would not have known about. Some were extremely poor, and some homeless. I think a monthly visit with a nurse was still better care than they would have been getting otherwise. So I think the higher numbers of people in clinical trials are mostly due to people losing health insurance, and less to do with there being more “poor” people out there. People who have had insurance in the past may not be aware of the network of clinics or state/county programs that might be available to them, and clinical trials does get them into that network. I recognize many clinical trials do not operate this way, and so many people maybe never get access to the resources they think they will. But many still do.
#2 Shin
December 15, 2009

Why did you quote the “choose” in the title? Do you believe that someone who participates in a clinical trial because of their personal financial situation did not make a choice? If this is the case, I have to disagree: Nobody is forced by others to participate, and I honestly find even considering this idea very disconcerting. Everyone who participates chose to do so one their own free will, because they considered the perceived advantages and disadvantages of this decision and came to the conclusion that the first outweigh the latter. I myself participated in clinical trials and believe that they are a very good way to make money especially for people without any special qualifications. And if they don’t want to, they don’t have to.
#3 Constance Reader
December 15, 2009

I am in the clinical research industry and the term for participants depends on the perspective. Sponsors will usually call them “subjects”, however, the sites conducting the studies invariably refer to them as “patients”. The thing to remember is that to the site personnel, trial participants are real people with names and faces and histories under the care of the investigating physician. Many participants will volunteer for multiple studies over the years at the same time, and so become friends of the site.
#4 Sanguinity
December 15, 2009

#2, @Shin: There’s always the question of how many other choices are available to someone. Hobson’s choice certainly deserves quotation marks. That you felt unconstrained in your choices does not speak to whether your experience is typical or atypical.

As Sonia Shah points out in The Body Hunters, it’s easiest to recruit test subjects from populations with little to no health care available to them. There are reasons such populations present advantages to the trial designer (high incidence of people who are not already receiving treatment for the disease; high incidence of people who aren’t receiving confounding treatments for something else). However, as FrauTech points out, from the subjects’ side of the matter, many people who sign up for clinical trials do so because they see it as a way to fill a gap in their health care. At best, they’re seeking access to treatments that do not yet exist; at worst, they’re seeking access to medical professionals under the best/only terms they can get. So, not only do areas without comprehensive health care have more people who fit the profile that the trial designer needs, they also have more people who are willing to enroll in a trial — i.e., people who are looking at Hobson’s Choice.

As to whether your experience is typical or atypical, Shin, my guess is that the selection bias present in who reads Zuska’s blog (computer literate and science literate; access to internet, browser, and free time) is going to bias toward people who felt little constraint in their choice to become a test subject, and against people who feel constrained in their choices.
#5 Sanguinity
December 15, 2009

Re your thought experiment, Zuska:

Another question worth asking is who decides what trials get priority under each system. Under the current system, who decides which drugs end up at the top of the testing queue? What criteria/characteristics push a drug to the top? Under a jury-duty like system, who decides which drugs end up at the top of the queue? Again, what criteria/characteristics push a drug to the top?
#6 Shin
December 15, 2009

#4, @Sanguinity
I should probably have mentioned that, as a student, my monthly income is way below that of people who are on welfare where I live (Germany). I took part in the trials for several reasons, but primarily because I needed the money. I would not say, though, that I or anybody else in a similar situation does not have a choice: As long as the scientists conducting the trials are required by law to inform the test subjects about advantages, disadvantages and the possible consequences, I don’t see how any responsible mature person could not have a choice here as long as they are not forced. People who participate in trials do so because they believe that this improves their personal situation, and as long as they are not mislead, I don’t see anything wrong with that.

By the way, as far as I know Hobson’s choice does not imply that there are no alternatives, but that your choice consists in either doing something or not doing it. Thus, as any choice can be broken down into one or more yes/no choices, any choice is Hobson’s choice in the end.
#7 anon@anon.com
December 15, 2009

You have some strange ideas about clinical trials. I’d personally never sign up for phase I trials outside of cancer. But then there’s a lot more to clin trials than phase I pharma testing.

“He insisted on referring to participants as “patients” rather than “subjects” (which I think is the preferred and correct term).”
This is incorrect – They are correctly referred to as participants. They are also correctly referred to as patients (at last in phase II/III/IV. My understanding is that “Subjects” are only used in animal studies these days.

“At least one of my coworkers was explicit in his belief that it was an ancillary “benefit” for clinical trial participants to obtain the attentions of medical professionals during a clinical trial.”
There is. It’s quite well documented that even if in the placebo arm of a trial that patients derive benefits either subjective objective or both.

Disadvantaged people. Clinical trial participants are generally richer and better educated than normal clinical patients. The problem is phase I. But then you’re also allowed to sell bodily fluids in some places.

“Many people don’t really understand that clinical trials are not really places to receive health care.” That’s true. Patients are quite surprised when it is explained to them at the end of a trial that they are now being handed back to a treating physician for their medical care for their own sake rather than being in an experiement. Which brings us back to the problem of how to tell whether a patient has actually given informed consent and whether they can remember what it is they have agreed to months later. But that’s really phase II/III.
#8 Murfomurf
December 16, 2009

I have noticed that since I and several friends in our fifties have become unemployed, we have been volunteering for absolutely anything that will get us some income. Consequently, some of us have volunteered for clinical trials. It probably means that the trial sampling is changing in Australia to more low-income adults besides uni students. Since a lot of us older people are volunteering now, the age choices are changing as well- if there is no effort to balance age to be the same diversity as before the GFC, then we may be biasing results.
#9 phaseIcoord
December 16, 2009

The issue of choice is much more complicated than Shin seems to realize. It is often a big sticking point with Human Subjects ethics committees and review boards that the benefits of participating in a trial are not viewed as coercive. That is, studies are supposed to avoid the situation where the monetary compensation is such that the target recruitment population would be very unlikely to turn it down. Sure, everyone has a “choice,” but if the remuneration is such that it ends up being coercive, that is a red flag for most trials.

With the current economic situation, a higher percentage of populations might end up being coerced into participating in trials that they otherwise would not have considered worth the time and potential risks. That is VERY important to consider for the people involved in the design and recruitment of clinical trials.
#10 zylph
December 17, 2009

Shin? Wrong. We have to be careful in this country about informed consent, and doctors still get it wrong. I work in an environment where HIV treatments are being tested clinically. And the best patients, which are treatment-naive populations are, guess what, in third-world countries. And, as people are not lab mice, you cannot ethically not treat an HIV-positive person enrolled in your study.

So typically, the choices are, for the patient approached for the study: an an unapproved drug in conjuction with two or more approved drugs (monotherapy with HIV is not an option) OR the two or more approved drugs on their own. No matter what, you’re better being in the study than not. If the new drug alone will kill the African patient in four years, well, from the patient’s standpoint, it’s worth it. If she would die in two years anyway from AIDS.

This is coercion. There is no way around it, unless something fundamental changes about our world or how researchers view people/subjects/lab mice. (I think it’s fair, Zuska, for the majority of researchers in modern clinical trials to call subjects “patients.” If there was a question that the drug/treatment would cause more harm than good, it should have been halted well before trials). The sucky part is, with the best intentions of both parties, there is still coercion.

The ultimate situation is that there is no possible benefit to the patient whatsoever in participating in the trial. Unfortunately, this is, of course, impossible. The next best thing would be that the patient participating in the trial would be willing to take on the risks of the the treatment in exchange for fair monetary/health gains. And in the world we live in where, for many people, participating in a drug trial means adequate health treatment or the next meal, that’s not possible. I have no solution beyond it all fucking sucks and it should be better.
#11 JustaTech
December 18, 2009

I was offered a chance to enroll in a trial of a new HPV vaccine (more strains than the current vaccine) and I was really conflicted about it. On the one hand that vaccine is expensive, and I would like to be protected against more strains 9more is better, right?) On the other hand, I didn’t need more access to pap smears (wee) and more seriously to my mind, I’m not exactly the optimal test subject for exposure to HPV. Then my fiance freaked out at the idea of me being a a subject in a vaccine trial and I dropped the whole thing.

I’ve done other studies, but they were mostly by accident, and while the money was nice, so was getting to say “ooh, I’m a data point!”

There was a trial in Seattle a year or two ago that was offering a lot of money because they needed to infect people with malaria. People applied from all over the country for about 10 slots, it was crazy.
#12 DNLee
December 19, 2009

I’m definitely signing up for more studies because of money.
I encourage people I reach out to (online and in real life) to consider doing research studies. I know it’s important for multiple demographics to be included in the process. But the fear and distrust of research trials among poor people of color is real and palpatable. The fear is historically understandable, but not always rationale.

From personal experience as a subject and as a scientist, I feel confident that doctors explain everything. But there still could be a problem. If one is motivated by money or serious health issues to participate in a study (and assuming you don’t really get the whole thing about research trials), then one might say “yes I understand” when they really don’t. Or worse, not fully disclose present health conditions or don’t follow instructions carefully and then become injured from the study. An injury in either situation is problematic because it only re-fuels the distrust of science and makes the research institution look like it’s taking advantage of the most vulnerable citizens.

Yet, another and very important reason why scientific literacy and science outreach are so woefully important to under-served audiences.