Inside The World Of Clinical Trial Guinea Pigs
14 CommentsBy Ed Silverman // July 13th, 2010 // 7:04 am
What is it like to volunteer for one Phase I clinical trial after another? Why do people particpiate? What is at stake? How risky is this practice? And should there be more university oversight? These are among the questions that are raised by Roberto Abadie, a visiting scholar in the health-sciences program at the Graduate Center of the City University of New York, who spent a year living in youth hostels and group houses in Philadelphia and has just published a book about the subject.
“Philosophers and bioethicists are very logical, and they can construct strong arguments,” Abadie tells The Chronicle of Higher Education. “But what they can’t do is to go in there and do what I did—to do an in-depth ethnographic analysis, spending weeks and months with volunteers. Knowing who they are, what their neighborhoods look like, how they go through the trials, how they think and talk about the risks they’re taking.”
Some guinea pigs participate for the money, of course, and you can imagine how much more popular this has become during the Great Recession. Others, however, such as HIV patients, enroll because they feel they have personal stake in the development of new drugs and, therefore, gain psychologically, not just financially, he says. Nonetheless, he finds that many participants are in a state of denial over the possible health risks involved. And the best way to reduce risk is to examine financial conflicts of interest among researchers and universities.
So Abadie would like to see Phase 1 volunteers be recognized legally as workers, which would offer them protection under labor laws, and favors the creation of a national registry of Phase 1-trial participants. Why? He thinks a central database would prevent people from participating in too many trials and could help researchers identify long-term adverse effects associated with certain trials. What do you think?
Should His Ideas Be Adopted?
- Yes (65%, 75 Votes)
- No (35%, 41 Votes)
Total Voters: 116
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pharmavet
A national registry of Phase I volunteers will never happen because it is entirely inconsistent with HIPPA and other laws protecting privacy and confidentiality. As a practical measure it is impossible to prevent too-frequent participation. Most Phase I protocols require that the subject not have participated in a Phase I trial at least 60 days prior to enrollment to allow for a proper washout interval, prevent possible drug interactions, and prevent anemia from frequent blood draws. However there is no practical way to verify this at the time of screening.
On an episode of “Law and Order”, one of the characters states that he can earn up to $70,000/year from Phase I volunteering. I believe such a statement to be completely plausible from my experience.
In the real world what is happening is that, especially for life-saving drugs companies are moving gradually from healthy volunteers to patients. I find this attractive not from the time-saving point of view, but the fact that certain classes of drugs are tolerated differently by patients than by healthy subjects. This is particularly true for psychotropic drugs, where oftentimes the dosing information that you get from healthy volunteers is not particularly useful in selecting dose ranges for Phase II studies in patients.
pharmavet
Correction on the above. Most companies require that the subject not have participated in a prior Phase I study for at least 30 days prior to screening, not 60.
@craiglipset
I would never say never.
A registry of participants for Phase I studies has been considered in the US and Canada before. It has merit to protect both participants, and the integrity of the studies.
A registry would not need to track health information, only that an individual participated in a particular clinical trial on a particular date. Since most Phase I trials enroll healthy volunteers, having participated in a certain trial does not necessarily imply any information about your medical history. And participants to sign an informed consent, which could theoretically include permission for inclusion in a registry.
Not to say such a system would not be without enormous logistical hurdles, but there is merit.
Dr. Talluri
Interesting…so someone like to see Phase 1 volunteers be recognized legally as workers, which would offer them protection under labor laws, and favors the creation of a national registry of Phase 1-trial participants. The idea is interesting but may not be future worthy.
As more and more evidence coming to light, that the PK/PD, safety and tolerability profiles can be vastly different in patients vs healthy individuals, regulators are pushing more and more studies to be conducted with target patients, not in healthy individuals (they are actually volunteers- some are professional-as mentioned above make a living doing this). This will eventually become mainstream for NCEs.
One area where the participation of healthy volunteers will continue could be in the generics, where most of the time, the requirement is just for bioequivalence studies.
JaT
A little nostalgia:
When I was a kid in the 70s, busses used to go around gathering people of all ages to pick berries, green beans, or whatever was in season. You could make some really decent money picking if you were good at it, being paid by the flat. Whole families used to go on weekends to pick together to fund vacations. Teenagers picked to finance their cars. Then came labor law advocates complaining over minimum wages & child labor rules. If you didn’t work hard you didn’t make enough money to sit in a field all day. And the farmers would rather not have you there.
Now these are seen as the jobs that Americans don’t want to do. Maybe kids these days don’t - but farmers sure didn’t have a hard time finding pickers back then.
Now we have little girls being hassled for having lemonade stands without a business license.
Why should pharma be exempt from labor laws?
Come on - these people are not volunteers. Volunteering requires wanting to do something good for someone other than yourself. They do it for the money or for their own treatments - making them employees.
I suspect the reason they are called volunteers and are not treated as employees is because pharma might find itself in violation of the Americans with Disabilities Act, or child labor laws, or some other rule that would find them discriminating against people with conditions that would exclude them from a study.
pharmavet
JaT, Phase I volunteers are indeed just that because they are completely free to withdraw their participation at any point in the study, just like in other types of studies. In terms of worker protection, go into some Phase I Units that are, for example on a restricted upper floor of an upscale hotel (yes this does occur as a revenue source for the hotel), and the volunteers are treated to great meals (room service excluded), wide screen TV and beds with down comforters. Aside from the few times that they actually have to do something that might be considered “work” (like giving blood), the rest of the time they are treated like well-pampered guests. I would hardly call these sweatshops.
JaT
Anyone can quit a job whenever they choose. Great meals lend to fed or fasted testing requirements. Of course the “volunteers” are made comfortable- a study may not get far if everyone was uncomfortable. And even I have stayed in high end hotels for job related business. Certainly you have too. So?
Now I’m just being obnoxious.
:D
pharmavet
Drug companies might very well be happy to see Phase I subjects classified as workers, since that classification would effectively indemnify the company against claims directly against the company. The injured party would then have to go after the company in Workers Compensation Court. They may then receive a payout or settlement from the company’s insurance carrier, but the reality is that compensation judges are far less generous with payouts than those that hear personal injury cases in product liability lawsuits.
PK
@pharmavet There are several companies in the U.S. that have produced HIPAA compliant solutions to track healthy volunteer subject enrollment across non-affiliated research sites [to prevent cross-enrollment / over-volunteering].
The real challenge is getting CROs to care.
pharmavet
Thanks, PK. Another big headache for Pharma are patients who enroll in more than one trial for the same drug, which has been known to happen, and is usually picked during database review. This really messes with the statistics, since a given patient can only be counted once.
Also, with Phase I, it is not impossible for the same subject to enroll in different studies under a different name, using fabricated credentials. Since subjects are paid in cash most of the time, they don’t have to worry about receiving a check that they would have to cash. This is not as hard as it may seem. For example, a driver’s license ID scam landed former Illinois Gov. George Ryan a prison term.
PK
@Pharmavet, I believe the cash compensation model is more common with academic research institutions, and generally for lower amounts. For healthy volunteer clinical trials conducted at CROs, subjects are often compensated in the thousands and they are issued checks. Subjects must also complete the appropriate tax forms, and in some cases provide a piece of mail to verify home address before they are allowed to participate in a trial.
raquelle morgan
i have been in several clinical trials, mostly with older women. many of the volunteers have medical issues that they conceal from the research center staff. worse yet, some of the doctors choose to ignore many side effects. i suffered severe side effects from an escalating dose trial of an unapproved drug and was stonewalled and told that there was “no scientific evidence” for my symptoms. later, i researched online and found that my symptoms were similar to ones from a similar drug. i am still having some of the symptoms 2 months later. some of us were desperate for money. one 70-year-old was living on basically nothing. she concealed that she had peripheral artery disease and had had cataract surgery. others in the same trial concealed worse conditions. i think the best solution will be to go to patient trials only.
M.
I have participated in paid research studies. I do not agree that people who participate in study after study should be considered “workers.” Most volunteers are lazy, and irresponsible types whom disrupt the study and the social atmosphere in the research facility. Often the staff of research sites are like teachers in under performing schools. They have to keep the unruly, ineffective, even violent volunteers in the study once the study is started. The disruptive volunteers prevent more serious volunteers from carrying out their own part of the study right,as has been my experience. I have heard some career research participants say that there ought to be a union of “lab rats.” I would object to bringing the politics of paid labor into what should be should be an elective act of altruism. I know that the irony is that no matter what, it is all about money not really benefiting science, medicine and mankind; and yet it would not help to unionize research volunteers, or to legally declare them as “workers.” (Volunteering in research is male-dominated because there are strong policies against using females since there is great fear of pharmaceutical companies that an experimental medication can harm a fetus. To make a point, I have trained in a male-dominated field , electronics, and have heard from females that when males harass them or steal from them or threaten them they cannot call the police because it is considered turning against one’s own union member, and the employer often cannot fire a unionized worker even if he commits certain illegal acts. Women are disadvantaged in unions meant for male-dominated occupations). I think that a special legal system has to be set up so that research volunteers are given certain particular rights that pertain to being research volunteers. Research facilities that recruit volunteers should be held liable if there is volunteer on volunteer violence, or harassment (etc). Volunteers should be held liable if they intentionally do not carry out their part of the study right. After all, if they deceptively participate in more than one study at once and/or are hiding prior drug-abuse histories they could be altering the results of a drug that is going to go on the market and could adversely affect the health of the public.
All this is easier said than done, I know. Yet I have seen such corruption and inefficiency in research studies. I know about it first hand as only a concerned career lab rat can.
original industry insider
M, you seem to know the score. By now you should have made enough money as a career lab rat to start your own CRO and do things the right way.