Journalist who wants to talk about your experiences

[maggiekb]

My name is Maggie Koerth-Baker. I'm a science journalist (science editor for BoingBoing.net and a columnist with The New York Times Magazine). I'm currently researching a possible story on healthy volunteer studies and I'm looking for some volunteers who would be willing to talk about their experiences (ideally with a real name attached, but that can be flexible - let's discuss). 

The story was inspired by conversations with doctors, including docs who run other kinds of clinical trials, who have told me that they think healthy volunteer studies are immoral and should be banned -- that it's wrong to experiment on healthy people who don't get a medical benefit from the treatments. I'm curious about your perspectives on this. I'm also curious about some of the side effects that several people talked about in honestlabrat's recent post about being picky with studies. From the doctors' point of view, the risks of those side effects (and the much more rare cases where people have died or been seriously injured) outweigh the benefits of a cash payment. It would be one thing to take the risk if you have the dis that needs treating, and maybe this can help you, they say. It's another thing to ask people who have nothing wrong with them to take that risk. They see the payment as a form of manipulation, in this case. One doctor told me that healthy volunteer studies were, in effect, preying on the needs and sometimes desperation of people who just want to survive. 

I'd love to talk to volunteers about how they view the trials they participate in, and the system of using healthy volunteers as medical guinea pigs, in general. I'm also curious to know what you think about the perspective I'm getting from doctors who want to see the practice banned. 

I'll be checking here, but if you'd like to talk, please do email me. You can reach me at [e-mail]. 

[travelingrat]

the issue for me is lack of protection of volunteers. the FDA does not provide direct oversight to volunteers (except in government trials such as NIH trials in bethesda) as supposedly that is done by the IRB for each clinic. there is a very incestuous relationship between a clinic/CRO and its IRB. a clinic can shop around for an IRB who will give them the answers they want. i have had negative experiences with many IRB's. i tried in january or february to get more info about possible side effects of a drug that was being tested at a large southwestern clinic. i emailed them that i thought the potential side effects were too strong for the elderly population that the drug was being tested on, and that the dosing schedule for each cohort should be much more gradual. i also made the point to them that if healthy volunteers become damaged, then any benefit to a patient with a condition is cancelled out. they do not understand this logic since the bottom line is profits. they kept saying they would email me back but finally all i received was a terse comment that if i thought the study was too risky, i should not do it. they made no attempt to send me any drug info at all.

i managed to glean some info from the internet but that was it. and the doctor at the second screening knew NOTHING, even gave me misinformation, said that there were NO human studies, only animal studies, even though right on the consent forms it was revealed that some humans who had received the drug developed parkingsonism. my question had been, were the tremors temporary or permanent? i did not want to go into a study and come out having permanent tremors. the consent process is usually a big joke ... any questions a rat has, he/she is told, ask the doctor at screening ... then the doctor is in a big rush, makes jokes, or has no knowledge whatsoever of the study, just is there to satisfy minimal requirements of choosing healthy volunteers.

imho, clinical trials in general are a black hole of corruption and deception. but because of many sad things that have happened to me in this life (no worse than lots of us in this business, i don't mean to sound sorry for myself!), i need the moola desperately and will keep struggling forward. i do believe that all of us should be asking MANY more questions at the screenings and i try to encourage rats that i know to do so. if nothing else, it lets the clinic know that we are not just dim-witted subjects, but proud, intelligent humans who care about our bodies and our lives. i wish there were more ways for rats to network before a trial begins ... i think also that many studies are underpaid and should be challenged at the outset. the clinics know just how desperate a lot of us are and really take advantage of that fact. if we could even get the food improved ... wow what a wondrous accomplishment that would be.

feel free to PM me but my laptop is fried so it may take a while for me to respond, jsut depends on whose laptop i can borrow.

[idoitforthepong]

I would have to disagree with the doctors that think trials are immoral and want them banned. If anything question the morality of testing on animals that don't get nice informed consents to sign. All of us human lab rats know that this is OUR decision to participate and we can opt out anytime...soing those beagles and real rats cant do.

I would like to see some hard data on the number of subjects that have had bad and long lasting side effects from a study out of all the subjects that came out ok. My guess is it wont be that higher than workplace injuries in some fields...even the more benign ones. Just speaking anecdotal, i know i haven't had any problems after doing this about two years and have just heard of a few cases of subjects getting sick temporarily from the drug but no hard-core side effects. Yes there is risk (small as it is), as there is everwhere in the world. Compared to other jobs i've work "lab-ratting" is one of the safest ones. I've almost been killed by falling tree limbs (one week at that place), fallen off roofs, passed out from heat exhaustion. And white collar jobs are not immune to ill effects as well: i've developed carpal tunnel and eye issues from a desk job! To me the riskiest part about studies is the early morning (caffeine and foodless) multi-hour drive to clinics, after all 1000+ people died in my state last year in auto accedients...0 deaths in trials.

As other are saying i do question some trials out there and do my part to diligently read and ask questions in the interviews. Some trials may do some questionable things that i will avoid...nasa trials are one of them. I think the clinics do their job well, i question big pharma since there are companies that have rushed studies or outright manipulated them. I more so question the morality of drug sales people and their relationships with scrip happy doctors.

Good luck on the article..i'll be curious to see it.

[carmel]

Jun 6, 2013 11:21:51 GMT -5 idoitforthepong said:

Some trials may do some questionable things that i will avoid...nasa trials are one of them.

I see this said often on this board. I think honestlabrat was the last one to say soing similar about the NASA studies. You guys mainly don't like the Houston bedrest studies, no problems with the sleep studies in Boston, right? Is it the deconditioning that the body goes through you don't like? You gain all your bone/muscle/heart back as long as you upkeep the physical rehabilitation by working out regularly months after you go. You should be strength training 2-3 days a week anyway, studies or no studies. To me the NASA studies are safer as there are no experimental drugs you have to take. They also put a lot of care into their subjects unlike the harsh treatment you can receive in pill studies. I know I must be in the minority here in thinking that way.

[idoitforthepong]

Well carmel sounds like your in the "don't knock it till you try it camp" with regards to the nasa studies. Props to you for going through with one though...that takes a unique individual. Me, i will still knock it (but will try to keep it to myself) but will NOT try it. I think most subjects like the down time that comes with trials, there is a lot of freedom in studies...as free as you can be behind clinic doors anyway. Being "chained" to a bed 24/7 is not my idea of freedom. That has to take a toll on you mentally and physically. But hey if your a patient person (i'm not) and you can pull it off, that's some good money...and you can help NASA with it's star wars program or whatever their up to these days.

Back to the original thread above: One big question i still have is what do these Doctors that are championing the ban of studies propose as a alternative to clinical trials?? Skip healthy subjects and head straight to the later phases? Test more on animals...gitmo detainees? (kidding on that don't go aclu on me) Really i would like to know what kind of plan they envision without phase 1 trials?!

[travelingrat]

i am not for the banning of healthy volunteer clinical trials either ... but i think there should be big changes in the consent process and also better protection of volunteers. i have been in 2 studies where some of the nurses actually discouraged the reporting of side effects and said that the clinic wanted to be able to present a "clean" (i.e no side effects reported) study to the sponsor. i have also been in 2 studies where i had to insist that my side effects were recorded. i have also been in a study in which i had major side effects and was treated like s--t. and i have had lesser side effects in other studies and not felt well taken care of. and i do know other rats who had bad side effects, and a few of them totally camouflaged them ... some clinics put it down in their files that persons who report side effects are "unusually sensitive to medication," and thus not good candidates for future studies. how do i know? it happened to me, and others too. we should be protected from such policies.

i do also know a number of rats who have NEVER had side effects ... that is great ... most of them (of the ones i know, that is) have been in the first cohort of a study or have the financial means to pick and choose ... but if you ever do have side effects, under the current system, you may be treated very poorly at a number of clinics, even major ones, so it would benefit all of us if more protections were to be put in place. i would like to know if anyone has ever received help or answers from an IRB. all i have ever gotten is: nothing!

one thing that could easily be done in Phase I trials is to not escalate the dosing in such high increments. what is the point of pushing a huge dose onto Group 5 cohorts just to see what is going to happen, especially if there have already been side effects in groups 3 and 4?

a bit off-topic perhaps: i think as humans we should also be concerned that more and more pharmas are their trials to third-world countries, or considering doing so. what oversight will be exercised in these countries? it reminds me of when certain pesticides started being banned in the US, and the corporations started heavily promoting them in the poor countries of the world.

anyway i am not going to stop doing clinical trials as my user name should be "desperate rat" instead of "traveling rat." but i AM going to keep encouraging others to ask questions and speak up for their rights, and remember, there is safety in numbers,if you have soing major to complain about, try not to do it as one person, get your fellow rats to join you!

and i hope that the NY Times article may spur some positive changes, even if they may be only small ones.

[carmel]

Jun 6, 2013 18:34:07 GMT -5 idoitforthepong said:

Props to you for going through with one though...that takes a unique individual.

No I haven't actually done one of those studies. Sorry if I sounded like that. However, I've done a lot of research into them so I know what I'm talking about. I've also looked at a few different journals of past participants who wrote down some detailed information about them. There's quite a bit of literature out there on those studies. I agree that it would be mentally difficult to do. That is why they don't accept just anyone. With the exceptionally high rate of failure to pass their Screening, it's very likely that you, honestlabrat and myself wouldn't even pass to get in anyway.

[labrat1]

I have so much to say that I don't know where to begin.
I am afraid that what some people say here will drown out the real issues that should be brought up.
I will probably post my comments several times here.
I don't like the comment by "idiotforthepong" in that it seems to say that volunteers don't really have it bad and that there are few cases of vounteers suffering very bad, or dying, and volunteers can always quit, and there is no need to consider doing away with phase 1 studies, and that the doctors who think it should be banned are wrong to think that it is exploting vulnerable people.

I do have to admit that in a sense it is true that other jobs exist with dangers so why single out guinea- pigging as particularly harmful to humans ? After all, human lab rats undeniably do have a good deal in just staying in a dorm for a few days and swallowing medicine and ten getting paid a pretty hefty check. So, saying that lab rats are so ultimately oppressed is not exactly fitting, unless you consider certain matters. I would still say that certain volunteers are indeed at great disadvantage, and in general, have teir rights violated .

I will post more on this. I definately would want to talk with the person who started this thread.

[vark]

hi maggie. i post at boingboing as arbitraryaardvark. i enjoy your work. happy to be quoted. overall i strongly disagree with the anti-study perspective of the people you have talked with. life entails risk, many jobs are more risky than what we do, and in my neighborhood not having any income is itself very risky. doing studies i've been able to a house and pay the bills; this is way better than being out on the street. it also beats the kind of jobs i had when i was younger and more desperate - stuff like working at mcdonalds. if anything i'd like to see what we do acknowledged as an actual job. we are called "volunteers", and there's a lot of hippocracy (sp) in the business. like, there can be pressure from irb's to keep the pay so low that it's a struggle to make a living wage. i don't know any other job that has similar constraints.

while i am overall positive about the industry, i have had problems with specific companies, lying or withholding information, and then as travelingrat said the irb is no help and there doesn't seem to any other recourse.

here's a recent example. 10 days ago i met a guy, andrew x, who had a story about how he had been banned from a certain clinic, the one that around here we call "the clinic that cannot be named." I don't have any way to verify whether what he said is true, i'm just repeating what he told me, as best i remember. because he ended up not getting into the study i'm doing, he went home before i could get his contact info.

he was screening for a study. edit: maybe he was checking in. he mentioned to one of the other people screening, a link to a post here at jalr, linking to medical articles about the drug. the articles said that the drug should not be given introvenously (sp), as there was a high risk of death. the study called for the drug to be given introvenously. a bunch of people decided they didn't want to be in the study, and they ended up not being able to fill the study and had to cancel it. they banned him from further studies there. if this story is true, it may be related to a cease and desist letter this site got, so that studies from that site are no longer listed here.

=
edit: i'm not saying we should be classed as employees for tax or employment law purposes. independent contractor is closest to what we are, which is a sort of dependent contractor - we don't bring our own tools or make any of our own decisions about how the job gets done.

[travelingrat]

hi vark: i am inclined to believe that guy as i have had problems, and rats i know and trust have told me of their problems, of being banned at clinics or kicked out of a particular study, for merely trying to get info, or asking logical questions that are eived somehow as "against" the clinic, or whatever.

simple changes i would love to see: 1) total transparency re consent. right now nearly every clinic i have been to, the nurse or tech ushers the rats into a room and reviews the consent forms... if there are questions, we are told to "ask the doctor at the physical exam;" when the exam happens, usually it is very hectic, usually the doctor doesn't know any more than what is already on the consent form, can't tell us whether the side effects listed were short-lived or went on for a while ...etc. etc. etc. i don't understand how it is even legal or right that we are asked to sign the consent BEFORE being able to ask questions of the study doctor. and sometimes there are temporary doctors who do not even work for the clinic who are brought in to help perform the exams, and know less than zero about a study. those of us who have questions (i know many rats do not care, but some of us do) should be able to ask a doctor or researcher who KNOWS what the study is about and can really give answers at least about what is KNOWN about side effects that have occurred.

i also think that the consent forms should be posted online as soon as the study dates are posted. that way it would be possible to discuss a study with others or God forbid, one's own doctor (for those of us fortunate to have health care). i reject the idea that there is secret privileged info in those forms that competitors might get hold of, as i was once told when i proposed this at a clinic.

2) i believe there should be recourse to some office in Health and Human Services or the FDA or whoever has ultimate jurisdiction, that if we cannot get answers or help from a clinic's IRB, there should be a phone number we can call connecting us to an impartial government representative. i agree that MANY other jobs also carry risk and that most studies are benign or at least just involve side effects such as nausea, vomiting, headaches, whatever, but once in a while there are major problems. when huge problems happened to me, i was treated horribly and had nowhere to turn. this is why i keep advocating for more protection, outside the clinic and IRB when necessary.

and i also do believe that some studies, especially escalating dose studies, go beyond what is necessary, with the sponsor perhaps too interested in the results and not interested enough in the humans who are dosing, and seeing them as expendable. i was in a study with elderly (65-80)where most of the subjects were vomiting numerous times every day (1 old guy fainted, hit his head, went unconscious, and left in an ambulance), and yet the sponsor went on with another cohort. and no, no one quit, because if we quit, we would not receive full payment. to me, such a scenario is simply wrong; maybe that is just me, who knows. right now there is no one to discuss such things with as the IRB's are useless in my experience.

3) on a lighter note, but i still advocate for this (!!!!!): i think every sponsor should be required to provide enough money for catered meals of high quality. even studies with no-salt diets or other requirements can be prepared at good restaurants. i have been in a few studies with excellent food and it makes such a difference.,,, realistically it probably makes for fewer side effects! the pharma corporations make billions ... they can manage to provide the funds for excellent food for us. we let them dose us, stick us with needles and suck out our blood, diligently collect our pee and sometimes our poo (ugh), provide skin biopsy samples, etc. etc. ... so give us some really good food. why not??!!!!

[idoitforthepong]

Travelingrat, i'm sorry to hear about your negative experience with the IRB and other clinics that suppress side effects and other non professional and corrupt behavior. I't is a shame that goes on and we as lab rats should not just let it go just because we want to see those dollars. I have not encountered any of this nonsense but i'm sure there are some questionable clinics out there somewhere.

We should all report AEs/side effects as accurately as we can. All of the clinics i have been to do stress this at the beginning of the but unfortunately it does seem to go over some subjects heads. I think a clinic would rather have a honest subject that reports things then one who just "sucks thing up" all the time...and thus distorts the science of the study.

It's sad to hear the story about the elderly gentleman hitting his head after passing out. Though clinics try their best to curb this I think they can do more to ensure our safety and make sure things like this DONT happen. For one thing, have easy access to nurse CALL buttons. Some places have pull cords in the room and bathrooms which helps, while some don't. Some times you just have to rely on others around you to look out for you. But if your the only one in your room and at the end of the hall what do you do if your having an emergency or pass out??...hope someone can hear you yell or gets to you sooner or later!? I'm not advocating making us all wear helmets and sit rooms with padded walls, but a little more thought and care for patients safety is a good start.

[labrat1]

OK so participating in research studies is no-more risky that holding certain other jobs such as being a construction worker, or being a coal miner, or maybe someone who works making dangerous chemicals , and don't forget that a lot of migrant farm workers have to pick vegetables in the hot sun, and I have heard that airplanes fly over their heads spraying pesticides and the farm workers have gotten sick because of those kinds of hazards to the job.
That being said, other jobs with risks are regulated and there are worker's rights as well as unions that protect worker'r rights ( except in cases in which an employer illegally hires undocumented people or other poverty-stricken desperate people who are illiterate (etc).

In research studies, it has been my experience, as well as the experience of my good friend "travelingrat," that IRBs generally do nothing for the rights of the volunteer. This is because , in the first place, the rights of research volunteers are not even legally defined. The only rights that are most established for human lab rats is the right to get a signed copy of the consent form, and the right to quit the study at any time. The right to a signed copy of the consent form is a very backhanded right since the consent form often does not describe much. The CROs only do the bare minimum required so as to keep themselves out of trouble with the law. Whatever they can get away with, they will try to get away with.
There is no "right" of the lab rat to be heard should s/he have complaints. Volunteers have no "right" to privacy while in a research facility. Often volunteers are put together in the same large bedroom, males and females. My lab-rat friend told me that when she complained to night nurses about feeling some severe medical symptoms from a study drug she was told by the night nurse that the staff have no obligation to watch over volunteers who are feeling sick. There are no regulations for CROs to follow regarding having "too many" volunteers in one dorm and in some CROs a dozen volunteers will be crowded into a room that is actually only meant for half as many people. Research volunteers are not like government volunteers or other kinds of volunteers who have rights defined by workplace laws, and also have responsibilities as defined by workplace laws.
People who volunteer for charities have rights to be protected from unsafe conditions, and even a hostile work environment and sexual harassment by other volunteers or by employees of the company. In certain cases an employer must provide the same rights to a volunteer as to an employee.

With being a research volunteer, nothing exactly addresses such a situation. It seems it should, but with the way CROs do things, there is no way to legally challenge them. In outwardness, it is just assumed that since the volunteer and the CRO enter into an agreement in which the volunteer will obey the study protocol and the CRO will treat the volunteer like a patient and care for his or her needs since the volunteer is very much a patient after being dosed.
But if the CRO does not listen to the patient's complaints or somehow avoids making the volunteer's stay at the CRO safe, or if the volunteer is threatened by other volunteers (etc), the volunteer's only recourse is to complain to the IRB and if the IRB does not get involved, which very often is the case, then the volunteer actually has no recourse. S/he cannot sue since s/he has the right to quit. The entire scenario is left up to the "good will" of the IRB and the study doctor and other study staff. It is assumed that they all are acting within ethical guidelines and if they all say that the volunteer is hard to please and should not be allowed to do studies, then no one will take the word of the volunteer that s/he was not treated right nor were his or her concerns taken into consideration by the IRB which is supposed to oversee the volunteer's rights.

There is no area of law that addresses the rights of research volunteers. There are workplace laws for people who are employees of a certain company or business, there are medical malpractice laws for cases in which there is absolute proof that medical personnel had misdiagnosed a patient or mistreated a patient or did not take proper steps to oversee the patient's well being. (etc) but there are no laws regarding the rights of volunteers who take part in phase 1 studies. People who have medical conditions and participate in research studies so as to be treated for their condition are the main persons who are referred to when it comes to research volunteer's rights.

Again the only rights that volunteers who participate for money and have nothing to gain from the medical experiment, only have the right to a signed copy of the consent form and a right to quit the study at any time.
Often the volunteer wants to participate and earn the money, and his/her desire to participate is used against him/her by the research staff. The volunteer is made to feel that if s/he complains then s/he cannot participate in the study.

There is still a lot more to be said. I will post more later on.

[labrat1]

It seems some lab rats think that our status should be officially changed from "volunteer" to "employee."
I discussed this with a fellow lab rat.
I was told that since the compensation is taxed, it means that the IRS thinks of what we earn as soing that is relevant and there is an acknowledgement that what we do to earn the money, is "work."
I am not so sure about the part regarding the IRS considering our earnings as soing significant and related to the "work" we do.
People who win lotteries for millions ( or less) have their winnings taxed. They did not work for the money, just gambled. It goes for people who win big at horse races too. It can't be said that the IRS taxes those winnings because it considers the money as soing significant related to the "work" that a gambler put into winning.
I was also told that it would only be a matter of changing the definition from "volunteers" to "employees."
This way there would be a better way for lab rats to have better protections. Employees have rights.
However I would be against unionizing. The reason why is that unions only tend to trade-off the kind of problems that their members have. Women tend to be very disadvantaged when it comes to being employed in a male-dominated field that is unionized. If she encounters sexual harassment or a hostile work environment the union only protects the male members from being fired or even disciplined in any way. I have heard this from women who work as construction workers, or electricians, etc. Being a test subject is actually a male-dominated field. In one research facility I went to, I found out that the women's bathroom is rarely used by women, only when there are women volunteers in the facility, and when there are women volunteers in the facility, a sign has to be put on the women's bathroom saying that men are not allowed to use it currently. Otherwise, it is all-males in the facility and they use the women's bathroom. Female volunteers are often also required to be surgically sterilized which is bizarre. It is impossible to get such a surgery just to participate in clinical trials.

I also feel that it would be trading altruism for the politics of paid labor. Of course I fully realize that people participate in clinical trials for money, and it is rather phony to say it is for the betterment of humanity and the development of medications that would help people. That is actually going into a different branch of the issue; but before clinical trials became so lucrative, there were people who participated for only a few dollars or because they wanted to help find a cure,and sometimes even for the adventure of it.(If any of you have access to a library which has archives of old newspapers even on microfilm or some other such format, there is an excellent small article that was written back in April 30 of 1972 in the New York Daily News's magazine section (a Sunday-edition magazine with different articles). The article was called "Testing Testing" by Dan Carlinsky and I actually have located that article in the archives of the NY Public Library and have copied the pages from a microfilm. (I am not sure if you can see the attachments here. I am taking a chance on doing it).

It tells of how some college students used to do research studies for $30 or $40 a week. But any of us who is aware enough knows that research studies began to be carried out by for-profit Contract Research Organizations slowly starting sometime after the 1970s, and it created a need for rapid enrollment of research volunteers which was facilitated by offering significant to astronomical amounts of money for swallowing medicine and being isolated in a dorm. It got to where there was much to gain by the pharmaceutical industry and the CROs and the volunteers by being corrupt).

My friend told me that people being employees does not give them an instant right to unionize and also lab rats tend to be under-educated, and/or unconcerned with politics and simply are not the type of individuals who would get together to unionize. They just want to make quick bucks and not be bothered with anything really intellectual or bothersome.
True, but then when it came to certain migrant farm workers, they too were ignorant, under-educated, politically-un-involved individuals and someone drove them to unionize.

Also, once a lab rat is dosed, s/he is a patient even though not like a patient who went into a research study with a medical condition.

A generally healthy lab rat who participates and volunteers his or her healthy body to be experimented on is not like a "worker."

It seems that patient-rights should definitely apply . A volunteer has to see to it that s/he is on time for blood draws and has to eat certain meals served to him ( etc) and it could be said that the volunteer has certain " duties" just like in a job. But even if a volunteer were called an employee s/he still would have to be given the right to quit the study at any time. Sure, this would be true in a job; an employee can quit at any time otherwise it is slavery.

Still a volunteer quitting a study does not have to mean that s/he cannot be allowed into another study at the same facility. I know that a lot of research facilities do decide to permanently oust a volunteer if s/he quits a study, but that is beside the point. It seems that if a volunteer is instead an employee, then quitting a study means quitting employment instead of quitting volunteering. In employment if you are a temporary worker and have done certain temporary work at one company various times, say you have been a receptionist during the holidays for a company which gets lots of calls during the holidays, and one time you decide to quit during a particularly hectic holiday season, you are just quitting one particular temporary assignment, but you as a worker and not a volunteer can be fired and not allowed to be a temp again.

Being a research volunteer means going to and from different research facilities to do different research studies. It is essentially doing temporary assignments at different locations and then often coming back to the same locations for another assignment.

There are many volunteers to choose from and usually no one volunteer is so valuable that a research site would worry much about hanging on to one volunteer ( unless the research facility itself is such a principled one that they appreciate good volunteers and try to keep reliable , responsible people). It is the same deal in being a temporary employee. Yet, there is a very counter-reversed irony. Volunteers are not employees and are not officially "hired" in the first place so they are not to be "fired."

I just don't see how it is possible to start calling volunteers employees as there are dynamics that would change and become more complicated. If a "volunteer" is considered an employee wouldn't s/he be a "job seeker" when s/he applies to the research facility and wouldn't the research facility have to interview him/her as they would an employee and ask him/her why he wants the job and how can s/he profit the company and what are his/her qualifications ( questions that all employers would ask employees)? How does that apply to being a research volunteer? Of course there are more responsible volunteers than others, there are more experienced volunteers than others, but then there is a need for rapid enrollment so ( as my friend told me) it is likely that the "hiring process" would remain the same and groups of research volunteers would just be "interviewed " together ( I guess meaning that the orientation which groups of volunteers go through during the explanation of the consent form would be called a mass interview, not a "consent process" or orientation), and it would not mean that any of them would be asked for their experience or their desire to do the job well (etc), and it should mean that the research facility has to be held accountable for violating the rights of employees.

Tricky.

But ultimately I think that, though our official title should be, or should stay as "volunteers" instead of calling ourselves "employees" I think that law should branch out to address specific rights that are applicable only to being generally-healthy paid research participants as it is indeed a particular type of occupation with it's own particular procedures, and arrangements that does not exist in any other way in any other kind of money-earning endeavor.

Attachments:

[mike]

I have been doing studies going on four years, and have completed probably at least thirty studies, I keep fairly good records of all the studies I have done. Offhand I can think of significant side effects I have had from two studies. One was for an opioid type pain killer, that was taken with another drug that was supposed to ixnay the euphoria, but the supplementary drug did not seem to work at all as I got quite high. It was like when I had for wisdom teeth removal.

Another study I did the drug caused significant blood pressure drops in the participants, and in the study we were required to have vital signs taken in lying, sitting, and then standing positions. I was not able to complete the standing vitals as I was about to pass out, and the other participants had similar reactions, one guy fell and hit his head on the footboard of his bed.

But in many of the studies, the drug may have a fairly innocuous risk profile to begin with, and then often the study will involve low doses of the drug, much lower than would be given to an actual patient who would be treated with the drug.
I have often said that I consider most studies to be less dangerous than a Friday night out drinking.

I agree with much of what has been said here already. I have always felt that for the most part the studies are not that risky, compared with other things one might be doing. I have previously delivered pizza for employment, for instance; I don't generally have to worry about getting in a car accident or getting robbed at gunpoint if I am in a study. Although, the old Austin Covance location was right next to a raised section of Interstate 35, I sometimes worried about one of the many drunk Texans crashing off the side of the freeway and into the clinic.

But of course, there IS risk with some of these drugs, and I think it's probably just a matter of time before soing serious happens to some participants. And it will be at least partly attributable to factors mentioned here:
-IRB's that are weak, toothless, and in bed with the clinics and sponsors on an administrative or political level.
-partly because of the reason above, clinics that don't give an F about participants, who know they can just tell you to hit the bricks.
Who can afford to walk out of a study? After they might have already invested hundreds of dollars in gas, time, motels, etc.? Not many rats can do that.

As for doctors or anyone else saying the healthy human studies are immoral? Well I guess in a grand philosophical sense, and in a perfect world, yes we could say this is a terrible thing that we should not allow, but in the real world, there are always going to be some people who are down on their luck and having trouble otherwise getting by; and how is this so different from other risks? and how much choice do we really have with regards to many risks that people have to take to make a living? Or to just live?

There is also a scientific/morality argument: you can't truly get an idea of what a drug is all about with regards to humans until you try it in actual humans, not rats or monkeys or dogs. So at some point, someone is going to be have to be a human guinea pig, if it's not healthy human volunteers then it will be the people with the conditions that are intended to be treated, and they may be sick, and perhaps less able to tolerate side effects that a healthy volunteer could. Your only other choice is to not allow the drug to be used.

So I think oversight/accountability of clinics needs to be improved somehow, the question is how. I'm not a big fan of unions overall, but this is not really the same situation as the bloated private and public unions that have been decimating our local and state governments and industries for many years now. Maybe the answer is a bit of both solutions: have some kind of collective organization of study participants combined with a REAL government agency engaging in REAL oversight and responsibility.

[carmel]

Was this a post-and-run topic creation, or have any of you received private communications from the journalist?