Tuesday, March 3, 2015

Bodies for Hire All Over the Country

Craig's List may not be where they do the recruitment, but there is a very active sector of the medical research community that is out there beating the bushes for healthy research "volunteers." Volunteers are those individuals who actually make a living from enduring whatever the researchers ask and spend their time being poked and prodded and set to a variety of tasks, all in the name of medical research. No doubt about it, it's a rather unusual lifestyle and it may require traveling all over the country, but what keeps them back? They appear to have no other ties or responsibilities that would prevent this nomadic rambling to parts unknown.

The title may have led you to believe that I was going to discuss the purchasing of body parts. But even this business may be waiting for the winds of change as these types of purchases may become more acceptable. Laws are beginning to receive new scrutiny as an emerging consumer base requests purchases from living donors of specific organs. Medical ethicists will have to sort out this new approach to medical interventions, but that's not what I'm discussing right now.  Perhaps sometime in the future. And I'm not advocating an investigation of the personal care business here, either, or ladies of the night or health spas.

Every medications you take has been run through a series of clinical steps to insure that it will not harm healthy volunteers, has some efficacy and does work on those who would benefit from it if it were prescribed.  Each step is referred to as a “phase” and they are 1, 2 and 3. So, it would seem that there’s scientific backing for each medication and it has sufficiently few serious side effects to warrant its release to the general medical community for use in their patients.

But have you ever given any thought to who these “healthy volunteers” might be and how they are brought into these clinical trials? Well, if you haven’t, you aren’t alone because, from my read, there’s not been too much in the medical literature on this group of people and how they are induced to enter the trials. You would be surprised, however, by how knowledgable some of them are, especially those who enter trial after trial after trial.

These individuals know what they need to avoid in terms of any substances, medications or anything that would limit their ability to enter the trial of their choice. They know all about “wash out” periods (how long it takes for something to leave your body and not show up on blood work).  For all I know, they know about trials even before they begin recruitment and they also know that there may be national trials which would give them a variety of choices as to where they want to spend the next six, 10 or more weeks.

But one interesting fact turned up by a study by an NIH (National Institutes of Health) research team  was that volunteers are most interested in the money and the time burden of studies. There was little concern, it appeared, regarding the level of risk involved and the researchers felt that the volunteers probably believed researchers would not truly expose them to any real risk and that whatever was present was minimal. Should volunteers make this assumption? If we look back at the infamous, totally unethical Tuskegee syphilis experiment in 1932 at the height of the Great Depression there is reason for concern.

The African-American men in the study were lied to and told they were receiving free medical care and health testing when, in fact, they were permitted to have the festering, mind-robbing killer, syphilis, remain untreated in them.  Three hundred and ninety-nine men were never told they had the disease and they received no treatment for it. The result was devastating for their families and loved ones. To say this is criminal seems appropriate. 

So, do researchers ever do something that can be harmful to the volunteers? We would hope not and we do have some safeguards, but only if everyone is truthful and it’s clear they’re not always truthful. Look at the number of retractions for clinical fraud and, possibly, unethical behavior that comes up on a daily basis in major scientific journals. You can follow Retraction Watch if you want to keep up on them.

Just as there are national databases for talk or game show contestants that afford the shows a place to find willing participants, I suppose their could be such a database of healthy volunteers, but I don’t know that there is.  Therefore, I would surmise that these folks watch the internet sites where funding is awarded to researchers for particular trials and they get a heads-up on who, when, where and for what the trials will be funded. When the time comes and the money is put in the budget, they can make the call, go to the facility or call a friendly clinical coordinator to see if it’s truly something for them.

First, a word about ethics and payments.  It’s usual for animal studies to be run in order to test safety prior to even considering volunteers. Such use comes with its own set of ethics vis-à-vis the care of animals and this has been a major area of contention.

The human ethical part of these trials comes to play whenever there is an inducement to be in the trial and this is in the form of a payment. You can imagine that the more pain, length of time or potential danger associated with the trial there has to be more of an inducement. The fact that there is inducement and payment may seem contradictory when you call these people “volunteers” because they are not volunteering in the strictest sense of the word. They are actually being used as independent contractors, aren’t they?

What about the “volunteers” in prisons who sign up for testing vaccines for nasty diseases or infections or even cancer? They are usually promised things like better food, nicer accommodations and socializing, TV or other things to which they would have had limited access were it not for the trials. Are they truly “volunteers?”

Then, of course, there’s the following: 1) reimbursement for any expenses the volunteer may have while in the trial (this can even include childcare or parking), 2) compensation for any injuries caused by the trial, 3) remuneration which is the actual pay to the volunteer.

The researcher, of course, is remunerated with a specific sum for each patient they enroll in the actual trial (Phase 2). The pay to the researcher for a patient can be several hundred dollars for each one enrolled in the study.  But not all trials are that big so we’re not looking at huge sums of money, but there are clinical centers that derive a great deal of their finances from running clinical trials. They may run multiple trials for many things at once and also do a bit of off-shoot research by adding on additional components to the original trial. This can add both to clinical knowledge and professional profile in addition to more funding from other sources.

I did have an opportunity to watch one interesting study before I worked in psychiatric research and it was truly an educational experience.

In the enclosed pod-like hospital room, the man seemed comfortable enough. He was reading a novel while perched on his bed, seemingly oblivious to the myriad of wires attached to his scalp and jaw, the small IV patch on his forearm and the lack of windows in the room. He'd been through it all before and he was now prepared to bed down for the next 30 days in magnificent isolation. No need to go food shopping, no mail to sort, no friends to call, no worries about inclement weather. He was free as a bird, if you call a bird in a wired, electronically monitored cage free.

Throughout the night, as he slept undisturbed, he would have blood samples taken via the line in his arm, his breathing and eye movements would be recorded and he'd awaken in the morning to go to the only modicum of privacy he would have; the bathroom. But he wouldn't choose that tiny enclosure as a refuge because, after all, he was being paid to be poked and prodded and tapped and watched 24-hours-a-day by a rotating team of medical professionals. The man was a healthy "volunteer" in a clinical trial for sleep disorders.

After his 30 days, he'd get his payment and go off to enter another study where they might have him take some investigational new drug. Since this study was on sleep and there were no medications involved, he’d have no need to worry about wash out and he could go right into another study. Most of them wouldn’t require that he sleep in the hospital and he could go on about  his day and return to the research center once a week or whatever the schedule required. It was an interesting life.

Right now I feel like a military recruitment poster pitcher looking for “healthy volunteers” for research studies. Nah, I don’t, but it almost seems that way when you only consider the more favorable side of being a volunteer in studies that don’t harm you in any way. Brings me back to that research study board in graduate school (we had to volunteer for 10 hours as a course requirement) where I scanned for ones that didn’t include pain, permitted women and those who wore glasses. The section outlining those was painfully small, but it was for me and I dove in. Drudgery all the way, but I managed to get my 10 hours done and, with great relief and much to the chagrin of the post-grad student, I walked off.

Volunteering, anyone?