Let's see what trouble Rose can get into today.

There is an article in the July 2009 issue of JAMA entitled, The Obligation to Participate in Biomedical Research. I would provide the link but, as JAMA is a subscription-only service, that would be against the rules. I would hope that JAMA is available to borrow from public libraries; one could also ask one's doctor.

Anyway, the article seems to represent a sea change in thinking. Here's an excerpt from the authors' overview, the sharing of which hopefully will not get me grounded till homecoming:

"The current prevailing view is that participation in biomedical research is above and beyond the call of duty....we propose a novel public goods argument for an obligation to participate....biomedical knowledge is a public good, available to any individual even if that individual does not contribute to it...Participation in research is a critical way to support an important public good....Consequently, all have a duty to participate...."

It's a good read.

Authors Schaefer, Emanuel and Wertheimer cover a lot of ground. They describe the standard view (participation is above and beyond the call of duty). They present 2 arguments for the obligation view: beneficence anid free-riding. Then they discuss implications of the obligation view: enforcement, personal obligation, cultural change, and paying others to participate in one's stead. Finally they consider likely objections.

What do you think?

Are we obligated to participate in research? If so, why? How much? What exceptions are there? If you've participated already, what inspired you?

Would so-called newbies or so-called old-timers be differently obligated? Parents of young children versus nonparents? Who would define the acceptable level and parameters of participation?

Do you wear your badge of participation proudly...why or why not? If you could somehow ensure that you didn't get the placebo would you? If you are able to access the therapy without the study would you? Why or why not? Is subcontracted (paid) participation ethical; does it get us off the hook? If yes, how so?

What other questions does this topic raise for you? Everyone is invited to reply based on your sense of ethics, philosophy or personal experience.

Rose

Rose - terrific brain teaser - here's my immediate reaction to one of the quotes from the article; hope this turns into a great discussion!

JAMA says: "The current prevailing view is that participation in biomedical research is above and beyond the call of duty....we propose a novel public goods argument for an obligation to participate....biomedical knowledge is a public good, available to any individual even if that individual does not contribute to it...Participation in research is a critical way to support an important public good....Consequently, all have a duty to participate...."

If this is true, then isn't good health a public good? If we have a duty or responsibility to participate, then don't the medical advances that result belong to everyone and not just to those with good insurance or more money?

In other words, it can be argued that the logical extension of JAMA's provocative idea would have major implications for the health care delivery system as well. The case for universal care would be strengthened. It would be difficult to argue that health care be denied for any reason if everyone were responsible to participate in trials. I kind of like it!

Hi Rose,

AMA says: "The current prevailing view is that participation in biomedical research is above and beyond the call of duty....we propose a novel public goods argument for an obligation to participate....biomedical knowledge is a public good, available to any individual even if that individual does not contribute to it...Participation in research is a critical way to support an important public good....Consequently, all have a duty to participate...."

I see where they are coming from, sort of, but the reasoning doesn't hold up IMHO, which these replies can only be - individual opinions about an individual decision.

Here's why I do not see trial participation as an obligation. Where are the public goods? and --why? I don't see them.

People sometimes die from clinical trials, with very little to show for it. Strokes, etc. can cause irrepairable damage. No treatments.

The trial is more likely to get cancelled and those with the placebo don't get the chance.

Since it has become public knowledge that business is determining our health outcome, I could not in good conscience ever consider it obligatory. It 's kind of like me making someone feel obligated to be married or to have children. It's a personal decision.

I do think every pwp ought to have a look at clinical trials.
Most doctors never mention them. So the new approach would take much work with the physicians.

Trust needs to be re-established for a real shift to be seen in trial paticipation. Trust comes from communication.

We aren't there yet. I definitely do not want the govt make clinnical trial decisions for anyone.......visions of the man from germany with the mustache....not comparing our pres. to him in anyway, but do not want a research czar telling me what to do either.

It's a personal decision and no judgement or guilt should be attached. on te other had, those who have and will do it are most appreciated. But it still doesn't obligate anyone else.

Now if there were treatments coming out of the trials I may think differently. But pd has a gold standard to beat? Curious minds want to know the answer to that question.


paula

I did say I see where they are going and a suggestion that comes to mind is -then cover them with insurance. Start to finish. Some of the testing gets covered now by medicare.

Before anyone argues these points, remember it's my opinion. so use the argument to state your opinion, not refute mine. Let's be good debaters.

Paula - this is why I argue that if they want universal participation in clinical trials, then the price is universal access to the fruits of that participation.

"Here's why I do not see trial participation as an obligation. Where are the public goods? and --why? I don't see them." - Paula

Universal, duitiful participation is only half of the equation.

You do have to wonder if there was more participation in clinical trials, would we be ahead of the game in disease cure and treatment right now?

We can't be required (not simply asked) to sacrifice our health for the greater good unless there is some benefit. I would argue the benefit would be access to the best health care without fear of bankruptcy or even lesser financial hardship.

i hope i understood what you are saying, which is basically what they are proposing right? public goods for all so let's do our public duty and all reap the benefits. but i don't see - oh you referred to them with the words fruits of the participation?

i do have to wonder with you whether more clinical trial participation would have us farther along. I don't know the answer, but know that a lot goes on overseas.

so i' m back to communicate with us first.........so we can develop trust.

That's the problem with the JAMA article - they are not proposing what I am proposing.

I think we are talking about the same thing, Paula - if I must be responsible for clinical trials, then I will also reap the benefit of the health care system built on our participation.

I have not read the entire JAMA article; Rose - is there mention of what benefit besides advancing science would be the benefit?

This is a great discussion! I would say that JAMA's call to action of patients seems a step in the right direction for a "novel public good", but how is this public good going to work when we can't even settle on having a truly, equitable public health care system? Instead we're bandying about with the status quo by maintaining private insurance and adding fuller public coverage for those who need it (amped up Medicaid and Medicare).

My thoughts are limited on this topic because JAMA holds their ideas hostage; we have to pay for access, so I have a limited idea of their vision. Let's see, patients may be expected to undergo extremely risky procedures or treatments for the sake of humankind (I don't think this is necessarily wrong), but what does any other key player give up in kind? When asking patients to act on a moral obligation, shouldn't we explore the role of patients in research within an entirely new paradigm based on a sense of what is right? I wish JAMA felt a moral obligation to provide free access to information. Questions that arise:

Patients are obligated to participate. Does this mean pharma, or any other proprietary researcher, is obligated to gift all intellectual property to a common "public good" research collective or database?

Would certain pharmas be acting in the public good by withholding potential curatives or novel treatments based on potentiality of profit?

What is the role of non-profit orgs like PDF?

How do we "recruit" (or do we "draft) PWP into research trials? Honestly, I didn't even know that non-participation was an issue until this forum.

Let's see journals like JAMA and other scientific research pubs and private databases pool together to develop a "public good" clearinghouse with epidemiology data and scientific articles for researchers. The patient would have free access to info written by specialists including annual reviews of key promising research leads, literature reviews on what we do know about PD, and treatment standards.

These are just a few questions that come to mind. I think that having more PWP involved in research actually might empower the patient- something that I think we all advocate. Is the patient considered a primary player in this and respected?

This is a great opportunity for research, clinical, and patient communities to all come together toward a humanistic goal of eradicating disease, but there's so much more to it than just expecting patients to have the moral obligation to ease suffering.

Laura

stepping into this one with very light toes!

it could be argued that we are all, by taking meds, having scans etc. already participating as data is collected from doctors hospitals etc.

further to this many people are ruled out of trials for things like atypical, de novo, co-existing conditions etc.

so universal participation could happen given one definition but be impossible by another

i can see why this is a good idea in part
an invitation to all would be better than an obligation
depending of course on the motivation of all parties.....

IMHO, and maybe I am missing something, but how can anyone be forced to participate in a clinical trial/research, risking their health (which may or may not be made worse by such participation, another issue entirely), when the fruits of that research, while technically "available" and "for the benefit of the public", really will only advance those doing the research?

An analogy could be made to eminent domain, where the government condemns your property to build a school, or library, or some such "public work". Taking private property (your body) for public purposes (research allegedly for the public good (of course not fame or profit), would require, at a minimum, compensation-after all, it's our health, try to put a price on that-next to impossible.

Does anyone really think that if a trial were conducted and a magic pill discovered, that the drug company wouldn't be racing to the patent office to secure their patent rights? Or that the researcher(s) wouldn't be racing to the publication office to be "the first" to have discovered X? Or would part of the new system mean that if people were forced to participate, any resulting research would be truly public property, such that anyone could get the formula and begin making the miracle drug themselves? I think not. Rather, they want to force participants to further their research, for free at that, but I seriously, seriously doubt that the research results would likewise be public property and free for all to use. Or am I misunderstanding this?

This is strictly my opinion (and please note that I think this is a wonderful discussion), but I don’t believe we can do justice in answering the original question, “Do we have an obligation to participate in biomedical research?” unless we drop the discussion of health reform. That’s a no brainer – we definitely need major health reform, but I am not sure we need a system of social medicine or just how that should be approached. One thing for certain, it should not be rushed. We got into this mess over many years, and it will not be appropriately solved if done so hurriedly. Enough said about that. I would like to answer the original question. And I am assuming the question is addressing whether or not one should actually be a clinical trial participant, differentiating that from the many of us here who are definitely “participating” in biomedical research, but not necessarily first-hand as a clinical trial participant.

I guess since I have made what I consider the “ultimate” sacrifice,” I am “obligated” to respond. Nearly a decade ago I became the second person in the world to participate in an experimental surgical procedure for Parkinson’s. The hypothesis being that by transplanting retinal cells (from a donor eye) into the area of my brain where “normal” dopamine production was deficient, the cells would continue to produce and sprinkle dopamine and relieve me of some or all PD symptoms. This was done unilaterally (one side – opposite side of the most affected side) using a system of microcarriers upon which these retinal cells would “stick.”

The trial (Spheramine) was in Phase I – the safety phase - and was open-label, meaning the small number of participants (3 men – 3 women) knew we were getting the “real thing.” At the time of my surgery, I knew next to nothing about the clinical trial process. Since that time I have learned more than the average person through first-hand experience as a participant and having friends who were participants in a number of trials and as a charter member of the Parkinson Pipeline Project, a grassroots effort to speed up the drug and treatment approval process ( www.pdpipeline.org ). Additionally, I have been working with the Parkinson’s Disease Foundation (PDF) through the Accelerating Parkinson’s Therapies collaboration (APT program) at www.pdtrials.org ) and served on the planning committee and attended PDF’s Clinical Research Learning Institute. Other areas where I have gained knowledge and experience is through volunteer work with the Michael J. Fox Foundation, the Parkinson’s Action Network, and the Parkinson Alliance. I also have volunteered to give presentations of my clinical; trial experiences at conferences sponsored by NPF and APDA, along with several other reputable organizations.

I give you my background because of what I am about to say: In my opinion the drug approval process at present is antiquated, often handled by those with only profit in mind, is not transparent, and is NOT patient-centered. To use an over-used quote: WE NEED CHANGE . . . adding . . . BUT NOT WITHOUT THE PATIENT VIEWED AS THE SINGLE MOST IMPORTANT STAKEHOLDER!

The question of whether or not we have an “obligation” to participate in biomedical research might best have been asked as “Why do people participate in biomedical research?” In 2005, a Harris Poll was conducted by PDF for the APT program. . The poll’s results showed that only one percent of PWPs participated in clinical trials; of those PWPs surveyed who were aware of trials, only 11 percent of them had received information about trials from their doctors.

Survey results such as the 2005 Harris Poll reinforce my earlier comment that the approval process is not patient-centered, or they would be the first to be made aware of relevant trials. Another factor is the difficulty of recruiting and retaining trial participants. The aforementioned “DOR or “Declaration of Clinical Research Rights & Responsibilities for People with Parkinson’s,” was written as a result of patients not being at the center of trials. Horror stories of patients picking up the newspaper and reading that a trial in which they were participating had been halted or hearing through the grapevine that the stockholders had cancelled further work in a study are just some examples why the DOR was written. (although a work still in progress this is a draft copy: http://pdpipeline.org/advocacy/rights.htm )

We hope that advocates of finding a cure or better ways to manage Parkinson’s disease will unite in the effort to educate others in what is the only acceptable and humane way to view the trial participant – i.e. as the single most important stakeholder in the approval process. If there are no trial participants, there will be no improvement or steps made forward in eradicating Parkinson’s disease. With 80 million babyboomers hitting age 60 (the average age of PD onset), I believe that Parkinson’s will be a force to be reckoned with on an equal plane as AIDS or the H1N1 virus.

By the way, in Phase II of the trial in which I participated (double-blind, sham surgery, placebo-controlled multi-facility design), the 72 participates were measured at 12 months and told that Spheramine did not meet its end points, meaning the treatment did not show efficacy over the participants receiving sham surgery. At this point of this “game” the big pharmaceutical company pulled its sponsorship, leaving the small biotech company who created the treatment high and dry – almost to the point of bankruptcy. It was then that I realized the trial was no longer a service or humanitarian act for the Parkinson’s community, but was a “business venture” gone sour. Whether or not the study will be revived or even salient points preserved for future studies remains to be seen.

Peer reviewed results of Spheramine, also known as the STEPS trial, have not yet been published – the trial was halted July 8, 2008. But that’s another story!

Sorry this was so long.
Peggy