Do we have an obligation to participate in biomedical research?

LindaH · 08-03-2009, 07:53 AM

Coincidentally an article on difficulties recruiting cancer patients for clinical trials is on the front page of today's New York Times. Recommentded reading - much of it applies to all types of clinical research . The article focuses on doctor's viewpoints, and once again comes down to money - given the time (a whole hour needed to explain the trial to possible participantd !) and paperwork required of doctors to enroll their patients in trials -- it is not financially worth it to them

see: Forty Years' War :Lack of Study Volunteers May Hobble Cancer Fight

http://www.nytimes.com/2009/08/03/he..._r=1&th&emc=th

indigogo · 08-03-2009, 10:00 AM

Seems like the overall problem is that a system that has worked until now is failing - the for-profit, market driven, pharmaceutical industry and medical researchers in general relied on pure altruism for human subjects. Medical research has become even more market oriented with the advent of gene science, new patents on biological discoveries, biotech devices, etc - it's all very competitive, expensive, and possibly money-making - but it still relies on altruistic patients.

The system is fundamentally flawed.

paula_w · 08-03-2009, 06:13 PM

[quote=SherylJ;546749]

Quote:

Originally Posted by LindaH

Many researchers state that patients should not enter trials with any expectations of being treated. That their participation is not for their own benefit , but for the benefit of other patients in the future. .. Is it realistic to think sick people who volunteer for trials should have no expectations, no hope of a better quality of life or of a longer life?"

This would be like telling a company that after all the time and money they invested in developing a new drug, a big pharma would take over, bring it to market and reap the financial rewards. Are the first company's execs likely to welcome this in the name of altruism?

Linda says, "We should participate in clinical trials, but we should also be part of the process and our rights must be protected."

This to me is the bottom line. The clinical trial system has major flaws, but it is the only game in town with the potential to give us improved treatments, if not a cure, in our lifetimes.

I do believe greater patient participation would move us toward a cure faster; if for no other reason than it would greatly shorten the trial recruitment period, but participation has to be voluntary. This is the only "carrot" patients have in their efforts to improve the clinical trial process.

I don't know how many of you know this, but we already have a tool -- written by a group of patient advocates (I won't try to name them all lest I inevitably leave someone out), including Linda and I -- that could jumpstart a better clinical trial process. It is a Declaration of Clinical Trial Participants' Rights and Responsibilities, and it was three years in the making. For the last 1-1/2 years or more it has languished, never seeing the light of day.

So, I throw out this challenge.... are we going to continue moaning amongst ourselves about the flawed clinical trial process, or are there enough of us here willing to come up with and carry out a plan to roll out the DOR for adoption as a new standard?

sheryl

"They always say time changes things, but you actually have to change them yourself. "The Philosophy of Andy Warhol US artist (1928 - 1987)

Sheryl, you don't have to respond if this makes you uncomfortable, but what is your impression of why the DOR never quite makes it to the light of day in a bigger way?

this document [ the DOR, formerly known as the BOR for PD clinical trial participants] is for the public good. it doesn't pander to anyone but instead tries to insure fairness, transparency in clinical trials, and its' purpose is to increase clinical trial participation.
paula

SherylJ · 08-03-2009, 07:23 PM

[QUOTE=paula_w;547057]

Quote:

Originally Posted by SherylJ

Sheryl, you don't have to respond if this makes you uncomfortable, but what is your impression of why the DOR never quite makes it to the light of day in a bigger way?

this document [ the DOR, formerly known as the BOR for PD clinical trial participants] is for the public good. it doesn't pander to anyone but instead tries to insure fairness, transparency in clinical trials, and its' purpose is to increase clinical trial participation.
paula

Paula,

Your question is a valid one and one I have pondered at great length. Like you,I see the DOR/BOR as being win win win for all stakeholders in the clinical trial process. So what's the problem?

Speaking only for myself, I think the stumbling block is that unlike patients, who have one very clear and overriding agenda -- A CURE --, the orgs have several different constituencies, each with a slightly different agenda, and they don't want to alienate any of them. The reforms called for in the DOR will cost drug companies more in time and money, but should yield more informed and committed trial participants. Low retention rates are costly, too. The orgs rely on drug company support in a variety of areas and do not want to jeopardize this. I am not alleging corruption, bribery or anything like that.It has just become a very difficult balancing act.

If patients want the DOR to become the new clinical trial standard, it will be up to us to shop it around.

sheryl

paula_w · 08-03-2009, 08:29 PM

i understand ...and i think you might agree that we can't accept that forever. we have a document now [the DOR} that is on a pdf pamphlet and that's good. hopefully teaches a patient what to expect [not passively but through letting the trial team know as a participant that you expect] what is physially possible on this document

this could be in the book under advocacy...might help and it certainly needs to be shared.

for the heck of it, no, actually very importantly we need to know,

who has seen the Declaration of Rights for parkinson's clinical trial participants [not sure of exact name.

now for the heck of it, if you can find it can you post in this thread the link where it is and either say already knew or it took me .....amount of time to ind it ? it would be fun to see comments as well like - what is it? or if you knew who wrote it.

this might make a good wpc poster....do a survey and then see if the baslines improves with an experiment designed to promote it.

most iimportantly, did participation in clinical trials for pd increase concurrently or following the promotion?

or should we do a survey and wait? nahh, we shouldn't be in the business of making anyone wait for anything. A survey - yes - but it wouldn't hurt much to do it here now.

i have enough to do. would you be interested in thinking about doing it for wpc and the book? we need to independently let everyone know just what has been available for them and has arisen out of this forum.

this in no way is against pdf, who have helped it get this far, but we have to move further and faster on it. we debate whether to participate and aren't using the tooks that it took years to create.
paula

potential hypothesis: did clinical trial participation in pd clinical trials increase concurrently during or following a global awareness campaign to share the DOR?

don't throw anything at me but i think it could be shortened....or......
have a complete version and a shorter promotional list.

think about it, is it copyrighted?
thanks, paula

SherylJ · 08-03-2009, 11:46 PM

Paula, I was on my way out the door when I answered your original question and I'm sure was not as tactful as I could have been. The truth is I'm ANGRY, VERY ANGRY, that those of us who worked so long and hard on the DOR have allowed it to languish in limbo... dead before it was ever born. If the orgs don't want to be involved in "selling" the DOR, we are on our own.

I was remiss not to credit PDF and especially Ronnie Todaro with helping us get one part of this project professionally designed and printed. What I never understood is why we put the cart before the horse or more accurately left the DOR on a cart on the side of the road with no horse to push it or pull it.

What we published was a Q & A pamphlet that was meant to be a guide to how to use the "invisible" DOR, the revised standards we hoped could guide future clinical trials and remedy many of the failings of the current system.

At one time the DOR was on the PPP site and an advocacy site Jean set up (she's w/o Internet access but will return shortly). I will see what I can find...Linda, Peggy, Carolyn... anyone have a final copy?

Thanks for asking about this topic Paula... it's one that I can't let go of.

sheryl

cochrankat · 08-04-2009, 06:53 AM

I did see the article. The central premise of the arguments, set forth at the beginning of the article, is this: "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."

The authors go on to note two characteristics of a public good:
"First, one individual’s use of that good does not diminish another’s use of that
good; and second, it is impractical to prevent individuals from using the good."

Impractical? Preventing individuals from using the good is a key feature of our dysfunctional health care system, just as preventing individuals from reading about the good is ingrained in JAMA's modus operandi.

If obligation to participate in clinical trials were based on access to the "good" derived from research, the ranks of trial participants would be disproportionately drawn from the upper echelons of insurance and pharma companies.

Kathleen

cochrankat · 08-04-2009, 10:28 AM

Another wrinkle on the subject of patient participation in clinical trials:
Ishttp://www.brightsurf.com/news/headl...s_experts.html

Kathleen

vlhperry · 08-04-2009, 11:43 AM

The patient must educate themselves about the type of research being done. Is it really a new way to improve the quality of life for other patients or is it just a knock off of anouther drug?

What side effects might it cause? I know this is what the researchers are trying to find out, but research usually begins on animals and sometimes side affects on animals are also found in people.

One important question to ask is this:

Is my anger over the current method of research done as it is done now, important enough to refuse to participate in research, even if I am sure my participation will help others with PD down the road? I have two gene mutations. I am totally against the contracts patients sign now giving up the right to knowledge of their personal genetic results. Fortunately I know about my mutations. But I am still angry over the patient research contracts. But should my ethical opinion take precedence over the knowledge that would allow NINDS to study my disease to understand how my genetic mutations affect the progression of Parkinson's disease? In my case, I feel the benefit of the many outway the ethical considerations of the one. I am part of a genetic study.

There is no black and white answer to this question. The AMA is wrong. Patients must be allowed to consider the study, the effects the participation may have on themselves and their family, and the future of Parkinson's Disease in general. The government cannot mandate ethical behaivior. That decision must be left to the patient.

rose of his heart · 08-04-2009, 09:03 PM

Quote:

Originally Posted by vlhperry

....The AMA is wrong. Patients must be allowed to consider the study, the effects the participation may have on themselves and their family, and the future of Parkinson's Disease in general. The government cannot mandate ethical behaivior. That decision must be left to the patient.

Dear Vicky,
Please don't misunderstand. I know it's hard to see some of this from the summary provided. Nevertheless, as I wrote in #15 above:

(1) To the best of my knowledge, JAMA's publication of this article in no way means that the Obligation View is endorsed by the AMA. Nor it is the "AMA's provocative idea." The idea's/argument's creators are C.O.Schaefer (Dept. of Bioethics at NIH), E. Emanuel, MD. PhD (The Clinical Center, NIH) and A. Wertheimer, PhD.

(2) Next: before we all get our knickers in a twist, the authors of the article make a point that while they believe any patient has a moral obligation to participate in a clinical trial, this does not mean that the patient should be legally compelled to do so.

Great discussion everyone!
Rose

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