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?

I think this is a really interesting and valuable discussion. While I believe participating in clinical trials is an ethical and admirable decision, and should be encouraged, I think the authors of the JAMA article might have benefited from discussing some of their ideas with a group of patients (like us) .

As others have stated if the highest ethical behavior is expected from patients, then the other stakeholders in the drug development/ clinical trial process need to be held accountable to the same high standards. If there is a weak link – the ethical becomes unethical. We should participate in clinical trials, but we should also be part of the process and our rights must be protected.

Some of the authors’ arguments offered in defense of their “obligation” theory

What after participating in a trial, a patient cannot afford to buy the new meds that are developed from that research? According to the authors they should just wait -- eventually they price will come down (or the US will adopt universal health care.) “There is some evidence that while poor populations lag behind in health improvements compared with the wealthy, the poor populations often manage to catch up as interventions become inexpensive and widely available. This is partially because medical knowledge is a public good; wealthy individuals’ access to medical knowledge
does not preclude poorer individuals from having access to it. Even if their access is delayed, poorer individuals still receive benefits from interventions originally targeted at the wealthy”

How long should they wait?

Likewise, If a treatment is developed by a pharma company and their patents keep the prices high for years – again just wait ! “Patents on medications eventually expire.” And in time will become available at generic prices . Will our PD wait too?

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 this realistic? Real life patients suffering with advanced PD should not have hopes that an experiemental treatement might help them not become totally disabled? Or a cancer patient would not hope for remission from a treatment received in a clinical trial? 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 ?
Linda

“Patents on medications eventually expire.”

NO, Parkinson's WILL NOT wait!!

But, bottom line, it IS all about the money. Just how many therapy ideas have not seen R&D because the profit projections were not worthy of R&D? or clinical trial?

This is even more interesting than I first imagined...thanks to everyone for your thoughtful contributions. The issues raised are way more complicated than they might first appear. Having read the article I would like to take a moment to clarify a couple of factual points:

(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.

Carey asked if the article mentions what other than advancing science would be the benefit? I'll give it a closer look for that on the 'morrow...right now, my eyes are officially glazing over.

Sleepy Rose

PS Yet, hark! Rick's talk of altruism and Laura's vision just might wake me up after all...

For a multiple million dollar bonus based on numbers, it's worth trying for several years; then off somewhere else.

nite
paula

Rose,
Excellent question and answers. Have you considered sending these responses to the NIH researchers if all the authors OK it?

Girija

I hadn''t considered that, Girija; interesting idea.

It did occur to me this morning that I could invite the authors to join the discussion and see what happens. Any objections?

Oh, wait; that's what you're saying, isn't it?

Still sleepy Rose

I have to chime in about the points raised that poorer patients can wait for the prices of the new treatment/drug developments to come down to where they are affordable....and have to laugh.

Just look at Azilect...it's now been out for awhile now and it still costs a fortune. I hear nothing about its price coming down, nor will I-there's still that patent on it (how long again is a patent, something like 17 years.....)
At our last neuro appt. our doc told us we were the only one in his practice still on it-and that although he starts all of his new patients on it, they simply cannot afford it so they quit taking it. I realize there are some places that help folks get meds, but we dont' quality for that, and the vast, vast majority of people I know don't either. And even if they do, I doubt pricey, new drugs like Azilect are on the list as freebies.

Further, I just read a news blip about drugs getting some new protection for TWELVE YEARS-that is a enternity for a PDer (or any other ill person, MS, AIDS, cancer, etc.) Like Paula said, PD does not wait, it is merciless, and relentless.

Those who "feel" that others (certainly not themselves nor their family) have a "moral obligation" to offer up their bodies for the public good should put their money where their mouths are. I could go on about what that would require but it'll never happen, they will never pay participants nor offer them the treatment/drug that comes out of research for free/reduced cost. And besides, those patients who feel compelled to help further the cause are already doing what they can, and are able, and they know better than anyone else what that is.

One more thing. Regardless of one's position on stem cells, I just read last night an article about those persistent Scotchmen, at the U of Edinburgh (I believe where Dolly the sheep was fashioned), they have just been awarded a sizable chunk of change to do stem cell work for PDers. The gist of the trial is that they will take skin cells from PD patients and several members of their family, with and without PD. They will then induce those cells to become embryonic in nature (called induced pluripotent cells) and watch them in culture, in various situations....then move to rodents, then people. First trial is set to begin January 2010, they are set to begin recruiting soon over there....now, if we have the equivalent of a bunch of patients in the form of cells sitting in a dish in some lab, we may just be able to do a lot of this research without real people (now THAT's a scary thought!), although we clearly need both. This stem cell stuff may just make real people unnecessary in the earlier research work. Neat, huh?

[QUOTE=LindaH;546562]
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)