Medical Forum / Diseases and Disorders / Alzheimer's / August 2004
Ethical Dilemma?
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CP - 11 Aug 2004 20:45 GMT Here’s an ethical dilemma that is perplexing and may give me some direction in the event this becomes possible. This is part of a multi part post over the next few days in which I am asking for input and opinions on a very real issue. My company researches nutritional remedies for major diseases. We have developed some successful oncology formulas in clinical testing. Based on our hypothesis, we may be very close to completing a nutritional supplement that may significantly help AD patients. We feel it could also be used as a preventative for the same reasons.
It has shown positive results in limited testing, and may reverse the effects of AD. I can be reached privately through this email address for additional questions or comments. As caregivers and most likely, the children of AD parents, the following may be an important decision, if not an ethical question to resolve among siblings.
We believe that AD is only the symptom, or end result, and not the root cause of the disease. If we can remove the cause of the symptom, it may lead to a reversal of the effects. We have a different hypothesis for dementia, unfortunately the prognosis for help is not too hopeful at this time.
We hold that the root cause is a blockage of a critical chemical produced by the body, which is not reaching the brain. Under normal circumstances, it would prevent the accumulation of beta amyloid plaque and/or tangles to accumulate on brain cells or in neuronal synapses. This may explain why it only affects a smaller but diverse percentage of the population. We also believe that contrary to current thinking, brain cell death in AD patient does not occur until late or very advanced stages. When cell death does begin, the patient declines rapidly leading to death.
In our theoretical model, brain cells are not dead in the early years of diagnosis, they may only be dormant as a result of the plaque buildup. It is possible that dormant cells are devoid of electrical energy, and show up on PET scans as dead. Post mortems can only confirm plaque and cell death after physical death, but may not confirm whether the brain cell(s) were alive at the time of physical death. So there may be room for doubt, or rather in this situation, hope.
If a removal of the cause could be achieved, it may be quite possible for an AD patient to be totally reversed of the effects of AD, unless the actual death of brain cells had begun. They might recover the full cognitive and motor skills and resume living as a normal person if it works. However, should brain cell death have occurred, it would not be possible for the patient to recover the cognitive or motor skills that had been controlled by those dead brain cells.
Here is the ethical dilemma I want to raise.
If the opportunity to reverse AD was actually achievable, how much risk would you as a child/caregiver be willing to take with this hope? The risk or trade off would be that if started early enough, it might be a full reversal. If started in late/advanced stage AD with brain cell death it may lead to a recovered patient with either:
A) some physical disabilities similar to a stroke victim, or B) permanent mental impairments or cognitive problems similar to a head injury
The trade off in a late stage/advanced patient is that they would not die from a slow degenerative decline, but might be able to live a healthy life and die of natural causes, not AD. They may regain some functions that would allow them to help themselves, but they might still be partially dependent on a caregiver.
I can not say that the level of care giving would be easier, or harder than your current situation, or the improving of personal and emotional relationships. One might surmise that if a major portion of their cognitive or physical skills returned, it would likely be a better situation. There are no guarantees, it is uncharted waters.
I would like to hear the opinions of everyone, but primarily the caregivers and siblings as it would be their responsibility to ultimately decide. Thank you, and I look forward to hearing your comments. CP
Evelyn Ruut - 11 Aug 2004 21:00 GMT > Here?s an ethical dilemma that is perplexing and may give me some > direction in the event this becomes possible. This is part of a multi [quoted text clipped - 72 lines] > ultimately decide. Thank you, and I look forward to hearing your > comments. CP If it really worked, and it was early enough in the process of the illness, it would be worth a try. If the impairment was farther along, no. Why would anyone want to live in such a state?
 Signature Regards, Evelyn
(to reply to me personally, remove 'sox")
CP - 12 Aug 2004 23:00 GMT <snip>
> If it really worked, and it was early enough in the process of the illness, > it would be worth a try. If the impairment was farther along, no. Why > would anyone want to live in such a state? At least one person honestly answered my question, at least until the first flamer, then the bandwagon. It's amazing to be flamed for no reason here. I've been reading the newsgroup for several weeks before I posted, and I really *WAS* impressed with the sincerity of the people.
My wife and I discussed posting this, and felt this group might just be able to help give some clarity to a difficult situation. I will pointedly say again, I am not here to sell anything. Just researching a legitimate question from real caregivers or guardians to get a feeling for what you feel or think.
In good conscience, what would/could I say to someone that wants to volunteer someone regardless of the unknown amount of recovery possible? We have some friends that have referred others to us, desperately begging us to put their late stage/advanced AD parent(s) in a trial.
They watched relatives die from AD, and do not want to watch their parent(s) to waste away like that in a home/hospice. Full liability release, waivers, anything we ask for legally, but they overlook the dilemma they have put me/us/them in. That was the real basis for my original question as our fledgling protocols did not address this issue. So I posted the question with a brief explanation of the theory and process to help make sense of the question.
No, I'm not the scientist with the big words someone accused me of not using, just the CEO. I could use them, but my associates get paid the big bucks to write those words. You probably wouldn't want to read a 53 page theoretical abstract with the big words, even if I could post it. Yes, I am here anonymously under legal restriction due to affiliated non-disclosure research agreements. And yes, the FDA overlords do swoop down on you if you violate the rules!
If it is marketable, it's 1-2 years off. I certainly wouldn't waste my time advertising in a newsgroup. If it happens, you'll be hearing about it on the news and probably get it at subsidized rates through the local ADEAR chapter in response to some other rant about giving the proprietary process away. It's also in the business plan to set up indigent care with half the income.
CP
hal@nospam.com - 12 Aug 2004 23:40 GMT ><snip> > [quoted text clipped - 12 lines] >legitimate question from real caregivers or guardians to get a feeling >for what you feel or think. I would like to echo the responses of the majority here and sum it all up with one word response to your query: horsehockey.
My first thought when I read your post was: "If this person was a legitimate researcher why on earth would that have to come to this forum and ask this question"? The answer is: there is no possible reason. If you were a legitimate researcher you would already be able to answer such an ethical question. You would already know risks vs. benefits questions because this issue is dealt with all the time in the development of treatments and medications. Your whole post stunk of manipulation and a plain and simple con to try to get contacts for marketing your product.
Hal
>In good conscience, what would/could I say to someone that wants to >volunteer someone regardless of the unknown amount of recovery possible? [quoted text clipped - 25 lines] > >CP Dennis White - 13 Aug 2004 05:56 GMT > <snip> > [quoted text clipped - 6 lines] > reason here. I've been reading the newsgroup for several weeks before I > posted, and I really *WAS* impressed with the sincerity of the people. Shame on you for insinuating that all but one who responded to you were dishonest! Or that there was no reason to criticisze you. I for one have seen far too many quacks to allow them to go without proof of their claims. Provide studies, the kind of research you are involved in, and your name and I will consider your position valid, even if I do not agree with it.
> My wife and I discussed posting this, and felt this group might just be > able to help give some clarity to a difficult situation. I will [quoted text clipped - 6 lines] > We have some friends that have referred others to us, desperately > begging us to put their late stage/advanced AD parent(s) in a trial. How can you possibly ask if this is ethical or not? There is a very well-established criteria orf ethics to follow.
> They watched relatives die from AD, and do not want to watch their > parent(s) to waste away like that in a home/hospice. Full liability > release, waivers, anything we ask for legally, but they overlook the > dilemma they have put me/us/them in. Then relieve yourself from your burden.
That was the real basis for my
> original question as our fledgling protocols did not address this issue. > So I posted the question with a brief explanation of the theory and > process to help make sense of the question. You neither explained the theory nor the process. It was nonsense.
> No, I'm not the scientist with the big words someone accused me of not > using, just the CEO. I could use them, but my associates get paid the > big bucks to write those words. You probably wouldn't want to read a 53 > page theoretical abstract with the big words, even if I could post it. Do not so blithely undersetimante the sincerity and the intelligence of those who post here. I have no doubt that every single individual who is interested in the eradication of dementia would and could read a 53 page theoretical abstract. I have no doubt that many who visit here have a much higher degree of medical, scientific and theoretical knowledge and understanding of dementia. If you are the CEO let the "big words" speak for themselves. You are obviously not a very good mouthpiece, considering the tone of the responses you've recieved.
> Yes, I am here anonymously under legal restriction due to affiliated > non-disclosure research agreements. And yes, the FDA overlords do swoop [quoted text clipped - 6 lines] > proprietary process away. It's also in the business plan to set up > indigent care with half the income. Good. I await reading about your work in medical journals and peer reviews....not in newsgroups which are notoriously unreliable, unscientific and full of loons.
Dennis White
Tumbleweed - 13 Aug 2004 07:13 GMT <snip>
> My wife and I discussed posting this, and felt this group might just be > able to help give some clarity to a difficult situation. I will > pointedly say again, I am not here to sell anything. Just researching a > legitimate question from real caregivers or guardians to get a feeling > for what you feel or think. I think you heard what we think, you just didnt like it.
> In good conscience, what would/could I say to someone that wants to > volunteer someone regardless of the unknown amount of recovery possible? > We have some friends that have referred others to us, desperately > begging us to put their late stage/advanced AD parent(s) in a trial. yada yada yada.
> They watched relatives die from AD, and do not want to watch their > parent(s) to waste away like that in a home/hospice. Full liability [quoted text clipped - 3 lines] > So I posted the question with a brief explanation of the theory and > process to help make sense of the question. Nothing in your message made sense, I'm waiting for Part 2 when there is an opportunity to buy this now before everyone else gets in on the secret or before the conspiratorial medical establishment tries to get your miracle cure banned.
> No, I'm not the scientist with the big words someone accused me of not > using, just the CEO. I could use them, but my associates get paid the > big bucks to write those words. You probably wouldn't want to read a 53 > page theoretical abstract with the big words, even if I could post it. Goodness me, a condescending spammer!
> Yes, I am here anonymously under legal restriction due to affiliated > non-disclosure research agreements. And yes, the FDA overlords do swoop > down on you if you violate the rules! translation "claim your product works when there is no evidence it does"
 Signature Tumbleweed
email replies not necessary but to contact use; tumbleweednews at hotmail dot com
Mare - 17 Aug 2004 01:08 GMT I'm not sure how much more honest I could have been in my previous answer which is pasted below:
"Mare" <nono@nanette.com> wrote in message news:... snip
> How can we give > you any real answers without real information. Before I could > make a decision like that I would need to see the research from > different studies(not just your own), what the side effects were,
> what were the odds of stopping or regressing AD and how far would
> the person recover statistically. snip
You just didn't like the answer. But this is MY answer and you would probably get as many different answers as there are people with AD. You've read this group for a few weeks and decided we were a sincere group of people which in my opinion is true. But if you had actually gone to Google and searched a bit you might have seen that people post here all the time touting the next best cure for AD. We are sincere not stupid and insulting us instead of trying to convince us that you really do need opinions and being up front with us wouldn't hurt either. We are here for support not as a marketing tool for some unknown person with an unknown agenda. See below for more comments.
> <snip> > [quoted text clipped - 17 lines] > We have some friends that have referred others to us, desperately > begging us to put their late stage/advanced AD parent(s) in a trial. I would ask to see the person with AD's POA. I would ask what the AD person would have wanted. I would make sure that the person volunteering someone else was not doing it just for themselves. Wouldn't the FDA have guidelines on the ethical issues you raise? Wouldn't you have some idea of the results that would be expected since you would have studies involving animals right? You wouldn't just start testing a product on humans without any kind of previous data would you? You already said it probably wouldn't do alot for late stage people. Have you told these family members that?
> They watched relatives die from AD, and do not want to watch their > parent(s) to waste away like that in a home/hospice. Full liability [quoted text clipped - 3 lines] > So I posted the question with a brief explanation of the theory and > process to help make sense of the question. Sounds like denial and hope all wrapped up together. If you had asked this question originally you might have gotten more answers but I question the email me part. Yes I am suspicious and rightly so IMHO.
> No, I'm not the scientist with the big words someone accused me of not > using, just the CEO. I could use them, but my associates get paid the > big bucks to write those words. You probably wouldn't want to read a 53 > page theoretical abstract with the big words, even if I could post it. You'd be surprised how many I've read and discussed over the years. What do you think is the reaction of pretty much everyone with a LO diagnosed with AD after the denial passes. We try to find any hope and train ourselves to understand or ask questions if I don't understand. I bettcha Darryl would understand most if not all of your abstract. Maybe you should rethink how dumb we are instead of telling us what we want.
> Yes, I am here anonymously under legal restriction due to affiliated > non-disclosure research agreements. And yes, the FDA overlords do swoop > down on you if you violate the rules! Then what the hell are you doing here?? Surely there are research companies that actually do this kind of research in a legal way. Talk to research doctors or medical ethicists, I know these questions have been thought of and researched before.
> If it is marketable, it's 1-2 years off. I certainly wouldn't waste my > time advertising in a newsgroup. If it happens, you'll be hearing about > it on the news and probably get it at subsidized rates through the local > ADEAR chapter in response to some other rant about giving the > proprietary process away. It's also in the business plan to set up > indigent care with half the income. Why not just answer the comments to ease peoples minds instead of being so demeaning. You came to us, we didn't volunteer to be your marketing research after all. We are NOT your business associates.
> CP
 Signature Mare mfcoleman@THEOLEmindspring.com http://www.muggsmulcher.com/kstuff/a.s.a/intro.htm alt.support.alzheimers' FAQs and Stuff Pages
Darryl - 11 Aug 2004 23:00 GMT >Heres an ethical dilemma that is perplexing and may give me some >direction in the event this becomes possible. This is part of a multi [quoted text clipped - 11 lines] >the children of AD parents, the following may be an important decision, >if not an ethical question to resolve among siblings. Talk about the results here, not privately in email.
>We believe that AD is only the symptom, or end result, and not the root >cause of the disease. So what you're saying is that AD is not the cause of AD. Interesting.
>If we can remove the cause of the symptom, it may >lead to a reversal of the effects. We have a different hypothesis for >dementia, unfortunately the prognosis for help is not too hopeful at >this time. > >We hold that the root cause is a blockage of a critical chemical What do you mean by "blockage". Is this critical chemical Acetylcholine by any chance? Or are we talking about GSK-3(beta)? Please, name the "chemical" that mainstream medicine has overlooked.
>produced by the body, which is not reaching the brain. Under normal >circumstances, it would prevent the accumulation of beta amyloid plaque [quoted text clipped - 4 lines] >advanced stages. When cell death does begin, the patient declines >rapidly leading to death. Amusing beliefs. Although a hypothesis is only a theory until its disproven.
[big snip]
>Here is the ethical dilemma I want to raise. > >If the opportunity to reverse AD was actually achievable, how much risk >would you as a child/caregiver be willing to take with this hope? The >risk or trade off would be that if started early enough, it might be a read: how much money will you spend early in your life on an unproven and potentially useless therapy?
>I would like to hear the opinions of everyone, but primarily the >caregivers and siblings as it would be their responsibility to >ultimately decide. Thank you, and I look forward to hearing your >comments. CP I look forward to a reply full of references and light on the jargon.
To everyone else, it is my opinion that this person is a charlatan. Do not allow yourself to be swayed with this empathic approach to the disease. Ask for references in peer-reviewed medical journals (that often can be dug up at Medline). In fact, I'm asking right now. ;-) Name your company, name your products and name the studies which support the efficacy of your products when treating a particular condition.
But hey, this is just my opinion. Darryl.
Evelyn Ruut - 12 Aug 2004 00:05 GMT > >Here's an ethical dilemma that is perplexing and may give me some > >direction in the event this becomes possible. This is part of a multi [quoted text clipped - 70 lines] > But hey, this is just my opinion. > Darryl. I agree with you Darryl. The guy is obviously a spammer taking advantage of sick people and their loved ones.
Shame on him.
 Signature Regards, Evelyn
(to reply to me personally, remove 'sox")
Dennis White - 12 Aug 2004 03:26 GMT "Darryl" <umpolung@REMOVEhotmail.com> wrote in >
snip...
> I look forward to a reply full of references and light on the jargon. > [quoted text clipped - 8 lines] > But hey, this is just my opinion. > Darryl. I second your opinion Darryl. Researchers with real advances in *any* area do not vet newsgroups for opinions. I consider the above poster to be either a schill or a charlatan, until and unless I am directed to truthful, empirical evidence that supports any of the claims he/she is professing. I urge anyone desperate enough to try just about anything to be VERY CAUTIOUS!!!! I am familiar with the kinds of scams perpetrated upon those looking for miracle cures.
Dennis
Baird Stafford - 13 Aug 2004 09:49 GMT <snip>
> I second your opinion Darryl. Researchers with real advances in *any* area > do not vet newsgroups for opinions. Not true in the past: the newsgroups were originally peer-to-peer research areas (this was before the alt.* hierarchy was formed, of course). Some newsgroups still do report research results for the purpose of peer review - though not many, since even medicine has become so commercial that no one dares publish results anywhere lest someone else snick up the patent.
<snip>
Blessed be, Baird
CP - 12 Aug 2004 03:47 GMT > To everyone else, it is my opinion that this person is a charlatan. > Do not allow yourself to be swayed with this empathic approach to the [quoted text clipped - 6 lines] > But hey, this is just my opinion. > Darryl. Darryl,
I am not the charlatan that you make me out to be in your opinion, and I am not looking to sell anything. I have already been faced with this difficult question and I asking for clarity here.
I started this question as an honest examination of the ethical dilemma, because there is the real possibility that this may happen. Even if some other company developed it, the same dilemma would exist. It will create a delicate situation people will have to answer.
I am unable to name the product, the company nor am I making any claims at this time. The product and process is proprietary, therefore I can not go into a more descriptive detail. To do that would be wrong, and the FDA overlords would swoop down on us.
It is far too early in the research, and unpublished. Publication usually takes the better part of a year in these type of research studies with peer review. What has been accomplished thus far looks very promising. This question came up in our research group outlining protocols for clinical trials.
I ask to help discern my own thoughts and feelings on this situation. If this can eventually help others so much the better, but the dilemma is real. If someone wants more information as to possible volunteer openings, then email me. I am asking those who do care for AD patients and may be faced with the inevitable question if it was possible. I certainly did not expect to be flamed for asking a question.
There is always a cause for any disease that is not the result of a bacterial or viral source. Alzheimer was the person who isolated this form of dementia, and later the symptomatic physical results were verified by science. In all our research models, we look for a primary nutritional cause or dysfunction that allows the disease manifestation(s) to occur.
I mentioned some of the background and theory to be more explanatory about the proposed dilemma. It appears likely that a one time regimen is all that may be required. If marketed, the cost would be much lower than you suspect.
Our ideal target market is in prevention, not therapy. Four million U.S. AD patients versus 200 million baby boomers and over 55 group. Why limit my market to AD patients? Why would I want to rip off those few who are afflicted when there is a huge potential market elsewhere?
What does it cost to care for an AD patient over ten years or until their demise? The Medicare/Medicaid bill for Alzheimers care is very disproportionate to their numbers. How much would you be willing to pay to save the life of a parent or relative for that matter? Cancer patients spend themselves into bankruptcy, and what do they usually get in return - an advance casket fitting.
If a major pharmaceutical company developed it, what would do think they would charge? We've been approached to buy and bury our formulas.
Now, can we please get back to the basic question I posted. I am asking for some honest responses.
Sincerely,
CP
Dennis White - 12 Aug 2004 07:56 GMT snip...
> Darryl, > [quoted text clipped - 11 lines] > not go into a more descriptive detail. To do that would be wrong, and > the FDA overlords would swoop down on us. If you were truly concerned about ethics, you would not bring this subject to a usent group. No ethical researcher would do such a thing. To suggest that the FDA *overlords* would swoop down upon you only suggests to me that you are involved in the kind of bogus practice that relies on the argument that the government is conspiring to keep all of us unhealthy. I am very familiar with the kind of argument you put forth and the quality of the folks who make this argument.
> It is far too early in the research, and unpublished. Publication > usually takes the better part of a year in these type of research > studies with peer review. What has been accomplished thus far looks > very promising. This question came up in our research group outlining > protocols for clinical trials. If you are a researcher involved in legitimate, scientific investigation you should alreeady know that bringing this question to a usenet group contravenes ethics, and there is no dilemna to be faced.
> I ask to help discern my own thoughts and feelings on this situation. > If this can eventually help others so much the better, but the dilemma > is real. If someone wants more information as to possible volunteer > openings, then email me. I am asking those who do care for AD patients > and may be faced with the inevitable question if it was possible. I > certainly did not expect to be flamed for asking a question. Yours was not only a question, but an insinuation. For others who might read this, please know that I am not easily drawn into flames...it is just that this poster is so obviously so ill-informed as to the protocol of medical and scientific review that it appears to me he/she is a quack ready to prey on the misfortune of others.
> There is always a cause for any disease that is not the result of a > bacterial or viral source. Alzheimer was the person who isolated *Isolated*? Boy, are you off the mark!!!
this
> form of dementia, and later the symptomatic physical results were > verified by science. In all our research models, we look for a primary [quoted text clipped - 5 lines] > is all that may be required. If marketed, the cost would be much lower > than you suspect. Like other quacks, the use of language that at first glance appears to be knowlegable is upon a second look simply subterfuge. These are not even very big words or concepts
> Our ideal target market is in prevention, not therapy. Four million > U.S. AD patients versus 200 million baby boomers and over 55 group. Why [quoted text clipped - 10 lines] > If a major pharmaceutical company developed it, what would do think they > would charge? We've been approached to buy and bury our formulas. If the research you are involved in is so effective your "company" will give up proprietary rights and relieve the world of much suffering. Why talk of money and saving money and disparage the major pharmaceutical companies of making money when it is obvious that is also your goal. BTW. threats and scare tactics invoking terms like "... what do they usually get in return - an advance casket fitting" are as sure a sign of quackery as blaming the FDA..
> Now, can we please get back to the basic question I posted. I am asking > for some honest responses. My comments are as honest as I can muster. Why abuse this newsgroup with *your* dishonesty? This is a place for AD sufferers and their caregivers to assist one another. Not a place for you to drum up business for your nutritional supplements. I have a very intimate knowledge of scams chicanery and quackery. Anyone involved in legitimate research or marketing is willing to publish his name, the nature of his business and clinical proof to back up claims. If you cannot do that I suggest you rely on mass-mailings of spam, which, in fact, you may already be involved in.
Dennis White
Dennis
Mare - 12 Aug 2004 00:48 GMT Nutritional remedies? Could that be because it's unregulated that way and no real tests are needed to market it? How can we give you any real answers without real information. Before I could make a decision like that I would need to see the research from different studies(not just your own), what the side effects were, what were the odds of stopping or regressing AD and how far would the person recover statistically. Posting from a real account and not an anonymous Yahoo account might give you more credence as well. If you start shilling here to sell something, I know Comcast would be interested.
 Signature Mare mfcoleman@THEOLEmindspring.com http://www.muggsmulcher.com/kstuff/a.s.a/intro.htm alt.support.alzheimers' FAQs and Stuff Pages
> Here's an ethical dilemma that is perplexing and may give me some
> direction in the event this becomes possible. This is part of a multi > part post over the next few days in which I am asking for input and [quoted text clipped - 71 lines] > ultimately decide. Thank you, and I look forward to hearing your > comments. CP Tumbleweed - 12 Aug 2004 07:08 GMT > Here?s an ethical dilemma that is perplexing and may give me some Spam spam spam......
 Signature Tumbleweed
email replies not necessary but to contact use; tumbleweednews at hotmail dot com
Dennis P. Harris - 12 Aug 2004 07:34 GMT > Heres an ethical dilemma that is perplexing the ONLY ethical dilemma is: WHY ARE YOU POSTING YOUR ADVERTISEMENT IN A NON-COMMERCIAL NEWSGROUP? The rest of your post is slick ad bullpucky disguised as psychobabble.
KEEP YOUR SPAM OUT OF THIS NEWSGROUP.
to everyone else: hey, if we all ignore this latest intruder, HE WILL GO AWAY.
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