What do you have to lose?

[Wise Young]

dr young, i have not seen, and that doesnt mean i did not miss it, a response from you on the ricci kilgore video where she stated she had recieved treatments by the medra group. i would like your comments on this, please. also, what is the risks in having the treatments offered by medra? i mean if there is nothing to loose? other than $ why should one not try it?...... i continue to look for a way to get better while trying to be skeptical of offers in which medra seemed to be one of those and then comes the ricci kilgore tape on utube. so any input you have would be appreciated. thanks.

Many people ask me the question, if there is nothing to lose, why don't they just try a therapy even when there is little evidence that it works? I usually give a stock answer, emphasizing the need to carefully assess risk-to-benefit ratios. But, such answers often go in one ear and come right out the other ear of people, almost as if I had said nothing. So, perhaps I should answer this question more bluntly. Deciding to undergo therapies, particularly cell transplants, is not the same as deciding which table at a casino you are going to play at. You are not only gambling with your money but your time and your life.

• Money. Let's take all the wishful thinking out by using a car analogy. Would you plop down $30,000 for a car that you are not sure will go around the block, much less run on the freeway? Would you trust a web site showing video pictures of somebody driving this car but they have never shown the car to legitimate inspectors to ensure that it works? Would you be willing to pay for a car that may works only a few of the people? I hope not. So, if you are not willing to spend this kind of money on a car that may not run, why should you willing to pay this money for a therapy for yourself?

• Time. The time involved in therapies is not trivial. Again, to take the wishful thinking out, let me use an analogy. In the 1980's, I visited a woman by the name of Barbara Divine who was working in a clinic in Cottonwood, Alabama. I was impressed by what she was doing, getting people with spinal cord injuries to walk, with the help of family, friends, and even volunteers from the local football team. Today, we of course know that ambulation training may be useful for some patients. However, in those days, it was not clear. Barbara did not charge much for this therapy. But, the cost was time. Many people did this for months or even years. That time is valuable and should not be thrown away unless the probability of benefit is higher.

• Life. Many people say that they have nothing to lose. I shake my head. What do you mean nothing to lose? Somebody is injecting foreign cells into you! You don't know the quality, the safety, or the efficacy of the cells. Most people don't even know what the cells are. People are going to places like the clinic of Geeta Shroff (who claims to have some kind of human embryonic stem cell) and clinics run by the Beike group in Shenzhen (who claim to be transplanting unmatched umbilical cord blood CD34+ cells). I don't think that you should accept a free unit of blood from a non-certified blood bank or some laboratory that has not been inspected by regulatory agencies. So, why should you go ahead and pay $20,000 or $30,000 for an unproven cell therapy with uncertain safety standards?

In my opinion, people have a great deal to lose when they go to have experimental therapies in overseas clinics. Please note that I am not pushing any scare buttons like AIDS, hepatitis, cancer, allergic or immune response to the cells, etc. I am not claiming that these therapies will disqualify you from most legimate clinical trials, even though this is likely to be the case. I am not even saying that the clinics may be providing contaminated cells, although low standards are very likely to be the case. What I am saying is that, you don't know. If you don't know, the risk is too high.

Most of the clinics that offer illegitimate cell therapies do not collect or present data concerning complications, morbidity, and mortality. Many have not been certified by government agencies. None are carrying out legitimate clinical trials. They all operate out of places where regulations are lax or poorly enforced. Why should they try to document problems with the therapy, if they can get people to pay $20,000-$30,000 for the therapies without asking for safety information? Why should they try to document efficacy, if a majority of people are willing to undertake the therapy after seeing videos of a couple patients.

Wise.

[Buck503]

I thought about Zhangs nerve rerouting procedure for a long time.
The funds wasn't an issue and it seems that he has had some
good results.

I still may go through with it, since my injury is a little different than
everyone elses and there aren't any clinical trials for my injury.

But if I had a straight spinal cord injury and was able to maintain the
bone and muscle below my injury, I wouldn't try any procedure that
hasn't been through a clinical trial and has published results.

The possibilty of more paralysis should be reason enough. That's
what has kind of kept me from going through with it.

[Wise Young]

I thought about Zhangs nerve rerouting procedure for a long time.
The funds wasn't an issue and it seems that he has had some
good results.

I still may go through with it, since my injury is a little different than
everyone elses and there aren't any clinical trials for my injury.

But if I had a straight spinal cord injury and was able to maintain the
bone and muscle below my injury, I wouldn't try any procedure that
hasn't been through a clinical trial and has published results.

The possibilty of more paralysis should be reason enough. That's
what has kind of kept me from going through with it.

I am trying to help Dr. Zhang publish his results. There is a lot of it.

Wise.

[lynnifer]

Re Buck's & Dr Young's comments ... that's the first glimmer of hope I've seen here since coming here - yay!

[Buck503]

I am trying to help Dr. Zhang publish his results. There is a lot of it.

Wise.

Now that's interesting! How long before you recommend I go over there?

[Tufelhunden]

In my opinion, people have a great deal to lose when they go to have experimental therapies in overseas clinics. Please note that I am not pushing any scare buttons like AIDS, hepatitis, cancer, allergic or immune response to the cells, etc. I am not claiming that these therapies will disqualify you from most legimate clinical trials, even though this is likely to be the case. I am not even saying that the clinics may be providing contaminated cells, although low standards are very likely to be the case. What I am saying is that, you don't know. If you don't know, the risk is too high.

Dr. Young,

I think you will agree with me that the Pareto-optimal result would be for people to try and be patient to undertake trials and treatments with statistical follow-up. Especially if trials to come may not want to accept people with previous intervention (multiple-treatment bias in the statistics). Knowledge is built by trial and error, but in order to hold consistency and integrity within the research and proceed with more promising results which are built-upon prior statistically significant results, people should only participate in trials with accountability and definite follow-up. It does not serve the betterment of the whole for someone to be treated, and then "let-go" without any follow-up. This is taking wild stabs in the dark.

I understand that not everyone is in the same boat and not everyone is patient. But, I have to be honest and say that in my most un-biased opinion, people are not getting the results that we as a group have in mind. How much more concise would it be if we, rather than asking these individuals on these boards, read about their results in a medical journal which displayed statistical rigor?

All I am saying is that by undertaking these treatments, you aren't the only one who is losing.

If I upset anyone, I truly apologize. Unfortunately, however, the way research works is:

Hypothesis---> Group selection (control/intervention group; preferably double-blind)---> intervention while keeping both groups in a symmetrically controlled environment---> ANALYSIS OF RESULTS (follow-up)---> Sensitivity analysis (pick another random sample, run the experiment again and see if you can REPLICATE). If replicable, submit for FDA approval.

If there is no follow-up, all we are doing is swimming up a waterfall.

[etexley]

progress

Doctor, one thing that we need to remember in the case of the ambulation training is that all the time that these individuals spent trying to improve their neurology...even if they saw no neurological improvements...they spent on their feet!

The physiological benefits of being vertical weight-bearing are countless. From circulation, to chronic wound healing, to muscle size, to the psychological aspect of being "tall" again.

Recovery from a spinal injury is a gradual, life-long persuit. Whether or not a biological treatment with a measurable, predictable outcome becomes available, I don't believe there will ever be a "magic bullet."

• Time. The time involved in therapies is not trivial. Again, to take the wishful thinking out, let me use an analogy. In the 1980's, I visited a woman by the name of Barbara Divine who was working in a clinic in Cottonwood, Alabama. I was impressed by what she was doing, getting people with spinal cord injuries to walk, with the help of family, friends, and even volunteers from the local football team. Today, we of course know that ambulation training may be useful for some patients. However, in those days, it was not clear. Barbara did not charge much for this therapy. But, the cost was time. Many people did this for months or even years. That time is valuable and should not be thrown away unless the probability of benefit is higher.

[Mike Honcho]

I was the 3rd American to undergo Dr. Huang's procedure. Given the exact same circumstances, I would make the same decision to do it again every day of the week and twice on Sunday.

[Quadcessible]

I was the 3rd American to undergo Dr. Huang's procedure. Given the exact same circumstances, I would make the same decision to do it again every day of the week and twice on Sunday.

So from your experience what did you benefit?

[Lindox]

Doctor, one thing that we need to remember in the case of the ambulation training is that all the time that these individuals spent trying to improve their neurology...even if they saw no neurological improvements...they spent on their feet!

The physiological benefits of being vertical weight-bearing are countless. From circulation, to chronic wound healing, to muscle size, to the psychological aspect of being "tall" again.

Recovery from a spinal injury is a gradual, life-long persuit. Whether or not a biological treatment with a measurable, predictable outcome becomes available, I don't believe there will ever be a "magic bullet."

I agree Eric.
Even without the being "tall" again.
You can dedicate time to "working out" just like any AB. You can fit it in. Go to school..go to work..and work out. It doesn't have to be called rehabilitation.
Or physio. Those words were invented to make us different as usual.

And we owe it to the most severe cases.
Not working as hard as possible when there is something to work with is like throwing away a bounty of food while people starve.

[Tufelhunden]

I was the 3rd American to undergo Dr. Huang's procedure. Given the exact same circumstances, I would make the same decision to do it again every day of the week and twice on Sunday.

This is precisely what I am referring to. You should only have to undergo a therapy once.

[Mike Honcho]

This is precisely what I am referring to. You should only have to undergo a therapy once.

Your wait is going to be even longer if you're hoping to have one "cure" procedure that gets you back all of the function you hope for. Many quads like me would gladly undergo a therapy now to get the function of a para, even if it meant having to wait another few years for a more effective treatment. Some paras (and ABs) don't get that.

I didn't say I would do the therapy every day of the week, but that I would make the same decision I made in 2003. At that time, 1) I had the money, 2) I didn't have a job so time wasn't an issue, and 3) I had no spouse or children. I'm also not saying I would have that same surgery today, mainly there are more known variables and my life has changed. Am I going to wait decades until I have another procedure? Hell no.

[Tufelhunden]

Your wait is going to be even longer if you're hoping to have one "cure" procedure that gets you back all of the function you hope for. Many quads like me would gladly undergo a therapy now to get the function of a para, even if it meant having to wait another few years for a more effective treatment. Some paras (and ABs) don't get that.

I didn't say I would do the therapy every day of the week, but that I would make the same decision I made in 2003. At that time, 1) I had the money, 2) I didn't have a job so time wasn't an issue, and 3) I had no spouse or children. I'm also not saying I would have that same surgery today, mainly there are more known variables and my life has changed. Am I going to wait decades until I have another procedure? Hell no.

Mike Honcho:

I didn't mean to sound condescending to you at all. If you refer to my original post I mentioned that not all of us are in the same boat and everyone is on a different train going at different speeds and in different directions as far as patience and relative position in life goes. If you took my post as an attack or adversarial, that was not the intent, so for that, I sincerely apologize. As a libertarian, my foremost belief is that those of us who are rational are completely free to do with our lives what we like.

However, as a social scientist, I am fully aware of how the classical scientific method works and it would be ignorant of me to not differentiate between methods with statistical control, and those which are uncontrolled.

The whole of our scientific knowledge, especially in medicine, is built in this very manner. So if we are going to expect more results from surgical interventions in the future, rigorous follow-up and clinical trials are just as important, if not more important than the method being tested.

[Mike Honcho]

I probably sounded too defensive, but that wasn't my intent. I know it wasn't an attack by you, but waiting for a single procedure for a cure, as defined by Dr. Young and others in his field, isn't for everybody. Some prefer the chance of incremental gains.

[Wise Young]

Doctor, one thing that we need to remember in the case of the ambulation training is that all the time that these individuals spent trying to improve their neurology...even if they saw no neurological improvements...they spent on their feet!

The physiological benefits of being vertical weight-bearing are countless. From circulation, to chronic wound healing, to muscle size, to the psychological aspect of being "tall" again.

Recovery from a spinal injury is a gradual, life-long persuit. Whether or not a biological treatment with a measurable, predictable outcome becomes available, I don't believe there will ever be a "magic bullet."

etexley, I agree. I guess that whatever example that I give, I would be in danger of somebody interpreting my example to mean that I think that treatment is no good. I was giving this example because it is long enough ago that it may no longer be controversial for most people on CareCure.

At the time that this was being done (1981-1983), many people had moved to Cottonwood and had spent months and some even spent years there, doing their exercises. They exhorted each other on and the camraderie was quite impressive. I had several friends who went.

The idea of walking to walk again was very controversial at the time. Many doctors thought that it was a waste of time. I did not think so. In fact, I was quite impressed by the gains of some people. Of course, today, we are used to seeing people walk after spinal cord injury. "Walking quads" were unusual in those days.

Some people chose between Cottonwood and other activities such as school. They postponed their lives in order to spend the time exercising. I was simply making the point that time is valuable and that one should not throw it away. For some, I am sure that it was worth it. For others, I am not so sure.

Wise.