This Is MS Multiple Sclerosis Community: Knowledge & Support

I understand how a double blind test with medication works.

But can anyone tell me how the Buffalo trial is organised? It's not about medication, but about an operation. Half of the people are not treated, but are told they are, I presume. I can't figure it out.

Does someone know how it's done?

Thanks!

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I'm ready, I'm ready !

According to some here, if they "obscure a sham treatment" with a general anesthetic then they are being highly unethical and the police should be alerted.

With the Buffalo study, the first ten people are treated and know that they are treated. The next twenty are divided into the two groups (treated group and sham group). I believe they are sedated during the procedure so that they are unaware whether they were treated or not. Dr. Sclafani had raised the concern that the first ten will be counted in their final results even though CCSVI has a learning curve and maybe they won't be as good on their first patient as they will be on their thirtieth. But the study is underway, as of last month!

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"However, the truth in science ultimately emerges, although sometimes it takes a very long time," Arthur Silverstein, Autoimmunity: A History of the Early Struggle for Recognition

Thank you all for your information.

This is a good start, but critics will say: It's only done on 20 patients... So I'm afraid we also have to wait for the results of a second trial.

What do you think?

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I'm ready, I'm ready !

I do not agree with this. If people were on their death bed, and they did not receive treatment, or a "sham" procedure, yes I take issue with it. But for fellow MSR's who are stable and have little disability, it is acceptable. How else are we going to find out if the improvements reported by people are placebo effect or not?

Yes Salvatore, i don't understand all the unethical fuzz. Is getting an untested medicin in a trial also unethical???

You have to test, and there i always a risk. But one small incision, is that so unethical?????

Rob

Hi Rob, nice to hear from you again.

As I understand, it's not only a small incision. The patient gets the full treatment EXEPT the dilation of the balloon.

So, the docter can see there is something wrong, but is not going to repair this problem (that must be a though moment for a vascular surgeon). Also, the patient is given contrast, and X-rays are used.

So:

# incision
# insertion of catheter
# contrast
# X-ray
# no intervention (that normaly would take place)

That adds up to five ethical questions.

On the other hand, the protocol of this trial is evaluated by the Intitutional Review Board. I presume they have considered all of this.

Any comments?

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I'm ready, I'm ready !

are they using people that have the same severity of disability, have had the condition for the same length of time, have the same symptoms, lesions in the same area, stenosis in the same area? Are they taking into account restenosis ? or that patients react differently?

I imagine that they are really trying to do a good study, but the fact is there are too many variables,in my view, to get any true results to compare. even if you had more constants you still have the fact that patient recovery varies on a case by case basis. Maybe if you did a large scale study you may get better feedback. But not with 30 people

How long does trial last ?

Again CECE thanks for all your input threwout this site

As far as the ethics are concerned, it seems to me that if the patients KNOW they might get a sham treatment and have signed a consent to that effect, then there is no ethics problem.

Its only a few people for now, but:

"If results suggest an appropriate safety profile and preliminary effectiveness, then researchers will approach the University at Buffalo Institutional Review Board (IRB) for an extension of the protocol to study a larger number of patients in order to convincingly prove or disprove a causal relationship between CCSVI and MS."

Not sure where I saw it, but I think I read 500 for the study referred to above.

GO GO BUFFALO!!

I had the same thoughts. I have also been involved in clinical trials, both as a subject and as staff member for a company that was conducting them. I think the ethical answer is as follows:

The informed consent ins something that the IRB must approve. They must also approve the study as a whole. The riskis assumed by the subjects are definitely weighed and considered, and the level of desperation of the patients taken into acount as to how "free and informed" the consent is. The more desperate the patient, the less free choice they are assumed to be able to exercise.

That said, in this case the risks of the procedure are as follows:

Incision--very very low risk.

Anesthesia-- angioplasty is not generally done under general anesthesia, it is generally done under fairly mild sedation. the same or less than, say, a typical colonoscopy. risk for this is very low.

Insertion of a catheter and advancememt the catheter up the veins--risk fairly low.

Use of fluoroscopic dye during the proceedure--risk very mild. However if the subject had preexisting kidney damage or diabetes with high riski of kidney damage, or already only had one kidney (i.e. a kidney donor) then that risk would definitely be too high. This would be handled by screening potential subjects to elliminate the ones where the risk is too high.

Level of desparation--depends on the individual subject. That too would be handled by the description of qualifications for being a subject.

Thus the study itself would, in detail, require that the subject be qualified before being enforlled in the study. Potential subjects that were alergic to the sedative used, that had pre-existing kidney damage or had shown that they were alergic to the dye, or had diabetes, or subjects that were in such a bad physical condition that they could not freelly give informed consent would be inelligable for the study.

With all that said, and all of that would necessarily be in the study descricption that would be submitted to the IRB, the informed consent should be ethically sufficient.


Make sense?

Some ethicists believe it's unethical to do an open-control study that doesn't protect against the placebo effect (or "meaning response") or bias.

thanks silverbirch

Though I notice a lot of my input begins with "Dr Sclafani says..." so I owe a lot to him as a source.

So, on the matter of trial ethics, Dr. Sclafani said:

And then he has been proven wrong, by the IRB at Buffalo at least! The problem is the treating by general anesthesia when local anesthesia is all that's needed. The general anesthesia is just to obscure whether a procedure is done or not. If a patient in the placebo group has a complication due to the general anesthesia and/or the invasive procedure itself, then the researcher has violated the "first do no harm" and with no benefit to the patient directly. (Although it was argued also that placebo itself is a benefit.) EDITED TO ADD: I was sure that the sham group in Buffalo was under general anesthesia, but this is not stated anywhere in the press releases, so now I am not sure.

We spent a week or two discussing this in DrS's thread, around page 75 or so.

The first part of the Buffalo trial began on June 30th and will last just thirty days. Depending on the results of that (safety results and side effects), the second part where twenty people are treated in a randomized trial will occur. I don't know how long that part will last.

here we go (this is about that second group of 20 randomized):
http://www.buffalo.edu/news/11500

Since they are looking for preliminary effectiveness and safety, that does not sound like it'll be a long drawn-out trial before they move on to a larger trial group...unless they don't have the funding, I imagine that could be an issue?

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"However, the truth in science ultimately emerges, although sometimes it takes a very long time," Arthur Silverstein, Autoimmunity: A History of the Early Struggle for Recognition

I thought I laid all that to rest, but now 'concerned' shows his concern by reviving it.

As I recall, what I objected to was his suggestion that 'we' should take 10 people and treat them with a sham procedure. Only not tell them, not only that they didn't get the procedure, but that they were even in a trial. Then, as now, I say that would be not only unethical but illegal. Consider: if they were not to be told they were in a trial, then presumably they would have to think they were *not* in a trial, in other words, they would have to think they were getting 'straight' Liberation.

So how did they get there? They would have been asking a doctor to perform Liberation on them. But what happened instead? "concerned" somehow got the doctors to agree that the next 10 victims should be given a sham, not told they were in a trial, and if even 1 of them actually improved, that would prove the placebo effect exists.

A heavy price to pay, I say, for such information.

I have been told that 5 people have to complain about someone (the same person) for anyone to investigate. I want to suggest we are all being duped. The persons who seem to do nothing but stir up trouble are: patientx, malden, scorpion, Lyon, and concerned. Sometimes they seem to post within a minute of each other. I think their purpose is to disrupt.

Most people who have sought out this discussion actually have MS. There are some really interested in the science, but I doubt most are.

But constantly repeating the same negative message about CCSVI and Liberation is one thing. I think another purpose (as witness the 'concerned' post, above) is to disrupt. I think my words were suitably twisted, and if I hadn't noticed it he would have got away with completely high-jacking a discussion that had originally been quite an innocent query about Buffalo, in a failed attempt to get a rise out of me.

I suggest that Lyon could be someone who joined a long time ago, perhaps when LDN was first being talked about. Now he pontificates on CCSVI. He also seems to be interested in chemo, tovaxin. stem cells, and a few other red herrings.

patientx and scorpion appeared at nearly the same time. concerned and malden round out the bunch, and I have not been the only one suspicious
of them.

As far as I am concerned, all of them might as well be the same person. They have the same message. They do not see enough evidence. Who knows what will be enough, but it should be clear by now that there is no intention to believe anything, only to claim skepticism. They've got me convinced, they are skeptical. But other than that, they have nothing to offer a discussion of CCSVI, and nothing to show proof the theory is untrue.

I could just ignore them. But I am increasingly concerned they are successfully steering and disrupting as much as they can. If anyone agrees with me, especially if they can point to the actual text, private or not, please tell your nearest moderator in a PM.

About controlled trials with placebo, sham treatments: you always get told you are in a trial. You are told the odds of being on placebo. You sign a disclaimer to that effect.

Randomization is to blind the trial, so nobody, not even 'concerned' knows who gets placebo. In this case the surgeons would have to know, but that is all.

If somebody sedates me so I won't know they didn't treat me, and doesn't tell me that might happen, they are acting criminally. If they don't even tell me I'm being sedated, and/or don't tell me why, well how would you feel?

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"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'_MS' is over - if you want it
Patients sans/without patience