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As a multiple sclerosis patient, Gianfranco Campalani has been treated for Chronic Cerebrospinal Venous Insufficiency (CCSVI) twice and knows firsthand how this procedure has improved the quality of his life. As a doctor, he feels the reluctance that CCSVI is getting from the medical community is “unethical”.................. http://www.msrc.co.uk/index.cfm/fuseact ... ageid/2954

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Thanks for posting that article.....this is one that I will print and take to my GP to pass on to her Vascular associates! Shame on them!

Good link Squiffy2! The concept of ethics hopefully comes to mind for doctors when they choose their plan of action related to CCSVI. If my doctor decided to be indifferent about peer-reviewed trial results it would make me concerned about how well I was being treated. I hope Dr. Gianfranco Campalani's words get more exposure.

Patrice

I agree with Gici. The double blind trial was not designed to assess the efficacy of surgical intervention, it was designed for pharmaceuticals to remove as much bias as possible. Trying to fit an assessment of risk vs. benefit of CCSVI treatment into a double blind trial paradigm seems narrow-minded and disingenious.

How can a surgical intervention be double blind? Can somebody explain?

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...print this article and post it on every doctor/ hospital/ clinic bulletin board in your path...
... research can , will, and does happen parallel to treatment.. !

Lyon wrote:Have a surgeon or group of surgeons perform the operation/sham and then remove them from farther participation in the trial....DON'T use stents as they would show up on imaging and ruin the blind.

Will someone who really knows weigh in? I don't think sham surgery can ever be done ethically. Surgery, especially if it involves anesthesia, always has some risk, and if there is guaranteed no benefit because the surgery is sham, then it is unethical to subject the patient to that risk, however minor.

In a company where I was recently on Sr. staff, we conducted a surgical trial to determine the efficacy of a catheter treatment, similar to a stent. Here is how we did the double blind type studyl to get scientifically valid data: We enrolled the patients in the study. They read and signed the informed consent. Then an envelope was chose at random that had either treatment or non-treatment arm in the sealed envelope. Half (or some percentage) of the patients enrolled were in the treatment arm, and the rest were in the non-treatment arm. At the end of the study the results were compared to see if the treatment resulted in a significant improvement.

This way the patients were segregated at random, and the results were compared.

This could be done here as follows: MS patients would be informed of the details of the study, and would agree to participate. (This would include an agreement NOT to get treatment if their envelope was a non-treatment envelope). They would then be tested for CCSVI. If they had it, half (or some percentage) would be designated at random to be in the treatment arm, and the rest would be designated to be in the noin-treatment arm. After the study, the results would be compared. I can imagine the primary endpoint could be.... relapses over a one year period. (this would mean a one year study) New lesions over the one year perioud (again a one year period) or progression (this would either have to be over a longer period or involve a very large number of participants.) Statistician can determine going in how many participants you need depending on the thing to be measured and the length of time of the study to get to statistical significance. The more frequent or dramatic the event to be measured and the more participants, the shorter the study can be.

Yours are brave and straightforward words GiCi! Go ahead, and stand for us please ...

thank you! and respect
alex

fogdweller wrote:

Lyon wrote:Have a surgeon or group of surgeons perform the operation/sham and then remove them from farther participation in the trial....DON'T use stents as they would show up on imaging and ruin the blind.

Will someone who really knows weigh in?

I was told by an interventional radiologist, who has run clinical studies, that future studies on CCSVI may indeed involve a sham procedure. Note I said may; nothing is really known at this point.

I don't think sham surgery can ever be done ethically. Surgery, especially if it involves anesthesia, always has some risk, and if there is guaranteed no benefit because the surgery is sham, then it is unethical to subject the patient to that risk, however minor.

You might be right, but ethics seems to be a matter of debate. Sham surgeries have been used in the past, and some doctors might still insist on them.

In a company where I was recently on Sr. staff, we conducted a surgical trial to determine the efficacy of a catheter treatment, similar to a stent. Here is how we did the double blind type studyl to get scientifically valid data: We enrolled the patients in the study. They read and signed the informed consent. Then an envelope was chose at random that had either treatment or non-treatment arm in the sealed envelope. Half (or some percentage) of the patients enrolled were in the treatment arm, and the rest were in the non-treatment arm. At the end of the study the results were compared to see if the treatment resulted in a significant improvement.

This doesn't sound like a double-blind trial, if the patients knew they weren't getting the procedure done - not necessarily saying that I agree they are absolutely necessary, but doctors seem to like them to rule out any placebo effect.

Lyon,

The phrase "acceptable risk" is NOT a scientific equation. What is an acceptable risk for one person is NOT an acceptable risk for another. I would NEVER skydive !! So "acceptable risk" IS in the realm of any one person. It is very nice that western medicine has procedures (i.e. the FDA and NIH, etc, etc) for ensuring the safety of drugs and medical procedures. We should listen to them. But everyone must make their own decisions for their own lives. We are not children to be told what to do. I WANT MY LIFE BACK !!!! I haven't gone to Costa Rica or Israel to have stem cell treatments because to me that is an unacceptable risk. I can't volunteer for any clinical trials because I am too old. I can't go to Poland or even Brooklyn because of my situation. But I have a neuroradiologist to consult with who is a top notch guy. And after I go for testing at BNAC and get my results (I am dying from waiting), it will be between me and my doctor whether I can be treated or not.

Sorry for the rant... I feel like !#@*& today.

ozarkcanoer

Is e.g. Tysabri acceptable risk? FDA approved, and yet, people have died. People also die, every day during heart surgery. Young people die every day riding bikes. Let's ban bikes. Sue Harley This is our life, and we, only we, will be the judge of what acceptable risk is.

TFau wrote:The double blind trial was not designed to assess the efficacy of surgical intervention, it was designed for pharmaceuticals to remove as much bias as possible. Trying to fit an assessment of risk vs. benefit of CCSVI treatment into a double blind trial paradigm seems narrow-minded and disingenious.

How did current surgical procedures become accepted practice? Were there double-blind studies involving angioplasty of the coronaries, for example?

I feel sham surgeries would be unethical--but a trial comparing stent vs. angioplasty on known stenosied veins might be a worthwhile pursuit. (These trials have been done in other parts of the body)

Here's a terrific paper from the NEJM on the ethical problem of sham surgeries in clinical research. It refers to Parkinson's research specifically, but I think it's applicable-

Sham surgery is ethically unacceptable as a placebo control in trials of fetal-cell transplantation in patients with Parkinson's disease. Sham surgery, with accompanying anesthesia, poses the risks of any surgical intervention that would not be used alone for therapeutic purposes. In trials that use antibiotics to protect subjects against infection, there are the added risks associated with antibiotic treatment. In trials that forgo the use of antibiotics in the sham-surgery group, there are the added risks of infection.

One question remains to be answered. Those who defend the use of sham surgery could argue that the possibility of a strong placebo response to surgery20 does, in fact, confer a benefit on the subjects who are randomly assigned to the control group. Might the benefit of the placebo effect outweigh the risks of the sham surgery and therefore justify its use in research? The answer is no, unless the sham surgery would be recommended solely for therapeutic purposes outside the research context.

A related question is whether it would be ethical to conduct trials specifically designed to document the placebo effect of surgery. Three groups would be needed: an untreated control group, a group undergoing sham surgery, and a group undergoing real surgery.20 Johnson argues that "for surgical procedures, as for drugs, the placebo effect must always be taken into account if any assessment is to be objective."20 Yet despite the importance of the research question, Johnson contends that "none of the means of measuring placebo [effects] can be applied to surgical operations because it is unethical, for example, to make an abdominal incision and sew it up again without undertaking any procedure."20

Perhaps some defenders of the use of sham surgery in randomized, controlled trials would be prepared to go this far. In response to the question, "If phony operations can help people, why not just do them?" one surgeon said, "That is an important point. What to do with it, medicine is going to have to decide."13 One cannot always predict what the medical community will decide. But one conclusion seems apparent. The placebo-controlled trial may well be the gold standard of research design, but unlike pure gold, it can be tarnished by unethical applications.

http://www.endo.gr/cgi/content/full/341/13/992

cheer