Double standard for MS patients: doctors
Posted: Fri Jul 23, 2010 6:46 am
Double standard for MS patients: doctors
BARRIE - Anecdotal evidence may not be on a scientific par with a double-blinded clinical trial, but it’s valuable nonetheless, according to several local physicians and surgeons.
Doctors talking to the Advance agree that the country-wide moratorium on a controversial multiple sclerosis (MS) treatment runs contrary to other unconfirmed but standard procedures.
“It seems like there are two standards,” said Barrie cardiovascular-thoracic surgeon Sandy McDonald, who has publicly championed a controversial MS-related procedure pioneered by Italian vascular surgeon Paolo Zamboni.
Considered experimental in many countries, including Canada, due to insufficient scientific studies, the Zamboni-named “liberation treatment” seeks to unblock veins in the head, neck and upper body using a relatively simple angioplasty – allowing blood to drain freely. The Italian’s research suggests MS patients experience an inordinate occurrence of these malfunctioning veins, which leads to a backup of blood that is then re-absorbed, leaving dangerous deposits of cell-killing iron in its wake.
In published papers, Zamboni not only linked what he called Chronic Cerebrospinal Venous Insufficiency (CCSVI) with the nerve damage associated with MS, but also said the treatment helped alleviate debilitating MS symptoms and the number of MS attacks.
Despite an immediate demand for the treatment from those afflicted with the disease, skeptics – including provincial and national governments across Canada – have cited low test-subject numbers and the absence of clinical trials to justify a lack of action.
However, McDonald said angioplasties on veins elsewhere in the body have been performed as a standard of practice – both with and without stents – for more than a decade. Patients suffering pain due to impeded blood flow in the iliac veins of the leg (a condition called May-Thurner Syndrome), for example, are routinely provided with a procedure similar to the liberation treatment to correct the problem.
“I’m not aware of any large controlled double-blind study that says we can do it – but we still do,” he told the Advance. “A patient with the abnormality would happily be given a balloon angioplasty and no one would take umbrage.”
Barrie ear, nose and throat surgeon Rob Ballagh says this practice is not uncommon across specialties even in funded treatments.
“We do not have a double-blind randomized controlled clinical trial for everything we do therapeutically in medicine,” he explained. “A lot of people would find that surprising, but it’s true.”
And even when there is such research available, it isn’t always conclusive.
Ballagh said studies of the various treatments for the inner-ear dizziness condition Meniere’s Disease were examined extensively and all found to have an approximate efficacy of 70 per cent (up as high as 85 per cent in recent years, he added.)
“This suggests a fairly high placebo effect,” he explained. “But if two-thirds feel better? I feel pretty good about giving them the treatment.”
Meanwhile, Dr. Brad Dibble thinks it’s “total garbage” to hold off on the treatment until definitive research is complete.
“We can give them what we know,” said the Barrie cardiologist, who promotes informed choice – even if the information is limited.
“I don’t think we should be making the decisions for our patients, or at least I don’t think we should be excluding options for them.”
Dibble said there have been two clinical trials showing chelation therapy is no better than a placebo, and “yet it is still ethical to offer it to patients” who want to pay for it.
Likewise, cosmetic surgery, which has no clinical trials of any kind, he adds.
“There are numerous examples of where we have to extrapolate from trials because the trials didn’t pertain to our precise patient – for example, if the trial only included men but showed benefit, can I offer the therapy to women?” he said.
“We offer treatments because we think it is in the patient’s best interest, and we want to help if we can and the risks seem acceptable – especially to the patient, so that we don’t deprive patients of some options simply because a clinical trial has yet to be completed."
http://www.simcoe.com/community/barriei ... cle/850931
BARRIE - Anecdotal evidence may not be on a scientific par with a double-blinded clinical trial, but it’s valuable nonetheless, according to several local physicians and surgeons.
Doctors talking to the Advance agree that the country-wide moratorium on a controversial multiple sclerosis (MS) treatment runs contrary to other unconfirmed but standard procedures.
“It seems like there are two standards,” said Barrie cardiovascular-thoracic surgeon Sandy McDonald, who has publicly championed a controversial MS-related procedure pioneered by Italian vascular surgeon Paolo Zamboni.
Considered experimental in many countries, including Canada, due to insufficient scientific studies, the Zamboni-named “liberation treatment” seeks to unblock veins in the head, neck and upper body using a relatively simple angioplasty – allowing blood to drain freely. The Italian’s research suggests MS patients experience an inordinate occurrence of these malfunctioning veins, which leads to a backup of blood that is then re-absorbed, leaving dangerous deposits of cell-killing iron in its wake.
In published papers, Zamboni not only linked what he called Chronic Cerebrospinal Venous Insufficiency (CCSVI) with the nerve damage associated with MS, but also said the treatment helped alleviate debilitating MS symptoms and the number of MS attacks.
Despite an immediate demand for the treatment from those afflicted with the disease, skeptics – including provincial and national governments across Canada – have cited low test-subject numbers and the absence of clinical trials to justify a lack of action.
However, McDonald said angioplasties on veins elsewhere in the body have been performed as a standard of practice – both with and without stents – for more than a decade. Patients suffering pain due to impeded blood flow in the iliac veins of the leg (a condition called May-Thurner Syndrome), for example, are routinely provided with a procedure similar to the liberation treatment to correct the problem.
“I’m not aware of any large controlled double-blind study that says we can do it – but we still do,” he told the Advance. “A patient with the abnormality would happily be given a balloon angioplasty and no one would take umbrage.”
Barrie ear, nose and throat surgeon Rob Ballagh says this practice is not uncommon across specialties even in funded treatments.
“We do not have a double-blind randomized controlled clinical trial for everything we do therapeutically in medicine,” he explained. “A lot of people would find that surprising, but it’s true.”
And even when there is such research available, it isn’t always conclusive.
Ballagh said studies of the various treatments for the inner-ear dizziness condition Meniere’s Disease were examined extensively and all found to have an approximate efficacy of 70 per cent (up as high as 85 per cent in recent years, he added.)
“This suggests a fairly high placebo effect,” he explained. “But if two-thirds feel better? I feel pretty good about giving them the treatment.”
Meanwhile, Dr. Brad Dibble thinks it’s “total garbage” to hold off on the treatment until definitive research is complete.
“We can give them what we know,” said the Barrie cardiologist, who promotes informed choice – even if the information is limited.
“I don’t think we should be making the decisions for our patients, or at least I don’t think we should be excluding options for them.”
Dibble said there have been two clinical trials showing chelation therapy is no better than a placebo, and “yet it is still ethical to offer it to patients” who want to pay for it.
Likewise, cosmetic surgery, which has no clinical trials of any kind, he adds.
“There are numerous examples of where we have to extrapolate from trials because the trials didn’t pertain to our precise patient – for example, if the trial only included men but showed benefit, can I offer the therapy to women?” he said.
“We offer treatments because we think it is in the patient’s best interest, and we want to help if we can and the risks seem acceptable – especially to the patient, so that we don’t deprive patients of some options simply because a clinical trial has yet to be completed."
http://www.simcoe.com/community/barriei ... cle/850931