Canadian Government Promises to Fund Junk Science to Appease Zamboni Cult
Posted by Colin Rose on June 29, 2011
It was inevitable that the federal government and its advisory committee would cave into the incessant political pressure of the Zamboni cult. The government is trying to appease the Zamboni zealots who have mercilessly intimidated politicians to fund “liberation” treatment, which is nothing more than high-tech faith healing. Unscrupulous politicians like Libby Davies and Kirsty Duncan have exploited the internet presence of the cult and the public’s sympathy for desperate people for political gain to make the government look uncaring and aloof when it was just trying to pursue the time-honoured scientific method of determining truth.
All that has changed since the advisory committee first recommended not to fund clinical trials was the introduction of a private members bill to mandate clinical trials. Obviously this spooked the government because it would have been forced to vote against the Zamboni cult and lose political capital with no political benefit. Scientists and politicians alike are being viciously slandered by the Zamboni cult using the tools of the internet. A neuroradiologist, Dr. Rubin, on the advisory committee even admitted that he remained unconvinced that Zamboni’s “CCSVI” existed but he still voted for trials of “liberation”. Clearly, the decision was politically motivated. The real scientists were tired of continuously being accused of pandering to pharmaceutical companies and threw in the towel.
Normally a staunch resister of blackmail, intimidation and appeasement in other areas, Prime Minister Stephen Harper should know better. Appeasement of totalitarians, terrorists and self-righteous zealots signals weakness of resolve and only empowers them. Zamboni zealots want nothing less than publicly funded “liberation” on demand. Promise of trials will not satisfy them. When well-blinded controlled trials eventually show that “liberation” is useless, the cult will still demand public funding by claiming that the trials were biased and influenced by Big Pharma. They have a religious faith in “CCSVI”, revealed, scientifically absurd truth from their saviour, Paolo Zamboni, and nothing will persuade them otherwise. I have tried and have been mercilessly attacked on blogs and Facebook. Absolute faith in revealed truth will tolerate no criticism.
There is now ample evidence that Zamboni’s “CCSVI” does not exist as a disease and that “liberation” is a cruel hoax bilking desperate people out of their life savings. See blogs for details of the junk science behind “CCSVI”.
https://medicalmyths.wordpress.com/2009/11/24/the-zamboni-myth-ccsvi-surreal/
At any rate, it is doubtful that any good well-blinded controlled trial of “liberation” will ever get done, at least in Canada. When the Saskatchewan Health Research Foundation asked for grant applications for trials of “liberation” it received only one and even that one didn’t meet the scientific standards of the Foundation. No true scientist is going to make him or herself a laughing stock by attempting to treat a nonexistent disease and go down in history as another fool who believed the Zamboni myth.
Panaceia or Hygeia 
CJ said
The expert panel of the CIHR made the decision unanimously, as announced by Dr. Alain Beaudet.
Steve Morgan said
This page is junk science.
chiefumtaga said
I would like to know what the health minister means by “…the evidence is now here”. Surely she cannot be referring to any recent credible research into the connection CCSVI and MS (or if CCSVI actually exists). Let us hope they did not base this decision based on anecdotal tales from “Liberated” patients (see Colin Rose’s previous blogs about faith healing of MS which appears to work just as well as Liberation therapy).If you doubt my skepticism you can go to PubMed and see what the medical literature says about CCSVI. I also note that the CIHR webpage (as of 30 June 2011) does not have any information on this announcement.
In my opinion the motivation of the federal government is stated later on in the CBC news story “…The federal government has been under pressure for more than a year to support nationwide clinical trials for the treatment, which MS sufferers across the country have been demanding”. Nothing to do with science based medicine and in my experience not all MS sufferers are demanding clinical trials of CCSVI.
Chris Young said
Colin. Don’t you have to be somewhere?
Chris Young said
Seems to me this is exactly what is needed to finally shut people up about it if it’s not true. But then again Colin is the same guy as what we call Republican in the states. They blame a President who wasn’t even in office for the majority of our problems in the USA.
mammananny said
The proof has been available for some time. That Canada chose to ignore it was as irresponsible as the adoption by some in the medical community of the 60 year old autoimmune theory. It’s time to stop the stupidity and greed. What you called “the incessant political pressure of the Zamboni cult”, in truth is called patient self-advocacy. The era of “the doctor knows best’ is thankfully on its way out.
nfarocks said
What rubbish. A very poor article by someone who knows absolutely nothing. The problem is that even when this guy is proven wrong, he won’t apologize for misguiding people.
The purpose of the study is to determine, without influence, whether or not the procedure is of benefit. My wife is one of the most fortunate MS patients on record. She had the surgery a year and a half ago and has her life back. She doesn’t exhibit any MS symptoms whatsoever. So, you cannot convince me that the surgery has no benefit because I’ve seen it. Gone are the days she spends in bed all day too tired to get up and function. She again has her balance back. Her cognitive function is greatly proved
So, we know there are people who have benefited, and there are those who received little or no benefit. Without a clinical study, we cannot know under what circumstances someone should have this done.
Thank you federal government for listening to all of the advocators of this procedure. Time will now tell us what some of us already know.
maldendj said
“….
There is now ample evidence that Zamboni’s “CCSVI” does not exist as a disease and that “liberation” is a cruel hoax bilking desperate people out of their life savings.
….”
…and from their lives, to.
There are four registrated death cases folowing Liberation treatment so far:
Holly Shean, August 2009, Liberated by dr. Dake team, Stanford.
Mahir Mostic, October 2010, Liberated by Dr Marcial Fallas CCSVI team, Costa Rica.
Margo Larayne Oliver, March 2011, Liberated by Dr Marcial Fallas CCSVI team, Costa Rica.
?, March 2011, Liberated in Newport Beach, CA.
creativecurmudgeon said
Why don’t you list all the people who have died or suffered permanent brain damage from using Tysabri?
maldendj said
2nd Canadian dies after MS surgery
(CBC News Posted: Jul 8, 2011 3:58 PM ET)
http://www.cbc.ca/news/health/story/2011/07/08/multiple-sclerosis-ccsvi-death.html
creativecurmudgeon said
Why can’t you answer a simple question? Perhaps because it might betray ignorance?
nfarocks said
“There are four registrated death cases folowing Liberation treatment so far:”
Malj – you are a one-sided coin. Your lack of understanding is laughable. How many people have died taking Tysabri. Actually, the clinical studies were halted because so many people started to die. Do you know what Tysabri is? Let me explain. It is a drug that costs each user $3,500 per month. Let’s just assume that there are 500,000 people currently taking the drug. That would be 1 Billion, Seven Hundred and Fifty Million dollars a MONTH of revenues. Tysabri makes you feel like shit. The side effects are hell. And, get this. It prevents up to 40% less lesions than if you don’t take it. Unfortunately, it only prolongs the inevitable and, while the drug is prolonging this, you have no life because you feel like crap. Guess what? Even though this drug kills people, IT GOT APPROVAL. Go figure.
Did you know that my friend died from complications to an achilles tendon surgery? This was 10 months ago. Should we stop doing achillies tendon surgery? Or should we research it and make it safer?
I look forward to your nonsensical response.
maldendj said
Here is one more fresh evidence now here from Austin hospital:
http://www.msra.org.au/abnormal-venous-drainage-brain-and-spinal-cord-patients-ms
nfarocks said
A comment from the Australia MS group who you purport do not support CCSVI treatment
Re: Canadian Announces Study of CCSVI
“It is our understanding that these trials will examine the merit of a procedure to treat CCSVI and its potential relationship with treatment of MS.
MS Australia supports research into the cause and cure of multiple sclerosis and through MS Research Australia we are also studying a particular aspect of the link between CCSVI and MS”
chiefumtaga said
Nfarocks, where on the MS Australia website do they make that statement? I looked on the MS Australia website and found nothing about them planning to do their own research into MS and “CCSVI”. Curious readers can view the statement (dated 1 July 2011)at http://www.mssociety.org.au/documents/CanadianCCSVI-trialsStatement.pdf
I trust that was a honest oversight on whoever made the quote you passed on in your posting. In fact the last paragraph says….” MS Autralia supports research into the cause and cure of Multiple Sclerosis. We recognise the importance of global research into the disease as one that affects people around the world, and we await the research findings from Canada.”
It seems like MS Australia is not jumping on the CCSVI bandwagon.
nfarocks said
http://www.msra.org.au/statement-regarding-canadian-ccsvi-trials
Actually, what it says is:
“MS Australia supports research into the cause and cure of multiple sclerosis and through MS Research Australia we are also studying a particular aspect of the link between CCSVI and MS”
nfarocks said
That is a cut and paste. No edits from me. Check the link.
nfarocks said
Further, this study has funding of $35,000. This study will pale in comparison to what the Canadian Federal Government will spend. I am confident that the truth, one way or the other, will be achieved. And I, for one, cannot wait. Don’t worry. You can apologize for your position once the results are in. :)
maldendj said
http://www.ncbi.nlm.nih.gov/pubmed/21735737
Rinsho Shinkeigaku. 2011 Jun;51(6):430-2.
[Evaluation of blood flow and the cross-sectional area of internal jugular vein in Japanese multiple sclerosis and neuromyelitis optica patients].
[Article in Japanese]
Tanaka M, Uchizumi H, Tanaka K.
SourceMS Center, Utano National Hospital.
Abstract
Zamboni et al proposed a new hypothesis for the pathomechanisms of multiple sclerosis (MS): chronic cerebrospinal venous insufficiency (CCSVI). Using Doppler ultrasound and venograms, they found severe extracranial venous stenosis in MS patients. They suggested that a venous obstruction in the neck caused a reflux back into the brain, which led to edema and demyelination. We examined the blood flow and the cross-sectional area of the internal jugular veins using Doppler ultrasound (Vivid 7 PRO, GE Health Japan, Tokyo) in 17 MS (8 males and 9 females; 20-58 years of age, median 38 years) and 11 neuromyelitis optica (NMO) Japanese patients (1 male and 10 females; 23-60 years of age, median 44 years). Nine of the 11 NMO patients were seropositive for anti-aquaporin4 antibodies. We did not find any obstruction or stenosis of the internal jugular veins in any patient. Other disorders such as bilateral internal and external jugular venous ligation or radical neck dissection, which result in venous stasis, are not known causes of demyelination in the central nervous system. Our data also does not support the hypothesis of CCSVI theory, despite the fact that our study was limited to a small group of patients and the examination was performed only using Doppler ultrasound.
PMID: 21735737 [PubMed – in process]
maldendj said
Chronic Cerebrospinal Venous Insufficiency and Multiple Sclerosis
Bridget A. Bagert, MD, MPH; Ellen Marder, MD; Olaf Stüve, MD, PhD
Arch Neurol. Published online July 11, 2011. doi:10.1001/archneurol.2011.179
http://archneur.ama-assn.org/cgi/content/abstract/archneurol.2011.179v1
Chronic cerebrospinal venous insufficiency has recently been proposed to be etiologic to multiple sclerosis. Independent investigation into this theory during the past 2 years has not succeeded in verifying this relationship. A critical analysis of the scientific methods used in the original studies of chronic cerebrospinal venous insufficiency in multiple sclerosis reveals several methodological problems with regard to potential bias and confounding. The current evidence calls into question whether chronic cerebrospinal venous insufficiency in multiple sclerosis exists at all.
Author Affiliations: Department of Neurology, Ochsner Clinic Foundation, New Orleans, Louisiana (Dr Bagert); and Neurology Section, Medical Service, Veterans Affairs North Texas Health Care System and Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center at Dallas (Drs Marder and Stüve).
MSstudent Hopeful said
Dr Rose thank you so much for caring
about this issue and wisely trying to
fight this medical tradegy. I just feel
terrible for all the patients and families
that have been so harmed, physically,
financially and emotionally. People
are dead because of this gross
negligence and it’s cheerleader. This
trash 3rd world medicine and science
is so far below Canada’s standards,
and at least the majority of victims
are more damaged now than previously.
So sad.
lyonro said
Thanks for never bowing down to the ccsvi cult members and for giving people with MS a place to get a truthful view of the “liberation” treatment.
creativecurmudgeon said
Speaking about “junk science”, take some time to read an article in July’s Scientific America “The Best Medicine”, p50. Let me quote from it, just for fun and your enlightenment. Mainly fun.
“The medical need for comparative effectiveness research (CER) arises from a fact that most patients realize and fewer doctors acknowledge: the scientific basis for many medical treatments is often flimsy or even nonexistent. More than half the guidelines issued by the Infectious Disease Society of America, for instance, are based on “expert opinion” alone and not on actual comparative data, let alone a clinical trial.”
I grant you the intelligence to know that randomized controlled testing is flawed because of its ineffectiveness when applied to the real world. People involved in RCTs often “break blind”. People who are picked “at random” really aren’t, An English bloke, whose name escapes me right now, has done a lot of research on the subject using California data. Interesting.
Simply put, “science based medicine” as presently practiced is about to be replaced by a new model. The old RCT model you hold so dear takes too long, costs too much, and is no more as effective as simple observational cause and effect. You are exactly what you accuse others of being. Ignorant, I believe, is the word. Maybe you would like to start your own personal cult of out-of-date physicians? When you start to believe everybody else is crazy except you, Houston I think we have a problem.
You are probably too young to remember the controversy over “Theory X and Theory Y” thinking, and the difference between “scientific management” and “management science”. It is easy to get stuck in an obsolete paradigm. But then doctors, besides being exceptionally intelligent, are also exceptionally conservative. Ruts get comfortable, no matter what your station in life. This would not be a problem except for the fact that doctors have so much influence over the lives of others.
How someone who has taken “the Oath”, and must by now know about Article 35 of the World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, can go around pontificating on a subject of which he is demonstrably ignorant, I do not know.
Maybe I grant you too much intelligence?
Peruse the following at your leisure.
Obtaining “Fairness” Can Be Complicated
If you are going to blog about the deaths connected with the Liberation Treatment, you should, in all fairness, cover the alternatives. (I am assuming you do want to be fair?)
• “Particular” deaths from MS itself, as per the official death certificate – four per year in Canada. If you think that figure seems low, you are absolutely correct. Many more deaths related to MS are not recorded that way when issuing cause of death certificates.
• General deaths from MS. MS are nine times as likely as people in the general population to not live out their normal lifespan. But these deaths are not listed as MS deaths. MS sometimes just wears people down until they die of something else. Who counts these deaths as MS deaths? Nobody.
• Suicide deaths of people with MS – the suicide rate of people with MS is seven times what it is in the general population. The 2005 general Canadian suicide rate was 11.6 per 100,000 population. Seven times this rate would be 81.2 deaths per 100,000 population. Applying this rate to an estimated 55,000 Canadian MS patients, yields a figure of 44.67 deaths per year. This means that at least one Canadian MS patient dies by his/her own hand every 10 days.
• Deaths caused by the “scientifically approved” drug trade, and blessed by the MS Establishment. As of July 15, 2011, Tsyabri, one of the latest wonder drugs for MS, had caused twenty-nine deaths, since 2007. Four years, twenty-nine deaths. That would work out to 7.25 deaths per year, and 2011 is not even over yet.
• Cases of brain poisoning caused by “scientifically approved” drugs.
o Progressive multifocal leukoencephalopathy (PML). As of July 15, 2011, one hundred and forty-five cases of PML, an opportunistic viral infection of the brain that usually leads to death or severe, irreparable, brain damage. Four years, one hundred forty-five cases. That would be 36.25 cases per year. And 2011 is not even over yet.
o Cases of immune reconstitution inflammatory syndrome (IRIS). This is a post-PML condition which often occurs as the immune system is re-activated after treatment for PML. Researchers think, but do not know, that as many as half of the deaths in MS patients experiencing PML were actually caused by IRIS after their blood was “cleansed” to remove Tysabri. Tysabri just keeps on giving! Number of deaths per year? Unknown.
This is not to mention the toxic side effects of all “accepted” MS drug therapies which are too numerous to list here. And don’ forget all those needles, and all the pain they cause.
A question that must come to mind is, why is Tysabri still on the market? Well, it was briefly withdrawn shortly after its 2004 introduction in 2006 when problems (like death and brain poisoning) first began to be noticed. But this was only after already having been approved by all those who were right and holy.
Tysabri was allowed back on the market “by the authorities” in 2007 due to the “clamour” that was raised by MS patients, and the fact that the “its clinical benefits outweighed the risks involved”. Yes, you read that correctly.
Where are all the “authorities” now, when Canadian MS patients are “clamouring” for a treatment whose clinical benefits outweigh the risks? I would like to say hiding in shame, but I am afraid that would be rather presumptive of me. Apparently when push comes to shove, politicians only hear “clamour” in the ear they want to.
Now compare and contrast the following figures:
Given that there have been at least 10,000 Liberation Treatments performed in clinics all around the world in the past year and a half, and given that there have been 4 fatalities in all that time (one that is quite directly related to the lack of follow up care in Canada), that works out to 2.67 deaths per year.
Now how alarming should it be to hear that there has been ONE more death related to the Liberation Procedure? And how alarming did you make it sound?
Let me summarize:
Deaths Cases of Brain Side Number of
Per Year Damage Per Year Effects Treatments
Type of Treatment
“Scientifically”
Approved Drugs 7.25 + 36.25 + Many Every month
Every year
Of Your Life
Liberation
Treatment 2.67 0 Few Varies from
0 to ? very few
As compared
With the above
In other words, report and respect the whole truth, not just part of it. A half truth is the worst kind of lie. To sensationalize one death caused by the Liberation Treatment, and not put that death in context is a disservice to all Canadians with MS. Do you actually understand the amount of harm and suffering you may have caused? Quite frankly, I don’t think you have a clue.
You don’t have to go into every exquisite detail every time you blog on this issue, but when you are talking about life and death the stakes are about as high as they can get.
If you are going to continue to report on Liberation Treatment deaths, you should at all times at least mention the occurrence of MS deaths caused by alternative courses of action. Balanced treatment is all we MS patients ask. Fair is fair.
You have obviously done some in-depth research, but you seem to have bought into the Fear, Uncertainty, and Doubt (FUD) tactics of the MS Establishment. In some ways I do not blame you.
Whose word would you take – that of a well dressed “suit”, with an impressive vocabulary and a string of initials after their name, or a scruffy looking woman in blue jeans who says she just had an operation and now feels better? (Of course that would be explained away by the placebo effect – after all, it’s all just in her head, even though she had the operation more than a year ago).
It is with this in mind that I will now present some information I presume you are not aware of.
Fighting the Establishment – Winners and Losers
All things considered, the MS drug status quo makes a lot of money for a lot of people in one way or another. So a new safe, effective, and inexpensive surgical treatment is considered a “clear and present danger” to a lot of powerful people.
The thought of an obscure Italian doctor making some of them irrelevant does not go down easily. They will fight it tooth and nail, and will do everything in their power to create fear, uncertainty, and doubt in the minds of as many people as possible. The status quo is much too comfortable.
Let us for consider, for just a moment, who will be the winners and who will be the losers if the Liberation Treatment should become a staple in the treatment of MS symptoms.
Winners:
• MS patients – no money won, just a loss of pain, a loss of suffering, and a chance for a better life.
• Vascular surgeons and interventional radiologists. (The estimated cost of receiving the Liberation Treatment at home in Canada is less than $2,000.) The Liberation Treatment is presently costing a great deal more outside of Canada precisely because it is prohibited at home. Yet the Liberation Treatment is still a bargain compared to commonly accepted drug therapy. (See below)
• Governments – once they wake up and find the MS doctors have no clothes. The Liberation Treatment is a fantastic bargain as compared to their current drug habit.
Losers:
• Drug companies – billions of dollars in sales. (MS is an excruciatingly painful medical condition, often beginning early in life, then lasts for a lifetime.) The best prescription for profits you could ever imagine. Their mantra – repeat sales, repeat sales, repeat as often as you can……..
• Institutional MS doctors – Drug companies in turn give hundreds of millions of dollars to universities and hospitals, so the MS doctors they employ can pursue their favourite research.
• MS doctors in private practice – These doctors stand to lose the least.
• MS Societies – Drug companies give millions of dollars to MS Societies. While most Society employees are a great source of help for MS patients, and will continue to be, those in high places will find their empires diminished, along with their salaries.
• In other words, “men in suits”.
These losers do not really care, that by prohibiting the Liberation Treatment at home; they are forcing MS patients to suffer more, spend more, and risk bringing back superbugs from other countries.
These “losers” are used to being the MS establishment – MS doctors, drug companies, and MS Society executives – and they all want to keep their privileges. Who do you listen to? How many were not members of the “losers” group? Be truthful.
So, at the end of the day, whose word are you going to take – that of a “suit” who does not know what he is talking about, or the word of woman in blue jeans who simply tells you she feels better? (The “suit” of course will tell you the woman is deranged, and just thinks she’s feeling better.)
Definition of an “Expert”
Your problem is to identify just who “can” be the “experts” on a “new” MS treatment when nobody really knows what really causes MS in the first place? That’s right, nobody. Despite over thirty years of research and the expenditure of billions of dollars, none of the so called “experts” know what causes MS. Not one. And I “know you know” that. (aka as a Rumsfeldian). But the search continues, and it is making a lot of people rich.
MS is most likely to be a multifactorial condition. No one claims the Liberation Treatment is “the one and only cause” of MS. All that has been claimed is that the Liberation Treatment can often significantly reduce MS symptoms.
But just think how much power the “losers” have as compared to the “winners”, at least until governments start catching on. With enough money in the bank, you too could become an expert. Just ask me what the subject is.
WINNERS LOSERS
MS patients Drug companies
Vascular surgeons &
Interventional radiologists MS doctors
Governments MS Societies
Current State of MS Drug Treatment, “Scientifically” Proven, and Authorized for Use In Canada.
Let us consider the mainstream MS drugs Avonex, Betaseron, Copaxone, Rebif and Tysabri. Why do you not report on their side effects – including death? If you have a soul, read about them and weep. Why do you not mention that the main side effect of the Liberation Treatment is a temporarily sore leg?
Why do you not talk about the fact that patients face a lifetime of taking these drug? Whatever their lifetimes turn out to be.
Why do you not talk about the fact that many – if not most – MS patients simply quit taking these drugs because, considering the side effects and all those painful injections, it is simply just not worth it.
The Cost of “Scientifically” Proven MS Drugs Authorized for Use In Canada
FYI here are some of the prices of MS drugs, as charged to our American cousins who do not have the luxury of our health care system:
Avonex $ 24,000 – 30,000 Per year For life
Betaseron $ 22,000 – 33,000 Per year For life
Copaxone $ 23,000 – 34,000 Per year For life
Rebif $ 25,000 – 31,000 Per year For life
Tysabri $ 32,000 – ? Per year For life
What is charged to the Canadian taxpayer? Who really knows, or is willing to tell?
Why do you not talk about the fact that the cost of the Liberation Treatment for Canadians leaving sovereign soil ranges from $ 7,000 – $ 15,000 for a one time treatment that may not have to be repeated in order to reduce symptoms? Why do you not report that the real cost of the procedure if done in Canada would be approximately $ 2,000?
Just Who Is Scamming Who?
I guess that the powers that be listen to MS patients when it enables the sale of expensive drugs. I guess scientifically approved deaths and brain damage are OK when it greases the wheels of commerce, and continues to contribute to the welfare of drug companies, MS doctors, and MS Societies. Why don’t you talk about that?
For some strange reason, when MS patients say that members of the MS establishment work together, they are accused of being conspiracy theory cranks. The fact that this has been going on for decades is no great secret, yet gets conveniently ignored.
It is not that members of the MS establishment have hatched some particular diabolical scheme. They are just keeping up relationships they have had for over thirty years, and have a common desire to make the most out of their investment (both in terms of time and money) in the status quo. It is merely a manifestation of the “territorial imperative”.
Perfectly understandable in terms of business and commerce, but a sad comment, I am sorry to say, on the character and morality of some Canadian physicians.
MS, the Liberation Treatment, and Morality
Given to choose between drug companies, MS Society employees, and MS doctors, what group would you think of as having the highest moral principles?
Let me take a wild guess – doctors? Right. The Hippocratic Oath, and all that. You probably think that the oath starts “First, do no harm”. Well, you are wrong. (Please see below.) Let us see how this morality has played out among many MS doctors in Canada.
As you now know, there are relatively few drugs that do anything to relieve MS symptoms. For one kind of MS, primary progressive multiple sclerosis, there is “no” drug that actually even treats MS. All doctors can try to do is try to address reducing the pain level – usually with steroids that weaken your general autoimmune system, exposing you to infections.
So, with the development of a procedure that showed promise of perhaps treating MS all kinds of MS, without the use of toxic drugs, and for a very low price, (given the alternative), would you not have thought those noble MS physicians you thought you knew would jump at the chance to learn more, and actually practice the procedure (don’t forget, the Liberation Treatment is a relatively minor surgery, generally with no side effects, and no monthly repeats). This is the stuff of nightmares for drug companies.
Well, if you wait to see Canadian MS doctors jumping, you could be waiting a very long time. A couple of doctors started to try, but got cut off at the knees by their local Colleges of Physicians and Surgeons. The Colleges have put the fear of the devil into our supposed angels of mercy.
Why, you might ask? Because a certain set of physicians, high on ego and long on money, did not want it to happen. They would rather see their harm, than approve of someone else’s help. These doctors would rather approve of scientifically sanctioned death, than take a chance on learning and healing using a method they were not familiar with.
These doctors are in contravention of their Hippocratic Oath, and in contravention of Article 35 of the World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects.
All Canadian MS doctors take the Hippocratic Oath.
The College of Physicians and Surgeons of Canada is a member of the World Medical Association, but it seems that it feels free to ignore both the words and spirit of their agreements, if they so choose. In other words, “if I can’t help someone, neither can anyone else”.
Now, there are no legal measures that can be taken against those physicians (or the various Colleges of Physicians and Surgeons, as may be appropriate) that do not comply. But they – one would assume – would like to be seen as embodying the principles of the following documents. See what you think.
I at least think you think. Doctors are very intelligent creatures, and represent the cream of the intellectual crop. I recognize and honour your intelligence, but I find despair in your use of it. You are using your intelligence to educate, but you take far too much pleasure in putting other people down. For this, you lose my respect. You are “operating” on ego drive. Just look in the mirror.
I have attached the following for the benefit of all those tortured readers who have made it this far, and for you to refresh your memory.
The Hippocratic Oath (Modern Version)
I swear to fulfill, to the best of my ability and judgment, this covenant:
I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow.
I will apply, for the benefit of the sick, all measures [that] are required, avoiding those twin traps of overtreatment and therapeutic nihilism.
I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon’s knife or the chemist’s drug.
I will not be ashamed to say “I know not,” nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery.
I will respect the privacy of my patients, for their problems are not disclosed to me that the world may know. Most especially must I tread with care in matters of life and death. If it is given to me to save a life, all thanks. But it may also be within my power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty. Above all, I must not play at God. (Are you paying attention?)
I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person’s family and economic stability. My responsibility includes these related problems, if I am to care adequately for the sick.
I will prevent disease whenever I can, for prevention is preferable to cure.
I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm.
If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.
World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects.
Article 35.
In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering.
Where possible, (not in Canada though, pity) this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be
recorded and, where appropriate, made publicly available.
In Closing
There are sick human beings in Canada, people with multiple sclerosis, and we are seeking help.
But will Canadian MS Doctors admit “I know not”, and ask for the help of another?
(There are Canadian doctors who know how to perform the Liberation Treatment, and would gladly share their knowledge if they were allowed. There are American doctors just across a magic line in the United States who have offered to share their knowledge with Canadian doctors but have been refused).
Those Canadian doctors that might heal us are prevented from doing so, and so MS patients continue to suffer and die. Those that would prevent our healing can do little or nothing to help us themselves, but it matters not. They will not admit they do not know. They will not take the outstretched hands of those who might help.
Assured as they are of their Godlike powers, and assured as they are of controlling the medical message, they continue to delay the timely treatment of their patients due to selfish egos and the sin of pride.
May shame be upon them. (And the likes of you.)
(Just watch for all the delaying tactics that will appear. Watch for all the trials and testing that will be called for, despite the fact that most of the work consists of reinventing the wheel. All delay benefits the “losers”. All delay results in the continuing suffering of the “winners”. Is this not justice turned upside down?) You do care about justice, don’t you?
It would seem quite clear that any “proven” interventions in multiple sclerosis are quite ineffective.
It would seem quite clear that thousands of so called “unproven” interventions have been successfully and safely been performed on people with multiple sclerosis, re-establishing quality of life and alleviating suffering.
It would seem clear that the “black market” in Liberation Treatments that the MS establishment feverishly warns about is a creature of their own making. Prohibition does not work, and never has.
Canadian MS doctors could have started to test for and treat CCSVI in Canada a year and a half ago, and this issue would now have been put to bed. But they chose not to. So any Canadian with a new hope for MS treatment is shut out at home. What would you do?
The really great surprise is that there have been so many Liberation procedures performed in “black markets” all over the world with very few fatalities.
The really great expectation met is that the Canadian Government is calling for unnecessary testing to be done.
The influence of egos and money is best carried out when least detected. Speaking truth to power is a loser’s game, in the true sense of the word “loser”. Ask the suffering MS patient who is slowly but surely dying, but cannot afford to be tested and treated outside of Canada.
Ask one.
I await your reply.
creativecurmudgeon said
Well, hello Dr. Rose.
I note that, alas, you have still not answered my questions. I am not surprised.
Your assumption seems to be that people with MS should be seen, but not heard. We are dumb and desperate, emotional wrecks who cannot decide for ourselves what is best for us. Surely we must defer to the “experts” in the MS Establishment – MS Doctors, MS Society executives, and the pharmaceutical companies that market MS drugs. Otherwise we might lose our lives and have all our money stolen by scam artists.
Why do I get the feeling that I am being talked down to? Hmmmmmm………..
You are a doctor, sir, and deserving of much praise. Doctors come from the intellectual cream of the crop. You have a great deal of energy, but it would seem a rather weak ego. You have to ask yourself “What kind of man would go to the effort of maintaining a blog just to put others in ‘their’ place”?
MS sufferers are well aware of pixie dust cures. Believe it or not. We are also aware that you do not know what causes MS, and neither does anybody else. MS is a symptom, not a disease. In infamous (but actually correct) Rumsfeld speak, I “know you know”. Which makes your position on the CCSVI issue all the more distressing.
However, as a dedicated man of science, I would like to draw your attention to an article in the July 2011 issue of Scientific American entitled “The Best Medicine”. Page 50, to be exact.
Let me quote a passage or two in the article, just to pique your interest.
“The medical need for CER (which I am sure you know stands for ‘comparative effectiveness research’) arises from a fact that few patients realize and fewer doctors acknowledge the scientific basis for many medical treatments is often flimsy or even nonexistent. More than half the guidelines issued by the Infectious Disease Society of America, for instance, are based on “expert opinion” alone and not on actual comparative data, let alone a clinical trial.”
and
“The new research promises to yield better information: data that are more useful in clinical practice than data from traditional trials”.
The cut and thrust of the article is that randomized controlled testing takes too long, costs too much, and is simply not worth the effort. CER is simply the application of computer horsepower to the analysis of massive amounts of anecdotal evidence.
Now, correct me if I am wrong, but what this amounts to in the world of the MS patient, is the application of one’s brain to the evidence provided by thousands of MS patients regarding the effects of CCSVI angioplasty on their MS symptoms. The connection of observed cause and effect. Gosh, how novel.
God bless science. It has delivered us out of the world of RCTs and into the world of CER. Hallelujah!
Previously, defenders of RCTs have been able to say that while RCTs are not perfect, but they are much better than any of the alternatives. (Reminds one of Churchill’s take on democracy, doesn’t it.)
Well, these staunch defenders of the scientific method cannot take up the cudgel of RCTs any longer. You are stuck in a rut, Dr. Rose, and have not yet noticed that there is a precipice ahead. You are wasting your time, and worse yet, are trying to get everybody else you can to jump into the same rut. Misery loves company, or something like that.
Now it must be acknowledged that ninety-five percent of “alternative” medicine is pure bull, and does take advantage of the discouraged and discontent. But there is that five percent that one must account for. With just a whiffle of luck, CER will “notice” that five percent. We live in hope.
Ordinarily I would not waste my time on you, but you have taken it upon yourself to judge the wisdom of others, and to offer counsel to the hoi polloi. “Judge ye not lest ye be judged”. Seems I have heard that expression somewhere. You are a dangerous doctor, and have brought shame on the M.D. designation.
Dr. Lou Francescotti, president of the Royal College of Physicians and Surgeons of Canada (as you must know), has dared to speak of some doctors as being “arrogant”. Tell me Colin, have you looked in the mirror lately? It would seem that Dr. Lou knew what he was taking about.
When you feel free from agonizing over all us stupid people, peruse the following.
Obtaining “Fairness” Can Be Complicated
If you are going to speak to the issue of deaths connected with the Liberation Treatment, you should, in all fairness, cover the alternatives:
• “Particular” deaths from MS itself, as per the official death certificate – four per year in Canada. If you think that figure seems low, you are absolutely correct. Many more deaths related to MS are not recorded that way when issuing cause of death certificates.
• General deaths from MS. MS are nine times as likely as people in the general population to not live out their normal lifespan. But these deaths are not listed as MS deaths. MS sometimes just wears people down until they die of something else. Who counts these deaths as MS deaths? Nobody.
• Suicide deaths of people with MS – the suicide rate of people with MS is seven times what it is in the general population. The 2005 general Canadian suicide rate was 11.6 per 100,000 population. Seven times this rate would be 81.2 deaths per 100,000 population. Applying this rate to an estimated 55,000 Canadian MS patients, yields a figure of 44.67 deaths per year. This means that at least one Canadian MS patient dies by his/her own hand every 10 days.
• Deaths caused by the “scientifically approved” drug trade, and blessed by the MS Establishment. As of July 15, 2011, Tsyabri, one of the latest wonder drugs for MS, had caused twenty-nine deaths, since 2007. Four years, twenty-nine deaths. That would work out to 7.25 deaths per year, and 2011 is not even over yet.
• Cases of brain poisoning caused by “scientifically approved” drugs.
o Progressive multifocal leukoencephalopathy (PML). As of July 15, 2011, one hundred and forty-five cases of PML, an opportunistic viral infection of the brain that usually leads to death or severe, irreparable, brain damage. Four years, one hundred forty-five cases. That would be 36.25 cases per year. And 2011 is not even over yet.
o Cases of immune reconstitution inflammatory syndrome (IRIS). This is a post-PML condition which often occurs as the immune system is re-activated after treatment for PML. Researchers think, but do not know, that as many as half of the deaths in MS patients experiencing PML were actually caused by IRIS after their blood was “cleansed” to remove Tysabri. Tysabri just keeps on giving! Number of deaths per year? Unknown.
This is not to mention the toxic side effects of all “accepted” MS drug therapies which are too numerous to list here. And don’ forget all those needles, and all the pain they cause. Colin, do you like getting needled? So to speak.
A question that must come to mind is, why is Tysabri still on the market? Well, it was briefly withdrawn shortly after its 2004 introduction in 2006 when problems (like death and brain poisoning) first began to be noticed. But this was only after already having been approved by all those who were right and holy.
Tysabri was allowed back on the market “by the authorities” in 2007 due to the “clamour” that was raised by MS patients, and the fact that the “its clinical benefits outweighed the risks involved”. Yes, you read that correctly.
Where are all the “authorities” now, when Canadian MS patients are “clamouring” for a treatment whose clinical benefits outweigh the risks? I would like to say hiding in shame, but I am afraid that would be rather presumptive of me. Apparently when push comes to shove, politicians only hear “clamour” in the ear they want to.
Please note the following information. It has been compiled as of July 25, 2011 from numerous sources, often from the information that pharmaceutical companies have been forced to disclose on their own websites.
Given that there have been at least 10,000 Liberation Treatments performed in clinics all around the world in the past year and a half, and given that there have been 4 fatalities in all that time (one that is quite directly related to the lack of follow up care in Canada), that works out to 2.67 deaths per year.
Now how alarming should it be to hear that there has been ONE more death related to the Liberation Procedure? And how alarming did you make it sound?
Let me summarize:
Deaths Cases of Brain Side Number of
Per Year Damage Per Year Effects Treatments
Type of Treatment
“Scientifically”
Approved Drugs 7.25 + 36.25 + Many Every month
Every year
Of Your Life
Liberation
Treatment 2.67 0 Few Varies from
0 to ? very few
As compared
With the above
In other words, report and respect the whole truth, not just part of it. A half truth is the worst kind of lie. To sensationalize one death caused by the Liberation Treatment, and not put that death in context is a disservice to all Canadians with MS. Do you actually understand the amount of harm and suffering you may have caused? Quite frankly, I don’t think you have a clue.
You don’t have to go into every exquisite detail every time you blog on this issue, but when you are talking about life and death the stakes are about as high as they can get.
If you are going to continue to report on Liberation Treatment deaths, you should at all times at least mention the occurrence of MS deaths caused by alternative courses of action. Balanced treatment. Fair is fair. Are you fair, Colin?
You are part of the FUD offensive (fear, uncertainty and doubt, in case you did not know) tactics of the MS establishment. In some ways I do not blame you. But in other ways I do. You should know better.
Tell me, Colin, whose word would you take – that of a well dressed “suit”, with an impressive vocabulary and a string of initials after their name, or a scruffy looking woman in blue jeans who says she just had an operation and now feels better? (Of course that would be explained away by the placebo effect – after all, it’s all just in her head, even though she had the operation more than a year ago).
It is with this in mind that I will now present some information I presume you are not aware of.
Fighting the Establishment – Winners and Losers
All things considered, the MS drug status quo makes a lot of money for a lot of people in one way or another. So a new safe, effective, and inexpensive surgical treatment is considered a “clear and present danger” to a lot of powerful people. The thought of an obscure Italian doctor making some of them irrelevant does not go down easily.
They will fight it tooth and nail, and will do everything in their power to create fear, uncertainty, and doubt in the minds of as many people as possible. The status quo is much too comfortable. Tell me, are you comfortable, Colin?
Let us for consider, for just a moment, who will be the winners and who will be the losers if the Liberation Treatment should become a staple in the treatment of MS symptoms.
Winners:
• MS patients – no money won, just a loss of pain, a loss of suffering, and a chance for a better life.
• Vascular surgeons and interventional radiologists. (The estimated cost of receiving the Liberation Treatment at home in Canada is less than $2,000.) The Liberation Treatment is presently costing a great deal more outside of Canada precisely because it is prohibited at home. Yet the Liberation Treatment is still a bargain compared to commonly accepted drug therapy. (See below)
• Governments – once they wake up and find the MS doctors have no clothes. The Liberation Treatment is a fantastic bargain as compared to their current drug habit.
Losers:
• Drug companies – billions of dollars in sales. (MS is an excruciatingly painful medical condition, often beginning early in life, then lasts for a lifetime.) The best prescription for profits you could ever imagine. Their mantra – repeat sales, repeat sales, repeat as often as you can……..
• Institutional MS doctors – Drug companies in turn give hundreds of millions of dollars to universities and hospitals, so the MS doctors they employ can pursue their favourite research.
• MS doctors in private practice – These doctors stand to lose the least.
• MS Societies – Drug companies give millions of dollars to MS Societies. While most Society employees are a great source of help for MS patients, and will continue to be, those in high places will find their empires diminished, along with their salaries.
• In other words, “men in suits”. Like you, Colin.
These losers do not really care, that by prohibiting the Liberation Treatment at home; they are forcing MS patients to suffer more, spend more, and risk bringing back superbugs from other countries.
These “losers” are used to being the MS establishment – MS doctors, drug companies, and MS Society executives – and they all want to keep their privileges. They have had them so long – they must be right. Of course. The truth be damned. Who dares to challenge their assembled right and might?
So, at the end of the day, Colin, whose word are you going to take – that of a “suit” who does not know what he is talking about, or the word of woman in blue jeans who simply tells you she feels better? (The “suit” of course will tell you the woman is deranged, and just thinks she’s feeling better.)
Definition of an “Expert”
Your problem, Colin, is the same as everybody else. How do you identify just who “can” be the “experts” on a “new” MS treatment when nobody knows what causes MS in the first place? That’s right, nobody. Despite over thirty years of research and the expenditure of billions of dollars, none of the so called “experts” know what causes MS. Not one. But the search continues, and it is making a lot of people rich. Colin, I know you know that.
MS is most likely to be a multifactorial condition. No one claims the Liberation Treatment is “the one and only cause” of MS. All that has been claimed is that the Liberation Treatment can often significantly reduce MS symptoms.
But just think how much power the “losers” have as compared to the “winners”, at least until governments start catching on.
Winners Losers
MS patients Drug companies
Vascular surgeons &
Interventional radiologists MS doctors
Governments MS Societies
Current State of MS Drug Treatment, “Scientifically” Proven, and Authorized for Use In Canada.
Let us consider the mainstream MS drugs Avonex, Betaseron, Copaxone, Rebif and Tysabri. Why do you not report on their side effects – including death? Surely you know about them, Colin. You must have read about them somewhere. Why do you not mention that the main side effect of the Liberation Treatment is a temporarily sore leg?
Why do you not talk about the fact that patients face a lifetime of taking these drug? Whatever their lifetimes turn out to be.
Why do you not talk about the fact that many – if not most – MS patients simply quit taking these drugs because, considering the side effects and all those painful injections, it is simply just not worth it.
The Cost of “Scientifically” Proven MS Drugs Authorized for Use In Canada
FYI here are some of the prices of MS drugs, as charged to our American cousins who do not have the luxury of our health care system:
Avonex $ 24,000 – 30,000 Per year For life
Betaseron $ 22,000 – 33,000 Per year For life
Copaxone $ 23,000 – 34,000 Per year For life
Rebif $ 25,000 – 31,000 Per year For life
Tysabri $ 32,000 – ? Per year For life
What is charged to the Canadian taxpayer? Who really knows, or is willing to tell?
Why do you not talk about the fact that the cost of the Liberation Treatment for Canadians leaving sovereign soil ranges from $ 7,000 – $ 15,000 for a one time treatment that may not have to be repeated in order to reduce symptoms? Why do you not report that the real cost of the procedure if done in Canada would be approximately $ 2,000?
Just Who Is Scamming Who?
I guess that the powers that be listen to MS patients when it enables the sale of expensive drugs. I guess scientifically approved deaths and brain damage are OK when it greases the wheels of commerce, and continues to contribute to the welfare of drug companies, MS doctors, and MS Society execs. Why don’t you talk about that?
For some strange reason, when MS patients say that members of the MS establishment work together, they are accused of being conspiracy theory cranks. The fact that this has been going on for decades is no great secret, yet this fact seems to get conveniently ignored when it suits you.
It is not that members of the MS establishment have hatched some particular diabolical scheme. They are just keeping up relationships they have had for decades, and have a common desire to make the most out of their investment (both in terms of time and money) in the status quo. It is merely a manifestation of the “territorial imperative”. Or the will to power. Call it what you will.
Perfectly understandable in terms of business and commerce, but a sad comment, I am sorry to say, on the character and morality of some Canadian physicians. I actually believe that they are so inward looking that they have convinced themselves by their own rhetoric. “We are going to form a firing squad. First we will form a circle.” It is a pity that it is the poor innocent MS patient who happens to have been stranded in the middle, and gets done in by the crossfire.
MS, the Liberation Treatment, and Morality
Given to choose between drug companies, MS Society employees, and MS doctors, what group would you think of as having the highest moral principles?
Colin, let me take a wild guess – doctors? Right. The Hippocratic Oath, and all that. “First, do no harm”. Right? Well, not exactly. Let us see how morality has played out among many MS doctors in Canada.
As you now know, there are relatively few drugs that do anything to relieve MS symptoms. For one kind of MS, primary progressive multiple sclerosis, there is “no” drug that actually even treats MS. All doctors can try to do is try to address reducing the pain level – usually with steroids that weaken your general autoimmune system, exposing you to infections.
So, with the development of a procedure that showed promise of perhaps treating MS all kinds of MS, without the use of toxic drugs, and for a very low price, (given the alternative), would you not have thought those noble MS physicians would jump at the chance to learn more, and actually practice the procedure. (Don’t forget, the Liberation Treatment is a relatively minor surgery, generally with no side effects, and no monthly repeats). This is the stuff of nightmares for drug companies.
Well, if you wait to see Canadian MS doctors jumping, you could be waiting a very long time. A couple of doctors started to try, but got cut off at the knees by their local Colleges of Physicians and Surgeons.
Why, you might ask? Because a certain set of physicians, high on ego and long on money, did not want it to happen. They would rather see their harm, than approve of someone else’s help. These doctors would rather approve of scientifically sanctioned death, than take a chance on learning and healing using a method they were not familiar with.
These doctors are in contravention of their Hippocratic Oath, and in contravention of Article 35 of the World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects.
(For the general benefit of the great unwashed, I have published a copy of the aforementioned documents below.)
All Canadian MS doctors take the Hippocratic Oath.
The College of Physicians and Surgeons of Canada is a member of the World Medical Association, but it seems that it feels free to ignore both the words and spirit of their agreements, if they so choose. In other words, “if I can’t help someone, neither can anyone else”.
Now, there are no legal measures that can be taken against those physicians (or the various Colleges of Physicians and Surgeons, as may be appropriate) that do not comply. But they – one would assume – would like to be seen as embodying the principles of the following documents. What do you think, Colin?
The Hippocratic Oath (Modern Version)
I swear to fulfill, to the best of my ability and judgment, this covenant:
I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow.
I will apply, for the benefit of the sick, all measures [that] are required, avoiding those twin traps of overtreatment and therapeutic nihilism.
I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon’s knife or the chemist’s drug.
I will not be ashamed to say “I know not,” nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery.
I will respect the privacy of my patients, for their problems are not disclosed to me that the world may know. Most especially must I tread with care in matters of life and death. If it is given to me to save a life, all thanks. But it may also be within my power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty. Above all, I must not play at God. Did you notice this part Colin?
I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person’s family and economic stability. My responsibility includes these related problems, if I am to care adequately for the sick.
I will prevent disease whenever I can, for prevention is preferable to cure.
I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm.
If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.
World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects.
Article 35.
In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering.
Where possible, (not in Canada though, pity) this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be
recorded and, where appropriate, made publicly available.
In Closing
There are sick human beings in Canada, people with multiple sclerosis, and they are seeking help.
But will Canadian MS Doctors admit “I know not”, and ask for the help of another?
(There are Canadian doctors who know how to perform the Liberation Treatment, and would gladly share their knowledge if they were allowed. There are American doctors just across a magic line in the United States who have offered to share their knowledge with Canadian doctors but have been refused).
Those Canadian doctors that might heal us are prevented from doing so, and so MS patients continue to suffer and die. Those that would prevent our healing can do little or nothing to help us themselves, but it matters not. They will not admit they do not know. They will not take the outstretched hands of those who might help.
Assured as they are of their Godlike powers, and assured as they are of controlling the medical message, they continue to delay the timely treatment of their patients due to selfish egos and the sin of pride.
May shame be upon them. And you too, Colin. To know right, but to choose wrong, is ………??? You supply the words.
(Just watch for all the delaying tactics that will appear. Watch for all the trials and testing that will be called for, despite the fact that most of the work consists of reinventing the wheel. All delay benefits the “losers”. All delay results in the continuing suffering of the “winners”. Is this not justice turned upside down? ) You do care about justice don’t you Colin?
It would seem quite clear that any “proven” interventions in multiple sclerosis are quite ineffective.
It would seem quite clear that thousands of so called “unproven” interventions have been successfully and safely been performed on people with multiple sclerosis, re-establishing quality of life and alleviating suffering.
It would seem clear that the “black market” in Liberation Treatments that the MS establishment feverishly warns about is a creature of their own making. Prohibition does not work, and never has.
Canadian MS doctors could have started to test for and treat CCSVI in Canada a year and a half ago, and this issue would now have been put to bed. But they chose not to. So any Canadian with a new hope for MS treatment is shut out at home. So tell me, Colin, what would you do?
The really great surprise is that there have been so many Liberation procedures performed in “black markets” all over the world with very few fatalities.
The really great expectation met is that the Canadian Government is calling for unnecessary testing to be done.
The influence of egos and money is best carried out when least detected. Speaking truth to power is a loser’s game, in the true sense of the word “loser”. Ask the suffering MS patient who is slowly but surely dying, but cannot afford to be tested and treated outside of Canada.
Ask one.
They say that justice delayed is justice denied. In this case, Liberation Treatment delayed is just that much more money in somebody’s pocket, or a stroke of somebody’s precious ego. Politicians, dupes and shape shifters as they sometimes are, have been scared spitless by MS doctors’ alarmist consultations.
I take my hat off to the Premier of New Brunswick who has actually listened to the stories of his electorate, and has dared to stand up to the bullying of the MS establishment version of the military-industrial complex.
We all trust out doctors. I do. You do. (You are trustworthy, aren’t you Colin?) It is automatic. And 99.99% of the time our doctors prove deserving of our trust. But every once in a while, no matter how sure we are of something, events so conspire as to leave us dumbfounded. Are you dumbfounded Colin? Probably not.
You are an intelligent man, Colin. But you have a mean spirit. So be it.
The End. (Aren’t you glad?)
So, speak to me Colin. I am waiting.
creativecurmudgeon said
It would seem that this sight does not appreciate long essays. With that in mind, I will attempt to deal with the following information in bits and chunks.
Well, hello Dr. Rose.
I note that, alas, you have still not answered my questions. I am not surprised.
Your assumption seems to be that people with MS should be seen, but not heard. We are dumb and desperate, emotional wrecks who cannot decide for ourselves what is best for us. Surely we must defer to the “experts” in the MS Establishment – MS Doctors, MS Society executives, and the pharmaceutical companies that market MS drugs. Otherwise we might lose our lives and have all our money stolen by scam artists.
Why do I get the feeling that I am being talked down to? Hmmmmmm………..
You are a doctor, sir, and deserving of much praise. Doctors come from the intellectual cream of the crop. You have a great deal of energy, but it would seem a rather weak ego. You have to ask yourself “What kind of man would go to the effort of maintaining a blog just to put others in ‘their’ place”?
MS sufferers are well aware of pixie dust cures. Believe it or not. We are also aware that you do not know what causes MS, and neither does anybody else. MS is a symptom, not a disease. In infamous (but actually correct) Rumsfeld speak, I “know you know”. Which makes your position on the CCSVI issue all the more distressing.
However, as a dedicated man of science, I would like to draw your attention to an article in the July 2011 issue of Scientific American entitled “The Best Medicine”. Page 50, to be exact.
Let me quote a passage or two in the article, just to pique your interest.
“The medical need for CER (which I am sure you know stands for ‘comparative effectiveness research’) arises from a fact that few patients realize and fewer doctors acknowledge the scientific basis for many medical treatments is often flimsy or even nonexistent. More than half the guidelines issued by the Infectious Disease Society of America, for instance, are based on “expert opinion” alone and not on actual comparative data, let alone a clinical trial.”
and
“The new research promises to yield better information: data that are more useful in clinical practice than data from traditional trials”.
The cut and thrust of the article is that randomized controlled testing takes too long, costs too much, and is simply not worth the effort. CER is simply the application of computer horsepower to the analysis of massive amounts of anecdotal evidence.
Now, correct me if I am wrong, but what this amounts to in the world of the MS patient, is the application of one’s brain to the evidence provided by thousands of MS patients regarding the effects of CCSVI angioplasty on their MS symptoms. The connection of observed cause and effect. Gosh, how novel.
God bless science. It has delivered us out of the world of RCTs and into the world of CER. Hallelujah!
Previously, defenders of RCTs have been able to say that while RCTs are not perfect, but they are much better than any of the alternatives. (Reminds one of Churchill’s take on democracy, doesn’t it.)
Well, these staunch defenders of the scientific method cannot take up the cudgel of RCTs any longer. You are stuck in a rut, Dr. Rose, and have not yet noticed that there is a precipice ahead. You are wasting your time, and worse yet, are trying to get everybody else you can to jump into the same rut. Misery loves company, or something like that.
Colin Rose said
That quote from SA was completely out of context. The “cut and thrust” of the article are the more good clinically relevant controlled trials are necessary to change practice patterns. Here is the conclusion of the paper:
“If there is any country in the world that needs comparative effectiveness research, it’s the U.S.,” Nissen says. “It’s safe to say the U.S. has the least cost-effective medicine in the world. There is so much money wasted that if we eliminated that waste, we could provide health care for everyone.” It will be an uphill battle in a country that reveres an individual’s right to choose much more than it does science. But comparative effectiveness research is our best hope for improving medical care equitably without breaking the bank.
The CER on “CCSVI” has been done. “CCSVI” is not a disease and therefore “liberation” is a hoax. So don’t waste your money on it.
creativecurmudgeon said
The CER has NOT been done. Alberta, for one, is just getting started. Can you give me any concrete examples of CER in CCSVI?
Those quotes I put in were NOT taken out of context..
Why you put in that last quotation I have no idea. Please indicate why it is relevant.
CER as actually applied to real data coming from CCSCI clinics around the world , and medical intelligence gathered there will show what you have to say is completely wrong.
Colin Rose said
CER can only be applied to OBJECTIVE measurements, like blood pressure or blood sugar, NOT to SUBJECTIVE symptoms such as those on YouTube videos that change instantaneously after “liberation” which are highly susceptible to the faith healing effect. All attempts to show any carefully controlled objective evidence for the existence of “CCSVI” have failed and since “CCSVI” doesn’t exist there is no point in even doing trials trying to cure it with “liberation”.
The last quote is highly relevant. Science must be the final arbiter of effective, cost-efficient treatment and a patient’s right to choose a treatment does not override scientific truth. So far, the Zamboni cult has totally ignored the real science disproving the existence of “CCSVI”.
creativecurmudgeon said
Being the smart lad you are, I would be surprised if you had not heard of the following:
Extended Disability Status Scale (EDSS)
Impact of Multiple Sclerosis Scale (IMSS)
Symptoms of Multiple Sclerosis )SMSS)
Maybe this will jog your memory ……….
————————————————————————————-
Arch Phys Med Rehabil. 2006 Jun;87(6):832-41.
The development and validation of the impact of multiple sclerosis scale and the symptoms of multiple sclerosis scale.
McMillan L, Moore KA.
Source
School of Psychology, Deakin University, 221 Burwood Highway, Burwood 3125, Australia.
Abstract
OBJECTIVE:
To develop and validate the Impact of Multiple Sclerosis Scale (IMSS) and the Symptoms of Multiple Sclerosis Scale (SMSS) using the Extended Disability Status Scale (EDSS) for construct validity.
DESIGN:
Panel design involving test-retest over 4 months.
SETTING:
A mailed survey.
PARTICIPANTS:
Volunteers with a diagnosis of multiple sclerosis (MS) recruited from an MS support service in Australia: 193 people (mean age, 39y) and 150 people participated at time 1 and time 2, respectively.
INTERVENTIONS:
Not applicable.
MAIN OUTCOME MEASURES:
Principal components analyses, the Cronbach alpha, and descriptive statistics for the 2 scales; correlations for construct validity with the EDSS and retest; and confirmatory factor analysis to test the stability of IMSS and SMSS components over time.
RESULTS:
The IMSS yielded 5 independent and reliable components; the SMSS yielded 3 components; both component structures were stable over time. These scales showed convergent validity with the EDSS.
CONCLUSIONS:
The IMSS and SMSS are psychometrically sound scales suitable for clinical and research purposes to assess the symptoms and impact of MS.
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So you see, many of the behavioristically determined results of MS intervention are considered to be quite objective when done by competent observers.
I don’t know about you, but if I see someone
who is in a wheelchair, and I note that
he spends much of his day in bed, and then
all of a sudden his brain fog clears,
his energy improves, and then
over the next couple of months he is back walking (takes his grandson bowling),
and just got his drivers license back……………………………………
What part of reality don’t you get Colin?
I would expect the physical performance changes would be, or could be, measured on one of the above scales, and that when measured by a Dr., physiotherapist, occupational therapist, etc. that these measurements would be considered quite objective, and of course would be picked up by CER.
The following is a copy of part of your original post from above – with your English corrected, of course
“That quote from SA was completely out of context. The “cut and thrust” of the article are (IS) the (THAT) more good clinically relevant controlled trials are necessary to change practice patterns. Here is the conclusion of the paper:
“If there is any country in the world that needs comparative effectiveness research, it’s the U.S.,” Nissen says. “It’s safe to say the U.S. has the least cost-effective medicine in the world. There is so much money wasted that if we eliminated that waste, we could provide health care for everyone.” It will be an uphill battle in a country that reveres an individual’s right to choose much more than it does science. But comparative effectiveness research is our best hope for improving medical care equitably without breaking the bank.
CET makes RCTs yesterdays news. RCTs will continue, but CER is promising to put them on the back burner.
CET is not a controlled trial. Can you read, Colin? Sometimes, I wonder.
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Oh, and another quote of yours:
“The last quote is highly relevant. Science must be the final arbiter of effective, cost-efficient treatment and a patient’s right to choose a treatment does not override scientific truth. So far, the Zamboni cult has totally ignored the real science disproving the existence of “CCSVI”.
So, Colin let me tell you what the “scientific truth” is about PPMS. The scientific truth is that no one knows what causes PPMS; and the scientific truth is that there is no treatment for PPMS. Despite the decades of research, and despite the expenditure of billions of dollars.
Your celebration of “scientific truth” in this instance is a joke.
Actually, I do support science based medicine. CET is an example of science based medicine. It is also an example of reality based medicine, as contrasted with RCTs which create artificial environments in an attempt to capture reality.
Try reading this Colin. Don’t strain your brain too much.
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Scientific American
Health Care Myth Busters: Is There a High Degree of Scientific Certainty in Modern Medicine?
Two doctors take on the health care system in a new book that aims to arm people with information
By Sanjaya Kumar and David B. Nash | March 25, 2011 | 28
Demand Better! Revive Our Broken Health Care System DO DOCTORS HAVE GOOD DATA?: An excerpt from Demand Better! Revive Our Broken Health Care System by Sanjaya Kumar and David B. Nash Image: Second River Healthcare Press
Editor’s Note: The following is an excerpt from the new book Demand Better! Revive Our Broken Health Care System (Second River Healthcare Press, March 2011) by Sanjaya Kumar, chief medical officer at Quantros, and David B. Nash, dean of the Jefferson School of Population Health at Thomas Jefferson University. In the following chapter they explore the striking dearth of data and persistent uncertainty that clinicians often face when having to make decisions.
Myth: There is a high degree of scientific certainty in modern medicine
“In America, there is no guarantee that any individual will receive high-quality care for any particular health problem. The healthcare industry is plagued with overutilization of services, underutilization of services and errors in healthcare practice.” – Elizabeth A. McGlynn, PhD, Rand Corporation researcher, and colleagues. (Elizabeth A. McGlynn, PhD; Steven M. Asch, MD, MPH; et al. “The Quality of Healthcare Delivered to Adults in the United States,” New England Journal of Medicine 2003;348:2635-2645.)
Most of us are confident that the quality of our healthcare is the finest, the most technologically sophisticated and the most scientifically advanced in the world. And for good reason—thousands of clinical research studies are published every year that indicate such findings. Hospitals advertise the latest, most dazzling techniques to peer into the human body and perform amazing lifesaving surgeries with the aid of high-tech devices. There is no question that modern medical practices are remarkable, often effective and occasionally miraculous.
But there is a wrinkle in our confidence. We believe that the vast majority of what physicians do is backed by solid science. Their diagnostic and treatment decisions must reflect the latest and best research. Their clinical judgment must certainly be well beyond any reasonable doubt. To seriously question these assumptions would seem jaundiced and cynical.
But we must question them because these beliefs are based more on faith than on facts for at least three reasons, each of which we will explore in detail in this section. Only a fraction of what physicians do is based on solid evidence from Grade-A randomized, controlled trials; the rest is based instead on weak or no evidence and on subjective judgment. When scientific consensus exists on which clinical practices work effectively, physicians only sporadically follow that evidence correctly.
Medical decision-making itself is fraught with inherent subjectivity, some of it necessary and beneficial to patients, and some of it flawed and potentially dangerous. For these reasons, millions of Americans receive medications and treatments that have no proven clinical benefit, and millions fail to get care that is proven to be effective. Quality and safety suffer, and waste flourishes.
We know, for example, that when a patient goes to his primary-care physician with a very common problem like lower back pain, the physician will deliver the right treatment with real clinical benefit about half of the time. Patients with the same health problem who go to different physicians will get wildly different treatments. Those physicians can’t all be right.
Having limited clinical evidence for their decision-making is not the only gap in physicians’ scientific certainty. Physician judgment—the “art” of medicine—inevitably comes into play, for better or for worse. Even physicians with the most advanced technical skills sometimes fail to achieve the highest quality outcomes for their patients. That’s when resourcefulness—trying different and potentially better interventions—can bend the quality curve even further.
And, even the most experienced physicians make errors in diagnosing patients because of cognitive biases inherent to human thinking processes. These subjective, “nonscientific” features of physician judgment work in parallel with the relative scarcity of strong scientific backing when physicians make decisions about how to care for their patients.
We could accurately say, “Half of what physicians do is wrong,” or “Less than 20 percent of what physicians do has solid research to support it.” Although these claims sound absurd, they are solidly supported by research that is largely agreed upon by experts. Yet these claims are rarely discussed publicly. It would be political suicide for our public leaders to admit these truths and risk being branded as reactionary or radical. Most Americans wouldn’t believe them anyway. Dozens of stakeholders are continuously jockeying to promote their vested interests, making it difficult for anyone to summarize a complex and nuanced body of research in a way that cuts through the partisan fog and satisfies everyone’s agendas. That, too, is part of the problem.
Questioning the unquestionable
The problem is that physicians don’t know what they’re doing. That is how David Eddy, MD, PhD, a healthcare economist and senior advisor for health policy and management for Kaiser Permanente, put the problem in a Business Week cover story about how much of healthcare delivery is not based on science. Plenty of proof backs up Eddy’s glib-sounding remark.
The plain fact is that many clinical decisions made by physicians appear to be arbitrary, uncertain and variable. Reams of research point to the same finding: physicians looking at the same thing will disagree with each other, or even with themselves, from 10 percent to 50 percent of the time during virtually every aspect of the medical-care process—from taking a medical history to doing a physical examination, reading a laboratory test, performing a pathological diagnosis and recommending a treatment. Physician judgment is highly variable.
Here is what Eddy has found in his research. Give a group of cardiologists high-quality coronary angiograms (a type of radiograph or x-ray) of typical patients and they will disagree about the diagnosis for about half of the patients. They will disagree with themselves on two successive readings of the same angiograms up to one-third of the time. Ask a group of experts to estimate the effect of colon-cancer screening on colon-cancer mortality and answers will range from five percent to 95 percent.
Ask fifty cardiovascular surgeons to estimate the probabilities of various risks associated with xenografts (animal-tissue transplant) versus mechanical heart valves and you’ll get answers to the same question ranging from zero percent to about 50 percent. (Ask about the 10-year probability of valve failure with xenografts and you’ll get a range of three percent to 95 percent.)
Give surgeons a written description of a surgical problem, and half of the group will recommend surgery, while the other half will not. Survey them again two years later and as many as 40 percent of the same surgeons will disagree with their previous opinions and change their recommendations. Research studies back up all of these findings, according to Eddy.
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There is a lot of material, Colin, and it certainly doesn’t support your devotion to your interpretation of scientific truth.
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Health & Medicine
Why Scientific Studies Are So Often Wrong: The Streetlight Effect
Researchers tend to look for answers where the looking is good, rather than where the answers are likely to be hiding.
by David H. Freedman
From the July-August special issue; published online December 10, 2010
A bolt of excitement ran through the field of cardiology in the early 1980s when anti-arrhythmia drugs burst onto the scene. Researchers knew that heart-attack victims with steady heartbeats had the best odds of survival, so a medication that could tamp down irregularities seemed like a no-brainer. The drugs became the standard of care for heart-attack patients and were soon smoothing out heartbeats in intensive care wards across the United States.
But in the early 1990s, cardiologists realized that the drugs were also doing something else: killing about 56,000 heart-attack patients a year. Yes, hearts were beating more regularly on the drugs than off, but their owners were, on average, one-third as likely to pull through. Cardiologists had been so focused on immediately measurable arrhythmias that they had overlooked the longer-term but far more important variable of death.
The fundamental error here is summed up in an old joke scientists love to tell. Late at night, a police officer finds a drunk man crawling around on his hands and knees under a streetlight. The drunk man tells the officer he’s looking for his wallet. When the officer asks if he’s sure this is where he dropped the wallet, the man replies that he thinks he more likely dropped it across the street. Then why are you looking over here? the befuddled officer asks. Because the light’s better here, explains the drunk man.
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That fellow is in good company. Many, and possibly most, scientists spend their careers looking for answers where the light is better rather than where the truth is more likely to lie. They don’t always have much choice. It is often extremely difficult or even impossible to cleanly measure what is really important, so scientists instead cleanly measure what they can, hoping it turns out to be relevant. After all, we expect scientists to quantify their observations precisely. As Lord Kelvin put it more than a century ago, “When you can measure what you are speaking about, and express it in numbers, you know something about it.”
There is just one little problem. While these surrogate measurements yield clean numbers, they frequently throw off the results, sometimes dramatically so. This “streetlight effect,” as I call it in my new book, Wrong (Little, Brown), turns up in every field of science, filling research journals with experiments and studies that directly contradict previously published work. It is a tradition that was already well established back in 1915 when an important experiment led by a rather prominent young physicist named Albert Einstein was published. To discover the ratio of magnetic forces to gyroscopic forces on an electron, Einstein had to infer what the electrons in an iron bar were up to based on a minuscule rotation their activity caused the bar to make. His answer was off by a factor of two, as corrected by more careful, but similarly inferential, experiments three years later. (What a loser!)
Physicists have a good excuse for huddling under the streetlight when they are pushing at the limits of human understanding. But the effect also vexes medical research, where you might think great patient data is there for the tabulating. The story of the anti-arrhythmia drugs only hints at the extent of the problem. In 2005, John Ioannidis of the University of Ioannina in Greece examined the 45 most prominent studies published since 1990 in the top medical journals and found that about one-third of them were ultimately refuted. If one were to look at all medical studies, it would be more like two-thirds, he says. And for some kinds of leading-edge studies, like those linking a disease to a specific gene, wrongness infects 90 percent or more.
We should fully expect scientific theories to frequently butt heads and to wind up being disproved sometimes as researchers grope their way toward the truth. That is the scientific process: Generate ideas, test them, discard the flimsy, repeat. In fact, testing ideas is supposed to be the core competence of most scientists. But if tests of the exact same idea routinely generate differing, even opposite, results, then what are we humble nonscientists supposed to believe?
I have spent the past three years examining why expert pronouncements so often turn out to be exaggerated, misleading, or flat-out wrong. There are several very good reasons why that happens, and one of them is that scientists are not as good at making trustworthy measurements as we give them credit for. It’s not that they are mostly incompetents and cheats. Well, some of them are: In several confidential surveys spanning different fields, anywhere from 10 to 50 percent of scientists have confessed to perpetrating or being aware of some sort of research misbehavior. And numerous studies have highlighted remarkably lax supervision of research assistants and technicians. A bigger obstacle to reliable research, though, is that scientists often simply cannot get at the things they need to measure.
Examples of how the streetlight effect sends studies off track are ubiquitous. In many cases it is painfully obvious that scientists are stuck with surrogate measures in place of what they really want to quantify. After decades of dueling studies about whether it was an asteroid or volcanic eruptions that did in the dinosaurs, it is apparent that the mineral-deposit evidence is indirect and open to interpretation, even if the scientists advancing the various claims sound pretty sure of themselves. Astronomers enlist surrogate measures all the time, since there is no way to stick thermometers in stars or to unreel tape measures to other galaxies. Likewise, economists cannot track the individual behaviors of billions of consumers and investors, so they rely on economic indicators and extracts of data.
How reliable are the results? In 1992 a now-classic study by researchers at Harvard and the National Bureau of Economic Research examined papers from a range of economics journals and determined that approximately none of them had conclusively proved anything one way or the other. Given that dismal assessment—and given the great influence of economists on financial institutions and regulation—it’s a wonder the global economic infrastructure is not in far worse shape. (Of course, scientific findings that point out the problems with scientific findings are fair game for reanalysis too.)
By far the most familiar and vexing consequences of the streetlight effect show up in those ever-shifting medical findings. Take this straightforward and critical question: Can vitamin D supplements lower the risk of breast, colon, and other cancers? Yes, by as much as 75 percent, several well-publicized studies have concluded over the past decade. No, not at all, several other equally well-publicized studies have concluded. In 2008 alone, around 380 published research articles addressed the link between vitamin D and cancer in one way or another. The ocean of data on the topic is vast, swelling, and teeming with sharp contradictions.
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Are you paying attention, Colin?
Try this.
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Discover Magazine. Science, Technology and The Future
The Problem With Medicine: We Don’t Know If Most of It Works
Less than half the surgeries, drugs, and tests that doctors recommend have been proved effective.
by Jeanne Lenzer & Shannon Brownlee; illustrations by The Heads of State
From the November 2010 issue; published online February 11, 2011
Lana Keeton is accustomed to taking her licks standing up. She has worked as a steel broker and boxing promoter who rubbed elbows with Don King in the rough-and-tumble fighting world. She is also a kickboxer who doesn’t like to lose. But in 2001 a routine surgical procedure knocked her off her feet and led to the loss of her health, her business, and her dream home, a three-bedroom condominium in Miami Beach.
Keeton was in her thirties when she began suffering from intermittent bleeding and pain caused by fibroids, benign tumors in her uterus. She had the tumors surgically removed in 1983 and a second time in 1991, after they recurred. When her symptoms flared yet again in early 2001, her surgeon recommended a hysterectomy to get rid of the problem once and for all. During a discussion with her doctor about the upcoming surgery, Keeton mentioned that she occasionally leaked a little bit of urine when she coughed or sneezed. Nothing serious; she was still kickboxing without any problem. The surgeon told her that as long as he was “in there” doing a hysterectomy, he could fix her urinary problem by using some synthetic mesh as a sling to support her bladder. “He told me it was new and that I’d like it,” Keeton says. “I didn’t question it. I trusted him.”
The mesh was indeed new, but it was also relatively untested, as Keeton would eventually learn. Just 48 hours after her discharge following surgery, she was rushed to a nearby hospital, where doctors diagnosed a life-threatening infection called necrotizing fasciitis and told her she required emergency surgery to remove dead tissue. After a rocky 16 days in the hospital, Keeton was sent home, where she was bedridden for the next three months. A nurse came twice a day to dress the gaping wound in her belly, which had to be left open to control the infection as she healed. Unable to work, Keeton couldn’t keep up with her condo payments.
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During the 16 subsequent surgeries and procedures Keeton would undergo, doctors discovered that the mesh had sliced its way through her bladder like a grater through cheese. Infections were forming on the mesh itself. Doctors worked to extract that mesh bit by bit, but it was so embedded in her internal tissues, they are still trying to remove every last piece today.
To understand why this was happening to her, Keeton went online. What she encountered left her dumbfounded: hundreds of patients talking about their problems with surgical mesh implants. Many told stories like hers, of recurrent pain, infections, and bleeding. Men whose hernias had been repaired with mesh were left incontinent and forced to wear adult diapers. Keeton was enraged. Here she was reading about serious, even life-threatening complications, yet her doctor either hadn’t known or hadn’t told her of any of the risks—risks she says “I would never have taken for such a minor inconvenience as urinary incontinence.”
MEDICINE’S DARK SIDE
In a recent poll conducted by the Campaign for Effective Patient Care, a nonprofit advocacy group based in California, 65 percent of the 800 California voters surveyed said they thought that most or nearly all of the health care they receive is based on scientific evidence. The reality would probably shock them. A panel of experts convened in 2007 by the prestigious Institute of Medicine estimated that “well below half” of the procedures doctors perform and the decisions they make about surgeries, drugs, and tests have been adequately investigated and shown to be effective. The rest are based on a combination of guesswork, theory, and tradition, with a strong dose of marketing by drug and device companies.
Doctors are often as much in the dark as their patients when they implant new devices (like the surgical mesh used on Keeton), perform surgery, or write prescriptions. The U.S. Food and Drug Administration (FDA) regulates drugs, devices, and many tests, but it does not control how doctors use them and has no control at all over surgeries. Lack of strong oversight means doctors often have limited information about side effects, even from products and procedures used for years. One surgeon who complained says, “Device makers could sell us a piece of curtain and call it surgical mesh and we wouldn’t know the difference.”
Of course, some treatments don’t have to be studied. Penicillin, for example, is an accepted drug for pneumonia. But a surprising number of treatments are later found to be useless or harmful when they are finally put to the test. Many widely adopted surgeries, devices, tests, and drugs also rest on surprisingly thin data. For instance, many doctors routinely prescribe a powerful blood thinner called warfarin to prevent a pulmonary embolism, a potentially deadly blood clot that blocks an artery in the lungs. Warfarin has been in use for decades. Yet when the Cochrane Collaboration, a highly regarded international consortium of medical experts, examined the evidence (pdf), they could find only two small (albeit randomized and controlled) studies supporting the use of warfarin for patients at risk of developing clots. Neither study proved that the risky blood thinner was superior to simply giving the patient ibuprofen.
Another widespread practice for more than 40 years is spinal fusion, a surgery for back pain that often involves implanting expensive devices known as pedicle screws. It can take weeks to recover from the surgery, and costs can run into the tens of thousands of dollars. Yet it is anybody’s guess whether any given patient will have less pain after surgery because nobody has conducted crucial studies to determine who needs spinal fusion and who would do better with less invasive treatment. Even the imaging tests that doctors use to make the case for back surgery, including MRI, X-rays, and CT scans, are not very good at pinpointing the cause of pain, comments Jerome Groopman, chief of experimental medicine at Beth Israel Deaconess Medical Center in Boston and author of How Doctors Think.
The Problem With Medicine: We Don’t Know If Most of It Works
Less than half the surgeries, drugs, and tests that doctors recommend have been proved effective.
by Jeanne Lenzer & Shannon Brownlee; illustrations by The Heads of State
From the November 2010 issue; published online February 11, 2011
The holes in medical knowledge can have life-threatening implications, according to an Agency for Healthcare Research and Quality report published in 2001: More than 770,000 Americans are injured or die each year from drug complications, including unexpected side effects, some of which might have been avoided if somebody had conducted the proper research. Meaningless or inaccurate tests can lead to medical interventions that are unnecessary or harmful. And risky surgical techniques can be performed for years before studies are launched to test whether the surgery is actually effective.
“All too often a new procedure is developed, it is used widely, and then if doubts appear we might or might not do the research that’s needed,” says Carol Ashton, a physician at the Methodist Hospital Research Institute in Houston who studies surgical evidence. Complicating matters, many clinical guidelines are written by physicians and members of professional societies who have financial conflicts of interest with drug, device, or test kit companies.
A 2002 study in the Journal of the American Medical Association (JAMA) found that 87 percent of guideline authors received industry funding and 59 percent were paid by the manufacturer of a drug affected by the guidelines they wrote. Evidence of resulting conflicts continues to mount. A report published this year found that authors of medical journal articles favorable to the controversial diabetes drug Avandia (thought to increase the risk of heart attack) were three to six times as likely to have financial ties to the manufacturer as were the authors of articles that were neutral or unfavorable. Physician David Newman, director of clinical research at Mount Sinai Medical Center’s department of emergency medicine in New York City, says, “We’re flying blind too much of the time, and it’s hurting patients.”
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Many policy experts believe we could substantially improve the quality of health care and reduce costs if only we would do more research to determine what works best in medicine, and for which patients. Giving patients care they don’t need and failing to give them care that is necessary account for an estimated 30 percent or more of the $2.4 trillion the nation spends annually on health care. “We don’t like to acknowledge the uncertainty of medicine, either to ourselves or to our patients,” says Michael Wilkes, a professor of medicine and vice dean of education at the University of California, Davis. “But patients deserve to know when their doctor’s recommendation is backed up with good evidence and when it isn’t.”
THE SURGERY PROBLEM
Nowhere in medicine is this more of a problem than in surgery. Even essential surgery may pose risk of infection, medical error, or a bad reaction to anesthesia. But risks are compounded because many common surgical techniques are not as effective as physicians believe or are simply performed on the wrong patients, says Guy Clifton, a neurosurgeon at the University of Texas Medical School at Houston and author of Flatlined: Resuscitating American Medicine.
Take the practice of cleaning out the carotid arteries, the large blood vessels that run up each side of the neck. Just like the coronary arteries, where heart attacks occur, the carotid arteries can become clogged with fatty tissue. If a clump of this tissue, called plaque, breaks free, it can travel into the brain and block a smaller blood vessel, causing a stroke. Several large clinical trials, involving thousands of asymptomatic patients in the United States and Europe, have shown that a surgical technique known as carotid endarterectomy can remove the plaques and slightly reduce the risk of a stroke, by about 1 to 5 percent over five years. But about 3 percent of the time, the surgery itself can trigger a stroke, heart attack, or even death, so it offers meaningful benefit only to people who are at the highest risk of having a stroke. That would be symptomatic patients, those with a serious blockage of a carotid artery and a history of at least one previous stroke. Nevertheless, neurologist Peter Rothwell, a researcher at Oxford University and specialist on stroke, has found that 80 percent of such procedures were performed on low-risk patients without symptoms—an inappropriate group.
Then there is the other half of the story. In 1989, as part of an effort to improve carotid surgery, vascular surgeons began employing a technique called stenting to prop open clogged carotid arteries with metal mesh tubes. Stenting is less invasive, but that does not necessarily mean it is safer. One study, conducted in France and published in 2006 in the New England Journal of Medicine, had to be stopped because stenting was killing patients. Another large study, out this year, found that 4.7 percent of endarterectomy patients had a stroke or died within four years after surgery, compared with 6.4 percent of those receiving stents. Rothwell is not optimistic that even this evidence will dampen surgeons’ enthusiasm for stents. “One issue is how these fashions arise in medicine—why do doctors accept a new technique and begin using it widely?” he says. “Innovation in medicine is not synonymous with progress.” Yet no country has set up a systematic program for evaluating new surgeries.
THE DRUG PROBLEM
If surgery is the wild west of medicine, shouldn’t oversight by the FDA ensure that drugs, at least, are safe and effective? Not necessarily. All drugs must undergo a slew of tests before they are approved, but many studies the FDA oversees are poorly designed or too small to answer important questions, such as how often rare but potentially harmful or lethal side effects occur, and which patients are unlikely to be helped. And many drugs are not adequately monitored for safety problems after they reach the market.
“It’s impossible to guarantee that unexpected problems won’t crop up over time,” notes Jerome R. Hoffman, a professor of emergency medicine at the University of Southern California. “But the FDA makes matters worse by failing to adopt the precautionary principle ‘Let’s be fairly sure it’s safe before we use it’ in favor of ‘We’ll approve it unless you can prove that it’s dangerous.’”
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The FDA currently relies on the drugmakers themselves, along with scattered reports from individual doctors, to identify problems once a drug is on the market. “The situation is hardly better with regard to effectiveness,” Hoffman continues. “The FDA requires only that a drug is by some measure better than nothing. Most new drugs are ‘me-too’s,’ and they don’t have to prove that they are an advance over older and cheaper drugs, including some long proven to be safe. These don’t have to be the terms under which the FDA operates. But as long as FDA’s primary mandate seems to be that it’s industry friendly, it is hard to see any of this changing.”
Although the FDA collects safety data on drugs, experts estimate that only a fraction of the potentially related harms and deaths—about 10 to 50 percent—end up in FDA databases, in part because reporting is voluntary. Also, what is reported is often so incomplete that there is no way to tell whether a drug or device is at fault. According to William Maisel, formerly of Harvard Medical School and now chief scientist at the FDA’s Center for Devices and Radiological Health, many trivial and unrelated events are thrown in along with serious incidents, “making it hard to find the signal amid all the noise.” To top things off, the FDA does not routinely analyze the reports for each drug or device, so serious side effects can be missed for years.
This is the issue that drew so much attention to Avandia, the diabetes drug made by pharma giant GlaxoSmithKline. In 2007 Steven Nissen, a prominent cardiologist from the Cleveland Clinic, and another researcher published an analysis of 42 studies, concluding that Avandia increases the risk of heart attack and death. This past February, the U.S. Senate Committee on Finance (which has jurisdiction over Medicare and Medicaid) released documents and other evidence suggesting that GlaxoSmithKline knew about possible cardiac side effects for several years before Nissen’s report. Rather than warn patients and government officials, company executives “attempted to intimidate independent physicians [and] focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk,” according to the committee.
Mary E. Money, an internist in Hagerstown, Maryland, says she became alarmed in 1999 after several of her patients on Avandia developed symptoms of congestive heart failure. She and a colleague looked at the records for all of their patients on the drug and found an unexpectedly high percentage was experiencing symptoms of heart failure. In January 2000 Money contacted the manufacturer to alert it to the problem. The company eventually sent a letter to the chief of staff at the hospital where Money worked, telling him that she should not be permitted to talk about the problem since, it said, the issue of congestive heart failure was not proved to be an effect of the drug. Money says she felt “highly intimidated” by the letter and what she perceived as the implicit threat of a lawsuit. She had planned to publish her findings, but after the hospital received the letter, one of her intended coauthors, an epidemiologist, stopped responding to her e-mails, effectively killing publication.
A spokesperson for GlaxoSmithKline called Money’s theories “unsubstantiated.” Nonetheless, this July, the FDA suspended enrollment in Glaxo’s large clinical trial comparing the safety of Avandia with that of a competing diabetes drug and may halt the study altogether. Nissen argues that the drug should be taken off the market.
Well, enough for now.
creativecurmudgeon said
Now it must be acknowledged that ninety-five percent of “alternative” medicine is pure bull, and does take advantage of the discouraged and discontent. But there is that five percent that one must account for. With just a whiffle of luck, CER will “notice” that five percent. We live in hope.
Ordinarily I would not waste my time on you, but you have taken it upon yourself to judge the wisdom of others, and to offer counsel to the hoi polloi. “Judge ye not lest ye be judged”. Seems I have heard that expression somewhere. You are a dangerous doctor, and have brought shame on the M.D. designation.
Dr. Lou Francescotti, president of the Royal College of Physicians and Surgeons of Canada (as you must know), has dared to speak of some doctors as being “arrogant”. Tell me Colin, have you looked in the mirror lately? It would seem that Dr. Lou knew what he was taking about.
When you feel free from agonizing over all us stupid people, peruse the following.
Obtaining “Fairness” Can Be Complicated
If you are going to speak to the issue of deaths connected with the Liberation Treatment, you should, in all fairness, cover the alternatives:
• “Particular” deaths from MS itself, as per the official death certificate – four per year in Canada. If you think that figure seems low, you are absolutely correct. Many more deaths related to MS are not recorded that way when issuing cause of death certificates.
• General deaths from MS. MS are nine times as likely as people in the general population to not live out their normal lifespan. But these deaths are not listed as MS deaths. MS sometimes just wears people down until they die of something else. Who counts these deaths as MS deaths? Nobody.
• Suicide deaths of people with MS – the suicide rate of people with MS is seven times what it is in the general population. The 2005 general Canadian suicide rate was 11.6 per 100,000 population. Seven times this rate would be 81.2 deaths per 100,000 population. Applying this rate to an estimated 55,000 Canadian MS patients, yields a figure of 44.67 deaths per year. This means that at least one Canadian MS patient dies by his/her own hand every 10 days.
• Deaths caused by the “scientifically approved” drug trade, and blessed by the MS Establishment. As of July 15, 2011, Tsyabri, one of the latest wonder drugs for MS, had caused twenty-nine deaths, since 2007. Four years, twenty-nine deaths. That would work out to 7.25 deaths per year, and 2011 is not even over yet.
• Cases of brain poisoning caused by “scientifically approved” drugs.
o Progressive multifocal leukoencephalopathy (PML). As of July 15, 2011, one hundred and forty-five cases of PML, an opportunistic viral infection of the brain that usually leads to death or severe, irreparable, brain damage. Four years, one hundred forty-five cases. That would be 36.25 cases per year. And 2011 is not even over yet.
o Cases of immune reconstitution inflammatory syndrome (IRIS). This is a post-PML condition which often occurs as the immune system is re-activated after treatment for PML. Researchers think, but do not know, that as many as half of the deaths in MS patients experiencing PML were actually caused by IRIS after their blood was “cleansed” to remove Tysabri. Tysabri just keeps on giving! Number of deaths per year? Unknown.
This is not to mention the toxic side effects of all “accepted” MS drug therapies which are too numerous to list here. And don’ forget all those needles, and all the pain they cause. Colin, do you like getting needled? So to speak.
creativecurmudgeon said
A question that must come to mind is, why is Tysabri still on the market? Well, it was briefly withdrawn shortly after its 2004 introduction in 2006 when problems (like death and brain poisoning) first began to be noticed. But this was only after already having been approved by all those who were right and holy.
Tysabri was allowed back on the market “by the authorities” in 2007 due to the “clamour” that was raised by MS patients, and the fact that the “its clinical benefits outweighed the risks involved”. Yes, you read that correctly.
Where are all the “authorities” now, when Canadian MS patients are “clamouring” for a treatment whose clinical benefits outweigh the risks? I would like to say hiding in shame, but I am afraid that would be rather presumptive of me. Apparently when push comes to shove, politicians only hear “clamour” in the ear they want to.
Please note the following information. It has been compiled as of July 25, 2011 from numerous sources, often from the information that pharmaceutical companies have been forced to disclose on their own websites.
Given that there have been at least 10,000 Liberation Treatments performed in clinics all around the world in the past year and a half, and given that there have been 4 fatalities in all that time (one that is quite directly related to the lack of follow up care in Canada), that works out to 2.67 deaths per year.
Now how alarming should it be to hear that there has been ONE more death related to the Liberation Procedure? And how alarming did you make it sound?
Let me summarize:
Deaths Cases of Brain Side Number of
Per Year Damage Per Year Effects Treatments
Type of Treatment
“Scientifically”
Approved Drugs 7.25 + 36.25 + Many Every month
Every year
Of Your Life
Liberation
Treatment 2.67 0 Few Varies from
0 to ? very few
As compared
With the above
In other words, report and respect the whole truth, not just part of it. A half truth is the worst kind of lie. To sensationalize one death caused by the Liberation Treatment, and not put that death in context is a disservice to all Canadians with MS. Do you actually understand the amount of harm and suffering you may have caused? Quite frankly, I don’t think you have a clue.
creativecurmudgeon said
Well, it would appear that the tables, such as they are, have been scrambled.
I will attempt to publish them again. Wish me luck.
Let me summarize:
Deaths Cases of Brain Side Number of
Per Year Damage Per Year Effects Treatments
Type of Treatment
“Scientifically”
Approved Drugs 7.25 + 36.25 + Many Every month
Every year
Of Your Life
Liberation
Treatment 2.67 0 Few Varies from
0 to ? very few
as compared
with the above
creativecurmudgeon said
Hmm. No luck. I will have to summarize again.
Please stay tuned. I will continue after my doctor’s appointment.
maldendj said
One more paper:
“Proposed chronic cerebrospinal venous insufficiency criteria do not predict multiple sclerosis risk or severity”
Article first published online: 22 JUL 2011, DOI: 10.1002/ana.22436
http://onlinelibrary.wiley.com/doi/10.1002/ana.22436/abstract
Authors:
Diego Centonze MD, Roberto Floris MD, Matteo Stefanini MD, Silvia Rossi MD, Sebastiano Fabiano MD, Maura Castelli MD, Simone Marziali MD, Alessio Spinelli MD, Caterina Motta MD, Francesco G. Garaci MD, Giorgio Bernardi MD, Giovanni Simonetti MD.
From:
Department of Neuroscience, University Hospital Tor Vergata, Rome, Italy;
Santa Lucia Foundation/European Center for Brain Research;
Department of Diagnostic Imaging, Molecular Imaging, Interventional Radiology and Radiotherapy, University Hospital Tor Vergata, Rome, Italy.
Annals of Neurology
Volume 70, Issue 1, pages 52–59, July 2011
Abstract
Objective:
It is still unclear whether chronic cerebrospinal venous insufficiency (CCSVI) is associated with multiple sclerosis (MS), because substantial methodological differences have been claimed by Zamboni to account for the lack of results of other groups. Furthermore, the potential role of venous malformations in influencing MS severity has not been fully explored. This information is particularly relevant, because uncontrolled surgical procedures are increasingly offered to MS patients to treat their venous stenoses.
Methods:
In the present study, CCSVI was studied in 84 MS patients and in 56 healthy subjects by applying the Zamboni method for CCSVI identification.
Results:
We found no significant differences (p = 0.12) in CCSVI frequency between MS and control subjects. Furthermore, no differences were found between CCSVI-positive and CCSVI-negative patients in terms of relevant clinical variables such as disease duration, time between onset and first relapse, relapsing or progressive disease course, and risk of secondary progression course. Statistically significant differences were not found between CCSVI-positive and CCSVI-negative MS subjects by analyzing direct measures of disability such as mean Expanded Disability Status Scale (EDSS) (p = 0.07), mean progression index (p > 0.1), and mean MS severity score (p > 0.1). The percentage of subjects who reached EDSS 4.0 and 6.0 milestones was not different among CCSVI-negative and CCSVI-positive subjects, and no significant correlation was found between severity of disability and number of positive CCSVI criteria.
Interpretation:
Our results indicate that CCSVI has no role in either MS risk or MS severity. Ann Neurol 2011;
Colin Rose said
Thanks for the reference. We now have at least seven well-blinded trials showing no difference in head and neck blood flow and anatomy between normal subjects and MS patients. This one is particularly devastating to the faith of the Zamboni cult because the investigators were obsessive in following Zamboni’s recommendations including spending weeks learning his technique and using the Esaote machine he recommends. This is also the second study from Italy exploding the Zamboni myth. One would expect that other Italians would be desperate to prove Zamboni right and advance his chances to get the first Italian Nobel Prize in Medicine in 60 years, so these studies have even more significance. Here are links to the full text of both those Italian papers.
http://db.tt/6hiQ3H5
http://db.tt/RwVAnIG
Of course, Zamboni cult members are not interested in scientific evidence. They have an absolute faith in the Zamboni myth that gives them hope and creates magical instantaneous subjective symptomatic improvements and nothing will convince them otherwise.
Because of the wealth of evidence against the Zamboni hypothesis now available, any doctor who continues to perform studies on neck veins looking for “CCSVI” or perform “liberation” on MS patients should be immediately delicensed.
maldendj said
Here is coordinated action resulted in publishing two articles in
ENDOVASCULAR TODAY – JULY 2011
COVER STORY:
CCSVI: What We Need to Know Now and in the Future
Multidisciplinary collaboration is a necessary step toward answering the many questions
about the relationship between MS and extracranial venous obstruction.
BY MICHAEL D. DAKE, MD
http://bmctoday.net/evtoday/2011/07/article.asp?f=ccsvi-what-we-need-to-know-now-and-in-the-future
Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis Patients
There is speculation that CCSVI may contribute to the symptoms experienced
by MS patients, but what do the data tell us so far?
BY GARY SISKIN, MD; KENNETH MANDATO, MD; AND MERIDITH ENGLANDER, MD
http://bmctoday.net/evtoday/2011/07/article.asp?f=chronic-cerebrospinal-venous-insufficiency-in-multiple-sclerosis-patients
They ask many questions, they are desperately looking for answers and, the bottom line, for getting their future studies approved and financed. No matter what they are so far performed hundreds of procedures and earned millions of dollars without knowing answers to those same questions!?
It seems that their number of applicants for Liberation are slowly drying up and they have switched to other funding sources – state funds for studies and research, for example. (I think it’s called: Beating a dead horse).
Reading Dake story/article, I can’t not to mention that one of his patients died several days after Liberation procedure he performed. (Holly Shean, died August 2009, Liberated by dr. Dake, Stanford)
He didn’t mention her death (“…Multiple large patient series published in the medical literature
document that any serious complications from PTA of jugular and azygous veins are exceedingly rare…).
Apparently, for him, her death is not “serious complication”. What a hypocrite.
creativecurmudgeon said
Even MORE studies from neurologists, who SAY they used Zamboni’s methods. Sure they did.
There are some thousands of people who know you are a fool, Colin – a dangerous fool.
I suppose you have read Dr. McDonald’s statement to Parliament. Is Dr. McDonald a fool too?
I suppose Dr. Campalani doesn’t know what he is talking about either.
—————————————————————————————
Dr. Gianfranco Campalani has had the Liberation Treatment twice and knows first hands about the benefits. Photo located on BBC Northern Ireland website.
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”.
“I believe that when a new treatment has practically only minor possible complications (as reported by Zamboni with venogram and angioplasty) and a good potential for benefits, as opposed to the pharmachological treatment rich in harmful side-effects, the need for rigorous scientific double-blind trials is nonsense. We need a few more intelligent and courageous vascular surgeons and radiologists to start treating vascular anomalies (strictures of the jugular veins) on their own merit, not mentioning MS. But the medical establishment is notorius for being conservative and generally lazy.”
http://for-greet.squarespace.com/journal/tag/superdoc
——————————————————————————————-
Or, let’s try Dr. Bill Code
“I started my medical career firmly entrenched in the western model of medicine. As a Board Certified Anesthiosologist in Canada and the United States, I recruited and taught Anesthesiology residents. I also spent six years in brain research and drug therapy for chronic pain.
But my paradigm shifted dramatically at the age of 42 when I was diagnosed with Multiple Sclerosis. Western medicine had little to offer me and I began seeking healthy, non-drug solutions to manage the neurological deterioration, depression and pain.
My journey has been a remarkable discovery of the wonders of nature and has completely changed the way I view health.
This site is the culmination of 20 years research, application and study. My hope is that you will use this information to improve your health and brain function. A decade ago I thought my diagnosis was my death sentence. Today I travel the world, lecture and enjoy all aspects of life.
___________________________________________________________
Too bad I have to leave right now. But I will be back.
maldendj said
Sadly… one more documented complication regarding unnecessary treatment:
Royal Society of Medicine Press Ltd, London,UK
First published on 29 July 2011
Phlebology
doi:10.1258/phleb.2011.011052
© 2011 Royal Society of Medicine Press Ltd, London, UK
Short report
Internal jugular thrombosis post venoplasty for chronic cerebrospinal venous insufficiency
Imperial College CCSVI Investigation Group:, A Thapar *, T R A Lane * , V Pandey *, J Shalhoub *, O Malik , M Ellis *, I J Franklin * , R Nicholas * and A H Davies *
* Imperial College London; Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK
Correspondence: T R A Lane BSc MBBS MRCS, Academic Section of Vascular Surgery, 4 North, Charing Cross Hospital, Fulham Palace Road, London W6 8RF, UK. Email: tristan.lane@imperial.ac.uk
Chronic cerebrospinal venous insufficiency (CCSVI) is a hypothesis through which cerebral venous drainage abnormalities contribute towards the pathogenesis of multiple sclerosis. CCSVI venoplasty is already practised worldwide. We report the case of a 33-year-old lady with multiple sclerosis who underwent left internal jugular venoplasty resulting in iatrogenic jugular thrombosis requiring open thrombectomy for symptom relief. This occurred without insertion of a stent and while fully anticoagulated. Clinicians should be aware that endovenous treatment of CCSVI could cause paradoxical deterioration of cerebral venous drainage. Patients with complications post venoplasty are now presenting to geographically distant vascular units.
maldendj said
missing link…
http://phleb.rsmjournals.com/cgi/content/abstract/phleb.2011.011052v1
chiefumtaga said
It sounds like a lot of this can be applied to “Liberation therapy”. From the paragraph for Medicine’s Dark Side “….a surprising number of treatments are later found to be useless.” and “Many widely adopted surgeries…also rest on surprisingly thin data.” To the best of my understanding this applies to Dr. Zamboni’s theory of CCSVI, poor research (that has not been replicated).
In “The Surgery Problem” the author states “…Why do doctors accept a new technique and begin using it widely? Innovation in medicine is not synonymous with progress.” Again this exactly fits the current fad of angioplasty and stenting veins in MS patients for an unproven (and likely non-existentent) pathology. Seriously if venous drainage of the brain was obstructed the head would swell (like any other organ that has impaired venous flow, think of what happens to the liver when it suffers from an occluded vein).
creativecurmudgeon said
chiefumtaga, you are 100% correct.
CCSVI angioplasty is just as prone to all the problems surrounding developmental medicine as any other drug / surgical procedure would be. And as you know, all the hype surrounding the Liberation Treatment hasn’t helped either.
It is a small thing, but it was not Zamboni who dreamed up the name “Liberation Treatment”. One of Zamboni’s sidekicks started using it, and of course once the Press heard the term, they loved the sound of it, and the rest, as they say, is history.
I do not know if you noticed, but I have never said that I think CCSVI angioplasty actually works. Because I don’t know if it does, or doesn’t.
All I have been trying to say is that “science based” traditional medical procedures are something of a cockup themselves, and are not “the” answer to all things. So when I see any “scientific” proof of any medication, be it related to MS or not, I am always suspicious.
All I am asking for is fairness, and that the Liberation Treatment be seen in the overall context of what are the alternatives. Colin surely does not do it.
For instance, there is no recognized treatment, let alone cure, for PPMS. Yet I know someone with PPMS who has dramatically improved since he took Liberation treatment. I know all about the placebo effect la-de-da, but I also know it doesn’t last forever, and it doesn’t allow people to finally get out of wheelchairs and get their driver’s license back.
So, given there is presently NO alternative for treating PPMS, and given you have lived with excruciating pain for 15 years, and given you have observed with your own eyes how someone with PPMS has improved since they took the Liberation treatment, what would you do, chief? What would you do?
Overall, there have been too many people who have improved too much, their improvements in many cases has lasted too long, and in other cases where there has been restenosis a new angioplasty has helped like it did the first time. It can’t all be pixie dust. I don’t think.
Anyhow, Colin talks as if he is sane and everybody else is crazy. You know what that means, I am sure. Colin’s style is abrasive, and all he does is get people (sometimes like me) all riled up to the point where pushing comes to shoving.
Any way, I am going to continue posting information that I think is relevant to putting CCSVI in perspective.
chiefumtaga said
In the W5 program, broadcast on CTV in November 2009, it was Dr. Zamboni who said the patients were “Liberated” (not a sidekick making that statement).
There are lots of physicians who are skeptical of Dr. Zamboni’s theory of CCSVI and its relationship to MS (not just Colin Rose). Take a look at the “Science Based Medicine” website and look at the articles “CCSVI Update” or “The Dark Side of Medical Globalization” and “Multiple Sclerosis and Irrational Exuberance” or “Venous Insufficency in Multiple Sclerosis”. And of course there are the numerous researchers who have tried to replicate Dr. Zamboni’s original findings and have had null results (lots of people have posted links to those papers on this site).
With all due respect, yes lots of MS patients claim dramatic improvement after “Liberation Treatment”, but again lots of MS patients also claim improvement after faith-healing (one can find numerous examples on youtube of both examples of healing). So shall we have IV infusions of holy water as an alternative therapy? I think that puts CCSVI in its proper perspective.
creativecurmudgeon said
Ah yes. Tables.
Deaths Cases of brain Side Number of
per year damage per year Effects Treatments
“Scientifically”
approved drugs 7.25 + 36.25 + Many Every day/week/month
of every year
of the rest of your life
Liberation
Treatment 2.67 0 Few From 0 to ?
So far, no more
than 2 per year
In other words, report and respect the whole truth, not just part of it. A half truth is the worst kind of lie. To sensationalize one death caused by the Liberation Treatment, and not put that death in context is a disservice to all Canadians. Do you actually understand the amount of harm and suffering you may have caused? Quite frankly, I don’t think you have a clue.
You don’t have to go into every exquisite detail every time you report on this issue, but when you are talking about life and death the stakes are about as high as they can get.
If you are going to continue to report on Liberation Treatment deaths, you should at all times at least mention the occurrence of MS deaths caused by alternative courses of action. Balanced treatment is all we MS patients ask. Fair is fair.
You have obviously done some in-depth research, and of course you are a Dr. to start with, but you still seem to have bought into the Fear, Uncertainty, and Doubt (FUD) tactics of the MS Establishment. In some ways I do not blame you. Whose word would you take – that of a well dressed “suit”, with an impressive vocabulary and a string of initials after their name, or a scruffy looking woman in blue jeans who says she just had an operation and now feels better? (Of course that would be explained away by the placebo effect – after all, it’s all just in her head, even though she had the operation more than a year ago).
creativecurmudgeon said
It is with this in mind that I will now present some information I presume you are not aware of.
Fighting the Establishment – Winners and Losers
All things considered, the MS drug status quo makes a lot of money for a lot of people in one way or another. So a new safe, effective, and inexpensive surgical treatment is considered a “clear and present danger” to a lot of powerful people.
The thought of an obscure Italian doctor making some of them irrelevant does not go down easily. They will fight it tooth and nail, and will do everything in their power to create fear, uncertainty, and doubt in the minds of as many people as possible. The status quo is much too comfortable.
Let us for consider, for just a moment, who will be the winners and who will be the losers if the Liberation Treatment should become a staple in the treatment of MS symptoms.
Winners:
• MS patients – no money won, just a loss of pain, a loss of suffering, and a chance for a better life.
• Vascular surgeons and interventional radiologists. (The estimated cost of receiving the Liberation Treatment at home in Canada is less than $2,000.) The Liberation Treatment is presently costing a great deal more outside of Canada precisely because it is prohibited at home. Yet the Liberation Treatment is still a bargain compared to commonly accepted drug therapy. (See below)
• Governments – once they wake up and find the MS doctors have no clothes. The Liberation Treatment is a fantastic bargain as compared to their current drug habit.
Losers:
• Drug companies – billions of dollars in sales. (MS is an excruciatingly painful medical condition, often beginning early in life, then lasts for a lifetime.) The best prescription for profits you could ever imagine. Their mantra – repeat sales, repeat sales, repeat as often as you can……..
• Institutional MS doctors – Drug companies in turn give hundreds of millions of dollars to universities and hospitals, so the MS doctors they employ can pursue their favourite research.
• MS doctors in private practice – These doctors stand to lose the least.
• MS Societies – Drug companies give millions of dollars to MS Societies. While most Society employees are a great source of help for MS patients, and will continue to be, those in high places will find their empires diminished, along with their salaries.
• In other words, “men in suits”.
These losers do not really care, that by prohibiting the Liberation Treatment at home; they are forcing MS patients to suffer more, spend more, and risk bringing back superbugs from other countries.
These “losers” are used to being the MS establishment – MS doctors, drug companies, and MS Society executives – and they all want to keep their privileges. (Just ask Kelly who her sources were, and whose word she took over that of another’s. How many were not members of the “losers” group?)
So, at the end of the day, whose word are you going to take – that of a “suit” who does not know what he is talking about, or the word of woman in blue jeans who simply tells you she feels better? (The “suit” of course will tell you the woman is deranged, and just thinks she’s feeling better.)
Definition of an “Expert”
So, who can be experts on a “new” MS treatment when nobody knows what causes MS in the first place? That’s right, nobody. Despite over thirty years of research and the expenditure of billions of dollars, none of the so called “experts” know what causes MS. Not one. But the search continues, and it is making a lot of people rich.
MS is most likely to be a multifactorial condition. No one claims the Liberation Treatment is “the one and only cause” of MS. All that has been claimed is that the Liberation Treatment can often significantly reduce MS symptoms.
But just think how much power the “losers” have as compared to the “winners”, at least until governments start catching on. With enough money in the bank, you too could become an expert. Just ask me what the subject is.
creativecurmudgeon said
Current State of MS Drug Treatment, “Scientifically” Proven, and Authorized for Use In Canada.
Let us consider the mainstream MS drugs Avonex, Betaseron, Copaxone, Rebif and Tysabri. Why do you not report on their side effects – including death? Read about them and weep. Why do you not mention that the main side effect of the Liberation Treatment is a temporarily sore leg?
Why do you not talk about the fact that patients face a lifetime of taking these drug? Whatever their lifetimes turn out to be.
Why do you not talk about the fact that many – if not most – MS patients simply quit taking these drugs because, considering the side effects and all those painful injections, it is simply just not worth it.
The Cost of “Scientifically” Proven MS Drugs Authorized for Use In Canada
FYI here are some of the prices of MS drugs, as charged to our American cousins who do not have the luxury of our health care system:
Avonex – $ 24,000 – 30,000 Per year – For life
Betaseron – $ 22,000 – 33,000 Per year – For life
Copaxone – $ 23,000 – 34,000 Per year – For life
Rebif – $ 25,000 – 31,000 Per year – For life
Tysabri – $ 32,000 – ? Per year – For life
What is charged to the Canadian taxpayer? Who really knows, or is willing to tell?
Why do you not talk about the fact that the cost of the Liberation Treatment for Canadians leaving sovereign soil ranges from $ 6,800 – $ 15,000 for a one time treatment that may not have to be repeated in order to reduce symptoms? Why do you not report that the real cost of the procedure if done in Canada would be approximately $ 2,000?
Just Who Is Scamming Who?
Once you look into the issue, just who do you think is scamming who?
I guess that the powers that be listen to MS patients when it enables the sale of expensive drugs. I guess scientifically approved deaths and brain damage are OK when it greases the wheels of commerce, and continues to contribute to the welfare of drug companies, MS doctors, and MS Societies. Why don’t you talk about that?
For some strange reason, when MS patients say that members of the MS establishment work together, they are accused of being conspiracy theory cranks. The fact that this has been going on for decades is no great secret, yet gets conveniently ignored.
It is not that members of the MS establishment have hatched some particular diabolical scheme. They are just keeping up relationships they have had for over thirty years, and have a common desire to make the most out of their investment (both in terms of time and money) in the status quo. It is merely a manifestation of the “territorial imperative”.
Perfectly understandable in terms of business and commerce, but a sad comment, I am sorry to say, on the character and morality of some Canadian physicians.
creativecurmudgeon said
MS, the Liberation Treatment, and Morality
Given to choose between drug companies, MS Society employees, and MS doctors, what group would you think of as having the highest moral principles?
Let me take a wild guess – doctors? Right. The Hippocratic Oath, and all that. You probably think that the oath starts “First, do no harm”. Well, you are wrong. (Please see below.) Let us see how this morality has played out among many MS doctors in Canada.
As you now know, there are relatively few drugs that do anything to relieve MS symptoms. For one kind of MS, primary progressive multiple sclerosis, there is “no” drug that actually even treats MS.
All doctors can try to do is try to address reducing the pain level – usually with steroids that weaken your general autoimmune system, exposing you to infections.
So, with the development of a procedure that showed promise of perhaps treating MS all kinds of MS, without the use of toxic drugs, and for a very low price, (given the alternative), would you not have thought those noble MS physicians you thought you knew would jump at the chance to learn more, and actually practice the procedure (don’t forget, the Liberation Treatment is a relatively minor surgery, generally with no side effects, and no monthly repeats).
This is the stuff of nightmares for drug companies.
Well, if you wait to see Canadian MS doctors jumping, you could be waiting a very long time. A couple of doctors started to try, but got cut off at the knees by their local Colleges of Physicians and Surgeons.
Why, you might ask? Because a certain set of physicians, high on ego and long on money, did not want it to happen. They would rather see their harm, than approve of someone else’s help. These doctors would rather approve of scientifically sanctioned death, than take a chance on learning and healing using a method they were not familiar with.
These doctors are in contravention of their Hippocratic Oath, and in contravention of Article 35 of the World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects.
All Canadian MS doctors take the Hippocratic Oath.
The College of Physicians and Surgeons of Canada is a member of the World Medical Association, but it seems that it feels free to ignore both the words and spirit of their agreements, if they so choose. In other words, “if I can’t help someone, neither can anyone else”.
Now, there are no legal measures that can be taken against those physicians (or the various Colleges of Physicians and Surgeons, as may be appropriate) that do not comply. But they – one would assume – would like to be seen as embodying the principles of the following documents. See what you think.
The Hippocratic Oath (Modern Version)
I swear to fulfill, to the best of my ability and judgment, this covenant:
I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow.
I will apply, for the benefit of the sick, all measures [that] are required, avoiding those twin traps of overtreatment and therapeutic nihilism.
I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon’s knife or the chemist’s drug.
I will not be ashamed to say “I know not,” nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery.
I will respect the privacy of my patients, for their problems are not disclosed to me that the world may know. Most especially must I tread with care in matters of life and death. If it is given to me to save a life, all thanks. But it may also be within my power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty. Above all, I must not play at God.
I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person’s family and economic stability. My responsibility includes these related problems, if I am to care adequately for the sick.
I will prevent disease whenever I can, for prevention is preferable to cure.
I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm.
If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.
World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects.
Article 35.
In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering.
Where possible, (not in Canada though, pity) this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be
recorded and, where appropriate, made publicly available.
maldendj said
One more new study:
No Cerebral or Cervical Venous Insufficiency in US Veterans With Multiple Sclerosis
Ellen Marder, MD; Pramod Gupta, MD; Benjamin M. Greenberg, MD; Elliot M. Frohman, MD, PhD; Amer M. Awad, MD; Bridget Bagert, MD; Olaf Stüve, MD, PhD
Arch Neurol. Published online August 8, 2011. doi:10.1001/archneurol.2011.185
http://archneur.ama-assn.org/cgi/content/full/archneurol.2011.185
ABSTRACT
Objective To determine if chronic cerebral venous insufficiency exists in patients with multiple sclerosis (MS) using ultrasonography and 4-dimensional color Doppler ultrasonography examination and unverified criteria proposed by Zamboni et al.
Design Patients with MS and clinically isolated syndrome were matched by age and sex with subjects with migraine or no neurological disease. All subjects underwent gray-scale, color, and spectral Doppler ultrasonography examination of the internal jugular veins (IJVs), vertebral veins, and deep cerebral veins for stenosis, absence of signal, and reflux.
Setting Academic MS center.
Patients All patients with MS fulfilled revised McDonald criteria for the diagnosis of MS. Patients with clinically isolated syndrome exhibited a typical transient focal neurological deficit and had magnetic resonance imaging lesions typical of MS. Control subjects were recruited from the VA migraine clinic or staff.
Main Outcome Measures Five parameters of venous outflow used by Zamboni et al were examined: (1) IJV or vertebral vein reflux, (2) deep cerebral vein reflux, (3) IJV stenosis, (4) absence of flow in IJVs or vertebral veins, and (5) change in cross-sectional area of the IJV with postural change.
Results There was no significant difference in the number and type of venous outflow abnormalities in patients with MS compared with controls.
Conclusion This study does not support the theory that chronic cerebral venous insufficiency exists in MS.
…
COMMENT
…
Current treatments for MS are only partially effective, some aimed at suppressing inflammation by broadly modulating or suppressing the immune system and others, by preventing inflammatory cells from entering the CNS through a disrupted blood-brain barrier. The most effective treatments have a potential risk of serious morbidity and even mortality. We welcome new insights into the disease process and especially the promise of a single effective treatment. However, our findings and those of other investigators call into question whether CCSVI plays a pathogenic role in a substantial fraction of patients with MS and whether it presents a valid therapeutic target. The results presented herein refute that hypothesis and corroborate those of other investigators who have recently been unable to replicate the Zamboni et al observations.
Author Affiliations: Neurology Section, Medical Service (Drs Marder and Stüve), and Radiology Division (Dr Gupta), VA North Texas Health Care System, and Department of Neurology, University of Texas Southwestern Medical Center at Dallas (Drs Marder, Greenberg, Frohman, and Stüve), Dallas; and Baton Rouge Neurology Associates, Baton Rouge General Medical Center, Baton Rouge (Dr Awad), and Department of Neurology, Ochsner Clinic Foundation, New Orleans (Dr Bagert), Louisiana.
maldendj said
One more new study, this time from Tel Aviv, Israel:
J Neurol Sci. 2011 Aug 3.
Extra-cranial venous flow in patients with multiple sclerosis.
Auriel E, Karni A, Bornstein NM, Nissel T, Gadoth A, Hallevi H.
SourceStroke Unit, Department of Neurology, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Abstract
INTRODUCTION: Recently, a chronic state of impaired venous drainage from the central nervous system, termed chronic cerebrospinal venous insufficiency (CCSVI) was claimed to be a pathologic condition exclusively seen in patients with multiple sclerosis (MS), suggesting that cerebral venous congestion plays a significant role in the pathogenesis of MS. This hypothesis has gained enormous attention among patients and physicians but has been questioned since.
METHODS: Twenty seven patients with MS and 32 healthy controls underwent color extra cranial Doppler exam aimed to detect four parameters of abnormal venous flow: no Doppler-detected flow in the IJV or vertebral veins (VV), reflux in the internal jugular veins (IJVs), venous flow stenosis in the IJVz (cross sectional area <0.3cm) or reverted postural control in the IJV.
RESULTS: Except for one healthy patient, blood flow direction in the IJVs was normal in all subjects. When aiming to detect at least one parameter of abnormal venous flow per subject, two parameters or three parameters no significant difference was found between subjects and controls (p=0.707, 0.62, 0.849 respectively).
CONCLUSION: We found no evidence to suggest that MS patients have excess of CCSVI. In addition we failed to observe a typical venous flow pattern in MS patients. Until carefully designed controlled studies to investigate CCVSI have been completed, invasive and potentially dangerous endovascular procedures as therapy for MS should be discouraged.
Copyright © 2011 Elsevier B.V. All rights reserved.
PMID: 21820131 [PubMed – as supplied by publisher]
One more new study:
maldendj said
Missing link:
http://www.ncbi.nlm.nih.gov/pubmed/21820131
maldendj said
One more new study, this time from Padova, Italy:
Progressive multiple sclerosis is not associated with chronic cerebrospinal venous insufficiency.
Baracchini C, Perini P, Causin F, Calabrese M, Rinaldi F, Gallo P.
2011 Aug 17.
Source
From the First Neurology Clinic (C.B., P.P., M.C., F.R., P.G.), Multiple Sclerosis Centre of The Veneto Region (P.P., M.C., F.R., P.G.), and Neuroradiology Unit (F.C.), Department of Neurosciences, University Hospital, Padova, Italy.
Abstract
OBJECTIVE:
Chronic cerebrospinal venous insufficiency (CCSVI) had been suggested to play a major pathogenetic role in multiple sclerosis (MS), but recent data on early stages of MS have not confirmed this theory. Nonetheless, CCSVI could represent a late phenomenon of MS or be associated with progression of disability. Thus, we studied CCSVI prevalence in primary progressive (PP) and secondary progressive (SP) MS, to clarify whether CCSVI characterizes the progressive forms of this disease.
METHODS:
A total of 35 patients with SPMS, 25 patients with PPMS, and 60 age- and gender-matched normal controls (NC) were enrolled into a cross-sectional study. Extracranial and transcranial high-resolution venous echo color Doppler sonography (ECDS-TCDS) was performed in all patients and NC. Those patients having any abnormal ultrasound finding were asked to undergo selective venography (VGF).
RESULTS:
Patients with PPMS (11 women, 14 men; mean age 47 ± 11 years) had a disease duration of 11 ± 7 years and Expanded Disability Status Scale (EDSS) score of 6.0 ± 0.5. Patients with SPMS (22 women, 13 men; mean age 45 ± 14.5 years) had a disease duration of 18 ± 14 years and EDSS score of 6.0 ± 0.8. TCDS was normal in all patients. ECDS showed one or more abnormal findings in 9/60 (15.0%) patients (7/35 [20.0%] SPMS, 2/25 [8.0%] PPMS) and in 14/60 (23.3%) NC (p not significant for all comparisons). CCSVI criteria were fulfilled in 0 NC and 4 (6.7%) patients with MS: 3 SPMS and 1 PPMS. VGF, performed in 6/9 patients, was abnormal only in one case who had bilateral internal jugular vein stenosis.
CONCLUSION:
<b<Our findings indicate that CCSVI is not a late secondary phenomenon of MS and is not associated with disability.
PMID: 21849656
maldendj said
Missing link, again:
http://www.ncbi.nlm.nih.gov/pubmed/21849656
callrespiratory said
I was thinking that this post had many comments and realized that a lot of it is just spam.
At any rate, I found you through a comment you left on the CBC site and was pleased to see somebody who thinks rationally and does not drink the kool-aid. This whole thing reminds me a bit of the antivax community in that no amount of science appears to quiet it down and no amount of rationalization can make converts to its cause see the light that what is being done is harmful and dangerous.
I think getting proper RCTs done is going to be difficult, and I’m not going to hold my breath on there being any well-designed well-powered research done in the next decade. I agree with the above commenter that there are some desperate people being exploited by opportunistic snake-oil salesmen, to the detriment of their health. These patients are being victimized by unscrupulous physicians and it’s terrifying that voices of intelligence are being drowned out in the roar of ignorance.
curmudgeonkamakazi said
We “desperate” people are not the deaf, dumb, and stupid idiots you seem to think we are. We know one heck of a lot more about MS than you do.
Read the above blogs by Creativecurmudgeon.
chiefumtaga said
For another report that casts doubt on the existence of CCSVI see “Extracranial venous hemodynamics in multiple sclerosis: A case-control study” PMID 21849653.
Essentially, they used the recently developed neurosonology criteria for CCSVI detection on 42 M.S. patients and on 43 healthy control subjects. No evidence of stenosis was seen in either groups, reflux in the internal jugular vein was seen in one (!) M.S. patient and one control subject. The abstract concludes that the “…data argue against CCSVI as the underlying mechanism of M.S.”
Very well stated, I hope someone brings this to the attention of the Federal Minister of Health, CTV’s medicine reporter and Dr. Zamboni.
curmudgeonkamakazi said
Here is where to find the story of a Canadian doctor with MS who has been treated for CCSVI.
Dr. Code has done a lot of research, and is worth reading whether you agree with the CCSVI hypothesis or not.
http://www.drbillcode.com/
chiefumtaga said
Looking at Dr. Code’s site, yes he did have the “Liberation treatment”, but you should read the fine print at the bottom of his anecdote on his treatment where he places the asterik and states it should not be taken as medical advice and read the second asterik that the Food and Drug Administration have not evaluated the statements on the website. Seems like the “Real Deal” (as Dr. Code refers to CCSVI ) needs to be taken with a lot of caution.
curmudgeonkamakazi said
You know Chief, you are proving yourself to be a lot less intelligent than I have been giving you credit for.
Any website that may seem to offer any kind of medical advise also has disclaimers all over the place. Find me any kind of medical website that does not have disclaimers. Come on, find me one. Find me one that is legally liable for what it says. Find me one that is FDA approved. You will a long time looking.
Litigation being what it is there days, nobody takes a chance on anything. Practically all sites have disclaimers somewhere. Dr. Code is simply following his lawyers advice.
Have fun.
curmudgeonkamakazi said
Here is some information about the clinic:
http://www.communitycare.com/
Here is some information on Dr. Gary Siskin:
http://www.communitycare.com/MedicalServices/Interventional_Radiology/Gary_Siskin_Bio.asp
curmudgeonkamakazi said
It is interesting to see Dr. Weir (former head of neurology at the University of Alberta until about 1993, and since then head of neurology at the University of Chicago. He recently retired.) Dr. Weir was a neurosurgeon as well as being a neurologist.
Note the last words from the abstract: “biological plausibility of the concept”.
Must make Drs like you Colin, (who have spoken about the necessity of bulging eyeballs for people with MS/CCSVI), feel rather stupid.
The Canadian Journal of Neurological Sciences
Issue: Volume 37, Number 6 / November 2010
Pages: 745 – 757
URL: Linking Options
Multiple Sclerosis – A Vascular Etiology?
Bryce Weir A1
A1 Department of Surgery, University of Chicago, Illinois, USA
Abstract:
From the earliest pathological studies the perivenular localization of the demyelination in multiple sclerosis (MS) has been observed. It has recently been suggested that obstructions to venous flow or inadequate venous valves in the great veins in the neck, thorax and abdomen can cause damaging backflow into the cerebral and spinal cord circulations. Paolo Zamboni and colleagues have demonstrated abnormal venous circulation in some multiple sclerosis patients using non-invasive sonography and invasive venography. Furthermore, they have obtained apparent clinical improvement or stabilization by endovascular ballooning of points of obstruction in the great veins in some, at least temporarily. If non-invasive observations by others validate their initial observations of a significantly increased prevalence of venous obstructions in MS then trials of angioplasty/stenting would be justified in selected cases in view of the biological plausibility of the concept.
Oh well, enough for now.
curmudgeonkamakazi said
For your purposes here, I think things can be said this way: if indeed there is a causal relationship between diagnosable CCSVI and the MS or just the worsening of MS, refusing the angioplasty and insisting that MS sufferers stick with only the traditional treatments is insisting on treating the symptoms at huge expense rather than going after the cause at very low expense. There is no compelling reason to wait before we take the low-expense route, and there is no reason at all to force MS patients simply to put up with a diagnosed restriction in normal blood flow.
curmudgeonkamakazi said
You should all read Dr. McDonald’s statement.
And think about all the Canadians who are being forced to go out of their country to get a simple day surgery.
Dangerous? A little. But MS drugs kill and injure many more people, cost 20 – 35,000 dollars per year, (for life), and are often proven to be ineffective. The average cost of CCSVI angioplasty is about 10 -20,000. With few repeats. If any.
We are being scammed, but it is the drug companies who are doing the scamming. But I guess you think death by approved drugs is OK while any death caused by angioplasty should be hyped to the max.
Good for Saskatchewan. Good for New Brunswick. Come on, Alberta
maldendj said
…You should all read Dr. McDonald’s statement:
“…I am a cardiovascular surgeon. I fix blood flow. I am in that sense a plumber. When I see a plumbing problem, particularly one which deprives the whole house of good clean water, I want to fix it. When I see the whole house suffering, I want to fix the pipes. I can do that without harming the wiring in any way and do not see why we condemn the family to misery while we wait for the electrician…”
…Plumbers everywhere unite! Super Mario Brothers: For Princess Toadstool (Pauline Zambioni), he defeats Donkey Kong to rescue her. A plumber battling mushrooms, turtles, CCSVI and wide-eyed fish (seems pretty strange ;)
Dr. Sandy McDonald, We have right not to understand, but We do. But You should understand. But You don’t. Shame.
curmudgeonkamakazi said
Maldendj – what kind of a garbled up comment did you make? It is not even understandable. Perhaps you should wait until you sober up before you comment next time.
Colin Rose said
curmudgeonkamakazi, please do not keep trying to paste entire documents into these comments. Just give the link to Dr. MacDonald’s statement and the interested reader can access it. If you persist I will have to block you.
curmudgeonkamakazi said
OK Colin. Fair warning. Thank you. I will respect your wishes. Most of what I post I have written myself, but I will be careful to paste links when referencing the works of others.
Cheers.
curmudgeonkamakazi said
Dr. McDonald’s statement seems to have a strange way of disappearing. We shall see.
As I have said previously, CCSVI is not the sole cause of MS. But treating MS patients who have CCSVI is proving to relieve many of their MS symptoms.
More people treated. More people helped. And more. And more . . . .
Now that Saskatchewan Health and the Community Care CCSVI Clinic in Albany have apparently agreed to team up for trials, we should, hopefully, get the best information that has been obtained to date. I, too, am worried about the lack of others to duplicate Zamboni’s findings.
Just what is the “normal” flow in the veins draining the CNS back to the heart? Everybody that is doing testing seems to have some idea of what “normal” is. I don’t know what “normal” is. Do you?
I actually agree that the scientific method should be followed when introducing new medicines, and perhaps even when introducing some surgeries. But just how you can “ethically” have a double blind RCT with one group having a surgical procedure that is real, and another group having a “sham” surgery, is beyond me.
“Scientific” medicine sounds great, but the danger is that we automatically assume “science makes right”. In the long hall, that is true. But, especially in the short run, the scientific process itself is often not properly applied (patients and doctors “breaking blind” etc.) Yet the outcomes of even short trials take on the aura of “science”. And who defines “science”? The drug companies who pay for it all. And all the rest of the people on the MS gravy train. Sad, but true, news.
curmudgeonkamakazi said
This is worthwhile for everyone to read, no matter what your position is on the Liberation Treatment
http://www.healthydebate.ca/2011/10/topic/politics-of-health-care/ccsvi-science
curmudgeonkamakazi said
Please “try” to read the following with an open mind. Thank you.
http://www.ccsvifoundationcanada.org/testimonials
curmudgeonkamakazi said
So, it seems that Dr. McDonald has disappeared again. Poor guy.
So Colin, are you about to dis Dr. McDonald?
Take a look folks.
http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=4519570&Language=E&Mode=1&Parl=40&Ses=3
maldendj said
This McDonald is a plumber (he categorized himself to be). Bad plumber, I say.
So is Zamboni, Sclafani, Salvi, Dake, Siskin… all bad plumbers.
curmudgeonkamakazi said
You sound like you have been drinking?
curmudgeonkamakazi said
Here is some info you folks may like.
Click to access jnnpsyc00537-0096.pdf
Colin Rose said
Any site of inflammation will show inflammatory cells in small veins. Please tell us what that has got to do with “CCSVI”, presumed mechanical blockages in large veins presumably causing increased venous pressure. If it “CCSVI” did exist how would increase pressure in small veins cause inflammation? Are there any animal experiments showing such an effect of increased venous pressure?
maldendj said
One more CCSVI study (http://www.ncbi.nlm.nih.gov/pubmed/22031530):
1. Neurology. 2011 Oct 26. [Epub ahead of print]
Venous drainage in multiple sclerosis: A combined MRI and ultrasound study.
Doepp F, Würfel JT, Pfueller CF, Valdueza JM, Petersen D, Paul F, Schreiber SJ.
From the Department of Neurology (F.D., S.J.S.), Clinical and Experimental Multiple Sclerosis Research Center (C.F.P., F.P.), and NeuroCure Clinical Research Center and Experimental and Clinical Research Center (J.T.W.), Charité University Medicine Berlin, Berlin; Max Delbrueck Center for Molecular Medicine (J.T.W.), Berlin; Neurological Centre (J.M.V.), Segeberger Kliniken, Bad Segeberg; and Institute of Neuroradiology (D.P.), University of Lübeck, Lübeck, Germany.
BACKGROUND: Chronic cerebrospinal venous insufficiency (CCSVI) was proposed as the causal trigger for developing multiple sclerosis (MS). However, current data are contradictory and a gold standard for venous flow assessment is missing.
OBJECTIVE: To compare structural magnetic resonance venography (MRV) and dynamic extracranial color-coded duplex sonography (ECCS) in a cohort of patients with MS.
METHODS: We enrolled 40 patients (44 ± 10 years). All underwent contrast-enhanced MRV for assessment of internal jugular vein (IJV) and azygos vein (AV) narrowing, graded into 3 groups: 0%-50%, 51%-80%, and >80%. ECCS analysis of blood flow direction, cross-sectional area (CSA), and blood volume flow (BVF) in both IJV and vertebral veins (VV) occurred in the supine and upright body position.
RESULTS: MRV identified 1 AV narrowing. IJV analysis yielded 12 patients for group 1 (30%), 19 patients for group 2 (48%), and 9 patients for group 3 (22%). By ECCS criteria, 4 patients (10%) presented with venous drainage abnormalities. Jugular BVF was different only between groups 1 and 3 (616 ± 133 vs 381 ± 213 mL/min, p = 0.02). No other parameters in supine position and none of the parameters in the upright body position, apart from the IJV-BVF decrease in groups 1 and 3 (479 ± 172 vs 231 ± 144 mL/min, p = 0.01), were different.
CONCLUSIONS: Our ECCS data contradict the postulated 100% prevalence of CCSVI criteria in MS. MRV seems more sensitive to detect IJV narrowing compared to ECCS. A measurable hemodynamic effect only exists in vessel narrowings >80%.
Our combined data argue against a causal relationship of venous narrowing and MS, favoring the rejection of the CCSVI hypothesis.
PMID: 22031530 [PubMed – as supplied by publisher]
MSstudent Hopeful said
Another big paper out just recently by Dr Kostecki – poland –
on the first venoplasty trial and follow-up, the results absolutely
did not hold up by the six month mark, so BIG question for pro-ccsviers,
why risk more trauma to the vessel wall and potential hyperplasia when
the long term results are not there? How about exploring new
ideas instead of this overwhelming pounding of this one treatment
approach…are you open to exploring medication options that
are about to commence? i.e. calcium channel blockers and other
cardio medications?
By the way the mouse models have been done in Kansas by
williams and levine et al and published and their results show
opposite theory to doctor zamboni, have you seen that paper?
Dr Zivadinov even links the paper on one of his recent papers.
I admire your resolve curmudgeon but feel some new ideas
are needed and less combativeness to move us all forward.
Colin Rose said
Thanks for the info. Could you give us the references to these studies?
creativecurmudgeon said
I agree. What has made CCSVI supporters so angry is the dismissive attitude that most neurologists have adopted from the get-go. As if they knew what causes MS!
The unwillingness to even try CCSVI testing and treatment was seen by most of us MS patients as a knee jerk fear reaction taken by those who stood most to lose. And Colin’s attitude towards CCSVI definitely encourages combative replies. Zamboni cult? How insulting! Maybe Colin should try nice instead of nasty. I can do nice, and have dialogue rather than argument. But that does not seem to be Colin’s style.
What makes Colin think he knows more about veins than a cardiovascular surgeon like Dr. McDonald? Come on. Colin is braggadocio unleashed.
Zamboni cult? Try to tell that to the thousands of MS patients who have been helped by CCSVI angioplasty. Are they all delusional?
For an opinion of an American neurologist, try http://hubbardfoundation.org/
For another doctor’s opinion on evidence based medicine, see
http://www.kevinmd.com/blog/2011/10/evidence-based-medicine-removes-physicians-autonomy.html
Bye for now.
MSstudent Hopeful said
BMC Neurosci 2011 Jan 23;12:59
Willams R.
cEAE model – iron doesn’t seem to be the primary inflammation event
NeuroEndocrinol Lett
2011;32(4):557-62
Kosteckj@op.pl
Tychy Poland
Hopefully got those references correct – can someone comment without
hyper-criticism
MSstudent Hopeful said
New study from published this month American Journal of Neuroradiology
done by Bonn University (Niggerman et al)and Toronto Western Hospital (T. Krings)
15 healthy controls – 8 had IJV stenosis in supine unilaterally or bilaterally
Method: fonar funtional mri, supine and sitting, operated independent study
so no ultrasound bias can be blamed for these negative findings
MSstudent Hopeful said
http://archneur.ama-assn.org/cgi/content/extract/68/12/1515
ArchNeurolo2011:68(12):1521-1525
chiefumtaga said
Another preliminary study (published in La Radiologia Medica 2012 Jan. 7 PMID:22228125), using US on Multiple Sclerosis patients and healthy controls found 55% of MS patients had signs of CCSVI and 35% of healthy controls had signs of CCSVI. The authors conclude that the difference was not statistically significant. Thus another example showing failure of the proposed link between CCSVI and MS. Will Health Canada re-consider their plan to commit more funds to the CCSVI study in light of the above information?
keyboardcurmudgeon said
Why have you never answered the question:
“Are the thousands of MS patients (from all over the world) who continue to say that they have been helped as a result of CCSVI Treatment delusional?”
I have been to Albany and was treated by Dr. Riskin, who is heading up the American team that will be treating the 86 people from Saskatchewan.
Now THAT will be interesting. I trust Dr. Siskin. He is a no-nonsense kind of guy. And he readily admits there is still much to be learned about CCSVI. But, like a lot of other people, he wonders why a simple and safe medical procedure that has a proven record of helping people needs to be held up by fools like Colin who masquerade as real doctors.
But why this trial has to happen in the U.S. is a national disgrace.
You want to know the REAL reason why CCSVI Treatment has been banished by the MS establishment?
“The total worldwide market for MS disease-modifying therapies is expected to grow at an 8.1% compound annual growth rate (CAGR) from 2010 through 2015, with sales reaching nearly $16.7 billion by the end of 2015, from $11.3 billion in 2010.”
CCSVI Treatment for MS symptoms threatens everybody downstream from this waterfall of cash. Companies are at risk. Careers are at risk. MS Society salaries are at risk. Hospital donations and research grants are at risk.
The lives of many well intentioned, good honest hard-working people will be negatively affected.
No wonder a lot of people feel threatened. They are.
No wonder there is much resistance to CCSVI Treatment for the symptoms of MS.
If the Canadian MS establishment had simply agreed to do some testing in the first place, none of this controversy would be going on. But they panicked instead, and simply prohibited venous angioplasty for people with MS.
Prohibition never works. You know that.
The fact is the Canadian MS establishment is responsible for forcing Canadians with MS to risk their lives and pocketbooks by having to needlessly travel outside of Canada for CCSVI Treatment.
I suppose you could say that science is “angelic”. But people like Colin and you think that that makes scientists into angels. How wrong you are.
You keep quoting studies that show no connection between CCSVI and MS. Meanwhile more than 60% of people with MS who have CCSVI Treatment just keep right on saying they get better.
Hmmm …. …..Cause & effect, cause & effect, cause & effect …. say it over to yourself Chief, you can do it.
Chief, the world of reason that you prize so highly is gradually ratting you out. Nobody cares what you or Colin have to say anymore, including me.
You are no longer a person of interest.
Bye bye.
chiefumtaga said
Well, I never thought of myself as a person of interest, but I have an interest in seeing that real information comes out about “Liberation Therapy”. Like your statement that “more than 60% of people with MS who have CCSVI treatment just keep right on saying they get better.” Does that mean :
(a)60% of all patients treated with “Liberation therapy” have been assesed for objective improvements or :
(b)on a particular website 60% of the MS patients posting an opinion about their symptoms after treatment say they got better?
I’m sure one can see the difference between the two methodologies and why the latter method ,(self reporting of symptoms) is not likely to include all outcomes (good and bad). After all 60% has an air of truthiness about it, but by itself that assertion of 60%seems to lack robust evidence for it. Thus the reason to view such assertion skeptically.
And there are many other people who have posted summaries and links to the numerous studies that have tried to replicate Dr. Zamboni’s initial findings and have found negative findings for MS and CCSVI
maldendj said
Here is the Big One from Nis, Serbia:
[URL=”http://www.jvascsurg.org/article/S0741-5214(11)02629-2/fulltext#article-outline”]Liberation Procedure in the Treatment of Chronic Cerebro-Spinal Venous Insufficiency – Is Chronic Cerebro-Spinal Venous Insufficiency Related To Brain Congestive Syndrome Rather Than Multiple Sclerosis[/URL]
More then 400 MS patients is treated so far in Nis clinic, but on overall [B]205 patients was completed an open, prospective, single-center study [/B], performed in order to determine the efficacy of “Liberation procedure” in the treatment of different forms of MS (relapsing remitting,secondary progressive, primary progressive, and progressive relapsing).
The evaluation of patient’s status before the procedure, 6 and 12 months after the procedure was performed using: EDSS, MSFC, PASAT and SDMT tests.
The outcome of the procedure was also analyzed using: PRO-patient related outcomes, SF-36 questionnaire, EQ-5D (EuroQol) and Functional Assessment of Multiple Sclerosis (FAMS) quality of life. In order to determine the effects of the procedure blood sample from jugular vein was analyzed 24h before the procedure and 24h, 72h and 7 days after the procedure (pH and bicarbonate, BE, pCO2 and pO2, K+, Na+, CRP).
On the check-up 6 and 12 months after the procedure the [B]EDSS did not show any statistical significant difference [/B]between the pre and post procedural values.
However, initial benefit of the procedure was seen in almost 70% of treated patients. [B]This benefit was impossible to quantify [/B]due to the fact that neurological tools measures quality of changes in different systems but not the quantity. (?!)
During the one year follow-up period [B]over 40% of treated patients developed almost all symptoms [/B]that were present before the procedure.
It is interesting that initial benefit was associated with the improvement in the biochemical parameters from the blood sample analysis. (?!)
Conclusions:
The results obtained in this study suggest that CCSVI is related to Brain Congestive Syndrome rather than MS indicating that “Liberation” procedure may improve clinical signs in patients with MS because of brain decongestion. (?!)
The results obtained in this study suggest that CCSVI is related to “Brain Congestive Syndrome” (?!) rather than MS indicating that “Liberation” procedure may improve clinical signs in patients with MS because of “brain decongestion”. (?!)
Seems that “…the efficacy of Liberation procedure in the treatment of different forms of MS…” definitly fail to prove itself, and that the followers of Zambini theory are trying to consolidate on new routes and to continue to practise this unnecessary tretment on desperate patients.
maldendj said
Here is the Big One from Nis, Serbia:
[URL=”http://www.jvascsurg.org/article/S0741-5214(11)02629-2/fulltext#article-outline”]Liberation Procedure in the Treatment of Chronic Cerebro-Spinal Venous Insufficiency – Is Chronic Cerebro-Spinal Venous Insufficiency Related To Brain Congestive Syndrome Rather Than Multiple Sclerosis[/URL]
More then 400 MS patients is treated so far in Nis clinic, but on overall [B]205 patients was completed an open, prospective, single-center study [/B], performed in order to determine the efficacy of “Liberation procedure” in the treatment of different forms of MS (relapsing remitting,secondary progressive, primary progressive, and progressive relapsing).
maldendj said
Here is the Big One from Nis, Serbia:
http://www.jvascsurg.org/article/S0741-5214(11)02629-2/fulltext#article-outline
Liberation Procedure in the Treatment of Chronic Cerebro-Spinal Venous Insufficiency – Is Chronic Cerebro-Spinal Venous Insufficiency Related To Brain Congestive Syndrome Rather Than Multiple Sclerosis
More then 400 MS patients is treated so far in Nis clinic, but on overall [B]205 patients was completed an open, prospective, single-center study [/B], performed in order to determine the efficacy of “Liberation procedure” in the treatment of different forms of MS (relapsing remitting,secondary progressive, primary progressive, and progressive relapsing).
maldendj said
The evaluation of patient’s status before the procedure, 6 and 12 months after the procedure was performed using: EDSS, MSFC, PASAT and SDMT tests.
The outcome of the procedure was also analyzed using: PRO-patient related outcomes, SF-36 questionnaire, EQ-5D (EuroQol) and Functional Assessment of Multiple Sclerosis (FAMS) quality of life. In order to determine the effects of the procedure blood sample from jugular vein was analyzed 24h before the procedure and 24h, 72h and 7 days after the procedure (pH and bicarbonate, BE, pCO2 and pO2, K+, Na+, CRP).
On the check-up 6 and 12 months after the procedure the [b]EDSS did not show any statistical significant difference [/b]between the pre and post procedural values.
However, initial benefit of the procedure was seen in almost 70% of treated patients. [b]This benefit was impossible to quantify [/b]due to the fact that neurological tools measures quality of changes in different systems but not the quantity. (?!)
During the one year follow-up period [b]over 40% of treated patients developed almost all symptoms [/b]that were present before the procedure.
It is interesting that initial benefit was associated with the improvement in the biochemical parameters from the blood sample analysis. (?!)
The results obtained in this study suggest that [b]CCSVI is related to “Brain Congestive Syndrome” (?!)[/b] rather than MS indicating that “Liberation” procedure may improve clinical signs in patients with MS because of “brain decongestion”. (?!)
maldendj said
Seems that “…the efficacy of Liberation procedure in the treatment of different forms of MS…” definitly fail to prove itself, and that the followers of Zambini theory are trying to consolidate on new routes and to continue practise this unnecessary tretment on desperate patients.
lyonro said
It’s impossible to blame people with MS for desperately seeking reason for hope but at the bottom of it all most people would like there to be some shred of truth and it’s just not there regarding the theory of ccsvi.
It only takes looking back on the history of MS research to see that over 99% of the hopeful research findings in the end prove not to be justified. In this case Zamboni announced to the media that his research has showed 100% correlation between people with MS and diagnosing criteria he had invented for ccsvi and 0% correlation between healthy normals and lack of venous stenosis.
lyonro said
And that 100% ccsvi/pwms and 0% healthy normal correlation soon proved to be nothing more than a ploy to put himself in the limelight….which it did….and sadly a number of people with MS want nothing more than to have a place to hang their hopes, and that’s fine but ccsvi is a HUGE disservice to all those other people with MS who want the truth and don’t want to waste their time, money and health on ccsvi fairy dust.
Russell (@aussievideoblog) said
I agree, CCSVI is actually causing more hopelessness and is very destructive emotionally when people with MS find out that it actually didn’t do anything and at best put their lives at risk and took money from their bank accounts. I am still waiting for any real evidence which is yet to be provided. My wife has end stage MS and I can tell you if there was real evidence it actually did anything she would have tried it. It’s amazing how this is supposed to be the cause of MS yet nowhere in the world are we seeing any evidence of everyone who has MS being cured? Why is that?
maldendj said
Atkinson W, Forghani R, Wojtkiewicz GR, Pulli B, Iwamoto Y, et al. (2012)
Massachusetts General Hospital and Harvard Medical School, Richard B. Simches Research Center, Boston, Massachusetts, United States of America
PLoS ONE 7(3): e33671. doi:10.1371/journal.pone.0033671
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0033671&annotationId=info%3Adoi%2F10.1371%2Fannotation%2F0f72d144-e722-48f4-a200-eba48d19f3c8
Ligation of the Jugular Veins Does Not Result in Brain Inflammation or Demyelination in Mice.
Abstract
An alternative hypothesis has been proposed implicating chronic cerebrospinal venous insufficiency (CCSVI) as a potential cause of multiple sclerosis (MS). We aimed to evaluate the validity of this hypothesis in a controlled animal model. Animal experiments were approved by the institutional animal care committee. The jugular veins in SJL mice were ligated bilaterally (n = 20), and the mice were observed for up to six months after ligation. Sham-operated mice (n = 15) and mice induced with experimental autoimmune encephalomyelitis (n = 8) were used as negative and positive controls, respectively. The animals were evaluated using CT venography and 99mTc-exametazime to assess for structural and hemodynamic changes. Imaging was performed to evaluate for signs of blood-brain barrier (BBB) breakdown and neuroinflammation. Flow cytometry and histopathology were performed to assess inflammatory cell populations and demyelination. There were both structural changes (stenosis, collaterals) in the jugular venous drainage and hemodynamic disturbances in the brain on Tc99m-exametazime scintigraphy (p = 0.024). In the JVL mice, gadolinium MRI and immunofluorescence imaging for barrier molecules did not reveal evidence of BBB breakdown (p = 0.58). Myeloperoxidase, matrix metalloproteinase, and protease molecular imaging did not reveal signs of increased neuroinflammation (all p>0.05). Flow cytometry and histopathology also did not reveal increase in inflammatory cell infiltration or population shifts. No evidence of demyelination was found, and the mice remained without clinical signs. Despite the structural and hemodynamic changes, we did not identify changes in the BBB permeability, neuroinflammation, demyelination, or clinical signs in the JVL group compared to the sham group. Therefore, our murine model does not support CCSVI as a cause of demyelinating diseases such as multiple sclerosis.
Colin Rose said
This is the sort of study Zamboni should have done before publishing anything on “CCSVI”. At a conference when Zamboni was asked why he didn’t try to produce demyelination in animals by ligation of jugular veins, he replied arrogantly that he wasn’t a “mouse doctor”. So what does Zamboni think of the likes of William Harvey would proved the circulation of the blood by animal experiments, the theory upon which his profession depends?
chiefumtaga said
Yet another study has been published that does not show association between “CCSVI” and MS. It was published in the journal called “Multiple Sclerosis”. The article is titled “No Association Between Cerebrospinal Insufficiency and Pediatric-Onset Multiple Sclerosis”. The abstract is available on PubMed (PMID 22513520). The researchers found that healthy controls had essentially the same rate of CCSVI in healthy controls and MS patients.
I hope Dr. Brandes on the CTV website will put this study on his blog (since he seems to be such a cheerleader for “Liberation Therapy” and Dr. Zamboni).
maldendj said
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm303318.htm
U.S. Department of Health and Human Services
U.S. Food and Drug Administration (FDA)
Alerts and Notices (Medical Devices):
FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients
Date Issued: May 10, 2012
Audience: People with multiple sclerosis (MS), their families and caregivers; Neurologists; Interventionalists (Radiologists, Vascular Surgeons and Neurosurgeons); Clinical Researchers; other MS health care providers; and Institutional Review Boards (IRBs).
Medical Specialty: Neurology, Interventional Radiology, Vascular Surgery.
Purpose: The FDA is alerting people with MS to the risks of serious injuries and death associated with procedures to treat chronic cerebrospinal venous insufficiency (CCSVI). Furthermore, the benefits of these experimental procedures have not been proven, and their promotion as a treatment for MS may lead people with the disease to make treatment decisions without being aware of the serious risks involved.
This communication is also intended to notify physicians and clinical investigators planning or conducting clinical trials using medical devices to treat CCSVI that they must comply with FDA regulations for investigational devices.
…
Some individuals, organizations and websites promote an experimental treatment of CCSVI that uses balloon angioplasty devices or stents to widen the narrowed internal jugular or azygos veins. This procedure is sometimes called “liberation therapy” or the “liberation procedure”.
The FDA believes that using these medical devices in CCSVI treatment procedures poses a risk to patients because:
There is no clear diagnostic evidence that CCSVI exists as a distinct clinical disorder or is linked to MS.
Venous stenoses seen on imaging tests may be normal variants that do not cause any symptoms or disease, since they are sometimes seen in healthy people.
The safety and effectiveness of using balloon angioplasty devices or stents in the internal jugular or azygos veins have not been established for any clinical condition; nor has the FDA approved the use of these devices in these veins.
There is no clear scientific evidence that the treatment of internal jugular or azygos venous stenosis is safe in MS patients, impacts the symptoms of MS, changes the overall course of MS or improves the quality of life for MS patients.
It is possible that stent placement can worsen any venous narrowing. This is because further narrowing has been shown to sometimes occur within stents placed in veins, due to the body’s response to the implant.
The FDA encourages research to evaluate the relationship between CCSVI and MS and to characterize the safety and effectiveness of treatment procedures. Rigorously conducted, properly targeted research can provide a more complete understanding of the existence of CCSVI and any relationship between CCSVI and MS, which will help people with the disease and their clinicians make the best treatment decisions.
…etc….
Colin Rose said
I gather that pseudo study in Albany voluntarily shut down. That is where Brad Wall was sending patients from Saskatchewan for a trial which couldn’t be done in Saskatchewan because the only application couldn’t meet scientific standards. I very much doubt that any application for for a trial of “liberation” would meet the requirement of any IRB or the FDA, simply because it is impossible to diagnose “CCSVI”. With the FDA warning, anyone continuing to do “liberation” in the US is putting themselves at risk of indefensible suit if something goes wrong. So I think “liberation” will shortly no longer be done in the US. Too bad the FDA didn’t have the balls to give a warning two years ago when it was just as obvious that “liberation” was a scam. $hundreds of millions would have been saved.
maldendj said
More from Padova University:
http://www.sciencedirect.com/science/article/pii/S2211968X1200006X
Fact or fiction: Chronic cerebro-spinal insufficiency
• Claudio Baracchini, ,
• Paolo Gallo
• Department of Neurological Sciences, University of Padua, Via Giustiniani 5, 35128 Padova, Italy
• Available online 19 April 2012.
Conclusions
Ultrasound investigation of intracranial and cervical veins is highly operator dependent owing to the wide anatomic and physiological variability of these vessels. Therefore a study of cerebral venous drainage requires very experienced neurosonographers, but most importantly, blinding algorithms are mandatory in assessing MS patients especially during venographic verification of ultrasound findings; these were completely omitted in Zamboni’s studies. To this day, a scientifically sound validation of each of the five criteria proposed by Zamboni for the diagnosis of CCSVI is missing, not to mention their combined application. Concurrently, there is growing evidence which rejects the role of CCSVI in the pathogenesis of MS and which suggests that the proposed CCSVI criteria are questionable due to miscitation, manipulation of known data and methodological flaws. Thus, any potentially harmful interventional treatment such as transluminal angioplasty and/or stenting should be strongly discouraged, not only for the lack of any evidence, but also for the risk of serious peri-procedural complications.
maldendj said
1. Neurol Sci. 2012 May 9. [Epub ahead of print]
http://www.ncbi.nlm.nih.gov/pubmed/2256956
7
CCSVI and MS: no meaning, no fact.
Baracchini C, Atzori M, Gallo P.
Department of Neuroscience-SSPNRR, Stroke Unit, First Neurology Clinic, University of Padova, via Giustiniani, 5, 35128, Padua, Italy.
A condition called “chronic cerebrospinal venous insufficiency” (CCSVI) has been
postulated to play a role in the pathogenesis of multiple sclerosis (MS). This
hypothesis implies that a complex pattern of extracranial venous stenosis
determines a venous reflux into the brain of MS patients, followed by increased
intravenous pressure, blood-brain barrier breakdown and iron deposition into the
brain parenchyma, thus triggering a local inflammatory response. In this review,
we critically analyze the scientific basis of CCSVI, the current literature on
the relationship between CCSVI and MS, as well as the ultrasound methodology that
has been claimed to provide evidence of impaired cerebral venous drainage. We
show that no piece of the CCSVI theory has a solid supportive scientific
evidence. The CCSVI appears to be a rather alien condition and its existence
should be definitely questioned. Finally, no proven (i.e., based on strict
scientific methodology and on the rules of evidence-based medicine) therapeutic
effect of the “liberation” procedure (unblocking the extracranial venous
obstruction using angioplasty) has been shown up to date.
PMID: 22569567 [PubMed – as supplied by publisher]
chiefumtaga said
The American Journal of Neuroradiology has an original research article titled “No Association Between Conventional Brain MR Imaging and Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis” PMID: 22576891 It was done at the Buffalo Neuroimaging Analysis Center, the lead authour is R. Zivadov.
The conclusion: CCSVI is not associated with more severe lesion burden or brain atrophy in patients with MS or Healthy controls.
chiefumtaga said
Here is another critique of Dr. Zamboni’s theory of Multiple Sclerosis and venous “abnormalities”.
CCSVI and MS: a statement from the European Society of neurosonology and cerebral hemodynamics.
Baracchini C, Valdueza JM, Del Sette M, Baltgaile G, Bartels E, Bornstein NM, Klingelhoefer J, Molina C, Niederkorn K, Siebler M, Sturzenegger M, Ringelstein BE, Russell D, Csiba L.
Source
Department of Neuroscience, University of Padua, Via Giustiniani, 5, 35128, Padua, Italy, claudiobaracchini@tin.it.
Abstract
To systematically review the ultrasonographic criteria proposed for the diagnosis of chronic cerebrospinal venous insufficiency (CCSVI). The authors analyzed the five ultrasonographic criteria, four extracranial and one intracranial, suggested for the diagnosis of CCSVI in multiple sclerosis (MS), together with the references from which these criteria were derived and the main studies that explored the physiology of cerebrospinal drainage. The proposed CCSVI criteria are questionable due to both methodological and technical errors: criteria 1 and 3 are based on a scientifically incorrect application of data obtained in a different setting; criteria 2 and 4 have never been validated before; criterion 2 is technically incorrect; criteria 3 and 5 are susceptible to so many external factors that it is difficult to state whether the data collected are pathological or a variation from the normal. It is also unclear how it was decided that two or more of these five ultrasound criteria may be used to diagnose CCSVI, since no validation of these criteria was performed by different and independent observers nor were they blindly compared with a validated gold-standard investigation. The European Society of Neurosonology and Cerebral Hemodynamics (ESNCH) has considerable concerns regarding the accuracy of the proposed criteria for CCSVI in MS. Therefore, any potentially harmful interventional treatment such as transluminal angioplasty and/or stenting should be strongly discouraged.
PMID: 22648477 [PubMed – as supplied by publisher]
I hope the health minster in Saskatchewan is aware of this publication.
chiefumtaga said
On the Neurologica blog Steven Novella has commented on the latest CCSVI research
http://theness.com/neurologicablog/index.php/yet-another-nail-in-the-ccsvi-coffin/
“The diagnosis of CCSVI was assigned by using specific color Doppler ultrasonographic criteria. Cerebral blood volume (CBV), cerebral blood flow (CBF), and mean transit time were assessed with dynamic susceptibility contrast material–enhanced magnetic resonance imaging in normal-appearing white matter (NAWM) in 39 patients with MS. Of these, 25 had CCSVI and 14 did not. Twenty-six healthy control subjects were also evaluated, and of these, 14 had CCSVI and 12 did not”
More than half of the healthy controls had “CCSVI”!!!
How can a subjective observer continue their support for the theory of CCSVI and MS, much use “Liberation Therapy” to treat people that suffer from MS
Dr. Novella wonders if the overwhelming evidence that fails to show a connection between CCSVI and MS will put a stop to clinics that promote “Liberation Therapy” and the research attempting to replicate Zamboni’s flawed hypothesis. He concludes sadly that it will live on as an alternative therapy. But what might help is if Dr. Zamboni admits his original work was incorrect.
maldendj said
Lawsuits Against Stanford, Dr. Michael Dake for Experimental Procedures, Filed by San Francisco Firms Rouda Feder Tietjen & McGuinn and Emison Hullverson LLP
Suits allege Stanford University, physician harmed patients by breaking rules for ethics, safety and medical research in performing CCSVI surgeries outside of a clinical trial.
http://www.businesswire.com/news/home/20121010006553/en
SAN FRANCISCO–(BUSINESS WIRE)
Today two men announced lawsuit filings (docket #112CV218823) against Dr. Michael Dake and Stanford University (Stanford) for performing experimental surgeries on them for purported CCSVI, a controversial theory hypothetically linked to multiple sclerosis (MS), outside of an approved clinical trial.
“I trusted Dake’s medical opinion – in no small part because of Stanford’s prestigious reputation – and wound up as a guinea pig for his experiments”
Plaintiffs Oliver Zahn and Mark Wittwer allege that Dake abandoned fundamental policies for medical research and patient consent when he conducted experimental surgery to insert arterial stents in their veins, according to their complaints. They also allege that Stanford failed to protect patients by allowing Dake’s unapproved experiments to continue outside of a clinical trial, despite the recognized, life-threatening risks associated with Dake’s procedures and a lack of evidence to support any benefit from the treatment, court documents state. As a result, both men now suffer permanent and life-altering injuries…..
Best regards,
Mladen..
maldendj said
Associazione Italiana Sclerosi Multipla:
http://www.aism.it/index.aspx?codpage=2012_10_stampa_ricerca_ccsvi_comunicato_eng
Lyon. 12th October, 2012. The CoSMo study, recently concluded, highlights that 97 % of people suffering from MS does not have the CCSVI (Chronic Cerebrospinal Venous Insufficiency). In the remaining 3 %, the CCSVI can be verified with a percentage which is totally equivalent observed both in healthy controls, in patients suffering from MS and in patients suffering from other neurological diseases. No difference is encountered between the CIS (Clinically Isolated Sindrome) with respect to relapsing-remitting, either secondary or primary progressive MS forms. In the CCSVI diagnosis no risk factors, like age and gender, were highlighted. These, in summary, are the results of the CoSMo study, promoted and financed by AISM (Italian Multiple Sclerosis Society) and presented to ECTRIMS, (European Committee for Treatment and Research in Multiple Sclerosis).
CoSMo “Observational Study of the prevalence of CCSVI in Multiple Sclerosis in Other Neurodegenerative Diseases (OND)” is the largest observational and multicentric study, with double-blind reading performed to date, with an investment of 1.5 million euros: 1767 case analysed, 35 neurological centres involved and 26 trained sonologists covering the whole country, 3 international expert for the centralised reading of the exams. A 2-year lasting work to achieve the completion of the study. The final evaluation of the CoSMo study has been performed on 1165 patients affected by MS, compared with 376 healthy controls and with 226 patients affected by other neurological diseases.
The mechanism of centralised blinded reading, competent and free from any biased judgement connected to the interaction with the person examined, combined with the wide multicentricity, the numbers of samples analysed and with the widest database of examined subjects (which remains at the complete disposal of the whole scientific community) are the strengthpoints and unicity of this study, and ensure its scientific reliability.
….
Read more here:
http://www.medpagetoday.com/MeetingCoverage/ECTRIMS/35292
Largest CCSVI Study Fails to Support Theory:
The largest study to date testing the venous-obstruction theory of multiple sclerosis failed to support it, leading the Italian Multiple Sclerosis Society to declare the theory dead.
maldendj said
It’s shocking to me that ‘dr.’ Marian Simka is able to do this slaughter and then document it (with pictures) in medical magazine:
http://www.hindawi.com/crim/surgery/2012/293568/
Case Reports in SurgeryVolume 2012 (2012), Article ID 293568, 5 pagesdoi:10.1155/2012/293568
Case Report
Internal Jugular Vein Entrapment in a Multiple Sclerosis Patient
Marian Simka, Eugeniusz Majewski, Marek Fortuna, and Maciej Zaniewski
Department of Vascular Surgery, EuroMedic Medical Center, Street Kościuszki 92, 40-519 Katowice, Poland
Received 16 June 2012; Accepted 16 September 2012
Academic Editors: I. Harirchi, H. Kawai, and G. Santori
Copyright © 2012 Marian Simka et al.
“…
We treated the 57-year-old female patient, with clinically defined MS, presenting with EDSS (extended disability severity score): 5.5 and MSIS-29 (multiple sclerosis impact scale-29): 103 points [11, 12]. She was given the diagnosis of CCSVI according to Doppler sonography results.
…
The patient was followed up 10 months after the endovascular procedure. Her neurological status remained unchanged.
…
Yet, control Doppler sonography revealed totally collapsed middle part of the left IJV in the supine position, with no flow through the vein detected.
…
According to the above-described sonographic findings, patient qualified for surgical decompression of the vein. Anatomic relationships were checked sonographically and locations of jugular vein and compressing muscle were marked on the skin before the procedure (Figure 4(a)). Surgical exploration revealed atypical OH, which was obviously squeezing the vein.
…
Transection of pathological muscle—performed in general anesthesia—resulted in widening of the vein (Figure 4(c)) and normal blood flow was restored
…
Still, neurological assessment performed 2 months after the operation has shown a slight deterioration of clinical status: EDSS was 6.5 and MSIS-29 was 110 points.
…”
??????
Is this poor woman a guinea pig or something? Two unnecessary procedures, lot of pain (and money) and dr. simka is still wondering:
“Of note, despite successful decompression of the vein, we did not observe clinical improvement in this patient. However, it is already known that only a subset of MS patients benefits from restoration of proper venous outflow after endovascular treatment for CCSVI [29, 30]. Patients with more severe disability, like our patient, were less likely to improve. Besides, clinical status in MS patients typically fluctuates and perhaps a longer followup, instead of 2 months, was needed to evaluate our patient properly. It is also likely that the worsening, perhaps temporary, was due to general anesthesia. Undoubtedly, results of the treatment of a bigger group of MS patients presenting with muscular compressions of IJVs should be prospectively evaluated in order to understand actual clinical meaning of such an entity.”
What a ‘Doctor’, and all this publiched in Academic Journal with Academic Editors?!
Best regards, Mladen.
p.s: (for those with good stomach) here is how dr. Marian Simka ‘cure’ MS patient:
http://www.hindawi.com/crim/surgery/2012/293568/fig4/
maldendj said
Zamboni theory is a hoax… It cost several thousend MS suffers all over the a world 10 000 dolars each, without positive results. If there where been some positiv results, there are by part of part of procedure (extrime X-tay radiaton, blood thinners, alticolagulants), not angioplasty itself. P.S. Where are you dr. Rose… problemos?
Greating from Croatia, home of the one of last bastions against CCSVI hoax.
maldendj said
University at Buffalo, News Releases, Release Date: March 15, 2013:
http://www.buffalo.edu/news/releases/2013/03/021.html
MS patients did not benefit from CCSVI intervention, landmark pilot study of ‘liberation treatment’ finds:
Procedure is safe but does not improve MS outcomes, a finding that the UB investigators call “surprising and unexpected”