Canadian Government Promises to Fund Junk Science to Appease Zamboni Cult

from the CBC

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”.

http://medicalmyths.wordpress.com/2009/11/24/the-zamboni-myth-ccsvi-surreal/

http://medicalmyths.wordpress.com/2011/02/04/the-perfect-crime-ccsvi-not-leaving-a-trace-in-ms-liberation-is-a-hoax/

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.

Olivia Chow, Desperate Wife of NDP Leader, Promotes Junk Food Addiction

Olivia Chow, wife of NDP leader, Jack Layton, has sunk to a new low her desperate attempt to be re-elected in the riding of Trinity-Spadina after winning by only 3500 votes in 2008. She is paying for the distribution of mini ice cream cones to attract and bribe voters. Ice cream is the quintessence of junk food, a concoction of sugar and fat that has been perfected over many years to appeal to those addictions. The money to pay for this promotion of addiction is coming from donations to the NDP. Obviously the NDP doesn’t care that the consequences of junk food addiction, obesity, Type 2 diabetes, knee osteoarthritis, high “cholesterol” and high blood pressure, account for the most of the exorbitant increases in spending on “health care.”

From MacLean’s

From the Star

The Cardiometabolic Risk Working Group: Another Coven Practising Drug-Induced Magical Thinking

The latest issue of the Canadian Journal of Cardiology, published by the Canadian Cardiovascular Society (CCS), both of which are largely funded by the drug industry has shamelessly published a “Position Statement by the Cardiometabolic Risk Working Group” (see highlights below). We have previously blogged about the American “Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults” and the Canadian “Working Group on Hypercholesterolemia and Other Dyslipidemias”. Now that the ability of “cholesterol” to induce terror in doctors and patients has become a little worn and less profitable, drug dealers have invented a new disease, “cardiometabolic risk” with which to terrorize asymptomatic people into demanding even more drugs and doctors into prescribing them. Many of the members of the previous covens have migrated to the new one.

These medical covens take it upon themselves to dictate to the rest of the medical profession what drugs should be prescribed to prevent diseases of lifestyle in the otherwise “normal” population, so-called primary prevention. How are these covens assembled and what gives them the authority to establish norms for other doctors? This paper reveals in stunning clarity the answers to these questions. As we can see from the Acknowledgements and Disclosures sections, most of the authors of this Position Statement have many long-term financial relations with many drug dealers. Of the ten members of the executive committee of the Cardiometabolic Risk Working Group, nine have multiple financial relations with drug dealers and of the whole Working Group 19 out of 21 have similar relations. Clearly, drug dealers have distributed tens, if not hundreds, of millions of dollars to these doctors, justified under various guises, to facilitate a culture of drug dependency. Drug dealers choose members of  the Working Group, pay them to be “authors”, pay a medical writer to compose the Position Statement and get it published in a journal which would not exist without the financial support of the same drug dealers. Why am I not impressed and why would any other doctor follow the advice of this coven? But most family physicians and many cardiologists treat this sort of statement, endorsed by presumably unassailable organizations like the CCS, as revealed truth by a mysterious higher authority in possession of occult knowledge that must be accepted or suffer ostracism by one’s colleagues. Of course it doesn’t hurt that a 30-second drug prescription for numerical symptoms of junk food addiction is much easier that spending many unpaid hours reducing the addiction, the only real way to prevent its consequences.

Here is an example of the occult numerological incantations of the Working Group. Compare this with the occult number philosophy of Agrippa based on the pentacle below.

“Optimize lipid levels. In patients with cardiometabolic risk with a moderate or high Framingham Risk Score, treatment should be initiated with a statin to reduce low-density lipoprotein cholesterol (LDL-C) by at least 50% and to 2.0 mmol/L. Apo B levels are a better measurement of lipid-related risk in these patients, and the target level for treatment is 0.8 g/L in high-risk and moderate-risk individuals. There is a large residual risk for patients at high risk for CVD, despite LDL-C reduction with high-dose statins. Many patients with cardio- metabolic risk may also have an acquired combined hyperlipidemia, associated with increased triglycerides (TGs), a modest increase in LDL-C, and low high-density lipoprotein cholesterol (HDL-C). LDL particle numbers are increased, as reflected by the increased levels of apo B100. Beyond LDL-C lowering, strategies that might reduce the residual risk include reducing the total cholesterol (TC) to HDL-C ratio, high-sensitivity C-reactive protein, and TG, although there are no clinical trial data to date to support such strategies. In the patient with diabetes, glycemic control optimization and health behaviour modification should be attempted prior to the addition of another agent, such as a fibrate. In the Action to Control Cardiovascular Risk in Diabetes trial the addition of fenofibrate to simvastatin in patients with type 2 diabetes failed to show any reduction of CV events, although there may have been benefit in the subset of individuals with high TG/low HDL-C.“

The deliberations of the Cardiometabolic Risk Working Group have much in common with pagan covens with occult rituals and symbols like the pentacle which when worn will drive out evil numbers such as "cholesterol". Expensive statins for "cholesterol" and ARBs for high blood pressure are the new pentacle. The significance of the pentacle, as described by Heinrich Cornelius Agrippa in his Three Books of Occult Philosophy, makes as much sense as the Position Statement of the Working Group. "A Pentangle also, as with the vertue of the number five hath a very great command over evil spirits, so by its lineature, by which it hath within five obtuse angles, and without five acutes, five double triangles by which it is surrounded. The interior pentangle containes in it great mysteries, which also is so to be enquired after, and understood; of the other figures, viz. triangle, quadrangle, sexangle, septangle, octangle, and the rest, of which many, as they are made of many and divers intersections...

When one manages to decode the occult numerology of the Statement one can see that the goal of the Working Group is to have every overweight junk-food addict in Canada, on some combination of pills for “high” blood pressure and “high” cholesterol. The “targets” for blood pressure and cholesterol are set low and arbitrarily to guarantee that most of the Canadian population would be on some drug. The drug dealers can be assured that doctors will prescribe the newest, most expensive patented drug rather than a cheaper generic alternative because they have already spend hundreds of millions of dollars in advertising the advantages of the patented drugs. This is called clever marketing but it has nothing to do with the health of the population. The consequences of self-destructive lifestyles will not be lessened by any number of drugs which will have the unintended consequence of worsening those lifestyles when people are convinced they can continue those lifestyles with impunity under the “protection” of drugs that make the numerical symptoms of those lifestyles look better. While the Position Statement gives lip service to the necessity of “health behaviour interventions” it insists also on the necessity of “vascular protective measures”, code for expensive drug prescription.

Canada is currently in the middle of a federal election campaign in which the most important issue for voters is “health care”. All parties are promising to increase “health care” spending by 6% a year indefinitely. With an inflation rate of only 2%, a PhD in mathematics is not required to see that in the not too distant future “health care” will consume the entire tax revenue of federal and provincial governments. The increase in “health care” spending is driven by the sort of activities represented by this Position Statement but no candidate dares to mention drug-induced magical thinking in their campaign speeches or platforms. The electorate loves its addictions and demands infinite “health care” to provide the mirage of protection from the consequences of those addictions and any candidate who points out the obvious absurdity of this belief is dead electoral meat.

How can we exorcise the myths promoted by these venal covens? There at two excellent drug review publications written by authors with absolutely no connection to drug dealers that should be required reading for every doctor: Prescrire, a French publication available in English, which is expensive but is the gold standard in independent thinking about drugs and the Drug and Therapeutics Bulletin of Navarre, a Spanish publication, available in English, which is free but covers a limited range of drugs. A recent excellent article from the latter, “Magical numbers in pharmacological prevention of cardiovascular disease and fractures: a critical appraisal“, analyzed in detail the occult numerology of the drug-funded covens’ pontifications on “primary prevention” and concludes,

A considerable part of the pharmacological recommendations to prevent cardiovascular events and fractures in healthy persons lack any solid justification. No clear efficacy, nor the size of the effect of these agents or a clear balance between risk and benefit make the intervention clinically and socially worthwhile. The “therapeutic targets” and the “operative definition” of disease or risk factor that include instruments or tables to calculate risk are new gateways to unnecessary medicalization. In the context of modern medicine, immersed in conflicts of interest, the physician is obliged to interpret the results of trials and the recommendations from guidelines and consensus at a critical distance, and to place emphasis on the development of clinical prudence as a desired skill.

In other words a truly professional doctor will ignore any advice from the drug dealer funded covens and use his or her own best judgement.

Lawrence A. Leiter, David H. Fitchett, Richard E. Gilbert, Milan Gupta, G. B. John Mancini, Philip A. McFarlane, Robert Ross, Hwee Teoh, Subodh Verma,  Sonia Anand, Kathryn Camelon, Chi-Ming Chow, Jafna L. Cox, Jean-Pierre Després, Jacques Genest, Stewart B. Harris, David C. W. Lau, Richard Lewanczuk, Peter P. Liu, Eva M. Lonn, MD, Ruth McPherson, Paul Poirier, Shafiq Qaadri, Rémi Rabasa-Lhoret, Simon W. Rabkin, Arya M. Sharma, Andrew W. Steele, James A. Stone, Jean-Claude Tardif, Sheldon Tobe, Ehud Ur

“The perfect crime? CCSVI not leaving a trace in MS” – “Liberation” is a hoax

Just published today, is a report of the first independent investigation by Christopher Mayer, et al from Germany with no connection to drug companies that attempts to use Zamboni’s Doppler technique for diagnosing “CCSVI” but in a rigorously controlled and blinded manner.

Conclusion: “This triple-blinded controlled study does not support insufficient extra- and intracranial venous flow in MS. Together with two other recent studies, this constitutes compelling evidence against a significant contribution of CCSVI to the pathogenesis of MS. As interventional procedures such as transluminal angioplasty are derived from the non-confirmed CCSVI concept and can result in serious adverse events, we strongly discourage the use of these procedures on the grounds of the present evidence.”

At least four blinded studies using magnetic resonance venography came to the same conclusion.

This is what we predicted in November, 2009 when Zamboni’s “breakthrough” was first announced by the scoop-hungry media. The absurdity of the concept was quite obvious but emotional YouTube videos of instantaneous improvement in symptoms overwhelmed rational thought.

Face it, true believers. No blinded study using any technique has been able to reproduce Zamboni’s data. Zamboni succumbed to irrational self deception in a futile attempt to cure his wife’s MS. “CCSVI” doesn’t exist. All “liberation” factories should be shut down, now. Any doctor who continues to do “liberation” should lose his or her license to practice.

If nothing else of use results from the Zamboni fad, which has cost patients, charities and governments at least $one billion, we should have learned a number of lessons:

• the absolute necessity for careful blinding of clinical trials before a paper on them is accepted by any medical journal.
• the necessity for regulation of surgical procedures in the same way as drugs are regulated.
• the necessity for ethical doctors to increase their presence in the internet social media to counteract patient hysteria and the venality of some members of their profession.
• before media reporters are allowed to report on medical and scientific topics must take a course in assessment of the validity of publications in journals.
• in this internet age, high school science education, in addition to the standard curricula, needs to teach skills in the assessment of the validity of data and conclusions drawn from them, using the Zamboni fad as a classic example of what not to do.

The fad has also put a focus on the powerful effects of faith healing on the symptoms of MS as seen in this video.

Exactly the same instantaneous “cures” are shown in numerous post “liberation” videos. Faith in modern technology, pseudo-science and surgeons is replacing faith in the traditional saviours. The psychology underlying faith healing in MS needs investigation. Because of the intermittent and prolonged nature of the disease, MS patients are particularly prone to faith healing, when they are given some hope for the future. There seem to be a lot of MS patients whose symptoms are to some degree subconsciously self-inflicted out of depression or to attract sympathy who could be helped with the right form of psychotherapy.

MS patients have normal intracranial pressure-Zamboni’s “CCSVI” does not exist, “liberation” is futile

Paolo Zamboni must be getting just a little nervous over the continuing failure of any other investigator to find the slightest evidence for “CCSVI”, his purported venous “reflux” that could only damage the brain by causing an increase in intracranial pressure. The latest is a report by Rolf Meyer-Schwickerath, et al., using the elegant, noninvasive technique of measuring venous occlusion pressure, who showed that intracranial pressure in MS patients is perfectly normal, but increased in patient with known causes of increased intracranial pressure. These observations confirm previous studies using magnetic resonance venography showing that MS patients have the same wide variation in head and neck venous anatomy as normal people. As we have explained in our original post on “CCSVI” even total occlusion of both internal jugular veins does not result in increased venous pressure of increased intracranial pressure due to the extensive venous collateral circulation from the head.

Their conclusion:  ”In summary, there is no evidence of an increase in intracranial venous pressure in our MS patients due to a CCSVI mechanism in MS. Our findings do not justify operative procedures.” In other words, Zamboni’s “liberation” treatment for MS is useless.

To date, at least $one billion has been wasted on Zamboni’s seductive myth. When will the medical profession start policing itself and shut down all the venal charlatans deceiving desperate MS patients and their families into depleting their savings to have “liberation”?

Paolo Zamboni-Medical Con Man Supreme-Patenting a Disease

When I first heard about Paolo Zamboni’s miraculous surgical “cure” for multiple sclerosis, I had supposed, that in addition to his desire to treat in wife’s MS, he was motivated by the delusion that he could earn a place in the medical pantheon, alongside Jenner, Salk, Banting etc. Only after viewing various internet postings has it become clear to me that Zamboni  plans to make himself a billionaire by patenting a disease, “CCSVI”, and the means to diagnose it. He realizes that he can’t patent the “liberation” procedure which is now done by dozens of avaricious, unscrupulous surgeons around the world but he can patent the machinery to diagnose the condition for which “liberation” is the treatment.

In 2008 he applied for a US patent for a “System for Diagnosing Multiple Sclerosis”.  Note that there is no mention of his employer, the University of Ferrara anywhere in the application. If the University had considered “CCSVI” to be a significant innovation it would surely have insisted on applying for the patent as is its right. Also, note that he does not claim just to be diagnosing “CCSVI” or just neck vein abnormalities. Apologists for Zamboni often claim that he is only diagnosing “CCSVI” and only secondarily MS. To quote: “An embodiment of the invention is a system for diagnosing multiple sclerosis based on the determination of the rate of reflux, increased indices of resistance in the cerebral veins for providing clinical data useful for diagnosing multiple sclerosis.”

At the same time Zamboni is acting as a consultant to Esaote, a Genoa-based manufacturer of ultrasound equipment which is selling the only machine approved by Zamboni for diagnosing “CCSVI”. No doubt Zamboni envisions this machine being bought by the thousands, if not tens of thousands by radiology departments in hospitals around the world to screen for “CCSVI” in everyone under age 40 so that they can  be treated for “CCSVI” by his “liberation” procedure and presumably prevent MS. Curiously, the description of this machine only appears in the site of the Bulgarian purveyor of “liberation” not in Esaote’s own site. I suspect that Esaote doesn’t want to publicize the use of transcranial Doppler for studying intracranial veins with the Zamboni machine because this technique has never been validated and is not used in legitimate ultrasound labs. Transcranial Doppler has a few uses for looking at cerebral arterial blood flow that do not include trying to image venous flow which would be hard to distinguish from arterial flow, as recommended by the US Agency for Healthcare Research and Quality.

“Settings in which transcranial Doppler ultrasonography (TCD) is able to provide information and in which its clinical utility is established.

1. Screening of children aged 2 to 16 years with sickle cell disease for assessing stroke risk (Type A, Class I), although the optimal frequency of testing is unknown (Type U).
2. Detection and monitoring of angiographic vasospasm (VSP) spontaneous subarachnoid hemorrhage (sSaH) (Type A, Class I-II). More data are needed to show if its use affects clinical outcomes (Type U).”

TCCS: "transcranial color-coded duplex sonography", ECD: "extracranial EchoColor-Doppler". These two forms of imaging are somehow combined by the special software in the PC to diagnose "CCSVI". In other words, this disease can only be diagnosed with Zambonis machine. Zamboni is attempting to patent a disease.

Of course, the only way one can learn to use the Zamboni “CCSVI” machine is to take special training from the master himself or from one of his franchises. The Hilarescere Foundation is Zamboni’s charity, the scientific committee of which doles out money to him and his friends.

Unfortunately for him, Zamboni is unlikely to make much from his machine. Most of the charlatans around the world doing “liberation” don’t bother to do transcranial Doppler to document “reflux” in intracranial veins. Too much hassle. Like Marian Simka in Poland, the scammers just do a fast scan of neck veins with  regular Doppler that shows pulses on the screen and makes swishing noises which seems  to be enough to convince the desperate patient that he/she needs “liberation” @ $10,000. Note that Simka is not doing transcranial Doppler, just neck scanning with a small portable Doppler machine. And there is certainly no computer in sight  to analyze the data as required  by the Zamboni patent application. This patient is even demanding to have stents inserted [more money], so fearful is he of having a “restenosis” and not being able to afford to return to Poland for another “liberation.”

Here is a Zamboni machine that isn’t a hoax.

Zivadinov proves Zamboni’s “CCSVI” does not exist

Almost a year ago at a much heralded news conference Dr. Robert Zivadinov, a Buffalo-based early disciple of Paolo Zamboni, claimed to show some difference in the presence of venous flow patterns in the heads of MS patients compared to controls using special Doppler ultrasound techniques that had never been validated. He never published the details of this study and has apparently abandoned ultrasound in favour of MRI venography which gives an overall picture of venous flow patterns in all head and neck veins. Zivadinov has now published a well-blinded study using MRV in MS patients and healthy controls which shows no difference in venous flow patterns in the two groups. There are almost blocked internal jugular veins in some MS patients and some normal people. But such blockages are insignificant because of the extensive collateral veins and the emissary veins connecting intra- and extra-cerebral venous circulations, as I described in my original response the Zamboni hypothesis.

I quote from the Discussion section of the paper: “We did not find significant differences between MS patients and HC subjects or between RR and SP MS patients in regard to collateral circulation. This is indeed an important finding because it does not support collateral circulation as a compensatory mechanism of CCSVI.” Such “abnormal” collateral flow was a crucial part of the Zamboni hypothesis.

As I said in response to Zivadinov’s first “study” of “CCSVI”, real scientific discussion is not conducted by news conference. Those who thought otherwise should now be convinced that only publications in respected journals following the time-honoured format for scientific communication are worthy of consideration.

With this paper and at least three others showing the same result, we now have overwhelming evidence that “CCSVI” is a fantasy, concocted by Paolo Zamboni, a varicose vein surgeon who convinced himself that he could “liberate” his wife from MS by dilating her neck veins. To date, at least $one billion has been wasted on this myth by desperate patients, granting agencies and governments. No further attention or money should be directed at this farce. All MS patients should refrain from paying for “liberation”, a very profitable scam based on the “CCSVI” myth.

“Low risk” nurse with normal cholesterol but self-destructive lifestyle ends up with heart transplant after CCTA

Here in a nutshell is a demonstration of the problem with expecting technology to substitute for good clinical medicine and save us from our self-destructive addictions. If anyone is puzzled about the dichotomy between the exorbitant cost of the US medical system and its relative lack of effect on any measure of health here is the reason.

Below is a story from theheart.org followed by the actual paper in the Archives of Internal Medicine minus the references.

In the absence of any symptoms attributable to coronary artery disease there was no reason to do any more testing but the temptation to use high tech tools without good indication is irresistible to many doctors. CCTA is the latest expensive test to detect coronary atherosclerosis. Patients think that they will never have a heart attack and live longer if the disease is detected and some surgical procedure, like an angioplasty or bypass is done and doctors making $millions from doing them are not about to discourage them and point out the total lack of evidence for any significant benefit from angiography or the surgical procedures in patients with chronic coronary disease.

The authors have labelled this patient “low risk” because her “cholesterol” was normal but clearly she was at high risk based on her obesity and hypertension, both indices generally of  junk food addiction, in spite of her being a nurse.  When she started new exercises she probably got muscle pain from weight lifting. With an obvious self-destructive lifestyle, she should not have been “simply reassured” as recommended by the editors. But instead of encouraging her to make meaningful lifestyle change her doctors ordered tests with no clinical indication.

Framingham scores, lipid profiles and CRPs can be very deceptive because they do not assess LDL modification in the arterial wall, essential to the formation of atherosclerotic plaque. In spite of having “normal” numbers for all the usual “risk factors” she had advanced atherosclerosis in her coronary arteries. Apparently no dietary history was taken and no attempt was made to encourage her to change her lifestyle, an example of gross diagnostic and therapeutic incompetence, all too common in an era of absolute faith in the power of technology to protect us from our self-destructive addictions. Doctors abdicate professionalism by ordering tests instead of dealing with the real problems, like junk food addiction, which take much time for which they are not compensated and risk alienating patients who demand a high-tech fix or reassurance so that they can continue their risky behaviour.

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Case study shows how “just-in-case” CCTA in a low-risk patient may spectacularly backfire

DECEMBER 17, 2010 | Reed Miller

San Francisco, CA – Coronary computed tomographic angiography (CCTA) in patients with a low pretest risk of coronary disease wastes resources and can even lead to horrendous outcomes, a case study published December 13, 2010 in the Archives of Internal Medicine shows. The report tells the story of a 52-year-old white female who initially presented with chest pain and had a CCTA; this was followed by an unfortunate chain of events in which she suffered an aortic dissection during cardiac catheterization and that culminated in her having a heart transplant.

Part of its ongoing “Less is More” series begun last April, the latest case, reviewed by Dr Matthew Becker (St Vincent’s Heart and Vascular Institute, Erie, PA), Dr John Galla (Providence Hospital, Mobile, AL), and Dr Steven Nissen (Cleveland Clinic, OH), describes how the well-meaning attempt to reassure a patient with a low risk of coronary disease backfired spectacularly.

“Perhaps the most important point to be learned from the case described by Becker and colleagues is that there are safer ways to reassure patients,” say journal editors Drs Rita Redberg, Mitchell Katz, and Deborah Grady (University of California, San Francisco) in an accompanying editorial. “Patients value our advice. Talking with our patients should be our first choice for reassurance.” They add that “applying the ‘less-is-more’ principles prospectively could have avoided this unfortunate case.”

From diagnostic uncertainty to disaster
The 52-year-old nurse had hypertension and mild obesity and had recently begun an exercise and diet regimen to control her weight and blood pressure. She presented to her primary physician with chest pain, but no other symptoms: she had a normal ECG with a normal lipid profile and normal C-reactive-protein level. Her doctor attributed the chest pain to a musculoskeletal cause but performed a CCTA to reassure her that she was not at risk for a coronary event.

The CCTA showed discrete, noncalcified, nonobstructive plaque in the mid and distal segments of the left circumflex and dominant right coronary arteries and diffuse, complex calcification in the proximal left anterior descending (LAD) coronary artery. Because that calcification was difficult to quantify, the physician recommended that she undergo cardiac catheterization to get a clearer look at the LAD.

This exam, performed at the local community hospital, revealed only a mild irregularity in the LAD, but during the procedure, the patient complained of chest pressure, which prompted an aortogram that revealed an aortic root dissection that was compromising the left main coronary artery.

So the patient underwent urgent coronary artery bypass graft (CABG) surgery and stayed in the hospital for two weeks with a residual left ventricular ejection fraction of 35%. The bypass graft soon failed and was treated with multiple drug-eluting stents, but despite her compliance with dual antiplatelet medical therapy, a stent in the vein graft supplying the circumflex artery developed a thrombosis, causing an ST-segment-elevation MI complicated by cardiogenic shock. The thrombosis was successfully treated, but the patient remained in refractory cardiogenic shock and ultimately underwent orthotopic heart transplantation.

Unnecessary testing happening every day
“With few cardiac risk factors and an atypical chest pain presentation, this patient had a low pretest probability for coronary artery disease and should have been reassured and not undergone any further risk stratification,” say the authors. “Lacking randomized data suggesting improvement in clinical outcomes and with clear risks, including contrast load, radiation exposure, and suboptimal diagnostic specificity, CCTA should have a very limited role in the evaluation of patients who present with chest pain.”

They acknowledge the risk of complications associated with cardiac catheterization is low, but catastrophic events are always a possibility. They believe the physicians in this case overestimated the stenosis in this patient’s coronaries because they did not fully appreciate the CCTA’s potential for false-positive findings. Complete visualization of all segments of the coronary tree with CCTA is often hindered by cardiac motion, which can lead to the appearance of “blooming artifacts” of coronary calcification that may cause the observer to overestimate the extent of stenosis.

Becker et al point out that previous studies comparing CCTA with conventional coronary angiography in diverse patient populations show CCTA’s sensitivity is between 79% and 100% for the detection of obstructive coronary disease, but its specificity is only 64% to 85%, corresponding to “an unacceptably high false-positive rate” of up to 81% in some populations.

As reported by heartwire, the recently released professional guidelines on Appropriate Use Criteria for Cardiac Computed Tomography list CCTA as “inappropriate” for detection of CAD patients with a low risk of heart disease, ability to exercise, nonacute symptoms that may be an “ischemic equivalent,” and an interpretable ECG.

Patient could have been simply reassured
“If a test is not sufficiently accurate to change clinical management in a particular setting, it should not be done,” but according to Redberg et al, often these tests are done anyway—sometimes even before the patient sees a physician—because nobody has assessed the patient’s pretest probability of the disease or properly considered how the test result will change the clinical management of the patient.

“There are cases where [the test presents] more risks than benefits, and you really need to consider the risks and benefits and not [assume that] just because you can do the test, you should do the test. And this case highlights that,” Redberg told heartwire.

Cases like this where an inappropriate test leads to many complications and near catastrophe are rare, “but to have a CT or another test that was just done for reassurance, when you could have just told the patient ‘You’re fine,’—I think that’s done every day lots of times.

“You don’t know which [tests] are going to lead to that kind of problem, but you do know which of those is not going to give you any benefit, so if there is no benefit, it’s better not to be taking any risk, even a small one.”

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Left Main Trunk Coronary Artery Dissection as a Consequence of Inaccurate Coronary Computed Tomographic Angiography

Matthew C. Becker, MD; John M. Galla, MD; Steven E. Nissen, MD

Arch Intern Med. Published online December 13, 2010. doi:10.1001/archinternmed.2010.464

ABSTRACT

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A 52-year-old woman presented to a community hospital with atypical chest pain. Her low-density lipoprotein cholesterol and high-sensitivity C-reactive protein levels were not elevated. She underwent cardiac computed tomography angiography, which showed both calcified and noncalcified coronary plaques in several locations. Her physicians subsequently performed coronary angiography, which was complicated by dissection of the left main coronary artery, requiring emergency coronary artery bypass graft surgery. Her subsequent clinical course was complicated, but eventually she required orthotropic heart transplantation for refractory heart failure. This case illustrates the hazards of the inappropriate use of cardiac computed tomography angiography in low-risk patients and emphasizes the need for restraint in applying this new technology to the evaluation of patients with atypical chest pain.

REPORT OF A CASE

A 52-year-old white female nurse with a medical history that was notable for hypertension and mild obesity presented to her local primary care physician with the recent onset of chest pain. Further investigation revealed that in an effort to lose weight and assist in the control of her hypertension, she had adopted a new diet and exercise program several weeks earlier. At her initial presentation, she described 48 hours of nonexertional, sharp chest pain that was aggravated by elevation of her right arm and deep inspiration. She denied associated symptoms of shortness of breath, nausea, vomiting, or diaphoresis, and her office electrocardiogram showed no abnormalities.Other than mild hypertension (blood pressure, 142/85 mm Hg), the results of her physical examination were unremarkable except that elevation of her right arm and palpation of the right chest wall reproduced the symptoms with which she presented. With a normal lipid profile and an ultrasensitive C-reactive protein level, she was diagnosed as having atypical chest pain most likely of musculoskeletal origin. Hydrochlorothiazide was used to treat her hypertension, and cardiac computed tomography angiography (CCTA) was performed to exclude the possibility of coronary artery stenosis and to reassure her. Interpretation of the CCTA findings suggested that both the left circumflex and the dominant right coronary arteries had discrete areas of mild, noncalcified, nonobstructive plaque in their mid and distal segments. The large-caliber left anterior descending coronary artery (LAD) was reported to have diffuse and complex calcification of the proximal segment, which made accurate quantification of the luminal stenosis challenging.

Subsequently, the patient’s physician recommended cardiac catheterization to enable more precise assessment of the LAD luminal stenosis. Selective coronary angiography was performed at the local community hospital and revealed only a mild luminal irregularity of the LAD. Shortly after the second injection of contrast, the patient complained of intense chest pressure and was noted to be hypotensive and tachycardic (blood pressure, 78/45 mm Hg; heart rate, 110/min). Mild “staining” of contrast was noted in the left coronary cusp of the aorta, and an ascending aortogram revealed a dissection of the aortic root extending into, and resulting in compromise of, the left main coronary artery. An intra-aortic balloon pump was placed, and the patient underwent urgent coronary arterybypass with saphenous vein grafting of both the LAD and the left circumflex coronary artery.

Following a prolonged, 14-day hospital course and a residual left ventricular ejection fraction of 35%, the patient was discharged home with intensive cardiac rehabilitation. Unfortunately, within 6 months of the bypass, she presented again with escalating chest pain and was noted have premature graft failure that was treated with percutaneous coronary intervention with multiple drug-eluting coronary stents. Despite her compliance with dual antiplatelet medical therapy (aspirin and clopidogrel daily), she presented 8 weeks later with an ST-segment elevation myocardial infarction complicated by cardiogenic shock. Emergent catheterization revealed thrombosis of the stent in the vein graft supplying the circumflex artery that was successfully treated with a catheter-based intervention. However, the patient remained in refractory cardiogenic shock and ultimately required urgent orthotopic heart transplantation.

COMMENT

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Emergency department visits for chest pain syndromes represent a large and growing health care burden. Because patients with chest pain require urgent triage and timely management, there are great incentives for developing a new generation of novel, complementary diagnostic strategies. A recent addition to the diagnostic armamentarium, multidetector CCTA, can noninvasively generate reconstructed images of the coronary circulation. However, the brisk expansion and rapid adoption of CCTA over the past decade has outpaced supportive clinical data and has led to the referral of a much larger, and often lower-risk, segment of the population for coronary artery catheterization. We believe that in this case the unwarranted use of advanced diagnostic imaging (false-positive CCTA findings) directly contributed to unnecessary cardiac catheterization that resulted in a tragic complication and significant morbidity.Advanced diagnostic imaging technologies or the latest biomarker cannot, and should not, replace a thorough history and physical examination with subsequent decision making guided by the bestevidence-based practice. The need for testing in patients with chest pain is based on the clinician’s estimation of the pretest probability of coronary disease. In a patient with a low pretest probability (<10%) of having significant coronary disease, the preferred course is to reassure the individual and to focus the treatment plan on primary or secondary prevention strategies. Additional diagnostic testing rarely garners useful information and exposes the patient to unnecessary risk—both from the diagnostic test itself and from subsequent invasive testing because of false-positive results. While the risk of complications associated with cardiac catheterization is low, catastrophic events can occur. As opposed to CCTA, in appropriately selected patients coronary angiography allows the presence, location, and, most importantly, the functional significance (eg, fractional flow reserve, intravascular ultrasonography) of lesions to be determined. Because there is often discordance between luminal stenosis and the physiologic significance of lesions, functional testing has assumed critical importance in the assessment of patients with a moderate pretest probability (10%-90%) of coronary disease.

Therefore, given the possible adverse consequences of the overuse of diagnostic imaging in a broad and uncensored population of patients with chest pain, recent joint professional guidelines emphasize that “ . . . an appropriate imaging study is one in which the expected incremental information, combined with clinical judgment, exceeds the expected negative consequences by a sufficiently wide margin for a specific indication that the procedure is generally considered acceptable care and a reasonable approach for the indication. . . . ”Furthermore, because of differences in body habitus, coronary physiology, exercise physiology, symptom presentation, and disease prevalence, the diagnostic accuracy of stress testing may be affected by the female sex. In addition to having a markedly different ST-segment response to exercise from a young age, data suggest that ST-segment depression tends to be less sensitive and specific for coronary artery disease in women. With normal electrocardiographic findings, negative cardiac biomarkers, and a classically atypical presentation, our patient had an age-specific risk level that was below average. She had a low pretest probability of coronary disease (<10% risk of myocardial infarction or death per 10 year interval), making further testing inappropriate and the chance of false-positive study results unacceptably high. However, in an era of rapid advancement in diagnostic imaging strategies, the savvy clinician must not forget the basic tenets of data-driven medicine, patient selection, and risk tolerance and ultimately realize when less may be more. Such is precisely the case with CCTA.

Because CCTA is rapid and noninvasive and has wide availability, it has increasingly been used to detect coronary atherosclerosis in a broad array of patient populations. However, the lack of randomized data suggesting clinical benefit, as well as technical and anatomical limitations, restricts its application in many patients. Studies comparing CCTA with conventional coronary angiography in diverse patient populations suggest that CCTA is highly sensitive (79%-100%) for the detection of obstructive coronary disease, with a positive predictive value ranging from 86% to 91%. However, these same studies report suboptimal specificity (64%-85%) and negative predictive values of 83% to 90% that correspond to an unacceptably high false-positive rate of up to 81% in selected subpopulations. Further limiting the diagnostic accuracy of CCTA is the fact that complete visualization of all segments of the coronary tree is hindered by cardiac motion (heart rate, >70/min), smaller vessel caliber (<2 mm), and tortuousity that may result in portions of a vessel moving in and out of an imaging plane. Furthermore, given its high attenuation coefficient, the presence of coronary calcification commonly produces a “blooming artifact” that makes accurate assessment of adjacent arterial luminal challenging and may result in overestimation of the degree of luminal stenosis, which is likely the case in the patient described herein. Therefore, CCTA often overestimates the presence and severity of coronary atherosclerosis to a degree that is dependent on the study population, the equipment used, and the experience of the interpreting physician, which may lead to unnecessary, higher-risk, and costly invasive procedures.

Nevertheless, the use of CCTA has increased dramatically over the past decade, with some estimates suggesting up to 26% per year. In an era in which comparative efficacy of therapies has assumed critical importance, the unchecked growth of CCTA seems not only unfounded but also irresponsible and unsustainable. Aside from its cost implications, CCTA also exposes the patient to substantial amounts of ionizing radiation. It is estimated that the collective dose received from medical radiation increased by more than 700% between 1980 and 2006, with increases in computed tomography accounting for more than 50%. Furthermore, 64-slice CCTA (without tube current modulation) exposes the patient to an average effective dose of 15 mSv of radiation compared with only 7 mSv for diagnostic coronary angiography. With recent data suggesting that 1.5% to 2.0% of all reported cancers in the United States may be linked to ionizing radiation from computed tomography, there is reason for pause.

In conclusion, our patient suffered a rare but devastating complication from an cardiac catheterization that was the direct result of unnecessary CCTA and false-positive findings. With few cardiac risk factors and an atypical chest pain presentation, this patient had a low pretest probability for coronary artery disease and should have been reassured and not undergone any further risk stratification. Lacking randomized data suggesting improvement in clinical outcomes and with clear risks including contrast load, radiation exposure, and suboptimal diagnostic specificity, CCTA should have a very limited role in the evaluation of patients who present with chest pain.

Zamboni is incapable of doing or unwilling to do legitimate research into his own “CCSVI” and “liberation” fantasy

Dr. Alain Beaudet is President of the Canadian Institutes of Health Research and has been trying to navigate between the incessant demands of politicians pressured by desperate MS patients to authorize “liberation” on demand while doing “trials” and the scientific evidence to date showing that “CCSVI” doesn’t even exist.

Apart from exposing more of this political pressure in the Committee hearings, the testimony of  Dr. Beaudet revealed the true nature of Zamboni’s mentality. It is very interesting that Zamboni has effectively dissociated himself from large controlled studies of “CCSVI” diagnosis in Italy by demanding that only he can interpret the images and that he hasn’t received ethical approval or funding for a controlled trial of “liberation”. If Zamboni can’t get ethical approval for “liberation” now, why did the University of Ferrara approve the ethics of Zamboni’s initial testing of “liberation”, even on his wife?  It seems that Zamboni is incapable of writing a successful grant application and that even the Italians are getting a little suspicious of his hypothesis and techniques. I doubt that Zamboni himself will ever do a controlled trial of “liberation”. Why should he? He has gained transient fame and probably fortune by generating world wide hysteria with the tantalizing mirage of an instantaneous surgical cure for MS supported only by YouTube videos of anecdotal miracles. He was very fortunate that his only clinical publication on his hypothesis, an unscientific  concoction of hallucinations, was published, albeit in an obscure journal. He has indirectly compelled real scientists, like Dr. Beaudet and many other legitimate researchers to divert their time and money into dealing with the scientific absurdity of “CCSVI”. So why should Zamboni risk proving himself to be a fraud? When he is proven to be so he will be liable for compensation for the hundreds of millions of dollars wasted on his scam by patients, doctors and granting organizations. Zamboni will eventually  join the ranks of the great medical con men of history in the company of the likes of Dr. Walter Freeman, the ice pick lobotomist.

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Subcommittee on Neurological Disease – Evidence from Alain Beaudet – December 7, 2010

Dr. Alain Beaudet:

I think this is an important point. First of all, Dr. Zamboni was originally part of the very large association studies that involved I think around 20 sites in Italy, and he withdrew from the study. The scientific director of the Italian MS Society told us that he withdrew because he asked that all the images from all the sites be vetted by his own laboratory, which obviously the committee didn’t feel was appropriate. Dr. Zamboni, however, is also applying for a therapeutic trial, a trial this time to investigate the treatment. As far as I know, the study doesn’t have all the funds necessary to be fully carried out. He did receive a bit of money from the province where his lab is, but I don’t know about the status of the ethical approval of this study. He was supposed to receive ethical approval at the beginning of December. I don’t know whether he did receive it.

Do you know? We don’t know.

The last time we spoke to Dr. Battaglia, the scientific director of the Italian MS Society, Dr. Zamboni still hadn’t received the ethical approval for his studies. It was pending, and we were told the beginning of December. What we know, however, is that right now the funding from the province that he’s receiving for that study is not sufficient to carry out the type of study that would be necessary to prove or disprove the efficacy of the treatment.

Therapeutic knee arthroscopy and vertebroplasty; surgical scams for which we all pay

These are just more examples of surgical impunity. There are many others such as “bariatric” surgery and coronary angioplasty for chronic coronary disease.

If one wishes to market a drug the FDA and Health Canada demand proof of effectiveness and safety requiring many years and many millions of dollars worth of research and clinical trials. But any surgeon can concoct some superficially attractive operation and he and his colleagues can make millions of dollars selling it before anyone gets around to doing a controlled trial of the procedure out of curiosity, not because surgeons are required to do so. Why do surgeons enjoy impunity from scientific proof demanded of drug makers?

Even if there is hard scientific proof that a procedure is totally useless, surgeons are still free to perform them and get paid for doing them by insurance companies and medicare. There are good trials of therapeutic knee arthroscopy for osteoarthritis and vertebroplasty with sham operated controls showing the total absence of benefit of these procedures and yet they are still done. See below for excerpts from these reports. These trials also show the necessity for SHAM OPERATED CONTROLS in testing any surgical procedure for chronic diseases. Sham operation are perfectly ethical when a procedure is not proven to have benefit and has risks associated with it.

Dr. Yee says, “… there’s a bit of a lag in catching up with the evidence. That’s normal.” What’s “normal” about the lag? Surgeons are illiterate? Surgeons are destitute? If a procedure is shown to be useless, just stop doing it. Why aren’t these procedures delisted immediately? Some surgeons might miss the payments on their Jags? They might decide to go to the US?  If they are doing useless operations who needs them anyway? If a drug, approved on the basis of small clinic trials, is found to have unexpected serious side effects when sold to the general population, it is delicensed and instantly removed from the pharmacist shelves. Why is should surgical procedures not be instantly halted if proven to be useless?

With this rampant dereliction of professionalism by some surgeons one can hardly blame patients with MS for also demanding that medicare support a more recent unproven, scientifically absurd surgical scam, Zamboni’s “liberation” treatment for “CCSVI”, his fantasy for the cause of MS.

A toilet money award goes to all surgeons performing therapeutic knee arthroscopy for osteoarthritis and vertebroplasty

 

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Common back and knee surgeries fail to ease pain: study

ANDRÉ PICARD,

PUBLIC HEALTH REPORTER— From Friday’s Globe and Mail

Published Thursday, Dec. 16, 2010 6:48PM EST

Last updated Friday, Dec. 17, 2010 7:12AM EST

There are thousands of unnecessary surgeries being done on the knees and backs of Canadians, particularly patients with osteoarthritis, a new report concludes.

There were 3,600 therapeutic knee arthroscopies and 1,050 vertebroplastiescarried out in Canadian hospitals in the fiscal year 2008-09, according to new data from the Canadian Institute for Health Information.

In both cases, there is mounting evidence that the procedures are largely ineffective to combat certain ailments, and those are but two examples cited in the report that more needs to be done to align care with evidence that it actually helps patients, said John Wright, the president and CEO of CIHI. “Evidence and appropriateness of care are a significant issue in Canada’s health-care debate,” he said.

Mr. Wright said improving efficiency is one of the keys to getting health spending under control.

Knee arthroscopy, a minimally invasive surgery, was once used to diagnosis and treat a host of minor knee problems. But it has fallen out of favour as studies showed it did little to reduce pain and that a large number of patients went on to have knee replacements within one year.

Vertebroplasty is a spinal surgery in which bone cement is infused into fractured vertebrae through a small incision. Recent research has shown that people with compression fractures (a common problem in those with osteoporosis) are not any better that those who undergo a placebo (or fake) procedure. Yet the number of vertebroplasties done in Canada has doubled over the past three years.

Albert Yee, an orthopedic surgeon at Sunnybrook Health Sciences Centre in Toronto, said that the new data are useful but they should not be interpreted as meaning that surgeons are ignoring evidence. With most innovative technologies and surgical techniques, he said, “over time, there are scientific studies that refine the appropriate indications and there’s a bit of a lag in catching up with the evidence. That’s normal.”

Dr. Yee said he hopes policy-makers will not use this data as an excuse to delist procedures like arthroplasty and vertebroplasty (meaning they would no longer be paid by medicare): “I think we need to be careful. These procedures work for some patients; we just need to use them for the proper indications.”

The CIHI report also underscored, once again, the large variations in the number of cesarean sections and hysterectomies performed in various parts of Canada. For example, 23 per cent of birthing women in Newfoundland and Labrador had a c-section, compared to just 14 per cent in Manitoba.

With hysterectomies – the surgical removal of the uterus and sometimes the fallopian tubes and ovaries as well – rates range from a low of 311 per 100,000 population in B.C. to a high of 512 per 100,000 population in PEI.

“When we see these kinds of variations, it is a cue to start asking questions about whether the care being provided is appropriate,” said Jeremy Veillard, vice-president of research and analysis at CIHI. “Reducing unnecessary surgical procedures is beneficial to the patient but there are cost implications for the system as well.”

Mr. Veillard noted that cesarean deliveries cost about twice as much as vaginal births – an average $4,930 versus $2,265. Nationally, hospital costs related to cesareans total about $292-million a year. If nationwide c-section rates were lowered to Manitoba’s level of 14 per cent, there would be 16,200 fewer surgeries annually and an estimated $36-million in savings. Flattening out the regional variations in hysterectomies would deliver similar savings.

According to CIHI, hospitalizations for hysterectomies cost $192-million a year. If the national rate was reduced to B.C.’s current level, 3,700 fewer women a year would undergo the procedure and that would generate savings of $19-million.

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