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Archive for the ‘surgery’ Category

Medical Devices – No Controlled Trials

Posted by Colin Rose on July 24, 2008

“I’m not allowed to prescribe one pill unless it has gone through years of trials,” said Dr. Colin Rose, a Montreal cardiologist. “Why can they license these [devices] — which can be just as dangerous — with no controlled trials? What is the difference?

National Post
24 Jul 2008

Late in the 1990s, Health Canada licensed a new artificial lens, the latest in an innovative generation of implants for treating cataracts. Made from a foldable material, it could be inserted in the eye with a smaller incision than usual and less-invasive surgery. It did not matter, under the department’s rules, that the device had been tested on relatively few people before being approved.

As thousands of the newly licensed lenses were installed worldwide, however, doctors started noticing a serious defect with many of the implants: they were turning opaque inside patients, and in some cases had to be removed with a much more complex operation through the individual’s temple.

“ The ophthalmologists were petrified,” said Dr. Pierre Blais, a former Health Canada official who now does consulting work on medical devices for insurance companies. “They said, ‘We can’t trust these [regulatory] agencies. We have to do our own trials.’ ”

But the eye implant case was no exception. Health Canada routinely approves surgical devices after limited — or no — study on humans, far less evidence than is required for the certification of prescription drugs. And now some experts are raising serious concerns about the process.

The number of devices being inserted into Canadians’ bodies is soaring, and there is no doubt many work wonders: saving patients’ eyesight, relieving debilitating joint pain or preventing lethal heart irregularities.

In a recent article, however, several prominent obstetricians and gynecologists accuse Health Canada of failing in its ethical duty to protect patients, and call on the regulator to impose the same kind of strict approval criteria for devices as for drugs.

“Most people assume that … any surgical device licensed in Canada must be safe for human use,” notes the paper, co-authored by the president of the Society of Obstetricians and Gynaecologists of Canada. “As things currently stand, this assumption is not justified.” The paper, published in the society’s scientific journal, cites Health Canada’s approval in 2006 of a new surgical implant to combat female incontinence. At the time, the device had never been tested on a single person. Within a year, though, the freshly approved “vaginal tape” had been permanently installed in more than 1,000 Canadian women.

Individual case reports have so far been generally positive, but a clinical trial proving they are safe and effective has yet to take place. Concerns reach beyond gynecology. A trial published last year found that angioplasty — a widely hailed procedure that uses a tiny balloon to clear harmful plaque from clogged arteries — did no better than much cheaper, intensive drug treatment and exercise to treat stable heart patients. The device had been used for years on about 40,000 Canadians annually, most of them stable.

“I’m not allowed to prescribe one pill unless it has gone through years of trials,” said Dr. Colin Rose, a Montreal cardiologist. “Why can they license these [devices] — which can be just as dangerous — with no controlled trials? What is the difference?”

Other doctors and the industry, though, argue that requiring devices to be extensively studied before approval would be impractical and hamper important innovation. With changes and improvements constantly being introduced, devices have a much shorter shelf life than drugs, meaning companies could not recoup the tremendous investment needed to conduct pricey clinical trials, they say.

“It would be great to have a perfect system that makes sure we understand what the benefits and risks are of everything,” said Dr. David Urbach, a Toronto surgeon who has studied how new surgical techniques are adopted. “But if it took 10 or 15 years to bring a device to market, you’d never use any devices, because they’d be obsolete. We still use drugs, antibiotics, developed 50, 60 years ago. We don’t use devices from even 10 years ago.”

Paul Duschene, a Health Canada spokesman, said the department submits devices to a “robust” approval process, including demands for information showing they are safe and effective. But devices do not need to be vetted the same way drugs do because “the hazards and risks posed to the patient are much different with a medical device,” he said.

Health Canada divides devices into four classes, depending on how much risk they pose to patients. The higher the class, the more evidence is required of a product’s safety and efficacy. Those considered to be incremental modifications of earlier products require less proof.

Class three — which includes gynecological implants such as the vaginal tape, and artificial hip replacements — and class four, including pacemakers and other heart devices, are the most controversial. The vaginal tape was approved based on lab tests and studies on animals, said the paper by the gynecology group.

Another, similar tape approved with no human studies a few years earlier caused considerable problems, frequently eroding inside bodies and triggering infection, said Dr. Sue Ross, a University of Calgary scientist and one of the paper’s authors.

Similar problems occurred with a sling used to reconstruct the uterine cavity in women who had had hysterectomies. The device was meant to prevent collapse of the cavity, but the mesh straps at the core of it would often deteriorate after a couple of years, causing abscesses and other problems, Dr. Blais said. He said the foldable lens — one version of a concept that has generally proven successful — was likely implanted in about 1,000 Canadians, many of them in Alberta, before being recalled.

Then there were heart valves coated with silver, an innovation meant to avoid infection but not tested widely in patients before being licensed in about 1997. As the device was widely distributed, doctors discovered the silver coating sometimes impeded proper melding of the valve with natural tissue, leading to leaks that may have killed some patients, Dr. Blais said. They were later recalled and are now the subject of class-action lawsuits.

In contrast to devices, drugs are regulated in a separate system that requires them to be studied on hundreds of people in a series of clinical trials, which compare the new product against a control group of patients taking a placebo or other treatment.

But Dr. Martin McKneally, a retired surgeon and bio-ethicist at the University of Toronto, argues that clinical trials cannot be carried out for devices when they are first introduced, since the products’ impact differs depending on how it is used by individual doctors, and techniques are honed over time. He believes the key is to adequately inform patients that the implant or other device they are about to receive is novel and has been tested on only a handful of other people.

“You have to learn in patients and keep modifying as you go along,” Dr. McKneally said. “The fact we have such excellent devices is a credit … in part to the patients.”

Even Dr. Blais, once fired and later reinstated over his outspoken comments while at Health Canada, said it may be unrealistic to expect the government to demand extensive clinical trials be done on surgical devices, except those with the highest risk.

It would be more practical for the regulator to simply be up front about the limited vetting that devices undergo before being licensed, and let patients decide if they will accept the risk, he said.

As it stands, Health Canada’s approval of devices “is a licence to test out an idea on somebody else, if possible at government cost,” Dr. Blais said. “What is happening now is we are becoming a nation of uninformed and unremunerated laboratory rats.”

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Medical Terrorism – The Chaoulli Decision

Posted by Colin Rose on July 20, 2008

Another example of medical terrorism and the big lie, this time from the surgical contingent. The Chaoulli  decision by the Supreme Court of Canada is misnamed. It should have been called the Doyle decision. Dr. Daniel Doyle, a cardiovascular surgeon, testified that patients waiting for a coronary bypass are “sitting on a bomb” and could “die at any moment”.

Where he got the figure of 0.45% per month mortality on the “waiting list” is a mystery. Mortality on the waiting list for elective coronary bypass is at most 1% per year, about the same as the general population of the same age group. He didn’t say and wasn’t asked about the mortality for a bypass operation, about 3%!

The judges seem to have been struck dumb by terror and lost their cool at hearing this. They forgot the old adage, “you don’t ask a barber if you need a haircut”. They didn’t even think to ask Dr. Doyle if surgery would actually prevent the rare deaths on the waiting list. As we know from the MASS-II trial mortality is the same for surgically and medically treated patients with stable coronary disease who, by definition, comprise the “waiting list”. So, a basic principal of Canadian medicare system, that all citizens should have equal access to disease care regardless of ability to pay, was instantly destroyed by the terrorist statements of a surgeon and irrational fear of death. Remind you of Ancient Egypt?

Medical terrorism. This was almost a full page size on the front page of the National Post the day after the decision. Note the ECG tracings at top and bottom. Implication? Your ECG will flat-line and you will die of heart attack because of public health care.

We look down on the Ancient Egyptians for their believe in the afterlife and the huge waste of resources that went into preparing for it. Are we really that much different? We might not believe in the afterlife but we put even more wasted resources into the futile attempt to live forever on Earth. The drug dealers and surgeons are only too happy to oblige.

Open Heart Surgery

Coronary Bypass Operation

Here is the Ancient Egyptian version of the "coronary bypass", a means of living forever administered by a secretive, priestly class. The heart was removed to be weighed against a feather representing Ma'at to determine moral righteousness. The brain was sucked out of the cranial cavity and thrown away because the Egyptian's thought it was useless. Personal belongings were usually placed in the tomb to make the Ka more at home and to assist the dead in their journey into the afterlife

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Bariatric Surgery – Psychic Surgery?

Posted by Colin Rose on March 9, 2007


Except for the anus, the smallest lumen of the entire gastrointestinal system is the esophagus, just after your mouth. No "bariatric" surgical procedure can make the lumen smaller than the esophagus; otherwise you would inhale your food instead of swallowing it.


Finally a commentator has had the guts to attack the bariatric surgery myth (see below).

We have been arguing for years that these operations to reduce stomach size in various ways cannot possibly have any physiological effect on caloric intake and that their effect is purely psychological. “I have been anesthetized, I have scars on my stomach and I have been told that I can’t eat as much as before”. Some sort of vague threat is implied. If they eat too much they will get abdominal pain, nausea or vomiting. But patients eventually figure out that they can indeed eat as much as before without pain or nauseas and the weight is regained. The reason is that the esophagus is the smallest part of the GI tract. It is impossible to make any part further along smaller than the esophagus or food will back up in the esophagus and cause aspiration of food into the lungs which can be fatal. So, whatever will go down the esophagus will go through the stomach no matter how small it is made as long as it is bigger than the esophagus and from there right into the small bowel where it is rapidly broken down by the digestive enzymes.

The only type of bariatric surgery that makes physiological sense is bypass of the small intestine to cause malabsorption, a much bigger and more hazardous procedure with many side effects.

The duodenal switch operation in which most of the small intestine is bypassed. This is the only sort of intestinal surgery that can reduce calorie intake by creating malabsorption. If one eats too much one gets massive diarrhea.

Bariatric Surgery. Psychic Surgery?

The lap band device, the latest in the surgical scams for treating obesity. There is no way this device per se will have the slightest effect on calorie intake; it only extends the esophagus by a few centimetres.

Remembering Susan

In the era before antibiotic treatment of ulcers, many gastrectomies were done to reduce stomach acid production and patient did not lose weight dramatically. Why? Because they were not told they had to eat less.

Here is a typical instruction to patients undergoing bariatric surgery ( ). Note that the patient MUST be “committed to your new lifestyle.”
Q: How much weight will I lose?

A: Studies show that most LAP-BAND patients successfully lose between one-half and two-thirds of their excess weight. Results vary due to numerous factors. You need to be committed to your new lifestyle and eating habits. We expect that your weight loss will be gradual (2 – 3 pounds per week). Twelve to 18 months after the operation, the rate of weight loss usually slows down. Losing weight too fast creates health risks and can lead to a number of problems. The goal is to have a weight loss that prevents, improves, or resolves the health problems connected with severe obesity.

And another from a review article in the NEJM by Dr Eric DeMaria in reference to his recommendation for bypass surgery in a case presentation.

“She should be required to make a commitment to an appropriate postoperative regimen of diet, exercise, and medical and surgical follow-up care.”

So why can’t obese patients commit to a new lifestyle WITHOUT the surgery? What is really effective, the surgery or the post-op diet and exercise. The only way to tell is to do a SHAM-OPERATED RANDOMIZED CONTROLLED TRIAL. Obese patients wanting surgery are randomly assigned to one group has some form of bariatric surgery or another group that is anesthetized, the same incisions made bowel is manipulated but no bypass or stapling is done. The post-op care team is blinded to the type of surgery and both groups get the same post op attention. Only after such a trial can we know if the effects of surgery are physiological of psychological, if bariatric surgery is just not another form of psychic surgery.

But there are a number of obesity “experts” who promote bariatric surgery as the ultimate answer to the obesity epidemic. One of these is Arya M. Sharma, MD, FRCPC, Professor of Medicine, Canada Research Chair for Cardiovascular Obesity Research & Management, McMaster University ( who is paid handsomely from taxpayer dollars and drug companies to promote the myth of bariatric surgery and various drugs for obesity. He refuses to even entertain the thought of doing a randomized, sham-controlled trial of bariatric surgery before spending billions of taxpayer dollars on the procedures with no proven benefit in a controlled trial.

Here is Dr. Sharma. “I think that much can be derived from careful objective observational studies, and indeed the majority of our knowledge in medical practice comes from empirical observation and NOT from controlled trials (the field of cardiology being the exception – this may be largely, because the field of cardiology lends itself best to such studies). These are far more difficult in other areas of medical practice, especially when dealing with long-term outcomes in low-risk populations. While providing the best possible care, we need to ensure that we do not degrade our patients to the level of laboratory animals just to prove a point that is reasonably obvious and biologically plausible based on what we already know. When you have no Class A evidence the right thing to do is to base your decisions on Class B or even Class C evidence, rather than do nothing. I come back to the point about checks and balances that need to be in place, but I also say that the time to act is now – the clock is ticking…..”

The same has been said about every treatment in the history of medicine; unethical not to do it, improved surgical techniques, can’t do a randomized trial, can’t wait for randomized trials, obviously effective, calculated benefit based on case controlled studies, Medicare pays for it, etc. If we continued to subscribe to the intuitive approach we would still be using blood-letting for pneumonia. Any treatment for any disease (other than hormone deficiency) must be subject to rigorous scientific investigation. Patients are NOT treated like “laboratory animals.” There are very detailed ethical guidelines about conducting controlled trials. Many “obvious and biologically plausible” treatments have turned out to be useless or harmful when subjected to controlled trial. Modern medicine like to pride itself on practicing evidence-based medicine. But when it comes to deeply held beliefs in the power of a treatment, particularly when it is good for one’s bank account, the search for evidence becomes less imperative.

The Roux-En-Y operation, a riskier type of "bariatic surgery." No controlled trials.

Dr. David D’Alessio of the University of Cincinnati says, bariatric surgery is “kind of the Wild West…huge demand, no regulation [and] patients are willing to do whatever it takes to get it.”

It is a mystery to me why the populace insists that its government scrutinize new drugs in great detail and insist on years of testing before they are licensed but any surgeon can come up with a superficially attractive operation and he and his colleagues can perform thousands of them at great expense in money and possibly lives before anyone gets around to doing an experiment to prove that the operation’s benefits outweigh its risks or have some benefit over medical treatment. See my blog on angioplasty for a classic example of billions of dollars spent on a procedure with no benefit. The latest surgical scam is the “liberation” treatment for multiple sclerosis upon which billions of dollars will be spent for a totally unproven, scientifically absurd procedure. Perhaps surgeons are the modern high-tech shamans. Surgery still maintains an aura of supernatural healing; evil spirits are being extirpated. To subject surgical procedures to controlled trials disturbs faith in its magical powers.

Will making the stomach smaller cure this women? The chocolate-coated ice cream bar will melt in the esophagus and pass through any orifice larger than a the diameter of a pin and pass rapidly through a gastic pouch no matter how small. The only cure for this women in mastering her food addiction. See my photo essay on food addiction.

Disney World


July, 26, 2006
Taxpayers the losers in weight-loss surgery funding


OTTAWA — ‘I n one form or another, the corset has swaddled women since Cleopatra laced herself breathless for Caesar. Medieval women used leather and wood plates to flatten bulges. In Shakespearean times, 13 inches — no more, no less — was deemed the proper circumference of a feminine waist. And 18th century ladies cinched themselves to the point of frequent fainting. The 1890s produced the hourglass silhouette made famous by [actress and singer] Lillian Russell. If modern fashion has its way, the stage joke of a husband lacing his wife’s corset will repeat itself endlessly in connubial bedrooms across the country.” – Life magazine 1948.
For centuries, women handled fat the old-fashioned way. They hid it. More precisely, they shaped it to a particular aesthetic form. Corsets served strictly architectural purposes. Throughout the Victorian era, corsets used vertical steel rods to keep the female figure rigidly aligned with the blueprint, though the use of whalebone continued into the 20th century. These rods were appropriately called stays, defined by Oxford as “appliances used to hold up part of a structure.” Corsets worked and they were cheap. Eatons listed an economy corset in its 1901 catalogue at 28 cents.
With lightweight plastic stays, as Life magazine’s postwar essay suggests, corsets became modern appliances. With further refinements, they remained (along with girdles) essential woman’s wear well into the 1960s when they were rendered obsolete, first by fashion and now, finally, by surgeons with vacuum pumps.
Men used corsets, too, both for aesthetic deception and for medical reasons (wounded by gunshot in 1968, Andy Warhol wore a corset every day for the last 20 years of his life). But corsets primarily shaped the lives of women, just as cosmetic surgery now primarily shapes the lives of women. Casual tummy surgery is probably preferable to corsets — people who have experienced neither really can’t say. But the public policy issue here isn’t the change in fashion.
It’s the difficulty in distinguishing cosmetic alteration from medical procedure — and in determining who pays.
Start with the soaring use of weight reduction surgery in the U.S. These operations range from minimalist procedures (say 10 pounds) to heavy-duty surgery (say 50 pounds or more). On the one hand, cosmetic surgeons insist they do shapes, not weights. But who determines real motives — doctor or client? Since it’s now the client who pays for most of these procedures, the distinction is mostly moot. On the other hand, weight-loss operations performed on the “morbidly obese” — any person 100 pounds or more overweight — are deemed medically necessary. Eighty seven per cent of these patients are women.
In the early 1990s, U.S. doctors performed 16,000 of these bariatric (meaning weight) operations a year. In 2004, they performed more than 100,000. This year, they will perform 200,000. Obesity is, after all, ballooning. And doctors now perform these operations on adolescents. The cost averages $30,000 (U.S.) per operation. Perform it 100,000 times and you have an invoice for $3-billion.
This is an interesting calculation because there are more than 100,000 people in Ontario alone who qualify, by medical definition, for this operation — perhaps 150,000. Last year, the Ontario Health Insurance Plan paid $15-million (Canadian) to send a mere 600 of them to the States for this surgery at an average cost of $25,000. In a study released Monday, however, the U.S. government reported that four bariatric operations in 10 result in serious complications within six months — driving the cost in these cases as high as $65,000 (U.S.).
But, ominous as these costs appear, no one should think that the provinces will be able to restrict medicare access to weight-loss surgery for long. Now that governments are paying for the removal of fat from people who are “morbidly obese,” it’s only a matter of time before they extend coverage. People 90 pounds overweight will want coverage, then people 80 pounds overweight.
Restrictions will finally be deemed discriminatory — violations, no doubt, of the Charter of Rights and Freedoms. Self-indulgent people who eat too much and exercise too little will inevitably come to regard shape and weight as entitlements.
Weight-loss surgery is a dubious proposition. In one Canadian study, Dr. Raj S. Padwal at the University of Alberta Hospital in Edmonton found that bariatric patients shed between 35 and 60 per cent of their baseline weight in these operations — and, 10 years later, may maintain a loss of only 16 per cent. This simply means that a 300-pound person will become — in the long run — a 255 pound person, almost as fat as when he or she started. This person could achieve the same result by losing 4.5 pounds a year.
Fifty per cent of Canadians are now deemed overweight. Depending on your perspective, this means either 17 million people or 17 million patients. What to do with them? A few years back, Dr. Kenneth Walker, the Canadian medical columnist, facetiously suggested the use of force — that fat people be locked up in prison camps until they lose weight. In the end, though, there’s only one responsible option. Self-government. And, perhaps, corsets.

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