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.
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.