Canadian diabetics are losing feet and legs at an alarming rate every year despite a growing body of scientific evidence which shows that a treatment already available can potentially prevent amputation in about 70 per cent of cases.
In Ontario alone, conservative estimates are that 2,100 diabetics suffer below-.or above-the-knee amputations every year due to foot ulcers, with some doctors quietly putting the number at twice that and a recent British study finding that amputation rates themselves are often unreliable and underestimated.
Statistically, every year about 2.5 per cent of the more than two million Canadians with diabetes develop foot ulcers - the disease often causes poor circulation and nerve damage in the extremities, with the result that such minor problems as calluses and cuts can quickly become infected before the patient realizes it - with about a quarter of those eventually going on to amputation.
Most are older people, if not elderly, their bodies worn down after decades of the disease's insidious effects.
Yet though the treatment - called hyperbaric oxygen therapy, or HBOT - is, on paper, available in most major Canadian cities, its controversial history of overblown claims, combined with ignorance about its legitimate efficacy in more than a dozen conditions and a pharmaceutical-driven medical establishment, has resulted in the therapy being relegated to the sidelines.
"It's got no champion," Dr. Wayne Evans, chair of the Ontario Medical Association's hyperbaric medicine division, said sadly of HBOT.
"It gets lost in the shuffle. It's not glamorous. The profession sees it as boring stuff involving yechy wounds mostly in old, smelly people."
Calgary hyperbaric physician Ross Harrison says the lack of information and widespread reluctance of doctors to refer their diabetic patients for HBOT is tantamount to a conspiracy of silence.
"That's definitely true," he told The Globe and Mail in a telephone interview from his office at HBOT Clinics Inc., a private facility that treated 12 diabetics last year.
"Diabetics are losing legs unnecessarily," Dr. Harrison said. "There's no question. We run into a great deal of resistance, from several different quarters," and mentioned one local health authority that flatly refuses to approve the treatment.
HBOT is long-established as a remedy for divers suffering from decompression illness and firefighters with carbon monoxide poisoning.
But since 1976, when the Undersea and Hyperbaric Medical Society first formed a committee to review research and clinical data, other therapeutic uses for HBOT have been added, with the recommended "indications" now refined to 13, including delayed radiation injuries (which may show up years after cancer treatment) and so-called problem wounds, the broad category into which diabetic foot ulcers fall.
Whether for treatment of "the bends" or a foot ulcer, patients enter a treatment chamber where they breathe 100-per-cent oxygen at a pressure typically 21/2 to three times that of sea level. With diabetic wounds, what this hyperoxygenation does is kick start a number of healing processes, chief among them the growth of new blood vessels.
Since 2001, there have been four randomized, controlled clinical trials of HBOT on diabetic ulcers - the gold standard in evidence-based medicine - though the patient numbers were small, ranging from 30 to 70.
All the studies found either markedly fewer amputations with patients who received HBOT compared to those who didn't, or enormously improved healing.
Yet the Canadian Diabetes Association, which defines one of its functions as "effective advocacy" for diabetics, makes not a single mention of the therapy on its website. Indeed only last month did the CDA announce it will soon begin an independent technical review of the HBOT literature, with recommendations expected this summer.
The agency was responding to a letter from Bill Roman, president of the Canadian Council on Clinical Hyperbaric Oxygen Therapy, urging the group to "take a leadership role and provide this information to patients, physicians and the [Ontario]minister of health" and flatly describing the loss of limbs in Ontario as "a carnage."
Diabetes in Ontario, published in 2003 by the Institute for Clinical Evaluative Sciences and considered a top-level "practice atlas," devotes an entire chapter to peripheral vascular disease (the underlying problem that causes nerve damage and leads to amputation) without any reference to HBOT.
Federally, Health Canada devotes two pages on its website to HBOT and lists 11 recognized uses of the therapy - but none for problem wounds like foot ulcers.
Indeed, Health Canada's "A-Z" on-line information guide has four listings about dengue fever, hardly the equal of the health crisis posed by diabetes, which experts universally estimate to be increasing by about 10 per cent a year due to the aging baby boomer generation and what is euphemistically called "over-nutrition."
Yet there is only one reference, currently unavailable, on the Ottawa website for hyperbaric oxygen therapy.
As Michael Garey, a hyperbaric doctor at Lakeview Hospital near Salt Lake City, Utah, says: "For some people, amputation is the best way to go. It's a good surgery. But a lot of people, we can save. And all of them deserve the right to have a say in it, and to know that there are options."
It was more than two years ago that the U.S. CentersÖ for Medicare and Medicaid Services, the federal agency that administers the federal Medicare plan and helps states administer Medicaid, issued a "national coverage decision" expanding approved use of HBOT to specifically include coverage for "diabetic wounds of the lower extremities."
Starting in April of 2003, U.S. diabetics with serious ulcers that failed to heal within a month using standard treatment were eligible for HBOT as an "adjunctive therapy," a decision described by the OMA's Dr. Evans as "a very logical but gutsy move."
Dr. Evans, a hyperbaric doctor of 14 years at Toronto General Hospital's small unit and a University of Toronto assistant professor, noted that "the U.S. decision isn't the only piece of information. There's tonnes of scientific material that supports it [HBOT] Admittedly, a large body of the older work is lower-quality evidence," he said, "but the recent work is pretty substantial evidence. It just doesn't get the headlines that a study of 5,000 patients gets. A huge study may be required to show a slight difference, but a smaller one can still show a statistically significant difference."
As Dr. Ted Sosiak, secretary of the OMA's committee on hyperbaric medicine, told The Globe, because "there's no patent [to be had]on oxygen and no financial incentive, there's no one coming in to do research with $20-million."
Yet Dr. Sosiak says, "the evidence is there" - not only that HBOT works "about 75 per cent of the time," but also that it's cost-effective. "Amputation in Canada, using the CDA's own figures, costs about $74,000," he said, while an average course of HBOT treatment - 30 or 40 are usually needed to fully heal a diabetic ulcer - costs between $8,000 and $12,000.
The situation in this country is complicated by provincial health insurance plans, which cover HBOT. But some, like Ontario's, pay only for physician consultation, using archaic codes that were developed in 1968 when hyperbaric oxygen was used primarily with divers. In other plans, such as Alberta, clinics are also compensated with a "facility fee," which is billed to the local health region.
Because the Ontario style of funding pays no facility or technical fee, it means there's little incentive for hospital-based HBOT clinics, such as the one at Toronto General Hospital - the only hospital clinic serving the country's largest city - to treat elective patients such as diabetics, or to expand. The TGH's so-called "standalone" budget is but $285,000, hospital spokeswoman Gillian Howard said, emphasizing that the clinic is meant to function as "an emergency service."
Ms. Howard said that in a given year, the clinic treats between 100 and 125 cases; there are about four elective patients a day, only two of whom, The Globe has learned from other sources, are diabetics. These sources say this has translated to a waiting list of about a year at TGH, and about eight months at the province's other hospital clinics, located in Ottawa and Hamilton.
With TGH treating only about 15 diabetics a year, and the other hospitals together averaging about 35 annually, it means, Dr. Sosiak said, that not more than 50 of the thousands of Ontarians with deteriorating leg ulcers are able to take advantage of HBOT.
According to the Undersea and Hyperbaric Medical Society, there are 23 HBOT clinics - a mix of hospital, private and military facilities - across Canada. And diabetics who resist amputation and learn about the therapy will dig into their own pockets if necessary and travel to get the treatment.
Mary Svitek, a 64-year-old from Windsor, guesses she spent about $10,000 for travel and accommodation while getting HBOT from a private Toronto clinic more than two years ago.
"Within two months," she told The Globe, the ulcer on her right foot healed, and even grew new skin. "That's still fine." But in early 2003, she developed three new sores on the bottom of the foot, and had to return for more treatment. "Two of them healed," Mrs. Svitek said, "but one is still open."
Yet she continues to walk, and remain active. "To me, it would be very, very difficult to lose my leg. I'm a very active person."
Mrs. Svitek learned about HBOT on the Internet, where, as the OMA's Dr. Evans said, "You have to be a very good Googler, and have an obsessive-compulsive" persistence to unearth information.
"None of the doctors in Windsor seemed to be aware of it," Mrs. Svitek said. When she asked her family physician for a referral, she said his attitude was, ".'Well, you can go ahead but I don't know if it's going to work.' He was very impressed when he saw how it healed."
"It's made a believer out of me," Toronto private investigator Jack Hunter said. "I'd never heard of it, but it worked wonders."
At 66, Mr. Hunter's journey through surgery is typical of the slippery slope that for many diabetics begins with a minor amputation and, several agonizing procedures later, ends in death.
First, the big toe on his right foot became discolored, then went black with gangrene; he had it amputated; then the adjacent toes went the same way, and on March 11, last year, the leg was amputated below the knee, and he walked out of hospital five weeks later on a brand-new prosthesis.
But three months later, informed enough now to be panic-stricken, Mr. Hunter noticed "a little black spot" between the toes on his left foot, and ultimately lost two toes and a piece of the sole. He credits HBOT, which he received at Toronto General Hospital from Dr. Evans, with saving his leg. "At the end of eight weeks, it's really doing well. It's almost healed. It's just amazing," he said.
Most of the physicians interviewed by The Globe say the demand for HBOT is primarily patient-driven. "Why isn't there more usage?" the OMA's Dr. Sosiak asked rhetorically. "Physician ignorance, no training [in HBOT]in our universities; patient ignorance; a culture of antagonism."
As Dr. Garey of Utah's Lakeview Hospital said sadly, "Part of it is politics; part of it is that doctors are not exposed to it in residency and what they're not exposed to, they're leery of. I run into that when I lecture at the university ..... I always reply, 'How many of the 39,000 articles have you read?'."
He said that in his six years of hyperbaric medicine, he has treated "dozens of people who were told they need amputation, and we were able to save their limbs." Given that most diabetics facing amputation are older, Dr. Garey said, saving their legs "is a tremendous quality-of-life issue. Rehabilitation is not a fast thing, not any faster than wound care. Prostheses are much better now, true, but most of the elderly can never successfully use them. Almost 50 per cent [of those who undergo amputation]die within months."
Dr. Garey said hyperbaric doctors often make the black joke that only when they develop a "scratch 'n' sniff panel for our pictures" will HBOT get the recognition it deserves.
In June, he will present a paper at the Undersea and Hyperbaric Medical Society conference in Las Vegas. The title of his paper? "Limb salvage." Who would have thought that in 2005, such a discussion would be necessary.