| 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
each 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.
Centers 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. |