By Sandy Szwarc 26 Oct 2004
The federal government recently ruled that taxpayers
will foot the bills for weight loss surgeries and other weight
loss treatments for
Medicare patients, if medical evidence can
demonstrates their effectiveness. This is the door opening
to broader obesity-related coverages, as a September 30th
New York Times article revealed. According to Karen
Ignagni, president of
America's Health Insurance
Plans, the national health insurance trade organization,
everyone's premiums will be impacted if, as expected, private
and employer-based health insurance plans follow suit. It's
anticipated that as coverage becomes more readily available,
more Americans will seek the surgeries and the numbers performed
will skyrocket from this year's estimated 144,000 surgeries. So
will the costs.
The American Obesity Association, whose
sponsors include bariatric surgical groups, weight loss
drug companies and weight loss programs like Weight Watchers and
Jenny Craig, already succeeded in April 2002 getting the IRS to
designate weight loss treatments, including weight loss
surgeries, as tax deductible and hence government sanctioned. As
our nation faces
rising healthcare costs, concerns over troubled
Medicare and
social security programs and an
aging population, many are asking if our healthcare
dollars are best spent on these surgeries and where's the proof
they're beneficial?
The "proof" appeared to come last week as headlines
announced a new study which "validates"
obesity surgeries and found them "beneficial"
and "can
save lives."
The "study" found nothing of the kind. But it did point
out how deadly and costly it can be to base healthcare policies
and healthcare decisions on bad science.
Digging Deeper for the Dirt
The
study published in the Journal of the American
Medical Association was conducted by seven bariatric
surgeons around the country, two, including the lead author
Henry Buchwald, MD, Ph.D., are paid consultants of the study
sponsor, Ethicon Endo-Surgery Inc. It concluded that weight loss
surgery (WLS) was effective in achieving weight loss and that "a
substantial majority of patients with diabetes, hyperlipidemia,
hypertension, and obstructive sleep apnea experienced complete
resolution or improvement."
They managed to do this without clinically examining a
single patient. Instead, they did a
data-dredge, gathering stats on obesity surgeries from
articles published between 1990 and 2003. This tactic, called a
"meta-analysis," combines the results of a lot of
poorly-controlled and problematic studies in an attempt to
arrive at something convincing. However, there have been no
randomized, controlled clinical trials that have shown any
long-term improvements to health or that lives are saved by
any of the dozens of types and variations of
obesity surgeries being performed. These gastrointestinal
operations, also called bariatric surgeries, cause weight loss
by restricting the size of the stomach and can rearrange or
bypass the small intestines to further reduce absorption of
nutrients. As the Agency for Healthcare Research and Quality's
Evidence Report "Pharmacological and Surgical Treatment of
Obesity" issued in July discovered, randomized controlled trials
or controlled clinical trials of these surgeries are so few in
number and short-term that the available studies couldn't be
used to make inferences about efficacy. So what did the
bariatric surgeons use?
All available data on WLS is self-reported from
surgeons. While it's well-known that published articles
universally report decidedly favorable results, a problem called
"publication bias," consumers, media and many in the healthcare
system may not be aware of the fallacies behind such results in
regards to WLS. Let's look at four.
Selective vision. If a researcher ignores
all the bad outcomes, it's sure a lot easier to show positive
results. In bariatric studies, an astounding 50% of patients on
average are not included in study results -- such patients are
termed "lost in followup." That was also the acceptable level by
these JAMA authors.
This fact can often be difficult to realize, especially
if one just reads a study Abstract, as they may describe the
study population as "including patients having undergone
bariatric surgery" which really says nothing.
Edward Eaton Mason MD, Professor Emeritus of General
Surgery at University of Iowa Hospital and inventor of gastric
bypass, launched the International Bariatric Surgery Registry (IBSR)
in an effort to promote reliable statistics on surgical
treatments for obesity and improve outcomes for patients. Still
after 20 years, recent research from surgeons, represented only
a 52.9% followup rate of eligible patients, leading him to
caution in 1998 "follow-up is insufficient for estimation of ...
mortality rates." And again in 2003 he wrote: "We do not have
the long-term follow-up information that is needed to fully
inform patients of the consequences of their choice of
operation."
Pick and choose what to count. These JAMA
authors completely ignored complications, didn't even consider
them in balancing the risks versus benefits, or look at whether
the surgeries actually improved quality of life. They also
ignored deaths except for "operative mortality" which they
claimed was 0.1% for the purely restrictive procedures (limiting
stomach size), 0.5% for gastric bypass, and 1.1% for two other
surgical techniques.
These cherry-picked statistics aren't even close to
those presented at the 2003 Clinical Conference of the American
College of Surgeons. According to the surgeons' own figures
based on nearly 63,000 weight loss surgeries, an average of 2%
of patients die within the first 30 days as a direct result of
their primary surgery. Yet such deaths are as high as 6% with
some surgeons and medical centers, especially those performing
fewer than 200 weight loss surgeries a year. But that's not all.
An April study in the Annals of Surgery
led by Dr. Adolfo Fernandez, Jr. of Wake Forest University
Baptist Medical Center, Winston-Salem, NC, noted that while WLS
is promoted for the extremely obese as a treatment for
comorbidities (health problems), mortality rates are
considerably higher among these patients, and are threefold
higher in patients older than 55 years. Yet, Medicare provides
coverage for the elderly! The unsoundness of paying for WLS for
them is compounded by the fact that being fat, even morbidly
obese, in retirement age has no effect in worsening
mortality risk, according to Glenn Gaesser, Ph.D., exercise
physiologist and obesity researcher at the University of
Virginia. In fact, voluntarily losing weight among the elderly,
even just 5%, is associated with an increased risk
of premature death, he says.
But looking just at operative deaths also ignores that
most deaths and complications happen to patients after they
leave the hospital, according to Marilyn Dahl, New Jersey deputy
health commissioner. David Knowlton, chairman of the New Jersey
Health Care Quality Institute, told the Star-Ledger
on May 2nd that hospital re-admissions for
complications are rarely classified in a way that connects them
to their earlier WLS. "We should be alarmed at the number of ...
deaths and serious injuries being hidden," he said.
In August, the Pennsylvania Health Care Cost
Containment Council released an astounding report that found 39%
of the state's WLS patients in 2001 required hospital
readmissions... at an additional cost of $21,524 each. That's
over and above the average hospital costs for the initial
surgeries of $35,643, making average total hospital costs for
all WLS patients over $44,000 apiece.
According to IBSR statistics, the majority of deaths
during the first six months following surgery are operative
deaths and the National Institutes of Health conservatively
estimates 10 to 20% of patients require surgery for
complications. Yet the risk of dying from these secondary
operations is 3 to 6 times higher than for the initial surgery,
according to the American Society of Bariatric Surgeons and Erik
Wilson, assistant professor of surgery at the University of
Texas.
Just look at the "honeymoon period."
Universally, weight loss surgery articles only report short-term
outcomes before long-term complications and weight regain
manifest themselves. Most of the reports used by the JAMA
authors were under 2 years, although their data gathering was so
sloppy that they didn't even know the follow-up period for 10%
of the studies they used, or the gender of 8% of the patients.
Dr. Ernsberger, Ph.D., of Case Western Reserve School
of Medicine, Cincinnati, Ohio, who's extensively researched the
risks and efficacy of WLS and documented more than 60
complications, says several clinical studies of the long-term
consequences and looking for improved life expectancies have
been started over the past 40 years these surgeries have been
performed, but the results were never released. "I think it's
because it's bad news," he said. There have, however, been
studies finding WLS survivors suffer many more health problems.
In fact, the complication rates are so high and the
complications so severe that even Dr. Mason cautioned: "For the
vast majority of patients today, there is no operation...without
introducing risks and side effects that over a lifetime may
raise questions about its use for surgical treatment of
obesity."
The Mayo Clinic reported in 2000 that 20 to 25% of
gastric bypass patients develop life-threatening complications,
but the recent Lap-Band U.S. clinical trials done to earn FDA
approval reported 89% of patients had at least one adverse
event, one-third of them severe. While many consumers believe
the newer, less invasive laparoscopic bypasses and
lap-band
procedures (which tighten a constrictive band around the stomach
to make it smaller) are safer, they merely have their own
"unique set of complications," according to surgeons Shanu N.
Kothari, MD, and Harvey J. Sugerman, MD writing in
Healthy Weight Journal. A September 2003 Blue Cross-Blue
Shield review concluded these newer procedures had also "not
demonstrated improved health outcomes."
Rarely spoken are the long-term effects of nutritional
deficiencies. The neurological decline and aging seen after WLS
is especially rapid and results from multiple vitamin and
mineral deficiencies, said Ernsberger. Both the
stomach and small intestines are critical for absorbing many
nutrients, including B-vitamins, calcium, iron, vitamin D and
protein. Even taking multiple times the recommended amounts of
supplements doesn't help because WLS eliminates the proper
function of the stomach and gastrointestinal system. Hence,
malnutrition problems are not uncommon, according to the
National Institute of Diabetes and Digestive and Kidney Diseases
and include anemias, osteoporosis and in some cases even brain
damage.
In the latest issue of the Journal of
Pediatrics, doctors from Cincinnati Children's Hospital
Medical Center reported several cases of beriberi, previously
identified among adult WLS patients, already showing up in
teenagers who'd undergone the surgeries. A formerly rare
disorder in Western societies, beriberi is caused by thiamine
deficiency typically seen in starvation and severe alcoholism.
It causes dementia and neurological damage that's usually
irreversible. In fact, next month's
Neurology reports 16% of WLS patients develop
permanent neuropathy largely explained by the nutritional
deficiencies imposed by the surgeries.
WLS also sentences patients to lifelong, severely
calorie-restricted diets. The unhealthfulness of long-term
starvation-level diets and protein shortages have been well
proven (with centuries of evidence) to significantly shorten
people's lives. And good nutrition, including a growing list of
micronutrients, is being shown to be imperative to help prevent
cancers and other chronic diseases. We may not have begun to
realize the true costs of these surgeries in human life and
suffering.
Use "false surrogate endpoints." If a
drug, diet or surgery claims success because it lowers some
believed risk factor like high blood sugar, but fails to tell
you that more people actually died after the "treatment," blood
sugar was a "false surrogate endpoint."
The JAMA authors claimed obesity surgeries to be
beneficial because blood cholesterol levels, body weight and
fasting blood sugars were lower after the surgery. Well, lots of
things reduce these numbers which are anything but healthful.
According to the Dr. Joseph F Smith Medical Library, acute
illness, high fevers, starvation and even recent surgery lower
blood cholesterol levels. And according to the National
Institute of Diabetes and Digestive and Kidney Diseases,
National Institutes of Health, gastric surgeries can reduce
blood sugars because of the rapid passage of food into the
intestine but fasting blood sugars also go down with critical
illnesses, hormonal deficiencies and certain tumors. Finally,
weight loss can result from any number of unhealthy and deadly
things such as heroin abuse, liver failure and cancer.
The authors cited a 1995 study led by David Williamson,
Ph.D. at the CDC as proof that weight loss meant reduced
mortality. This study was based on questionnaires submitted by
women in 1959 and 1960 about their diets, compared with 1972
national vital statistics. There was a companion study done on
men. But what these studies actually found was that among
healthy fat people, losing weight gave no reduction in all-cause
mortality or premature deaths from cancer or heart disease. In
fact, it increased risks.
The JAMA authors also ignored two recent prospective
studies Williamson teamed on, one in a 2003 issue of
Annals of Internal Medicine and one in the March issue of
Diabetes Care which found that people simply
improving their eating and exercise habits had lower death rates
and rates of diabetes...whether or not they lost weight! In
fact, the CDC authors specifically noted they found "losing
weight per se was not associated with mortality
reduction...[and] weight gainers did not have an appreciably
higher mortality rate."
On September 29, ECRI, a nonprofit health services
research agency, announced a landmark
report evaluating the effectiveness of bariatric surgery
for obesity. While they noted the surgeries can produce
significant initial weight loss, "three years after surgery, the
typical patient is still obese." Most importantly, they
concluded that based on the quality and strength of the
available evidence, claims of improved "quality of life and
long-term health impacts are less conclusive." They found
available evidence weak for demonstrating that comorbidities can
resolve and "it was also not evident whether bariatric surgery
extends survival."
Medical evidence has not soundly demonstrated the
effectiveness of weight loss surgeries. Let's hope government
officials notice before too many pay the price.
© 2004 Sandy Szwarc. All rights reserved (Shared
here via Title 17 Fair use)