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Hey, Feds, Weight a Minute...
By Sandy Szwarc, RN, BSN
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.
© Sandy Szwarc. All rights reserved (first appeared on TCS
daily) - permission given to obesitysurgery-info.com to reprint...
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