Download The Deadly Human Gondotropin Hormone (HCG) Diet

The Deadly Human Gondotropin Hormone (HCG) Diet
A PPIC® Closed Claim Case Review by Deborah J. Price, RN, MSN, PhD, Director, Risk Services
Abstract
According to an article published by the Mayo clinic, the HCG diet is neither effective nor safe
(Nelson, 2011). Weight loss is attributed to the diet’s severe caloric restriction and not the hormone
itself. An article on WebMD agrees and additionally cautions that scientific studies have shown no
evidence that HCG has any effect on weight loss (HCG for Weight, 2012). Although HCG is approved
by the FDA to treat fertility issues, it is not approved for weight loss. The drug prescription label
states there “is no substantial evidence that it increases weight loss beyond that resulting from caloric
restriction, that it causes a more attractive or ‘normal’ distribution of fat, or that it decreases the
hunger and discomfort associated with calorie-restricted diets.”
The basis of the diet is a 500-calorie per day intake and supplemental HCG. The route the hormone is
given affects the absorption and many of the diets call for oral ingestion such as liquid drops or pills.
When taken orally, HCG metabolizes similar to that of food and becomes relatively ineffective as a
hormone.
Overview
This case involves a 30-year-old mother of two who worked as a surgical nurse. She had been a longstanding patient of the defendant, a board certified OB/GYN who practiced at the same hospital. The
defendant described their relationship as “casual friends.” During a routine physical examination,
the plaintiff inquired about weight loss. She weighed 166 pounds at that visit. The following day the
defendant emailed her diet information for a 500-calorie HCG diet and prescribed HCG drops to
suppress her appetite.
The defendant himself had lost a significant amount of weight on the diet. He also had prescribed the
diet to his father and to many of the nurses at the hospital. At no time did he order laboratory studies
on any of them, nor did he provide any follow-up. It is interesting to note that the patient’s motherin-law had also begun the same diet one month earlier as prescribed by a diet physician. Her motherin-law was unable to maintain the 500-calorie diet, but continued on at a 1,200 calorie per day rate.
She had undergone pre-diet laboratory testing.
According to the patient’s calendar, on the first day of her diet she weighed 164.2 pounds and lost
11 pounds over the following 18 days. Her husband and mother-in-law testified that on a daily basis
they were unaware of how much she weighed, what her caloric intake was, or how large her food
portions were. They also testified that she was religious about the diet and that she certainly
appeared to have been losing weight. Her mother-in-law indicated that the patient had dropped
from a size 10-12 to a size 8 dress. The patient had no complaints at any time while on the diet. The
defendant did not see her in his office during the course of her diet; however, he did run into her
while she was at the hospital and according to him, she had no complaints. There is no
documentation to substantiate his claim.
On the day in question the patient’s husband went to work and twice spoke to his wife by phone. She
picked up her two children from school around 3 p.m. Her husband arrived home around 6 p.m. and
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noted that all lights but one in the house were off. As he went up to the second floor, he turned the
lights on and saw his wife lying at the top of the landing. The two children were in their rooms. He
screamed their names, then returned to his wife and noticed that she had no pulse or respiration. He
immediately called 911 and began CPR. It is his opinion that his wife had been dead at that time. The
EMTs transferred her to the nearest hospital, where she was pronounced dead.
Injury Claim
Hypoglycemia causing pulmonary hemorrhage and death
Negligence Allegations
Failure to monitor and order laboratory studies prior to and while on HCG diet
Expert Opinions
Neither of the plaintiff experts were supportive of the diet; both opined the physician breached the
standard of care. The plaintiff procured a pathologist whose opinion was that the low calorie diet was
the precipitating cause of death. He stated that the pathology slides conclusively prove that the cause
of death was a consequence of hypoglycemia. He based that opinion on the fact that her vitreous
glucose at autopsy was 2. The slides revealed that the dentate gyrus of the hippocampus
demonstrated that the neurons were black and dying. It was his opinion that in this area of the
brain this occurrence can only result from hypoglycemia and that there was no other explanation.
He opined that the patient’s hypoglycemic state caused her to pass out and led to pulmonary
hemorrhage. He did not believe there was any other underlying condition that would have caused
or contributed to her death.
The other plaintiff expert, an internist, provided an Affidavit of Merit opining that the defendant
breached the standard of care and caused an injury to the decedent.
Defense expert opinions varied. The coroner obtained by the defense opined that the patient’s death
was not caused by the diet. She based her opinion primarily on the fact that at autopsy the decedent’s
weight was listed as 164 pounds. She further stated there are many causes of a low vitreous level.
The autopsy showed that the patient had a hypoplastic right coronary artery consistent with sudden
death syndrome. The defense expert noted that the cause of death was unable to be determined. The
cardiologist obtained by the defense agreed that a hypoplastic right coronary artery was the likely
cause of death.
Another defense expert, a bariatric surgeon, stated that he prescribes many diets but will not
prescribe the HCG diet. The American Society of Bariatric Physicians does not recommend this
approach to weight loss.
The final defense expert, a board certified OB/GYN, gave perhaps the most concerning statements.
He was of the opinion that the HCG diet has never been demonstrated to be effective in controlled
weight loss studies. The drops have not been shown to be effective and are not FDA approved. Low
caloric intake is associated with muscle loss, ketosis from breakdown of muscle, dehydration, renal
failure, and in the most extreme cases, death. This is particularly true in patients with an active
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lifestyle, such as this working nurse with two children. The prescription of a severely restricted
calorie diet requires close medical supervision with attention to metabolic imbalance, dehydration,
impaired renal function, and potential ketosis. The findings in the autopsy report just such a situation
with this patient, suggesting hypoglycemia and hyperkilemia, both associated with starvation.
Standard of Care
The plaintiff asserted that a physician is required to perform medical testing prior to placing a patient
on an HCG Diet, and to continue regular monitoring during the course of the diet. The defendant
failed to do any testing or monitoring and thus breached the standard of care.
Causation
The excessively restrictive low caloric diet caused hypoglycemia and death. The plaintiff expert,
a pathologist, stated that the pathology slides conclusively proved that the decedent died as a
consequence of hypoglycemia. He based that opinion on the fact that her vitreous glucose at autopsy
was 2. The defense experts opined that the decedent died of an underlying heart condition.
Discussion
The major issue with this case is the lack of monitoring before or during the patient’s diet and the
very casual prescription of the diet itself. The defendant had placed many of his staff, family, and
friends on the diet without any formal monitoring. In deposition, he stated labs were not necessary
as they cost money. The diet is essentially a “starvation diet” and HCG for weight loss is not
approved by the FDA. The patient’s death was sudden and consistent with a hypoplastic coronary
artery. Her husband had spoken to her twice the day she passed away and she had made no
complaints then or at any time while she was on the diet.
The patient’s calendar showing an 11-pound weight loss was problematic. However, it was
contradicted by the coroner’s report, which showed that she had lost no more than two pounds
while on the diet. At deposition, her husband and mother-in-law testified to her weight loss and
religious execution of the diet. The decedent had two small children. Her husband had to quit his
job to care for his children and would have presented as a very sympathetic witness.
Because of the concerns with the case, it was settled in mediation for $1 million. The hospital settled
separately.
Risk Prevention Pearls
1.
Medication uses not approved by the FDA are ill-advised.
2.
Casual prescribing for colleagues, friends, and/or family increases exposure.
3.
Baseline diagnostic/ laboratory tests should be completed prior to beginning any new diet
regimen and appropriate monitoring throughout the course of treatment.
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4.
Due diligence in researching new or fad-type therapies is paramount.
5.
Document all patient interactions.
References
FDA
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm281333.htm
Nelson, Jennifer K. Does the HCG diet work – and is it safe?
http://www.mayoclinic.org/hcg-diet/expert-answers/FAQ-20058164
WebMD HCG for Weight Loss
http://www.webmd.com/diet/hcg-and-weight-loss
Best Practices for Medical Offices
Allergies and adverse reactions to medications and/or NKDA need to be prominently and
consistently documented in the medical record. The allergies and sensitivities should be updated at
every visit along with the current medication list. It is important to reconcile any discrepancies.
Distinguishing between an allergy and sensitivity is a very important component of documenting
allergies. Based on the current National Patient Safety Goals, this is a crucial component of
medication safety. For example, a patient may report getting hives from PCN and a headache from
Codeine. That differentiation should be clearly noted. Allergies and sensitivities to non-medications
should also be noted including those to latex.
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