Fast Track to Hell-th, Part 2

Heartfelt congratulations should go to The National Health and Medical Research Council in Sydney Australia (“NHMRC”). The impending announced research study funded by the NHMRC and to be conducted by researchers at two major Children’s Hospitals in Australia is already incredibly successful, not just on a national scale in Australia, but internationally as well. And for this, the doctors and medical professionals who will be participating in the study should be lauded.

But, it is not for the reasons those medical professionals may believe.

In the eating disorder industry, it is very rare, perhaps non-existent for the vast majority of players (organizations, doctors, counselors, dieticians, advocates, families) to “circle the wagons,” to unite and speak with one clear, unambiguous voice on any issue, let alone an issue that may be regarded as controversial. Silo mentality in the eating disorder industry is prevalent. The race to become the next Jonas Salk permeates the industry. And so, the thought that a single issue could arise which would unite all factions seemed unlikely at best.

No longer.

The international eating disorder community became aware of the aforementioned research study to be conducted by the NHMRC. This twelve (12) month study is to be performed on children from the ages of 13 years to 17 years of age who are classified as “well above a healthy weight.”

The Study requires the children to follow extreme calorie restriction diets (800 calories per day) for one month, and not in a laboratory or carefully controlled setting. This is to be followed by 12 months of low calorie dieting for half the participants, and alternate day fasting for the other half. Children in the fasting group will eat just 600–700 calories a day for three days a week, approximately 25–35 per cent of estimated daily energy needs. The remaining four days will be a “standard diet.”

These children and their parents will be required to closely monitor the children’s daily food intake not only at home but at school as well to make sure that the exact amount of caloric intake is strictly followed. Nothing like pristine laboratory conditions capable of being duplicated in future studies!

The outcry from the eating disorder community started as a whisper, became a loud talking point and has now escalated to become a mighty roar. Counselors, doctors, dietitians, organizations and advocates in Australia and New Zealand began to communicate, collaborate, review the published proposed trial study and organize a unified response. Clinical psychologist Louise Adams organized industry replies to this ill-advised research study. Her blog article can be found here:

The preeminent eating disorder foundation in Australia, The Butterfly Foundation, in conjunction with the Australia & New Zealand Academy for Eating Disorders, Eating Disorders Victoria, and Eating Disorders Queensland issued a joint release stating in part:

“Eating disorders are complex neuropsychiatric illnesses with severe mental and physical implications. Given such, we still have concerns and believe further action is required.

In discussion with the principal researchers involved in the trial, we have requested the following:

  • The risks of developing an eating disorder are clearly stated in the participant and parent information sheets, and on the trial website;
  • Additional psychological support for participants throughout the trial;
  • Additional screening for anxiety and distress at key points during the trial;
  • Specific training in Eating Disorders for all clinicians involved with participants.”

In a separate statement, the Australia & New Zealand Academy for Eating Disorders in material part stated:

“The risks of developing an eating disorder were reportedly deemed to be justified on the basis of likely benefits of the trial and the inclusion of a risk management plan that would minimise risks and communicate risks associated with potential eating disorder development to participants and their parents/guardians. ANZAED is highly concerned about this justification. Eating disorders have the highest mortality rate of any mental illness, with onset common during adolescence. With consideration of these points, it is ANZAED’s position that the risk of developing an eating disorder is not warranted in this or any other research trial. …

As a result of careful consideration of the points raised above, ANZAED does not support this trial of an extremely low calorie weight loss intervention in adolescents.”

A petition condemning the study and demanding that it be stopped has now reached over 16,000 signatures worldwide and continues to increase every day.

Last week, doctors, counselors and advocates drafted and submitted a collaborative ethics complaint to the study. A copy of this report is attached at the end of this article. Some of the more significant statements include:

“Because the trial places participants in a prolonged state of calorie restriction, the risk of bulimic episodes is considerably heightened. Calorie restriction is a known primary trigger for hyperphagia (often termed binge eating), and is often accompanied by purging. The “Fast Track” trial induces participants to behave in a way that mimics Anorexia Nervosa (AN) (severe restriction of calories), placing them in considerable risk of going on to develop AN, Bulimia Nervosa (hyperphagia with or without purging), or Binge Eating Disorder (hyperphagia).”

“There is abundant evidence that bulimic episodes carry with them an immediate risk of death due to electrolyte imbalance and its impact on a variety of bodily systems if left untreated. Other risks associated with bulimic episodes include refeeding syndrome, cardiac failure, kidney failure, haemorrhage, dental erosion, hernia, compromised pulmonary function, impaired reproduction.”

“Although the research proposal suggests that the risk of bulimic episodes is secondary, and not warranting disclosure of risk to participants and their guardians, there has been no consideration given to the increase in the likelihood of such episodes stemming from both the premise of the study itself, and also the deliberate placement of the participants in a calorie deficit that falls within the category of “clinical starvation.”

“Dieting at any level has been termed the “most important predictor of eating disorders.” It has also been identified as “a risk factor for both obesity and eating disorders.”

“Extreme calorie restriction causes bone density loss, with many studies of starvation and the bone metabolism in laboratory animal models and humans finding evidence of either developmental delays, stunted bone growth, decreased bone mineral density or decreased cortical strength.”

“Given that weight loss is generally maximal at 6-12 months, the results of the “Fast Track to Health” trial run the risk of being skewed, because the subjects would not be followed for the length of time necessary to ascertain long term sustainable change.”

“There is compelling evidence that the “Fast Track to Health’ trial is incapable of achieving its express goal of “reducing weight and improving risk factors for heart disease and diabetes”, given that weight loss is not sustainable, with a 97% rate of regain. Calorie restriction can cause prolonged psychological distress, which in itself has been identified as a contributing factor to a number of physiological conditions, including cardiovascular disease, T2D, and metabolic syndrome because of the mechanisms involved in cyclic loss and gain.”

“Added to this established evidence that dieting in adolescence can trigger the onset of an eating disorder, including AN, BN, BED and OSFED. Even if the person does not acquire an eating disorder, they are at a considerably heightened risk of entering into cyclic weight loss and gain, which carries already mentioned health risks, including bone density loss.”

This is the second ethical complaint regarding the study.

The aforementioned Louise Adams appeared on radio station ABC Melbourne to bring public awareness to this ill-advised study.

The advocacy group, Eating Disorders Families Australia released a statement condemning the study and requesting that it be stopped.

HAES Australia endorsed the Complaint, condemned the study and issued its statement.

And then, the Academy for Eating Disorders, the world’s largest eating disorder organization issued its statement. This statement includes the following language: “Ultimately, the AED Board of Directors concluded that there is merit to many of the concerns raised. In particular it is critical to judge the likely benefits of any proposed research against its risk of harm and in this case, we are not convinced that the prospects of benefits sufficiently offsets the risks. We agreed that the AED will compose a position statement about the importance of fully considering the risk of increasing eating disorders and related problems alongside the gravity of this risk for the individuals put in harm’s way. When children or adolescents are the ones affected, the stakes are particularly high.”

To support their brethren and colleagues “Down Under,” organizations in the United States rallied to the cause. The international parent organization F.E.A.S.T., under the leadership of Laura Collins Lyster-Mench, has been speaking out against the study since it came to light in the latter part of 2018. The Eating Disorder Coalition condemned the study. Chevese Underhill Turner, Founder of the Binge Eating Disorder Association (“BEDA”) which recently merged with NEDA, stated: “There is no way to make a very low calorie diet and intermittent fasting trial safe for children. The risk clearly outweighs the benefit.” Doctors, dieticians and counselors to a person have uniformly questioned the efficacy of the study.

Other than the research doctors participating in the study, it appears as if the eating disorder industry has risen as one and not only condemned the study, but are taking proactive steps to attempt to stop the study … before even one child can be hurt by the hubris and egomaniacal needs of the research doctors.

Ms. Turner also stated, “We must also get past not speaking up because we are worried about offending colleagues. This can be done respectfully. Good people make poor decisions in research at times —they are human and have biases and blind spots like we all do. Protecting those biases and blind spots does not help anyone.”

Up to this point, the opposition to this study has been collegial and respectful. The opposition has been organized and scholarly. The legion of information establishing the extreme risks of this study has been provided in a professional manner. As such, the researchers can no longer claim “a blind spot.” The extreme risks have been disclosed by medical professionals, counselors and interested persons who have decades of experience. The researchers must know that this study will never be duplicated anywhere else in the world because of the risks. And if the doctors and medical professionals insist on proceeding with the study regardless of this overwhelming information, then surely, the gloves must come off.

Imagine a parent of one of the children in this study. Imagine not being informed of all of the possible risks. And your child is one of the children who develops an eating disorder. The frantic trips to the emergency room. Repeated blood tests showing irregularities in potassium, magnesium, and blood sugar. Perhaps a heart valve starts to leak. Seizures. And you find yourself in the fight for your child’s life. Fear becomes an every day, every minute visitor in your household. And then you discover that the doctors and professionals in this study had actual knowledge of these risks … and did not disclose all of these risks to you. The disbelief you would feel. The rage.

And so, dear doctors and other professionals conducting this study … proceed with the study … at your professional peril. But know that when you do, you too have risks. If and when the study does not produce any duplicable, tangible results. If and when a number of children in this study develop eating disorders. If and when you read the numerous complaints and studies opposing your studies. If and when you realize that the world eating disorder community has united as one condemning your study … and yet, you elected to proceed.

You will be alone. You very well may have blood on your hands. You will be a worldwide pariah. Your career may very well be over. But, that is ok. You can always find employment as a short order cook in a fast food restaurant serving up double cheeseburgers while you pontificate on how starvation diets actually do work.

But regardless, thank you. Thank you for uniting the eating disorder community and industry. Thank you for providing the platform by which one, strong unified voice was heard.

You may very well have discovered the formula by which collaboration and concerted efforts can come together to provide the basis upon which new breakthroughs are possible. Proving that even the Village Idiot can serve a useful purpose.

Ethics Complaint

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