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Vyvanse and BED: Money-making in Disguise as Treatment?

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Fairly recently, Vyvanse – a drug known for treating ADHD – was approved to treat binge eating disorder (BED). I was first made aware of this drug via a message sent to my blog from a woman living in the US who was angry about the effects this could potentially have on people who were prescribed it. I did a bit of reading up about it, but soon forgot about it. The topic came up again when a friend linked me to an article about the drug being used for treating BED, which I read, and my interest was piqued. I started thinking about the problems that would arise from it’s approval to treat BED that are both numerous and highly concerning.

In May 2013, the DSM-V was published, with BED being newly recognised as a psychiatric disorder. On the surface, this sounds great: sufferers of BED were finally being recognised and validated, but a further look into this and the subsequent approval of Vyvanse to treat it raises some serious questions.

In a society where almost two in five (37%) women and one in six (18%) men in the UK are dieting “most of the time”, and 108 million people are on diets in the US, a huge amount of us are restricting on a daily basis, and when we “fail”, we feel shame, guilt, hopeless, and anger at ourselves. And failing is inevitable, because diets do not work. Dieters often end up in a restriction/binge cycle, and mistake their dieting for normal behaviour, and so only take note of their binging and see this as a weakness rather than a normal biological response to starving the body. If the body has an energy deficit due to restriction, it will seek to restore balance by compensating later on. So with that in mind, we can now look at the criteria for BED:

  • Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following:
    • eating, in a discrete period of time (for example, within any 2-hour period), an amount of food that is definitely larger than most people would eat in a similar period of time under similar circumstances
    • a sense of lack of control over eating during the episode (for example, a feeling that one cannot stop eating or control what or how much one is eating)
  • The binge-eating episodes are associated with three (or more) of the following:
    • eating much more rapidly than normal
    • eating until feeling uncomfortably full
    • eating large amounts of food when not feeling physically hungry
    • eating alone because of feeling embarrassed by how much one is eating
    • feeling disgusted with oneself, depressed, or very guilty afterwards
  • Marked distress regarding binge eating is present.
  • The binge eating occurs, on average, at least once a week for three months.
  • The binge eating is not associated with the recurrent use of inappropriate compensatory behavior (for example, purging) and does not occur exclusively during the course Anorexia Nervosa, Bulimia Nervosa, or Avoidant/Restrictive Food Intake Disorder.

For me, this criteria is extremely problematic. This criteria is pretty vague, and in conjunction with a society that vehemently fears over-eating and weight gain, becomes a fit for a large proportion of people. Let’s take a look at it in more detail:
– “an amount of food that is definitely larger than most people would eat in a similar period of time under similar circumstances” – this is particularly non-specific, and in our society, many people have a distorted view on what is larger than most people, especially when so many are restricting. It is also normal for someone who has been restricting to experience eating more than normal, because of the body trying to restore itself to being energy-balanced.
– “a sense of lack of control over eating during the episode” – many people feel out of control when it comes to food because we are made to feel that out of control if we are not eating in some strict and regimented way. That feeling is even more accentuated when the drive to survive overcomes the person’s desire to diet, and the body makes up for lost energy by “binging”.
– Eating rapidly is also part of the drive to get energy in as fast as possible when it needs it.
– Eating until uncomfortably full is easy to do when the body requires more energy than the stomach has room. The desire for food is just another way for the body to communicate hunger, and people often do not recognise this as a type of physical hunger (the brain is part of our physical being as well).
– Eating alone when eating what someone considers more than normal, or when someone is experiencing reactive eating in response to restriction, is – unfortunately – normal because of the way our society has surrounded food in a thick layer of shame.
– And if you are dieting, or misinterpreting your eating as a “binge” (because I would argue that many people have a distorted view of what a binge actually is), this is likely to happen “at least once a week for three months”.

“With these diagnostic criteria [for BED], there is huge potential for a false positive. Do a lot of people struggle with binge-eating? Absolutely. Are all of these people actually ill? That is the major question around this diagnosis and the Vyvanse treatment,” said Lisa Cosgrove, a professor and clinical Psychologist at the University of Massachusetts, Boston.

So what we have here is a list of things that those with BED suffer from, but written in a way that it could easily fit someone misinterpreting their eating habits because they have distorted ideas of what binging is, or are not aware of the effects that dieting has on the body. This means that these people could go to the doctors, tick all the boxes, and receive a diagnosis. Our fatphobic society steeped in diet culture would have no problem with that. A quote from Ray Moyniham in  Motherboard talks about this:

“You have to be extremely sensitive to the fact that there are people who are really suffering severe and debilitating symptoms from a condition,” said Ray Moynihan, a senior research fellow at Bond University in Australia and the author of Selling Sickness: How the World’s Biggest Pharmaceutical Companies Are Turning Us All Into Patients. “But when we put so much energy into medicalizing normality, it takes resources and attention and care away from people who are seriously ill.”

Now on to June 2014, where Shire wins the key patent ruling for the drug Vyvanse. The Telegraph writes:

Shire hopes to increase sales of the drug by broadening its uses into other patient groups, such as very young children and sufferers of the newly-recognised psychiatric problem binge-eating disorder (BED).
The drug maker told investors on Monday that it expected to make $300m from sales of Vyvanse to BED patients by 2020, following a successful clinical trial showing the drug helped control binge eating.

This raises a red flag for me: Shire will desperately want to make as much money as possible before its patent expires, and this means expanding its treatment to those with other illnesses other than ADHD. Shire had already thought of BED as an option, and already had that idea in the pipeline. Is the fact that BED was finally recognised and put into the DSM-V just when Shire needed a new illness to treat a convenient coincidence, or something more dubious?

In January 2015, Vyvanse was approved to treat BED. The fairly vague criteria for BED could mean that BED is over-diagnosed and over treated, with a drug that is an amphetamine. Hang on, what?

Amphetamines became extremely popular in the mid 1900s as a weightloss drug, before concerns about the dangerous side effects caused the FDA to ban amphetamines from diet ads.

The most serious risks include psychiatric problems and heart complications, including sudden death in people who have heart problems or heart defects, and stroke and heart attack in adults. Central nervous system stimulants, like Vyvanse, may cause psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a prior history of psychotic illness. The most common side effects reported by people taking Vyvanse in the clinical trials included dry mouth, sleeplessness (insomnia), increased heart rate, jittery feelings, constipation, and anxiety. – take from here.

Vyvanse was approved for treating BED after only two 12-week studies.

“I tried (and failed) to persuade the DSM 5 group that BED was a premature and dangerous idea precisely because I feared it would be a backdoor excuse for drug companies to promote stimulant diet pills,” Dr. Frances Allen, a psychiatrist and frequent critic of the DSM-5, told Motherboard in an email. He has had particular concerns about the new criteria for diagnosing eating disorders. “The rushed approval of Vyvanse realizes my worst fears”

People actually suffering from BED are desperate to get rid of their mental illness, but therein lies the issue: BED is a mental illness. I have severe reservations about an appetite suppressant being used to combat an eating disorder that for a lot of people has roots in trauma, and other deep-seated emotional problems. The appetite of that person isn’t the issue: the drive to eat as a coping mechanism is. And not only are we going to be dealing with actual sufferers, but those misdiagnosed because of the ill-defined criteria, and those faking the illness to get a hold of Vyvanse, either because of its street value, or because of its use as a weightloss drug. Which brings me to the dangers of those with restrictive eating disorders reeling off the list of BED symptoms, and getting a prescription of Vyvanse to continue their downward spiral that only leads closer and closer to death. Because a binge eating disorder diagnosis relies on self-reported behaviour, it means that it is not difficult to fake, and consequently, it is not difficult to get a diagnosis. Pro-ana sites are already sharing their experiences with Vyvanse, and tips on how to get hold of the drug. The consequences of this could be catastrophic.

I received a message to my blog recently when the subject of Vyvanse came up:

I was recently diagnosed with BED and prescribed Vyvanse. My psychiatrist gave it to me because he said I was gaining too much weight. He gave it to me to use as a weightless pill. I don’t think that’s okay. In the past I have suffered from anorexia and bulimia. So of course, I accepted the pill. Hoping it would be easier to not eat at all. I think this may be a problem for a lot of people very soon.

This shows that already Vyvanse is being misused by doctors themselves, who are supposed to be people that we trust with our healthcare. But with the pharmaceutical industry being all about the money-making, it’s hardly surprising.

In my opinion, the inclusion of BED in the DSM-V, the vague diagnosis criteria, the subsequent research into using Vyvanse to treat BED, and the swift approval of that usage, are linked together. The pharmaceutical company have helped themselves to make more profit off both those with BED, and so many without it, with a drug that in my opinion will not successfully treat the disorder it has been approved for. And this drug is likely to have devastating consequences.

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Diagnosing Anorexia Nervosa VS EDNOS: What Does the Weight Criteria Really Mean?

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Making a distinction between EDNOS and Anorexia Nervosa is a tricky one when it comes down to the Atypical Anorexia Nervosa (a type of EDNOS) side of things. There are those that adhere to the strict weight criteria for the diagnosis of Anorexia Nervosa (even though there is now no specific cut off point in the DSM-V), and there are those that use it as a guideline. The argument on whether or not a specfic weight is required or not for the diagnosis of Anorexia Nervosa is rife across the eating disorder communities, so I decided to do some research on what the medical community has to say on the matter.

According to the DSM-5 criteria, to be diagnosed as having Anorexia Nervosa a person should display:

  • Persistent restriction of energy intake leading to significantly low body weight (in context of what is minimally expected for age, sex, developmental trajectory, and physical health) .
  • Either an intense fear of gaining weight or of becoming fat, or persistent behaviour that interferes with weight gain (even though significantly low weight).
  • Disturbance in the way one’s body weight or shape is experienced, undue influence of body shape and weight on self-evaluation, or persistent lack of recognition of the seriousness of the current low body weight.

The Subtypes of Anorexia Nervosa are: restricting type, and binge-eating/purging type.

(I should also first mention that the DSM-V has already been widely criticised, and The National Institute of Mental Health withdrew their support for the manual, stating that “patients with mental disorders deserve better.”  Another thing to consider is that the cut off point for what is a healthy BMI varies from medical institution to medical institution. Many use 18.5 as the cut off point. Others use 19. My pharmacist had a chart on the wall that stated that a normal BMI was between 20 and 25 (it also states that here). So that already can create problems when there is no consensus between medical communities on what is underweight. You can go to one doctor’s surgery and be told you are underweight and another where you are told you are not. Really, we should just be going on each personal individually, and using these charts as a guide.)

To start with, Kate Donovan wrote “Problems in the way we diagnose anorexia” – a blog post exploring the weight criteria when we still had the DSM-IV – which is relevant because Anorexia Nervosa is still being diagnosed using an outdated weight criteria.

The reason this is so important is that Atypical Anorexia Nervosa and Anorexia Nervosa are barely distinguishable – so why are there two different diagnosis’s dividing the two when they are the same disease and both require extremely similar treatment which only differs in terms of the individual rather than the label? Results of Jennifer Thomas’s study (The relationship between EDNOS and officially recognized eating disorders: meta-analysis and implications for DSM) indicated that EDNOS did not differ significantly from AN on eating pathology or general psychopathology, and “moderator analyses indicated that EDNOS groups who met all diagnostic criteria for AN except for amenorrhea did not differ significantly from full syndrome cases.” (Jennifer Thomas is an assistant Professor of Psychology at Harvard.)

In another of her studies (which is about the criteria in the DSM-IV “refusal to maintain body weight at or above a minimally normal weight for age and height e.g. weight loss leading to maintenance of body weight less than 85% of that expected”), she writes

“Although the 85% weight cut-off is intended to represent a ‘suggested guideline’ for diagnosis (APA, 2000, p. 584), investigators who enroll eating disorder patients in clinical trials (Dare et al. 2001; Powers et al. 2002) and insurance companies that determine treatment eligibility typically adhere to this percentage when assessing underweight. The 85% criterion is also frequently used to calculate AN prevalence in epidemiological studies (Walters & Kendler, 1995; Garfinkelet al. 1996), which inform the perceived public health significance of the disorder. The widespread use of the 85% criterion probably reflects a desire to standardize diagnosis across diverse settings.”

She also states;

“Data from clinical and non-clinical samples suggest that eating disorder not otherwise specified (EDNOS) is the most prevalent of DSM-IV eating disorders, and individuals who meet all criteria for AN except the weight cut-off represent a common subtype of this group (Watson & Andersen, 2003; McIntosh et al. 2004). A computer simulation of 193 eating-disorder treatment seekers indicated that the prevalence of AN would increase significantly if the weight criterion were relaxed from 85% to 90% of EBW (Thaw et al. 2001). It is therefore likely that if some clinics use more lenient methods of calculating EBW, they will diagnose a greater proportion of their patients with AN and a relatively smaller proportion of patients with EDNOS, even if they consistently apply an 85% cut-off.”

Jennifer Thomas also makes an important point regarding diagnosis and treatment regarding weight cut off points:

“The finding that investigators use different weight criteria for AN has important implications for eating disorder diagnosis, treatment, research and insurance reimbursement. Our results raise the possibility that a patient of a particular height, weight and symptom profile could receive a diagnosis of AN at one treatment center and a diagnosis of BN or EDNOS at another, and be eligible for one investigator’s AN treatment outcome study but not another. On average, discrepancies are possible within a 15-lb weight range for females and a 25-lb weight range for males, and could occur even if the assessing clinicians at each treatment center referred to the same DSM-IV criteria to assign diagnoses. If each clinician then attempted to recommend an evidence-based treatment, the patient diagnosed by the stricter weight cut-off and therefore classified as BN or EDNOS might receive out-patient therapy whereas the patient diagnosed by the more lenient weight cut-off and therefore classified as AN might receive a more intensive intervention (e.g. in-patient care) because of the perception that he or she is more underweight.”

She also made the following comment on a post by Science of Eating Disorders (‘Are There Any Meaningful Differences Between Subthreshold and Full Syndrome Anorexia Nervosa?’):

“I share your frustration with the 85% EBW guideline — it’s not only arbitrary but inconsistently applied (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2847836/). Interestingly, the DSM-IV Work Group never meant it to be a “cut-off” (just a guideline), so it’s a good thing it’s being omitted from DSM-5. My work also suggests that EDNOS is typically just as severe as AN and BN (http://www.ncbi.nlm.nih.gov/pubmed/19379023), and clinically I think too many patients find their suffering invalidated when they are diagnosed not with a specific eating disorder, but an acronym. I also agree with you that DSM-5 represents a big improvement (especially the inclusion of named subtypes like purging disorder)…”

The post by Science of Eating Disorders (which is linked above) talks about a study conducted by Daniel Le Grange and colleagues, published in the European Eating Disorders Review, where they compared eating-related and psychopathology measures between 59 anorexia nervosa and 59 subthreshold anorexia nervosa women, and found that there were no differences between the two other than the bingeing and purging frequency, which was higher in the AN group, and body checking behaviours, which was higher in the EDNOS-AN group. They said:

“There is little evidence that participants with EDNOS-AN were any different from those with AN. Therefore, our results confirm the now accepted notion that menstrual status is probably not a helpful diagnostic marker for AN (Attia, Robero, & Steinglass, 2008) and also challenge the generally accepted cut point of 85% of ideal body weight (or BMI 17.5 ) for a diagnosis of AN.”

We know that the weight threshold that is used so rigidly by some can cause massive problems for those seeking treatment: many insurance companies and inpatient facilities will only accept those meeting the “anorexic BMI” criteria – even though the specific weight criteria has been removed with the publication of the DSM-V. We also know that the DSM-V is to be used as a guide, and that the “anorexic BMI” is also a guide, not an absolute. There is no weight that you MUST be to be diagnosed with anorexia nervosa.

What I’ve seen from observing both the reactions from some who have suffered from eating disorders (specifically those who have, or are in recovery from, anorexia nervosa) and doctors in response to the idea that you don’t have to meet the weight criteria (that actually doesn’t exist any more in the DSM-V) of 17.5 to be diagnosed with anorexia nervosa, it is those with anorexia that tend to become outraged when it is suggested, whereas all different doctors have different opinions, many leaning towards using the manual as a guideline. Medical professionals that I have spoken to recently do not believe in weight criteria rigidity being exceedingly important to the diagnosis of Anorexia Nervosa. I recently spoke to a doctor in the UK, and a medical director in the US. Both told me that the DSM-V (and the ICD-10) are guidelines, and are to be used as such. When asked about anorexia, EDNOS, and the weight criteria, the US medical director said it is subjective:

“DSM criteria are not absolute, like many things in medicine with variable presentations, symptoms, and severities. The diagnostic criteria are best used as a guide. Unfortunately some take it too literally (many payors, insurances, etc) will not cover care unless strictly adherent to these criteria. I believe the key is to recognize and anticipate before the process progresses to a unstable or potential irreversible condition…Following strict criteria in my opinion results in delayed therapy of patients in worse conditions.”

In the DSM-V, it states:

“Criterion A requires that the individual’s weight be significantly low (i.e., less than minimally normal or, for children and adolescents, less than that minimally expected).Weight assessment can be challenging because normal weight range differs among individuals, and different thresholds have been published defining thinness or underweight status. Body mass index (BMI; calculated as weight in kilograms/height in meters2) is a useful measure to assess body weight for height. For adults, a BMI of 18.5 kg/m2 has been employed by the Centers for Disease Control and Prevention (CDC) (Centers for Disease Control and Prevention 2011) and the World Health Organization (WHO) (World Health Organization 1995) as the lower limit of normal body weight. Therefore, most adults with a BMI greater than or equal to 18.5 kg/m2 would not be considered to have a significantly low body weight. On the other hand, a BMI of lower than 17.0 kg/m2 has been considered by the WHO to indicate moderate or severe thinness (World Health Organization 1995); therefore, an individual with a BMI less than 17.0 kg/m2 would likely be considered to have a significantly low weight. An adult with a BMI between 17.0 and 18.5 kg/m2, or even above 18.5 kg/m2, might be considered to have a significantly low weight if clinical history or other physiological information supports this judgment. For children and adolescents, determining a BMI-for-age percentile is useful (see, e.g., the CDC BMI percentile calculator for children and teenagers). As for adults, it is not possible to provide definitive standards for judging whether a child’s or an adolescent’s weight is significantly low, and variations in developmental trajectories among youth limit the utility of simple numerical guidelines. The CDC has used a BMI-for-age below the 5th percentile as suggesting  underweight; however, children and adolescents with a BMI above this benchmark may be judged to be significantly underweight in light of failure to maintain their expected growth trajectory. In summary, in determining whether Criterion A is met, the clinician should consider available numerical guidelines, as well as the individual’s body build, weight history, and any physiological disturbances.”

This means that people need to be treated on an individual basis, and not strictly by a weight criteria.

What I find worrying is that some (emphasis on some) of those with the diagnosis of Anorexia Nervosa feel that the criteria should be rigid: so much so that they actually believe that it is. I would suggest that this is because some can see it as a badge of honour that you only “deserve” when you reach a certain weight. Those with such black and white thinking regarding AN are particularly (and disorderedly) protective of the diagnosis. This only reinforces to those diagnosed with EDNOS that they are “not sick enough” until they have “achieved” that particular BMI. It also reinforces the (untrue) notion that you can only be diagnosed with AN at a certain weight, and this results in the spreading of misinformation.  It is important that we are educated about the facts, rather than going purely on beliefs when we are not medical professionals ourselves. The negative emotional connection some of those with Anorexia Nervosa seem to have to the diagnosis and the “badge of honour” mentality can cloud judgement and rational thought, and become an issue as it invalidates others.

Obviously in no way is this article intended to invalidate those with EDNOS. In fact, I hope to validate the diagnosis more as those with EDNOS routinely present with symptoms and behaviours that are as serious as AN or BN. My aim was to show that there is barely any difference between those with Atypical Anorexia Nervosa and those with Anorexia Nervosa, and it is my opinion that they should all be diagnosed with the same illness, and any difference in physical symptoms be treated accordingly. Any doctor or professional who is worth their salt will pay attention to the mental and physical condition their patient is in and diagnose that way, or if they have been diagnosed before, they will reassess and treat accordingly. Using the guidelines as absolutes can be extremely harmful, misguided, and unhelpful, and spreading the notion that they are absolutes within the eating disorder community on social media and within our culture in general, is harmful to those seeking help, support, and treatment.