Wednesday, August 29, 2018

Benzodiazepines and Leeches ... Like Peas and Carrots


Most people associate the use of leeches as a medical treatment with the Dark Ages, bloodletting and witchcraft. They believe that the medical profession stopped using leeches over three centuries ago. And yet, in 2004, the FDA approved the commercial marketing of leeches for limited medical purposes, mainly to help heal wounds and restore circulation in blocked blood veins.  Leeches apparently may be effective on a very limited basis … but are used in very few instances and have been largely replaced by more effective methods. 

Today, this same thought process must be utilized regarding the use of pharmaceutical drugs, particularly benzodiazepines in the treatment of eating disorders. If not, the consequences could be deadly.

Medications and Eating Disorders

The United States Food and Drug Administration has approved only two drugs to treat eating disorders. Lisdexamfetamine dimesylate (Vyvanse) is the first FDA-approved drug to treat binge eating disorder in adults. It's also used to treat ADHD. It is not clear how the drug works in binge eating, but it is thought to control the impulsive behavior that can lead to bingeing. In studies, patients who took the medicine had fewer episodes of binge eating.

The FDA also approved the use of Prozac (Fluoxetine) for Bulimia Nervosa.

However, guidelines issued by the Royal Australian and New Zealand College of Psychiatrists’ (RANZCP) warn there is no evidence supporting the use of psychotropic medications for adult anorexia. In fact, a recent meta-analysis found there is absolutely zero evidence supporting the use of antipsychotics to treat anorexia. This is bolstered by Stephanie Zerwas, clinical director of the UNC Chapel Hill Center of Excellence for Eating Disorders who stated, “Antidepressants and even antipsychotics are really much more ineffective when people are in a malnourished state.”

In a fasting or malnutrition state, the individual is not producing neurotransmitters (i.e. serotonin, norepinephrine, dopamine) at a level where there can be maximum therapeutic benefit. Medications are less effective until re-feeding has taken place.

No medication has been FDA-approved for the treatment of Anorexia Nervosa. Studies show that antidepressants are no more effective for weight gain than placebo. Three trials studied tricyclic antidepressants, while the fourth studied the selective serotonin reuptake inhibitor, Prozac (2,3,4,5). Pharmacotherapy (medication treatment) is not an initial or primary treatment for anorexia nervosa. Various psychotherapy modalities, i.e. Cognitive Behavioral Therapy and Family Based Therapy have far more supportive evidence.

Despite these studies, doctors have been known to prescribe an aggressive medication regiment to treat eating disorders. Remeron (mirtazapine), which has not even been studied in trials with Anorexia Nervosa, is nonetheless often used in patients with Anorexia Nervosa (especially if there is co-occurring depression or anxiety) due to its ability to help with sleep and increase appetite, thereby potentially increasing weight gain.

In order to treat the symptoms of eating disorders and the co-current conditions, doctors often prescribe a plethora of drugs not specifically approved to treat the disease. This is called "off-label" prescribing. Since those classes of drugs are not specifically approved to treat eating disorders, one is left to speculate whether doctors are prescribing medications for symptomology alone based upon their own “Confirmation bias” and not based upon peer-to-peer scientific research.

In psychology and cognitive science, “Confirmation bias” is a tendency to search for or interpret information in a way that confirms one's preconceptions, leading to statistical errors. Confirmation bias is a type of cognitive bias and represents an error of inductive inference toward confirmation of the hypothesis under study.

Confirmation bias is a phenomenon wherein decision makers have been shown to actively seek out and assign more weight to evidence that confirms their hypothesis, and ignore or under weigh evidence that disconfirms their hypothesis. As a result, a prescription drug regiment which is designed more to address various symptoms of co-occurring conditions is becoming commonplace and is based more upon that practitioners intuition, observations, personalities and colleagues’ endorsements rather than peer-to-peer reviewed scientific research. This is particularly true with regard to the use of benzodiazepines.

Benzodiazepines

Benzodiazepines are becoming one of the more readily prescribed medications in treating symptoms of eating disorders. When benzos first came to the market in the 1950s, they were prescribed for a range of neurological disorders such as epilepsy as well as anxiety related disorders such as insomnia. But over time, using the loophole in federal drug control laws known as the “practice of medicine exception,” doctors began to prescribe the drug for any perceived disorder.

Klonopin seems to be becoming the benzo drug of choice being prescribed for persons with eating disorders. Some doctors indicate that benzos have been shown to increase the palatability of food and result in increased consumption of food.

However, the manufacturer of Klonopin indicates that it is for short term use only, between 7 – 10 days. In part, that is because Klonopin is a highly addictive substance and its side effects are many. These include seizures, accidental falls, hallucinations, unusual heartbeat, insomnia, drowsiness, blurred vision and slurred speech.

There is no dispute that benzos are highly addictive. Stevie Nicks of Fleetwood Mac fame, with regard to klonopin, stated" “This drug was more deadly than the coke.” (when asked which drug had the most significant impact on her). "The overwhelming feeling of wellness and calm equals blah, nothing. My creativity went away. The fabulous Stevie everyone knew just disappeared. I became what I call the 'whatever' person. I didn't care about anything anymore. I got very heavy. One day I looked in the mirror and said, 'I don't know you.' And I went straight to the hospital for 47 days."

When an RTC does not engage in aggressive discharge planning, does not properly educate parents and does not coordinate with a patient’s treatment team at home, the results can be an overdependence, abuse and addiction on drugs with a deadly outcome.

Hypothetical and speculation turns into reality.

During one of my daughter’s many residential treatment stops, after being in a certain treatment center (“The Program”) for six (6) weeks, United  Behavioral Healthcare (“UBH”), our then insurance provider, made the determination that it was stopping payment for all treatment for eating disorders and trauma and mandated that it would only pay for a detox program for Morgan.  Naturally, this determination was quite mysterious since Morgan had been under the exclusive care of this residential treatment program for six (6) straight weeks and had come to this facility from another hospital.

The Program appealed this determination and the following day, UBH approved an additional six (6) day stay, ostensibly to allow The Program to begin a detox and titration program off of klonopin. 

The doctor at the Program overseeing her treatment protocol had actual knowledge that UBH was terminating all payment for Morgan’s eating disorder treatment, that Morgan was being overmedicated and had become dependent on medication and was going to be discharged.  The doctor knew that Morgan needed to be titrated off klonopin and have its administration overseen by a trained medical professional. Nonetheless, not only did this doctor not start a titration protocol, but continued to subject Morgan to 6 mg of klonopin per day. When Morgan was discharged to our care, the Program had not even begun a detox program. It also did not make any recommendations or advice about a detox program.  And, it discharged Morgan unsupervised, on a Super Shuttle van for transport to the airport with a large, gallon size baggie filled with prescription drugs, including at least 36 doses of klonopin. This conduct was tantamount to an alcohol rehab facility giving its patient a case of beer as a parting gift.  

However, the Program did start a process of covering their own conduct. In Morgan’s Transition/Discharge Summary, Morgan’s treatment team, stated: “PT did not initially disclose a hx of substance abuse, but OP team informed treatment team of pt’s severe alcohol and substance abuse issues.  Therapist presented pt with this information who stated that she was not “ready to give that up” at this time.  Pt would periodically seek more benzodiazepines from psychiatrist.

The logical conclusion one can draw from these notes is that the treatment team was woefully unprepared, there was a lack of communication between the intake team and treatment providers and the Program was already pointing fingers elsewhere for its own incompetence.

After Morgan came home, the predicted catastrophe happened. Three days later, she was in an emergency room at Presbyterian Hospital in Plano, Texas because of an overdose of klonopin.  Her vital signs were erratic, she was lethargic and was generally not responsive to stimuli.  She was placed in the Intensive Care Unit. She survived that time. But, the incredibly difficult road to recovery was made that much more rocky because of her addiction to klonopin. 

Morgan Claire Dunn died on October 30, 2016. We discovered that she had been prescribed the following drugs by doctors and RTCs who were attempting to treat her eating disorders:

1.             Fluvoxamine;
2.            Ambien;
3.            Lithium;
4.            Potassium;
5.            Vayarin;
6.            Fluoxetine HCL;
7.            Buspirone HCL;
8.            Gabapentin;
9.            Mirtazapine;
10.          Latuda;
11.          Metronidazole;
12.         Vitamin B-1;
13.         Divalproex;
14.        Doxepin;
15.         Zolpidem;
16.         Mag Oxide;
17.         Cymbalta;
18.         Hydroxyzine Pamoate;
19.         Trazadone;
20.        Mynocycline;
21.         Baclofen;
22.        Topiramate;
23.        Thiamine HCL;
24.        Ondansetron ODT;
25.        Prazosin;
26.        Sulfamethoxazole;
27.        Citracal Plus D3;
28.        Omeprazole;
29.        Spironolactone;
30.        Ferrous Gluc;
31.         Venlafaxine;
32.        Lamotrigine;
33.        Ranitidine;
34.        Trifluoperazine;
35.        Olanzapine;
36.        Vancomycin;
37.        Oxcarbazepin;
38.        Risperidone;
39.        Naltrexone;
40.       Neurontin;
41.        Vistaril;
42.        Trileptal;
43.        Klonopin

Again, the FDA has approved two drugs to treat eating disorders.  

Morgan Dunn was prescribed at least forty-three (43) different medications.

Forty-Three (43).











Monday, August 27, 2018

PE Owned RTCs and the Military ... Admittance Verboten


We owe an enormous debt of gratitude to those who serve or have served in our country's military, as well as to the families of those individuals. Whether protecting our freedoms in foreign fields or making contributions here at home, the value these men and women bring to the American workforce and our way of life is beyond measure.
Sylvia Mathews Burwell, Former U.S. Secretary of Health and Human Services and President of American University
So long as I'm Commander-in-Chief, we will sustain the strongest military the world has ever known. When you take off the uniform, we will serve you as well as you've served us - because no one who fights for this country should have to fight for a job, or a roof over their head, or the care that they need when they come home.
          President Barack Obama
The U.S. Military is us. There is no truer representation of a country than the people that it sends into the field to fight for it. The people who wear our uniform and carry our rifles into combat are our kids, and our job is to support them, because they're protecting us.
Tom Clancy, Author
On the battlefield, the military pledges to leave no soldier behind. As a nation, let it be our pledge that when they return home, we leave no veteran behind.
Dan Lipinski, U.S. Congressman (Illinois)
It is difficult to imagine a greater calling involving selfless service at potentially great personal risk, than the call to serve your country. For some, it is a possible path out of poverty. Some are motivated by a patriotic fervor. Some believe it may help them find clarity, purpose or strength that they had not been able to previously embrace. Whatever reason, the potential, the likelihood of them being placed in harm’s way is the reality faced by every military person each day they serve. Is there a more noble calling?
When they return home to their loved ones, society’s debt of gratitude that must assuredly be extended to them must not shrink because of inconvenience or reduced profitability. And nowhere is this debt of gratitude more profound than in insuring we provide the best medical and mental health care available to our service personnel.
With regard to our service members suffering from eating disorders, the eating disorder industry has the highest duty, derived from a sense of moral and ethical obligation, to provide the best care available.

The Stars and Stripes Journal recently reported that eating disorder diagnoses among military personnel are up 26 percent over a five-year period, according to a new military study that suggests the actual incidence of such illnesses is even higher. The study, published in the Defense Health Agency’s Medical Surveillance Monthly Report, found that incidence rates had risen steadily from 2013 to 2016.

This study further found military service could increase the risk of developing an eating disorder due to potential exposure to trauma and the need to meet physical fitness and weight requirements. The study found, “It is well recognized that factors that increase emphasis on weight and shape elevate the risk of eating disorders among both women and men.”

Similar to civilian populations, trauma, including post-traumatic stress disorder, is associated with eating disorder risk in service members. However, military personnel are uniquely exposed to combat trauma and trauma associated with sexual assault, which is high in the military. These experiences may present their own risks for the development of eating disorders and associated symptoms.

The types of food available to military personnel during deployment are different than those when not deployed. Switching from Meals Ready-to-Eat (MREs), which are high calorie ready-to-eat packages of food used in combat when organized food facilities are unavailable to “regular food” that is consumed when individuals are at home could contribute to eating disorder symptoms.

With what we know about eating disorders and the unique risks faced by our service members, our resolve to attend to their health care needs both during their active service and upon their return as well as their dependents must be of paramount importance. And yet, the eating disorder industry has shirked its moral and ethical obligation in the most egregious manner.

Tricare and our Service Members

Tricare is the health care program for service members, retirees and their family members around the world. Tricare provides comprehensive coverage to all beneficiaries including health plans, special programs, prescription drugs and dental plans.

Tricare is managed by the Defense Health Agency under the leadership of the Assistant Secretary of Defense. It states that its mission is to enhance the Department of Defense and our nation’s security by providing health support for the full range of military operations and sustaining the health of all those entrusted to their care. It states its vision is to be a world-class health care system that supports the military mission by fostering, protecting, sustaining and restoring health.

There are approximately 9.4 million service men and women and their families who are currently enrolled to receive Tricare benefits. And of these 9.4 million, the number who can utilize these benefits to receive care from Private Equity owned Residential Treatment Centers is … ZERO.

Private equity owned residential treatment centers (“RTC”) hold themselves out to the general public as being elite, of being a gold standard, of providing the highest quality of care. On each of the their websites, they present a glowing picture of health, that their patient’s well-being comes first and foremost and that they utilize only “evidence-based” treatments. One RTC laughingly represents that “… 99% of parents of child/adolescent patients report that treatment at Eating Recovery Center was helpful, and 97% would recommend Eating Recovery Center to other families in need of treatment.” These statistical representations are made on their website.
And yet, these RTCs have closed their doors to our heroes, our service members and their families.

Part of the reason lies within the policies of Tricare. Tricare states that it only pays for medically necessary treatment and treatment that is considered “proven.” As a result, and for some “undisclosed reason,” Tricare does not pay for treatment at “freestanding” eating disorder centers. However, Tricare does state that it pays for necessary eating disorder treatment… just not at “freestanding” eating disorder centers.

Not all PE owned RTCs are freestanding. For example, in Texas, ERC Dallas is housed on location at the Baylor Scott & White Hospital in Plano, just north of Dallas. ERC’s parent company could approach Tricare, comply with Tricare requirements and become an authorized Tricare service provider.

Naturally, this begs the question that if the treatment regiment provided by these freestanding RTCs is considered the “gold standard,” if it is strictly “evidence-based,” if their treatment regiment is “proven,” why won’t Tricare amend its standards to reflect that services rendered by freestanding RTCs are now covered? For that matter, has the eating disorder industry even approached Tricare to negotiate the manner in which freestanding RTCs can be taken under the Tricare wing?

In 2000, the eating disorder industry organized the Eating Disorders Coalition in part, to spearhead and chart a path on legislative and administrative issues. The Eating Disorders Coalition was formed to advance the recognition of eating disorders as a public health priority by purportedly building relationships with Congress, federal agencies and nation and local organizations dedicated to health issues. Certainly, the ED Coalition is the ideal entity to handle negotiations with Tricare representative and overcome any and all hurdles to allow our service members access to the presumed, “elite” of eating disorder treatment.
However, of the four current officers, two work for PE owned RTCs, and a third is inextricably intertwined with one of those members.
With PE owned RTCs having control over the ED Coalition, one cannot help but speculate as to which entities set the agenda and legislative priorities for the ED Coalition. One should also wonder whether legislation that would necessarily help the eating disorder industry as a whole, but which could reduce the profit margins realized by those private equity firms is even considered let alone pursued? Why hasn’t the ED Coalition aggressively approached Tricare about freestanding eating disorder treatment centers?  Why do Moody’s, S&P and Bloomberg reduce a corporation’s rating if they accept government reimbursed program?
Our service men and women lay their lives on the line. They put themselves in harm’s way. And yet, PE owned RTCs, along with the ED Coalition, whose mission is purportedly building relationships with Congress, federal agencies and national and local organizations dedicated to health issues do not see fit to negotiate with TriCare so that treatment rendered by freestanding RTCs are accepted within the TriCare program.
Apparently, protecting our freedom, our very way of life, by giving themselves up as the ultimate sacrifice to be offered on the altar of freedom is not a significant enough sacrifice to enable them to be treated by these self-proclaimed gold standard, freestanding RTCs.
To call such oversight or ignorance "reprehensible" would be charitable.


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