Narcolepsy, a Disease so Disturbing of Daily Activities that Patients Favor Treatment with Illegal Drugs

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Xyrem: A Debate On the Medicinal Use of an Illicit Drug in Treating Narcolepsy

Due to the exponential acquisition of knowledge and development of technology in the twenty-first century, scientists have begun to piece together the mysteries of the human brain and how it functions. With this information, they have been able to determine why certain neurological illnesses occur and how to prevent and/or treat them. Xyrem, for example, is a drug developed to treat symptoms that emanate from narcolepsy. Like most pharmaceutical drugs, Xyrem’s healing properties are accompanied by a running list of side effects. Ideally, a medication’s benefits far outweigh its side effects, thus, providing incentive for patients to use the drug. Drugs presenting more risks than benefits are typically withdrawn from the market, or never introduced to the public in the first place (United States Food and Drug Administration). As a result of the vast quantity of drugs pending approval by the FDA to enter the public pharmaceutical market, the line between their supposed benefits and potential risks has been blurred, enabling drugs that could potentially cause more harm than good to enter the public market. Xyrem is one of these drugs; with its severe side effects, high risk of addiction, and history of abuse, the utilization of Xyrem in the treatment of narcolepsy can easily lead to an incredibly dangerous and possibly deadly outcome. In order to acquire an in-depth comprehension of Xyrem though, one must first have a fundamental understanding of the disorder it helps remedy: narcolepsy.

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Narcolepsy is a debilitating, chronic neurological disease that disrupts the sleep-wake cycle, causing excessive daytime sleepiness (EDS) and a multitude of other neurological issues such as cataplexy, hallucinations, sleep paralysis and automatic behaviors (Feldman). After years of research, scientists have uncovered one specific trait that narcoleptic animals and humans all have in common: the deficiency or complete absence of a neurotransmitter called hypocretin in the brain, which is believed to control the sleep-wake cycle and is found in the hypothalamus (Feldman). Additionally, scientists have discovered that “the destruction of hypocretin-producing cells is consistent with an autoimmune process” (qtd. in Feldman), providing an explanation as to why most narcoleptics do not show symptoms until adolescence or later (Feldman). Furthermore, “once narcolepsy symptoms occur, they generally persist without remission” (qtd. in Fuller and Hornfeldt, 1206). Narcolepsy can be difficult to diagnose as the symptoms often lead to the misdiagnosis of other neurological problems (Feldman). The most common method of testing patients for narcolepsy is a succession of two time consuming, uncomfortable, and expensive sleep tests called the polysomnography, and the multiple sleep latency test (MSLT) (Feldman). Although the tests may be severely mind numbing, those that receive diagnosis as a result are usually quite relieved to have explanations for the strange occurrences that typically result from narcolepsy.

The symptoms of narcolepsy can severely alter the life of one who suffers from the disorder, causing social distress, job loss, family issues, low self-esteem, and lack of motivation among other issues. With excessive daytime sleepiness being the most common symptom of the disorder, many narcoleptics suffer from “sleep attacks”, during which they will fall asleep unexpectedly, often at inappropriate times such as during conversation, while driving, or even in mid-step (Fuller and Hornfeldt, 1205). This is not to be confused with the disorder’s second most common symptom: cataplexy. Cataplexy is the sudden loss of muscle tone during periods of intense emotion that can result in temporary paralysis of small muscle groups or in many cases full body paralysis for a brief period of time, possibly extending into several minutes or even hours (Feldman). Frighteningly, those experiencing cataplexy remain completely conscious and aware of what’s occurring, but lose the ability to talk, or even control facial muscles (Feldman). Interestingly, another common symptom of the disease causes narcoleptics to experience vivid hallucinations that can be visual, audible, and even tangible, either while falling asleep (hypnogogic hallucinations) or waking up (hypnopompic hallucinations) (Fuller and Hornfeldt). To make matters worse, these hallucinations are often accompanied by another common symptom of the disorder called sleep paralysis (Feldman). Sleep Paralysis occurs when the brain is immediately thrust from rapid eye movement (REM) sleep into wakefulness, skipping the H1 through H4 levels of sleep that gradually allow the brain to resume control of the bodily muscles that have been specifically paralyzed during REM sleep to prevent the body from physically enacting the movements the individual is dreaming of having (Feldman). The paralysis can occur for a few seconds to several minutes and, similar to cataplexy, the patient remains fully conscious and awake during the experience (Feldman). Lastly, another common symptom is called automatic behavior. During automatic behavior episodes, sleep consumes the brain of narcoleptics while “the body continues to perform familiar tasks with complete retrograde amnesia” (qtd. in Feldman). These episodes often create embarrassing situations; for example, I have personally been teased on numerous occasions for dozing off while taking notes in class, ensued by an abrupt awakening with those around me laughing and my hand still moving – adding to the mass of illegible scribbles on the page that would have formed words had my brain not taken a short snooze. Regardless of the number of symptoms experienced by a narcoleptic, the disorder is so difficult to live with that even the smallest relief can make a world of difference.

The two most debilitating symptoms of narcolepsy, EDS and cataplexy, can be minimized by using stimulants to reduce sleepiness during the daytime, and either tricyclic or selective-serotonin reuptake inhibitor (SSRI) antidepressants on account of their inexplicable capacity to reduce the occurrence rate of cataplexy attacks (Fuller and Hornfeldt, 1206). While these medications can minimize the symptoms and reduce the stress associated with narcolepsy, they are accompanied by their own side effects. Common side effects include: lack of appetite, hot flashes, cold sweats, increased anxiety, elevated heart rate, and the feeling of being “wired”. For years, narcoleptics relied solely on these drugs to bring a sense of normality to their lives until 2002, when Xyrem was introduced as a treatment (Fuller and Hornfeldt, 1205).

As explained by a group of experts on the substance, “Gamma-hydroxybutyrate sodium and sodium oxybate are the chemical and drug names, respectively, for the pharmaceutical product Xyrem (sodium oxybate) oral solution” (Carter et. al. 1). For the purpose of this text, the term GHB will be used from this point forward only to describe the substance being used recreationally, illegally, and/or irresponsibly, while the terms sodium oxybate and Xyrem will refer to the substance and its use medicinally in narcoleptic patients ensuing legitimate prescription. Additionally, the substance will henceforth be addressed by the term gamma-hydroxybutyrate, when referring to the general chemical substance without regard to the manner of consumption.

When gamma-hydroxybutyrate was first discovered in 1960, scientists had a very limited understanding of the substance, but realized that small amounts of the chemical naturally occurred in the human body, mostly in the central nervous system (Anderson, 293). It was not until several years later that the drug caught the attention of the general public, being “marketed as an unregulated dietary supplement in health food stores, training gyms, fitness centers, and on the Internet…” (Fuller and Hornfeldt, 1206). GHB especially became popular among bodybuilders as a result of its alleged “anabolic effects” and possible influence on the production of the growth hormone (Fuller and Hornfeldt, 1206). Over time, “several reports of overdose” gave rise to a nationwide ban of the sale of GHB by the Food and Drug Administration (Fuller and Hornfeldt, 1206). However, the ban failed to remove GHB from the hands of Americans because of its ease of production and growing popularity in the party and “rave” scene; the drug became infamous for its euphoric high and similarity to alcohol without the unpleasant feelings of a hangover the following day (Fuller and Hornfeldt, 1206). Finally, after GHB gained a new reputation as a “date-rape” drug and more reports of severe side effects surfaced, “the Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000 (Public Law 106-172), which amended the Controlled Substances Act, [made] GHB a schedule I agent” (qtd. in Fuller and Hornfeldt, 1207). However, with extensive medical research on the possible benefits of the drug already in progress, “successful lobbying efforts on behalf of physicians and patients led to modification of Public Law 106-172, creating for the first time a bifurcated or split schedule for GHB-sodium oxybate. Provisions of this act allowed sodium oxybate for medical purposes to be controlled under schedule III after FDA approval while retaining severe schedule I penalties for illegal use” (Fuller and Hornfeldt, 1207). After years of research and development in addition to the removal of legal restrictions by the FDA, Orphan Medical (now Jazz Pharmaceuticals) released Xyrem (sodium oxybate) oral solution for the treatment of cataplexy and other narcolepsy symptoms of those diagnosed with the disorder (Anderson et. al., 293).

Initially, the negative reputation associated with the consumption of GHB caused quite a stir within the medical community. Already familiar with the high risk of consuming the substance, “Orphan Medical collaborated with the FDA, experts in drug diversion and drug abuse prevention, and clinicians to create the Xyrem Risk Management Program” (Fuller and Hornfeldt, 1208). Sodium oxybate quickly became the remedy of choice among narcoleptics because of its ability to drastically increase their quality of sleep and almost completely eliminate their symptoms. In fact, research shows that Xyrem reduces the rate and severity of cataplexy attacks by up to 90% while drastically minimizing other symptoms as well (Fuller and Hornfeldt, 1208). Additional studies have shown that Xyrem not only reduces the severity of cataplexy, but drastically increases the amount of time spent in deep sleep, reduces nighttime awakenings and according to the Stanford University Sleep Disorders Clinic director, Jed Black, “represents an incremental improvement beyond stimulant therapy” (Orphan Medical Gets Positive Xyrem Clinical Results). After countless studies on Xyrem, it is clear that the benefits of the drug are extraordinary and that narcoleptics have finally been granted the freedom to live life unhindered by their debilitating condition. Even though sodium oxybate does not permanently treat narcolepsy, it effectively minimizes the symptoms of the disease with little to no safety issues. The former statement is comforting to those who use sodium oxybate; consequently, the vast majority of these consumers become willingly ignorant to indicators that the drug may not be as safe as they were told.

In actuality, Jazz Pharmaceuticals fully uses the concept of consumer ignorance to their advantage. For instance, by branding the drug Xyrem and sodium oxybate, the company misleads consumers to believe that the drug is an entirely different substance than GHB. This devious tactic is ethically comparable to filling pill capsules with cocaine and marketing them off as “energy pills” to unsuspecting customers. In addition, numerous disturbing cases of addiction, withdrawal, psychosis, overdose and even death have emerged since the release of sodium oxybate. For example, in May of 2013 reports tell the story of an 18-year-old female who was hospitalized after a violent psychotic outbreak that caused her to stab herself in the chest repeatedly with a kitchen knife. Before the outbreak, the girl allegedly complained of mental disturbances prior to experiencing hallucinations and exhibiting signs of delirium. Sodium oxybate was determined to be the cause of the incidence (Chien, Osterman and Turkel, 300). Another report reveals a similar case of severe mental side effects in association with ingestion of sodium oxybate. The patient in this report started to exhibit strange behavior before entering a state of delirium where she had verbal outbreaks of psychotic nature and had to be hospitalized. The woman’s prescription of sodium oxybate was discontinued resulting in the subsidence of strange behavior (Langford and Gross, 665). Additionally, a medical journal published an article describing the incredibly addictive qualities of GHB stating that “the adverse consequences of GHB abuse have been postulated to be worse than those of other sedative/hypnotic drugs because the dose-effect curve for GHB appears to be steep and there is a narrow range between doses that are used for recreational purposes and those that can result in loss of consciousness” (qtd. in Carter et. al., 5). Yet another report from 2009 describes three separate fatalities directly correlated with the use of Xyrem and urges physicians to use caution when prescribing the drug, even advising them only to prescribe it for extreme cases of narcolepsy (Zvosec, Smith and Hall). Furthermore, one report telling the story of a 53-year-old man who was prescribed xyrem raises concern in stating “…the patient developed suicidal ideation, saying ‘I do not want to live’ and ‘I will kill myself, but I do not know how.’ He even told his wife to hide the shotguns he had in his house. We immediately decreased sodium oxybate to 4.5 grams / night, and his depression symptoms soon resolved” (Suicidal Ideation Secondary to Sodium Oxybate). Another journal article published in 2000 describes the risks associated with using GHB, followed by information on how to identify the drug, emergency procedures for GHB overdose, and methods of treatment for those who are addicted. Some of the street names of GHB are truly indicative of its destructive nature; such names include cherry meth, grievous bodily harm, liquid ecstasy, and poor man’s heroin (O’Connell, Kaye and Plosay III). Moreover, a scientific report was created by a group of doctors over the withdrawal syndrome of GHB. With eight in depth examples of patients requiring hospitalization due to GHB withdrawal, the potential danger of the drug is made even more apparent. The results of their studies are as followed:

Eight patients had a prolonged withdrawal course after discontinuing chronic use of GHB. All patients in this series were psychotic and severely agitated, requiring physical restraint and sedation. Cardiovascular effects included mild tachycardia and hypertension. Neurologic effects of prolonged delirium with auditory and visual hallucinations became episodic as the syndrome waned. Diaphoresis, nausea, and vomiting occurred less frequently. The onset of withdrawal symptoms in these patients was rapid (1 to 6 hours after the last dose) and symptoms were prolonged (5 to 15 days). One death occurred on hospital day 13 as withdrawal symptoms were resolving. (Dyer, Hyma and Roth, 147)

With such chilling reports of gamma-hydroxybutyrate’s potential dangers, how can the FDA knowingly allow a company to distribute the drug to thousands of individuals? Even Jazz Pharmaceuticals addresses the dangers of gamma-hydroxybutyrate in an article stating, “GHB was also being implicated in a number of sexual assault cases during this time and, like flunitrazepam (Rohypnol, Roche), was being labeled as a ‘date-rape’ drug in the U.S.” (Anderson et. al., 297). Shortly after, the article describes GHB’s tendency to cause anterograde amnesia in assault victims and explain some of the other issues of the drug (Anderson et. al. 297).

As disturbing as these official reports are, the most compelling evidence of the risks of Xyrem can be found in the outrageously large number of narcoleptics like myself who were deceived by their physicians into taking a drug that would ultimately lead to addiction, confusion, and for those like myself who were fortunate enough to break free, withdrawal. When I began to experience some incredibly strange side effects, I began to search for answers online and quickly found that I was not alone. From my research, I read hundreds and hundreds of stories full of addiction, confusion, suicide, overdose, and ultimately loss – all of this from Xyrem. The reason few of these stories are ever reported to the FDA is simple, filing a report to the FDA consumes a large amount of time and effort. Furthermore, addicts usually do their best to hide their addiction from others. Furthermore, it would be against the nature of addiction for an addict to report their addiction, especially to the source of the substance that they are addicted to.

After a careful examination of sodium oxybate, it is obvious that the risks far outweigh the benefits provided by the medicine. Despite the difficulty of living with narcolepsy, the numerous and extreme side effects that come from this “cure” are much worse than narcolepsy itself. Ultimately, the narcoleptic community as a whole still seeks to find a permanent cure to their disease. Through the introduction of Xyrem, we have simply learned what may result in attempts to cure illnesses with dangerous street drugs. Will the scientific community ever find a way to restore hypocretin to the brains of narcoleptics?

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