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Focusing in on Adderall FOCUSING IN ON ADDERALL By Jared Geist FOOD & DRUG LAW Professor Neal Fortin 12-7-2007 Jared Geist Focusing in on Adderall 2 FOCUSING IN ON ADDERALL TABLE OF CONTENTS Introduction ..................................................................................................... 3 I. Background .................................................................................................. 4 A. The History of Adderall as a Prescription Drug ..................................... 4 B. Adderall Abuse ........................................................................................ 6 II. Investigating Adderall's Health Risks ....................................................... 8 A. Health Canada Bans Adderall ................................................................ 8 B. The FDA Investigation and cases of American Adderall-related death . 11 III. The Harm-Benefit Analysis ...................................................................... 13 A. The Case Against Adderall Use ............................................................... 14 B. The Case For Adderall Use (And Why it is Wrong) ................................ 17 IV. Where do we go from here? ...................................................................... 18 A. The Problems with the FDA's Drug Approval Process ........................... 19 B. A Plan of Action ...................................................................................... 20 Conclusion ....................................................................................................... 22 Jared Geist Focusing in on Adderall 3 INTRODUCTION When the United States Congress passed the Controlled Substance Act in 1970, amphetamines were listed as Schedule II drugs, meaning that they have a high potential for abuse, and that such abuse leads to severe psychological or physical dependence.1 Cocaine, opium, and morphine are examples of drugs that are listed in the same category.2 Today, various forms amphetamines are prescribed to 1.5 million children annually in the United States.3 This paper will focus on the prescription drugs ADDERALL and ADDERALL XR (both hereinafter Adderall), the most commonly used drugs used to treat Attention- Deficit/Hyperactivity Disorder (hereinafter ADHD) in the United States today.4 It will investigate whether the benefits gained from Adderall use actually outweigh the harms that necessarily enjoin. Part I will set forth a background detailing the history of Adderall, including both its intended use to treat ADHD, and its abused use as a recreational drug. In Part II, this article will examine the problems caused by Adderall, paying special attention to both the Health Canada ban, and the FDA investigation. Part III will explore the alleged benefits of Adderall use and comparatively analyze them in relation to the problems. Finally, Part IV proposes solutions to the problem, and provides recommendations for reform. Ultimately, this article will suggest that the FDA engage in certain reforms to create a policy that better balances the harms and benefits of Adderall use in the United States when making its decision to approve the drug. 1 21 U.S.C. § 812(b)(2) 2 United States Department of Justice. (2007). Controlled Substances in Schedule II. Retrieved October 24, 2007 from http://www.deadiversion.usdoj.gov/schedules/listby_sched/sched2.htm. 3 Children’s Hospital Boston. (2005). Adderall Response. Retrieved October 24, 2007 from http://www.childrenshospital.org/clinicalservices/Site457/Documents/Adderall%20Response.pdf 4 ADDERALL XR Medication Information. (2007). About ADDERALL XR. Retrieved October 11, 2007 from http://www.adderallxr.com/about_adderallxr/index.asp. Jared Geist Focusing in on Adderall 4 I. BACKGROUND Before it is possible to engage in a harm-benefit analysis of Adderall, it is first necessary to provide pertinent background information that showcases the drug’s history, and discusses its current status today. Specifically, the purposes of this section are to establish Adderall’s uses in the United States- both legally, and recreationally. Although a plethora of amphetamine-based concoctions have been used since the stimulant was first synthesized in 18875, it is important to note that the purpose of this paper is solely to examine Adderall. A. The History of Adderall as a prescription drug Approved by the FDA in the 1960’s, a drug named “Obetrol” was used primarily as a weight-loss medication to treat obesity.6 Obetrol, however, never became popular, and eventually was not profitable enough to stay on the market. Eventually, in 1994, Rexar Pharmaceuticals sold the Obetrol formula rights to Richwood (now Shire Richwood).7 And, in 1996, Adderall was approved by the FDA for treatment of ADHD in children.8 Adderall first was introduced in the form of instant-release capsules, but later was made available in an extended-release form (ADDERRALL XR).9 Both forms of Adderall have the exact same amphetamine-based ingredients and identical composition, with the only difference being the amount of time by which they are released into the body.10 The Adderall composition is also identical to the original 5 PBS Frontline. (2007). A Social History of America’s Most Popular Drugs. Retrieved October 24, 2007 f r o m http://www.pbs.org/wgbh/pages/frontline/shows/drugs/buyers/socialhistory.html. 6 Drabs, Julia. (2005). Drugs for the Treatment of Attention-Deficit Hyperactivity Disorder. Retrieved November 2, 2007 from faculty.smu.edu/jbuynak/Med%20chem%20ppt.ppt. 7 Id. 8 ADDERALL XR Medication Information. (2007). About ADDERALL XR. Retrieved October 11, 2007 from http://www.adderallxr.com/about_adderallxr/index.asp. 9 Id. 10 Id. Jared Geist Focusing in on Adderall 5 Obetrol form.11 Specifically, Adderall is comprised of four active ingredients, each of which make up an equal 25 percent portion of the drug.12 These ingredients are: dextroamphetamine saccharate, dextroamphetamine sulfate, amphetamine aspartate monchydrate, and amphetamine sulfate.13 As is common with most drugs, there are also a number of inactive ingredients, but the mixture of the four amphetamine-based salts above give Adderall its effects. Adderall is prescribed in either 5, 10, 15, 20, 25, or 30 mg doses.14 As mentioned, the FDA approved the use of Adderall as treatment for ADHD. ADHD is a neurological condition related to the brain's chemistry and anatomy.15 ADHD manifests itself as a persistent pattern of inattention or hyperactivity/impulsivity that occurs at a much more frequent and severe level than is typically observed in people at comparable levels of development.16Although most commonly used in children, adults can sometimes be prescribed Adderall for “Adult ADHD”.17 Specifically, Adderall is approved for use in children over the age of three.18 I t is also sometimes prescribed for use as treatment for narcolepsy, but ADHD is by far the most common prescription reason.19 11 Drabs, Julia. (2005). Drugs for the Treatment of Attention-Deficit Hyperactivity Disorder. Retrieved November 2, 2007 from faculty.smu.edu/jbuynak/Med%20chem%20ppt.ppt. 12 ADDERALL XR Medication Information. (2007). Prescription Information. Retrieved October 11, 2007 from http://www.adderallxr.com/assets/pdf/prescribing_information.pdf. 13 Id. 14 Id. 15 ADHD.com (2007). What is ADHD? Retrieved October 11, 2007 f r o m http://www.adhd.com/parents/parents_adhd.jsp. 16 Id. 17 Adult ADHD. (2007). Resources for People with ADHD. Retrieved October 24, 2007 from http://www.adult-adhd.com/. 18 Iannelli, Vincent, M.D. (2005). Adderall and Adderall XR for ADHD. Retrieved October 24, 2007 from http://pediatrics.about.com/od/adhd/a/adderall.htm. 19 ADDERALL XR Medication Information. (2007). Prescription Information. Retrieved October 11, 2007 from http://www.adderallxr.com/assets/pdf/prescribing_information.pdf. Jared Geist Focusing in on Adderall 6 By nature of its mixture of amphetamine-based salts, Adderall is a stimulant.20 The stimulant effects of Adderall are the reason for its use in ADHD treatment. That is, the drug is used to aid in controlling the attention span and minimizing hyperactivity in children who are diagnosed with ADHD.21 The makers of Adderall claim that the drug is thought to restore the balance of the naturally occurring chemicals, dopamine and norepinephrine, available in the brain.22 However, Adderall’s stimulant effects create a problematic alternative use for the drug. B. Adderall Abuse Because amphetamines are listed as Schedule II Drugs under the Controlled Substance Act23, and because Adderall contains amphetamines, Adderall is considered to be a Schedule II Drug. As such, it is deemed to have a high potential for abuse.24 And, as is often the case with drugs that have such potential, it is certainly abused. According to Columbia University Health Services, Adderall can have “speed- like” effects when used by those who do not have ADHD.25 Many adolescents and young adults snort Adderall to get high, believing it to be a “safe alternative” to cocaine – which of course, it is not.26 A 2004 study conducted by “Partnership for a Drug Free America” revealed that one in ten teenagers tried Adderall without a prescription.27 Dangerous side 20 Iannelli, Vincent, M.D. (2005). Adderall and Adderall XR for ADHD. Retrieved October 24, 2007 from http://pediatrics.about.com/od/adhd/a/adderall.htm. 21 Id. 22 ADDERALL XR Medication Information. (2007). About ADDERALL XR. Retrieved October 11, 2007 from http://www.adderallxr.com/about_adderallxr/index.asp. 23 21 U.S.C. § 812(b)(2)
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