Hostname: page-component-78c5997874-lj6df Total loading time: 0 Render date: 2024-11-06T13:47:15.523Z Has data issue: false hasContentIssue false
  • English
  • Français

Reining in the Pharmacological Enhancement Train: We Should Remain Vigilant about Regulatory Standards for Prescribing Controlled Substances

Published online by Cambridge University Press:  01 January 2021

Katherine Drabiak-Syed
Get access Rights & Permissions [Opens in a new window]

Extract

In the March 2010 edition of Mayo Clinic Proceedings, Drs. Rose and Curry declared that resident physicians have an ethical duty to reduce error during periods of fatigue. Problematically, however, they argued this means ingesting a stimulant for performance enhancement and sleep avoidance (hereinafter “PESA”) during a shift when a resident physician is experiencing fatigue as the more ethical choice than forgoing ingesting a stimulant. Rather than accepting enhancement as an unstoppable technological imperative, this article will examine the underlying motivations for enhancement embedded in our culture and the corresponding legal framework relating to stimulant drugs. Although our society seems to be engaged in a pharmacological arms race of efficiency, competition, and self “betterment,” the FDA has not approved stimulant drugs such as modafinil for PESA. As a result, the off-label use of modafinil for PESA means these individuals are part of a large-scale experiment that poses serious immediate and long-term side effects to the individual user as well as society.

Type
Independent
Information
Journal of Law, Medicine & Ethics , Volume 39 , Issue 2 , Summer 2011 , pp. 272 - 279
Copyright
Copyright © American Society of Law, Medicine and Ethics 2011

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Rose, S. and Curry, T., “In reply to: Fatigue Countermeasures, and Performance Enhancement in Resident Physicians,” Mayo Clinic Proceedings 85, no. 3 (2010): 301–302, at 301–302.CrossRefGoogle Scholar
Id.Google Scholar
Greely, H. et al., “Towards Responsible Use of Cognitive Enhancing Drugs,” Nature 456, no. 7223 (2008): 702–705.CrossRefGoogle Scholar
de Jongh, R. et al., “Botox for the Brain: Enhancement of Cognition, Mood and Pro-Social Behavior and Blunting of Unwanted Memories,” Neuroscience and Behavioral Reviews 32, no. 4 (2008): 760–776, at 761.CrossRefGoogle Scholar
Ravelingien, A. and Sandberg, A., “Sleep Better Than Medicine? Ethical Issues Related to ‘Wake Enhancement,’” Journal of Medical Ethics 34, no. e9 (2008): 1–5, at 1, 2.CrossRefGoogle Scholar
Id., at 2.Google Scholar
Launis, V., “Cosmetic Neurology: Sliding Down the Slippery Slope?” Cambridge Quarterly of Healthcare Ethics 19, no. 2 (2010): 218–229 (quoting Chatterjee on the obligation to extend one's self in social and work environments.)CrossRefGoogle Scholar
Pasquale, F., “Toward a General Theory of Law and Technology: Technology, Competition, and Values,” Minnesota Law, Science & Technology 8, no. 2 (2007): 607–622, at 618.Google Scholar
Cascio, J., “Get Smarter,” The Atlantic, July/August 2009.Google Scholar
Capt.Fraser, J., “Performance Maintenance During Continuous Flight Operations,” at slide 26, available at <http://www.public.navy.mil/navsafecen/documents/aviation/operations/performancemaintenance.ppt> (last visited November 1, 2010) (hereinafter “Fraser”); see generally Annas, C. and Annas, G., “Enhancing the Fighting Force: Medical Research on American Soldiers,” Journal of Contemporary Health Law & Policy 25, no. 2 (2009): 283–308.Google Scholar
Id. (Fraser).Google Scholar
Id., at slide 19; Warfighter Endurance Management During Continuous Flight and Ground Operations and Air Force Counter Fatigue Guide, at 4, available at <http://www.scribd.com/doc/1512815/US-Air-Force-WarfighterEnduranceManagement> (last visited November 1, 2010) (hereinafter “Counter Fatigue Guide”).+(last+visited+November+1,+2010)+(hereinafter+“Counter+Fatigue+Guide”).>Google Scholar
See Ravelingien, and Sandberg, , supra note 5, at 4.Google Scholar
See Counter Fatigue Guide, supra note 12, at 4.Google Scholar
See Ravelingien, and Sandberg, , supra note 5, at 4; Chatterjee, A., “Cosmetic Neurology: The Controversy over Enhancing Movement, Mentation, and Mood,” Neurology 63, no. 6 (2004): 968–974, at 972 (Issue and end-page numbers?); Rose, and Curry, , supra note 1, at 301–302.Google Scholar
Id. (Chatterjee, ), at 972; see Rose, and Curry, , supra note 1, at 301–302; Annas, and Annas, , supra note 10, at 292–300.Google Scholar
Westcott, K., “Modafinil, Sleep Deprivation, and Cognitive Functioning in Military and Medical Settings,” Military Medicine 170, no. 4 (2005): 333–335.CrossRefGoogle Scholar
Appel, J., “When the Boss Turn Pusher: A Proposal for Employee Protections in the Age of Cosmetic Neurology,” Journal of Medical Ethics 34, no. 8 (2008): 616–618 (proposing a prohibition against employer coerced or mandated use of enhancement drugs); Glannon, W., “Psychopharmacological Enhancement,” Neuroethics 1 (2008): 45–54, at 52 (discussing employer pressure to use enhancement drugs or face a competitive disadvantage.)CrossRefGoogle Scholar
Maher, B., “Poll Results: Look Who's Doping,” Nature 452, no. 7188 (2008): 674–675. Twenty-five percent of respondents (n=1400) answered they had used drugs for non-medical reasons to stimulate their focus, concentration, or memory. Of those individuals who used these drugs, 62% reported taking methylphenidate; 44% reported taking modafinil; and 15% took beta blockers.CrossRefGoogle Scholar
See DeSantis, A. et al., “Illicit Use of Prescription ADHD Medications on a College Campus: A Multimethodological Approach,” Journal of American College Health 57, no. 3 (2008): 315–324.CrossRefGoogle Scholar
Food and Drug Administration (FDA), Provigil Package Labeling, available at <http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020717s020s013s018lbl.pdf> (last visited March 17, 2011).+(last+visited+March+17,+2011).>Google Scholar
Cephalon, , Media Fact Sheet: Provigil, available at <http://www.cephalon.com/fileadmin/media/downloads/PROVIGIL_Fact_Sheet.pdf> (last visited November 1, 2010); de Jongh, et al., supra note 4, at 762.+(last+visited+November+1,+2010);+de+Jongh,+et+al.,+supra+note+4,+at+762.>Google Scholar
de Jongh, et al., supra note 4, at 763.Google Scholar
See FDA, supra note 21; Cephalon Response to JAMA Article, “The Effects of Modafinil on Dopamine and Dopamine Transporters in the Male Human Brain,” available at <http://www.cephalon.com/media/jama-article-the-effects-of-modafinil-on-dopamine.shtml> (last visited March 17, 2011).+(last+visited+March+17,+2011).>Google Scholar
See FDA, supra note 21.Google Scholar
Mariani, J. and Hart, C., “Letter to the Editor: Psychosis Associated with Modafinil and Shift Work,” American Journal of Psychiatry 162, no. 10 (2005): 1983.CrossRefGoogle Scholar
Food and Drug Administration, “Division of Drug Marketing, Advertising, and Communications Warning Letter to Cephalon, Inc. 27-Feb-07,” available at <http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm076308.htm> (last visited March 17, 2011); Food and Drug Administration, “Division of Drug Marketing; Advertising, and Communications Warning Letter to Cephalon, Inc. Re: NDA # 20–717,” available at <http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM164556.pdf> (last visited March 17, 2011).+(last+visited+March+17,+2011);+Food+and+Drug+Administration,+“Division+of+Drug+Marketing;+Advertising,+and+Communications+Warning+Letter+to+Cephalon,+Inc.+Re:+NDA+#+20–717,”+available+at++(last+visited+March+17,+2011).>Google Scholar
Id.Google Scholar
See Westcott, , supra note 17.Google Scholar
Volkow, N. et al., “Effects of Modafinil on Dopamine and Dopamine Transporters in the Male Human Brain,” Journal of the American Medical Association 301, no. 11 (2009): 1148–1154.CrossRefGoogle Scholar
Id.; Ledford, H., “Cognitive Enhancement Drug May Also Cause Addition,” Nature News, available at <http://www.nature.com/news/2009/090317/full/news.2009.170.html> (last visited March 17, 2011).CrossRef+(last+visited+March+17,+2011).>Google Scholar
See Ravelingien, and Sandberg, , supra note 5, at 1.Google Scholar
The military problematically argues that prescribing and ingesting stimulants during combat or in circumstances of “operational necessity” does not constitute an enhancement but rather “performance maintenance.” See Fraser, , supra note 10.Google Scholar
Mehlman, M. and Berg, J., “Human Subjects Protections in Biomedical Enhancement Research: Assessing Risk and Benefit in Obtaining Informed Consent,” Journal of Law, Medicine & Ethics 36, no. 3 (2008): 546–549, at 547 (discussing what constitutes an enhancement in research).CrossRefGoogle Scholar
See Chatterjee, , supra note 15, at 970; Chatterjee, A., “The Promise and Predicament of Cosmetic Neurology,” Journal of Medical Ethics 32, no. 2 (2006): 110–113, at 111; Glannon, , supra note 18, at 51. But see Larriviere, D. et al., “Responding to Requests from Adult Patients for Neuroenhancements: Guidance of the Law, Ethics, and Humanities Committee,” Neurology 73, no. 17 (2009): 1406–1412, at 1410. Larriviere, et al. state that the FDA approval process would constrain risks within an acceptable range. However, this calculation relies on a physician prescribing the drug for a medically indicated use where the drug would provide benefit, not exposing the patient to risk balanced by not medically necessary enhancement benefits.CrossRefGoogle Scholar
See Chatterjee, , supra note 15, at 970; Chatterjee, , supra note 35, at 111; Glannon, , supra note 18, at 51.Google Scholar
See Chatterjee, , supra note 35, at 111 (discussing safety risks and the limitations of short term clinical trials.)Google Scholar
Racine, E. and Forlini, C., “Expectations Regarding Cognitive Enhancement Create Substantial Challenges,” Journal of Medical Ethics 35, no. 8 (2009): 469–470 (discussing why concerns of safety are substantive enough to warrant consideration of pharmaceutical enhancement); Kennedy, D., “Editorial: Just Treat, or Enhance?” Science 304, no. 5667 (2004): 17 (discussing how the human nervous system is labile and demands treating it with extra caution).CrossRefGoogle Scholar
See Glannon, , supra note 18, at 53.Google Scholar
Id., at 53; Greely, et al., supra note 3, at 703.Google Scholar
See Annas, and Annas, , supra note 10, at 296 (discussing how Air Force pilots’ sustained use of amphetamines produced a cumulative effect on their brain which may have undermined their reaction time, patience, and contributed to a devastating accident.)Google Scholar
See Larriviere, et al., supra note 35, at 1410.Google Scholar
See de Jongh, et al., supra note 4, at 770–771 (discussing a trade-off between cognition and mood).Google Scholar
Id., at 763 (discussing how modafinil can produce anxiety and aggression); id., at 770–771 (discussing a trade-off between cognition and mood); see also Talbot, M., “The Brain Gain,” The New Yorker, April 27, 2009 [quoting Martha Farah on the trade-off between focus and creativity.])Google Scholar
Id. (Talbot).Google Scholar
Id.; Glannon, , supra note 18, at 48.Google Scholar
See Ravelingien, and Sandberg, , supra note 5, at 1.Google Scholar
See Glannon, , supra note 18, at 47.Google Scholar
Id., at 47.Google Scholar
Id.Google Scholar
Id.Google Scholar
See Counter Fatigue Guide, supra note 12, at 4.Google Scholar
See Glannon, , supra note 18, at 47.Google Scholar
Rose, S. and Curry, T., “Fatigue, Countermeasures, and Performance Enhancement in Resident Physicians,” Mayo Clinic Proceedings 84, no. 11 (2009): 955–957, at 956.CrossRefGoogle Scholar
See Annas, and Annas, , supra note 10, at 294–297 (discussing the role of amphetamines on impaired judgment involving an accident where Air Force pilots mistakenly bombed and killed Canadian soldiers while flying over Afghanistan); see also H. Ray Evers v. State of Alabama, 434 So. 2d 813, 814 (Ala. 1983) (discussing how taking amphetamines merely to stay awake while driving on a trip is not a legitimate medical purpose because it poses hazards to one's self and others on the road because of impaired judgment, confusion, delusions and hallucinations.)Google Scholar
Id.; see Rose, and Curry, , supra note 1.Google Scholar
See Appel, , supra note 18, at 616 (discussing how enhancement constitutes “unchecked tinkering” on patients.)Google Scholar
21 USC § 829; 21 USC§ 812.Google Scholar
Campbell, D., “Academics Say ‘Smart’ Drugs Could Be Prescribed,” The Guardian, available at <http://www.guardian.co.uk/education/2010/may/11/ritalin-drugs-young-people> (last visited March 17, 2011) (discussing how scholars have compared cognitive enhancing drugs such as Ritalin to enhancement through caffeine, academic tutors, vitamins, and Baby Mozart); see Greely, et al., supra note 3, at 702 (discussing how cognitive enhancing drugs should be viewed in the same category as education, good health habits, and information technology.)+(last+visited+March+17,+2011)+(discussing+how+scholars+have+compared+cognitive+enhancing+drugs+such+as+Ritalin+to+enhancement+through+caffeine,+academic+tutors,+vitamins,+and+Baby+Mozart);+see+Greely,+et+al.,+supra+note+3,+at+702+(discussing+how+cognitive+enhancing+drugs+should+be+viewed+in+the+same+category+as+education,+good+health+habits,+and+information+technology.)>Google Scholar
See FDA, supra note 21; 21 USC§ 812 (b)(4).Google Scholar
21 USC §829. The statute does provide an exception where a practitioner other than a pharmacist may directly dispense the drug in a circumstance such as where the practitioner provides the patient a sample size drug during the office visit.Google Scholar
See Larriviere, , supra note 35, at 1407; Chatterjee, , supra note 15, at 968.Google Scholar
See Glannon, , supra note 18, at 53.Google Scholar
See Appel, , supra note 18, at 616 (discussing how individuals assert that enhancements are a right and the essence of freedom.)Google Scholar
Miller, F. and Brody, H., “Open Peer Commentary: Enhancement Technologies and Professional Integrity,” American Journal of Bioethics 5, no. 3 (2005): 15–17.CrossRefGoogle Scholar
Id.Google Scholar
See Appel, , supra note 18, at 616.Google Scholar
See US v. Boettjer, 569 F2d 1078 at 1082 (9th Cir. 1978) (“when a doctor stops treating people, when he instead, gives drugs to people because they like them, he becomes a pill pusher”); US v. David Demaret Chube II and Charles Randall Chube, 538 F.3d 693 at 696–697 (7th Cir. 2008) (discussing how a physician becomes a “pill-pusher” when he writes a prescription without a legitimate medical purpose and outside the scope of professional practice.)Google Scholar
Id.Google Scholar
See generally Ten. Code Ann. § 63-6-214; La. Rev. Stat. Ann. §§ 37: 1275, 1261; Ohio Rev. code ann. § 4731.22.Google Scholar
21 USC § 829.Google Scholar
See generally mich. comp. laws ann. § 333.7333; ten. Code ann. § 63-6-214.Google Scholar
See generally mich. comp. laws ann. § 333.7333; ten. Code ann. § 63-6-214.Google Scholar
Ten. Code ann. § 63-6-214. This statute refers to what would not constitute a valid prescription and serve as grounds for professional license denial, suspension, or revocation. For the sake of argument I reversed the language in the statute.Google Scholar
Bharmota v. State Medical Board of Ohio, 1993 Ohio App. 5858 at *2,*8 (Ohio Ct. App. 1993).Google Scholar
US v. David Demaret Chube II and Charles Randall Chube, 538 F.3d 693 at 695 (7th Cir. 2008) (discussing how the patients did not present with true medical complaints); In the Matter of Lucas Anthony Dileo, 661 So. 2d 162 (La. Ct. App. 1995) (discussing how pain, injury, or complication constitute legitimate medical purposes).Google Scholar
James D. Williams v. Tennessee Board of Medical Examiners, 1994 Tenn. App. LEXIS 443 (Tenn. Ct. App. 1994) (describing how the physician must have a reason for prescribing the drug and the prescription should be reasonable and necessary to treat the patient's symptoms.)Google Scholar
Many scholars have pointed out the oddity of attempting to adapt people to society's “needs” of long hours, competition, and high productivity levels that can only be achieved by drugs. Rather than requiring members of society to adapt to this standard, society should adapt to human needs for a balanced lifestyle, sleep and restoration. See Ravelingien, and Sandberg, , supra note 5, at 2; Annas, and Annas, , supra note 10, at 299–308; Pasquale, , supra note 8, at 618.Google Scholar
H. Ray Evers v. State of Alabama, 434 So. 2d 813, 814 (Ala. 1983) (discussing the reason for the prescription).Google Scholar
Id. (discussing whether the physician committed a violation of the statute).Google Scholar
Id. The court relies on the fact that the statute defining what constitutes selling, furnishing, or giving away controlled substances does not specifically contain a prohibition for non-therapeutic prescriptions, which suggest the court did not want to find a criminal violation based on a vague statute as a matter of criminal law policy rather than a substantive discussion of the issue.Google Scholar
US v. David Demaret Chube II and Charles Randall Chube, 538 F.3d 693 at 697, 699 (7th Cir. 2008) (discussing how a physician must examine a patient's medical chart to determine a patient's complaint, history, and symptoms to inform the physician's judgment whether a prescription for a controlled substance is an appropriate course of treatment); In the Matter of Lucas Anthony Dileo, 661 So. 2d 162 at 165–168 (La. Ct. App. 1995) (discussing short-term use plan for an addictive controlled substance when a patient is in active pain).Google Scholar
Robert E. Holladay v. Louisiana State Board of Medical Examiners, 689 So. 2d 718 at 727 (Mo. Ct. App. 1997) (discussing formulating a treatment plan based on a patient's diagnosis and prescribing a controlled substance that is medically necessary for a patient's treatment plan).Google Scholar
US v. Merrill, 513 F. 3d 1293, 1306 (11th Cir. 2008) (discussing how the standard of practice does not consider the physician's subjective intent but constitutes an objective standard).Google Scholar
Bharmota v. State Medical Board of Ohio, 1993 Ohio App. 5858 at *11–13 (Ohio Ct. App. 1993) (discussing how a state medical licensing board has the authority to determine the acceptable practice of medicine and is not required to recognize a minority viewpoint of care which it does not believe is medically acceptable).Google Scholar
US v. Paskon, 2008 US Dist. LEXIS 38446 at *13–15 (E.D. Mo. 2008) (discussing how a physician cannot prescribe a controlled substance to a patient simply because the patient requests a particular medication or a certain amount of medication); Frances E. White v. Board of Medical Quality Assurance, 128 Cal. App. 3d 699 at 703 (Ca. Ct. App. 1982) (discussing prescribing a medication for the purposes of falling asleep or staying awake).Google Scholar
The Ethics, Law, and Humanities Committee of the American Academy of Neurology assumes prescribing of drugs for neuroenhancement is legally permissible, but does not explain its conclusion. Additionally, the Committee states that the medical principles for prescribing medications for treatment are the same as for enhancement, but this ignores the goals and guidelines within the purpose of medicine. See Larriviere, et al., supra note 35, at 1408.Google Scholar
Id.Google Scholar