Dementia and antipsychotics: A prescription for problems

Journal of Legal Medicine

Volumn 33, Issue 4, 2012, Pages 553-569

  Berns, Artie ^a  

^a SOUTHERN ILLINOIS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEUROLEPTIC AGENT;

AGED; ALZHEIMER DISEASE; ARTICLE; CAUSE OF DEATH; CONFLICT OF INTEREST; DRUG APPROVAL; DRUG COMBINATION; DRUG CONTRAINDICATION; DRUG INDUSTRY; DRUG RECALL; FOOD AND DRUG ADMINISTRATION; HOME FOR THE AGED; HUMAN; INAPPROPRIATE PRESCRIBING; LEGAL ASPECT; MORTALITY; NURSING HOME; UNITED STATES;

AGED; ALZHEIMER DISEASE; ANTIPSYCHOTIC AGENTS; CAUSE OF DEATH; CONFLICT OF INTEREST; DRUG APPROVAL; DRUG INDUSTRY; DRUG THERAPY, COMBINATION; HOMES FOR THE AGED; HUMANS; INAPPROPRIATE PRESCRIBING; NURSING HOMES; SAFETY-BASED DRUG WITHDRAWALS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84871481910     PISSN: 01947648     EISSN: 1521057X     Source Type: Journal    
DOI: 10.1080/01947648.2012.739067     Document Type: Article

References (41)

1. Valerie Jablow, Lawsuits Challenge Use of "Chemical Restraints" in Nursing Homes, 44 Trial 12, 12-13 (Mar. 2008).
2. Press Release, U.S. Food & Drug Admin. Public Health Advisory: Deaths with Antipsychotics in Elderly Patients with Behavioral Disturbances (Apr. 11, 2005), available at http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHe athcareProfessionals/PublicHealthAdvisories/ ucm053171.htm [hereinafter Antipsychotic Advisory];
3. Press Release, U.S. Food & Drug Admin., Antipsychotics, Conventional and Atypical (June 16, 2008), available at http://www.fda.gov/Safety/MedWatch/ SafetyInformation/SafetyAlertsforHum anMedicalProducts/ucm110212.htm [hereinafter Atypical Press Release].
4. Daniel R. Levinson, Inspector Gen., Dep't Health & Human Servs., Off. Inspector Gen., Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents 15 (2011), available at http://oig. hhs.gov/oei/reports/oei-07- 08-00150.pdf.
5. PDR Medical Dictionary 37 (3d ed. 2006).
6. Douglas Mossman & Jill L. Steinberg, Promoting, Prescribing, and Pushing Pills: Understanding the Lessons of Antipsychotic Drug Litigation, 13 Mich. St. U. J. Med. & L. 263, 274-75 (2009).
7. FDA, Information on Conventional Antipsychotics, (2011), available at http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm107211.htm.
8. Mossman & Steinberg, supra note 14, at 278. Extrapyramidal refers to descending nerve tracts other than the pyramidal tracts. Merriam-Webster's Medical Desk Dictionary (Rev. ed. 2005), available at http://www.credoreference. com/entry/mwmedicaldesk/extrapyramidal.
9. Churchill Livingstone's Dictionary of Nursing (2006), available at http://www.credoreference. com/entry/ehscldictnursing/corticospinal tracts.
10. FDA, Atypical Antipsychotic Drugs Information (2011), available at http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm.
11. Aaron S. Kesselheim, Off-Label Drug Use and Promotion: Balancing Public Health Goals and Commercial Speech, 37 Am. J.L. & Med. 225, 241 (2011).
12. Sharon B. Gardner et al., Dementia and Legal Capacity: What Lawyers Should Know When Dealing with Expert Witnesses, 6 NAELA J. 131, at 131, 132-33 (2010).
13. Alzheimer's Association, Alzheimer's Association Report: 2012 Alzheimer's Disease Facts and Figures 137 (2012), available at http://download.journals. elsevierhealth.com/pdfs/journals/1552-5260/PIIS1552526012000325.pdf.
14. U.S. Census Bureau, Statistical Abstract of the United States: 2012, at 11 tbl.7 (131st ed. 2012), available at http://www.census.gov/compendia/statab/ 2012/tables/12s0007.pdf.
15. Lon S. Schneider et al., Effectiveness of Atypical Antipsychotic Drugs in Patients with Alzheimer's Disease, 355 New Eng. J. Med. 1524, 1526 (2006).
16. Lon S. Schneider et al., Risk of Death with Atypical Antipsychotic Drug Treatment for Dementia: Meta-analysis of Randomized Placebo-Controlled Trials, 294 J.A.M.A. 1934, 1934 (2005).
17. Sudeep S. Gill et al., Antipsychotic Drug Use and Mortality in Older Adults with Dementia, 146 Annals Internal Med. 775, 775-76 (2007).
18. Compare id. with Sebastian Schneeweiss et al., Risk of Death Associated with the Use of Conventional Versus Atypical Antipsychotic Drugs Among Elderly Patients, 176 Can. Med. Ass'n J. 627 (2007).
19. John B. Breaux & Orrin G. Hatch, Confronting Elder Abuse, Neglect, and Exploitation: The Need for Elder Justice Legislation, 11 Elder L. J. 207, 224 (2003).
20. Press Release, Centers for Medicare & Medicaid Services, CMS Announces Partnership to Improve Dementia Care in Nursing Homes (May 30, 2012), http://www.cms.gov/apps/media/press/release. asp?Counter=4368&intNumPerPage= 10&checkDate=&checkKey=&srchType=1&numDays=350 0&srchOpt=0&srchData=&keywordType=All&chkNewsType= 1%2C+2%2C+3%2C+4%2C+5& intPage=&showAll=&pYear=&year=&desc= &cboOrder=date.
21. Nursing Home Compare, http://www.medicare.gov/NHCompare/Include/ DataSection/Questions/SearchCriteriaNEW.asp?version=default&browser= Chrome%7C20%7CWindows+7& language=English&defaultstatus=0&pagelist= Home&CookiesEnabledStatus=True.
22. Stephen H. Grimes, Pressure Rising: Health Care Businesses Face Tougher Fraud Enforcement Amid Increased Criminal Presence in the Industry, 6 Bus. L. Brief (Am. U.) 43, 47 (2010).
23. IMS Health, Top 15 Global Products, 2009, Total Audited Markets (2010), available at http://www.imshealth.com/ims/Global/Content/Corporate/Press%20Room/ Top-line%20Market%20Data/2009%20Top-line%20Market%20Data/Top%2015%20Global%20 Products 2009.pdf.
24. Daniella A. Zipkin & Michael A. Steinman, Interactions Between Pharmaceutical Representatives and Doctors in Training, 20 J. Gen. Internal Med. 777, 777 (2005).
25. Sandra H. Johnson, Polluting Medical Judgment? False Assumptions in the Pursuit of False Claims Regarding Off-Label Prescribing, 9 Minn. J.L. Sci. & Tech. 61, 79 (2008).
26. James T. O' R eilly, Food and Drug Administration § 13:79 (3d ed. 2007).
27. Ultra vires is defined as "[u]nauthorized; beyond the scope of power allowed or granted by a corporate charter or by law." Black's Law Dictionary 1662 (9th ed. 2009).
28. The PFDA "prohibited the interstate commerce of misbranded and adulterated food, drink, and drugs." Bernice Schacter, The New Medicines: How Drugs Are Created, Approved, Marketed, and Sold 16 (2006).
29. The term was later co-opted by the group to describe courageous exposition of social problems. Muckraker, 8 Encyclopædia Britannica 390 (2007).
30. FDA, Centennial of FDA (2009), available at http://www.fda.gov/AboutFDA/ WhatWeDo/History/CentennialofFDA/default.htm.
31. Quack is defined as "relating to boasting or unfound pretension" or "pretending to cure diseases." Webster's Third New International Dictionary 1856 (1993).
32. Roseann B. Termini, Health Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods and Dietary Supplements 3 (2d ed. 2004).
33. Patricia J. Zettler, The Implications of Post-Phase 1 and "Off-Label" Treatment Use of Experimental Drugs: How Expansive Should Expanded Access Be?, 18 Kan. J.L. & Pub. Pol'y 135, 137-38 (2009).
34. Dan Eggen, Health Sector Has Donated Millions to Lawmakers, Wash. Post, Mar. 8, 2009, at A9.
35. Marc-André Gagnon & Joel Lexchin, The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States, 5 PLoS Med. 29, 31 (2008).
36. Jeff Wyble, Methamphetamine-The New Epidemic, 11 Mich. St. U. J. Med. & L. 115 (2007).
37. Erin Reed, The Prescription for Eradicating Meth Labs: A Call for States to Enact Stricter Chemical Control Over Precursors, 37 Cap. U. L. Rev. 787, 791 (2009).
38. PDR for Nonprescription Drugs 8, 214 (33d ed. 2012). Mississippi and Oregon each require a prescription for meth precursors. Miss. Code Ann. § 41-29-117(d) (Supp. 2010);
39. 50 State Statutory Surveys: Criminal Laws: Controlled Substances: Methamphetamine, State by State Analysis Table (attached pdf file), 0030 Surveys 4 (West 2011) [hereinafter Meth Survey].
40. 50 State Regulatory Surveys: Health Care: Health Care Providers: State Licensure of Physicians, State by State Analysis Table (attached pdf file), 0100 Surveys 24 (West 2011);
41. 50 State Statutory Surveys: Health Care: Health Care Providers: State Licensure: Physicians, State by State Analysis Table (attached pdf file), 0100 Regsurveys 16 (2011 West) .