Source: http://pharmagossip.blogspot.com/2012/01/plos-medicine-challenging-medical.html
Timestamp: 2017-11-20 00:12:29
Document Index: 33823882

Matched Legal Cases: ['§ 310', '§ 311', '§ 311', '§ 3729', '§ 3730', '§ 301', '§ 3571', '§ 1320']

PharmaGossip: PLoS Medicine: Challenging Medical Ghostwriting in US Courts
Xavier Bosch1*, Bijan Esfandiari2, Leemon McHenry3
1 Department of Internal Medicine at the Hospital Clínic and the Institut d'Investigacions Biomèdiques August Pí i Sunyer, University of Barcelona, Barcelona, Spain, 2 Law Firm of Baum, Hedlund, Aristei & Goldman, Los Angeles, California, United States of America, 3 Department of Philosophy, California State University, Northridge, California, United States of America
Citation: Bosch X, Esfandiari B, McHenry L (2012) Challenging Medical Ghostwriting in US Courts. PLoS Med 9(1): e1001163. doi:10.1371/journal.pmed.1001163
Copyright: © 2012 Bosch et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abbreviations: FCA, False Claims Act; KOL, key opinion leader
* E-mail: xavbosch@clinic.ub.es
Legal Remedies for Medical Ghostwriting Top
Personal Injury and Wrongful Death Damages Caused by the Guest-Authors' Misrepresentations Top
False Claims Act Top
Liability under the Anti-Kickback Statute Top
Since paying physicians to become honorary or guest authors of a ghostwritten paper may influence their clinical judgment, subsequently increasing product sales (and government health care costs), and putting patients at risk by misrepresenting risk-benefit, both physicians and sponsor companies may be legally liable. The FCA, in conjunction with the Anti-Kickback Statute, can also be utilized to curb unethical ghostwriting. Via the FCA, a claim can be filed on behalf of the government by anyone possessing information regarding the anti-kickback violation and, if successful, the claimant or “relator” can share in any damages collected on behalf of the government. In addition, once the government is apprised of a kickback violation, the Department of Justice may bring criminal actions against violators of the Anti-Kickback Statute. Classified as a felony, the maximum individual punishments are fines of up to US$250,000 and imprisonment for up to five years [46]. Furthermore, individuals guilty of violating the statute can be excluded from participation in government programs such as Medicare and Medicaid [47]. The threat of civil and potential criminal prosecution is another potential manner of curbing guest authorship, especially when it is the result of reciprocal agreements between physicians/guest-authors to prescribe the drug and manufacturers promising to use the physician as a guest author.
No Recourse to the First Amendment Top
Conceived and designed the experiments: XB BE LM. Analyzed the data: XB BE LM. Wrote the first draft of the manuscript: XB BE LM. Contributed to the writing of the manuscript: XB BE LM. ICMJE criteria for authorship read and met: XB BE LM. Agree with manuscript results and conclusions: XB BE LM. Jointly developed the structure and arguments of the paper: XB BE LM. Made critical revisions and approved final version: XB BE LM.
Gøtzsche PC, Kassirer JP, Woolley KL, Wager E, Jacobs A, et al. (2009) What should be done to tackle ghostwriting in the medical literature? PLoS Med 6: e23. doi:10.1371/journal.pmed.1000023.
Ross JS, Hill KP, Egilman DS, Krumholz HM (2008) Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA 299: 1800–1812. Find this article online
Fugh-Berman AJ (2010) The haunting of medical journals: how ghostwriting sold ‘HRT.’ PLoS Med 7: e1000335. doi:10.1371/journal.pmed.1000335.
Flanagin A, Carey LA, Fontanarosa PB, Phillips SG, Pace BP, et al. (1998) Prevalence of articles with honorary authors and ghost authors in peer-reviewed medical journals. JAMA 280: 222–224. Find this article online
Gøtzsche PC, Hróbjartsson A, Johansen HK, Haahr MT, Altman DG, et al. (2007) Ghostauthorship in industry-initiated randomisedtrials. PLoS Med 4: e19. doi:10.1371/journal.pmed.0040019.
The PLoS Medicine (2009) Ghostwriting: the dirty little secret of medical publishing that just got bigger. PLoS Med 6: e1000156. doi:10.1371/journal.pmed.1000156.
McHenry LB, Jureidini J (2008) Industry-sponsored ghostwriting in clinical trial reporting: a case study. Account Res 15: 152–167. Find this article online
Sismondo S (2007) Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry? PLoS Med 4: e286. doi:10.1371/journal.pmed.0040286.
Barbour V (2010) How ghost-writing threatens the credibility of medical knowledge and medical journals. Haematologica 95: 1–2. Find this article online
Bosch X (2010) Safeguarding good scientific practice in Europe. EMBO Rep 11: 252–257. Find this article online
Dunbar CE, Tallman MS (2009) ‘Ghostbusting’ at blood. Blood 113: 502–503. Find this article online
Lacasse JR, Leo J (2010) Ghostwriting at elite academic medical centers in the United States. PLoS Med 7: e1000230. doi:10.1371/journal.pmed.1000230.
The PLoS Medicine (2011) Ghostwriting revisited: new perspectives but few solutions in sight. PLoS Med 8: e1001084. doi:10.1371/journal.pmed.1001084.
Matheson A (2011) How industry uses the ICMJE guidelines to manipulate authorship—and how they should be revised. PLoS Med 8: e1001072. doi:10.1371/journal.pmed.1001072.
Bosch X, Ross JS (2012) Ghostwriting: research misconduct, plagiarism, or fool's gold? Am J Med. In press. Find this article online
Sterns S, Lemmens T (2011) Legal remedies for medical ghostwriting: imposing fraud liability on guest authors of ghostwritten articles. PLoS Med 8: e1001070. doi:10.1371/journal.pmed.1001070.
Steinman MA, Bero LA, Chren MM, Landefeld CS (2006) The promotion of gabapentin: an analysis of internal industry documents. Ann Inter Med 145: 284–293. Find this article online
Healy D, Cattell D (2003) Interface between authorship, industry and science in the domain of therapeutics. Br J Psychiatry 183: 22–27. Find this article online
Mundy A (2001) Dispensing with the truth: the victims, the drug companies, and the dramatic story behind the battle over Fen-Phen. New York: St. Martin's Press.
Jureidini J, McHenry L (2011) Conflicted medical journals and the failure of trust. Account Res 18: 45–54. Find this article online
World Association of Medical Editors (WAME) (2005) Ghostwriting initiated by commercial companies. Available: http://www.wame.org/resources/policies#g​host. Accessed 14 December 2011.
Committee on Publication Ethics (COPE) (2011) COPE code of conduct for journal editors. Available: http://www.publicationethics.org/files/C​ode_of_conduct_for_journal_editors_Mar11​.pdf. Accessed 14 December 2011.
Singer N, Wilson D (17 September 2009) Medical editors push for ghostwriting crackdown. New York Times.
Wislar J, Flanagin A, Fontanarosa PB, DeAngelis CD (2011) Honorary and ghost authorship in high impact biomedical journals: across sectional survey. BMJ 343: d6128. doi:10.1136/bmj.d6128.
Randi W. v. Muroc Joint Unified School Dist., 14 Cal.4th 1066, 1077 (1997).
Glanzer v. Shepard, 233 N.Y. 236, 239 (1922).
Randi W., 14 Cal.4th at 1077; Garcia v. Superior Court, 50 Cal.3d 728, 734 (Cal.1990); Clark v. St. Dominic-Jackson Mem'l Hosp., 660 So. 2d 970, 974 (Miss. 1995); Brown v. Neff, 603 N.Y.S.2d 707, 709 (N.Y. Sup. Ct. 1993).
Restatement (second) of Torts §§ 310 and 311 (1977).
Rest. 2d Torts § 311, com. b (Garcia, supra, 50 Cal.3d at pp. 728, 735, 268 Cal. Rptr. 779, 789 P.2d 960, quoting Rest.2d Torts, § 311, com. b, at p. 106).
Knipe v. SmithKline Beecham, 583 F.Supp.2d 602, 621 (E.D.Pa. 2008).
Risperdal Litigation (Philadelphia Court of Comm. Pleas, March Term 2010). Available: http://www.courts.phila.gov/pdf/clc/1003​00296-05262010.pdf. Accessed 14 December 2011.
31 U.S.C. § 3729–3733. Available: http://www.taf.org/federalfca.htm. Accessed 14 December 2011.
Kesselheim AS, Mello MM, Studdert DM (2011) Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints. PLoS Med 8: e1000431. doi:10.1371/journal.pmed.1000431.
31 U.S.C. § 3730. Section 3730: Civil actions for false claims.
Kesselheim AS, Studdert DM (2008) Whistleblower-initiated enforcement actions against health care fraud and abuse in the United States, 1996 to 2005. Ann Intern Med 149: 342–349. Find this article online
Loucks MK (2006) Pros and cons of off-label promotion investigations and prosecutions. Food Drug Law J 61: 577–583. Find this article online
Mello MM, Studdert DM, Brennan TA (2009) Shifting terrain in the regulation of off-label promotion of pharmaceuticals. N Engl J Med 360: 1557–1566. Find this article online
21 U.S.C. §§ 301–97.
Department of Justice (13 May 2004) Warner-Lambert to pay $430 million to resolve criminal & civil health care liability relating to off-label promotion. Department of Justice [press release]. Available: http://www.justice.gov/opa/pr/2004/May/0​4_civ_322.htm. Accessed 14 December 2011.
Associated Press (5 December 2007) Drug whistleblower collects $24M. Available: http://www.cbsnews.com/stories/2004/05/1​3/health/main617223.shtml. Accessed 14 December 2011.
Center for Medicare Advocacy, Inc (2010) Medicare coverage for off-label drug use. Available: http://www.medicareadvocacy.org/2010/09/​cma-report-medicare-coverage-for-off-lab​el-drug-use/. Accessed 19 December 2011.
Fiegl C (18 March 2011) Medicare ordered to pay for off-label drugs. American Medical News. Available: http://www.ama-assn.org/amednews/2011/03​/14/gvse0318.htm. Accessed 19 December 2011.
US Food and Drug Administration. FD&C Act Chapter III: Prohibited Acts and Penalties. Available: http://www.fda.gov/RegulatoryInformation​/Legislation/FederalFoodDrugandCosmeticA​ctFDCAct/FDCActChapterIIIProhibitedActsa​ndPenalties/default.htm. Accessed 4 December 2011.
42 U.S.C. 1320a-7b; see also United States ex rel. Hutcheson v. Blackstone Med., Inc., __ F.3d __, 2011 WL 2150191 (1st Cir. June 1, 2011).
Studdert DM, Mello MM, Brennan TA (2004) Financial conflicts of interest in physicians' relationships with the pharmaceutical industry–self-regulation in the shadow of Federal prosecution. N Engl J Med 351: 1891–1900. Find this article online
18 U.S.C. § 3571.
42 U.S.C. § 1320a-7.
Illinois, ex rel. Madigan v. Telemarketing Associates, Inc., 538 U.S. 600, 612 (2003).
United States v. Caronia, 576 F.Supp.2d 385 (E.D.N.Y. 2008).
via plosmedicine.org