i. See Paul Basken, “As He Worked to Strengthen Ethics Rules, NIMH Director Aided a Leading Transgressor” (i.e., Charles Nemeroff), The Chronicle of Higher Education, June 6, 2010, http://chronicle.com/article/While-Revising-Ethics-Rules/65800; Silverman, “Grassley Targets Brown’s Keller Over Grants,” Pharmalot.com, July 14th, 2008,
http://www.pharmalot.com/2008/07/grassley-targets-browns-keller-over-grants/; Firestone and Kelsh, “Keller’s findings on Paxil disputed by doctors, FDA,”The Brown Daily Herald, September 24, 2008,
http://www.browndailyherald.com/campus-news/keller-s-findings-on-paxil-disputed-by-doctors-fda-1.1669707#.ToN-EYIa-dA; Firestone and Kelsh, “Senator targets professor’s ties to big pharma,” The Brown Daily Herald, September 24, 2008, http://www.browndailyherald.com/campus-news/senator-targets-professor-s-ties-to-big-pharma-1.1669703#.ToN98oIa-dA; Silverman, “Antidepressant Use And Conflicts Of Interest,” Pharmalot.com, September 7, 2007,
ii.See September 13, 2004 Psychopharmacological Drug Advisory Committee transcript, http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004‑4065T1.htm, p.445; September 14, 2004 PDAC transcript, http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004‑4065T2.htm, p. 83. See also Jureidini, Doecke, Mansfield, Haby, Menkes, Tonkin, Efficacy and safety of antidepressants for children and adolescents, BMJ 2004;328:879‑883 (10 April), doi:10.1136/bmj.328.7444.879 available in full at http://www.bmj.com/cgi/content/full/328/7444/879; Newman, A Black‑Box Warning for Antidepressants in Children? N Eng J Med, Vol. 351:1595‑1598, October 14, 2004, abstract available at http://content.nejm.org/cgi/content/short/351/16/1595
iii. Even so, both Prozac’s and Lexapro’s efficacy for the treatment of children and adolescents is dubious. As Dr. Thomas Newman, an epidemiologist from UC San Francisco and an FDA advisor, explained during the September 14, 2004 PDAC, “We have I think very strong evidence of harm and really not very good evidence of efficacy, and although I know many practitioners are convinced that these drugs work, if you look very closely at the [Prozac pediatric] trial, just as an example, … the improvement over placebo was really very, very small, and I would say not detectable by a clinician treating individual patients. …” See September 14, 2004 PDAC transcript at
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004‑4065T2.htm, p. 338. With respect to Lexapro, its approval for children ages 12-17 in March 2009 came, curiously enough, amidst charges by the Department of Justice that its manufacturer, Forest Labs, illegally marketed Lexapro for children and paid pediatricians kickbacks to prescribe the drugs off-label. Forest labs ended up paying over $313 million to settle the unlawful marketing allegations and pled guilty to felony obstruction of justice, two misdemeanor counts and paying kickbacks to doctors. See: Department of Justice press release, “Drug Maker Forest Pleads Guilty; To Pay More Than $313 Million to Resolve Criminal Charges and False Claims Act Allegations,” September 15, 2010, http://www.justice.gov/opa/pr/2010/September/10-civ-1028.html. Another oddity about Lexapro’s approval is that it was approved based on only one favorable clinical trial of Lexapro (the FDA normally requires two well-controlled clinical trials). The FDA accepted the company’s combination of one positive Lexapro trial and one positive trial of Lexapro’s “sister” drug Celexa, which, on its own, Forest was never able to prove effective. Two other pediatric clinical trials (one Lexapro and one Celexa) failed. Forest was also unable to prove that Lexapro was effective for maintaining treatment for depression in children and/or adolescents.
iv. Knipe v. GlaxoSmithKline, 583 F.Supp.2d 602, 640 (E.D.Pa. 2008).
v. Jureidini et al., Efficacy and safety of antidepressants for children and adolescents, Brit. Med. J., p. 879, 10 April 2004.
vi. See Jon Jureidini, The Black Box Warning: Decreased Prescriptions and Increased Youth Suicide?, 164 Am. J. Psychiatry 1907 (2007).
vii. See Alex Berenson & Benedict Carey, Experts Question Study on Youth Suicide Rates, N.Y. Times, September 14, 2007.
viii.See Joint Meeting of the Peripheral and Central Nervous system drugs advisory committee and the Psychopharmacological Drugs Advisory Committee, (“PDAC”) FDA (Beltsville, Maryland) (July 10, 2008), Hearing Tr. at 52.
ix. See Tony Sheldon, Dutch Academics Criticise Suicide Claims in American Journal, 336 Brit. Med. J. 112 (2008).
x. Interview with Ron Herings, Argos, VPRO/VARA, Radio 1 (December 7, 2007).
xi. See e.g., Jorgen Bramness et al., The sales of antidepressants and suicide rates in Norway and its counties 1980-2004, 102 Journal of Affective Disorders 1 (2007)Jorgen Bramness et al., The sales of antidepressants and suicide rates in Norway and its counties 1980-2004, 102 Journal of Affective Disorders 1, 6-7 (2007). (“Ecological studies cannot infer causality;” “the observed relationship [between declining suicide rates and antidepressant prescriptions] could be a spurious finding”); Gibbons et al., The Relationship Between Antidepressant Medication Use and Rate of Suicide, 62 Arch Gen Psych 165 (2005) Gibbons et al., The Relationship Between Antidepressant Medication Use and Rate of Suicide, 62 Arch Gen Psych 165 (2005) (“the aggregate nature of these observational data preclude direct causal interpretation of results.”)
xii. See Charles Barber, Comfortably Numb, How Psychiatry is Medicating a Nation 7 (2008).
xiii. Spending on antidepressants rose from $5.1 billion in 1997 to $13.5 billion in 2006. Id. at 8. Pieters and Snelders, Psychotropic Drug Use: Between Healing and Enhancing the Mind, 2 Neuroethics 63 (2009).
xiv. Gordon Parker, Is Depression overdiagnosed? 335 Brit. Med. J. 328 (2007). See also, Jureidini and Tonkin, Overuse of Antidepressant Drugs for the Treatment of Depression, 20 CNS Drugs 623 (2006); Pieters and Snelders, Psychotropic Drug Use: Between Healing and Enhancing the Mind, 2 Neuroethics 63 (2009).
xv. Pieters, Snelders, “Psychotropic Drug Use: Between Healing and Enhancing the Mind,” Neuroethics, 11 February, 2009.
xvi. See Rampton and Stauber, Trust Us, We’re the Experts – How Industry Manipulates Science and Gambles With Your Future 229 (2001).
xvii. See Tobacco and the Health of the Nation at
http://legacy.library.ucsf.edu/cgi/getdoc?tid=dxb34f00&fmt=pdf&ref=results and Smoking and Health Proposalat http://legacy.library.ucsf.edu/tid/rgy93f00, 690010954 (“Doubt is our product since it is the best means of competing with the ‘body of facts’ that exists in the mind of the general public. It is also the means of establishing a controversy … .”)