by Alison Bass
155, "suicidality in any of these drugs" FDA Talk Paper, October 27, 2003, http://www.fda.gov/.
155, among children and adolescents Erica Goode, "British Warning on Antidepressant Use for Youth," New York Times, December 11, 2003; and http://www.mhra.gov.uk/.
156, "have not been published" Gardiner Harris, "Debate Resumes on the Safety of Depression's Wonder Drugs," New York Times, August 7, 2003.
157, "the chances ofpositive studies" Shankar Vedantum, "Antidepressant Makers Withhold Data on Children," Washington Post, January 29, 2004.
157, agency's own public hearing Rob Waters, "Drug Report Barred by FDA," San Francisco Chronicle, February 1, 2004.
158, Pfizer, and Eli Lilly Executive Summary, Preliminary Report of the American College of Neuropsychopharmacology Task Force on SSRIs and Suicidal Behavior, January 21, 2004.
159, "induction ofsuicidality" Thomas P. Laughren, memo to committee members, "Background Comments for February 2, 2004, Meeting of the Psychopharmacological Drugs Advisory Committee (PDAC) and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee (Peds AC)," January 5, 2004.
160, Sharav charged Transcript of the February 2, 2004, meeting of PDAC and Peds AC, 104, http://www.fda.gov/.
160, constituted suicidal behavior Ibid., 349.
Chapter Fifteen
This chapter is based on interviews with Rose Firestein, Tom Conway, Joe Baker, Shirley Stark, Robert Milin, Marcia Angell, and Arnold Relman, among others.
167, "SSRI Use in Children" Wayne Kondro and Barbara Sibbald, "Drug Company Experts Advised Staff to Withhold Data about SSRI Use in Children," Canadian Medical Association Journal 170, no. 5 (March 2, 2004): 783.
167, "the profile ofparoxetine" SmithKline Beecham position piece, "SB Confidential -For Internal Use Only," attached to memo from Jackie Westaway, October 14, 1998.
168, "negative commercial impact" Ibid.
170, object to the wording Deposition of Martin B. Keller in Smith v. GlaxoSmithKline, September 7, 2006.
170, Back in November 1997 Ibid.
170, decided thumb's-down Review of Paxil study by Journal of the American Medical Association reviewers, produced by GlaxoSmithKline in Smith v. GlaxoSmithKline.
170, "in the discussion" Mina Dulcan, editor of Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP), letter to Martin Keller enclosing reviewers' comments, July 27, 2000, produced by GlaxoSmithKline in Smith v. GlaxoSmithKline.
171, Emslie was a paid consultant Preliminary Report of the American College of Neuropsychopharmacology Task Force on SSRIs and Suicidal Behavior, January 21, 2004.
171, `purchase 500 reprints" Matt Battlin, GlaxoSmithKline, e-mail to Sally Laden, April 25, 2001, produced by GlaxoSmithKline.
171, the ACNP report Deposition of Karen Wagner in Smith v. GlaxoSmithKline, March 22, 2006; Deposition of Neal Ryan in Smith v. GlaxoSmithKline, October 4, 2006; and 2004 Preliminary Report of the ACNP Task Force.
172, "remarkable" in his memo Zachary Hawkins, Paxil Product Management, memo to all sales representatives selling Paxil, August 16, 2001.
173, "emergence of suicidal ideation" FDA Talk Paper, March 22, 2004, http://www.fda.gov/.
173, "help they deserve" APA press release, March 23, 2004.
173, "a really tragic outcome" Denise Grady and Gardiner Harris, "Overprescribing Prompted Warnings on Antidepressants," New York Times, March 24, 2004.
174, in treating pediatric depression Legal complaint, People of the State of New York by Eliot Spitzer, Attorney General of the State of New York v. GlaxoSmithKline, filed in the Supreme Court of the State of New York, June 2, 2004.
177, "few weeks on medication" Mitch Parsons, MD, letter to the editor, Journal of the American Academy of Child and Adolescent Psychiatry 41, no. 4 (April 2002): 364.
177, in May 2003 Jon Jureidini, PhD, and Anne Tonkin, BM, PhD, letter to the editor, Journal of the American Academy of Child and Adolescent Psychiatry 42, no. 5 (May 2003): 514.
Chapter Sixteen
This chapter is based on interviews with Rose Firestein, Tom Conway, Joe Baker, Shirley Stark, Eliot Spitzer, Barry Perlman, Tonya Brooks, Cheryl Brooks, and Jeffrey Drazen.
179, "Their effort to suppress" Barbara Martinez, "Spitzer Charges Glaxo Concealed Paxil Data," Wall Street Journal, June 3, 2004.
180, "Similar suits are likely" Gardiner Harris, "New York State Official Sues Drug Maker over Test Data," New York Times, June 3, 2004.
180, "data from those studies" GlaxoSmithKline statement on PR Newswire, June 2, 2004.
180, falling 13 percent Jeanne Whalen and Elena Barton, "Glaxo's Earnings Decline 13%," Wall Street Journal, July 28, 2004.
180, "The new wrinkle" Harris, "Official Sues Drug Maker."
181, "an outrageous cost" Jeanne Whalen, "Glaxo CEO: Litigation Is 'Getting Out of Control,"' Wall Street Journal, June 3, 2004.
181, "bullying in these tactics" Robert Peston and Sylvia Preiffer, "Garner Hits Back at Spitzer over Allegations of Fraud at GSK," Sunday Telegraph (London), June 6, 2004.
181, "odds are 100 percent" Ibid.
183, "associated with the drug" Kay A. Chitale, FDA consumer promotion analyst, letter to P. Kaia Agarwal, senior director, Regulatory Affairs, GlaxoSmithKline, June 11, 2004, http://www.fda.gov/cder/.
183, aired months earlier Jeanne Whalen, "Glaxo Is Rebuked by FDA over Ad for Paxil CR Drug," Wall Street Journal, June 14, 2004.
183, "dangerous industry practice" Jeanne Whalen, "Glaxo Releases Studies on Drug for Depression," Wall Street Journal, June 16, 2004.
184, and their outcomes Press release from the American Medical Association, June 15, 2004, http://www.ama-assn.org/ama/pub/.
185, catch such manipulations An-Wen Chan et al., "Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials," Journal of the American Medical Association 291 (2004): 2457-65.
185, "scared out of prescribing"' Editorial in Review and Outlook section, Wall Street Journal, June 21, 2004.
186, "harming innocent bystanders" Ibid.
Chapter Seventeen
This chapter is based on interviews with Rose Firestein, Joseph Sedwick Sollers, Dwight Davis, Donna Howard, and other sources.
189, its SSRI, Celexa Barry Meier, "A Medical Journal Quandary: How to Report on Drug Trials," New York Times, June 21, 2004; and Christopher Windham and Barbara Martinez, "Saga of Unpublished Drug Data Takes an Unexpected Twist," Wall Street Journal, June 21, 2004.
189, children and adolescents News Roundup, "Forest Labs Asked for Information on Trials, Promotion of Its Drugs," Wall Street Journal, June 30, 2004.
193, "the study medication" Final Clinical Report, A Multi-Center, DoubleBlind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression (study 329), November 24, 1998, 35, http://www.gsk.com/media/paroxetine.htm.
193, the Brown study Ibid., 277.
193, the published 2001 Paxil study Keller et al. "Efficacy of Paroxetine."
194, "for non-compliance" Martin Keller, memo to Dorinda Williams, Brown University IRB Staff Assistant, "Re: Adverse Event Report for "A Multiceter, Double-Blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression,"' October 30, 1995.
194, memo to the Brown IRB Martin Keller, memo to the IRBs of Brown University and Bradley and Butler Hospitals, "Re: Adverse Event in `A Multicenter, Double-Blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression,"' January 30, 1995.
195, for being "noncompliant" Martin Keller, memo to Ivan W. Miller, chair of the Brown University Institutional Review Board, "Re: Annual Review of Project Entitled: `A Multicenter Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression,"' November 11, 1995.
195, company's final report Final Clinical Report, A Multi-Center, Double Blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolesce
nts with Depression (study 329), November 24, 1998, 318, http:// www.gsk.com/media/paroxetine.htm.
Chapter Eighteen
This chapter is based on interviews with Rose Firestein, Shirley Stark, Tom Conway, Eliot Spitzer, Joe Baker, Joseph Sedwick Sollers, Dwight Davis, Mary Ann Rhyne (spokeswoman for GlaxoSmithKline), and congressional sources.
197, division of GlaxoSmithKline Charles E. Grassley, chairman of the Senate Committee on Finance, letter to Christopher Viehbacher, president of U.S. Pharmaceuticals, GlaxoSmithKline, August 3, 2004, produced by GlaxoSmithKline in Smith v. GlaxoSmithKline.
197, "and/or suicidal behavior" Ibid.
197, "some drug companies" Ibid.
198, drug test results Barry Meier, "Results of Drug Trials Can Mystify Doctors through Omission," New York Times, July 21, 2004; Wall Street Journal, July 28, 2004, and August 3, 2004.
198, an antianemia medication Barry Meier, "Spitzer Asks Drug Maker for Off-Label Use Material," New York Times, August 5, 2004.
198, reached by Mosholder Anne Wilde Mathews, "FDA Revisits Issue of Antidepressants for Youth Wall Street Journal, August 5, 2004.
203, "make informed judgments" Gardiner Harris, "Glaxo Agrees to Post Results of Drug Trials on Web Site," New York Times, August 27, 2004.
205, "The arrogance of " Christopher Bowe, "Spitzer Sounds Further Warning to GSK," Financial Times, August 31, 2004.
Chapter Nineteen
This chapter is based on interviews with Martin Teicher, David Healy, Rose Firestein, and congressional sources.
209, those taking sugar pills FDA Talk Paper, August 20, 2004, http:// www.fda.gov/; and Mark Kaufman, "FDA Alters Tack on Children and Antidepressants," Washington Post, August 21, 2004.
210, he told Bell. Julie Bell, "FDA Review Renews Antidepressant Debate," Baltimore Sun, August 21, 2004.
211, "dollars in the process" "House Committee on Energy and Commerce, Subommittee on Oversight and Investigations, transcript of hearing on Publication and Disclosure Issues in Antidepressant Pediatric Clinical Trials, 108th Cong., 2nd sess., September 9, 2004.
211, `placebo" Ibid.
211, "and Alibis, "Barton said Ibid.
211 "FDA to do its job " Ibid.
212, Rep. Greg Walden Ibid.
212, "data that is available" Ibid.
213, prescribing the drugs FDA Statement on Recommendations of the Psychopharmacologic Drugs and Pediatric Advisory Committee, September 16, 2004.
213, on the secondary outcomes Jon Jureidini et al., "Efficacy and Safety of Antidepressants for Children and Adolescents," British Medical Journal 328, no. 7444 (April 10, 2004): 879-83.
214, Teicher told Johnson Carolyn Johnson, "What's Next for Depressed Kids?" Boston Globe, September 21, 2004.
215, "attempting to obstruct justice" House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, transcript of hearing on FDA's Role in Protecting the Public Health: Examining the FDA's Review of Safety and Efficacy in Antidepressant Use by Children, 108th Cong., 2nd sess., September 23, 2004.
216, "effects of drugs on children" Ibid.
216, "informal `partner' to the industry" Trudy Lieberman, "Bitter Pill," Columbia Journalism Review, July-August 2005.
216, investigator David Graham "Study of Pain Killer Suggests Heart Risk," Bloomberg News, August 26, 2004.
217, jump on the story Mark Kaufman, "Merck Withdraws Arthritis Medication," Washington Post, October 1, 2004.
217, "three years too late" Ibid.
218, of similar side effects Carolyn Johnson, "Suicide Warning Ordered on Drugs," Boston Globe, October 16, 2004.
Epilogue
This chapter is based on interviews with Donna Howard, Rose Firestein, Eliot Spitzer, Tom Conway, Joe Baker, Sheldon Krimsky, Arnold Relman, Ross Baldessarini, Julie Zito, Peter Lurie, Robert Gibbons, Roger Grimson, and Susan Cruzan of the FDA, among other sources.
221, relative risk was 3.76 Alan Apter et al., "Evaluation of Suicidal Thoughts and Behaviors in Children and Adolescents Taking Paroxetine," Journal of Child and Adolescent Psychopharmacology 16, no. 1 -2 (March 2006): 77-89.
222, "the paroxetine group" Regan Fong, GlaxoSmithKline, e-mail to Martin Keller, Neal Ryan, and Karen Wagner, February 3, 2004.
222, in the Paxil arm Ibid.
225, to remain accredited Daniel Carlat, "Diagnosis: Conflict of Interest," New York Times, June 13, 2007.
224, money from the industry R. H. Perlis et al., "Industry Sponsorship and Financial Conflict of Interest in the Reporting of Clinical Trials in Psychiatry," American Journal of Psychiatry, 162, no. 10 (October 2005): 1957-60.
224, children in that state Gardiner Harris and Janet Roberts, "Doctors' Ties to Drug Makers Are Put on Close View," New York Times, March 21, 2007; and Joseph S. Ross et al., "Pharmaceutical Company Payments to Physicians," Journal of the American Medical Association 297, no. 11 (March 21, 2007): 1216-23.
225, the Times analysis Gardiner Harris et al., "Psychiatrists, Children and Drug Industry's Role," New York Times, May 10, 2007.
226, In 2005, drugmakers Harris and Roberts, "Doctors' Ties."
226, between 2003 and 2004 Transcript of the FDA's Psychopharmacologic Drugs Advisory Committee meeting on December 13, 2006, http://www.fda.gov/.
226, Centers for Disease Control WISQARS Injury Mortality Report, http://www.cdc.gov/.
226, maker of Effexor, another SSRI Robert D. Gibbons, et al., "Early Evidence on the Effects of Regulators' Suicidality Warnings on SSRI Prescriptions and Suicide in Children and Adolescents," American Journal of Psychiatry 164, no. 9 (September 2007): 1356-63.
226, Dr. J. John Mann Executive Summary, Preliminary Report of the American College ofNeuropsychopharmacology Task Force on SSRIs and Suicidal Behavior, January 21, 2004.
227, only fifty-eight in 2005 CDER 2005 Report to the Nation (latest available figures), http://www.fda.gov/.
228, already approved drugs GAO Report on Drug Safety, March 2006, http://www.gao.gov/.
229, prescribed diabetes drug Steven E. Nissen et al., "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes," New England Journal of Medicine 10, no. 356 (May 2007), http://www.nejm.org/.
230, "a treasure trove" Barry Meier, "For Drug Makers, a Downside to Full Disclosure," New York Times, May 23, 2007.
230, New England Journal of Medicine Christine Laine et al., "Clinical Trial Registration: Looking Back and Moving Forward" New England Journal ofMedicine 10, no. 1056 (June 2007): 8110, http://www .nejm.org/.
232, 2006 election cycle http://www.opensecrets.org/.
233, the testing of new drugs Angell, Drug Companies, 243 -44.
233, "for its own purposes" Jerry Avorn, "Dangerous Deception: Hiding the Evidence of Adverse Drug Effects," New England Journal of Medicine 355, no. 21 (November 23, 2006): 2169-71.
234, depression for adolescents Deposition of Martin Keller in Smith v. GlaxoSmithKline, Sept. 7, 2006.
234, 2006 deposition Ibid.