by Alison Bass
The lingering controversy over how the 2001 Paxil study was conducted does not seem to have harmed Keller's career or his ability to attract research funding. The department he oversees at Brown received $50 million in research funding from external sources, including pharmaceutical companies and the taxpayer-funded National Institute of Mental Health, according to Keller's own testimony in the 2006 deposition. There has been no ultimate finding by any professional association or federal or state authority of wrongdoing by Keller, and his employer continues to stand by him. Responding to questions for this book, a spokesman for Brown said that "Brown takes seriously the integrity of its scientific research. Dr. Keller's research regarding Paxil complied with Brown's research standards."
NONE OF THIS comes as any surprise to Donna Howard. Her experience with Martin Keller and Brown University has made her exceedingly wary of the medical establishment.
"I'm certainly not antimedication," she said. "It saved my daughter's life. But I have become so cynical about the whole medicalpharmaceutical establishment. They want to rush the drugs to market and convince you that you're depressed or that your cholesterol is higher than it should be or whatever it is-all so they can make huge profits. I think it's clear that not everyone needs that much medication."
In the spring of 2006, Howard took a job that had nothing to do with the medical community. She began working for the National Housing Partnership Foundation, a national nonprofit that provides housing and services for the poor. Her job, as the resident services manager for one of its community centers in Fall River, was to develop programs that help break the cycle of poverty.
Now in her late fifties, Howard is not particularly interested in raking up the past. She has her feet firmly planted in the present. Her large green eyes are clear and untroubled. She accepts the fact that she will always be an outsider, a renegade attempting to bring justice to deeply flawed systems. She will never make much money and she will always have to struggle with bipolar disorder. But that's okay. What matters to Howard is that she has friends and admirers in the mental health field who still turn to her for counsel and support. And if you ask her to name the one thing she is proudest of, she will say without hesitation her daughter, Maria.
Maria dropped out of community college in 2005-"the stress was too much for her," Howard said. But her daughter is working full-time at an inn near her home. It's a supportive and welcoming environment, her mother said. Although Maria still lives with Howard and continues to take medications to manage her mental illness, she is financially and emotionally independent.
"She is doing extraordinarily well-better than anyone predicted," Howard said. "I don't come from a privileged background. I never had it in my head that she should go to Harvard. She has a healthy, independent, rewarding life and she is an extraordinary individual. She just inspires me."
Tonya Brooks, who turned twenty-one in May 2008, is doing well too. The Texan teenager who repeatedly tried to kill herself while on Paxil works full-time as a veterinary technician in Pflugerville, Texas. Now that she is off Paxil and Ambien, she says she's fine. She lives on her own with two cats and two dogs. She is still uncomfortable in social situations and knows she will never be "the life of the party." She has learned to accept her anxieties and is not taking any medication for them. She dyed her hair an eye-catching red, and she has a boyfriend for the first time in her life. Speaking on the phone recently, she sounded happy, even bubbly. It's clear that Tonya Brooks is at peace with herself, which is all anyone in this world can really ask.
THIS BOOK COULD NOT have been written without the assistance of the people who appear in it. I owe an enormous debt of gratitude to Donna Howard, Rose Firestein, Martin Teicher, and Tonya and Cheryl Brooks, who opened their lives to me and made themselves available to answer my questions. I'm also grateful to Donna's daughter for being part of this project.
My special thanks go to the team at the New York attorney general's office: Shirley Stark, Joe Baker, Tom Conway, Mark Violette, and Eliot Spitzer. I am grateful to the medical experts who helped tutor me, especially David Healy, Sheldon Krimsky, Arnold Relman, Marcia Angell, Jonathan Cole, Julie Zito, Malkah Notman, Jerry Avorn, Peter Lurie, and Ethan Kisch.
Karen Gievers, Bernard Perlmutter, Carol Marbin Miller, Barry Perlman, David Levoy, Janice Firestein, Linda Jorgenson, Jon Albano, Skip Murgatroyd, Joel Shames, David Gessner, Russell Ames, Robin McCall, Nils Bruzelius, Judy Foreman, Larry Tye, Stephen Solomon, and Ryan Derousseau all helped in many ways. I'd like to thank Martin Teicher's assistant, Cynthia McGreenery, who treated me kindly.
I would also like to thank my literary agent, Jim Levine, and his assistant, Lindsay Edgecombe, without whom this book would not have happened. And I am indebted to my editor, Amy Gash, whose incisive comments allowed me to see the forest without forgetting the trees. I'd also like to thank Rachel Careau, whose thoughtful copyediting saved me from myself.
I owe a special debt to the late Laura Van Dam, who knew there was a book in there somewhere and encouraged me to keep trying. I'd also like to thank Judy Foreman and Nils Bruzelius, whose wise counsel and support kept me going.
The Alicia Patterson Fellowship gave me the time I needed to complete this enterprise, for which I am deeply grateful.
I would also like to thank the friends and colleagues who took the time to read part or all of my manuscript and offer support and criticism, both equally helpful: David Rosenbaum, Sarah Scalet, and Scott Berinato. I am especially grateful to Ross Gelbspan and Michael Goldberg, who were there for me throughout the entire writing process. Their support and wise counsel kept me going.
I'd also like to thank my mother, Estelle Brager, who has taught me much about the craft of writing and whose belief in my work has been a sustaining force over the years.
Finally, I would like to thank my husband, Jim, whose unflagging support made this book possible, and my two boys, David and Jake, who bring joy to my life and whose patience with this project never ceased to amaze me.
Prologue
This chapter is based on interviews with Tonya Brooks, Cheryl Brooks, and a spokeswoman for the Baum Hedlund law firm in Los Angeles, which represents the Brooks family.
Chapter One
This chapter is based on interviews with Martin Teicher and Jonathan Cole.
7, Ms. D. Martin H. Teicher et al., "Emergence of Intense Suicidal Preoccupation during Fluoxetine Treatment," American Journal of Psychiatry, 147, no. 2 (February 1990): 08.
8, norepinephrine and dopamine Joseph Glenmullen, Prozac Backlash (New York: Simon and Schuster, 2000), 10.
10, she kill herself Martin Teicher, letter to the Massachusetts Board of Medicine, June 12, 1992.
10, that "deadly drug" Teicher et al., "Suicidal Preoccupation," 208.
11, self-destructive urges abated Ibid.
12, Valium and alcohol Ibid.
Chapter Two
This chapter is based on interviews with Donna Howard and people who know her.
18, "Victor" Brief filed in U.S. District Court in support of Richard Doe v. New York City Department of Social Services, September 23, 1987.
19, extreme cases ofpsychosis Ibid.
Chapter Three
This chapter is based on interviews with Donna Howard and people who know her.
23, Maria Donna Howard and I agreed to use the middle name of her adopted daughter to protect her daughter's privacy.
Chapter Four
This chapter is based on interviews with Martin Teicher, Jonathan Cole, Ida Hellander, and Paul Leber, and also relies on a transcript of the September 20, 1991, FDA hearing.
29, Psychopharmacological Drugs Transcript of the FDA's Psychopharmacological Drugs Advisory Committee hearing, September 20, 1991.
30, "the country has ever seen" R. Behar, "The Thriving Cult of Greed and Power," Time, May 6, 1991, 32-39.
33, the McLean authors wrote Martin H. Teicher et al., "Antidepressant Drugs and the Emergence of Suicidal Tendencies," Drug Safety 8, no. 3 (1993
): 197.
35, she told the committee Transcript of FDA hearing, September 20, 1991, 13-15, 24-26.
36, Moneymaker said Ibid., 78-80.
36, "break into his apartment" Ibid., 81-86.
36, "kitchen knife beside him" Ibid., 86.
37, Leber said Ibid., 128-29.
37, "working together on the suicide issue" Exhibit 109, Forsyth v. Eli Lilly, Lilly memo, September 12, 1990; and Exhibit 104, Forsyth v. Eli Lilly, Lilly memo regarding call from Paul Leber, July 18, 1990.
37, "injury to public health" Transcript of FDA hearing, September 20, 1991, 129.
38, "suicidal acts or ideation" Ibid., 210.
38, "a very serious disease" Ibid., 232-33.
39, "interpreting those data" Ibid., 257.
39, caused by the SSRI David Healy, Let Them Eat Prozac (New York: NYU Press, 2004), 131.
39, bestselling drugs in pharmacological history Data from IMS Health. (From 1992 to 2000, Prozac was among the five top-selling drugs in the United States, and in 1997 it was ranked the second-bestselling drug.)
40, "a few moments to talk" Transcript of FDA hearing, September 20, 1991, 278.
40, `prior to or following" Ibid., 286.
40, "some more to say? " Ibid., 287
41, shutting Teicher off Ibid., 290.
42, "might prefer it to be" Paul Leber, memo to Robert Temple, ODE, "Subject: Zoloft NDA Approvable Action Recommendation," August 26, 1991.
42, Zoloft must be approved Paul Leber, memo to Robert Temple, director, ODE, "Subject: Recommendation to Approve NDA 19-839 (Zoloft)," December 24, 1991.
42, annual sales of $3.4 billion IMS Web site, "Leading Products by Global Pharmaceutical Sales, 2003," http://www.imshealth.com/.
43, entire drug-review budget Anna Wilde Mathews, "Druge Firms Use Financial Clout to Push Industry Agenda at FDA," Wall Street Journal, September 1, 2006.
44, approximately twelve months Philip J. Hilts, Protecting America's Health (New York: Knopf, 2003), 279.
44, owned stock in Lilly The Integrity in Science Web site, http://cspinet .org/cgi-bin/integrity.cgi/.
Chapter Five
This chapter is based on interviews with Rose Firestein, Tom Conway, Joe Baker, Shirley Stark, Eliot Spitzer, Joseph Sedwick Sollers, Dwight Davis, and Mark Violette, PR spokesman for the AGs office.
49, "repeated and persistent"fraud 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.
Chapter Six
This chapter is based on interviews with Donna Howard, Alice Tangredi-Hannon, Ron Seifer, and other sources.
68, "reasons of noncompliance" Martin B. Keller memo, to Ivan W. Miller, chair, Brown 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.
70, several thousand dollars Alison Bass, "Brown Researcher Faced Billing Question in Past," Boston Globe, January 21, 1996.
70, whistleblower's career at Brown Alison Bass, Five Ex-Employees Allege Harassment by Brown," Boston Globe, January 21, 1996.
Chapter Seven
This chapter is based on interviews with Donna Howard and other sources.
Chapter Eight
This chapter is based on interviews with Martin Teicher and other sources and also relies on a transcript of the deposition of Martin Teicher in the matter of Greer v. Eli Lilly, October 29 and 30, 1996.
80, "dismissed... as settled " Glenmullen, Prozac Backlash, 173 -76.
86, show her that he cared Respondent's Memorandum on Disposition in the matter of Board of Registration in Medicine v. Martin H. Teicher, September 5, 1997.
88, medical board documents reveal Ibid., 8.
88, resulted in a mistrial Alison Bass, "Doctor Brings Lawsuit against Lozano Attorney," Boston Globe, May 1, 1992.
Chapter Nine
This chapter is based on interviews with Rose Firestein, Tom Conway, Joe Baker, Shirley Stark, Mark Violette, Joseph Sedwick Sollers, Dwight Davis, David Healy, and Thomas Laughren.
97, suicides in adults T. P. Laughren, "The Scientific and Ethical Basis for Placebo-Controlled Trials in Depression and Schizophrenia: An FDA Perspective," European Psychiatry 16 (2001): 418-23.
97, wanted to kill themselves Teicher et al., "Antidepressant Drugs," 188-212.
98, in a press release AMA press release, June 15, 2004, http://www .amassn.org/ama/pub/.
98, "junk science" Richard A. Knox, "Doctor Lashes Out in Prozac Battle," Boston Globe, May 15, 2000.
98, while taking Prozac Healy, Let Them Eat Prozac, 87-102.
98, link between SSRIs and suicidal behavior Ibid., 215 -16.
99, trust in the medical profession Jeanne Whalen, "Doctor Defends Linking Suicide, Antidepressants," Wall Street Journal, July 20, 2004.
99, $645,000 to the institute Karen Birmingham, "Dark Clouds over Toronto Psychiatry Research," Nature Medicine 7, no. 6 (June 2001): 643.
Chapter Ten
This chapter is based on interviews with Martin Teicher, Alan Schatzberg, Stephen Goldfinger, and others who attended the 1998 annual meeting of the American Psychiatric Association (APA), along with Sheldon Krimsky and officials from the APA, Brown University officials, the Massachusetts Board of Registration in Medicine, and the National Institutes of Health.
104, not a reliable witness Final Decision and Order in the matter of Martin H. Teicher, Massachusetts Board of Registration in Medicine, November 19, 1997.
106, "above-described disadvantages" U.S. Patent 5708035, January 13, 1998, http://www.uspto.gov/.
107, "Optimizing Long-Term Treatment" Program for the 1998 annual meeting of the American Psychiatric Association in Toronto.
108, published with much fanfare Martin B. Keller et al., "A Comparison of Nefazodone, the Cognitive Behavioral Analysis System of Pscyhotherapy, and Their Combination for the Treatment of Chronic Depression," New England Journal ofMedicine 342 (May 18, 2000): 1462-70.
108, "extensive financial associations" Marcia Angell, "Is Academic Medicine for Sale?" New England Journal of Medicine 342 (May 18, 2000): 1516-18.
108, testimony in a later lawsuit Deposition of Keller in Beverly Smith v. GlaxoSmithKline, Sept. 7, 2006.
109, chronically depressed patients Martin B. Keller et al., "Maintenance Phase Efficacy of Sertraline for Chronic Depression," Journal of the American Medical Association 280, no. 19 (November 18, 1998): 1665 -72.
111, from the pharmaceutical industry Bass, "Drug Companies Enrich Professor," Boston Globe. (This article was based on Keller's income tax returns from 1997 and 1998.)
111, on the disclosure form APA Disclosure Index 1998.
112, the pharmaceutical industry Alison Bass, "Drug Companies Enrich Professor," Boston Globe October 4, 1999.
112, his tax returns Alison Bass, "Drug Companies Enrich Professor."
112, per patient for clinical trials Kurt Eichenwald and Gina Kolata, "Drug Trials Hide Conflicts for Doctors," New York Times, May 16, 1999.
114, "present positive findings" Les S. Friedman and Elihu D. Richter, Journal of General Internal Medicine 19, no. 54 (2004): 51-56.
Chapter Eleven
This chapter is based on interviews with Rose Firestein, Janice Firestein, and several attorneys in Florida, including Karen Gievers, Andrea Moore, and Bernard Perlmutter.
119, series on the problem Carol Marbin Miller, "Foster Kids Describe Drugs' Effect," Miami Herald, April 23, 2001.
120, "concentrate on my schoolwork" Affidavit of Leslie F., Foster Children Bonnie L et al. v. Jeb Bush et al., March 2001.
120, 45 to 46 percent of foster children Carol Marbin Miller, "Report Decried Giving Drugs to Kids," Miami Herald, May 11, 2001.
Chapter Twelve
This chapter is based on interviews with Donna Howard, Nicki Sahlin, Jim McNulty, Sheldon Krimsky, Jim H
allon of Butler Hospital, and other sources.
127, June 1995 progress report Progress Report Summary on NIMH grant MH48877-04, "Lithium Prophylaxis in Adolescents with Bipolar Illness," 1995.
128, In January 1996 Alison Bass, "State Paid School $218,000 on Falsely Billed DMH Study," Boston Globe, January 7, 1996.
130, NAMI s posted annual reports http://www.nami.org/.
132, "cover the matter up" Alison Bass, "Whistleblowers Question Brown Settlement," Boston Globe, January 12, 1999.
Chapter Thirteen
This chapter is based on interviews with Rose Firestein, Joe Baker, Tom Conway, Shirley Stark, Eliot Spitzer, Peter Lurie, and Julie Zito.
141, the Public Citizen survey http://www.citizen.org/publications/.
142, lobbying members of Congress http://www.opensecrets.org/lobbyists/.
143, Parke-Davis and Warner-Lambert Marcia Angell, The Truth about the Drug Companies (New York: Random House, 2004), 157-60.
145, an SSRI antidepressant Daniel Safer and Julie Magno Zito, "Treatment-Emergent Adverse Effects from Serotonin Reuptake Inhibitors by Age Group," Journal of Child and Adolescent Psychopharmacology 16, nos. 1-2 (2006): 159-69.
145, accompany suicidal behavior Julie Magno Zito and Daniel J. Safer "The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents," in Pharma covigilance, 2nd ed., ed. Ronald D. Mann and Elizabeth B. Andrews (London: John Wiley and Sons, 2007).
145, "major depressive disorder" FDA Talk Paper, June 19, 2003, http:// www.fda.gov/.
146, "depression in adolescents" Martin B. Keller et al., "Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial," Journal of the American Academy of Child and Adolescent Psychiatry 40, no. 7 (July 2001): 762-72.
148, these dubious circumstances Paul Edward Parker, "Brown Pays $300,170 to Settle Dispute," Providence Journal-Bulletin, December 30, 1998; and Bass, "Whistleblowers Question Brown Settlement."
Chapter Fourteen
This chapter is based on interviews with Rose Firestein, Janice Firestein, Shirley Stark, Tom Conway, Joe Baker, Ross Baldessarini, Martin Teicher, and others.