THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF CHILDREN FOR RESEARCH
Vera Hassner Sharav
ETHICAL HUMAN SCIENCES & SERVICES
Summer 2003, vol. 5 pp. 83-108
Agency for Health Care Research & Quality. (1999). Treatment of attention-deficit/hyperactivity disorder: Summary, evidence Report / Technology assessment number 11. AHQR Publication No. 00-E005. Retrieved January 15, 2003 from http://www.ahrq.gov/clinic/adhdsum.htm
Alderman J, Wolkow R, Chung M, Johnston HF. (1998) Sertraline treatment of children and adolescents with obsessive- compulsive disorder or depression: pharmacokinetics, tolerability, and efficacy. Journal of the Association of American Child & Adolescent Psychiatry, 37:386-94.
American Academy of Pediatrics. (2000). Clinical practice guideline: Diagnosis and evaluation of the child with ADHD. Pediatrics, 105, 1158-1170.
American Psychiatric Association. (1994). Diagnostic and statistical manual of mental disorders, 4th ed. Washington, DC: Author.
American Psychiatric Association-American Academy of Child and Adolescent Psychiatry. (2002, September 26). Are children being overmedicated? Testimony before the U.S. House Government Reform Committee on ADHD. Retrieved October 26, 2002 from http://www.psych.org/pub_pol_adv/testimonys.cfm
Ambrosini, P. J., Wagner K. D., Biederman, J., Glick, I., Tan , C., Elia, J., et al. (1999). Multicenter open-label sertraline study in adolescent outpatients with major depression. Journal of the American Academy of Child and Adolescent Psychiatry, 38, 566-572.
Anderson, G. M., Segman, R. H., King, R. A. (1995). Serotonin and suicidality: The impact of fluoxetine administration. II. Acute neurobiological effects. Israel Journal of Psychiatry and Related Sciences, 32, 44-50.
Angell, M. (2000). Is academic medicine for sale? New England Journal of Medicine, 342, 1516-1518.
Angold A, Erkanli A, Egger HL, Costello EJ. 2000. Stimulant treatment for children: a community perspective. Journal of the American Academy of Child & Adolescent Psychiatry. 39:975-94.
Barkley, R. A. (2000). Commentary on the multimodal treatment study of children with ADHD. Journal of Abnormal Child Psychology, 28, 595-599.
Bauchner, H., & Sharfstein, J. (2001). Failure to report ethical approval in child health research: Review of published papers. British Medical Journal, 323, 318-319.
Baughman F. (2000, September 29). The rise and fall of ADHD. Testimony before U.S. Congress Committee on Education and the Workforce. Retrieved on February 5. 2003, from http://www.house.gov/ed_workforce/hearings/106th/oi/ritalin92900/baughman.htm
Biederman, J., & Spencer, T. (2000). Non-stimulant treatments for ADHD. European Child & Adolescent Psychiatry, 9(Suppl 1), I51-I59.
Biotechnology Industry Organization. 2003. FDA’s Pediatric Rule: History of Pediatric Studies, Rule, Legislation and Litigation. http://www.bio.org/reg/pedhist.asp
Birmaher, B., Waterman, G. S., Ryan, N. D., Perel, J., McNabb, J., Balach, L., et al. (1998). Randomized, controlled trial of amitriptyline versus placebo for adolescents with “treatment-resistant” major depression. Journal of the American Academy of Child & Adolescent Psychiatry, 37, 527-535.
Black, K., Shea, C., Dursun, S., & Kutcher, S. (2000). Selective serotonin reuptake inhibitor discontinuation syndrome: Proposed diagnostic criteria. Journal of Psychiatry and Neuroscience, 25, 255-261.
Boseley, S. (1999, September 4). Revealed: The danger of taking Prozac. Drug maker knew 20 years ago of possible link to suicide. The Guardian, p. 1. Retrieved September 4, 1999 from http://www.guardian.co.uk/Print/0,3858,3898467,00.html.
Bowers, M. B., Jr., & Swigar, M. E. (1988). Psychotic patients who become worse on neuroleptics. Journal of Clinical Psychopharmacology, 8, 417-421.
Breggin, P. R. (2000). A critical analysis of the Multimodal Treatment Study for attention-deficit/hyperactivity disorder (the MTA study). Ethical Human Sciences and Services, 3, 63-72.
Breggin, P. R., & Breggin, G. R. (1994). The war against children. New York: St. Martins.
Breggin, P.R., & Cohen, D. (1999). Your drug may be your problem. Cambridge, MA: Perseus.
Brief of Amici Curiae. (2001, September 17). Grimes v. Kennedy Krieger, Court of Appeals of Maryland. Filed by Association of American Medical Colleges, Association of American Universities, Johns Hopkins University, and University of Maryland.
Carey, W. B. (2000). What the MTA study did and did not say about the use of methylphenidate for attention deficits (Letter). American Journal of Pediatrics, 105, 863-864.
Carey, W. B. (2002). Is ADHD a valid disorder? In P. S. Jensen & J. R. Copper (Eds), Attention deficit hyperactivity disorder: State of the science. Best Practices (pp. 3-19). Kingston, NJ: Civic Research Institute.
Case Reports. (2002). Growth attenuation found in four pediatric patients on SSRIs. Brown University Child and Adolescent Psychopharmacology Update, 4, 2-4. http://www.medscape.com/viewarticle/442653
Castellanos, F. X. (2002) Proceed, with caution: SPECT cerebral blood flow studies of children and adolescents with attention deficit hyperactivity disorder. Journal of Nuclear Medicine. 43, 1630-1633.
Chakos, M. H., Lieberman, J. A., Bilder, R. M., Borenstein, M., Lerner, G., Bogerts, B., Wu, H., Kinon, B., & Ashtari, M. (1994). Increase in caudate nuclei volumes of first-episode schizophrenic patients taking antipsychotic drugs. American Journal of Psychiatry, 151, 1430-1436.
Coyle, J. (2000). Psychoactive drug use in very young children (Editorial). JAMA, 283. Retrieved February 23, 2000 from http://jama.ama-assn.org/issues/v283n8/ffull/jed90109.html
Dembner, A. (2001a, February 18). Dangerous dosage. Boston Globe, p. 1. Retrieved February 18, 2001 from http://www.boston.com/dailyglobe2/049/nation/Dangerous_dosageP.shtml
Dembner, A. (2001b, March 20). Should a healthy child ever be a test subject? Boston Globe, p. 1. Retrieved March 20, 2001 from http://18.104.22.168/contWriter/yhd7/2001/03/21/medic /4902-0204-pat_nytimes.html
Dembner, A. (2001c, March 25). Who’s protecting the children? Drug research raises concerns about policy and penalties. Boston Globe, p. 1. Retrieved March 25, 2001 from http://www.boston.com/dailyglobe2/084/nation/Who_s_protecting_the_children_+.shtml
Department of Health & Human Services. (2001, last revised March 12). Draft policy and procedures for DHHS research involving children – 45 CFR 46.407.
Diller L. (1998). Running on Ritalin: A physician reflects on children, society and performance in a pill. New York. Bantam.
Diller, L. (2000, February 2). Over-medicating America’s kids. Washington Post, p. A21.
Eli Lilly summary company profile. (2003) Business Week online. Retrieved June 15, 2003. http://research.businessweek.com/business_summary.asp?Symbol=LLY
Elliott, C. (2001, September 24-October 8) Pharma buys a conscience. The American Prospect, 12(17).
Drug Enforcement Agency. (1995). Methylphenidate: A background paper. Washington, DC: United States Department of Justice.
Drug Enforcement Agency. (2000, May 16). Statement by Terrance Woodworth, Deputy Director. Office of Diversion Control. Congressional testimony before the U.S. Senate Committee on Education and the Workforce: Subcommittee on Early Childhood, Youth and Families. Retrieved March 1, 2003 at: http://www.usdoj.gov/dea/pubs/cngrtest/ct051600.htm
Faraone, S. V., Brown, C. H., Glatt, S. J., & Tsuang, M. T. (2002). Preventing schizophrenia and psychotic behaviour: Definitions and methodological issues. Canadian Journal of Psychiatry, 47, 527 – 537.
Food and Drug Administration. (1998, December 2, 1998). Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients: Final rule. Federal Register, 63, 66631-66672.
Food and Drug Administration. (1999). Center for Drug Evaluation and Research. Pediatric Subcommittee. November 5, 1999. Ethics Presentation Online. Ethical issues in pediatric pharmaceutical research where there is no primary intention of direct benefit. Online at http://www.fda.gov/cder/pediatric/pedethics-1199.htm
Food and Drug Administration (FDA). (2000a) Center for Drug Evaluation and Research. Pediatric Information. FDA Ethics Working Group Consensus Statement on the Pediatric Advisory Subcommittee’s November 15, 1999 Meeting. April 19, 2000a. Final. Online at http://www.fda.gov/cder/pediatric/ethics-statement.htm
Food and Drug Administration (FDA). (2000b). Center for Drug Evaluation and Research website. Pediatric Depression: Background comments on pediatric depression. In Sample Written Requests for Antidepressants. Online at: http://www.fda.gov/cder/pediatric/antidepressant_wr_template.htm
Food and Drug Administration. (2000c, March 23). Talk Paper: Janssen Pharmaceutica stops marketing Cisapride in the US. Available on World Wide Web at: http://www.fda.gov/bbs/topics/ANSWERS/ANS01007.htm
Full disclosure. (2000, May 2). Editorial. Pittsburgh Post-Gazette. Retrieved May 2, 2000 from http://www.post-gazette.com/forum/20000502eddrugtest1.asp
Garnett, L. R. (2000, May 7). Prozac revisited: As drug gets remade, concerns about suicides surface. Boston Globe, p. 1.
Glantz, L. (1998). Research with children. American Journal of Law & Medicine, 24, 214-244.
Glenmullen, J. (2000). Prozac backlash. New York: Simon & Schuster.
Goode, E. (1999, December 7). Doctors try a bold move against schizophrenia. New York Times, p. F1.
Goode, E. (2000, July 18). Once again, Prozac takes center stage, in furor. New York Times. Retrieved July 18, 2000 from http://www.nytimes.com/library/national/science/health/071800hth-behavior-prozac.html
Gorman, J. M., Kent, J., Martinez, J., Browne, S., Coplan, J., & Papp, L. A. (2002). Physiological changes during carbon dioxide inhalation in patients with panic disorder, major depression, and premenstrual dysphoric disorder: Evidence for a central fear mechanism. Archives of General Psychiatry, 59, 567-569.
Greeley, W. (2002). Pediatric clinical trials: Shall we take a lead? (Editorial). Anesthesia and Analgesia, 94, 1-3.
Grimes v Kennedy-Krieger Institute. Maryland Court of Appeals. August 16, 2001. Available online at http://www.courts.state.md.us/opinions/coa/2001/128a00.pdf
Grinfeld, M. (1998, March). Psychoactive medications and kids: New initiatives launched. Psychiatric Times, 14 (3): 69.
Gur, R. E., Cowell, P., Turetsky, B. I., Gallacher, F., Cannon, T., Bilker, W., & Gur, R. C. (1998). A follow-up magnetic resonance imaging study of schizophrenia. Archives of General Psychiatry, 55, 145-152.
Gur, R.E., Maany, V., Mozley, P. D., Swanson, C., Bilker, W., & Gur, R. C. (1998). Subcortical MRI volumes in neuroleptic-naive and treated patients with schizophrenia. American Journal of Psychiatry, 155, 1711-1717.
Harrison P. J. (1999). The neuropathological effects of antipsychotic drugs. Schizophrenia Research, 40, 87-99.
Healy, D. (1997). The antidepressant era. Cambridge, MA: Harvard University Press.
Healy, D. (2000). Emergence of antidepressant induced suicidality. Primary Care Psychiatry, 6, 25-28.
Healy, D. (2002a). Randomized controlled trials: Evidence biased psychiatry. Available online at: https://www.ahrp.org/COI/healy0802.php Healy, D. (2002b) Testing psychotropic drugs in children. Available online at: https://www.ahrp.org/children/healy0402.php
Hegarty, J. D., Baldessarini, R. J., Tohen, M., Waternaux, C., & Oepen, G. (1994). One hundred years of schizophrenia: A meta-analysis of the outcome literature. American Journal of Psychiatry, 151, 1409-1416.
Huget, J. (2001, January 2). Scandal! They haven’t tested Ritalin on the children it’s prescribed for! Scandal! They’re going to test Ritalin on the children! Washington Post, p. T-6.
Hyman, S. E., & Nestler, E. J. (1996). Initiation and adaptation: A paradigm for understanding psychoactive drug action. American Journal of Psychiatry, 153, 151-162.
Hypericum Depression Trial Study Group. (2002). Effect of Hypericum perforatum (St John’s Wort) in major depressive disorder: A randomized controlled trial. Journal of the American Medical Association, 287, 1807-1814.
Institute of Medicine. (2002, October 3) Report. Responsible research: a systems approach to protecting research participants. Washington, DC: The National Academies Press. Retrieved on April 15, 2003 at: http://www.nap.edu/books/0309084881/html/
Jablensky, A. (2000). Prevalence and incidence of schizophrenia spectrum disorders: Implications for prevention. Australian and New Zealand Journal of Psychiatry, 34(Suppl), S26-S34.
Jauss, M. (1998). Severe akathisia during olanzapine treatment of acute schizophrenia. Pharmacopsychiatry, 31, 146-148.
Jetter, A. (2000, September 12). Efforts to test drugs on children hasten drive for research guidelines. New York Times. Retrieved September 12, 2000 from http://www.nytimes.com/yr/mo/day/ science/12ETHI.html
Khan, A., Warner, H. A., & Brown, W. A. (2000). Symptom reduction and suicide risk in patients treated with placebo in antidepressant clinical trials: An analysis of the Food and Drug Administration database. Archives of General Psychiatry 57, 311-317.
Khan A., Khan, S. R., Leventhal, R. M., Krishnan, K. R., & Gorman, J. M. (2002). An application of the revised CONSORT standards to FDA summary reports of recently approved antidepressants and antipsychotics. Biological Psychiatry, 52, 62-67.
Kaiser, D. (1996, December). Against biologic psychiatry. Psychiatric Times, 13. Retrieved January 30, 2003 from http://www.mhsource.com/pt/p961242.html .
Kalia, M., OâCallaghan, J. P., Miller, D. B., Kramer, M. (2000). Comparative study of fluoxetine, sibutramine, sertraline and dexfenfluramine on the morphology of serotonergic nerve terminals using serotonin immunohistochemistry. Brain Research. 858(1), 92-105.
Kendler, K., & Diehl, D. (1993). The genetics of schizophrenia: A current, genetic-epidemiologic perspective. Schizophrenia Bulletin, 19, 261-285.
King, R. A., Riddle, M. A., Chappell, P. B., Hardin, M. T., Anderson, G. M., Lombroso, P., Scahill, L. (1991). Emergence of self-destructive phenomena in children and adolescents during fluoxetine treatment. Journal of the American Academy of Child and Adolescent Psychiatry, 30, 179-186.
Kirsch, I., Moore, T. J., Scoboria, A., & Nicholls, S. S. (2002). The Emperor’s new drugs: An analysis of antidepressant medication data submitted to the U.S. Food and Drug Administration. Prevention & Treatment, 5, Article 23. Available at: http://journals.apa.org/prevention/volume5/pre0050023a.html
Klassen, T. P., Wiebe, N., Russell, K., Stevens, K., Hartling, L., Craig, W. R., & Moher, D. (2002). Abstracts of randomized controlled trials presented at the society for pediatric research meeting: An example of publication bias. Archives of Pediatric and Adolescent Medicine, 156, 474-479.
Klein , R. G., Mannuzza, S., Koplewicz, H. S., Tancer, N. K., Shah, M., Liang, V., & Davies M. (1998). Adolescent depression: Controlled desipramine treatment and atypical features. Depression & Anxiety, 7, 15-31.
Koller, E., Malozowski, S., & Doraiswamy, P. M. (2001). Atypical antipsychotic drugs and hyperglycemia in adolescents (Letter). JAMA, 286. Retrieved November 28, 2001from http://jama.ama-assn.org/issues/current/ffull/jlt1128-4.html .
Konradi, C., Leveque, J. C., Hyman, S. E. (1996). Amphetamine and dopamine-induced immediate early gene expression in striatal neurons depends on postsynaptic NMDA receptors and calcium. Journal of Neuroscience, 16, 4231-4239.
Kutcher, S. (1997). Practitioner review: The pharmacotherapy of adolescent depression. Journal of Child Psychiatry, 38, 755-767.
Kye, C. H., Waterman, G. S., Ryan, N. D., Birmaher, B., Williamson , D. E., Iyengar, S., & Dachille, S. (1996). A randomized, controlled trial of amitriptyline in the acute treatment of adolescent major depression. Journal of the American Academy of Child Adolescent Psychiatry. 35, 1139-1144.
Lambert , N. M., & Hartsough, C. S. (1998). Prospective study of tobacco smoking and substance dependencies among samples of ADHD and non-ADHD participants. Journal of Learning Disabilities, 31, 533-544.
Lambert, N. M. (1998). Stimulant treatment as a risk factor for nicotine use and substance abuse. Presented at NIMH Consensus Conference, available online from http://www.add.about.com/health/add/library/weekly/aa1119v.htm
Leo, J. (2002, January/February). American preschoolers on Ritalin. Society, 39, 52-60.
Lieberman, J. A., Sheitman, B. B., Kinon, B. J. (1997). Neurochemical sensitization in the pathophysiology of schizophrenia: Deficits and dysfunction in neuronal regulation and plasticity. Neuropsychopharmacology, 17, 205-229.
Madsen, A. L., Keidling, N., Karle, A., Esbjerg S, Hemmingsen R. (1998). Neuroleptics in progressive structural brain abnormalities in psychiatric illness. Lancet, 352, 784-785.
March, J. S., Biederman, J., Wolkow, R., Safferman, A., Mardekian, J., Cook, E. H., et al. (1998). Sertraline in children and adolescents with obsessive-compulsive disorder. JAMA, 280, 1752-1756.
Marshall, E. (2000a). Planned Ritalin trial for tots heads into uncharted waters. Science, 290, 1280-1281.
Marshall, E. (2000b). Duke study faults overuse of stimulants for children. Science, 389, 721.
Martin, S. (2000, October 5). Are schools pushing Ritalin? Congress gets involved in the controversy. WebMD. Retrieved December 10, 2002 http://webmd.lycos.com/content/article/1728.61890
Mazo, E. (2000, April 27). Infant’s death raises alarms on who’s used in drug trials. Pittsburgh Post-Gazette. Retrieved April 27, 2000 from http://www.postgazette.com/healthscience/20000427propulsid1.asp
McKeen, D. (2000). The ethics of drug testing: Kids as guinea pigs. Salon. Retrieved May 31, 2000 from http://www.salon.com/health/feature/2000/05/31/drug_trials/index2.html
Mezzacappa, E., Steingard, R., Kindlon, D., Saul, J. P., & Earls, F. (1998). Tricyclic antidepressants and cardiac autonomic control in children and adolescents. Journal of the American Academy of Child & Adolescent Psychiatry, 37, 52-59.
Mittleman, B. B., Castellanos, F. X., Jacobsen, L. K., Rapoport, J. L., Swedo, S. E., & Shearer , G. M. (1997). Cerebrospinal fluid cytokines in pediatric neuropsychiatric disease. Journal of Immunology, 159, 2994-2999.
Montero, D. (2001, February 12). Risking kids’ health for sake of science. New York Post. Retrieved February 12, 2001 from http://members.fortunecity.com/siriusw/riskingkids.htm
Moore, T.J. (1997, December). Hard to Swallow. The Washingtonian. Available online at: http://www.washingtonian.com/health/hardtoswallow.html
Moore, T. J. (1998). Prescription for disaster. Simon & Schuster, 1998.
MTA Cooperative Group. (1999a). A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Archives of General Psychiatry, 56, 1073-1086.
MTA Cooperative Group. (1999b). Moderators and mediators of treatment response for children with attention-deficit/ hyperactivity disorder: The Multimodal Treatment Study of children with attention-deficit/hyperactivity disorder. Archives of General Psychiatry, 56, 1088-1096.
Murphy, D. (2001). Challenges unique to pediatric new product development (Slide presentation). Retrieved May 31, 2002 from http://www.wcuppd.org/pediatric/sld013.htm
National Institutes of Health. (1998, March 6). NIH policy and guidelines on the inclusion of children as participants in research involving human subjects. Available online: http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Neergaard, L. (2000, February 15). A warning for tiny hearts: Safety of heartburn drug Propulsid in question. Pittsburgh Post-Gazette. Retrieved on February 28, 2003 from http://www.msbp.com/propulsid.htm
Neergaard, L. (2000a, December 12). FDA cast doubts on doctors: New drug warnings often ignored. Associated Press release retrieved December 12, 2000 from http://abcnews.go.com/sections/living/DailyNews/drugban001212.html
Neergaard, L. (2000b, February 7). Is Propulsid safe for babies? Associated Press release retrieved February 7, 2000 from http://onhealth.webmd.com/baby/briefs/reuters/item%2C79331.asp
The Need to Test Drugs on Children . (2002, April 7). Editorial. New York Times. Retrieved April 7, 2002 from http://www.nytimes.com/2002/04/07/opinion/07SUN2.html?pagewanted=print&position=top
Pfizer. (1996, May 23). Suicide-related behavior in children and adolescents in the sertraline OCD clinical development program. Safety Evaluation and Epidemiology. Report submitted to the FDA. Obtained under Freedom of Information Act.
Pfizer. (1997). Expert Report on the clinical documentation of sertraline hydrochloride for obsessive compulsive disorder in paediatric patients. Report submitted to the FDA. “Approved October 20, 1997.” Obtained under Freedom of Information Act.
Picard A. (2002, May 29). Pediatrics data buried if negative, study says. Globe and Mail (Toronto), p. A8. Also available online from: http://www.antidepressantsfacts.com/Pediatrics-data-buried.htm
Pine DS, Coplan JD, Wasserman GA, Miller LS, Fried JE, Davies M, Cooper TB, Greenhill L Shaffer D, Parsons B. (1997). Neuroendocrine response to fenfluramine challenge in boys. Archives of General Psychiatry. 54: 839-846.
Lurie, P., & Wolfe, S. (1998, December). FDA medical officers report lower standards permit dangerous drug approvals. Public Citizen report, available online: http://www.citizen.org/publications/release.cfm?ID=7104
Public Citizen. (2000) Report by Australian Adverse Drug Reactions Advisory Committee. (1999) Available online: http://www.citizen.org/eletter/ARTICLES/olanzapine.htm
Public Citizen. (2001a, July 23) Report. The other drug war: big pharma’s 625 Washington lobbyists. http://www.citizen.org/congress/drugs/pharmadrugwar.html
Public Citizen. (2001b, November 9). Patently offensive: Congress set to extend monopoly patents for Cipro and other Drugs. Retrieved November 2002 http://www.citizen.org/congress/reform/drug_patents/pediatric/articles.cfm?ID=6435
Riddle, M. A., Hardin, M. T., King, R., Scahill, L., & Woolston, J. L. (1990). Fluoxetine treatment of children and adolescents with Tourette’s and obsessive compulsive disorders: Preliminary clinical experience. Journal of the American Academy of Child and Adolescent Psychiatry, 29, 45-48.
Riddle MA, Geller B, Ryan N. (1993) Another sudden death in a child treated with desipramine. Journal of the Americn Academy of Child and Adolescent Psychiatry, 32:792-7
Roberts, R. (2002, October 15) Presentation.The Federal Government: Recent Changes at FDA and the Implications for Pediatric Clinical Trials. Retrieved on February 15, 2003:
Rushton, J. (2000). Ritalin and Prozac: More kids using both drugs. Abstract from Pediatric Academic Societies, retrieved June 1, 2001 from http://www.wcanews.com/archives/2000/Jul/jul0300d.htm
Rustad, M. (2000, March 7) Antidepressants found to alter brain cells in rats. Retrieved
Sabo, E. (2001, January 23). Fuzzy math in drug studies. Medscape Health. Retrived January 23, 2001 from http://health.medscape.com/cx/viewarticle/232469
Sharav, V. H. (2001, April 5). Comments concerning “Draft policy and procedures for DHHS research involving children – 45 CFR 46.407. Unpublished manuscript submitted to Office of Human Research Protections.
Sharav, V. H. (2002, May 6). Conflicts of interest. Paper presented at U.S. Army Medical Department and Henry Jackson Foundation, San Antonio, Texas. Available online from https://www.ahrp.org/testimonypresentations/armymeddept.php
Sherman, C. (2002) Antisuicidal effect of psychotropics remains uncertain. Clinical Psychiatry News. August 2002, 30: p1
Siberry, G. K., Iannone, R., & Childs, B. (Eds.). (2000). Harriet Lane handbook: A manual for pediatric house officers (15th ed.). Baltimore, MD: Mosby Publishers.
Spice, B. (2000, July 9). Was baby treated for ailment he didn’t have? Pittsburgh Post-Gazette. Retrieved July 9, 2000 from http://www.post-gazette.com/healthscience/20010709gage0709p5.asp
Steinbrook R. (2002) Testing medications in children. New England Journal of Medicine, 347, 1462-1470.
Stolberg, S. G. (2001, February 11). As children help test medicines, profits and questions are raised. New York Times. Retrieved February 11, 2001 from http://www.nytimes.com/2001/02/11/national/11DRUG.html
Surgeon General. (1999). Mental health: A report of the Surgeon General (Chapter 3: Children). Available on World Wide Web at: http://www.surgeongeneral.gov/library/mentalhealth/toc.html#chapter3
Surgeon General. (2001, January 3). Report of the Surgeon General’s conference on children’s mental health: National action agenda. Available on World Wide Web at: http://www.surgeongeneral.gov/cmh/childreport.htm
Swanson, J. M., Kraemer, H. C., Hinshaw, S. P., Arnold, L. E., Conners, C. K., Abikoff, H. B., et al. (2001). Clinical relevance of the primary findings of the MTA: Success rates based on severity of ADHD and ODD symptoms at the end of treatment. Journal of the American Academy of Child & Adolescent Psychiatry, 40, 168-179.
Swanson, J. R., Jones GR, Krasselt W, Denmark LN, Ratti F. (1997). Death of two subjects due to imipramine and desipramine metabolite accumulation during chronic therapy: A review of the literature and possible mechanisms. Journal of Forensic Science, 42, 335-339.
Tanouye, E. (1999, August 25). New weapons in the war on schizophrenia. Wall Street Journal, p. B-1.
Teicher, M. H., Glod, C., & Cole, J. O. (1990). Emergence of intense suicidal preoccupation during fluoxetine treatment. American Journal of Psychiatry, 147, 207-210.
Teicher MH, Glod CA, Cole JO. (1993). Antidepressant drugs and the emergence of suicidal tendencies. Drug Safety.8:186-212, p. 186.
Teva Pharmaceuticals USA. (2000) Comments on the content of FDAâs report to Congress on pediatric exclusivity issues. Docket no. OON-1266, June 2. Retrieved January 18, 2003 from http://www.fda.gov/ohrms/dockets/dailys/00/jun00/060500/c00003.pdf
The Prozac question (Editorial). (2000, June 13). Boston Globe, p. A-26.
Tsuang, M. T., & Faraone, S. V. (2002a). Diagnostic concepts and the prevention of schizophrenia. Canadian Journal of Psychiatry, 47, 515-517.
Tsuang, M. T., Stone, W. S., & Faraone, S.V. (2000). Toward reformulating the diagnosis of schizophrenia. American Journal of Psychiatry, 157, 1041-1050.
Tsuang, M. T., Stone, W. S., & Faraone, S. V. (2002b). Understanding predisposition to schizophrenia: Toward intervention and prevention. Canadian Journal of Psychiatry, 47, 518 – 526.
Tsuang, M.T. & Faraone, S.V. (2002c). (Editorial) Diagnostic Concepts and the Prevention of Schizophrenia. Canadian Journal of Psychiatry, 47, 515-7.
United States Code of Federal Regulations. (1983) US 45 CFR 46, Subpart D “Additional Protections for Children” were adopted March 8, 1983. Retrieved November 2001 from http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#46.405.
U.S. Public Law. 102-571 (1992). 21 USC 301.
U.S. Public Law 105-115. (1997) 21 USC 301.
Valenstein, E. (1998). Blaming the brain: The truth about drugs and mental health. New York: The Free Press.
Van Putten, T., & Marder, S. R. (1987). Behavioral toxicity of antipsychotic drugs. Journal of Clinical Psychiatry, 48(Suppl.), 13-19.
Van Reekum, R., & Cleghorn, J. M. (1992). Pamphlet #9: Report on the evidence supporting a biological basis for schizophrenia. Toronto: World Fellowship for Schizophrenia and Allied Disorders. Retrieved Month, Day, Year from http://www.world-schizophrenia.org/publications/09-biological/html
Varley, C. K., & McClellan, J. (1997). Case study: two additional sudden deaths with tricyclic antidepressants. Journal of the American Academy of Child & Adolescent Psychiatry, 36, 390-394.
Vastag, B. (2001). Pay attention: Ritalin acts much like cocaine. JAMA, 286. Retrieved August 29, 2001 from http://jama.ama-assn.org/issues/v286n8/ffull/jmn0822-1.html
Vitiello, B., Jensen, P. S., & Hoagwood, K. (1999). Integrating science and ethics in child and adolescent psychiatry research. Biological Psychiatry, 46, 1044-1049.
Vitiello, B. (2001). Psychopharmacology for young children: Clinical needs and research opportunities. Pediatrics, 108, 983-990. .
Voelker, R. (1999). SSRI use common in children. JAMA, 281. Retrieved May 26, 1999 from http://jama.ama-assn.org/issues/v281n20/ffull/jqu90003-3.html
Volkow, N. D., Ding, Y. S., Fowler, J. S., Wang, G. J., Logan, J., Gatley J. S., et al. (1995). Is methylphenidate like cocaine? Studies on their pharmacokinetics and distribution in the human brain. Archives of General Psychiatry, 52, 456-463.
Whitaker, R., & Kong, D. (1998, November 15-18). Doing harm: Research on the mentally ill (Investigative series). Boston Globe, p. 1.
Whitaker, R. (2002). Mad in America. Cambridge, MA: Perseus.
Wilens, T. E., Biederman, J., Baldessarini, R. J., Geller, B., Schleifer, D., Spencer, T.J., Birmaher , B., & Goldblatt, A. (1996). Cardiovascular effects of therapeutic doses of tricyclic antidepressants in children and adolescents. Journal of the American Academy of Child & Adolescent Psychiatry, 35, 1491-1501.
Willman, D. (1998, December 6). “Fast-track” drug to treat diabetes tied to 33 deaths. Los Angeles Times, p. 1.
Willman, D. (2000a, December 20). How a new policy led to seven deadly drugs. Los Angeles Times, p. 1. Retrieved December 20, 2000 from http://www.latimes.com/news/nation/reports/fda/lat_fda001220.htm
Willman, D. (2000b, December 20). Propulsid: A heartburn drug, now linked to children’s deaths. Los Angeles Times, p. 1. Retrieved December 20, 2000 from http://www.pulitzer.org/year/2001/investigative-reporting/works/willman2.html
Wirshing W, VanPutten T, Rosenberg, J, Marder S, Ames D, Hicks-Gray T. (1992). Fluoxetine, akathisia, and suicidality: is there a causal connection? Archives of General Psychiatry, 49: 580-581.
World Health Organization. (2000, November 3). WHO Pharmaceuticals Newsletter. Uppsala, Sweden: WHO Collaborating Centre for International Drug Monitoring. Available on World Wide Web at: http://www.who.int/medicines/library/pnewslet/pn32000.html
Zimmerman M, Mattia JI, Posternak MA. 2002. Are subjects in pharmacological treatment trials of depression representative of patients in routine clinical practice? AJP. 159::469-73.
Zimmerman, R. (2000, July 26). Radical study on schizophrenia may be expanded: Researchers seek to discover whether antipsychotic drugs can prevent the disease. Wall Street Journal. Retrieved July 26, 2000 from http://www.contac.org/contaclibrary/research70.htm
Zimmerman, R. (2001, February 5) Drug makers find a windfall testing adult drugs on kids. Wall Street Journal, p. 1.
Zito, J.M., Safer D. J., dosReis, S., Gardner, J. F., Boles, J., & Lynch, F. (2000). Trends in the prescribing of psychotropic medications to preschoolers. JAMA, 283, 1025-1030.
Zito, J. M., Safer, D. J., dosReis, S., Gardner, J. F., Magder, L., Soeken, K., et al. (2003). Psychotropic practice patterns for youth: A 10-year perspective. Archives of Pediatric and Adolescent Medicine, 157, 17-25.
Zuckoff, M. (2000, June 11). Prozac new directions: Science, money drive a makeover. Boston Globe, p. 1.