by David Healy
55. American Psychiatric Association, “APA responds to FDA's new warning on antidepressants,” news release, Oct. 15, 2004, http://www.psych.org/news_room/press_releases/04–55apaonfdablackboxwarning.pdf.
56. US District Court for the Central District of California, Flora Motus v. Pfizer Inc. (Roerig Division), CV 00–298, Nov. 11, 1999.
57. US Court of Appeal of the Ninth Circuit, Motus F v. Pfizer Inc. (Roerig Division), No 02–55372, 02–55498, Amicus Brief D Troy et al., Sept. 3, 2002.
58. US Court of Appeal of the Ninth Circuit, Motus F v. Pfizer Inc. (Roerig Division), No 02–55372, 02–55498, Amicus Brief D Troy et al., Sept. 3, 2002.
59. Montag v. Honda Motor Co., 75 F. 3d 1414, Jan. 22, 1996, http://www.appellate.net/briefs/geieramicus.pdf.
60. Joint Meeting of the CDER Psychopharmacologic Drugs Advisory committee and the FDA Pediatric Advisory Committee, Bethesda, Sept.ember 13, 2004, 435.
61. Joint Meeting of the CDER Psychopharmacologic Drugs Advisory committee and the FDA Pediatric Advisory Committee, Bethesda, Sept. 13, 2004, 332.
62. Greg D. Curfman, Stephen Morrissey, and Jeffrey Drazen, Why doctors should worry about pre-emption, NEJM 359, 1–3 (2009).
63. Warner-Lambert v. Kent Supreme court docket 06–1498. See www.scotuswiki.com/index.php?title=Warner-Lambertv.Kent.
64. Wyeth v. Diana Levine. In US Supreme Court, No. 06–1249 Citations 555 US 555
65. “Supreme Court rules against Wyeth in liability case,” Reuters, March 4, 2009, http://www.reuters.com/article/domesticNews/idUSTRE5233VS20090304.
66. Clifford J. Rosen, The Rosiglitazone story: Lessons from an FDA advisory committee, NEJM 357, 844–846 (2007), 1056/nejmp078167; Steven Nissen and Kathy Wolski, Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes, NEJM 356, 2457–2471 (2007).
67. Deborah Cohen, Rosiglitazone: What went wrong? BMJ 341, 530–534, c4848 (2010).
68. Philip D. Home et al., Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): A multicentre, randomised, open-label trial, Lancet 373, 2125–2135 (2009).
69. Cohen, Rosiglitazone: What went wrong?
70. US Senate, Committee on Finance, Staff report on GlaxoSmithKline and the diabetes drug Avandia (2010), http://finance.senate.gov/newsroom/chairman/release/?id=bc56b552-efc5–4706–968d-f7032d5cd2e4.
71. Adrienne Fugh-Berman et al., Promotional tone in reviews of menopausal hormone therapy after the women's health initiative: An analysis of published articles, Public Library of Science Medicine 8, e1000425 (2011).
CHAPTER 8
1. Annemarie Mol, The Logic of Care (London: Routledge, 2008).
2. Samuel Sessions and Alan Detsky, The “Shadow Government” in Health Care, JAMA 304, 2742–2743 (2010).
3. This is similar to the use of intelligence tests for political purposes in 1920s as outlined by Steven J. Gould. The Mismeasure of Man (Harmondsworth, UK: Penguin Books, 1980).
4. Deposition of Ian Hudson in Tobin v. SmithKline Beecham, Dec. 15, 2000, 30–33 (Harlow, UK).
5. Joseph S. Ross et al., Pooled analysis of rofecoxib placebo-controlled clinical trial data: Lessons for postmarketing pharmaceutical surveillance, Archives of Internal Medicine 169, 1976–1984 (2009).
6. Philip Fine, Make Big Pharma provide their raw data, University World News, Jan. 18, 2009, http://www.universityworldnews.com/article.php?story=20090115191615198.
7. Transcript from BBC Panorama program “Secrets of the Drugs Trials,” Jan. 29, 2007, news.bbc.co.uk//i/hi/programmes/panorama/6317137.stm.
8. Jon Thompson, Patricia Baird, and Jocelyn Downie, The Olivieri Report (Toronto: Lorimer, 2001).
9. David Healy, Derelie Mangin, and Barbara Mintzes, The ethics of controlled trials in prenatal depression, International Journal of Risk and Safety in Medicine 22, 1–10 (2010), doi:10.3233/JRS-2010–048.
10. Sessions and Detsky, “Shadow Government” in Health Care.
11. Geoffrey Venning, Validity of anecdotal reports of suspected adverse drug reactions: The problem of false alarms, BMJ 284, 249–253 (1982).
12. David Healy and Dinah Cattell, The Interface between authorship, industry and science in the domain of therapeutics, British Journal of Psychiatry 182, 22–27 (2003).
13. Erick H. Turner et al., Selective publication of antidepressant trials and its influence on apparent efficacy, NEJM 358, 252–260 (2008).
14. Gonzalo Laje et al., Genetic markers of suicidal ideation emerging during citalopram treatment of major depression, American Journal of Psychiatry 164,1530–1538 (2007).
15. R. Bordet et al., Analysis of the direct cost of adverse drug reactions in hospitalised patients, European Journal of Clinical Pharmacology, 56, 935–941 (2001), doi:10.1007/s0022 80000260.
16. Sessions and Detsky, “Shadow Government” in Health Care.
17. Richard J. Wurtman and R. L. Bettiker, The slowing of treatment discovery, 1965–1995, Nature Medicine 1, 1122–1125 (1995).
18. Paul R. Gross and Norman Levitt, Higher Superstition: The academic left and its quarrel with science (Baltimore: Johns Hopkins University Press, 1994).
19. Ivan Illich, Limits to Medicine (Medical Nemesis) (Harmondsworth, UK: Penguin Books, 1976).
20. John Abramson, Overdosed America: The Broken Promise of American Medicine (New York: Harper Perennial, 2005).
21. Zyprexa: Primary Care Sales Force Resource Guide, Zyprexa MDL 1596, Plaintiffs' Exhibit 01926 (2002), 7.
22. Gardiner Harris, “Senator Grassley seeks financial details from medical groups,” New York Times, Dec. 7, 2009, http://www.nytimes.com/2009/12/07/health/policy/07grassley.html.
23. Emory University's Charles Nemeroff, Stanford's Alan Schatzberg, and Brown's Martin Keller—the “author” of Study 329.
24. Meredith Wadman, The senator's sleuth, Nature 461, 330–334 (Sept. 17, 2009).
25. Sandra Hempel, The Strange Case of the Broad Street Pump: John Snow and the Mystery of Cholera (Berkeley: University of California Press, 2009).
26. Dwight D. Eisenhower, Military industrial complex speech (1961), http://www.cnn.com/SPECIALS/cold.war/episodes/12/documents/eisenhower.speech (accessed April 21, 2002).
27. Kenneth Kiple, Plagues, Pox and Pestilence (London: Weidenfield and Nicholson, 1997).
28. Hank McKinnell, A Call to Action (New York: McGraw Hill, 2005).
Index
The index that appeared in the print version of this title does not match the pages in your eBook. Please use the search function on your eReading device to search for terms of interest. For your reference, the terms that appear in the print index are listed below.
Abbott Pharmaceuticals
Abilify
access to data: lack of, for clinical trials, restricted, in “controlled trials,” need for, and US Data Access Act
ACE inhibitors
acetanilide
Actonel
Adam, Christopher
Advair
agoraphobia
AIDS
Air Force, US
Alzheimer's disease
American Academy of Child and Adolescent Psychiatry, Journal of (JAACAP)
American Association of Pediatricians
American College of Neuropsychopharmacology (ACNP)
American College of Obstetricians
American Diabetes Association
American Journal of Psychiatry
American Medical Association (AMA), Council on Pharmacy Approval, Journal of (JAMA)
American Psychiatric Association (APA), Diagnostic and Statistical Manual (DSM-III)
amitriptyline
amphetamines
anemia
angiotensin-converting enzyme inhibitors. See ACE inhibitors
angiotensin receptor antagonists (ARBs)
Antefebrin
Anthony, Paul
anthrax
antibiotics. See also specific drugs; in children, clinical trial
s of, discovery and development of marketing of
anticonvulsants
antidepressants. See also SSRIs; specific drugs; for children clinical trials of in drug cocktails, guidelines for marketing of neurotransmitters and pain relief from patents on, during pregnancy prophylactic use of suicide on
antihistamines See also specific drugs
antihypertensives. See also diuretics; specific drugs; thiazide
antipsychotics. See also specific drugs; for children and adolescents clinical trials of, guidelines on marketing of neurological side effects of suicidality on
antiretrovirals
antiseptic practice
anxiety in children treatment of. See also tranquilizers; specific drugs
Aranesp
Archives of General Psychiatry
arthritis rheumatoid
Asperger's syndrome
Aspirin
asthma treatment of. See also beta-agonists; specific drugs
Astra-Zeneca
attention deficit hyperactivity disorder (ADHD)
Austin (Texas) State Hospital
Australia
Australian Society for Bipolar Disorders
Austria
autism
Avandia
avian flu
Aviation Safety Board
Axis Healthcare Communications
AZT
bacterial endocarditis
bacteriology
barbiturates
BASF chemical company
Bauby, Jean-Dominique
Bayer Chemical Company
Bayh-Dole Act (1980)
Beasley, Charles
Beecham's Pills
Benzedrine
benzodiazepines
Best Practices
beta-agonists
beta-blockers
Bilious Pills
biphosphonates. See also Actonel; Fosamax; clinical trials of marketing of
bipolar disorder, in children and adolescents treatment of. See also mood stabilizers; specific drugs Bipolar Disorder (journal)
birth defects
Bittker, Thomas
Black, James
Blair, Jayson
blockbuster drugs adverse effects of doctors the primary consumers of and drug interactions, human cost of clinical trials for increased consumption and sales of side effects of as a primary driver of health system growth
Blumsohn, Aubrey
Boehringer-Ingelheim
bone scans. See also DXA scans
Borison, Richard
Brazil
breast cancer
Bright's disease
Bristol-Myers Squibb
Britain navy, Medical Research Council (MRC) Medicine and Healthcare Products Regulatory Agency (MHRA)-National Institute for Health and Clinical Excellence (NICE) Royal College of Physicians
British Association for Psychopharmacology
British Broadcasting Company (BBC)
British Journal of Psychiatry
British Medical Journal (BMJ)
Brown, Francis
Brown University
Burroughs Wellcome
Bush, George W.
Cabot, Richard
California, University of, at Los Angeles (UCLA)
Cambridge University
Canada
cancer breast lung treatments for
carbutamide
cardiovascular disease
See also heart attack; drug- induced increased risk for guidelines for
cargo cults
Carlsson, Arvid
Carter's Little Liver Pills
Casey, Annie E., Foundation
Catalyst Healthcare Communications
catatonia
Celebrex
Celexa
censorship self-censorship
Centers for Disease Control
Chain, Ernst
Chalmers, Iain
Champix
Chemical Bureau, US
chemical imbalance
chemotherapy
China
chlorpromazine
cholera
cholesterolblood tests for drug induced increased levels of drugs for lowering. See statins; specific drugs
Christian Scientists
cimetidine
Cipro
cisapride
citalopram
Clearasil
Clements, Paul
Cleveland Clinic
Clinical Approaches to Bipolar Disorders (journal)
clinical immuno-deficiency virus (CIV)
clinical research organizations (CROs)
Clinton, Bill
clozapine
Clozaril
Coca Cola
Cochrane, Archie
Cochrane Center
Cohn & Wolf Global Communications and Public Relations Agency
colic
Commonwealth Fund
conflict of interest and cultivated friendship networks, false attribution of problems to and ghostwriting history of in medical-pharmaceutical interaction Royal College meeting on
congenital malformations. See birth defects
Congress, US. See also House of Representatives, US; Senate, US
Congressional Budget Office
consensus conferences
Console, Dale
Contemporary Psychology
Cora (daughter of Demeter)
Cora (patient)
coronary care units (CCUs)
Covance Inc.
Cox-2 inhibitors
Crimean War
Current Medical Directions
Cymbalta
Czechoslovakia
data, access to
Data Access Act (1999)
data-based medicine
David, Michelle
DeAngelis, Catherine
dementia. See also Alzheimer's disease; in tertiary syphilis
Demeter
Democratic Party
Denmark
Depakote
depression in children and adolescents DSM criteria for rating scales for treatment of. See also antidepressants; SSRIs; specific drugs
desvenlafaxine
dexamphetamine
Dexedrine
dexfluoxetine
diabetes antipsychotic induced in children genetic factors in testing for blood sugar levels in treatment of. See also hypoglycemics; insulin; screening for
diacetylmorphine
Diagnostic and Statistical Manual (DSM)
Diamond, Bruce
Dianette
Diehl, Howard
diphtheria
disease mongering
diuretics
Diuril
Donna (fictional patient)
“doubt is our product,”
Downing, Mathy
dual energy X-ray absortiometry scans. See DXA scans
Duchenne muscular dystrophy
Dukes, Graham
Dulcan, Mina
duloxetine
DXA scans
Eastell, Richard
Efexor
Ehrlich, Paul
Eisenhower, Dwight
electroconvulsive therapy (ECT)
Emslie, Graham
endocarditis bacterial
England. See also Britain seventeenth century
Envision Pharma
epidemiology junk
Epidemiology (journal)
Epstein-Barr virus
erectile dysfunction
esfluoxetine
es-omeprazole
European Bipolar Forum
Evarts Ed
evidence-based medicine (EBM) clinical trials in
guidelines and
marketing and
Exxon Valdez oil spill
ezetimibe
female sexual dysfunction (FSD)
fertilizers
fibromyalgia
Firestein Rose
Fisher Ronald
Florey Howard
fluoxetine. See
Prozac
Food Drugs and Cosmetics Act (1938) Humphrey-Durham amendments
(195I)
Food and Drug Administration (FDA) adverse events reported to advertising regulations of on antidepressants and suicidality Central Nervous System division criteria for approval by drugs banned by hazard warning requirements of licensing of drugs by Modernization Act (FDAMA: 1998) submission of placebo-control trials to
Food and Drugs Act (1906) Kefauver-Harris amendments (1962)
Ford Henry
Forest Research Institute
Fosamax
Framingham study
France. See also French Revolution; Academy of Medicine ; National Institute
Franklin Benjamin
French Revolution
Fromm Gina
gastroesophageal reflux disease (GERD)
Geigy J. R. Ltd.
generic drugs
genetics
Geodon
Georgia Medical College of
Germany
ghostwriting: adherence of ghostwriters to ethical standards author's articles on ghostwriting complicity of medical journals in lack of access to data in by pharmaceutical companies 261; and self-censorship truthfulness in
Glasgow Royal Infirmary
Glaxo Pharmaceuticals
GlaxoSmithKline (GSK) clinical trials of. See also Study FDA and legal actions against marketing by miscoding of study results by patents held by and Paxil-induced suicide restless leg syndrome invented by Senate investigation of
Glaxo Wellcome
Gleason Aliah
Glenmullen Joseph Prozac Backlash
Gollum (character in J.R.R. Tolkien novel)
Goodman Bob
Gordon Alles
Gore Albert Sr.
Graham David
Grassley Charles
Grave's disease
Greenland Sandor
Griffith Walter
guidelines for bipolar disorder in Britain consensus conferences on discretion versus pediatric
GYMR Public Relations