Guide to Sources
The references for Shipwreck lie in several different places. Many specific references to the material in Shipwreck set out in traditional format, are in the Healy books below:
- The Antidepressant Era
- The Creation of Psychopharmacology
- Let Them Eat Prozac
- Mania
- Pharmageddon
- Children of the Cure
These books also hinge on a set of Healy papers covering psychopharmacology and adverse event issues that can be found at and most downloaded from Samizdat.org\Shipwreck:HealyReferences.
On davidhealy.org a blog has been running since 2012 containing over 500 posts most of which touch on the general political and social issues raised here, from ghostwriting to Sense about Science, Clinical Trials and lack of access to the trial data. Perhaps most important are a set of posts around the death of Stephen O’Neill and the implications of his death for all of us – see video links below.
On RxISK.org, another blog has been running since 2012. This contains approximately 500 pieces which hinge on specific adverse events, including the psychiatric effects of drugs for asthma, Anne-Marie’s case, the enduring sexual dysfunctions following antidepressants, finasteride and isotretinoin, as well as dependence on, withdrawal from and birth defects linked to antidepressants and problems on other drugs from the statins to the bisphosphonates.
Some key materials are linked to The Psychopharmacologists volumes 1-4 which contain 100 interviews with figures in the field. These can all be found at and downloaded from Samizdat.org/The Psychopharmacologists. The interviews from volume 4 have never been published.
The materials below are articles and books being read around the time each of the Shipwreck chapters were being written, which for the most part have not been referenced in the articles and books above. The better part of thirty years worth of materials in the books and articles above are not listed here.
I have undoubtedly stolen from friends, colleagues and opponents and will be happy to add in things that may seem obvious to some readers but which I’ve forgotten – adding is one of the advantages to an online format for Sources.
Video
The videos below cover central Shipwreck issues.
Shipwreck Maastricht (2019)
Shipwreck Bangor (2019)
Sex and Evidence Based Medicine (2021)
These three lectures give a precis of the Shipwreck problem. The first two are not for the squeamish – there are 4 decapitations. The third contains sexual material that may offend some.
These two clips about Stephen O’Neill’s death encapsulate the Shipwreck issues. There is extensive correspondence about his death with Ministers of Health, NICE Guidelines, Regulators and others on davidhealy.org. These make it painfully clear the authorities know about the problems but have opted to wash their hands.
These two lectures look at Shipwreck through an Economics is from Mars and Medicine from Venus lens rather than Decapitation.
Time to Abandon Evidence Based Medicine
A key Shipwreck claim is that Controlled Trials can be useful but we need to be cautious in how we use their findings.
All of the problems Shipwreck tackles show up in the use of antidepressants for children and especially in Study 329.
Drug Story: The Antidepressant Era
Psychotropic Drugs and Violence
Pharmageddon and Slow Medicine
A series of related lectures.
Post SSRI Sexual Dysfunction. PSSD
Persistent Genital Arousal Disorder PGAD
Sex has the capacity to disrupt everything, including the best laid plans of the pharmaceutical industry
Introduction
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The Two Medicines
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Accidents of Birth
The argument about controlled trials in this section was written up as The Fault Lies in Our Stars. This is on DavidHealy.org. An earlier version was sent out to the following who responded largely supportive (N indicates negative), and responses are built into the current version.
Tom Ban and the INHN listserv, Corrado Barbui, Lisa Bero, Alan Cassels, Angus Deaton, Andrew Leigh (author of Randomistas), Silvio Garattini (& Mario Negri Institute), Juan Gervas, Peter Gøtzsche, Jeremy Howick, Irving Kirsch (N), Joan-Ramon LaPorte, Joel Lexchin (N), John MacMillan, Leemon McHenry, Barbara Mintzes, Florian Naudet, Abel Novoa, Anne Springer, Jacob Stegenga, Sean Valles,
The Responses are in Fawlty Stars.
Some of the following declined because of time issues. All future responses will be added in on dh.org.
Virginia Barbour, Paul Glasziou, Ralph Edwards and Rebecca Chandler of UMC, Prescrire in Paris, Carl Heneghan Tom Jefferson and Nicholas DeVito linked to the Centre for Evidence Based Medicine in Oxford, University of Toronto Dept Statistics, McMaster University Dept of EBM, John Ioannides, Aaron Kesselheim, Harlan Krumholz, Vinay Prasad,
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Neo-Medicalism
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Access to Medicines
William Haddad
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Most of Bill Haddad’s papers were lost when a fire consumed his house. Given so colourful a career, any number of people might have been motivated to ensure his papers never saw the light of day. Some remaining papers can be found in the New York State Archive in Albany, where the library staff are wonderfully helpful.
Another key source was Alfred Engelberg, whose interview is posted along with those from the Psychopharmacologists on Samizdat.org/Shipwreck.
Louis Lasagna
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- Lasagna has several hundred peer reviewed articles; many on Samizdat.org or online.
- Lasagna L (1998). Interview with Healy D see Psychopharmacology references.
His papers are in the Archive at Rochester, New York, where the library staff just like those in Albany are extraordinarily friendly and helpful.
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Big Risk
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Footprints in the Sand
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Shadow Government
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Hitting the Reef
The major resource for this chapter is Study329.org. This site contains all the timelines, published papers and company and other documents that underpin these issues, along with video of programs made on the issues, lectures given and other materials.
Also on the site are the Zyprexa papers – linked to Jim Gottstein’s book The Zyprexa Papers. Between the Study 329 papers and the Zyprexa papers, this site offers more pharmaceutical company materials than any site on earth other than the UCSF DIDA site. We offer Guides to the origin of the documents in Children of the Cure and The Zyprexa Papers, both of which can be made available for free to individuals or groups who want to engage with these issues.
Another central element of this chapter is the James Holmes case. Panorama made a Feature on Holmes this. I was an expert witness in the case and wrote a report.
- Panorama Prescription for Murder – the third video down on The Pill that Steals Lives
- Brady Transcript
- Brauchler Transcript
- Metzner Transcript
- Reed Transcript
- Resnick Transcript
- Zoloft Defence Manual
- Healy Report
- Healy Appendix 1
- Healy Appendix 2
- Healy Appendix 3
- Healy Appendix 4
- Healy Appendix 5
- Hindmarch Aggression
- Hindmarch protocol
- Hindmarch report
- Hindmarch Doogan memo
- Lane Article
- Study 329 Aggression
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Once is Not Never
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Thalidomide
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What’s Done Cannot be Undone
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Crusoe we say was “Rescued”
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Lasagna Articles
- Beecher HK, Keats AS, Mosteller F, Lasagna L. The effectiveness of oral analgesics (morphine, codeine, acetylsalicylic acid) and the problem of placebo “reactors” and “non-reactors”. J Pharm & Exp Therapeutics 109: 393-400, 1953.
- Lasagna L, Mosteller F, von Felsinger J, Beecher H (1954). A study of the placebo response. American J Medicine 770-779.
- Lasagna L, Von Felsinger JM. The volunteer subject in research. Science 120, 359-61, 1954.
- Lasagna L, Beecher HK. The optimal dose of morphine. JAMA 156, 230-4, 1954.
- Lasagna L. Nalorphine (n-allylnormorphine); practical and theoretical considerations. A.M.A. Archives of Internal Medicine 94: 532-58, 1954.
- Lasagna L, Beecher HK. The analgesic effectiveness of codeine and meperidine (demerol). J Pharmacology & Experimental Therapeutics 112, 306-11, 1954.
- Lasagna L. The controlled clinical trial: theory and practice. J Chronic Diseases 1, 353-67, 1955.
- Lasagna L. A study of hypnotic drugs in patients with chronic diseases; comparative efficacy of placebo; methyprylon (noludar) meprobamate (miltown, equanil) pentobarbital; phenobarbital; secobarbital. J Chronic Diseases 3, 122-33, 1956.
- Lasagna L, Meier P. Clinical evaluation of drugs. Annual Review of Medicine 9, 347-54, 1958.
- Lasagna L. The drug industry and American medicine. J Chronic Diseases. 7: 440-3, 1958.
- Lasagna L, Laties VG, Dohan JL. Further studies on the pharmacology of placebo administration. J Clinical Investigation 37, 533-7, 1958.
- Lasagna L. A training program in clinical pharmacology. Postgraduate Medicine 26: 559-61,1959.
- Lasagna L (1960). Thalidomide, a new nonbarbiturate sleep–inducing drug. J ChronDis11, 627-31
- Lasagna L The role of a division of clinical pharmacology in a university environment. Postgraduate Medicine 29, 525-8, 1961.
- Hoehn R, Gross G, Gross M, Lasagna L. A double-blind comparison of placebo and imipramine in the treatment of depressed patients in a state hospital. J Psychiatric Research 1, 76-91, 1961.
- Lasagna L Analgesic drugs. American J Medical Sciences 242, 620-7, 1961.
- Lasagna L. A matter of perspective. J Chronic Diseases 15: 3-5, 1962.
- Lasagna L. Controlled trials: nuisance or necessity? Methods of Information in Medicine 1, 79-82, 1962.
- Lasagna L. The investigator’s responsibility to the patient. J Chronic Diseases 16, 955-9, 1963.
- Lasagna L. Problems of drug development. The government, the drug industry, the universities, and the medical profession: Partners or enemies? Science 145, 362-7, 1964.
- Lasagna L. The diseases drugs cause. Perspectives in Biology & Medicine 7, 457-70, 1964.
- Lasagna L. Drug toxicity in man: The problem and the challenge. Ann NY Acad Sciences 123, 312-5, 1965
- Lasagna L. The mind and morality of the doctor 1. The physician and the microcosm. Yale J Biology & Medicine 37, 345-60, 1965.
- Lasagna L. The mind and morality of the doctor 11. The physician and the macrocosm. Yale J Biology & Medicine 37, 361-78, 1965.
- Lasagna L. The quantification of desired and undesired effects of reproductive controls; some principles and problems. J Chronic Diseases 18, 1173-9, 1965.
- Lasagna L. Is narcotic addiction a chronic disease? J Chronic Diseases 19, 949-51, 1966.
- Lasagna L. The clinical pharmacologist as a servant of society. Canadian Med Assoc J 97, 109-13, 1967.
- Sjoqvist F, Lasagna L. The hypnotic efficacy of doxylamine. Clinical Pharmacology & Therapeutics 8, 48-54, 1967.
- Stolley PD, Lasagna L. Prescribing patterns of physicians. J Chronic Diseases 22, 395-405, 1969.
- Lasagna L. The pharmaceutical revolution: its impact on science and society. Science 166, 1227-33, 1969.
- Epstein LC, Lasagna L. Obtaining informed consent. Form or substance. Arch Int Med123, 682-8, 1969.
- Lasagna L. Challenges in drug evaluation in man. Ann Review Pharmacology 10, 413-20, 1970.
- Becker MH, Stolley PD, Lasagna L, McEvilla JD, Sloane LM. Characteristics and attitudes of physicians associated with the prescribing of chloramphenicol. HSMHA Health Reports. 86, 993-1003, 1971.
- Lasagna L. FDA ‘efficacy’ rule: does it work? Missouri Medicine 68, 712-4, 1971.
- Lasagna L. Preferences in antibiotic prescribing. BMJ 3: 474, 1971.
- Macaraeg PV, Lasagna L, Bianchine JR. A study of hospital staff attitudes concerning the comparative merits of antibiotics. Clinical Pharmacology & Therapeutics 12, 1-12, 1971.
- Lasagna L. The impact of scientific models on clinical psychopharmacology: a pharmacologist’s view. Seminars in Psychiatry 4, 271-82, 1972.
- Lasagna L. The nature of evidence. Triangle 11,145-52, 1972.
- Lasagna L. Hypnotic drugs. New England Journal of Medicine 287: 1182-4, 1972.
- Becker MH; Stolley PD; Lasagna L; McEvilla JD; Sloane LM. Differential education concerning therapeutics and resultant physician prescribing patterns. J Medical Education 47, 118-27, 1972.
- Lasagna L. Research, regulation, and development of new pharmaceuticals: past, present, and future. 1. American J Medical Sciences 263, 9-18, 1972. II. American J Medical Sciences 263, 66-78, 1972.
- Lasagna L. Constraints on innovation in drug development and use. Psychopharmacology Bulletin. 8, 43-50, 1972.
- Lasagna L. Minimum acceptable requirements for introduction and marketing of drugs. Drugs. 7, 409-13, 1974.
- Mundy GR, Fleckenstein L, Mazzullo JM, Sundaresan PR, Weintraub M, Lasagna L. Current medical practice and the Food and Drug Administration. Some evidence for the existing gap. JAMA 229, 1744-8, 1974.
- Lasagna L. Editorial: A plea for the “naturalistic” study of medicines. European J Clinical Pharmacology 7, 153-4, 1974.
- Morgan JP, Wardell WM, Weintraub M, Mazzullo JM, Lasagna L. Clinical trials and tribulations. Archives of Internal Medicine 134, 380-3, 1974.
- Dengler HJ, Lasagna L. Report of a workshop on fixed-ratio drug combinations. European J Clinical Pharmacology 8, 149-54, 1975.
- Joubert P, Lasagna L. Commentary: Patient package inserts. I. Nature, notions, and needs. Clinical Pharmacology & Therapeutics 18, 507-13, 1975.
- Joubert P, Lasagna L. Patient package inserts. II. Toward a rational patient package insert. Clinical Pharmacology & Therapeutics 18, 663-9, 1975.
- Karch FE, Lasagna L. Adverse drug reactions. A critical review. JAMA 234, 1236-41, 1975.
- Lasagna L. Clinical trials of drugs from the viewpoint of the academic investigator (a satire). Clinical Pharmacology & Therapeutics 18, 629-33, 1975.
- Lasagna L, Wardell WM. Commentary: the FDA, politics, and the public. JAMA 232,141-2, 1975.
- Lasagna L. Drug discovery and introduction: regulation and overregulation. Clinical Pharmacology & Therapeutics 20, 507-11, 1976.
- Lasagna L. Randomized clinical trials. NEJM 295,1086-7, 1976.
- Lasagna L. Consensus among experts: the unholy grail. Perspectives in Biology & Medicine 19, 537-48, 1976.
- Karch FE, Smith CL, Kerzner B, Mazzullo JM, Weintraub M, Lasagna L. Adverse drug reactions-a matter of opinion. Clinical Pharmacology & Therapeutics 19, 489-92, 1976.
- Binns TB, Gross F, Lasagna L, Nicolis FB. Letter: Medical advisers in the pharmaceutical industry. Clinical Pharmacology & Therapeutics 19, 247-8, 1976.
- Fleckenstein L, Joubert P, Lawrence R, Patsner B, Mazzullo JM, Lasagna L. Oral contraceptive patient information. A questionnaire study of attitudes, knowledge, and preferred information sources. JAMA 235,1331-6, 1976.
- Wardell WM, Hassar M, Anavekar SN, Lasagna L. The rate of development of new drugs in the United States, 1963 through 1975. Clinical Pharmacology & Therapeutics 24, 133-45, 1978..
- Lasagna L. The development and regulation of new medications. Science 200, 871-3, 1978.
- Lasagna L. Generic substitution: trick or treat? JAMA. 239, 1888, 1978.
- Lasagna L. Wanted: a new type of consumer advocate for drugs. NEJM 298, 906, 1978.
- Lasagna L. The impact of regulations on the development of psychoactive drugs. NIDA Research Monograph 27, 29-35, 1979.
- Lasagna L. Placebos and controlled trials under attack. European J Clinical Pharmacology. 15, 373-4, 1979.
- Lasagna L. Drug Regulation Reform Act. Psychopharmacology Bulletin 15, 54-6, 1979.
- Udkow GP, Lasagna L, Weintraub M, Tamoshunas Z. The safety and efficacy of the estrogen patient package insert. A questionnaire study. JAMA 242, 536-9, 1979.
- Lasagna L. The powerful cipher. Sciences-New York. 20:31-2, 1980.
- Lasagna L. The Halcion story: trial by media. Lancet. 1: 815-6, 1980.
- Lasagna L. Post-marketing surveillance. Triangle 19, 107-11, 1980.
- Lasagna L. The World Health Organization list of “essential drugs.” Annals of Internal Medicine 93, 368-9, 1980.
- Lasagna L. Analgesic methodology: a brief history and commentary. J Clinical Pharmacology 20, 373-6, 1980.
- Francetic I, Lasagna L, Weintraub M, Karch FE. Prescription prices under the New York generic substitution law. Annals of Internal Medicine 92, 419-23, 1980.
- Weintraub M, Glickstein S, Lasagna L. Estrogen patient package insert: medication acceptance despite negative attitudes. Clin Pharmac & Therapeutics 30, 149-53, 1981.
- Lasagna L. Are we an over-medicated society? Internist 23, 6-7, 1982.
- Lasagna L. Sounding Boards. Historical controls: the practitioner’s clinical trials. NEJM 307, 1339-40, 1982.
- Lasagna L. Patient package inserts: goals versus achievements. Drug Therapeutics 181-9, 1982.
- Lasagna L. Will all new drugs become orphans? Clin Pharmac & Therapeutics 31, 285-9, 1982.
- Lasagna L. Murder most foul. Sciences-New York 22, 7-8, 1982 Aug-Sep.
- Lasagna L. Generic drugs and the elderly. J Amer Geriatrics Society 31, 571-2, 1983.
- May MS, Wardell WM, Lasagna L. New drug development during and after a period of regulatory change: clinical research activity of major United States pharmaceutical firms, 1958 to 1979. Clinical Pharmacology & Therapeutics 33, 691-700, 1983.
- Lasagna L. Discovering adverse drug reactions. JAMA. 249, 2224-5, 1983.
- Bakke OM, Wardell WM, Lasagna L. Drug discontinuations in the United Kingdom and the United States, 1964 to 1983: issues of safety. Clinical Pharmacology & Therapeutics 35, 559-67, 1984.
- Lasagna L. Clinical pharmacology in the United States: a personal reminiscence. Annual Review of Pharmacology & Toxicology 25, 27-31,1985.
- Spivey RN, Lasagna L, Trimble AG. New drug applications: how long to gain approval? Clinical Pharmacology & Therapeutics 37, 361-6, 1985.
- Lasagna L. The economics of generic prescribing: winners and losers. JAMA 256, 2566, 1986.
- Lasagna L. The placebo effect. J Allergy & Clinical Immunology 78, 161-5, 1986.
- Lasagna L. The desire to regulate: the wish to discover. Drugs Under Experimental & Clinical Research 13, 659-64, 1987
- Kaitin KI, Richard BW, Lasagna L. Trends in drug development: the 1985-86 new drug approvals. J Clinical Pharmacology 27, 542-8, 1987
- Lasagna L. Does the public need protection from itself? Clinical Therapeutics 9, 240-2, 1987
- Lasagna L. Ethics and informed consent. J Chronic Diseases 40, 277-8, 1987.
- Mattison N, Trimble AG, Lasagna L. New drug development in the United States, 1963 through 1984. Clinical Pharmacology & Therapeutics 43, 290-301, 1988.
- Richard BW, Ulcickas M, Lasagna L Approvable letters in the FDA new drug approval process. J Clinical Pharmacology 29, 680-4, 1989
- Lasagna L. Congress, the FDA, and new drug development: before and after 1962. Perspectives in Biology & Medicine 32, 322-43, 1989.
- Lasagna L. Are drug benefits also part of pharmacoepidemiology? J Clinical Epidemiology 43, 849-50, 1990.
- DiMasi JA, Bryant NR, Lasagna L. New drug development in the United States from 1963 to 1990. Clinical Pharmacology & Therapeutics 50, 471-86, 1991.
- DiMasi JA, Hansen RW, Grabowski HG, Lasagna L. Cost of innovation in the pharmaceutical industry. J Health Economics 10, 107-42, 1991.
- DiMasi JA, Kaitin KI, Fernandez-Carol C, Lasagna L. New indications for already-approved drugs: an analysis of regulatory review times. J Clinical Pharmacology 31, 205-15, 1991.
- Kaitin KI, Bryant NR, Lasagna L. The role of the research-based pharmaceutical industry in medical progress in the United States. J Clinical Pharmacology 33,:412-7, 1993.
- Lasagna L. The Helsinki Declaration: timeless guide or irrelevant anachronism? J Clinical Psychopharmacology 15, 96-8, 1995.
- Lasagna L. Recent trends in drug development. American Institute of the History of Pharmacy. 16:217-22, 1997.
- Lasagna L. Balancing risks versus benefits in drug therapy decisions. Clinical Therapeutics 20 Suppl C: C72-9, 1998.
- Lasagna L, Kaitin KI. Issues facing the new FDA commissioner. Science 282: 1263, 1998.
- Lasagna L Diuretics vs alpha-blockers for treatment of hypertension: lessons from ALLHAT Trial. JAMA 283, 2013-4, 2000.
The Shipwreck of the Singular
Healthcare’s Castaways
By Dr. David Healy
Publisher: Samizdat Health Writer’s Co-operatrive Inc.
Publish Date: Forthcoming in 2021