Book

Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare

Peter C. Gøtzsche. Radcliffe Publishing (London), 2013. ISBN 9781846198847

Gøtzsche, a physician who co-founded the Cochrane Collaboration and directed the Nordic Cochrane Centre, argues in 22 chapters that the major drug companies' repeated fraud, illegal marketing and suppression of trial data meet the definition of organized crime. Chapter 3 lists one recent U.S. settlement for each of the ten largest companies and invokes the racketeering statute. Later chapters cover trial design, ghostwriting, medical journals, paid opinion leaders, regulators, and case studies of Neurontin, Vioxx, celecoxib, rosiglitazone, SSRIs, Study 329 and antipsychotics. Chapter 21 estimates that prescription drugs are the third leading cause of death and proposes public funding of drug trials and regulation. The argument rests on settlements, court documents, journal articles and the author's own studies, with first-person anecdotes throughout.

Who made it

Author: physician (1984) with an MSc in biology and chemistry (1974); worked in the drug industry 1975-83, including as a sales representative and product manager at Astra (book ch. 2, shelf copy); hospital posts in Copenhagen 1984-95; co-founded the Cochrane Collaboration and established the Nordic Cochrane Centre in 1993; professor of Clinical Research Design and Analysis, University of Copenhagen, from 2010 (author note).
Publisher per the copyright page of the shelf copy: Radcliffe Publishing Ltd, St Mark's House, Shepherdess Walk, London N1 7LH; shelf (digital) copy carries ISBN 978-190891-112-4; the print ISBN 9781846198847 is from the candidate record. A Kennedy Institute of Ethics Journal review lists the publisher as CRC Press, 2013.
Forewords by Richard Smith (former editor-in-chief, BMJ) and Drummond Rennie (deputy editor, JAMA).
The book uses the author's own studies as primary evidence on ghost authorship, placebo effects, observer bias and NSAID trial quality (ch. 4, ch. 9).
Author's statement in Pol Arch Med Wewn 2015;125:105-106: the book won first prize in the 'Basis of Medicine' category of the 2014 British Medical Association book awards. The award page itself was not located.
The author was director of the Nordic Cochrane Centre when the book appeared. Cochrane's Governing Board terminated his membership and his director post on 25 September 2018, on grounds its statement describes as conduct (see responses).

Its claims checked against the record

16 claims checked:4 supported · 12 partly supported · 0 contradicted · 0 not in the record

A verdict rests on the documents named in its row.

Claims, verdicts and the documents behind them
The work says	Verdict	What the record shows
Prescription drugs are the third leading cause of death in the United States and Europe, after heart disease and cancer: about 100,000 Americans a year die from drugs taken correctly and another 100,000 from errors such as too high a dose or use despite contraindications. Ch. 1 Introduction; ch. 21 'Our drugs kill us'; repeated in the author's paper Pol Arch Med Wewn 2014;124:628-34	Partly supported	Lazarou's meta-analysis estimates 106,000 (76,000-137,000) fatal reactions in hospitalized patients in 1994, excludes administration errors and overdose, and ranks them 'between the fourth and sixth leading cause of death'. Starfield reaches 'the third leading cause' only by adding 80,000 hospital infections, 12,000 unnecessary-surgery deaths, 7,000 hospital medication-error deaths and 20,000 other hospital errors to the 106,000; neither Lazarou nor Starfield gives 100,000 deaths a year from drug errors. The book's '9% directly, 9% indirectly' comes from Ebbesen, who counted 133 drug-associated deaths among 732 deaths (18.2%) in one Norwegian internal medicine department, and the book extrapolates it to all U.S. hospital deaths. Exhibit 168, Exhibit 172
Pfizer agreed to pay $2.3 billion in 2009, the largest healthcare fraud settlement in DOJ history at the time: a subsidiary pleaded guilty to misbranding drugs 'with the intent to defraud or mislead', Pfizer illegally promoted Bextra, Geodon, Zyvox and Lyrica, $1 billion was civil, six whistleblowers received $102 million, and Pfizer was breaking the same laws while it signed its 2004 agreement. Ch. 3 'Hall of Shame', item 1	Supported by the record	The release says Pfizer and Pharmacia & Upjohn 'agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice'; Pharmacia & Upjohn pleaded guilty to a felony count of misbranding Bextra 'with the intent to defraud or mislead'; $1 billion resolved False Claims Act allegations on Bextra, Geodon, Zyvox and Lyrica; six whistleblowers receive more than $102 million. The U.S. Attorney is quoted that Pfizer was 'in its other operations violating those very same laws' while resolving the Warner-Lambert case; the First Circuit opinion records Warner-Lambert's plea in that case and a $240 million criminal fine plus $190 million civil payment.
GlaxoSmithKline pleaded guilty and paid $3 billion in 2011, the largest healthcare fraud settlement in U.S. history, for illegally marketing Wellbutrin, Paxil, Advair, Avandia and Lamictal; in a separate case it pleaded guilty to felony fraud over the Cidra plant and was fined $750 million. Ch. 3 item 4; Cidra	Partly supported	The 2 July 2012 release gives $3 billion, calls it 'the largest health care fraud settlement in U.S. history', and describes a three-count plea: misbranding Paxil and Wellbutrin and failing to report Avandia safety data to FDA, with $1 billion criminal ($956,814,400 fine plus $43,185,600 forfeiture) and $2 billion civil. Advair and Lamictal appear only in the civil settlement, the Avandia criminal count is a reporting count, and the announcement is dated 2012, not 2011. For Cidra, the plea was by the subsidiary SB Pharmco Puerto Rico; the criminal fine was $150 million including $10 million forfeited, and $600 million was a civil False Claims Act settlement with a whistleblower share of about $96 million.
Eli Lilly agreed in 2009 to pay more than $1.4 billion over off-label marketing of Zyprexa ($800 million civil plus a $600 million criminal fine on a guilty plea); Abbott agreed in 2012 to pay $1.5 billion over Depakote ($800 million civil plus $700 million criminal fine and forfeiture, $84 million to whistleblowers). Ch. 3 items 9-10	Supported by the record	Lilly: $1.415 billion total, a $515 million criminal fine plus $100 million forfeiture (the book's $600 million), up to $800 million civil, on a plea to a misdemeanor misbranding charge for promoting Zyprexa for dementia and other unapproved uses. Abbott: $1.5 billion, a misdemeanor misbranding plea with a $500 million fine, $198.5 million forfeiture and $1.5 million to Virginia's Medicaid Fraud Control Unit, $800 million civil, and $84 million to the whistleblowers.
AstraZeneca paid $520 million in 2010 over Seroquel, Novartis $423 million in 2010 over Trileptal and five other drugs, Sanofi-Aventis more than $95 million in 2009 over Medicaid price reporting, and Merck $670 million in 2007 over Medicaid rebates and kickbacks; the Attorney General said 'These were not victimless crimes' about the AstraZeneca case. Ch. 3 items 2, 3, 5, 8	Partly supported	The amounts hold: AstraZeneca $520 million, civil only ($301,907,007 federal, up to $218,092,993 states, more than $45 million to the whistleblower); Novartis $422.5 million ($185 million criminal fine and forfeiture on a misdemeanor plea, $237.5 million civil); Aventis Pharmaceutical $95.5 million. Merck's release is dated 7 February 2008, not 2007, and states 'more than $650 million' ($399 million plus interest and $250 million plus interest). The AstraZeneca release quotes Attorney General Holder beginning 'Illegal acts by pharmaceutical companies'; the words 'These were not victimless crimes' do not appear in it.
Johnson & Johnson and Janssen were fined more than $1.1 billion in Arkansas in 2012 for hiding Risperdal risks, plus a $327 million penalty in South Carolina and a $158 million settlement in Texas; J&J paid kickbacks to Omnicare; marketing vice president Alex Gorsky had firsthand knowledge and was made CEO. Ch. 3 item 7	Partly supported	The DOJ release gives a $2.2 billion resolution: Janssen pleaded guilty to misbranding Risperdal for elderly dementia patients ($334 million fine plus $66 million forfeiture), $149 million resolved the Omnicare kickback complaint, and J&J's Texas payment in March 2012 is stated as $118 million, not the book's $158 million. The release names no individual executive. The Arkansas Supreme Court decided the state's appeal on 20 March 2014; the reversal of the roughly $1.2 billion judgment is reported in trade press and the opinion text is to be pulled (see notes).
Roche failed to publish most of its Tamiflu trial data, there is no convincing evidence that Tamiflu prevents influenza complications, at best it shortens illness by 21 hours, its harms were concealed, and governments spent billions on stockpiles. Ch. 3 item 6	Supported by the record	The Cochrane update states that '60% of patient data from phase III treatment trials of oseltamivir have never been published'. The BMJ review of clinical study reports for 83 trials obtained from the European Medicines Agency and Roche reports a 16.8-hour reduction in time to first alleviation of symptoms in adults (the book's 21 hours is higher), no difference in hospital admissions in adult treatment trials, no significant reduction in complications classified as serious, and increased nausea (number needed to harm 28) and psychiatric and renal syndromes.
The drug industry's business model fulfils the criteria for organized crime under the U.S. racketeering statute (RICO); the crimes are deliberate because crime pays, fines are treated as a marketing expense, and the crimes are increasing (three-quarters of 165 settlements worth $20 billion in the five years to 2010). Ch. 3 'The crimes are repetitive' and 'It's organised crime'	Partly supported	Section 1961(1) lists mail fraud (§1341) and wire fraud (§1343) as racketeering acts and requires at least two acts within ten years; it does not list Food, Drug and Cosmetic Act misbranding or health care fraud (§1347), the offenses in the DOJ pleas above, and none of the releases read mentions racketeering. A jury found Pfizer liable under civil RICO to Kaiser in a Neurontin marketing case ($47,363,092, trebled to $142,089,276), and the First Circuit affirmed the verdicts for Kaiser in April 2013. Public Citizen counted 165 settlements totaling $19.8 billion in 1991-2010, of which 121 settlements (73%) and $14.8 billion (75%) fell in 2006-2010, and 74 more settlements worth $10.2 billion in the following 21 months; Biddle's review in the Kennedy Institute of Ethics Journal says the book lacks an analysis of the legal standard for a pattern of racketeering and treats 'big pharma' as one organization.
Merck concealed Vioxx's cardiovascular risk: the VIGOR report omitted heart attacks, the sales force was told not to discuss VIGOR, Merck pleaded guilty and paid nearly a billion dollars, and Vioxx killed about 120,000 people from thrombosis. Ch. 13 'Merck, where the patients die first'	Partly supported	The journal's expression of concern states that 'Three myocardial infarctions, all in the rofecoxib group, were not included in the data submitted to the Journal' and that at least two authors knew of them at least two weeks before the first revision and four and a half months before publication. DOJ announced $950 million (November 2011): a plea to one misbranding count for promoting Vioxx for rheumatoid arthritis before FDA approval, and a $628,364,000 civil settlement covering alleged misleading statements about cardiovascular safety, so the safety statements are civil allegations. Graham testified that applying the VIGOR and APPROVe risk levels gives 88,000 to 139,000 excess U.S. cases, of which '30-40% probably died'; the book's 120,000 deaths is the author's estimate for 80 million patients worldwide and appears in no document.
Glaxo's Study 329 was fraudulent: it was ghostwritten, negative on all eight protocol-specified outcomes, hid at least eight suicidal children on Paxil against one on placebo, and was published with a conclusion that paroxetine was 'generally well tolerated and effective'. Ch. 18 'Glaxo study 329'	Partly supported	DOJ alleges GSK 'participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy', and GSK pleaded guilty to misbranding Paxil for under-18 use. The BMJ reanalysis found paroxetine and imipramine not significantly better than placebo on any prespecified efficacy outcome and recorded suicidal or self-injurious behavior in 11 of 93 paroxetine patients and 2 of 87 placebo patients (the original article reported 5 and 1); JAACAP attached an expression of concern to the 2001 article in September 2025, which is not a retraction, and the original authors dispute the reanalysis. The record read contains no adjudication that the article was fraudulent. Record partly withheld. The contemporaneous documentation of the analysis plan GSK claimed for Study 329, which the RIAT authors report GSK did not supply despite repeated requests, and the 77,000 pages of case report forms, which GSK made available only through a restricted remote-desktop portal (Le Noury et al., BMJ 2015;351:h4320, methods and limitations). Exhibit 093, Exhibit 094, Exhibit 092, Exhibit 091
SSRIs 'likely increase the risk of suicide at all ages', and it has never been demonstrated that SSRIs decrease the risk of suicide. Ch. 18	Partly supported	In the FDA pooled analysis the odds ratio for suicidal behavior in adults under 25 was 2.30 (1.04-5.09); the authors conclude the 'net effect seems to be neutral on suicidal behaviour but possibly protective for suicidal ideation in adults aged 25-64' and that antidepressants 'reduce the risk of both suicidality and suicidal behaviour' at ages 65 and older. FDA labels state that short-term studies 'did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction' at 65 and older, which contradicts the book's all-ages and never-decrease statements.
Olanzapine (Zyprexa) has killed about 200,000 of the 20 million people who took it, and antipsychotics increase the risk of dying substantially. Ch. 18 'Zyprexa, another terrible Eli Lilly drug'	Partly supported	The meta-analysis of 15 trials (3,353 drug and 1,757 placebo patients with dementia, 10-12 weeks) found death in 3.5% on drug and 2.3% on placebo, odds ratio 1.54 (1.06-2.23), with no differential risk by individual drug. The book multiplies one extra death per 100 patients by the 20 million people reported to have taken Zyprexa, of all ages and indications, to reach 200,000; that count appears in no document.
Statins offer very small benefit for primary prevention (a 16% mortality reduction from 2.8% means a number needed to treat of 222), and statins cause muscle pain and weakness that the trials did not report. Ch. 4	Partly supported	The 2011 Cochrane review (14 trials, 34,272 participants) reports all-cause mortality RR 0.83 and concludes 'Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk'. The 2013 update (18 trials, 56,934 participants) reports mortality OR 0.86 (0.79-0.94) and 'no evidence of any serious harm', and CTT 2012 reports all-cause mortality RR 0.91 (0.85-0.97) per 1.0 mmol/L LDL reduction in people without vascular disease. In CTT 2022, 27.1% of statin and 26.6% of placebo participants reported muscle pain or weakness (RR 1.03, 1.01-1.06), and 'only one in 15' reports among statin recipients were due to the statin, so the trials did record muscle symptoms and the excess was small.
Hormone replacement therapy was an off-label use that harmed hundreds of thousands of healthy women; a randomized trial showed hormones cause heart disease, and Wyeth was secretly behind the promotion. Ch. 8 'Rent a key opinion leader to educate'	Partly supported	The WHI estrogen-plus-progestin trial was stopped on 31 May 2002 with coronary heart disease hazard ratio 1.29 (1.02-1.63), breast cancer 1.26, stroke 1.41 and pulmonary embolism 2.13 (nominal intervals), the book's 29%. The estrogen-alone WHI trial found coronary heart disease HR 0.91 (0.75-1.12) and stroke 1.39 (1.10-1.77), which the book does not describe. Fugh-Berman documents ghostwritten manuscripts for hormone therapy drugs from unsealed litigation documents.
Ghostwriting is widespread and fraudulent: 75% of industry-initiated trials showed ghost authorship in the author's study, 55 of 96 sertraline papers were written by one agency, and companies recruit academics as 'authors' for papers they never wrote. Ch. 9 'Ghostwriting'	Supported by the record	The author's cohort of 44 industry-initiated trials approved in Copenhagen in 1994-95 found ghost authorship in 33 (75%; 91% counting acknowledged contributors). Ross, from Merck litigation documents, describes Merck employees and publishing companies preparing manuscripts and recruiting academics as authors of trial reports and reviews. The DOJ AstraZeneca release says the company 'recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct'. Healy and Cattell's abstract reports agency-linked sertraline articles with 6.6 authors per article against 2.95 and a citation rate of 20.2 against 3.7; the 55-versus-41 article count is not in the abstract.

Show the other 1 claims checked

Remaining claims, verdicts and the documents behind them
The work says	Verdict	What the record shows
Selective publication distorts antidepressant evidence, and very few patients benefit from the drugs they take: a 60% versus 50% improvement implies a number needed to treat of 10, the true effect is likely smaller, and in the book's worked example the drug 'didn't work'. Ch. 4 'Very few patients benefit from the drugs they take'; ch. 18	Partly supported	Turner (NEJM 2008, cited by the book at) found 94% of published trials positive against 51% in FDA reviews and a pooled effect size inflated by 32%; the 2022 follow-up found transparent publication of negative trials rose from 11% to 47%. Whittington found that adding unpublished data turned risk-benefit unfavorable for paroxetine and sertraline in children. The Cochrane primary-care review gives RR 1.28 for SSRIs and a median NNT of 9 for tricyclics, close to the book's NNT of 10. Cipriani's network meta-analysis of 522 trials including unpublished data (116,477 participants) found all 21 antidepressants more effective than placebo, odds ratios 1.37 to 2.13, against the odds ratio of 1.02 the book derives from an assumed 36% unblinding bias. Exhibit 089, Exhibit 090

What the record shows that it leaves out

Lazarou's estimate has a published critique: Kvasz et al. (MedGenMed 2000;2(2):E3) found heterogeneity across the pooled studies, imputations that 'may overestimate the results of any individual study', and large errors from small numbers of fatal events. The book cites Lazarou without the critique. A commenter at Aalborg University cites the same critique in Tidsskriftet (Blomkvist, 8 July 2015).
A direct estimate of preventable hospital deaths from physician record review: 3.1% of hospital deaths, about 22,165 U.S. deaths a year (Rodwin et al., J Gen Intern Med 2020; Exhibit Exhibit 172; all pooled studies from Canada and Europe).
Age gradient in FDA's own suicidality analysis: increase under 25, neutral on behavior at 25-64, reduction at 65 and over (Stone et al., BMJ 2009; FDA labels since 2007).
The estrogen-alone arm of the Women's Health Initiative (JAMA 2004;291:1701): coronary heart disease HR 0.91 (0.75-1.12), stroke HR 1.39, hip fracture HR 0.61, trial stopped February 2004.
The Cholesterol Treatment Trialists' individual-participant meta-analysis of 27 trials in low-risk people (Lancet 2012;380:581), published a year before the book and not among the references of the statin passage; the 2013 Cochrane update of the review the book cites.
AstraZeneca 'brought certain conduct to the attention of the government' in March 2006 and cooperated, per the DOJ release of 27 April 2010; the book says only that the company denied wrongdoing.
DOJ's 2013 J&J resolution ($2.2 billion, with a Janssen guilty plea, $400 million criminal) and the 2014 reversal of the Arkansas judgment, both after the book.
Lauren Stevens, the former GSK lawyer the book says was charged with false statements and obstruction, received a judgment of acquittal from the District of Maryland on 10 May 2011 (reported by Ropes & Gray, ABA Journal and NPR; the court order is the primary to pull). The book names the charge and omits the acquittal.
The Cochrane review of oseltamivir was rewritten from clinical study reports in 2014 and found a smaller symptom benefit (16.8 hours) than the figure the book gives; the U.S. qui tam action United States ex rel. Jefferson v. Roche Holding AG (D. Md. No. 14-cv-03665) alleges Roche misrepresented Tamiflu's effect on pandemic complications to government purchasers, and a motion to dismiss was denied in 2020 (press reports; docket to pull).
The 2018 Cochrane Governing Board statement gives its grounds as a 'consistent pattern of disruptive and inappropriate behaviours' and use of Cochrane's name for personal views, including as an expert witness in a criminal trial; the book is not mentioned.

Documented efforts and withheld records

Each item is a documented act, with its source: an act against the work, its author or its sources, or the withholding of records on its subject. The list states what was done and does not state why.

2015-06-09 and 2015-09-18. Cochrane's leadership (Steering Group co-chairs Lisa Bero and Cindy Farquhar, CEO Mark Wilson, Editor in Chief David Tovey) published a statement that Gøtzsche's views on the benefits and harms of psychiatric drugs 'are not those of the organization', after his MailOnline article of 15 September 2015 'Prescription pills are Britain's third biggest killer'; Cochrane's letter of 9 June 2015 had already asked him to stop using the title 'Director, Nordic Cochrane Centre' when writing or speaking on projects that are not Cochrane reviews or methodology. Mark Wilson to Gøtzsche, 11 April 2018 (e-mail quoting the June 2015 letter and the 18 September 2015 statement; document published by Gøtzsche)
2018-04-11. Cochrane CEO Mark Wilson wrote to Gøtzsche that he had breached Cochrane's Spokesperson Policy in two of three complaints (a letter on Cochrane paper requesting data from the Stanley Medical Research Institute, and a power of attorney giving the Nordic Cochrane Centre's address for a complaint to a Dutch disciplinary court) and that failure to comply in future 'will result in disciplinary action, which may include... the de-registration of the Nordic Cochrane Centre'. Mark Wilson to Gøtzsche, 11 April 2018 (e-mail as published by Gøtzsche; the PDF carries the author's 24 September 2018 creation date)
2018-01. Gøtzsche, through a Dutch attorney, filed a complaint against Professor Anton Loonen with the Regional Disciplinary Court for Healthcare at Eindhoven, an act by the author's own side that Wilson's e-mail lists as one of the three complaints considered. Mark Wilson to Gøtzsche, 11 April 2018 (e-mail as published by Gøtzsche)
2018-08-29. Cochrane's Editor in Chief David Tovey and Deputy Editor Karla Soares-Weiser published a response to the 27 July 2018 BMJ Evidence-Based Medicine article by Gøtzsche and Tom Jefferson on Cochrane's HPV vaccine review, stating that the article 'substantially overstated' its criticisms and that the review did not miss nearly half of the eligible trials. Cochrane, 'Cochrane's Editor in Chief responds to BMJ EBM article criticizing HPV review'
2018-09-13 to 2018-09-26. Cochrane's Governing Board met on 13 September, voted on 25 September unanimously to end Gøtzsche's membership of Cochrane and his posts as Board member and Nordic Cochrane Centre director, and issued a statement on 26 September; it found by eleven votes that he breached the Trustees' Code of Conduct and gave as grounds 'an ongoing, consistent pattern of disruptive and inappropriate behaviours', presenting personal views as Cochrane's (including as an expert witness in a criminal trial), and public statements that breached his confidentiality obligations. Cochrane Governing Board, 'Statement from Cochrane's Governing Board', 26 September 2018
2018-09-13 to 2018-09-28. Four Cochrane Governing Board members resigned after the 13 September vote; Board co-chair Marguerite Koster told STAT and Retraction Watch that the decision was not based on Gøtzsche's criticism of the HPV review and cited his use of Cochrane Nordic letterhead for personal views, including in a homicide trial. STAT, 28 September 2018
2018-08 (reported 2018-09-19; letter 2018-12-19). Denmark's Health Minister Ellen Trane Nørby ordered an evaluation of the state-funded Nordic Cochrane Centre (about 18 million DKK a year in the 2019 finance bill), saying it had been funded for 25 years without any evaluation; she told the press she had started it about a month earlier. Her letter to Gøtzsche of 19 December 2018, as he quotes it, dates the decision to August 2018 and says the evaluation would run in 2019. Altinget, 19 September 2018; Gøtzsche's complaint to the Danish Ombudsman, 21 June 2019 (quotes the minister's letter)
2018-10-12 and 2018-12-19. The Danish Ministry of Health sent Rigshospitalet a letter announcing that payment of the Centre's finance-act appropriation would be withheld from the fourth quarter of 2018 until Rigshospitalet had created the basis for compliance with the grant's conditions, including that the Centre may be part of the international Cochrane Collaboration (the letter is Appendix 6 to Gøtzsche's complaint; his description). The minister's letter of 19 December 2018, as he quotes it, says the funds 'are no longer being withheld' and payment had resumed. Gøtzsche's complaint to the Danish Ombudsman, 21 June 2019, citing Appendix 6 (ministry letter, 12 October)
2018-10-29. Rigshospitalet's management suspended Gøtzsche during an official call, barred him from his office and barred staff from contacting him, according to Gøtzsche; he states the hospital offered a 'mutual agreement on resignation' with ten months' extra pay and a clause that 'the content of the agreement is not communicated to third parties', which he declined. Gøtzsche, 'My dismissal is scientific judicial murder' (English translation of his Politiken op-ed, 11 December 2018; the author's account)
2018-11-06. Rigshospitalet announced in a press release that it relieved Gøtzsche of his post as head of the Nordic Cochrane Centre 'indtil videre' (for now); deputy director Karsten Juhl Jørgensen became acting head. The Ministry of Health had stated that the centre must meet the conditions for its funding. Videnskab.dk, 7 November 2018; Läkartidningen, 7 November 2018
2019-01-07, 2019-01-31, 2019-04-30. Rigshospitalet recommended Gøtzsche's dismissal to the Capital Region on 7 January 2019, and the Capital Region decided on dismissal on 31 January 2019, the last weekday of the month; his employment ended on 30 April 2019. Rigshospitalet's stated ground, as he quotes it, was that it had lost confidence that he could continue to manage the Centre. Gøtzsche's complaint to the Danish Ombudsman, 21 June 2019 (Appendices 8 and 9 are the hospital's and Region's decisions)
2018-09 to 2018-10. Gøtzsche's complaint states that Cochrane CEO Mark Wilson, in e-mails to the Ministry of Health and Rigshospitalet obtained under Danish freedom-of-information law by his lawyer Poul Heidmann (Appendix 2), requested his dismissal, and that neither authority examined whether Wilson's explanations were correct. Gøtzsche's complaint to the Danish Ombudsman, 21 June 2019 (the complainant's statement)
2018-12-11 and 2019-06-21. Gøtzsche wrote in Politiken that he and his lawyer would assess lawsuits for damages against Rigshospitalet for unjustified firing and against Cochrane for 'seriously defamatory statements', an act by the author's own side; on 21 June 2019 he filed a complaint with the Danish Ombudsman about the dismissal. Gøtzsche's Politiken op-ed (English translation) and his Ombudsman complaint
2007-08-20 to 2010-11-24. The European Medicines Agency refused the Nordic Cochrane Centre's request of 29 June 2007 for clinical study reports and protocols for orlistat and rimonabant (decisions of 20 August and 17 September 2007, citing commercial interests) and maintained the refusal on 26 February 2009; the European Ombudsman inspected the documents on 6 October 2009, found no commercially confidential information, and on 19 May 2010 found the refusal maladministration. EMA accepted the draft recommendation on 31 August 2010 and undertook to grant access within three months. European Ombudsman, decision on case 2560/2007/BEH, 24 November 2010
2009-10-08 to 2011-04-26. Roche declined Cochrane reviewers' request for Tamiflu trial data on 8 October 2009 ('a similar meta analysis is currently commencing'), proposed a confidentiality agreement barring disclosure of 'the existence and terms of this Agreement' that the reviewers declined, supplied about 3,200 pages of partial reports in 2010, and wrote on 26 April 2011 'You have all the detail you need to undertake a review and so we have decided not to supply any more detailed information'; Roche's Donald MacLean refused to answer clarification questions sent by Chris Del Mar on 13 April 2011. Doshi, Jefferson and Del Mar, PLoS Medicine 9(4):e1001201 (2012), quoting Roche's letters; Jefferson et al., BMJ 2014;348:g2545
2012-01-18 and 2013. The Cochrane update states that GSK offered the reviewers individual patient data and answered their queries, 'but Roche did not provide us with complete clinical study reports'; Roche stated it had provided 3,200 pages and that more detailed reports were on a password-protected site for investigators. The reviewers report that Roche supplied the full clinical study reports for its oseltamivir programme during 2013. Jefferson et al., Cochrane Database Syst Rev 2012 (CD008965.pub3) abstract; CIDRAP, 19 January 2012; Jefferson et al., BMJ 2014;348:g2545
2013-06-14 onward (paper published 2015-09-16). After the RIAT researchers asked on 14 June 2013 whether GSK intended to restore any of its trials, GSK did not signal an intent to publish a corrected version of Study 329; it later made all 275 case report forms (about 77,000 pages) available only through a remote-desktop portal open to users approved by GSK, and did not supply contemporaneous documentation of a claimed analysis plan 'despite having repeatedly requested it'. Le Noury et al., 'Restoring Study 329', BMJ 2015;351:h4320
2012-07-02. GlaxoSmithKline pleaded guilty to failing to report Avandia safety data to FDA, one of three counts in the plea it entered under the $3 billion resolution announced by the Department of Justice. U.S. Department of Justice press release, 2 July 2012
2005-12-08. The editors of the New England Journal of Medicine published an expression of concern stating that three myocardial infarctions, all in the rofecoxib group, 'were not included in the data submitted to the Journal' for the VIGOR report. Curfman, Morrissey and Drazen, N Engl J Med 2005;353:2813

Published responses

Cochrane Governing Board: 26 September 2018 statement: the Board voted unanimously on 25 September to terminate Gøtzsche's membership of Cochrane and his posts as Board member and Nordic Cochrane Centre director, after eleven members found at a 13 September meeting that he breached the Trustees' Code of Conduct; the stated basis was 'an ongoing, consistent pattern of disruptive and inappropriate behaviours' over a number of years and repeatedly representing personal views as Cochrane's. The statement does not mention the book.
BMJ (Nigel Hawkes), 28 September 2018: News report that the Board confirmed the dismissal on appeal, ending his membership, his directorship of the Nordic Cochrane Centre and his Board seat (elected 2017).
STAT and Retraction Watch, 16 and 28 September 2018 (press reports): Board co-chair Marguerite Koster said the decision was not based on Gøtzsche's criticism of the Cochrane HPV vaccine review and cited use of Cochrane Nordic letterhead for personal views, including in a homicide trial; Gøtzsche attributed the vote to pressure from his work on the drug industry, circulated a letter calling the action disproportionate, and wrote that he no longer belonged to Cochrane. Four Board members resigned after the first vote.
Cochrane Editor in Chief David Tovey and Deputy Editor Karla Soares-Weiser: Reply to the BMJ Evidence-Based Medicine critique of the Cochrane HPV review by Jørgensen, Gøtzsche and Jefferson (Nordic Cochrane Centre): Cochrane said its investigation found the review did not miss 'nearly half of the eligible trials', that a small number of studies were missed and adding them 'makes little or no difference to the results', and that the review complied with its conflict-of-interest policy. The Nordic authors answered in BMJ EBM in September 2018.
Rigshospitalet (Copenhagen), via Videnskab.dk, 7 November 2018 (press report): Relieved Gøtzsche of his post as head of the Nordic Cochrane Centre 'indtil videre' (for now); deputy director Karsten Juhl Jørgensen became acting head.
Roman Jaeschke (McMaster University), Pol Arch Med Wewn 2015;125:105-106: Comment on Gøtzsche's 2014 paper restating the third-leading-cause claim: some points are valid but mixed with opinion, the language is 'unnecessarily dramatic', and the estimates of deaths from specific drugs rest on assumptions 'as one-sided as the calculations made by industry would be, only in a different direction'. Gøtzsche replied in the same issue that his paper is correct, that drugs are the third leading cause of death, and that Jaeschke had not read the book.
Justin B. Biddle (Georgia Institute of Technology), Kennedy Institute of Ethics Journal book review: The organized-crime comparison is 'flawed in its treatment of big pharma as an organized monolith'; individual companies could perhaps be criminal enterprises; the book lacks an analysis of the legal standard for a pattern of racketeering and 'often feels like an unstructured list of anecdotes'.
Kerry J. Breen, Medical Journal of Australia 2014;200(6):351: Favorable review: 'a must-read for all doctors in clinical practice'; the author 'understands the need to substantiate the allegations he makes'.
Tom Yates (University College London), PLOS Speaking of Medicine, 10 March 2014: Strong assertions are often backed by anecdotes, single trials or no reference (he cites the unreferenced statement that bipolar disorder is 'mainly iatrogenic, caused by SSRIs'); the account of antidepressants and falls is selective. He writes that Gøtzsche 'has made many important contributions to this field. Sadly, this book is not one of them.'
Andreas Wahl Blomkvist (Aalborg University), Tidsskriftet 8 July 2015, commenting on Steinar Madsen's 2014 review: Says the book is at times written in affect and lists errors: that LSD causes permanent brain damage, the claim at p. 186 that exercise is by far the best intervention in established type 2 diabetes (he cites Look AHEAD), the chapter 4 title, and reliance on Lazarou's estimate; he also writes that Gøtzsche is right in his message. Gøtzsche asked Madsen for concrete examples of inaccuracies.

Where it connects

The Filtered Record: Roche's withheld Tamiflu study reports, GSK's restricted Study 329 case report forms, EMA's refused orlistat and rimonabant reports, ghost authorship and the omitted VIGOR heart attacks.
Money, Fees and the Revolving Door: The ten settlements and pleas in chapter 3 of the book and the 165-settlement tally from Public Citizen.
What Was Known and When: What Merck, GSK and Roche held internally against what each reported, including the Avandia reporting count and the VIGOR omission.
Harm from Care: The 'third leading cause of death' claim set against the range of published estimates of drug-related deaths.

Where to get it: http://www.radcliffehealth.com/shop/deadly-medicines-and-organised-crime-how-big-pharma-has-corrupted-healthcare (publisher page; print and e-book through Radcliffe/Taylor & Francis; library catalogs)