Peter C Gøtzsche's research while affiliated with Innovation Centre Denmark and other places
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Publications (535)
BACKGROUND: Depression drugs can be difficult to come off due to withdrawal symptoms. Gradual tapering with tapering support is needed to help patients withdraw safely. OBJECTIVE: To review the withdrawal success rates, using any intervention, and the effects on relapse/recurrence rates, symptom severity, quality of life, and withdrawal symptoms. M...
The current paradigm in psychiatry is that psychosis should be treated with neuroleptics as first-line therapy. Neuroleptics should not be used at all. Randomised trials have shown that they kill many patients and do not have clinically relevant effects but cause permanent brain damage in most patients treated long-term and prevent them from coming...
Randomized controlled trials remain the reference standard for healthcare research on effects of interventions, and the need to report both benefits and harms is essential. The Consolidated Standards of Reporting Trials (the main CONSORT) statement includes one item on reporting harms (i.e., all important harms or unintended effects in each group)....
Background
Psychiatric patients’ human rights are often violated when forced treatment orders are issued.
Methods
We assessed the records for 30 consecutive petitions for mental health commitment in which an involuntary medication order was requested, from Anchorage, Alaska.
Results
In 29 cases, the commitment petition was granted. The forced med...
BACKGROUND: Depression drugs can be difficult to come off due to withdrawal symptoms. Gradual tapering with tapering support is needed to help patients withdraw safely. We reviewed the withdrawal success rates, using any intervention, and the effects on relapse/recurrence rates, symptom severity, quality of life, and withdrawal symptoms.
METHODS: S...
Introduction: Serious harms of the COVID-19 vaccines have been underreported in published trial reports.
Methods: Systematic review of papers with data on serious adverse events (SAEs) associated with a COVID-19 vaccine.
Results: We included 18 systematic reviews, 14 randomised trials, and 34 other studies with a control group. Most studies were of...
We assessed the records for 30 consecutive petitions for mental health commitment in which an involuntary medication order was requested from Anchorage, Alaska. In 29 cases, the commitment petition was granted. One patient requested a jury trial and the jury found in her favor. The forced medication order was granted in 27 of the 30 cases. In 26 ca...
Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and...
Background:
Fluoxetine was approved for depression in children and adolescents based on two placebo-controlled trials, X065 and HCJE, with 96 and 219 participants, respectively.
Objective:
To review these trials, which appear to have been misreported.
Methods:
Systematic review of the clinical study reports and publications. The primary outcom...
Anonymous sources are used by journalists when it is important to protect whistleblowers from repercussions. Healthcare is heavily influenced by vested interests which are often financial, but academic prestige and protection of guild interests also play a major role. If anonymous authorship is not allowed, many potential whistleblowers would prefe...
Background:
Attention deficit hyperactivity disorder (ADHD) is a psychiatric diagnosis increasingly used in adults. The recommended first-line pharmacological treatment is central nervous system (CNS) stimulants, such as methylphenidate, but uncertainty remains about its benefits and harms.
Objectives:
To assess the beneficial and harmful effect...
It has been widely suspected that SARS-CoV-2, the coronavirus that caused the Covid-19 pandemic, escaped from the Wuhan Institute of Virology because of sloppy safety procedures and that it was man-made as part of the so-called gain-of-function research at the institute (1). If this is the case, it makes China responsible for over 5 million deaths...
Objective: To assess potential dose-response relationships of extended-release methylphenidate for ADHD in adults on efficacy outcomes.
Study design and setting: Post-hoc analysis based on a systematic review of extended-release methylphenidate (https://doi.org/10.1002/14651858.CD012857). Using data from clinical trials comparing multiple fixed-dos...
Objectives
To assess whether drug regulatory agencies decided on applications for extended-release methylphenidate for use in adult ADHD based on select samples of trials.
Study design and setting
Case series of publicly available regulatory documents. We matched an index of extended-release methylphenidate trials for adult ADHD with trials appear...
Objectives
To determine to which degree industry partners in randomised clinical trials own the data and can constrain publication rights of academic investigators.
Methods
Cohort study of trial protocols, publication agreements and other documents obtained through Freedom of Information requests, for a sample of 42 trials with industry involvemen...
Background
Healthcare professionals are exposed to advertisements for prescription drugs in medical journals. Such advertisements may increase prescriptions of new drugs at the expense of older treatments even when they have no added benefits, are more harmful, and are more expensive. The publication of medical advertisements therefore raises ethic...
Aims
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) produce guidelines for the design of pivotal psychiatric drug trials used in new drug applications. It is unknown who are involved in the guideline development and what specific trial design recommendations they give.
Methods
Cross-sectional study of EMA Clinica...
Concern has been raised about whether HPV vaccines might cause serious neurological disorders including postural orthostatic tachycardia syndrome (POTS) and chronic regional pain syndrome (CRPS). The European Medicines Agency (EMA) investigated the issue and declared in 2015 that there is no link between HPV vaccines and serious neurological advers...
Objective:
To study whether three widely differing drug classes, benzodiazepines and similar agents, stimulants and lithium, showed similar patterns of long-term usage.
Method:
I constructed usage curves over a ten-year period, from 2007 to 2017, based on data from Statistics Denmark.
Results:
In 2007, a total of 478,097 patients deemed a pres...
Background:
Selective reporting of trial results is common.
Objective:
To study selective reporting in clinical study reports, company trial registers and publications of quality of life in placebo-controlled trials of antidepressants.
Methods:
We compared clinical study reports of four antidepressants (fluoxetine, duloxetine, paroxetine and s...
Background:
Antidepressants are much used and have been tested for many conditions.
Objective:
To investigate the type of diagnoses in placebo-controlled trials apart from depression and anxiety.
Methods:
This was a systematic review.
Results:
We downloaded 5471 records from PubMed and excluded 3017 that contained depression or anxiety. Afte...
Background:
Many people use the Internet for obtaining information about their medications.
Objective:
To investigate whether information about antidepressants on popular websites reflects the scientific evidence and enables people to make informed choices.
Methods:
Cross sectional study using a checklist with 14 predefined criteria of 39 webs...
Background:
No study has looked at differences of pooled estimates-such as meta-analyses-of corresponding study documents of the same intervention. In this study, we compared meta-analyses of human papillomavirus (HPV) vaccine trial data from clinical study reports with trial data from corresponding trial register entries and journal publications....
Abstract Objective To assess the benefits and harms of the human papillomavirus (HPV) vaccines. Data sources Clinical study reports obtained from the European Medicines Agency and GlaxoSmithKline from 2014 to 2017. Eligibility criteria Randomised trials that compared an HPV vaccine with a placebo or active comparator in healthy participants of all...
This is a protocol for the project entitled "FDA and EMA clinical research guidelines: Assessment of trial design recommendations for pivotal psychiatric drug trials".
Objective
To investigate to what extent evidence from previous similar trials or systematic reviews was considered before conducting new trials.
Design
Cohort study of contemporary protocols for trials with ethical approval.
Methods
All protocols for randomised trials approved by the five ethical committees in Denmark between January 2012 and Mar...
On September 13, 2018, one of the founders of the Cochrane Collaboration was expelled from the organisation, by a narrow vote of 6 to 5. Many see this as a moral collapse in what was once a magnificent grassroots organisation, guided by ethical principles and helping people make better decisions about healthcare interventions. I am that excommunica...
Objective:
We investigated if the law and the patients' rights are being respected in Denmark when patients appeal forced medication orders.
Method:
We assessed 30 consecutive cases described on the webpage of the Psychiatric Appeals Board.
Results:
No clear and convincing evidence was presented in any case that the proposed treatment was in t...
Objective:
To study the benefits and harms of antipsychotics in drug-naïve patients with psychosis.
Methods:
This study is a systematic review and meta-analysis of placebo-controlled trials.
Main outcome measures:
Mortality, activities of daily living, quality of life, core psychiatric events, and relapse and recovery rates.
Data sources:
Pu...
Objective:
To assess if lithium treatment in patients with mood disorders, for instance depression, bipolar disorders and schizoaffective disorders has an effect on total mortality and suicide.
Design:
Systematic review and meta-analysis.
Main outcome measure:
Total mortality. Secondary outcome was suicide.
Data sources:
PubMed and ClinicalT...
Background:
Screening for malignant melanoma has the potential to reduce morbidity and mortality from the disease through early detection, as prognosis is closely associated with the thickness of the lesion at the time of diagnosis. However, there are also potential harms from screening people without skin lesion concerns, such as overdiagnosis of...
Background:
General health checks are common elements of health care in some countries. They aim to detect disease and risk factors for disease with the purpose of reducing morbidity and mortality. Most of the commonly used individual screening tests offered in general health checks have been incompletely studied. Also, screening leads to increase...
Background:
Millions of people are treated with antidepressants like selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This clinical practice is based on short-term trials that have exaggerated the benefits and underestimated the harms. We also know too little about long-term harms.
Aim:
To...
Objectives
To determine the role of academic authors, funders, and contract research organisations in industry funded trials of vaccines, drugs, and devices and to determine lead academic authors’ experiences with industry funder collaborations.
Design
Cross sectional analysis of trial publications and survey of lead academic authors.
Eligibility...
Key findings
The Cochrane human papillomavirus (HPV) vaccine review missed nearly half of the eligible trials.
The review was influenced by reporting bias and biased trial designs.
Authors of Cochrane reviews should make every effort to identify all trials and the trials’ limitations.
In May 2018, the Cochrane Collaboration published its review...
Objective
To describe the redactions in contemporary protocols for industry-sponsored randomised drug trials with patient relevant outcomes and to evaluate whether there was a legitimate rationale for the redactions.
Design
Cohort study. Under the Freedom of Information Act, we requested access to trial protocols approved by a research ethics comm...
Background
Unabridged access to drug industry and regulatory trial registers and data reduces reporting bias in systematic reviews and may provide a complete index of a drug’s clinical study programme. Currently, there is no public index of the human papillomavirus (HPV) vaccine industry study programmes or a public index of non-industry funded stu...
In response to my paper, where I call for abolishment of patents and for drug research and development as a public enterprise, Raj asserts that there is an increase in novel drug discoveries. The fact is that even the drug industry laments that drug innovation has dried out, which is why they buy start-up companies. Big pharma doesn't invest in inn...
This is a protocol for a Cochrane Review (Methodology). The objectives are as follows: The primary objectives are to investigate to what degree: funding of systematic reviews by drug, device, and imaging companies and authors' other financial conflicts of interest are associated with effect size estimate; and funding of systematic reviews by drug,...
Our current system for researching, developing, approving, marketing and using drugs is financially and morally unsustainable. I propose an entirely new system where drug research and development will be a public enterprise, with no patents, and defined entirely by the public interest. Drug companies will have a limited role, selling services on a...
Many patients are taking psychiatric drugs for years despite little knowledge about their long-term harms. Here, we summarise the findings of whether psychiatric drug exposure causes long-term harms in mammals after a drug-free period.
We searched PubMed, Biosis and Embase for controlled animal studies (no behavioural priming; behavioural assessme...
Objective
To study whether cognitive behavioural therapy decreases suicide attempts in people with previous suicide attempts.
Design
Systematic review and meta-analysis.
Setting
Randomised trials that compare cognitive behavioural therapy with treatment as usual.
Participants
Patients who had engaged in any type of suicide attempt in the six mon...
BACKGROUND
Few studies have reported on long-term harms caused by ADHD drugs but they are known to impair growth.
OBJECTIVE
To assess whether ADHD drugs impair reproduction in mammals.
METHODS
Systematic review of reproduction in studies of animals treated with ADHD drugs.
DATA SOURCES
PubMed, Biosis and EMBASE.
RESULTS
We included 17 studies....
A Cochrane systematic review on immediate-release methylphenidate for adults with attention deficit hyperactivity disorder (ADHD) was withdrawn from the Cochrane Library on 26 May 2016 after substantial criticism of its methods and flawed conclusions. Retraction of scientific papers on this basis is unusual but can be necessary. We provide a summar...
Mendel and colleagues highlight the problem of unethical trials getting approved by research ethics committees while the participating patients are kept in the dark.1
I agree with their proposals but not with their statement that “the difficulties in accessing basic ethics documents means that [a systematic review] is unlikely to be feasible.” We...
This chapter argues two evidence-based conclusions: not only are psychiatric drugs dramatically overprescribed and overvalued but the harms they unleash completely overwhelm any benefits accrued. While accepting numerous reasons for our current prescribing epidemic, this chapter focuses on the manipulation of most placebo controlled trials, the sys...
Background:
Effective breast cancer screening should detect early-stage cancer and prevent advanced disease.
Objective:
To assess the association between screening and the size of detected tumors and to estimate overdiagnosis (detection of tumors that would not become clinically relevant).
Design:
Cohort study.
Setting:
Denmark from 1980 to...
Citations
... Implementing CONSORT recommendations is necessary to correctly measure and report the effectiveness and safety of the intervention. 65 Stroehlein et al found insufficient evidence to determine the benefits and harms of vitamin D supplementation as a treatment for covid-19 because of limited safety ...
... This impairment of GL function may result in skewed inflammatory responses, compromised immunity, a procoagulatory state, and disease processes. In particular, COVID-19 vaccines did not prevent infection 381,382 or transmission 151,383 and were associated with a significant risk of chronic disease, serious AEs or death 7,20,121,384 . ...
... We conducted a population-based cross-sectional electronic survey between 3 December 2019 and 31 January 2020, to describe the use of EPRs and encrypted email communication among Swiss chiropractors, as well as the geographic distribution of chiropractors in Switzerland. Our study is reported according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement for cross-sectional studies [13]. The independent research ethics committee of Canton Zurich con rmed that ethical approval was not required for this survey of Swiss chiropractic clinicians pursuant to Art. 2 (outside scope) of the Swiss Federal Act on Research involving Human Beings (Human Research Act, HRA). ...
... Anonymous or pseudonymous whistleblowing is frequently employed to report misconduct in the healthcare or pharmaceutical industries, but these may be presented with a higher proportion of suspicion over factual evidence. While some are supportive of the anonymity in terms of protection of whistleblowers and the projected consequential benefits of avoiding harm (Gøtzsche, 2022), others may dismiss such acts as being akin to hearsay (Healy, 2022). The specificity and clarity in terms of factual evidence in IME-PPPRs would allow the audience to examine and verify the issue or concern for itself, without being unduly distracted by an upfront allegation of misconduct. ...
... Данная проблема приобретает особую акту-альность в современном обществе в связи с ускорением темпа жизни. Процесс информатизации и компьютеризации непрерывно увеличивают число событий за единицу времени в повседневной жизни человека [46]. С ростом числа происходящих событий интенсифицируется поток сообщений о них, который воспринимается и перерабатывается сознанием человека с возрастающим напряжением. ...
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... As a subset, the distortion of arguments in one or another direction through the selective choice of literature that favors or amplifies such arguments, in the favor of the author's opinion, can also be equated to a form of "citation bias" (Urlings et al., 2021). There are aspects of citation bias that invoke ethical arguments, or authors' responsibilities (Gøtzsche, 2022). And where citations to work of a particular cultural or racial group might be more amplified relative to other groups, the latter may feel victimized (Ray et al., 2022). ...
... Finally, following the outbreak of COVID-19 pandemic, conspiracy theories emerged, holding China responsible for the global pandemic (Gøtzsche, 2021). These conspiracy theories may have changed customers' attitude toward Chinese manufactured products in the international market. ...
... There were variations in the studies' methods and research foci. One study comprised qualitative interviews focusing on nurses' perspectives of delegation of medicines management to unlicensed/ unregistered staff [27]; another was a mixed-methods study consisting of survey and focus groups with pharmacists regarding ADR reporting and knowledge of pharmacovigilance legislation [28]; two studies were retrospective case reports of medicolegal litigation and the management of clinical risk [30] and legal aspects of patients' rights in forced medication orders [31]; one was a cross-sectional study of ADR reporting before and after legislation changes and the conditions for nurse reporting [29] and another was a cross-sectional interrupted time-series analysis of prescription drug-monitoring programs and the related patient risk [32]. ...
... In a cross-sectional study of medical advertising published in the Journal of the Danish Medical Association in 2015, the most commonly advertised drugs had no proven substantial added benefit over older treatments, while being substantially more expensive [22]. ...
... One study assessed the characteristics of 30 methods guidance published between 2009 and 2018 that were labeled as ''frameworks'' and included a methods section (i.e., a small fraction of methods guidance) [22]. Another study assessed 18 guidance articles for psychiatric drug trials from the European Medicines Agency (EMA; published between 2005 and 2017) and the United States Food and Drug Administration (FDA; published between 2015 and 2019) and found limitations regarding generalizability and under-representation of nonconflicted stakeholders [23]. ...