Fluoxetine in children and adolescents with depression is unsafe and ineffective

Published on November 8, 2022

By Peter C Gøtzsche

Psychiatrist David Healy and I have restored the two pivotal fluoxetine trials in children and adolescents with depression, which led to approval of this drug for minors. This drug, or any other depression pill, should never have been approved for children, as they do not work and double the risk of suicide. Here is our full report and the abstract is below. I also provide the peer review comments and our replies, as they tell a story about the first peer reviewer being so blind that he or she WILL NOT SEE. This denial, which is very common in psychiatry, has tragic consequences for our children. I have uploaded the two clinical study reports Eli Lilly submitted to the UK drug regulator that we used for our research, and also the statistical review and the medical review by the FDA.

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 outcomes were the efficacy variables in the trial protocols, suicidal events, and precursors to suicidality or violence.
RESULTS: Essential information was missing and there were unexplained numerical inconsistencies. The efficacy outcomes were biased in favour of fluoxetine by differential dropouts and missing data. The efficacy on the Children’s Depression Rating Scale-Revised was 4% of the baseline score, which is not clinically relevant. Patient ratings did not find fluoxetine effective. Suicidal events were missing in the publications and the study reports. Precursors to suicidality or violence occurred more often on fluoxetine than on placebo. For trial HCJE, the number needed to harm was 6 for nervous system events, 7 for moderate or severe harm, and 10 for severe harm. Fluoxetine reduced height and weight over 19 weeks by 1.0 cm and 1.1 kg, respectively, and prolonged the QT interval.
CONCLUSIONS: Our reanalysis of the two pivotal trials showed that fluoxetine is unsafe and ineffective.

Horrible YouTube censorship – again related to COVID-19

Published on November 8, 2022

By Peter C Gøtzsche

On 30 September, I was interviewed by enGrama in Spain for an hour about organised crime in psychiatry and the drug industry. I spoke about COVID-19 for 5 minutes, which made YouTube instantly eliminate the whole interview. This was utterly ridiculous. What I said was true, but YouTube even refused to allow the interviewers to download their own video. Later, they succeeded to reproduce it via the YouTube Studio and it is now up again, but without the forbidden 5 minutes. I have seen these 5 minutes and describe verbatim what they were about and also give an overview of the interview: enGrama interview.

Book review: Critical psychiatry textbook

Published on November 2, 2022

This book review was published by Haakon Rian Mancient Ueland in Norway on LinkedIn.

In the mid-50’s, a revolution in psychiatric treatment happened. Psychotropic medication entered the scene with a blast. New drugs that would give those afflicted with psychosis, depression and anxiety a new life. Since then, the pharmaceutical industry has launched an amazing number of concoctions. Xanax, Zyprexa, Prozac – the names have become household names, and are liberally doled out by the medical profession. “Mother’s little helper” – benzodiazepines – got some serious competition.

The marketing campaign had a lot of help from the media. Books were written about their life changing effect,  magazines such as Time featured them on the cover, and the world was changed.

For the better? …

More on YouTube censorship of world class vaccine research

Published on October 18, 2022

See my previous post from 11 October 2022, Live attenuated vaccines decrease total mortality while nonlive vaccines increase total mortality.

In February 2022, a US law firm wrote a 3-page letter to Susan Wojcicki, Chief Operating Officer, Legal Support, YouTube, asking her to restore Professor Aaby’s video about the beneficial and harmful effects of vaccines so that a healthy conversation surrounding medical science could continue.

Aaby has shown in several high-quality studies (see my expert report) that the use of the diphtheria, tetanus and pertussis vaccine (DTP) increases total mortality in infants in areas with a high risk of infectious diseases and a high child mortality. The immunological mechanism for this effect seems to be that DTP introduces “tolerance” in the immune system. We have seen this happening with the influenza vaccines, which increase the risk of getting infected with other strains in future, and most recently also when COVID-19 vaccines are used repeatedly. Earlier this year, the European Medicines Agency sent a dire warning to the world.  The agency was concerned that repeated boosters every four months could weaken a person’s immune response to the coronavirus.

In 1978, Aaby established the world renown Bandim Health Project, a Health and Demographic Surveillance System site in Guinea-Bissau. He has studied and promoted vaccines in Africa for decades, and in 2000, he was awarded the Novo Nordisk Prize, the most important Danish award within health research. In 2009, the Danish Ministry of Foreign Affairs selected Aaby as one of the leaders in the fight against global poverty. Aaby is a proponent of vaccines and has been relied upon by the World Health Organization to promote and study vaccines.

Aaby’s findings that the DTP vaccine increases total mortality in poor countries are very convincing and there has not been any research that tells us otherwise.

So, how did YouTube react to the letter from the law firm? YouTube ignored it. The lawyer received an automated message saying that the video had violated YouTube’s Community Guidelines, adding that “If you think a Community Guidelines strike was applied to your account in error, you can appeal it.”

The lawyer appealed and received no reply. This blatantly arrogant behaviour and censorship by social media has been experienced by many top class researchers. We must work together on changing this situation, which is very harmful for science and for our citizens. Censorship kills. It is as simple as that. See also my recent book, The Chinese virus: Killed millions and scientific freedom, where I describe social media censorship at length, also in areas not related to vaccines.

Live attenuated vaccines decrease total mortality while nonlive vaccines increase total mortality

Published on October 11, 2022

From my book, Vaccines: truth, lies, and controversy: “The immune system is immensely complicated, and it is not possible to predict which nonspecific effects a targeted vaccine might have. Vaccines can affect nontargeted infectious diseases both positively and negatively. Danish professor Peter Aaby has done ground-breaking research in this area spanning 40 years.14 His group has published many papers that provide support to their hypothesis that live attenuated vaccines decrease total mortality while nonlive vaccines increase total mortality. The measles vaccine, for example, decreases mortality much more than what can be explained by its effect on preventing measles. The sequence of vaccinations also seems to be important for total mortality, and it is best to end with a live vaccine. Such observations do not render decision making about vaccines easy.

Bacillus Calmette-Guérin (BCG) for tuberculosis and the measles vaccine probably reduce mortality from pneumonia and sepsis. In contrast, the combined diphtheria, tetanus, and pertussis (DTP) vaccine is suspected to double overall mortality in low-income countries, which is worrying because the vaccine apparently induces tolerance and increases the risk of unrelated infections, in particular respiratory infections, which are bigger killers than the targeted diseases in such settings15 (see more about this in Chapter 8). These findings did not make Aaby popular at WHO headquarters. Public health messages become difficult when such totally unexpected results appear and become supported by subsequent studies.”

In 2019, I wrote an expert report, Effect of DTP vaccines on mortality in children in low-income countries. This was because a WHO systematic review from 2014 had assessed the effect of three vaccines on total mortality in infants and children: BCG (Bacille Calmette-Guérin), DTP (diphtheria, tetanus, and pertussis) and measles. I found serious flaws in the WHO review while I confirmed Aaby’s findings that the DTP vaccine doubled mortality in low-income countries. WHO also found that the DTP vaccine increased mortality but in trying to explain away what they found, they violated basic scientific principles. You can read my expert report here.

Psychiatry textbooks are filled with errors and propaganda

Published on August 3, 2022

Students of medicine, psychology and psychiatry, and allied health professions learn about psychiatry by reading psychiatric textbooks. They generally believe what they read and reproduce it at their exams. University textbooks are therefore a powerful tool for indoctrination – for arriving at the “right opinion” even when it is wrong. When I read the five psychiatric textbooks in Denmark most commonly used by medical and psychology students, I uncovered a litany of misleading and erroneous statements about the causes of mental health disorders, if they are genetic, if they can be detected in a brain scan, if they are caused by a chemical imbalance, if psychiatric diagnoses are reliable, and what the benefits and harms are of psychiatric drugs and electroshocks. Much of what is claimed amounts to scientific dishonesty. I also describe fraud and serious manipulations with the data in often cited research. Read more.


Published on July 5, 2022

Watch 6 min satire with American “ADHD expert” Professor Chip Cash, have a laugh, and then get serious and do something to help end this profitable, hypocritical, pseudoscientific, 21th century form of child abuse.

Anonymous authorship may reduce prescription drug deaths

Published on June 12, 2022

I just published the article, Anonymous authorship may reduce prescription drug deaths, in Ind J Med Ethics, online first. I argue why the current peer review system is unfair and invites abuse and give examples of misconduct at the FDA and in drug companies which has caused hundreds of thousands of deaths we could have avoided.

I very much hope you will read my paper and open a much needed discussion of why we not only need anonymous whistleblowers but also anonymous authors to protect public health and scientific freedom and freedom of speech. Please also look up upcoming articles about this subject in the journal,

The decline in scientific freedom has been particularly visible during the COVID-19 pandemic. The Institute for Scientific Freedom in Copenhagen and Centre for Evidence-Based Medicine in Oxford will therefore hold a joint conference with the title above in Copenhagen 24-25 October 2022. We hope to see you.

Book review of “The Chinese virus: killed millions and scientific freedom”

Published on June 9, 2022

Written by Dr. Dick Bijl, President, International Society of Drug Bulletins.

Peter Gøtzsche continues to be productive. The Danish doctor and researcher is publishing articles and books at a rapid pace. His latest book is about the impact of the pandemic on science. According to Gøtzsche, truth, science, honesty, decency, and respect for human rights were among the first victims of the COVID-19 pandemic. Read more

When will the COVID-19 follies stop?

Published on April 6, 2022

I wonder when the authorities will think outside the “perpetuum mobile” (more of the same, indefinitely) box and conclude that we are in a situation that is not much different to flu seasons and allow us to live normally … And why did Sweden do relatively well, with fewer deaths per million than in France, Italy, Spain, the UK, and USA, despite having very little lockdown and not recommending face masks, which very few people used? Read more