Unjustified attack on randomised trials and evidence-based medicine from an epidemiologist
By Peter C Gøtzsche
Two weeks ago, US epidemiologist Harvey Risch published a paper criticising evidence-based medicine (EBM) and its reliance on randomised clinical trials (RCTs) quite substantially. At the same time, he praised observational studies based on arguments that are untenable.
After Gordon Guyatt had coined the term EBM in the early 1990s, some prominent epidemiologists provided similar criticisms of it as Risch. It is therefore worthwhile to discuss Risch’s key arguments. …
Chest pain during exercise – or how to avoid getting stented
Inserting stents into people with chest pain during exercise is big business. But is it also beneficial for the patients? This is doubtful. The reliability and usefulness of exercise stress tests and coronary angiography is also doubtful in relation to deciding whether a patient needs stents or not. As this will surprise most people, I have decided to republish a section about these issues in my 2019 book, Survival in an overmedicated world: Find the evidence yourself. You can read this section here.
Pure nonsense about the secrets of water on national Danish TV
By Peter C Gøtzsche
9 Dec 2022
Many alternative practitioners claim that the water in homeopathic drops can remember what was once in it, even though there isn’t a single active molecule left after all the dilutions. In 2019, national Danish TV broadcast similar nonsense in the programme, “The secrets of water,” under the heading Nature, Science and Technology.
It was claimed that water flowing past a closed container of “Grander water” extracted from a mountain spring in the Alps can render the water more orderly and a better cleaning agent. The miraculous alp water, which is sold in a household version for the handsome sum of €1000, defies the 2nd law of thermodynamics, which states that the entropy (the degree of disorder) in a closed system will always increase with time unless you add energy to the system.
Some Germans claimed that with the power of thought you can influence water in a closed container several thousand kilometers away. This was documented by graphs that ran roughly in parallel until people started thinking about the container. Then the graphs diverged, quite considerably so.
In the broadcast, there were interviews with Danish researchers who came up with some generalities that if this were true, the perceptions in the natural sciences would need to be revised. Sure, and if one day we saw a man from space kidnapping people from Earth and transporting them away in a spaceship, so-called alien abduction, there is also something we need to revise.
Science is under attack. It is not helpful that national TV stations, whose economy all citizens need to contribute to involuntarily, publishes utter nonsense under the guise of scientific credibility. The astrophysicist Carl Sagan wrote a whole book about popular nonsense, The Demon-Haunted World: Science as a Candle in the Dark. We should take care that this candle does not get blown out.
Ritual circumcision of boys: a barbaric practice that must stop
We cannot justify banning female circumcision while allowing male circumcision. There is no relevant ethical difference, and none of the arguments offered in favour of male circumcision at a hearing in the Danish parliament in November 2014 held water. I have translated an article I published in 2015 about the hearing because it is still highly relevant. Genital mutilation of boys must stop in all countries and doctors should refuse to perform any such barbaric operations unless medically indicated, which they very rarely are. Read more
Big marketing hoax: Non-steroidal, anti-inflammatory drugs (NSAIDs) are not anti-inflammatory
By Peter C Gøtzsche
The name non-steroidal, anti-inflammatory drugs (NSAIDs) suggests that NSAIDs reduce inflammation like corticosteroids do, but this is not correct. In a meta-analysis of the placebo-controlled trials, they did not reduce the swelling of finger joints measured by jeweller rings in patients with rheumatoid arthritis. And in a placebo-controlled trial in 173 patients with acute ankle distortions, they did not reduce the oedema. In this trial, the patients were also randomised to a group that was instructed to immobilize the foot and was given crutches and to a group that was instructed to walk as normally as possible despite the pain. Mobilisation quickly reduced the oedema. After 2-4 days, the difference in volume between the healthy and the injured foot was 42 mL when the patients were mobilised compared to using crutches (P = 0.01). In contrast, there was no significant effect of naproxen (P = 0.42; difference 11 ml compared with placebo, which could simply be due to more mobilisation because of less pain). Thus, mobilisation was anti-inflammatory, which naproxen wasn’t, and it also led to much faster recovery, 44% versus 16% had recovered after 2-4 days (P = 0.0006). I have spared the internal company report of our study, which is where these data are. The company resisted to have these embarrassing data published. It is rare to name drugs after what they are not (non-steroidal), but this was a carefully planned marketing trick that has worked very well for the drug companies while it has killed hundreds of thousands of patients who didn’t really need such a drug but could have done well on paracetamol or no treatment.
Famous US comedians are not censored by YouTube: The Wuhan lab leak
In June 2021, comedian Jon Stewart appeared on Steven Colbert’s late night show. The video on YouTube is remarkable. Colbert tries to stop Stewart when he, a couple of minutes into the show, wants to discuss the origin of the COVID-19 pandemic, and not only suggests it was a lab leak but also that the pandemic was likely caused by science. It is also remarkable that YouTube, which has removed a lot of content that to a lesser degree went against the official Chinese narrative that the virus originated in nature, did not remove this video. I have written a transcript of the video. About making Frankenstein new corona viruses in gain-of-function experiments, like the one recently created in Boston that killed 80% of the mice, Stewart says: The final words ever spoken on this Earth will be a scientist’s musing, “Huh, it worked.”
Fluoxetine in children and adolescents with depression is unsafe and ineffective
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
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
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
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.