How we got access to clinical study reports in 2011 despite EMA’s steadfast refusal
On 1 February 2011, we got access to the clinical study reports and their corresponding protocols of placebo controlled trials of two slimming pills, rimonabant and orlistat, submitted by the manufacturers to the European Medicines Agency (EMA) for obtaining marketing approval in the European Union.
We applied for access in June 2007, but EMA did not grant us access arguing that it would undermine the protection of commercial interests. We appealed to the European Ombudsman and after 3.5 years and 133 pages of correspondence between EMA, the European Ombudsman and us we got access.
We have described the case briefly here: Gøtzsche PC, Jørgensen AW. Opening up data at the European Medicines Agency. BMJ 2011;342:d2686.
We have also written a more comprehensive 26-page report: Getting access to unpublished clinical trials at the European Medicines Agency.
All the documents in the case are available below. …
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Made in China: the coronavirus that killed millions of people
It is highly likely that SARS-CoV-2, the coronavirus that caused the COVID-19 pandemic, escaped from the Wuhan Institute of Virology because of sloppy safety procedures. It is also likely that the virus was fabricated on purpose to make it dangerous to humans as part of the so-called gain-of-function research at the institute. Read more
Cochrane: a sinking supertanker? Funding of UK Cochrane groups in jeopardy
I describe what is likely the beginning to the end for Cochrane. According to its major funder, the writing has been on the wall for 8 years, which is exactly the period when Cochrane’s new CEO, journalist Mark Wilson, ruled the organisation and destroyed it. He suddenly left his job, in the middle of a month, five days before the webinar where the major funder criticised Cochrane. Read more
Vera Sharav, President for the US Alliance for Human Research Protection, believes in corona conspiracy theories and makes totally unjustified comparisons with Nazi Germany
At a meeting about COVID-19, Sharav talked endlessly about Nazi atrocities. Much of what she said was pure speculation or constituted totally unjustified parallels to current day societies. Sharav considers Andrew Wakefield, one of the biggest fraudsters in medicine, a hero, and as she is believed by corona deniers to be a credible witness for the thesis that the governments only want to subdue their populations, I found it worthwhile to report some of what she said at the meeting. See here
COVID-19 vaccine passports are not evidence-based and violate people’s freedom of choice
(Rapid response to a BMJ article, reproduced here)
08 April 2021
Maryanne Demasi, Researcher, journalist and Prof Peter Gøtzsche, Institute for Scientific Freedom, Copenhagen 2970, Denmark
The conversation about COVID-19 vaccine passports has reached fever pitch, with many media outlets reporting that proof of vaccination may be required for entry into pubs, restaurants, entertainment venues, gyms, workplaces or to travel abroad. …
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“Anti-vaxxer” letter about COVID-19 and the vaccines
An “anti-vaxxer” group of people, United Health Professionals, has sent a totally misleading letter to the governments in 30 countries. Peter Gøtzsche has highlighted the many falsehoods and nonsense statements in their letter. Open letter to President Jair Bolsonaro
Editors refused to publish systematic review of animal studies on long-term harms of psychiatric drugs
We submitted our review to four different journals that all accept systematic reviews of animal research, but ended up publishing the review on our website.
Serious editorial misconduct at Scientific American related to COVID-19
Peter C Gøtzsche writes: In March, the world’s most cited medical researcher, Professor John Ioannidis from Stanford University, became the subject of one of the worst witch hunts in newer medical history after he had published an opinion article about the COVID-19 pandemic. Journalists Jeanne Lenzer and Shannon Brownlee described this in an opinion piece with a sidebar in Scientific American, only to be exposed to serious editorial misconduct by the journal.
The journal violated the first rule of journalistic integrity by publishing accusations without inquiring of the accused. The editors uploaded “corrections” on the journal’s homepage, several of which were errors committed by themselves; others were not true or irrelevant. Lenzer and Brownlee tried to correct the false “corrections” but the editors also denied them this opportunity. The inappropriate “corrections” triggered an outpouring of hate mail and false claims about Ioannidis and the integrity of Lenzer and Brownlee as journalists.
It was so bad that Jeffrey S. Flier, former Dean at Harvard Medical School, wrote to the editors asking them to take proper action. Scientific American has not published his letter.
It is essential to expose misconduct. Flier’s letter and Lenzer and Brownlee’s corrections of the erroneous “corrections” made by the editors can be found on Lenzer’s website.
Elation or caution over COVID-19 vaccines? The evidence so far.
Maryanne Demasi reflects on the reports published this week about two corona vaccines. The new vaccines have offered some hope that, sometime down the road, our lives can return to normal. Read more
The coronavirus has created a nanny state
When the state knows best and violates human rights, we are on a dangerous course. History has shown that leaders who assure us that the situation is so serious that we must give up our freedom to gain security against an external or internal danger usually end up giving us neither freedom nor security but themselves the absolute power. Read more