About trust - and pharmaceuticals' regulation
Wishing that regulators would be doing more and better in the public interest.
Regulating drugs and vaccines is a key aspect of the complex system of health and medicine. However, regulators are trapped in a rather complicated framework. On one hand, they count on the fees pharmaceutical companies pay in order to manage their organisations. Conflicts of interest, you say? Yes, all over the place.
On the other hand, it's hard to assess if a pharmaceutical product or a device can be called "safe and effective". All things considered, sad but true fact: we can't really trust regulators, and the last few years have shown it beyond doubt.
Two recent publications shall be a wake-up call for everyone.
Enter the Food and Drug Administration (FDA) and mRNA vaccines.
A group of scientists and advocates for drug safety have asked the FDA to make critical changes to the product labels of the biologicals. The proposed amendments could have been a quite straight-forward task to solve for the most influential regulator of the planet, as they pertained effectiveness in reducing viral transmission, that the agency itself considers unproven, and a series of well-documented potential side effects. Four months later, in a 33-page response letter, the agency turned down almost every single request. Read the details, with sources, in this rather depressing and yet essential report by The Hill.
Also, medical investigative journalist Maryanne Demasi has just published on her Substack another example on how things can go terribly wrong with labeling and regulating drugs. It's a less-known case, and yet one that will give you the creeps, around a sometimes-irreversible side effect of antidepressants, mainly selective serotonin reuptake inhibitors (SSRIs). Sufferers have described it as ‘chemical castration’. Patients are not warned, doctors don't know about it, regulators ignore it, and victims are let down.
#Feature: mRNA instability, an investigation that is unfortunately ageing well
In 2021 Re-Check’s Serena Tinari published an original investigation inThe BMJ about some of the unknowns of applying mRNA technology to new pharmaceuticals. The piece “The EMA covid-19 data leak, and what it tells us about mRNA instability” is unfortunately ageing well. doi: https://doi.org/10.1136/bmj.n627.
#OnTheRoad: a scientific congress on all things Covid
In November 2022, Re-Check participated with a panel on pandemic journalism disasters to the international congress POLI-COVID-22 Salute, Scienza e Società alla prova della pandemia, which took place in Turin (Italy). Among the international speakers: John Ioannidis, Tom Jefferson, Peter Doshi, Sunetra Gupta.
Available online in open access: program and recordings.
#GIJNHealthGuide: The Guide Investigating Health and Medicine we wrote on commission for the Global Investigative Journalism Network is now available in: English, French, Russian, Italian, and Spanish. The Guide is published under Creative Commons License and can therefore be freely reproduced and distributed after getting in touch with GIJN (hello@gijn.org) or with us (presence@re-check.ch).
Pandemic Re-Check’s Series: Journalism in pandemic mode: embedded, complacent and unable to inform democratic debate; Science in Pandemic Mode: The Strange Case of the Swiss National COVID-19 Science Task Force; Democracy in Pandemic Mode: the Strange Case of the COVID Certificate; Function creep in pandemic mode: the strange case of the Covid-19 certificates.
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#GoodReads
FDA oversight of clinical trials is "grossly inadequate". By Maryanne Demasi.
Covid-19 vaccines and drugs were developed at warp speed, and now experts are concerned about the US Food and Drug Administration’s inadequate surveillance of clinical trial sites. Inspections of trial sites are vital to ensure the integrity of data generated in clinical trials, but only 9 out of 153 Pfizer trial sites were subject to FDA inspection prior to licensing its Covid-19 mRNA vaccine. Similarly, 10 out of 99 Moderna trial sites and five of 73 Remdesivir trial sites were inspected.
The BMJ, November 16, 2022.
https://www.bmj.com/content/379/bmj.o2628
Trust the evidence. By Carl Heneghan and Tom Jefferson.
In-depth analysis and plenty of food for thought around science, health and medicine. Especially worth reading: the series The SARS-CoV-2 Transmission Riddle and the ongoing series Story of Influenza Antivirals.
Churnalism, misinformation and much more. By Sensible Medicine.
A shared Substack featuring the voices of physicians, scientists and thinkers. Ideas and opinions about all things bio-medicine.
Davids versus Goliaths: Pharma and academia threats to individual scientists and clinicians. By Charles L. Bennett, Nancy Olivieri et al.
Scientists and clinicians may be reluctant to report research findings contrary to corporate interests, out of fear of retaliation from the industry. A report on threats and intimidation leveled against people who had communicated safety, efficacy, or data integrity findings contrary to corporate interests.
Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials. By Joseph Fraiman et al.
In 2020, prior to Covid-19 vaccine rollout, the Coalition for Epidemic Preparedness Innovations and Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to the vaccines. The authors leveraged the list to evaluate serious adverse events of special interest observed in phase III randomized trials of mRNA COVID-19 vaccines. Combined, the mRNA vaccines were associated with an absolute risk increase of serious adverse events of special interest. The excess risk of serious adverse events of special interest surpassed the risk reduction for Covid-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials.
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4125239
Films
Impfen – Die ganze Geschichte – Des vaccins et des hommes. By Anne Georget.
For this international documentary co-produced by ARTE, Anne Georget interviewed experts from many different countries. In her calm, fascinating storytelling she dives deep into the history of vaccination, the unknowns, the way biologics are tested and how they were implemented through dozens of years of public health campaigns.
Available in German and French, paywalled:
https://boutique.arte.tv/detail/des-vaccins-et-des-hommes
COVID-19 epidemiology: risks, measures, and ending the pandemic.
A John P.A. Ioannidis lecture hosted in 2021 by the University of Salzburg.
Everything you wanted to know but never dared asking. What is the best estimate of the infection fatality rate with SARS-CoV-2? What happened in the hospitals, and what about ethics in public health? 50 minutes lecture, and an hour of Q&A.
#Evergreen
Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies. By Richard Smith.
“The most conspicuous example of medical journals' dependence on the pharmaceutical industry is the substantial income from advertising (..) The much bigger problem lies with the original studies, particularly the clinical trials, published by journals. (…) A large trial published in a major journal has the journal's stamp of approval (unlike the advertising), will be distributed around the world, and may well receive global media coverage, particularly if promoted simultaneously by press releases from both the journal and the expensive public-relations firm hired by the pharmaceutical company that sponsored the trial. For a drug company, a favorable trial is worth thousands of pages of advertising, which is why a company will sometimes spend upwards of a million dollars on reprints of the trial for worldwide distribution.”
PLOS medicine, May 2005: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1140949/
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