Monday, June 05, 2023

French Research Establishment Intensifies Attack Against Hydroxychloroquine Proponents during COVID-19

A controversial French physician-investigator and hydroxychloroquine proponent continues to find trouble, as it’s now reported in French media that top researchers in an op-ed in a popular media seek to punish Didier Raoult and colleagues given that they designed and conducted the large study investigating the use of hydroxychloroquine targeting COVID-19, what the opponents tout as being described as “the largest ‘unauthorized’ clinical trial ever seen.”

Why the ongoing, continued attacks, given French society has moved beyond the COVID-19 emergency? Just about nothing was more controversial than the use of repurposed drugs targeting COVID-19.

Of course, this news represents the continued controversy of the repurposed generic drug hydroxychloroquine as a possible treatment for COVID-19. Much of the medical establishment has written off this drug, yet the studies have trickled in suggesting some promise regardless of the naysayers. But whom to believe? This is the challenge.

The medical establishment, defined for purposes herein represents the leading opinions emanating from the predominant health care systems, hospitals and clinics, medical research universities and government health agencies from regulators to public health of a nation, region or even worldwide. In the intensive controversy and conflict over key topics during the COVID-19 pandemic, TrialSite observed that nothing can become more politicized than the topic of medicine and broader healthcare. It’s a $1+ trillion economy in America and a lot of smart people with a lot of evidence-backed options, at times on both sides of a polar oppositional equation. But the world can be a complex place, as can be science, and an open mind, with an objective stance is required, along with the wherewithal to continuously scan unfolding data from around the world.

Controversy & politicization

Perhaps, no drug was more politicized than hydroxychloroquine (of course unless its ivermectin), as early on in the pandemic as under the Trump presidency. The Food and Drug Administration in March 2020 reluctantly issued an emergency use authorization for the drug. This action was seen as the Trump administration trying to force a solution on the regulatory agencies, leading to mounting tension, and according to TrialSite accounts, outright information war between different factions of power. Ultimately, according to the National Institutes of Health (NIH), FDA and a majority consensus of the medical and research establishment, the drug was to be avoided for any use involving COVID-19. See the ongoing FDA recommendation to not prescribe the drug.

Similar tensions broke out in other countries, such as Brazil, where their conservative president Jair Bolsonaro also openly supported use of the drug in response to the pandemic. Along the way, strange and even shady situations emerged such as Surgisphere, a Chicago-based analytics company that came under scrutiny by May 2020. The company purportedly provided large datasets of COVID-19 patients, publishing the data in The Lancet and the New England Journal of Medicine by May 2020. TrialSite openly questioned the credibility of the studies based on the highly questionable access to pervasive health data around the world.

TrialSite engaged with the company to elicit questions while the prestigious journals that strangely published the Surgisphere material ultimately retracted those articles.

But why did such prestigious journals publish such questionable material so fast? Was it the urgency of the moment—those early days in the pandemic? Or were more nefarious elements involved? The data suggested a “significantly higher risk of death” associated with hydroxychloroquine. An anti-hydroxychloroquine fervor intensified and even the World Health Organization dropped its clinical trials testing the drug.

The NIH backed off on any positive finding, only to recommend the drug if for a clinical trial. Several studies showed promising results as reported in TrialSite, such as an observational study conducted at Henry Ford Health System.

The situation became so ridiculous in America that at one point during the pandemic if someone raised the topic of hydroxychloroquine, they were immediately labeled a right wing, Trump-loving, MAGA supporter, or loon from the mainstream. And dare to challenge its efficacy to the drug’s proponents, and you were a bought off shill for Big Pharma. The pandemic revealed the worst of our character.

On the one side was an all-encompassing, uniform response that the drug just didn’t work against SARS-CoV-2—ignoring any positive data that may have been generated; while a vocal minority, backed at first by Trump and MAGA, swore the drug could do miracles. Both sides were incorrect.

The French study

TrialSite reported on some of the research led by Dr. Raoult, who used to head the IHU Mediterranee research hospital, and his colleagues who were, especially before the introduction of the COVID vaccines, open to the use of repurposed drugs such as hydroxychloroquine and ivermectin during the height of the pandemic. The medical establishment in France is outraged that this cohort of physician-scientists continued their stance during vaccination.

In a recent France24 entry the French media highlights the influence of Dr. Raoult in his effort to “push” the anti-malaria drug “into public consciousness in the early days” of COVID-19.

In March, Raoult and colleagues published the results of a study involving more than 30,000 COVID-19 patients via the preprint server, meaning the results have yet to be peer reviewed.

By March 2022, TrialSite reported that the French Medicines Agency was investigating Raoult due to the claim that their research lacked ethics committee review.

TrialSite reported, “An infectious disease medical research center and hospital run by the controversial microbiologist Didier Raoult is in serious trouble in France. Criminal charges will be filed by the French Medicines Agency (ANSM) with the Marseilles public prosecution unit against hospital-university institute (IHU). Raoult was an outspoken proponent of using hydroxychloroquine against COVID-19.”

But the research ensued, and as TrialSite reported just in April that while still in preprint, “A large group of French researchers conducted a real-world retrospective study of monocentric cohorts comparing patients who were exposed or not exposed to antiviral regimen using a standard of care in a hospital setting in France from March 2, 2020, to December 31, 2021.

All of this real-world patient data was obtained from the electronic health record and reported to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) standard. The patients were cared for at the Institut Hospital Méditerranée Infection Center in Marseille, France. Note, one of the lead authors has been a controversial figure during the pandemic and proponent of Hydroxychloroquine (HCQ).”

During the same month (April), ANSM, the French medication regulatory emphasized that the repurposed drug “exposes patients to potential side effects that can be serious.” Also, just last week, French media including France24 reported that French medical bodies reminded all providers that they should take “measures appropriate to the infractions” for the sake of patient safety as well as “the credibility of French medical research.”

The French media reports that so far none of the physicians have been charged in the Marseille-based investigation opened up in 2022, as reported by TrialSite. But the media is repeating the claim that the IHU Mediterranee clinical trials were both fraudulent and unwarranted—strong claims that need backing with evidence and a court trial assuming any criminal allegations.

The pressure mounts, however, as a group of 16 research bodies in France wrote an op-ed article in Le Monde alleging that Raoult engaged in “systematic prescription of medications as varied as hydroxychloroquine, zinc, ivermectin and azithromycin to patients suffering from Covid-19... without a solid pharmacological basis and lacking any proof of their effectiveness.” The authors argue that despite the drugs being shown to be absolutely ineffective the Marseille group continued to use them for care and research.

Ongoing investigations

An interesting observation, 17 clinical trials continue to investigate the use of hydroxychloroquine as a regimen for COVID-19 based on a search of for active studies. TrialSite does note, however, that at least some of them are all but terminated.

What a difference an interpretation makes

A website tracking the study of repurposed drugs like ivermectin and hydroxychloroquine provides an interesting vantage point. While the site is controversial because the owners of the website don’t reveal themselves (likely for fear of losing their scientific and/or medical-based jobs), it reports 480 hydroxychloroquine COVID-19 studies, 388 peer reviewed, 393 comparing treatment and control groups.

Late treatment and high dosages may be harmful, the aggregate of study interpretation points out, while early treatment consistently shows positive results. Negative evaluations typically ignore treatment delay. Some In Vitro evidence suggested therapeutic levels would not be reached, however, that was incorrect, according to Ruiz. TrialSite reminds all that medical establishments have written any of these positive outcomes off to any number of reasons—badly designed study, etc.

U.S. medical & research establishment: rejects use for COVID-19

So, what’s the answer to the hydroxychloroquine question? Well, that depends on a number of factors, including point of view and paradigm, place of employment and sources.

Check the National Institutes of Health and its clear the apex research institute, along with the rest of the American medical establishment, along with the French and all of the West rejects the use of the anti-malarial drug for COVID-19, both in hospital and non-hospital settings.

The NIH points out, “The safety and efficacy of chloroquine or hydroxychloroquine with or without azithromycin and azithromycin alone have been evaluated in randomized clinical trials, observational studies, and/or single-arm studies.”


Is the UK’s Drug Regulatory Agency Covering Up COVID-19 Vax Death Data? Two Oxford Professors Believe So

Concern for coverups involving deaths associated with the COVID-19 vaccines now stirs the UK tabloid news. Two University of Oxford professors, experts in the field of drug development, have come out and disclosed that despite a 2-million-pound investment in an AI system to improve the Yellow Card safety reporting system at the UK medical regulatory called the Medicines and Healthcare Products Regulatory Agency (MHRA), it was a complete mess.

Professor Carl Henheghan and Dr. Tom Jefferson made the allegations recently according to DailyMail and other UK media. Is the very watchdog charged with transparency and reporting of adverse events associated with the COVID-19 vaccines involved with obfuscating the details involving AstraZeneca COVID-19 vaccine-related deaths?

To date, the reporting system included 2,743 logged deaths, but these by no means represent all deaths. Much like the U.S. Vaccine Adverse Event Reporting System (VAERS), these systems typically underreport safety events.

While the Oxford professors report a firm called Genpact was retained to improve the system with AI, there is no evidence that such technology advancements have been used at all. Moreover, the pair report in their own blog that “We can’t find a single analysis or publication from the AI-based system involvement.”

They also note that the MHRA’s expert advisory group tracking clinical trials produced minutes on vaccine safety since 2020, but none of those minutes have been released due to confidentiality until and only when a “final decision has been made.”

They note, “Contradictions galore and the absence of a gizmo to identify deaths. Yes, deaths, not arcane events.” TrialSite asks, "What's going on with the MHRA? Does human life not matter?" A similar pattern appears to be a concern with U.S. agencies. The MHRA alleges that there are inaccuracies in the blog.

Meanwhile, lawsuits mount against AstraZeneca in the UK.




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