Did France’s Regulator Follow the Law When Rejecting a Temporary Use Request for Ivermectin Targeting COVID-19?

Did France’s Regulator Follow the Law When Rejecting a Temporary Use Request for Ivermectin Targeting COVID-19

Apparently, the topic of ivermectin isn’t appreciated by drug regulators in the great nation of France. France’s National Agency for the Safety of Medicine and Health Products (ANSM) may have flouted the law in making a decision to reject ivermectin under the Recommendation for Temporary Use (RTU) in total secrecy, reports Gerard Maudrux, a French physician. He was showcased by TrialSite in March. Authoring an informative piece in FranceSoir Le miracle de l’ivermectine recently, Dr. Maudrux explored the importance of ivermectin as a potential therapy targeting SARS-CoV-2, the virus behind COVID-19. The French physician shared that ANSM completely disregarded disclosure requirements. While the 2011 “Reinforcement of Health Security of Medicinal and Health Products” law is clear in regards to the necessary transparency associated with key drug and device decision making, government representatives chose not to follow along. Outraged at this decision (and the way they went about making it), Dr. Maudrux secured the signatures of 1,500 physicians in 100 French departments in a letter protesting what the collective group deems an egregious violation of transparency principles promulgated and codified in law to protect the interests of the people of France.  

The ACT  

The French Act No 2011-2012, dated December 11, 2011, related to the Reinforcement of Health Security of Medicinal and Health Products and in ways is similar to America’s “Sunshine Act” involving conflict of interest associated with medicines. This particular French Act included three primary objectives, including 1) both stopping conflicts of interest while promoting transparency, 2) bolster the monitoring and tracking of medicinal products as well as medical devices and produce more transparency for both patients and healthcare professions with rules governing how drugs and devices are advertised.   

Again, the ACT paved the way for the Agence Nationale de Securite des Medicaments or the ANSM, referred to in English as the National Agency for the Safety of Medicine and Health Products, replacing its predecessor known as AFSSAPS in August 2012. With greater authority, ANSM moving forward could enact administrative and financial penalties, for example, but as mentioned, such powers also included accountability to the people of France in the form of transparency requirements.   

The ivermectin proponent refers to Article L1451-1-1 of this Act that arose out of the fallout from scandals of contaminated blood and related conflicts of interest among industry and regulators. Economists refer to this as “regulatory capture.”  

Consequently, a transparency imperative delineates; for example, that debates concerning the market authorization process known as Autorisation de Mise sur le Marché (AMM) as well as decisions involving Temporary Authorization for use (ATU) or the Recommendation for Temporary Use (RTU) are in fact made more transparent. It is imperative that these important discussions and decisions are documented and preserved, and as with all good transparency-promoting rules, such decision-making has “details and explanations of the votes, including minority opinions.” 

Introduce Ivermectin: Rules of the Game Change 

Dr. Maudrux  and colleagues sought to “access the debates” associated with the ivermectin decision within ANSM.  Hence, they requested a recording of that particular discussion, but they were not anticipating what was to happen next.  ANSM came back with the following response:  

“In this regard, articles L. 300-2 and L. 311-1 of the Code of relations between the public and the administration provide that the documents requested are in the nature of administrative documents, communicable to any third party who requests them. 

However, in this case, such documents do not exist.” 

OK. So, while the law includes numerous transparency measures for the public—and in fact, a major driver for the Act in the first place was the infusion of transparency to mitigate conflicts of interest associated with regulatory capture—apparently, the enlightened professionals within ANSM found some form of exemption associated with decisions involving ivermectin. As Maudrux and his colleagues discovered, ANSM’s further elaborations only confused matters more:  

 “Indeed, the relevance of developing the aforementioned RTU has been the subject of a purely internal assessment, carried out by the competent services of the agency. In this regard, it may be recalled that while article R. 5322-14 of the Public Health Code allows the director general of the agency to set up expert advisory bodies, the establishment and then referral of the latter is not, however, an obligation and remains purely discretionary. … Finally, the provisions of the Public Health Code specific to the development of RTUs also do not provide for mandatory consultation of such bodies.” 

France’s top drug regulator is essentially declaring, ‘We do whatever the hell we want to do” in regard to this generic troublemaker know as ivermectin! But Maudrux and the other French doctors won’t have any of it. They asked who made the decision? Were there any credentialed physicians involved? Did they bother to review data, and, if so, which data? Why didn’t they bother to take one note? What’s the basis for the secret decision-making process?   

Does Pandemic Activity Demonstrate the Need for Reform? 

The French author suggests that observations made here in France about secret ivermectin nixing ceremonies aren’t necessarily unique to this great European nation. In fact, when it comes to ivermectin it seems nearly universal. Maudrux declared: 

“It seems that ivermectin is entitled to special treatment, not only in France. The behavior is the same everywhere: unable to oppose medical evidence (the presumption of effectiveness), the ANSM, WHO, EMA, NIH openly cheat, unscrupulously, with the blessing of so-called democratic governments.” 

TrialSite reviewed the somewhat bizarre behavior of the U.S. Food and Drug Administration (FDA), the Gold Standard medicines regulatory body, which issued a cautionary letter about the approved drug, warning the public that they could get hurt if they take too much of it or if they use the animal variety. Yet, as TrialSite pointed out, the regulator shared absolutely no data and no material facts as to why they even bothered to publish such a cautionary communication. The Front Line COVID-19 Critical Care Alliance (FLCCC), a group of U.S.-based physicians in favor of ivermectin use targeting COVID-19, suggest that this was actually part of a broader disinformation campaign, serving to support commercial industry interests—that is, billions in revenues and profits and market power.  

Dr. Maudrux agrees, going so far as to even suggest an anti-ivermectin conspiracy may be at work, from unrealistically narrow reviews of existing ivermectin studies to wide-scale censorship of anything with the word “ivermectin.” For example, the notorious YouTube policy has dinged TrialSite’s podcast series for daring to publish objective, unbiased newscasts, interviews and documentaries about the topic. The doctor reminds all about the YouTube policy declaring that it is “forbidden to contradict information from local health authorities or WHO”, and “It is forbidden to recommend the use of ivermectin, to say that it is an effective treatment.”  

While the ANSM took about three (3) months to review what is a three decades-old product with what is comparatively considered a well-known and stable safety record in combination with a handful of studies, the regulatory reviewers were able to accelerate Market Authorization in record time for remdesivir. On that topic, Dr. Maudrux suggests it might be an interesting project to request and review the process for remdesivir authorization within ANSM. 

Clearly, when the regulatory agencies tasked with enforcing the laws on behalf of the people aren’t in fact following those laws then something is terribly off, and a root cause analysis of the predicament must be considered. That’s when the elected officials, via pressure from their constituents, must start investigations into what is actually needed in the situation, and what should be reformed.

Call to Action: Follow the link to read the entire translated article.