The ivermectin situation continues in controversy as a new French civic group known as the BonSens Association makes allegations of scientific misconduct associated with the ivermectin meta-analysis authored by Dr. Andrew Hill and a group of researchers affiliated with the University of Liverpool and Unitaid. TrialSite has gained insight on this imbroglio from a series of conversations with relevant and associated parties, some that wish to remain anonymous that have shared that in fact this study was modified separate and apart from the investigator. According to some ivermectin proponents, at stake here is more than just issues of scientific integrity but importantly, the health of hundreds of millions of people and the operation of free markets, which depend on the rule of law, scientific transparency, and rational actions by government health authorities and regulatory bodies. On the other hand, the overwhelming consensus among research institutes, regulatory entities and academic medical centers not to mention international health bodies such as the World Health Organization (WHO) declare emphatically the need for large randomized controlled trials. Dr. Hill, a well-respected researcher and advocate for economical treatments for COVID-19, is resolute and stands behind the study.
This allegation first picked up in interviews and then in a French media centers on the meta-analysis authored by Dr. Andrew Hill and titled “Preliminary meta-analysis of randomized trials of ivermectin to treat SARS-CoV-2 infection.” The BonSens Association claims that this particular study was actually interfered with by either Unitaid (one of the study’s sponsors) or other to-be-named individuals and modified so as to dampen or lessen the highly respected researcher’s initial positive recommendation associated with ivermectin in the thoroughly pooled and analyzed clinical trial paper.
Of course, if the modification separate and apart from the principal investigator(s) was in fact accomplished by the study team directly as part of the study design, that is, those changes were anticipated and part of the study’s review cycle, then that certainly isn’t indicative of meddling.
The question raised by the BonSens allegation: Did a third party not named as an investigator take Dr. Hill’s meta-analysis and materially modify it to, in effect, mitigate or lessen any perceived pro-ivermectin attributes of the reported outcomes?
TrialSite offers a brief breakdown of the parties and players involved, while the World Health Organization (WHO) has already done what ivermectin proponents had feared—made a recommendation to only use the generic drug for clinical research during the pandemic. A key assertion in this charged situation is that the alleged altered meta-analysis study results influenced the WHO decision.
TrialSite was able to catch up with one of the BonSens founders Xavier Azalbert for a brief interview. Considered a controversial group by some in Europe, TrialSite wanted to learn more about what was going on with the allegations associated with the ivermectin-focused meta-analysis study. What follows are excerpts from that transaction. Additionally, TrialSite elicited a response from Dr. Hill directly who stands steadfast behind the work.
What is Mr. Azalbert’s professional background?
Mr. Azalbert’s background includes many years of professional experience in management consulting, finance and business; he noted that he also runs a popular news site called FranceSoir currently reporting at least five million visitors per month.
What is BonSens Association?
BonSens (“Common Sense”) is a civil liberties group that takes issue with many of the actions of governments in France and elsewhere in Europe associated with the pandemic.
The idea for BonSens comes out of this notion during the pandemic that a diverse group of common sense, civic-minded citizens, from scientists and business people and entrepreneurs to lawyers and many other pragmatic and common sense-minded citizens needed a sincere forum to come together and address real health and environmental challenges facing the world. The group took on some of the more challenging dilemmas during the pandemic, such as where and when it’s scientifically rational for forcing the children in French society to wear a mask.
With 30,000 members and growing, it turns out a lot of people in France, and beyond, seek to take on the health of the individual, society and the planet; organizations such as BonSens Association seek the scientific truth, and that sharing the correct information about health and welfare of the broader public is in fact of grave concern, widely apparent with rampant censorship, distortion of scientific data and seemingly ubiquitous conflict of interest.
We have heard there is some controversy with this group—like it doesn’t support mask wearing—is that true?
No not at all. BonSens is not against masks as a means for personal protection against the virus. We simply ask intelligent questions about the risk and benefit analyses associated with mass government actions. For example, widespread mask mandates, nationwide, even for small children, without scientific backing, is a measure that could be interpreted as a reduction of liberty with considerable impacts on children and others.
So BonSens sought a true risk-benefit analysis to demonstrate the science behind such broad and sweeping measures. But now we see a tendency for draconian responses and broad sweeping allegations that are not even based on fact.
Another area that could possibly be considered controversial is the organization’s referral to hydroxychloroquine as a potential therapy. Many consider this topic done. What’s the stance?
It goes back to the balance of the risks and benefits: when one reviews a majority of the studies involving hydroxychloroquine and COVID-19 when administered early on in disease onset, there is a positive trend toward efficacy data points.
The BonSens organization has considerable concerns about some of the hydroxychloroquine studies, such as what occurred in RECOVERY and others. Some of our members have had some of these critiques published. For example, the proper use of the drug was early onset COVID-19 but yet in the RECOVERY trial it was used in very high dosages in severely ill patients, which was never recommended.
TrialSite sought to remind readers that in the spirit of an objective and unbiased discussion, dozens of countries are still recommending hydroxychloroquine and, in fact, this drug remains the standard of care in many African nations and is a central drug in the large ANTICOV study led by the organization known as Drugs for Neglected Diseases Initiative (DNDI). DNDI is funded by among others the European Union, the U.S. National Institutes of Allergy and Infectious Diseases (NIAID) and many other prominent groups. Hence indirectly many nations that have taken anti-hydroxychloroquine stances continue to contribute to studies using this very drug, at least in Africa. So, in effect, the European Union and NIAID supports an organization sponsoring one of the biggest COVID-19 trials in Africa based on the use of hydroxychloroquine.
Also there are a number of metanalysis reviews indicating the drug may have positive impact if used at the early stages.
Mr. Azalbert reminded the TrialSite that back in December the Italian Consiglio di Stato, the highest administrative court, suspended the hydroxychloroquine ban previously imposed by the drug regulator known as Agenzia Italiana del Farmaco (AIFA) that allowed use of the drug for COVID only during research.
The Ivermectin Meta-Analysis Allegation
In addition to Mr. Azalbert’s media, France Soir, TrialSite learned from others not only about the alleged modifications made to this important paper but also that the group had already sent a demand letter alleging scientific misconduct to the University of Liverpool. TrialSite has interviewed parties with first and second hand information that claim that this modification did in fact occur and that Dr. Hill didn’t have any authority to do anything about it.
What is BonSens Objective with the allegations as to the ivermectin meta-analysis?
Mr. Azalbert shared with TrialSite that they have sent the letter demanding that Professor Hill retract the study and address their allegations of scientific misconduct. He also noted that they have sent a copy to INSEM, the National Institute of Health and Medical Research. Azalbert told TrialSite that they wanted to give Dr. Hill an opportunity to respond to the claims in a public forum. Thus far no response. The ultimate goal here is to call attention to bias and undue influence in the health research system.
Given BonSens is not a legal or administrative authority, what if there is no response—there is no authority to compel anything else—is this not the case?
Yes. Of course BonSens is a civic group with a lot of very smart members that care about the truth. We wanted to give the parties the opportunity to engage and respond and if they don’t do well, we have a record should any future investigations at the university level or beyond actually occur.
Dr. Hill’s POV
TrialSite reached out directly to Dr. Andrew Hill for his perspective. A highly respected researcher who in many ways has led the way in identifying ivermectin as a potential treatment for COVID-19 was unwavering in his support of the study.
Dr. Hill informed TrialSite, “I am happy with the final version of this meta-analysis as posted on Research Square.” Reiterating the dominant consensus of major research-based institutions and regulators, Dr. Hill emphasized, “Large randomized trials will be required to validate the clinical efficacy of ivermectin.” Dr. Hill reminded all that, “This is also the opinion of the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and the World Health Organization (WHO).”
Call to Action: TrialSite will continue to monitor this situation.