Tide is turning for the media-savvy French professor Didier Raoult and his chloroquine, even US President Donald Trump is suddenly barely even mentioning the miracle drug for COVID-19. Maybe this is because the only clinical data supporting the malaria drug chloroquine cure against coronavirus comes from Raoult himself. And only after Raoult denounced controls and other basics of clinical research as unethical. Outside of Raoult’s alternative reality, clinical data from France, Sweden, Brazil and USA already now shows that chloroquine not only does not work against COVID-19, it seems to even kill. Predictably so, since the drug’s side effects are well known.
This is why chloroquine proponents changed their stance and now scream that it is wrong to treat very sick COVID-19 patients with chloroquine. Instead, they insist that the drug must be given very early during infection or even prophylactically, i.e., to healthy and asymptomatic people only. Given the evidence that the coronavirus is apparently lethal for less than 1% of the infected, you can see where this is going. The safest way to successfully heal with witchdoctor magic is to treat those who are not really ill and recover anyway.
But now Raoult seems to have gone completely off the rails. He namely attacked the data integrity expert Elisabeth Bik, on Twitter and in full Trump manner:
Heal the healthy, avoid the sick
The microbiologist Raoult is director of the Institut hospitalo-universitaire en maladies infectieuses de Marseille (IHU Méditerranée Infection) and its URMITE department, which was previously funded by the French research networks CNRS and INSERM. Both withdrew in 2018, after Raoult proved a despotic tyrant who allowed sexual harassment, discrimination and bullying to happen in his institute (read more here). There is also a history of data manipulation, for which Raoult himself was made responsible in 2006. Bik found even more irregularities in his papers, which makes sense: a bullying and totalitarian research environment with a personality cult, where compliance and fear rule, can only produce unreliable or falsified research.
Like these copy-pasted disease-spreading ticks, or these copy-pasted fraud-spreading gel bands, newly discovered at IHU:
P Renesto, P Dehoux, E Gouin, L Touqui, P Cossart, D Raoult Identification and Characterization of a Phospholipase D–Superfamily Gene in Rickettsiae J Infect Dis (2003) doi: 10.1086/379080 Also “lanes two and three show concerning similarities.“
- “At enrollment, 92% of the patients had a “low” score in the National Early Warning Score (NEWS), suggesting they were not very sick.
- The average time between onset of the COVID-19 symptoms and being enrolled in the study was 5 days. This suggests that the patients had already been sick for a while.
- Only 15% of the enrolled patients had a fever. Fever is one of the characteristic symptoms of COVID-19, so people with a positive PCR but no fever are probably only mildly ill, or maybe already recovering.
- Of the 12 patients who had a fever, the mean temperature was 38.6C (101.5 degrees F).
- Only half of the enrolled patients had a lower respiratory tract infection.
- 15% of these patients required oxygen.
- Four patients were asymptomatic.“
Obviously it is easy to cure patients who are not really that sick in the first place. But what about the treatment itself? Problem is, that especially the combination of the immunosuppressive hydroxychloroquine and the antibiotic azithromycine, as promoted by Raoult, has very serious side effects which can lead to death. It should be noted that while Raoult’s IHU hospital in Marseille boasts a very low COVID-19 mortality rate of 1.7% (while refusing to treat the very ill) it is still higher than the estimate for the rest of France which is 0.53% according to this study from Institut Pasteur.
Because of Raoult, chloroquine became standard COVID-19 therapy in many countries worldwide. Including in France. Yet an observational study on 11 patients from Paris (Molina et al 2020) reported already on 30 March “no evidence of rapid antiviral clearance or clinical benefit”:
“At the time of treatment initiation, 10/11 had fever and received nasal oxygen therapy. Within 5 days, one patient died, two were transferred to the ICU. In one patient, hydroxychloroquine and azithromycin were discontinued after 4 days because of a prolongation of the QT interval from 405 ms before treatment to 460 and 470 ms under the combination. Mean through blood concentration of hydroxychloroquine was 678 ng/mL (range: 381–891) at days 3–7 after treatment initiation.
Repeated nasopharyngeal swabs in 10 patients (not done in the patient who died) using a qualitative PCR assay (nucleic acid extraction using Nuclisens Easy Mag®, Biomerieux and amplification with RealStar SARS CoV-2®, Altona), were still positive for SARS-CoV2 RNA in 8/10 patients (80%, 95% confidence interval: 49–94) at days 5 to 6 after treatment initiation.“
Sweden, which initially followed Raoult’s teachings and started to treat COVID-19 patients with chloroquine, swiftly aborted the method when patients developed severe side effects. A retrospective study on 84 patients receiving hydroxychloroquine and azithromycine from New York University (Chorin et al medRxiv 2020) also demonstrated how serious those side effects in COVID-19 patients can be:
“We report the change in the QT interval in 84 adult patients with SARS-CoV-2 infection treated with Hydroxychloroquine/Azithromycin combination. QTc prolonged maximally from baseline between days 3 and 4. in 30% of patients QTc increased by greater than 40ms. In 11% of patients QTc increased to >500 ms, representing high risk group for arrhythmia. The development of acute renal failure but not baseline QTc was a strong predictor of extreme QTc prolongation.”
Above the law?
As it happened, Raoult’s most recent (literally) uncontrolled clinical trials were ethically approved by his own submissive IHU. He even treated 14 year old children with chloroquine as part of his 1000 patients trial (Table 1 here, recruitment age was >12 years old), which is actually quite illegal. In his paper Gautret et al TMID 2020 Raoult admitted that his thousands of patients were kept in the dark about the risks, since none of them received a patient information sheet and an informed consent to sign:
“There is no formal consent to sign in our institution by patients“
IHU’s human guinea pigs were unaware of the experimental nature of the therapy, quite the opposite: because Raoult decreed that the hydroxychloroquine+azithromycine method must work, he retrospectively defined it a “standard treatment“. They believed to be undergoing an established, internationally approved therapy for COVID-19. Even more schizophrenically: all studies which Raoult designed in advance, with the explicit purpose to prove his therapy, were declared “retrospective” to deny the need for an ethics approval. This horrendous ethics breach passed peer review at Elsevier with flying colours. In 1 day.
On 20 April 2020, news came of Raoult being in serious legal trouble with the French authorities because of his human experiments with chloroquine:
“The National Agency for the Safety of Medicines and Health Products (ANSM), which did not authorize the second study on hydroxychloroquine (Plaquenil *, Sanofi) conducted at the institute hospital-university (IHU) in Marseille by Pr Didier Raoult, awaits that the investigators bring objective elements to demonstrate its observational nature, indicated Dominique Martin in an interview with APMnews.”
That was sure something unexpected for Raoult, after the President of France, Emmanuel Macron, has visited his lab just days before and described Raoult as “great scientist”. On 24 April IHU retorted that the study never needed any ethics approval or patient consent, because it was “retrospective”, a hair-raising argument their Italian colleagues routinely used to cover up intentional patient abuse. And anyway, Raoult and his colleagues “deemed it ethically unacceptable to conduct a therapeutic trial“.
Meanwhile, in USA, an NIH Expert Panel, convened by the National Institute of Allergy and Infectious Diseases (directed by US epidemics expert Anthony Fauci), recommended in its COVID-19 guidelines on 21 April 2020:
“Except in the context of a clinical trial, the COVID-19 Treatment Guidelines Panel (the Panel) recommends against the use of the following drugs for the treatment of COVID-19:
– The combination of hydroxychloroquine plus azithromycin (AIII) because of the potential for toxicities.”
Chloroquine is about to become a major embarrassment for everyone. And Raoult is the central figure in this international Il pleut de la merde.
No wonder that the grand old man, unused to being contradicted or ridiculed, is losing it. The object of Raoult’s public wrath is now Bik whom he describes as “witchhunter”, as well as this study from Veterans Affair hospitals in USA:
Joseph Magagnoli, Siddharth Narendran, Felipe Pereira, Tammy Cummings, James W Hardin, S Scott Sutton, Jayakrishna Ambati Outcomes of hydroxychloroquine usage in United States veterans hospitalized with Covid-19 doi: 10.1101/2020.04.16.20065920
The retrospective controlled clinical study found out that hydroxychloroquine-treated patients had a high risk of death and concluded:
“In this study, we found no evidence that use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with Covid-19. An association of increased overall mortality was identified in patients treated with hydroxychloroquine alone.”
The study made all the big news, maybe because it was the first one from the US. Raoult (or maybe his personal assistant in charge of social media) tweeted his views:
“The witchhunter @MicrobiomDigest is not attentive to details when she judges that a study is useful to her paranoiac fights!
Control group was treated with azithromycin.
Nearly dying patients with lymphopenia were treated with hydroxychloroquine.
Fraudulent study. Fake news“
When you spend so much time admiring Trump, you start sounding like your idol. After dealing with Bik, Raoult tweeted his criticism about a study by his French colleagues in Paris and their study Mahevas et al medRxiv 2020.
Unlike his own clinical trials, Mahevas et al was really an observational study of 181 French COVID-19 patients treated after Raoult’s method, but with a control group. The paper, published on 14 April, concludes against the use of hydroxychloroquine on COVID-19 hypoxic pneumonia patients and mentions:
“Eight patients receiving HCQ (9.5%) experienced electrocardiogram modifications requiring HCQ discontinuation.“
On 24 April Raoult and his IHU issued another press release or a white paper, where they openly accused their Paris colleagues Mahevas et al of “scientific fraud“, already in the headline. Raoult’s J’accuse partners are IHU group leader Philippe Broiqui and clinic head Matthieu Million. If you naively think such institutional fraud accusations happen in the scientific community at least occasionally: not really. IHU seems to have evolved under Raoult’s leadership into a lunatic asylum for the criminally insane.
Prior to that outpour, Raoult endorsed a bizarre telemedicine (sic!) study by a Brazilian insurance (sic!), which was never published anywhere, not even as preprint. It is only available as document on the file sharing platform Dropbox (sic!):
Bik blogged about that Brazilian “study”, where 636 patients, distance-assessed by telemedicine only, themselves decided which drug to take after they self-diagnosed themselves with COVID-19 (sic!). Afterwards, the study’s authors somehow pulled up the numbers of who died and who went to intensive care, and fabricated p-values which did not fit. Bik then provided an update on 20 April:
“It was announced today that the study described below has been suspended because of ethical violations. As pointed out by Natalia Pasternak and Carlos Orsi and Ricardo Parolin Schnekenberg […], the study had already started before the ethical approval had been obtained. This could be figured out by looking at the disclosed study days in the preprint and the trial registration at the Clinical Trials website.“
But for Raoult, that was a proper scientific clinical trial. Not the one done by his US peers in the Veterans Affairs hospitals, that was a “fraudulent” and “fake news”. What about this other Brazilian study, Silva Borba et al medRxiv 2020, published on 16 April?
“The high dose CQ arm presented more QTc>500ms (25%), and a trend toward higher lethality (17%) than the lower dosage. Fatality rate was 13.5% (95%CI=6.9-23.0%), overlapping with the CI of historical data from similar patients not using CQ (95%CI=14.5-19.2%). In 14 patients with paired samples, respiratory secretion at day 4 was negative in only one patient.”
In this double-blinded phase IIb clinical trial, all patients were treated just as Raoult says, with hydroxychloroquine+azithromycine only, without those evil controls Raoult hates? Chloroquine was applied in two different doses, and the doctors had to halt the high dose arm because the patients were dying from heart failure. Raoult doesn’t talk about that study.
Instead, he lets his loyal bootlickers attack his critics. On 14 April 2020, Raoult’s IHU Marseille openly and publicly threatened a clinician Damien Barraud, who has been very critical of their chloroquine “studies” on Twitter and in newspaper interviews. IHU tweeted a demand for Baraud to be stripped of his medical licence and be sacked by his hospital employer in Metz, and announced lawsuits for libel:
As I reported before, the International Society for Microbial Chemotherapy (ISAC), with which Raoult published his initial chloroquine study Gautret et al IJAA 2020, distanced themselves from it, in a public statement from 4 April 2020. ISAC (and then the publisher Elsevier) insist however that the peer review process “did adhere to the industry’s peer review rules.” Which is strange, since it seems the paper was reviewed and sent back for minor revision on the same day it was submitted. The next day, the authors returned a revised version which was immediately accepted.
Raoult’s follow up clinical trial with 80 patients treated with chloroquine and azithromycine and without any control arm (criticised by Bik above) was published in a different Elsevier journal, and accepted the next day after submission. The first author of the new Gautret et al TMID 2020, Philippe Gautret, is incidentally associate editor of that of that journal.
Regardless of the obviously repeatedly rigged peer review process, that wretched first Gautret et al IJAA 2020 paper serves as the ONLY clinical study on which the pharma giant Novartis bases its newly announced phase 3 clinical trial in USA, on 440 patients. Do check the references here.
Not just this. Somehow Raoult’s Marseille buddy Jean-Paul Moatti managed to smuggle an opinion piece into The Lancet promoting chloroquine. The author declared no conflict of interest, despite being the husband of Raoult’s co-director at IHU, Yolande Obadia.
Now Raoult, the 1-hour-peer review man, suddenly has enough of the traditional publishing he constantly games. He tweeted his YouTube video, saying that he prefers to have his studies assessed by “confined people” at his institute than by some external reviewers he cannot control:
In that same video, Raoult is saying things which make less and less sense:
“Maybe I was capable of responding to this situation because I’m part African and part of my ancestry leave me with the idea that we should treat infectious diseases“
The signs that Raoult might be losing his mind are already there. Problem is, having cemented his totalitarian power at IHU, having stifled all dissent years ago and having surrounded himself by loyal yes-sayers only, there is nobody to tell Raoult that he is making an utter arse of himself, in public and even on video.
In that recent preprint, where Raoult claimed to have cured with chloroquine over 1000 patients mildly or barely suffering from COVID-19 (including children), he counted 5 levels of evidence that his method works. The highest level of evidence is Raoult’s own Gautret et al IJAA 2020 paper, plus two studies from China which don’t even fit. Who cares, it will sure pass peer review in one of Elsevier journals Raoult controls. It is all very surreal.
The manuscript lists these key words: “SARS-CoV-2; COVID-19; hydroxychloroquine; azithromycin; ethics; Hippocratic oath“. The last two strongly suggest that there is a kind of religious mass psychosis going on at IHU. These keywords are listed because Raoult firmly believes that it is unethical NOT to treat COVID-19 patients with chloroquine, and every doctor who insists on scientific process and evidence, breaches the Hippocratic oath of not doing harm. Nobody at Marseille laughed or told Raoult to check himself in into an asylum. The entire IHU plays his game like a devout doomsday cult on hallucinogenic drugs.
The “great scientist” believes in his delirium to be actually just like a World War I general, commanding thousands of men to get out the trenches and die for the glory of France.
What next? To be updated, proper randomized controlled clinical trials on chloroquine against COVID-19 are ongoing and might soon deliver results. But Raoult is sure a tough guy who won’t go down without a fight.
This article has been updated several times since it was first published.
TCM as chloroquine adjuvant?
There seems to be a clear pattern how Raoult evaluates scientific studies. Those which do not fit his general world view, are all flawed or outright fraudulent. Those which seem to support his chloroquine claims are infallible and perfect.
So now Raoult endorses Traditional Chinese Medicine (TCM) as a chloroquine adjuvant. Really, he does:
The reference is to a new preprint from Tongji Hospital in Wuhan, China, Yu et al medRxiv 2020. It reports a retrospective analysis of a clinical trial with “568 critically ill patients” with mortalities of 18.8% (9/48) in hydroxychloroquine (HCQ) group and 45.8% (238/520) in no-HCQ group. Astounding, right? Only that the Wuhan authors never mention azythromycine, while Raoult so far insisted HCQ does not help critically ill COVID-19 patients at all.
Now, the preprint by the Tongji cardiologist Wang Daowen and colleagues claims all 568 patients received “baseline treatments [..] of antiviral drugs (Lopinavir and Ritonavir, Entecavir hydrate, or Ribavirin)“. 48 of these allegedly received HCQ. The ethics approval references a clinical trial with Daowen as principal investigator, which however used only one drug: Shuanghuanglian. It is a herbal TCM concoction, the trial had 4 arms with 3 different Shuanghuanglian quantity, plus control arm. A total of 400 patients (as opposed to the preprint’s 568), nobody was treated with HCQ or any other drug mentioned in the preprint.
Unless completely made-up fraud, there is only one way to explain it: For controls, Daowen et al lied about baseline treatment because serious scientists outside of China tend to laugh at TCM. Where the extra 158 patients and the HCQ group came from, is anyone’s guess, unless invented they were borrowed from different trials or hospitals. Raoult says this is good science. Maybe he will replace azythromycine with TCM now?
Raoult was possibly made to resign his job, he was cited to go to China already this summer. Incidentally, by leaving France and Europe, he would escape any eventual criminal charges for illegal human experimentation.
The French newspaper Entreprendre cited his letter to Robert Lafont, the CEO of this publishing house. The online article was swiftly deleted, but here is a backup. Newspapers were quick to denounce the report as fake news and a prank, Lafort himself played stupid, but I personally am not so sure (although it is likely Raoult was never offered a job in Peking). This was Raoult’s letter, translated:
“Since you have been one of the rare journalists to have exhibited exemplary behaviour during this period, I would like to take this opportunity to reserve for you the first news: my upcoming departure for China (by the end of the summer). I was indeed recruited as Professor by the Peking University (PUHSC), the most renowned medical school in the country, which happens to be very advanced in the field of virology. It became very complicated to undertake research projects in the health sector in France, the sector being plagued by partisan quarrels, sprawling bureaucracy and political correctness. “
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