I have posted other articles covering the controversial treatment of Covid-19 with hydroxychloroquine and azithromycin. These were translations of articles written by people in France who have a favorable disposition toward the treatment and want to see fair and impartial studies of it carried out.
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The perception of the treatment in France is entirely different than it is in the United States because in France there is no despised political leader taking the treatment and speaking hopefully about it. In contrast, in France the president is not speaking favorably about the treatment, and the government has not endorsed it, but there is a leading virologist, Dr. Didier Raoult, who, with a hippy haircut and anti-establishment credentials, claims that hydroxychloroquine is a safe, effective and inexpensive treatment. He has developed an effective and safe treatment protocol that he says can reduce the case fatality rate, reduce viral load and shorten the period of infection. Concerns about the risk of heart failure caused by the drug can be offset by daily EKG monitoring (very inexpensive) and screening of patients whose heart problems disqualify them for treatment.
Several small observational studies have been conducted. The proponents of the treatment make no claim that it can save patients who have reached the critical late stages of infection. They claim instead that if the treatment is given to at-risk patients in the early stages, the treatment can reduce the possibility that such patients will spread the disease to others, die or suffer the permanent damage that comes from a long battle with the infection. The problem with these observational studies is that the chances for natural recovery from Covid-19 are quite high, so when patients recover on the hydroxychloroquine + azithromycin treatment, even if they had co-morbidities that made them high-risk patients, it is difficult to prove that they recovered because of the treatment. Nonetheless, samples taken from the patients on the treatment show a positive effect on the viral load.
There is enough ambiguity in these results for detractors to pounce upon the proponents of Dr. Raoult’s treatment protocol, and pounce they did, especially in the United States where all the Trump haters just piled on with outrageous claims that Dr. Raoult must be some kind of hippy charlatan—ignoring that he is a professor of virology at a major university hospital in Marseille. The latest excuse for this outrage came with the publication of a Lancet article that claims to conclude once and for all that the treatment doesn’t work and is even dangerous because of cardiac side-effects.
What is remarkable is that so many lay people are willing to cheerlead for the medical establishment, and for journals like the Lancet, at a time when they should be outraged at the levels of corruption in medical science. The article below by Swiss journalist Jean-Dominque Michel goes into the details of what is wrong with the recent Lancet article on hydroxychloroquine and what is wrong with the major medical journals themselves. Before Monsieur Michel’s article, I post a brief extract from an interview with Dr. Raoult himself in which he reacts to the Lancet publication.
“Coronavirus: Dr. Raoult—If you don’t provoke a controversy, you’re doing something wrong.” Franceinfo, May 27, 2020.
Interviewer: After two months of confinement policy, was it the best way to stop the epidemic?
Dr. Raoult: I don’t know, but it probably prevented panic and fear among the population. I’m loathe to see a panic occur because fear is dangerous, particularly collective fear.
“We have no more patients. We are seeing the final moments of the epidemic.” That is why the government’s withdrawal of permission to prescribe hydrochloroquine “doesn’t worry” Professor Didier Raoult.
[In the Lancet paper] we don’t know where the patients came from. No hospital is named, nor are the doctors who saw the patients. How is it that in their study there is 8% mortality and 0% in another study [ours at IHU in Marseille]? They published something that cannot be taken seriously. We didn’t hide dead bodies in the parking garage.
In Marseille, 3,300 persons followed Dr. Raoult’s protocol. Among them, eighteen died after three days of treatment [0.5% case fatality rate]. None of them died of the causes attributed to hydroxychloroquine in the Lancet study.
UPDATE, June 4, 2020: Shortly after this article was posted, The Lancet withdrew the article in question. The problems outlined here were recognized by the authors who came under a barrage of criticism, then they asked to have their names withdrawn from the publication.
lancet: a surgical knife with a short, wide, sharp-pointed, two-edged blade
A translation of:
Anthropo-logic, The Blogs of Tribune de Genève, May 24, 2020
by Jean-Dominique Michel
Translated by Dennis Riches
Medical journals are drowning in their own contradictions: on the one hand, they have been contrite for several years about the poor quality of the research they publish (often to the point of it being false) and they have acknowledged the role they themselves play in this worrisome state of affairs. On the other hand, they re-offend at the first opportunity, in such a crude way that they disgrace themselves shamelessly, like The Lancet with its latest article [on treatment of Covid-19 with hydroxychloroquine]. “Politics make strange bedfellows,” say the English with their irrepressible sense of observation and their devastating sense of humor.
As far as the debate over hydroxychloroquine treatment is concerned, frankly, I think we are all a little tired of the matter. We are currently in a situation where all reasonable certainty is out of reach: studies and counter-studies follow one another, each “camp” reacting to those who serve its cause like supporters of a soccer club—cheering for every goal scored by their team and incriminating the referee with each goal conceded. All of this no longer looks much like science.
Each side accuses the other of bias or even cheating. Our good Swiss press (always subservient to the dominant interests) speaks only of studies that concluded the remedy is ineffective…
All this demonstrates, if the point still needs to be made, that we have lost the ability to intelligently sustain a controversy: as Professor Arnaud Stimec (Political Science, specialist in conflict management and mediation) asserts with great finesse, disagreements and divergent points of view are natural, inevitable… and potentially fruitful if we know how to make them such.
I said in early April this would be the case, and we are now unfortunately floundering in the swamp of medical “scientific research,” which allows us to confuse endlessly and sterilely a worthwhile research question. For more than two and a half months, no indisputable clinical trial [of hydrochloroquine + azithromycin], done with integrity and impartiality, has been produced, so this suggests something of the religiosity that prevailed in the debate, and it points to the obvious lack of real will from medical and scientific authorities to establish evidence.
A Lancet study published the day before yesterday and echoed by all the press might suggest that the debate is over. The result seems unimpeachable: no benefit from the prescription of hydroxychloroquine, associated or not with azithromycin; and even higher mortality than the control group. Opponents of this drug leapt with joy in a triumphant clamor. “End of this deception!” they rejoice.
Readers of this blog will remember what I said very early on. I repeated it yesterday: if it were to be shown that hydroxychloroquine does not have a therapeutic advantage, I would not be at all devastated, but the balance of possible benefits and risks was sufficiently convincing to justify its defense, pending further study.
The a priori ban on doctors consulting with their patients on the best available treatment is an unprecedented act of health dictatorship. Invoking uncertainty about hydroxychloroquine prescription for Covid is an important issue, no doubt, but daring to forbid it legitimizes an unprecedented and truly indefensible violation of doctors’ right to prescribe.
That said, is the study published in The Lancet definitive? Far from it. It even raises serious methodological and ethical questions. For those who missed one or two episodes [of this blog] (“Educational Quizz” available), the observation has been made for fifteen years that there is a huge validity problem in the research published by medical publications.
Among other difficulties, there are biases (intentional or not) in many studies, but also there is the problem of the instrumentalization of research by the pharmaceutical industry and/or financiers.
The New England Journal of Medicine paved the way with two studies on hydroxychloroquine that were examples of bad faith… and very bad science! Previously, two former editors-in-chief of this prestigious magazine had expressed their disillusionment in recent years in unequivocal terms:
It is simply no longer possible to believe much of the clinical research that is published, nor to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I have reached slowly and reluctantly during my two decades of work as editor-in-chief.
The medical profession is bought by the pharmaceutical industry, not only in terms of medical practice, but also in terms of teaching and research. Academic institutions in this country allow themselves to be paid agents of the pharmaceutical industry. I think that is shameful.
Now, suddenly, the NEJM has released two perfectly misleading studies to denigrate hydroxychloroquine [as a treatment for Covid-19]. In the first, a retrospective study of medical records, the NEJM compared a group of terminally ill patients who were treated only with hydroxychloroquine vs. a group of oxygenated patients in emergency departments to conclude that mortality was higher in the first group!
Let us remember in passing (since this also concerns the Lancet article) that the research center IHU Mediterranean-Infection [proponent of hydroxychloroquine treatment] has always indicated that the treatment it advocates is useful in the early stages of the disease (when it is crucial to reduce viral load) but not in critical phases during which the viral infection is no longer the determining factor [because it has done all its damage—any treatment would be aimed at making the damaged organs function].
The second compared two groups, one to whom the hydroxychloroquine was prescribed and the other not, with similar outcomes in both groups… except that the hydroxychloroquine group included patients in a more serious prior condition than the second. The study focused on the equal outcomes, but any mind with two grains of logic (or rather intellectual honesty) would see that the focus should be on noting any improvement and not on the equal outcomes!
I stressed as early as early April that we would not have clear results for months. The reason is strategic: the risk is too high [for those who would be threatened by favorable results from chloroquine + azithromycin treatment ].
For governments (and the French government in particular), the effectiveness of the treatment done in Marseille [by Dr. Didier Raoult’s team] would open the door to mass prosecution for non-assistance to anyone in danger, and even charges of manslaughter or negligence. Again, nothing in the legal order and medical ethics laws can justify the deprivation of the general practitioners’ right to prescribe. If thousands of deaths have resulted, the ministers and health directors involved could be charged with felonies. The number of lawsuits looming on the horizon is impressive, and we understand that it has become a struggle for life by any means for those (ir)responsible. Truth no longer comes into play when this priority exists.
For the pharmaceutical industry, the effectiveness of hydroxychloroquine would put a definitive end to all juicy prospects for gain, whether it is through an innovative drug (Remdesivir was a fiasco) or a vaccine imposed on the world population: 8 billion doses at $X—a nice return on investment.
And yes, the list of conflicts of interest of the authors of this “study” is edifying, as one Internet user tells me:
The study was funded by (see page 9): “Abbott, Medtronic, Janssen, Mesoblast, Portola, Bayer, Baim Institute for Clinical Research, Nupulse CV, FineHeart, Leviticus, Roivant and Triple Gene”, i.e. private companies with an interest in discrediting a treatment that, being virtually free and composed of compounds that have fallen into the public domain, harms their business prospects.
Contributing to the funding of the Harvard Medical School (home of the author of the study): The Bill and Melinda Gates Foundation, Mark Zuckerberg, Lakshmi N. Mittal, the Rockefeller Foundation etc., involved in vaccination projects against Covid-19. All of this information is available in the study itself, on The Harvard Business School sites or on the sites of the foundations mentioned above.
As recently as November 2019, The Lancet (as Dr. Jekyll this time, not Mr. Hyde) published Dr. Patricia Garcia’s op-ed entitled “Corruption in Global Health: the Open Secret” in which the author noted:
Corruption is an integral part of health systems. Throughout my life as a researcher, public health specialist and minister of health, I have seen that dishonesty and fraud are entrenched everywhere. But while it is one of the main obstacles to universal medical coverage around the world, corruption is rarely openly mentioned.
Here’s some context.
Bad Bad Science
With regard to the Lancet study, let us first note that it is an observational study of nearly 100,000 patients. Opponents of Professor Raoult have consistently challenged his position favouring precisely such observational studies rather than randomized double-blind clinical trials (RCTs), which scientists consider to be the best method and even the only one that should prevail.
Having taken the trouble to verify what was happening, I shared that the research fully validates Raoult’s position: not only does the emergency situation of an epidemic make randomized clinical trials ethically problematic, but the superiority of the latter over observational studies is not conclusive. Other studies show that when RCTs are funded by the pharmaceutical industry, the validity of their results suffers!
I am therefore delighted to see the supporters of the Lancet study suddenly converted to the methodology that they abhorred quite recently (observational studies) as soon as it arrives at the results they wanted.
However, it is in reading the research methodology that things take a turn for the worse. Here is the critique by the group “Covid: Allow Doctors to Prescribe”:
This is a study of 96,032 medical records from 671 hospitals on 6 continents. Patients hospitalized between 20/12/19 and 14/04/20 – Publication on 21/05/20 – 4 authors signing. Bravo! A record in efficient data collection, translation into different foreign languages—including Asian languages—statistical analysis, the article written, reviewed, and published within a month! At the very least, it’s a publication worth 50 million euros. Who funded it? We pass on the lists of the links to the pharmaceutical industry declared by the authors.
More of their notes:
Patients hospitalized in serious states of illness.
Patients followed in countries that do not have the same therapeutic practices.
Blurred inclusion criteria e.g. antiviral co-prescriptions in 40% of cases, with no information on their distribution in the groups analyzed.
Inaccuracies in treatment analyses: we are talking about macrolides [a class of antibiotics]. It is impossible to know who received azithromycin [one type of macrolide].
Patients with co-morbidities make for a poor representative sample group (e.g. 1 in 3 patients with hypertension in the hydroxychloroquine-macrolide group).
Non-comparable groups: ex. group given HCQ-macrolide more severe with 20% mechanical ventilation versus 7.7% of patients in the so-called “control” group, ditto on parameter sao2 ˂ 94. Meanwhile they write, “No significant-group differences were found among baseline characteristics or comorbidities.”
The footnote in Table 2 is surprising: “Age and BMI are continuous variables. The 95% cis have not been adjusted for multiple testing and should not be used to infer definitive effects.”
Unspecified doses and treatment durations.
Results expressed as averages. We would also have liked to know medians and ranges.
No information on “missing values.” We find phrases such as “multiple imputation for missing values was not possible,” and “it was assumed that the characteristic was not present.” Yet it is clear that missing values must be counted in a multi-center, multi-country analysis with varied care.
No group analysis based on associated treatments or cardio risks.
No chest scans for heart damage by the virus—common for a correct analysis of what is called adverse events.
No measurement of QT intervals or a data on torsades de pointe!!! [a French term also used by English-speaking cardiologists]
A prescription given early (less than 48 hours after hospitalization) that obscures the date of the first symptoms and gives the impression of being a timely prescription!
And the list goes on, then concludes:
Was the Review Committee asleep??? Enough of such misinformation! Does the WHO have an interest in making it look like hydroxychloroquine is ineffective and dangerous when properly prescribed? LET THE DOCTORS PRESCRIBE!
What is certain is that the Lancet study is very, very bad science. Here we have the most prestigious medical journal which has admitted the ethical difficulties associated with the low quality of most publications and identified the major problem of conflicts of interest, yet it dares to publish such a paper. It is actually quite breathtaking.
The Lancet provides us here with an emblematic example of scientific dishonesty, and there are so many examples systemically rotting the field.
Newspapers and the audiovisual press (who simply cannot read science, as my excellent colleague Laurent Mucchielli has written) were at full throttle, spreading the poison of disinformation and propaganda. The headlines are: “Hydroxychloroquine is not effective and even increases the risk of mortality!” which is a blatant untruth. What the study shows is that giving hydroxychloroquine to patients in critical or terminal phases has no proven therapeutic effect, which Professor Raoult has been saying for ten weeks!
It’s a bit like giving aspirin to dying people to conclude after their death that aspirin doesn’t relieve migraines! The dominant interests who have financed (to the tune of tens of millions of dollars) such an inept study are reduced to this level of filthy dishonesty.
I have shown how the Discovery study was villainous precisely because of this manipulation of prescribing in the critical phase of the disease, where the treatment is no longer indicated. They did not even find enough patients foolish enough to accept the risk of being prescribed a placebo rather than the cure!
Then they denounced the first “study” published in the NEJM. Propagandists have no scruples: they propagate a lie as many times as they can until the crowd eventually accepts the idea without balking.
This raises two questions: first of all that of the general press, in Switzerland as much and even more than elsewhere, which obviously rolls for harmful interests by preventing any intelligent, detailed and nuanced debate.
For journalists, it seems too complicated to understand that testing an early-stage treatment of the disease on hospitalized patients in advanced severe condition simply provides no answer to the question of the effectiveness of the treatment.
No, there is currently no definitive evidence that hydroxychloroquine, prescribed as advocated by the center Mediterranean-Infection IHU, is effective against Covid. But there are promising signs that it is effective.
The reverse evidence, falsely asserted by the major medical journals, does not exist to any advantage—and the scandalous study of the Lancet does not change that.
An interesting question for the future: bad practices like those of The Lancet worked without too much difficulty as long as it was done in the darkness of a reserved and therefore confidential domain. In this case, the eyes of the world are on the journals and I wonder how they will be held to account for such acts. By publishing this paper unworthy of a peer-reviewed magazine, The Lancet risks having its reputation damaged.
There was a surreal scene on the “information channel” BFM, where a doctor of the group Let Doctors Prescribe was cut off while she was dangerously close to conveying her point!
As for Dr. Philippe Douste-Blazy, former Minister of Health, he dared to mention on the same channel not only the glaring weaknesses of the Lancet study, but also the “criminal logic” and the omerta that presides over medical research subservient to pharmaceutical interests! That’s not to say that the cat is out of the bag—not on the Swiss media of course that is too busy looking elsewhere.
The question that just about everyone seems to be in a hurry to put under the carpet, beyond these worrying events, is indeed that of the subordination of health policies (and information) to private interests. For those who are still deluded that all is well, perhaps this soundbite mentioned above from a former Federal Health Adviser will be useful in raising some doubts?!
There are a number of questions that will eventually have to be asked:
- Is it acceptable in our banana democracies (in the words of Professor Murat Kunt) to have corporations arm-twisting elected leaders to get their way? The quality of our future—and our health—depends on our ability to dare to ask this question. Here and now.
- And are we not entitled to demand that the press finally resolve to play its role as a counter to power through works of investigation, in accordance with its vocation and ethics and what we pay for?
- As a sector in serious difficulty (I was one of the first to go down), the mass media has shot itself in the foot with a Kalashnikov through its constant subservience to power. It has become no more than a conveyor of propaganda. Can we say to the RTS [Radio Télévision Suisse] that as we are forced to finance it month after month with a fee—that I was the first to defend—we are entitled to expect from it pluralistic, substantiated, quality information, and not press releases from Big Pharma and other dominant interests, stripped of the slightest critical analysis?!