Robert HARNEIS -TDO- (FRANCE)- The French government is facing a growing scandal over its banning of the use of hydroxychloroquine and azithromycine (HCQ + A) in the treatment of Covid 19, favored by the leading expert in infections, Professor Didier Raoult of Marseille.

With what has been described as unseemly haste, on May 25, the Minister of Health, Olivier Véran, advised all doctors in France, including specialists in hospitals and doctors conducting trials, to stop using hydroxychloroquine (HCQ) because of the dangerous side effects. On the advice of the government’s medical advisers, he particularly cited an article in The Lancet. HCQ has been the only available treatment for Covid 19 and is cheap but its use has been bitterly opposed in some medical circles, particularly in France and the United States, because of its alleged dangerous side effects. This despite the medicine having been freely available for sale in pharmacies in France, over the counter with no apparent problems, for thirty years until January this year.

The government clearly stated that they were relying on a wide ranging data based study of 97,000 cases from 679 hospitals. ‘The Lancet’ article was written by a cardiologist Dr Mehra and three colleagues in the US. The article claimed that the treatment HCQ + A was associated with a 30% higher rate of mortality from cardiac problems than in the untreated control group. It also claimed that the treatment showed no improvement in the patients.

The United Nations World Health Organization (WHO), the Swiss, Belgian and Italian governments followed the French example with as much precipitation.  The WHO recommended that HCQ be no longer used in treating Covid 19. The anti-HCQ and anti-Raoult lobbies were satisfied that that was the last that would be heard of the tiresome drug and its equally tiresome sponsor Professor Raoult. Despite (or because of?) his brilliant medical career, Raoult is not a popular man in the French conservative medical establishment. HCQ is a very cheap generic drug that stands in the way of more expensive solutions. Medical critics were backed by widespread media support.

The critics had always claimed that HCQ did no good and could do harm and that its use was unsupported by any serious medical trials. Here was a serious medical trial in a ‘prestigious’ journal that confirmed their opinion. Ominously however a number of countries – Spain, Algeria, Senegal, Morocco and others, flatly refused to stop using the treatment on the grounds that they had no evidence that it did any harm under proper medical supervision and that it seemed to help patients.

Within 24 hours the Lancet article was under intensive attack by informed medical critics. It is common for medical experts to disagree but the criticisms of this article were far more serious than a simple technical difference of opinion.

First of all Australian medical experts pointed out that the number of deaths recorded in the trial from five hospitals there, exceeded the total number of deaths for the period for the entire country. Challenged on this point Dr Mehra and his team explained that one of the hospitals had been mistakenly described as Australian when it was in fact Asian! They also pointed out that the statistical material for the study came from a specialist agency Surgisphere. They said that they had corrected the study but that it in no way altered the conclusions. The Lancet for their part passed on this explanation adding that they sought to ‘encourage debate’ on medical topics.

Meanwhile the reliability of the study attracted other widespread international criticism from leading experts from around the world. In an open letter to the Lancet and Dr Mehra and his team, some 120 of them demanded the answer to 10 critical questions. The Lancet replied that they had passed on the enquiries to Dr Mehra who replied that he had in turn passed them onto to Surgisphere.

At the same time Professor Raoult and his colleagues drew attention to the strange fact that the study claimed, for example, that the level of obesity recorded was the same in North America as in Africa and Asia, which they not unreasonably pointed out was extremely unlikely. An Australian statistical expert, went further and wrote that after careful study he had come to the conclusion that the figures in the article were “fabricated”.

Other information regarding the reliability of Surgisphere emerged. Professor Raoult pointed out that the control group was not made up of comparable patients to the treatment groups and that the treatment described and criticized was not what he had recommended. French researchers wanted to know how the study was able to list the French patients by race and religion, when it is against the law in France, to collect such information. Where, it was asked, did the company get the financial resources to conduct a worldwide study given that they had an annual turnover of only $45,000?

The credibility of the study was not enhanced when it emerged that an officer of Surgisphere was a ‘hostess’ of some sort based in Las Vegas.

Under this extreme pressure, on 2 June, the Lancet issued a formal “Expression of Concern”, warning that the article was under query and therefore should not necessarily be relied on. The journal said they were expecting the results of an audit of the data “very shortly”.  Such a disavowal in a leading medical journal is extremely rare, notably because articles are supposedly reviewed by leading specialists in the field before publication. There can be little doubt that the journal will soon be obliged to withdraw the article from publication unless full answers are provided to the many queries.

All this leaves the French government and the responsible Minister, Olivier Véran very exposed. He is under pressure to explain why he forced the withdrawal from the market of a potentially lifesaving treatment. They have changed their position on the use of HCQ now four times in five months. Their sudden banning of the medicine has generated widespread suspicions of favoring the pharmaceutical industry at the expense of the French public in the middle of a major pandemic.  The WHO have increased that isolation by reversing their ban on HCQ on June 3. The French Minister of Health, commented to a French journalist on 29 May, “just because an article is contested does not mean it is in dispute”. He made this comment just before the Lancet itself contested the article. A government spokesman has since explained that the Minister has written to the Lancet asking for ‘a review of the data exactly as it was received”.

The WHO are themselves especially embarrassed at this loss of credibility at a time when US President Trump has chosen them as a target and is threatening to withdraw funding. Why did their experts not detect the obvious defects in the article before stopping trials into the use of HCQ?

The UK based Lancet itself is in a difficult position as the supposed gold standard for medical information. Not only have they published an obviously dubious article very damaging to CHQ but they are also accused of refusing to publish an unquestionably serious study of 90000 rheumatologists showing no cardiac ill effects with its use. The fact that the Lancet has common shareholders with the pharmaceutical company Gilead the maker of Remdesivir, a failed rival drug to HCQ, may be a coincidence but it has not gone uncommented.

Professor Peter Horby, Professor of Emerging Infectious Diseases and Global Health in the Nuffield Department of Medicine, University of Oxford, has commented to journalists “I welcome the statement from the Lancet, which follows a similar statement by the New England Journal of Medicine regarding a study by the same group on cardiovascular drugs and COVID-19.

“The very serious concerns being raised about the validity of the papers by Mehra et al need to be recognized and actioned urgently, and ought to bring about serious reflection on whether the quality of editorial and peer review during the pandemic has been adequate. Scientific publication must above all be rigorous and honest. In an emergency, these values are needed more than ever.”

There is no doubt the Covid 19 pandemic and HCQ have left their mark on all concerned. Meanwhile, despite the extraordinary fuss over its use in France and the United States, it is currently employed in treating patients in the pandemic, without particular problem, in countries representing half the population of the world.

Meanwhile Professor Raoult says he is very satisfied with what he has been able to achieve in treating the pandemic in Marseille using HCQ + A with zinc, only regretting that he was unable to persuade the rest of France to follow him in his range of measures that have resulted, he points out, in much lower levels of mortality than in other reasonably comparable French urban centers. Quoting Winston Churchill during the Second World War, on 29 May, he twittered ‘«Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning"... of the war against chloroquine.’

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