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Maverick French Covid doctor reprimanded over ‘breaches’ in clinical trials

A French doctor who shot to global notoriety during the Covid pandemic with an unproven treatment for the virus has been formally admonished by health authorities over "serious breaches" in several other clinical trials.

Maverick French Covid doctor reprimanded over 'breaches' in clinical trials
Didier Raoult at the IHU medical institute in Marseille. Photo by Christophe SIMON / AFP

Didier Raoult, a respected tropical disease specialist, earned fans but also widespread condemnation from peers by insisting that Covid could be treated with the anti-malaria drug hydroxychloroquine.

Despite an absence of peer-reviewed evidence, Raoult administered the drug to hundreds of people and helped spur its promotion by former US president Donald Trump and his populist Brazilian counterpart Jair Bolsonaro.

His outspoken defence of hydroxychloroquine despite several trials and studies discrediting its Covid effectiveness earned him an official admonishment from the French Medical Association last December.

The reprimand had little impact, however, because Raoult had already resigned as a practising physician at the hospital university of Marseille in southern France.

But the controversy also drew scrutiny of his other research by health regulators, who opened inquiries late last year of trials at the Mediterranean Infection Foundation of Marseille, which he still directs.

On Wednesday, the ANSM drug security agency said it had found “serious breaches” in clinical tests, most of which were begun several years before the Covid pandemic.

It was the first time France’s national health authorities have explicitly faulted Raoult over his practices.

“Ethical rules have not been systematically respected, which did not allow the proper protection of participants,” the ANSM said in a statement.

In some cases patients were not asked to sign waivers proving their consent, and in others the doctors did not obtain the required notice of opinion from an independent evaluation committee.

It ordered a halt to the faulty trials still underway and said it would oversee “corrective and preventive measures” to ensure proper conduct.

It also filed a legal complaint against Raoult’s foundation, saying it had illegally launched some trials and had submitted a fake document to justify one of them.

But it did not take any action over the administration of an experimental treatment for tuberculosis that provoked severe side-effects in a large number of patients, a scandal revealed by the Mediapart investigative website in October 2021.

The ANSM said Raoult’s foundation had not registered the treatments as a clinical trial, meaning it did not have grounds to intervene – but an inquiry is ongoing and legal complaints may still be made, it said.

Raoult denied doing any tuberculosis research and said at a press conference last week that he might sue Mediapart for describing the treatments as “uncontrolled tests.”

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TRAVEL NEWS

Paxlovid, tests and isolation: Covid care for tourists in France

With travel opening up, many people are planning trips to France over the next few months, but the Covid pandemic has not gone away. Here are your questions answered on testing, isolation and medical treatment if you do fall sick while on holiday.

Paxlovid, tests and isolation: Covid care for tourists in France

Travel rules

Covid-related travel rules have mostly been relaxed now but you will still need to show proof of being fully vaccinated at the French border. If you are not vaccinated you will need to show a negative Covid test – find the full breakdown of the rules HERE.

Testing

Once in France if you develop symptoms or you have been in contact with someone who has tested positive you will need to get a Covid test.

The good news is that testing is widely available in France, both for residents and tourists.

The easiest way to get a test is head to a pharmacy, most of which offer the rapid-result antigen test on a walk-in basis Tests are available to everyone who wants one, there is no need to fulfill any set criteria.

For full details on how to get a test, and some handy French vocab, click HERE.

The difference for tourists is that you will have to pay for your test, while residents get their costs reimbursed by the French state health system.

In the pharmacy you may be asked for your carte vitale – this is the health card that residents use to claim refunds. As a tourist you won’t have the card – you can still get the test, you will just need to pay for it. Costs vary between pharmacies but are capped at €22 for an antigen test or €54 for a PCR test.

Isolation

If your test is positive you are legally required to isolate, but how long your isolation period is depends on the your vaccination stats – full details HERE.

Treatment

For most fully-vaccinated people without underlying health conditions the symptoms of Covid are fairly mild, but if you do become ill, here’s how to access medical help while in France.

Pharmacy – one of the first things you will notice about France is that pharmacies are everywhere, just look out for the green cross. As well as selling over-the-counter medication, pharmacies all have at least one fully-qualified pharmacist on the staff who can offer medical advice. 

Take advantage of pharmacists – they train for at least six years so they’re very knowledgeable and they’re easy to access by simply walking into the shop. In tourist areas it’s likely that they will speak English. Pharmacists can also signpost you to a nearby doctor if you need extra help.

Doctors – if you need to see a doctor, look out for a médecin généraliste (a GP or family doctor). There is no need to be registered with a doctor, simply call up and ask for an appointment if you need one. If you have a smartphone you can use the medical app Doctolib to find a généraliste in your area who speaks English. You will need to pay for your consultation – €25 is the standard charge and you pay the doctor directly using either cash or a debit card.

You may be able to claim back the cost later on your own health/travel insurance depending on the policy.

Ambulance – if you are very sick or have difficulty breathing you should call an ambulance – the number is 15. All non-residents are entitled to emergency treatment in France, whether or not you have insurance, but if you are admitted or have treatment you may need to pay later.

READ ALSO Emergency in France: Who to call and what to say

Paxlovid – several readers have asked whether the Covid treatment drug Paxlovid is available in France. It was licenced for use in February 2022 and is available on prescription from pharmacies, mainly for people with underlying health conditions or an impaired immune system. You can get a prescription from a medical practitioner.

The drug is reimbursed for French residents, but as a tourist you will have to pay.

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