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Paris / Berlin: A 65-year-old malaria drug that has not been shown to work against the new coronavirus seems to have captured the imagination of another president.
Frenchman Emmanuel Macron unexpectedly flew to Marseille on Thursday and spent more than three hours meeting with Didier Raoult, the researcher whose work has fueled a famous drug called hydroxychloroquine in just three weeks. Raoult’s unconventional studies won over the President of the United States, Donald Trump, who suggested he would be willing to take the drug himself.
Doctors say the hype has been ahead of science, although many have tried hydroxychloroquine in patients because they don’t have anything better. Based on little more than a small but encouraging study, the United States has stored 29 million doses. India temporarily banned its export. Patients in Nigeria were poisoned by it. Still others, who need it for chronic diseases, are now discovering that it is scarce.
“The message that President Macron is sending is one of support, which is detrimental to the scientific community,” said Christine Rouzioux, a virologist at Necker Hospital in Paris and a researcher at the Paris Descartes University, on BFM TV. “Professor Raoult certainly has an interesting personality, but he does not heal with personality.”
Popular hero
Raoult has become a popular hero for some in France, especially the old yellow vest movement that disrupted the country for much of last year, for his willingness to bend the rules, avoid Parisian politics, and blame the pharmaceutical industry for the status of the investigation. People have lined up outside their hospital to seek treatment. He also suggested that politicians ignored his work, a claim that may lose traction after Macron’s visit.
Presidential advisers say that instead of being an endorsement, the trip was intended to show that the president listens to a wide swath of scientific opinion.
Highlighting the confusion over the drug, Sanofi, France’s largest drug maker, said on Friday it would donate 100 million doses of hydroxychloroquine to 50 countries, and repeated that there is not enough clinical evidence to conclude that the drug works and is safe. for Covid-19 patients
Whether the drug helps or hurts such patients, or if it makes any difference, may not be clear for weeks or even months.
Also read: How humble hydroxychloroquine has become India’s unexpected new global strategic asset
Lupus treatment
“This molecule needs to prove itself,” said Vincent Dubee, a doctor at the university hospital in the French city of Angers, who is leading one of many studies around the world that will try to resolve the debate. “We know it well for other diseases, but it’s not something we’ve prescribed for 75-year-olds who have respiratory distress.”
In fact, how the drug works is not well understood, which is not unusual when it comes to older drugs. Hydroxychloroquine and its more toxic cousin, chloroquine, are synthetic compounds that were designed to replace quinine, the active ingredient in the bark of the Chichona tree, as a treatment against malaria in the middle of the last century. Later, doctors began using them against chronic inflammatory diseases like lupus and rheumatoid arthritis. Both can be dangerous for patients with heart conditions, and doubling the daily dose could be fatal.
Both showed some promising results in animals against SARS and MERS, two other coronaviruses. The Chinese National Health Commission was the first national authority to suggest the use of chloroquine to treat the new coronavirus on February 19, but did not disclose the results of patient trials that supported the recommendation. And the warnings quickly followed.
In Hubei province, the region where the coronavirus arose, health officials asked hospitals to closely monitor for possible side effects. On February 29, national authorities released a list of patients who should not receive the drug, including people with heart, liver and kidney disorders.
With little published data from China, old malaria drugs were still a medical gamble. But as the coronavirus spread in Europe, filling hospital wards, desperate doctors began using them anyway.
Then came Raoult’s work at the IHU-Mediterranee infection hospital in Marseille. The iconoclastic doctor, who wrote an article in early March comparing the new coronavirus to the common cold, was administering hydroxychloroquine, a drug he had worked with for decades, to an increasing number of patients with Covid-19.
He published results on March 16 showing that the drug reduced the presence of the virus in the respiratory tract of 24 patients. In some of them, he combined the medicine with an antibiotic called azithromycin, a medicine that the Chinese authorities had explicitly advised against for use with chloroquine.
Readers around the world took advantage of the results. Three days later, Trump made his first endorsement of the medicine after it was promoted on Fox News. He tweeted that the combination could be “one of the biggest game changers in the history of medicine.”
HYDROXYCHLOROKIN AND AZYTHROMYCIN, taken together, have a real shot at being one of the greatest game changers in the history of medicine. The FDA has moved mountains – Thank you! Hopefully BOTH (H works best with A, International Journal of Antimicrobial Agents) …
– Donald J. Trump (@realDonaldTrump) March 21, 2020
Doctors and clinical trial experts have pointed out several weaknesses in Raoult’s study (and a later one in which all but two of 80 patients improved). They cite the small number of people participating, the questionable inclusion and exclusion of some patients, and the lack of a control group, which means that the results could be an accident.
“The only way to know if you’re doing something worthwhile is to do a controlled study,” said Derek Lowe, a drug discovery scientist. “It is sad but it is true.”
Another complication is that hospitalized patients with Covid-19 tend to be older and have other types of diseases, compared to those who normally take these drugs for malaria or chronic diseases.
“We need to see this drug in a wide variety of patients,” said William Schaffner, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center in Nashville, Tennessee. “This is not a trivial drug.”
Unorthodox approach
Raoult insists that he is right, and that in most cases not using hydroxychloroquine or azithromycin may not be ethical. He argues that there is no need to put a group of patients on a placebo to draw conclusions about the impact of the drug.
“In infectious diseases, it is extremely easy to measure if the virus goes away,” meaning there is no real need for large patient samples or to follow the traditional method of comparing two random patient samples, one of whom gets experimental drugs. and the other a mannequin. Raoult told Radio Classique of France on April 1. “This is not science, it is a habit,” he said of the placebo-controlled studies. He declined to be interviewed for this article.
That line of argument leaves clinical trial experts wringing their hands. Because four out of five patients can clear the virus from their system on their own, a comparison is the only way to show “how much is related to the drug and how much is related to the patient’s immune system,” said Navin Jacob, pharmaceutical industry analyst at UBS AG in New York. “It could be that the drug really did the job; we just don’t know. “
So for science to catch up on the hype, some Covid-19 patients will need to show altruism in the face of a disease that currently has no treatment. Instead of demanding the drug for themselves, they should volunteer for studies where they might not get it.
Enlisting Subjects
Dubee, the Angers doctor, said patients respond when he explains the need for reliable scientific data. But you have heard from colleagues who are struggling to recruit people because some just want hydroxychloroquine.
The study he leads will include a maximum of 1,300 patients aged 75 and older who will be randomly divided into two groups: one will receive the active drug and the other a placebo, in addition to standard treatment. Some people in both groups will receive azithromycin, which will test Raoult’s results. After 14 days, scientists will compare how many people died or had to be put on a ventilator in both groups.
Similar trials are looking at the same thing around the world, including studies supported by the World Health Organization and the National Institutes of Health, as well as more than a dozen trials in China. Some initial results could come in weeks, but doctors say it may take months before the matter is resolved. – Bloomberg
Also read: Hydroxychloroquine: The special drug Trump and the world are marking PM Modi for
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