A drug presented in January as a major discovery to treat COVID-19 by the Montreal Heart Institute is far from having kept its promises.
Almost a year later, the use of colchicine is still not in the therapeutic arsenal to fight the coronavirus. And the situation is not about to change.
“We have just provided the planet with hope! “Had however launched Dr. Jean-Claude Tardif, director of the research center of the Heart Institute, in an interview with La Presse, during the unveiling of the preliminary results of the study on colchicine at the end of last January.
Listen to Philippe-Vincent Foisy’s interview with Jean-Louis Fortin, director of the Quebecor investigation office, on QUB radio:
Since then, scientific opinions have multiplied across the world to question the effectiveness of the drug.
The National Institute of Excellence in Health and Social Services (INESSS), responsible for evaluating the benefits of drugs in Quebec, intervened on two occasions to advise against their use.
In October, the scientific journal The Lancet published the final results of a large British study concluding that colchicine is ineffective in the treatment of COVID-19.
The final results of the Heart Institute study, released a few months after the January announcement, concluded they were not significant.
The envelope that was delivered to the colchicine study participants.
Dr. Tardif and the Heart Institute are now silent.
Despite repeated requests from our Bureau of Investigation, it was not possible to obtain comments from them.
We also tried to reach seven researchers who were part of the scientific committees overseeing the colchicine study, without obtaining a response from them.
However, expectations were high at the start of the pandemic when the Institute and Dr. Tardif announced that they were undertaking a study on colchicine by touting the potential of the drug.
Prime Minister François Legault had even been called upon to recruit study participants during his famous daily press briefings. The Quebec government also contributed $ 5 million.
The study was promoted during press conferences by Prime Minister François Legault.
In January 2021, the publication of preliminary results of clinical trials by the Heart Institute suggested a resounding success, which the Canadian and international media immediately seized upon.
The Institute’s triumphant press release referred to a “major scientific discovery”.
But, in May, the publication of the final results of this same study in The Lancet, but this time revised by a group of external scientists, reveals a very different picture.
Thus, when all the participants in the clinical trials are taken into account, the results become “not statistically significant”.
At most we suggest in The Lancet to carry out new studies to confirm effects which seem favorable in some of the participants recruited by the Heart Institute.
“It’s the problem of press release science,” said Professor Joe Schwarcz, who heads the Organization for Science and Society at McGill University.
“The field of research has become very competitive,” he adds, “and everyone is trying to be the first to make a discovery. So everyone wants to mark their territory. It becomes a question of marketing. ”
Doctors criticize the approach
In Quebec medical circles, the way of doing things by Dr. Jean-Claude Tardif and the Heart Institute aroused disbelief and many questions.
” When [le communiqué initial sur l’étude] was published, I did not understand, I was startled, ”said in an interview with Dr. Michel de Marchie, doctor in the intensive care unit of the Jewish Hospital in Montreal.
“If steroids, which are the anti-inflammatory drugs par excellence, have a mixed effect on COVID, we can think that colchicine was unlikely to be effective (as an anti-inflammatory)”, adds the intensivist, who has had to deal with numerous cases of COVID-19 since the start of the pandemic.
His colleague from the intensive care unit at Hôpital Maisonneuve-Rosemont, Dr. François Marquis, adds: “When we want to go too fast, we sometimes get false good news. It happens, it’s a shame. “
Dr Marquis harshly judges this way of exaggerating results because of the expectations it can create, especially in the context of a pandemic.
“There were a lot of announcements [au sujet de la COVID-19] which unfortunately have confused people. “
Unlike colchicine, Pfizer’s new antiviral, Paxlovid, which was approved before the holidays by US authorities for vulnerable people, has a clear impact in reducing complications from COVID-19. Here is how the two drugs differ. *
* This comparison has been validated with a reliable scientific source.
Photo courtesy, Euro-Pharm
-Prevent two in 10 hospitalizations or deaths in people with COVID-19
-The Heart Institute clinical study has been completed for almost a year and colchicine is still not recommended as a valid treatment
-Uses a general property of colchicine, namely its anti-inflammatory effects, to potentially reduce the impact of COVID-19
-Prevent nine in 10 hospitalizations or deaths in people with COVID-19
-The antiviral is so effective that it was submitted for US government approval even before its clinical study was completed
-Is designed to target a mechanism of action specific to COVID-19
Very active in research, Dr. Jean-Claude Tardif also carried out another clinical study on the effects of a drug, dalcetrapib, to reduce the complications of COVID-19. The study was funded by the company DalCor, in which Dr. Tardif is a shareholder alongside the wealthy Desmarais family. Clinical trials have been completed since May, according to the reference site Clinicaltrial.gov, but no results had yet filtered before the holidays.
It was not possible for us to obtain the reasons for this delay, despite our repeated requests to DalCor and Dr Tardif.
Final results published in The Lancet
In the scientific publication where the final results are presented after having been reviewed by external experts, the results for all participants become “not statistically significant”. The major discovery turns into a recommendation to carry out new trials to validate the effectiveness of colchicine.
Press release from the Heart Institute
The results for all the patients in the study are presented in an ambiguous manner. They are said to be approaching “statistical significance”. In addition, by removing the results of some participants (see text on the right), the Institute does not hesitate to speak of a “major scientific discovery”.
The tablets that the participants received.
To claim victory, the Heart Institute withdrew the results from 329 of the 4,488 participants in its clinical study. These are people with symptoms of COVID-19, but whose diagnosis could not be confirmed by a test, unlike the other participants, due to shortages of tests at the start of the pandemic. With this withdrawal, the effects of colchicine become measurable, but limited. However, if we evaluate the results of the study as a whole, that is to say with all 4488 participants, colchicine only has a “not statistically significant” effect, as indicated. The Lancet, on the complications of COVID-19.
Philanthropist Sophie Desmarais, billed as lead sponsor of the Heart Institute study, is so convinced of colchicine’s effectiveness that she wouldn’t hesitate to take it if she had COVID-19 .
“The first thing I would do: I would take colchicine,” she said in an interview.
Ms. Desmarais believes that colchicine is the subject of resistance from governments and pharmaceutical companies.
“As colchicine is an inexpensive generic drug […], governments and pharmaceutical companies had little interest in helping us because there was no money to be made for them, ”she says.
Ms. Desmarais contributed $ 1 million out of her pocket for the study. The other major sponsors were the Government of Quebec ($ 5.3 million) and the Bill & Melinda Gates Foundation ($ 3 million).