The title may seem exaggerated. Yet, it’s based on reality. Canadian research, has opted for self-screening and self-reporting, instead of letting people see a doctor. For the chloroquine arm of the research, it will ship suboptimal medications and placebos to innocent volunteers by overnight courrier!
Some details of the Canadian research program to find therapies for COVID-19 have been made public. And like with the UK situation, it seems that there are multiple flaws.
While the research in France by Professor Raoult and his colleagues achieved a high success rate in treating patients with hydroxycholorquine / azitromycin, Canada is not only lagging with its research, but also risking the lives of those volunteering for the trials.
An early-release paper released on March 26 by Matthew P. Cheng et al explains that the Canadians trials will be integrated into the so called SOLIDARITY research program by the World Health Organization.
« CATCO (Canadian Treatments for COVID-19), a large treatment trial in Canada, will be part of the WHO Solidarity Protocol, a global protocol to evaluate the best available agents for patients admitted to hospital. » reads the paper.
Also part of the Canadian approach is the REMAP-CAP (A Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia), which will include interventions specific to COVID-19 and supportive interventions, including macrolides, steroids and interferon-β-1a, with antiviral administration.
The early-release paper highlights the medications that have been identified by WHO: lopinavir– ritonavir, remdesivir and (hydroxy)chloroquine; and mentions that, as new data emerge, others may be added.
All this looks really serious, but is it?
The paper asserts that there is « no proven effective treatments for COVID-19, showing that any drug has a net clinical benefit is a public health priority. »
This false assertion is similar as what can be found in the UK RECOVERY and the WHO DISCOVERY protocols.
All of this ignores the latest results achieved at the IHU Méditerranée in Marseille, France, where 97.5% success rate was achieved in terms of having the patients to test negative within days of treatment.
The Canadian approach also ignores the role of azitromycin as it only refers to hydroxycholorquine, while it’s now known that hydroxycholorquine alone is less effective.
Now what does the early-release paper say about the testing for hydroxychloroquine?
« Canada will allow health care workers and community-dwelling adults with high-risk exposures or early symptomatic disease to screen themselves electronically, receive their assigned study drug (hydroxychloroquine v. placebo) via overnight courier, and follow up by self-report. »
Yes, those people will screen themselves « electronically », get their drugs by courrier, and then « self report» ! And yes, it will be « overnight » courrier …
This is pretty insane, given how deadly this disease is. It looks like these patients will not be even tested before receiving the treatment.
In addition, in France, as a precautionary measures, electrocardiograms are made on day 0 and day 2 of the treatment. Nothing of that is foreseen in this trial.
Unless the protocols are changed, none of the volunteers for this research will benefit from the most effective available treatment and care.
It looks like it’s a 50% chance they will receive hydroxychloroquine alone, and a 50% chance they will receive glorified sugar in the form of a placebo, this without any real medical care.
A friend was commenting this to me: this looks worse than Russian roulette!
With this protocol, none of those volunteers will receive proper early medical attention, as they should.
And yes, half of the volunteers will be sent by courrier a placebo instead of the hydroxychloroquine, which is itself suboptimal, as not as effective as when combined with azithromycin.
Compared to the UK protocol, which is flawed, the Canadian protocol seems even worse when it comes to the testing of hydroxychloroquine, as it relies on self-screening and self-reporting, with no testing, in addition to relying on placebos and on hydroxychloroquine alone.
This Canadian approach is a huge contrast when compared to the work done in Marseille, where patients benefit from very close medical supervision, in the most advanced hospital in the country for contagious diseases.
The French government has now authorized other hospitals in the country to adopt the screening and treatment approach already taking place in Marseille. There are already over 20 major hospitals that operate the treatment.
At the IHU-Marseille, Professor Didier Raoult and his team have decided against the use of placebos in their research.
They seek to treat people and to save as many lives as possible. They see placebo-based research protocols as unethical and a violation of the Hyppocratic Oath.
In addition to the flaws in the research protocol, what is extremely worrisome is that the Canadian government, like in the UK, may wait for results of such research before making treatment widely available.
This would be a considerable and extremely deadly mistake.
My message to the Canadian government, and each of the provinces is simple: please immediately embrace the French research results, after of course checking them for any unlikely flaw.
The French research was conducted by some of the very best in the world. Professor Didier Raoult is ranked #1 expert in the world when it comes to transmissible diseases.
What can be inferred from the the Marseille research and clinical experience for application in Canada and elsewhere?
First, there should be mass screening for the virus.
At the same time, the hydroxychloroquine / azithromycin treatment should be made available as soon as possible to all medical institutions in the country, in sufficient quantities – we are talking about millions of pills here, so production needs to be ramped up.
Fortunately both hydroxychloroquine and azithromycin are generic and cheap to produce. A treatment costs about 30 Canadian dollars. The challenge is to boost the supply, as there may be shortages of some ingredients, with India for example having introduced export restrictions.
Patients need to receive therapy at an early stage, i.e. shortly after positive testing for the virus, and the therapy should be administered, as far as possible, with close medical supervision.
This is a huge endeavor. In Canada, this means that several millions of Canadians will need to be administered the treatment in the coming weeks and months.
The strict social distancing, lockdown and other measures will of course need to continue to be enforced, to limit the spread of the virus and avoid overloading hospitals and other medical facilities.
And yes, research and clinical trials can take place in parallel. But the threshold should be much higher than just be an improvement over an absence of treatment.
Only therapies that truly have the potential to improve over the current therapeutic outcomes achieved in Marseille with the hydroxychloroquine / azithromycin therapy should be considered.
What is also required is safe trials, without any « placebo patients. » Indeed, it’s totally unacceptable, and probably illegal, to deny patients the best available treatment and care available.
The priority of the Canadian government should be to provide access to hydroxychloroquine / azithromycin treatment as soon as possible to every citizen in the country.
Treatment should be provided in the best medical conditions possible, at an early stage of the development of the disease, after testing, and in a hospital or another appropriate medical setting.
Generating randomized trial evidence to optimize treatment in the COVID-19 pandemic – by Matthew P. Cheng et Al. Pre-Release. March 26 2020.