The story about chloroquine and hydroxychloroquine is convoluted as it is confusing. And it can leave you feeling dazed and fazed.
But I’m going to try to put it out as coherently as I can.
And if you also read between the lines, you'll get it that scientists and researchers are not very much different from the rest of us.
Most times, most of us are driven by our own personal agendas – if we are honest to admit it, that is. It's all about 'me, myself and I'.
That explains why there is so much misinformation about Covid-19 and everything related to it. I guess everybody wants their 15 minutes of fame.
Chloroquine and hydroxychloroquine were first identified as potential treatments for Covid-19 in February, when scientists in Beijing and Wuhan, China, found that the drugs blocked SARS-CoV-2 from infecting monkey cells in a petri dish.
Then the eminent French microbiologist Didier Raoult (left) and a couple of dozen co-authors published two observational studies on hydroxychloroquine that’s already being used by some doctors, including Raoult himself, to treat Covid-19.
In a paper, released on March 27, they claimed that Covid-19 patients given the drug along with azithromycin, an antibiotic, had a reduction in detectable virus. They noted “clinical improvement” in nearly all of the 80 patients tested, with the exception of one severely ill 86-year-old who died.
They wrote that the results “confirm the efficacy” of the drug combination, and they implored fellow researchers to “urgently evaluate this therapeutic strategy both to avoid the spread of the disease and to treat patients”.
But many other researchers were skeptical, and they wasted no time in pointing out why. For starters, the Raoult et al. study was not a randomized clinical trial, which is the gold standard in medical research. That means there was no control group. Other details seemed curious, like the fact that only 15 percent of the patients had fevers, a very common symptom of the disease.
As one particularly thorough dissection of the study put it: “We just don’t know how good this treatment was or frankly if it was any good at all”.
What’s notable about Raoult’s study, and perhaps why it had received outsized attention, is that hydroxychloroquine is the drug that had been taken up by the US president as a likely cure.
On April 04, Donald Trump (left) tweeted the drug’s potential as a “game changer” for fighting the coronavirus. [Read my post titled “Two Snake Oil Peddlers” published April 14, 2020 for the background story].
Soon after, the Food and Drug Administration, a US federal agency granted chloroquine and hydroxychloroquine emergency use approval – a formal but temporary, green light allowing doctors to freely treat Covid-19 patients with these drugs.
Researchers have alleged that the widespread emergency use of hydroxychloroquine early in the pandemic delayed rigorous studies to prove whether or not the drug is actually useful.
And in that same month of April, the National Institutes of Health, the US medical research agency discouraged doctors from using chloroquine or hydroxychloroquine to treat Covid-19 patients – unless the treatment was part of a clinical trial.
In late May, a high-profile study published in the Lancet concluded that the drugs may increase the risk of death in Covid-19 patients – that study prompted WHO to suspend trials of the drugs. [Read my post titled “Dicing with Death with Hydroxychloroquine” published May 26, 2020].
But the authenticity of the data was soon called into question, leading to the paper’s retraction during the first week of June. [Read my post titled “Lancet's Fake Research Paper” published June 05, 2020].
WHO then quickly announced they were resuming trial of the said drugs – even as two research groups announced results that concluded the drugs neither treated nor prevented infections of SARS-CoV-2, the coronavirus that causes Covid-19.
One was by researchers at the University of Minnesota, who conducted a study of 821 people to see if hydroxychloroquine could prevent sickness in those who were recently exposed to someone with Covid-19, a treatment strategy known as post-exposure prophylaxis (PEP). Among those who received the drug, 11.8% became sick, versus 14.3% who received a placebo, a difference that was not statistically significant (The New England Journal of Medicine, 2020, DOI: 10.1056/NEJMoa2016638).
[Note: The University of Minnesota’s PEP trial was said to be the first peer-reviewed study to provide data from a double-blind, randomized, placebo-controlled trial of hydroxychloroquine. And which concluded that the drug did not offer any significant protection against SARS-CoV-2 infection].
In the UK, investigators also announced preliminary results from a study involving more than 4,600 people hospitalized with Covid-19. In the study, called the RECOVERY Trial, 25.7% of 1,542 people who got hydroxychloroquine died after 28 days, compared with 23.5% of 3,132 people who received standard care. Again, the difference was not statistically significant.
On June 15, the FDA followed the NIH and made a similar recommendation when they revoked the emergency use authorization.
Two days later, WHO announced that the hydroxychloroquine (HCQ) arm of the Solidarity Trial to find an effective Covid-19 treatment was being stopped.
Apparently, the trial's Executive Group and principal investigators made the decision based on evidence from the Solidarity trial (including the French Discovery trial data), UK's Recovery trial and a Cochrane review of other evidence on hydroxychloroquine which showed that the drug does not result in the reduction of mortality of hospitalised Covid-19 patients, when compared with standard of care.
In spite of the above, there are scientists who remain unconvinced. Already larger studies are in the works to test chloroquine and hydroxychloroquine as PEP therapies that prevent infection in healthy people.
I wonder if any of these initiatives by scientists and researchers are really about serving humanity – or a quest for stardom?! Everybody seems to be doing their own thing. A mishmash of exertions.
As Michael White (right), head of the department of pharmacy practice at the University of Connecticut School of Pharmacy correctly puts it: “Everyone wants to be the captain of the ship, from the big-name investigators to institutions, but we could have made more progress in finding a very effective regimen to treat Covid-19 if everyone worked together to vet these therapies as efficiently as possible. That doesn’t seem to have happened”.
