At the tail end of last week, Lagos State Commissioner for Information and Strategy, Mr. Gbenga Omotoso, said the state will, this week, commence the clinical trial treatment of Covid-19, using chloroquine as approved by NAFDAC.
The state, which is the epicenter of the virus in the country, had previously disclosed plans to carry out the chloroquine clinical trial.
“We are ready for the chloroquine clinical trial because we have just secured all the approvals. The documentation has also been completed. Those that will be used for the trials are ready too. By next week, we should be ready for the trial.
“Also, Lagos got a supply of additional 20,000 testing kits, although, we were expecting 40,000. It means that the testing will increase now.” Said Omotoso.
Considering the fact that chloroquine has not gotten satisfactory approval by relevant global authorities, this decision to embark on this clinical trial by the Lagos State government may be premature.
For a pandemic that global pharmaceutical and virological agencies are yet to find a proper vaccine for, chloroquine cannot, advisedly, be adopted as a cure for Coronavirus.
Rising from its obscurity as a malaria drug, chloroquine has crept its way into medical conversation on Coronavirus curative drug, largely via social media than a conclusive scientific certification of its potency.
So, where did the Lagos State government pick this up, all of a sudden and how did it come to the decision, quickly, that the chloroquine most Nigerians would rather avoid, for its itchy side-effect as a malaria drug, is good enough to be experimented on Covid-19 positive patients in Lagos?
Chronicling the crazy course of chloroquine onto social media stardom as a cure for Coronavirus, Inverse, an online science journal, detailed the trajectory of this controversial drug muzzling its way into global pharmaceutical space as a Covid-19 cure.
The chloroquine journey according to its April 7, 2020 edition, began on Tuesday, March 17, when preliminary study on the anti-malarial drug chloroquine (pronounced klaw· ruh·kwn) as a treatment for Covid-19, published, in a peer-review journal online. While the findings appeared tentatively promising, the society publishing the journal issued a statement, on April 3, expressing grave concerns about the paper’s standards and methods, calling its conclusions into question.
Unfortunately, the internet does not wait for peer review and scientific debate, however. As soon as it published, the study exploded into something far bigger, thanks to the power of Elon Musk’s 32 million followers on Twitter and a Google doc.
This signalled the story of how chloroquine went from anonymity to a proposed cure for a pandemic, in a matter of days.
By this time, the global case count for Covid-19 surpassed 211,000, and research on drugs like Remdesivir, which was used to treat Ebola, was in progress.
Since the 1940s, Chloroquine, as an anti-malarial drug had treated and prevented malaria, and it had become the subject of at least, three clinical trials registered with the U.S. National Library of Medicine.
The journal noted that, as a treatment for Covid-19, chloroquine did hold some promise. A paper published on Monday, March 16, in the journal, Bioscience Trends, suggested that chloroquine is a “breakthrough treatment” for Chinese patients.
The drug has since been added to treatment guidelines in South Korea, Belgium, and China, except Belgium’s guidelines which stipulated the drug should only be used on hospitalized patients, while the results of ongoing clinical trials were eagerly awaited. In other words, the evidence of its potency was still preliminary.
Thursday, March 19, Trump suggested during a White House press conference that the Food and Drug Administration (FDA), which had not previously recognized any drug as a treatment for Covid-19, had approved the use of chloroquine to treat Covid-19.
Trump claimed the anti-malaria drug had gone through the approval process and had been approved. “They [the FDA] took it down from many many months to immediate. We’re going to be able to make that drug available by prescription.” Trump said.
As chloroquine is already FDA-approved for the treatment of malaria, it does not have to undergo the traditional rounds of safety testing that a new drug would have to, before it could be put to the market.
Inverse contacted the FDA seeking confirmation that the agency is now approving the use of the drug as a treatment for Covid-19. However, at the time, the edition was published, and as Bloomberg news reported, the FDA had not officially approved the use of the drug for Covid-19.
The confusion is symptomatic of the drug’s incredibly rapid rise from obscurity to national news.
Within one week, Cholorquine had gone from anonymity to the forefront of medical conversation using channels outside of academia and drug development.
On Monday, Musk tweeted a link to a google document titled “An effective treatment for Coronavirus. Maybe, worth considering chloroquine for C19,” the billionaire founder of Tesla, SpaceX and the Boring Company, commented.
But the subject of Musk’s tweet is not a scientific paper, rather, a Google document that has since spawned a new conversation around the drug’s efficacy for Covid-19 treatment.
Though, the Google document was not peer-reviewed, it however, cited several peer-reviewed studies, as well as phone calls and email conversations with scientists. Despite zero evidence, it has gone on a media blast on other news outlets like Fox News and English-language French news website, The Connexion, as if it was a scientific study.
This is just not the case. Still, it served as the opening act for a far larger conversation that had unfolded that week.
Gregory Rigano, who is a co-author of the Google document, is not a scientist. He is a lawyer who spoke about chloroquine as a Covid-19 treatment three times on Fox News that week.
Lawyer Rigano informed the journal that he had been organizing scientists across the biopharmaceutical world for over ten years; making big claims including stating that chloroquine and the antibiotic azithromycin (used to treat infections like pink eye) are “cures” for Covid-19.
He also boasted he is working with scientist Didier Raoult, the Director of the Mediterranean Institute of Infection, on a chloroquine-based treatment. When contacted for comment by the online journal, Raoult did not respond to repeated requests.
Rigano was reluctant to take full credit for the findings touted in the document, while Raoult is reported to be the lead author of a study that claims to be published in the International Journal of Antimicrobial Agents as of Tuesday, March 17. As of the time of publication, the cited link to the study returned no results, but Raoult’s institution had gone ahead to release a manuscript of the paper on their website.
A professor emeritus of pharmaceutics at the University of Floria and editor of The International Journal of Antimicrobial Agents, Hartmut Derendorf, confirmed that the study had been peer-reviewed and submitted.
The study was conducted on 36 participants with confirmed Covid-19 infections. It found that all six patients who took hydroxychloroquine and azithromycin, tested negative for Covid-19 after six days of treatment. A further 14 patients took only hydroxychloroquine, and eight of them tested negative after the study period. In the control group, two patients tested negative at the close of the study.
But the International Society of Antimicrobial Chemotherapy, which publishes the journal, has since questioned the rigor of the peer-review process.
The group’s statement, released April 3, noted that the article does not meet the society’s expected standard. It also mentioned that there was no satisfactory explanation for why some patients were included in the study at all, questioning if steps were taken to ensure patient safety.
The concerns put the study’s findings into doubt, and reinforce that further work is needed to determine the drug’s effectiveness for Covid-19.
The DOI listing for Raoult’s paper is not functional, as at the time the report was published. The paper however, was accepted to the International Journal of Antimicrobial Agents.
Importantly, Trump did not discuss the use of azithromycin when he endorsed the use of chloroquine during the press conference on Thursday.
The author stated that for ethical reasons and because the first results are so significant and evident, they decided to share their findings with the medical community.
Mattias Gotte (also researching Remdesivir), who is Chair of the University of Alberta’s Department of Medical Microbiology & Immunology, said that the paper’s findings are interesting, but warrant further investigation with respect to both efficacy and underlying mechanism of these drugs as potential Covid-19 treatment.
According to the authors, the study is preliminary in nature with limitations, just as promising research on chloroquine suggests that it may be time to take it seriously. But the way that research has gained mass attention is unorthodox, to say the least, and moving at lightning speed.
Gregory Poland, a professor of medicine and infectious diseases at the Mayo Clinic and director of the Clinic’s Vaccine research group, urged that the claim on chloroquine’s efficacy as Covid-19 cure should be taken with a pinch of salt.
“Until randomized clinical trials are published, we can’t tell if it’s anecdote. Is it due to some unforeseen or improbable set of circumstances? The medical literature is littered with tens of thousands of case reports like this; where there is a claim of efficacy, only to fall apart when randomized clinical trials are done.” He said.
Allegedly, it would appear that the rationale behind Lagos State’s conviction, that it could confidently go on a clinical trial of a drug that has not been fully certified by scientific means, was fabricated by a Lawyer who has no scientific certification or background except hobnobbing with Scientists.
In what could be termed, a medical executive order by a United State President, Donald Trump issued an emergency use authorization (EUA) for two malaria drugs to treat Covid-19 on March 19, based on thin evidence of efficacy.
Former agency executives under President Donald Trump and former President Barack Obama, say it is a move, scientists believe, has jeopardized research to learn the drugs’ real value against the Coronavirus pandemic.
They also charge that the March 28 EUA for chloroquine phosphate and hydroxychloroquine sulfate undermines FDA’s scientific authority because it appeared to be a response, not to scientific evidence, but to fervent advocacy of the drugs by Trump and other political figures.
FDA has multiple mechanisms to allow the use of unapproved, experimental drugs for small numbers of desperately ill patients outside of clinical trials. Because chloroquine and hydroxychloroquine are approved for malaria, doctors could prescribe them “off label” for Covid-19 patients even without the EUA. Since Trump first endorsed the drugs on 19 March, however, shortages have been reported, depriving some people with autoimmune disorders such as lupus who also depend on hydroxychloroquine. The EUA will immediately add tens of millions of doses of the drugs for distribution to hospitalized Covid-19 patients through health care centres.
Many scientists lament Trump’s embrace of risky malaria drugs for Coronavirus as insane!
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Trump has suggested the EUA was needed because effective clinical trials of the drugs would take too long during the global crisis. At an April 5, news conference, he said ”there is no time to go and say, ‘Gee, let’s take a couple of years and test it out, and let’s go and test with the test tubes and the laboratories.”
“I’d love to do that, but we have people dying today,” he added.
Trump’s sentiment may be similar to the type driving Lagos State Governor Babajide Sanwo-Olu, who perhaps, believes time is of the essence and such an expedient action is what was needed to stem the tide of the pandemic in the state and the country at large.
However, the science of it all is what has created deepening concerns over the haste to have the drug being touted as a Covid-19 cure.
Scott Gottlieb, FDA commissioner under Trump, who, until last year, has consistently called for more research on the efficacy of hydroxychloroquine, with or without the antibiotic azithromycin, tweeted on April 5 that if the drug combo is working, its effect is probably subtle enough that only rigorous and large-scale trials will tease it out.
Margaret Hamburg, FDA commissioner during most of Obama’s tenure, including the H1N1, Zika, and Ebola crises, was “surprised and perturbed” by the EUA.
“I understand the desire to find hope, but we need more evidence than is currently available before we encourage widespread use,” said Hamburg, who is a past president of AAAS, which publishes Science Insider.
According to Hamburg, valuable clinical trial evidence on the two malaria drugs could be gathered in a few weeks, adding that the EUA could make that more difficult.
“Making the drugs available in a more widespread way might actually interfere with the ability to get the data that we need.” She said.
Just like Trump told Americans on the day he was endorsing the controversial drug, Sanwo-Olu may as well tell Lagosians and Nigerian Covid-19 patients isolated in Covid-19 facilities in the state, “what have you got to lose…”
Such reckless prescription driven by some flowery hope-seeking, hope-poking political proclamation has been described as unguarded and misguided because Chloroquine comes with side-effects that makes it unsafe, to a large extent, as the curative solution to the Coronavirus crisis.
Risks rise when millions use a drug.
In defense of US government’s decision, some FDA observers pointed out that it has occasionally given full commercial approval to drugs based on relatively scant evidence, including a controversial treatment for Duchenne muscular dystrophy last year.
Erika Lietzan of the University of Missouri School of Law, who studies Food and Drug Regulation, cited Ceprotin, a biologic to treat patients with a genetically linked, life-threatening blood clotting problem which was approved by FDA in 2007, based on a nonrandomized trial of only 18 subjects.
But the rare diseases addressed by those FDA actions affect few people compared with Covid-19. When FDA endorses a drug with known, life-threatening side-effects for use by millions of hospitalized people to treat a poorly understood condition, experts warned that the potential for harm rises exponentially.
According to them, what is quite certain is that when large numbers of people are exposed to [hydroxychloroquine], there will be important adverse effects, including sometimes-lethal cardiac toxicity.
This is the risk Lagos State government and any other in Nigeria, may have to put up with in their bid to desperately use its patients as guinea pigs for a drug that has not been scientifically certified as potent enough to cure Coronavirus without a discomforting side-effect.
