Updated: Aug 4, 2020
Hydroxychloroquine and a related drug, chloroquine, had been under study as possible treatments for Covid-19.
The World Health Organization (WHO) last month accepted the recommendation from the Solidarity Trial’s International Steering Committee to discontinue the trial as interim results showed that the drug produced little or no reduction in the mortality of hospitalized Covid-19 patients when compared to standard of care.
Last week, Stella Immanuel, a doctor at the centre of a controversy over unproven and potentially dangerous claims that the anti-malaria drug can treat Covid-19 had her video removed from Facebook and Twitter, with the social media platforms saying that it violated their policies about misinformation.
Dr Brighton Chireka gives his view on Dr Immanuel and whether there is any truth in hydroxychloroquine being a viable drug to cure Covid-19.
As people, we are expected to make choices about how we respond to what we hear or read. We cannot just accept other people’s opinion without questioning, or asking ourselves whether what were have read or heard is true or false.
The purpose of asking questions, is to have a deeper understanding or appreciation of what is being said. Some choose to be 'sponges' that accept whatever they are told, while others dig a little deeper to separate facts from falsehoods.
While we need to be open to those that offer arguments that threaten or violate our beliefs, many of us are often threatened when others present a conclusion contrary to our own. However, we need to put our emotions and feelings aside if we are to have constructive dialogue.
The pandemic and the race to find a cure
Covid-19 has wreaked havoc and scientists are under pressure to come up with a cure. Even with that pressure, researchers must properly analyse their data and make carefully considered decisions. So far, no pharmaceutical products have yet been shown to be safe and effective for the treatment of Covid-19. However, a number of medicines have been suggested as potential investigational therapies, including hydroxychloroquine.
What can Hydroxychloroquine be prescribed for?
In the United Kingdom, hydroxychloroquine is licensed medication for active rheumatoid arthritis, systemic and discoid lupus erythematosus and dermatological conditions caused or aggravated by sunlight.
According to the British National Formulary, it must be administered on expert advice. I currently prescribe it under the guidance of specialists for the three conditions named above.
Medicine can be prescribed outside it’s license and we call it off-label use. There are rules and regulations that govern prescriptions such as these and should be done on a case-by-case basis.
According to WHO, it is ethically appropriate to offer individual patients experimental interventions on an emergency basis outside clinical trials, provided that no proven effective treatment exists; it is not possible to initiate clinical studies immediately; the patient or his or her legal representative has given informed consent; and the emergency use of the intervention is monitored, and the results are documented and shared in a timely manner with the wider medical and scientific community.
The decision to offer a patient an unproven or experimental treatment is between the doctor and the patient but, must comply with national law. If early results from an unproven or experimental treatment are promising, the treatment should be studied in the context of a formal clinical trial to establish its safety, efficacy, risks, and benefits. This means if a doctor uses a drug off-label for my patients and the results are promising, they must present their findings so that clinical trials can take place.
Hydroxychloroquine and chloroquine
Hydroxychloroquine and its sister drug chloroquine, have been used against malaria and other diseases for decades. Evidence that they might work against SARS-CoV-2 first came from test tube data. Since then, hundreds of trials have been launched around the globe.
Scientists are trying the drugs in low doses and high doses; alone or combined, with the antibiotic azithromycin, the antiviral compound favipiravir, or other drugs; and in patients with mild or severe diseases, health care workers, pregnant women, and people living with HIV. Therefore, it is inaccurate to say that no studies have been done about these drugs.
In Brazil, there was overwhelming political support for hydroxychloroquine, which led to clinical trials by researchers in the country.
In April, a team led by Marcus Lacerda, a clinical researcher at the Heitor Vieira Dourado Tropical Medicine Foundation in Manaus, published a study showing that chloroquine can increase mortality in Covid-19 patients. 16 out of 81 patients died in this trial. Since then, Marcus Lacerda is now being accused of poisoning patients with a high dose of chloroquine, just to give the drug a bad name. He has been receiving death threats and is now facing legal inquiry.
On 22 May, a study published in The Lancet, made a claim, based on alleged data, that from 96,000 patients around the world, that hydroxychloroquine and chloroquine, whether given alone or in combination with another drug, caused a steep increase in deaths. This led many regulatory agencies to ask scientists to halt their trials and make sure they were not harming their patients.
The Recovery study and Solidarity study, were temporarily halted but resumed after a safety committee took a look at the data, which l have detailed below.
On 27 May 2020, Hernandez and his team published a systematic review on hydroxychloroquine or chloroquine in the Annals of Internal Medicine journal. They looked at four randomized controlled trials, 10 cohort studies, and nine case series. They concluded that evidence on the benefits and harms of using hydroxychloroquine, to treat Covid-19, is very weak and conflicting. They admitted that they did not have enough controlled studies. This conclusion was based on the studies that had been carried out before 27 May.
On 3 June, David Boulware from the University of Minnesota and his colleagues published results of their findings in The New England Journal, the largest study to date, looking at post exposure prophylaxis using hydroxychloroquine.
They studied 821 people and concluded that after high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within four days after exposure. The conclusion was that hydroxychloroquine does not prevent anyone from developing Covid-19 symptoms, after getting infected.
Another post exposure trial in Barcelona, Spain involving 2300 people exposed to coronavirus concluded that that hydroxychloroquine does not prevent you from developing symptoms of Covid-19 after getting infected.
On 5 June, Professor Peter Horby and Professor Martin Landray, chief investigators of the Recovery study announced the findings of part of the study that started in March this year. They concluded that there is no beneficial effect of hydroxychloroquine in patients hospitalised with Covid-19 and they stopped enrolling participants to the hydroxychloroquine arm of the Recovery trial with immediate effect.
The Recovery trial involved 11,000 patients and many thousands of doctors, nurses, pharmacists, and research administrators at 175 NHS Trusts across the whole of the UK, supported by staff at the NIHR Clinical Research Network, Public Health England, Department of Health & Social Care, and the NHS in England, Scotland, Wales and Northern Ireland. The trial has shown that hydroxychloroquine is not an effective treatment in patients hospitalised with Covid-19.
On 17 June, WHO announced that the hydroxychloroquine (HCQ) arm of the Solidarity trial to find an effective Covid-19 treatment was being stopped.
The trial's executive group and principal investigators made the decision based on evidence from the Solidarity trial, UK's Recovery trial and a Cochrane review of other evidence on hydroxychloroquine. Data from Solidarity (including the French Discovery trial data), showed that hydroxychloroquine does not result in the reduction of mortality of hospitalised Covid-19 patients, when compared with standard of care.
As a result of numerous trials that have been conducted, it begs the question, why would a drug get all this attention when all the studies are showing that it does not make any difference? The answer lies with the US president, Donald Trump, who has promoted hydroxychloroquine, despite the fact that there is evidence that shows that the drug is ineffective when it comes to Covid-19.
Dr Stella Immanuel's claim about hydroxychloroquine
Houston doctor, Stella Immanuel has claimed that hydroxychloroquine is effective in treating patients with Covid-19 and has dismissed masks as unnecessary in stopping its spread.
In the past, Ms Immanuel has made several unreliable medical claims, including the alleged use of alien DNA in various medicines, and the production of a vaccine to inoculate people against being religious.
Dr Immanuel's claims that she has cured 350 patients with hydroxychloroquine raises a number of questions. On 8 July, she claimed to have cured 200 people. What is alarming, is that in a video she recorded previously, she asked 'all the patients she cured', to record videos saying how good hydroxychloroquine is. This again begs the question, why would she do that instead of writing to these patients?
Immanuel has discouraged people from wearing masks but she is seen wearing a mask in a number of pictures. We have cures for a number of illnesses but I have never heard any doctor who encourages people to go out and get infected just because there is a "cure".
Dr Stella Immanuel knows how research or clinical trials work, or are done. In other words, findings have to be critiqued by colleagues in the field. We know from studies, that 80 % of people with Covid-19 will recover without needing treatment. Meaning, if you give them water, they will get better because they were going to get better without taking anything.
Dr Stella does not work in a hospital so the patients she is likely to see are those with mild symptoms and are likely to recover without needing any treatment. If it was the case that she had found a cure, she would have rushed to publish her findings.
Any claim for a cure must be analysed to make sure that the treatment works as per the claim. In Dr Immanuel's case, there was no need for soliciting public support as her data should speak for itself. It is a well-known fact that doctor's or anyone conducting research does not shy away from proper clinical trials. Immanuel would be better off publishing her findings rather than wasting her time getting likes on social media.
It is my conclusion that the majority of people with Covid-19 do recover without needing any treatment and that the overwhelming evidence available shows that hydroxychloroquine does not cure Covid-19. It was withdrawn from the clinical trials, so we should forget about it and focus on finding a cure from other drugs. No amount of publicity can make an ineffective drug effective.
About Dr Chireka:
Dr Brighton Chireka is an International Health Consultant, GP Partner & Clinical lead of SKC CCG. He is a Fellow of the Faculty of Medical Leadership and Management.
Dr Chireka is the Founding Chairperson of Zimbabwean Diaspora Health Alliance (ZDHA) and also a Founder Trustee of CC Foundation in Zimbabwe which offers scholarships to students from deprived backgrounds.