Martin Shelley –
As the push to find a cure for Covid-19 intensifies, here’s our take on the latest developments…
The search for a drug that’s safe enough to treat existing Covid-19 patients could take months, if not longer, despite the best efforts of Big Pharma to repurpose products originally specified for use against diseases like malaria and ebola.
And finding an effective vaccine – immunisation now being widely accepted as the only real exit strategy from socially repressive lockdowns – could be more than a year away, even though rival companies and consortia are racing to shorten development timelines and deliver sooner.
These delays have inevitably led to hastily devised, albeit useful, stopgap measures – lockdowns, social distancing and testing. But they’ve also opened up a window of opportunity for a ragbag of rogues, from online fraudsters with an eye for a quick buck – vitamin C-based ‘immune boosting’ IV drips at £350 a pop, anyone? – to conspiracy theorists peddling the use of liquid silver and sliced onions, all the way up to democratically elected politicians endorsing unproven crackpot fixes.
Take US president Donald Trump, for example, whose latest suggestions – injecting disinfectant and bathing in UV light to hasten recovery from Covid-19 – have rightly engendered confusion and hilarity among experts and commentators alike. “I can’t believe that in 2020 I have to caution anyone listening to the president that injecting disinfectant could kill you,” said one in despair.
In India, members of the ruling BJP party have touted the idea of drinking cow urine as a cure for Covid-19, while over in Brazil a congressman has claimed a day of fasting would easily do the trick.
Next door in South America, Venezuelan president Nicolas Maduro mooted the notion that lemongrass and elderberry tea could ward off the virus, an idea taken up more recently in Africa, where Madagascar’s president Andry Rajoelina has launched a herbal tea ‘cure’ for those considered most vulnerable.
Taking a more responsible approach, thankfully, is France, where the government is warning citizens to be wary of taking cocaine or spraying the body with chlorine, bleach or alcohol in order to reduce the chance of catching Covid-19 – all myths recently promoted on social media.
The idea that nicotine patches can protect smokers from catching the virus is, however, being taken more seriously in the land of Gitanes, as it’s now the subject of clinical trials following research undertaken at a Paris hospital.
But let’s go back to Mr Trump and consider his (now former) ‘go to’ treatment of choice, hydroxychloroquine and its close relative chloroquine. He’s been relentlessly hyping up these pharmaceutical cocktails, originally developed to target malaria, for most of this year, and has taken to verbally abusing any journalist brave enough to question him on the topic at his regular media briefings. Perhaps we’ll never know the real reasons for Trump’s enthusiasm – he even falsely claimed that these drugs had been approved by the Food & Drug Administration to treat Covid-19 – but we note that the New York Times wrote earlier this month that he holds a “small personal financial interest” in Sanofi, a company that makes a branded version of the drug called Plaquenil.
Quite what effect that enthusiasm had on his electorate we can’t say, but last month in Arizona a man died after taking chloroquine phosphate, an additive used to clean fish tanks but also found in the anti-malaria medication.
The president and his conservative supporters at Fox News have since backed away from promoting hydroxychloroquine after a large trial at US military hospitals showed that it offered no benefits to the veterans who were the trial’s subjects. A third of those patients died when treated with the drug, more than the number who had received standard treatments.
Similarly poor outcomes emerged during a more recent Brazilian study, which had to be halted after a high dose of hydroxychloroquine proved lethal for some patients.
But while Trump may have now seen the error of his ways, other drug trials are continuing to examine the possible efficacy of hydroxychloroquine, if only, perhaps, to rule it out. Its seeming ubiquity has also been boosted by reports that, in the absence of a proven remedy, hospitals in several US states have started giving the drug to patients.
Take as an example the Recovery trial, said to be the largest trial in the world, which has just been set up in the UK, with more than 5,000 patients in 165 NHS hospitals. Despite a paucity of supporting data for the anti-malaria drug, the professor co-leading the trial admits hydroxychloroquine will nevertheless be tested.
Hydroxychloroquine was also selected as one of four products chosen by the World Health Organisation (WHO) for its international clinical trial. And in another recent trial, not peer-reviewed, and this time in China, claims were made that patients with mild Covid-19 symptoms who were given hydroxychloroquine recovered faster than those who didn’t, and none went on to display more serious symptoms.
However, last month a team of French researchers were unable to duplicate the positive results of an earlier and much disputed study – examining the effectiveness of hydroxychloroquine when used in combination with an antibiotic called azithromycin – by a group of scientists in Marseille, which had led to misleading claims of a “100% cure rate” being made on Fox News in the US. A panel set up by the US National Institute of Allergy and Infectious Diseases (NIAID) later advised against the combination of these two drugs, however, because of the associated risk of cardiac arrhythmia.
And last week the pharmaceutical giant Novartis, parent company of Plaquenil manufacturer Sanofi, announced it was going to conduct a trial “within the next few weeks” of hydroxychloroquine as a treatment for patients hospitalised with Covid-19 at more than 12 sites in the US.
Despite all the hype, let’s not forget that hydroxychloroquine is just one of more than 100 potential treatments for Covid-19 that are in various stages of being tested. More innovative drugs are also on trial, focusing on antibodies taken from patients who have recovered from the virus, and also on thwarting the human body’s sometimes dangerously hyperactive immune response to Covid-19.
Swiss pharmaceutical giant Roche is evaluating its rheumatoid arthritis drug tocilizumab to see if it can interrupt and control that immune response, while biotech start-up AbCellera – in collaboration with Indiana drugs firm Eli Lilly – and New York company Regeneron are both rushing ahead testing products using antibodies, but the results of these trials could still take months, with no guarantee of success.
But it was another drug, remdesivir, that until recently appeared to hold out the best hope of success. Made by US company Gilead Sciences, and first developed – with a little help from the US government to the tune of nearly $80m – for use during the 2013-16 ebola outbreak in west Africa, remdesivir was considered to have potential because Covid-19 shares important features with that earlier virus.
Like hydroxychloroquine, it has been given to Covid-19 patients on compassionate grounds ahead of any trial results, and its popularity has led to supply shortages serious enough to preclude its presence in the Recovery trial. Earlier this year Gilead released purely anecdotal data from this compassionate use, instead of waiting for the outcome of formal clinical trials, which led Trump to talk it up at his next media briefing.
Anticipation of its success is said by some US commentators to be behind the decision of the Trump administration to award the product ‘orphan’ status, thus entitling Gilead to profit from remdesivir exclusively for seven years, ruling out the possibility of cheaper generic versions becoming available which could be distributed more widely. It has been noted in the US that a member of Donald Trump’s ‘coronavirus task force’ previously worked for Gilead.
However, following widespread criticism of the move – senator Bernie Sanders branded the decision “outrageous” – Gilead asked the Federal Drug Administration to rescind the designation.
Back in February, WHO’s assistant director-general said, “There’s only one drug right now that we think may have real efficacy. And that’s remdesivir.” Initial results from researchers at Chicago University were encouraging, but documentation that briefly appeared on the WHO clinical trials database this month revealed that remdesivir did not work in its first full trial in China, and that the trial had to be stopped early because of side-effects.
Similar false starts will no doubt feature in the parallel race to develop a vaccine to immunise against the virus. There are reported to be more than 100 development projects on the go across the globe – looking at every possibility, including repurposing products currently used to treat tuberculosis and polio – with nearly 80 said to be on the WHO’s radar, and among the more high-profile participants already conducting trials, or with regulatory approval to start them, are Pfizer (in collaboration with Germany biotech company BioNTech), Sanofi (working with GSK) and Johnson & Johnson.
In the UK, researchers from Oxford University have just begun human trials as part of the Oxford Vaccine Group project, having recruited more than 1,000 volunteers across study sites in Bristol, London and Southampton, in addition to Oxford.
But even if one or more of these trials proves successful, taking a vaccine all the way through to regulatory approval and widespread distribution takes time – historically up to a decade or more. Hopefully the timetable during the current pandemic will be much shorter, but – despite Trump’s plea for a vaccine to be ready in time for the US presidential election in November – senior medical experts such as Anthony Fauci, director of the US NIAID, have cautioned that a vaccine won’t be available for at least another 12-18 months, which is the shortest timeline to complete clinical studies.
So it looks like we’ll be living with face masks, lockdowns and social distancing for some time yet. The mobile phone apps slowly coming on stream, designed to boost the effectiveness of the contact tracing measures that should have been in place for the past few months in the UK, will no doubt help, but it’s going to be a long, slow process before we see light at the end of the tunnel…
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