May 19, 2020

expert reaction to Trump saying he is taking hydroxychloroquine

US President Donald trump has announced that he is taking hydroxychloroquine as a COVID-19 preventative measure.

Mr Jonathan Burton, Pharmacist and Chair of the Royal Pharmaceutical Society Scottish Pharmacy Board, said:

“Hydroxychloroquine does indeed have many potential side effects.  These include nausea and abdominal pain as very common side effects, and headache, itching, blurred vision, rashes, vomiting, diarrhoea and emotional disturbances are all listed as common.  Other serious eye, skin, liver and heart problems are less common, or have unknown frequency, but can also occur.

“In terms of monitoring for patients who take Hydroxychloroquine, annual eye check ups are recommended for patients who take the drug for 5 years or more.  No routine lab / blood tests are currently recommended for patients taking Hydroxychloroquine.  Info from SPS: https://www.sps.nhs.uk/articles/hydroxychloroquine-used-as-a-dmard-drug-monitoring-during-covid-19-for-stable-patients/ & https://www.rcophth.ac.uk/wp-content/uploads/2020/02/HCR-Recommendations-on-Monitoring-Executive-Summary.pdf.”

Prof Gino Martini, Royal Pharmaceutical Society Chief Scientific Officer, said:

“Due to the large number of clinical trials which have been initiated including the UK Recovery trials run out of Oxford there has been a huge demand for Hydroxychloroquine and Chloroquine for use in these trials.

“Certainly, in England, there have been some shortages but these seem to have been solved now and pharmacies are dispensing hydroxychloroquine and Chloroquine to patients who have been prescribed it.”

Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:

“Hydroxychloroquine has a number of side effects, some of which are very serious.  The benefit-risk balance is generally favourable if you have one of the auto-immune diseases like lupus, because it is a) known to be effective and b) you have the disease.  The benefit/risk balance for prevention of a disease like malaria is slightly less easy, but is still positive because there is very good evidence that it works.

“For prevention or treatment of Covid-19 the benefit/risk balance is unfavourable (which is why it has no license for the treatment of Covid-19) because the risks are known and real, and there is no reasonable evidence that it works in either prevention or treatment.

“There is no doubt at all that its availability has been reduced because of demand from those who believe (wrongly) that it will prevent Covid-19.  The lack of availability has seen its price rise dramatically, and the cost may be borne by pharmacists or their patients.”

Prof A V Ramanan, Consultant Paediatric Rheumatologist at Bristol Royal Hospital for Children & Royal National Hospital for Rheumatic Diseases, and Professor of Paediatric Rheumatology at the University of Bristol, said:

“Hydroxycholoroquine is an immunomodulatory drug which has been used for adults and children with rheumatic diseases.

“There is no clear evidence of its effectiveness in COVID-19 currently.  Multiple trials including RECOVERY trial in UK are trying to answer this question.

“As it stands, it is not appropriate for patients to take Hydroxycholoroquine except in the context of clinical trials.”

Dr Jeffrey K Aronson, Consultant Physician and Clinical Pharmacologist, University of Oxford, said:

“The use of hydroxychloroquine to prevent or treat COVID-19 has several advocates, including Donald Trump, who has argued that it is widely used and safe.  Indeed, he has recently announced that he is taking the drug prophylactically to protect against COVID-19.  Although the US Food and Drug Administration (FDA) has issued emergency use authorization for hydroxychloroquine in treating some patients hospitalised with COVID-19, the regulatory agency advises against use outside of clinical settings.

“No drug is guaranteed to be safe, and wide use of hydroxychloroquine will expose some patients to rare but potentially fatal harms, including serious cutaneous adverse reactions, fulminant hepatic failure, and ventricular arrhythmias (especially when prescribed with azithromycin); overdose is hazardous and difficult to treat.

“There are currently over 150 trials registered worldwide involving hydroxychloroquine in COVID-19, used alone or in combination with other drugs.  These have so far been inconclusive.  For example, an open, non-randomised study of hydroxychloroquine, published in preprint, reportedly supported efficacy in 20 patients, but the trial design was poor and the results unreliable: six patients dropped out of the treatment arm (two because of admission to an intensive care unit and one because he died); the measure of efficacy was viral load, not a clinical endpoint; and assessments were made on day 6 after starting treatment.  Many aspects of the prespecified protocol were changed without reasons being given.  Later studies have failed to support efficacy.

“We should be cautious about proposed treatments for COVID-19.  No intervention should be assumed to be efficacious.  Even drugs initially supported by evidence of effectiveness may later prove to be more harmful than beneficial.  We need better, properly powered, randomised controlled trials of potential drugs.”

Prof Simon Gibbons, Professor of Natural Product Chemistry and Head of School of Pharmacy, UEA, said:

“Hydroxychloroquine is not on “script” to treat covid-19 infections.  It is a synthetic antimalarial based on quinine from the bark of the Cinchona tree from South America.  An infusion of the bark was used to treat fevers (mostly caused by malaria).  The bark was called “Jesuit” bark after the priests who recognised its use in the 16th century.

“As there is a paucity of data for the use of hydroxychloroquine as an antiviral, it should not be taken by the General Public.  Even a GP would hesitate to prescribe it in the UK for that use.

“Finally, this drug in overdose can cause severe cardio-toxicity leading to death.  My concern is that members of the general public may be tempted to take this drug in large doses, which is very dangerous.  They must NOT do so.”

Dr Ayfer Ali, Assistant Professor of Strategy at Warwick Business School and an expert in drug repurposing, said:

“Repurposing existing drugs presents our only hope of treating COVID-19 in the short term, as a vaccine could be months or years away.

“Using drugs to treat new diseases, for which they are not approved, is perfectly legal and more common that you might expect, but it is not without its challenges.

“A drug may be less safe for a different disease or in sicker patients.  For example, preliminary data from the US indicates that patients with COVID-19 who took hydroxychloroquine were more likely to die than patients who did not take the drug.

“To promote such drugs for prophylactic use among healthy individuals without appropriate clinical evidence is irresponsible.  This not only exposes millions of people to dangerous side effects, but also risks exhausting the supplies of such drugs for people who need them for proven uses.”

Dr Stephen Griffin, Associate Professor in the School of Medicine, University of Leeds, said:

“The announcement from President Trump that he has been taking Hydroxychloroquine as a preventative measure against infection with SARS-CoV2 is a staggering, irresponsible act that could very well also amount to self-harm.  The president seems either unaware or unconcerned that his actions will have profound influence amongst his supporters and perhaps the wider US or world population.  The sad aftermath of comments the President made regarding the internal use of disinfectants seemingly has not changed his modus operandi.

“Hydroxychloroquine has valid clinical uses for the treatment of malaria, or more commonly nowadays for various autoimmune conditions.  It is prescribed and monitored carefully as it can have severe side effects, not least those affecting the heart and cardiovascular system, for which the President has a medical history.  Thus, people that follow the President’s example might not only endanger themselves, but could also deprive patients with chronic autoimmune conditions of their much-needed medication.

“Hydroxychloroquine is not licensed for the treatment or prevention of COVID19 by the FDA, or any other agency.  In fact the weight of evidence from most recent patient trials shows it to be ineffective, with the potential for adverse side effects including those affecting the heart.  Given the current state of the global COVID19 pandemic, it seems that the regrettable example set by Mr Trump is more likely to add to an already overwhelming clinical burden, rather than to reduce it.”

All our previous output on this subject can be seen at this weblink:

www.sciencemediacentre.org/tag/covid-19

Declared interests

Prof Stephen Evans: “No conflicts of interest.  I am funded (1 day/week) by LSHTM.  They get funding from various companies, including Astra Zeneca and GSK but I am not funded by them, I have no involvement in obtaining funding from them and I am not an investigator or any grants obtained from them.  I am the statistician to the “meta-Data Safety and Monitoring Board” for CEPI [https://cepi.net/].  I will probably be paid for my attendance at meetings and expenses for travel.”

Dr Jeffrey K Aronson: “No conflicts.”

Prof Simon Gibbons: “None.”

Dr Stephen Griffin: “No conflicts.”

None others received.