"If drugs with evidence of value are found, we will stop using those. It is a repurposed use of the drugs. And it is practised all over the world during a pandemic"
To treat coronavirus patients, Bangladesh hospitals are using a controversial drug hydroxychloroquine used for malaria treatment about which the US authorities have issued warnings of "serious and potentially life-threatening heart rhythm problems".
The drugs can cause dangerous abnormalities in heart rhythm in coronavirus patients, and should be used only in clinical trials or hospitals where patients can be closely monitored for heart problems, the Food and Drug Administration (FDA) warned in a safety communication issued on Friday.
The drugs – chloroquine, hydroxychloroquine and azithromycin – have been recommended in the treatment protocol of Covid-19 patients in Bangladesh, according to the "National Guidelines on Clinical Management of Coronavirus Disease-2019" published in the health directorate's website.
But health experts have questioned the inclusion of these controversial medicines in the treatment guidelines, suggested by the National Technical Advisory Committee, which was formed to advise the government on the ongoing coronavirus situation.
They said any drug can be used at this time of the pandemic to save people's lives. But there is a lack of enough evidence to include those drugs in the guidelines.
Professor Sayedur Rahman, chairman of Bangladesh Pharmacological Society, told The Business Standard that none of the drugs – hydroxychloroquine, azithromycin, favipiravir and steroid – are recommended by the World Health Organisation.
Instead, the WHO said it should not be right for the professional body of a country to use those medicines including hydroxychloroquine.
Professor Sayedur Rahman said during a pandemic, drugs are used out of compassion. Doctors are trying to treat patients with whatever arsenal they have. But when it comes to making treatment guidelines, there has to be proper evidence of their effectiveness prior to suggesting any drug in it.
Compassionate drug use means the use of a new, unapproved drug to treat a seriously ill patient.
"The evidence that we have so far is the results of clinical trials on 60-70 people, and those are contradictory. Some showed benefit while some others did not. Indeed, there are not enough proofs to include those in the guidelines," he added.
There are also reports of deaths among those who were given hydroxychloroquine, one of the recommended medicines.
Many countries are using different drugs but they are not using those as the guidelines. Those drugs should have been used only under the supervision of physicians on a case-by-case basis, not as a general recommendation. Some countries have got better results without even giving any medicine, he pointed out.
Prof Sayedur said, "Our country has no culture of identifying the reasons for deaths. Therefore, no organised research is done to know the death rate for the drugs we are using for treatment. But what we see in the western countries is that they try to know who are dying more when the death rate goes high. Their research found more deaths among those given hydroxychloroquine versus standard care."
Different countries used hydroxychloroquine on the grounds that the use of it would lessen the necessity of ventilators. But the rate of mortality is seen higher among those who are given this drug.
Md Robed Amin, professor of medicine at Dhaka Medical College, also a member of the coronavirus treatment protocol and guideline committee, said "Many countries are using hydroxychloroquine. Various studies are also done to learn whether the drug is safe and effective against coronavirus. Some study results were good while some were bad. For not having high quality evidence, the FDA and the NHS cannot recommend any medicine. Because they have neither any reason to support nor to oppose it. It is up to hospitals which medicines they will use."
"Our National Committee has reasoned that there is not much of a probability for the survival of critical patients. It recommended those medicines in the hope that health conditions of mild and moderate cases will not deteriorate," he said.
The WHO has not recommended any drug for Covid-19 treatment. Because, it will not do so if it is not of good quality, he added. Nevertheless, many hospitals across the world are using hydroxychloroquine to save patients.
"The personal opinion of most doctors who are treating coronavirus patients is that they are getting good results after using hydroxychloroquine. But it is not scientifically proven."
It is very difficult to say whether they are getting good results for the drug or those recovered cases were with mild conditions. Determining it scientifically is different – doing a follow-up on a particular drug given to patients every day and checking the concentration of that medicine in the patient's blood.
But no one is following a specific procedure. The treatment guideline is not permanent, rather a living document, it will be changed if we get a better one.
"We are not giving the medicine based on evidence, rather we are giving it on the experiences of others. China has got good results.
If drugs with evidence of value are found, we will stop using those. It is a repurposed use of the drugs. And it is practised all over the world during a pandemic," Robed Amin said
With no vaccine or effective treatment for Covid-19, the disease caused by the coronavirus, many hospitals have been using hydroxychloroquine, sometimes with the antibiotic azithromycin, in the hope that they might help. In recent interviews, doctors around the country have cited their desperate need to help patients and try any potential treatments despite limited evidence.
Results of small studies have trickled out in the last few weeks that signalled more problems with using malaria drugs to treat coronavirus patients. The latest report, on Friday in the journal Nature Medicine, describes abnormal heart rhythms in 84 patients treated with the drugs.
Several medical societies, including the Infectious Diseases Society of America, the American Thoracic Society and the American College of Cardiology, have warned of the risks of using malaria drugs with azithromycin to treat patients with Covid-19 outside of a clinical trial or without close monitoring.
"The FDA is aware of reports of serious heart rhythm problems in patients with Covid-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin" and other drugs that can disrupt heart rhythm, the statement said. It also noted that many people were getting outpatient prescriptions for the drugs in the hopes of preventing the infection or for self treatment.
The message is the second warning about the drugs this week from a US federal health agency. On Tuesday, the guidelines from the National Institute of Allergy and Infectious Diseases cautioned that patients receiving hydroxychloroquine or chloroquine should be monitored for adverse effects, particularly an abnormality in heart rhythm called prolonged QTc interval. And at a White House briefing that day, the FDA commissioner, Dr Stephen Hahn, emphasised that the agency wanted data from randomised clinical trials before considering the drugs as a valid treatment.
There is no proven treatment for the coronavirus, and there is no proof that hydroxychloroquine and chloroquine can help coronavirus patients. Those two drugs are approved to treat malaria and the autoimmune diseases lupus and rheumatoid arthritis. But earlier reports from France and China suggesting a benefit led to an interest in the drugs, even though the reports lacked the scientific controls needed.
Doctors said hydroxychloroquine is given to coronavirus patients who undergo treatment in different hospitals in the country.
The Institute of Epidemiology Disease Control and Research (IEDCR) does not have any data on how many coronavirus patients have died from heart attacks under the impact of hydroxychloroquine as no death review is done yet.
IEDCR Director Prof Meerjady Sabrina Flora told The Business Standard, "We are keeping info on the number of coronavirus death cases and infections. We have not done any death review yet. So, we do not get any information on the causes of deaths."
"We shall start to collect info on whether any patient died from a heart attack after giving them hydroxychloroquine. Not all patients are given hydroxychloroquine. It is used in some cases," she added.