Covid-19 Immunomodulator Clinical Trials with BPOM Guidance
The Food and Drug Monitoring Agency (BPOM) has never supported claims that herbal medicines can cure Covid-19. A drug must undergo a series of tests before it enters the stage of clinical trials.
By
DEONISIA ARLINTA
·4 minutes read
JAKARTA, KOMPAS – The accelerated research and procurement of drugs for treating Covid-19 is being encouraged. However, drug testing protocols should continue to be prioritized to guarantee people’s security and safety. Guidance and oversight in the trials is also one aspect that requires attention.
The deputy for Traditional Drug, Health Supplement and Cosmetics Control of the Food and Drug Monitoring Agency (BPOM), Mayagustina Andarini, said at least 11 immunomodulator products, or compounds with immunological properties for boosting the immune system of Covid-19 patients, were being developed in Indonesia. The products are still in the trial stage and are being monitored by the BPOM.
“So far, the BPOM has never approved any claims about the effectiveness of herbal medicines in curing patients of Covid-19. A medicine must be subjected to a series of tests to enter the stage of clinical trials to prove its efficacy. All of the registered products are still being tested,” she said in Jakarta on Monday (10/8/2020).
If some products are believed to be suspicious, they should not be consumed.
One of the immunomodulators still under BPOM monitoring for its Covid-19 clinical trial is guava leaf extract, developed by the National Research and Innovation Agency (BRIN) in cooperation with IPB University and PT SOHO. It is being trialed on patients at the Athletes Village Emergency Hospital as well as Persahabatan Central General Hospital.
The other products in the trial stage are the ethanol extractions of ketepeng Cina (candle bush; Cassia alata) and a hemiparasite, the Malaysian mistletoe (Dendrophthoe pentandra), as alternative treatments for Covid-19 infection. These products were developed by researchers from the Indonesian Institute of Sciences (LIPI).
Mayagustina suggested the public to be more alert to the distribution of drugs that claim to prevent or cure Covid-19. The public’s anxiety and fear over the increasing spread of the disease should not lead to reduced vigilance against such products in circulation. People should make sure that the products have BPOM distribution licenses, are securely packaged, have not expired and bear certain warning labels.
“If some products are believed to be suspicious, they should not be consumed. This is even more the case with products that carry a risk of serious physical side effects. Just report such products, so that the BPOM can follow up,” she added.
(FILES) In this file photo taken on May 20, 2020 a pharmacy tech holds a pill of Hydroxychloroquine at Rock Canyon Pharmacy in Provo, Utah. - The World Health Organization said on May 25, 2020 that it had "temporarily" suspended clinical trials of hydroxychloriquine as a potential treatment for COVID-19 being carried out across a range of countries as a precautionary measure.
Causing public anxiety
Daily executive chairman Tulus Abadi of the Indonesian Consumers Foundation (YLKI) said that more than 33 percent of all complaints received during the Covid-19 health crisis involved drugs, face masks and hand sanitizers. In addition, complaints about drugs or jamu (herbal medicine) that claimed to prevent Covid-19 had been a large source of public anxiety.
According to him, the many claims drugs have made in relation to the coronavirus stemmed from a number of factors. Among them were the government’s poor political communication and management in controlling the crisis, the prevalence of psychological pressures in society, poor health literacy regarding medicinal products and less than optimal law enforcement.
“The government should improve its communication management. The widespread drug claims can, in fact, also be triggered by the poor examples public officials have presented, ranging from [claims that] nasi kucing (a rice dish) prevents Covid-19, Pancasila jamu, to eucalyptus necklaces to ward off Covid-19,” said Tulus.
Tulus said it was therefore necessary for the government to improve management of political communication. Without bringing the Covid-19 health crisis under control, economic recovery would be hard to achieve. Apart from that, the public’s health literacy should be increased with regard to pharmaceutical products, jamu and traditional herbs. This should be integrated with consistent law enforcement, especially as regards online content and products.
Article 197 of Law No.36/2009 on Health stipulates that manufacturers and sellers of pharmaceutical products that do not have distribution licenses are liable to 15 years in prison and a fine of up to Rp 1.5 billion.
“This legal action also applies to those who help [promote] the products, so great care should be taken. Law enforcement personnel should also be strict in creating a deterrent effect among violators,” said Tulus.
