JAKARTA – When the Covid-19 pandemic struck Indonesia early last year, it didn’t take long for businessman Haryoseno to latch on to a 40-year-old parasitic drug known as Ivermectin as a potentially cheap and effective way to treat the coronavirus.
Using raw materials imported from India, his Jakarta-based Harsen Laboratories pharmaceutical firm produced a large cache of the drug, aware that its use against Covid-19 had not been approved by the World Health Organization (WHO) or national health regulators.
Even presidential chief of staff Moeldoko lent his support to getting the drug officially approved for the retail market, but it wasn’t until June 20 this year that Indonesia’s National Agency of Drug and Food Control Agency (BPOM) finally gave Harsen the go-ahead.
BPOM head Penny Kusumastuti Lukito insists that so-called Ivermax 12 was specified only for parasitic diseases – something that was faithfully noted on the boxes Harsen distributed to local pharmacies at a price of 256,000 rupiahs (US$18) for a strip of 10 tablets.
Long before then, however, social media had already stoked a public clamor for the drug as an affordable way to stem the pandemic. With sales soaring, BPOM abruptly withdrew the license a fortnight later and gave it instead to state-owned pharmaceutical company PT Indofarma.
There is only one problem. Indofarma reportedly has only a limited supply, barely enough to allow it to conduct the clinical trials needed to prove the drug’s efficacy against Covid-19, which has surged to its highest-ever level and forced the government to introduce partial lockdowns.
With Indofarma at the end of a long global waiting list, the stockpile of the drug in Harsen’s tightly-guarded warehouse – and a firm order for another year’s supply – has now become the object of an unseemly game of political football.
Threatened with prosecution, Haryoseno, now in his 70s, risks the loss of his business after spending large sums of money, not only on the raw material from India and China, but on conducting his own early research.
BPOM’s Lukito has accused Harsen of failing to cooperate with the regulatory agency’s monitoring program by illegally importing the raw materials for Ivermax 12, distributing free samples of the drug without permission and illegally extending its expiry date.
Under the 2019 Public Health Law, anyone who manufactures or distributes pharmaceutical products that do not meet BPOM’s safety, efficacy and quality standards is liable to a maximum of 10 years in prison and a US$70,000 fine.
However, claims that Harsen’s Ivermectin is substandard don’t seem to jibe with reports that one high-ranking official suggested to the company that it would be allowed to continue production if it repackaged all of its pills under Indofarma’s name.
Most of Harsen’s early supplies were given free of charge to charitable organizations, a gesture that fits with Haryoseno’s reputation as a philanthropist who has built 131 schools across Papua alone and provides scholarships to underprivileged children.
But one prominent recipient was Defense Minister Prabowo Subianto, whose aides met with Haryoseno through an intermediary and expressed interest in making Ivermax available to the 400,000-strong Indonesian Armed Forces (TNI).
Tempo magazine quoted two members of Prabowo’sinner circle as claiming that the ministry subsequently received a donation of “thousands” of Ivermectin pills from Harsen, apparently for future trials of its own.
Moeldoko, a long-standing acquaintance of Haryoseno, had seen the possibilities too. He has a ready market for the drug as head of the Indonesian Farmers Association (HKTI), a position Prabowo had previously occupied in an effort to broaden his support base in his first bid for the national presidency.
Health Minister Budi Sadikan has made it clear that any decision on nationwide distribution will depend on the Health Ministry’s planned clinical trials to be held under strict guidelines and involving 10,000-20,000 patients in 10 state hospitals.
“There is no conclusion yet whether it is effective or non-effective,” he told Asia Times. “My approach is let science do this. It should not be in social media, it should not be in Parliament, it should not even be in formal meetings. It should be between scientists.”
But with Indofarma as the new license holder, State Enterprise Minister Erick Thohir appeared to jump the gun, declaring recently that Indofarma was planning to produce 4.5 million Ivermectin pills. “We’re trying to help people get cheap drugs or cheap therapies,” he said in what was taken as a partial endorsement of the drug.
Relatively cheap to produce, the 40-year-old Ivermectin has proved highly effective in treating parasitic infestations, from head lice and scabies to such diseases as River Blindness and Elephantiasis that were once the scourge of African villages.
But debate continues to rage over its effectiveness against Covid-19, with Ivermectin’s supporters claiming that Big Pharma, including global firms like Pfizer and Moderna, has deliberately downplayed the drug in the interest of making a fortune from Covid-specific vaccines.
Ivermectin is attractive to many in Indonesia’s needle-averse citizenry because instead of a vaccination, often a confusing, time-consuming process anyway, it can be employed as either a treatment or a prophylactic.
Indonesian doctors, including those at state hospitals, have been routinely prescribing the drug from unknown suppliers since mid-2020, about the time Haryoseno started taking an interest in the results of the earliest preliminary trials.
Stories abound of people who have staged quick recoveries. The secretary of a close friend of this correspondent recently shook off a diagnosed case of coronavirus after taking the prescribed course of two pills on the first day and a single tablet for the next three days.
Health authorities have consistently warned against Ivermectin’s use, but demand for approval of the drug has been growing globally after Australia’s Monash Biomedicine Discovery Institute showed it could inhibit coronavirus replication – but apparently in doses that could produce severe side effects.
The US Federal Drug Administration (FDA) says it has received multiple reports of people being hospitalized after self-medicating with Ivermectin intended as a treatment for horses.
The drug’s manufacturer, pharmaceutical giant MSD, says that its analysis of Ivermectin found there was no scientific basis for a potential therapeutical impact on Covid-19 in pre-clinical studies and a “concerning lack of data on its safety.”
But as with Monash, numerous clinical trials have been encouraging. The American Journal of Therapeutics reported in late June that the drug significantly reduced mortality, compared with no Ivermectin, based on a meta-analysis of 15 trials conducted among 2,500 recipients.
The researchers say “low-certainty evidence” revealed that taken as a prophylactic, Ivermectin actually lowered infections by an average of 86%.
“Using Ivermectin early in the clinical course may reduce numbers progressing to severe disease,” it said. “The apparent safety and low cost suggest that Ivermectin is likely to have a significant impact on the SARS-Cov-2 pandemic globally.”
More than 30 countries, including European Union members Greece, Bulgaria, Slovakia and the Czech Republic, have now brought Ivermectin into their Covid-19 management strategies. Others, like Indonesia, the Philippines and Thailand, are actively considering its use.
In the United States, the Front-Line Covid-19 Critical Care (FLCC) Alliance has long called for the rapid introduction of Ivermectin to curb infections that have killed 621,900 Americans and are still claiming up to 300 new deaths a day.
US critical care physician Dr Pierre Kory, who has called Ivermectin “miraculous” and a “wonder drug,” gained widespread attention last year when he charged that suppression of its efficacy had caused the “crime of the century.”
Whatever the eventual outcome, the Ivermectin debate puts a spotlight on the disparity in vaccine access for low and middle-income countries, with Indonesia struggling to find sufficient supplies for its 270 million population.
“The consequences of global healthcare inequality are clear,” says Darcy Jiminez, writing in Pharmaceutical Technology. “If life-saving vaccines aren’t available, people will be driven to take matters into their own hands – with potentially catastrophic results.”