"What are we to make of the actions of Duque and Domingo?"
Ever since reports of ivermectin as having potential prevention and treatment properties for COVID-19 began surfacing, both the Department of Health and the Food and Drug Administration headed by Francisco Duque and Eric Domingo, respectively, have been consistent in blocking the potential pandemic game changer while promoting more expensive drugs.
In fact, this puzzling position of both agencies prompted Anakalusugan Rep. Michael “Idol” Defensor to opine that “the strong reaction of people against the crackdown on ivermectin is understandable as while the DoH and FDA continue to harp on the law as the escape goat, they themselves violate the law themselves and the pronouncements of the World Health Organization.”
According to Defensor, a friend of his messaged him saying she had to pay P300,000 pesos for her COVID hospitalization because of her P13,000 per injection for Remdesivir even when it was already rejected by WHO in November of last year.
“We were part of the WHO Solidarity trial and yet we do not follow the recommendations and continue to allow Remdesivir to be given to patients. For Remdesivir we don’t follow and DOH continues to purchase but for ivermectin where data is still inconclusive and clinical trials are allowed, we crackdown on the supply,” Defensor said.
In November last year, WHO issued a conditional recommendation against the use of Remdesivir in hospitalized patients, regardless of disease severity, as there is currently no evidence that Remdesivir improves survival and other outcomes in these patients.
According to WHO, only corticosteroids have so far been proven effective against severe and critical COVID-19.
“We now have evidence from several large-scale international trials on Remdesivir, hydroxychloroquine, lopinavir/ritonavir, and interferon beta. Unfortunately, the trials showed that none of these interventions had a meaningful effect on any patient important outcomes,” read WHO’s statement.
Defensor even quoted WHO’s other studies regarding drugs being used by DoH and granted permit by the FDA for use on COVID-19 patients in the country:
“The Solidarity Trial published interim results on 15 October 2020. It found that all four treatments evaluated (Remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon) had little or no effect on overall mortality, initiation of ventilation and duration of hospital stay in hospitalized patients.”
As for tocilizumab, the cost is about $2,000 per patient from the information I have gathered. Although, I have not read any official recommendation by the WHO, the same report states:
“95-percent credible intervals included both substantial benefit and harm for azithromycin, colchicine, favipiravir, hydroxychloroquine plus azithromycin, and tocilizumab -26- (all very low certainty).”
Defensor also noted that tocilizumab is used for arthritis and has recorded thousands of adverse effects with its use, which means the DoH is allowing use of off-label drugs or drugs being used for purposes other than its original intent.
As such, it would be quite normal for some sectors to believe that there could be someone or some group which is benefitting from the use of these expensive drugs.
Of course, both the DoH and the FDA are quick to refute these allegations, issuing a statement to that effect, which Defensor shared with us.
“The DOH and FDA categorically deny the insinuation that there are people from the department who financially benefit from the use of Remdesivir and tocilizumab. The use of Remdesivir and tocilizumab are based on WHO Solidarity Trials and are used only for critical and severe COVID-19 cases. Remdesivir and tocilizumab are not yet recommended for the use of mild and asymptomatic cases,” read the statement.
However, the statement added that “the WHO has yet to set the appropriate treatment of COVID-19 patients and these are used to help in discovering effective therapeutics for COVID-19. Moreover, the Philippine Society for Microbiology and Infectious Diseases (PSMID) COVID-19 Living Recommendations suggest the use of Remdesivir and tocilizumab as a treatment for patients with critical and severe COVID-19 cases. Remdesivir is used under Compassionate Special Permit and tocilizumab is a registered anti-inflammatory drug.”
Clearly, the DoH and the FDA are using WHO’s position against ivermectin as it suits them, but not WHO’s recommendation on Remdesivir and other expensive drugs. And it doesn’t add up. Can they blame the people for accusing them of making something out of those expensive drugs?
According to Defensor, the DoH continues to spend hundreds of millions (maybe billions now) of pesos to buy Remdesivir and tocilizumab not to mention the purchase of private hospitals, which of course will be charged to Philhealth.
Defensor stresses that the FDA law, in theory, is to protect our people in the use of drugs.
“That is why there is a process for drug registration, labelling, and marketing among others. The law also allows for flexibility in times of a public health crisis such as the one we are experiencing. The Compassionate Special Permit and Emergency Use Authorization are, in fact, exemptions from the provisions of the law in recognition of the pandemic which is infecting so much of us and killing our people,” he explains.
The solon says that so far, there have been two administrative orders signed by the DoH as regards in this regard, the first one was signed by former Sec. Juan Flavier in 1992 and the other one signed by Duque in July of 2020.
“These AOs provide them latitude to use such drugs as Remdesivir and tocilizumab and approve vaccines that are given to our people to date,” he says.
“But what about ivermectin?” Defensor asks as he noted “the drug is listed in the WHO, US FDA and the Philippines FDA essential list of drugs. It is considered a wonder drug along with penicillin and aspirin and considered one of the safest with a testimony spanning for 40 years and has a 3.7 B dosage on record.”
While the argument is that there is no registered drug, Defensor says is true, it is because for many years it was donated for river blindness and other parasitic illness.
Now, can Duque or the FDA allow its production?
Defensor says yes, in the same manner that they have allowed the expensive drugs to be used. An AO, he says, allowing drug manufacturers to produce can be done.
“This then would allow them to import legally and not suffer from arrest and confiscation given the current policy of the DoH and FDA. The manufacturers can be monitored as for quality and more importantly on the studies which we hope will benefit our people and the global effort to stop COVID,” Defensor adds.
And with ivermectin costing only P35 per capsule making it affordable even for the poor, Defensor says the government need not drain the PhilHealth funds for it nor make families pay for their hospitalized loved ones.
Unfortunately, Duque’s and Domingo’s biases don’t see the wisdom on this. They prefer to have their biases favor the really expensive drugs, even if they don’t meet the standards of the WHO, which they are conveniently using in blocking ivermectin.