DOH, FDA clarify claims on the approval of potential Covid-19 treatments and calls for resignation of the SOH
By DOH and FDA
MANILA, Apr. 5 — The Department of Health (DOH) and the Food and Drugs Administration (FDA) clarified claims on the approval of potential COVID-19 treatments and the call for the resignation of the Secretary of Health.
ON THE INITIAL BANNING OF LIANHUA QINGWEN
The DOH and the FDA would like to clarify that Lianhua Qingwen is a prescription medicine approved by FDA in the Philippines but is not registered as a COVID-19 medication. Moreover, the role of the FDA, as per Republic Act (R.A.). 3720, is to license, monitor, and regulate medicines like Lianhua Qingwen for the safety of Filipinos. Any food or medicinal products not registered in the Philippines should not be sold and are subject to seizure or confiscation hence the FDA issued Advisory No. 2020-767 before the registration of Lianhua Qingwen.
It was only on 7 August 2020 that Lianhua Qingwen was able to acquire FDA registration but for purposes of being used as a traditional herbal product that helps remove “heat-toxin invasion of the lungs, including symptoms such as fever, aversion to cold, muscle soreness, stuffy and runny nose”. Additionally, the use of Lianhua Qingwen is only allowed with a doctor’s prescription.
ON BANNING OF IVERMECTIN
All current Ivermectin products registered in the country are for veterinary use and are only allowed for the treatment of internal and external parasites as well as prevention of heartworm disease in animals hence the issuance of FDA Advisory No. 2021-0526. The FDA is currently processing an application filed on 31 March for product registration from concerned parties.
Moreover, studies from The Philippine COVID-19 Living CPG Reviewers of a systematic review of 6 randomized controlled trials showed that:
1.Ivermectin DID NOT SIGNIFICANTLY REDUCE the risk of mortality among patients with mild to severe COVID-19 cases;
2. Ivermectin was NOT ASSOCIATED with a definite benefit of other clinically important outcomes such as clinical improvement at Day 6-10, clinical deterioration, and need for mechanical ventilation;
3. Ivermectin DID NOT SIGNIFICANTLY REDUCE the duration of hospitalization and the time to resolution of symptoms; and
4. The Rate of hospitalization discharge DID NOT DIFFER SIGNIFICANTLY between the ivermectin group and the placebo group;
Based on the current evidence from randomized controlled trials, the DOH agrees with the COVID-19 Living CPG Reviewers and does not recommend the use of Ivermectin for the treatment of COVID-19. Moreover, Dr. Rabindra Abeyasinghe, World Health Organization (WHO) Representative to the Philippines, has stated that there is no evidence that supports the use of ivermectin to treat COVID-19, even as a preventive measure. The use of ivermectin for COVID-19 has to be evaluated through clinical trials.
The DOH and FDA are open to allowing pharmacies for compounding Ivermectin. Moreover, we, the DOH and FDA, as well as Malacañan put the safety of Filipinos first before allowing unproven and uncertified medicines in the country.
ON PRICE DIFFERENCE OF INDIA AND PH MEDICINES
The Philippines is importing medicines from India and making them available to lower-income households through village pharmacies through R.A. 9502 or Cheaper Medicines Act. Additionally, a Philippine Institute for Development Studies (PIDS) policy note explains that India has cheaper medicines since it is the home market effect. India is the second most populated country in the world and is a large home market for medicines hence, giving it an advantage in medicine prices compared to other countries.
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 Tocilzumab are not yet recommended for the use of mild and asymptomatic cases. The WHO has yet set 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. Remedesivir is used under Compassionate Special Permit and Tocilizumab is a registered anti-inflammatory drug.
ON CALLING FOR THE RESIGNATION OF THE SECRETARY OF HEALTH
The entire DOH fully supports Secretary Francisco Duque III in handling the COVID-19 pandemic. Despite criticism, the DOH is still working hard to serve our countrymen and ending the COVID-19 pandemic. Furthermore, President Rodrigo Duterte has also expressed his continuing support for the Secretary of Health even with the calls for resignation.
The DOH calls on everyone to be a BIDA+ citizen and share only verified information with the public. Being a BIDA+ citizen is not just observing the MPHS but also fighting disinformation regarding the COVID-19 pandemic. Sharing misleading and unverified information with the public may lead to panic and further lives claimed by COVID-19. By being a BIDA+ citizen, together, we can curb the transmission and spread of COVID-19. (DOH and FDA)
