Undermining the FDA

SKETCHES - Ana Marie Pamintuan (The Philippine Star) - May 7, 2021 - 12:00am

In this ruinous, killer pandemic, our country’s drug regulator gets so little respect.

And the disrespect, unfortunately, starts from the top echelons of government.

There are the congressmen, giving away Ivermectin as COVID treatment and prophylaxis, despite reminders from the Department of Health (DOH) that the anti-parasitic drug is not yet authorized for this purpose, or even for human use, by the Food and Drug Administration.

FDA head Eric Domingo announced last month that President Duterte had ordered clinical trials to be conducted on the use of Ivermectin against COVID. This week Domingo said there are similar trials now underway in other countries. So we surmise that peer-reviewed results of those trials could come out much earlier than the projected six months in our country and speed up the approval process in the FDA.

In the meantime, there are suspicions that politics played a role in the FDA’s approval of Ivermectin for compassionate use as supplemental treatment for COVID in several hospitals.

The compassionate use authorization might have further emboldened the congressmen to step up their distribution of Ivermectin to the public. The distribution is assisted by physicians who say they just want to save lives, and who cite anecdotal evidence of the drug’s efficacy as a supplemental COVID treatment. Even Deputy Speaker Mikee Romero says that he takes Ivermectin as a prophylactic.

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The weakening of the FDA started much earlier, with what Defense Secretary Delfin Lorenzana described as the “smuggling” last year of vaccines developed by Chinese state-owned Sinopharm for use by the close-in security of President Duterte.

On orders of Duterte himself, the Presidential Security Group (PSG) has refused to face probes by the FDA and the Bureau of Customs regarding the smuggling.

Sinopharm applied for emergency use authorization for its COVID vaccine only last March 1. This was over two weeks after the FDA granted compassionate use authorization to the PSG for 10,000 Sinopharm jabs.

In the case of the jab used on Duterte, the FDA said it was never notified about the arrival of the vaccine. It turned out that 1,000 doses were donated by the Chinese government through its embassy to the PSG. How were the vaccines transported? In a Chinese navy submarine from Panganiban (Mischief) Reef? By diplomatic pouch?

President Duterte became an eager recipient of the donation, with his shot administered by his “hero” of the pandemic, the DOH secretary himself who has supervision over the FDA.

Malacañang explained that the compassionate use authorization granted to the PSG in February for the Sinopharm jab extended to their principal. Duterte, nevertheless, apologized and ordered the rest of the donated vaccines returned to sender, except one dose for his second shot.

If we ever manage to develop our own vaccine against COVID-19, like Vietnam and Thailand are doing, we’re sure to have a tough time getting international recognition of its efficacy.

This also goes for any product developed by our domestic pharmaceutical industry – unless the clinical trials and testing are partly supervised and vetted directly by any of the handful of stringent regulatory authorities or SRAs abroad recognized by the World Health Organization.

Why? Because our FDA, the regulatory authority for all medicines, supplements and other pharmaceutical products in our country, is looking increasingly useless in this pandemic.

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The FDA, which is under the DOH, has its share of critics. Industry players decry red tape and its snail-paced procedures for approving pharmaceutical products for entry, sale or distribution and use in the Philippines even during a once-in-a-century pandemic.

Recently, eyebrows were raised when it was reported that FDA members must first visit the production site of the Gamaleya Research Institute in Moscow to assess whether the Russian-made Sputnik V vaccine should get an EUA in the Philippines.

I don’t know if the trip pushed through. But the report elicited snide remarks about junketing even in the middle of a pandemic. The Sputnik V jab has not been approved by the SRAs. But it has been peer-reviewed and the findings published in the respected medical journal The Lancet, which declared that the Russian jab has a 91.6 percent efficacy against COVID. That’s even higher than the efficacy of the vaccine produced by British-Swedish pharma AstraZeneca and the University of Oxford.

Despite the complaints and criticisms, it’s still the country’s FDA, and its mandate must be strengthened rather than eroded. And public officials must set the example in according it respect.

Esperanza Cabral, who was social welfare chief and then health secretary during the administration of Duterte ally Gloria Macapagal-Arroyo, said one option for Eric Domingo as the FDA is emasculated is to resign.

Cabral, as social welfare chief, had pushed for the launch of the conditional cash transfer or 4Ps to alleviate poverty. Asked to assess the government’s COVID pandemic response, she told us on “The Chiefs” last Wednesday on One News that it “needs improvement” – with a dismal score of 70.

Which are the weakest points in the response? Cabral said all the problems emanate from weak leadership. She pointed out that even the WHO has listed this as a critical component in effective response to the pandemic.

This weakness is evident in the erosion of the FDA’s authority.

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GOODBYE, RICKY: As if we didn’t have enough sickness, death and heartbreak around us, we in The STAR are mourning the loss of our Entertainment editor, Ricky Lo.

Ricky lived and breathed show business and he was unparalleled in Philippine entertainment journalism. Despite his renown, he was always humble, soft-spoken, funny, gentle and always ready to help in any way he could. My mother and I knew him since my youth and I will miss him terribly.

Ricky Lo is a grievous loss to The STAR. Rest in peace, dearest Ricky. This long, evil night will eventually come to pass. Until we meet again!

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