Saving pigs but not kids

After intense lobbying on the part of affected industry stakeholders for approval of the African swine flu (ASF) vaccine, the Food and Drug Administration (FDA) has finally but “conditionally” issued “a two-year Certificate of Product Registration (CPR) under monitored release with specific conditions and is subject to annual evaluation,” according to FDA director general Samuel A. Zacate.

This recent development has endeared DG Zacate with the livestock industry that recently recognized him as a Haligi ng Agri Siyensa or Pillar of Agri-Science. Sadly, this recent approval comes with many lessons to consider for 2025.

First is “Mabuti pa ang baboy may bakuna na,” The loss of millions of pigs got more priority than the lives of approximately 1,220 Filipino men, women and children who died from dengue in 2024 for one simple reason – the hog and feed industry lobbied hard while the Japanese dengue vaccine manufacturer remained circumspect and polite, patiently waiting on the FDA for almost two years to do their work.

If Filipinos want to get results from the FDA, they must push, pressure and lobby for the FDA officials to put the equivalent speed in their work directly proportional to their caution or playing safe.

Looking back to the COVID-19 pandemic, I am reminded of the fact that when the FDA was subjected to public pressure online, as well as by the media and politicians, they fast-tracked test and approvals based on compassionate use.

While hog raisers and bacon lovers celebrate the breakthrough ASF vaccine, the bad news is, if it took the FDA two years to process and “conditionally” approve a vaccine for pigs, is it safe to say that it will take a total of three or four years for the FDA to approve the Qdenga vaccine or TAK-003? Do we now take out memorial plans and dig graves for another 1,000-plus Filipinos nationwide who might die from dengue in 2025?

Last 2024 there were a total 340,860 cases of dengue recorded from January to November, while 881 Filipinos died due to dengue. According to a long-time veteran at the DOH, the numbers by year-end went over 400,000 cases, with approximately 1,220 individuals dying due to dengue.

Given such numbers, can the PhilHealth and the DOH handle and finance the cost of dengue-related claims for another year, given they have no new additional budget? From January to June 2024, the PhilHealth paid out almost P1.02 billion for 102,322 dengue-related claims.

By November, the cases were 340,000. By end of 2024, 400,000 plus. At times four, you have 409,288 claims costing approximately P4.8 billion (guesstimate). That will hurt PhilHealth’s delivery of services for sure.

Secretary Ted Herbosa failed to deliver on his claim that the new Japanese dengue vaccine Qdenga would be out in a year. Instead, the product review has been ongoing for close to two years or way past the time limitations set for government review. The evaluation for quality took nearly 18 months; now, an insider says, it will be another year for “safety” evaluation and maybe the same for “efficacy.”

Is it true that the FDA will drag its feet until President Bongbong has safely left Malacañang in 2028 to avoid another Dengvaxia controversy or are there “secret anti-vaxxer agents” at the FDA?

President Bongbong Marcos was recently quoted as saying to Secretary Ted Herbosa “to shift the DOH’s focus from cure to prevention as “an ounce of prevention is better than a pound of cure.” Someone should tell him that a two-dose vaccine weighs approximately 0.03 of an ounce.

It is cheaper in the long run than the estimated P4-billion price tag for dengue in 2024. More importantly, HOW MANY MORE FILIPINOS NEED TO DIE before the FDA develops a sense of urgency? Unfortunately, only the President can cure the FDA and the DOH of all the red tape and delays.

Perhaps PBBM should also ask his staff to check on how many cases or complaints have been filed against the FDA with the ARTA? I was told that in a “kapihan” event, a high-ranking lady official of the FDA appealed to the audience (where many unhappy clients were in attendance) to please be patient and more understanding of the FDA.

The official’s appeal was valid since the FDA is under-manned despite spending so much money for their new building. The FDA has to call in outside experts to review various food, preparations and drugs being submitted to the agency for approval.

The fact that they must review both agricultural and non-agricultural products has created a burden that causes delays and huge inefficiencies in the agency’s work output, thus the stream of ARTA cases.

But while the public understands the situation, the FDA is its worst enemy because of its lack of transparency, being inconsiderate of the concerns, pressure and costs incurred by various companies and corporations whose activities are hamstrung or seriously delayed by the FDA’s tedious and deliberate processing, not to mention their indifference to the death and suffering of dengue patients each year.

One employee whose job is government relations with the FDA told me: “Gets namin that they have a lot of work. But do they ever stop to think that just like them, we are also employees with unhappy bosses who are second guessing if we are just making excuses or if we are doing our job? In government they keep their jobs, kami replaced or tangal sa trabaho.”

It is not just about vaccines, what about cancer patients, blood disorders or mental health patients who could benefit from the other products languishing at the FDA?

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