The letter to PBBM

Given the horror stories I’ve heard of how letters addressed to PBBM tend to disappear in the Bermuda grass in Malacañang, intercepted or undelivered, I thought it best to reprint a very important letter to PBBM in this column.

The letter is from the Philippine Medical Association, triggered by the dengue outbreak in Quezon City and other outbreaks that are about to be declared in eight other hot spots in three regions.

There are other reasons that I will cite after the letter that will surely make our readers curious, so please read on.

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Your Excellency:

Dengue continues to be a major public health concern in the Philippines with over 380,000 cases (81 percent increase vs previous year) and 881 deaths in the Philippines from January to November 2024.

Philippines continues to be number one in Southeast Asia in terms of dengue cases and deaths consistently in the past years up to the present. The disease poses significant economic burden with at least P2-billion allocation by PhilHealth every year for dengue hospitalization.
We appreciate the efforts of the government to eradicate the disease by prevention strategies such as the 5S. However, these prevention strategies have been in existence since 1993 – that is 32 years since the establishment of the national dengue prevention and control program in 1993.

Despite these efforts, dengue remains to be a public health concern, with rising cases all year round. We need to consider other innovative strategies available to address dengue.

The World Health Organization (WHO) recommends a multi-pronged approach to dengue prevention and control that includes dengue immunization aside from vector control and clinical management.
We understand that safety of dengue vaccines is of utmost concern because of our previous experience with CYD-TDV (Dengvaxia). With recent advances in vaccine technology, there are new generation dengue vaccines in the market or in Phase 3 clinical trial, which showed promise in terms of vaccine effectiveness and safety.

There is one new generation dengue vaccine that has been licensed in more than 40 countries including Indonesia, Brazil and European Union, which is the Tak-003 from the Japanese manufacturer Takeda.

Tak-003 has been recommended by WHO for dengue prevention in highly endemic countries like the Philippines. This vaccine has pending application with the Philippine FDA since April 2023.

Having witnessed the devastating impact of dengue on our patients and their families, we strongly urge the government to grant access to these new generation dengue vaccines and allow Filipinos the right to protect themselves from this dreadful disease, as enshrined in the Philippine Constitution. – Philippine Medical Association

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Given the authority and eminent status of the Philippine Medical Association and its 28,000 members (Google), the hope is that President Bongbong Marcos will take a close look at what is causing the delay in the review and processing of the NEW dengue vaccine made by Takeda Pharmaceutical of Japan.

If the country’s largest representation of medical experts is calling for faster review and evaluation of a much-needed vaccine, the letter to the President calls attention to the fact that the FDA is overwhelmed by the challenge and demands that come from their work and responsibility.

The FDA is underfunded, forcing them to charge P45,000 for every application, and if the same product comes in different sizes or volumes, each variant is charged P45,000 under the new FDA rates.

A Certificate of Product Registration costs P215,000, plus the P45,000 = P260,000 per product, not including months and months of employees monitoring and asking “insiders” about their product status. So don’t blame companies for losing patience over delays.

But more than the high prices, what has been infuriating companies both local and international, even before the PBBM administration, are the year-long delays in reviewing medicines for critical care such as for cancer.

In the case of the dengue vaccine, I learned that Dengvaxia was licensed in six months. The Qdenga or Tak-003 vaccine of Takeda has been “pending” for 22 months or nearly two years and only the “initial review” has been done. At that rate, the review will indeed last until 2028 when PBBM has left office.

The FDA is undermanned, they have a serious lack of equipment and expertise relative to the volume and non-stop applications for food and drugs intended for the Philippine market. The FDA does not have sufficient full-time experts and regularly relies on external experts or consultants.

They are dependent on scientists and physicians who, because of their skills and knowledge, are also involved or leading other medical and scientific institutions, many of them from government universities and hospitals.

The FDA should have full-time, in-house experts and regular reviewers in order to speed up reviews and studies of products submitted to the agency. Having to call in and wait for the availability of expert panels is time consuming.

If the FDA is in dire need of clinical and scientific experts, it follows that it also needs high caliber leaders and executives in charge of the institution and given tenure or fixed residency and not co-terminus political appointments.

Now that the Philippine Medical Association has written a letter to the President, let’s all hope that the situation will call the President’s attention enough to investigate the matter personally.

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