Boxes of Dengvaxia stored at the Research Institute for Tropical Medicine (RITM) in Muntinlupa City. ABS-CBN News file photo

MANILA - "Bad science" is the root of the problem regarding the dengue vaccine causing a health scare in the country, a specialist who was among the first to raise red flags about it, said Thursday.

Dr. Antonio Dans, a scientist at the National Academy of Science and Technology, said there had been "strong signals" of harm in patients who had not contracted the dengue infection many years ago, but "it was ignored initially and it led to a delayed recognition of that harm, and the end result is that we have patients who were uninformed."

He said there had been debates among scientists whether the efficacy of the Dengvaxia vaccine, which was used by the Department of Health in its immunization program in 2016, was an age-issue or a sero-status issue.

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"It’s an issue of whether patients had previous dengue infection or not. That signal was ignored, and in our opinion, we are all victims of that bad science," Dans told lawmakers.

"The main issue that led to the whole problem is the bad science and the bad science, we think, that whatever legislation that comes from here should address how the science was assessed, and there should be a separation between people assessing the science and people rendering policy," he said.

Dans thus proposed to make the Food and Drug Authority independent from the Department of Health.

He said scientists at the Formulary Executive Council (FEC), which recommends medicines procured by the government and implemented in its health programs, knew of this and pointed out the problems.

Like the FEC, the Food and Drug Administration, which approves medicine and food sold to the public, is also an attached agency of the DOH.

"Because there was no adequate separation between policy and science, the Food and Drug Administration is under the Department of Health, then we lose that check and balance," he said.

"I feel that assessment of the science should be separate from policy; the FDA should not be under the Department of Health and should be a separate institution, independent from DOH," he added.

The Senate is investigating the purchase of P3.5-billion worth of the Dengvaxia vaccine after manufacturer Sanofi Pasteur admitted it may cause severe cases of dengue if given to those who have not had the mosquito-borne disease.