DOJ indicts ex-DOH chief Garin, et al. for Dengvaxia ‘mess’

By: Tetch Torres-Tupas - Reporter / @T2TupasINQ

INQUIRER.net / 03:05 PM March 01, 2019

DOJ indicts ex-DOH chief Garin, et al. for Dengvaxia 'mess'

In this June 4, 2018 photo, former Health Secretary Janette Garin attends preliminary hearing on the Dengvaxia issue together with former Budget Secretary Butch Abad and former President Noynoy Aquino at the DOJ. INQUIRER file photo / MARIANNE BERMUDEZ

MANILA, Philippine–For “inexcusable lack of precaution and foresight,” former Health Secretary Janette Garin and several others were indicted by the Department of Justice (DOJ) for reckless imprudence resulting to homicide for the deaths of schoolchildren linked to the controversial Dengvaxia vaccine.

In its 127-page resolution dated February 11, 2019 but released to the public Friday, the DOJ said Garin and the other respondents “have exhibited inexcusable lack of precaution and foresight when they facilitated with undue haste, the registration and purchase of Dengvaxia and used the vaccine in implementing a school-based dengue mass immunization program.”

Aside from Garin, the other personalities facing eight counts of reckless imprudence resulting to homicide are doctors from the Department of Health (DOH) namely Vicente Belizario Jr., Kenneth Hartigan-Go, Gerardo Bayugo, Lyndon Lee Suy, Irma L. Asuncion, Julius A. Lecciones, Maria Joyce Ducusin, Rosalind Vianzon and Mario Baquilod.

Others facing eight counts of reckless imprudence resulting to homicide are Dr. Socorro Lupisan and Dr. Maria Rosario Capeding of the Research Institute for Tropical Medicine (RITM) and officials of Sanofi Pasteur Inc. Carlito Realuyo, Stanislas Camart, Jean Louis Grunwald, Jean Francois Vacherand, Conchita Santos and Jazel Anne Calvo. Sanofi is the manufacturer of the Dengvaxia shots.

Meanwhile, Maria Lourdes Santiago and Melody Zamudio of the Food and Drug Admnistration (FDA) are facing four counts of reckless imprudence resulting to homicide.

The Public Attorneys’ Office’s forensic team has conducted examination on the children who died after being inoculated with the Dengvaxia. PAO filed a string of criminal complaints against Garin, other former and incumbent health officials, as well as those from Sanofi.

The DOJ said Garin and the other respondents “circumvented various regulations” to purchase the vaccine in 2016 even when it has yet to undergo complete laboratory testing.

The DOJ panel led by Senior Assistant State Prosecutor Ma. Emilia Victorio stated in the resolution that at the time of the purchase, the Dengvaxia vaccine was not listed in the so-called Philippine National Drug Formulary (PNDF).

Under Republic Act 9502 or the Universally Accessible Cheaper and Quality Medicines Act of 2008, the government is prohibited from procuring drugs and medicines not under PNDF.

If not under PNDF, the approval of the Formulary Executive Committee (FEC) is required and to get its approval, the medicine’s safety and efficacy must be established. The DOJ panel noted that records of FEC deliberations showed that the committee labeled Dengvaxia’s safety as “low.” However, Dengvaxia still managed to get an approval although it was only provisional.

The DOJ panel also noted that the implementation of the mass immunization program was also “careless” with only Barangay Health workers administering the vaccine despite lack of information about the recipient.

Sanofi, according to the DOJ should have also monitored the Dengvaxia recipients.

The DOJ said Garin and the others “totally disregarded the identified risks and adverse effects of the vaccine.”

This is Garin’s first indictment for the Dengvaxia vaccine mess. /jpv