By Vann Marlo M. Villegas, Reporter
THE Department of Justice (DoJ) indicted former health secretary Janette P. Loreto-Garin and 19 others for reckless imprudence resulting in homicide over eight complaints in relation to deaths allegedly linked to the Dengvaxia vaccination.
In a statement, the DoJ said a panel it had formed found that Ms. Garin and other respondents “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.”
“The Panel found sufficient evidence that Garin and the other respondents circumvented various regulations in the purchase of P3.5 (billion) worth of Dengvaxia vaccine which constituted proof of their reckless imprudence,” the DoJ said.
The DoJ said the panel of prosecutors led by Senior Assistant State Prosecutor Ma. Emilia L. Victorio found that when the Dengvaxia vaccine was purchased in March 2016, it was still not listed in the Philippine National Drug Formulary (PNDF) which is prohibited under the law.
Purchase of non-PNDF listed drugs must have the approval of the Formulary Executive Committee (FEC), which, according to the DoJ, said Dengvaxia’s safety for the most common type of dengue in the Philippines was deemed low.
But the FEC on Feb. 1, 2016 recommended provisional exemption of Dengvaxia from the PNDF requirement for one year, “conditioned upon a ‘post-license study to determine its long-term safety and effectiveness,’” according to the DoJ.
It also found that the FDA approved the registration of the vaccine December 2015, when clinical trials for the vaccine have not yet been completed. “Thereafter, Garin and other respondents fast-tracked its exemption from the PNDF-listing requirement, purchased the vaccines, and used it to vaccinate schoolchildren through the government’s mass immunization program.”
“The Panel concluded that Garin and the other respondents, most of whom are medical professionals, exhibited such degree of neglect when they ‘totally disregarded the identified risks and adverse effects of the vaccine.’ Said risks materialized with the death of the victims,” the DoJ said.
Indicted for all eight counts are Ms. Garin and health officials Vicente Belizario, Jr., Kenneth Hartigan-Go, Gerardo Bayugo, Lyndon Lee Suy, Irma L. Asuncion, Julius A. Lecciones, Maria Joyce U. Ducusin, Rosalind Vianzon, and Mario S. Baquilod.
Research Institute for Tropical Medicine officers Socorro Lupisan and Mario Rosario Capeding and Dengvaxia manufacturer Sanofi Pasteur, Inc. officers namely: Carlito Realuyo, Stanislas Camart, Jean Louis Grunwald, Jean Francois Vacherand, Conchita Santos and Jazel Calvo were also indicted.
Food and Drug Administration (FDA) officers Maria Lourdes Santiago and Melody Zamudio were charged with four counts only.
If convicted, penalties include imprisonment of up to six years.
DUQUE CLEARED
Meanwhile, the complaints against Health Secretary Francisco T. Duque III and officers of Dengvaxia distributor Zuellig Pharma Corp. were all dismissed.
The DoJ also dismissed for insufficiency of evidence the complaints against Mr. Duque for violation of the Anti-Torture Act and obstruction of justice.
For her part, Ms. Garin in a statement said she respects the decision of the prosecution but raised concern on its impact on “the already suffering DoH Immunization program.”
“People might think again that there is something wrong with the vaccine which is not true. Let us put primary importance to saving lives rather than politicking. The whole world is presently benefitting from the protection of the vaccine and even expanding its use. It is only the Philippines that has politicized the issue,” she said.
“I believe the criminal case is very weak because there is absolutely no evidence linking the vaccine to the deaths. We are confident in the dismissal of this case,” she added.
The FDA on Feb. 19 revoked permanently the registration of Dengvaxia, citing Sanofi Pasteur’s repeated noncompliance to submitting post-approval commitment documents.
The complaints are the first batch to be resolved out of a total of 35 pending complaints filed by families of alleged Dengvaxia victims, assisted by the Public Attorney’s Office.