The Department of Justice has recommended the indictment of former Health Secretary Janette Garin and 19 others for reckless imprudence resulting in homicide, in connection with the deaths of eight children allegedly after being inoculated with the anti-dengue vaccine Dengvaxia.
In a statement, the DOJ’s panel of prosecutors found probable cause to hold Garin and other respondents criminally liable for the deaths of eight children, arising from their “inexcusable lack of precaution and foresight.”
However, complaints against incumbent Health Secretary Francisco Duque III and officers of Zuellig Pharma Corp. were dismissed.
The panel said Garin and the others 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 also found sufficient evidence that Garin and the other respondents circumvented various regulations in the purchase of P3.5 billion worth of Dengvaxia. “which constituted proof of their reckless imprudence.”
The investigating prosecutors, who conducted the preliminary investigation on the complaints, said these in their 127-page resolution approved by Acting Prosecutor General Richard Anthony Fadullon.
The prosecutors also found sufficient basis to charge nine other officials from the Department of Health, two from the Food and Drug Administration, two from the Research Institute for Tropical Medicine, and six from vaccine maker Sanofi Pasteur for the same offense.
Aside from Garin, also indicted for eight counts of reckless imprudence resulting to homicide were Dr. Vicente Belizario Jr., Dr. Kenneth Hartigan-Go, Dr. Gerardo Bayugo, Dr. Lyndon Lee Suy, Dr. Irma Asuncion, Dr. Julius Lecciones, Dr. Maria Joyce Ducusin, Dr. Rosalind Vianzon and Dr. Mario Baquilod from the DOH;
Maria Lourdes Santiago and Melody Zamudio from the FDA; Dr. Socorro Lupisan and Dr. Maria Rosario Capeding from the RITM; and Carlito Realuyo, Stanislas Camart, Jean Louis Grunwald, Jean Francois Vacherand, Conchita Santos and Jazel Anne Calvo, all of Sanofi Pasteur Inc.
The resolution covers nine of 35 complaints filed mostly by parents of Dengvaxia recipients, who died of different causes.
Prosecutors have yet to resolve the remaining 26, which made similar allegations against the same set of respondents.
Meanwhile, the DOJ panel faulted Sanofi for failing to actively monitor and conduct close surveillance of Dengvaxia recipients. It also found that Sanofi did not extend medical assistance to the victims or their families even after reports of serious adverse reactions occurred.
In reaching its conclusion, the DOJ prosecutors held that reckless imprudence as a crime of neglect punishes those who exhibited “dangerous recklessness, the lack of care or foresight” as to the outcome of their actions.
“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 stressed.
If convicted, Garin and other respondents face a penalty of imprisonment of up to six years.
The DOH has repeatedly asserted that the supposed connection has not been proven.
The DOJ six-man investigating panel is composed of Senior Assistant State Prosecutor Ma. Emilia Victorio, Assistant State Prosecutors Christine Perolino, Susan Azarcon, and Alejandro Daguiso, and Associate Prosecution Attorneys Joan Carla Guevarra-Garcia and Jerome Coronel.
The panel said that at the time of its purchase by the government, Dengvaxia was not listed in the so-called Philippine National Drug Formulary. A purchase request for the vaccine was made as early as January 2016, but actual purchase was made in March 2016.
Republic Act No. 9502, the Universally Accessible Cheaper and Quality Medicines Act of 2008, prohibits the government from procuring drugs and medicines that are not included in the PNDF.
Meanwhile, Executive Order No. 49, Series 1999, requires PNDF listing before drug purchases by the government can be made.
To purchase drugs that are not PNDF-listed, the approval of a Formulary Executive Committee under the Health department is required.
Since government purchase of non-PNDF listed drugs is an exception rather than the rule, FEC approval requires that the medicine’s safety and efficacy are duly established, and that the medicine will be used for a national health program or for a current or potential urgent health situation.
Based on FEC deliberation made available to the DOJ panel, the Dengvaxia vaccine safety for dengue virus serotype 2, which is the common type of dengue in the Philipines, was low. One FEC member even noted its negative efficacy, indicating that the vaccine may be hazardous.
“Despite the foregoing, on February 1, 2016, FEC recommended the provisional exemption of Dengvaxia from PNDF requirement for one year, conditioned upon post-licensure study to determine its long-term safety and effectiveness,” the prosecutors noted.
The DOJ prosecutors also found out that clinical trials for Dengvaxia were not yet completed when it was purchased and rolled out for use in the mass immunization program. “But despite ongoing clinical trials, the FDA approved the vaccine’s registration,” the prosecutors noted.
The DOJ panels found that Sanofi submitted its application for the registration of Dengvaxia in January 2015. In December of the same year, FDA approved the marketing of Dengvaxia and issued its product registration, well before the completion of the two clinical trials.
READ: Aquino, Sanofi execs rapped over Dengvaxia
“Thereafter, Garin and other respondents fast-tracked its exemption from the PNDF listing requirement, purchased the vaccines and used it to vaccinate school children through the government’s mass immunization program,” the resolution stated.
The DOJ prosecutors also pointed out that Garin and other respondents were “careless” in implementing the mass immunization program.
“The registration issued to Dengvaxia classified it as a prescription drug. As such, it had to be administered by licensed physicians and nurses who were deemed to be in the best position to inform recepients regarding its nature and risk. Furthermore, those implementing the program were required to obtain the informed consent of its recipients,” the DOJ said.
READ: FDA revokes Dengvaxia certificate
Also, the DOJ clarified that the finding of neglect against those who administered the immunization program using Dengvaxia should not, in anyway, be used to stoke public fear of vaccination.
“The resolution reiterates the high degree of accountability and caution demanded of those who adopt and implement policies and programs involving public health,” the DOJ statement stressed.
“Holding to account those who neglect to discharge their duties to the public with utmost caution and competence is the best deterrents against the repetition in the future of the criminal neglect exhibited by respondents.”
“It is likewise the best assurance that all government health programs—immunization drive included—will conform to the highest standards of safety and efficacy,” the DOJ said.
