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Sanofi Rejects Refund, Indemnity
OFFERINGS – School children who received Dengvaxia shots offer flowers Monday at the makeshift shrine at the Public Attorney’s Office for 15 students who were also inoculated and whose deaths are being investigated by PAO. Below, Health Secretary Francisco Duque (left) and Sanofi head for Asia Pacific Thomas Triomphe at Monday’s House hearing on the vaccine controversy. (Alvin Kasiban and Kevin Tristan Espiritu)
February 6th, 2018 | 12:33 PM | 1328 views
DOJ won’t stop PAO from conducting autopsies of children who died of Dengvaxia vaccine
Sanofi Pasteur, the French pharmaceutical firm behind Dengvaxia, rejected yesterday an appeal from the Philippine government to refund about P1.8 billion in payment for used doses of its controversial anti-dengue vaccine and put up an indemnity fund for those administered with the vaccine, who later developed serious or fatal cases of dengue.
“This morning Sanofi Pasteur responded to the Department of Health’s (DOH’s) request that we refund the government for the used doses of Dengvaxia and financially support an indemnification fund. In our letter to the Department of Health we respectfully declined both requests,” the Sanofi said in an official statement sent to the press.
At yesterday’s joint House panel hearing on the Dengvaxia mess, Sanofi Asia-Pacific head Thomas Triomphe confirmed that they have declined the requests from DOH Secretary Francisco Duque III.2
“The reason why (we are declining) is because doing so would imply that the product is ineffective, [and] does not provide the effect provided, which actually is not the case,” Triomphe told the joint Committees on Good Government and Public Accountability and Health conducting the probe.
Last November, Sanofi announced new findings on its Dengvaxia vaccine. It stated: “For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection.”
This has raised a furor over the government’s mass immunization program which was implemented since 2016 at the time of the Aquino Administration in which around 830,000 children were vaccinated.
“As you know today, by using Dengvaxia in the Philippines… will make sure that there are less dengue cases than not using Dengvaxia. We stand behind the efficacy and safety of the product. And that is why we are not reimbursing the already used doses,” Triomphe told legislators, as he explained further the his firm’s refusal to refund P1.8-billion worth of used Dengvaxia vaccines.
Sanofi also explained why it had decided earlier to reimburse to the Philippine government the unused doses of Dengvaxia. “When Sanofi Pasteur agreed to reimburse the Philippine government for unused doses of Dengvaxia, we did so to show our continued commitment to cooperate with the Department of Health in ensuring the best possible health outcomes for the people of the Philippines. This decision was not due to any safety or quality concerns about the Dengvaxia vaccine,” it said in a statement.
Duque told congressmen that they have properly received the pharmaceutical agency’s earlier reimbursement of P1.16 billion for the unused Dengvaxia vaccines.
He said the amount has been reverted to the national treasury.
Likewise, Duque said the unused P500 million-plus that had been allocated for the supposed anti-dengue immunization program had also been returned to government coffers.
The Philippines became the first country in the world to launch in April, 2016 a public inoculation plan against dengue using Dengvaxia, but it was stopped following the new findings published by Sanofi.
Since then, 29 deaths among those vaccinated have been recorded.
Still, Sanofi said it would provide free doses to children who previously received at least a dose of the three-dose vaccination program.
“If the Department of Health decides to reinstate the community-based dengue vaccination program following a more complete evaluation of the new data on the vaccine, Sanofi Pasteur would be willing to provide new doses of the vaccine free of charge. These new doses would allow people who previously received one or two doses of the vaccine in the public program to complete the three-dose schedule and, thus, have the opportunity to benefit from the full potential of Dengvaxia’s ability to protect against dengue,” the company assured.
Meanwhile, it explained that it will not support an indemnification fund as there are no safety concerns about the vaccine.
“As for the indemnification fund, there are no safety or quality concerns about the Dengvaxia vaccine. The UP-PGH expert panel declared again on Friday that there is no evidence directly linking the Dengvaxia vaccine to any of the 14 deaths. Sanofi Pasteur has always followed the highest ethical standards and should there be any case of injury due to dengue that has been demonstrated by credible scientific evidence to be causally related to vaccination, we will assume responsibility,” it said.
Senior administration congressmen yesterday called on the DOH to initiate immediately the process of blacklisting Sanofi from conducting future pharmaceutical sales with the government.
This developed as opposition Rep. Lito Atienza (Buhay Partlylist) demanded the presence of former Budget Secretary Florencio Abad and representatives of former President Benigno Aquino III in the next hearing of the Dengvaxia probe.
Ako Bicol Rep. Rodel Batocabe aired the appeal as he lashed at the French pharmaceutical firm for rejecting demands for the refund of payment made by government in the purchase of the vaccines.
Complaint vs DOH officials
Meanwhile, the Volunteers Against Crime and Corruption (VACC) and the Vanguard of the Philippine Constitution, Inc., (VPCI) yesterday filed a joint administrative complaint against six officials of the DOH before the Office of the President over the dengvaxia mess.
Roque welcomed the joint administrative complaint against DOH undersecretaries Carol Tanio, Gerardo Bayugo, Lilibeth David, and Mario Villaverde; and assistant secretaries Lyndon Lee Suy, and Nestor Santiago.
Also included in the complaint are Financial and Management Service (FMS) Director Laureano Cruz; OIC Directors Joyce Ducusin, and Mar Wynn Bello; Director IV Leonila Gorgolon, Rio Magpantay, and Ariel Valencia; and Director Julius Lecciones.
“Very good, because I’d like to know the reasons, too,” Roque said during the Palace briefing.
The VACC and the VPCI are also calling for the dismissal from service of the respondents for grave misconduct and gross negligence for “ill-advisedly, thoughtlessly, and imprudently implementing” the school-based dengue vaccination program.”
Malacañang rejected the appeal of former Health Secretary Esperanza Cabral to stop the autopsy conducted on the bodies of children who allegedly died after getting Dengvaxia shots.
Cabral and the Doctors for Public Welfare (DPW) made a similar call on the Department of Justice to order the Public Attorney’s Office (PAO) to stop the autopsy on children and leave the matter of determining the cause of death to competent experts.
“The PAO must show that they did perform the right process of examination on the exhumed bodies of the deceased kids,” said Dr. Francisco Tranquilino of the DPW.
“Hindi mo kasi maaring sabihin kaagad na ‘pag kinuha mo organ sa katawan ng tao dun sa cadaver kahit ba nakita mo may hemmorrhage ay sabihin mo na kaagad dahil ito sa dengvaxia…. ‘Di maaring pag nakuha mo ang organ nakita mo may dugo sabihin mo dengue yan kasi dengue namamatay sa hemorrhage. Hindi maaring gano’n (You cannot immediately say that the death is caused by dengvaxia when you see hemorrhage in the organ under examination. Not because you see blood, you conclude that it is already dengue because of the hemorrhage. It’s not that way),” Tranquilino explained.
“We are flatly rejecting the call to stop autopsies. We will perform autopsies as they are required, because we need to find the truth,” Roque said, adding government will exercise all options until the truth is reached.
“We will proceed with the autopsies because the UP-PGH (University of the Philippines-Philippine General Hospital) study itself said that autopsy may have to be conducted on the three,” he added.
Roque was referring to the PGH-Dengue Investigative Task Force (DITF) report which revealed that three of the 14 child victims died of dengue. Two of the three child deaths “may have been on account of vaccine failure,” the report added.
Justice Secretary Vitaliano Aguirre II said he will not stop the PAO from conducting autopsies of children who were suspected to have died after receiving the vaccine.
“I have no order to stop the autopsies,” said Aguirre yesterday. “But I welcome the group of Sec. Cabral to give its written position to us why the autopsies should be stopped,” he added.
Roque said UP-PGH, PAO, or even the National Bureau of Investigation (NBI) can conduct the autopsies as long as it is done by a government physician affiliated either with the public hospital or the NBI.
“We’re not telling anyone to stop what they are doing. We are just saying that we are flatly rejecting the call of the physicians to put an end to the exhumation because the position of the government is we’re in search of the truth; we will resort to autopsy when it is needed,” he said.
courtesy of MANILA BULLETIN
by Charina Clarisse L. Echaluce and Ellson A. Quismorio
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