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Garin admits meeting Sanofi execs in Paris, says there’s nothing wrong with briefing

Former Health Secretary Janette Garin on Friday admitted meeting executives of Sanofi Pasteur in Paris sometime in 2015.

Sanofi Pasteur is the manufacturer of the controversial dengue vaccine Dengvaxia.

Garin said the briefing on Dengvaxia with the firm's executives was above board as she was with officials not only of the Department of Health but also those from the Department of Foreign Affairs.

"Kung may malisya yun, eh bakit all throughout meron kaming kasamang kasamahan natin sa Department of Foreign Affairs?" Garin said in an interview on ANC.

"Yung una po talaga kasing intensyon, andun yung paguusap na labas ba ang bakuna, kailan ba, magkano ba talaga ang presyo?" she added.

Garin said she made a mistake in denying ever meeting with officials from vaccine manufacturer Sanofi Pasteur in Paris in 2015.

"Nagkamali po talaga ako kasi I was being asked about a dinner that happened two years ago," Garin said.

The government's dengue vaccine program using Dengvaxia has been put on hold after Sanofi Pasteur advised against using the vaccine on patients who have not had the virus in the past, since it may cause severe diseases in the long run.

Garin indicated that stakeholders had been keen on the vaccination program.

"Ang daming naghihintay — private doctors, mga pasyente, mga ospital, including the Department of Health, at ilang beses nang nagtatanong ang mga tao, magkano ba?" Garin said.

She reiterated a point she made in 2016 that her predecessor Enrique Ona was already inquiring about the price of Dengvaxia as early as 2014.

"Kung meron akong tinatago, I will not do it in the presence of DFA," Garin said.

Garin also defended her trip to the Sanofi manufacturing plant in Lyons, France in 2015.

Garin said she made the tour to complete her predecessor Enrique Ona's inquiries on how to revive the P400 million vaccine production plant of the Research Institute of Tropical Medicine (RITM).

"Nung kausap ko kasi sila sa Pilipinas, naghihindi sila pero hindi categorically no. Sinasabi nila na 'mahirap, mahirap," Garin said.

"Bottomline is they would not say yes or no kasi may political implication eh kasi may existing project na hindi umaandar. Pero pinapakita nila na yung hinihingi at pinapaayos mo eh ang hirap gawin kasi nasa Metro Manila siya," she added.

‘Sanofi announcement caused panic’

Garin said Sanofi should not have announced their findings on Dengvaxia without putting it in layman's terms.

"Mahirap kasing nag-announce silang una, kasi nagbigay sila ng takot, nalito ang mga tao. Hindi pwede yung announcement nila, eh akala nila technical people makikinig," Garin said.

Garin said that she and her own children were inoculated with the vaccine distributed to some 830,000 schoolchildren through a vaccination program she had defended from critics.

"I understand the concern, and kailangan itong tutukan. Maski kami, galit na galit nung malaman namin yung announcement ng Sanofi, lalong-lalo na nakita mo, severe dengue," Garin said.

"Nanay rin ako, anak ko nabakunahan, ako nabakunahan din," she added.

The former health secretary remarked earlier that the school-based dengue vaccination program was implemented "according to the guidelines and criteria set" by the World Health Organization.

She added that she was ready to face the consequences should she be called up by any investigation on the dengue vaccination program.

The plans for a dengue vaccination program has been in the works since 2010 which coincides with the term of former health secretary Enrique Ona or long before the controversial dengue vaccine was available.

"Kailan ba nagsimula ang usapan sa dengue vaccine? 2010. Ang daming naghihintay — private doctors, mga pasyente, mga ospital, including the Department of Health, at ilang beses nang nagtatanong ang mga tao, magkano ba," Garin said.

"Precisely, si Secretary Ona, 2014 pa lang, nagtatanong siya, magkano ba, iimplement namin yan, pero wala pang presyo," she continued.

Anti-dengue drug trials

The former health secretary added that her predecessor approved drug trials for the anti-dengue drug ActRX TRIACT.

Ona approved the clinical trials in 2012 and 2013 before the manifestation of long term effects on subjects' reaction to compounds, berberine and anti-malarial, herbal artemesin derivatives artemether and artesunate.

The clinical trials were heavily criticized, even within the DOH itself, for not complying with the "basic steps of a sound scientific research using people as subjects" and before proper testing could be conducted elsewhere in the world.

It was deemed that ActRx TRIACT "had no legal basis to be present in the Philippines, especially for clinical trials", was not registered with the Food and Drug Administration, and did not have a permit from the Research Institute of Tropical Medicine.

Then acting health secretary Garin butted heads with Ona after she suspended the anti-dengue drug clinical trials done in several areas in Palawan where a child's death was blamed on the experimental drug.

"Nung merong nanay sa Palawan na lumabas at nagreklamo na yun nga ang ikinasawi ng kanyang anak, e biglang nag-investigate ang DOH," Garin recalled.

She claimed that by the time she stepped in, the initial trials expanded from Palawan to six hospitals in Metro Manila with aid from the Department of Science and Technology (DOST) during Ona's term.

"Nung naabutan ko nga, ay meron nang parang national roll-out. So kaakibat ng DOH ang DOST," Garin said.

"Kaya nga kami ay nagkaroon ng katanungan na kung ito ay gamot at dapat nasa FDA ito, Food and Drug Administration, at sa RITM, hindi sa Department of Science and technology."

No approval

The Food and Drug Administration approved the sale of Dengvaxia in December 2015 but the DOH's Formulary Executive Council did not give the government the go signal to purchase the vaccine.

Executive Order 49, series of 1993 states that drugs must be approved by the Philippine National Drug Formulary (PNDF), which uses requirements from the World Health Organization, before they can be purchased by the government.

Garin gave Dengvaxia an exemption from this assessment in February 2016, a month after an invitation to bid and a purchase request for the vaccine was prepared.

According to Department of Health (DOH) Department Order No. 2014-0088, exemptions can only be granted for "a current or potential urgent health situation" and "for concerns that are of public health importance upon decision and endorsement of the Secretary of Health." — Rie Takumi/NB/BAP, GMA News