'Conflict of interest?' RITM official conducted studies on Dengvaxia

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'Conflict of interest?' RITM official conducted studies on Dengvaxia

Mike Navallo,

ABS-CBN News

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Nueva Ecija Rep. Estrellita Suansing on Monday lashed out at an official of the Research Institute for Tropical Medicine (RITM) who conducted clinical studies on the Dengvaxia vaccine.

Suansing said RITM Microbiology Department Chief Dr. Ma. Rosario Capeding had “conflict of interest.”

Capeding admitted during the resumption of the House Committees on Good Government and Public Accountability on the Dengvaxia controversy that she was commissioned by Sanofi Pasteur to conduct the clinical trial on Dengvaxia and was paid P40,000 monthly for six years.

“Ang laki pala ng ibinayad sa iyo,” Suansing remarked. “Alangan naman di ka maglabas ng positive report.”

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A representative from the Food and Drug Administration confirmed that the results from the active phase of Capeding’s clinical trial (from 2011 to 2013) was among those considered by the agency before giving the accreditation.

Capeding said the clinical trial consisted of a 25-month active phase (from 2011 to 2013) and a follow-up phase called a long-term surveillance phase from 2014 to 2017.

Sanofi Pasteur officials claimed they only learned about the increased risk of the vaccine on seronegative patients or those who had not been previously exposed to the dengue virus in November 2017 and they immediately informed DOH about the results.

Suansing blamed Capeding for the positive recommendation, saying she should have waited for the conclusion on the follow-up trials.

But Capeding repeatedly insisted her participation was limited to conducting the clinical trials and she had no control over the licensing, a response which ticked Suansing off.

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“Di ko ma-accept na you are under RITM, under DOH that you were commissioned by Sanofi to do studies in their behalf. What you’re saying is hugas-kamay ka dito,” she told Capeding.

Suansing even warned Capeding she will bring parents of children adversely affected by the Dengvaxia vaccine to Capeding’s residence.

“Pahingi ng address mo, at dadalhin ko sila sa iyo at kukuyugin ka nila. Ikaw ang una kong paturukan,” she said.

In her defense, Capeding said it had been the practice for RITM to be commissioned by pharmaceutical companies to conduct clinical studies. “There’s an executive order signed by Marcos in 1981,” she said.

Ma. Lourdes Santiago from the FDA also clarified that at the time Sanofi Pasteur submitted the results of the active phase of the clinical trial, proof of product efficacy was enough.

Santiago said that aside from RITM, there were also other clinical trial sites in Southeast Asia such as Indonesia and Vietnam.

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