The House committee on good government and accountability chaired by Rep. Johnny Pimentel (2nd District, Surigao del Sur) and committee on health chaired by Rep. Angelina Tan, M.D. (4th District, Quezon) in a joint inquiry on Wednesday grilled Sanofi Pasteur executives and government officials involved in the purchase and use of the dengue vaccine Dengvaxia.
The inquiry is based on the privilege speech of Rep. Doy Leachon (1st District, Oriental Mindoro) lamenting the “apparent, obvious and manifest” illegality of the procurement and misappropriation of public funds amounting to P3.5 billion by the Department of Health (DOH) for its mass dengue vaccination program.
“It is now high time that we probe deeper into this issue in order to uphold the truth, transparency, and accountability in government policies, particularly in the prudent use of the resources of the government,” said Tan.
Leachon questioned the purchase of the drug, noting higher priority issues that need to be addressed, such as transportation infrastructure and the increased congestion of roads. He said dengue is not even in seventh in terms of diseases with highest morbidity in the country, coming in eighth overall.
“Tandaan natin, sa GAA (General Appropriations Act) natin, ang budget ng lahat ng vaccines—P 3.2 billion. Pero ito, isang vaccine lang, P3.5 billion,” said Leachon.
He also pointed out that procurement of Dengvaxia was the fastest procurement in the DOH history. On December 22, 2015, the Food and Drug Authority (FDA) gave Sanofi Pasteur a Certificate of Product Registration (CPR). Less than a week after, the Department of Budget Management (DBM) was instructed to release the P 3.5 billion for the drug despite the vaccine not being in the Expanded Program on Immunization (EPI) of the DOH.
He further said that based on meetings of the Formulary Executive Council (FEC) on January 7, January 25, and February 1, 2016, FEC recognized that the vaccine may pose risks to severe forms of dengue.
Moreover, FEC declared that Dengvaxia was not included in the GAA and therefore not a priority.
“From the time of procurement on March 9, na-deliver in 26 days. This is the fastest procurement in the DOH history,” Leachon stated.
Also tackled during the meeting were House Resolution 444 by Tan and HR 48 by Rep. Estrellita Suansing (1st District, Nueva Ecija). Both resolutions called for a House inquiry to study the program implemented of DOH, particularly the safety and efficacy of Dengvaxia.
Dr. Anthony Leachon, president of the Philippine College of Physicians Foundation Inc. and resource speaker at the hearing, attested that the issue could have been avoided if the involved government agencies followed proper protocol for new drugs entering the market.
In particular, the absence of a thorough post-marketing surveillance (PMS) program leaves the market vulnerable to a new drug that may not be safe.
“A post-marketing surveillance would entail a doctor-patient relationship. Now when you do mass vaccination, you eliminate that. What is the ratio right now of a doctor, let’s say, in the community? It’s one is to 10,000. If there’s a side effect in that particular community, that would be a problem,” Dr. Leachon stated.
In product launch protocol, cases of about 5,000 to 10,000 entail patients following up with their doctor. Findings should be submitted to the FDA before the FEC is consulted.
“But in this particular issue, even the FEC required Sanofi and the DOH to submit the PMS. And this is not actually achieved prior to the mass vaccination,” he said.
Leachon further cited the belated efforts to launch a PMS program to track down and monitor every child who may have suffered severe dengue. The logistics of the program would be extremely complicated given the dearth of doctors in the country and the lack of accessible medical care in far-flung rural areas.
Rep. Cecilia Leonila Chavez (Party-list, BUTIL) asked how DOH is handling the issue, and further enjoined Sanofi to be an active participant in the government’s efforts. She noted the distress and increased distrust growing in the Filipino public demands attention and immediate action.
DOH Secretary Francisco Duque III informed the committee of steps being taken to heighten surveillance of the vaccinated children as well as the reported incidents of dengue. The department is also coordinating with PhilHealth to ensure coverage for vaccinated children who may suffer from severe dengue.
Sanofi Pasteur executive Thomas Triomphe said the company will comply with Philippine regulations and that it will continue to engage with DOH to address the matter. Triomphe also maintained the drug manufacturer’s position that Dengvaxia is a safe and effective drug.
In response, however, Dr. Leachon shared to the committee that after the issuance of the CPR for Dengvaxia, the Philippine College of Physicians Foundation Inc. wrote a letter to express the lingering uncertainty about the long-term safety of Dengvaxia.
Evidence from the manufacturer’s trials showed a paradoxical increase in the incidence of severe dengue beginning a few years after the children are vaccinated, and likely continuing for the rest of their lives. The danger especially applies in children who have not had dengue before. This was confirmed by further analysis by Dr. Leachon’s organization. The organization recommended further investigation and that until more trials are completed, children should be tested for previous dengue infection before vaccination.
Dr. Leachon said it was possible Sanofi had this information at the time of issuance of CPR for Dengvaxia. Despite this, Sanofi continued with the P3.5 billion sale and announced a year later the label change that would include this information. (Congress)
