Leaving Urgent Questions Unanswered in the Dengvaxia Controversy

 

THE DENGVAXIA controversy reflects a policy issue, with critical implications for public health. Unfortunately, there are questions of governance that have drawn out the worst partisan reactions.  So far, the Senate and the House of Representatives have held a total of eight hearings, three in 2017 and five in 2018.

But the amount of time given to the controversy in either house has not provided the kind of information that will help the concerned agencies to move forward with an effective plan of action to address the threat of dengue and the fears of vulnerable communities.

Media following the political lead has been derailed into recording much of the pointless talk during the hearings. Focused on establishing accountability of public officials who were involved in the decision to adopt Dengvaxia in 2015, including then President Benigno Aquino III, the hearings however failed even to identify who should be further investigated so that court cases can be filed.

The most recent hearing was conducted by the House committees on Health and Good Government and Public Accountability on February 26. To shed light on the issue, current and former health and budget officials, health experts and advocates, as well as resource persons from the Public Attorney’s Office (PAO) and the Food and Drug Administration (FDA) were interrogated.

CMFR monitored reports by the three main broadsheets (Manila Bulletin, Philippine Daily Inquirer and The Philippine Star), prime time newscasts (ABS-CBN 2’s TV Patrol, CNN Philippines’ News Night, GMA-7’s 24 Oras and TV5’s Aksyon), as well as select online news websites from February 26 to 28, 2018.

Unexplored leads, lacks initiative

The hearings established leads to be explored, but stopped short of clarifying the areas of accountability.

During the joint committee hearing, Dr. Anthony Leachon, a health reform advocate, claimed that Sanofi was already aware of risks posed by Dengvaxia as early as December 2015. In his 5-minute oral presentation, Leachon referred to the annex of a certificate of product registration (CPR) issued on December 22, 2015 in which Sanofi listed four risks for seronegative individuals (persons with no prior dengue infection). The risks identified in the document were allergy/anaphylactic reaction, viscerotropism and neurotropism, and increase in severity of dengue disease. Leachon accused Sanofi of “concealment of data and safety” as these were supposedly not written in the informed consent for vaccine recipients, calling the lapse “a great sin to the Filipino nation.”

Leachon also emphasized that the CPR issued to Sanofi then for Dengvaxia was only for prescription basis, not mass vaccination.

FDA Director General Nela Charade Puno, for her part, shared some findings of the agency’s special task force on Dengvaxia. For one, upon the task force’s review of documents by Sanofi, the FDA learned that the company had informed regulators in Singapore of the risks posed by Dengvaxia. However, it was unclear in the hearing and in media reports that followed when exactly these documents were submitted to Singapore by Sanofi. Commercial sale of the vaccine in Singapore was allowed in October 2016, ten months after Philippine authorities did the same.

In addition, Puno also claimed Sanofi may have been given special accommodation in the FDA then.

Sanofi Pasteur Asia-Pacific head Thomas Triomphe denied these allegations, explaining that what was communicated before were “theoretical risks to look for” and that the company had no definitive data yet before their November 2017 advisory.

Online news sites GMA News Online (“Sanofi Pasteur knew of Dengvaxia risks as early as 2015, FDAP exec says”) and Rappler, which included photos of the document Leachon was referring to, (“Sanofi knew Dengvaxia risks in 2015 but didn’t tell PH – FDA, physician”) were quick to highlight these points and published reports on the same day as the hearing. The Inquirer followed suit in its February 27 issue (“Noy says he didn’t know vaccine risks”).

By February 28, media reports carried the statement of Sanofi disputing the claims of Puno and Leachon regarding the company’s transparency.

TV reports were not helpful as they were limited to providing a quick recap about what was said. Much focus was also given to former President Aquino’s statement during the hearing, particularly his veiled swipe at supposedly unqualified experts and parties politicizing the issue.

CMFR previously noted: “Live coverage is useful, but media cannot presume that everyone catches the important points” (See: “The Dengvaxia Debacle: The Volatile Mix of Politics, Health and a Failure of Science”). The revelations in the House hearing should have served as cues for journalists to check or investigate further on their own. Unfortunately, CMFR did not observe further efforts to investigate.

Was Sanofi really remiss in informing the Philippine government about the risks posed by Dengvaxia? Were regulators in Singapore given information that might have affected the decision-making of their Filipino counterparts? Should government review its protocols for vaccine approval? Such questions could have been explored more thoroughly by the press by seeking other sources which could have provided such information.