September 7, 2019

#TPonMB: Health Sec. Duque, let’s respect FDA’s independence

Department of Health (DOH) Secretary Francisco Duque recently announced that he’ll consult with the UP-PGH Dengvaxia Task Force regarding the possible reintroduction of the controversial anti-dengue vaccine Dengvaxia, saying he wants a decision on Dengvaxia’s fate through a consensus among all sectors “because a lot of groups have varying positions about this.”

But before we go any further, here’s some context.
[NOTE: This piece was first published in the Manila Bulletin on 10 August 2019].

The 2017 Dengvaxia scandal stemmed from the haphazard DOH-led mass vaccination program affecting almost a million school-age children. Despite Sanofi’s own studies admitting that the drug may have serious adverse effects on recipients who have not had dengue, DOH still mass vaccinated in 2016 and 2017 4th graders in Central Luzon, Metro Manila, and Calabarzon.

The Scandal erupted in November, 2017, when Sanofi through a press release admitted that Dengvaxia worsens dengue symptoms in recipients who have no prior history of dengue, thereby confirming Sanofi’s earlier statement prior to the mass vaccination program, which Sanofi published in a peer-reviewed journal in 2015.

Hundreds of vaccine recipients have allegedly died so far, with Public Attorney’s Office (PAO) autopsy reports show that most of the kids exhibited swelling and bleeding in their internal organs, which eventually led to multi-organ failure. The affected families, with PAO’s help, have filed cases against DOH, manufacturer Sanofi, and local distributor Zuellig Pharma.

The cases are still pending in various courts and Sanofi has consistently denied liability over these deaths. After Sanofi failed to submit mandatory post-marketing surveillance reports, the Food and Drug Administration (FDA) permanently revoked Dengvaxia’s Certificate of Product Registration (CPR) in February this year, making it illegal in the country.

Hence, I cannot understand why a health secretary is so actively involving himself over an illegal drug that is not even part of the Philippine National Formulary, the official list of drugs that the DOH is legally allowed to procure.

Criminal liability on the part of DOH, Sanofi, and Zuellig, in relation to the mass vaccination program, is a matter that the courts are already handling and let’s allow them to decide on it. The issue at, is the propriety of the reinstatement of Dengvaxia’s CPR and subsequently, the question of who are the right persons to be involved its reinstatement.

Manufacturer Sanofi by nature wants Dengvaxia’s CPR reinstated, but it’s also clear that Congress mandated the FDA and no one else to review such submissions… and Sec. Duque isn’t in FDA.

As a side note, this writer also finds it odd that Dengvaxia advocate and former Health Secretary Esperanza Cabral has been doing media rounds lately without disclosing in any of those interviews that she is a trustee of the Zuellig Family Foundation, the philanthropic arm of Dengvaxia local distributor Zuellig Pharmaceuticals.

Former Philippine College of Physicians president Dr. Tony Leachon is right when he recently asked whether Sanofi has already submitted the post-marketing surveillance reports, as those missing reports are what made the FDA revoke Dengvaxia’s CPR in the first place.

If it still hasn’t submitted these reports, then the debate is over. Otherwise, it’s up to the FDA and FDA alone to independently review these reports, check for compliance, and decide whether to reinstate Dengvaxia’s registration or not. With that said, this writer can’t help but feel sympathy for the UP-PGH professionals who are now under extreme and unnecessary pressure.

If Sec. Duque insists on dipping his hands into the issue, then he must at least make public Sanofi’s missing post-surveillance reports that it must have submitted recently. The secretary should let the public see what Sanofi has to say about the hundreds of thousands of kids that, as Senator Richard Gordon put it, “were treated like guinea pigs.”

Dengvaxia’s proponents argue that the drug may be sufficiently safe for those who have had dengue, and this writer agrees with them. However, if Dengvaxia must be reinstated, then it must be reinstated with clear guidelines on how it should administered, taking into account data collected over the past three years that it was available in the market, the same data that can be found only in Sanofi’s post-marketing surveillance reports, the same reports that are still missing, apparently.

Sec. Duque is strongly encouraged to let the FDA do its job without undue external interference. FDA officer-in-charge Usec. Eric Domingo is more than capable of accomplishing that, especially since he hails from Pampanga, one of the provinces covered by the botched 2017 Dengvaxia mass vaccination Program.

Sec. Duque must focus only on tasks that he is legally allowed to do, and that doesn’t include FDA’s job. Truth be told, Sec. Duque’s latest moves may even be construed as engaging in acts beyond his authority to perform, opening him up to possible lawsuits from the FDA and even from any citizen who feels that the secretary’s actions are endangering public safety.

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