DENGVAXIA FLAP | Gordon accuses ex-FDA acting head of bias due to Zuellig Foundation ties

December 12, 2017 - 12:35 AM
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Senator Richard Gordon. Photographed by Alex Nuevaespaña / PRIB

Senator Richard Gordon has accused former acting director general of the Food and Drug Administration, Dr. Kenneth Hartigan-Go, of pushing for the use of Dengvaxia given that he had worked for Zuellig Foundation, although Hartigan-Go said the foundation was distinct from Zuellig Pharma, which distributes the drug.

“Kasama ka sa nagtutulak dito (You’re among those who are pushing for this)… You’re biased towards Zuellig,” Gordon said Monday during the Senate Blue Ribbon Committee hearing about the controversial vaccine, following manufacturer Sanofi Pasteur’s recent findings that people who were not previously infected by the virus but were vaccinated could be at risk of “severe dengue” once they do get an infection.

Gordon cited Dr. Joyce Ducusin, the director of the Department of Health’s Family Health Office, as saying that concerns on the dengue vaccine were raised to Hartigan-Go, and that he mentioned that the vaccine many be granted an exemption by the Formulary Executive Council (FEC) while it had not yet been evaluated for inclusion in the Philippine National Drug Formulary (PNDF).

Former Health Secretary Janette Garin explained that when considering an immunization program for the DOH, internal and external experts are consulted. They will recommend to the government what it should do. If there is a drug or medicine that is not yet in the PNDF, they will request the FEC to convene and discuss in the presence of the experts.

FEC’s Atty. Froilan Bagabaldo said that, in recommending the exemption of Dengvaxia so that procurement could be done, it placed the following conditionalities, among others.

1. Given that it has not yet been given to a big population and they don’t know the risks involved, phased (“dahan-dahan”) implementation is recommended.

2. Procurement must also be little by little (“dahan-dahan”) because the value of the drug to health and the economy is not yet known; more information is needed, which will be gathered during the implementation. Also, the DOH might be able to get a better price.

3. There must be an FDA-approved risk management plan.

4. There must be an approved protocol for post-licensure study to determine the long-term safety and effectiveness of vaccine. This includes information about adverse effects, hospitalizations, mortality, and morbidity.

5. There must be a plan for the training of personnel.

6. There must be operational guidelines on the use and administration of vaccine.

7. There must be appropriate risk communication to parents and school children about the extent of protection provided by the vaccine, and environmental interventions and personal protection against dengue should continue to be implemented.

8. DOH should actively monitor the outcomes to determine the real clinical value of vaccine so they can figure out the real-time, cost-effective price for the government.

In response to Gordon’s accusation that surveillance was blocked, Hartigan-Go said that it was not.

He said FDA did post-marketing surveillance where they got both Philippine and global data, or “post-surveillance periodic safety update report for new products in the market,” in determining the safety profile of the drug.

Gordon also asked FEC’s Dr. Melissa Guerrero if she felt rushed while doing the review of the drug.

Although she did not answer with a simple yes or no, she said that they were asked by Ducusin to prioritize the review of Dengvaxia, given that there was already a budget allotted for the vaccine. Guerrero acknowledged that it was the first time she witnessed such speed in the allotment of the budget.

She added that there were a lot of concerns because there was no long-term safety data, the drug’s effectiveness at only 60 percent was questionable, and the cost-effectiveness was done by Sanofi Pasteur, which could not be considered objective. But, she said, the justification for it was submitted by the Family Health Office.

Prodded by Gordon, former Secretary Paulyn Rosell-Ubial admitted that dengue was not in the 10 leading causes of death in the Philippines. Gordon pointed out that more people die from tuberculosis, which the government must prioritize over the mosquito-borne disease.

Nevertheless, Ubial said that 500 to 600 people die of dengue each year.

For her part, expert resource person Dr. Mary Ann Lansang said she believes it was premature to launch a mass immunization program, although she added that Dengvaxia was still a “breakthrough” product because it can protect those who have had prior dengue from getting severe dengue.

But, she said, the downside was that the safety of the drug was not really considered.