Dr. Tony Leachon, nagbigay ng isang brilliant suggestions para sa tamang gagawin sa gulong idinulot ng Dengvaxia - The Daily Sentry

Saturday, February 10, 2018

Dr. Tony Leachon, nagbigay ng isang brilliant suggestions para sa tamang gagawin sa gulong idinulot ng Dengvaxia

Dr. Anthony "Tony" Leachon, photo from Facebook
Isang beteranong cardiologist ng Manila Doctors Hospital at isang kilalang health advocate Dr. Anthony "Tony" Leachon, ang nagpahayag ng interesting na mga suhestiyon sa tamang bagay na gawin sa mga kasalukuyang problema sa health industry dahil sa gulong idinulot ng Dengvaxia.

Ayon kay Dr. Leachon, ang Dengvaxia ay kasangkot sa mga safety issues batay sa November 29 label change ng Sanofi dahil walang prior ng katayuan ng sero at ang mass vaccination ay natupad sa kabila ng pagtutol mula sa Formulary Executive Council.

Sinabi ni Dr. Leachon na kung kailangan nating pasiglahin ang mga pasyente at publiko, kailangang isaalang-alang ang causal assessment. Inamin din ng kilalang doktor na pinagsisisihan niya ang desisyon ng DOH na napapatibay na maaprubahan ang Dengvaxia sa kabila ng hindi pagkumpleto nito ng phase 3 clinical trial.

Narito ang kumpletong suggestions ni Dr. Tony Leachon:

Adverse Drug Reporting: The Right Thing to Do

Dengvaxia is involved with safety issues based on Sanofi 's Nov 29 label change. There was no prior determination of sero status and yet mass vaccination was carried out despite objection from the Formulary Executive Council.

Drug safety science or (Pharmacovigilance) operates on individual case safety report (ICSR). 

Each school child who experienced the adverse event needs to be assessed individually using parameters in causality assessment:

-temporal relationship with the drug (post-vaccination)

-biological plausibility that the drug may cause the event (antibody-dependent enhancement)

-pharmacological plausibility, any underlying medical condition that may have caused the event, other drug that may have caused the event.

If we are to reassure patients and the public causality assessment needs to be done individually. Severe dengue was the adverse event in the new product label in patients not previously exposed to dengue . But other adverse events were not disclosed as well - viscetropism , anaphylactic reaction , severe allergy , neutropism. Deaths whether drug related or not should be reported to FDA within 15 calendar days and for non serious adverse events quarterly.

Severe dengue with death as outcome is not in the label, but there are 30 deaths reported now ( 14 PGH and 16 PAO ) - whether drug related or not , this is for the health authorities ( FDA and DOH ) to assess from the aggregate reports, to determine if it is indeed a new safety signal that can be attributed to the drug or assess as not related.

But with the data being concealed on Dec 22 on the time of the release of CPR - severe allergic reaction / anaphylactic reaction , viscetropism , neutropism and severe dengue, Sanofi might be liable like Vioxx by Merck in concealing safety data in the pull out of the blockbuster painkiller drug in 2004.

On a personal note, I regret DOH pushed hard to have Dengvaxia approved despite its non completion of phase 3 clinical trial. This is despite' the National Formulary did not recommend its approval due to unfinished clinical trial and a there is no defined implementation program and infrastructure for a mass vaccination at the LGU level considering Dengvaxia is a New Drug. There is no wide experience with Dengue vaccines. Never in the history of DOH that a procured vaccine was distributed in the LGU nationwide within a month after its delivery.

This is sad.

Source: Dr. Tony Leachon FB page