After the spread of news about Dengvaxia, many questions are now arising as Filipinos come to think of how Sanofi Pasteur’s vaccination program has passed and was accepted by the government’s Health agencies. Filipinos are asking who are really the people behind the ‘magic processing’ of this project and how did it surpassed the necessary verification processes which are conducted to test its efficacy and safety.
In a statement made by Senator Richard Gordon, he mentioned that the usual and necessary process to accept and prepare the implementation of this program was totally, and intentionally, rushed based on his understanding during the court hearings regarding Dengvaxia issue. Here is an excerpt from his statement:
“The process was really fast as if they rushed it. The process for the implementation of new vaccination programs wasn’t followed. We saw in the December hearing last year that each time Sanofi executives and President (Benigno) Aquino or Secretary (Janette Loreto-) Garin meet, there came a new development in the procurement process and it further accelerates.”
Sanofi consult’s FDA for their “Registration Strategy”
In March 2014, Sanofi Regulatory Affairs Manager, Jervin Papelleras sent a letter addressed to Kenneth Hartigan-Go, Director of FDA, and FDA Center for Drug Research (CDRR) head Lourdes Santiago. This letter includes the minutes of the meetings between Sanofi and FDA. The letter has an attached file which is labeled as “registration strategy in 2015, following the last meeting with FDA in 2012”.
When did the FDA start including the discussion of “registration strategy” on their regulatory processes, when all the information needed about product registration is already posted on their website? Added to this, Sanofi is a huge pharmaceutical firm; why would it even need to personally talk to FDA officials for its registration? Here’s what a senior Health Department Official thinks:
“There’s a registration strategy? There should be no strategy because there’s only one way to register. If you look at the FDA website, on ‘how to register a product’, I’m sure there are no meetings involved. There should have been no private meetings involved in the entire registration process.”
When it took place
The suspicious consultation between Sanofi and the FDA was recorded to happen during the phase 3 trial of Dengvaxia. In this case, FDA is actually helping a product get registered even though it hasn’t passed the appropriate clinical trials! In short, FDA helped Dengvaxia get registered even if, by all its intents, was still an EXPERIMENTAL drug!
In the last months of 2017, the Senate found out that Hartigan-Go’s career was closely intertwined with Zuelig, the exclusive distributor of Sanofi’s Dengvaxia here in the Philippines.
According to the Philippine Diplomatic Records, it was on May 2015 when Garin has been into various official engagements in France which included a dinner in Paris with the VP of Sanofi-Pasteur’s, Guillaume Leroy. Just 4 days after this meeting, an email was sent out by the FDA deputy director-general Lourdes Santiago to other FDA officials about the “Sanofi’s Rolling Submission of Dengue Vaccine”.
Santiago wrote, “Kumpleto na ba? Any submission recently? Meeting with Sec. Garin later to inquire about the progress.”
Going back, it has been also recorded that on December 2, 2015, President Aquino had a meeting with Sanofi Pasteur in Paris, along with President Aquino was the Health Secretary Janette Garin, Finance Secretary Cesar Purisima, Trade and Industry Secretary Gregory Domingo, and Transportation and Communications Secretary Joseph Emilio Aguinaldo Abaya.
On exactly the same day, Sec. Garin sent an email to director Santiago, “When will the CPR (Certificate of Product Registration — a document issued by the FDA which serves as the product license) for dengue vaccine be probably released?”
After a month, another email was leaked from FDA and Hartigan-Go’s thread that really mentioned about ‘bending the rules’ for the benefit of Sanofi. January 2016, Hartigan go told agency officials, “If a protocol needs to made, and technically and ethically reviewed, I think you should all focus and fast-track this work, otherwise, we all get into trouble or create preventable problems.”
This is a clear evidence that FDA, a government agency that is supposed to regulate and protect consumers, have been in coordination with the business firm in passing an untested and unreliable product. Indeed, it’s very frustrating to know that some government agencies need to bend rules which they also set just for greed. Obviously, the FDA manipulates even the rules that were supposed to protect the welfare and safety of Filipino people just to feed their hunger for wealth.
You can read the full article at Thinking Pinoy’s website or click here https://bit.ly/2Pxpgf7.