February 5, 2018

#DengGate: Leaked emails show Pnoy, Garin, Hartigan-Go intentionally bent rules for Sanofi

Leaked emails and other documents show how Aquino, Garin and Hartigan-Go magnificently orchestrated the approval of the untested Dengvaxia vaccine... and how they broke more than a few laws in the process.

But before that, here's a recap of recent developments.

Recent Developments

In a press briefing held earlier today, [Presidential Spokesperson] Harry Roque said, “Finally, good news to the 830,000 parents whose children were given the Dengvaxia vaccine. The UP-PGH… reported that… out of 14 remains examined by UP-PGH, 13 of them were found to be totally unrelated to the vaccine. This means that only one case maybe causally associated with the vaccine.”

“…iyan po ay mabuting balita doon sa 830,000 na mga nanay-tatay na naaabala’t natatakot na baka may banta sa buhay ng kanilang mga anak,” Roque added.

[TRANSLATION: That’s good news for the 830,000 parents who are troubled and worried that their lives of their kids are at risk.]

Roque misinterpreted the UP-PGH report.

Verifying Roque’s claims

ThinkingPinoy spoke via phone with Department of Health Undersecretary Eric Domingo, who heads the Dengue Task Force technical committee that asked the University of the Philippines​ - Philippine General Hospital​ to create the Expert Panel on Dengvaxia.

Doming said, “Parang hindi pa niya nakita yung report. Ni-report ng expert panel na at least tatlo ay siguradong dengue, tapos may six na kailangang pag-aral pa para maging certain kung ano yung cause of death, kung connected siya [sa Dengvaxia].”

[TRANSLATION: It seems like he hasn’t seen the report. The expert panel reported that at least three are certainly dengue cases, while we still need to further investigate six cases to ascertain the causes of death, if they’re related to Dengvaxia.]

“Baka si Harry Roque, hindi niya naintindihan yung report. Actually, hindi pa niya nakikita ang report. Ang nakakita pa lang ng full report, sigurado ako, ako pa lang at si Sec. Duque,” Domingo added.

[TRANSLATION: Maybe Sec. Roque didn’t understand the report. Actually, he hasn’t seen the report. I’m certain that only Health Sec. Duque and I have seen the report so far.]

“Ang sinasabi nga natin, sigurado nang may na-dengvaxia at namatay siya ng dengue kaya kailangan silang bantayan at alagaan, yun yung [essence] ng report,” Domingo said.

Domingo corrected Roque’s interpretation of the PGH report.

Domingo said, ”Ang conclusion namin doon sa report, kailangang mag-ingat kasi may namamatay ng Dengue, hindi naman ganoon kadami pero mayroon. At saka, yung anim na nabakuhanan, may sakit sila so hindi dapat nag-mass immunization program nang hindi pa nacheckup isa-isa ang mga bata.”

[TRANSLATION: We concluded in the report that we need to be cautious because there are deaths from dengue [even after inoculation with Dengvaxia]. It’s not that many, but there still are. Moreover, six of the children may have had pre-existing conditions so there should not have been a mass immunization program without screening each of the kids.]

“Yung anim na namatay, parang may pre-existing conditions so hindi dapat nag-mass immunization na tusok nang tusok. Mali talaga, hindi talaga dapat siya ginawa,” Domingo added.

[TRANSLATION: Six of the kids may have pre-existing conditions so they shouldn’t just inject one after another. It’s wrong, it should not have been done.]

Domingo said, “Dengvaxia should not have been used in a mass immunization program without screening each and every child prior to injection kasi mukhang may association with pre-existing conditions.”

[TRANSLATION: Dengvaxia should not have been used in a mass immunization program without screening each and every child prior to injection because there appears to be an association with pre-existing conditions.]

In another text conversation, Usec. Domingo said, ”DOH also feels justified that the Dengvaxia mass vaccination was stopped. Several children with pre-existing illnesses died within 30 days of vaccination, which means Dengvaxia is not safe for a mass immunization program where children are not thoroughly screened one by one.”

Roque takes a swipe at PAO

Coincidentally or not, both the Public Attorney’s Office (PAO) and the UP-PGH expert panel are conducting investigations on the same number of alleged Dengvaxia victims, so that Roque’s February 3rd announcement may have led to some confusion as it was interpreted by some people as an assessment of the 14 cases being handled by PAO.

Further exacerbating the confusion was Roque’s statement that, given his awareness of PAO’s efforts, can easily be interpreted as a swipe against PAO.

In yesterday’s press briefing, Roque said, “Kung maalala niyo po, ang DoH po ang nagtatalaga at humihingi sa UP-PGH na sila na ang mag-aral para magkaroon ng objective na pag-aaral kung ano talaga ang naging epekto ng Dengvaxia.”

[TRANSLATION: If you can recall, the DoH requested the UP-PGH to investigate (the Dengvaxia Scandal) so there can be an objective study of the actual effects of Dengvaxia.] PAO swiftly reacted to Roque’s announcement.

In a statement, PAO said, “Noong nagdeklara ang UP PGH na may 14 cases sila, nakaka LIMANG (5 batang namatay na naturukan ng Dengvaxia) Forensic Examination pa lamang ang PAO FORENSIC TEAM. Nitong Thursday (Pebrero 1, 2018) lang naisagawa ng team ang pang #14 at #15, patunay na walang basehan at pinanggalingan ang sinasabi na ang 14 cases nila ay galing sa PAO. (sic) [PAO]”

[TRANSLATION: When UP-PGH declared their 14 cases, only 5 kids have been under PAO’s Forensic Examination. It was only this Thursday (01 Feb 2018) that the team performed autopsy #14 and #15, proof that their claims – that the 14 cases are from PAO – are baseless.]
Health undersecretary Domingo confirmed PAO’s claims.

Domingo said, “Magkaiba yon, kasi yung 14 ng PGH, sourced ito since 2016 so hindi naman siguro lahat na ýan e yung na-autopsy ng PAO.”

[TRANSLATION: They’re different because the PGH’s 14 were sourced since 2016 so I don’t think they have all been autopsied by PAO.]

One of the several Dengvaxia cases being handled by PAO.

Asked if PAO and UP-PGH indeed have different list of Dengvaxia victims, Doming said,”Oo. Siguro magkamukha yung listahan ng 29 cases, pero yung 14 cases doon sa expert panel report, hindi siguro yun yung 14 cases ng PAO na kanilang na-exhume. Kasi yung kanilang na-autopsy, bago pa lang.”

[TRANSLATION: Yes. The list of 29 cases may be the same, but the 14 in the expert panel report are probably not the same as the 14 exhumed by PAO because they are fairly newly-discovered.]

But the misinformation doesn’t stop with Roque, because we also have former Health Secretary Esperanza Cabral doing her part.

The heavily conflicted Sec. Cabral

“We urge the Department of Justice to order the Public Attorney’s Office (PAO) to stop performing autopsies on these children and leave the matter of determining the cause of death [of the children who received the Dengvaxia vaccine for free] to competent forensic pathologists,” Doctors for Public Welfare (DPW), which is led by former Health Secretary Esperanza Cabral, said in a statement on Saturday [GulfNews].

Cabral, like Roque, clearly took a swipe at the Public Attorney’s Office, which was mandated by the Deparment of Justice to provide legal assistance to the families of Dengvaxia victims.

DPW, through Cabral, said, ““It makes no sense for any more families to be subjected to the torture of having a loved one exhumed and cut up only to find out that no useful information was derived from the cruel act.”

“In fact, the deaths of 13 of them were totally unrelated to the [Dengvaxia] vaccine,” the DPW said.

Health undersecretary Domingo has clarified this issue in the previous section, i.e. the UP-PGH expert panel never said that 13 of the 14 cases handled by UP-PGH are unrelated to Dengvaxia.

Where did Cabral base this information from, especially since she’s not even part of the UP-PGH panel to begin with?

Cabral and DPW’s uncanny enthusiasm to defend Dengvaxia is disconcerting, to say the least.

According to sources within the PAO, it was Cabral who convinced DOH officials to continue the Dengvaxia program after Aquino stepped down.

But then, it appears that it actually is in Cabral’s personal interest to defend Dengvaxia, because she is a Trustee of the [Zuellig Foundation] [A].

Former Health Sec. Cabral is Zuellig Foundation Trustee. Zuellig Pharma is Dengvaxia's exclusive distributor in the Philippines.

Zuellig Foundation’s parent company, Zuellig Pharma, is the exclusive distributor of Sanofi’s Dengvaxia in the Philippines. In fact, the anomalous P3-billion purchase order for Dengvaxia was addressed not to Sanofi Philippines, but to Zuellig Pharma.

Sec. Cabral, the flag-bearer of Doctors for Public Welfare, is part of the “Sanofi-Zuellig Family”.

Now that can explain her enthusiasm. She fights not for this country, but for her personal interests.

When Politics mixes with Public Health

Since the Dengvaxia Scandal erupted in November 2017, there have been several calls by so-called experts to depoliticize the problem, as they claim Mixing that public health should be the paramount concern, and the legal issues as, somewhat, a secondary priority.

But therein lies the fundamental problem: it is the politicization of public health that got the country into this mess.

ThinkingPinoy agrees that the Health Department should take a more aggressive stance in addressing the Public Health issue arisingfrom the Dengvaxia Scandal. Going after erring officials, however, is just as important.
Putting corrupt officials who were instrumental in creating this mess is the best way to restore the general population’s trust in Philippine Public Healthcare, trust that was lost after the previous administration decided to roll out an insufficiently tested drug en masse.

With that said, however, ThinkingPinoy believes that establishing the causal link between Dengvaxia and the deaths should best be entrusted to medical professional who have the requisite knowledge, experience, and integrity.

The politics part of the issue, however, is well within ThinkingPinoy’s domain, and that’s what shall be discussed next.

A Quick Recap

The question on whether there was undue haste in the government’s procurement of Dengvaxia need not be asked. At this point, it is now question of how hasty the procurement process was, who exactly did what in the railroaded procurement process, and whether their actions are merely coincidences or whether there was a deliberate effort to violate the law to favor Sanofi and/or its affiliates.

In a statement last month, [Senator Richard Gordon] said, ”Napakabilis talaga ng proseso, parang minadali nila. Hindi nasunod yung usual na process ng pag-peprepare for implementation of a new vaccination program. Nakita na natin sa hearing nung December last year na after every meetings abroad between Sanofi executives and President (Benigno) Aquino or Secretary (Janette Loreto-) Garin, magkakaroon ng bagong development sa procurement process at lalo itong bumibilis.”

[TRANSLATION: 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.”]

Most of what has been revealed so far are a few testimonies from Senate Hearing resource persons but there’s little in the way of actual direct documentary evidence showing the Health Department’s hand in railroading the procurement process… and that’s what we’ll help provide right now.

An FDA official who can't stomach the corruption in the Public Healthcare System contacted ThinkingPinoy to provide him with copies of internal documents showing several officials from the FDA and DOH actively moving to railroad the approval of Sanofi-Pasteur’s Dengvaxia.

Let’s go.

March 2014: Sanofi “consults” FDA

On 11 March 2014, Sanofi Regulatory Affairs Manager Jervin Papelleras sent a letter addressed to then FDA director Kenneth Hartigan-Go and FDA Center for Drug Regulation and Research (CDRR) head Lourdes Santiago. It was a cover letter for the minutes of the meeting between FDA and Sanofi held on 03 March 2014.

The document, along with the attachments, is embedded below:

The letter in itself doesn’t look like it’s anything out of the ordinary. What’s troubling, however, are the attachments. According to the minutes attached to this letter, Sanofi in 2014 was discussing with FDA its “registration strategy in 2015, following the last meeting with FDA in 2012”.

Why is Sanofi consulting the FDA about its “registration strategy” when all the information about product registration is readily available in the [FDA website]? Sanofi is a gigantic pharmaceutical firm, so why would it even need to personally coordinate its registration with FDA officials when they must already be very familiar with the process?

ThinkingPinoy consulted a senior Health Department official about this and she said, “Meron pang registration strategy? E wala naman dapat strategy e isa lang naman dapat ang paraan ng pagre-register. Pag tiningnan mo yung FDA website, yung how to register a product, I’m sure walang meeting-meeting (involved). Dapat nga, walang private meetings required yung buong registration process.”

[TRANSLATION: 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.]

The “Minutes of the Meeting”

Sanofi’s highly irregular consultation with FDA took place at a time when Dengvaxia’s Phase III Trials in the Philippines was still ongoing, as shown in the screenshot taken from the embedded document in the previous section:

That is, FDA was actively helping Sanofi register a product that, at that time, has completed only its Phase II trials. That is, FDA was helping Sanofi register Dengvaxia even if Dengvaxia was still, by all intents and purposes, an EXPERIMENTAL drug.

This is wrong. The FDA is a regulatory body that approves or rejects registration applications, it should not be in the business of coordinating the marketing efforts of pharmaceutical companies, especially those involving untested products!

Scrolling further down the attachment, ThinkingPinoy stumbled upon a clue, as shown below:
The image above is a screenshot of the Sanofi’s proposed Dengvaxia registration timeline as submitted to FDA. The first column refers to the stage of registration while the last column shows the pertinent laws and regulations that Sanofi should comply with.

Hartigan-Go’s FDA Circular 2013-004

ThinkingPinoy takes great interest in one of the cited regulations, which is FDA Circular 2013-004.

In December 2017, ThinkingPinoy questioned the credibility of FDA head Kenneth Hartigan-Go when it was found out that Hartigan-Go’s career is too closely intertwined with Zuellig, whose pharmaceutical division is the exclusive distributor of Sanofi Dengvaxia in the Philippines.

Hartigan-Go was the head of the Zuellig Foundation prior to joining the Aquino Administration in 2010 and after he left in 2016, he headed the Asian Institute of Management’s Zuellig Graduate School [AIM].

(Note that former Health Sec. Esperanza Cabral, who leads the group “Doctors for Public Welfare” that has been making PR rounds in the media lately, is a trustee of the Zuellig Foundation that Hartigan-Go used to manage.)

In that critique, ThinkingPinoy wrote:

“…through Hartigan-Go's FDA Circular No. 2013-004, Phase IV trials for new vaccines were made optional, so that new drugs can basically enter the market right after Phase III… Hartigan-Go's FDA circular immensely benefitted Sanofi Pasteur Inc​, whose defective anti-dengue vaccine Dengvaxia just finished Phase III trials in late 2014, so that a Phase IV trial would have delayed mass market sales to 2017.”

And voila! FDA Circular 2013-004 is indeed in Sanofi’s “Registration Strategy”.

Again, why is FDA going out of its way to actively assist Sanofi in legalizing Dengvaxia?

FDA’s director is a Sanofi beneficiary, for one.

FDA Circular 2013-004 greatly benefitted Sanofi as it accelerated the latter’s marketing efforts. By making Phase IV trials optional, Hartigan-Go allowed Sanofi to mass-market Dengvaxia three years earlier than it would have.

Hartigan-Go’s circular made the controversial “Registration Strategy” possible. And it appears that Hartigan-Go wasn’t content with just that: he helped Sanofi all throughout the registration process, and more.

We shall go back to Hartigan-Go a little later. Let's talk about the bigger fish first.

Garin and Sanofi in May 2015: A Coincidence?

At this point, the reader may already have an inkling that the FDA is “in on it”, but the FDA, by itself, cannot orchestrate this entire hullabaloo: it must have the imprimatur from upstairs.

According to Philippine diplomatic records, Garin was in various official engagements in France in May 2015, including a dinner in Paris on May 14, 2015 between Garin and Guillaume Leroy, Vice President of Sanofi-Pasteur’s Dengue Vaccine Program [ABS].

Garin would probably deny that there’s anything fishy that went on, but a leaked email will say otherwise, as shown below:

On 18 May 2015, just four days after the Garin-Sanofi meeting, FDA deputy director-general Lourdes Santiago emailed other FDA officials about “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.”

FDA and DOH’s collective enthusiasm over Dengvaxia would have been acceptable if there was a massive dengue epidemic in the country. According to sources from the Deparment of Health, while there are seasonal dengue fever outbreaks, there has never been a dengue outbreak of epidemic proportions in recent history.

Another email provides more clues. This email shown in the image belowis an 11 May 2015 invitation for FDA officials to attend a World Health Organization conference in Switzerland about Sanofi’s Dengvaxia, at the time still called CYD-TDV.

Healthcare industry veterans that Thinkingpinoy consulted said that given modern telecommunications, these trips are just junkets that pharmaceutical companies give to industry decision-makers to curry their favor.


PNoy and Sanofi in December 2015: Another Coincidence?

On 02 December 2015, the [Official Gazette] reported that officials of Sanofi Pasteur met with President Aquino in Hotel Scribe in Paris. With Aquino were Health Secretary Janette Garin, Finance Secretary Cesar Purisima, Trade and Industry Secretary Gregory Domingo and Transportation and Communications Secretary Joseph Emilio Aguinaldo Abaya. A photo of their meeting is shown below.

Aquino, Garin, Purisima, Abaya and Co. meet Sanofi execs in France on 02 December 2015

A courtesy call is just a more formal term for a quick “Hello!”, but it seems that more than just a courtesy call happened, as evidenced by the email shown below:

On the same day, Sec. Garin asked FDA deputy director Santiago, “When will the CPR for dengue vaccine be probably released?”

CPR is the Certificate of Product Registration, a document issued by the FDA that serves as the license for a product which, in this case, is Sanofi’s Dengvaxia.

Santiago replied, “We are trying the (sic) have the final assessment report done by the second week of December po.”

“Ok. Please keep me posted. TY,” Garin replied.

Did Garin ask (and obviously, pressure) FDA about Dengvaxia just because she felt like it?

Of course not, as shown in the email below:

On 18 December 2015, or about two weeks after the previous email, Garin asked FDA, “When can the Dengue vaccine be approved?”

Garin didn’t ask the FDA if it will approve Dengvaxia or not: she asked when FDA shall approve it!

Changing the Rules to benefit Sanofi?

A month later, another leaked email from former FDA head and then Health undersecretary Kenneth Hartigan-Go (yes, the same guy who made Phase IV trials optional) reveals very disturbing reality: that the Aquino-era DoH really intended to bend the laws to benefit Sanofi.

After getting its hastily-issued FDA Certificate of Product Registration (CPR) in December 2015, Dengvaxia’s fate was transferred into the hands of the Formulary Executive Committee (FEC). In simple terms, a CPR makes a new product legal to sell, but it requires an additional FEC clearance to allow the government to buy it.

That is, an FEC clearance is required for the Aquino Government to buy P3 billion worth of dengue vaccines from Sanofi. Without FEC or an FEC exemption, that would not be even in the least bit legally possible.

In a 27 January 2016 email shown above , Usec. Hartigan-Go told key regulatory 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.”

Why did Hartigan-Go say this?

Dengvaxia was a newly-registered drug at the time and it has not even completed Phase III trials, let alone Phase IV trials, by the time it was handed over to the FEC approval.

FEC regulations require a Post-marketing Surveillance Report (PMS), which would have existed had there been a Phase IV trial for Dengvaxia. But as the reader may recall, Hartigan-Go himself made Phase IV trials optional in 2013, while he was still FDA chief.

Dengvaxia, at that point, was in limbo: how can the FEC clear Dengvaxia when it is not compliant with existing rules?

Here’s where Usec. Hartigan-Go’s message becomes relevant, as he explicitly told regulators that the Aquino Government was willing to change the rules – or even create new regulations (protocols) – to ensure that the government can purchase Dengvaxia.

Again, and this bears repeating: there had been no Dengue Epidemics in the recent past.

In the same email, Hartigan-Go even gave a heads up to regulators as he informed them of possible questions from President Aquino.

What we have seen here is not just simple negligence, but one magnificently orchestrated crime that involves the top officials of the Aquino Administration.

ThinkingPinoy's Takeaways

ThinkingPinoy agrees with Senator JV Ejercito in that we need a more sober discussion of the #DengGate Scandal.

However, that is easier said than done given Sanofi's massive PR operations, including the efforts of former Health Sec. and "Doctors for Public Welfare" head Esperanza Cabral, a trustee of Zuellig Foundation.

Zuellig Pharma is the exclusive distributor of Dengvaxia in the Philippines.

Some camps dismiss PAO's announcements as mere histrionics, but as the legal counsels of marginalized Dengvaxia victims, it is their job to advocate for their clients, in the same way that Cabral et Al advocate for their Big Pharma benefactors.

The Pharmaceutical Lobby has very deep pockets. It's more than probably armed with a war chest bigger than the National Government's. And just like any creature, it will do everything it can - including emptying that massive war chest - to survive.

The problem, however, is that Big Businesses are borne not out of altruism, but for the amoral end of profit.

Sanofi is not immoral: it is amoral. Without the government giving it considerable incentive to align with Public Interest, it will not do so.

Hence, what we need is a government response that definitively displays Political Will to force Sanofi into submission, something that our government, so far, has failed to demonstrate. Needless to say, the current government should go after the corrupt officials that were instrumental in the creation of this Public Health debacle.

PAO, despite its flaws, is doing its best to advocate for the victims. Without PAO, this issue would have already been covered up, just like most of the corrupt acts of government officials in the not too distant past.

With that said, I wish all other government agencies involved in this mess will show the same kind of tenacity that PAO has been showing since the Dengvaxia Scandal began.

Filipino first, dear friends... and neither Sanofi nor Zuellig are Filipinos.


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