December 13, 2017

#DengGate: Dear Mr. President, here’s the memo you asked for


Dear Mr. President,



I did some arm twisting so I can be seated next to you during the bloggers’ Christmas Party held yesterday in Malacañang. I felt the need to do so because I wanted to be sure that you are already aware of the #DengGate scandal, where over 800,000 kids have been injected with a defective vaccine, thanks to corrupt officials in the government and a greedy pharmaceutical company.

You instructed me to write a memo about it and give it to Sec. Bong Go, so here it is. You said I don't have to sign it, but I decided to publish it on my blog too. I stand by what I write, pero salamat pa rin po sa pag-unawa.

I have spoken with dengue experts, government officials, and victims’ families to learn more about what happened. Adding the results of extensive research about this particular issue, here’s a relatively short brief of the nightmare that’s haunting almost a million children and their families today. This is by no means an exhaustive discussion of the problem. Please consult experts on the issue, experts from both sides, so that you can get a better picture of what has happened.

With that said, let's start with the basics.

How dengue basically works

Persons who get sick with the dengue virus for the first time suffer from mild dengue, which is generally not a serious disease. The problem, however, is when the same person gets sick for the second time, because it’s when severe dengue happens.

Severe dengue is a potentially deadly complication due to plasma leaking, fluid accumulation, respiratory distress, severe bleeding, or organ impairment[1].

Hence, a person’s first dengue infection is like a “warning”, sort of like a “free pass”, a message saying, “You should be very careful because it’ll be so much worse, if not fatally worse, the next time.”

Senator Richard Gordon has warned about this in as early as December 2015[2] when he said Sanofi itself admitted risks, but the DoH ignored him.

Anti-Dengue Mass Vaccination Program

In early April 2016, the DoH launched a massive anti-dengue immunization program covering 1 million 4th grade students in Central Luzon, CALABARZON, and NCR[3]. The program used Sanofi’s newly-developed vaccine Dengvaxia which, at the time, was recommended only for individuals have had dengue before and are 9 years or older[4].

At the time, both Sanofi and the World Health Organization have warned against vaccinating those with no history of dengue[5]. This warning stems from the vaccine’s tendency to act as the “first infection”, so that the first “real” infection (through a mosquito bite) will mimic the symptoms of a second infection.
Let me state this more clearly: If a person has never had dengue before and gets bitten by a mosquito for the first time, that person will get mild dengue. However, if that same person who has never had dengue is vaccinated with Dengvaxia AND gets bitten for the first time, he gets severe dengue right away. In short, Dengvaxia dramatically worsens dengue symptoms for those who have never had dengue before[6].

I feel that Sanofi was a bit sneaky with this warning because they called it a “theoretical risk”, as clinical trials on 2- to 14- y/o kids confirmed that Dengvaxia has the exact same effects on those aged 2 to 9. The trial, however, has very few test subjects aged 9 and up, so Sanofi can’t say yet if Dengvaxia does the same to that age group. 

Sanofi’s material concealment, DoH’s mathematical manipulation

However, instead of finding additional suitable test subjects (i.e. aged 9 and up with no dengue history), Sanofi marketed the vaccine right away. After all, Sanofi’s trials basically proved that Dengvaxia is not for 9 and below. If they did another trial for those 9 and above and confirmed the same adverse results, then Dengvaxia would’ve gone straight to the trash bin. That is, the $1.78 billion they’ve invested in the past 20 years would’ve gone to waste[7].

And here comes another problem.

DoH wanted to inject 1 million kids with Dengvaxia, even if they are not sure who among them have had dengue before (seropositive) or and those who have not (seronegative).

According to WHO’s April 2016 paper on Dengvaxia, the vaccine may still be used for mass immunizations if at least 70% of target population is seropositive, and that’s what the DoH used to justify its vaccination program[8].
To do this, they cited a 2016 study[9], where it was found out that 90% of 1,000 randomly selected residents of Punta Princesa, Cebu City are seropositive. The DoH extrapolated Cebu City data to say that 90% of 4th graders in NCR, CALABARZON, and Central Luzon are seropositive, which would supposedly fulfill WHO’s guidelines.

This is bad math, to say the least, because the test samples (from Cebu) ARE NOT representative of the target population (from Luzon). And despite this glaring flaw, Malacañan, through Spokesperson Roque[10] and Secretary Duque[11], still uses this justification.

DoH endangered over 830,000 kids

DoH was actually unsure about how many and which among the 1 million kids targeted are seronegative[12]. As I have said before, Dengvaxia worsens dengue symptoms for seronegative recipients, i.e. children who have not had dengue.

I should also note that the same WHO document advises against mass vaccinating populations where less than 50% are seropositive[13]. The problem, however, was that DoH was in a strange rush so they did away with testing children and vaccinated them right away.

DoH Sec. Duque has confirmed that at least 830,000 kids[14] have been vaccinated so far. The vaccine, which was for a time also available from local private vendors, was also privately administered to many Filipinos. DoH doesn’t know which ones of those 830,000 kids have never had dengue before. That is, DoH doesn’t know which ones require monitoring and which ones who don’t.

Mr. President, this is a big mess. A big, deadly mess.

Let’s take care of the 830,000 kids first

Before I discuss how the situation has gone this bad, let me first recommend a few preliminary courses of action so that we can minimize the harm caused to the 830,000 kids by this DoH debacle.

First, de-escalate through information

Simply telling people not to panic will not prevent them from panicking. Instead, you may want to ask for airtime from the major networks so you can address the entire country and explain to them what’s going on and what you are doing or planning to do about it.

You can also ask DepEd to to discuss the issue during PTA meetings. You may also order social workers in affected areas to visit the homes.

Reach out to Dengvaxia victims to reassure them that the government is doing its best to address the situation. Instruct the social workers to educate the families on ways to mitigate the situation. More than lowering mortality rates, this can help calm down panicky parents who are clueless about what’s going on. 

Second, create an emergency fund

Please set up an emergency fund that hospitals, whether private or public, can tap into anytime. Set it up in such a way that a hospital can withdraw from it to cover the expenses of any patient who reports a fever and fits the profile of those who were under the botched vaccination program, or shows any proof that they have been vaccinated with Dengvaxia.

This way, parents of Dengvaxia victims, who are typically not well off, will be less likely to think twice about consulting doctors[15], enabling the medical establishment to diagnose dengue cases early, thereby lowering mortality rates.

Third, restore trust in the public health system

Please suspend or terminate all officials who have a lot to do with this mess. This way, we can help quell the public’s doubts on the integrity and general reliability of the public healthcare system.

Now, let’s ask: How did it come this far?


First, FDA changed rules in 2013 to favor Sanofi

One major main point of contention in this vaccine scandal is the uncertainty of Dengvaxia’s effects on seronegative recipients (never had dengue) aged 9 and up. An issue where the WHO said “it is critical to evaluate as soon as possible whether there is any risk to this population[16].”

Phase IV drug trials could have addressed this issue. In Phase IV drug trials, a new drug is sold publicly to 3,000 people per year for three years as doctors closely monitor recipients for adverse effects[17].

That is exactly what Malaysia demanded in April this year before it clears Dengvaxia there[18], and that is exactly what the Philippine failed to do in as far as Dengvaxia.In 2013, then FDA chief Kenneth Hartigan-Go made Phase IV trials optional when he said manufacturers, by themselves, can decide whether to do Phase IV trials or not[19]. Thus, Sanofi was able to market Dengvaxia right after their Phase III trials ended.

I have reason to believe that Hartigan-Go did this to benefit Sanofi. Before joining government, Hartigan-Go was an Executive Director of Zuellig Foundation, the philanthropic arm of Zuellig Pharma, Sanofi’s official local distributors. After leaving government in June 2016, Hartigan-Go headed AIM’s Zuellig School[20].

He is Zuellig through-and-through. Suffice it to say, the Philippines’ de facto Phase IV Dengvaxia trial was done on 830,000 innocent children. Hartigan-Go, regardless of intent, indeed used 830,000 Filipino kids as laboratory rats.

Second, corruption in procurement

The Aquino Government has been in talks with Sanofi in as early as 2014, when PNoy met Sanofi during the Beijing APEC summit[21]. In May 2015, DOH Sec. Garin clandestinely met Sanofi in France and taught the French executives how to entice our Congress to purchase Dengvaxia[22]. Lastly, in early December 2015, Pnoy, Garin, and other cabinet members met with Sanofi on the days surrounding the Paris Accord meetings[23].

Less than a month after the Paris meetings and before 2015 ended, DBM has already released a SARO for P3.5 billion, sourced from the Office of the President’s Miscellaneous Personnel Benefits Fund and transferred to the Philippine Children’s Medical Center[24]. That is, despite the DAP ruling issued earlier in February 2015[25], the Aquino Government used a DAP-like mechanism just 10 months later[26].

PCMC received P3 billion from these funds and used it to buy Dengvaxia. This amount raises suspicion because Sanofi declared only EUR 20 million (P1 billion) in Dengvaxia sales for Q1 2016[27].

Where did the other P2 billion pesos go?

What made this whole thing even more irregular is that all these procurement steps were taken before Dengvaxia was discussed by the Formulary Executive Council. All drugs require FEC approval before the government can procure them, and the Aquino Government procured Dengvaxia without one, as the FEC approval (exemption) was issued after the fact.

Third, coverup within DOH

Evidence suggests that DoH rank and file may be trying to cover up the Dengvaxia mess[28].

I stumbled upon the case of a 12-year-old child in Capas, Tarlac, who contracted severe dengue just three months after receiving the third and final dose of Dengvaxia[29]. She was among the 500,000 fourth graders who actually received the vaccine during launch.

I spoke to the mother over the phone and she told me that she did not sign any consent form, that she found out about her daughters vaccination only after the fact.

The child’s family is very poor. The mother even had to borrow money just to get the child admitted to a hospital in Tarlac City. She was openly soliciting for financial through social media and I told her that I will visit her the next day to speak to her, to hand her a few thousand pesos from my own pocket, and to ask her to ask her to fill out several forms so I can help her get more substantial financial help from charitable GOCCs and public officials.

Upon arriving at the hospital, however, I discovered that DOH-Tarlac has whisked her away to Pampanga two hours prior. I would’ve given DOH the benefit of the doubt, if not for the fact that the hospital staff told me that DOH paid for her outstanding balance. The hospital is privately-owned the child has been in ICU for a couple of days or so. I doubt that DOH has discretionary funds that it can use to bail out patients just like that.

I smell a cover up. If the DOH bailed out that 12-year-old, then why didn’t it bail out the 12-year-old’s neighbors, who were also stricken with dengue and admitted in the same hospital?

With that said, I have serious doubts about the accuracy of reports that Secretary Duque has been receiving.

Fourth, a massive coverup upstairs

The issue could have been addressed sooner and more thoroughly if it weren’t for some government officials apparently trying to cover up the mess. Prior to Sanofi’s November admission[30] that Dengvaxia is bad for those who have never had dengue, the House of Representatives has actually attempted to investigate the issue in as early as October 2016[31].

However, according to some of the resource persons invited in the first hearing, several congressmen, including then party-list Representative Harry Roque, attempted to prevent anti-Dengvaxia resource persons to testify.

On the first day, Roque told Philhealth director Dr. Tony Leachon, a resource person, that the latter cannot be allowed to testify because of the lack of approval from the Philippine College of Physicians, of which Leachon was president. This defies logic because Leachon is an expert on the issue with or without PCP approval.

According to Leachon, Roque and the other congressmen stayed mum as former Health Sec. Janette Garin, who was just an audience member during the hearing, kept on standing up and intimidating the witness. Leachon said Garin went hysterical so the presiding officer was forced to adjourn the first hearing only an hour after it started, no complaints or admonitions against Garin came from Roque.

A few hours prior to the second hearing, Roque approached Leachon and asked him to state his credentials as Roque had it videotaped. When the hearing started, Roque played a spliced version of the footage and made it appear that Leachon, a very accomplished physician, was overconfident. That is, Roque character-assassinated Leachon even before Leachon was able to speak in front of the committee.

Please call Dr. Tony Leachon to confirm these allegations.

I would not have made a big deal out of this if not for the fact that Roque actively defended Sanofi when the Dengue Vaccine Scandal erupted a couple of weeks ago. As a presidential spokesperson, he should have exercised restraint and put into mind that he speaks on the president’s behalf. Surely, the president that I supported from Day One would have better things to say than “Don’t panic.”

It’s also weird that Secretary Duque flip-flopped on his pronouncements and I suspect Roque has a hand in it.

About a week ago, Duque said Aquino should attend the Senate probe on Dengvaxia[32]. Recently, however, Duque seems to have forgotten about Aquino’s liability as he focused solely on Sanofi in his announcements, in line with the Liberal Party’s general PR storyline[33].

My sources said Roque pressured Duque in the same way Roque pressured then Health Sec. Paulyn Ubial during her confirmation hearings. Roque was instrumental in blocking Ubial’s confirmation, mainly because of Ubial’s opposition to the defective Dengvaxia vaccine. Duque, Ubial’s replacement, is also up for confirmation, so my sources said Roque told Duque that the latter will suffer the same fate if the latter doesn’t co-operate.

I have reason to believe that the Office of the President has two primary sources for this Dengvaxia mess: Health Secretary Duque, who is under intense pressure to get confirmed; and Presidential Spokesperson Harry Roque, who still wields influence in the Lower House and who has historically antagonized those who oppose Dengvaxia.

Mr. President, you said before that you will axe anyone in your cabinet who demonstrates even a whiff of corruption.

Mr. President, behold Harry Roque. He may not be addicted to money, but he's addicted to power.

And I believe that that kind of addiction, Mr. President, is a problem worse than drugs. [ThinkingPinoy]


Sincerely,

Rey Joseph Nieto
Publisher

ThinkingPinoy



[2] Gordon, R. Gordon Alarmed as Sanofi Admits Dengue Vaccine Poses Risks. Senate Press Release. 01 December 2015.
[4] Sage Working Group on Dengue Vaccines and WHO Secretariat. Background Paper on Dengue Vaccines. 17 March 2016. p 26.
[5] Ibid. p 4.
[6] Ibid. p 24.
[8] Department of Health Integrity Management Committee. Review of the “Report on the Introduction of the Tetravalent Dengue Vaccine in the Department of Health Immunization Program”. IMC Resolution No. 2017-01.
[12] Punay, E. DOJ sets probe of dengue vaccine mess. Philippine Star. 04 December 2017.
[13] Refer to (5).
[16] Sage Working Group on Dengue Vaccines and WHO Secretariat. Background Paper on Dengue Vaccines. 17 March 2016. p 6.
[17] US Food and Drug Administration. The Drug Development Process.
[20] Tiglao, R. Senate should probe why Sanofi got Zuellig for Dengvaxia sale. The Manila Times. 13 December 2017.
[21] Radio-Television Malacañang. Business Meeting with Sanofi. 9 November 2014.
[22] Grande, G. An evening with Dengvaxia makers in Paris. ABS-CBN News. 07 December 2017.
[25] Supreme Court of the Philippines. Araullo vs Aquino. G.R. No. 209287. 03 February 2015.
[27] Sogonowsky, E. Sanofi's Dengvaxia launch rocked by turmoil in Latin America. FiercePharma. 29 July 2016.
[28] Nieto, R. #DengGate: Botched Tarlac Dengvaxia case hints DoH-led coverup. ThinkingPinoy. 06 December 2017.
[31] Suansing, E. HR Res. 480. House of Representatives. 17 October 2016.
[32] Gita, R. Duque urges Aquino, Garin to clear names in Dengvaxia mess.  Sunstar Manila. 08 December 2017.
[33] Tamayo, B. Duque hits Sanofi for ‘mental dishonesty’. Manila Times. 12 December 2017.

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