TWO advocacy groups have charged former President B. S. Aquino 3rd, former Budget Secretary Florencio “Butch” Abad, former Health Secretary Janette Garin, and 17 others with serious criminal wrongdoing, in connection with the government’s rushed purchase in 2016 of three million doses of Dengvaxia vaccine, which has been blamed for the death of least three schoolchildren, and the serious dengue infection of so many others after receiving the vaccine. Corporate officers of Zuellig Pharma, the Philippine representative of Sanofi-Pasteur, the French manufacturer of the vaccine, are expected to be impleaded soon.
This comes at a time when the Prosecutor of the International Criminal Court at the Hague has decided to open an “examination” into allegations of extrajudicial killings in the context of President Rodrigo Duterte’s war on drugs in the Philippines. Those involved in filing the charges against Aquino appear confident they would see PNoy in court soon, before the ICC Prosecutor Fatou Bensouda completes her “examination” into allegations of killings in DU30’s war on drugs.
Who will get it first?
Volunteers against Crime and Corruption (VACC) and Vanguard of the Philippine Constitution (VPC), represented by lawyers Manuelito Luna and Eligio Mallari, respectively, have accused Aquino, Abad, Garin and company of graft and corruption and criminal negligence, among others, before the Department of Justice, and violations of the election law before the Commission on Elections. They expect preliminary investigations to follow promptly.
The Dengvaxia scandal has been in the public eye since Sanofi released the results of its latest clinical tests on its own vaccine on November 29, 2017. These showed that if Dengvaxia was given to a child who had not had dengue before, it would increase the risk of the child contracting a more severe type of dengue infection. This information came after hundreds of thousands of schoolchildren, aged 9 and up, had received Dengvaxia in the DoH mass immunization campaign under Garin, which kicked off on April 4, 2016.
Garin is blamed for rushing the purchase of Dengvaxia without waiting for the results of the clinical trials of the Research Institute for Tropical Medicine to ascertain the risks before launching the immunization program. This happened in the run-up to the 2016 presidential election, when the multi-billion-peso transaction gave Aquino’s candidates access to political funds not otherwise available, and a health program to exploit on the campaign trail.
According to lawyer Luna, VACC is prepared to show that on April 5, 2016, in Iba, Zambales, Aquino, Garin and company, dressed in their yellow campaign uniforms, used Dengvaxia as a propaganda platform for Liberal Party presidential candidate Manuel Roxas and others.
Improprieties and shortcuts
The immunization program was attended by shortcuts and improprieties from the very beginning. These included Aquino and Garin meeting with Sanofi officials in unexplained circumstances, preparatory to giving the vaccine marketing approval in the Philippines.
On November 9, 2014, Aquino met with Sanofi senior vice president for Asia, Jean-Luc Lowinski, of all places, at the Philippine embassy in Beijing.
In May or June, 2015, the Philippine ambassador to France reported that Garin had come to Paris unannounced, and dined privately with a Sanofi official during which they discussed ways and means of creating a demand for Dengvaxia in the Philippines. Garin tried to deny this in the beginning, but ultimately owned up, saying she had come “to negotiate” a reduced price of the vaccine.
On October 29, 2015, Sanofi asked the DoH that Dengvaxia be included in the Philippine National Formulary, a list of drugs which all pharmacies in the country must carry, pending approval by the Food and Drug Administration.
On December 1, 2015, Aquino and Garin met with Sanofi officials in Paris, during the UN Conference on Climate Change. After this meeting, the Dengvaxia transaction moved like an express train.
On December 10, 2015, Garin submitted to the Department of Budget and Management a proposal to buy three million doses of Dengvaxia. The DBM releases all authorized appropriations, but does not have the power to appropriate. In fact, in July 2014, the Supreme Court struck down as “unconstitutional” the multi-billion Disbursement Acceleration Program, by means of which the President illegally appropriated billions of pesos for his own programs without the knowledge of Congress.
The cart before the horse
The request to purchase three million doses preceded every process needed to make the vaccine legally accessible to the public. It did not have the approval of the Food and Drug Administration, it was not part of the Philippine National Formulary, and not licensed to be sold and distributed anywhere in the Philippines. So, Garin stepped on the accelerator.
On December 22, 2015 the Philippines granted marketing approval to Dengvaxia, making it the first anti-dengue vaccine to be licensed in Asia, and making the Philippines the first country to approve use of the vaccine. The FDA approved the vaccine for preventing four types of dengue in individuals 9 to 45 years old in high-risk areas.
On December 28, 2015, the DoH Family Health Office asked the health secretary to exempt Dengvaxia from the mandatory review by the Formulary Executive Council (FEC), which determines what drugs are to be included in the National Formulary.
The money trail
On December 29, 2015, the DBM released a Special Allotment Release Order (SARO) worth P3.5 billion to Garin’s office for the purchase of the vaccines.
There was no appropriation for such vaccines in the DoH budget, and the sum was much bigger than the DoH’s total budget for immunization. It was also only a year after the Supreme Court had declared the DAP “unconstitutional.”
On January 21, 2016, the Philippine Children’s Medical Center made a purchase request for Dengvaxia worth P3 billion, without the required approval of the FEC, nor any covering memorandum between the DoH and the PCMC. Within four days, 145 doses of the vaccine were delivered, followed by a second batch of doses on February 11, 2016.
On February 3, 2016, Garin issued a certificate exempting Dengvaxia from various requirements in its pilot implementation in the National Capital Region, and Regions 3 and 4-A.
Dengvaxia poster girl
On February 11, 2016, Garin hosted the worldwide launch of Dengvaxia on behalf of the Philippines.
This complied with her commitment to Sanofi to become a poster girl for the vaccine during that Paris private dinner.
On February 19, 2016, the DoH and PCMC finally signed a memorandum of agreement covering the already ongoing Dengvaxia project.
On March 2, 2016, the DBM issued to the DoH a Notice of Cash Allocation worth P4.5 billion.
The date, not just the amount, of this release is significant. The DBM may have intended to preempt the law, which prohibited the release of public funds for any project starting March 25, 2016 until the end of the May 2016 elections.
On March 8, 2016, Garin issued a P3 billion disbursement voucher to the PCMC to fund the Dengvaxia purchase.
Enter Zuellig Pharma
On March 9, 2016, PCMC issued a purchase order to Zuellig Pharma for the vaccines.
That same month, the World Health Organization released a paper saying Dengvaxia “may be ineffective and even increase the risk in those who are seronegative at the time of first vaccination.” (Seronegative refers to people who have not yet had dengue). WHO called for more studies into the vaccine.
On April 4, 2016, the DoH rolled out its mass immunization program. This coincided with the summer break, while school was out. The DOH said the gradeschoolers were to be given three doses of the vaccine, administered every six months.
In July, after DU30 became president, the WHO released another paper saying Dengvaxia “may act as a silent natural infection that primes seronegative vacinees to experience a secondary-like infection upon their first exposure to dengue virus.” This means the vaccine “may be ineffective or may theoretically even increase the future risk of hospitalized or severe dengue illness in those who are seronegative at the time of first vaccination, regardless of age.”
That month, DU30’s Health Secretary, Paulyn Ubial, suspended the school-based program, saying only the 489,003 pupils who had received the first dose would be given the second and third doses. But by September 2016, the DoH decided to continue the program.
At the same time the Medical Research Council Center for Outbreak Analysis and Modelling at Imperial College, London, released a study saying Dengvaxia could lead to an “increase in the number of cases if not implemented correctly. The second time you get it is likely to be more severe than the first time, Neil Ferguson, the director of the center was quoted as saying.
Sanofi’s own critique
Then on November 29, 2017 Sanofi-Pasteur released the results of its own tests, and expressed serious reservations about the continued use of the vaccine.
On December 1, 2017, Health Secretary Duque suspended the program. He said 733,713 schoolchildren from Central Luzon, Cavite, Laguna, Batangas, Rizal, Quezon and Metro Manila had been vaccinated, and about 70,000 of them had not had any dengue yet.
On December 5, 2017, the FDA suspended the sale and distribution of Dengvaxia, even as WHO made it clear it never recommended the use of Dengvaxia in any immunization program.
On December 6, 2017, the DoH said 800,000 young children had received the vaccine. Twenty-nine who had received the vaccine have died, but UP-PGH doctors linked only three of such deaths directly to the vaccine; 40 cases of serious infection were being closely monitored. Meantime, the Public Attorney’s Office continued to conduct autopsies on the dead children.
In Congress, where inquiries were ongoing, and in the media, the focus shifted to the money paid for the vaccine.
The DOH said it would return 800,000 leftover vaccines worth P1.4 billion, but demanded a full refund from Sanofi. On January 19, 2018 Duque was quoted as saying in San Fernando, Pampanga that Sanofi had already refunded P1.16 billion worth of unused vaccines.
Through all this period, we heard nothing of how much money actually went into this project, and who were specifically involved in the transaction/s.
If P3 billion was all that Garin disbursed to the PCMC (per March 8, 2016 transaction), what happened to the P500 million remainder from the P3.5 billion which DBM had released to Garin through a Special Allotment Release Order on December 29, 2015?
Better still, what happened to the P1.5 billion difference between this P3 billion transferred to PCMC and the P4.5 billion contained in the DBM’s Notice of Cash Allocation to the DoH on March 2, 2016?
Most important of all, was Garin the only person involved in all these transactions? Should Zuellig Pharma, Sanofi’s agent, remain faceless forever? A friendly investment banker would like to know, how many purchase orders were involved here? Who issued the POs for the DOH or the PCMC and to whom were they issued, by name? How many check payments were made? To whom were they payable, and by whom? Were the payments made in Philippine pesos or in US dollars?
None of these details have come up in the press or in the Senate investigations. I tried to get an interview with former Foreign Secretary Bobby Romulo, who is supposed to chair the Zuellig Family Foundation, in order to clarify some questions. At first, he showed some interest, but he ultimately declined. He said he did not feel inclined to speak for Sanofi or Zuellig and saw no point in seeing an old friend. Perhaps Sen. Richard Gordon or somebody else could help us fill up the details.