Corruption Drives Philippines Pharma

Published December 4, 2017 by Carl De Luna

Dengue is a viral infection caused by the Aedes aegypti mosquito and according to the World Health Organization, it has become the leading cause of hospitalization and death of adults and children in Asian and Latin American countries. It is normally found in mostly urban and semi-urban areas in sub-tropical and tropical climates worldwide. It was first known in the 1950’s when dengue epidemics in the Philippines and Thailand became rampant. A recent estimate indicates that there are 390 million dengue infections per year (with a 95% credible interval of 284-528 million), with 96 million (67-136 million) manifest clinically. Two-thirds of those infected are in Asia. Thus, there is a great demand for a dengue vaccine.

Dengue had been a hard case to crack for scientists as it has four separate strains which forced researchers to make a drug which would fight all strains at once. While early detection and access to proper medical care lowers fatality rates to below 1%, dengue or severe dengue has no specific treatment. It has similarities with the common flu but is not considered fatal if proper medical care is provided. So, it was a huge medical breakthrough when French pharmaceutical giant Sanofi Pasteur announced that it had found a vaccine for dengue.  Over two years ago, Sanofi Pasteur Executive President of Vaccines and Current Executive Vice President of General Medicines and Emerging Markets Olivier Charmeil said their vaccine was a major step in the prevention of dengue and for public health.

A clinical test on 40,000 people from 15 countries, found that their product Dengvaxia immunized two-thirds of people aged nine years and older. It increased success to 93% for dengue hemorrhagic fever, the more severe form of dengue. The test also found out that the risk of hospitalization went down by 80%.

Sanofi Pasteur was one of the competing pharmaceutical companies vying for the development of dengue vaccines. Some competitors include British firm GlaxoSmithKline, Takeda from Japan and US firm Merck. In 2015, Sanofi had a million doses of the vaccine ready to ship, with an expected annual production of 100 million doses by 2017. Their research and development took 20 years and cost more than $1.6 billion USD (1.5 billion euros). Analysts estimated it would make the company more than $1 billion annually from 2018 or 2019. Its first regulatory approval was in Mexico and was being reviewed by 20 Asia and Latin American nations.

Their first client was the Philippines. It was no wonder as the Philippines experienced a spike in dengue incidences in 2015, with over 200,000 dengue cases. They were the first in Asia to approve the vaccine when the Food and Drug Authority passed it on December 23, 2015, for use by individuals aged 9 to 45. However distribution was put on hold as the Philippine Health Department had to wait for the WHO vaccine pre-qualification guidelines and recommendations before funding could be provided for large-scale procurement. After a few days, in an interview in national television, the then Health Secretary Janette Garin said she had complete faith with the vaccine and even highlighted that the vaccine is perfect for those between the ages of 9 and 45 years old. She gave her approval of Dengvaxia despite the lack of WHO guidelines.

The Philippines hosted the global launch of Dengvaxia on February 11, 2016.  The Health Department admitted during the event that they would be getting a discount on the vaccine for the vaccination program which would start on March 2016. They also revealed that the vaccine has side effects which include fever, headache, muscle pain, weakness, redness and swelling. They claimed the vaccine was launched in the Philippines since it is the only country which completed all three phases of clinical development.

A month after the launch, the World Health Organization released their background paper Dengue Vaccines on their website. This was supposedly the basis of Secretary Garin’s decision to introduce a mass vaccination program. The program was launched the following month on April 4, 2016 with the presence of then President Benigno Aquino III, the son of democracy icon Corazon “Cory” Aquino. The target regions of the school based immunization program were the National Capital Region (which include the capital Manila), Region III- Central Luzon and IV-A (CALABARZON). The immunization program was worth $75.78 million USD (Php 3.5 billion) and would be administered to over 700,000 4th Grade students, with plans to administer it to a million 4th graders.

Despite warnings from the World Health Organization about the vaccine, the program was rolled out. A report from London School of Hygiene and Tropical Medicine professor of tropical epidemiology to the World Health Organization stated that there is a possibility that the vaccine would be ineffective or even increase the risk of severe dengue to recipients aged 9 and above who have not had dengue before. It also stated that there are insufficient trial subjects for that same large group for any approval to be made.

Recently, Sanofi announced that those not previously infected with dengue and who got vaccinated with Dengvaxia could contract “severe disease”. At risk are some 70,000 children vaccinated since the inception of the program in 2016. The previous Health Secretary Paulyn Ubial stopped the program pending the results of the pilot program. There have been calls for an investigation about the vaccine scandal and most likely serious corruption from the public and public officials.

Government officials ignored expert advice about Dengvaxia. Sanofi must also take responsibility as it meant that Filipino school kids were treated as guinea pigs for the vaccine. There should have been stricter guidelines with the vaccination program and the screening process. Only those who had previously had dengue should have been injected with the vaccine. Officials such as former President Aquino should be held accountable as purchases over $1 million USD (Php 50 million) requires his signature.

FILE PHOTO: A logo is seen in front of the entrance at the headquarters French drugmaker Sanofi in Paris October 30, 2014. REUTERS/Christian Hartmann/File Photo

A recent case of a student in Tarlac (ironically Aquino’s province) who never had dengue and received three shots every 6 months showed that there was no consent form or waiver or screening. There might also be a case for corruption in the deal involving Sanofi Pasteur and the Philippine government. President Aquino and Health Secretary Janette Garin met in France on December 1, 2015. Nine days later, then President Aquino scoured for funds for the immunization program despite it not yet being approved for use in the Philippines. The more damning was they took the $75.78 million (Php 3.5 billion) from savings meant for retired personnel, which was against the Supreme Court ruling which banned the Executive branch from reallocating savings.

Sanofi itself is embroiled in bribery scandals in Africa, China, Europe and the Middle East. This scandal looks like just another one of its regular business practices. Heads must roll in this issue of public health and it would serve as warning to those planning to purchase Dengvaxia for their own citizens. It would be best if they would hold off from buying the vaccine until clinical trials are complete and have sufficient tests for short-term, medium-term and long-term effects of the drug to those who have and haven’t been affected with Dengue.

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