DENGUE: SANOFI AT THE HEART OF A DEADLY VACCINE CASE IN THE PHILIPPINES

A Must read. Ms. Isoux was at the funeral parlor where Elijah Rain was being autopsied.

Article of French journalist CAROL ISOUX....... translated from original L’OBS French newspaper (link to original French article below)

DENGUE: SANOFI AT THE HEART OF A DEADLY VACCINE CASE IN THE PHILIPPINES

By Carol Isoux Posted on 09 December 2018 at 17h51
(Through the kindness of and thanks to Lourdes De Las Cagigas 
https://m.facebook.com/story.php?story_fbid=2036544599767516&id=1786768584745120.... )

In a room with white tiles, at the back of Taytay's funeral parlor about twenty minutes from Manila, the body of 12-year-old Elijah Rain De Guzman sits on a stainless steel table. He is lying on his back, his legs slightly bent in a frog position.

The five members of the PAO Forensic Team are getting ready, put on the blue plastic outfits and get on with their long and painful task. For nearly four hours, they will dissect, take tissue samples, measure the organs: heart, liver, brain ... Everything is carefully photographed. Outside, the family is waiting.

Dr. Erwin Erfe, who works for the prosecutor's office, have autopsied two to three a week in recent months. With always the same findings: "Internal bleeding, especially in the brain and lungs ... and organs swollen."

For him, no doubt, it is the vaccine Dengvaxia, marketed by the French laboratory Sanofi who is responsible for these deaths. His Forensic team of has already identified 103 concordant cases. Poor children, who do not have easy access to the care system.

For prosecutor Persida Acosta, passionate about social inequalities, the responsibilities are shared between the French laboratory that sold "a dangerous vaccine", and the Philippine government that has set up a vaccination campaign "massive and indiscriminate "in deplorable conditions. Without informing the health staff, without excluding children with compromised immune systems, without medical follow-up and often without even asking for parental consent. She is suing 38 people for "irresponsible conduct causing homicide and criminal negligence". Including three French from Sanofi, who are already all out of the country.

DENGVAXIA, A BAD VACCINE?

Dengvaxia promised itself as a global triumph. In 2015, Sanofi-Pasteur confirmed with great pomp the marketing of a revolutionary vaccine against dengue fever. This is a world first, the product of twenty years of research and 1.5 billion euros of investments. Dengue, a viral disease transmitted by the mosquito, is expanding rapidly in the world: it affects 100 million people a year and its severe form, hemorrhagic, kills 20,000, mainly children and pregnant women. The hundreds of thousands of hospitalizations due to the virus represent a significant cost for some countries like the Philippines.

Yet, looking closely, the results of the first clinical trials are poor. 56% effectiveness after two years on Asian children (Clearly, almost half of the participants who received the injection are not immune), and this figure drops significantly in the following years. Importantly, there is a significant risk for younger children, who are almost eight times more likely to become seriously ill after the vaccine has been injected. Several deaths are unexplained: the results indicate that the numbers and causes of death are "consistent with the mortality rates of their age group, mainly injuries and 'infections'"

Looking at it even more closely, these results are riddled with small inaccuracies, uncalculated risks, details that are missing ... "Not a high-level manipulation of figures, says Dr. Antonio Dans, doctor and statistician at the Philippines General Hospital, rather the compliments of statisticians who want to please their hierarchy.

THE RISKY BET OF SANOFI

In any case, these results do not matter, it seems, to Sanofi, which is all about this new vaccine, at all costs: as of 2009, well before the start of human clinical trials, the firm had already invested 350 million euros for the construction of a factory dedicated to Dengvaxia in Neuville sur Saône, near the headquarters of Lyon. Objective was announced at the time: to produce 100 million doses per year. "An industrial bet", according to Antoine Quin, then director of the site. "Anticipation was the only way to make vaccines available in a timely manner," it says today at headquarters.

But potential customers are skeptical and sales are struggling to take off. Despite marketing authorization in several countries, stocks do not run out.

THE FRENCH HEALTH AUTHORITIES, FOR EXAMPLE, DO NOT RECOMMEND THE USE OF DENGVAXIA IN OVERSEAS TERRITORIES (RÉUNION, GUYANA...) AFFECTED BY THE DISEASE. THE YEAR 2015 PASSES, SANOFI STILL HAS NOT WON THE GRAIL OF THE VACCINE MARKET: A PUBLIC CONTRACT.

"It was becoming very urgent for them to sell," said Dr. Francisco Cruz, an epidemiologist, a former official at the Philippine Ministry of Health, "SOME DOSES WERE DUE TO EXPIRE IN SEPTEMBER 2017."

BEHIND THE SCENES, THE LOBBYING WORK OF THE GROUP LEADERS IS IN FULL SWING. IN NOVEMBER 2014, SANOFI VICE PRESIDENT JEAN-LUC LOWINSKI GETS AN INTERVIEW WITH THE THEN PHILIPPINE PRESIDENT, BENIGNO AQUINO III. THEY MEET AT THE PHILIPPINE EMBASSY IN BEIJING ON THE SIDELINES OF THE APEC SUMMIT. BUT THE EXACT CONTENT OF THEIR EXCHANGE REMAINS SECRET, A FEW WEEKS LATER, THE FRENCH LAB GETS A REQUEST FOR DENGVAXIA FROM THE ADMINISTRATION IN CHARGE OF THE REGULATION OF DRUGS IN THE COUNTRY.

50 MILLION EUROS

A FEW MONTHS PASS, AND IT IS THE YOUNG HEALTH MINISTER, JANETTE GARIN, ANOINTED OF THE PHILIPPINE PRESIDENT AND NEWLY APPOINTED, WHO TRAVELS NOT ONLY TO PARIS BUT ALSO TO LYON, WHERE SHE VISITS THE FACTORY OF DENGVAXIA. SHE HAS ONLY FUZZY MEMORIES OF THE TRIP, WHERE SHE "SLEPT A LOT IN CARS AND VISITED CHURCHES, BUT I DO NOT KNOW WHICH ONES". SHE DOES NOT SPECIFICALLY REMEMBER ANY OF HER INTERVIEWS WITH SANOFI. NOT EVEN THIS DINNER, MAY 14, 2015 WHERE ACCORDING TO A REPORT FROM THE EMBASSY OF THE PHILIPPINES IN PARIS SHE DISCUSSES THE PRICE OF DENGVAXIA WITH THE LEADERS OF SANOFI, INCLUDING GUILLAUME LEROY, THE CURRENT PRESIDENT OF FRANCE. A DINNER ON THE CHAMPS-ELYSEES INCONSISTENT WITH THE CODE OF ETHICS OF THE LABORATORY, BUT "EVERYONE DOES IN THE PHARMACEUTICAL INDUSTRY," GARIN SWEEPS AWAY.

The price indicated on the contract of sale of Dengvaxia is thus fixed: 1.000 pesos per dose (17 euros) - a price "outrageously inflated" estimates Dr. Francisco Cruz for a total of 3 billion pesos (50 million euros). This is more than the overall budget allocated to all other immunization programs in the Philippines combined, while dengue fever is not among the top ten causes of death.

However, THE DOCUMENTS OF THE BUDGET DEPARTMENT INDICATE THAT 3.56 BILLION WAS REQUESTED AND PLACED AT THE DISPOSAL OF THE MINISTRY OF HEALTH FOR THE ANTI-DENGUE PROGRAM: BUT 556 MILLION PESOS (9 MILLION EUROS) IS MISSING, NOT ACCOUNTED FOR. 

"It's the lure of profit, which killed these children," said the prosecutor. Legal Cases for abuse of public property and personal enrichment are under way against the former president and ex-minister of health at the ombudsman's office in the Philippines.

BEHIND THE VACCINE, A POLITICAL AGENDA

ON THEIR RETURN FROM THE COP 21 SUMMIT IN DECEMBER 2015 IN PARIS, (2015 UNITED NATIONS CLIMATE CHANGE CONFERENCE) WHERE PRESIDENT AQUINO AND GARIN MEET AGAIN WITH SANOFI'S LEADERS, OFFICIALS OF THE MINISTRY OF HEALTH ARE BUSY SETTING UP A HUGE CAMPAIGN IN JUST A FEW WEEKS, MASS VACCINATION, ON NEARLY 800,000 CHILDREN. "MADNESS," SAYS PAULYN UBIAL, WHO BRIEFLY SUCCEEDED GARIN AS HEAD OF THE MINISTRY OF HEALTH, "NORMALLY, ONE TO TWO YEARS IS NEEDED TO PREPARE COMMUNITIES, THE HEALTH SECTOR, FOR A NEW VACCINE. AND WE START WITH A TARGET POPULATION OF ABOUT 40,000 INDIVIDUALS. “BUT A MAJOR DEADLINE IS APPROACHING: THE PRESIDENTIAL ELECTIONS OF APRIL 2016.

"It was vital that the campaign could be put in place and announced before the elections," recalls Paulyn Ubial. To speed things up, Filipino officials do not hesitate to violate several rules, including the procedure for awarding public contracts. JANETTE GARIN SELF-APPOINTED DIRECTOR OF THE AGENCY OF MEDICINE (PHILIPPINE FDA) WITHIN A FEW WEEKS, JUST THE TIME TO ORDER AN IMMEDIATE AUTHORIZATION TO MARKET DENGVAXIA WITHOUT GOING THROUGH OFFICIAL CHANNELS. AS OF JANUARY, THE ANNOUNCEMENT IS MADE: 1 MILLION FILIPINO CHILDREN WILL BENEFIT FROM THIS MIRACLE VACCINE FREE OF CHARGE THANKS TO THE GOVERNMENT.

INSTEAD OF PROTECTING, DENGVAXIA COULD MAKE THE CHILDREN VULNERABLE

In response, the first voices rose in the scientific community in the Philippines and abroad. Notably, in the United States, that of PROFESSOR SCOTT HALSTEAD, 82, A WORLD-RENOWNED SPECIALIST IN THE DISEASE, WHO WORRIES AND EVEN SENDS A VIDEO BROADCAST IN THE PHILIPPINE SENATE TO URGE TO SUSPEND THE VACCINATION PROGRAM. FROM HIS DECADES OF RESEARCH HE NOTICED THAT THE DENGUE VIRUS OPERATED BY A SINGULAR MECHANISM: THE ADE, ANTIBODY DEPENDENT ENHANCEMENT, DURING WHICH THE ANTIBODIES DEVELOPED DURING A FIRST ATTACK, DENGUE FEVER CAN TURN AGAINST THE BODY DURING A SECOND ATTACK BY A DIFFERENT STRAIN, HELPING THE VIRUS TO PASS THE BARRIERS OF THE IMMUNE SYSTEM; USUALLY IT IS THE THE SECOND ATTACK THAT IS FATAL.

By mimicking a first infection, Dengvaxia can make people who have never been infected by the virus more vulnerable to a second attack, instead of protecting them. THIS RISK LASTS A LIFETIME BUT IS PARTICULARLY HIGH IN THE THIRD YEAR AFTER INJECTION. THIS MECHANISM IS AT THE ROOT OF THE DISTURBING RESULTS OF CLINICAL TRIALS OF YOUNG CHILDREN, MANY OF WHOM HAD NEVER BEEN EXPOSED TO THE VIRUS. THE MORE CHILDREN GROW UP, THE MORE CHANCES THEY HAVE OF HAVING BEEN INFECTED, WITHOUT NECESSARILY DEVELOPING SYMPTOMS. THE AGE OF NINE, CHOSEN AS A SAFETY THRESHOLD BY THE LABORATORY, IS THEREFORE QUITE ARBITRARY: "THE RISK DOES NOT DECREASE MAGICALLY FOR PEOPLE WHO ARE HIV-NEGATIVE WITH AGE," INDIGNANT PROFESSOR HALSTEAD.

Estimates indicate 10% to 20% of seronegative children vaccinated. For him, those who launched this vaccine, have shown a "TOTAL CYNICISM, WHERE IT IS CONSIDERED THAT IF MATHEMATICALLY THE OVERALL BENEFIT FOR SOCIETY IS POSITIVE, AND IF THE COSTS OF HOSPITALIZATION ARE REDUCED, THEN IT DOES NOT MATTER WHAT AFFECT IT IS ON THE HEALTH OF SOME, WHILE IT IS CONTRARY TO THE MOST BASIC PRINCIPLES OF MEDICINE.”

Nothing works, the vaccination begins. NOT IN THE PROVINCES MOST AFFECTED BY DENGUE, BUT IN THOSE WITH THE HIGHEST CONCENTRATION OF VOTERS. FOR THE PRESS PHOTOS ON THE DAY OF THE LAUNCH, THE CHILDREN WERE GIVEN YELLOW T-SHIRTS, COLOR OF THE PARTY IN POWER.

Injections take place first in schools, then in health centers in barangays, neighborhoods, most of which do not even have a doctor. In many cases, parents are not notified. "I did not find out until after her death, in the school papers, that my daughter had received Dengvaxia," says the mother of Riceza Salgo, 12, who died of a dengue haemorrhagic attack.

THE FILTERING SYSTEM FOR CHILDREN WITH WEAKENED IMMUNE SYSTEMS IS NOT APPLIED. "CHILDREN WITH PRE-EXISTING CONDITIONS, WHETHER THEY WERE DIAGNOSED OR NOT, WERE ALSO INOCULATED WITH THE VIRUS," SAID DR. ERFE. AMONG THE POTENTIAL VICTIMS OF DENGVAXIA, CHILDREN WHO HAD LUPUS, LEUKEMIA, CANCER... "Maybe my child would eventually have died from a tumor, says Romeo Cariño, the father of Roshaine, 12 years old. I would have had a few months, a year more with her, they deprived me of that."

CHIMERIC VACCINE

Dengvaxia is a chimeric vaccine that is to say it is composed of two combined viruses, that of yellow fever and that of dengue fever. "SANOFI HAS CREATED A NEW VIRUS," SAYS HALSTEAD, "IT'S HARD TO PREDICT HOW IT WILL EVOLVE." ACCORDING TO THE DOCTORS OF THE PROSECUTOR'S OFFICE, IN ADDITION TO DEATHS FROM DENGUE HAEMORRHAGIC FEVER, SOME CHILDREN DIED FROM AN ATTACK OF VISCEROTROPIC OR NEUROTROPIC DISEASE (AN INFECTION OF THE VISCERA OR BRAIN), A SIDE EFFECT OF THE YELLOW FEVER VIRUS PRESENT IN THE VACCINE. BUT THESE DISEASES ARE NOT MENTIONED IN THE PACKAGE LEAFLET AS POTENTIAL RISKS OF THE VACCINE, SANOFI SAYS THERE WERE NO CASES IN CLINICAL TRIALS.

ON THE OTHER HAND, THE LABORATORY FINALLY ADMITTED IN NOVEMBER 2017 "AN INCREASED RISK OF SEVERE DENGUE FOR THOSE WHO HAVE NEVER BEEN EXPOSED TO THE VIRUS". The vaccination program is suspended. In the Philippines, paranoia rises: almost one million children have been vaccinated, without prior testing and in total disorganization.

THE MINISTRY OF HEALTH DOES NOT HAVE A SPECIFIC LIST OF NAMES. IN ADDITION TO 500 DEATHS REPORTED BY PARENTS PANICKED AT THE PROSECUTOR'S OFFICE, THOUSANDS OF CHILDREN WERE HOSPITALIZED. SOME NEED OPERATIONS TO CLEAR THE BLOOD AFTER SEVERE BLEEDING. MOST FAMILIES CANNOT AFFORD IT.

FOR NOW, SANOFI'S MAIN LINE OF DEFENSE IS TO POINT OUT THAT NONE OF THESE PROBLEMS HAVE BEEN REPORTED IN THE OTHER 19 COUNTRIES WHERE THE VACCINE IS MARKETED. BUT IN THESE COUNTRIES IT WAS RESERVED FOR THE PRIVATE SECTOR, FOR FAMILIES WHO HAVE THE MEANS OF A MEDICAL FOLLOW-UP ( NO MASS VACCINATIONS).

THE ONLY OTHER PUBLIC VACCINATION PROGRAM IN BRAZIL WAS CARRIED OUT MAINLY ON INDIVIDUALS AGED BETWEEN 15 AND 27 YEARS. SANOFI LABORATORY, WHICH REFUSED ANY INTERVIEW FOR THIS ARTICLE, SAID IT WAS READY TO COMPENSATE THE VICTIMS IF A "CAUSALITY BETWEEN THE CASES AND THE VACCINE IS ESTABLISHED ON SCIENTIFIC GROUNDS AND IF THE RESPONSIBILITY OF SANOFI IS ESTABLISHED ON LEGAL BASES".

ALTHOUGH IN SOME CASES THE VACCINE HAS FAVORED THE ONSET OF DENGUE HAEMORRHAGIC FEVER, THE CAUSE OF DEATH REMAINS THE DISEASE, NOT THE VACCINE. A POSSIBLE FAULT WILL REMAIN DIFFICULT TO PROVE AND THE CASE PROMISES TO BE A LEGAL PUZZLE.

Carol Isoux

This project was funded with the help of the European Journalism Center (EJC) through its fellowship program dedicated to global health.

https://www.nouvelobs.com/monde/20181127.OBS6092/dengue-sanofi-au-c-ur-d-une-affaire-de-vaccin-mortel-aux-philippines.html