The president of Sanofi Pasteur Inc., along with a former health chief and now politician, Rep Janette Garin have all been indicted by the Department of Justice (DOJ) in the Philippines for reckless imprudence, resulting in homicide as a result of the deaths of children associated with the anti-dengue vaccine Dengvaxia. As a result of an ongoing investigation, government prosecutors found probable cause to file the charges against the named defendants as well as nine unnamed officials from the Department of Health, Food and Drug Administration (FDA), and the Research Institute for Tropical Medicine. Additional Sanofi Pasteur officials were indicted for violations of the Consumer Act of the Philippines.
Known as the Dengvaxia controversy, there were hundreds of deaths associated with a Philippines Deng immunization program in 2017. The Department of Health there ultimately suspended a school-based vaccine program utilizing French drug maker Sanofi Pasteur’s Dengvaxia vaccine due to a number of deaths from various complications that allegedly attributed to the vaccine product. Thereafter, the company went public with a statement that its product, in fact, poses higher risk to people without prior dengue infection. By August 2019, over 600 people, mostly children, who received the vaccine have died. It must be emphasized that not all of these deaths are due to the vaccine itself. Regardless, the DOH banned the vaccine’s sale or use in the Philippines.
Reactions Lead to more Deaths?
Some are correlating the Dengue vaccine incident and ensuing scare caused by this controversy to the lost confidence of a great number of the public there in vaccines and lower immunization rates. This potentially had grave consequences as more deaths occurred in 2019 due to infectious disease and a measles outbreak. It truly is a tragic situation for all those that have lost loved ones.
TrialSite News has tracked this situation in which some local officials may get up to 48 years in prison. Now, Philstar Global reports that it would appear more activity in the form of charges ensues, such as a formal charge against Sanofi Pasteur itself for violation of the Consumer Act of the Philippines for manufacturing the Dengvaxia vaccine “which poses certain risks to seronegatives, or those who have not previously contracted the Dengue disease.” These officials could face up to six years in prison. The case has had a number of twists and turns, and, at times, various political agendas may be unfortunately a factor.
Personal Criminal Liability for Drug Executive
Moreover, the Philippines government centered prosecutorial powers on Sanofi Pasteur’s President, noting that the facts of this case (documented in a 78-page DOJ resolution released on Feb 19) merit the criminal prosecution of the firm’s President and four officers of the company.
Legitimate indictment or Political Theatre?
The indictments evidence the Philippine government’s readiness to come after its own if there is evidence of exercising “inexecusable lack of precaution” when “fast-tracking of the procurement process” for a drug despite “low efficacy results” combined with high risks associated with use. Hence, the Philippine’s physician and 1st district of Iloilo Janette Garin and the other public health officials’ indictment. However, Garin herself has responded that these charges are “baseless and reek of politics.”
In a twist that perhaps surprised some, the DOJ indicted officials from the FDA itself in the Philippines. Apparently, the government prosecutors found a technical element of law that perhaps was violated as they claimed the FDA in the Philippines purchased the vaccine before completion of clinical trials then later on, approved the registration even while clinical trials were ongoing.
Failed Informed Consent
Informed consent represents a fundamental ethical element of legitimately conducted clinical trials. In the case of the Dengue immunization program, the prosecutors alleged that Garin and others failed to inform the patents of the children about the level and nature of the risks associated with the Dengvaxia and, hence, “failed to obtain informed consent of its recipients.”
The Philippine government elected what essentially can be described a nationalist and “strongman” under the Presidency of Rodrigo Duterte. He launched a bloody drug war and has made it almost policy to round up and mistreat addicts. International rights groups express concern about some of his policies. However, he has huge popularity with the people garnering up to 90+% popularity in polls. Under this tough law and order regime that hasn’t necessarily been as friendly to traditional allies, these indictments, if followed through with prison sentences, will establish some precedent in this country and send signals to others.
Lessons for Sanofi Pasteur
A little over a year ago at the J.P Morgan Healthcare Conference in San Francisco, vaccine head David Loew took some time to speak with FiercePharma about the lessons learned from the product launch of its world-first dengue vaccine. What were those lessons?
· Market projections for sales overly optimistic (remember, not all countries’ residents can afford top dollar for a vaccine).
· Regulatory issues—when launching in emerging economies first, those regulatory agencies often refer to FDA and EMA, and, in this case, the drug wasn’t approved yet. Better to wait for FDA/EMA approval before launching new vaccines.
· Moreover, after spending 20 years and $1.5 billion to develop the vaccine, the failure of the company to identify that the vaccine posed more risk in people who haven’t been infected before and not calling this out until after the deaths in the Philippines cost the company dearly—and of course, precious lives were lost.