Gov’t urged to seek US help over Dengvaxia controversy
A lawyer representing several parents of alleged Dengvaxia victims has urged the Duterte administration to ask the United States to probe French pharmaceutical firm Sanofi Pasteur for possible violation of American laws in relation to the administration of the anti-dengue vaccine to almost a million Filipino children.
In a letter sent to Executive Secretary Salvador Medialdea and three other officials, lawyer Ernesto Francisco Jr. said Filipino children were inoculated with Dengvaxia at a time when even Sanofi’s own clinical trials showed that “there are serious questions on the efficacy and safety” of the vaccine.
“This is to request your good offices to study and pursue legal remedies or actions available in the United States of America which the Philippine government may avail against Sanofi or Sanofi Pasteur in connection with the conduct of clinical trials on the anti-dengue vaccine Dengvaxia, then known as CYD-TVD,” Francisco said.
“The Philippine government may request the United States government, specifically its Department of Justice or Attorney General, to conduct an investigation of Sanofi for possible violation of (US) laws, including but not limited to the Foreign Corrupt Practices Act (FCPA) and federal statutes on health care,” he added.
The 12-page letter, a copy of which was sent to
late last week, was addressed to Medialdea, Justice Secretary Vitaliano Aguirre II, Health Secretary Francisco Duque III and Solicitor General Jose Calida.
Francisco said he mentioned the FCPA “because of the admissions made by Philippine government officials that they received monetary compensation from Sanofi in connection with their official functions relative to the conduct of clinical trials of Dengvaxia and the issuance of regulatory approvals.”
He said the US government would likely accommodate a request to investigate Sanofi because the company has headquarters in Pennsylvania, its shares listed in the New York Stock Exchange. Clinical trials on Dengvaxia were also conducted in Puerto Rico, an unincorporated territory of the US.
The company has claimed that the clinical development of the vaccine has complied with the standards set by the US Food and Drug Administration and US-based foundations were involved in the development of the dengue vaccine.
Francisco also claimed that the clinical trials on Dengvaxia were “far from over” at the time Sanofi sought and was granted regulatory approval for the vaccine.