Date: 29th August, 2017
Basseterre, ST KITTS (KYSS) — Dr. Patrick Martin, Chief Medical Officer from October 1st 2004 to 16th June, 2016, has confirmed that he was unaware of a herpes vaccine trial in St. Kitts and Nevis during that period, therefore the entire study, and any results stemming from it, are “unethical and fake.”
This week, United States media reported that St. Kitts and Nevis had been used as the location for testing the experimental herpes vaccine, Theravax, from April to August in 2016.
Addressing the issue, Dr. Martin said at no point during his tenure as Chief Medical Officer did a vaccine trial anywhere in the federation come to his attention.
In a detailed statement, Dr Martin listed numerous requirements that must be satisfied in order for any experiment or study involving human subjects to be approved in St. Kitts and Nevis.
He noted, “All persons seeking to carry out research involving human subjects (resident or non-resident) must submit proposals in writing and receive approval in writing from the Chief Medical Officer prior to the start of the research activity.”
He continued that the approval of an IRB, or Institutional Review Board, is mandatory for studies or experiments involving human subjects.
Such studies include, but are not limited to, investigations into disease and injury causes, risk factors, and trends; studies to identify effective polices, programs, services and practices; trials to find new medicines, vaccines and devices; and health screenings e.g. kidney function tests, HIV testing, prostate health, blood pressure levels, etc.
Additionally, Dr. Martin informed that in 2014, legislation was drafted by the government to establish a formal IRB. He explained that this was a direct response to increased interest in carrying out health research in the federation, including stem cell research.
He also explained that in the absence of an IRB, all IRB functions are carried out by the Chief Medical Officer, a task force of competent persons convened by the chief medical officer, or by the IRBs of partner research institutions.
These institutions include PAHO, CARPHA, Ross University, and the University of Virginia at Charlottesville.
The former CMO also stated unequivocally that any and all research proposals and other investigations that either come to the office of the CMO, or are not sanctioned and subject to IRB examinations by the office of the CMO are to be regarded as “unethical and fake.”
According to Rational Vaccines, the company that oversaw the trial, most of the 20 participants were Americans infected with herpes who were flown to St. Kitts several times to be vaccinated during the first phase of testing.
Concern is also heightening in the face of this new scandal as the resulting vaccine, ‘Theravax’, became available for sale in St. Kitts and Nevis on August 1st, 2017.