Rogue state or banana republic? Douglas wants answers to unethical herpes testing scandal; St.Kitts-Nevis Government Launches Investigation into UNAUTHORISED Herpes Vaccine Trials

August 31, 2017 in National

Leader of the Opposition, the Rt. Hon. Dr. Denzil L. Douglas said Tuesday that the use of St. Kitts and Nevis to conduct tests of a vaccine to cure herpes not only raises ethical questions but promotes the nation in the international community as a rogue state or a banana republic.

“This scandal has rocked the nation around the world with this negative image,” said Dr. Douglas in response to US media reports that some 20 Americans were flown to St. Kitts and Nevis to participate in an unethical testing programme between June and August 2016.

According to the reports in several media around the world at least US$7 million has been pumped into the testing of an experimental drug which did not rely on traditional US Government safety oversight in the first trial. Neither the Food and Drug Administration (FDA) nor a safety panel known as an institutional review board, or IRB, monitored the testing of a vaccine its creators say prevents herpes outbreaks.

St. Kitts and Nevis’ Chief Medical Officer at the time, Dr. Patrick Martin in a statement Monday said no vaccine trial in the Federation came to his attention when he served from October 1st 2004 to 16th June 2016.

“Where did the testing of the herpes vaccine take place? Where did the material, the drugs, the storage equipment for these vaccines housed? Were there appropriate Customs Declarations? That is why we say that the government must know and our people must not be misled by this government which we know will claim it does not know,” said Dr. Douglas during his weekly radio call-in programme “Ask the Leader” on Kyss 102.5 FM.

The former prime minister accused the Timothy Harris Government of exposing the citizens of St. Kitts and Nevis to diseases and the country to reputational damage on the altar of personal greed and enrichment and has demanded answers to several other questions raised by the citizens of St. Kitts and Nevis after the scandal broke in the US media.

“Was the testing carried out at our Joseph N. France General Hospital as the illegal and unauthorised stem cell application last year? Was it at the Mary Charles Hospital which underwent physical improvement last year and which the prime minister boasted that he received large sums of money from donors to upgrade the medical facility? Is this donation money coming from these people who are using our country as a guinea-pig site for research,” he asked.

“Was the upgrading of the hospital funded by the group that brought some 20 herpes-infected patients to St. Kitts in 2016 and vaccinated them with trial drugs? We want to know and demand answers from the prime minister and the ministry of health. Were the tests carried out at the Pogson Medical Center in Sandy Point or a private residence of one the cronies of this government,” were further questions asked.

Dr. Douglas also wants to know whether the federation’s trained and professional nurses were involved in the testing phase.

“How many were involved? Were their services used on this government’s time? Were they paid extra money? Were local and foreign doctors involved? How many were involved and how much were they paid? Those are the questions being asked by the people of St. Kitts and Nevis stated Dr. Douglas.

He also wants the local authorities to indicate whether the nurses were told in advance and precautionary measures taken to protect them, their colleagues, their patients, their families and the residents of St. Kitts and Nevis.

The herpes virus scandal is the second medical ethics issue to rock the federation within the past two years since the Team Unity Government of St. Kitts and Nevis Prime Minister Dr. Timothy Harris took office in February 2015.

Then Chief Medical Officer Dr. Patrick Martin in June 2016, stopped an unauthorised and illegal stem cell operation which was taking place at the Joseph N France General Hospital without his knowledge and approval as required by the Public Health Act.

A Brazilian doctor who was overseeing the procedure was not registered or licensed to practice in the Federation.

Following his decision, Dr. Patrick Martin was sent on pre-retirement leave the same day.

Meanwhile The Government of St.Kitts-Nevis has issued a statement regarding reports of Herpes Vaccines Tests taking place on St.Kitts . The government has stated categorically that they nor any arm or chief servant of government had any knowledge of the Southern Illinois University supported tests which have been reported to have taken place in St.Kitts since 2016. According to the statement the Cabinet, the Ministry of Health, the office of Chief Medical Officer (CMO) nor the St. Kitts and Nevis Medical Board has ever been approached on regarding the project neither have they approved such a project. In light of the reports the Government has luanched a full investigation into the matter.

The full statements reads as follows:

It has been brought to the attention of the Ministry of Health that certain clinical trials were being conducted in the Federation, with the support of Southern Illinois University in the United States of America (USA). The Ministry of Health states categorically that neither the Cabinet, the Ministry of Health, the office of Chief Medical Officer (CMO) nor the St. Kitts and Nevis Medical Board has ever been approached on this project. By extension, none of these agencies has approved such a venture. As a result, an active investigation has commenced into this project. The Ministry of Health will always ensure that all research involving human participants follow international standards which protect the safety and security of persons involved. In order to help fulfil this mandate, the Chief Medical Officer convened an Interim Ethics Review Committee (IERC) to vet all medical research protocols in the Federation in keeping with international best practices. The role of the IERC is to ensure that the basic ethical principles and guidelines that govern the conduct of research involving human beings are maintained at all times. An update will be provided to the public once the investigations by the Ministry of National Security have been concluded.

The study was backed by Southern Illinois University and a group of wealthy libertarians – including prominent Donald Trump supporter Peter Thiel, who co-founded Paypal.

The trial was labelled “patently unethical” by Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division.