BASSETERRE, ST. KITTS, AUGUST 30TH 2017 – The citizens of St. Kitts and Nevis, local, regional and international media houses and medical oversight institutions are waiting for answers from Prime Minister Dr. Timothy Harris and his two ministers of health, Eugene Hamilton and Wendy Phipps, in response to an unethical herpes vaccine trial in St. Kitts and Nevis from June to August of last year.
Late Tuesday it was disclosed however that vaccine tests were also carried out in St. Kitts during the period March 2016 to June 2016 and British citizens were among the Americans used as guinea pigs.
Twenty pre-screened participants were flown to St. Kitts in two groups. Group 1 received three shots of the trial vaccine Theravax HSV2 March to June and Group 2 during the period June – August.
On each visit blood was drawn and with a follow up after two days with an administering physician, identified as a Dr. Luisa Veloz.
Leader of the opposition in St. Kitts and Nevis, Rt. Hon. Dr. Denzil L. Douglas said Tuesday reports of drug testing in the federation in an effort to avoid US safety regulations could negatively affect the country’s international reputation.
During his weekly radio program on Kyss 102.5FM, Dr. Douglas pointed a number of questions towards the government.
“Where did the testing of the herpes vaccine take place? Where did the material, the drugs, and the storage equipment for these vaccines housed?” he asked.
“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.”
“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?” said Douglas, who was prime minister of St Kitts and Nevis between 1995 and 2015.
“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?”
The issue has implications beyond the shores of St. Kitts and Nevis which seemed to have become a pariah state in the past two and a half years.
According to the reports at least US$7 million has been pumped into the testing of the experimental drug.
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 1st2004 to 16th June 2016.
Southern Illinois University’s standing as an accredited research institution could be at risk after the developers of a herpes vaccine, including a professor, bypassed U.S. safety standards to test the shot on Americans flown to a Caribbean island.
Researchers said they feared that desperate herpes patients would seek to be test participants or get the vaccine without being informed properly of the risk.
Researchers at several universities and private clinical research centers are working on two different herpes vaccines under FDA and IRB oversight. One is expected to undergo final trials by 2018 before being submitted to the FDA for final approval. In addition, the National Institutes of Health has conducted a first trial of a third potential vaccine.
Kayte Spector-Bagdady, who leads the University Of Michigan Medical School’s Research Ethics Service, said the St. Kitts trial could be seen as a violation of SIU’s commitment to the Department of Health and Human Services.
SIU voluntarily agreed to follow U.S. safety requirements and set up an IRB for all research involving human subjects, according to records. Many universities make such a commitment to HHS, even if the experiments are abroad and don’t rely on federal grants.
Rational Vaccines was established in February 2015 and the company entered into its patent agreement with the university later that year, Fernández said.
But when asked about its commitment to HHS, Carlson, the university spokeswoman, said the university first learned about the trial in October 2016 — after it had ended. Carlson said Halford didn’t need to bring the trial to SIU’s IRB because the trial wasn’t overseen by the university.
Experts said the offshore trial was dangerous because it wasn’t monitored under U.S. drug safety rules.
Rich Mancuso, who claims he “once suffered terribly but was lucky enough to receive the herpes vaccine” posted: “As of August 1st, The therapeutic vaccine Theravax, will be available for purchase in St. Kitts. All questions and information can be found on the website below.”
He posted that MINERVA is the Dominican Republic’s largest independent contract research organization (CRO). The headquarters is located in Santo Domingo, with satellite offices in Santiago de los Caballeros and Basseterre, in the Federation of Saint Kitts and Nevis, providing comfortable access to the most important and progressive places of the Caribbean.
“They will also book visits to St. Kitts and also be facilitating the necessary interviews with Dr.Veloz and Dr. Hanley. These are the physicians who will be handling interviews and injections of the vaccine,” said Mancuso.
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