Offshore Human Testing Of Herpes Vaccine Stokes Debate Over U.S. Safety Rules - Marisa Taylor, Kaiser Health News:
August 28, 2017 - "Defying U.S. safety protections for human trials, an American university and a group of wealthy libertarians ... are backing the offshore testing of an experimental herpes vaccine.
"The American businessmen, including Trump adviser Peter Thiel, invested $7 million in the ongoing vaccine research, according to the U.S. company behind it. Southern Illinois University also trumpeted the research and the study’s lead researcher, even though he did not rely on traditional U.S. safety oversight in the first trial, held on the Caribbean island of St. Kitts.
"Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an 'IRB,' monitored the testing of a vaccine its creators say prevents herpes outbreaks. Most of the 20 participants were Americans with herpes who were flown to the island several times to be vaccinated, according to Rational Vaccines, the company that oversaw the trial....
"'This is a test case,' said Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, who is another investor in the vaccine. 'The FDA is standing in the way, and Americans are going to hear about this and demand action'....
"Agustín Fernández III co-founded Rational Vaccines with tenured SIU professor William Halford. He said Halford, the lead investigator, took the necessary precautions during the trial conducted from April to August in 2016. Halford died of cancer in June....
"Fernández, a former Hollywood filmmaker, said he and his investors plan to submit the trial data to the FDA in hopes of getting the vaccine approved for treatment. If the FDA does not respond favorably, he said, the company will continue its trials in Mexico and Australia. Fernández said he hopes to set up an IRB for these next trials. No matter what, he plans to manufacture the vaccine offshore....
"Fernández said he hoped the trials would put political pressure on the FDA to give the vaccine a closer look. He said his vaccine would be initially aimed at helping patients who experience the 'worst of the worst' symptoms. He believed the vaccine eventually would be shown to be effective in preventing the spread of the disease. According to the CDC, about 1 in 6 people ages 14 to 49 have genital herpes....
"Before the trial, Halford tested the vaccine on himself and Fernández. After he failed to secure federal funding and an IRB, Halford moved ahead with the trial offshore....
"The results have not been published in a peer-reviewed journal and Halford’s previous attempt to publish was rejected.... Yet some herpes patients, who are part of a tight-knit online community, have followed the project with hope and enthusiasm. One American participant ... Richard Mancuso said ... the vaccine has stopped his severe outbreaks. 'This has saved my life,' he said."
Read more: http://khn.org/news/offshore-rush-for-herpes-vaccine-roils-debate-over-u-s-safety-rules/
August 28, 2017 - "Defying U.S. safety protections for human trials, an American university and a group of wealthy libertarians ... are backing the offshore testing of an experimental herpes vaccine.
"The American businessmen, including Trump adviser Peter Thiel, invested $7 million in the ongoing vaccine research, according to the U.S. company behind it. Southern Illinois University also trumpeted the research and the study’s lead researcher, even though he did not rely on traditional U.S. safety oversight in the first trial, held on the Caribbean island of St. Kitts.
"Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an 'IRB,' monitored the testing of a vaccine its creators say prevents herpes outbreaks. Most of the 20 participants were Americans with herpes who were flown to the island several times to be vaccinated, according to Rational Vaccines, the company that oversaw the trial....
"'This is a test case,' said Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, who is another investor in the vaccine. 'The FDA is standing in the way, and Americans are going to hear about this and demand action'....
"Agustín Fernández III co-founded Rational Vaccines with tenured SIU professor William Halford. He said Halford, the lead investigator, took the necessary precautions during the trial conducted from April to August in 2016. Halford died of cancer in June....
"Fernández, a former Hollywood filmmaker, said he and his investors plan to submit the trial data to the FDA in hopes of getting the vaccine approved for treatment. If the FDA does not respond favorably, he said, the company will continue its trials in Mexico and Australia. Fernández said he hopes to set up an IRB for these next trials. No matter what, he plans to manufacture the vaccine offshore....
"Fernández said he hoped the trials would put political pressure on the FDA to give the vaccine a closer look. He said his vaccine would be initially aimed at helping patients who experience the 'worst of the worst' symptoms. He believed the vaccine eventually would be shown to be effective in preventing the spread of the disease. According to the CDC, about 1 in 6 people ages 14 to 49 have genital herpes....
"Before the trial, Halford tested the vaccine on himself and Fernández. After he failed to secure federal funding and an IRB, Halford moved ahead with the trial offshore....
"The results have not been published in a peer-reviewed journal and Halford’s previous attempt to publish was rejected.... Yet some herpes patients, who are part of a tight-knit online community, have followed the project with hope and enthusiasm. One American participant ... Richard Mancuso said ... the vaccine has stopped his severe outbreaks. 'This has saved my life,' he said."
Read more: http://khn.org/news/offshore-rush-for-herpes-vaccine-roils-debate-over-u-s-safety-rules/
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