Offshore testing of a herpes vaccine on human subjects absent U.S. Food and Drug Administration monitoring is creating a medical ethics controversy.
Without FDA oversight, Rational Vaccines, which received about $7 million from investors including Trump-supporting libertarian Peter Thiel, reportedly tested the experimental drug on 20 people on the island of St. Kitts during the April-August 2016 time frame.
“Rational Vaccines last October announced that its ‘potentially revolutionary Theravax vaccine’ had achieved groundbreaking results in its Phase 1 clinical trial,” CNBC reported.
The government of the Caribbean nation, which claims it never was asked for or granted approval, has now launched an investigation.
Some pharmaceutical companies have left the U.S. because bringing a drug to market has become very expensive, Kaiser Health News noted in its story about the unconventional vaccine trial.
American researchers are increasingly going offshore to developing countries to conduct clinical trials, citing rising domestic costs. But in order to approve the drug for the U.S. market, the FDA requires that clinical trials involving human participants be reviewed and approved by an [institutional review board] or an international equivalent. The IRB can reject research based on safety concerns.
Rational Vaccines co-founder Agustin Fernandez III, a Hollywood movie producer, says his late partner and lead investigator William Halford, a Southern Illinois University professor, took appropriate safety precautions during the herpes vaccine trial. Halford passed away from cancer in June 2017, but specifics as to which St. Kitts official he spoke to or how the vaccine was imported into the country are apparently unknown. Fernandez described Dr. Halford as a hero and a great scientific mind who is being defamed by critics.
“Fernandez said the trial had shown the drug’s promise both as a vaccine that would prevent herpes infections and as a therapeutic treatment to alleviate the often painful outbreak of sores that people with herpes can suffer,” CNBC added.
Founded in February 2015, the company plans to submit its findings to the FDA in an attempt to get formal approval, which may be difficult in that, as alluded to above, the testing operated outside U.S. regulations and safety protocols. The company apparently has a patent agreement with SIU, but SIU seemed to distance itself from the St. Kitts vaccine trial, noting that it didn’t find out about it until it was over.
Fernandez claims that Halford injected himself and Fernandez with the vaccine, and subsequently moved the trial offshore after failing to obtain federal funding and an institutional review board.
“The risks are real. Experimental trials with live viruses could lead to infection if not handled properly or produce side effects in those already infected,” Kaiser Health News explained.
The company downplayed the risks because the American test subjects already suffered from herpes. The participants also supposedly signed an informed consent waiver.
Fernandez now vows that future testing of the herpes vaccine will comply with FDA rules.
Ironically perhaps, as Natural News readers are well aware, the FDA has given a green light to various Big Pharma drugs and vaccines with toxic side effects even after the compounds passed various regulatory checkpoints. (Related: Read more about the pharmaceutical drug industry at BigPharmaNews.com.)
PayPal co-founder Thiel, one of a very few public Trump supporters in Silicon Valley, and who has gone on record as a critic of FDA red tape, has previously claimed that current government regulations would prevent the invention of the polio vaccine. Whether the herpes vaccine firm has drawn more scrutiny from the anti-Trump media because of Thiel’s POTUS connection is a matter of speculation.
According to the U.S. Centers for Disease Control and Prevention, about 17 percent of those in the age 14-49 age cohort suffer from genital herpes.