Offshore vaccine tests to shortcut FDA delays

Peter Thiel is backing the offshore testing of an experimental herpes vaccine. 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 St. Kitts several times to be vaccinated, according to Rational Vaccines, the company that oversaw the trial.

The push behind the vaccine is as much political as medical. President Trump has vowed to speed up the FDA’s approval of some medicines. FDA Commissioner Scott Gottlieb, who had deep financial ties to the pharmaceutical industry, slammed the FDA before his confirmation for over-prioritizing consumer protection to the detriment of medical innovations.

“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.”

American researchers are increasingly going offshore to developing countries to conduct clinical trials, citing rising domestic costs.

Rational Vaccines downplayed safety concerns, asserting there was little risk the participants would be harmed because they had herpes already.

The 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. However, without U.S. approval, the challenges to market such a vaccine in the United States remain significant.

Southern Illinois University indicated the outcomes from the Phase I clinical trial suggest the live TheravaxHSV-2 vaccine may be a game-changer in how doctors manage recurrent herpetic disease in the future.

There are two serotypes of herpes simplex virus: HSV-1 and HSV-2. They are subtle variations of a single virus. HSV-1 causes oral and ocular herpes, as well as genital herpes, and infects about one-half of the world’s population, an estimated 3.5 billion people. Most people acquire HSV-1 as infants and don’t know they carry HSV-1. Only 2 to 5 percent of HSV-1-infected persons experience recurrences of cold sores, ocular herpes or genital herpes. Rare, but unfortunate, complications of HSV-1 infection do occur: HSV-1 is the leading cause of fatal encephalitis and infectious blindness in the United States.

HSV-2 is a more aggressive virus, and predominantly causes genital herpes, the infamous sexually transmitted disease. HSV-2’s ability to spread faster allows it to superinfect people who already carry HSV-1. Lifelong HSV-2 infection can cause recurrent outbreaks of embarrassing and painful genital sores. An estimated 700 million people worldwide carry HSV-2, and 3 to 4 percent (30 million) live with recurrent genital herpes disease caused by HSV-2. The Centers for Disease Control reports that genital herpes doubles a person’s risk for acquiring HIV, the virus that causes AIDS.

Genital herpes is one of the most common sexually transmitted diseases in the U.S., and it has spread to “epidemic levels,” according to the Illinois Department of Public Health.

In the United States, about one in seven people ages 14 to 49 have genital herpes. As many as 3 million suffer herpes outbreaks four to 24 times per year. The infected must constantly work to maintain their health against the periodic assaults. For about 3 percent, it also means living with chronic pain that can affect daily activities like walking, eating and sleeping.

Other researchers said they were appalled by what they described as the university’s complicity in ignoring more than 70 years of safety protocols. Scientists called for more rigorous clinical trial oversight in the wake of Nazi atrocities involving human experiments in the 1940s.

“You can’t just ignore human-subject protections that have evolved since the end of the Second World War,” said Zenilman, who served as a technical consultant to the presidential commission on bioethical issues during the Obama administration.