One dead doctor's journey to cure herpes and say 'F-you' to the FDA

One dead doctor's journey to cure herpes and say 'F-you' to the FDA

CultureJanuary 17, 2018 By Jessie O'Brien

Dr. William Halford believed he had a breakthrough therapy for herpes, so much so he injected himself — and more than a dozen others — without any approval from the FDA. Now his peers are asking: was he maverick, or maniac?

For decades, Richard Mancuso has lived with a chronic oral herpes that causes him extreme distress and discomfort. He endures each painful breakout knowing another will soon follow. With little help from the few treatments available, Mancuso was willing to try anything — even participating in an unregulated human trial with a live herpes vaccine that hadn’t gone through any kind of FDA approval process.

Because of a treatment that ducked government regulations, Mancuso hasn’t had any painful flare-ups in almost a year. Dozens more from the same trial have had similar results. Yet some criticize the rushed and dangerous actions of a dying doctor who led the trials, while others applaud the cowboy spirit to get a possible treatment to the public and change lives as pharmaceutical companies should.

The doctor, Dr. William Halford, was a microbiologist at Southern Illinois University and creator of the herpes vaccine. Halford did not have herpes, but he was so certain his vaccine worked that he injected himself, and his family, with it over 24 times to prove it was safe.

During his tenure at SIU, Halford researched the tricky virus with a live attenuated vaccine, a less powerful form of the viral disease that boosts the body’s defense of it. After completing successful animal trials, he founded Rational Vaccines in 2015 with Hollywood producer Agustin Fernandez III. 

But something may have encouraged the hasty gamble to himself and to others. Halford was diagnosed with a rare form of nasal cancer in 2011. With little time to live, the inventor felt he had to move quickly around FDA regulations to test his supposed herpes “miracle drug” during an offshore human trial. Close to two dozen herpes-positive participants from around the world traveled to the St. Kitts island in the Caribbean for three injections of a therapeutic form of the vaccine called Tharavax in April of 2016.

Mancuso was one of them. 

[left to right: Richard Mancuso, Dr. William Halford, billionaire Peter Thiel]

After a three-hour conversation with Halford discussing risks and the possibility of it not working, Mancuso agreed to be a human guinea pig, confident in the vaccine and in Halford. 

“I’ve had this lovely disease for 20-plus years,” says Mancuso, a concrete truck driver, upright bass player and one of the few trial participants who is talking about his experience without anonymity. “... I like to think I’m open-minded to science, so I was like, ‘What the hell?’” 

Mancuso describes Halford as “the typical type of person you’d think would be a scientist.” Someone who is matter-of-fact and who clearly was most at home in the scientific world. He says he seemed comfortable lecturing behind the podium, but less so in large social settings. “If you had the chance to talk to him one-on-one, he had a sweet side,” Mancuso says. 

The fact that the trial was taking place outside of the United States without standard protocol didn’t register any red flags for Mancuso. After all, pharmaceutical companies complete trials outside of the United States to save money and avoid FDA red tape all the time. Called foreign clinical trials (or FCTs), circumventing the rules isn’t exactly rare, though considered ethically unsound in the medical community. 

“There was a part of me that was just like, ‘I’ve tried everything and if this doesn’t work then you know what, screw it. At least I tried,’” Mancuso says. “I was at the end of my rope.” 

There are eight herpetic diseases that include chickenpox, shingles, cold sores and genital herpes, the most stigmatized of the bunch. It’s increasingly common to get one of the two types of herpes genitally and the other orally. An estimated two-thirds of people have type one, and an estimated one in six (likely more) have type two, according to the Centers for Disease Control. 

While both types can be manageable or completely unnoticeable for some, they can be devastating for others, causing horrific outbreaks and psychological distress. For decades, antiviral medications and natural remedies have been the only option for herpes sufferers. Neither of those options worked for Mancuso’s consistent outbreaks. 

“My first exposure (to herpes), my body really didn’t know what it was,” Mancuso says. “Herpes — the term — means to creep, to sneak in. So herpes kind of gets into the cell immediately before the immune system has a chance to get a good look at it. My body pretty much accepted the sneakiness of herpes as something that normally happens within my body.”

Similar to the chickenpox vaccine, Halford’s live attenuated herpes vaccine, in theory, allows for the body’s immune system to recognize the foreign invader and develop proper antibodies to fight it. Rational Vaccines developed two vaccines like this in its time. Theravax, what was administered to the participants in St. Kitts, is a therapeutic vaccine used for those who already have herpes. Profavax is a true vaccine, and the one that Halford said he injected himself with multiple times. The latter has the potential to make it so the human body is immune to herpes.

Mancuso received his last shot of Theravax in July 2016. Since, he says his outbreaks have become less frequent and are shorter in duration. As of late March 2017, he has been symptom-free. His belief is that most of the people in the trial are doing 80 to 100 percent better, though few participants are speaking out about their results. And because of the controversy, no official numbers of success are allowed to be printed — too many holes, not enough peer review.

Though there have been some reports from anonymous trial participants who say they experienced adverse effects, such as swelling at the site of injection, flu-like aches and worse outbreaks, among other symptoms. Brian Bergstein, a reporter for Neo.Life, says he was contacted by at least one participant who had a negative reaction to the vaccine after he wrote an article on the story last August. 

None of this was even that big a deal in the grand scheme of pharmaceuticals, however, and the overseas trial flew under the radar initially, avoiding the spotlight like most FCTs often do. That was, until tech billionaire Peter Thiel brought the stranger-than-fiction story to light early last October when his firm made a $7 million investment in Halford’s company. 

Thiel, who invested in Rational Vaccines after the trial was complete, has been outspoken about his contempt of the slow-moving regulatory processes. In 2015, at an Economist event, Thiel was quoted as saying, “You would not be able to invent the polio vaccine today (due to FDA regulations).” It currently takes eight years on average, according to one Los Angeles Times article, to conduct the trials from preclinical animal testing to approval — a long time for millions who are infected. Even too long for someone who didn’t have that long to live to see results of his life’s work. 

The major criticisms of the Rational Vaccines trial, most coming post-Thiel, is that it didn’t have an institutional review board to oversee safety and ethics while human subjects were involved, as per protocol. Many also claim there just wasn’t enough data to make any conclusions. These are two of multiple reasons why Halford’s paper on the trial, sent to peer review journal “Future Virology,” was rejected.

The St. Kitts government is also investigating. In an August 2017 government press release, officials stated that Rational did not ask for permission to conduct the trial and that “an active investigation has commenced into this project.” 

And as of late November, Halford and his methods came under even more scrutiny. A Kaiser Health News investigation revealed the doctor injected eight participants in the United States at a Holiday Inn near the SIU campus in 2013, in clear violation of U.S. laws and regulations. 

Halford is no longer around to defend himself or clear the haze on any of this. He passed away from cancer this past June at 48 years old. Although, a quote taken from his rejected paper gives some insight into a frustrated Halford’s thought process.  

“Some readers may find this course of action reckless, as it deviates from how (herpes) vaccines have traditionally advanced to U.S. clinical trials,” Halford wrote. “However, from my perspective, I would suggest the opposite. The protracted process by which vaccines currently advance to U.S. clinical trials is well meaning, but violates the Hippocratic Oath; do not harm! There is an ongoing herpes pandemic that demands the scientific community’s attention today, not tomorrow. The risk I accepted by self-injecting the live vaccine pales in comparison to the morbidity that actually occurred in the ~1.5 billion people who were newly infected with (herpes) whilst FDA sanctioned herpes vaccine trials have failed for three decades.”

Josh Bloom, the self-proclaimed “Dr. Herpes,” has followed Halford’s trials, Rational Vaccines and other herpes vaccine developments around the world as the director of chemical and pharmaceutical sciences at the American Council on Science and Health.

“Until they get peer-reviewed papers out there, there is not much anybody can say because really no one knows what happened,” he says.

“There are all kinds of strange things that went on here — the death of the inventor, the rush of the trials, (conducting) it out of the United States — there are so many issues going on,” Bloom adds. “Plus, there are a few people that certainly wanted this to fail. There is a fortune to be made for the company that solves this.” 

Both Bloom and Mancuso say Thiel’s investment politicized the Rational trial, and it’s what brought the events to the media’s negative attention. Theil’s connection may seem like it has done more harm than good, but Bloom understands the money is “absolutely essential” for smaller companies.

“It costs five to 10 million dollars to run a good phase one and two clinical trials and they didn’t have it,” he says. 

While Halford’s research with his company was separate from his work at Southern Illinois University, the school still holds the patent to the drugs along with Rational Vaccines, even though SIU officials say they were unaware of Halford’s trial. Kaiser Health News reported the university’s independent ethics committee found Halford’s experiments to be a “serious noncompliance.” If the FDA and Department of Health and Human Services find out the school itself violated any rules, it may cost SIU $15 million in research funding. 

In the meantime, many people desperate for an answer to their symptoms have to wait. According to Mancuso, Rational plans on releasing data and information about the trial sometime around the beginning of the year. It’s also rumored to be pursuing phase II of the trials in other countries — but it’s uncertain when. 

Mancuso is staying vocal about his experience by writing a book and gathering petition signatures to gain an audience in front of Congress to discuss why the FDA should allow Rational a fast-track trial in the U.S. 

A documentary about Halford’s life story and his work to fight herpes is currently in the works, with a due date not yet released (though a trailer of it can be found online). 

“Results will let us know whether what (Rational) was doing was careless and sloppy and too fast or whether they were mavericks,” Bloom continues. “They will be judged by their results of the vaccine.”