In a photo from 2009, Bill Halford, who was then 40 years old, looks like a schoolboy who hasn’t quite grown into his big ears. He wears an ill-fitting red shirt tucked into belted khakis; his jawline is square and his eyes are full of wonder. The picture was taken at Southern Illinois University, where he was a respected professor. A few years before, he had made a significant discovery—one that would determine the course of his life.
Halford, a microbiologist, had taken an interest in the peculiar nature of herpes—how it lies dormant in the nervous system and reactivates to cause disease. Herpes is one of the most pervasive viral infections in the world, sometimes causing painful genital blisters, and it has frustrated scientists attempting to find a cure. But in 2007, Halford realized that a weakened form of the virus he’d been studying might serve as a vaccine. He designed an experiment in which he inoculated mice with this variant, then exposed them to the wild-type form of the virus. In 2011 he published the results: Virtually all the mice survived. By contrast, animals that were not injected with his vaccine died in large numbers. It was promising science.
That same year, however, Halford became seriously ill. At first he thought he had a sinus infection, but it turned out to be a rare and aggressive form of cancer, sinonasal undifferentiated carcinoma. Halford was 42 years old at the time, with two teenage children. He underwent chemotherapy and radiation followed by surgery, but he was told that the form of cancer he had did not usually stay at bay for long. Halford had always been determined—“a 90-hours-a-week sort of researcher,” as his wife, Melanie Halford, puts it. The cancer diagnosis only seemed to harden his focus. Others had tried, and failed, to develop a herpes vaccine, but Halford was convinced that his method—using a live, attenuated form of the virus—would succeed. He would use whatever time he had left to show he was right.
The trouble was that the institutional gatekeepers of science—the agencies that fund research—didn’t view his work with the same urgency. He wasn’t getting the grants he thought he deserved. He felt “alone in the wilderness,” Melanie says, but also certain that his formula held unique promise. The question that drove him was not the practical “Will this work?” but rather an ethical one: “If I can help people suffering from herpes, isn’t it my duty to do so?” Melanie told me that “it was completely obvious to him what needed to be done.” Halford decided to barrel forward on his own unorthodox terms.
People with herpes who scoured the internet for research on their condition often discovered Halford’s scientific writing and blog posts, which combined technical information and a wry frustration with the status quo. Several readers reached out to Halford for help. A woman named Carolyn, who ran a private Facebook group devoted to genital herpes, approached him in 2012, and a few months later, Halford got back in touch and suggested they talk by phone. “That’s when he told me he had been fighting cancer and felt he needed to find out if the vaccine he developed could be therapeutic,” Carolyn recalls. In his animal research, Halford was testing whether his attenuated virus could prevent herpes, but scientists were also studying whether herpes vaccines could treat the disease. Carolyn suffered from debilitating nerve pain, and when Halford asked if she wanted to try the drug, she says, “I felt like I had hit the lottery.”
Through his blog and Carolyn’s Facebook group, Halford found other potential research subjects. He told them that the vaccine carried risks, as all vaccines do, but claimed that his formulation was “much safer” than those used for measles, mumps, polio, and chicken pox. Halford reassured the skeptical that he had tested his formula on himself, despite being weak from chemo, and had injected family members, and that they had “no side effects,” says Carolyn, who did not want to give her last name because of the stigma attached to herpes. Halford answered the potential volunteers’ questions by email and in long phone conversations. He sent at least one of them pictures of the large, red welts that were likely to develop on their calves around the injection site.
In August 2013, Carolyn drove six hours from Kentucky, where she lives, to Springfield, Illinois, where she had booked a room at the Holiday Inn Express. That evening, she and seven other volunteers, who had come from all over the country, gathered with Halford in one of the hotel rooms, where they sat on chairs, the couch, and the bed. “People were excited,” Carolyn recalls. Halford arrived with a box, which contained a tray and small vials, and began “mixing what appeared to be components of the vaccine right there,” Carolyn says. When her turn came, he took a sample of blood, then swabbed her calf with alcohol and drew a circle on the skin with a black felt-tip pen. Within the circle, he injected the mixture. A bump appeared, followed later by a welt.
In subsequent months, the volunteers gathered in Springfield twice more for injections. The Halfords invited them to their home for dinner. “We were telling Bill and his wife our stories, and they listened,” Carolyn says. “They are good people.”
As a seasoned researcher, Halford was certainly aware that his behavior violated ethical norms, and probably federal regulations as well. The Food and Drug Administration requires that researchers get permission before using an unapproved drug or agent on people in the United States, according to Hank Greely, an expert in biomedical ethics at Stanford Law School. Halford had not said a word to the agency about his plans, nor did he intend to say anything publicly. That “would be suicide,” he told participants in an email obtained by Kaiser Health News. Still, he believed that his brazen behavior would advance the cause of his vaccine; and in one sense, he was right.
Agustin Fernandez is a Hollywood film executive—Badge of Honor, a Martin Sheen drama, is his best known movie. Brash and gregarious with a bald head and, sometimes, a trim goatee, he splits his time between New York and Los Angeles. He also has an outsize fear of herpes. Years ago he started dating a woman with the virus. And at first he thought, “OK, what’s the big deal, you get a rash.” But over time he saw how she suffered during outbreaks and began to fear that he would become infected. “It just completely consumed me,” he says.
Fernandez threw himself into online research and, like Carolyn, soon came across Halford’s work. “I just made it my mission to meet him,” Fernandez says. Eventually, Fernandez persuaded Halford to fly to New York and join him for dinner at Frankies 570 Spuntino Italian restaurant. They talked for hours. “Bill probably still thought I was a crazy guy,” Fernandez says. “I was just on a very selfish mission.” Still, they met again in Chicago. Halford confided to Fernandez that he’d secretly tested the vaccine in humans and that a participant named Carolyn had not experienced herpes outbreaks since the injections and had even stopped taking antiviral medications. “I thought I’d found the holy grail,” Fernandez says.
To Fernandez, the next step seemed obvious: Start a company. Fernandez didn’t know much about scientific research, but he did know how to intrigue investors. He figured a herpes vaccine would be an easy sell, and more gratifying than raising money for a Hollywood movie. “It’s not like, ‘This is so great, Steven Seagal is going to punch a mummy in the face!’ This is like, ‘We can really change the world.’ ”
In 2015 Halford and Fernandez founded Rational Vaccines. Fernandez provided most of the initial money and then reached out to friends and family, raising a total of around $700,000. Halford cared mainly about intellectual control; he would oversee the science. The company also licensed a patent for Halford’s work from Southern Illinois University, where Halford remained a professor.
Halford started making plans for a clinical trial overseas, outside the jurisdiction of the FDA—a not uncommon strategy. He never seriously considered submitting plans to the agency, which would have required him to manufacture the vaccine in a standardized manner and comply with the FDA’s oversight and requirements. “It takes years and years,” Melanie says—years that Halford did not anticipate having.
Pharmacological testing of any kind involves risks, and the standards for vaccine safety have evolved over time. Edward Jenner, the late-18th-century English scientist, demonstrated that he could protect an 8-year-old boy from smallpox by exposing him to a related virus called cowpox. It wasn’t until the 1950s, however, when the American virologist Jonas Salk developed a polio vaccine, that the modern era of mass inoculation began. Polio had left thousands of children paralyzed, and Salk’s vaccine is rightly viewed as a triumph of 20th-century science. At the same time, problems at one of the first production labs led to vaccine contamination that paralyzed 164 children and killed 10 others, a tragedy that might have been averted with better safety testing.
Improved oversight of drug development arrived in 1962 with the modernization of the FDA. In the wake of the thalidomide scandal, in which a drug to treat morning sickness was found to cause birth defects, the agency began requiring companies to complete three phases of clinical testing, demonstrating the safety and efficacy of their products. Scrutiny of vaccines increased too. In the early days, researchers typically tested vaccines on a few thousand people at a cost of several million dollars. Now they are expected to conduct trials with tens of thousands of subjects, with expenses in the hundreds of millions. Regulators also have strict requirements for ensuring the purity of products that will be tested in humans and tend to be cautious about side effects. “The bar has gotten much higher,” says Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
This can make it hard for small companies to develop vaccines, even when they report promising data. Last fall, Genocea, a small biotech firm, got as far as successful Phase II trial results for a herpes vaccine, but then the company announced that it was halting the effort. It lacked the capital to continue to the next phase of trials, which CEO Chip Clark says would have cost $150 million. (Genocea says it’s still looking to partner with a larger pharmaceutical company.) Given the FDA’s regulatory standards, some good vaccines surely don’t make it to market because the financial burdens are too great.
To Halford, however, any obstacle to his vaccine seemed an injustice. His cancer returned in early 2016, and this time “his doctors were out of good options,” Melanie says. Neither radiation nor surgery was feasible, so he was left with chemotherapy. Each month he received several days of grueling treatment, which left him nauseated and exhausted. Then he plunged into work again, conducting research and planning for a clinical trial on the Caribbean island of Saint Kitts, before starting the chemo cycle over again.
Halford began to recruit participants for the clinical trial through his personal blog. The desperation he found in the potential volunteers echoed the urgency of his own prognosis, and he was more responsive to their queries than many of their own doctors had been. A woman named Beth Erkelens, who lives in Colorado, learned about Halford’s work from a Google search that led to his blog. She called him about the clinical trial, and they talked, she says, “for like an hour.” At the time, Erkelens felt desperate. She was 45 years old and, for years, experienced nearly constant itching, as well as about 12 full-blown outbreaks a year. She felt she had nothing to lose and was swayed by Halford’s bold assurances, as well as his promise that Rational Vaccines would reimburse her for airfare and hotel for three trips to Saint Kitts. “It was his confidence that drew everyone in,” she says.
So when Halford sent Erkelens an informed-consent document laying out the potential risks of participation and noting that the trial would not include FDA oversight, she signed it without hesitation.
In June 2016, Erkelens arrived on the tiny island of Saint Kitts, which was quiet in the summer. Rational Vaccines had set up shop in a house high above a turquoise bay. One room became a makeshift medical office. There, Erkelens’ blood was drawn and her temperature taken. Then, as Halford looked on, a physician administered the injection. “We all had high hopes,” she recalls.
Initially, Erkelens’ only reaction was a walloping welt, which she had been told to expect and which seemed more of a curiosity to her than anything else. It was also a kind of badge. Before coming to Saint Kitts, Erkelens had avoided talking about her woes, except with potential partners. But on the island it was easy to spot other Americans who had also flown down for the clinical trial. “How do you miss another person with a giant red mark on the back of their leg when there’s no one else around?” In many ways, the trip felt like a group vacation.
Erkelens spent about five days on the island and recalls afternoons lounging on the beach, drinking beers at the bar, and exploring the island, where vervet monkeys ambled down from the hills. In the evenings, Fernandez sometimes paid for seafood dinners and drinks out of his own pocket. Participants had been flying to the island since March, receiving injections on a staggered schedule. Fernandez had been there for much of the time. When Erkelens returned home, she was already looking forward to her next island jaunt. She even planned to bring her 11-year-old son to Saint Kitts and stay between her second and third shots so he, too, could enjoy a “big, beachy vacation.”
In July, however, when Erkelens and her son arrived in Saint Kitts for her second shot, things did not go so well. This time she experienced an intense herpes outbreak after the injection, along with severe aches and pains, numbness and tingling in her arms and legs, shooting sensations, and “crazy, crazy shaking.” Halford had warned that she might feel flu-like symptoms, but this went far beyond that. By the time her symptoms started setting in, however, the other trial participants and researchers were leaving the island.
A little more than a week later, Erkelens sent frantic messages to Halford telling him how sick she was. “That’s when he called me,” she says. “He was really angry,” insisting, she says, that the symptoms were caused not by the vaccine but by a mosquito-borne virus called chikungunya. But he called back and offered to discuss her symptoms. (Erkelens says she later tested negative for chikungunya.)
In early August, Erkelens called Halford in distress from Saint Kitts, where she had remained for several weeks. Halford was in Portland, Oregon. He had flown there to ask a herpes expert named Terri Warren to join the board of Rational Vaccines. Warren, who was trained as a nurse practitioner and ran a sexual-health clinic in Portland for decades, has served as an investigator on more than 100 clinical trials, mostly involving herpes. She and Halford had worked together previously, but as he sat at her kitchen counter and described the experiment already under way in Saint Kitts, she grew increasingly alarmed. “There were no protections for these people,” she says. “There was no one watching over the conduct of this trial.”
While US companies frequently pursue clinical research abroad, often to save money, they virtually never do so without oversight from some kind of institutional review board, which tries to ensure that the potential benefits of an experiment outweigh the risk to participants. IRBs review every aspect of a trial: the script researchers use to recruit participants, the entry criteria for the study, the wording of the informed consent document, the protocol for administering the drug or vaccine, rules for record keeping and reporting adverse events. These norms were established in response to historic abuses like the Tuskegee study, in which, over the course of 40 years, researchers observed how syphilis affected African American men without explaining fully what they were researching and failing to treat them even when an effective cure was found. Part of the idea of having a review board, though, is that even well-meaning researchers can lack perspective on their own work and require a third party to set them straight.
With mounting agitation, Warren grilled Halford on the kinds of issues an IRB might care about: Where did this vaccine come from? Who manufactured it? How was it shipped? How had he made sure that it was free from contaminants? Halford did not have satisfying answers. Warren also wanted to know how he had screened trial participants and was disturbed to learn that he had included people with two different strains of herpes virus, HSV-1 and HSV-2. The vaccine contained a live form of HSV-2, so the risks to individuals who only had HSV-1 were potentially higher. “I mean,” Warren told me, “what was he thinking?”
Compounding Warren’s concerns was Halford’s approach to data collection. He relied on questionnaires that participants filled out regarding their symptoms. Warren felt that the self-reports could potentially be influenced by a desire to please the researchers, especially since personal relationships had developed on an isolated island. “There was a lot of socializing with the investigators and the guy from Hollywood,” Warren says. “They’d sit around at the bar and drink and talk, and that’s just not appropriate.”
And then there was Halford’s casual approach to adverse events. When he admitted to Warren that some participants were having bad reactions to the vaccine, she asked, “Well, what are you going to do about that? How are you going to follow them?” His response, she says: “We removed them from the trial.” But that solves nothing, Warren told him. It leaves research subjects vulnerable and doesn’t answer crucial questions about the vaccine. “That’s not how you do it,” she told him. “You continue them in the trial and you follow them” because you want to know what the vaccine does.
Throughout the two-and-a-half-hour conversation, Warren felt she made little headway with Halford. “I wouldn’t describe him as belligerent, but he was not introspective in any way,” she says. “Just defensive.” She told him she wanted nothing to do with the clinical trial or the company. (Rational Vaccines declined to comment on Warren’s account.)
In early August, when Halford returned to Saint Kitts to oversee another round of injections, he asked Erkelens to meet him, Fernandez, and the doctor who administered the injections at a coffee shop. She still felt acutely ill, and as she approached the meeting with her son in tow, she was anxious that her symptoms would not be taken seriously. She also worried about letting Halford down, knowing how much he’d invested in the vaccine. Almost as soon as the conversation started, Erkelens says, Fernandez reminded her that she had signed a legal document acknowledging that the vaccine carried risks. It seemed her relationship with Rational Vaccines had shifted: “I was no longer their friend,” she says. “I was a foe.” (Fernandez denies that he brought up the informed-consent document and says that the company’s primary concern was to address Erkelens’ symptoms.)
Halford was not well. “He looked like he might throw up or pass out,” Erkelens says. At one point, she says, he shot her a sympathetic look and brought her and her son outside, where they could talk alone. As they walked along the road, in the direction of Erkelens’ hotel, Halford told her that he wanted to draw her blood again and try to understand why she’d become so ill; she could decide if she wanted the third injection. He had “a very big heart,” says Erkelens, who agreed to provide another blood sample. But she was afraid to continue with the vaccine. “I’m convinced the third shot would have killed me,” she says. “I felt like I was 100 years old.”
Halford’s cancer was taking an increasing toll. When Melanie picked him up at the airport in August, at the end of the clinical trial, he was seeing double and couldn’t drive. She later learned that he had a seizure in Saint Kitts but kept it from her, not wanting her to worry.
Racing against time, Halford wrote up the results of the Saint Kitts trial. He reported that 17 out of 20 subjects completed the three-injection series and described, on average, a “3.1-fold reduction in their frequency of herpes-symptomatic days.” For one participant, Halford also presented blood test results, which seemed to indicate a greater range of antibodies to the herpes virus after the vaccine than before. Nowhere in the manuscript did Halford provide data on the three participants who did not complete the trial, nor did he refer to adverse events beyond welts at the injection site.
When Halford submitted the manuscript to a peer-reviewed journal called Future Virology, the response was scorching. In reviews later obtained and posted online by Kaiser Health News, one scientist argued that “neither safety nor efficacy has been demonstrated by the data presented” and described the paper as “partly a vision, partly science, and partly wishful thinking.” The reviewers also came down hard on the lack of documented oversight: “Who is giving the immunizations in Saint Kitts and who is following them medically when they return to the US? Where is the clinical protocol based? Is this an end run around the FDA?” The manuscript was rejected.
If Halford failed to win approval from academic peers, he struck gold with investors. Earlier that year, Fernandez says, an angel investor named Paul Bohm, who had cofounded a hackerspace called Metalab and had Silicon Valley ties, reached out to Rational Vaccines and offered to put the company in touch with venture capitalists. Drawing on these connections, Fernandez spent months pitching the research. In April 2017, at a symposium at Southern Illinois University, Halford stood in an auditorium and described the long arc of his research. A former managing director of Credit Suisse named Bart Madden was in the audience, and he was enthralled. “He’s got a patch on his eye, he can’t hear out of one ear, he’s all messed up, but he gets up there for 20 minutes,” Madden says. “I felt like I was watching history being made, just like the smallpox cure with [Edward] Jenner.” Madden later invested $750,000, Fernandez told me. (Bohm did not respond to requests for an interview, and Madden declined to confirm or comment on the size of his investment.)
Madden, who retired from Credit Suisse in 2003, is an author and policy adviser to the conservative-libertarian Heartland Institute. He focuses on market-based solutions to public policy issues. In 2010 he wrote a book called Free to Choose Medicine, which argues that the FDA’s risk-averse approach to drug approval gets in the way of innovation and keeps life-saving medicines off the market. He first heard about Halford in early 2017, when a documentary filmmaker contacted him for an interview about Halford’s research and free-to-choose medicine. In Madden’s eyes, Halford embodied the part of the brilliant outsider tangling with the scientific establishment.
Madden also took note that Peter Thiel, the legendary early investor in Facebook, was also interested in Rational Vaccines. Thiel is known for contrariness and taking arms against regulation and norms. A libertarian, he has criticized the FDA, calling the agency too restrictive and questioning whether an innovation like the polio vaccine could be achieved today.
“It caught my attention that Peter Thiel had done an incredible amount of due diligence on this,” Madden says. (Fernandez says he was first introduced to Jason Camm, the chief medical officer of Thiel Capital, by Paul Bohm, in early 2017. Camm was present at the April symposium, according to Fernandez, but Thiel was not.)
Madden also was moved by the testimony of a trial participant named Rich Mancuso, who attended the symposium. Mancuso has red hair and a puckish smile. He was working as an exterminator in New Jersey when he first met Halford online. He had been infected with herpes for more than 20 years, and though the symptoms waxed and waned, he experienced outbreaks as often as twice a month on his genitals and face. Mancuso told Madden about the humiliation of living with inflamed facial sores and the financial toll of paying for antiviral medicines. Dating was nearly impossible, and one rejection in particular brought him to the verge of suicide. Since receiving three shots of Halford’s vaccine, however, he had intervals of several months without the blistering sores. In gratitude, Mancuso chose to speak publicly to make his support more credible. “I had to take a chance,” he told me. “Dr. Bill was dying. Nobody wanted to speak up, so I was like, ‘I’ll do it.’ ”
With strong interest from investors—and at least one public success story—the company’s fortunes appeared to be ascendant. Halford’s health, however, was spiraling downward. By May 2017, it was no longer possible for him to work. And by early June, it was clear that he was close to death.
Halford had a jade necklace that he wore at all times, “like a talisman, to remind him to seize the day,” Melanie says. He got it a couple of years after his diagnosis, on a family trip to New Zealand. On June 22, he placed the necklace on his nightstand; when Melanie saw it there, she realized it was his way of saying, “I’m giving this up now.”
In August, two months after Halford’s death, the company received a total of $7 million from investors, Fernandez says, including $4 million from Thiel funds. At nearly the same time, however, Kaiser Health News broke the story that Halford had carried out a clinical trial with no guidance from the FDA or an institutional review board. The dean of Southern Illinois University’s School of Medicine had once referred to Halford as a “genius,” and the school had promoted his vaccine work on its website. But when details of the Saint Kitts research emerged, the university quickly distanced itself, saying that the institution was unaware of the trial’s oversight issues until after the work was done.
The university has acknowledged that there were serious problems with Halford’s work, and its medical school has halted all herpes simplex virus research. A spokesperson confirmed that “the government is conducting an investigation, and we are fully cooperating.”
Rational Vaccines is trying to weather the storm. As CEO, Fernandez is now charting a new course for the company, leaning on a recently hired chief technical officer as well as his investors. Madden says he first learned of the hotel-room injections and lack of oversight in Saint Kitts from news reports and admits he is troubled by what he heard. At the same time, “I don’t want to give opinions about this scientist that I revere,” he says, referring to Halford. “Was it done the right way? No.” But he said that now the company would comply with “the highest standards of gathering data.” Fernandez says Thiel Capital is also encouraging Rational Vaccines to conduct Phase I trials to follow FDA protocols. Camm, the chief medical officer at Thiel Capital, is “really one of the driving forces behind this whole thing,” Fernandez says. “If it were up to him, we’d be at the FDA already. I’m the one saying, ‘Let me get all the ducks in a row.’ ”(Neither Camm nor Thiel responded to numerous requests for interviews. )
The US market is lucrative and large, and “if you want to sell a treatment in the US, you have to play by US rules,” says Greely, of Stanford Law School. “I don’t care how libertarian you are.”
That doesn’t mean that the company will have an easy time with the FDA, which will likely ask to see all the data from Saint Kitts, as well as the lab notes for the animal studies. “The FDA will go back and look at the records, and if they’re not in order, they can’t be used,” says Robert Califf, a former commissioner of the agency. Still, if the company can convince the agency that the vaccine looks promising in animals—and that it is prepared to follow the rules—the agency is likely to allow further research. The FDA’s goal is not to punish, Califf says, speaking generally. “If there’s a good product and a bad company, the role of the FDA is to help get the good product through the system.” (The FDA declined to comment.)
Of course, more often than not, products that seem exciting in preclinical work fail in subsequent rounds of testing. Plenty of potential herpes vaccines, both preventive and therapeutic, have disappointed researchers in late-stage animal testing or in clinical trials over the years. “I think collectively we’ve all thrown the kitchen sink” at herpes efforts, says Clark, of Genocea. “It’s a hard virus, it really is.”
For months after she received the injections in Saint Kitts, Erkelens struggled to take her son to school, then often lay in bed for the rest of the day, unable to move. She continues to experience relentless tremors and intermittent nerve pain. “Nobody knows what’s going on,” she says.
Trial participants who felt better after the vaccination have a different concern: future access to the vaccine, both for themselves and others who are suffering. Rich Mancuso says he has not had an outbreak in more than a year but worries that if his symptoms do return, he won’t be able to get a booster shot—an option that Halford discussed with him. Carolyn says her symptoms disappeared for more than two years but “slowly started creeping back.” Now she gets occasional nerve pain, lasting a few minutes. “Most of the time it’s bearable, but I have been woken up in the middle of the night a few times as it got severe.”
Erkelens has hired a lawyer and is suing Rational Vaccines in state court for negligence and lack of informed consent. (Her lawyer argues that the document she signed before the trial did not fully represent the risks of the vaccine.) One other trial participant and one person who received hotel-room injections from Halford in 2013 have also filed suit against the company. (Rational Vaccines declined to comment on any legal proceedings.)
Before Halford died, Erkelens says, he called her “over and over and over” to see how she was doing. Halford always tried to understand the pain of the participants in his study; his empathy was part of what drew them to him. Yet it was perhaps his own suffering that made him blind to the larger implications of his actions. In what felt like the final insult, Erkelens said she had to reveal her identity in order to proceed with the lawsuit. It was an agonizing choice. Herpes had always felt like a mark of dishonor, and now it threatened to stain her public reputation as well. In the days after she filed the lawsuit, she set the wheels in motion to change her name.
Amanda Schaffer (@abschaffer) is a science writer based in Brooklyn, New York.
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