What's the Holdup on the Heroin Vaccine?

He was supposed to fly to see his parents for Christmas break. He never made it on the plane. By the time they found him in his dorm, he was gone.

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Jun 22 2017, 4:25pm

Like many heroin addicts, Patrick Schnur spent his youth in the revolving door of rehabs and treatment facilities. He'd tried everything to kick his addiction: Suboxone, a drug used to wean addicts off of opioids, and Vivitrol, a monthly injection to relieve opioid cravings. He'd tried therapy and in-patient treatment programs. He'd stay sober for a few months, then relapse again. Each time something seemed to work, suddenly, it wouldn't.

Just before he relapsed for the last time in December, his parents Kathy and Dennis Schnur learned about something else: a vaccine, which could numb him to the effects of heroin and prevent him from overdosing. Patrick was doing well—had been sober nearly two years at that point—but they knew better than to consider him cured. The vaccine was still in development, but they thought if they could just get their hands on it, then maybe they could breathe easier, stop worrying every time the phone rang.

But then the phone did ring, and it was too late. No one knows why Patrick decided to use again, other than the strong pull of addiction and perhaps the desire to celebrate—he'd just completed his first semester of pharmacy school with a 4.0 GPA and his life finally seemed back on track, after years of spiraling out of control. The next day, he was supposed to fly to see his parents for Christmas break. He never made it on the plane. By the time they found him in his dorm, he was gone.

Watch: Inside America's Opioid-Fueled Epidemic

These are the stories Kim Janda thinks about when he shows up each morning to his lab at the Scripps Research Institute in San Diego—the Philip Seymour Hoffman-type stories, where someone seemed to be doing so well, maybe stayed clean for a few years or even decades, and then in an instant, got pulled under. It's not just that the stories are harrowing, heartbreaking; it's that they're so common. The relapse rate for heroin and opioid addicts is, according to some research, nearly 100 percent.

Janda started developing the heroin vaccine six years ago. Back then, he says, the idea was "to develop a heroin vaccine for third-world countries"—places like Russia, where more than half of HIV infections are caused by needle sharing among intravenous drug users, and where clean needle programs and recovery methods like methadone are often inaccessible. But when he started working on it, he realized the vaccine could be so much more.

"As soon as we published our first paper, [we saw there was] a real need in the US for this. I didn't expect that," Janda says. "I had people come by my lab—mothers, families," people like Kathy and Dennis Schnur, who had already tried everything else on the market and needed to know there was another option.

That first paper, published in 2011, tested a vaccine that could coax an immune antibody response to block the effects of heroin in rats. By training the immune system to recognize heroin molecules as a threat, the vaccine could prevent the drug from crossing the blood-brain barrier and blunted some of its effects, without harmful side effects. The experiment was a slam-dunk. "In my 25 years of making drug-of-abuse vaccines, I haven't seen such a strong immune response as I have with what we term a dynamic anti-heroin vaccine," Janda said at the time.

In 2013, Janda and his team followed up with a second study on rats, in which vaccinated rats actually stopped pressing levers to receive hits of heroin. Earlier this month a study in monkeys showed the vaccine was effective for about eight months. The drug simply stopped having an effect—no high, no cravings, nothing. Last year, they tested a new vaccine against fentanyl, a potent synthetic opioid responsible for a massive spike in overdoses across the country. That vaccine also proved effective.

But for all the promising results on heroin-addicted rats and monkeys, Janda has nothing to say to the people who send him letters and emails, or show up at the lab, asking to be vaccinated. He can't give them the vaccine, and isn't sure if he can any time soon, because he can't secure the funding to get FDA approval to test the drug on humans. That means he can't give the vaccine to anyone, no matter how desperately they ask.

Addiction-related vaccines have been in the works since at least the 1970s; Janda has worked on them for the last quarter century. He's experimented with vaccines for cocaine and nicotine addiction, alcoholism and marijuana abuse, all to varying degrees of success. Each vaccine takes copies of the drug and stimulates T cells and B cells to produce antibodies against the drug. The result is essentially a firewall—the drug can't cross the blood-brain barrier, so the user can't get high.

"The strategy is that if people don't get pleasure from using, because the molecule doesn't get to the brain, then they'll stop using," says Ronald Crystal, the chairman of the Department of Genetic Medicine at Weill Cornell Medicine, who is developing a vaccine for cocaine addiction. "It works in studies on experimental animals: They give up trying to get the abusive molecules."

Janda will be the first to point out that these vaccines aren't magic bullets. Addiction is exceedingly complex, and dealing with the effects on the brain is just one piece of recovery. But vaccines are compelling because they're cheap to manufacture, long lasting, and can be used in combination with other treatment options. The same can't be said of Vivitrol, the injection that prevents heroin overdoses, which has to be re-injected every month and costs upwards of $1,500 per shot without insurance.

So having a vaccine, as Crystal told me, would add a very good option. "It's terrific that Dr. Janda and his colleagues have developed what looks like an extremely effective vaccine in animals," Crystal tells me. "Whether it'll work in humans, you don't know until you try."

And yet, Janda hasn't been able to move the vaccine to clinical trials, because no one wants to pay for it. No pharmaceutical company or private investors have stepped forward with an interest in sponsoring his work; he's secured a small amount of government funding, but it's not nearly enough.

"If you look at the billions of dollars that have been spent on a flu vaccine, the amount that's been spent on these drugs of abuse is virtually nothing," he says.

To date, the money he's been able to raise has come primarily from the National Institute on Drug Abuse, which awarded him a two-year grant in 2015 to fund further research. That grant expires this year, leaving Janda and his team without the means to petition the FDA for investigational new drug status, which would allow them to test the drug on human participants.

"If you don't have the IND status, you can't go to clinical trials," Janda says. "It's really very basic work—a series of toxicology studies, dosing schedules, a number of things like that—but it's very expensive. We're talking probably $3 to $5 million."

If finding the money to create this vaccine is out of reach, no one has told Caron Block. Block, whose son is a recovering heroin addict, is like a one-woman fan club for Janda: She runs a Facebook group with nearly 4,500 members devoted to updates about his research; she's organized crowdfunding campaigns to raise money from private donors. Listening to her talk about him and his work is almost like listening to someone describe their favorite pop star.

Block's son went to his first in-patient rehab when he was 14. Since then, he—like Patrick Schnur—tried every treatment option available, but kept slipping back until five years ago, when he got clean for good. Block talks about her son's progress with cautious optimism, all too aware of the possibility of a relapse, even after all these years.

"His best friend had been sober for two years when he shot up in his parents house," she told me. He overdosed, and even though he was eventually revived, he has permanent brain damage from lack of oxygen. "Had he had the vaccine, [his family's] lives might not be ruined the way they all are today."

When Block first heard about Janda's vaccine, it felt like the miracle she'd been waiting for—something that could help her son stay alive indefinitely. "I figured getting this funded was going to be a piece of cake," she says. "Boy was I wrong."

She's reached out to places like the Clinton Foundation and Bono. She managed to get the ear of Michael Botticelli, who until this year was the director of the White House Office of National Drug Control Policy. They were all polite, but ultimately rebuffed her requests for money. Then in 2014, she started an online crowdfunding campaign to raise money from individuals. She figured if everyone who had a loved one struggling with addiction pitched in just $20, they could come up with $3 million in no time.

"It's been dismal," she said. "We've raised somewhere between $35 and $40,000. It helps to clear the patents and stuff, but it's not going to fund his research."

Janda believes people don't want to pony up because they see addiction as a moral failing. "If I told you that person had Alzheimer's versus another person who is a heroin addict, you're going to look at those people so differently," Janda says. "That's how funding goes, too."

Others think the vaccine research is simply not as compelling as Janda makes it out to be. Tracey Helton, a recovering addict and the author of The Big Fix, told me while she was open to new solutions, an abstinence-based method like the vaccine, which would prevent the user from getting high at all, seemed like it would tempt disaster by encouraging addicts to try other substances that would produce a high. "Just because someone's desperate to try it doesn't make it a good intervention," she says.

Thomas Kosten, a professor at Baylor College of Medicine who has also worked in addiction-related vaccine research for the last 25 years, told me a heroin vaccine would be "redundant" to treatments like Vivitrol, which is already FDA approved, and "unhelpful," as there are multiple classes of opiates and addicts would need to separately vaccinate against all of them. (Kosten is involved in research around cocaine and nicotine vaccines.) And while many addicts would point out that Vivitrol is an inelegant solution compared to the vaccine—it's expensive, requires regular shots, and comes with a litany of side effects, like anxiety, nausea, and muscle aches—the vaccine isn't perfect either.
Gary Matyas, a biochemist who is also developing a heroin vaccine out of the Walter Reed Army Institute of Research in Maryland, conceded that people given a vaccine would need additional treatment for cravings and psychological issues.

But still, it can't hurt to have more solutions available. "I view a heroin vaccine as another therapy that can be used to help treat addiction," Matyas says. "In addition and maybe more importantly, it should prevent accidental overdose."

Matyas, who has also published studies demonstrating the efficacy of his heroin vaccine in rodents, hopes he too can move to clinical trials soon. Unlike Janda, he's secured a patent for his vaccine that's licensed to the pharmaceutical company Opiant.

Block doesn't care who releases the vaccine; she just wants it out there. "If there were answers out there—if AA was the answer, or rehab, or therapy, or if there was a black and white way to handle addiction, we wouldn't have people dying from relapses," Block says. That's why she's been working to raise awareness both from other families affected by addiction and big ticket donors like former US representative Patrick Kennedy, hoping that more people will step up to donate to Janda's research.

Indeed, the most famous vaccine in American history was also left to be funded by the public: In the years before the polio vaccine was made available, polio paralyzed upwards of 20,000 children annually. It was a health crisis, to be sure, but if it wasn't for the attention of President Franklin Roosevelt (a polio sufferer himself) who founded the National Foundation for Infantile Paralysis, no scientist could've raised the money to fund the necessary research. In 1952, the year the vaccine was finally made available, 80 million people donated to the National Foundation for Infantile Paralysis—which would later be renamed the March of Dimes, since many donors pitched in whatever they could, even if it was just a few cents. It didn't require a pharmaceutical company to sign onboard, or a governmental grant to fund the research. It took the tenacity and generosity of the public to say, We need this vaccine.

Block, who spends so much time raising awareness for Janda's vaccine that it's practically a full-time job, hopes that eventually, people will look around and see their friends and family and neighbors dying of heroin overdoses and come to the same realization.

For Kathy and Dennis Schnur, who are still reeling from their son's recent death, the vaccine is worth fighting for—even if the fight will be a long one. Though she doesn't consider herself an activist like Block, Kathy has called her friends who work in venture capital and philanthropy to ask for donations to Janda's research and she's traveled from St. Louis to San Diego to visit Janda in person to see what more she can do. If there's anything she can do in memory of her son, it's to prevent another kid from dying the way he did.

"This is about as close as you can come to a cure," Kathy says of the vaccine. "This is something that needs to be done."