2 scientists are locked in a race to develop a groundbreaking vaccine for heroin, but it might not be a 'magic bullet'

• A new vaccine for heroin is getting closer to human trials.
• But it's still 10 to 15 years from reaching the market.
• Addiction experts and treatment professionals are wary of how much it will help the current opioid crisis.

Two scientists are locked in a race to develop a groundbreaking vaccine for heroin. But many addiction experts and health officials warn that the medicine is unlikely to be the end game for the current opioid crisis and is a decade from reaching the market, at the earliest.

Dr. Kim Janda, a chemist at the Scripps Research Institute in La Jolla, California, has been developing vaccines targeting addictive substances for nearly 30 years and has pioneered much of the research in the field. He began developing the heroin vaccine about a decade ago and in recent years has begun work on a vaccine for fentanyl, a painkiller 50 times more powerful than heroin and the cause of an increasing number of overdose deaths.

His competitor, Dr. Gary Matyas, has been developing his vaccine since 2011 at the Walter Reed Army Institute of Research in Maryland, a facility run by the Department of Defense. Matyas' work largely builds on Janda's and grew out of a research push to develop a vaccine for HIV - his vaccine has since become a combination heroin and HIV vaccine. So far, both Janda's and Matyas' vaccines have been tested only in animals.

While work on opioid vaccines stretches back decades, the research has gained added urgency in light of the opioid crisis. Last year, more than 30,000 Americans died from overdoses related to opioids, with that number rising nearly every year since 1999. President Donald Trump announced that he was declaring the crisis "a national emergency" last month, but his administration has yet to officially do so.

Still, the prospect of a heroin vaccine has stoked a lot of interest and enthusiasm in the research. But as more is learned about the vaccine, its limitations as a moonshot cure have become clearer.

"Vaccines are an innovative approach that may be promising, but it won't be the panacea," Dr. Ivan Montoya, a director at the National Institute on Drug Abuse, who has approved grants for both projects, told Business Insider.

Keeping heroin from entering the brain

Vaccines help the body create antibodies. For example, a measles vaccine works by helping the body's immune system make antibodies that can confront the virus should you come across it. That way, you won't get sick.

That's how a heroin vaccine would work, in theory, helping the body's immune system recognize the heroin molecule and knock it out of the body before it can get to the brain receptors that give you a high. If you aren't able to get high - ideally for a long period after the vaccine's given - it could make it easier to quit, or at least protect you from overdose.

"These drugs have to get in the brain to have their function," Matyas said.

While the details are still being worked out, each vaccine works in different ways. Janda's vaccine is designed to specifically eliminate heroin, while Matyas is working to make his vaccine bind to the substances that heroin breaks down to. If successful, that would mean Matyas' vaccine could block the effects of a wider variety of opioids.

That's important because one of the main concerns is that many addicts switch between substances to get their fix. A persistent opioid addiction leaves the brain perpetually lacking endorphins for long periods after use stops. Because neither vaccine fixes that, it could leave addicts trying to alleviate cravings by opioids not covered by the vaccine.

"If you create a vaccine for morphine, people could switch to fentanyl. We already have people using fentanyl rather than heroin to avoid triggering drug tests because fentanyl is so difficult to detect," Mark Willenbring, a leading addiction psychiatrist who runs Alltyr, a treatment clinic in Minneapolis, told Business Insider.

On the other hand, creating a vaccine that targets a broad spectrum of opioids has its own problems. One of the most effective treatments for opioid use disorder are maintenance drugs like buprenorphine (commonly known as Suboxone) and methadone, which are chemically similar to opioids and work by attaching to the same brain receptors, preventing users from using other opioids to get high while reducing cravings and withdrawal symptoms.

Matyas acknowledged that creating a vaccine that stops problematic opioids while avoiding treatment drugs is the goal.

What it will take to get a heroin vaccine approved

For now, the vaccine has been tested only in animals. Montoya at NIDA called current studies of the vaccines' use in animals "encouraging" but said it remains to be seen whether they will work in humans.

The hope is to get a human clinical trial started within a couple of years, but that could take up to 15 years from the earliest of human trials to approval. First, researchers will have to show that the vaccine is safe to administer, then you have to show it's effective at what it sets out to do. A heroin vaccine will likely take just as long, by Matyas' estimate.

That process won't be cheap and will need the backing of a drug company.

While Matyas has licensed his vaccine to biotech company Opiant, which developed the NARCAN anti-overdose spray, CEO Dr. Roger Crystal told Business Insider it is waiting for more pre-clinical data before deciding whether to proceed. The data should be available by the end of the year.

In the event Matyas' vaccine doesn't pan out, Crystal said Opiant would look to license other potential vaccines until the company found a success. "We're here for the long run," Crystal said.

Despite being the trailblazer in the field, Janda has had more difficulties attracting significant interest for his vaccine, at least until recently. He said that just a few years ago he nearly gave away the vaccine free. As the opioid crisis has intensified, so has interest. He is now working on a deal with a small biotech company - he declined to name which since the deal isn't done - to bring his vaccine through clinical trials, which he says will cost between $30 million and $40 million.

Janda says his focus is on getting the vaccine to the public as soon as possible.

"I'm not looking to make money off this," he said. "The people out there that have these problems don't have deep pockets."

Making 'a good decision once'

The heroin vaccine appears to be part of a trend in addiction research focusing on long-acting treatments that rely less on patients' decision-making.

Opioids hijack the brain's rewards system, resulting in fundamental changes to addicts' brain wiring. The longer one uses, the more profound changes are to an addict's ability to make choices. One recovering addict, Andi Peterson, told Business Insider that even while enrolled in a treatment program, getting high "required no thought" and was "like breathing."

Most addicts go through years and several stints of treatment to achieve abstinence. Relapse is a common and expected part of the process.

Addiction experts and treatment professionals have long worked toward solutions that acknowledge this aspect of brain science. The "gold standard" of opioid-use-disorder treatment, according to them, are psychological therapies in conjunction with maintenance medication like buprenorphine or methadone, which prevent users from getting high while reducing cravings.

But such treatments must be taken daily, and while buprenorphine can be taken anywhere, methadone must be taken at a clinic often far from the patient's home. If a patient forgets or misses a dose, the cravings return and can trigger a relapse.

Researchers such as Matyas and Janda are looking to work around that daily-choice issue. The first medication to achieve that is Vivitrol, a monthly injection approved by the FDA in 2010 that blocks opioid receptors in the brain. But the drug has been criticized for its side effects - including a painful withdrawal process - and questionable success.

Many patients that do end up trying Vivitrol, according to treatment professionals that spoke to Business Insider, tend to stop after the first monthly shot, largely because the drug, like the vaccine, has no effect on cravings.

"Some places have good luck with patients returning for their monthly shot, but we haven't had much success," Sandi Kuehn, the CEO of the Center for Addiction Treatment in Cincinnati, told Business Insider. Most patients aren't interested in the treatment, she said.

 

Crystal, Opiant's CEO, thinks the vaccine will be more effective than Vivitrol precisely because it works for longer than Vivitrol's one-month timeline, and requires patients to only "make a good decision once."

While it is unclear how long a vaccine will remain effective, Janda said it would likely require three injections over three months, with the possibility of a booster shot at a later date. A study presented in August at an industry conference found that the vaccine lasted as long as eight months in monkeys.

NIDA is also funding research into long-acting versions of buprenorphine, particularly Probuphine, an implant that doles out the medicine for six months. Approved last year, Probuphine has been called a "game changer" by Dr. Nora Volkow, the director of NIDA, largely because it solves the daily-decision issue while alleviating cravings, unlike the vaccine or Vivitrol.

"The more often you have to administer the medication, you lower the adherence to treatment," said Montoya of NIDA, adding that the agency thinks long-acting treatments will improve adherence.

Another Vivitrol

Vivitrol has drawn headlines over the past year after investigations by ProPublica, The New York Times, and the Associated Press reported how Alkermes, which developed the drug, grew its business from $30 million in 2015 to $209 million a year later, primarily by marketing its product directly to drug courts, prisons, and other parts of the criminal-justice system.

In many cases, the company targeted judges in areas hard hit by the opioid crisis wary of maintenance treatment and with a bias toward viewing addiction as a moral weakness. Vivitrol was pitched as a way to avoid treatment that "substitutes one opioid for another," a still common misconception of buprenorphine repeated in May by Health and Human Services Secretary Tom Price.

Daniel Wolfe, a director at progressive organization Open Society Foundations, slammed Vivitrol in STAT News as a treatment that "prioritizes the fantasy of being drug-free over the real interests of people in need of help."

Addiction experts and treatment professionals worry that the heroin vaccine, if marketed improperly, could go down the same path - providing governments another reason to avoid maintenance therapies, which they see as more effective.

"When the courts start practicing medicine from the bench, there is a real fear that they may latch onto vaccines and mandate them without involving clinicians," Dr. Devang Gandhi, the head of the University of Maryland's addiction residency program, told Business Insider. "That is often the case now, where decisions are made by judges who don't really understand what these medications are."

That fear may not be entirely unfounded. When asked what Opiant saw as a potential market for the vaccine, Crystal said it would be "ideal" to administer to those with a history of abuse, "particularly in the prison setting."

'You can't find a magic bullet for this'

While addiction experts and treatment professionals expressed excitement at the prospect of Janda's and Matyas' research, many wondered how "practically useful" such a vaccine would be for those on the front lines of the crisis.

Willenbring, the addiction psychiatrist, said that solving the opioid crisis is not a matter of developing new treatments but expanding access of current treatments to those that need it.

"The problem right now is not that we don't have effective treatments, it's that we don't have enough of it," said Willenbring, who was the director of treatment research at the National Institute of Alcohol Abuse and Alcoholism from 2004 to 2009.

The treatment paradigm - psychological therapies in conjunction with buprenorphine or methadone - represents "some of the most effective treatments not just in addiction but all of medicine," Gandhi said.

While the Obama administration made administrative changes to increase the number of prescribers administering buprenorphine last year, a study conducted by the Johns Hopkins School of Medicine earlier this year found that only 44% of physicians who had obtained a waiver to prescribe buprenorphine were doing so at full capacity. The White House opioid commission recommended expanding access to buprenorphine and other medication-assisted treatments in its July report.

Willenbring put it bluntly: "It's hard for me to talk about highly theoretical treatments that may not work when we already have highly effective treatments that people can't access," he said. "If we're serious about ending this crisis, we'd make sure anybody who wants medicated-assisted treatment can have immediate access at an affordable price, if not free."

Kuehn, the CEO of the Ohio treatment center, said that the complicated nature of addiction makes it unlikely that any one treatment will work for all patients, but that any additional treatments could be effective tools.

"You can't find a magic bullet for this. It would be misleading for the public to think that it can be easily cured," she said.

While Janda acknowledged the limitations of the vaccine, he said it's not designed to be a cure-all, but something that could be used in conjunction with current treatments to help addicts.

"If we think that the treatments we have right now are going to solve our problems, I don't think that's going to be the case," he said. "We've got to start looking outside the box to try to find some alternative or other therapies."

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