A Heroin Vaccine -- Is It Possible?

Yes, you read that right. A vaccine for heroin. I first ran across this concept on Twitter last week. I saw a posting from @heroin_research about a heroin vaccine. I was trained by my parents, and through practical experience over the past 55+ years, I've learned that if something sounds too good to be true then it probably is. This sounded too good to be true. But, being The @RxProfessor, I had to check it out. And that led to a Saturday conversation with Caron Block. Caron's son has been in recovery from heroin for over four years. It has been a long journey. Unlike the new trend in heroin users, his abuse did not start with a legitimately prescribed opioid after an injury or surgery. It started with drinking himself to sleep in 8th grade, then escalation to marijuana, then meth, then cocaine, then heroin. Naloxone literally saved his life multiple times from an overdose death. He has had open-heart surgery for Endocarditis (a heart valve infection very common with heroin users). He was adjudged to be a "use till death" person given the nature of his genetic predisposition to addiction. By all accounts, the fact that he is still alive is a miracle. That he's on his way this Fall to Columbia University after restarting his education at a community college is astounding. While his battle with addition will last a lifetime, his is a story of victory ... achieved every single moment of every single day. See also: Progress on Opioids — but Now Heroin?   But Caron knew that her son's victory was unfortunately not common. She had personal experience with death and devastation among friends and family. Many of his friends (past co-users) have died. And many still use. Rather than preaching to those still suffering from the addiction, he's trying to lead by example. But it is frustrating. And overwhelming. And so that turned Caron into an evangelist for the work of Kim Janda, Ph.D., the Ely R. Callaway Jr. Professor of Chemistry at The Scripps Research Institute (TSRI), and his pursuit of immunopharmacotherapy. He is really smart, working initially on a cocaine vaccine, then a nicotine vaccine, then a methamphetamine vaccine, and now a heroin vaccine. Note that each drug requires it's own unique vaccine, so a heroin vaccine will not be an opioid vaccine. But it's certainly a step in that direction since the heroin vaccine deals with morphine, one of the two metabolites, along with  6-acetylmorphine or 6-AM, that come from heroin, which as a chemical actually only lasts for about 30 seconds in the body. If you have 47 minutes available, watch this YouTube video titled "Heroin Vaccine and Understanding Addiction with Dr. Kim Janda & Caron Block." If you only have 5 minutes, a June 28, 2016 article published by Science News entitled "Vaccines could counter addictive opioids" is a detailed accounting of the vaccine. Included is a sobering statistic:

More than 60 percent of people with addiction experience relapse within the first year after they are discharged from treatment

In essence, the heroin vaccine "trains the immune system to usher the drugs out of the body before they can reach the brain." Just like how all vaccines work, it creates antibodies and turns the immune system into the front-line defense. In this case, it keeps heroin away from the brain. The "active vaccination" is primarily to help people get through rehab/detox or to stay clean afterwards (even if they relapse, the vaccine has made heroin an enemy of the body and they can't get the reward effects of the drug). Importantly, the vaccine is only valuable to those who desire to defeat their addiction, so vaccine recipients would need to be carefully vetted. The expectation is three to four boosts would be needed every two weeks to build up the antibodies that could last for several months. For more details, please read the Science News article. According to a January 2015 TIME magazine article ...

In 2013, preclinical trials of the drug on heroin-addicted rats showed those vaccinated didn’t relapse into addiction and were not hooked by high amounts of heroin in their system. “It’s really dramatic,” says Dr. George Koob, director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) who was involved in the heroin vaccine research. “You can inject a rat with 10 times the dose of heroin that a normal rat [could handle] and they just look at you like nothing happened. It’s extraordinary.

In 2015 TSRI and Dr. Janda received a $1.6M grant from the National Institute on Drug Abuse (NIDA), with the potential of three additional years of funding, to support pre-clinical trials of the heroin vaccine. That is really good news. TSRI has a very specific plan forward:

• Pre-clinical meeting with the FDA
• Production of the vaccine under cGMP
• Animal toxicity studies (2 species)
• Efficacy study in another animal model (likely primate)
• IND filing with the FDA prior to initiating human trials

The corresponding bad news is that a lot more money will be required to take it to human trials and ultimately to FDA approval and production. They have estimated a minimum of $10.5M and 3 years to get through Phase II trials, after which they'll need even more money and time for Phase III trials, NDA application, FDA review and approval. There are a lot of financial headwinds for a variety of reasons (if you consider a heroin vaccine reducing demand, you can probably speculate on who might not be supportive). Caron is doing her part with a Facebook page and the aforementioned@heroin_research on Twitter. Dr. Janda believes that addiction is perceived to be a moral failing (of the individual or society as a whole) where it should be seen as a brain disease. Dr. Nora Volkow, Director of NIDA, believes in "treating addiction like a disease that needs to be managed, such as diabetes or high blood pressure, with a multiplicity of treatment options would help addicts find a treatment that works well for them over the long haul." That stigma certainly doesn't help fundraising. See also: Opioids Are the Opiates of the Masses   I'm an ALL OF THE ABOVE kind of person. For any complex multi-dimensional issue, there is no single solution. We need Medication Assisted Treatment. And greater access to substance abuse and mental illness treatment facilitated by the series of bills recently signed into law ("What will $180 Million Buy Us?"). And the use of PDMPs to identify prescription drug abuse/misuse. And the trending yet controversial "safe spaces" for heroin users to be guaranteed clean needles and clinical oversight (and, hopefully at some point, a recognition for the need to change). And any number of other initiatives around the country focused to combat the dual epidemics of painkiller and heroin abuse. At this point, I'm a believer that this is not "too good to be true." But it might not ever be one of the solutions available without other evangelists and dollars to fund the research to validate whether this really works on people. Are you willing to be an evangelist? Do you know somebody who would be willing to be an evangelist? Do you have access to research dollars? If the answer to any of those questions is "yes", let me know. Or contact Caron (@heroin_research). Or contact Christopher Lee (clee@scripps.edu) at TSRI. It would be yet another tragedy for this vaccine to hit a dead-end because of funding. If it truly does work, this should be one of the biggest no-brainers in our lifetime.