No Profit In Junkies, New Heroin Vaccine Ignored
An existing heroin vaccine might save many, but neither the government nor Pharma care enough to finance it—even now. Why?
A vaccine that could stop heroin addiction cold would seem to be a societal must in light of the national heroin epidemic. Yet while researchers in La Jolla, California at The Scripps Research Institute have developed a new heroin-specific vaccine that has delivered astonishing results when tested on animals, both federal and private research funding have ignored the work being done.
Professor Kim Janda, the Director of the Wirm Institute of Research and Medicine, and Professor George F. Koob, Chair of the Committee on the Neurobiology of Addictive Disorders, published their findings on May 6, 2013 in the Early Edition of the Proceedings of the National Academy of Sciences.
In an interview with The Fix, Janda described in detail the impressive success the research team achieved with rats that had become completely dependent on or addicted to heroin:
“The heroin vaccine has been superior to the other drug vaccines we’ve developed," Janda said. "With the latest version, we have been able to give doses 15 to 20 times greater than a dose that normally would kill the animals and they are fine.
"Whether this translates to humans, I don’t know. But with rodents we can give them huge amounts of heroin and they don’t die and they don’t get high. Not only are they not dying, but they seem to be perfectly fine. This is why I believe the vaccine could be used to treat overdoses as well.”
Not only do the vaccinated rats spurn the heroin, Janda added, they practically become immune to overdose.
Employing the same approach as the cocaine vaccine by Dr. Ronald Crystal (about to enter human trials at the Cornell Medical Center), Janda’s heroin vaccine is considerably more specific in its targeting mechanism. At this stage with such promising results, the hope at Scripps was that the next level of research funding would be available to determine whether such a targeting mechanism will deliver effective and lasting results in human subjects. Further testing is needed to determine what will happen when the complications presented by human physiology, free will, and the baffling impulses engendered by drug abuse are thrown into the mix.
According to Janda, a core attribute of the new vaccine that makes it superior to previous attempts is that it addresses the complexity of heroin as it breaks down in the human body. “Previous vaccines didn’t take into account these breakdown products," Janda said. "They didn’t have the specificity of this vaccine that focuses exclusively on heroin. The goal was to stop the morphine from crossing the blood brain barrier.
"This vaccine was designed to counter all of the breakdown products involved with heroin in particular. You need to look at how the drug interacts with the body and how the body interacts with the drug."
One current example is a vaccine being developed in Mexico at the National Institute of Psychiatry, which some scientifically uninformed news sources have asserted is more advanced in its development than Janda's. Although Janda said he wishes his Mexican colleagues well, he doubts the outcome because the Mexican research employs the outdated approach that has failed in the past - that is, trying to address all opiates across the board rather than, as at Scripps, directly targeting heroin and all of its byproducts. "The Mexican vaccine is the same general opiate vaccine that was first tested over 40 years ago," Janda said. "[Ours] is a vast improvement on past vaccines.”
But will Janda's vaccine ever make it to the market? Probably not. As Janda told The Fix, “We are not anywhere near human trials because nobody wants to pay for them.”
The early research on and testing of Janda’s heroin vaccine was funded by the Scripps Research Institute, the Pearson Center for Alcoholism and Addiction Research at TSRI and by the National Institute of Health (NIH). Given the positive results, you would think obtaining the needed funding from the government or a pharmaceutical company for human trials in exchange for the rights to the vaccine would not be a problem.
You would be wrong. Despite outreach by Janda and others on his behalf, the NIH, whose budget was cut by congressional "sequestration," isn't stepping up, nor has any pharmaceutical company offered funding. The general consensus is there is no money to be made in funding a heroin vaccine.
Asked if some new unpublished data showing improvements in his heroin vaccine (and more success with the animal trials) would help gain a pharmaceutical sponsor, Janda responded with a palpable sense of resignation in his voice.
“I wish, but I think we’ll probably just have to keep going it alone. Hopefully by putting in grants to the government - a much harder road to take than finding a pharmaceutical partner - we’ll be able to get to the point of human trials. I don’t see any pharmaceutical partners stepping up to fund this heroin vaccine. I have talked to many different companies and not one has shown any interest whatsoever. They don’t feel there is value for their company. I don’t understand it from the standpoint of the greater good for our society, but that’s the cold hard facts that we face.”
According to the Foundation for a Drug-Free World, an estimated 9.2 million people used heroin in 2008 worldwide. According to a Central Intelligence Agency Report in 2012, “There are an estimated 2 million heroin users in the United States, with some 600,000 to 800,000 considered hardcore addicts.”
Not only have such numbers not created the impetus for investment in a heroin vaccine, Janda has not even been able to raise $50,000 needed to renew the patent on the specific medical technology behind the development of the vaccine. This raises the possibility that some pharmaceutical company might seize the work for itself once the patent expires.
With Professor Koob on leave of absence from The Scripps Research Institute to work with the National Institute on Alcohol Abuse and Alcoholism, Janda has found himself practically on his own.
The Scripps Research Institute normally does not itself provide ongoing financial support for such research ventures. It offers powerful name recognition and first-rate laboratories while still forcing researchers to scramble for funding. Even more challenging, researchers must cover costs that most foundations refuse to even address in their grants.
Scripps has, however, sought unsuccessfully to raise funds for further testing of Janda’s vaccine. William Burfitt, the director of Scripps’ Office of Philanthropy, told The Fix: “We’re focused on individuals, family foundations, large national foundations, even corporate foundations… To bring an idea from the lab ultimately to market can take 10 to 15, 20 years. There’s many hurdles to jump over… Kim’s work is often cited all over the world, whether it’s in The New York Times, The Wall Street Journal - he will get inquiries from all over this country, Mexico, Europe, Russia, from parents saying, ‘Where does this stand? We need to get our kids on this.’”
Despite the obvious need and market, Burfitt added, donors are hesitant to write checks for a project that centers on heroin addiction or any other illegal drug. “People just don’t want to talk about it,” Burfitt said.
Frustration with the lack of support has been palpable, and an ad-hoc group of Los Angeles activists have taken up the cause. Led by concerned citizen Caron Block, they have formed a nascent organization called FAR or For Addiction Research.
In an interview, Block described the funding bind for medical research and vaccine development that Janda and medical professionals across the country face. “Although Scripps and NIDA did contribute some money to Janda’s research, in general researchers are on their own. They have to fund their own labs and their own salaries. They spend the majority of their time writing grants or they use valuable resources to hire someone to write grants for them. They seem to be clawing to stay alive. As a researcher, it’s not just publish or perish. Instead, it’s find money or perish because you are completely on your own.”
Together with FAR, Block has been trolling the waters of both the Los Angeles recovery community and high society, trying to find financial support for Janda’s vaccine. At the very least, she wants to raise $50,000 to renew the patent; thus far, she has not succeeded.
Asked why she took up such a difficult cause, she said: “Too many people were falling out left and right. After vetting Janda’s research, we realized we wanted to help them because they are on to something big. But I can’t access people who can actually help and I can’t seem to get the word out. There is so much resistance.
"It’s pretty heartbreaking when the recovery community won’t support itself. When I asked a person in recovery to help me get the information about the vaccine to a celebrity on their board of directors, ‘That’s never going to happen’ was the response I got. There seems to be an overall lack of community.”
Block recently set-up a crowdsourcing fundraising page on Crowdrise.com for the vaccine technology patent renewal, at the very least. Although she only has been able to raise 15% of the money needed to help Janda’s project, she says she is confident that a positive turn is on the near horizon.
Software billionaire Bill Gates would not be surprised by the difficulties that Janda has encountered. Gates once openly stated that vaccines are not a priority for pharmaceutical companies.“If 15 years ago, you had said, ‘How important are vaccines to these various businesses?’ They would have said, ‘You know, our drug businesses are going to do so well. And vaccines are so tough, particularly because of liability issues.’” Gates then created incentives for pharma companies to work with his charitable foundations in developing vaccines for a number of diseases that afflict third world countries.
According to the Bill & Melinda Gates Foundation, “Vaccines save millions of lives a year and are among the most cost-effective health interventions ever developed…. At the Bill & Melinda Gates Foundation, all of our investments in vaccines and immunization contribute to the goals of the Decade of Vaccines. As one entity within the greater vaccine community… we are working to ensure that existing life-saving vaccines are introduced into countries where people need them most, and we support the innovation needed to develop new vaccines and delivery technologies and approaches.”
Interestingly, the Gates emphasis on the Third World was mirrored by Janda’s intent for the heroin vaccine. “I originally designed this vaccine for third world countries and to stop the spread of needle-based viruses caused by the sharing of needles," Janda said. "In Africa, Russia and China, the spread of HIV among heroin addicts is very high. When I first started making this vaccine, I wanted to create an inexpensive option to specifically address that problem. I was trying to make it as inexpensive as possible.”
Asked if he had approached the Gates Foundation for support, Janda explained: “We can’t take their money. We have both direct and indirect costs, and indirect costs are things like basic infrastructure costs; paying for administrative people and janitors and keeping the lights turned on. They won’t cover those costs that we need. We can’t take their money because then we can’t subsidize the indirect costs.”
John Lavitt is a regular contributor to The Fix.