Showing posts with label National Institute on Drug Abuse (NIDA). Show all posts
Showing posts with label National Institute on Drug Abuse (NIDA). Show all posts

Monday, October 17, 2011

Why Big Pharma (and the Public) Doesn't Want an Addiction Vaccine

Scientists and sobriety veterans alike seem to agree that the addiction vaccine is an unachievable goal, but they also seem to disapprove of the dream itself. 
By Walter Armstrong, The Fix
Posted on October 10, 2011

This week in its Science section The New York Times ran an article tantalizingly titled “An Addiction Vaccine, Tantalizingly Close.” The piece profiled the research of a pioneer in anti-addiction vaccines, Dr. Kim Janda, a professor at the prestigious California’s Scripps Research Institute.

Janda has been obsessively working on a vaccine against one addictive drug or another for some 25 years. He saw the concept of a vaccine against, say, cocaine or heroin as a no-brainer, “simplistically stupid,” he told the Times. Since vaccines had already proved they could for the immune system to mount antibody defenses against something as complex as a living virus, there was no reason to doubt that the same mechanism could neutralize a coke or smack molecule.

The Times quotes no less an addiction luminary than Dr. Nora Volkow, the neuroscientist director of the National Institute on Drug Abuse, who called Janda “a visionary” and expressed solid confidence that his trailblazing would eventually bring anti-addiction vaccines to the market, revolutionizing treatment. Endorsements don't come any better than that—and Janda has also enjoyed plenty of federal funding along the way.

In fact, he had little choice. Big Pharma long snubbed addiction vaccines—partly because vaccines tend to be one-shot products that earn chump change compared to the billions raked in by daily high-cholesterol pills, and partly because addiction is a marketer’s nightmare, involving as it does a stigmatized disease and a “criminal” market, no matter how big. Janda raised money from venture capitalists to advance his most promising vaccines into clinical trials, but the start-ups tanked when the vaccines failed.

Unfortunately, Janda has a slew of vaccine failures to show for his many years of single-minded dedication to the cause. He also has no successes—at least if success is defined as, say, an anti-nicotine vaccine on pharmacy shelves. In this respect, the “Tantalizingly Close” is so much happy talk. And one of the most striking things about the long Times piece is how skeptical—how downright negative and even nasty—the vast majority of the 60-plus readers’ responses were. From scientists and sobriety veterans alike, the consensus seemed almost to be that a vaccine for addiction was nothing but pie in the sky and therefore a fool’s errand. Also detectable was a subtle disapproval of the dream itself—a judgment that would be rightly condemned as bigoted if voice against a vax for AIDS or cancer.

This is all very curious. Anyone who reads the New York Times regularly, and even just scans the comments posted by readers, knows that these are people who, as odd as it may sound, think before they type. The discussions tend to be more informative, diverse and provocative than the articles themselves. But the readers of “An Addiction Vaccine, Tantalizingly Close” were an audience of all boos and raspberries. Yet surely many, if not most, of them would agree that addiction is, at least in part, a disease—a pathology in certain brain functions—that medical treatments (such as Chantix for nicotine addiction and Vivitrol for alcoholism) are beginning to emerge as tools, however blunt, in the multi-front battle against addiction.

There are currently more than 400 experimental vaccines against addictions in the pharmaceutical pipeline; few will ever make it far enough to be tested in humans, and of those that do, nine out of 10 will fail. Those are the odds of drug development. But hand it to Janda for first plowing the field—and more than that. Janda came up with the platform necessary to adapt the vaccine model to the daunting specifications of cocaine, nicotine, heroin, meth and other major substances.

The initial problem confronting Janda was that these drugs, once in the bloodstream, make terrible targets because they are way too small for the immune system to even detect them. Zoom—they fly straight to the brain. But Janda figured out a way to bulk up these minute molecules by attaching them to a big, fat, harmless protein, like a small plane flying a giant banner at the beach. In addition, Janda had to find the right mix of chemicals to create an adjuvant, which is an additional lure to get the immune system jumping. “It’s not like some magical premise,” the sweetly humble Janda told the Times. “And the beauty of it is you’re not messing with brain chemistry.”

(Alcohol and marijuana have so far baffled vaccinologists: ethanol is too miniscule to be manipulated, while pot’s active ingredient, THC, hides inside cells, invisible to antibodies.)
In July, Janda made news when he announced that an anti-heroin vax seemed to work in rat experiments, meaning it could move into safety trials for humans. Yet as the Times reported, “as has often been the case in Dr. Janda’s career, that breakthrough came on the heels of a setback: A Phase 2 clinical trial for a nicotine vaccine that was based largely on his work was declared a failure this summer.”

And so it goes for Janda, who estimates he has five to ten years left to realize his vision, his dream, of an effective anti-addiction vaccine. Yet a number of his experimental vaccines have worked well in small numbers of people—for example, an anti-coke vax helped some addicts in clinical trials either stay off the drug longer or, when they did use, feel like the high was too low to be worth the money.

And every day, Janda, like other leading researchers toiling on science’s margins to develop a vaccine for addictions, gets calls, emails, even visits from alcoholics or drug addicts (or their parents or doctors) who are desperate—even dying—to stick out their arm for a shot of an experimental vax and a shot at recovery. But unless you are already enrolled in one of the (small) clinical trials, tough luck.

But desperation day after day seems insufficient to squeeze a drop of compassion from the article’s readers’ hard hearts. Perhaps the reason is that “a shot a recovery” is not supposed to be as simple as “a shot in the arm.” For veterans of recovery, men and women with five, ten, twenty years of sobriety, who work the program faithfully, who know rock bottom in all its lurid detail, the prospect of a “magic bullet” is absurd. Yet no one expects an effective vaccine to be a magic bullet—it would probably offer partial protection against the effects of a drug and therefore remain but one of many weapons against what can otherwise be a terminal disease.

Scratch “one of many weapons” because there are actually only a few.Which is why the knee-jerk negativity of this addiction vaccine anti-claque is so unworthy of anyone in the so-called recovery community.

Here’s a sample of three comments coming from distinctly different areas of expertise:

"These studies betray a startling lack of understanding of the learned neurobiology of addiction. It does not take many exposures before the habits associated with drug consumption themselves acquire rewarding properties. It is not surprising that simply blocking the actions of nicotine would not substantially affect the habits of people who have been addicted to cigarettes for many years. Sorry, guys, but the brain had got to be messed with since it calls the shots."

"Behavior is multiply over determined as any clinician working in the trenches will recognize. Craving a high, an individual can overwhelm the blockade with super high doses of the abused substance, or can substitute another (alcohol for benzos), design another ("bath salts" and artificial cannabis are just two examples)."

"So while I have nothing but admiration for Dr. Nora Volkow, whose "name was dropped," what I see, in addicts "clamoring" for Dr. Janda's cure is nothing more than some very subtle enabling with a "meta message" that they can avoid abstinence-only programs where bluntness and tough love—and serious lifestyle changes—are de rigueur (the insurance companies decided long ago against long-term inpatient treatment, preferring cheaper outpatient programs)."

Wednesday, February 23, 2011

​ Feds Will Study Only 'Negative Consequences,' Not Medical Pot

 
Nearly two years ago, the Obama Administration issued its heralded "Scientific Integrity" memorandum which said "Science and the scientific process must inform and guide decisions of my Administration."

Coming, as pointed out by NORML's Paul Armentano at AlterNet, just months after the American Medical Association called for "facilitating ... clinical research and [the] development of cannabinoid-based medicines," the memorandum stoked the hopes of pot activists who want to see the commencement of long-overdue human studies into the safety and effectiveness of medical cannabis.

But that was before cold gray reality, also known as the National Institute on Drug Abuse (NIDA), weighed in. NIDA, which oversees 85 percent of the world's research on controlled substances, reaffirmed its longstanding policy of "no medical marijuana" to The New York Times

"As the National Institute on Drug Abuse, our focus is primarily on the negative consequencs of marijuana use," a spokesperson told the Times in 2010. "We generally do not fund research focused on the potential beneficial medical effects of marijuana."
 
This is the federal government's marijuana mindset, in a nutshell: That any use of marijuana is by definition "abuse"; therefore, we'll study only "negative consequences" and not medical benefits. It's a circular and hollow argument, but it still holds a lot of sway.

A review of the U.S. National Institute of Health website, clinicaltrials.gov, shows that NIDA's ban of medical marijuana research continues. Though an online search of ongoing FDA-approved clinical trial using the keyword "cannabinoids" (the active components in marijuana) yielded Armentano 65 hits worldwide, only six studies involved subjects' use of actual cannabis.

The other 59 studies used synthetic cannabinoid agonists like dronabinol or nabilone, the commercial marketed marijuana extract Sativex, or the cannabinoid receptor blocking agent Rimonabant, which keeps you from getting high.

So much for the AMA's request for clinical cannabis research.

On the other hand, preclinical (animal) trials of cannabinoids are continuing at a record pace, Armentano points out. 

Many of these studies highlight the ability of cannabinoids to manage a wide range of symptoms. But even more intriguing, Armentano points out, are the results indicating the potential to halt the development of serious diseases including cancer, diabetes and multiple sclerosis.

"Nevertheless, without abrupt changes at the highest levels of government -- changes that do not appear to be forthcoming despite this administration's public demand for 'scientific integrity' -- scientists will indefinitely lack the human follow-up data necessary to adequately answer societal questions regarding cannabis safety, efficacy and proper dosage," Armentano writes.