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Under My Tongue 

The new face of the anti-addiction drug buprenorphine — safer, easier and FDA-approved

Thursday, Aug 21 2003
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Illustrations by Daniel Peacock

For almost as long as people have been chasing the dragon, people have been trying to slay it as well. The list of heroin-addiction cures comes in all forms. Urban legend says light-bulb inventor Thomas Alva Edison came up with a multispiced detox wonder called either “Poly-Form” or “Golden Liquid Beef Tonic,” the historical records being a little unclear. Just past the turn of the 19th century, two New York doctors, Alexander Lambert and Charles Towns, doled out a wondrous concoction containing the poisonous plant belladonna, among other things. There was a pre–World War II eugenic program designed to weed out the junkie bad seeds, which sounds mildly similar to the warehousing of addicts via government-approved methadone clinics or the recent suggestion that the ingestion of Tetrodotoxin, the toxin found in puffer fish, could work as well. And last year, on October 9, the FDA approved a new potion, the drug buprenorphine, for the treatment of heroin addiction.

Buprenorphine didn’t start out as a heroin cure-all. It was discovered 30 years ago at a time when drug companies were rushing to fill the pharmacological gap that existed between mild analgesics like codeine and hardcore painkillers like Percocet. Buprenorphine is a wonderful dampener with an analgesic potency 20 to 30 times stronger than morphine. For this purpose, it was first sold in the United States as an injectable, under the brand name Buprenex.

But before Buprenex was allowed onto the market, the FDA ordered a series of abuse liability tests, required by the DEA to ensure that any drugs capable of becoming recreationally abused are not. The results were startling. First published in a 1978 issue of The Archives of General Psychology, they showed that buprenorphine — a derivative of thebaine, a major constituent of opium — is a narcotic agonist-antagonist, a partial agonist or an “opioid partial agonist.” Buprenorphine is more powerful than heroin — not in terms of high, but in terms of chemistry — and it binds to the same receptors in an addict’s brain that opium uses. So if you’re taking buprenorphine, heroin won’t work. Unlike methadone, which can be (and often is) teamed up with heroin and taken as a speedball, buprenorphine doesn’t cocktail.

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Buprenorphine does produce an opiate euphoria, but the high is so mild it’s barely perceptible. “When the initial drug studies were done,” says Dr. Frank Bocci, of the National Institute on Drug Abuse (NIDA), “the first five test subjects couldn’t tell the difference between buprenorphine and a placebo.” But it is still an opiate, which means that after an addict switches from heroin to buprenorphine, all the nasty side effects associated with dope withdrawal are taken care of. And as far as detoxing off buprenorphine is concerned, there are still symptoms, but according to one ex-addict I talked to, Gary, the side effects are “about 5 percent of what heroin detox feels like.”

 

Gary would know. He spent eight years shooting smack and three and a half years trying to get clean on methadone. Neither worked. In fact, methadone was worse. “There’s no way to have a life with methadone. The high is way too heavy. It’s incapacitating. And it’s so much harder to kick than heroin. The withdrawal is much more treacherous.” Making matters even worse, Gary was still binging on speedballs, the meth-smack dynamic duo that many addicts end up turning toward to satisfy their need. Then, in the mid-’80s, he had what he refers to as “a moment of clarity” while watching his father die of cancer, and decided to do whatever it took to get clean.

“I heard about this guy — Dr. Howard Mark,” says Gary. “He was an L.A.-based medical doctor who owned some kind of medical-equipment company that had gone under and was looking for some easy cash. He stumbled across the Buprenex research and started treating addicts. He would charge $1,000 for the first visit, and then he would sell you Buprenex and clean needles. It didn’t matter to me. The stuff worked. I took Buprenex for about two years, I got off heroin and got my life back.”

Unfortunately, things didn’t go so well for Dr. Mark. In 1989, Jason McCallum, the adopted son of actress Jill Ireland and actor David McCallum, died while trying to detox under Mark’s care. He was cocktailing buprenorphine with other downers and went into respiratory failure — a danger that still exists today. Mark lost his license to prescribe controlled substances and died a few years ago.

One of the stumbling blocks to bringing buprenorphine to market was the lethal reputation it earned as the cause of McCallum’s well-publicized death. Still, the fact remains that buprenorphine works, and the risks are far less than the risks of methadone. The FDA knew all this almost 30 years ago. So what took them so long?

“There was a lot of legislation to overcome,” says Bocci. “The Harrison Narcotic Act of 1914 says that physicians can only prescribe opiates for the treatment of medical disorders. This was followed up by U.S. v. Webb in 1919, which said opiate addiction wasn’t a medical disorder. This is why methadone isn’t prescribed — it’s dispersed.”

 

In 2000, President Clinton signed the Drug Addiction Treatment Act, which reverses earlier decisions and permits physicians (who meet certain qualifications) to prescribe FDA-approved Schedule III, IV and V narcotic medications for the treatment of opiate addiction. This means that specially trained doctors (mainly psychiatrists) in the United States will now be able to treat patients in the privacy of their offices rather than making them suffer through the methadone circus, clearing the way for doctors to begin prescribing buprenorphine. Currently, in California, there are 175 doctors who have taken the required training. (To find them, go to http://buprenorphine.samhsa.gov/ and click on the “physician locator” tab.)

Also significant to the FDA approval process was the development of a non-injectable, and therefore less risky, version of buprenorphine, the result of a 10-year joint effort between Reckitt Benckiser, an English household-products company with a side business in pharmaceuticals, and the NIDA. Together they developed two different buprenorphine sublinguals (they’re dissolved under the tongue), Subutex and Suboxone.

The main difference between the two versions is that Subutex is pure buprenorphine, while Suboxone combines the opiate with Naloxone, which is a pure opiate antagonist (it’s what smack addicts get injected with when they end up in the emergency room). “If someone tries to crush the Suboxone and shoot it up,” says Dr. Anne Linton, who runs the Betty Ford Center and assisted with the early buprenorphine research, “they’re going to immediately find themselves sober and going into withdrawal.”

In these new formulas, buprenorphine is now much less of a liability; some health professionals predict it will make methadone obsolete. To others, however, there is still reason to worry. “I’m always concerned about supposed miracle cures,” says Joycelyn Woods, president of the National Alliance of Methadone Advocates. “You want to know why it took so long to get buprenorphine on the market here? It was introduced as a heroin cure in India, France and Scotland. These are countries where they don’t have methadone programs, but now they have buprenorphine addicts. The DEA knew about that and was trying to find a safer version. This is what they’ve come up with. We’ll see if it works.”

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