Pharmaceuticals

Why aren’t there more ways to treat alcoholism?

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News organizations were quick to trumpet the recent findings of a small study suggesting that “magic mushrooms” could be part of a breakthrough treatment for alcoholism.

It’s no wonder. Every year, alcohol abuse kills more than 140,000 Americans and affects millions more, with a steep increase in deaths in recent years, according to data published by the Centers for Disease Control and Prevention on Nov. 4. But excitement about the psilocybin study also raises a question: Why aren’t there more medical treatments for such an obviously devastating problem?

“There is a desperate need for new medications, and there are many good avenues that we’re pursuing,” said Dorit Ron, a neurology professor at the University of California at San Francisco Medical Center, who has been studying potential treatments that include rapamycin, a drug designed to help transplant patients tolerate new organs.

But getting promising new medications into the hands of doctors and their patients has proved difficult, said George Koob, director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), adding “it doesn’t go for lack of trying.”

Lack of awareness by doctors, funding decisions by the pharmaceutical industry and the stigma surrounding alcoholism have all held up progress, he said.

Ron and other researchers say medication can play a vital role in combating alcohol use disorder, the medical condition commonly known as alcoholism. But fewer than 2 percent of people with an alcohol addiction take medication for the condition, national surveys show, compared with 13.4 percent of those dealing with opioid addiction.

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A possible contributing factor is that existing treatments are limited. Since 1949, the Food and Drug Administration has approved just three medications to treat heavy drinking, none of which is commonly used. Nor are several medications that doctors sometimes prescribe “off label” — without FDA approval for use as an alcoholism treatment — including gabapentin, baclofen, topiramate and ondansetron.

Several researchers said problems with the existing FDA-approved medications, including limited efficacy, play into undertreatment.

Acamprosate, which can dull cravings in patients who have already stopped drinking, must be taken three times a day and cannot be used by people with kidney problems. Naltrexone, designed to block the pleasure of drinking, can block the pleasure of other activities, such as eating, and cannot be used by those with liver failure, which frequently accompanies alcohol abuse disorder. Disulfiram, marketed as Antabuse, can cause headaches, nausea, choking and vomiting following consumption of even small amounts of alcohol.

“I tried them all,” said Jon Kostas, 32, who took his first drink at age 13 and was drinking so heavily by age 25 that doctors warned him he might not live until 30. “Nothing worked.”

Desperate for another answer, Kostas, who today runs a nonprofit group advocating research into medical uses of psychedelics, was one of the first patients to join the psilocybin study, results of which were published in August in JAMA.

Researchers led by Michael Bogenschutz, the director of the NYU Langone Center for Psychedelic Medicine, studied 93 people diagnosed with alcohol use disorder. Those who received two doses of psilocybin reduced their alcohol consumption by 83 percent within eight months, compared with 51 percent of those who received a placebo.

Twenty-five percent, including Kostas, who first received psilocybin in 2015, stopped drinking altogether, the study says, compared with 9 percent who took the placebo.

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All the participants received an extraordinary amount of psychotherapy: 12 outpatient sessions, each lasting an hour to 90 minutes, plus two all-day sessions for those who took the drug. This was key both to ensure patients’ safety while experiencing an altered state of reality and to provide maximum benefit, Bogenschutz said.

While it’s still unknown precisely how the psilocybin helps, it may work by magnifying the effect of the therapy, such that “the person who has taken the drug becomes more open … and more flexible and willing to learn new behaviors and patterns,” he added.

The three FDA-approved drugs could help many more people if doctors only knew they existed, said Koob, adding: “I dare you to ask any primary care doctor to name even one of them.”

In its ongoing efforts to address this problem, Koob said, the NIAAA this year launched an online educational program, “The Healthcare Professional’s Core Resource on Alcohol,” that offers continuing education credits on topics including alcohol’s clinical effects and strategies for prevention and treatment.

Patients may be even more in the dark about medications than their doctors.

Unlike drugs for depression, cancer and erectile dysfunction, medications for alcoholism are not abundantly promoted on television or in magazines, even as ads for alcohol and positive portrayals of drinking abound.

“A lot of people still think all you can do is go to rehab for 28 days and then [Alcoholics Anonymous] for the rest of your life,” Bogenschutz said. Surveys suggest many patients are reluctant to do that, with fewer than 6 percent of those with alcohol use disorder getting treatment of any kind.

The stigma surrounding someone’s lack of control with alcohol can also make both patients and doctors hesitant to discuss treatment, Koob said.

But yet another factor is lack of interest by the large pharmaceutical firms that once paid for many of the costly trials needed for FDA approval of psychiatric drugs, including those for addiction, Koob added. This is a particular problem, he said, with repurposed drugs such as gabapentin and rapamycin that have shown promise in treating alcoholism in trials but which have expired patents, making them less lucrative to sell.

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Andrew Powaleny, a spokesman for PhRMA, a lobbying association for major pharmaceutical firms, took issue with Koob’s characterization. Powaleny shared a 2019 report showing that biopharmaceutical research firms were developing 138 medicines to treat mental illness, including six for excessive drinking. As of mid-September, Powaleny said, the number of alcohol use disorder medications in development had risen to 17.

Regardless, Ron said she has not heard from pharmaceutical firms interested in furthering her research, even as news reports on her studies of existing drugs have generated letters from people seeking to join clinical trials.

Ron and other researchers continue to hope their work will one day make a meaningful difference. Meanwhile, the CDC estimates that excessive drinking cost the United States almost a quarter-trillion dollars as far back as 2010.

“We may have a current epidemic of opioid use, but our alcohol use disorder has been of epidemic proportions for thousands of years,” said Susan E. Bergeson, editor in chief of the Alcoholism Treatment Quarterly and a professor of women’s health at Texas Tech University Health Science Center.

“I think the pharmaceutical firms must be interested in this market and are just waiting for the right approach with lower risks,” said Bergeson, who has received $7.5 million in federal funding to study how a molecule derived from the antibiotic tetracycline might be used to reduce drinking.

After testing it on alcohol-loving pigs, which subsequently preferred to drink water when offered both options, she is applying for FDA approval of human trials and has also applied for patents that will be owned by Texas Tech. “I am grateful to be on the cusp of something this productive,” Bergeson said.

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