“There’s a desperate need for new drugs, and there’s a lot of good leads we’re pursuing,” said Dorit Ron, professor of neurology at the University of California San Francisco Medical Center, who has studied potential treatments. which include rapamycin. , a drug designed to help transplant patients tolerate new organs.
But getting promising new drugs into the hands of doctors and their patients has proven difficult, said George Koob, director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), adding that ” it won’t go for lack of trying”.
Lack of awareness among doctors, funding decisions by the pharmaceutical industry and stigma surrounding alcoholism have all held back progress, he said.
Ron and other researchers say drugs can play a vital role in combating alcohol use disorder, the medical condition commonly referred to as alcoholism. But less than 2% of people with alcohol addiction take medication for the condition, according to national surveys, compared to 13.4% of those with opioid addiction.
A possible contributing factor is that existing treatments are limited. Since 1949, the Food and Drug Administration has only approved three drugs to treat heavy drinking, none of which are commonly used. Nor are there several drugs that doctors sometimes prescribe “off-label” – without FDA approval for use as a treatment for alcoholism – including gabapentin, baclofen, topiramate and ondansetron.
Several researchers said problems with existing FDA-approved drugs, including limited efficacy, played a role in undertreatment.
Acamprosate, which can reduce food cravings in patients who have already quit 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 people with impaired liver function, which frequently accompanies drug abuse disorders. ‘alcohol. Disulfiram, marketed as Antabuse, can cause headaches, nausea, choking, and vomiting after consuming even small amounts of alcohol.
“I’ve tried them all,” said Jon Kostas, 32, who had his first drink at 13 and was drinking so much at 25 that doctors warned him he might not live to see his 30s . “Nothing worked.”
Desperate for another answer, Kostas, who now heads a nonprofit group advocating research into the medical uses of psychedelics, was one of the first patients to join the psilocybin study, the results of which were published in August in JAMA.
Researchers led by Michael Bogenschutz, 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% over eight months, compared with 51% of those who received a placebo.
According to the study, 25%, including Kostas, who was first given psilocybin in 2015, quit drinking altogether, compared to 9% who took the placebo.
All participants received an extraordinary amount of psychotherapy: 12 outpatient sessions, each lasting from one hour to 90 minutes, plus two full-day sessions for those who took the drug. This was essential both to keep patients safe while experiencing an altered state of reality and to provide maximum benefit, Bogenschutz said.
Although it’s not clear exactly how psilocybin helps, it may work by amplifying the effect of therapy, so 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 only doctors knew they existed, Koob said, adding, “I defy you to ask any primary care doctor to name any of them. -what a.”
In its ongoing efforts to address this issue, Koob said, the NIAAA this year launched an online educational program, “The Healthcare Professional’s Core Resource on Alcohol,” which offers continuing education credits on topics such as clinical effects. alcohol and prevention and treatment strategies.
Patients may be even more in the dark about drugs than their doctors.
Unlike drugs for depression, cancer, and erectile dysfunction, drugs for alcoholism are not heavily promoted on television or in magazines, even though alcohol advertisements and positive portrayals of alcohol consumption alcohol abound.
“A lot of people still think that 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 that many patients are reluctant to do so, with less than 6% of those with alcohol use disorders receiving treatment of any kind.
Stigma surrounding a person’s lack of control over alcohol can also make patients and doctors hesitant to discuss treatment, Koob said.
But another factor is the lack of interest from big pharma, which once paid for the many expensive 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 whose patents have expired, which makes them less lucrative to sell.
Andrew Powaleny, spokesman for PhRMA, a lobbying association for big pharma, disputed Koob’s characterization. Powaleny shared a 2019 report showing research-based biopharmaceutical companies were developing 138 drugs to treat mental illness, including six for heavy drinking. By mid-September, Powaleny said, the number of alcohol use disorder drugs in development had risen to 17.
Either way, Ron said she hasn’t heard of any drug companies interested in continuing her research, even though news stories about her studies of existing drugs have generated letters from people wanting to take part in trials. clinics.
Ron and other researchers continue to hope that their work will one day make a meaningful difference. Meanwhile, the CDC estimates that excessive alcohol consumption cost the United States nearly a quarter of a trillion dollars as early as 2010.
“We may have a current epidemic of opioid use, but our alcohol use disorder has been at epidemic proportions for thousands of years,” said Susan E. Bergeson, editor of Alcoholism Treatment. Quarterly and Professor of Women’s Health at Texas Tech. University Center for Health Sciences.
“I think pharma companies need to look at this market and are just waiting for the right approach with less risk,” Bergeson said, which received $7.5 million in federal funding to study how a molecule derived from the antibiotic tetracycline could be used to reduce alcohol consumption.
After testing it on alcohol-loving pigs, which then preferred to drink water when offered both options, she seeks FDA approval for human trials and also asked patents that will belong to Texas Tech. “I’m grateful to be on the cusp of something so productive,” Bergeson said.
