Can Science Make Alcohol Safer?

The scion of an Indian pharmaceutical giant spent $35 million to make your martini more liver-friendly. But regulators aren’t raising their glasses just yet.

Source: WSJ

By Heidi Mitchell

March 14, 2018

As the son of the founder of Granules India Ltd. , one of the world’s largest manufacturers of off-patent drugs, Harsha Chigurupati saw the damage that pain relievers like acetaminophen can do to the liver. He watched as scientists at Granules sought to mitigate those effects using additives. In 2002, he left Hyderabad, India, for Boston University and, after a night of drinking, woke up with a headache and an idea.

“I don’t believe in abstinence,” says Chigurupati, who, at 33 years old, still looks young enough to get carded. “What I do believe in is using technology to make life better. I’m not going to stop drinking, so why not make it safer?”

After graduation, Chigurupati spent 12 years and $35 million to create a compound that, he says, helps protect against the liver and DNA damage caused by drinking. In 2006, he hired six biopharmacologists to comb through the ingredients that the Food and Drug Administration deems safe to consume. By 2013, they settled on a three-ingredient formula: potassium sorbate, glycyrrhizin and mannitol, an anti-inflammatory derived from licorice root. Chigurupati created a company (Chigurupati Technologies) and named his compound NTX-short for “no-tox.” Compared with rats given plain vodka, rats given NTX-infused vodka showed a 40% to 70% reduction of biomarkers known to indicate liver damage, according to studies funded by Chigurupati.

Human trials, also funded by Chigurupati, began in 2013. In a study conducted by a California research team, biomarkers that presage liver damage were 93% lower for human participants who got drunk on NTX-infused vodka versus those who drank plain vodka. Later studies showed that NTX-infused vodka reduced the amount of DNA damage caused by drinking.

Later that year, Chigurupati joined with Bellion, a Secaucus, N.J.-based spirits brand, to infuse its vodka with NTX just after distillation. He hoped to upend the liquor industry with a new category called “functional spirits,” a term he trademarked, and envisioned labels informing the public of NTX’s reputed health benefits. The agency that regulates such claims is the U.S. Alcohol and Tobacco Tax and Trade Bureau, or TTB. Chigurupati assumed that TTB approval for his health claims would not come easily. But he set up a meeting anyway and walked in armed with his own research and more than 100 independent studies and articles by researchers from around the world showing that the key ingredients in NTX mitigated liver damage and oxidative stress. He was hopeful that the agency would give the green light to a health-claim label for his high-tech vodka.

He was wrong.

The TTB rejected his petition citing, among other things, the concern that Americans might confuse NTX with Naltrexone, a medication commonly used to manage alcohol and opioid addiction. Jonathan Emord, a lawyer Chigurupati hired in 2014, petitioned the TTB, and the agency eventually allowed Bellion to put a rubber ring stating “Made with NTX” around each bottle. But Bellion was forbidden to say what NTX is or purports to do.

Undeterred, Chigurupati kept funding studies and kept petitioning. In 2016, he hired Sid Stohs, a toxicologist and former dean of the School of Pharmacy and Health Professions at Creighton University, to conduct more research and help prepare the next petition to the TTB, this time for labels with up to eight health claims. In May, the TTB rejected Chigurupati again. According to the agency, “the proposed labeling and advertising statements create a misleading impression that consumption of alcohol beverages infused with NTX will protect consumers from certain serious health risks associated with both moderate and heavy levels of alcohol consumption.” Claiming that NTX “reduces the risk of alcohol-induced liver diseases,” for instance, could distract consumers from the health risks NTX doesn’t protect against (addiction, birth defects) and also from the fact that drinking NTX-infused vodka still raises one’s risk for liver diseases, even if less so than its unadulterated counterparts.

Stohs says that the science is sound but that no amount of studies would sway the TTB. Asked for comment, TTB Director of Congressional and Public Affairs Tom Hogue wrote in an email: “The timeline and characterizations fail to accurately represent the entirety of our interactions with the petitioners on this matter and TTB declines your invitation to comment specifically on the timeline or the characterizations.”

He referred to the agency’s 47-page response to Bellion and Chigurupati, available online.

Liver experts have other concerns. Ramon Bataller, a professor at the University of Pittsburgh and a liver physician with the American Association for the Study of Liver Diseases, says that the science behind NTX is promising, but he worries about the diuretic effects of mannitol, which is given to people with brain edema in a coma to reduce intracranial pressure. Other hepatologists reiterate some of the TTB’s concerns: that the data are still preliminary and don’t address long-term effects.

They’re waiting for larger and longer independent studies before passing judgment.

Emord, Chigurupati’s lawyer, says that because NTX is an additive, not a drug, with scientific studies showing its protective benefits, his client has a First Amendment right to make health claims on his bottles, and he may soon have his day in court.

Neither liver experts nor the TTB claim that NTX-infused vodka is less healthy to drink than traditional booze, and Bellion is currently available in 11 states at both bars and restaurants, with a larger rollout planned for 2018.

Chigurupati, meanwhile, is working with Bellion to create NTX-infused tequila, gin and bourbon, which he hopes to release next year as well. With or without the TTB’s explicit approval, Chigurupati plans to continue his quest to make alcohol safer and laments the lack of progress so far.

“How is it,” he asks, “that despite centuries of technological advancements, alcohol has the same safety profile that it did before the lightbulb was discovered?”

One possible reason: An effort that spanned more than a decade and cost tens of million of dollars has left regulators unconvinced.