The fight over a drug that’s great for horses but terrible for humans

Penny, a 3-year-old chestnut mare with a white blaze, had been drooling over her food and struggling with her teeth, signs of a likely toothache. An examination confirmed that she had to have two wolf teeth extracted and the sharp edges of some molars ground down, procedures that required opening her jaws with a speculum.

To protect Penny from pain and to protect himself from being kicked by a horse that weighed him ten times, Boyd Spratling, Penny’s veterinarian, gave her an injection of xylazine, a common animal tranquilizer. Within moments her long neck drooped and her eyelids fluttered to half-staff. Forty-five minutes later, after dental surgery, Penny strolled out of the clinic in rural Nevada and into her trailer.

for dr Spratling uses xylazine, an essential analgesic and tranquilizer, which he also occasionally uses on cattle for procedures such as caesarean sections in cows and penile injury repairs in bulls. It’s also a staple for zoo veterinarians.

But in recent years, the drug has also morphed into something else: a cheap, addictive adulterant to illicit fentanyl that’s contributing to the rise in overdose deaths across the country. The xylazine-fentanyl combination, known in the drug trade as “tranq-dope,” is a life-threatening compound that lowers breathing, heart rate and blood pressure and can cause blackened, chemical burn-like flesh wounds that can lead to amputation.

In a xylazine alert in March, the Drug Enforcement Administration said it had detected the drug in nearly a quarter of fentanyl samples seized in 48 states by 2022.

Last week, the White House Office of National Drug Control Policy classified the drug mix as an “emerging drug threat,” a classification that requires the office to create a government-wide response plan. Dealing with the threat, however, is proving to be a tricky balancing act involving stakeholders in fields as diverse as addiction medicine, livestock farming and law enforcement. The challenge is to walk a diligent path by managing a drug that is essential for veterinarians but is fueling a public health crisis.

Law enforcement officials are pushing for xylazine to be listed as a controlled substance, which would criminalize distribution for human use. At this time, police cannot arrest anyone for the sale or distribution of Xylazine. Your resources to track down its production are modest. A controlled substance designation would make a crucial difference, law enforcement officials said.

However, veterinarians fear that if they did, their access to the drug would be heavily regulated. They would have to keep separate logs for federal control. Even more worrisome, manufacturing a classified drug would require additional quality control and safety measures that are so costly that a manufacturer could increase the price of the drug or discontinue it altogether.

“When we first heard on the news that xylazine had been mixed with fentanyl, we were horrified,” said Dr. Spratling storing his xylazine in a double sealed container.

But, he added, “let’s not shoot from the hip because then the people who are really paying the regulatory price are paying, the ones who have been using it responsibly all along.”

Some addiction medicine professionals and harm reduction groups have other concerns. They fear new tough restrictions could trigger a domino effect like the one that contributed to the fentanyl crisis, including criminal charges against people with addiction problems.

Approving a drug for listing as a federally controlled substance can be done either by Congress or jointly by the Food and Drug Administration and the DEA

A state may also list the drug. On Tuesday, Gov. Josh Shapiro of Pennsylvania, where the Kensington neighborhood of Philadelphia is ground zero for narcotics, announced his administration would do so.

A spokesman for the governor, Manuel Bonder, said Mr Shapiro decided to proceed with the appointment “instead of waiting for future opportunities in DC.”

Xylazine was approved by the FDA for use in veterinary medicine in 1972. Since then it has been used for procedures on sheep, deer, elk and even cats and dogs, as well as horses and cattle. Previous human trials had been halted because the drug caused respiratory depression, so manufacturers never applied for approval for human use. So far, there has been no incentive to research the effect on humans. Its causal connection with the flesh wounds that can result from its use has not been clarified. And unlike the protocols for opioids, the protocols for reversing narcotic withdrawal or managing rehabilitation are not standardized.

Last month, a bipartisan bill introduced in both houses of Congress by members from rural states — including Nevada, Iowa, New Hampshire, California, Florida, Texas and Colorado — offered a compromise. Instead of listing xylazine as a controlled substance, the bill proposes that a person who uses it for “illegal” purposes — selling or distributing it for human consumption — faces the same penalties as if it were listed as a Schedule III drug , including fines of up to $500,000 and an initial sentence of up to 10 years in prison.

Controlled substances are classified according to medical necessity and potential for abuse and addiction. Schedule III includes buprenorphine, the drug used to treat opioid use disorders. In comparison, Schedule I contains heroin and Schedule II LSD contains oxycodone and fentanyl, which can be prescribed for pain.

Lawmakers said that path represents a hard-fought middle ground for bipartisan approval and, they hope, a fast track to passage.

“We need to make sure we make it illegal for human use because of the devastating effects we’re seeing, but I also know they need to be able to treat their horses and large animals with this drug,” the senator said Catherine Cortez Masto, a Nevada Democrat, who introduced the bill with Sen. Chuck Grassley, a Republican from Iowa, and Sen. Maggie Hassan, a Democrat from New Hampshire.

Her bill was supported by veterinary, rancher and police associations. If it goes into effect, manufacturers would need to improve xylazine records and send follow-up reports to a DEA database. Law enforcement officials could pursue merchants.

But it exempts the legal use of xylazine for “administration to non-human species.” With this spin-off, veterinarians would not be subject to the restrictions of a controlled substance.

Typically, domestic veterinary grade xylazine comes as a liquid in a vial, while bulk xylazine appears as a cheaper powder that may be imported. The FDA has already announced that it will increase surveillance of imported xylazine.

Beau Kilmer, co-director of the RAND Drug Policy Research Center, said, “It’s important to know where xylazine is mixed. The DEA reports finding empty xylazine bottles in US stash houses, so there is some mixing going on here, but in the US does mixing make up the majority or minority of cases?”

At this point, however, it is unclear what impact the planning would actually have on human consumption and health.

Many harm reduction groups and drug policy experts question the long-term effectiveness of scheduling xylazine.

The recent history of efforts to tighten controls on prescription painkillers underscores some of their concerns. As federal and state agencies imposed tight controls on prescription opioids, drug dealers and people who use drugs switched to illegal opioids — heroin, counterfeit pills, and illegal fentanyl. Many people arrested as sellers are themselves addicted to these drugs.

Maritza Perez Medina, the director of federal affairs for the Drug Policy Alliance, a nonprofit harm reduction organization, said she was concerned that criminalizing xylazine would not substantially solve its problems. “Put simply, raids put us in a game of whack-a-mole. When we try to eradicate one drug, a new one emerges.”

Xylazine emerged sporadically as an addictive substitute for heroin in the 2000s: In 2011, a study observed that people in agricultural areas of Puerto Rico were injecting equine anesthetics and developing severe lesions.

Around 2006, the drug was found in the Kensington neighborhood of Philadelphia, which has a sizeable Puerto Rican population. Its use there began to escalate around 2018, after which it spread throughout the Northeast, following the path of fentanyl.

Addiction physicians said their main concern is to reduce the health risks posed by xylazine. They urged that newly introduced xylazine test strips, which people can use to check the drugs they are buying, be as widely available as fentanyl test strips.

But dr Joseph D’Orazio, the chief of medical toxicology and addiction medicine at Temple University Hospital in Philadelphia, which has treated hundreds of patients for the effects of narcotics, says street drugs are mixed with so many different additives that tests can even be done on strips are not enough to save lives.

He said the immediate focus should be on developing better treatments to manage acute xylazine withdrawal. “So many patients avoid or discontinue treatment because our current medications are insufficient to combat the doses of fentanyl and xylazine found on the street.”

dr For his part, Spratling remains horrified by the wildfire that Xylazine has become. “I have been using Xylazine for 45 years and have never seen the skin ulcers and lesions on a horse that humans get. It’s terrible. I’m speechless,” he said.

Penny, the filly, not only jumped back from her xylazine shot, but also made a quick recovery from her dental surgery. Her spirits and mouth healed, she did well at a local stock horse competition in the county a few weeks ago.

But dr Spratling, who uses Xylazine for procedures at least half a dozen times a week, is restless. He said if the government regulated the drug for him and his colleagues, many veterinarians would have an easy answer. “They’ll just stop using it,” he said.