How tramadol, touted as safer opioid, became 3rd world peril

KAPURTHALA, INDIA (AP) – Reports rolled in with escalating urgency – pills seized by the truckload, pills swallowed by schoolchildren, pills in the pockets of dead terrorists.

These pills, the world has been told, are safer than the OxyContins, the Vicodins, the fentanyls that have wreaked so much devastation. But now they are the root of what the United Nations (UN) named “the other opioid crisis” – an epidemic featured in fewer headlines than the American one, as it rages through the planet’s most vulnerable countries.

Mass abuse of the opioid tramadol spans continents, from India to Africa to the Middle East, creating international havoc some experts blame on a loophole in narcotics regulation and a miscalculation of the drug’s danger. The man-made opioid was touted as a way to relieve pain with little risk of abuse. Unlike other opioids, tramadol flowed freely around the world, unburdened by international controls that track most dangerous drugs.

But abuse is now so rampant that some countries are asking international authorities to intervene.

Grunenthal, the German company that originally made the drug, is campaigning for the status quo, arguing that it’s largely illicit counterfeit pills causing problems. International regulations make narcotics difficult to get in countries with disorganised health systems, the company said, and adding tramadol to the list would deprive suffering patients access to any opioid at all.

“This is a huge public health dilemma,” said Secretary of the World Health Organization’s (WHO) committee, that recommends how drugs should be regulated, Dr Gilles Forte. Tramadol is available in war zones and impoverished nations because it is unregulated. But it is widely abused for the same exact reason. “It’s a really very complicated balance to strike.”

Tramadol has not been as deadly as other opioids, and the crisis isn’t killing with the ferocity of America’s struggle with the drugs. Still, individual governments from the United States (US) to Egypt to Ukraine have realised the drug’s dangers are greater than was believed and have worked to rein in the tramadol trade. The north Indian state of Punjab, the centre of India’s opioid epidemic, was the latest to crack down. The pills were everywhere, as legitimate medication sold in pharmacies, but also illicit counterfeits hawked by street vendors.

People walk past drugstores where tramadol was once easily accessible in Amritsar, in the northern Indian state of Punjab. PHOTOS: AP
A medic administers medicine to a recovering drug user at a de-addiction centre in Kapurthala
Recovering drug users perform yoga at a de-addiction centre in Kapurthala

This year, authorities seized hundreds of thousands of tablets, banned most pharmacy sales and shut down pill factories, pushing the price from 35 cents for a 10-pack to USD14. The government opened a network of treatment centres, fearing those who had become opioid addicted would resort to heroin out of desperation. Hordes of people rushed in, seeking help in managing excruciating withdrawal.

For some, tramadol had become as essential as food.

“Like if you don’t eat, you start to feel hungry. Similar is the case with not taking it,” said auto shop welder Deepak Arora, a gaunt 30-year-old who took 15 tablets day, so much he had to steal from his family to pay for pills. “You are like a dead person.”

Officer with the UN Office on Drugs and Crime Jeffery Bawa realised what was happening in 2016, when he travelled to Mali in western Africa, one of the poorest countries, gripped by civil war and terrorism. They asked people for their most pressing concerns. Most did not say hunger or violence. They said tramadol.

One woman said children stumble down the streets, high on the opioid; parents add it to tea to dull the ache of hunger. Nigerian officials said at a UN meeting on tramadol trafficking that the number of people there living with addiction is now far higher than the number with AIDS or HIV.

Tramadol is so pervasive in Cameroon, scientists a few years ago believed they’d discovered a natural version in tree roots. But it was not natural at all: Farmers bought pills and fed them to their cattle to ward off the effects of debilitating heat.

Their waste contaminated the soil, and the chemical seeped into the trees.

Police began finding pills on terrorists, who traffic it to fund their networks and take it to bolster their capacity for violence, Bawa said.

Most of it was coming from India. The country’s sprawling pharmaceutical industry is fuelled by cheap generics. Pill factories produce knock-offs and ship them in bulk around the world, in doses far exceeding medical limits.

In 2017, law enforcement reported that USD75 million worth of tramadol from India was confiscated en route to the Islamic State terror group. Authorities intercepted 600,000 tablets headed for Boko Haram. Another three million were found in a pickup truck in Niger, in boxes disguised with UN logos. The agency warned that tramadol was playing “a direct role in the destabilisation of the region”.

“We cannot let the situation get any further out of control,” that alert read. Grunenthal maintains that tramadol has a low risk of abuse; most of the pills causing trouble are knock-offs, not legitimate pharmaceuticals, and American surveys have shown lower levels of abuse than other prescription painkillers. The company submitted a report to the WHO in 2014, saying that the abuse evident in “a limited number of countries,” should be viewed “in the context of the political and social instabilities in the region.”

But some wealthy countries worried about increasing abuse also have acted to contain the drug.

The United Kingdom and United States both regulated it in 2014. Tramadol was uncontrolled in Denmark until 2017, when journalists asked doctors to review studies submitted to regulators to support the claim that it has a low risk for addiction, said Acting Director of the Nordic Cochrane Centre Dr Karsten Juhl Jorgensen and one of the physicians who analysed the materials.

They all agreed that the documents did not prove it’s safer.

“We know that opioids are some of the most addictive drugs on the face of the planet, so the claim that you’ve developed one that’s not addictive, that’s an extraordinary claim, and extraordinary claims require evidence. And it just wasn’t there,” said Jorgensen. “We’ve all been cheated, and people are angry about that.”

Jorgensen compares claims that tramadol is low risk to those made by American companies now facing thousands of lawsuits alleging misleading campaigns touting the safety of opioids unleashed the US addiction epidemic.

Chief at the International Narcotics Control Board Stefano Berterame said there is a critical difference: The crisis is not as deadly as the American one, which began with prescription opioids and transitioned to heroin and fentanyl.

Tramadol does not as routinely cause the respiratory depression that leads to overdose death.

But it is mostly afflicting poor nations, where overdose statistics are erratic, he said, so the true toll of tramadol is unknown.

The United Nations established the International Narcotics Control Board in 1961 to spare the world the “serious evil” of addiction. It has since tracked most opioids.