Tramadol, Billed as 'Safer' Opioid, Wreaks Worldwide Havoc – Courthouse News Service

Reports rolled in with escalating urgency — pills seized by the truckload, pills swallowed by schoolchildren, pills in the pockets of dead terrorists.
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 OxyContin, Vicodin and fentanyl, which have wreaked so much devastation. But now they are the root of what the United Nations 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 manmade 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Grunenthal, the German company that originally made the drug, is campaigning for the status quo, claiming that it’s largely illicit counterfeit pills causing problems. International regulations make narcotics difficult to get in countries with disorganized health systems, the company says, and adding tramadol to the list would deprive suffering patients access to any opioid at all.
“This is a huge public health dilemma,” said Dr. Gilles Forte, the secretary of the World Health Organization’s committee that recommends how drugs should be regulated. Tramadol is available in war zones and impoverished nations because it is unregulated. It is widely abused for the same reason. “It’s a really very complicated balance to strike,” Forte said.
Tramadol has not been as deadly as other opioids, and is not killing with the ferocity of America’s struggle with the drugs. Still, governments from the United States to Egypt to Ukraine have realized the drug’s dangers are greater than was believed and have tried to rein in the tramadol trade.
The north Indian state of Punjab, the center of India’s opioid epidemic, was the latest to crack down. The pills were everywhere, as legitimate medication sold in pharmacies, and as illicit counterfeits hawked by street vendors.
This year authorities seized hundreds of thousands of tablets, banned most pharmacy sales and shut down pill factories, pushing the price up fortyfold, from 35 cents for a 10-pack to $14. The government opened a network of treatment centers, fearing those who had become 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.”
Worldwide Effects
Jeffery Bawa, an officer with the United Nations Office on Drugs and Crime, realized what was happening in 2016, when he traveled to Mali in western Africa, one of the world’s 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 United Nations meeting on tramadol trafficking that the number of people there living with addiction is far higher than those with AIDS or HIV.
Tramadol is so pervasive in Cameroon that 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 comes from India. The country’s sprawling pharmaceutical industry is fueled by cheap generics. Pill factories produce knockoffs and ship them in bulk around the world, in doses far exceeding medical limits.
Rampant corruption in the Indian generic drug industry was exposed this year in a heavily researched book by U.S. author Katherine Eban, “Bottle of Lies: Ranbaxy and the Dark Side of Indian Pharma.” The book also revealed lax enforcement of drug purity by an industry-compliant U.S. Food and Drug Administration.
In 2017, law enforcement reported that $75 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 3 million were found in a pickup truck in Niger, in boxes disguised with U.N. logos. The agency warned that tramadol was playing “a direct role in the destabilization of the region.”
“We cannot let the situation get any further out of control,” that alert said.
Grunenthal claims that tramadol has a low risk of abuse; that most of the pills causing trouble are knockoffs, not legitimate pharmaceuticals; and that U.S. surveys have shown lower levels of abuse than other prescription painkillers.
But tramadol is available only by prescription in the United States, which limits possibilities of abuse.
Grunenthal 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 Dr. Karsten Juhl Jorgensen, acting director of the Nordic Cochrane Centre and one of the physicians who analyzed 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,” Jorgensen said. “We’ve all been cheated, and people are angry about that.”
Jorgensen compares claims that tramadol is low risk to those made by U.S. companies facing thousands of lawsuits that say misleading campaigns touting the safety of opioids unleashed the U.S. addiction epidemic.
Stefano Berterame, a chief at the International Narcotics Control Board, 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.
Tramadol’s Exemption
The United Nations established the International Narcotics Control Board in 1961 to spare the world the “serious evil” of addiction. It tracks most opioids.
Tramadol’s exemption means authorization is not required as the drug moves across borders. Its easy availability also leads to confusion about what tramadol even is, experts say.
In many countries, it is thought to be a mood enhancer or treatment for depression and post-traumatic stress. Some take it to improve sexual stamina or endure grueling labor.
Grunenthal synthesized tramadol in the 1960s, as the company was embroiled in scandal over its marketing of the sedative thalidomide, which caused extreme birth defects in thousands of babies whose mothers took it.
Tramadol was initially believed to have a low risk of abuse because initial trials studied injected tramadol, the most potent route for opioids. But researchers later found that tramadol releases a far more powerful dose taken orally because of how it is metabolized by the liver.
Tramadol’s worldwide market quickly expanded in the 1990s. In 2000, the World Health Organization, which assesses medications and recommends scheduling, found reports of dependence. A committee has reviewed the drug numerous times since, recommended it remain under surveillance but declined to add international regulation.
There is no alternative to tramadol, said Forte, the committee’s secretary. It is the only opioid available in some of the world’s most desperate places; relief organizations rely on it in war zones and natural disasters.
It is used extensively not because it is a particularly good medication, he said. The most effective opioid is morphine, but morphine is strictly controlled and countries in crisis fear abuse. Tramadol became the default precisely because it’s uncontrolled.
The WHO is analyzing whether any other drug could take its place but so far has found none. Forte said the agency is working with battered nations to ferret out counterfeits.
Legitimate tramadol remains a lucrative business: Market research estimates the global market comes to around $1.4 billion, according to Grunenthal. The medication long ago lost its patent protection. It is now manufactured by many companies and sold under some 500 brand names. Grunenthal markets it as Tramal as well as Zaldiar, tramadol combined with paracetamol. In 2018, those products brought in $191 million, according to the company’s annual report.
“Our purpose at Grunenthal is to develop and deliver medicines and solutions which address the unmet needs of patients with the goal of improving their quality of life,” the company said in a statement that said it acknowledges opioids pose a risk of abuse and addiction. “”We do so with the highest ethical standards.”
Grunenthal also sells other opioids and is expanding around the world. The Associated Press this year revealed that executives were swept up in an Italian corruption case alleging they illegally paid a doctor to promote the use of opioids.
The company campaigns to keep tramadol unregulated. It funded surveys that found regulation would impede pain treatment and paid consultants to travel to the WHO to make their case that it’s safer that other opioids.
Spokesman Stepan Kracala said regulation would not necessarily curtail illicit trade and could backfire, that some desperate pain patients turn to the black market if no legal options exist. Egypt’s long struggle with tramadol abuse is an example, he said. The country enacted strict regulation in 2012 and a later survey found some suffering from cancer using counterfeit tramadol for relief.
Kracala also cited regulatory decisions as proof of tramadol’s comparable safety: The United States in 2014 added tramadol to its list of controlled substances but included it in a lesser category than opioids like oxycodone or morphine, signaling it is less risky.
There are growing calls to change that.
The Mayo Clinic hospital in Minnesota worked to reduce opioids prescribed post-surgery as the U.S. epidemic escalated, said surgeon Cornelius Thiels. Doctors there started shifting patients to tramadol because it was billed as safer. But Thiels and his colleagues analyzed prescription data and were surprised to find patients prescribed tramadol were just as likely to move on to long-term use.
They published their findings this year to alert authorities, he said: “There is no safe opioid. Tramadol is not a safe alternative. It’s a mistake that we didn’t figure it out sooner. It’s unfortunate that it took us this long. There’s a lot more that we need to learn about it, but I think we know enough that we also can’t wait around to act on this.”
The Indian Nexus
Indian regulators knew the massive quantities manufactured in the country were spilling over domestically and that countless Indians were addicted. But S.K. Jha, responsible for the northern region of India’s Narcotics Control Bureau, said he was shocked to learn in 2018 that tramadol from India was ravaging African nations. They realized then they needed to act, he said.
India regulated tramadol in April 2018. Regulators say exports overseas and abuse at home came down. But they acknowledge that the vastness of the pharmaceutical industry and the ingenuity of traffickers makes curtailing abuse and illegal exports all but impossible. Tramadol is still easy to find.
Jyoti Rani stood on her front steps and pointed to house after house where she said tramadol is sold in her neighborhood of narrow roads and open drains, where school-age boys sit hunched over the street in the middle of a weekday.
Rani’s addiction began with heroin. When her 14-year-old son died, she fell into depression.
“I wanted to kill myself, but I ended up becoming an addict,” she said, weeping.
A doctor prescribed tramadol to help kick the habit — instead, she formed a new one. She locked herself in her room, not eating or taking care of her two children. Rani used tramadol until she ran out of money and entered treatment. Now her family tells her she’s her old self again.
The crackdown on tramadol coincided with the opening of dozens of addiction clinics that administer medicine and counseling to more than 30,000 Indians each day.
“We are trying our level best,” Jha said, “but it’s a challenge for all of us.”
Countries’ efforts to control tramadol often fail, particularly in places where addiction has taken hold, according to the Center for Strategic and International Studies.
India has twice the global average of illicit opiate consumption. Researchers estimate 4 million Indians use heroin or other opioids, and a quarter of them live in the Punjab, India’s agricultural heartland bordering Pakistan, where some of the most vulnerable are driven to drugs out of desperation.
Amandeep Kaur was pregnant when her husband died of a heart attack. She turned to the sex trade to make ends meet. She wanted not to feel, and a fellow sex worker suggested tramadol. She had no idea she’d get addicted, but eventually needed three pills to get through the day.
“If I didn’t have it I felt lifeless, my body ached as if I was going to die,” she said, and joined the line stretching from the addiction clinic’s doors.
(Courthouse News contributed to this report.)
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