The World Sees The Rise Of A Different Kind Of Opioid Crisis

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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 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the German company that originally made the drug, is campaigning for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 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. 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 U.S. to Egypt to Ukraine have realized 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 center 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.

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 $14. The government opened a network of treatment
centers, 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.”

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 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 fueled 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 $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 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 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,” 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 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.

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.

Tramadol’s exemption means authorization
isn’t 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 most 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 WHO, which
assesses medications and recommends scheduling, noted 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 have so far found none. Meanwhile, 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 amounts 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 174 million euros ($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
wrote 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 executives were swept up in an
Italian corruption case alleging they illegally paid a doctor to promote
the use of opioids.

The company has campaigned 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: 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 pointed to regulatory decisions as proof
of tramadol’s comparable safety: The U.S. 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 American 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.”

Indian
regulators knew the massive quantities manufactured in the country were
spilling over domestically and 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 still sold in her neighborhood of narrow roads and open drains,
where school-aged 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 cried. 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
each day.

“We are trying our level best,” Jha said, “but it’s a challenge for all of us.”

Countries’
efforts to control tramadol on their own 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.


By Emily Schmall and Claire Galofaro. Associated Press journalist Rishi Lekhi contributed to this report. This story was produced with support from the Pulitzer Center on Crisis Reporting.