A world of pain: How a ‘safe' painkiller unleashed a new wave of opioid addiction

Yahoo

20-03-2025

After years of misery, Brad Lievoort managed to beat his addiction to oxycodone. In 2018, he and his wife, Linda Matthews, from Victoria, Australia, were hosting game nights and taking weekend trips.
They had made it, Linda thought. Brad felt happy to be alive.
But when Brad developed chronic headaches, a doctor prescribed a drug they weren't familiar with: tapentadol. Another opioid.
Brad trusted his doctor – but within two years he would be dead.
In the last five years, prescriptions of this lesser-known opioid have surged as Grünenthal, the family-owned German company that developed tapentadol, has marketed the drug as a safer alternative to traditional opioids.
Now it is accused of having downplayed addiction risks to doctors and influencing regulation governing its prescription, in an investigation by The Examination, a specialist team of global health reporters.
Grünenthal gained notoriety in the late 1950s with thalidomide, branded as Contergan, a drug used for morning sickness that caused thousands of miscarriages, stillbirths, and severe birth defects.
The company developed tapentadol, branded as Palexia or Nucynta, as patents expired on tramadol, its first blockbuster opioid, which is now widely abused globally.
Approved in 2008 in the US and 2010 in Europe and Australia, Grünenthal sells tapentadol in Europe and Latin America and collects royalties from licensees elsewhere.
Sales and prescriptions have risen around the globe in recent years in at least 10 countries, according to data collected by The Examination.
In Spain, tapentadol prescriptions have now surpassed oxycodone. In Australia, tapentadol has become the most prescribed opioid, with CSL Seqirus, the licenced seller, boasting last year that it was the 'only opioid with consistent growth.'
But experts are worried the opioids' addictive properties have been played down, causing the drug to be prescribed for long term for chronic pain, against the guidance of UK and US regulators.
Grünenthal and other opioid sellers have funded studies and articles in medical journals suggesting tapentadol is less likely to cause dependence or abuse.
Yet six independent experts who reviewed this research unanimously found no convincing evidence to support such claims.
'I have tried to find evidence – solid, impartial evidence – of tapentadol's less addictive properties, and I have not been able to find this,' said Eveline van Dorp, an anaesthesiologist and epidemiologist with a specific interest in opioid research at Leiden University Medical Center in the Netherlands.
In a medical journal, The Examination found that Grünenthal employees touted the drug's supposed 'low level of abuse,' a misleading claim repeated in a video posted on the company's website for Latin American doctors.
The video also minimised the drug's risk of respiratory depression – slower breathing – a known opioid side effect. Grünenthal took down the website following enquiries from The Examination.
Seven former Grünenthal employees who worked in the marketing, science and sales divisions also said in interviews for this story that tapentadol causes less dependence than other opioids.
In Germany, Grünenthal promoted tapentadol to doctors as 'highly effective' for chronic pain, contradicting guidance from the World Health Organization, and from regulators in the United States and the United Kingdom.
Grünenthal wields wide-ranging influence through funding doctors, medical organisations, patient groups and educational initiatives across Latin America and Europe.
In the last decade, Grünenthal has paid more than $9 million to help support at least 900 European patient groups and medical organisations, according to data analysed by The Examination. One company-funded association lobbied the Mexican Congress to loosen regulations around prescribing tapentadol.
Rob Poole, a psychiatrist who ran a clinic in Wales to help patients come off opioids, said many pain doctors are enthusiastic about tapentadol, prescribing it as a 'wonder drug'. He described Grünenthal's promotion of tapentadol as 'a classic drug company disinformation campaign.'
In a statement, Grünenthal acknowledged that 'a few' company documents had mischaracterised tapentadol's addiction risks.
The company commissioned an independent audit in 2019 and found that claims that tapentadol was less addictive than other opioids were 'not backed up by sufficient scientific references.'
But Grünenthal denied actively promoting the drug as less addictive and said addiction risks are included in every pack of pills and in product information for doctors.
And, it said, tapentadol is approved for moderate to severe chronic pain in some countries and the labels vary depending on the regulations.
The World Health Organization, the US Food and Drug Administration and independent doctors have warned that tapentadol, like any other opioid, causes dependence and has potential for addiction, misuse and abuse.
Lucas Trautman, medical director at Oxford Treatment Center in Mississippi, said his facility has gone from rarely seeing tapentadol-dependent patients to treating them regularly over the past three years.
In Australia, a report by the Coroners Court of Victoria noted an increase from zero 0 to 118 overdose deaths over a seven year stretch ending in 2023.
'The rise in tapentadol-involved overdose deaths is reminiscent of what happened when other analgesic products (such as extended release oxycodone …) were introduced,' the report states.
CSL Seqirus said in a statement that the report's findings show that there is an 'ongoing need to ensure all healthcare professionals are aware that tapentadol has potential for harm.'
In India, where generic companies sell tapentadol instead of Grünenthal's branded product, there is anecdotal evidence of a sharp rise in teenage boys becoming addicted since 2017, according to psychiatrists at a major addiction centre.
Patients from impoverished areas buy the tablets to crush, mix with water and inject. One 21-year-old who became addicted in high school said withdrawal left him weak, tired and without the energy to brush his teeth, wash his face or speak. 'I would always be sad,' he said.
Since tapentadol's introduction, Grünenthal, its licensees or researchers receiving industry funding have published studies or articles suggesting it causes less dependence, addiction or abuse.
The Examination sent five such studies to medical experts who identified a variety of shortcomings. 'The studies do NOT permit the conclusion that tapentadol leads to less dependence with any certainty,' said Kyla Thomas, professor of public health medicine at Bristol Medical School.
Health authorities have also raised concerns. When approving tapentadol, the FDA concluded it had 'high abuse potential.' The World Health Organization warned about its risks in 2014. French and Canadian health authorities also recommended against reimbursing slow-release tapentadol due to high costs, lack of evidence for chronic pain benefit, and abuse concerns.
At least seven former Grünenthal employees in Germany and the UK said in interviews with The Examination that they promoted tapentadol as less likely to cause dependence.
One former sales representative, who left in 2023 after six years and did not want to be named out of fear for her career, said she was trained to promote the drug this way using company-provided materials and seminars. Lack of dependence played a 'major role' in her marketing, she said.
Jan-Uwe Claas, a former senior vice president for marketing in Europe, who worked for Grünenthal for two decades until 2022, downplayed the possibility of addiction,
A video on Grünenthal's educational site for healthcare professionals across Latin America featured Silvia Allende-Pérez, head of a public pain clinic in Mexico and former Grünenthal employee, promoting tapentadol. It included a Grünenthal-branded slide claiming tapentadol has a 'minimum potential of abuse' and that respiratory depression is 'not reported' despite this being a well-known opioid side effect.
Grünenthal said the video did not reflect current evidence and, after The Examination's inquiry, removed it and took the website offline for review. Allende-Pérez did not respond to requests for comment.
Grünenthal has also funded the Mexican Association for the Study and Treatment of Pain, according to Angel Juárez, president of the organisation until last year.
Grünenthal said in response that it operates with the 'highest ethical standards' when partnering with healthcare professionals and organisations.
In Wales, the Abertawe Bro Morgannwg University Health Board raised warnings about Grünenthal's marketing of tapentadol in 2019 after discovering the area had more prescriptions than anywhere else in the country.
'Tapentadol is extremely similar to tramadol which was also launched (by the same pharmaceutical company) with similar claims of safety, tolerability and lack of 'addiction' potential, all of which have subsequently been proven false,' the health board said in an internal report.
Caroline Hildenbfrand-Nixdorf, a family doctor in northern Bavaria said Grünenthal sales representatives told her tapentadol was 'not an opioid' but a 'hybrid between an opioid and normal pain medication' that leads to 'no or little dependence' and encouraged its use for chronic pain.
'There is a feeling among doctors, nursing staff, but also patients … that these are harmless substances,' said Dominikus Bönsch, addiction specialist and medical director at the District Hospital Lohr am Main in Bavaria.
'It's pure nonsense,' he said. 'A myth.'
In Australia, Linda Matthews had given birth to triplets. But her husband Brad's tapentadol prescription triggered a relapse. His addiction raged. He couldn't keep a job and hardly helped with the children.
When he skipped the triplets' first Christmas, Linda, seeing no hope, asked him to move out.
Five months later, police found Brad dead, clutching pills in his hand.
A coroner's report found he had overdosed on tapentadol and oxycodone, both drugs found in life-threatening amounts.
In the six months before his death, he had been prescribed opioids by more than 10 doctors.
'Brad made some really, really bad decisions,' said Linda. 'But he shouldn't ever have been able to get the amount of stuff that he was getting.'
World of Pain is an investigative collaboration involving reporting by The Examination, Paper Trail Media, Latin American Center for Investigative Journalism (CLIP), PlatôBR, Salud Con Lupa, El Espectador and Der Spiegel.
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