Debbie Thompson is a grandmother of five who likes to crochet in her spare time. The 64-year-old is also an addict.

Key points: Pain specialist says Mundipharma distributed misleading brochure on strong pain medications to GPs

Pain specialist says Mundipharma distributed misleading brochure on strong pain medications to GPs The company avoided scrutiny because it opted out of Australia's self-regulatory system

The company avoided scrutiny because it opted out of Australia's self-regulatory system The Therapeutic Goods Administration can't act because false advertising laws exclude marketing to GPs

The former curtain shop manager remembers the first time her GP prescribed a mild painkiller to relieve ankle pain from a slip at work.

"The pain was like shards of glass," Ms Thompson said.

"He didn't tell me anything just 'well, this should help with pain'."

For Ms Thompson, this was the start of a two-decade "rollercoaster" that would see her taking double the recommended dose of the strong painkiller oxycodone.

"From then on, operations, pain, meds, 19 years and I'm still suffering," she said.

One Australian GP believes misleading practices by one global pharmaceutical company are contributing to patients like Ms Thompson becoming hooked on opioids.

He wants the Federal Government to crack down on them.

Pain specialist Simon Holliday said a massive loophole was allowing pharmaceutical companies to falsely advertise the purported benefits of their products to general practitioners.

He has evidence pharmaceutical giant Mundipharma has been misrepresenting the position of two major doctors' groups on how to prescribe pain medicines to those with chronic pain in order to promote their drugs.

Mundipharma is the Australian arm of Purdue Pharma, the United States company behind Oxycontin, which is facing multi-million-dollar legal challenges because of allegedly deceptive marketing practices.

Those practices have been blamed for contributing to the opioid crisis in that country.

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Opioid brochure gives 'bad advice' for chronic pain

Dr Holliday said the company had widely distributed a misleading brochure to Australian GPs advocating Mundipharma's new-generation strong opioid, Targin.

Targin is a blend of oxycodone and a second drug to relieve constipation from opioids.

Dr Holliday said he was "shocked" when he read the brochure and that it contained "bad advice for several reasons".

He said two claims in the brochure combined to falsely suggest strong opioids — like oxycodone — were better for chronic pain than weak ones — like codeine.

Major brands of painkillers with the active ingredient oxycodone. Some are short and others long-acting. ( ABC News: Hugh Sando )

That claim is based on an assumption weak opioids give people an instant hit and are more likely to lead to addiction whereas strong opioids in slow-release formulas do not.

But Dr Holliday said there was no medical evidence behind that assumption.

In fact, Dr Holliday said there was now growing evidence to the contrary, with one key animal study suggesting nerve damage in rats was not just masked by opioids, but the medication created an immune response that actively made their pain worse.

In one claim, the brochure misrepresented the Royal Australian College of General Practitioners guidelines on treating osteoarthritis by quoting its advice out of context.

The brochure also quoted the Royal Australian College of GPs, but then in the footnote incorrectly referenced the Royal Australasian College of Physicians.

Dr Holliday said that reference was quoting guidelines that were nearly a decade old and had been superseded following scientific developments.

The Royal Australian College of GPs agreed, saying the company should have referenced its 2015 guidelines.

Following inquiries from the ABC, the Royal Australian College of GPs said it would also file an official complaint about the brochure with the TGA.

The college's president, Harry Nespolon, said the material was outdated, misleading and "improperly represented" the college's position.

"Mundipharma have a responsibility to use updated clinical guidelines in their material, which they seem to have deliberately ignored in this instance," he said.

Dr Holliday said the other claim in the brochure about conducting opioid trials failed to mention the Faculty of Pain Medicine's advice on opioids came with an overarching caveat there was little evidence about the effectiveness of the drugs for chronic pain and doctors should consider other strategies first.

A spokesman for the Australia and New Zealand College of Anaesthetics Faculty of Pain medicine said the reference to its guidelines were "true in a narrow sense" and could be considered an oversimplification.

Dr Holliday said he was concerned the brochure was reflective of marketing practices around the country.

"That is actually a reflection of the way the face-to-face advertising reps come in and talk to GPs as well.

"This is corrupting the ability of doctors to give safe and effective care."

Across Australia, GPs write the majority of opioid prescriptions and treat most cases of chronic pain.

In a statement, Mundipharma said the information in printed material was "limited", but the advice should be read in the context of the case study provided, which included a patient who wasn't responding to codeine.

Company says its dosage table 'not to be used'

The brochure also provided a conversion chart for weaning the patients onto the Targin medication, something that was only supposed to be used in hospitals, not by GPs, Dr Holliday said.

He also estimated the company's calculations for dosage recommendations were out by up to 25 per cent.

"Incautious use of these tables in the community has contributed to many overdoses," Dr Holliday said.

In a statement, Mundipharma said its dosage table for transferring patients came with a disclaimer that it was an approximation and should not be used for dose conversion.

The statement said their figures came from an app developed by College of Anaesthetics that was not limited to hospitals.

"We have reviewed the information sources, and the information included in the table is correct," it said.

A brochure distributed to Australian GPs by Mundipharma for its Targin pain relief product in 2017. ( ABC News: Hugh Sando )

When Dr Holliday complained to the industry body Medicines Australia, he was told they could not take action because Mundipharma was not a member.

The company chose to opt-out of the complaints process under Australia's system of self-regulation, and Dr Holliday said he was concerned this system was not sufficient to crack down on misleading marketing.

Documents submitted in a United States court in one lawsuit alleged members of the Sackler family, which own Purdue Pharma, led the company's effort to mislead doctors and patients about oxycodone's potential for abuse — something they have denied.

Opioids in Australia: In 2016, 1,045 Australians died from opioid overdose

In 2016, 1,045 Australians died from opioid overdose Of those, 712 were attributed to pharmaceutical opioids like morphine, codeine, oxycodone, fentanyl and tramadol

Of those, 712 were attributed to pharmaceutical opioids like morphine, codeine, oxycodone, fentanyl and tramadol The overdose rate rose from 3.8 to 6.6 per 100,000 people between 2007 and 2016

The overdose rate rose from 3.8 to 6.6 per 100,000 people between 2007 and 2016 The highest death rates were between ages 35 and 44 and among males Source: NDARC and AIHW

The rate of misuse of prescription opioids in the US is 5.2 per cent and Dr Holliday says "we're heading that way in Australia".

"In the last decade, opioid poisonings have doubled," he said.

Latest figures show Australian misuse rates are at 3.1 per cent, well ahead of Canada where the number is 1 per cent.

At the moment, 16 per cent of Australians are using opioids, and patients are moving away from weak opioids like codeine and onto stronger oxycodone products.

In a statement, a spokesman for the Therapeutic Goods Administration (TGA) defended the self-regulatory system for the industry, saying it allowed the regulator to focus on consumer protection.

"The TGA expects prescription medicine sponsors to engage constructively with the self-regulatory system, irrespective of whether they are members of the industry body concerned," he said.

In a statement, Mundipharma said it declined to have its complaint dealt with by Medicines Australia because it felt the brochure was "balanced accurate and correct" and said only one in five pharmaceutical companies in Australia were members of the industry body.

"This decision was not an effort to avoid scrutiny, nor has it had that effect," he said.

"Mundipharma … remains committed to comply with all aspects of the Medicines Australia Code of Conduct, as required by the TGA."

A spokesman for the College of Anaesthetics said Mundipharma should have agreed to have the complaint assessed.

"We expect industry representatives to adhere to the Medicines Australia Code of Conduct in their interactions with our fellows, regardless of whether they are members of Medicines Australia or not," he said.

False advertising laws do not cover marketing to GPs

When Medicines Australia was unable to help, Dr Holliday then took his complaint about the marketing material to the TGA.

He said, more than a year later, the regulator had not responded.

A TGA spokesman said it had written to Mundipharma following the complaint, but Australia's false advertising laws for therapeutic goods explicitly excluded marketing direct to doctors.

Taree GP and pain specialist Simon Holliday is concerned by potentially misleading claims in marketing to doctors for opioid medications. ( ABC News: Alison Branley )

Dr Holliday said he had "no idea the system was so corrupt and so porous".

"I'm really surprised that actually nobody in the whole system really cares whether pharmaceutical advertising is misleading or not," he said.

A TGA spokesman said physicians had the "critical analytical skills" to interpret scientific information and "question claims in promotional materials that may be perceived to mislead a consumer".

The regulator was also planning to educate health professionals about pain management and opioid alternatives, he said.

Opioid facts Opioid addiction has killed more than 200,000 Americans in two decades

Opioid addiction has killed more than 200,000 Americans in two decades Purdue Pharma was behind OxyContin and its successor Targin

Purdue Pharma was behind OxyContin and its successor Targin Targin is oxycodone mixed with naloxone to mitigate some of the digestive symptoms

A Mundipharma spokesman conceded one of its references was incorrect, but also said references in the brochure were "accurate and not misleading".

Mundipharma said it strongly rejected any suggestion it had misrepresented medical guidelines or engaged in unethical practices.

"Mundipharma has always prioritised the safety and wellbeing of patients," a spokesman said in a statement.

He said it supported multi-faceted approaches to pain management and reducing the risk of harm to patients, including introducing special small packs of oxycodone to help reduce addiction.

"As a sponsor of prescription medicines in Australia, we are bound by the conditions of product registrations and other applicable laws and regulations," the spokesman said.

'I want to watch my grandkids grow up'

Ms Thompson said during her decades on opioids her doctors would try her on new medications and with each change her dose was increased.

During these years she moved like a robot between work and home under the influence of the powerful painkillers.

"They were like jelly beans," Ms Thompson said.

"I'd come home and I never left the house. I'd just sit. It did mask the pain for a while but then it wouldn't stay away."

For Ms Thompson, the turning point came when she was hospitalised with stomach pains so severe she was put on strong intravenous drugs for two weeks.

Debbie Thompson was addicted to opioid medication until she sought help from a pain specialist. ( ABC News: Alison Branley )

More than a decade of taking opioids had done untold damage to her gut and she could no longer stomach the drugs.

"I lived on Imodium for a couple of years because I just never knew when I was going to get caught short," Ms Thompson said.

With the help of Dr Holliday, she now manages her pain using anti-inflammatory medications and local anaesthetic patches. She also uses distractions therapies, like craft.

Her quality of life has improved, but Ms Thompson admits the pain never really goes away.