Row erupts over latest OA ‘wonder drug’

Sensational headlines proclaiming the arrival of a potential new ‘wonder drug’ for OA has incited a frenzy of consumer interest and exposed a rift in the rheumatology world.

Last Sunday a ‘world exclusive’ story about how the semi-synthetic polysulfated xylan Pentosan Polysulfate Sodium (PPS) could be a potential cure for osteoarthritis ran on the front page of a major tabloid and on national television.

The coverage generated buzz for its manufacturer Paradigm Biopharmaceuticals which is planning a phase 2 trial investigating the drug to treat bone marrow oedema lesions in patients with OA. The company says it has since received hundreds of emails from patients wanting to join the study.

The next day Paradigm put out a release to the stock exchange which described how PPS “significantly reduces pain with long durability of pain remission” and “has positive regenerative properties to stop or slow the degenerative process of OA”.

In the release the company describes how the phase 2 randomised, double-blind placebo-controlled trial comes on the back of its case report of a 70-year-old who experienced significantly reduced OA pain, knee swelling and improved joint function after treatment and the experience of 30 other patients who apparently had favourable results after treatment.

“There is the potential for PPS to be a safe and effective treatment for osteoarthritis,” it states.

But the noise has drawn criticism from Arthritis Australia and University of Sydney rheumatologist and researcher Professor David Hunter, who argue it’s unwarranted when the treatment is not yet proven and could give patients false hope.

Professor Hunter said this week patients were asking about the medication, and it’s created a distraction.

“The problem with a story like this is it creates false hope and generates a lot of questions related to a product that does not have any robust evidence to support the claims made. It also wastes a lot of time trying to point people away from this.

“My biggest concern is it’s misleading to the three million consumers with OA desperately looking for a treatment. This isn’t ready.”

The company has claimed it wanted to generate publicity for the company’s clinical development program and advise investors about how funds were being used.

But Professor Hunter is sceptical.

“I don’t know where the trial is (located) but there is usually no shortage of patients for trials like this.”

Arthritis Australia had concerns about the media coverage.

Arthritis Australia policy manager Franca Marine said while the drug showed early promise “it seems a little premature to say it’s a breakthrough”.

“For patients who get their hopes up there is something (they) can get tomorrow… it can be disappointing to hear that nothing available yet and there needs to be trials, and there is a prospect it may not work.”

But Paradigm Biopharmaceuticals CEO Paul Rennie said the coverage clearly indicated the drug was in the research phase, corroborated by the fact about 85% of the over 500 emails from patients received this week were requests to join the trial.

“Of course there is a great sense of interest in the story, currently there is no disease modifying drug on the market,” he said. “There are no drugs that are currently highly effective and safe (ie without adverse side-effects) to treat people with painful OA.”

He also rejects criticism about lack of evidence for PPS for OA, pointing to a pilot double-blinded randomised controlled trial published in 2005 of 114 patients with knee osteoarthritis which investigated four injections of PPS at 4-week intervals which suggested the drug could improve functional disability in OA, and a second clinical trial published in 2010.

“You have to consider the drug has been used in humans with osteoarthritis with statistically significant results.”

Mr Rennie also questioned why Professor Hunter was making the comments, when he himself was potentially going to be involved in research investigating PPS.

“If he’s saying negative comments about this while at the same time investigating a similar compound then that could be a conflict of interest,” Mr Rennie claimed.

Professor Hunter confirmed to the limbic that there was “potential to be involved in a trial of PPS for OA” but this had not been finalised.

“To address the supposed conflict… I have no commercial ties (to the company involved),” he said.

“I don’t generate income from it.”

Professor Flavia Cicuttini, head of the musculoskeletal unit at Monash University, who was part of a team that performed MRI measurements for Paradigm, said news stories highlighting early trial results were commonplace and she did not understand why this one had generated so much antipathy.

“There are a whole lot of times where people discuss a study that is about to happen…I am not saying it’s justified or not justified, I am asking ‘why the hysteria?’

“It hasn’t been claimed as a treatment, it is a trial about to start. There is interesting preliminary data,” she said.

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