Medicinal cannabis crackdown looms as high-strength products hit market
The Therapeutic Goods Administration this week put the industry on notice, floating in a confidential consultation paper obtained by this masthead that it would gauge support for 'significantly restricting or preventing access' to more than 1000 unapproved cannabis products prescribed to hundreds of thousands of Australians.
The wide-ranging review will canvass substantial changes to the system permitting access to the once-illegal drug, although the consultation paper specifically notes the federal government 'is not intending to remove access to medicinal cannabis'.
The TGA review warns that the strength of cannabis extracts is not limited in Australia and has grown rapidly, with some containing up to 88 per cent tetrahydrocannabinol (THC), the component in cannabis that makes users feel 'high'.
One pro-cannabis MP said this was more than eight times as strong as the 'pot' many people had smoked in previous decades.
Access to cannabis for medical purposes was legalised in Australia in 2016, and has sharply increased as many recreational users realise they no longer need to access the drug illicitly.
Cannabis use in Australia has not changed dramatically. The federal government's Australian Institute of Health and Welfare found 13 per cent of Australians used cannabis in 2001 compared with 11.5 per cent in 2023. But the institute found that among people who used cannabis, the use of prescribed cannabis for medicinal purposes was on the rise.
In the past 12 months, this masthead has detailed the supercharged growth of corporate-backed telehealth cannabis clinics and the explosion in prescribing since 2016. Major companies have emerged supplying the drug. The biggest, Montu, turned over $263 million last year.
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7NEWS
11 hours ago
- 7NEWS
B6 class action raises concerns for pregnant women and supplement safety
A proposed class action against Blackmores has revealed the potentially devastating effects of vitamin B6 toxicity — with growing concern around pregnant women unknowingly consuming dangerous levels. More than 1,000 Australians have contacted lawyers about neurological symptoms they believe are linked to excessive B6 in over-the-counter supplements, many marketed as safe multivitamins or magnesium blends. Among them is 33-year-old Dominic Noonan O'Keefe, a father from Victoria, who started taking supplements to prepare for the arrival of his baby daughter. 'The main motivation was my daughter's coming. I want to be as ready as possible for that period,' he said. He says what followed was months of escalating, unexplained symptoms including nerve pain, loss of balance, visual issues and overwhelming fatigue. "I remember standing at my desk and I had this electric shock of nerve pain shoot up in my scalp. Everything became overwhelming. I couldn't deal with it. The light was too bright. The noises were too loud ... I thought I was having an aneurysm or something ... I thought I was dying" Dominic continued to deteriorate over several months as specialists searched for answers, but routine tests failed to check his B6 levels. The turning point came not from the medical system, but a family barbecue. 'My whole family knew I was incredibly unwell ... I just said, 'Oh, my arms are just so numb and they feel like they're vibrating…' and [my stepsister] stopped for a second, she's like, 'Are you taking any supplements?' he said. 'She flipped me some peer-reviewed literature ... and immediately I knew what was going on. 'The next day I got a blood test and my results were double what they needed to be for peripheral neuropathy, which is just shorthand for nerve damage.' Polaris principal lawyer Nick Mann is leading the proposed class action against Blackmores. He says the firm has now received more than 20 inquiries from women who were pregnant or breastfeeding while taking B6-containing supplements. "You could be taking a pregnancy multivitamin and a magnesium supplement combined. You could have 50, 60 times the recommended daily intake of B6." 'To date, we've also received about 20 inquiries from women who were taking multivitamins while pregnant or breastfeeding. That's something that we're investigating.' Mann believes this is just the beginning of what could be a much larger health issue, driven by regulatory gaps and marketing practices within the supplement industry. 'What we've since discovered is that there are thousands of Australians out there who are likely to have been affected by this,' Mann said. While most people associate vitamin supplements with health benefits, B6 — also known as pyridoxine — can accumulate in the body over time, particularly if consumed through multiple sources. 'One of the things that I think the companies haven't well understood or appreciated is that you could be taking a few different supplements at the same time ... you could be taking 50 times the recommended daily intake of B6,' he said. 'We are yet to see any convincing evidence that it needs to be in these supplement. You can go down to your local chemist and find an almost identical product which contains magnesium as the primary supplement sitting next to one that contains 30 to 40 times the recommended daily intake of B6.' A spokesperson for Blackmores has told 7NEWS it's committed to the 'highest standards of product quality and consumer safety'. 'All our products, including those containing vitamin B6, are developed in strict accordance with the safety and regulatory requirements of the Therapeutic Goods Administration (TGA). 'This includes compliance with maximum permitted daily doses and the inclusion of mandated warning statements on product labels. We acknowledge the interim decision issued by the TGA and we will ensure full compliance with its final determination, prioritising the safety of our products. 'Vitamin B6 is in a range of products within the vitamins and dietary supplement industry and its inclusion in some Blackmores products is consistent with industry practice and meets current regulatory requirements in all markets.' Dominic is one of the first to come forward and says he hopes speaking out will prompt real change. 'I feel embarrassed initially and a bit of shame like I think everyone does ... there's a part of you that realises you were doing it, you were taking the supplements and unknowingly poisoning yourself,' he said. 'You can go into chemists still to this day and there won't be warning labels. I didn't have the luxury of that on any of my supplements. There are still supplements to this day in chemists without warnings on them.' "This whole thing doesn't seem right and I think we need to do something about it." Mann says the proposed legal action is the first B6 class action of its kind globally. It's gaining international attention and even prompting whistleblowers from inside the supplement industry to come forward. "This is the first class action in the world that's been brought in relation to B6 toxicity. " 'We're proud to bring it. 'What I can say so far is that from those inquiries, what we understand is that there was a huge reliance on what was approved by the TGA, but then no other consideration of safety and efficacy. "The regulation of complementary medicines in Australia seems to have followed what's called a light-touch regulatory approach." Mann stresses that their legal case is not against the regulator, but against the companies with a duty of care to protect the public. 'The TGA regulation doesn't and can't be the beginning and the and of the legal liability ... You can't, at law, say, well the regulator allowed us to do this and so therefore that's our legal liability.' Vitamin B6 is also added to food and drinks particularly breakfast cereals, protein bars and energy drinks. Dr Terri-Lynne South from the Royal Australian College of General Practitioners says there needs to be better regulation in the food industry. "There needs to be better regulation of those energy drinks because it is quite high. " 'There needs to be education and potentially some recommendations to pull them in line with what we're seeing in those vitamin and mineral supplements.' The TGA also responded to 7NEWS enquires: 'The TGA has alerted consumers to the risk of neuropathy from vitamin B6, including a safety alert in 2022. 'Since March 2022, medicines providing over 10 mg equivalent vitamin B6 per day have required the label warning statement: 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].' 'In June, the TGA released an interim decision that proposes to change the current scheduling of vitamin B6 (pyridoxine, pyridoxal and pyridoxamine) such that oral preparations containing 50 mg or less per recommended daily dose are available for general retail sale (unscheduled). 'Oral preparations containing more than 50 mg but less than 200 mg per recommended daily dose would become Pharmacist only medicines (Schedule 3). This decision, if implemented, will reduce the maximum amount of vitamin B6 allowed in oral products than currently available for general sale. 'The interim decision balances the risks and benefits of using vitamin B6 including the risk of peripheral neuropathy, acknowledging its potential for irreversible harm at higher doses and variability in individual metabolism. It also considers the limited clinical need for supplementation due to dietary sufficiency, alongside the widespread use of vitamin B6 in fortified products and listed medicines.' Dominic, now a year into recovery, still faces flare-ups triggered by illness or stress and lasting symptoms like numbness, vision problems, and fatigue. 'It feels like a heavy veil is over me and I've receded back into myself and I'm sort of just operating something that doesn't a body that doesn't work. But when I feel good, I feel present again,' he said. 'I feel me today.' For him, the fight is about protecting others.
The Advertiser
17 hours ago
- The Advertiser
'I'm 20, strokes don't happen': signs that told Jayme's family something was wrong
It was a strange request at a tea shop that alerted 20-year-old Jayme Bertram's boyfriend that something was wrong and she was suffering a stroke. "It was April this year," Ms Bertram, of Raymond Terrace, said. "I'm very much an avid Tilly's (Matildas) fan, and we had just been to see them play in Newcastle. "The next day, I slept all day, which isn't like me at all. Later, my partner and I went to Green Hills. "We went to Chatime, and apparently I asked for a frozen coke... Chatime doesn't sell frozen cokes, so my partner was like, 'okay, something's wrong'." Ms Bertram's mum also became worried by her daughter's text messages, and then was more alarmed when Jayme arrived home and her speech was slurred. "My texting was bad," Ms Bertram said. "My speech was bad. My communication was bad. That's how my mum figured it out." Her mum called triple-0, and the operator said it sounded like Jayme was having a stroke. Paramedics arrived and took her to Maitland hospital. Ms Bertram said the hospital staff thought she may have been having a mental health episode. "I don't remember any of this," Ms Bertram said. "But my mum was there, and mum's very much a helicopter mother, which is both great and bad. She demanded an MRI." Further tests revealed Ms Bertram has antiphospholipid syndrome (APS), an autoimmune disorder that can increase the risk of blood clots forming in arteries and veins. She said it was a huge shock when she realised she had suffered a stroke. "It was kind of scary, to be honest," Ms Bertram said. "I mean, I'm 20. I like to think I'm pretty healthy. A few broken bones, but nothing serious. "I've had a few people say, 'oh, you're 20. You didn't have a stroke. Only old people have strokes', which sucks. It's hard." Ms Bertram spent two weeks in a rehabilitation unit, and has since been recovering, but she is still impacted by the stroke. "My memory is bad, and my speech is bad as well," she said. "And stroke fatigue: stroke fatigue is a big one. "But it's improving. I have my license back. "Luckily, I have a good support system around me. My immediate family has been great. "I mean, I could have been dead by now because of a stroke, which my mum doesn't like to think about." Ms Bertram said, looking back, some of the early warning signs were headaches and fatigue. "Strokes can happen to anyone at any age," she said. "I had a major mental breakdown. I was like, 'Oh, I'm 20. strokes don't happen', but they do." Ms Bertram is speaking out as part of National Stroke Week, and her message has been echoed by Stroke Foundation CEO Lisa Murphy. "As we saw with Jayme, stroke doesn't discriminate - it affects people of all ages, which is why it's important for all Australians to know the F.A.S.T. signs of stroke," Dr Murphy said. "When a stroke strikes, it attacks up to 1.9 million brain cells per minute, so it is critical to receive emergency treatment as soon as possible. "The first important step is recognising the signs of stroke. Knowing the signs can save a life." The F.A.S.T. acronym highlights the three most common signs of stroke (face drooping, arm weakness, and speech difficulty) while emphasising the importance of time when it comes to recognising and treating a stroke. It was a strange request at a tea shop that alerted 20-year-old Jayme Bertram's boyfriend that something was wrong and she was suffering a stroke. "It was April this year," Ms Bertram, of Raymond Terrace, said. "I'm very much an avid Tilly's (Matildas) fan, and we had just been to see them play in Newcastle. "The next day, I slept all day, which isn't like me at all. Later, my partner and I went to Green Hills. "We went to Chatime, and apparently I asked for a frozen coke... Chatime doesn't sell frozen cokes, so my partner was like, 'okay, something's wrong'." Ms Bertram's mum also became worried by her daughter's text messages, and then was more alarmed when Jayme arrived home and her speech was slurred. "My texting was bad," Ms Bertram said. "My speech was bad. My communication was bad. That's how my mum figured it out." Her mum called triple-0, and the operator said it sounded like Jayme was having a stroke. Paramedics arrived and took her to Maitland hospital. Ms Bertram said the hospital staff thought she may have been having a mental health episode. "I don't remember any of this," Ms Bertram said. "But my mum was there, and mum's very much a helicopter mother, which is both great and bad. She demanded an MRI." Further tests revealed Ms Bertram has antiphospholipid syndrome (APS), an autoimmune disorder that can increase the risk of blood clots forming in arteries and veins. She said it was a huge shock when she realised she had suffered a stroke. "It was kind of scary, to be honest," Ms Bertram said. "I mean, I'm 20. I like to think I'm pretty healthy. A few broken bones, but nothing serious. "I've had a few people say, 'oh, you're 20. You didn't have a stroke. Only old people have strokes', which sucks. It's hard." Ms Bertram spent two weeks in a rehabilitation unit, and has since been recovering, but she is still impacted by the stroke. "My memory is bad, and my speech is bad as well," she said. "And stroke fatigue: stroke fatigue is a big one. "But it's improving. I have my license back. "Luckily, I have a good support system around me. My immediate family has been great. "I mean, I could have been dead by now because of a stroke, which my mum doesn't like to think about." Ms Bertram said, looking back, some of the early warning signs were headaches and fatigue. "Strokes can happen to anyone at any age," she said. "I had a major mental breakdown. I was like, 'Oh, I'm 20. strokes don't happen', but they do." Ms Bertram is speaking out as part of National Stroke Week, and her message has been echoed by Stroke Foundation CEO Lisa Murphy. "As we saw with Jayme, stroke doesn't discriminate - it affects people of all ages, which is why it's important for all Australians to know the F.A.S.T. signs of stroke," Dr Murphy said. "When a stroke strikes, it attacks up to 1.9 million brain cells per minute, so it is critical to receive emergency treatment as soon as possible. "The first important step is recognising the signs of stroke. Knowing the signs can save a life." The F.A.S.T. acronym highlights the three most common signs of stroke (face drooping, arm weakness, and speech difficulty) while emphasising the importance of time when it comes to recognising and treating a stroke. It was a strange request at a tea shop that alerted 20-year-old Jayme Bertram's boyfriend that something was wrong and she was suffering a stroke. "It was April this year," Ms Bertram, of Raymond Terrace, said. "I'm very much an avid Tilly's (Matildas) fan, and we had just been to see them play in Newcastle. "The next day, I slept all day, which isn't like me at all. Later, my partner and I went to Green Hills. "We went to Chatime, and apparently I asked for a frozen coke... Chatime doesn't sell frozen cokes, so my partner was like, 'okay, something's wrong'." Ms Bertram's mum also became worried by her daughter's text messages, and then was more alarmed when Jayme arrived home and her speech was slurred. "My texting was bad," Ms Bertram said. "My speech was bad. My communication was bad. That's how my mum figured it out." Her mum called triple-0, and the operator said it sounded like Jayme was having a stroke. Paramedics arrived and took her to Maitland hospital. Ms Bertram said the hospital staff thought she may have been having a mental health episode. "I don't remember any of this," Ms Bertram said. "But my mum was there, and mum's very much a helicopter mother, which is both great and bad. She demanded an MRI." Further tests revealed Ms Bertram has antiphospholipid syndrome (APS), an autoimmune disorder that can increase the risk of blood clots forming in arteries and veins. She said it was a huge shock when she realised she had suffered a stroke. "It was kind of scary, to be honest," Ms Bertram said. "I mean, I'm 20. I like to think I'm pretty healthy. A few broken bones, but nothing serious. "I've had a few people say, 'oh, you're 20. You didn't have a stroke. Only old people have strokes', which sucks. It's hard." Ms Bertram spent two weeks in a rehabilitation unit, and has since been recovering, but she is still impacted by the stroke. "My memory is bad, and my speech is bad as well," she said. "And stroke fatigue: stroke fatigue is a big one. "But it's improving. I have my license back. "Luckily, I have a good support system around me. My immediate family has been great. "I mean, I could have been dead by now because of a stroke, which my mum doesn't like to think about." Ms Bertram said, looking back, some of the early warning signs were headaches and fatigue. "Strokes can happen to anyone at any age," she said. "I had a major mental breakdown. I was like, 'Oh, I'm 20. strokes don't happen', but they do." Ms Bertram is speaking out as part of National Stroke Week, and her message has been echoed by Stroke Foundation CEO Lisa Murphy. "As we saw with Jayme, stroke doesn't discriminate - it affects people of all ages, which is why it's important for all Australians to know the F.A.S.T. signs of stroke," Dr Murphy said. "When a stroke strikes, it attacks up to 1.9 million brain cells per minute, so it is critical to receive emergency treatment as soon as possible. "The first important step is recognising the signs of stroke. Knowing the signs can save a life." The F.A.S.T. acronym highlights the three most common signs of stroke (face drooping, arm weakness, and speech difficulty) while emphasising the importance of time when it comes to recognising and treating a stroke. It was a strange request at a tea shop that alerted 20-year-old Jayme Bertram's boyfriend that something was wrong and she was suffering a stroke. "It was April this year," Ms Bertram, of Raymond Terrace, said. "I'm very much an avid Tilly's (Matildas) fan, and we had just been to see them play in Newcastle. "The next day, I slept all day, which isn't like me at all. Later, my partner and I went to Green Hills. "We went to Chatime, and apparently I asked for a frozen coke... Chatime doesn't sell frozen cokes, so my partner was like, 'okay, something's wrong'." Ms Bertram's mum also became worried by her daughter's text messages, and then was more alarmed when Jayme arrived home and her speech was slurred. "My texting was bad," Ms Bertram said. "My speech was bad. My communication was bad. That's how my mum figured it out." Her mum called triple-0, and the operator said it sounded like Jayme was having a stroke. Paramedics arrived and took her to Maitland hospital. Ms Bertram said the hospital staff thought she may have been having a mental health episode. "I don't remember any of this," Ms Bertram said. "But my mum was there, and mum's very much a helicopter mother, which is both great and bad. She demanded an MRI." Further tests revealed Ms Bertram has antiphospholipid syndrome (APS), an autoimmune disorder that can increase the risk of blood clots forming in arteries and veins. She said it was a huge shock when she realised she had suffered a stroke. "It was kind of scary, to be honest," Ms Bertram said. "I mean, I'm 20. I like to think I'm pretty healthy. A few broken bones, but nothing serious. "I've had a few people say, 'oh, you're 20. You didn't have a stroke. Only old people have strokes', which sucks. It's hard." Ms Bertram spent two weeks in a rehabilitation unit, and has since been recovering, but she is still impacted by the stroke. "My memory is bad, and my speech is bad as well," she said. "And stroke fatigue: stroke fatigue is a big one. "But it's improving. I have my license back. "Luckily, I have a good support system around me. My immediate family has been great. "I mean, I could have been dead by now because of a stroke, which my mum doesn't like to think about." Ms Bertram said, looking back, some of the early warning signs were headaches and fatigue. "Strokes can happen to anyone at any age," she said. "I had a major mental breakdown. I was like, 'Oh, I'm 20. strokes don't happen', but they do." Ms Bertram is speaking out as part of National Stroke Week, and her message has been echoed by Stroke Foundation CEO Lisa Murphy. "As we saw with Jayme, stroke doesn't discriminate - it affects people of all ages, which is why it's important for all Australians to know the F.A.S.T. signs of stroke," Dr Murphy said. "When a stroke strikes, it attacks up to 1.9 million brain cells per minute, so it is critical to receive emergency treatment as soon as possible. "The first important step is recognising the signs of stroke. Knowing the signs can save a life." The F.A.S.T. acronym highlights the three most common signs of stroke (face drooping, arm weakness, and speech difficulty) while emphasising the importance of time when it comes to recognising and treating a stroke.
Perth Now
a day ago
- Perth Now
Swimmer reflects on shock discovery before major event
Feeling helpless as a growing number of friends were diagnosed with cancer, Kim Wellington organised an open water swim to raise money for life-saving research. The champion Masters swimmer, then 47, never imagined she'd be also be diagnosed with triple negative breast cancer in the weeks before she hit the water. "It was the most surreal feeling, just to be feeling so strong and so healthy and wanting to get involved in this fundraiser for other people that I cared about and then finding myself in that exact spot," Ms Wellington told AAP. "It just kind of highlights that cancer does not discriminate." Still reeling from her own health shock, she and about 100 others relished the chance to take a dip in the freezing cold water off Adelaide's Henley Beach. They raised almost $7000. "In that water was just pure joy, everyone put aside their grief, fear and everything else and just had fun with it," she said. This year, she's organised two swims to raise money for Daffodil Day on August 21 with participants urged to don bright yellow - the colour of hope - and lean into their inner silliness. "It's easy to brush off, there's such a need for money for everything and I think people do get a little bit compassion fatigued," she said. "But you're talking about cancer in particular, affecting one in two people in their lifetime." About 8000 people have signed up for Daffodil Day Dips around the nation this year, a quirky fundraiser on top of daffodil stalls and thousands of workplace fundraisers aiming to raise $4 million nationally. The money raised through the Cancer Council will mainly go towards research. That includes work to understand risk factors, improve diagnosis, public health prevention and clinical trials of new drugs, including medicines with fewer side effects. Peter Diamond is general manager of support and research at the Cancer Council. He said while almost 170,000 Australians were diagnosed with cancer in the last year and almost 53,000 patients died, the world was "absolutely" getting closer to cures for certain forms. The overall survival rate within five year of a diagnosis has drastically improved, going from 52 per cent in 1989/93 up to 70 per cent in 2014/18. Dr Diamond said knowledge, treatments and research were rapidly improving but more work was needed to be done - and funded. "I do think that we're always on the precipice of something new and exciting," he said. "We're now implementing all these new technologies which many years ago were considered complete science fiction. "As we get a better understanding and as technology improves, the things that used to take us really long time to do now don't take us long." Ms Wellington knows times are tough for many Australians but wants people to know it's still valuable to donate just a few extra dollars to help improve outcomes for patients. "They're making such amazing advances in research for cancer, but it needs to keep going and the only way to get that is to keep holding these kinds of events," she said.
