TMR’s top 10 clinical stories for 2023

10 minute read

Take a look back at some of the most popular stories over the past 12 months.

Shortages of Mounjaro, Shingrix and a popular ADHD medication were hot talking points this year – but what else made headlines?

This is why we can’t have nice things (Part 1): Mounjaro

Way back in February the TGA announced its approval for tirzepatide (Mounjaro) in the treatment of insufficiently controlled type 2 diabetes, following previous approvals for semaglutide (Ozempic) and dulaglutide (Trulicity).

Following the announcement, Associate Professor Sof Andrikopoulos, CEO of the Australian Diabetes Society, hoped PBAC would add Mounjaro to the PBS in a timely, but these hopes were dashed when an application from manufacturer Eli Lilly was rejected in July.

Despite getting the thumbs down from PBAC, Eli Lilly announced Mounjaro would be available as a private script from September, launching the product at the 2023 Australasian Diabetes Congress.

The buzz surrounding Mounjaro continued to grow throughout 2023, peaking last month when a preprint suggested it was more effective than Ozempic with respect to weight loss, particularly over a 12-month period.

But the buzz ceased somewhat earlier this month when the TGA announced all strengths of Mounjaro would be in short supply until at least August next year, citing higher-than expected demand for the drug, which, like Ozempic, has gained popularity around the world as an off-label therapy for weight loss.

Have two slices of pizza and call me in the morning

The title of tastiest study of the year goes to a group of Italian researchers (I mean, who else?) who found eating at least four slices of pizza once a week reduced rheumatoid arthritis disease activity by a whopping 70% compared with people who only ate pizza once or twice a month.

“These beneficial effects were likely driven by mozzarella cheese and, to a lesser extent, by olive oil, even though we were unable to assess the possible contribution of tomato sauce,” they concluded.

The researchers were quick to point out that just any old pizza won’t bring about the same benefits, so think twice about ordering from Domino’s or some other multinational chain outlet.

“Within Italian tradition, pizza is a stand-alone meal, usually made from fresh, high-quality ingredients [that] generally balances carbohydrates, proteins and fats well. Outside Italy, pizza generally belongs to a “Western-like” dietary pattern, along with other junk foods,” they said.

Genetic carrier testing expanded for Ashkenazi Jews

Last month a trio of item numbers relating to genetic testing for a suite of severe and life-limiting conditions were added to the MBS.

The new item numbers are relevant for the approximately 100,000 Australians who identify as Jewish. Most of these individuals are Ashkenazi Jewish, who have a one in five chance of carrying at least one of a dozen disorders including Tay-Sachs disease, Bloom syndrome, Fanconi anaemia type C, spinal muscular atrophy and Gaucher disease.

A fetus’ risk of inheriting such a condition jump by 25% if one prospective parent is a known carrier.

The first item, 73453, is for characterising whether an Ashkenazi Jew of reproductive age carries any of the relevant genetic markers for the severe and life-threatening disorders.

The second item, 73454, allows the partner of any patient testing positive to any of the genetic variants to have their whole gene sequenced to calculate the couple’s combined risk of potential children inheriting such a disorder.

The final item, 73455, relates to testing during pregnancy to determine if the fetus carries any of the genetic markers for these diseases.

This is why we can’t have nice things (Part 2): Shingrix

PBAC’s decision for Shingrix to replace the Zostavax vaccine on the National Immunisation Program – while also making it available to an increased range of patients – was met with welcome arms following the announcement in August.

The decision meant almost five million Australians would be able to access the vaccine for free from 1 November, including:

  • All people aged 65 and over.
  • First Nations people aged 50 and over.
  • Immunocompromised people 18 years and over.

However, disconnect between the federal government (who supply the vaccine) and the state and territory health departments (who distribute the vaccine) meant the Shingrix rollout hit a roadblock before it even got going.

Dr Rod Pearce, chair of the of Immunisation Coalition, was one of many clinicians to express frustration over the bungled transition.

“It’s a very frustrating part of this rollout but it’s also inherently built into the way Australia rolls out vaccines,” he told TMR in November.

The DoHAC denied there was a shortage of vaccines, stating they expected 1.6 million Shingrix doses to be distributed between November and the end of June next year, with half a million of these doses to be delivered to providers before we ring in the new year.

Opioids for back pain: yay or nay?

In June the OPAL study challenged clinical practice guidelines, suggesting opioids should no longer be considered for the treatment of acute back pain.

Associate Professor Michael Vagg, a Melbourne-based pain medicine specialist, told The Medical Republic the researchers were trying to inappropriately generalise their results.

“They studied oxycodone and naloxone in a modified-release formulation. But modified-use opioids have never been on-label for use in acute pain and they are not recommended as such and have not ever been PBS-listed for such.

“In layman’s terms, they’ve done a study where they tried to look at doing push-ups to help with back pain and then they’ve decided that all exercise is no good for the back pain,” he said earlier this year.

The authors penned a response to the comments from Professor Vagg, stating the regular doses of modified-release opioids achieve comparable concentrations to immediate-release opioids within the first 48 hours.

“This is important as our treatment period was weeks, not hours. The benefits of the modified-release oxycodone/naloxone formulation (better adherence, less constipation, maintaining blinding) outweighed the downside of not being able to titrate the dose as quickly compared to an immediate-release formulation,” they wrote.

But The Lancet paper may not have been completely off base, with an overview of seven Cochrane reviews (published in the Cochrane Database of Systematic Reviews) failing to find any evidence opioids were beneficial in acute back pain.

There was, however, some evidence suggesting certain opioids (tapentadol and buprenorphine) were effective for chronic treating low back pain.

A CVD risk calculator in your pocket

July saw the release of an Australian-specific cardiovascular disease risk calculator, along with the first update to prevention guidelines in a decade.

The AusCVDRisk calculator replaces the previous algorithm which was developed using data from one town in the United States more than 50 years ago.

The risk assessment is recommended for the following groups of individuals without a known history of atherosclerotic cardiovascular disease:

  • All people aged 45-79 years
  • People with diabetes aged 35-79 years, and
  • First Nations people aged 30-79 years.

The calculator estimates the likelihood of an individual being hospitalised or dying from cardiovascular disease over a five-year period as either low (< 5%), intermediate (5-10%) or high (10% or more). Future assessment and management strategies are recommended based on the calculated risk.

The calculator also allows clinicians to include risk factors, such as coronary calcium score and the patient’s family history, as optional extras in addition to things such as age, sex, smoking status, blood pressure and postcode.

“The cardiovascular disease calculator is the new gold standard in assessing the risk of cardiovascular disease in Australians, [and the] new guidelines will help medical professionals across the country to provide earlier detection and treatment for the disease, bringing new hope and help to thousands of Australians,” Health Minister Mark Butler said at the launch.

This is why we can’t have nice things (Part 3): ADHD medication

Lisdesamfetamine (Vyvanse, Takeda), a popular ADHD drug, also joined the shortages party in 2023.

At the time of publishing, the TGA’s Medicine Shortage Reports Database lists the 30mg and 50mg capsules as having limited availability, with supplies expected to arrive in March next year.

The 20mg capsules are anticipated to be in shortage from 18 December.

Associate Professor John Kramer, chair of the RACGP’s specific interest group on ADHD, ASD and neurodiversity, was frustrated by the announcement, but recommended an interesting strategy to help patients deal with shortages over the coming months.

Professor Kramer’s advice involves breaking up a larger dose and mixing it in water, which can then be consumed over the course of two days. For example, a 60mg dose dissolved in 10ml of water turns into two 30ml doses (in 5ml of water).

The approach is safe and has backing from pharmacists and biochemists, according to Professor Kramer.

DIY cervical screening tests

Self-collected cervical screening tests experienced a Taylor Swift-esque explosion in popularity this year, with Medicare data released in June showing a 13-fold increase in the number of completed self-tests compared to the previous 12 months.

The Northern Territory, Tasmania and South Australia were the biggest adopters of cervical self-screening, with the ACT and NSW being slower on the uptake.  

The eligibility criteria for self-screening were expanded in July last year to include all sexually active cervix owners aged 25 to 74, rather than those who had never been screened, or had been under-screened compared to other women of a similar age.

Professor Julia Brotherton, professor of cancer prevention policy and implementation at the University of Melbourne, told TMR self-collected tests were as accurate as provider collected tests and provided and increased level of comfort for patients.

“Overall self-collection is highly acceptable to patients across the socioeconomic spectrum and our research and that of others in Australia and internationally shows it is acceptable across culturally diverse groups,” she said.

The latest AIHW data indicates one in ten cervical screening tests are positive for an oncogenic type of HPV.

The 17 most important factors predicting dementia

In April the University of New South Wales and Neuroscience Research Australia (NeuRA) published results validating CogDrisk, their dementia risk prediction tool, in four separate and international cohorts of patients.

As the name implies, CogDrisk assesses 17 individual risk factors for dementia and Alzheimer’s disease, including BMI, hypertension, cholesterol, engagement with physical and cognitively stimulating activity, loneliness and the amount of fish you consume each week.

“There’s lots of information about the risk factors for dementia in the academic literature. But there’s a gap between just knowing the risks and actually being able to assess whether or not you have the risk, and then knowing what to do about it. CogDrisk was developed to address this,” Professor Kaarin Anstey, the study’s lead author, told media earlier in the year.

The CogDrisk tool is freely available online and can be completed by anyone aged 18 years and older. The tool develops a personalised risk profile highlighting factors relevant to the individual and provides strategies to target these specific factors. The whole process takes about 20 minutes.

These aren’t your grandparent’s constipation treatments

There was movement among gastroenterology circles in May when the American Gastroenterological Association and the American College of Gastroenterology released a new set of pharmacological treatment guidelines for constipation in adults.

Strong recommendations were made for the osmotic laxative polyethylene glycol (Macrogol, Movicol), the stimulant laxative bisacodyl (Dulcolax) and sodium picosulfate (Dulcolax SP drops).

Associate Professor Rebecca Burgell, a gastroenterologist from Alfred Health, told TMR the recommended products were safe to use on a daily basis, and that using them as per the doctor’s orders would not damage the bowel.

“When a patient that has chronic constipation and needs a stimulant laxative every day, that is not the end of the world. But if that patient started increasing and increasing the doses, having loose stools, having other complications, that’s when it becomes a problem,” she said.

In contrast, there was limited and uncertain evidence on bran, and no mention of prunes.

Australia does not currently have official guidelines for treating constipation, although Therapeutics Guidelines offer some evidence-based advice (for a price).

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