New triple therapy inhaler approved for COPD maintenance treatment

A new inhaled triple therapy budesonide/glycopyrronium/formoterol fumarate inhaler, Breztri Aerosphere, has been approved by the TGA for maintenance treatment to prevent exacerbations and relieve symptoms in adults with moderate, severe, or very severe COPD.

According to manufacturer AstraZeneca, the metered dose inhaler containing a combination of an inhaled corticosteroid (ICS), long-acting β2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA) was approved based on trials that showed it a reduced the rate of moderate or severe exacerbations by 24% compared to LAMA/LABA therapy and by 3% reduction compared to  ICS/LABA.

Another study showed it improved FEV1 AUC0–4 compared to ICS/LABA and also showed improvement in change from baseline in morning pre-dose trough FEV1 over 24 weeks compared to  LAMA/LABA and ICS/LABA therapy.

Doctor wins $450k damages for malicious reviews

A Sydney surgeon has been awarded $450,000 in defamation damages from a woman who mounted a campaign of online abuse and false claims against him after he refused to operate on her.

Dr Warwick Nettle, a Bondi-based plastic and reconstructive surgeon, became the target of virulent abuse, falsehoods and negative reviews from Catherine Cruse in 2018 when he declined to perform surgery on her, based on warnings from another surgeon who had previously treated her.

Dr Nettle took his case to the Federal Court of Australia, which found that his behaviour was professionally appropriate and justifiable, and that the online comments and maliciously false reviews reviews had seriously damaged both his professional reputation and his thriving practice.

As a results of Ms Cruse posting negative reviews, Dr Nettle’s “Google rating” fell from 5 to 3.5 stars and his workload declined significantly.

The court awarded damages of $450,000 to Dr Nettle and granted permanent injunctions barring Ms Cruse from posting further false and defamatory material about him. However Ms Cruse did not take part in the proceedings and could not be traced, having apparently deliberately concealed her whereabouts, the court was told.

Child asthma trial criticised for unethically withholding care

A clinical trial that investigated the effects of vitamin D supplements for asthmatic children has been branded as unethical for having a control group that did not provide supplements for children who had low levels of the vitamin

The US ‘Vit-D-Kids” study recruited children with asthma from the ages 6 to 16, who had vitamin D levels between 10 and 29 ng/ml. According to an article in Science journal, half the 400 participants received a daily high-dose vitamin D supplement for about a year while the control group received ‘usual’  care’ which the investigators said would mean they did not receive supplements.

However critics have said some children were found on entry to the trial to have  vitamin D levels in  the deficient range, below 20ng/ml, and it was unethical to deny them vitamin D supplements once this was revealed.

The investigators defended their approach as reflecting real world conditions but later amended their trial protocols to exclude children to with vitamin D levels below 14 ng/ml.

The journal said the trail highlighted the ethical question of the use of  ‘usual care’ control groups in clinical trials.