Off-label use is when an approved medicine is prescribed for a different reason, at a different dose, or in different patient groups than originally intended.
Benny Lin/Flickr
The off-label use of medicines is not illegal and it doesn’t mean regulators have specifically “disapproved” its use. But there are a number of issues to consider before using a medicine off-label.
The company that makes powdered alcohol says it will begin selling four different flavours this year.
Lindsey G/Flickr
The Victorian government is calling on other state governments to join it in banning powdered alcohol, which was recently approved for marketing and sale in the US.
In Australia, the manufacturing of cells for therapy is regulated but only for donated cells.
koya979/Shutterstock
Once thought to be a problem only in poorly regulated jurisdictions overseas, unproven stem cell treatments are increasingly being offered in Australia. Now, the Therapeutic Goods Administration (TGA…
New treatments have minimal side effects and cure rates of over 90%.
Dubova/Shutterstock
Hepatitis C is a hidden epidemic affecting 170 million people worldwide. Hepatitis C kills nearly 700 Australians every year, mostly from chronic liver failure and liver cancer, and costs over $78.9 million…
Research of supplements already in the market has no incentive for robustness.
Health Gauge/Flickr
TESTING ALTERNATIVE THERAPIES - La Trobe University’s decision to accept funding from Swisse for a new centre to research alternative medicines has sparked controversy. This article considers the ethical…
In their “natural” form herbal medicines are so variable from batch to batch and across brands that gathering reliable evidence of effectiveness is unlikely ever to be possible.
Mickey_Liaw/Flickr
TESTING ALTERNATIVE THERAPIES - La Trobe University’s decision to accept funding from Swisse for a new centre to research alternative medicines has sparked controversy. This series looks at how the evidence…
Before a new drug can be tested in humans it must undergo comprehensive preclinical screening and testing.
Flickr / SandiaLabs
It seems that every week a major breakthrough in the understanding of cancer is announced in the media. So where are all the drugs that should flow from these discoveries? Unfortunately, the road from…
The case raises important issues about the consistency of regulations that apply across the food-medicine interface.
Chuck Grimmett
Ken Harvey, La Trobe University and Melanie Voevodin, Monash University
It seems there’s no end to the production line of so-called “therapeutic” products promoted to trusting consumers by companies willing to make untested claims. The latest is Souvenaid®, a product promoted…
Reform of medical regulations has become a hot potato being passed from one agency to another.
eltpics/Flickr
Two bills in the national parliament provide a snapshot of our health regulatory system, and just like a smoker’s lungs, it’s not a pretty picture. The bills show that we’re slow in fixing regulatory incapacity…
The class action against the implant manufacturer has fallen over and despite the TGA’s failings, victims can’t sue the regulator.
Ilaria Gallo
The announcement this week by plaintiff law firm Tindall Gask Bentley that it was abandoning a class action against the Australian distributors of Poly Implant Prosthese (PIP) breast implants illustrates…
This class of drug poses significant risks of misuse and dependence, paradoxical reactions, disinhibition, amnesia and intoxication.
Jacek Becela
The body responsible for regulating drugs in Australia, the Therapeutic Goods Administration (TGA), is poised to decide whether to restrict access to benzodiazepines, such as Xanax, Valium and Normison…
How can you tell what products might be of use and which ones will only lighten your wallet?
Image from shutterstock.com
Australia’s complementary and alternative medicine (CAM) industry is worth about A$4 billion annually. Around two thirds of Australians use CAM – which includes therapies such as chiropractic and naturopathy…
The biggest delay is arguably at the stage where sponsors can exert the most control over timing.
Chris Kelly
The Australian government introduced a controversial delay to the approval process for subsidised medicines last year, in an attempt to cut costs. We decided to examine the timelines of the approval process…
Recent consultations found continued inaction on regulatory matters means the community has lost trust in the TGA.
Pharmacare Laboratories' website
Pharmacare Laboratories is facing a new complaint about its Kids Smart homeopathic medicines amid concerns parents who use the products may delay seeking medical treatment. The complaint – lodged by a…
This product is being sold despite being removed from the Australian Register of Therapeutic Goods by the TGA.
Ken Harvey
I submitted a complaint about the promotion of “FatBlaster Reducta” (ARTG no: 176366) to the Therapeutic Goods Administration in March 2011. The product is a “complementary medicine” containing an extract…
Australia has almost no capacity to fill international medicine shortages.
artisrams
The earthquake in the Northern Italian town of Medolla this May devastated the local community, killing 17 people and leaving 14,000 homeless. Because Medolla is the manufacturing epicentre of the Italian…
The CHC Complaints Resolution Committee did not consider a $675 gift to be “undue influence, pressure or unfair tactics”.
Bradley Stemke
In April 2012 Swisse made the following offer to GPs, “For those who on-sell full sized Swisse Practitioner products, Swisse will sponsor the full cost for you or one of your staff members to complete…
Pharmaceutical companies undertake clinical trials to determine whether a potential new drug meets the requirements for market authorisation.
Chain of figures photo from www.shutterstock.com
New medicines must be approved as safe, efficacious and of good quality before they can be prescribed. But authors of two recent articles in the British Medical Journal argue that governments should introduce…
Nurofen was criticised for claiming its products “target” different sites of pain.
samcatchsides.com/flickr
In 2010, the promotion of the Nurofen range of products “targeting” migraine, back pain, tension headache and period pain was awarded a CHOICE shonky award. This was because all these products contained…
The dietary supplements, nutraceuticals or vitamins industry makes a lot of money.
hit thatswitch/Flickr
Pills made from “wild krill” (apparently so much better for you than domestic krill)? Antioxidants from exotic plants, chlorophyll or the “Sicilian Blood Orange”? Promises of extra vitality, vim and vigour…
Professor - Emerging Technologies (Stem Cells) at The University of Melbourne and Group Leader - Stem Cell Ethics & Policy at the Murdoch Children's Research Institute, The University of Melbourne