Update February 23, 2007: Xenical advertising banned by regulatory agency
The National Drugs and Poisons Scheduling Committee has withdrawn permission for Xenical to be advertised directly to consumers. However, it did not change Xenical's status to a S3 'pharmacist only' drug. CHOICE argues that Xenical needs to be dispensed by doctors to ensure that consumers are not paying for a product that wont work for them.
In their decision the NDPSC "noted the advice from professionals and consumers that direct-to-consumer advertising increased pressure on pharmacists to provide orlistat to consumers. This in turn had the potential to result in inappropriate patterns of use, in patients for whom orlistat was neither indicated nor appropriate."
Xenical entered the Australian market in 2000 as a prescription drug (schedule 4). In 2004 it became a ‘pharmacist drug’ (schedule 3), this means that it can be sold without a prescription.
Roche obtained advertising approval for Xenical in February 2006. The advertising started in September 2006 on the show Australian Idol.
Why this is an important issue
Advertising like this suggests that the drug could be appropriate for anyone who thinks they have a weight problem.
Changes to diet and exercise are essential to weight loss. While weight loss drugs can help some people, Xenical is appropriate only for those people with a Body Mass Index (BMI) of 30 or 27 if a person has risk factors such as high blood pressure or cholesterol. It is not suitable for those in a healthy weight range (BMI 20-25) who just want to lose a few kilograms.
What we’re doing
CHOICE made a complaint about the advertisements to the regulator (the Therapeutic Goods Advertising Code Council (TGACC) Complaints Resolution Panel) in October 2006.
Our complaint was upheld and Roche had to withdraw the ads.
We have also written to the National Drugs and Poisons Schedule Committee (NDPSC) asking that advertising approval for Roche be immediately removed and the schedule changed back to S4 (requiring a prescription).
The NDPSC called for submissions on rescheduling Orlistat as a result of our complaint. We also conducted a shadow shop to determine if the drug was being dispensed according to the Pharmaceutical Society of Australia (PSA) guidelines. We sent a young looking 19 year old girl with a BMI of 24.8 to 30 pharmacies in Sydney to see if Xenical would be dispensed to her. She does not meet the clinical profile for the drug but was dispensed the product in 24 out of 30, or 80%, of pharmacies.
We have made a submission to the NDPSC outlining our findings from the shadow shop.
CHOICE continues to campaign on this issue.
We want Xenical to be rescheduled as a prescription drug.
Read our letters to the TGACC and NDPSC.