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Is this the end of unproven breast imaging in Australia?

A recent story from the West Australian reports that a Perth clinic that falsely claimed to offer an alternative breast screening service which could detect cancer has been fined $75,000, while the controversial former doctor involved must pay a $25,000 penalty. In the following piece public health Lawyer Caitlin Kameron discusses the implications of the decision for breast screening in Australia. Caitlin writes:

Recent Federal Court judgments highlight the effectiveness of community advocacy and consumer law against unproven cancer screening technologies.
In what will likely sound the death knell for the industry, the Federal Court has handed down severe penalties against two breast imaging companies that engaged in misleading and deceptive conduct. An internet search for similar clinics in Australia now returns scarce results, but it remains to be seen whether alternative devices will take their place.

Safe Breast Imaging Pty Ltd operated across four Australian States using an unproven device known as the Multifrequency Electrical Impedance Mammograph (MEM). The MEM and various digital thermography devices were offered to women in Perth by Breast Check Pty Ltd.

Following proceedings instigated in 2011 by the competition watchdog, the Australian Competition and Consumer Commission (ACCC), the court found that the companies had falsely represented that their services could be used to reassure a customer that she did not have breast cancer, to assess her risk of breast cancer and to provide an effective substitute for mammography. All of these representations were without an adequate scientific and medical basis. In addition, Safe Breast Imaging Pty Ltd was found to have falsely claimed that a medical doctor was involved in interpreting images and preparing a breast health report.

Penalties of $200,000 and $75,000 were imposed on Safe breast Imaging Pty Ltd and Breast Check Pty Ltd respectively, reflecting the seriousness of the contraventions and the risk of harm to women who may have been diverted from the gold-standard, mammography. It is expected that the penalties will act as a strong deterrent against the making of health claims about unproven therapeutic devices.

In 2009, Cancer Council WA became concerned about the aggressive marketing and promotion of breast imaging technologies that were not evidence-based and the rapid proliferation of such clinics. This prompted Cancer Council WA to conduct an internal literature review and collaborate with BreastScreen WA to develop a consumer fact sheet. Research conducted with the Centre for Behavioural Research in Cancer Control found that 80% of respondents were led to believe that the advertised breast imaging device was equally or more effective than a mammogram in detecting breast cancer.

Cancer Council WA’s complaints to the Therapeutic Goods Administration (TGA) resulted in several devices being removed from the market because their sponsors could not substantiate claims about breast cancer detection.

There was a need, however, to explore other legal avenues, including consumer law. Cancer Council WA approached the ACCC and provided ongoing assistance as it conducted its investigations. The matter attracted considerable media attention and in June 2011, Cancer Council Australia, the ACCC and the TGA issued a joint media statement urging women not to rely on unproven commercial breast imaging technologies to detect breast cancer.

Cancer Council WA advocated to Federal government for an enforceable, statutory code of conduct for unregistered health care workers because providers of complementary and alternative therapies were typically behind unproven breast imaging clinics. The government has since undertaken to introduce such a code. It is submitted that such workers should be prevented from claiming they can cure, diagnose or detect cancer.

The ACCC’s successful prosecutions have led to a dramatic reduction in the number of Australian clinics offering unproven breast imaging technologies in an industry that had been expanding rapidly.

 

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