The TGA Complaints (lack of) process

Here are reposts from two recent pieces by Dr Ken Harvey: Both examine Australia’s Therapeutic Goods Authority (TGA).

The first is a letter written to Melbourne’s Age newspaper.

The second, published on Dr Harvey’s own website is about Detox Foot Pads and more than adequately demonstrates the contention, made in the first piece, that the TGA is not really interested in consumer protection.

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Letter to The Age 5/9/18 Spotlight on regulators

Your editorial (4/9) says the government should have a more rigorous process to protect consumers from ineffective treatments and products. There are government regulators that are meant to do this job but they are weak and ineffective.

The Australian Health Practitioner Regulation Authority refuses to state that certain practices should not be performed because they lack evidence, waste scarce health resources and are potentially harmful. These include surgeons performing arthroscopy for osteoarthritis and chiropractors manipulating the newborn to correct “birth trauma”. AHPRA refuses to lay down standards of practice because this might limit innovation.

The Therapeutic Goods Administration has recently taken over all complaints about advertising medicines and medical devices to the public. It closes complaints about ineffective products by sending an “educational” letter to the offender without checking to see if this has any effect; usually it does not. It also fails to publicly disclose the company or product that had an upheld complaint. The TGA appears more concerned with industry assistance than consumer protection. I suggest The Age puts its investigative spotlight on the regulators of therapeutic goods and services.

Associate Professor Ken Harvey, Monash University

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Another ineffective TGA complaint outcome: Detox Foot Pads Scams

Image purporting to show toxins withdrawn by detox foot pads. From (6/9/18): https://www.happynaturaltherapies.com.au/shop/happy-feet-foot-patches-box-40-20-pairs/

This product is on the ARTG no: 148412, sponsor: Rebark Trading Pty Ltd – Absorbent; Intended purpose: to absorb (to draw into itself) undesired toxins from the body.

My complaint about Detox Foot Pads / Patches noted there have been at least 33 complaints upheld by the CRP [Complaints Resolution Panel] about this well-known scam.

This including two referrals to the Secretary (2010-10-016) and (2017/09/010).  I can find no outcome on the TGA web site for the latter. However, the former resulted in a “Regulation 9 order” against Happy Feet Detox Foot Patches. The delegate of the Secretary ordered the sponsor:

“to withdraw any representations that the advertised product can detoxify the body, remove or “draw out” toxins from the body, help the body function more effectively, or offer therapeutic benefits in relation to stress, excessive alcohol intake, nicotine consumption, poor diet, environmental contaminants, pollutants or harmful chemicals.”

More recently, the CRP sent an additional 22 complaints to the TGA because they required regulatory action rather than repeatedly upholding complaints with determinations that had no effect. The TGA appears to have taken no action about these referrals.

I now have the “outcome” of seventeen additional documented complaints I sent to the TGA (AC-UA26W8I4/2018); all were regarded as “low priority” and closed by sending an educational letter.  Meanwhile, the promotion complained about continues, e.g.

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NOTE: We Vic Skeptics are familiar with the Foot Detox scam described above, having often demonstrated it at our presentations to Science teachers and other groups. In our experience however, the discolouration which purports to represent toxins being extracted from the body sets in after minutes, not days.

Dr Ken Harvey

Dr Ken Harvey, along with some of his students from Monash University will be the featured presenters at our Skeptics Cafe in November. See https://vicskeptics.wordpress.com/events/

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