Is the TGA out to lunch? Ken Harvey on the weight loss pill that lets you “have the cake without the calories”
The Therapeutic Goods Administration’s response to concerns about the marketing of a weight-loss pill, which lets youÂ â€śhave the cake without the caloriesâ€ť, suggests that the many reviews and promises of reform have not resulted in real change at the much-critiqued organisation, according to Dr Ken Harvey,Â Adjunct Assoc Prof of Public Health at La Trobe University.
TGA is still a â€śblack holeâ€ť for advertising complaints
Dr Ken Harvey,Â Adjunct Assoc Prof of Public Health at La Trobe University, writes:
Little seems to have changed inside the Therapeutic Goods Administration (TGA). And thatâ€™s despite two years of reviews into the shortcomings of its regulatory processes and the release, late last year, of the governmentâ€™s blueprint for reform.
Complaints about breaches of the Therapeutic Goods Advertising Code continue to generate a weak response â€“ the latest of which involves the TGA-listed weight-loss product UndoitÂ®. Its suppliers claim you can eat â€śfat-laden, carb-dense snacksâ€ť and just pop a pill to â€śundoâ€ť their effects.
Stakeholders put a ton of effort into submissions that documented problems with the TGA and suggested improvements. But the governmentâ€™s â€śreformâ€ť document contained only an ounce of movement.
Stakeholders had pointed out, for instance, that numerous reports over the past decade recommended timely and effective sanctions to deter manufacturers or importers of complementary medicines (known as sponsors) from repeated breaches of the Therapeutic Goods Advertising Code.
Yet the reform â€śblueprintâ€ť merely said, â€śThe TGA will develop options for consideration by Government in consultation with stakeholders on â€¦ developing a more effective approach to sanctions and penalties for breaches of advertising requirements.”
Many stakeholders had expressed concern in the past that the TGA was a â€śblack-holeâ€ť of communication. Consumers could submit a complaint about a product but received no communication from the TGA about the outcome of the investigation.
In response to these concerns, the reform â€śblueprintâ€ť said, â€śthe TGA will adopt a strong focus on improving its communication and engagement with the communityâ€ť.
Following the publication of the governmentâ€™s reform â€śblueprintâ€ť, several TGA staff have resigned, although these changes are not reflected on the current TGA organisational chart.
The sponsors of UndoitÂ® claim their pills let you â€śhave the cake without the caloriesâ€ť â€“ itâ€™s â€śthe snack without the guiltâ€ť and â€śthe taste without the tummyâ€ť. The sponsors claim a biscuit can be undone with one tablet, a tub of ice-cream may take two and a Big Mac and fries requires the maximum does of five pills.
Each tablet (Aust L 166770) contains Ascorbic acid 7.5 mg, Chitosan 337.5 mg and Phaseolus vulgaris 375 mg.
Another version listed on the Australian Register of Therapeutic Goods (Aust L 193428) adds the laxative Cassia senna 62.5 mg (although the marketing manager of Undoit, Michael Romm, says this version â€śhas not been manufactured yetâ€ť).
Regardless, there is no scientific evidence that taking five pills containing Ascorbic acid, Chitosan and Phaseolus vulgaris will â€śundoâ€ť the impact of eating a Big Mac and fries.
More worryingly, the dose of Cassia senna contained in just one pill of the second version of the product is potentially dangerous and likely to cause diarrhoea, abdominal pain, cramping, loss of fluids and hypokalemia (low potassium). The usual recommended laxative dose of Cassia senna is 17.2 mg daily, with a maximum of 34.4 mg daily â€“ almost half the dose of a single UndoitÂ® pill.
The claims made for UndoitÂ® exploit the large and vulnerable population of overweight and obese people. They undermine the crucial public health message that reducing the health impact of obesity requires fundamental lifestyle change. In my opinion, they breach numerous sections of the Therapeutic Goods Advertising Code.
Regrettably, UndoitÂ® is just the latest in a long line of ineffective complementary medicine weight loss products listed by the TGA. These include Xantrax, Weight Loss Accelerate, Fat Blaster, Fat Magnet, SensaSlim and Hunger Buster.
A reformed TGA?
So, what happened when a complaint about UndoitÂ® alleging at least eight breaches of the Therapeutic Goods Advertising Code was sent to the new, hopefully more transparent TGA?
The TGA sent the following response (my emphasis added):
â€śThank you for your correspondence dated 17 February 2012 in relation to Undoit. The TGA has noted your complaint in relation to this matter.
â€śThe TGA may use this information and conduct investigations in relation to the safety, quality and regulatory status of the goods as part of the TGAâ€™s ongoing regulatory activities.
â€śInvestigations are prioritised upon potential level of risk to public health and safety.
â€śPlease note that you may not be informed of the outcome of any investigations as the information may be confidential to the owner of the medicine. Thank you again for referring this matter to us.â€ť
Consumer or commercial protection?
The issue of what should constitute commercial-in-confidence information was a hot topic in the TGA reviews.
Unsurprisingly, the views of consumers and health professionals differed from those of industry. While consumers accepted that genuine trade secrets, such as manufacturing processes, should be commercial-in-confidence, they did not accept that information about product safety or advertising violations should be suppressed.
One problem concerning potentially commercial-in-confidence information, raised by the TGA in the past, is Section 47 of the Freedom of Information Amendment (Reform) Act 2010, which states that a document is an exempt if its disclosure under this Act would disclose:
(a) trade secrets; or
(b) any other information having a commercial value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed.
The latter provision (b) is of particular relevance if the TGA determines that a complaint about the efficacy of a product, such as UndoitÂ®, is justified because sponsors can argue that the commercial value of their product would be diminished by such disclosure.
Consumers and health professionals need access to such information but the TGA currently appears to rate the commercial protection of sponsors more highly that the public interest. On this matter, the governmentâ€™s blueprint for reform merely said, â€śThe TGA will develop and publish a policy on the disclosure of commercial-in-confidence informationâ€ť.
The TGAâ€™s website explains its policy is â€śto publish the outcome of certain investigations into complaints about therapeutic goods advertising directed to consumers which have been referred to the TGA by the Complaints Resolution Panel for follow-up actionâ€ť. The criteria the TGA use to disclose â€ścertainâ€ť investigations have not been made public.
Iâ€™m aware of at least 20 complaints referred to the TGA by the Panel over the last 18 months because of sponsor non-compliance. The TGA has yet to report any outcome of their â€śinvestigationsâ€ť. These include Nurofen, Homeopathy Plus, FatBlaster Reducta and Fat Magnet, Maqui Berry Capsules, Virility Pills, Energy Slim and Berocca Performance.
â€˘ This article was first published atÂ The Conversation.
Dr Harvey has accepted travel expenses only to talk about problems of complementary medicine regulation to pharmaceutical companies and industry associations. He has also been paid travel expenses and sitting fees for his involvement with government inquiries and working groups concerning pharmaceutical promotion and the regulation of complementary medicines.