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Healthy Skepticism Updates

Update 2009-04-24

Healthy Skepticism Update April 2009

Surrogate endpoints
In randomised controlled trials, the use of surrogate end points may be misleading when they do not translate into clinically important outcomes, or when the clinical outcome is different from what was expected. In this month’s Healthy Skepticism International News, Staffan Svensson brings us a collection of failed surrogate end points to illustrate the problem. You can find them here:

Submission to the Australian Therapeutic Goods Administration
The TGA is Australia’s regulatory agency for medical drugs and devices. Healthy Skepticism members recently contributed comments on its Draft Guideline for Levels and Kinds of Evidence for Listed Medicines with Indications and Claims for Weight Loss. (“Listed” medicines in Australia, as opposed to “registered” medicines, are considered to be of lower risk. They are some of the medicines sold without prescription, and they contain ingredients assessed by the TGA for quality and safety, but not efficacy.) Here is a summary of the recommendations in Healthy Skepticism’s submission:
Given the significant health burden of overweight and obese Australians and the false hope that most listed weight-loss products offer, Healthy Skepticism recommends that:

  • The European Medicines Agency standard of evidence for evaluating medicinal products used in weight control be followed; not the weaker standards proposed in the TGA draft guidelines;
  • The TGA notify industry that the final (strengthened) guidelines will apply to all existing listed products within 6 months of being finalised; that sponsors of these products must either de-list non-conforming products from the Australian Register of Therapeutic Goods (thereby taking them off the market) or submit evidence (according to the new guidelines) that substantiates their efficacy; failure to do so will result in automatic loss of the product listing.
  • The government adds “weight loss” to the Restricted Representations in Appendix 6, Part 2, of the Therapeutic Goods Advertising Code 2007 (the list of diseases, conditions, ailments and defects for which the advertising of serious forms is restricted). This would mean that these products could no longer be promoted to the public until such time as the sponsor sought approval from the TGA; such approval requires the sponsor to convince an appropriate expert committee of the efficacy of their product.
  • The evidence supporting claims made for listed products (which sponsors certify they hold) be made available for public scrutiny.
  • Claims relying on “medium level” evidence be qualified by use of the word "may", that is "May aid/assist in the management of a named symptom/disease/ disorder/condition".
  • This submission, and all others received on this topic, be made publicly available on the TGA web site to facilitate open and transparent debate.



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