Medical Device Code: Anonymous whistle-blowing hotline accompanies new version of the Code

Posted 26 August 2019

For the attention of healthcare practitioners & other healthcare stakeholders

SAMED’s ability to enforce the Medical Device Code and contribute to raising the levels of ethics in the South African medical technology sector entered a new era on 15 August 2019. This is when its anonymous whistle-blowing hotline for reporting contraventions of the Medical Device Code of Ethical Marketing and Business Practice became operational.

SAMED has decided to add to its complaint-lodging approach and allow for anonymous complaints – through an independently managed service – in order to overcome concerns that many potential whistle-blowers, including healthcare professionals, have due to fears of damaging relationships with colleagues, suppliers and other industry role-players, or of risking a disciplinary procedure or dismissal.

Known as the Medical Device Code ethics hotline, the mechanism is part of Deloitte’s global service which the company introduced in 1999 and which is ISO certified Read the rest

ThetaHealing®debunked

Posted 25 August 2019

Jonathan Jarry, M.Sc. has looked closely at ThetaHealing®, which uses testimonials to claim that it produces miraculous effects.

Jarry notes:

  • ThetaHealing is a philosophy according to which a healer and a patient tap into a type of brainwave to allow divine energy to heal them.
  • Its founder was successfully sued for fraud over a degree she was offering in ThetaHealing; and she has said she thinks her healing method can regrow limbs and organs.

The only study published in the scientific literature found that the theta-wave activity of experienced practitioners did not go up during their procedures.

Reference: Jarry J. ThetaHealing: The money you’ll spend never existed. McGill Office for Science and Society, Aug 1, 2019

Source: Consumer Health Digest #19-34, August 25, 2019

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TGA cracking down on non-compliant advertising of bioresonance and similar devices

Posted 18 August 2019

In May 2019, the Therapeutic Goods Administration (TGA – Australia) commenced work on a sector-wide compliance activity relating to the advertising of ‘bioresonance’ devices, which are sometimes mistakenly promoted as ‘biofeedback’ devices. This sector has been identified as having a high rate of advertising non-compliance, with widespread advertising. The advertising of bioresonance has been the subject of previous regulatory compliance actions.

(Editor: Beamer, Scio and Quantum SCIO-EPFX devices are included in this category)

Bioresonance is based on the belief that human beings emit electromagnetic waves, which can only be measured by bioresonance devices. Advertisers claim these devices can measure these waves to detect illness in the human body as well as sending ‘rehabilitated bad’ waves to the patient to alleviate illness.

The TGA is currently investigating the scientific credibility relating to the diagnostic and therapeutic use of these devices. The TGA is also working Read the rest

EU supplement law ‘among world’s strictest,’ as study finds two thirds adulterated

Posted 15 August 2019

An industry group declares the EU legal framework for food supplements ‘among the strictest in the world,’ in response to a study that finds almost two-thirds of supplements contain pharmacological active substances or plant toxins… Read

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The FDA Is Literally Warning People Not to Drink Bleach (MMS)

Posted 15 August 2019

David Nield 16 AUG 2019

Just in case you were in any doubt, the US Food and Drug Administration (FDA) has spelled it out: please don’t drink bleach. It will mess up your insides, and it’s most certainly not a miracle cure.

If you’re wondering why such a warning is even necessary, it all comes down to an alternative remedy that people purchase, mix at home, and ingest with the hope to cure various conditions – including autism, cancer, HIV/AIDS, hepatitis, and even the flu.

Various bad actors are pushing this so-called Miracle Mineral Solution or Master Mineral Solution (MMS) as a fix for a variety of ills on social media; it’s been going on for a while, despite plenty of authoritative, scientific, informed advice that it’s all a scam.

“The solution, when mixed, develops into a dangerous bleach which has caused serious

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UK ASA rules claims of USN Phedracut breach advertising code

Posted 06 August 2019

USN and owner, Albe Geldenhuys, is suing Dr Harris Steinman alleging that Steinman had defamed them. Steinman had argued that, among other, they were scamming consumers with unsubstantiated claims for products.  The Advertising Standards Authority of South Africa had ruled against claimes for their products numerous times, including multiple rulings against their ‘fat-burning’ supplement which Steinman called an unsubstantiated scam.

Now the UK Advertising Standards Authority (ASA) rules that claims made about the green tea extract contained in a weight management supplement are misleading and unsubstantiated… Read

From the UK ASA ruling:

USN (UK) provided a copy of a study on Phytofare®, which they believed supported the advertising claim. However, we understood that the study’s objective was to compare levels of different catechin profiles of Phytofare® with a generic green tea extract. Therefore, the study did not assess whether the green tea extract had the effects Read the rest