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“Complementary medicine” (CM) use linked to worse outcomes for cancer patients

Posted 23 July 2018

From a national database of more than 1.9 million patients, researchers identified 258 users of CM who were diagnosed with non-metastatic breast, prostate, lung, or colorectal cancer from 2004 through 2013. This group was compared to four times as many nonusers of CM who were similar in neighborhood of residence, age, stage of cancer, concurrent health problems, insurance type, race/ethnicity, year of diagnosis, and type of cancer. All patients in both groups had undergone chemotherapy, radiotherapy, surgery, and/or hormone therapy. The modalities involved were herbs and botanicals; vitamins and minerals; probiotics; Ayurvedic medicine; traditional Chinese medicine; homeopathy and naturopathy; deep breathing; yoga; Tai Chi; Qi Gong; acupuncture; chiropractic or osteopathic manipulation; meditation; massage; prayer; special diets; progressive relaxation; and/or guided imagery. The findings included:

  • CM use was associated with higher stage of cancer, younger age, being female, having private insurance, higher socioeconomic status, higher income, and
… Read the rest
July 23rd, 2018 | Tags: , , | Category: General | Leave a comment

Finalised Medicines Regulations have been published

Posted 28 August 2017

The Finalised Medicines Regulations have been published at last: http://www.gov.za/sites/www.gov.za/files/41064_gon859.pdf

Regulation 42(5)(c)(ii)(cc) requires that advertisements for unregistered complementary medicines include the disclaimer: “This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.”

It also includes regulations governing Complementary medicines, and “Health Supplements“

“complementary medicine” means any substance or mixture of substances that –

(a) originates from plants, fungi, algae, seaweeds, lichens, minerals, animals or other substance as determined by the Authority;

(b) is used or purporting to be suitable for use or manufactured or sold for use –

(i) in maintaining, complementing or assisting the physical or mental state; or

(ii) to diagnose, treat, mitigate, modify, alleviate or prevent disease or illness or the symptoms or signs thereof or abnormal physical or

mental state of a human being or animal; and is used-

  • as a health
… Read the rest
August 28th, 2017 | Tags: , , | Category: MCC (Medicines Control Council) | Leave a comment

Complementary medicines: When regulation results in revolution

Posted 30 May 2017

This article, published in the South African Medical Journal (SAMJ), is in related to the recent publication of regulations and drafts that will regulate so-called ‘complementary medicines (CAMS). The authors point out that “[T]he majority of complementary medicines that were on the market before the General Regulations came into effect, are now under threat and the nature of the industry will change once the new laws are fully implemented”. The important point is made that the Amendments do not change the process of regulation of complementary medicines.

… Read the rest
May 29th, 2017 | Tags: , | Category: General, MCC (Medicines Control Council) | 6 comments

Complementary Medicines – 2 more guidelines published for comment

Posted 21 April 2017

Two more complementary medicines/health supplements guidelines have been published for comment by the MCC:

The deadline for comment is 31 May 2017.

… Read the rest
April 21st, 2017 | Tags: , | Category: MCC (Medicines Control Council), Supplements | Leave a comment

MCC: Two new sets of regulations

Posted 31 January 2017

The Minister of Health has published two sets of regulations on 27 January 2017

  1. General Regulations to the Medicines and Related Substances Act (GoN 50, GG. 40577, 27 January 2017), for comment by 27 February 20167 according to the gov.za web site, but within 3 months according to the text – http://www.gov.za/sites/www.gov.za/files/40577_gon50.pdf

This is a comprehensive set of proposed regulations to accompany the launch of SAHPRA and allow for the promulgation of the 2008 and 2015 Amendment Acts. The ToC is as follows (and includes 25A. Sub -categories of complementary medicines):

… Read the rest
January 31st, 2017 | Tags: , | Category: MCC (Medicines Control Council) | Leave a comment

In the UK Herbex removes its claims; in SA, Herbex takes the ASA to court

Posted o4 January 2017

In June 2016, a complaint was lodged with the UK Advertising Standards Authority against website claims being made by Herbex in the UK. The claims were that Herbex is a herbal drink that “boosts metabolism, increases energy and controls appetite”. It is likely that, as in South Africa, the UK ASA was provided with evidence based on the botanical substances (ingredients) contained in the product. Herbex then agreed (after negotiation?) to withdraw the claims. This has now been done. The complaint is listed on the UK ASA’s website under “informally resolved cases” at: https://www.asa.org.uk/Rulings/Adjudications.aspx?date=04/01/2017#2 (scroll down to Herbex (PTY) Ltd). The list is prefaced with the following statement: “After consideration by the [UK] ASA of complaints received, the following companies and organisations agreed to amend or withdraw advertising without the need for a formal ruling.”

In South Africa, Herbex was ruled against by the Final Appeal … Read the rest

January 29th, 2017 | Tags: , , , , | Category: ASA (SA) Rulings, ASA (UK) Rulings | Leave a comment

Medicines Control Council (MCC): guidelines on complementary medicines

Posted 13 June 2016

A number of updated guidelines for complementary medicines have been published on the MCC web site:

7.01 Complementary Medicines – Discipline Specific Safety and Efficacy V3 13-Jun-2016  –
http://www.mccza.com/Publications/DownloadDoc/4411

7.03 Complementary Medicines – Use of the ZA-CTD format in the Preparation of a Registration Application V3 13-Jun-2016  –
http://www.mccza.com/Publications/DownloadDoc/4413

7.04 Complementary Medicines – Health supplements Safety and Efficacy V2 13-Jun-2016 –
http://www.mccza.com/Publications/DownloadDoc/4412

7.05 Complementary Medicines – Registration Application ZA-CTD – Quality V1 13-Jun-2016 –
http://www.mccza.com/Publications/DownloadDoc/4414

The definition of a complementary medicine, to include the category ‘Health Supplements’ as suggested in a previous draft,  is expected to be finalised soon. CAMs will in future be divided into discipline-specific CAMs (linked to the AHPCSA-regulated disciplines) and ‘Health Supplements’. Guidelines on safety and efficacy will be then separated for the two types of CAMs, but the quality guideline and ZA-CTD guidelines are common to both types.

… Read the rest
June 13th, 2016 | Tags: , | Category: MCC (Medicines Control Council) | Leave a comment

GroundUp Op-Ed: Complementary medicine companies are destroying consumer protection

Posted 31 May 2016

First published by GroundUp

What do these have in common?

  • Herbex Attack the Fat Syrup will help you lose weight.
  • Solal’s anti-ageing pill can increase your lifespan and improve heart function.
  • Antagolin combats insulin resistance and will help you to lose weight effectively.
  • USN’s Tribulus is a “testosterone booster” and “libido enhancer”.

They’re all claims by complementary medicine companies about products they sell. All of them are at best misleading, not properly tested and probably false. All were ruled against by the Advertising Standards Authority (ASA).

And all four of these companies are doing their utmost to destroy the ASA. They may have succeeded, which means there is little protection left for consumers from misleading or unsubstantiated medical claims.

… Read the rest
May 31st, 2016 | Tags: , | Category: | Leave a comment

D-day for complementary weight loss medicines?

On 15 November 2013 the Minister of Health finally published Regulations to the Medicines Act (Medicines and Related Substances Act, 1965 (Act 101 of 1965), not for comment, but for implementation. They defined complementary medicines for the first time in South Africa. In addition the Regulations incrementally “called up” various complementary medicines over the following six years.

If a product that has been called up, and has not been registered, or an application for registration has not been received by the MCC, then according to the Medicines Act (Section 14(1)) it may no longer be sold.

The Regulations also created a new category of medicines – category D – which are complementary medicines “subdivided into such disciplines as may be determined by the Council after consultation with the Allied Health Professions Council of South Africa.”

This left “dietary supplements” out in the cold and the Health Products Association … Read the rest

November 15th, 2015 | Tags: , , , , , , , , , | Category: MCC (Medicines Control Council) | 2 comments

Safety and quality of herbal supplements

Posted 13 February 2015

This interesting article written by the pharmacist, Scott Gavura, in 2013 (but still relevant) and posted to Science-Based Medicine, argues that it is unfair to require decent proof that certain medicines are safe, and have efficacy, compared to others, e.g., complementary medicines.

Some extracts that are pertinent.

“And when it comes to ensuring the products we buy are of high quality, we’re all effectively reliant on regulation to protect us. As a pharmacist, I can’t personally verify that each tablet in your prescription contains the active ingredient on the label. I am dependent on a supply chain that may stretch around the world. While the product manufacturer may be reputable, it’s only a regulator that can realistically verify and enforce production to strict quality standards. The same cannot be said for products like supplements and herbs which are regulated differently than drugs, and held to … Read the rest

February 13th, 2015 | Tags: , , , | Category: | Leave a comment
 
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