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Posted 04 May 2018
Activist puts the blame on SA’s new drugs regulator, which in turn claims it is under-resourced
Desperate to lose weight, a Joburg woman was eager to try a weight-loss pill readily available online – one that promised to be a herbal remedy. But then things took a turn for the worse for her health.
Four days after starting to use Wondernut, she started shaking all over. The woman has severe bipolar disorder but has been stable for years on a range of psychiatric medications.
“We thought she was having a ‘depressive’ episode as she was a wreck and couldn’t talk properly. This was accompanied by gastritis with nausea, vomiting, inability to eat and severe pain. She was in bed for 10 days. She stopped using the product, and is only just getting better now, physically and emotionally,” her daughter explained.
Enter Harris Steinman, a doctor and activist, and a man on a mission against unregulated medicines. Central to this is a delay in registering complementary medicine by the SA Health Products Regulatory Authority (Sahpra).
Formerly the Medicines Control Council, Sahpra’s job is to regulate both actual medicines and complementary medicines that include weight-loss tablets, herbal remedies and vitamins on pharmacy shelves.
In his spare time Steinman has started collecting complaints from people who reportedly fell ill after using the weight-loss remedy.
For months, he has been writing on his website about Wondernut, which goes by various names.
Two weeks ago a person wrote to Steinman saying his niece was in ICU after using it.
“She had had three dialysis treatments for failing kidneys, she is having multiple blood transfusions as we speak and is on morphine for pain.”
This followed use of the herbal product.
Another woman wrote that she started having excruciating stomach pain.
“I literally felt as if I had been poisoned … I was devastated as I had hoped this would help me, but I would rather be healthy and alive at a higher weight than do damage to my body internally.”
She has now joined a gym and started to meditate, and is slowly shedding the weight.
Steinman makes it a mission to warn people against products that are untested for safety or efficacy.
In November 2017, South Africa’s then Medicines Control Council also issued a strong warning that the nuts of Aleurites moluccanus (L.) Willd. – also known as Indian Walnut‚ and marketed in South Africa as the Wondernut – had reportedly toxic effects in humans‚ ranging from severe gastrointestinal irritation to death, consumer journalist Wendy Knowler reported.
That was because it contains compounds that have irritant properties and are very strong purgatives‚ the regulator said.
“They may also act as potent tumour promoters and be very irritating to the skin and eyes. Ingestion of the nuts has been reported to cause vomiting‚ gastrointestinal pain and diarrhoea.
“Health agencies in countries such as Spain‚ Argentina‚ Chile and Brazil have prohibited the use of the seeds due to deaths reportedly caused by their ingestion for weight-loss purposes.”
In November 2013, the then Medicines Control Council issued new regulations for herbal medicines that promise to cure everything from high blood sugar and high cholesterol to sexual problems, insomnia and anxiety, and to improve sporting performance.
The manufacturers of these herbal remedies needed to provide scientific evidence that the product was safe and effective in doing what it claimed to do.
Sahpra didn’t approve a single application last year, former Registrar Joey Gouws confirmed (she left at the end of last year). She said the dossiers provided and scientific research were not of the required standard.
Sahpra acting CEO Portia Nkambule did not respond to questions sent about this issue three weeks ago, despite giving an undertaking to do so.
Herbal medicine advocate Anthony Rees says many herbal companies who have submitted applications are, fou-and-half years later, yet to get a receipt from Sahpra.
“Many of the companies I spoke to haven’t even received acknowledgement of receipt for their submitted applications, nor receipts for their application fees.”
“This can only mean the applications are either not being assessed, have been lost, or Sahpra has bitten off more than they can chew by imposing requirements for these products.”
“Frankly, the whole complementary medicines regulatory system has become quite a farce and it’s evident why a large segment of the industry are not willing to comply, and have recently launched a legal review of the basis of the complementary medicines in the High Court.”
Judging from a parliamentary presentation Sahpra still has some way to go before it becomes functional.
Sahpra was formed last year out the Medicine Control Council that used to regulate both ordinary pharmaceutical medicines and herbal vitamins and remedies.
Sahpra has a new board, new staff and is structured legally to get less funding from government than the Medicines Control Council did and become largely self-sufficient.
But it recently told parliament it had yet to fill CEO and CFO posts due to strict regulations around hiring government staff. A new IT system is also expected to be ready by the beginning of 2019.
Nkambule explained that, if it is to achieve its goals, financial resources, IT infrastructure, resource capacity and a skilled human capital are critical.
But she told Times Select they are severely understaffed. “The Sahpra business model will require a staffing complement of around 450 full-time employees to carry out all required regulatory functions and will be phased in over a period of five years. Sahpra currently has 178 full-time employees and a similar number of external evaluators supporting regulatory activities currently.”
Of its R215-million budget, almost R149-million will go to salaries, they told parliament.
The Wondernut website states: “This organic weight loss seeds (sic) has not been evaluated by the MCC. [It] is not intended to diagnose‚ treat‚ cure or prevent any disease.”
The website features a series of video interviews with sales agents‚ conducted by director and co-founder Maureen Botes‚ who makes health statements‚ including: “It has worked on cancer patients‚” and: “It can make your blood pressure drop.”
She repeatedly says those taking the product have seen a dramatic reduction in their cholesterol levels.
Contacted for comment‚ Botes told Knowler: “Our legal team has asked us not to talk to you people.”
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