Possibly the first case in the Asia-Pacific region, Prema*, who consumed Herbalife products to lose weight, died instead
She was all of 23 years old, a young mother of two. Last year on her older son’s birthday, Prema* clutched her abdomen, experiencing acute pain. This was unexpected, because until then everything was normal.
Speaking to The Lede, her husband Suresh* said - “After my wife developed the abdominal pain, we must have visited at least 8 hospitals, within a month’s time. First we went to gynaecologists, who said it was a urinary infection. That treatment went on for a few days, but the pain kept getting worse. My wife could not even get up from her bed.”
Suresh, who is a hospital worker in Kerala, remembers with a heavy heart, how they went from doctor to doctor, hospital to hospital, only to be told finally that her liver had been damaged beyond repair and she required an immediate liver transplant to survive.
But no doctor could figure out what had caused such acute liver damage in Prema. At the fifth hospital they went to, the Ernakulam Medical Centre’s liver unit, Dr Cyriac Abby Philips, probed further.
“I had been telling every doctor that she had taken Herbalife products for losing weight 6-7 months ago. Everyone except Dr Abby Philips, did not take cognisance of it. Even we did not think it was a big deal,” recalled Suresh.
In 2017 at a fair, the family saw an advertisement that spoke about products to help lose weight. Prema then weighed 75 kilos and for her height she was supposed to weigh only around 52 kilos.
Enticed by the advertisement they got in touch with a local Herbalife clinic and she took their products for nearly two months. It cost the family Rs 10,000 and after that they had to stop because they could not afford it.
She lost 4-5 kilos of her weight and life resumed as usual, until that fateful day of 26 January 2018 when her stomach ache began.
“After the doctor explained to me about the possible side effects of using the products, I read about it online. And yes all the side effects that I read about, my wife had been suffering since her abdominal pain started,” recollects Suresh.
Prema’s family refused to donate a liver and she was waitlisted for a donor. Before she could get one, Prema died on 28 February 2018.
Suresh, 37, is now left with two young sons, a 6-year-old and a 2-and-half-year-old, forced into debt to the tune of Rs 16 lakh, as a result of all the treatment and tests in the short span of a month.
Dr Abby Philips then researched, and tested the samples of the Herbalife products. Although he was unable to test the actual samples that Prema had consumed, the research team managed to get the products from the same vendor and also ordered more samples online.
After a year of research and peer-review, the study was published in the Journal of Clinical and Experimental Hepatology in their March-April volume this year.
“She was admitted under my care in the month of February 2018 for four days,” said Dr Philips. “She was deeply jaundiced, in and out of consciousness. She could identify people around her, but was confused as to time and place. It took us less than 72 hours to figure out the cause for her liver injury, and she was discharged to a transplant centre for further management.”
He explained how their unit made the diagnosis. “In our unit for every liver injury that is acute in onset (that is occurring within days to weeks) we look for all common causes for such acute events - acute viral hepatitis A, B and E; rare viral diseases such as herpes, dengue, prescription drugs such as painkillers and antibiotics and also rare diseases of the liver such as Wilson’s disease or autoimmune hepatitis. In this particular patient, all of these were negative.
So we went ahead and took an intense drug history that included herbal and dietary supplement questioning also. The husband of the patient provided us with the history of Herbalife product intake.
Once this was identified, we apply something known as a Causality Tool to identify association of drug or dietary supplement with the acute liver injury. In this patient, we could ascertain a strong association.
This was followed by a liver biopsy that showed extensive damage to the liver cells and loss of liver cells that was compatible with the diagnosis of drug/dietary supplement related liver injury,” he explained to The Lede.
This means that Prema, according to the research, died because her liver gave way as a result of consuming Herbalife products.
The results of the peer-reviewed research report that was subsequently published in the Journal of Hepatology showed the alarming nature of the composition of the Herbalife products.
Dr Philips added that he has also come across about 4 to 5 new cases of acute liver injury in his daily practice. The common causes he observes at the moment, in his unit and also in the Asian subcontinent are complementary and alternative medications (such as ayurvedic herbals, herbal dietary supplements, traditional herbal medicines).
The other causes are acute viral hepatitis A, B and E and also medications such as anti-tuberculosis drugs and painkillers. He says that however, the latter groups are becoming fewer while alternative medications related liver injury is on the rise the world over.
He concludes his study saying that the supplements must be reclassified and put through scientific studies.
It all begins with the urge to be thin. Everyone wants to be thin, because thin is “appealing” – but that is another story altogether.
So how do we achieve this much desired ‘thinness’? We look for home remedies, like eating less, drinking things like green tea, taking less fatty foods, eating less rice and wheat (reducing carbohydrate intake), food that make us curb our appetite and getting some exercise too on the side.
After this when we are not losing weight we look for other options, talk to people around us, take advice, we look for products to aid us in the quest for losing that extra weight.
When it comes to weight, the idea of going to a doctor comes only when the situation is life threatening - say if this weight is causing diseases, of affecting our productivity severely.
This is the story of the middle class and the poor, for whom any other method is way better than going to a doctor, a very expensive prospect.
That is how the majority of the population ends up at the doorstep of options like natural medicine, supplements, food with health benefits, which are classified under food category and do not require medical prescriptions to consume. They can be bought over the counter pretty much anywhere and are deemed safe for consumption.
Sometimes though, like with Prema, things can go horribly wrong.
The above mentioned study reports that Prema’s is the first case of death, due to the consumption of Herbalife products, in the Asia-Pacific.
Herbalife associated liver injury was initially reported from Israel, followed by Spain, Switzerland, Iceland, Argentina and the United States.
As early as 2008, it was noted in the Journal of Hepatology, by an Israeli researcher, that the estimated incidence of liver toxicity is 25–30 cases per 100,000 consumers of Herbalife products.
Herbalife is an American herbal and dietary supplements company whose products have been in the Indian market for the last 20 years. For the global multi-level marketing corporation, India and Asia is a major market.
When contacted by The Lede about the report on Prema’s death and the associated reports about liver damage due to their products, Herbalife, in an official statement wrote:
“Every day, millions of consumers safely use Herbalife Nutrition products around the world and we stand by the quality and safety of our nutrition products. All of our products and manufacturing procedures comply with relevant government regulations governing quality in each of the 94 markets where our products are sold, and no hepatotoxins have ever been found in our products. In addition to our robust routine testing program in India, we asked an independent, government-certified laboratory to test the products mentioned in the recent journal article and the results confirm the products are completely safe and comply with all relevant Indian government safety regulations.”
Apart from this test, dated 10 May 2019, the company has also appointed an agency to investigate the report findings. Their enquiry report, they say, is expected very soon.
In India, the Food Safety and Standards Authority of India, an autonomous body, under the Ministry of Health and Family Welfare, regulates the health supplements and nutraceuticals (nutrition + pharmaceuticals) sector with the use of the Food and Safety Standards Act of 2006.
These products are regulated under the Food Safety and Standards Regulations, last amended in 2016. The regulations cover eight categories of food and are defined based on their contents and use.
While nutraceuticals are regulated by the FSSAI, its CEO and IAS officer, Pawan Kumar Agarwal told The Lede that this report has come to their notice and they have asked for an explanation from Herbalife.
“Even though it is a peer-reviewed study, we are not legally bound to take action based only on it. In our first step, we have asked the company for an explanation on the issue. They still have time to respond. We will take action after we hear from them,” he said.
When asked what would be the FSSAI’s course of action once the response from Herbalife comes in, he said - “This does not happen on an everyday basis, we have to figure out how to investigate it in the first place. First and foremost, give the company an opportunity to explain its position, after that what corrective and preventive action is to be taken.”
Emails have also been sent by The Lede to the Kerala Health Minister, Chief Secretary, Additional Chief Secretary of the DHS as well as the Union Health Minister and other officials in the ministry.
The Union Minister’s secretary redirected this reporter to the FSSAI whose response has been recorded above.
None of the others have responded despite multiple follow-up phone calls. This article will be updated when the Kerala state government officials respond.
This is not the first time nutraceuticals have come under scrutiny in India.
In July 2018 during the 4th National Symposium on Nutraceuticals summit, the then chairman of FSSAI, Ashish Bahuguna said, “Everyone expects the acceptability of nutraceuticals to grow. I feel the first challenge is that consumers have ‘bramh’ (confusion). There is so much misinformation.”
There are also false claims about the products. The consumers want claims on labels to be clear. The industry should clarify the difference between nutraceuticals and pharmaceuticals, he said asking the industry to work in this direction. Consumer interest and safety should be the priority for the industry, for which it should adopt self-regulation, he added.
Currently nutraceutical products are left to the discretion of its manufacturers and are also encouraged to self-regulate.
At the same event, a joint report by ASSOCHAM-MRSS (Associated Chambers of Commerce of India & MRSS India, a market research firm) was released, which revealed that the Indian nutraceuticals market was expected to grow at a compounded annual growth rate of 21% and reach USD 18 billion by 2025 from USD 4 billion the previous year.
Globally the nutraceutical market was expected to reach USD 578.23 billion by 2025 from USD 294.49 billion in 2017
With such huge growth prospects, a lot of eager consumers, the nutraceuticals sector is staring at a lucrative market.
And with it comes an urgent need for more stringent regulations and enforcement by the government.
Prema’s husband, Suresh says that the Herbalife clinic that they had visited has now expanded and many more people are consuming the products.
“I am a poor person in huge debt with two young children,” said Suresh. “So I cannot do anything to stop people from going to such clinics or to stop such clinics from running. But I wish that no other family should experience a loss like mine. During my work I momentarily forget my loss and help people out. But once I am home, I am very deeply disturbed. I lost my wife, because of something that should have helped her lose weight.”
(*Names have been changed to protect identity)