Sunday, December 16, 2012


Two years ago liver doctors sounded the alarm about cases of liver damage in users of Herbalife products. They were unable to say which component in Herbalife products was causing the liver damage, but researchers at the University of Bern made an attempt to do so in an article published this year in the Journal of Hepatology. They found the bacteria Bacillus subtilis in Herbalife products.

In the article the doctors discuss two cases of people who became ill after using Herbalife products: a man aged 78 and a woman aged 50. The man's urine had turned dark brown, he had hepatitis and had been feeling unwell for a couple of weeks. He had been using the Herbalife F1 Shake [Strawberry and Cappuccino flavours] for three years on his daughter’s advice [she was a Herbalife salesperson], as well as various other medicines. According to the analyses, the man had a liver complaint. When the doctors took him off the shake his blood values recovered, but they deteriorated again later. The doctors gave the man corticosteroids and ursodeoxycholic acid, after which he recovered completely. You can see the fluctuations in the man’s blood values in the graph below.

The woman sold Herbalife supplements. She took half a dozen different Herbalife supplements, including the Personalized Protein Powder Mix Formula 3. She had stomach pain and hepatitis and the doctors found signs of liver damage in her blood. They got the woman to stop taking the supplements and the graph below shows how the liver values in her blood improved.

The researchers examined samples from the livers of the man and the woman and found signs of damage in both. The doctors turned the supplements that the men and women had used inside out, but found no contaminants: no heavy metals, no pesticides, no antibiotics, nothing. But when they examined the Herbalife products for micro-organisms, they did come across something. The meal substitutes the man and woman had been using contained the bacteria
Bacillus subtilis. [see photo.] This was the cause of the liver complaints, according to the researchers.

Honestly speaking, we’re not sure what to make of this. As far as we know, B. Subtilis is found in pretty much everything, and it’s not particularly dangerous. [Wikipedia] Some studies even regard it as a probiotic. It would seem pretty unlikely then that B. subtilis is the cause of such serious liver damage. 
Yet more reports of liver damage from Herbalife

Yet more reports of liver damage from Herbalife
In 2007 liver doctors sounded the alarm about cases of liver damage in users of Herbalife products. [J Hepatol. 2007 Oct;47(4):521-6. ] [J Hepatol. 2007 Oct;47(4):514-20.] According to researchers at the Universidad de Oviedo in Spain there are still problems with the products. The Spaniards analysed data from the Pharmacovigilance Centres and discovered twenty cases of liver damage among Herbalife users.

In their article the Spanish researchers refer to the cases that were reported in 2009 and to other more recent references that have since cropped up in the literature. These included a case of hepatitis in a 63-year-old Argentinian woman who was using Herbalife [Acta Gastroenterol Latinoam. 2008 Dec;38(4):274-7.] and cases reported by Icelandic researchers in 2010. [Laeknabladid. 2010 Mar;96(3):167-72.]
According to the Spanish researchers 30 cases of liver damage in Herbalife users have been described in the literature. When they looked into the Spanish pharmacological databanks they found another 20, bringing the total now to 50.

The researchers studied the period from 2003 to 2010.

In 15 of the 20 cases the patients were not using any medicine, therefore ruling out possible interaction between Herbalife products and other substances which might cause liver damage.

Yet more reports of liver damage from Herbalife

In nine cases the researchers found measurements that doctors had made of the enzyme ALT during after use of Herbalife products [below left]. ALT is an indicator of liver damage. The higher the ALT level, the worse the state of the liver. Stopping Herbalife products improved the subjects' liver condition.

Yet more reports of liver damage from Herbalife

Two of the patients started to use the Herbalife products again afterwards. In the figure above on the right you can see that their ALT level rose again, and then fell when the patient stopped using the products.

The researchers don't know which Herbalife products cause liver damage. Many of the patients used Rose Ox – a supplement containing extracts of turmeric, rosemary and clove – and the protein shake Formula 1, some patients did not use these products.

As far as the Spaniards are concerned though, the matter is clear. "Our results emphasize the need to establish further regulatory measures", they write.

Herbalife responded several months after the Spanish study results were published. [Pharmacoepidemiol Drug Saf. 2012 Mar;21(3):333-4.] According to Herbalife the Spanish used the wrong method when claiming that Herbalife products were the cause of liver damage, and the researchers themselves were dubious. "The failure to acknowledge these assessments raises questions about the authors' scientific balance given the serious and unsubstantiated accusations about a company's whole product line", wrote Herbalife.

The first author of the Spanish study, Gloria Manso, is not impressed with the way Herbalife denied the research findings.

"This is perhaps an understandable attitude after the first publications but not when after a considerable period, new cases keep being reported and are added to the list", Manso writes. "Herbalife should, at least, consider the possibility that some of their products can induce hepatotoxicity in certain circumstances and should make an effort to actively collaborate in the identification of the agents responsible."

Herbs and healthy livers

Few consumers hear about the reports in the medical literature of liver and other toxicities from herbal products. Dr. Leonard B. Seeff, M.D., of the National Institutes of Health, reviewed the herbal products that have been associated with liver damage in the journal Clinical Liver Disease. His concerns about the growing numbers of medical cases were similar to an earlier 2005 comprehensive review for the European Association for the Study of the Liver in the Journal of Hepatology, led by Dr. Felix Stickel, M.D.. These doctors reported that, depending on the geographic region, 21% to 65% of patients seen for liver disease have been taking herbal preparations. Most evident is that women are at greatest risk not only because they use more herbals, but because of their higher susceptibility to herbal- and pharmaceutical-induced liver damage. Because many practitioners and consumers believe herbals are safe, the doctors noted the many times patients will even continue to take them as their liver diseases worsen.
Dr. Stickel and colleagues added:
Another problem is that herbals are usually mixtures of several ingredients or plants harvested during different seasons and extracted through variable procedures, which makes the identification of both the pharmacologically active and toxic compounds difficult. Also, contamination of herbals with microorganisms, fungal toxins such as aflatoxin, with pesticides, heavy metals and synthetic drugs has been described. Interactions between herbs and chemical drugs are another source of problems associated with the intake of herbal compounds.
While liver damage appears infrequently, the consequences are serious enough for patients that these cases are getting the notice of doctors. Another article in this month’s issue of the Journal of Hepatology by researchers at Hadassah-Hebrew University Medical Center in Israel reported on 12 patients (11 women) with acute liver injury after using Herbalife products. Incredibly, after three patients recovered, they resumed taking Herbalife products and succumbed to a second bout of hepatitis.
Another article in the same issue reported on a study by doctors in Switzerland. They had become concerned after seeing several patients with severe liver damage who had been using Herbalife products and tried to determine how prevalent liver toxicity due to Herbalife products might be. They surveyed all departments of medicine at 121 Swiss public hospitals, divisions of gastroenterology/hepatology, pathology and the Swiss pharmacovigilance database and identified 10 cases of liver toxicity in otherwise healthy people not taking any other herbal products or medications from 1998-2004. Rigorous questioning proved necessary as patients consistently underreported their use of herbal products, they said. They carefully documented the cases, including obtaining liver biopsies in most. Three of the ten patients had potentially life-threatening liver failure requiring liver transplants.
“The lack of labeling of contents of these products renders causality assessment impossible,” they reported. But using the WHO criteria for Causality Assessment of Suspected Adverse Reactions and expert hepatopathologists blinded to the patient information of herbal use, they determined that two were certainly caused by the Herbalife products, seven cases were probably and one case possibly.
This is not the first time that Herbalife has been in the news and the target of governmental regulatory agencies and concerned medical professionals. As recently reported, it is one of the oldest multi-level marketing companies selling vitamin and herbal products promising better health and slimness. Herbalife has found it especially lucrative to take advantage of poor people in developing countries. MLM is a sales technique where people, working as independent distributors, buy sales kits and products which they sell and, in return, are promised they’ll make money from those sales as well as from a percentage of the sales of those who they recruit as new distributors. However, fewer than 1% of distributors ever earn much money and many are stuck with thousands of dollars of products. MLM and pyramid schemes are listed on many attorney generals' top ten lists of consumer complaints. At MLM, you can read more about MLM, including a summary of complaints that have previously been submitted to the FTC on Herbalife products.
A few years ago, the National Council Against Health Fraud issued a position paper on MLM health product companies. It listed important precautions for consumers, as well as described the harm that’s come to people who’ve gotten mixed up in them. Dr. Stephen Barrett, M.D., NCAHF Vice President, examined more than 100 MLM companies offering health-related products and concluded “that every one of them has made false or misleading claims in their promotional materials.” He said:
The products promoted as remedies are either bogus, unproven or intended for conditions that are unsuitable for self-medication...Most supplement companies get their raw ingredients from the same bulk wholesalers and merely repackage them...During the past several years, many physicians have begun selling health-related multilevel products to patients in their offices. Doctors are typically recruited with promises that the extra income will replace income lost to managed care....During the past 20 years, more than 25 health-related MLM companies have faced regulatory actions for false advertising, operating a pyramid scheme, or both. Although such actions usually improve future behavior, they rarely provide adequate redress for victims. Moreover, the number of MLM frauds known to Federal Trade Commission vastly exceeds its capacity to prosecute them on a case-by-case basis.
The growing reports of life-threatening health risks among users of these products remind us to not to be taken in by claims of magical benefits of any dietary intervention. Beyond preventing deficiencies — which is easily achieved by virtually everyone simply when enjoying all sorts of foods — no food or supplement is supernatural. When we hear claims that optimal or personalized nutrition is science-based and can improve our heart, digestive or immune health; help us age healthfully, improve our memory or eyesight, or remove wrinkles; increase our energy and fitness; or manage weight, control our appetite or boost metabolism...we know it sounds too good to be true.

The pursuit of optimal nutrition, ‘wellness’ and slim bodies has become fertile ground for the marketing of products, diets and regimens that promise “a lifetime of good health.” Herbal and natural dietary and weight loss supplements can be alluring because they may seem safe. Three new studies, however, have documented liver toxicity among healthy people using natural herbal supplements — more than 20 cases were just among Herbalife customers in two small countries.