UNFOUNDED SPECULATION ABOUT CUUR FROM THE SWEDISH MEDICAL PRODUCTS AGENCY
(NGM:SCN)
The Swedish Medical Products Agency yesterday published allegations stating that the natural product CUUR may cause liver interactions. In the opinion of SCN, there is no foundation for such speculation. CUUR has undergone extensive studies, of which none has shown any adverse effects. The Agency has not placed any restrictions on the product, and the action of the Agency will not affect the company’s plans for an international launch of CUUR.
The Swedish Medical Products Agency yesterday published allegations stating that six cases of suspected liver interactions might be connected to the weight control product CUUR.
“This action by the Medical Products Agency is at best pure speculation. SCN has carried out extensive internal and external evaluations of the alleged side effects the Agency is referring to, also together with our raw material suppliers, and the conclusion is that CUUR has nothing to do with the alleged side effects”, says Ulf Söderberg, CEO of SCN.
“This will not affect our plans for an international launch of CUUR. CUUR is a safe product, and this has been shown in several studies. One should also take into consideration that CUUR has been sold in more than 400,000 boxes in Sweden (equals to 36 million doses), and in relation to this, six cases of suspected side effects is a very small number. For pharmaceuticals, a side effect is considered common if one or more of 100 doses produces side effects, and rare if less than one of 1,000 doses produces side effects. In addition to this, there are no reports about side effects of CUUR in any of the other markets in which the products is sold, neither for the ingredients, which all have GRAS approval (Generally Regarded As Safe) from the Food and Drug Administration (FDA).
To be able to draw any conclusions about CUUR and liver effects, other factors that might interfere must be eliminated. In the six cases the Medical Products Agency is referring to, the following has not been eliminated:
a. Effects of pharmaceuticals consumed by the patients, which, according to the Swedish pharmaceutical reference guide have liver effects as common side effects
b. How dieting in itself affects the liver
c. Already existing liver problems in three of the cases
Three of the cases that the Agency is referring to, already had a so called non-alcoholic fatty liver diagnose (hepatic steatosis), which is present in up to 70 per cent of subjects considered obese. Hepatic steatosis has been suggested as an important component in metabolic syndrome, and has connections to both production of pro-inflammatory cytokines and insulin resistance. This diagnose can be aggravated when dieting, since the weight reduction causes release of fatty acids from the fat tissue in the body. When free fatty acids reach the liver they increase the hepatic load, with consequences for liver function and elevated markers for liver function as a result – a fact well known and documented in medical literature. In addition to this, obese women have a higher frequency of gallstone, and dieting can induce gallstone release.
CUUR has undergone toxicity studies, in which rats have been given the product for 3-6 months (the normal life span of a laboratory rat is approximately two years). None of these studies have shown any effect on pancreas, intestines, kidneys or liver. Extensive studies in both Sweden and France have also been done on green tea, a main component in CUUR, and none of these have shown any side effects.
More information:
CEO Ulf Söderberg, ulf.soderberg@scnutrition.com, +46 708 13 22 81
Business Strategy Manager Anders Struksnes, anders.struksnes@scnutrition.com, +47 911 98 942
Scandinavian Clinical Nutrition AB (publ) works in R&D and sales of scientifically documented products within the field of
nutrition (nutraceuticals). Established in 2006, SCN maintains a product portfolio with established trademarks, such as
CUUR, Membraseven and Ledactin. Core competence and strategic alliances, within both R&D and sales, in combination
with innovative and scientifically documented products, create the right conditions for profitable growth both in Sweden and
in the company’s export markets. The SCN share is listed for trade on NGM Nordic MTF since December 6, 2006.