With regard to the question of safety in using a product containing the Nerium extract NAE-8 scientist at Nerium Biotechnology retained a prominent laboratory and testing for product safety and clinical application was initiated with Science, Toxicology & Technology, Inc. (ST&T Research). ST&T Research is comprised of a group of prominent scientist, including M.D. and Ph.D. pharmacologists/toxicologist and research product development oriented physicians, scientist, and regulatory compliance specialists which include a legal team specializing in US FDA/FTC/Customs regulations.
Dr. Robert A. Newman, Ph.D., Professor Emeritus, Professor of Experimental Therapeutics, Founder and Co-Director of the Pharmaceutical Development Center at the University of Texas M.D. Anderson Cancer Center (MDACC) serves as lead researcher and scientific advisor to Nerium Biotechnology, Inc. Dr. Newman, who serves as a scientific advisor to Nerium SkinCare, assisted by providing safety data from previous studies, experience from a FDA cancer trial at The University of Texas M. D. Anderson Cancer Center, and the analytical analysis for the determination of oleandrin (CG) in blood plasma.
Each study’s primary end-point was to evaluate the Nerium test articles for safety/toxicity, a) Determine if the Nerium oleander CG metabolites were being absorbed through the skin, b) If so, how much, c) If there was any noticeable blood pressure or heart rate changes, and d) If there were changes in blood chemistry or organ system functions. In addition, subjects were observed for inflammation, rash, or tenderness possibly related to the cream application.
ST&T utilized blood chemistry and CBC analysis whereby a comparison was made of the participant’s baseline results with measurements taken throughout the study. As an example, participant blood samples were taken on day one (1) (one hour after cream application), day seven (7), day fifteen (15), and on day thirty (30) of product use to test for oleandrin (CG) absorption and accumulation in the blood.
Analysis was non-eventful. The blood analysis showed all subjects within normal ranges, there were no detectable CG’s in the blood and no adverse reactions noted. The cardiac glycosides contained in Nerium oleander extracts were NOT ABLE to penetrate the skin at detectable levels in the blood.
Four human trials were done with results being, “There does not appear to be any toxicity associated with exposure of a Nerium oleander extract to the skin. Both animal and human studies suggest that dermal application of Nerium oleander extract is safe. In four human studies in which a Nerium oleander extract was applied to the skin of people with different dermal conditions, sensitive mass spectrometry based blood analyses were not able to detect the presence of cardio glycosides such as oleandrin, indicating that these compounds are not readily absorbed through the skin.
Testing has been done since the mid-1990s, and the product NeriumAD with the NAE-8 compound was released in August 2011, so much clinical testing has been done and should allay any fears of safety concerns.
It should be noted that between 1985 and 2002 there were three deaths reported from people eating the Nerium oleander plant. Please compare this to one 30 year report that showed over 1,641 illnesses and 17 deaths from people eating mushrooms.
Sources include: http://neriumskin.com/research/clinical.htm and http://www.neriumbiotech.com/product.htm, http://namyco.org/images/pdf_files/Poisonings30year.pdf
1. Further sources: ^ a b c ST&T Research Intl. An open label, non randomized, pilot study to test the safety and efficacy of Nerium-AS, a topical natural Nerium-based solution, (the Test Article) in patients with solar lentigines (Age Spots) and actinic keratosis. 2008c. Report to Nerium Biotechnology, Inc.
2. ^ a b c ST&T Research Intl. A double blind product comparison randomized two product study to test the safety and efficacy of a natural topical Nerium based Solutions, Nerium-ACW & Nerium ACA, against a typical Acne OTC product, in volunteers exhibiting mild to moderated Acne Vulgaris. 2008a. Report to Nerium Biotechnology, Inc.
3. ^ a b ST&T Research Intl. An industry-initiated pilot study to test the safety and efficacy of a natural topical Nerium-based antiseptic solution, NeriumDerm, to help promote and speed the healing, reduce symptoms, and/or to mitigate and reduce pain and the spreading of skin irruptions or wounds to outside mouth areas in form of lip lesions, pimples, blemishes, fever blisters, or active cold sore(s) or HSV-1, in otherwise healthy volunteers. 2009. Report to Nerium Biotechnology, Inc.
4. ^ Kelly PJ. Anvirzel Topical Skin Cream Treatments. 1998. Unpublished Report.