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Denture Cream Manufacturers: What Did They Know?
Recent media attention about over-the-counter denture cream causing crippling neurological damage raises two obvious questions for the drug companies: What did they know and When did they know it?
February 17, 2010 /Dental PR News/ -- Denture Cream Manufacturers: What Did They Know?
Recent media attention about over-the-counter denture cream causing crippling neurological damage raises two obvious questions for the drug companies: What did they know and When did they know it? When you are trying to determine what a drug company knew, and when they knew it, the first place to look is the medical literature. They do after all make billions of dollars selling products to be placed in our bodies. And general legal principles and FDA regulations, not to mention, the Hippocratic oath, dictate that drug companies carefully analyze the potential toxicity of the ingredients of their products. So when GlaxoSmithKline and Proctor & Gamble began putting Zinc in denture cream, what did the medical literature tell them about the health risks to the people buying their products?
The answer: It told them that excess zinc can cause a crippling neurologic syndrome, involving myelopathy and sometimes polyneuropathy. This syndrome is characterized by a loss of the ability to feel or use the arms and legs, and can even result in complete paralysis.
As early as 1978 [1] , and then again in 1988 [2] it was reported that oral zinc therapy could cause copper deficiency in patients. Furthermore, diseases associated with altered copper levels in animals and humans have been recognized since the early 20th century. An illness known as swayback disease, which is caused by a nutritional deficiency of copper, was first identified in sheep in 1937. Additionally, Menkes Disease which is a congenital disease in humans characterized by low copper levels has been studied since 1962.
The first study linking copper deficiency to neurologic disease was published in Medical Hypotheses in 1992. [3] In 2001, a study was published reporting copper-deficiency associated paralysis and myelopathy in a 46 year old woman. [4] As a result of her copper deficiency, the woman developed severe spastic movements and loss of sensation from the middle of her back down to her feet. In 2003, two additional studies reporting the correlation between high levels of zinc and neurologic degeneration and polyneuropathy were released. The first study reported the neurotoxic effects of zinc and its potential to cause neurologic degeneration. [5] The second study discussed a patient who was unable to walk without the aid of a walker, because of progressive polyneuropathy and myelopathy resulting from copper deficiency and high levels of zinc. [6]
The Journal of Neurology again published a report in 2004, identifying a patient with high zinc levels and a copper deficiency who was suffering from a neurological syndrome characterized by myelopathy and neuropathy of the lower extremities. [7] This study discussed the emergence of zinc neurotoxic syndrome in the medical community, and reported the patient's symptoms to include: loss of sensation and weakness of the hands, legs, and feet; inability to stand; and sensory loss in the legs. Within two years of initially seeking treatment, the patient's condition deteriorated with her eventually developing: myelopathy characterized by spastic paralysis; complete paralysis of the muscles below the knee; weakness in the legs and hands; inability to walk without assistance; and sensory ataxia (gross lack of coordination of muscle movements).
The American Journal of Clinical Pathology, published an article in 2005 which clearly established the link between excess zinc exposure and neurodegeneration. This study focuses on three patients suffering from high zinc levels, low copper levels, and myelopathy. [8] One of the patients was 47 years old and confined to a wheel chair; another patient was 42 years old and unable to walk with a steady gait or hold objects in his hands. The source of his excess zinc was determined to be denture cream.
More recent studies such as the highly publicized 2008 Nations article, has clearly identified Denture Cream as a source of excess zinc. [9] This article directly linked the use of denture cream to copper deficiency and serious neurological disease in several patients. In 2009, medical research further confirmed that denture cream is a primary source of excessive zinc, which can cause both myelopathy and neuropathy. [10] In this study 100% of the patients examined had a history of wearing ill-fitting dentures which required large amounts of denture cream, ultimately resulting in significant exposure to zinc.
It is obvious from this extensive body of medical literature that overexposure to zinc causes copper deficiency, and copper deficiency causes crippling neurologic diseases. It is almost certain that GlaxoSmithKline and Procter & Gamble knew this when they put zinc in denture cream. It was their legal and regulatory responsibility to know it. And if they claim they did not know, then they were not paying attention. More importantly, if they are now simply adding flavors to mask the taste of zinc while only adding packaging inserts about the remote dangers of denture cream overuse, then they are doing something far worse: misleading their customers as they continue to manufacture dangerous products.
[1] A. Prasad et al., Hypocupremia Induced by Zinc Therapy in Adults, JAMA, 1978; 240: 2166-68.
[2] H. N. Hoffman et al., Zinc-induced Copper Deficiency, Gastroenterology, 1988; 94 (2): 508-12.
[3] H. A. Hartmann & M. A. Evenson, Deficiency of Copper Can Cause Neuronal Degeneration, Med Hypotheses, 1992; 38(1):75-85.
[4] Bert Schleper, Copper Deficiency-Associated Myelopathy in a 46-year-old Woman, J Neurol, 2001; 248:706-06.
[5] K. Dineley et al., Zinc Inhibition of Cellular Energy Production: Implications for Mitochondria and Neurodegeneration, J. Neurochem., 2003; 85: 563-70.
[6] P. Hedera et al., Myelopolyneuropathy and Pancytopenia Due to Copper Deficiency and High Zinc Levels of Unknown Origin: Further Support for Existence of a New Zinc Overload Syndrome, Arch Neurol, 2003; 60:1303-06.
[7] S. Greenberg & H. Briemberg, A Neurological and Hematological Syndrome Associate with Zinc Excess and Copper Deficiency, J Neurol, 2004; 251:111-14.
[8] M. Willis et al., Zinc-Induced Copper Deficiency: A Report of Three Cases Initially Recognized on Bone Marrow Examination, Am J Clin Pathol, 2005; 123:125-31.
[9] S. P. Nations et al., Denture Cream: An Unusual Source of Excess Zinc, Leading to Hypocupremia and Neurological Disease. Neurology 2008; 71:639-43.
[10] P. Hedera et al., Myelopolyneuropathy and Pancytopenia Due to Copper Deficiency and High Zinc Levels of Unknown Origin II: The Denture Cream is a Primary Source of Excessive Zinc, Neurotoxicology, 2009, doi: 10.1016/j.neuro.2009.08.008.
Article provided by Blizzard, McCarthy & Nabers
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