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RESEARCH ETHICS By Kristie Sullivan, M.P.H.
Five New EPA Polices Reduce Animal Testing
The Environmental Protection Agency released five new policies in June that will reduce animal testing and improve safety assessments for pesticides.
Three of the policies are designed to optimize the use of existing data, rather than conduct new animal tests. Two of the policies will reduce animal tests—including tests for eye irritation and genotoxicity—through the use of in-vitro and human cell based tests.
OECD Publishes New In-Vitro Test Guidelines
In July, the international Organisation for Economic Cooperation and Development published six new in-vitro test guidelines, which are used by companies and governments worldwide to assess the potential hazards of chemicals without live animals. Since 2006, the Physicians Committee has served as the Secretariat of the International Council for Animal Protection in OECD Programmes.
For the first time, an in-vitro test guideline is available for acute fish toxicity testing. Five other in-vitro tests were revised to expand their use beyond what they had been previously approved. For the first time, the BCOP and ICE tests can now be used by companies to certify a chemical does not cause eye irritation, replacing live rabbits. Three in-vitro skin irritation and corrosion tests were also revised to allow additional uses, replacing rabbits for painful skin corrosion testing.
The Work Plan for the Test Guidelines Programme was also published, giving a glimpse of what’s ahead. Regulators and stakeholders, including the Physicians Committee, are working on three nonanimal tests for endocrine disruption testing, a nonanimal test for skin allergenicity testing, and a test to assess the metabolism of chemicals, a key need that, once solved, will allow much more replacement of animal tests with in-vitro ones.
NEW NONANIMAL SKIN TESTS
Skimune is a new test that uses human skin and immune cells to reveal possible skin sensitization, such as a rash or blistering, or adverse reactions to drugs, cosmetics, and chemicals that may not be identified by using animal models.
Developed by researchers at Newcastle University in the United Kingdom, Skimune has been successfully tested by a number of large pharmaceutical companies on drugs in development.
A new study validates the ability of the nonanimal SenCeeTox test to predict a chemical’s likelihood of causing a human skin sensitization reaction. The test, developed by contract research organization CeeTox, uses reconstructed human epidermis, which could spare tens of thousands of mice and guinea pigs from painful skin sensitization testing.
Cosmetics Europe will conduct further validation of SenCeeTox that will be submitted to ECVAM, the European laboratory body that certifies new tests as valid.
Nonanimal tests such as Skimune and SenCeeTox are particularly important for companies to adopt now that the EU has banned sales of all animal tested cosmetics in Europe. Once approved, the tests will also prevent thousands of animal tests under Europe’s REACH chemicals legislation.
NUTRITION by Susan Levin, M.S., R.D.
Red Meat Increases Diabetes Risk
People who increase their red meat intake gain weight and increase their risk for diabetes, according to a recent study published by the American Medical Association. Researchers analyzed the data from 149,143 participants from the Health Professionals Follow-up Study, the Nurses’ Health Study, and the Nurses’ Health Study II and found that an increase of more than half of a serving of red meat per day increased the risk for type 2 diabetes by 48 percent. Decreasing red meat intake resulted in weight loss and a reduced risk for diabetes.
Pan A, Sun Q, Bernstein AM, Manson JE, Willett WC, Hu FB. Changes in red meat consumption and subsequent risk of type 2 diabetes mellitus. JAMA Intern Med. 2013;173:1328-1335.
Fish Oil Increases Prostate Cancer Risk
The omega-3 fatty acids found in fish oil pills may increase men’s risk of developing prostate cancer, according to a large study published in the Journal of the National Cancer Institute. Researchers tracked 834 men with prostate cancer, of which 156 had high-grade cancer, and 1,393 men without cancer. They found a significant increase in prostate cancer risk among men with high concentrations of omega-3s in their blood. These men were 43 percent more likely to develop prostate cancer and 71 percent more likely to develop a high-grade form of the disease, compared with men who had lower levels of omega-3.
Brasky TM, Darke AK, Song X, et al. Plasma phospholipid fatty acids and prostate cancer risk in the SELECT Trial. J Natl Cancer Inst. 2013;105:1132-1141.
Red and Processed Meat Linked to Colorectal Cancer Patient Deaths
Colorectal cancer survivors who consumed the most red or processed meat were more likely to die over a 7.5-year follow-up period, compared with those who ate the least, according to a new study from the American Cancer Society. Researchers analyzed the diet records of 2,315 participants from the Cancer Prevention Study II Nutrition Cohort and found a 29 percent higher risk of death from all causes and a 63 percent higher risk of death from heart disease for those who consumed the most red and processed meat before diagnosis, compared with those who ate the least.
McCullough ML, Gapstur SM, Shah R, Jacobs EJ, Campbell PT. Association between red and processed meat intake and mortality among colorectal cancer survivors. J Clin Onc. 2013;31:2773-2782.
High Blood Sugar Levels Linked to Dementia
High blood glucose levels may increase the risk of developing dementia, according to a new study in the New England Journal of Medicine. Researchers from the Adult Changes in Thought study followed 2,067 men and women aged 65 or older who were members of Group Health Cooperative in Washington state. Over a 6.8-year observation period, high blood sugar levels were associated with an increased likelihood of developing dementia. Compared with an average blood glucose value of 100 mg/dl, an average blood glucose of 115 mg/dl was associated with a 15 percent increased risk of developing dementia.
Crane PK, Walker R, Hubbard RA, et al. Glucose levels and risk of dementia. N Engl J Med. 2013;369:540-548.