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RESEARCH ETHICS By Kristie Sullivan, M.P.H., and Nancy Beck, Ph.D.


Big News on Testing Tiny Materials
Nonanimal methods should be used first to test the safety of nanomaterials, the Environmental Protection Agency recommended in September. Nanomaterials are manufactured to be many times smaller than their conventional counterparts. As a result, they can have unusual properties, raising concerns about safety. The EPA’s Nanomaterials Research Strategy says research efforts will focus on methods using human cells and tissues instead of on animal tests. It also recommends a strategy that uses cellular methods exclusively in the first two steps of testing.

U.S. Environmental Protection Agency. Nanomaterials research strategy. Washington, DC: Office of Research and Development, U.S. Environmental Protection Agency. EPA 620/K-09/011; June 2009.

White House Directs EPA to Prevent Duplicate Animal Tests White House officials have directed the EPA to accept existing information on how chemicals affect the hormone system, rather than require additional animal tests. This decision by the White House Office of Management and Budget could save more than 40,000 animals.

At issue is the Endocrine Disruptor Screening Program, a new testing program that assesses chemicals’ potential to disrupt the hormone system. Companies that produce any of the 67 chemicals included in the program’s first phase must give the EPA information about how the chemical may affect humans’ hormone systems. The EPA established a set of tests that, if completed for the first phase, would use and kill many animals. The EPA asked the Office of Management and Budget for permission to require these tests, even though some of the chemicals are already known to affect the hormone system.
After receiving recommendations from PCRM and other organizations, the White House directed the EPA to allow existing information to satisfy the requirements. The White House also directed the EPA to reevaluate the tests after phase one to consider new nonanimal methods.


New Human Bladder Tissue Model
A new model of human bladder tissue could decrease the number of animals used to test therapies for urinary disorders. Biopta Ltd., a British company specializing in human tissue models for drug testing, developed this new model, which pharmaceutical companies can use to confirm the efficacy of therapies without animal tests. Efficacy testing measures whether a new drug will be more effective than current medications. It typically represents a significant use of animals in pharmaceutical development.

Botox Lab Exposed for Killing Mice with Ballpoint Pens
A laboratory that uses mice to test Botox is breaking the law by conducting unnecessary animal tests and deliberately increasing animals’ suffering, according to the British Union for the Abolition of Vivisection (BUAV). In an undercover investigation, BUAV revealed that staff at Wickham Laboratories in the United Kingdom killed mice by breaking their necks with ballpoint pens.

Wickham Laboratories tests batches of Botox products in lethal poisoning tests on more than 70,000 mice each year. Botox products are derived from poison and are injected to reduce wrinkles.

The BUAV also faults the U.K. Home Office for allowing these lethal tests when a test-tube alternative has been available for at least a decade.

NUTRITION By Susan Levin, M.S., R.D., and Kathryn Strong, M.S., R.D.


Soy Reduces Cholesterol in Diabetes PatientsConsumption of soy protein may help people with type 2 diabetes lower their cholesterol levels, according to a study in the Journal of Nutrition. Study participants who consumed soy protein reduced LDL (“bad”) cholesterol levels and the ratio of LDL cholesterol to HDL (“good”) cholesterol significantly more than did those who consumed milk protein. The study participants were 29 adults with type 2 diabetes. This randomized study consisted of three phases: a 57-day consumption phase of one protein, a 28-day washout phase, and a 57-day consumption phase of the other protein. The amount of protein consumed from either source was 40 grams per day.

High cholesterol is a contributing factor to heart disease, which affects people with diabetes more than twice as much as those without diabetes.

Pipe EA, Gobert CP, Capes SE, Darlington GA, Lampe JW, Duncan AM. Soy protein reduces serum LDL cholesterol and the LDL cholesterol:HDL cholesterol and apolipoprotein B:apolipoprotein A-I ratios in adults with type 2 diabetes. J Nutr. 2009;139:1700-1706.

Fish Does Not Protect Against Heart Failure
Eating fish does not reduce the risk of heart failure, researchers found in a large study of 5,000 men and women. After 11 years, almost 670 study participants had developed heart failure. Those who consumed the most fish had no protective effect compared with others. This research was part of the Rotterdam Study in the Netherlands, where, as in all Western nations, heart failure is common.

Dijkstra SC, Brouwer IA, van Rooij FJA, Hofman A, Witteman JCM, Geleijnse JM. Intake of very long chain n-3 fatty acids from fish and the incidence of heart failure: the Rotterdam Study. Eur J Heart Fail. 2009;11:922-928.


Pregnant woman eating healthyMore Vegetables for Mom Decreases Baby’s Diabetes Risk
Women who consume fewer veg etables during pregnancy are more likely to have babies who develop type 1 diabetes, according to a new study in Pediatric Diabetes. Type 1 diabetes was previously known as juvenile or insulin- dependent diabetes. Compared with women who ate veg etables daily, those consuming vegetables only three to five times per week had a 71 percent increased risk of having a child with diabetes.

Brekke HK, Ludvigsson J. Daily vegetable intake during pregnancy negatively associated to islet autoimmunity in the offspring—The ABIS Study. Pediatr Diabetes. Advanced access published September 16, 2009. DOI:10.1111/j.1399-5448.2009.00563.x.

Meat Consumption Increases Diabetes Risk
A review published in the journal Diabetologia offers more evidence linking meat consumption to diabetes risk. The people who ate the most meat had the highest risk of type 2 diabetes. Intakes of red meat and processed meat were associated with 21 and 41 percent increased risk, respectively. The study was a review of data from 12 prior studies.

Aune D, Ursin G, Veierod MB. Meat consumption and the risk of type 2 diabetes: a systematic review and meta-analysis of cohort studies. Diabetologia. 2009;52:2277-2287.


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