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New Study Challenges How Regulators Determine Risk

A new study provides the strongest evidence yet that a key portion of the traditional dose-response model used in drug testing and risk assessment// for toxins is wrong when it comes to measuring the effects of very low doses.

Edward J. Calabrese, a scientist at the University of Massachusetts Amherst. The findings, based on a review of more than 56,000 tests in 13 strains of yeast using 2,200 drugs, are published in the journal Toxicological Sciences and offer strong backing for the theory of hormesis, Calabrese and his colleagues contend.

Calabrese says the size of the new study and the preponderance of evidence supporting hormesis, a dose-response phenomenon in which low doses have the opposite effect of high doses, is a breakthrough that should help scientists assess and predict risks from new drugs, toxicants and possibly carcinogens. Calabrese says, “This is a fundamental biological principle that has been missed.”

Calabrese says that the field of toxicology got the dose response wrong in the 1930s and this mistake has infiltrated all regulations for low-dose exposures for toxic chemicals and drugs. These low-dose effects can be beneficial or harmful, something that the regulations miss because they are currently based on high-dose testing schemes that differ greatly from the conditions of human exposures.

In this latest study, which uses data from a large and highly standardized National Cancer Institute tumor-drug screening database, Calabrese says the evidence of hormesis is overwhelming. In the study, high doses of anticancer drugs frequently inhibit yeast growth, but at low doses they enhance growth, exactly what the homesis model predicts.

Whether one accepts the hormesis theory is not the critical public policy issue, according to Calabrese. He says that the major issue is that the risk assessments models used by the federal Environmental Protection Agency and the Food and Drug Administration
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