The Study

DO NOT USE … INCORPORATED INTO OTHER POSTS Causality and clinical usefulness of dietary interventions require direct human experimentation not extrapolation from animal models

Human dietary studies and interventions most often  fail to provide consistent, human-relevant causal results. There is no consistent set of protocols and lab standards for conducting these trials with te results that

This chaos and inconsistency leads one substantial study (Carra, p.9) to declare:  “With this type of data, it is difficult to draw a meaningful, intellectually honest conclusion.”

Significantly,a search of the scientific literature failed to locate controlled clinical direct human studies measuring clinically significant health effects of low-level Plastic-Derived Chemical (PDC) contamination. However, a literature search did reveal a handful of investigations in which human test subjects were directly administered Bisphenol A in order to assess BPA pharmacokinetics (but not health effects).

Compounding that lack of health-effects knowledge, human dietary intervention studies published so far on BPA and other plastic chemicals have focused only measuring levels of marker chemicals and have not measured direct, clinically relevant health outcome indicators.

Extrapolation of human health effects from murine model mostly fails and creates controversy

The absence of clinically relevant human studies required that human health outcome conclusions require  extrapolation from murine models.

However, no clinically credible conclusions about causation can be drawn from that extrapolation because murine model results frequently fail to translate accurately to humans. This is especially the case in drug trials where up to 92% have been shown to fail in humans following successful murine results.

That situation has, in turn, contributed to an internationally divisive scientific controversy that has prevented health professionals and consumers from making scientifically valid health decisions.

On one side of the controversy are university and independent scientists who contend that hundreds of published studies indicate that micro- and pico-molar concentrations of BPA are unhealthy. Three many examples include:

On the other side, corporate and some federal regulatory scientists point to the recent CLARITY-BPA study whose results — they contend — demonstrated that low levels are safe.

National Toxicology Program. 2018. NTP Research Report on the CLARITY-BPA Core Study: A Perinatal and Chronic Extended-Dose-Range Study of Bisphenol A in Rats. NTP RR 9. Research Triangle Park, NC. National Toxicology Program (9): 1-221.

CLARITY-BPA and most other published studies have been based upon an in vivo murine model whose accurate extrapolation to humans is not known. As a result, the current debate centers on protocol flaws, confounding factors, sources of contamination and the finer points of how the murine studies were conducted.

CLARITY-BPA Conclusions Challenged

Further, the CLARITY-BPA study and its predecessor are plagued by serious and scientifically fatal protocol errors that invalidate any conclusions regarding human safety or health:

Resistance to human dosing: Nuremberg’s legacy?

The lack of controlled-dose human studies has been attributed to a Nuremberg-based ethical reluctance to expose human to harmful substances.

Human experimentation ethics: Industry and federal government compliance?

The Nuremberg ethical argument fails because but humans are already legally exposed to Plastic-Derived Chemicals with scores of other potentially harmful chemicals as evidenced by the National Health and Nutrition Examination Survey (NHANES) and numerous studies confirming chronic Bisphenol A levels in human serum and urine.


Human dosing

Wolfgang Völkel Thomas Colnot György A. Csanády Johannes G. Filser Wolfgang Dekant, Metabolism and Kinetics of Bisphenol A in Humans at Low Doses Following Oral Administration, Chem. Res. Toxicol. 2002, 15, 10, 1281-1287 Publication Date:September 24, 2002

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