2018 CLARITY study of BPA safety is substandard science & repeats previous fatal errors

By Lewis Perdue

Chairman, Co-Founder, Center for Research on Environmental Chemicals in Humans
Co-Principal Investigator, Stealth Syndromes Human Study

Last Friday’s draft of a new study by the FDA on the safety of the chemical Bisphenol A (BPA) is a glaring example of substandard federal regulatory science that continues to place public health at risk. What’s more, the FDA draft is riddled with amateurish mistakes, poor scientific practices, and an inexplicable blindness to obvious experimental flaws that render its data and conclusions invalid.

BPA is a component in many plastics and consumer products, including thermal cash register receipts, and, according to the Centers for Disease Control, contaminates the bloodstreams of nearly every American.

Contrary to this seriously flawed FDA draft, the vast majority of hundreds of well-conducted university research studies indicate BPA can cause or contribute to obesity, Type 2 diabetes, cancer, reproductive problems, and other maladies. Many of those current studies are cited among the 845 citations in this article: Hormones and Endocrine-Disrupting Chemicals: Low-Dose Effects and Nonmonotonic Dose Responses.

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Format designed to bias public discussion, thwart transparency?

On February 23, Stephen Ostroff, FDA Deputy Commissioner issued a premature news release pronouncing chemical BPA (Bisphenol A) safe to consume.

The news release, which seemed calculated to bias the public discussion, was issued before any peer review, before any scientific consensus, and without the substantial data from several teams of university experts.

Further, the study seems deliberately calculated to prevent public examination of all the evidence: It fails to incorporate 34 appendices which are located obscurely on a separate web page: List of Appendices. What’s more, 9 of those 34 appendices are unavailable online and available only by a separate request.

What’s more, the current FDA study repeats the same fundamental scientific errors as a preliminary study four years ago.

Contaminated Controls: A fundamental scientific error lab invalidates the study

The most egregious  science flaw committed by the FDA study is the fact that their control animals were already contaminated with BPA before the experiment began.

This is important because valid scientific experiments are about measuring the “before” and the “after.” To do this, you must have a control.

The control is the “before” — the measured state of a system (or an animal) before it is affected by the experiment (the “after”).

The control offers a valid way of measuring whether an experiment has had an effect, and if so, by how much.

In this case, the FDA and its BPA-contaminated mice don’t provide a valid “before” to benchmark the “after.”

You can’t get valid data in a controlled environment if the environment is not controlled.

The data in this study is thoroughly tainted by contaminated controls. That is aggravated by the failure of this, and the previous study, to measure BPA serum levels in test animals.

Insanity is doing the same thing over and over again and expecting different results

Often attributed to Albert Einstein, that quote has no confirmed author, but contains a great truth — something the FDA investigators behind this study may want to heed if they try this again.

In 2014, my collaborator, Rebecca Yeamans-Irwin and I pointed out the very same mistakes in a prior study by the very same key FDA study authors, and recommended at the time that their paper should have been retracted. It was not retracted and is now one of the footnote citations in this newly released draft that commits the same serious blunders.

Among the other serious scientific mistakes also repeated in this new study include:

• Improper feeding method (oral gavage) which fails to replicate real-world BPA absorption. Oral gavage forces a dose directly into the esophagus of test animals. In normal food consumption, BPA and many other substances are absorbed by gums and the mucosal tissue of the oral cavity where it passes directly into the bloodstream. Other amounts of BPA are digested and metabolized in different ways which can affect the overall health impacts.
• Not only does oral gavage distort the measurement of BPA level,  but it is a stressor that could affect the test animal and skew study outcomes.
• They used a type of lab animal — the Sprague-Dawley rat — that is notoriously resistant to BPA and other endocrine disruptors.

A lengthier list of more significant scientific mistakes — also repeated in this study — can be found in our 2014 paper.

Regulatory science inherently substandard

Federal regulatory science uses 40-year-old science and lab practices that have long been superseded in modern university laboratories. Instead, regulatory science must use the mis-named “Good Laboratory Practices” (GLP) which froze lab practices in 1978 in a program that tried — but has failed — to curtail fraudulent studies done by corporations.

Science has advanced in the past 40 years. Federal regulatory practices have not.

This article about GLP in Environmental Health Perspectives (a scientific journal published by the National Institutes of Health) notes that today:

“[T]he procedures of GLP are actually surpassed by the procedures required for NIH-funded science published in peer-reviewed journals.

“NIH-funded studies pass through three phases of peer review that are far more challenging than GLP requirements.

“First, the principal scientists must have demonstrated competence to conduct the research, and experimental methods, assays, and laboratory environment must involve use of state-of-the-art techniques to be competitive for NIH funding.

“Second, results are published in peer-reviewed journals, with detailed evaluations by independent experts examining all aspects of the study.

“And third, the findings are challenged by independent efforts to replicate….”

In other words, federal regulatory science — like the FDA draft released on Feb. 23 — uses old, flawed science that can adversely affect public health.

To learn more about how and why the U.S. government rejects modern science with the highest standards, please refer to this article by the Boston University School of Law: “Equal Treatment for Regulatory Science.”