The Center for Research on Environmental Chemicals in Humans (CRECH) was founded in 2017 to provide support and financing for the first controlled human trials of the low-level effects environmental chemicals (including endocrine disruptors).
The need for CRECH grew out of the past four years of experience by the The Stealth Syndromes Project and its research arm, the Stealth Syndromes Study.
CRECH founder Lewis Perdue, Co-Founder is the principal co-investigator and designer of the study. Perdue’s co-principal investigator is University of San Francisco Medical School Professor Dr. Victor Reus.
The UCSF Medical School’s Committee on Human Research approval letter can be accessed at this link.
That study (Clinical blood profile assays as biomarkers to assess potential health effects resulting from the controlled elimination of suspected dietary and environmental chemical toxins.) was approved in November 2015 by the University of California, San Francisco Medical School’s Committee on Human Research.
The Stealth Syndromes Study began in 2014 as an effort by Perdue to make sense of the stalemated morass of science and associated contentious and contradictory assertions about risks.
After two years of intense study, it became apparent that the since had serious missing links.
Missing was the science that directly indicated health effects of low levels of environmental chemicals in humans. This gap persisted because:
- All risk assessments of environmental chemical effects on humans were epidemiological. But those are unacceptable to government regulations because correlation does not prove causation.
- No studies had ever been done on humans because of ethical concerns.
- Available in vivo research on a murine model (mice and rats) does not necessarily translate to human effects.
- More modern techniques such as those used in pharmaceutical research is not acceptable to environmental chemical researchers.
The only way to bridge those missing links was to conduct new science to bridge the gaps.
The study bridges the fields of research and medical diagnostics and is designed to provide outcomes-based, human health-indicator data. The protocols are designed to associate precisely determined levels of nutritional and environmental exposure to Bisphenol A (BPA) with accepted health indicators such as standard clinical blood panels, epigenetic profiles, and double-stranded DNA breaks.
If the study results support the main thesis, the outcomes have the potential advance current diagnostics and precision toxicology as well as offer professional health and lifestyle advice beyond epidemiological associations or the lab results of murine-model research. It also has the potential to offer new tools for health professionals and their patients, and could also provide a path to close the knowledge gap that currently exists for government regulatory bodies.
The study is also designed to create actual practices and strategies that individuals could act on to reduce their exposures to environmental chemicals.
Why is this study vitally needed?
Currently, irreconcilable differences dividing the scientific and regulatory communities have made it impossible to determine how to regulate environmental chemicals. That uncertainty has also confused the public and made it impossible for individuals to make valid personal health choices — or even decide of those choices are helpful.
The dangers of low-level exposure to environmental chemicals have been confirmed by hundreds of rigorously peer-reviewed studies published in well-respected, mainstream scientific journals. However, those scientific conclusions have been disputed, primarily by chemical manufacturers.
The disputes and resulting confusion are rooted in — and complicated by — in the inability of traditional toxicologists to acknowledge the developing field of “precision toxicology” founded on recent advances in understanding effects at the internal cell level.
Those advances include the fields of epigenetic, intracellular molecular pathways and the applicability of knowledge gained from the extensive research and approval process for pharmaceuticals.
It is vital to recognize that many of the disputes and differences of opinion cited above have valid scientific justifications:
- Correlation is not causation.
- Tests in animals, while helpful and often indicative, are flawed by significant genetic differences among species. This issue has received great current attention as the leading cause underpinning the failure of new pharmaceuticals which show promise in animal trials , then fail during human trials.
- It is not ethical to experiment on human subjects with substances suspected of being harmful.
Because of ethical issues involved with human experimentation, no studies have ever been done on humans to assess the dangers — or lack thereof.
Stealth Syndromes Project
The Stealth Syndromes Project was founded by Lewis Perdue in 2013 to address those issues. Initially, the goal was to locate and translate published, peer-reviewed scientific studies on environmental chemicals into suitable forms that could be understood by the intelligent non-scientist.
However, it became clear by 2015 that the evidence — while highly suggestive of multiple human harms — could not resolve deep and bitter differences of opinion among scientists, chemical manufacturers, and government regulators.
Manufacturers have successfully convinced government regulators that the extensive body of science regarding the hazards of environmental chemicals are not suitable for regulatory decision making because correlation is not causation and tests in animals are far from conclusive. They are correct on both counts. Indeed, the failure of a high percentage of human pharmaceutical trials — after success in animals — is frequently caused by genetic differences.
The Stealth Syndromes project recognized that human experimentation was the only way to move beyond the current scientific impasse.
Stealth Syndromes Study – Ethically Studying BPA In Humans
The Stealth Syndromes Project recognized that those scientific and regulatory shortcomings and controversies created “missing links” that effectively prevented it from fulfilling its goals of helping the general public to take individual action to reduce exposure and harms. Clearly, some way needed to be found in order to conduct experiments directly on humans without crossing any ethical boundaries.
CRECH co-founder Lewis Perdue managed to design an experimental protocol that effectively addressed the three missing links listed above by creating a study protocol designed to eliminate those substances from the environments of human test subjects in a carefully controlled and monitored step-wise manner. This first study will focus on Bisphenol A.
We have decided to focus solely on BPA, partly for three reasons:
(1) BPA exposure is ubiquitous in our environment.
(2) Historical (2004) CDC’s NHANES data shows that most Americans (at least 93%) carry persistent levels.
(3) BPA is rapidly metabolized (roughly 24 hours) and does not accumulate in the body. Sustained levels, therefore mean that exposure is constant. However, rapid metabolism of BPA means that measured serum and urine levels should show statistically significant deltas over relatively short periods of time.
Given that the study protocol calls for the weekly elimination of a class of known sources of BPA, there should be ample time for serum and urine concentrations to quickly stabilize. Theoretically, the other accepted health indicators will also have begun to reach a level of equilibrium.
However, that last thesis is unknown because no study has ever been done in humans. That is because human research committees have unanimously rejected human studies on ethical grounds.
In addition, this study makes an important contribution because studies in murine models are experimentally flawed for multiple reasons including the use of oral gavage (which overlooks substantial direct absorption into the circulatory system by mucosal tissues) and the subsequent measurement using only urine samples.
It’s also worth noting that NHANES data indicate that Americans are exposed to a wide variety of environmental chemicals, not just BPA. It is likely that the protocol for the controlled elimination of BPA may also reduce the presence of other compounds such as phthalates. However, budget constraints for this first-of-a kind, proof-of-concept study make it impractical to monitor more than one compound.
The only way to isolate effects of a single compound such as BPA from other environmental chemicals would be to introduce known concentrations of that chemical in a controlled manner. But even if such a protocol limited itself to concentrations currently deemed safe by federal regulatory bodies, such a study would not be approved by human research committees because of the ethical concerns mentioned above.
Center for Research on Environmental Chemicals in Humans (CRECH) – Progress & Resources To Date
To date, all efforts have been funded entirely by Lewis Perdue’s personal resources. However, the undertaking of an approved human research study exceeds his ability to fund that entirely.
CRECH has applied for federal 501(c)(3) federal tax exempt status to advance that project.
The study is currently translating the approved study into a human subject procedure that is both accurate and facilitates adherence to the protocol. In addition, the study is currently assembling scientific collaborators and support organizations.