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).
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. Also a key collaborator is Rebecca Yeamans-Irwin who has a lengthy background in biomedical research and clinical trials.
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 and Yeamans-Irwin 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 and Rebecca Yeamans-Irwin 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.
The Committee on Human Research (CHR) at the University of San Francisco Medical School has approved the Stealth Syndromes experimental protocol.
This study approval allows Stealth Syndromes co-founder Lewis Perdue to become the test subject for a “proof of concept” study to determine if standard clinical blood tests can be used to detect physiological changes that may be caused by the absorption of environmental chemicals, including endocrine disrupting compounds.
The CHR gave its go-ahead for the study on on Nov. 11, 2015.
The Stealth Syndromes Project is very fortunate (and grateful) to have had the guidance and institutional mentorship of UCSF Professor Victor Reus, M.D.
Dr. Reus is an internationally renowned and widely published biomedical scientist whose interests include neurobiology and behavior as well as the genetic origins of psychiatric disorders.
In the coming days, I will be writing numerous posts that describe the various facets of the study and examine them in more detail. Those will look at the value of a first “proof of concept study,” and what makes this study different from the hundreds of others dealing with environmental chemicals.
iRIS – Let a Thousand Computer Forms Blossom
Study submissions at UCSF are entirely electronic. Everything is submitted through the secure, web-based iRIS system which provides scores of forms in a relatively intuitive framework.
iRIS centralizes all aspects of study, makes sure that all the relevant parts of a study are included, assures compliance with human research protections, and makes all that available to the university compliance process without needing paper versions.
The complexity of the iRIS system lies somewhere between IRS income tax forms and the paperwork associated with buying and mortgaging a new house.
The following is from the iRIS FAQs:
iRIS is a web-based system that enables online application submission, real-time submission tracking, review, post-approval compliance activities, and data management. The system also functions as a document repository, providing investigators with easy access to submission records and study documents.
The committees that will conduct their reviews using the iRIS system include the:
- Committee on Human Research (CHR),
- the CTSI Clinical Research Services (CRS) Advisory Committees, and
- the Human Gamete, Embryo, and Stem Cell Research Committee (GESCR committee).
Investigators can use the system anywhere they have Internet access, helping to connect faculty, researchers, students and partners around the world. The iRIS system also has expedited the CHR review and approval process. In addition, prior to the implmenetation of iRIS, the CHR received about 5 million pieces of paper each year. The electronic system has helped us eliminate this waste and supports UCSF’s efforts to incorporate environmentally-friendly practices across campus.
Summarizing the study submission
The text below is taken directly from the UCSF iRIS system.
I have included ALL of the sections relevant to the study and omitted only those sections associated with administrative details and the online human research protection training courses I needed to pass in order to qualify as a study co-principal investigator. Correct section numbers from iRIS are used to designate each portion.
10.0 STUDY DESIGN
This is an interventional dietary study to determine the usefulness of carefully selected tests from standard medical blood profiles to indicate health effects resulting from the reduction of specific foods and substances known to contain certain environmental chemicals.
This study is the first to use easily accessed and medically accepted laboratory methods to directly measure health effects of dietary intervention on the reduction of persistent and ubiquitous environmental chemicals. While this is an n=1, proof-of-concept study using co-Principal Investigator Lewis Perdue as the test subject, it expands upon previous studies with a longer observation period, and by designating specific substances (packaged in glass vs plastic or cans, elimination of dermal contact) for intervention instead of general parameters (fresh versus prepared foods).
The primary aim of this study is to determine whether a positive correlation exists between CEC intervention, test subject blood profiles, and CEC levels in serum and urine. Because the significance of CEC urine and serum levels is controversial, the primary aim of this study is to provide a measurement of direct CEC health effects (or lack thereof) using widely available laboratory blood profile indicators.
A secondary aim of this study is to provide a method to correlate potential health effects of CECs with their observed human levels as previously measured by NHANES and other investigations.
The human health effects of low-level concentrations of certain Chemicals of Emerging Concern (CECs) has stirred immense controversy between traditional toxicologists and a more recent, emerging body of scientists grounded in epigenetics and molecular-level effects. Traditional toxicologists insist that current risk evaluations at high concentration levels can be monotonically extrapolated to low concentrations and that a firm No Observed Adverse Effects Level (NOAEL) of safety can be established.
On the other hand, a more recent and growing body of peer-reviewed, published data indicates that many CECs exhibit non-monotonic behavior and present risks to humans at low concentrations. That controversy continues partly because of the lack of controlled human studies and the almost complete absence of investigations into effects of combinations of CECs.
Exposure to environmental chemicals in the U.S. is widespread20.
More than 84,000 chemicals are approved for use in the United States today1, and at least 4,000 of those are present in food contact materials2,3,4. The health effects of most of those chemicals is unknown and/or incomplete5..
While controversial, many of these chemicals in low-level concentrations are increasingly classified as endocrine disruptors22,23.
Among chemicals of emerging concern (CEC) are Bisphenol A (BPA) and phthalates, both of which are present in approximately 97% of the U.S. population.6,8 Public concern over the risks from these chemicals have resulted in the reduction of concentrations of some7, but has also led increases in concentrations of substitutes which are also of concern. 39
BPA is used to strengthen and offer heat resistance to common plastics such as polycarbonate. Phthalates are added to plastics for flexibility. Those two compounds are among the most common and widely studied chemicals of emerging concern. For that reason, this study will use them as proxies for overall chemical contamination.
BPA and phthalates have become nearly ubiquitous in our environment and can be found in many different products, including the plastic in water bottles and baby bottles, thermal paper for printers, and even in dental sealants and medical devices including intravenous fluid and chemotherapy bags and tubing 8,9,10,1,12,13,14.
In addition, food and beverage packaging are substantial contributors to the CEC burden8,15,16,17,25,26.
Consumers are exposed to many CECs from leaching and migration of chemicals from plastics and other food contact materials.8,14,15,16, 30-37
Other chemicals of concern are deliberately added to consumer and household products such as detergents, cosmetics, lotions, and fragrances38.
Still other contamination may result from the harvest and processing of food products17.
Causes For Concern
Human and animal studies have identified these compounds as contributors to cancer24,40-52,, cardiovascular disorders53-61, obesity62-68, type 2 diabetes69-72, metabolic syndrome73-77, neurological and behavioral disorders including Alzheimer’s Disease78-84, as well as reproductive85-94, and developmental95-102 disorders and allergies103-110.
Specific Exposure Routes
Exposure routes for all products include:
- Migration/leaching of chemicals from packaging materials,
- Deliberate addition of chemicals used as preservatives, flavorings, scents, texture enhancers, coloring agents etc.4,
- Contamination by unknown compounds formed by chemical reactions among multiple intentionally used constituent chemicals18.
Exposure routes for food and beverages specifically include:
- Incidental contamination via migration/leaching of chemicals from harvesting and processing17.
- Home food-handling can also accelerate migration through heating, microwaving, ultraviolet light exposure (including fluorescent lighting) and the contact of oils and alcohols with plastics.
12.2 PRELIMINARY STUDIES
So far, all studies that evaluate potential adverse health effects of CECs by controlled exposure have been done in vitro or in vivo using murine or other non-human models. Despite the fact that all of the CECs in question are nearly ubiquitous in the human environment, ethical concerns have prevented controlled exposure studies. Practical concerns also complicate controlled human exposure studies because ubiquitous exposure to mixtures of CECs make it impossible to create an adequate control population.
Because of that, a small number of interventional dietary studies have been done. These studies have focused on foods and beverages because they constitute major sources of CECs. Dietary interventions are easier to control and offer opportunities to reduce health risks24,27.
Recent dietary interventions16, 17,28 have found significant reductions in the targeted chemicals measured concurrent with study designs to replace pre-prepared meals and other foods with known levels of endocrine disruptors with a fresh, home-prepared diet.
Those interventional studies have been:
- time-limited (3 -16 days),
- involved relatively small numbers of test subjects (20 – 40),,
- imposed very general dietary restrictions (whole diet, fresh foods).
The most significant failing, however, is the failure to connect the reduced levels of CECs to any measurable indication of health benefits.
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- Weekly blood profile as direct clinical health-linked proxies for CEC body burden.
- Weekly blood profile and urine measurements of Bisphenol A and phthlates for correlation with blood biomarkers.
- Monthly double-stranded DNA break levels.
- Monthly epigenetic profiles of specific methylation locations known to be associated with cancer, obesity, aging, infertility, or Alzheimer’s disease.
We propose using specific elements of standard blood profiles that can provide direct health assessments of inflammation, glucose tolerance, lipid and cholesterol levels and similar well-established indicators.
Rationale For Selection of Specific Clinical Blood Tests
Preliminary universe of tests based on known cellular and biological mechanisms of BPA, phthalates and other CECs. To be narrowed down in consultation with a qualified hematologist.
- Estrogenic activity
- Anti-androgenic activity
- Oxidative stress / inflammation
- Glucose metabolism
- Insulin resistance
- Adipocyte functioning
- Epigenetic alterations
- Interference with Mitosis (centrioles)
- CDK5 effects (thyroid cancer)
- Prostate cancer (PSA levels)
- Accelerated cell proliferation and decreased apoptosis
- Affects on G-Protein Coupled Receptors
- TNF alpha
- BDNF, VEGF,IGF-BP#3,EGF,FGF,FGF-2?,NGF
- F2 isoprostanes
- Hormones:cortisol,prolactin,GH,adiponectin,ghrelin,leptin,insulin, fasting glucose,NPY
- Vit E,C,D
- Cell adhesion molecules:VCAM-1,ICAM
- Oxidative stress markers:glutthione peroxidase,superoxide dismutase,nitric oxide,
- Human methylation 450 bead chip
- telomere length; telomerase
Bisphenol A & Phthlates As Markers For Chemicals Of Concern
Any given product may contain multiple compounds, which makes the task of identifying which compounds (or synergistic combinations) are responsible for a given health effect impractical for this study.
Indeed, given the lack of data on the health effects of most chemicals involved, the task would be impossible for the budgets and technical abilities of the most advanced laboratories. Significantly, even less data is known about combined health effects of the everyday mixtures to which consumers are exposed.
To make this study possible and yield the best possible data, the products chosen for stepwise abstention have been categorized primarily with an eye towards those with established and previously measured levels of BPA and phthalates.
Given that the now-well-studied BPA and phthalate compounds are often used together — and always used in combination with other polymers, resins, and product enhancement chemicals — we theorize that they are suitable markers for the presence of other “bad actors.”
Significantly, any health effects that may be observed from our study will clearly reflect possible synergistic effects from combinations of chemicals since it is impossible for us to know exactly which compounds are in a given product.
Study Product Category Rationale
In addition to selecting products with BPA and phthalate markers, we have also categorized products by their method of exposure:
- Consumption – migration and leaching from packaging8
- Consumption – migration and leaching from preparation stressors: heat, microwaving, ultraviolet/sunlight exposure, use of suspected utensils, preparation and eating surfaces
- Skin contact, inhalation
- Consumption – inherent content as purchased – resulting from harvest and processing
Product Category 1: Food (migration and leaching from packaging)
- Eliminating all products packaged in cans and plastic.
- Use of fresh products when possible.
- Products packed in glass may be substituted.
- Plastic-wrapped dry foods (bread, pasta, etc)
- Plastic-wrapped wet fresh foods (veggies, cheese, meat)
- Plastic storage bags
- Milk, Cheese, dairy products
- Cutting boards
Product Category 2: Food (migration and leaching from preparation stressors)
- Foods with metalized plastic “crisping” surfaces (Hot Pockets, frozen pizza)
- Paper or plastic plates, glasses and cups
- Take-out and deli plastic containers of all sorts.
- Restaurant and fast food
- Frozen and similar convenience foods
Product Category 3 (Non-alcoholic beverages, migration and leaching from packaging)
- Filtered tap water versus unfiltered.
- Homes/Offices where the water supply comes via PVC or Pex plastics.
- Beverages in pouches, boxes and “paper bottles’
- Water in hydration bladders like Camelbak
- Drip coffee maker and Keurig (plastic) as well as the Sodastream
Product Category 4 (skin contact/inhalation)
- Laundry detergents (phthalates, fragrances, surfactants)
- Dish and dishwasher soaps (same as laundry)
- Toothpaste (plastic tube) … alternative?
- Toothbrush … what are the bristles made of?
- Fitbits, plastic watch bands
- Gore-Tex and other waterproof coatings
- Paper currency
Product Category 5 (Alcoholic Beverages – Non-alcoholic beverages, migration and leaching from packaging, Ethanol known solvent for chemicals)
Alcohol consumption limited to two five-ounce pours of 14% wine or the equivalent.
- Wine in plastic pouches/bottles/boxes
- Distilled spirits in glass versus plastic bottles.
- Wine and beer “on tap”
Product Category 6 (Alcoholic Beverages in glass bottles).
Alcohol consumption limited to two five-ounce pours of 14% wine or the equivalent.
Product Category 7 (Dairy products: Consumption – inherent content as purchased – resulting from harvest and processing)
The present study will focus on dairy products as a category for its own abstain/intervention. This is because a recent study found an unexpected increase in phthalates especially in children. That study theorized this increase was due to their greater consumption of milk than adults. Investigators in that study theorize that the extensive use of plastics in the milk-production process was responsible for the phthalates increase despite the fact that milk was delivered in glass bottles. In fact, that study calculated that children were exposed to 183 micrograms/kg/day and noted that level was more than 9X higher than, the EPA oral reference dose of 20 micrograms/kg/day.
15.2 INTERVIEWS, QUESTIONNAIRES, AND/OR SURVEYS WILL BE ADMINISTERED OR FOCUS GROUPS WILL BE CONDUCTED:
Test subjects will engage in real-time, daily logging of everything they eat, drink use, or apply to their bodies and will involve the removal of one item category per week.
Because BPA and phthalates are cleared within 24 hours8,17,21,22, a weekly schedule should provide adequate time for clearance of BPA and phthalates
However, given the certainty of unknown chemicals and their uncertain clearance rates from the body, this period is uncertain.
Items chosen for removal will be selected according to peer-reviewed, published data measuring CECs in consumer products.
We theorize that removal of items known to contain or leach chemicals of concern will result in improvement of test subjects’ blood profiles as well as epigenetic profiles and double-stranded DNA break analysis
If that is confirmed, then it may be reasonable to conclude that the removal of those items was responsible.
It is possible that the change of chemical levels measured may fall beneath the noise level or the margins of error for an individual test. In those cases, we anticipate that the longer term levels will show a decrease.
16.4 BENEFITS TO SOCIETY
- First connection established between dietary intervention and health indicators.
- Establishment of a framework to move risk assessment of low-level Chemicals of Emerging Concern (CECs) beyond traditional toxicological evaluations toward molecular and epigenetic evaluations.
- Development of techniques to reduce exposure to CECs.
- Emphasis on techniques (#2, above) that can easily and economically be implemented by the average person without significant disruption to daily lives.
- Overall improvement in public health and a potential path to reducing the rising incidence of obesity, Type 2 Diabetes, Alzheimer’s disease and other behavioral disorders, fertility and developmental disorders.