See also: GLP Part 2: Federal Regulation’s Buggy Whip Science, and the multi-part series: Why You Can’t Trust Corporate & Federal Regulatory “Science”
Federal regulatory science is flawed in many aspects, but one of the primary reasons lies in the outdated and rudimentary rules embodied in “Good Laboratory Practices” (GLP).
GLP was created in 1978 as a reaction to fraudulent science, but requires only a set of rock-bottom, rudimentary rules for basic lab practices. Any college student who earns a “C” in a sophomore-level science lab must master an equivalent set of rules.
Despite its intent, GLP has done little to stop shoddy science because studies for regulatory science are based on outdated science and laboratory methods and are conducted mostly in secret by corporations and the private laboratories they hire.
GLP’s outdated and frequently inappropriate rules are often and easily “gamed” by private labs who have learned how to create regulatory approval by the savvy application of scientific half-truths, fraud, procedural loopholes, obsolete science, and other significant scientific and ethical lapses.
According to this article about GLP in Environmental Health Perspectives (EHP), the federal government’s obsession with GLP has resulted in flawed regulatory decisions that can adversely affect public health. EHP is a scientific journal published by the National Institutes of Health.
GLP’s Origin In Scientific Fraud
According to the EHP article, the need for better standards or corporate science was illustrated when two men from a private science company were sentenced to prison in 1983 for deliberately skewing results of tests to make it easier for chemical company clients to gain regulatory approval.
“What began as serious concerns about poor quality research expanded into a criminal investigation of Industrial Bio-Test (IBT), one of the largest private laboratories at the time and a subsidiary of Nalco Chemical Company,” said the EHP article.
“In response to the federal investigation, the U.S. Environmental Protection Agency (EPA) demanded that 235 chemical companies reexamine the >4,000 tests conducted by the laboratory.
“In 1983, three men from IBT were found guilty of deliberating doctoring data and were sentenced to prison. The fraudulent practices of IBT brought into question 15% of the pesticides approved for use in the United States. That same year, the U.S. EPA issued similar GLP rules for regulatory testing.”
This article shows how fraud continues to plague corporate science: Covertly Stretching “Peer Review” Until It Breaks
Sophomore-Level Science Standards
The EHP article notes that “GLP outlines basic guidelines for conducting scientific research, including the care and feeding of laboratory animals, standards for facility maintenance, calibration and care of equipment, personnel requirements, inspections, study protocols, and collection and storage of raw data.”
Proper adherence to those fundamental basics is one of the lowest bars a college sophomore biology or chemistry student must master on the way to a “C.”
NIH Standards Stricter, Yet Rejected By Regulators
The the EHP article notes that,
“[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….”
FDA In Forefront Of GLP Support
The EHP article pointed out that the Food and Drug Administration ruled that the chemical BPA (Bisphenol A) was safe only after rejecting more than 700 peer-reviewed, published studies done to NIH standards because they did not adhere to the looser GLP rules.
Instead, the FDA made its safety determination on two chemical company-funded studies because they used GLP.
The EHP article noted that independent researchers later found those studies flawed and their results unreliable.
The federal government’s substandard science and its misguided preference for GLP over university studies was dissected in detail in this article from the Boston University School of Law: Equal Treatment for Regulatory Science
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GLP: No Guarantee Against Incompetence Or Carelessness
The NIH standards and associated scrutiny of researchers and the design and conduct of their experiments provide solid safeguards for reliable, reproducible and honest science.
GLP, on the other hand, offers many opportunities for misconduct, incompetence and carelessness.
This 2014 article details the pitiful state of some GLP experiments and the appalling incompetence of those who practice it: Bad FDA Science Makes For Bad Public Health That study on Bisphenol A makes so many bone-headed and obvious experimental errors that it would merit an “F” in high-school biology.
More incompetence of this nature remains un-exposed because of time and career concerns. It took literally weeks to create the scientific paper underpinning that FDA piece: Low-Dose BPA Paper In Toxicological Sciences is Contaminated By Massive Errors & Should Be Retracted.
Few NIH-level researchers have the time to devote to dissecting badly done GLP studies.
But there is a bigger issue that keeps even the most ardent opponents of GLP incompetence from speaking up: career issues. The FDA and other federal agencies have money and facilities that are rarely made available to dissenters.
While corporate science and private labs have virtually limitless funds to conduct secret, substandard GLP studies, those who do the best and most reliable science remain under-funded and vulnerable to being left out in the cold if they point out the regulatory emperor’s clothes.
More details of a few of the FDA’s other failures can be found here: Just Because The FDA Says Something’s Safe Doesn’t Mean It Is.
Reliability and Validity
The EHP article emphasized that:
“Of central importance is that the results of a study must be reproduced under a similar methodology to be considered to be reliable.
“Validity” refers to whether the research measures what it was intended to measure, and valid findings are considered to be true.
“In other words, reliability is determined by whether the results are replicable, whereas validity is assessed by whether the methods used result in finding the truth as a result of the investigator actually measuring what the study intended to measure.
“Unfortunately, although GLP creates the semblance of reliable and valid science, it actually offers no such guarantee.
“GLP specifies nothing about the quality of the research design, the skills of the technicians, the sensitivity of the assays, or whether the methods employed are current or out-of-date. (All of the above are central issues in the review of a grant proposal by an NIH panel.)
“GLP simply indicates that the laboratory technicians/scientists performing experiments follow highly detailed U.S. EPA requirements [or in the EU, Organization for Economic Co-operation and Development (OECD) requirements] for record keeping, including details of the conduct of the experiment and archiving relevant biological and chemical materials.”
FDA Ignores Highest Standard Of Research: Reproducibility
The gold standard in scientific research is reproducibility: Can the experimental results be replicated by independent third parties? And not just reproduced once, but many times.
However, reproducibility requires complete transparency, ethical scientists and competent science. There must also be publication of the results along with all the protocols and other details that allow another scientist to duplicate the experiment and the results. This extensive series of articles demonstrates why federal and corporate science fails at every step and cannot afford the scrutiny that transparency sould bring.
According to the EHP article:
“Typically, within a laboratory, interesting findings are also followed by subsequent publications extending the prior findings…. In particular, independent replication by competent, respected scientists is the main criterion of acceptance of the findings as having been demonstrated to be reliable and having been validated by virtue of coming to the same conclusion using a variety of sophisticated techniques in multiple publications.
“[T]he U.S. FDA, in its assessment of the now [2009] approximately 1,000 articles on BPA, is that it appears to have made no attempt to connect the dots between replicated studies; instead, the U.S. FDA appears to have assessed each study without regard to whether it had been confirmed by other studies.
“Thus, collectively, many phases used to verify the reliability and validity of NIH-funded published research have been completely ignored by the U.S. FDA, whereas industry-funded GLP research is rarely, if ever, subject to these central requirements and yet is accepted by regulatory agencies as reliable and valid.”
Sadly, the vast majority of GLP studies used for regulatory approval are kept secret and cannot be reproduced or validated.
These studies are created by private labs and corporations who are allowed to unilaterally declare the studies as “confidential business information.”
For more, see Secret Chemicals: What The Government Won’t Tell You, Can Kill
American Chemical Council Supports GLP
Unsurprisingly, the American Chemical Council (ACC) — the industry trade and lobbying association — was the only defender of GLP against the charges leveled in the EHP article: Good Laboratory Practices and Safety Assessments.
Significantly, the ACC has a serious load of its own fraud issues which vastly undermine the article’s credibility.
In this piece, a former ACC consultant shows how the ACC lied about its lobbying role on flame retardants.
And this article A Lack Of Ethics: Covertly Stretching “Peer Review” Until It Breaks, uses exhibits in a federal court case to demonstrate how the ACC admitted to a continuing practice of laundering industry money to recruit shills willing write derogatory comments regarding published studies it disagreed with.
The authors of the original EHP piece — on which this article is based — responded with documented details — Good Laboratory Practices: Comments — that gutted the ACC’s contentions.
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