Bad FDA Science Makes For Bad Public Health

Please note that this post is based on an earlier version of our scientific paper at Low-Dose BPA Paper In Toxicological Sciences is Contaminated By Massive Errors & Should Be Retracted (caution: footnotes and citations ahead). That paper has been expanded to more than twice its size in preparation for scientific journal publication. We will update this post as soon as that happens.

By Lewis Perdue & Becca Yeamans

Flawed studies make for bad science. Bad science makes for bad decisions.

That’s especially serious when the bad science is done by the same people who make regulatory decisions on Hormone Disruptors.

An excellent example of this very bad science – written in 2014 by Federal Drug Administration (FDA personnel – can be found in the journal Toxicology That study, which concluded that low-dose BPA is not harmful, contains so many basic scientific flaws that contains no valid conclusions.

Among the more obvious bone-headed failure:

  • Control animals were contaminated which invalidates the whole study.
  • Covering up the contamination by burying the disclosure deep toward the study’s end.
  • Choice of a type of lab rat well-known to be insensitive to BPA.
  • Improper method of dosing the lab rats
  • Failure to use current science

Contaminated controls

Every animal experiment needs a negative control group. This consists of  exactly the same sort of animals used in the experiment. But instead of being tested, the negative controls just keep on living their usual lives. That way, the effects of an experiment on the test animals can be compared to a group that has not been tested.

Without a negative control group for comparison, experimental conclusions are essentially worthless. This is a hammered into the heads of every freshman or sophomore biology student.

In the FDA study, in order to have a true control, no control animal could have BPA nor any other endocrine disruptors (EDC) in their body that interact with or act similar to BPA.

Unfortunately, ALL rats in the FDA study, even the supposed negative controls were contaminated with BPA prior to experimentation.

This means that the authors of this study cannot validly conclude (as they did) that low-dose BPA causes no harm. This flaw alone invalidates any conclusions made by this study.

Covering Up Contamination

Rather than realize the controls were contaminated and re-doing the study the correct way, The authors buried the contamination issue very deep, toward the end in the paper perhaps hoping no one would notice.

Burying this fatal error meant that they spent more than 30 pages of a study discussing results and conclusions that have no basis in science.

That cover-up misleads even the scientifically informed reader who reads the article abstract and most of the rest of the report, into thinking that this is a valid study. That often gets picked up by mainstream media which continues to mislead consumers.


Inappropriate Rat Strain

Laboratory animals are specifically bred so that they are as close to genetically identical as possible. These closely related animals are called “strains.” Having such closely related DNA reduces the effects of genetic variations on an experiment’s results.

The strain in this study — Sprague-Dawley rats, white rats that have a lot of genetic variability, are very insensitive to BPA and other estrogenic compounds.

Even without the well-known insensitivity to BPA and other Hormone Disruptors, the genetic variability alone could produce inconsistent results.

Experienced scientists with a knowledge of the field and current scientific knowledge would have known of these flaws.

Failure to use current science in BPA and EDC research

Federal agencies like the FDA continue to publish information on the safety of BPA, based on the results of a tiny number of studies following out-of-date and inappropriate guidelines.

At the same time, these agencies continue to ignore more than 1,000 peer-reviewed academic articles that have shown primarily harmful effects of low levels of BPA on human health

Through the end of 2004, 90% of government-funded peer-reviewed research articles found adverse effects of BPA exposure.  On the other hand, of those industry-funded research articles on BPA, 0% found any adverse effects of BPA exposure, which raises more red flags.

Cluelessness on Contamination Sources

While the sources of the contaminated control rats are blatantly obvious, the authors of this study claim to be clueless about the origins of their control rat contamination.

As pointed out in detail in Low-Dose BPA Paper In Toxicological Sciences is Contaminated By Massive Errors & Should Be Retracted, the lab rat food was contaminated and the cages were contaminated. Numerous published studies also point out the presence of Hormone Disruptors in the plastics commonly used in labs including: water bottles, water, equipment used to feed the animals, and disinfectant cleaners. None of these were addressed by the FDA study.

Failure to measure BPA levels in any of the animals until the very end of the trial

If the researchers had tested the animals at the very beginning, they would have found that all animals were contaminated.

But, BPA levels of any of the animals were never measured until the end of the experiment, no consideration was given to actual levels of BPA in the animals.  Without having a starting point to compare to, it’s impossible to draw any conclusions based on what was seen at the end

The FDA study used the wrong method to feed its test rats

Numerous studies have shown that significant amounts of BPA are absorbed directly by mouth and throat tissues of lab animals who consume food dosed with it. This direct absorption into the bloodstream bypasses the digestive process which may decrease the amount of BPA in the bloodstream.

Instead, the FDA researchers used an out-moded method called “oral gavage.” This injects liquid food directly into the stomach using a syringe attached to plastic tubing. Both the tubing and the syringe are also potential sources of BPA contamination.

Conclusion: This Paper Fails On So Many Levels It Should Never Have Been Published

The FDA especially needs to raise its standards to match those of the National Institutes of Health which has three stringent levels of scrutiny involving peer review before grants are awarded:

1) assessment of investigator competency;

2) assessment of experimental design, appropriateness of outcomes and use of the most current science and lab techniques; and

3) post-investigation peer-review, publication in peer-reviewed journals and efforts to follow up the study with replication and updated results.

The FDA and the old-line toxicology establishment must bring its last-century knowledge base and paradigms up to date and begin to conduct itself in the public interest.

Remember, if you can handle footnotes and some biology, our deeper scientific analysis, along with footnotes and citations, can be found here: Low-Dose BPA Paper In Toxicological Sciences is Contaminated By Massive Errors & Should Be Retracted.


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