Just Because The FDA Says Something’s Safe Doesn’t Mean It Is

This article is a stub for work in progress and is included here to offer readers a view of a few  of the links describing a few of the FDA’s numerous failures. The roots of those failures have a bearing on other articles on Stealth Syndromes.

This article is one in a series. For the other articles, please see:  INDEX: “Why You Can’t Trust Government Science”


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

That’s especially serious when the bad science is done by the FDA — the same people who make regulatory decisions on hormone disruptors.

A good example of this flawed science – a study 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 the article 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

As every high school science student learns, having a control group for an experiment is fundamental. This is because if you are going to try out a chemical or some other experiment on a group of animals, you need to make sure you have an uncontaminated group — controls — so you have a “before” to compare your “after.”

Despite a number of ways to make sure their control animals were not contaminated, the FDA scientists failed. The controls were contaminated which invalidates the study. They tried to cover up the contamination by failing to disclose it, burying the revelation deep toward the end of the paper.

More details on the other flaws in that paper  — Bad FDA Science Makes For Bad Public Health — shows that it resulted from a perfect storm of:

  • Incompetence,
  • Failure to keep up with scientific advances,
  • Ignorance of recent peer-reviewed studies, and
  • A contaminated pool of lab animals from a federal breeding facility which may have handled the animals improperly.

That last issue may affect hundreds of other scientific studies using contaminated animals.

The only saving grace with that massively flawed FDA study is that it made its way into a publicly viewable journal where its fatal errors are still being debated.

Several prominent researchers followed up on that FDA study critique with their own published reviews. As one example, please see Should oral gavage be abandoned in toxicity testing of endocrine disruptors?

We will expand this page, but for now, the following links detail a few of the FDA’s failures.

FDA knew of design flaw in scope linked to UCLA superbug deaths

FDA Let Drugs Approved on Fraudulent Research Stay on the Market

FDA Approval Is Often Based on Drug Company Information

FDA staff travels on drug industry dollars

EPA Contaminated by Conflict of Interest

Top economists say FDA Dramatically Underestimated the Net Benefits of Graphic Warning Labels on Cigarette Packaging

U.S. Supreme Court Rejects Challenge to New Cigarette …

Appeals Court Allows Farmers To Keep Feeding Unnecessary Antibiotics To Animals

The Future of Government-Mandated Health Warnings After …

Cigarette Graphic Warnings and the Divided Federal Courts

Regulation of tobacco by the US Food and Drug … – Wikipedia

F.D.A. Unveils Proposed Graphic Warning Labels for …

FDA Scraps Graphic Cigarette Warnings – WSJ

Will The FDA Ever Get Around To New Warning Labels For …

FDA changes course on graphic warning labels for cigarettes

27 cigarette warning labels nixed by the FDA – CBS News

Cigarette Health Warnings – Food and Drug Administration

Report Raises Questions About FDA’s Approval of Knee-Surgery Device

FDA staff travels on drug industry dollars

consulting firm FDA staff – Google Search

fda regulatory failures

consulting firm EPA staff – Google Search

 Drug Secrets: What the FDA isn’t telling.

Food Ingredients: Trade Secrets vs. Public Disclosure

prescription drugs inShare1 Drugs Approved Due To Fraudulent Research Still On Market, FDA Shrugs

Public comment on FDA’s process of documenting substantial equivalence: Need high standards of evidence and real transparency

FDA Approval Is Often Based on Drug Company Information

Scientists cry fowl over the FDA’s regulatory failure

FDA Regulations Should Be Safe and Effective

Oversight Failures Documented in Meningitis Outbreak

Metal on Metal Hip Replacements: A Tragic Failure of the FDA Regulatory Process

In Medicine, New Isn’t Always Improved

Criticism of the Food and Drug Administration

FDA review of new sunscreen ingredients languishes, frustrating advocates

FDA Food Inspections Fail To Catch Vast Majority Of Pathogens, ‘Bloomberg Markets’ Finds

American Journal of Transplantation Regulatory Failure Contributing to Deaths of Live Kidney Donors

Tobacco Unregulated: Why the FDA Failed, and What To Do Now (not printed)

 

REFERENCES: University Versus Corporate Study Results

An extensive new literature concerning low-dose effects of Bisphenol A shows the need for a new risk assessment. Environmental Health Perspectives 113(8): 926-933, vom Saal, F.S., and Hughes, C. 2005.

Why public health agencies cannot depend on Good Laboratory Practices as a criterion for selecting data: The case of Bisphenol A,  Environmental Health Perspectives 117(3): 309-315, Myers, J.P., vom Saal, F.S., Akingbemi, B.T., Arizono, K., Belcher, S., Colborn, T., Chahoud, I., Crain, D.A., Farabollini, F., Guillette, Jr., L.J., Hassold, T., Ho, S., Hunt, P.A., Iguchi, T., Jobling, S., Kanno, J., Laufer, H., Marcus, M., McLachlan, J.A., Nadal, A., Oehlmann, J., Olea, N., Palanza, P., Parmigiani, S., Rubin, B.S., Schoenfelder, G., Sonnenschein, C., Soto, A.M., Talsness, C.E., Taylor, J.A., Vandenberg, L.N., Vandenbergh, J.G., Vogel, S., Watson, C.S., Welschons, W.V., and Zoeller, R.T. 2009.

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