Part 2 of a 4-Part Series
- View Part 1 here: How To Separate Good Science From Sketchy Tales
- View Part 3 here: The Corporate Fact-Fiddling Industry
One massive, gaping hole in American scientific peer review — especially for public safety purposes — can be found in the near-total absence of proper peer review in the science information that corporations submit to government regulatory bodies.
More dangerous for the public health, however, are thousands of secret corporate studies submitted to the Food and Drug Administration and other federal agencies for regulatory approval.
Federal regulatory practice allows companies seeking regulatory approval to keep their studies locked away from peer review because they are alleged to include trade secrets.
This practice extends to approvals for every sort of product that affects the public health including plastics, pharmaceuticals , tobacco, medical devices, chemical fragrances, cosmetics, personal care products, food additives and more.
In addition, many studies done by regulatory agencies themselves are kept secret and the data and experiments out of reach of proper peer review. In fact, the Environmental Protection Agency has been tangling with Congress over this for years: Committee Investigation into EPA’s Secret Science.
“Trade Secrets” Frequently Not Secrets At All
The Food & Drug Administration is also one of the worst offenders in thwarting proper peer review of the science it uses for its regulatory decisions: Drug Secrets: What the FDA isn’t telling.
The issue of the FDA’s trade secrets policies was looked into by an internal 2010 FDA task force which found that FDA staff was allowing companies to keep far more things secret than was appropriate.
The task force report (whose findings still have not been acted upon) found that:
“FDA’s current practice is to treat a substantial amount of the information that is submitted to FDA by companies and that does not fall under FDA’s definition of trade secrets as confidential commercial information that is not publicly disclosed [emphasis added].
The full task force report can be found here: FDA Trade Secrets (.pdf).
Trade secrets mean no peer review. And without all the original data, methods, formulations and processes, the evidence presented by corporations to regulators like the FDA or EPA, cannot undergo scrutiny by qualified reviewers and no one can attempt to reproduce the study and its conclusions.
“Just Trust Me” No One Audits Corporate Science Used For Government Regulation.
That leaves the science of product safety in the dubious, unreliable and unverifiable category of “just trust me.”
Most scientists and other people are honest. But there is a valid reason why the IRS and public corporations have auditors. Ordinary citizens have used cars and houses inspected by experts before purchasing. And “I’m from the government and I am here to help you,” produces howls of skeptical laughter.
“Just trust me “is no guarantee of anything and leaves the door wide open to abuse and malfeasance.
Hundreds of articles have been written dealing with the sometimes deadly consequences of this system. Too many exist to list here, but these example are typical:
- FDA Let Drugs Approved on Fraudulent Research Stay on the Market
- Report Raises Questions About FDA’s Approval of Knee-Surgery Device
- Improving Public Access To Data On Drug Safety
- Public comment on FDA’s process of documenting substantial equivalence: Need high standards of evidence and real transparency
- Federal District Court Orders FDA to Produce Records Regarding New Drug Application Pursuant to FOIA
- FDA Approval Is Often Based on Drug Company Information
Next in This Series: The Corporate Fact-Fiddling Industry