Saturday, April 16, 2005

The Shelby Amendment - Massive Theft of Intellectual Property of Environmental Health Investigators

The "Shelby Amendment" advanced the bad guy counterattack to the Harvard Six Cities Study. The Amendment, and the OMB Circular A-110 which implemented the legislation, are dissected at the site below:

This amendment was a direct result the attack on EPA regulation on clean air. [Others think it may be aimed at CDC studies of firearm fatalities. In any event, it was without doubt a bad guy idea.] The Harvard Six Cities study was NIH funded.This data that was used by the EPA in writing the particle rule. Industry forces fighting the EPA rule wanted the underlying data that Harvard had generated so they could re-analyze it and criticize the EPA regulatory policy. EPA publicly provided aggregated data used in its risk assessment and cost-benefit analysis, but did not provide the underlying information which was retained by Harvard.

The FOIA applies to data in government hands. Data in the hands of private institutions was not subject to FOIA prior to the Shelby Amendment and OMB's A-11o amendments.

The rule makes "research data relating to published research findings produced under an award that were used by the Federal Government in developing an agency action that has the force and effect of law" publicly accessible under the procedures of the Freedom of Information Act. Only data produced by nonprofit grantees, and not data from contractors is covered.

Think of this in personal terms. A researcher toils for years to produce data deemed important to protect public health by the funding agency. The researcher risks these career years coming up empty. A research career depends on important results published. Now, an idea pans out, it's important. All of a sudden, the full force of industry which is impacted by the scientific results comes out.

Now comes the unoriginal researcher, bankrolled by industry, not peer reviewed or qualified by the study section, to the original researcher, and says "give me your work product." Even if time and effort are paid for, time and effort of scientists on turning over files brings negative career rewards. Nobody ever got tenure for running a xerox machine. Because the original result was important enough for publication, the unoriginal analyses will be publishable.

To rub salt, research by for profit contractors is exempt, only research by non-profit grantees is covered. Industry sponsored "money tox" is completely exempt.

BrooklynDodger will blog on the reanalysis of the Six Cities study later.

No comments: