FDA Approves Nonexistent Product from Nonexistent Company for Human Testing

by Heidi Stevenson 10 January 2011          gaia-health

A sting nailed a company the HHS authorized to oversee human drug trials. The absurdities in the application are belly laugh funny, but in their rush to keep the money coming, they approved it.

The FDA farms out drug and medical device testing. It’s in the hands of the companies hoping to gain approval for their products, but they must first get approval before doing tests on humans. Even here, though, there’s a catch. The FDA doesn’t review the testing plans. That’s done by more for-profit companies, Institutional Review Boards (IRBs). But it gets worse. The IRBs are paid by the companies hoping to gain FDA approval for their products. So, it’s a conflict of interest on top of a conflict of interest.

The First Sting

Congress became suspicious, so they got together with the General Accountability Office (GAO) to set up a sting. They sent out an application for testing of a nonexistent product, Adhesiabloc, by a nonexistent company, Device Med-Systems.

Subtlety is apparently not one of the GAO’s strong suits. Adhesiabloc was described as a gel that would be poured into a patient’s stomach after surgery to collect the bits and pieces left over from the operation. The instructions were to pour more than a liter into the wound.

EPA approves complex GE crop behind closed doors

The Environmental Protection Agency (EPA) has approved the most complex genetically engineered (GE) crop ever to enter the U.S. food supply

…without notifying the public or inviting public comment.

SmartStax, a variety of corn containing eight new genes—six for insect resistance and two for herbicide tolerance—is significantly different from the three-gene corn varieties that the agency previously approved. Monsanto and Dow Chemical, the joint developers of SmartStax, expect the new variety to be grown on three to four million acres next year, the largest launch ever of a GE crop.

UK Gov rejects experts’ advice not to use Tamiflu

Experts warned dispersal of Tamiflu would do more harm than good

By James Sturcke

The government rejected advice from its expert advisers on swine flu, who said there was no need for the widespread use of Tamiflu and suggested that the public should simply be told to take paracetamol.

An independent panel set up by the Department of Health warned ministers that plans to make the stockpiled drug widely available could do more harm than good, by helping the flu virus to develop resistance to the drug.