Tag Archives: Oversight

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.

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Ex Monsanto Lawyer Clarence Thomas to Hear Major Monsanto Case

By D. Snodgrass
Celsias

In Monsanto v. Geertson Seed Farms, No. 09-475, the U.S. Supreme Court will hear arguments in a case which could have an enormous effect on the future of the American food industry. This is Monsanto’s third appeal of the case, and if they win a favorable ruling from the high court, a deregulated Monsanto may find itself in position to corner the markets of numerous U.S. crops, and to litigate conventional farmers into oblivion.

Here’s where it gets a bit dicier. Two Supreme Court justices have what appear to be direct conflicts of interest.

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Systemic Failures, by Design

designed to fail

Sunday 31 January 2010

by: Mark Montgomery, t r u t h o u t | Op-Ed

Over the past dozen years, the US has experienced a series of dangerous and costly systemic failures throughout our security and regulatory framework. The unfettered bubble in technology, missed opportunities to prevent 9/11 – leading to two ongoing wars, the tragic response to Katrina, the largest financial crisis in history, the Fort Hood massacre and the “underwear bomber” incident on Christmas Day all share one commonality.

In each of these cases, data had been collected by US government agencies that contained a high probability of either entirely preventing or substantially mitigating each event, if only the information had been recognized and acted upon within the window of time allowed by circumstances. In case after case, repeated warnings by recognized experts, sourced internally and externally, were ignored or suppressed.

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