FDA Duped Into Approving Fake Product for Human Testing

Vaccine Truth

By Christina England | January 22nd, 2011

When a drug or a vaccine is approved for testing on humans we naturally expect all the paperwork to be thoroughly checked. We assume that background checks have been made and the doctors involved will have had their credentials investigated. To ensure that this task is undertaken correctly the FDA use the skills of Institutional Review Boards.

IRB’s are committees designated by an institution to approve, monitor, and review biomedical and behavioural research. They approve all of the vaccines and drugs for use in human trials. The IRB committees are made up typically of medics, persons from the criminal justice, education, physiology, and public health.

The primary purpose of such a review is to assure the protection of the rights and welfare of the human subjects. IRBs are a quality control measure and they ensure studies are conducted ethically. For full information on IRB’s see (http://www.umresearch.umd.edu/IRB/faqs.html).

Last year a report in the New York Times entitled Testing Firm Finds Itself Being Tested(http://www.nytimes.com/2009…), found that one company paid to do just that, failed on every level. The company, Coast Independent Review Board, was found to be approving drugs and possibly vaccines to be tested on humans without researching them fully.

In 2008, federal officials became suspicious about work carried out by Coast Independent Review Board located in Colorado. Based on several leads, the General Accountability Office (GAO) decided to fully investigate the quality control measures of Coast. The GAO engineered a product for Coast to approve for human testing. The investigation included a non existent product from a non existent company submitted to Coast.

Coast was asked to approve the product Adhesiabloc and approve its safety for testing on humans. Adlesiabloc was described as a gel designed to reduce scar tissue after surgery manufactured by the dummy company Device Med Systems.

As expected, Coast failed to investigate the product fully and their committee approved its use for human testing. The inquiry into Coast only came to light in 2009 when Coast put out a news release.

The New York Times reported:

“The company, Coast Independent Review Board, said it had been duped by federal officials last year when it agreed to oversee a study of Adhesiabloc, a product designed to reduce scar tissue after surgery.”

They continued to say that:

“The company’s president, Daniel Dueber, said he believed the operation was an unwarranted effort by the House Energy and Commerce Committee’s Subcommittee on Investigations and Oversight to embarrass firms like his.”

After the fake product was approved for testing on humans all Coast could say was that it was a “trick to EMBARRASS companies like theirs.” Nothing to do with putting lives at risk then?

The product that Coast approved was from a fake company and using a fake address (which was in fact a PO Box address). They even used a fake doctor with fabricated credentials. Despite this, not one member of the committee – used to approve drugs, vaccines and medical devices – picked up on this! It is a total and utter disgrace.

The New York Times went on to say that Coast only began investigating the validity of Adhesiabloc five months after they had in fact approved it for testing on humans.

Coast has since been reported to have complained about their treatment at their hearing. Pharma Times said:

“An institutional review board (IRB) in the US has complained about being targeted in a ‘sting’ operation to inform a Congressional hearing on IRBs scheduled for later this week.

Coast Independent Review Board of Colorado Springs had already publicised its discovery during “a routine audit” that a clinical trial protocol submitted by Device Med Systems of Clifton, Virginia for a medical device called Adhesiabloc was fraudulent in violation of US state and federal law.” (http://www.pharmatimes.com/Article/09-03-23…)

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