FDA Duped Into Approving Fake Product for Human Testing

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…)

I researched Coast and found that in April 2009 they said this on their website,

“April 14, 2009: FDA directed Coast IRB to suspend review of all new clinical trials and to suspend further enrolment of any new subjects in current trials.

April 23, 2009: Coast announced that all its studies would be transferred to other IRBs in preparation of closure. Transfer actions were initiated on April 24, 2009 via email blast and telephone calls to all clients.” (http://www.coastirb.com/)

The FDA has since been reported to have sent Coast a warning letter. Medical Products Outsourcing said:

A congressional probe has prompted the U.S. Food and Drug Administration (FDA) to send a warning letter to Coast Independent Review Board, a company that monitors testing of experimental drugs and medical devices on humans.

The agency identified “serious violations” of several federal rules that protect human subjects. A congressional hearing last month exposed flaws in experiments that could put patients at risk.” (http://www.mpo-mag.com/news/2009…)

A link to of one of the letters can be found here (http://www.fda.gov/ICECI/Enforcement…).

This whole episode has shown very serious issues concerning the way the FDA conduct their business. One gets the impression that the FDA is passing the buck and using unreliable sources to approve medication and vaccines for the purpose of testing on humans. If this investigation had not been carried out then no one would be any the wiser.

My concern is how many vaccines and drugs have Coast approved for testing on humans that have had inadequate research?

Currently Gardasil, the HPV vaccine to protect women from cervical cancer, has massive problems. So far there have been a total of 21,133 reports of adverse reactions reported to the Vaccine Adverse Events Reporting System VAERS and a total of 89 deaths. This is in the USA alone. Many adverse reactions are not reported or not even connected to the vaccine due to the time frame.

Two brothers of one Gardasil victim who began to have seizures after her Gardasil shot are so outraged about the hidden dangers of this vaccine that they are making a documentary. This documentary is to warn others about the dangers of the Gardasil vaccine. It will feature many girls and their families speaking about their experiences. The preview of One More Girl can be found on (http://www.kickstarter.com/projects…).

Leslie Botha of SANE VAX says this on her press release about the project:

This is a new and exciting concept that puts film production back into the hands of the people who appreciate the power of documentary story telling instead of allowing the film industry to determine the nature and content of the message.” (http://www.prlog.org/11212653…)

One has to wonder about who exactly did the FDA use to check the research and approve this vaccine for human testing. Could it have been Coast by any chance? Or did they use another equally dodgy company to do their work for them?

The FDA is an agency used to approve drugs and vaccinations for worldwide distribution. Is it any wonder they are getting it wrong time after time? This may shed some light as to how some drugs such as Vioxx and vaccines such as Gardasil are allowed onto the market.

Perhaps a bigger question is why wasn’t this disgraceful affair publicised worldwide? It was quietly swept under the rug getting minimal coverage. Was this because it gave the FDA a black eye for allowing a fake product to be approved for testing on humans? If Coast did not check this product, how many others have they also neglected to research? How many drugs and vaccines are on the market today which are poorly researched or even not researched at all by agencies such as Coast?

Is Coast just one of many companies used by the FDA who fail to do their job to the standard expected by the public?

About the author

Christina England, BA Hons