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?

  • Catherine

    It is clear that these people do not like to get caught out. it is as simple as that.

    How much easier and noble it would be to hold their hands up and say – OK, we are crooks, deceivers, thieves etc. They will never own up and take responsibility like real men and women, because they are totally self serving and see the people as LESS than them. It is the same pattern as the church abuse truth. These men of god and gods of medicine felt they had some divine right to play god. Now, thanks to decent human beings, change comes into creation. Real positive change where medicine returns to its natural form- there to heal the sick, not kill the healthy.

  • Stacy

    It makes me sick to think that this is most likely going on all the time. I am certain that this was not a one time incident. As a parent, I monitor what comes into my house and what goes into my kids bodies. It is a shame that when I try to do the same with vaccines and medications, I am criticized. The disregard of human life all in the name of the almighty dollar is an absolute crime. And unfortunately, our kids are the most affected by it.

  • http://health.groups.yahoo.com/group/WeThePeopleUnitedForVaccinationEducation/ Marsha McClelland

    Wow. This is big. Thank you Christine. I just shared it in the newsfeed & will be spreading it far & wide.

    My first post went;

    Please share this everywhere. This is really big. I just shared it here;

    http://www.huffingtonpost.com/2011/01/20/vaccine-seizures-feds-checking-post-flu-shot_n_811756.html

    Please come help drown out the liars. The shills who hang in these threads at Huffington Post out number us. We really need the help so those watching won’t buy their bull.

    And I’m going to send it here, too;

    http://www.huffingtonpost.com/jenny-mccarthy/vaccine-autism-debate_b_806857.html

    End

    If we had more of you great journalists writing articles at Huffingtonpost.com, we could be waking more & more people because that online newspaper is read by a huge number of people from all over the world.

    My task with a small number of dedicated activists is to expose the shills & help educate our people, there. We are still out numbered by the paid shills. When we drown them out by growing our numbers & articles they will have to give up or hire more bad people to dupe ours which would be a hard thing to keep secret & that, too, would be more exposure on what’s going on when the whistle is blown by those with conscience who won’t go along with the program. This is our children we’re talking about & there’s no way this cover will be continuing at the expense of their health & very lives when enough of us become activists & cover all fronts.

  • Barbara

    Another wonderful article by Christina England.
    I wish I could say I am surprised by this news but unfortunately I am not. This type of story seems to be the norm these days. As long as government departments and pharmaceutical companies are making profits out of the sick and disabled they have no incentive to end this sort of thing.
    What we all need to understand is that we are just not important to them and do our very best to expose their cheating and lying.
    Like Marsha I hope for someone of conscience is strong enough to be a brave whistle blower.
    Thanks Christina.

  • Sandy

    This excellent and eye opening article by Christina England reveals the shocking fact that the FDA has neither satisfactory monitoring, nor control over safety issues regarding clinical trials.

    Not only should the article be widely spread, it should also be sent to doctors and it should be obligatory reading for, amongst others medical students so that they be made aware of some of the dark realities behind the issue of clinical trials.

    Pharmaceutical companies steer their own protocols and carry out trials in a way which produces results which are in their favour. It is therefore imperative that the trials are reviewed by a serious and reliable institution.

    The FDA, which has the ultimate responsibility for overseeing the trials designates the reviews to numerous Institutional Review Boards (IRB’s). The FDA regularly issues dozens of warning letters to IRB’s, many of these letters revealing total lack of protection regarding the safety of the participants in the trials.
    http://www.circare.org/FOIA/irblast.htm

    How many more cases are there where warning letters should have been issued?
    It is estimated that only 1 percent of all clinical trials were audited between 2000 and 2005. A report by Department of Health and Human Services Office of Inspector General found that there was a significant lack of follow ups after the FDA had issued warning letters.
    http://www.naturalnews.com/z022135_the_FDA_clinical_trials.html

    The example in the article, where the FDA used a hoax product from a non existent company would be amusing if it wasn’t for the fact that behind the story are tragic implications for so many, involving much suffering and reduced quality of life.

    Christina E asks “Why wasn’t this disgraceful affair publicized worldwide?” and gives the obvious answer – that the FDA does not want a poor reputation. She rightly questions the scandalous approval of the drug Vioxx and whether vaccines such as Gardasil, which has already caused incredible suffering for thousands of young girls, should have been allowed on the market.

    Many competent medical experts maintain that it is only a question of time before the huge and ugly “Gardasil tower” collapses and crashes down to earth with a thunderous roar, the sounds of which will resonate across the world.

    The whole issue of clinical trials is riddled not only with lack of competence, but also lack of ethics. It is downright deceitful of the FDA to lead us to believe that drugs and vaccines which are on the market today have been properly tested and are safe.

    Sometimes clinical trials are designated “clinical safety trials”, an ironic contradiction in terms.

    Maybe they should instead be called “cynical trials”?

  • http://gdsajj.wordpress.com/ John H

    It’s really quite simple.

    As I’ve stated before. The FDA is simply a ‘clowns costume’ for big pharma and petro-chemical (two birds of a feather) to slip on in order to ‘PLAY’ government oversight.

    There are very few cries from the public concerning the FDA’s gross and fraudulent conflicts of interest within the agency. The root of ALL the problems. The FDA stands to protect ‘SPECIAL INTEREST’. The public better get a clue and, look at the cold hard facts, that the FDA has absolutely NO INTEREST in what is best for them.

    There is a much bigger outcry from the public, including politicians, when an NBA player leaves a city to work elsewhere than when the FDA’s gross disregard kills and maims a loved one. Until the public at large comes to grip with the ‘reality’ of what’s important in this life, the foolishness at the FDA will just go on.

    BTW Jeff,
    Great job on your website! Keep up the good work!

  • Ellen

    We risk our lives, and the lives of our children, every time we walk into the doctor’s office and he/she hands over a prescription or advises a vaccine. The odds for success are better at the local casino.

  • Sandy

    Correction to comment no. 5.
    Please change “The example in the article, where the FDA used a hoax product ” to “The example in the article, where the General Accountability Office (GAO) used a hoax product ”
    Sorry about that!

  • patrons99

    “It is a total and utter disgrace.”

    Well said! This is just the “tip of the iceberg”. The drug and biological approval process has been thoroughly corrupted for quite a long time. The public trust has been completely betrayed. Whistle-blowers end up road kill. The pharma cartel deals in fear. They are masters of creating and perpetuating myths. So-called “Vaccine-preventable diseases”, “Torches of Liberty”, and “Fluoride is safe and good”, are just marketing taglines for big business. It is about time that the public woke up. We are just fodder for corporate greed by pharma. It’s time to “just say no” to pharma. Our law makers need to hear our voices on this subject.

    “If we understand the mechanism and motives of the group mind, it is now possible to control and regiment the masses according to our will without them knowing it.” – Edward Bernays, 1928.

    “The great enemy of the truth is very often not the lie — deliberate, contrived and dishonest, but the myth, persistent, persuasive, and unrealistic. Belief in myths allows the comfort of opinion without the discomfort of thought.” ~ John F. Kennedy, 35th president of US 1961-1963 (1917 – 1963)

    Promotion by pharma and the orthodox medical establishment of the myths of vaccine-induced “herd immunity” and “vaccine-preventable” diseases allows the comfort of opinion without the discomfort of thought. Global vaccine policy is a false flag operation against the people. The myths of vaccine-induced “herd immunity” and “vaccine-preventable” diseases are important elements of their propaganda campaign to control the population.

  • patrons99

    With regard to the FDA approval of the HPV vaccines, FDA bears substantial culpability. They have “blood on their hands”. Widespread placebo fraud by pharma and FDA is rampant. To say that the nature of the placebo can influence trial outcomes, is an understatement. The expedited market approval of Gardasil by FDA is a case in point.

    FDA permitted pharma to “poison the placebo” by allowing hepatitis B vaccine and aluminum salts to be used in the “placebo” arms of several of the pivotal NDA studies upon which expedited market approval was granted under PDUFA timelines. They knew exactly what they were doing and why they did it. To say this was an innocent “mistake” is seriously delusional. Hep B vaccine used VLPs. There is a tacit assumption that VLP technology, polysorbate 80, and aluminum are “safe”. Without a true placebo controlled study, this assumption has quite simply NEVER BEEN PROVEN.”

    “Placebo fraud rocks the very foundation of modern medical science; thousands of clinical trials invalidated” by Mike Adams on October 28, 2010.

    http://www.naturalnews.com/z030209_placebo_medical_fraud.html
    http://www.annals.org/content/153/8/532.abstract

    “Placebos were seldom described in randomized, controlled trials of pills or capsules. Because the nature of the placebo can influence trial outcomes, placebo formulation should be disclosed in reports of placebo-controlled trials.”

    Most new biologicals, including new vaccines, are approved on the non-inferiority margin method whereby all that pharma need show is that the new agent is no more acutely toxic than a particular marketed biological of the same class. Hence, all that is now really required for expedited market approvals by FDA under the PDUFA (“Prescription Drug User Fee Act”) timelines is a showing of political expediency. Drug and biological safety and efficacy are now irrelevant. FDA Advisory Committee meetings are nothing more than kabuki theatre. FDA has become an operational arm of pharma. COIs? Who are they kidding?

  • http://www.facebook.com/people/David-Hill/100000932326908 David Hill

    A very good article about how Big Pharma have evolved, their roots and mindset is outlined in ‘Return To Nuremberg: Big Pharma Must Answer For Crimes Against Humanity’.

    http://foolscrow.wordpress.com/2010/07/27/return-to-nuremberg-big-pharma-must-answer-for-crimes-against-humanity/

    It makes very interesting reading.

    Dr David Hill
    Executive Director
    World Innovation Foundation Charity
    Bern, Switzerland