International Criminal Court                                                                                               02 December 2005

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                                                                           SCIENTIFIC FRAUD AND BIOWEAPONS-“BARDA”

European Commission                                                                                                              
Hearing Office
Rue de la Loi 200
J79 - 05/211
B-1049 Brussels

+32 (0)2 296.95.78

 

Office of the High Commissioner for Human Rights
United Nations Office at Geneva
1211 Geneva 10, Switzerland
Fax: + 41 22 917 9022

+41 22 917 9011

 

Dear Sirs,

 

Yale University (New Haven, CT), and the “front” the American Lyme Disease Foundation (www.aldf.com), and it’s twin spin firm Europe’s EUCALB, created a condition of scientific fraud and racketeering, wherein they changed the testing for Lyme borreliosis to make it almost undetectable.

 

The scheme was this:

 

Lyme is a borreliosis- a relapsing fever organism.  That is, it changes its out surface proteins such that the antibody panel created by the infected mammal is useless for the next relapse or mutation in outer surface components.  Think of it as a bacterium which changes the color of its freckles.

 

For this reason, the only means to detect the bug is to look for markers from what is known NOT to change, and that is, largely, flagellin, or the inner bundle of “muscle” fibers.  The little these parasites are, are a small amount of cell material wrapped around this bundle of muscle, which expands and contracts, making the bug appear spiral.  They can penetrate cells “end-on” (Malawista, Yale), or tip first.  Yale has such an early and accurate test, patented in the US under 5,618,533.

 

There is very little difference between Relapsing Fever borreliosis and Lyme borreliosis.  They both actively seek out brain and nerve tissue (Barbour, The Biology of Borrelia Species, 1986).

 

The vaccine created by Yale and SmithKline Belgium never worked, and in fact, suppressed the immune system, creating a multi-system disease in vaccinated individuals which is quite like chronic Lyme.  The mechanism is known:  Downregulating of immune system action in response to the fungal-like vaccine, OspA or LymeRIX, or, simply, one of the freckles in the analogy above.

 

Now, as you can see, the immune cells cannot “see” the freckles, and make antibodies.

 

The only problem is, this freckle, OspA, or LymeRIX, is a Pam3Cys conformed lipopeptide which is only seen elsewhere in mycobacteria (leprosy, tuberculosis) or mycoplasmal infections (infections which have no cell-wall), and in no other bacteria.

 

Mycoplasmal infections are also stealth infections that turn off the immune system.

 

Knowing what we know now, it is easy to see why Lyme is so devastating.

 

In my presentation to the US Food and Drug Administration in January 2001, I told the FDA that LymeRIX appeared to NOT be “preventing asymptomatic Lyme,” as claimed, but was making people symptomatic.

 

This turned out to be more true than I knew at the time.

 

SmithKline and Yale reported that there were no “asymptomatic” Lyme cases in the vaccine-receiving group, while there were 15 in the placebo group.

 

That means 15 people out of ~5500 of whom got the placebo – became infected with Lyme, but did not have any symptoms.  (Half the people who are infected with Lyme have no symptoms, yet will always harbor this latent infection.)

 

SmithKline reported that 1/3 of all people who had the erythema migrans (characteristic Lyme rash). Or, were bitten by a tick, did not test positive via the bloodwork, but tested positive via DNA testing for the bug from skin puncture sample of the rash.

 

The people involved in this crime of LymeRIX conspired to change the CDC’s official bloodtesting standard so that they could capture all of the national testing for Lyme, because they were th only ones licensed to use the false test which was used to qualify LymeRIX.  Those involved were Yale’s L2 Diagnostics, Corixa Corporation (Washington State), and Imugen of Norwood Massachusetts.

 

The Corixa patent is US patent No. 6,045,804.

 

They specify in the body of the claim of that patent that:

 

“The present invention provides a method useful to detect a B. burgdorferi infection in a subject. The method provided by the invention is particularly useful to discriminate B. burgdorferi infection from OspA vaccination, although it is sufficiently sensitive and specific to use in any general Lyme disease screening or diagnostic application. Thus, the method of the invention is particularly appropriate for large scale screening or diagnostic applications where only part of the subject population has been vaccinated or where the vaccination status of the population is unknown.”

 

Yale owned the patent for OspA or LymeRIX (US Patent No. 5,747,294).  Corixa’s David Persing own this patent, and he only licensed it to Yale and Immugen, and later claimed he could not read Western Blots from either Lyme vaccine trial, 2 years after the publications of the results of those vaccines trials.

 

In,

1: Clin Infect Dis. 2000 Jul;31(1):42-7. Epub 2000 Jul 17.

Related Articles, Links

Click here to read 
Detection of multiple reactive protein species by immunoblotting after recombinant outer surface protein A lyme disease vaccination.

Molloy PJ, Berardi VP, Persing DH, Sigal LH.

Rheumatology Associates of Southeastern Massachusetts, Plymouth, MA, USA.

Laboratory confirmation of the diagnosis of Lyme disease is based on the detection of an immune response to Borrelia burgdorferi. The serodiagnosis of B. burgdorferi infection is complex and may be further confounded by the immune response to the recombinant outer surface protein A (OspA) Lyme disease vaccine. To describe how the serological response to the recombinant OspA Lyme disease vaccine affects testing for antibody to B. burgdorferi, 240 specimens from 80 study subjects were obtained at defined intervals after recombinant OspA Lyme disease vaccination. Samples were tested by indirect enzyme-linked immunosorbent assay (ELISA), antibody capture enzyme immunoassay (EIA), and Western blotting (WB). After recombinant OspA Lyme disease vaccination, ELISA for 98% of the study subjects revealed reactivity. WB with use of OspA-containing B. burgdorferi strains as sources of antigens demonstrated multiple bands. Results of testing with a US Food and Drug Administration-approved WB kit showed homogeneous reactivity in the molecular weight region >30 kDa. Testing with OspA-free strains completely eliminated all vaccine-associated reactivity by both antibody capture EIA and WB.   PMID: 10913394 [PubMed - indexed for MEDLINE]

 

In the full text of that report, the authors claim that:

 

In the case of the FDA-approved immunoblot test kit, the identification of discrete bands at molecular weights >30 kDa is often unreliable or impossible because of the homogeneous staining in this area, compromising the ability of this test to diagnose Lyme disease in vaccinated study subjects. The manufacturer of the only currently FDA-approved (and released) recombinant OspA Lyme disease vaccine has suggested that vaccination does not interfere with serological evaluation of Lyme disease in vaccine recipients—a statement that is not supported by the data presented here.

 

 

In other words, they were unable to read the Lyme tests in people who were vaccinated, yet the two vaccine manufacturers, SmithKline and Connaught, reported 76% and 92% safe and effective vaccines.

 

Sigal (author, above) was the principal investigator for Connaught’s ImmuLyme vaccine (never came onto the market), yet here he reports that his 92% safe and effective Lyme vaccine was qualified with data that he could not even read:  vaccination does not interfere with serological evaluation of Lyme disease in vaccine recipients—a statement that is not supported by the data presented here.”

 

 

Sigal could not read the results, but he reported a 92% safe and effective vaccine.

 

I hope that is clear and simple.      Clear and simple scientific FRAUD.

 

 

We Lyme activists got LymeRIX off the market by having people report the adverse events that the vaccine trial administrators refused to report to the FDA, and later via the Lyme Disease Foundation’s Karen Forschner (www.lyme.org - not a spin firm) having found a Tuft’s patent for a new version of LymeRIX, in which they specify what they know to be potential harmful about LymeRIX, based on their perception of Lyme as an autoimmune reaction.

 

Some people have the hypersensitivity reaction to OspA, which Allen Steere calls Lyme arthritis, but State University of New York’s Raymond Dattwyler says is rare.  Dattwyler says he sees only about one such case per year, and states that Allen Steere only has about 40 such patients, total.

 

 

I told the FDA in a meeting in Bethsda Maryland in Jaunary 2001 that:

 

http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3680t2.rtf     (See page 148 of that transcript- they misspell my last name as “Dixon.”

 

               “As Dr. Luft alluded to earlier this morning, the western blot serology from these unconfirmed lyme cases will need to be reviewed for evidence of other BB specific bands, and compared to the placebo group by an independent group of analysts.

                             If there are any other specific bands besides OspA the case must be counted as lyme disease in the presence of symptoms.  Note that there were only two asymptomatic cases in the first year of the vaccine group, versus 13 of the placebo group, and in the following year there were zero asymptomatic cases, and 15 asymptomatic cases in the placebo group.

                             We believe that these results do not show that the vaccine is effective at preventing asymptomatic lyme disease, but rather that it is turning asymptomatic lyme disease into symptomatic cases.

                             Continued follow-up on these unconfirmed patients should have been with further western blotting from one of the CDC recommended strains, and the original case definition, which would be to look for changing bands, or any other specific bands besides OspA.

                             Or maybe one of these newer antigens D complexing messenger has been developed at SUNY and by Leonard Siegel.

                             We already discussed this earlier.  It was mentioned earlier that an adverse vaccine event can't be distinguished from vaccine failure.  An adverse vaccine event in a previously infected asymptomatic lyme patient.

                             An asymptomatic BB infected adverse LYMErix event case may never be detected until the patient is vaccinated and symptoms occur, which we think explains the majority of adverse events regarding LYMErix.

                             Many previously infected lyme cases report systemic symptoms after vaccination, and many find out they had lyme disease after being vaccinated, becoming ill, being tested for lyme disease, and finding other specific antibodies.

                             The FDA should, therefore, not be looking just for arthritis as a potential adverse event, but rather -- and not to the exclusion of systemic illness.

                             According to Allan Steere the rate of asymptomatic infection to symptomatic infection is one to one.  So that for every person walking around with lyme disease that has symptoms, there is a person walking around with asymptomatic lyme disease. And we think those people are at the greatest risk.

                             Vaccine failure and exacerbation of asymptomatic infection are identical according to the patient data collected and on the on line VAERS data base.

                             The Dressler Dearborne Steere standard is not a valid criteria for assessing lyme disease, the former CDC criteria of changing bands is more valid.  Until there is an independent review of the western blot data from the SmithKline Beecham adult trial, we have no idea how safe this vaccine is, it all needs to be retabulated.”

 

 

All of that turned out to be completely true, as we later learned.

 

Therefore, my complaint, and the risk here, in our US Department of Justice’s refusal to prosecute this crime, manipulation of data, harm and fraud, is that now the NeoCon Gods of Our Destiny, have a new proposal to make such “data,” and the conduct of such frauds, even more secret.

 

“BARDA”

 

“Biomedical Advanced Research  and Development Agency”

 

What we learned from Lyme and the secrecy and the fraud, especially by sneeking into a conference given by Mark Klempner- who will now head a CDC Biohazard Level 4 Lab in Boston – and audiotaping him revealing that there is a genetic susceptibility to suffer more serious consequences of this fungal like OspA and mycobacterial exposures, just as there is a genetic susceptibility for black people to acquire AIDS.

 

The difference in the latter is that black people are 5 times more liable to become infected with HIV and that Nordic peoples have the lowest risk.  The link is in the chemokine receptor CCR5.

 

It isn’t common knowledge that black people have a greater risk of contracting AIDS.  Our crazy war president tries to associate AIDS and black people and character flaws.  This is the real reason for the denial of care to AIDS victims.  These NeoCons, as I previously demonstrated to you, believe black people are stupid, and belong in cages (“Custodial Democracy”).

 

The NeoCon Gods of BigPharma frauds, like Yale University and Mark Klempner and all the people who are privileged to this secret Lyme data- like the sponsors of the ALDF (Mortimer Zuckerman, and the Bush Walker Weld Walton international banker/investors)- having failed to create the monopoly on national bloodwork (Imugen and Yale) because LymeRIX was removed from the market  (and we no longer need Dave Persing’s special Lyme test – US patent 6,045,804), now have a replacement monopoly in the works.

 

Setting up more biotech spin, fraud and abuse.  Lyme patients are accused of everything, from hypochondria to Munchausen’s by Proxy (they literally have accused us of poisoning our kids).

 

You must take a stand.  We have no help here.  They (Yale staff) threw me in jail and falsely charged me with being a criminally insane terrorist.  I am not exaggerating.

 

 

Kathleen M. Dickson 23 Garden Street, Pawcatuck, CT 06379    http://actionlyme.org

courant.com

 


http://www.courant.com/news/nationworld/ats-ap_top13dec02,0,5631743.story?coll=sns-newsnation-headlines


GOP Wants to Create Secretive Gov't Agency

By ANDREW BRIDGES
Associated Press Writer

December 2 2005, 3:44 AM EST

WASHINGTON -- By creating a federal agency shielded from public scrutiny, some lawmakers think they can speed the development and testing of new drugs and vaccines needed to respond to a bioterrorist attack or super-flu pandemic.

The proposed Biomedical Advanced Research and Development Agency, or BARDA, would be exempt from long-standing open records and meetings laws that apply to most government departments, according to legislation approved Oct. 18 by the Senate health committee.

Those exemptions would streamline the development process, safeguard national security and protect the proprietary interests of drug companies, say Republican backers of the bill. The legislation also proposes giving manufacturers immunity from liability in exchange for their participation in the public-private effort.

"We must ensure the federal government acts as a partner with the private sector, providing the incentives and protections necessary to bring more and better drugs and vaccines to market faster," Sen. Richard Burr, R-N.C., said when the Committee on Health, Education, Labor and Pensions approved the bill.

The agency would provide the funding for development of treatments and vaccines to protect the United States from natural pandemics as well as chemical, biological and radiological agents.

But it is the secrecy and immunity provisions of the legislation that have alarmed patient rights and open government advocates. The agency would be exempt from the Freedom of Information and Federal Advisory Committee acts, both considered crucial for monitoring government accountability.

"There is no other agency that I am aware of where the agency is totally exempt either from FOIA or FACA," said Pete Weitzel, coordinator of the Coalition of Journalists for Open Government. The coalition is an alliance of journalism groups, including the American Society of Newspaper Editors and Associated Press Managing Editors, that wrote to lawmakers seeking amendments to the bill. "That is a cause for major concern and should raise major policy concerns," Weitzel said.

Burr spokesman Doug Heye said the provisions would keep competitors from gaining proprietary information through FOIA. However, confidential business information already is exempt from FOIA.

"There's no secrecy involved in BARDA," Heye said. "That is absolutely false. This is an agency that will be putting out information daily."

Some Democrats question whether the public would accept drugs or vaccines developed in conjunction with the agency, citing the abortive 2003 effort to vaccinate 500,000 front-line health care workers against smallpox. Only about 40,000 workers ultimately received the vaccine amid concerns about the vaccine's safety, which health authorities initially downplayed.

"Republican leaders in Congress are now proposing a plan that would make exactly the same mistake," Sen. Chris Dodd, D-Conn., said in a statement. "Their plan will protect companies that make ineffective or harmful medicines, and because it does not include compensation for those injured by a vaccine or drug, it will discourage first responders and patients from taking medicines to counter a biological attack or disease outbreak."

The bill does provide for limited compensation. However, another provision would grant drug companies immunity unless "willful misconduct" can be shown.

The Pharmaceutical Research and Manufacturers of America said it was reviewing the bill. Another industry group, the Biotechnology Industry Organization, declined comment.

The National Vaccine Information Center, an advocacy group, called the legislation "a drug company stockholder's dream and a consumer's worst nightmare."

The proposed law comes amid growing concern about pandemics and the government's ability to meet such threats. For instance, the United State needs another three to five years to develop the manufacturing capacity to produce 300 million doses of flu vaccine, Health and Human Services Secretary Mike Leavitt said Sunday on NBC's "Meet the Press."

The agency would improve on Project BioShield, a barely two-year-old program also meant to encourage production of vaccines and drugs, Heye said.

"While some progress has been made, we still haven't seen the participation from companies, universities and research institutions in developing vaccines we might need to protect us from the next threat, whatever that might be," Heye said. "One of the reasons is (they) don't want to put their very existence on the line."

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said the agency as proposed would represent a setback to decades of progress in opening up to the public the process of testing the safety and efficacy of drugs.

"These provisions are extremely dangerous," Wolfe said. "The fact that they are being proposed, really exploiting people's fears about pandemics and epidemics, is outrageous and goes backward on the progress on the use of the Freedom of Information Act and Federal Advisory Committee Act to increase public scrutiny and increase the correctness of decisions that are made."

Republican and Democratic lawmakers alike agree the drug industry needs some protections to encourage it to produce emergency stocks of vaccines and drugs, but Democrats have balked at providing blanket immunity without first establishing a compensation fund for patients.

Republicans are pushing for liability protections for vaccine manufacturers on other fronts as well. Senate Majority Leader Bill Frist, R-Tenn., is seeking to add such protections to a defense appropriations bill.

Frist spokeswoman Amy Call said drug company concerns about liability are real.

"There's really no financial incentive for them to get into the market, sell to the government at a reduced rate and then open themselves up to losses that could potentially bankrupt them," Call said.

The push for liability exemptions may force the Burr bill to the sidelines until the next session of Congress, Republican and Democratic aides said. But Call said Frist intends to pursue the legislation.

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On the Net: Information on the bill, S. 1873, can be found at http://thomas.loc.gov/     Copyright 2005 Associated Press