Ebola Manufactured by Western Pharmaceuticals, US DoD?: Scientists Allege
Are bio weapons being tested on Africans. Reports have linked the Ebola virus outbreak to an attempt to reduce Africa’s population. Liberia happens to be the continents' fastest growing population.
FULL TEXT BELOW THE FOLD
Tekmira / DoD Ebola Clinical Trial Summary Also Below in Full Text
Dear World Citizens:
I have read a number of articles from your Internet outreach as well as articles from other sources about the casualties in Liberia and other West African countries about the human devastation caused by the Ebola virus. About a week ago, I read an article published in the Internet news summary publication of the Friends of Liberia that said that there was an agreement that the initiation of the Ebola outbreak in West Africa was due to the contact of a two-year old child with bats that had flown in from the Congo. That report made me disconcerted with the reporting about Ebola, and it stimulated a response to the “Friends of Liberia,” saying that African people are not ignorant and gullible, as is being implicated. A response from Dr. Verlon Stone said that the article was not theirs, and that “Friends of Liberia” was simply providing a service. He then asked if he could publish my letter in their Internet forum. I gave my permission, but I have not seen it published. Because of the widespread loss of life, fear, physiological trauma, and despair among Liberians and other West African citizens, it is incumbent that I make a contribution to the resolution of this devastating situation, which may continue to recur, if it is not properly and adequately confronted. I will address the situation in five (5) points:
1. EBOLA IS A GENETICALLY MODIFIED ORGANISM (GMO)
Horowitz (1998) was deliberate and unambiguous when he explained the threat of new diseases in his text, Emerging Viruses: AIDS and Ebola – Nature, Accident or Intentional. In his interview with Dr. Robert Strecker in Chapter 7, the discussion, in the early 1970s, made it obvious that the war was between countries that hosted the KGB and the CIA, and the ‘manufacture’ of ‘AIDS-Like Viruses’ was clearly directed at the other. In passing during the Interview, mention was made of Fort Detrick, “the Ebola Building,” and ‘a lot of problems with strange illnesses’ in “Frederick [Maryland].” By Chapter 12 in his text, he had confirmed the existence of an American Military-Medical-Industry that conducts biological weapons tests under the guise of administering vaccinations to control diseases and improve the health of “black Africans overseas.” The book is an excellent text, and all leaders plus anyone who has interest in science, health, people, and intrigue should study it. I am amazed that African leaders are making no acknowledgements or reference to these documents.
2. EBOLA HAS A TERRIBLE HISTORY, AND TESTING HAS BEEN SECRETLY TAKING PLACE IN AFRICA
I am now reading The Hot Zone, a novel, by Richard Preston (copyrighted 1989 and 1994); it is heart-rending. The prolific and prominent writer, Steven King, is quoted as saying that the book is “One of the most horrifying things I have ever read. What a remarkable piece of work.” As a New York Times bestseller, The Hot Zone is presented as “A terrifying true story.” Terrifying, yes, because the pathological description of what was found in animals killed by the Ebola virus is what the virus has been doing to citizens of Guinea, Sierra Leone and Liberia in its most recent outbreak: Ebola virus destroys peoples’ internal organs and the body deteriorates rapidly after death. It softens and the tissues turn into jelly, even if it is refrigerated to keep it cold. Spontaneous liquefaction is what happens to the body of people killed by the Ebola virus! The author noted in Point 1, Dr. Horowitz, chides The Hot Zone for writing to be politically correct; I understand because his book makes every effort to be very factual. The 1976 Ebola incident in Zaire, during President Mobutu Sese Seko, was the introduction of the GMO Ebola to Africa.
3. SITES AROUND AFRICA, AND IN WEST AFRICA, HAVE OVER THE YEARS BEEN SET UP FOR TESTING EMERGING DISEASES, ESPECIALLY EBOLA
The World Health Organization (WHO) and several other UN Agencies have been implicated in selecting and enticing African countries to participate in the testing events, promoting vaccinations, but pursuing various testing regiments. The August 2, 2014 article, West Africa: What are US Biological Warfare Researchers Doing in the Ebola Zone? by Jon Rappoport of Global Research pinpoints the problem that is facing African governments.
Obvious in this and other reports are, among others:
(a) The US Army Medical Research Institute of Infectious Diseases (USAMRIID), a well-known centre for bio-war research, located at Fort Detrick, Maryland;
(b) Tulane University, in New Orleans, USA, winner of research grants, including a grant of more than $7 million the National Institute of Health (NIH) to fund research with the Lassa viral hemorrhagic fever;
(c) the US Center for Disease Control (CDC);
(d) Doctors Without Borders (also known by its French name, Medicins Sans Frontiers);
(e) Tekmira, a Canadian pharmaceutical company;
(f) The UK’s GlaxoSmithKline; and
(g) the Kenema Government Hospital in Kenema, Sierra Leone.
Reports narrate stories of the US Department of Defense (DoD) funding Ebola trials on humans, trials which started just weeks before the Ebola outbreak in Guinea and Sierra Leone. The reports continue and state that the DoD gave a contract worth $140 million dollars to Tekmira, a Canadian pharmaceutical company, to conduct Ebola research. This research work involved injecting and infusing healthy humans with the deadly Ebola virus. Hence, the DoD is listed as a collaborator in a“First in Human” Ebola clinical trial (NCT02041715, which started in January 2014 shortly before an Ebola epidemic was declared in West Africa in March. Disturbingly, many reports also conclude that the US government has a viral fever bioterrorism research laboratory in Kenema, a town at the epicentre of the Ebola outbreak in West Africa. The only relevant positive and ethical olive-branch seen in all of my reading is that Theguardian.com reported, “The US government funding of Ebola trials on healthy humans comes amid warnings by top scientists in Harvard and Yale that such virus experiments risk triggering a worldwide pandemic.” That threat still persists.
4. THE NEED FOR LEGAL ACTION TO OBTAIN REDRESS FOR DAMAGES INCURRED DUE TO THE PERPETUATION OF INJUSTICE IN THE DEATH, INJURY AND TRAUMA IMPOSED ON LIBERIANS AND OTHER AFRICANS BY THE EBOLA AND OTHER DISEASE AGENTS.
The U. S., Canada, France, and the U. K. are all implicated in the detestable and devilish deeds that these Ebola tests are. There is the need to pursue criminal and civil redress for damages, and African countries and people should secure legal representation to seek damages from these countries, some corporations, and the United Nations. Evidence seems abundant against Tulane University, and suits should start there. Yoichi Shimatsu’s article, The Ebola Breakout Coincided with UN Vaccine Campaigns, as published on August 18, 2014, in the Liberty Beacon.
5. AFRICAN LEADERS AND AFRICAN COUNTRIES NEED TO TAKE THE LEAD IN DEFENDING BABIES, CHILDREN, AFRICAN WOMEN, AFRICAN MEN, AND THE ELDERLY. THESE CITIZENS DO NOT DESERVE TO BE USED AS GUINEA PIGS!
Africa must not relegate the Continent to become the locality for disposal and the deposition of hazardous chemicals, dangerous drugs, and chemical or biological agents of emerging diseases. There is urgent need for affirmative action in protecting the less affluent of poorer countries, especially African citizens, whose countries are not as scientifically and industrially endowed as the United States and most Western countries, sources of most viral or bacterial GMOs that are strategically designed as biological weapons. It is most disturbing that the U. S. Government has been operating a viral hemorrhagic fever bioterrorism research laboratory in Sierra Leone. Are there others? Wherever they exist, it is time to terminate them. If any other sites exist, it is advisable to follow the delayed but essential step: Sierra Leone closed the US bioweapons lab and stopped Tulane University for further testing.
The world must be alarmed. All Africans, Americans, Europeans, Middle Easterners, Asians, and people from every conclave on Earth should be astonished. African people, notably citizens more particularly of Liberia, Guinea and Sierra Leone are victimized and are dying every day. Listen to the people who distrust the hospitals, who cannot shake hands, hug their relatives and friends. Innocent people are dying, and they need our help. The countries are poor and cannot afford the whole lot of personal protection equipment (PPE) that the situation requires. The threat is real, and it is larger than a few African countries. The challenge is global, and we request assistance from everywhere, including China, Japan, Australia, India, Germany, Italy, and even kind-hearted people in the U.S., France, the U.K., Russia, Korea, Saudi Arabia, and anywhere else whose desire is to help. The situation is bleaker than we on the outside can imagine, and we must provide assistance however we can. To ensure a future that has less of this kind of drama, it is important that we now demand that our leaders and governments be honest, transparent, fair, and productively engaged. They must answer to the people. Please stand up to stop Ebola testing and the spread of this dastardly disease.
Thank you very much.
Sincerely,
Dr. Cyril E. Broderick, Sr.
About the Author:
Dr. Broderick is a former professor of Plant Pathology at the University of Liberia’s College of Agriculture and Forestry. He is also the former Observer Farmer in the 1980s. It was from this column in our newspaper, the Daily Observer, that Firestone spotted him and offered him the position of Director of Research in the late 1980s. In addition, he is a scientist, who has taught for many years at the Agricultural College of the University of Delaware.
BELOW IS A MIRROR OF THE CRITICAL REFERENCE
A service of the U.S. National Institutes of Health
Safety, Tolerability and Pharmacokinetic First in Human (FIH) Study for Intravenous (IV) TKM-100802
This study has suspended participant recruitment.
(This clinical trial has been suspended following a clinical hold placed on the investigational new drug TKM-100802.)
Sponsor:
Tekmira Pharmaceuticals Corporation
Collaborator:
Information provided by (Responsible Party):
Tekmira Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT02041715
First received: January 9, 2014
Last updated: July 31, 2014
Last verified: July 2014
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Purpose
Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single ascending dose (SAD) study followed by multiple ascending dose (MAD) cohorts in healthy male and female subjects.
| Condition | Intervention | Phase |
|---|---|---|
| Ebola Virus Infection | Drug: TKM-100802 for Injection Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Placebo-Controlled, Single-Blind, Single-Ascending Dose Study With Additional Multiple-Ascending Dose Cohorts to Evaluate the Safety, Tolerability, and Pharmacokinetics of TKM-100802 in Healthy Human Volunteers |
Resource links provided by NLM:
Further study details as provided by Tekmira Pharmaceuticals Corporation:
Primary Outcome Measures:
- Safety and tolerability of TKM-100802 [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Subjects will be monitored for treatment-emergent and dose-limiting toxicity (DLT). If there are any adverse events (changes from baseline in laboratory parameters, vitals and/or infusion reactions) during these monitoring periods, the Independent Safety Committee, will discuss the dosing of the remaining subjects.
Before proceeding to the next dose cohort, the Independent Safety Committee will evaluate whether dose escalation will be permitted based on demonstration of adequate safety and tolerability.
Secondary Outcome Measures:
- Pharmacokinetics – Cmax, Tmax and AUC [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Time-points: Before infusion, mid-point of infusion, end of infusion and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours after end of infusion and day 7, day 10, day 15, day 22 and day 29.
| Estimated Enrollment: | 28 |
| Study Start Date: | January 2014 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: TKM-100802 for Injection | Drug: TKM-100802 for Injection
IV infusion
|
| Placebo Comparator: Placebo | Drug: Placebo
IV infusion
Other Name: Normal saline
|
Approximately 28 male and female healthy adult subjects, 18 to 50 years of age at the time of dosing, will participate in this study. The SAD phase of the study is planned to have up to 4 cohorts with 4 subjects (3 receiving TKM-100802 and 1 receiving saline) in each cohort. Additional cohorts may be enrolled in the SAD phase if a MTD is not established after the initial 4 cohorts. In the MAD phase, a dose escalation scheme will be proposed following review of the findings from cohorts 1 to 4 of the SAD phase. The MAD phase is expected to have at least 3 cohorts with 4 subjects (3 receiving TKM-100802 and 1 receiving saline) in each cohort.
Eligibility
| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Informed of the nature of the study and are able to read, review, agree to, and sign the informed consent document at Screening.
- Able to comply with all protocol-specified visit schedules and requirements.
- Healthy male and female subjects 18 to 50 years of age, inclusive, at the time of dosing.
- Body mass index (BMI) between 22 kg/m2 to 35 kg/m2, inclusive, and weigh at least 110 lbs (50 kg).
- Judged by the PI to be in good health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead ECG, clinical laboratory assessments, and by general observations. Any abnormalities or deviations outside the normal ranges for any of clinical testing (laboratory tests, ECG, vital signs) can be repeated at the discretion of the PI and if judged not to be clinically significant, the subject may be considered for study participation.
- Adequate hepatic, renal, hematologic and clotting function as defined by total bilirubin, AST, ALT, serum creatinine, D-dimer and International normalized ratio (INR) within normal range as determined by the PI and Sponsor Medical Monitor.
- Female subjects must be one of the following:
- naturally postmenopausal (no menses) for >2 years and has a documented FSH level >40 mIU/mL; or
- have a documented history of ovarian failure; or
- surgically postmenopausal (bilateral oophorectomy or hysterectomy). Female subjects that are surgically postmenopausal must provide documentation of the bilateral oophorectomy or hysterectomy prior to Day 1 dosing to be eligible for participation in the study; or
- Women of childbearing potential (FSH ≤40 mIU/mL) must have negative serum hCG at Screening, a negative urine pregnancy test prior to the first study treatment, and must agree to utilize highly effective contraception methods (2 separate forms of contraception, 1 of which must be an effective barrier method, or be non-heterosexually active, or have a vasectomized partner) from Screening throughout the duration of study treatment and for 1 month after the last administration of study treatment.
- Male subjects who are sexually active must be willing to use effective barrier contraception (e.g., condom with spermicide) during heterosexual intercourse from Screening throughout the duration of study treatment and for 1 month after the last dose of study treatment.
Exclusion Criteria:
- Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease at Screening or medication for comorbidity which according to the PI and Sponsor Medical Monitor preclude subject participation in the clinical study.
- Reports an uncontrolled psychiatric disorder or neurologic disease or seizure disorder not controlled by medication.
- Subject has a history of, or existing clinically significant cardiovascular disease (for example, uncontrolled hypertension, unstable angina, congestive heart failure or serious cardiac arrhythmias). In addition New York Heart Association Functional Classification Class II or greater will be excluded.
- Reports history of coronary heart disease (CHD), CHD-equivalent disease or CHD risk >20% as designated by the National Cholesterol Education Program Adult Treatment Panel III.
- Current diagnosis or known history of liver disease (e.g., acute or chronic hepatitis or liver cirrhosis).
- History of allergy to cosyntropin (MAD cohort only).
- Presence of any clinically significant results from laboratory tests, vital signs assessments and ECGs as judged by the PI.
- Reports receiving investigational drugs, biologics, or devices, or any antiviral drugs within 28 days prior to study treatment or planned use during the course of the study.
- Reports receiving naturopathic medications, herbal supplements, or lipid lowering therapies within 28 days prior to study treatment or planned use during the course of the study.
- A medical condition requiring a prescription treatment which it would be unsafe to discontinue.
- Recent treatment with alternative therapies which, in the view of the PI or the Sponsor Medical Monitor, could potentially confound clinical and laboratory assessments.
- Demonstrates a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms).
- Reports concomitant use of any medication that prolongs the QT/QTc interval.
- Reports a history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- When confirmed upon additional testing, demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
- Reports infections requiring antibiotic therapy within 28 days of Screening (as determined by the PI).
- Reports a history of Ebola virus exposure.
- Reports an occupational health risk of exposure to Ebola virus known to be higher than that of the general population.
- Reports a known or suspected hypersensitivity or previous severe reactions to any of the constituents of the TKM-100802 including oligonucleotide- or lipid-based products, liposomal drug products, and phospholipid-based products (parenteral nutrition, Intralipid).
- Reports a history of clinically significant allergies including food or drug allergies.
- Demonstrates a positive drug or alcohol screen.
- Reports a history of drug or alcohol addiction or abuse within the past 1 year.
- Subject is unwilling to refrain from alcohol consumption when it is completely restricted or when it is not completely restricted, is unwilling to limit alcohol consumption to 2 drinks/day, <12 drinks/week for males and 1 drink/day, <6 drinks/week for females (1 drink is equal to 12 ounces of beer, 5 ounces of wine, or 1 ounce of liquor).
- Reports donating blood within 28 days prior to study treatment. All subjects will be advised not to donate blood for 4 weeks after completing the study.
- Reports donating plasma (e.g., plasmapheresis) within 28 days prior to study treatment. All subjects will be advised not to donate plasma for 4 weeks after completing the study.
- Demonstrates, in the opinion of study staff, veins unsuitable for repeated venipuncture or IV infusion (e.g., veins difficult to locate, access, or puncture; veins with a tendency to rupture during or after puncture).
- Pregnant, lactating, breastfeeding, or intends to become pregnant over the course of the study.
- Demonstrates a positive pregnancy screen.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.Please refer to this study by its ClinicalTrials.gov identifier: NCT02041715
Locations
| United States, Texas | |
| Healthcare Discoveries, LLC d/b/a ICON Development Solutions | |
| San Antonio, Texas, United States, 78209 | |
Sponsors and Collaborators
Tekmira Pharmaceuticals Corporation
Investigators
| Study Director: | Mark Kowalski, MD | Tekmira Pharmaceuticals Corporation | |
| Principal Investigator: | Emanuel DeNoia, MD | ICON Development Solutions |
More Information
No publications provided
| Responsible Party: | Tekmira Pharmaceuticals Corporation |
| ClinicalTrials.gov Identifier: | NCT02041715 History of Changes |
| Other Study ID Numbers: | TKM-EBOV-002 |
| Study First Received: | January 9, 2014 |
| Last Updated: | July 31, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Tekmira Pharmaceuticals Corporation:
| Virus Diseases Hemorrhagic Fever, Ebola Hemorrhagic Fevers, Viral |
RNA Virus Infections Filoviridae Infections Mononegavirales Infections |
Additional relevant MeSH terms:
| Communicable Diseases Hemorrhagic Fever, Ebola Infection Virus Diseases |
Filoviridae Infections Hemorrhagic Fevers, Viral Mononegavirales Infections RNA Virus Infections |
ClinicalTrials.gov processed this record on October 20, 2014
See Also:
Everything the Ebola Czar Knows About the Virus Summed Up in One Painfully Awkward White House Video
