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Thursday, August 7, 2014

"EBOLA ATTACK": SMOKING GUN... OR SMOKE AND MIRRORS?

The mainstream media has been providing much hype and reporting regarding the recent Ebola "outbreak" that has been claiming lives in the African nations of Liberia, Sierra Leone and Guinea.  There is no argument that the Viral Hemorrhagic Fever (VHF) disease complex is a severe one, carrying a mortality rate of 50-90% for those who are infected (depending on access to advanced medical care) however, it is unclear what the current outbreak status means for those who don't live or work in the affected areas of Africa;  specifically, will this be a potentially deadly situation for the world overall, or simply limited to those nations?

The lines became blurred recently, as two U.S. citizens (reportedly two physicians) were infected with one of the VHF viral strains in Africa, and were transported back to Emory University Hospital for emergent treatment.  The U.S. State Department and the Department of Defense took the lead in assisting the two U.S. citizens to get back stateside, and receive the urgent treatment they needed.  In an official statement from Marie Harf, State Department Spokesperson, Ms. Harf said:

"The State Department, together with the Centers for Disease Control and Prevention (CDC), is facilitating a medical evacuation for two U.S. citizens who have been infected by Ebola in West Africa. The safety and security of U.S. citizens is our paramount concern. Every precaution is being taken to move the patients safely and securely, to provide critical care en route on a non-commercial aircraft, and to maintain strict isolation upon arrival in the United States.

These evacuations will take place over the coming days. CDC protocols and equipment are used for these kinds of medical evacuations so that they are carried out safely, thereby protecting the patient and the American public, as has been done with similar medical evacuations in the past.

Upon arriving in the United States, the patients will be taken to medical facilities with appropriate isolation and treatment capabilities.

Because of privacy considerations, we will not be able to confirm the names or other specific details of these particular cases.

For matters relating to public health precautions in the United States, we would refer to the CDC, which has the overall lead role on those issues within the U.S. Government."  

The transport of the two ignited a world-wide discussion on the appropriate treatment of those affected with Ebola, a known pathogen which causes severe illness and likely death if untreated.  Even with appropriate treatment, fears were sparked over the uncontrolled outbreak virus, as well as concerns regarding whether bringing infected persons with Ebola was appropriate and/or safe for areas like the United States where the virus has previously not been identified.

According to the Centers for Disease Control (CDC), Ebola is not a disease likely to cause widespread disease in the U.S.  Yet, the CDC stance has been challenged, primarily because not much is known about Ebola, despite it being around since 1976.  The uncertainty surrounding Ebola is particularly strong due to conflicting statements from top-level health officials in various infectious disease agencies such as the CDC and WHO.  According to official statements from the CDC "the natural reservoir of ebolaviruses has not yet been proven, the manner in which the virus first appears in a human at the start of an outbreak is unknown. However, researchers have hypothesized that the first patient becomes infected through contact with an infected animal.
When an infection does occur in humans, there are several ways in which the virus can be transmitted to others. These include:
  • direct contact with the blood or secretions of an infected person
  • exposure to objects (such as needles) that have been contaminated with infected secretions
The viruses that cause Ebola HF are often spread through families and friends because they come in close contact with infectious secretions when caring for ill persons.
During outbreaks of Ebola HF, the disease can spread quickly within health care settings (such as a clinic or hospital). Exposure to ebolaviruses can occur in health care settings where hospital staff are not wearing appropriate protective equipment, such as masks, gowns, and gloves.
Proper cleaning and disposal of instruments, such as needles and syringes, is also important. If instruments are not disposable, they must be sterilized before being used again. Without adequate sterilization of the instruments, virus transmission can continue and amplify an outbreak."  
Not helping the situation, was a comment by Marie Harf on July 30, 2014, where she used the term "Ebola attack" during a State Department Press Briefing. 


Given the nature of Ms. Harf's statement, calling it an "Ebola Attack," red flags went up among many investigative journalists, as Ebola and the VHF class of pathogens are in fact classified as CLASS-A Bioweapons according to several U.S. Government Agencies.  The U.S. public health system and primary healthcare providers must be prepared to address various biological agents, including pathogens that are rarely seen in the United States. High-priority agents include organisms that pose a risk to national security because they
  • can be easily disseminated or transmitted from person to person;
  • result in high mortality rates and have the potential for major public health impact;
  • might cause public panic and social disruption; and
  • require special action for public health preparedness.
Diseases and/or agents that fall into the CLASS-A category include:

Because of the vast uncertainty surrounding the recent Ebola outbreak (or attack, depending on which source you rely on), ongoing investigations by several investigators/journalists/medical specialists continue.  Based on conflicting reports, limited unclassified information regarding VHF's and the overall high mortality rate surrounding Ebola virus agents, the following information is being provided for general public investigative purposes.  Here is what we know:

1.  1976 is the first reported "Ebola Virus" outbreak on record according to the CDC.  Subsequently, in 1989 and again in 1990, Ebola was present in the United States;  the Ebola-Reston virus was introduced at facilities in Virginia and Pennsylvania where workers were exposed but did not get ill.  Again in 1996, the same strain of Ebola was introduced in a facility in Texas by imported monkeys from the Philippines.   Most of the Ebola outbreaks only consisted of a few persons;  a few had a few hundred, and the current outbreak, the largest, has over 1000 persons infected.  Therefore, the average of 412 deaths per year is actually high due to the large outbreak now, and a few others that had a few hundred deaths.  Most outbreaks did not have high numbers.  A full outbreak table is provided here: http://www.cdc.gov/vhf/ebola/resources/outbreak-table.html

  




2.  1998, a major scientific study was done to determine if Ebola could be transmitted via the air. The potential of aerogenic infection by Ebola virus was established by using a head-only exposure aerosol system. Virus-containing droplets of 0.8-1.2 microns were generated and administered into the respiratory tract of rhesus monkeys via inhalation. Inhalation of viral doses as low as 400 plaque-forming units of virus caused a rapidly fatal disease in 4-5 days.  This study proved that it could be transmitted via the air.  (Source: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1997182/ )

3.  2003, the EMBO Journal lists various bioweapon pathogens, with Ebola listed among others such as Anthrax.  Extensive review of the use of pathogens both historically and moving forward.  (Source: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1326439/ )

4.  July, 2004, an extensive report in yet another clinical journal reviewing the Ebola and Marburg viruses as potential bioweapons.  The research focuses again on airborne transmission:

"The term viral hemorrhagic fever refers to a clinical syndrome characterized by acute onset of fever accompanied by nonspecific findings of malaise, prostration, diarrhea,and headache. Patients frequently show signs of increased vascular permeability, and many develop bleeding diatheses. The hemorrhagic fever viruses represent potential agents for biologic warfare because of capability of aerosol transmission, high morbidity,and mortality associated with infection, and ability to replicate in cell culture in high concentrations."

It appears that scientists are liking this virus as a potential weapon;  other medical professionals begin the race for anti-viral medications and vaccines.  (Source: http://www.ncbi.nlm.nih.gov/pubmed/15207310/ )

5.  In 2004, Congress passed the Project BioShield Act (P.L. 108-276) to provide the federal government with new authorities related to the development, procurement, and use of medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents. However, the government still lacks countermeasures against many of the CBRN terrorism agents determined by the government to pose the greatest threat.  (Known as P.L. 108-276, the full text of the bill as passed can be found here: http://www.gpo.gov/fdsys/pkg/PLAW-108publ276/pdf/PLAW-108publ276.pdf )
 
6.  December, 2005, SOCCOM runs a mock-scenario using Ebola and "Freedom Fighters" as the villains.  John Hopkins University runs the drill with SOCCOM.  The slides that accompany this drill clearly outline the intent of the U.S. government to utilize each State's National Guard units to implement "Martial Law" and to "Enforce Quarantine."  If there was ever a doubt regarding plans for "Martial Law" or use of the military to enforce a quarantine, this single event erases all doubt... it is clear that Martial Law and/or use of the US Military to enforce a medical quarantine is a very real plan.  (Source: http://www.dtic.mil/ndia/2005ussocom/thursday/canter.pdf )





7.  2006, National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), convened a Blue Ribbon Panel on Bioterrorism and Its Implications for Biomedical Research. This panel of experts came together to provide guidance on the Institute’s biodefense research agenda, which was published soon afterward. The panel included researchers from academia, industry, government, civilian agencies, and the military.  In 2003, NIAID released its first progress report on accom­ plishments toward the goals outlined in the Research Agenda. Since that time, extraordinary progress has been made to advance scientific knowledge of these potentially deadly pathogens. To demonstrate the enormity of the research efforts conducted over the last several years, the 2006 progress report details many examples of scientific accomplishments organized according to the areas of emphasis specified in the Research Agenda: biology of the microbe, host response, vaccines, diag­ nostics, and therapeutics. The achievements made meet all of the immediate goals outlined in the Research Agenda.  (Full 2006 Report here: http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/Documents/cata_2006.pdf )

8.  August, 2008, a study is published in a clinical journal, Virology, titled " A paramyxovirus-vectored intranasal vaccine against Ebola virus is immunogenic in vector-immune animals " and is the first known study to show positive effects of a potential Ebola Vaccine.  Funding for this research was done through NIAID as part of Project BioShield.  Full study here:  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2519172/#

9.  2012, an annual report is filed for Congress from the Department of Health and Human Services (HHS) on its progress with Project BioShield.  The purpose of this report, besides being required by law, is to advance further funding and to promote Project BioShield as a "success" so that when it comes time to renew or amend P.L. 108-276, there will be little doubt that funding for Project BioShield should continue.  The report outlines what vaccines have been developed as of 2012, as well as antitoxins and current or pending contracts with healthcare vendors.  Full report here: https://www.medicalcountermeasures.gov/media/33065/pbs_report_2012_hires_final2_508.pdf

10. March 13, 2013, Congress passes the "Pandemic and All-Hazards Preparedness and Reauthorization Act of 2013" also known as P.L. 113-5.  This replaces Project BioShield in name, but encompasses all of Project BioShield components, leaves Project BioShield essentially in-tact, and broadens the Scope and Authority of the Secretary for the Department of Health and Human Services (HHS).  What the Secretary is now able to do, is utilize funds without prior approval, able to authorize non-FDA approved medications, vaccines and tests if deemed emergent, able to suspend HIPPA rights, and no longer requires a Prescription for any vaccines, medications or tests for any person during any emergency.  The Secretary of HHS does not need Congressional or Presidential approval for any of this, and can do so independently within the context of this new law.  Full law here: http://www.gpo.gov/fdsys/pkg/PLAW-113publ5/pdf/PLAW-113publ5.pdf    Additional information can be found on the HHS PAHPA website: http://www.phe.gov/Preparedness/legal/pahpa/Pages/pahpra.aspx

11.  June, 2013:  The 113th Congress is presented with a report to review Project BioShield / P.L. 113-5.  This report outlines all potential concerns with the law, as well as the progress of Project BioShield.  The 113th Congress reauthorized and modified some of the authorities granted by the Project BioShield Act. The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (P.L. 113-5) extended the Project BioShield procurement program through FY2018 and authorized appropriations of up to $2.8 billion for FY2014 through FY2018. This law also modified authorities related to the use of countermeasures during an emergency. The Consolidated Appropriations Act, 2014 (P.L. 113-76) provided $255 million for Project BioShield procurements to remain available until expended.

This report provides a brief overview of the Project BioShield authorities and appropriations, identifies the medical countermeasures obtained through Project BioShield, reviews the relationship between Project BioShield and the Biomedical Advanced Research and Development Authority (BARDA), and discusses policy issues for congressional policy makers and related legislation in the 113th Congress.   Full report here: http://fas.org/sgp/crs/terror/R43607.pdf

12. June 17, 2014, Biomedical Advanced Research and Development Authority or BARDA puts out a news release regarding pandemic-influenza vaccine.  This is the first milestone for BARDA and HHS, and further strengthens Project BioShield.  "In pursuing new technology, BARDA leverages public-private partnerships. We also support development of medical countermeasures – drugs, vaccines, diagnostics and devices – that can be used to diagnose or treat illness or injury in public health emergencies like pandemics or following acts of bioterrorism, as well as day-to-day medical conditions. This multi-use approach strengthens everyday systems and increases our resilience in emergencies."  Full news release here: http://www.hhs.gov/news/press/2014pres/06/20140617a.html

13.  July 31, 2014:  The CDC issues a travel alert - "An outbreak of Ebola has been ongoing in Liberia since March 2014. This outbreak also affects Sierra Leone and Guinea; to date more than 1320 cases have occurred in the three countries and more than 725 people have died, making this the largest outbreak of Ebola in history. At least three Americans have been infected; two are health care workers in an Ebola clinic. Affected districts include Bomi, Bong, Grand Gedeh, Lofa, Montserrado (including the capital city of Monrovia), Margibi, and Nimba. Instances of civil unrest and violence against aid workers have been reported in West Africa as a result of the outbreak. The public health infrastructure in Liberia is being severely strained as the outbreak grows."  The travel alert isn't issued until the end of July, 2014 as seen here: http://monrovia.usembassy.gov/sm_cdc_073114.html

14.  August 4th, 2014, the following statement is released from the State Department:  "U.S. Secretary of Health and Human Services (HHS) Sylvia Mathews Burwell, and Centers for Disease Control and Prevention (CDC) Director Dr. Tom Frieden, along with the Department of State, other agencies, private sector representatives, and the World Bank, consulted today with President of Guinea Alpha Condé and senior officials from Liberia, Sierra Leone, and Nigeria about the outbreak of Ebola in West Africa. The group identified national and regional priorities and held intensive discussions on the types of assistance needed to mount an effective response. Secretary Burwell and Director Frieden reiterated U.S. engagement and support for efforts to control the outbreak and address the challenge. The discussions took place on the margins of the U.S.-African Leaders Summit now taking place in Washington."  Link: http://www.state.gov/r/pa/prs/ps/2014/230217.htm

15.  Also on August 4th, 2014,  Jen Psaki, Spokesperson for the State Department announces the following:

"As you all know, we kicked off the U.S.-Africa Leaders Summit this morning. This is a historic opportunity to strengthen ties with our African partners and highlight America’s longstanding commitment to investing in Africa’s development and its people. The summit theme, “Investing in the Next Generation,” reflects the common ambition to leave our nations better for future generations by making concrete gains in peace and security, good governance, and economic development. There’s long been bipartisan support for U.S. engagement with Africa, and the summit will build on that record.

The summit opened this morning with a civil society forum to underscore our longstanding investment in strong democratic institutions and Africa’s next generation of leaders. We support the aspirations of Africans from our open and accountable governance and respect for human rights. And we are deepening our connection with Africa’s young leaders who are promoting positive change in their communities.

There are also signature events today on investing in women for peace and prosperity, there’s a working luncheon on that issue, and investing in health, investing in health, investing in Africa’s future, and sessions on resilience and food security in a changing climate, and combating wildlife trafficking.

The day opened with the 13th African Growth and Opportunity – AGOA ministerial. AGOA, as you know, is our most generous trade preference arrangement. And finally, tomorrow will be a landmark U.S.-Africa business forum, which will provide opportunities for increased investment and trade between America and the continent. Africa, home to six of the world’s ten fastest-growing economies, wants American investors who are looking to Africa like never before. In doing so, they’re creating new jobs and opportunities for Americans at home and abroad. Today’s challenge is to ensure these gains are expanded and spread to benefit of all of Africa’s people."  


16.  Also on August 4th, 2014, World Bank, produces a video response for the victims of the ongoing Ebola "epidemic" : http://www.worldbank.org/en/news/press-release/2014/08/04/ebola-world-bank-group-mobilizes-emergency-funding-for-guinea-liberia-and-sierra-leone-to-fight-epidemic

World Bank Group President Dr. Jim Yong Kim, a medical doctor experienced in treatment of infectious diseases, said the new financing commitment was in response to a call from both the three African countries hardest-hit by Ebola and the World Health Organization (WHO) for immediate assistance to contain the outbreak.

These are the facts as of August 7, 2014.  Additional resources listed below.

3. Medical Countermeasures (HHS): https://www.medicalcountermeasures.gov/home.aspx