21 January 2010
Daniel R. Lucey, MD, MPH
14 Anthrax cases (7 fatal) in Scotland include some with necrotizing fasciitis and Rx with Anthrax Immunoglobulin
The number of injection drug (heroin) users in Scotland with laboratory-confirmed Bacillus anthracis infection is currently 14, with seven deaths. The Health Protection Scotland (HPS) website, updated on a daily basis and including outbreak management and treatment information, can be found at: http://www.hps.scot.nhs.uk/anthrax/index.aspx
A rapid communication in the 14 January issue of Eurosurveillance by Ramsay and colleagues from the UK reported that at least some of the patients presented with the unusual manifestation, for anthrax, of necrotizing fasciitis. http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19465. In addition, at least two of the patients presented with hemorrhagic meninigitis or subarachnoid hemorrhage (SAH). The paragraph from this publication citing the clinical presentation is quoted in full below, given the unusual form of anthrax being seen in these patients:
“Generally, the cases have presented with inflammation or abscesses related to sites of heroin injection. Symptoms began between one and two days or longer after injection of heroin and admission to hospital generally followed within four days. Localized lesions developed into necrotising fasciitis in a number of cases, some of whom died. The fatal cases in Glasgow (three men and one woman) died between three and seven days after admission. Cellulitis with very marked oedema has been noted in limbs with infection sites in a number of these cases. In a few cases the presentation has been of patients in advance stages of systemic sepsis some of whom died within hours. At least two cases presented with symptoms thought of at initial assessment as suggestive of a sub-arachnoid haemorrhage or haemorrhagic meningitis. Others presented with relatively localized lesions which have not progressed. The range of presentations is therefore wide and inconsistent”.
In terms of therapy, in addition to antibiotics this paper by Ramsay et al., stated that anthrax immunoglobulin (AIG) had been made available via the US CDC: “Acknowledgements: The role of CDC in providing advice and support by way of personnel and a supply of the anthrax immunoglobulin (AIG) is gratefully acknowledged, in particular Dr. Nicki Pesik and Dr. Theresa Smith regarding use of the AIG and colleagues Dr. Sean Shadomy and Dr. Kendra Stauffer in support”.
The working case definitions for “confirmed”, “probable” and “possible” anthrax cases for this particular outbreak have been defined on the Health Protection Scotland website as a pdf at: http://www.hps.scot.nhs.uk/anthrax/documents/case-definition-anthrax-outbreak-v5.pdf
Further clinical details and specific treatments including surgical, antibiotic combinations, and anthrax immunoglobulin (AIG) are keenly awaited, even more so now that a similar patient has been reported from Germany in the same 14 January issue of Eurosurveillance.
2 April 2010
Daniel R. Lucey, MD, MPH
WHO to Convene Expert Committee April 12-15 to Review the Global Response to Pandemic Influenza
This week the World Health Organization (WHO) announced details of the upcoming April 12-14 initial review of the global response to the pandemic influenza A (H1N1) virus. Yesterday (April 1st) a two–page document was posted on the WHO website summarizing the three key objectives, an overview of the (29-person) committee membership, proceedings, and participation by International health Regulations (IHR) States Parties.
The three stated objectives of this expert review committee are:
–“Assess the functioning of the International Health Regulations (2005);
–Assess the ongoing global response to the pandemic H1N1 (including the role of WHO); and
–Identify lessons learned important for strengthening preparedness and response for future pandemics and public health emergencies.”
This WHO April 1st document can be found at: www.who.int/csr/disease/swineflu/frequently_asked_questions/review_committee/en/index.html
Earlier this week, on March 29th, a press conference was held addressing this review committee process. Dr. Keiji Fukuda, Special Advisor to the Director-General (Dr. Margaret Chan) on Pandemic Influenza outlined the process involved with this review committee.
Dr. Fukuda also answered a journalist’s question regarding how WHO defined “pandemic” with regard to the pandemic Influenza A (H1N1) 2009 virus. In particular, he noted that the “severity” of the influenza disease was not part of the definition. He also noted that no change was made in the definition of the pandemic in 2009.
The 12-page transcript of this press conference March 29th can be found at: www.who.int/mediacentre/multimedia/pc_transcript_29_march_10_fukuda.pdf
The first (interim) report of this 29-member is due next month in time for the annual May World Health Assembly. The committee will meet in Geneva at WHO headquarters April 12-14. The final report of the committee is due in 13 months, at the May 2011 World Health Assembly.
The report of this expert committee is anticipated to address many important issues regarding this influenza pandemic, the global public health response, the International Health Regulations (IHR 2005), and potential lessons for future disease outbreaks, whether influenza or not, whether pandemics or not.
News Release
| FOR IMMEDIATE RELEASE Thursday, August 19, 2010 | Contact: HHS Press Office (202) 690-6343 |
Review calls for new federal approach to medical countermeasures
HHS Secretary releases review and recommendations driven by pandemic flu experience
U.S. Department of Health and Human Services Secretary Kathleen Sebelius today released an examination of the federal government’s system to produce medications, vaccines, equipment and supplies needed for a health emergency, known as medical countermeasures. The Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs reviews the process and makes recommendations for a better approach.
“Our nation must have a system that is nimble and flexible enough to produce medical countermeasures quickly in the face of any attack or threat, whether it’s a threat we know about today or a new one,” Secretary Sebelius said. “By moving towards a 21stcentury countermeasures enterprise with a strong base of discovery, a clear regulatory pathway, and agile manufacturing, we will be able to respond faster and more effectively to public health threats.”
Secretary Sebelius requested the comprehensive review when the department encountered challenges with the 2009 H1N1 pandemic flu vaccine, highlighting the need for a modernized countermeasure production process. The review covered the steps involved in the research, development, and FDA approval of medications, vaccines, and medical equipment and supplies for a health emergency.
The review identified a need to upgrade science and regulatory capacity at the FDA. As a result, HHS will make a significant investment to provide FDA scientists with the resources to develop faster ways to analyze promising new discoveries and give innovators a clear regulatory pathway to bring their products to market.
The review also found that U.S. must more quickly develop manufacturing processes that can be used for multiple medications or vaccines rather than processes that can be used to produce only one type of countermeasure. As a result of this finding, in the coming weeks HHS expects to release a draft solicitation for one or more Centers of Innovation for Advanced Development and Manufacturing. The center(s) will focus on new manufacturing platforms that can produce a variety of countermeasures. The equipment and methods could provide a way to meet a surge in demand using facilities in the U.S. rather than relying on foreign manufacturing.
The review found that some of the most promising research and development on countermeasures is done by small, emerging biotech companies with little experience in large-scale manufacturing. Therefore, the Centers of Innovation for Advanced Development and Manufacturing will also serve as resources for young companies, helping them bring products to market and helping the U.S. government increase the number of new countermeasures available in an emergency.
The review made clear that the federal government must do a better job nurturing discoveries in their earliest stages to push them to greater maturity. Therefore, HHS will be creating new teams at the National Institutes of Health to identify promising research and facilitate its translation into vaccines, drugs, and treatments that keep Americans safe.
The review placed a special focus on the federal government’s flu response, identifying a need to upgrade flu vaccine manufacturing – from modernizing ways to test a vaccine’s strength, known as potency, to new methods to show that the vaccine is safe, as well as ways to produce the early “seed virus” for vaccines faster. Taken together, this will shave weeks of time off vaccine manufacturing. HHS will make investments in these areas as a result of the review.
The review also found that private companies have difficulty attracting investors in countermeasures where there is little or no market for these products outside of that currently needed for government stockpiles. As a result of this finding, HHS will explore ways to help small companies attract investors to develop promising countermeasures that have multi-use potential.
The HHS Assistant Secretary for Preparedness and Response led the review. All federal agencies working with medical countermeasures participated, including the Department of Homeland Security, Department of Defense, and HHS divisions of ASPR and ASPR’s Biomedical Advanced Research and Development Authority, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration. The review also incorporated input from state and local health departments, two federal advisory committees of outside experts, industry groups, venture capital experts, and the Institute of Medicine.
Read the review and its recommendations at www.hhs.gov/secretary/.
16 September 2010
Daniel R. Lucey, MD, MPH
Public Readiness and Emergency Preparedness (PREP) Act includes specific countermeasures for Anthrax, Botulism, Smallpox, Acute Radiation Syndrome and Pandemic Influenza.
According to the current (16 Sept 2010) US government website homepage for the Public Readiness and Emergency Preparedness (PREP) Act (www.hrsa.gov/gethealthcare/conditions/countermeasurescomp/prepact.html) the following explanation is provided for the PREP Act.
Afterwards, to emphasize the importance of the PREP Act covering specific countermeasures, the list is provided of all current declarations and specific covered countermeasures for Anthrax, Botulism, Smallpox, Acute Radiation syndrome, and Pandemic Influenza, as provided (below) at:www.hrsa.gov/gethealthcare/conditions/countermeasurescomp/coveredcountermeasures.html
“The PREP Act provides compensation to individuals for serious physical injuries or deaths from pandemic, epidemic, or security countermeasures identified in a declaration issued by the Secretary pursuant to section 319F-3(b) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d-6d). The PREP Act which is a part of the “Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act of 2006” (PL 109-148), was enacted on December 30, 2005, and confers broad liability protections on covered persons, as defined in section 319F-3(i)(2) of the PHS Act, and compensation to individuals injured by the receipt of covered countermeasures, as defined in section 319F-3(i)(1) of the PHS Act, in the event of designated public health emergencies.”
“Following are all current declarations:
Pandemic Influenza Vaccines – or (PDF – 60 KB): Notice of amendment to the September 28, 2009 Republished Declaration under the Public Readiness and Emergency Preparedness Act. Federal Register notice, 3/5/2010. Note: Included is a controlling republication of the five previously published pandemic influenza declarations:
Pandemic Influenza Vaccines—Amendment or (PDF – 54 KB): Notice of first amendment to the June 15, 2009 Republished Declaration under the Public Readiness and Emergency Preparedness Act. Federal Register notice, 10/05/2009.
Amendment to H5N1, H2, H6, and H9 Pandemic Influenza Vaccines to Add 2009 H1N1 Vaccines: Pandemic Influenza Vaccines–Amendment or (PDF – 54 KB). Federal Register notice, 06/25/2009.
Amendment to H5N1 Pandemic Influenza Vaccine to Add H7 and H9 Subtypes: Amendment to January 26, 2007 Declaration Under the Public Readiness and Emergency Preparedness Act or (PDF – 57 KB). Federal Register notice, 11/30/2007
Amendment to Pandemic Influenza Vaccine to Add H2 and H6 Subtypes: Pandemic Countermeasures Amendment to H5N1 Declaration Under the Public Readiness and Emergency Preparedness Act or (PDF – 52 KB). Federal Register notice, 10/17/2008
H5N1 Pandemic Influenza Vaccine: Pandemic Countermeasures; Declaration Under the Public Readiness and Emergency Preparedness Act or (PDF – 50 KB). Federal Registernotice, 02/01/2007
Amendment to Pandemic Antiviral Countermeasures to Add H1N1 Virus under Category of Disease: Pandemic Influenza Antivirals–Amendment or (PDF – 51 KB) Federal Register notice, 06/19/2009
Addition of the Pandemic Antiviral Peramivir as a Covered Countermeasure: Declaration Under the Public Readiness and Emergency Preparedness Act for the Influenza Antiviral Peramivir or (PDF – 49 KB). Federal Register notice, 10/02/2009
Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices and Respiratory Support Devices (Mechanical Respirators): Declaration Under the Public Readiness and Emergency Preparedness Act or (PDF – 50 KB). Federal Register notice 12/22/2008
Anthrax Countermeasures: Anthrax Countermeasures: Declaration Under the Public Readiness and Emergency Preparedness Act or (PDF – 56 KB). Federal Register notice, 10/06/2008
Botulism Countermeasures: Botulism Countermeasures: Declaration Under the Public Readiness and Emergency Preparedness Act or (PDF – 54 KB). Federal Register notice, 10/17/2008
Pandemic Antiviral Countermeasures: Pandemic Countermeasures: Declaration Under the Public Readiness and Emergency Preparedness Act or (PDF – 58 KB). Federal Registernotice, 10/172008
Smallpox Countermeasures: Smallpox Countermeasures: Declaration Under the Public Readiness and Emergency Preparedness Act or (PDF – 51 KB). Federal Register notice, 10/17/2008
Acute Radiation Syndrome Countermeasures: Acute Radiation Syndrome Countermeasures: Declaration Under the Public Readiness and Emergency Preparedness Act or (PDF – 55 KB). Federal Register notice, 10/17/2008”
21 October 2010
Daniel R. Lucey, MD, MPH
Ministry of Health of Saudi Arabia issues requirements and recommendations for the Hajj and Umra Seasons this year
The annual Hajj season for pilgrims in Saudi Arabia begins next month in November. According to the Ministry of Health of Saudi Arabia: “In 2009, Hajj was attended by over 2.5 million Muslims, of whom at least 1.6 million were foreign visitors. The vast majority (88% of all pilgrims) arrived by air and although the Hajj ritual only takes one week many will gather for the month-long Hajj season.” Memish ZA. The Hajj: Communicable and non-communicable health hazards and current guidance for pilgrims. Euro Surveillance. 2010; 15 (39):pii=19671. (30 September).
Public Health guidance for next month’s 2010 Hajj is provided in this Eurosurveillance paper and in a related one, also by Dr. Ziad A. Memish, Assistant Deputy Minister of Health for Preventive Medicine, Ministry of Health, Saudi Arabia. The latter publication is referenced in the World Health Organization (WHO) 30 September 2010 “International travel and health” website under the heading “Saudi Arabia-Hajj”, and is available online at: http://www.who.int/ith/updates/20100930/en/ This 30 Sept 2010 WHO update states: ‘Requirements and recommendations for entry visas for the Hajj seasons in 2010 have been published in the latest issue of the Saudi Arabian “Journal of Infection and Public Health’ (volume 3, pages 92-94). This paper by Dr. Ziad Memish, titled “Health conditions for travelers to Saudi Arabia for (Hajj) for the year 1431H/2010” is available online at: http://dpownload.journals.elsevierhealth.com/pdfs/jpurnals/1876-0341/PIIS1876034110000717.pdf
Both of these papers provide succinct and clear guidance for what is one of the largest mass gatherings of persons worldwide. The 30 September Eurosurveillance paper is divided into five main sections: (1) Introduction; (2) Preventive measures during Hajj in Saudi Arabia; (30 Communicable disease at the Hajj; (4) Non-communicable hazards at the Hajj; and (5) Pre-and post-Hajj travel advice.
In the “Introduction” section it is noted that combining the Umra and Hajj pilgrimage season the Kingdom of Saudi Arabia (KSA) “hosts more than four million people from around 160 countries worldwide…From the European Union close to 45,000 pilgrims arrive to KSA each year…One of the major contributors to the planning and strategizing for the well-being of the guests is the Ministry of Health (MoH), whose Infection Control and Preventive Medicine Policies are established every year, based on knowledge of current global outbreaks, epidemiology of infectious diseases, and established effective preventive medicine strategies.”
In the “Preventive measures during Hajj in Saudi Arabia” a synopsis is given of the extensive and remarkable efforts to anticipate a surge in medical needs and a highly interconnected electronic disease surveillance system. For example, “In 2009, the KSA MoH prepared 24 hospitals with a total bed capacity of 4,964, of which 547 were critical care beds. Moreover 136 healthcare centers in the vicinity of the Hajj were equipped with the latest emergency management medical systems and staffed with 17,609 specialized personnel to provide state of the art healthcare to all pilgrims free of charge…39 public health teams are distributed around where the Hajj takes place. These include 18 stationary teams located in healthcare facilities and 21 mobile teams which rotate through the different pilgrim camps.
At the Hajj terminal based at King Abdulaziz International Airport in Jeddah, the key port of entry for the majority of pilgrims, an independent, newly renovated Hajj terminal now accommodates 80,000 pilgrims at any one time. At each of its 18 hubs receiving pilgrim flights there are two clinical examination rooms and a large holding area to assess arriving pilgrims and check their immunization status and administer any recommended prophylactic medicines. Any pilgrim with a suspected communicable disease requiring isolation will be escorted back through the airport grounds by ambulance to a nearby dedicated 200 bed hospital. The public health teams (stationary and mobile) as well as the ports of entry teams report directly to the command center on nine communicable diseases using an electronic surveillance form based on an updated disease case definition submitted via mobile phones. These diseases include influenza, influenza-like illness, meningococcal disease, food poisoning, viral hemorrhage fevers, yellow fever, cholera, polio, and plague.”
The section on “Communicable disease at the Hajj” has four subsections: (1) Meningococcal disease; (2) Respiratory tract infection; (3) Blood-borne diseases; and (4) Diarrhea and food poisoning.
Included in the respiratory infections are discussions about viral diseases, TB, and pertussis. Of the many viruses that can cause upper respiratory tract infection it is reported that “at the Hajj the main culprits are respiratory syncytial virus (RSV), parainfluenza, influenza and adenovirus”.
Of note, it is stated that “In an attempt to reduce the risk of respiratory tract infections during the Hajj, the Saudi MoH encourages pilgrims to wear surgical face mask when in crowded places. In addition the MoH recommends that international pilgrims be vaccinated against seasonal influenza before arrival into the kingdom of Saudi Arabia…”In KSA seasonal influenza vaccine is recommended for internal pilgrims particularly those with pre-existing conditions and all healthcare workers working in the Hajj premises.”
In the section on diarrhea specific guidance on polio prevention and use of oral polio vaccine (OPV) is provided. For example, all pilgrims from the four countries where transmission of wild polio virus has never been completely interrupted (Afghanistan,India, Nigeria, and Pakistan) “should receive one dose of oral polio vaccine (OPV. Proof of OPV vaccination at least six weeks prior departure is required to apply for an entry visa for Saudi Arabia. These travelers will also receive a dose of OPV at border points when arriving in Saudi Arabia. All visitors age under the age of 15 travelling to Saudi Arabia from countries reinfected with poliomyelitis should be vaccinated against poliomyelitis with OPV. Proof of OPV vaccination is required six weeks prior to the application for an entry visa. Irrespective of previous immunization history, all visitors under 15 arriving in Saudi Arabia will also receive a dose of OPV at border points.”
In the final paragraph Dr. Memish emphasizes that “Planning and supporting Hajj has become a forum for collaboration crossing any political considerations. The Saudi MoH every year publishes the Hajj requirements for the upcoming Hajj season which is a good guide to all needed precautions to ensure safe Hajj for all pilgrims.”
In my opinion, much can be learned by other countries, including the USA, from these yearly preparedness and response efforts by the MoH in the KSA related to the Hajj. In particular, practical lessons could be learned regarding specific surge issues for healthcare facilities, healthcare workers, and healthcare resources (including rapid large scale vaccination and antimicrobial distribution), as well as the electronic surveillance system with highly-coordinated real-time reporting by both stationary and mobile teams.
Commemorating the 30th anniversary of smallpox eradication
Dr Margaret Chan
Director-General of the World Health Organization
Dr Mahler, Dr Henderson, Mr Roy, colleagues in public health, ladies and gentlemen,
It is a great honour to welcome this statue to such a prominent place on the WHO grounds. It will remind staff and visitors alike of a truly remarkable success story with permanent gains for health in every corner of the world.
I am likewise honoured by the presence of people who played such a key role in this success story, Dr Mahler, Dr Henderson, and many others.
Leadership at WHO was important, but an achievement of this scale ultimately depended on tens of thousands of dedicated workers who literally crisscrossed this entire earth, by jeep, donkey, and fishing boats, on foot in jungle and desert journeys, from nomadic tribes in remote mountain areas to pavement dwellers in the scorching heat of Asia’s slums.
When the intensified eradication programme was launched, no one knew exactly what needed to be done, how progress would evolve, or even if the initiative would succeed. And there were indeed many near misses and setbacks.
The history of smallpox and its eradication has been written, and public health continues to benefit from the many lessons learned. Success has been attributed to a strong research component, an emphasis on epidemiology and surveillance, and the flexibility to adapt to new findings and change course when needed.
The strategy of ring vaccination emerged and was validated, vastly simplifying operational and logistic demands. The bifurcated needle was invented, and some like to argue that the war against smallpox was eventually won by a modified sewing needle.
Smallpox fighters had to contend with war zones, vast population displacements, religious and cultural beliefs, fetishes, and traditional healers with their tin boxes of smallpox scabs.
And yet despite the incredible odds, one of history’s longest chains of virus transmission, dating back at least 3,000 years, was broken in a small harbour on the Indian Ocean more than 30 years ago.
By definition, the eradication of a disease requires cooperation from every single country in the world. The history of smallpox eradication is also a story about the quiet collaboration of the two superpowers during some of the hottest years of the Cold War.
This statue stands as a reminder of the significance of such an achievement, and of how resources available to WHO can be vastly magnified when the entire world unites behind a humanitarian cause.
It commemorates a time of great idealism that attracted talent and inspired commitment and personal sacrifice. Above all, it stands as a reminder of the power of international health cooperation to do great and lasting good.
Thank you.