Global & Disaster Medicine

Tunisia: 31 people to death over the 2014 terrorist attack and a possible anthrax attack in 2019

March 8th, 2019

“……19 letters containing potentially deadly toxins addressed to prominent journalists, politicians and trade unionists, have been intercepted by police at the central Post Office in Tunis and taken for testing.

The National Unit of Investigation for Terrorist Affairs and Organized Crime revealed that the toxic substance was made in Tunisia inside a laboratory.

The Ministry of Interior indicated that it is monitoring the movements of the terrorist cells that plotted the attack, especially that the deadly poison was made with local Tunisian expertise and required huge financial support. …..”

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Streamlining The WHO: Can it be done?

March 7th, 2019

NYT

“……The World Health Organization …..announced a long-awaited restructuring intended to streamline the agency — and strongly hinted that it intended to shake up some staffers’ resistance to change.

The announcement, made in a lengthy and mostly cheerful speech delivered jointly by the organization’s director general, Tedros Adhanom Ghebreyesus, and the directors of the agency’s six regional offices, aims to serve the W.H.O.’s new targets: to get affordable health care to the world’s poorest 1 billion people; to better protect them against epidemics; and to help them enjoy better health, including protection from noncommunicable diseases like cancer…..”

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Bayer has launched a combination indoor residual spray called Fludora Fusion, which combines neonicotinoid clothiandin with pyrethroid deltamethrin. The product is sprayed onto walls inside a house and when a mosquito comes into contact with it, it is killed within 24-48-hours.

March 7th, 2019

Reuters

“……After several years of steady declines, annual cases of the mosquito-borne disease are leveling off, the World Health Organization’s 2018 malaria report showed in November.

The report showed around 435,000 deaths and 219 million malaria cases in 2017 worldwide, both little changed from 2016. Global case numbers fell steadily from 239 million in 2010 to 214 million in 2015, and deaths from 607,000 to around 500,000 from 2010 to 2013……”

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The WHO’s ambitious “triple billion” targets

March 7th, 2019

WHO

WHO unveils sweeping reforms in drive towards “triple billion” targets

6 March 2019

News Release

Geneva

WHO today announced the most wide-ranging reforms in the Organization’s history to modernize and strengthen the institution to play its role more effectively and efficiently as the world’s leading authority on public health.

The changes are designed to support countries in achieving the ambitious “triple billion” targets that are at the heart of WHO’s strategic plan for the next five years: one billion more people benefitting from universal health coverage (UHC); one billion more people better protected from health emergencies; and one billion more people enjoying better health and well-being.

These changes include:

Aligning WHO’s processes and structures with the “triple billion” targets and the Sustainable Development Goals by adopting a new structure and operating model to align the work of headquarters, regional offices and country offices, and eliminate duplication and fragmentation.
Reinforcing WHO’s normative, standard-setting work, supported by a new Division of the Chief Scientist and improved career opportunities for scientists.
Harnessing the power of digital health and innovation by supporting countries to assess, integrate, regulate and maximize the opportunities of digital technologies and artificial intelligence, supported by a new Department of Digital Health.
Making WHO relevant in all countries by overhauling the Organization’s capabilities to engage in strategic policy dialogue. This work will be supported by a new Division of Data, Analytics and Delivery to significantly enhance the collection, storage, analysis and usage of data to drive policy change in countries. This division will also track and strengthen the delivery of WHO’s work by monitoring progress towards the “triple billion targets” and identifying roadblocks and solutions.
Investing in a dynamic and diverse workforce through new initiatives including the WHO Academy, a proposed state-of-the-art school to provide new learning opportunities for staff and public health professionals globally. Other measures include a streamlined recruitment process to cut hiring time in half, management trainings, new opportunities for national professional officers, and previously-announced improvements in conditions for interns.
Strengthening WHO’s work to support countries in preventing and mitigating the impact of outbreaks and other health crises by creating a new Division of Emergency Preparedness, as a complement to WHO’s existing work on emergency response.
Reinforcing a corporate approach to resource mobilization aligned with strategic objectives and driving new fundraising initiatives to diversify WHO’s funding base, reduce its reliance on a small number of large donors and strengthen its long-term financial stability.

“The changes we are announcing today are about so much more than new structures, they’re about changing the DNA of the organization to deliver a measurable impact in the lives of the people we serve,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Our vision remains the same as it was when we were founded in 1948: the highest attainable standard of health for all people. But the world has changed, which is why we have articulated a new mission statement for what the world needs us to do now: to promote health, keep the world safe and serve the vulnerable.”

The new measures were developed following an extensive period of consultation with staff, and were developed jointly by WHO’s Global Policy Group, which consists of the Director-General and each of the organization’s six regional directors: Dr Matshidiso Moeti (Regional Director for Africa), Dr Carissa Etienne (Regional Director for the Americas), Dr Poonam Khetrapal Singh (Regional Director for South-East Asia), Dr Zsuzsanna Jakab (Regional Director for Europe), Dr Ahmed Al-Mandhari (Regional Director for the Eastern Mediterranean) and Dr Takeshi Kasai (Regional Director for the Western Pacific).

WHO’s new corporate structure is based on four pillars which will be mirrored throughout the organization.

The Programmes pillar will support WHO’s work on universal health coverage and healthier populations. The Emergencies pillar will be responsible for WHO’s critical health security responsibilities, both in responding to health crises and helping countries prepare for them. The External Relations and Governance pillar will centralize and harmonize WHO’s work on resource mobilization, communications. The Business Operations pillar will likewise ensure more professionalized delivery of key corporate functions such as budgeting, finance, human resources and supply chain.

The four pillars will be supplemented by the Division of the Chief Scientist at WHO Headquarters in Geneva to strengthen WHO’s core scientific work and ensure the quality and consistency of WHO’s norms and standards.

Underpinning the new structure, 11 business processes have been redesigned, including planning, resource mobilization, external and internal communications, recruitment, supply chain, performance management, norms and standards, research, data and technical cooperation.

The Global Policy Group stressed the role of working with partners. Dr Tedros said WHO must develop a new mindset to seek out and build partnerships that harness the combined strength of the global health community – both in the public and private sectors. One example of this is a new Global Action Plan for Healthy Lives and Well-Being for All, under which 12 partner organizations are working together to achieve health-related Sustainable Development Goals.

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A Longitudinal Study of Ebola Sequelae in Liberia

March 7th, 2019

NEJM

“…….Results

A total of 966 EBOV antibody–positive survivors and 2350 antibody-negative close contacts (controls) were enrolled, and 90% of these participants were followed for 12 months. At enrollment (median time to baseline visit, 358 days after symptom onset), six symptoms were reported significantly more often among survivors than among controls: urinary frequency (14.7% vs. 3.4%), headache (47.6% vs. 35.6%), fatigue (18.4% vs. 6.3%), muscle pain (23.1% vs. 10.1%), memory loss (29.2% vs. 4.8%), and joint pain (47.5% vs. 17.5%). On examination, more survivors than controls had abnormal abdominal, chest, neurologic, and musculoskeletal findings and uveitis. Other than uveitis (prevalence at enrollment, 26.4% vs. 12.1%; at year 1, 33.3% vs. 15.4%), the prevalence of these conditions declined during follow-up in both groups. The incidence of most symptoms, neurologic findings, and uveitis was greater among survivors than among controls. EBOV RNA was detected in semen samples from 30% of the survivors tested, with a maximum time from illness to detection of 40 months…….”

March 7, 2019
N Engl J Med 2019; 380:924-934
DOI: 10.1056/NEJMoa1805435

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3 suspicious packages that appeared to contain homemade bombs capable of igniting a small fire were found Tuesday in and around transport hubs in London

March 6th, 2019

NYT

“…..While the motive behind the transit center packages is still unknown, London has been target of terrorism many times over the last 15 years. On July 7, 2005, suicide bombers killed 52 subway and bus travelers in London. In 2017, there were various deadly attacks on pedestrians on Westminster Bridge, on London Bridge and near the Finsbury Park Mosque. And a bomb that partially exploded on a commuter train that year burned 23 people.….”

https://www.youtube.com/watch?v=uMlaeJdrNzU

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Guess who owns the bridge that collapsed in Genoa and killed 43 people? Benetton: the Italian family famous for wool sweaters and a global clothing..

March 6th, 2019

NYT

“……The calamity in Genoa is now the subject of a criminal inquiry, with 21 people under investigation, including nine employees of Autostrade and three officials from the Ministry of Infrastructure and Transport. The authorities are sorting through years of email exchanges and documents, plus the contents of a few dozen mobile phones, to try to determine who is to blame.….”

https://www.youtube.com/watch?v=vc_E3lTzMGY

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12 minutes of warning and still people died. Why? Poverty

March 6th, 2019

NYT

“……On Sunday afternoon, sirens wailed and cellphones erupted with about 12 minutes of notice that a funnel cloud had dropped from a foreboding Alabama sky and was bound for Beauregard.

In forecasting, double-digit lead time is considered an extraordinary scientific feat, and officials said the warning was issued as soon as there was data available. But in a place with widespread poverty and few places to hide, the urgent forecast could not save everyone who did not have time to find safe shelter. Others simply disregarded the warning…….”

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Crisis at the border

March 6th, 2019

USA Today

‘….”We are currently facing both a border security and humanitarian crisis along our southwest border,” Customs and Border Protection Commissioner Kevin McAleenan told reporters.

During the five-month period ended Feb. 28, Border Patrol officers apprehended some 268,000 migrants who entered the United States without legal authorization. More than 76,000 entered in February alone…..’

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FDA: Mitigation Strategies to Protect Food Against Intentional Adulteration

March 6th, 2019

FDA

FDA takes new steps to protect food products from deliberate attacks

March 5, 2019

Media Inquiries

Lindsay Haake
301-796-3007

“The U.S. has one of the safest food supplies in the world. However, to keep it safe we must recognize that our foods can be vulnerable – not just from unintended contamination, but from those who would do us harm. We’ve taken steps to minimize the risk of an intentional attack on our food supply, and today we’re advancing new steps to help manufacturers implement additional activities that can help identify and mitigate the risk of intentional food adulteration. To secure these goals, in 2016 we put forth a rule outlining smart, risk-based steps food production facilities must implement to help protect our foods from acts of intentional adulteration. This is a serious issue that warrants serious attention and is why today we’re taking some additional steps to help ensure food facilities will implement the rule as effectively as possible,” said FDA Commissioner Scott Gottlieb, M.D. “When it comes to modernizing our approach to food safety, our core aim is to shift the FDA’s focus from reacting to food safety problems to preventing them from occurring in the first place. To help secure this goal when it comes to the risk of intentional adulteration and acts of terrorism, today we’re providing additional draft guidance to help producers implement the rule’s protective standards, identify their biggest risks, and mitigate these risks from those who might try to use food products to cause deliberate harm to American consumers.”

The U.S. Food and Drug Administration today released a revised draft guidance, “Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry,” to support compliance with the intentional adulteration (IA) rule set forth under the FDA Food Safety Modernization Act (FSMA).

The IA rule is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause widespread harm to public health. Unlike the other FSMA rules that address specific foods or hazards, the IA rule requires certain facilities – both domestic facilities and foreign facilities that export to the U.S. – to develop and implement food defense plans that assesses their potential vulnerabilities to such acts of deliberate contamination.

The draft guidance issued today outlines two, flexible methods for how facilities can conduct vulnerability assessments to identify their areas of highest risk and provides information about requirements for education and training. This installment of the draft guidance includes all of the information in the first installment, including information on the Key Activity Type method to conduct vulnerability assessments, mitigation strategies, and food defense monitoring procedures, released in June 2018.

In the near future, the FDA also intends to provide a third installment of this draft guidance that will include additional information on corrective actions, verification, records maintenance, reanalysis requirements, and how to calculate small and very small business sizes in order to determine what requirements of the rule are applicable. When finalized, this draft guidance is intended to be a resource that will help the food industry implement the IA rule’s provisions in a flexible and cost-effective manner. For more information on this guidance, as well as instructions on how to submit comments, please visit FDA.gov.

FDA

March 2019

Contains Nonbinding Recommendations

Draft-Not for Implementation

The FDA Food Safety Modernization Act (FSMA) added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) several new sections that reference intentional adulteration. For example, section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food, and that are required to register under section 415 (21 U.S.C. 350d). Section 420 of the FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the context of high-risk foods and exempts farms except for farms that produce milk [2].

We implemented these intentional adulteration provisions through a rule entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration” (IA rule).We published the final rule in the Federal Register of May 27, 2016. (81 FR 34166).

The rule, which includes the requirements for food defense measures against intentional adulteration, and related requirements, can be found in 21 CFR part 121, as shown in Table 1.

Table 1. Subparts Established in 21 CFR Part 121

Subpart	Title
A	General Provisions
B	Reserved
C	Food Defense Measures
D	Requirements Applying to Records That Must Be Established and Maintained
E	Compliance

As shown in Table 2 below, the amount of time we are allowing you to comply with the IA rule depends on your particular business.

Table 2. Compliance Dates for IA Rule Based on Size of Business

Size of Business	Compliance Date
Very Small	July 26, 2021
Small	July 27, 2020
Other businesses that do not qualify for exemptions	July 26, 2019

The IA rule applies to the owner, operator, or agent in charge of a domestic or foreign food facility that manufactures/processes, packs, or holds food for consumption in the United States and is required to register under section 415 of the FD&C Act, unless one of the exemptions provided in 21 CFR 121.5 applies. (21 CFR 121.1).

Acts of intentional adulteration may take several forms: acts intended to cause wide scale public health harm, such as acts of terrorism focused on the food supply; acts of disgruntled employees, consumers, or competitors; and economically motivated adulteration (EMA). Acts intended to cause wide scale public health harm are associated with intent to cause significant human morbidity and mortality. The other forms are typically not intended to cause wide scale public health harm, although some public health harm may occur because of the adulteration. For example, acts of disgruntled employees, consumers, and competitors are generally intended to attack the reputation of a company, and EMA is intended to obtain economic gain. In the spectrum of risk associated with intentional adulteration of food, attacks intended to cause wide scale public health harm to humans are ranked as the highest risk. Therefore, the IA rule is focused on addressing those acts and not acts of disgruntled employees, consumers, or competitors, or acts of EMA [3].

This document is directed to those persons who are subject to the Intentional Adulteration (IA) requirements of 21 CFR part 121 (you). Identifying significant vulnerabilities at your facility and implementing mitigation strategies and mitigation strategy management components enables you to apply a proactive and systematic approach to your food defense program to protect your food from intentional adulteration intended to cause wide scale public health harm.

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

Download the Draft Guidance for Industry

[1] This guidance has been prepared by the Office of Analytics and Outreach, Food Defense and Emergency Coordination Staff, in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.

[2] The IA rule did not include any requirements for farms that produce milk. As such, farms that produce milk are not covered under this draft guidance.

[3] As we noted in the final rule, the protections required by the rule will help minimize the likelihood of success of a disgruntled employee, consumer, or competitor who attempts an act of intentional adulteration at an actionable process step—even if that act is not intended to cause wide scale public health harm. (81 FR at 34183).

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