Thursday, April 24, 2014

Washington Diplomat: African Bioethicist Urges More Oversight for Clinical Trials


http://www.washdiplomat.com/index.php?option=com_content&view=article&id=8871:african-bioethicist-urges-more-oversight-for-clinical-trials&catid=1498:february-2013&Itemid=508


The Washington Diplomat

African Bioethicist Urges More Oversight for Clinical Trials


A few years ago, medical ethics expert Paul Ndebele, a noted African scholar, saw something at a malaria research site in Malawi that disturbed him: The project was using junior staff as bait to collect mosquitoes for research colonies and feeding the malaria-carrying insects human blood — straight from the source.
When the staffers offered their arms at mosquito mealtimes, they naturally risked infection, Ndebele said, warning that those who continued doing this while taking drugs to prevent or treat malaria were potentially sparking malarial drug resistance in mosquito populations.
Using humans as insect bait — a practice that has its own scientific label, Human Landing Catch (HLC) — is considered the most effective way to capture adult mosquitoes, but Ndebele questioned the ethics of it in an article for the Malawi Medical Journal in 2011.
Ndebele, assistant director for research ethics at the University of Botswana, was recently tapped to be a bioethicist contractor by the Henry Jackson Foundation in Bethesda, Md. With research sponsors at the National Institutes of Health and the European Commission, he's a well-connected, peripatetic activist and academic.
c2.medical.paul.ndebele.wife.story
Paul Ndebele and his wife Sharon attend a reception for international scholars at Michigan State University. After political unrest in his native Zimbabwe threatened his work on bioethics, Ndebele was able to leave the country in 2003 with the help of a fellowship from the Institute of International Education's Scholar Rescue Fund.
He alerted his networks throughout sub-Sahara Africa about the issue of HLCs. He visited multiple malaria study sites in a number of nations. He brainstormed at his workshops for professionals and laypeople who monitor medical research.
Ndebele's resulting report dealt with the tensions between existing scientific standards and the principles of justice and "human dignity" written into contemporary medical research worldwide. "It was an ethical choice involving mosquitoes, humans and science," Ndebele told The Washington Diplomat.
Still, his report was labeled an opinion piece. Human Landing Catches are considered common medical practice — and are even called the gold standard for estimating malaria transmission by mosquitoes. A 2012 study on the incidence of malaria among mosquito collectors in western Kenya conducted by the Centers for Disease Control and Prevention and other health groups found that if properly treated, "concern about increased risk of malaria among collectors should not be an impediment to conducting HLC studies."
But Ndebele questions the practice, and his report offers practical alternatives, such as using anesthetized animals to feed mosquitoes or getting blood from transfusion services. It also suggested ways to use existing products to protect workers from bites.
In addition to being a dogged problem solver, Ndebele doesn't mince words when it comes to thorny bioethical issues.
He chastised the principal investigators and other researchers in malaria vector studies for "resting in their comfortable homes" while their low-literacy and poorly paid staffers endured mosquito bites overnight for hours on end — and he even listed the bite rates to make his point.
Not only were such things ethically dubious, he warned, they could stir public controversy and thus do serious harm to important research.
Bioethics itself is a critical field of research that tackles the murky moral quandaries spurred by the ever-advancing march of medicine — a field that's been around as long as medicine has been in existence. Though debated in ancient times, bioethics grabbed the public's attention after the Nazis' horrifying medical experiments on humans during World War II. The subsequent Nuremberg Code outlined a set of international standards for research involving human subjects.
But bioethics as an academic interdisciplinary field evolved and solidified throughout the 1960s and '70s in the wake of game-changing advances such as organ transplants and end-of-life care. Key standards for governing ethics in medical research were set by the 1967 Helsinki Declaration and by groups such as the World Medical Association, World Health Organization, the Council for International Organizations of Medical Sciences, the Council of Europe and the U.S. Department of Health and Human Services, which has established extensive regulations on human testing.
But just because standards have been set and regulations adopted doesn't mean they've always been followed — or that they've kept up with the rapid pace of medical innovation.
In 2010, a six decade-old injustice resurfaced when the U.S. government apologized to Guatemala for deliberately infecting hundreds of Guatemalans with venereal diseases in an attempt to study the effectiveness of penicillin. The experiments, conducted between 1946 and 1948, were particularly egregious. As documented by the New York Times, "American tax dollars, through the National Institutes of Health, even paid for syphilis-infected prostitutes to sleep with prisoners, since Guatemalan prisons allowed such visits. When the prostitutes did not succeed in infecting the men, some prisoners had the bacteria poured onto scrapes made on their penises, faces or arms, and in some cases it was injected by spinal puncture."
Today, though not as extreme, clinical trials on human subjects continue around the world — and particularly in the developing world. An eye-opening 2011 exposé by Vanity Fair called "Deadly Medicine" investigated how pharmaceutical companies scour far-flung corners of the globe to test their products on communities where recruiting patients is cheap and safety standards are lax or nonexistent — all in the hopes of eventually marketing their drugs to Americans for a healthy profit.
Though the ultimate destination is America, human drug testing in the United States has dwindled, while the number of such clinical trials abroad has skyrocketed — nearly 60,000 in more than 170 countries, according to the National Institutes of Health.
"Throw a dart at a world map and you are unlikely to hit a spot that has escaped the attention of those who scout out locations for the pharmaceutical industry," wrote Vanity Fair's Donald L. Barlett and James B. Steele, noting that China and India are home to hundreds of drug trials. Other popular pharmaceutical testing grounds include Russia, Thailand and Turkey.
Africa, of course, is also represented in this cocktail of questionable clinical trials — and that's where Ndebele's specialty lies.
Ndebele, who's worked in Botswana and Malawi, began his career in Zimbabwe, where he'd been a researcher with the principal monitoring agency for all medical and clinical trials in the country. But Ndebele was not immune to Zimbabwe's political unrest, which made his work increasingly impossible. He was able to leave the country in 2003 with the help of a fellowship from the Institute of International Education's Scholar Rescue Fund. The fund supports "persecuted academics" at risk around the world — 450 of them in 48 countries over 10 years. In 2012, it highlighted Ndebele as one of 10 scholars featured to celebrate its decade of work.
c2.medical.paul.ndebele.class.story
African scholar and bioethics expert Paul Ndebele gives a lecture on responsible authorship at the Harry Oppenheimer Okavango Research Centre at the University of Botswana. Ndebele has pushed for greater oversight of research ethics committees that monitor clinical trials and other studies using human subjects.
But the scholar wears many hats, serving on the editorial boards of journals and advising governments about medical research. However, his most important contribution, colleagues say, may be his campaign to train and strengthen the various boards, committees and agencies in developing nations that are supposed to oversee medical research that recruits their citizens — much of it spearheaded by large international corporations, including many based in the United States.
Monitoring of such research is done by research ethics committees, or RECs, that can approve, reject and track a medical project. (They're called institutional review boards, or IRBs, in the United States.) However, in many countries their oversight has been unsophisticated, and even in nations with tough regulations, including the United States, scandals are not uncommon.
"In the 1980's and '90s, there was an expansion of international medical research conducted by developed countries in less developed nations," Ndebele said. "I became concerned about weak local oversight of this research and issues of justice, and asked myself, 'What can I do?'"
His work started in 2001 with improvements he initiated at the Medical Research Council of Zimbabwe. His efforts to strengthen REC oversight have continued throughout sub-Sahara Africa ever since — with, he says, some success.
The extent of the problem became painfully clear to Ndebele in 2007 when he became part of a group that examined studies of RECs and IRBs around the world and took a detailed look at research ethics committees in nine African nations. The results were not encouraging.
Most African committees they examined were weak, with poorly trained staff and insufficient funds. So Ndebele set out to strengthen them, focusing on training, support and, through his published research, creating new cross-cultural understandings of the ethics involved.
Sorrell L. Schwartz, professor emeritus of pharmacology at Georgetown University Medical Center in Washington, D.C., and an expert on RECs, praised Ndebele for his granular approach, bringing specifics and sophistication to the recruitment and training of people on research review boards.
This is particularly important in countries that don't have regulations controlling oversight, Schwartz added — because very detailed understandings are needed to monitor and judge the merits of a clinical trial.
"You can be a Nobel Prize winner and still lack the insight to understand good human research protections," Schwartz noted.
Much of that insight comes down to culture. To that end, Ndebele has studied the issue of "informed consent" and whether trial participants know what they're getting into. For example, he's written finely grained field studies of medical confidentiality in cultures where family members share everything and examined the independence of women who must offer informed consent before enrolling their children in medical research.
In addition, he's questioned the meaning of "voluntary" participation in medical studies conducted in regions where health care is scarce and researchers entice participants with access to high-quality Western medicine as part of the deal.
One of his papers took a hard look at a clinical trial for two new drugs to prevent HIV transmission (they ultimately didn't work). The research was conducted in a farming community in Africa, and Ndebele found that most participants didn't understand the basic concepts behind scientific trials. Most had a poor grasp of three key research fundamentals — "randomization," "double-blinding" and "placebo use" — which was so poor that many felt cheated or deceived at the end of the trial.
Ndebele and colleagues then developed research explanations that used story-telling techniques popular in the local culture and everyday examples taken from their farming employment to help participants understand the scientific concepts behind clinical trials.
One factor in Ndebele's persistence to advocate for vulnerable trial subjects — and wade into territory fraught with thorny ethical debates and unglamorous research analysis — is his family's roots. Ndebele says his native Tonga ethnic group of Zimbabwe, a culturally distinct people who have traditionally lived by farming in a harsh climate, has an ethos of hard work. His father, a farmer, eventually became a pastor "and encouraged me and my brothers to work hard in school as well. It's the reason why we all went to university."
And perhaps it's why the quiet scholar continues the hard work of asking tough questions to hold the medical industry accountable. "I'm glad I can say I've contributed an African voice internationally in my professional work."


About the Author

Carolyn Cosmos is a contributing writer for The Washington Diplomat
.

Wednesday, April 23, 2014

Internship Opportnities: CP12 *Army Safety and Occupational Health Career Program

1. CP12 Intern process, a Fort Jackson P.O.C Vernell Sample 803-751-3625/6004 (tell her Rj referred you) )

Enter as an scholar...

2. Intern Selection Process Facts:

a. The intern selection process begins when an ACOM identifies the need for an intern.  All CP-12 interns are assigned to USACR/Safety Center, centrally managed, and placed at a primary duty location for training purposes.  Selection of a primary duty location is based, in large part, on assurance of placement of the graduating intern.

b. The intern positions are filled through the hiring practices of the Office of Personnel Management.  Job announcements are posted throughout the OPM system to all federal agencies.  Interested parties must submit their applications by mail to the address shown in the job announcement.  All needed information on how to apply is listed in the job announcement.

c. Interested applicants may locate the job announcement at the following links: http://www.usajobs.gov/ or www.cpol.army.mil/ .  Search under series 0018 for Safety and Occupational Health job announcements 7/9/11. (See attached example)  The intern positions can also be accessed on the intern website: https://ncweb.ria.army.mil/dainterns/default.htm


OUTSTANDING SCHOLAR:
US citizen college graduate with a GPA of 3.45 or higher on a 4.0 scale for all under-graduate work or have graduated in upper 10% of class or major university subdivision.


Tuesday, April 22, 2014

DHS FEMA Grant Program. All bark and no bite.

   Does DHS and FEMA Office of Inspector General report on your jurisdiction?
   Are 80 %  of grant funds allocated to local jurisdictions?

   So a state is in violation, what are the next steps for DHS or the local jurisdiction that still
   require funding for planning, preparedness, and mitigation?

   All bark and no bite.

      Black Emergency Managers Association  
   bEMA 

      Leaders don’t create followers, they create more leaders.   Tom Peters
       …….The search is on.


http://www.oig.dhs.gov/assets/Mgmt/2014/OIG_SLP_14-62_Apr14.pdf
Alaska's Management of Homeland
Security Grant Program Awards for
Fiscal Years 2010 Through 2012

What We Determined

Alaska developed written procedures for program administration. The State also ensured that
grant expenditures for equipment purchases, planning, training, exercises, and administrative
activities were allowable and complied with grant reporting requirements. It linked its
homeland security strategy goals and objectives to DHS mission areas in compliance with
applicable FEMA guidance. We identified the State’s subgrantee application and award
processes as best practices.

However, Alaska can improve its homeland security strategies by including target levels of
performance and the means to measure progress toward enhancing preparedness at both the
state and subgrantee level. The State needs to ensure that 80 percent of grant funds are
obligated to local jurisdictions, improve compliance with procurement procedures and
documentation requirements, strengthen its subgrantee monitoring by updating its policies
and processes, and ensure that updates to policies and manuals include a list of changes.
What We Recommend

We recommended that the FEMA Assistant Administrator, Grant Programs Directorate,
require the Alaska Division of Homeland Security and Emergency Management to:

  • Assess the current processes and procedures for allocating funds to ensure at least 80 percent of Homeland Security Grant Program funds are allocated to subgrantees as required.
  • Develop comprehensive performance measurement systems for grant program goals and objectives that include target levels of performance and criteria against which to measure progress toward enhancing preparedness.
  • Ensure updates to Alaska’s Threat and Hazard Identification and Risk Assessment include details and descriptions of desired outcomes as required by FEMA guidance.
  • Evaluate and update monitoring and oversight policies to ensure policies and procedures align with Federal and state regulations as well as current practices.
  • Ensure enforcement of all Federal and state policies and regulations for oversight of Federal grants.
  • Ensure that any updated policies or guidance include a list of changes.

Preparedness should be marketed like Coca-Cola

Imagine the following storyboard...or commercial.

Think of a scene of your favorite breakfast food or other product.
Child (daughter or son) eating a breakfast nutritional cereal at the kitchen table.
Mother placing two boxes of cereal with a list of other items in a Tupperware container.
Child asking mom:  "Mom why are you placing those away?"
Mom: "Oh, these are part of our emergency or disaster kit, of things everyone likes that will last us three days ."
Child:  Gets up from table and places another box of the cereal in the container as mother checks off list on counter-top.
Child:  "Just in case."
Note: Multinational and other organizations could handle the costs in their EXISTING BUDGETS of adding emergency preparedness marketing costs.  EM agencies (FEMA, State, County, City, etc. ) try a little bit more out-of-box innovation and cut spending costs.  These organizations are part of the 'whole community' and can share the costs.
Coca-Cola could even market their product, and their water purification systems.
 
1231  Good Hope Road  S.E.
Washington, D.C.  20020
Office:   202-618-9097 
bEMA 

Leaders don’t create followers, they create more leaders.   Tom Peters
…….The search is on.


http://www.preventionweb.net/english/professional/news/v.php?id=29966

Preparedness should be marketed like Coca-Cola

September was National Disaster Preparedness Month. Many emergency management programs are now working on other mission areas that might include disaster planning or exercises. But the month of emphasis on preparedness is over, and we won’t concentrate on the topic again until next year.

Is this the right thing to do? Should we have one month of preparedness and 11 months of maintenance messaging on the topic of becoming prepared for disasters? We need to change this mentality.

No matter how prepared you become as a single government or coalition of governments, you can’t overcome the lack of disaster preparedness by your general population if the event is catastrophic. No matter how many government resources you throw at problems, there isn’t enough mutual aid or Emergency Management Assistance Compact aid to overcome the hole that has been dug by having your citizens and businesses unprepared for a disaster. 

While the general message in the past has been to become prepared for three days or 72 hours, most people, emergency managers included, are not ready to be on their own for even three hours. I don’t believe the national surveys that tout that upward of 30 to 40 percent of the general population is prepared for a disaster. It just can’t be true based on my own personal experience in talking with individuals and families.

What’s needed to overcome this woeful lack of disaster preparedness is a national-level campaign that is continuous and never-ending in encouraging and motivating people to become prepared for the next disaster. And three days is not enough. 

Look at how Coca-Cola is advertised. We know Coke is sold using polar bears and Santa Claus as marketing mascots, and the symbol of Coke is emblazoned on our brains so that we can mentally recall what the logo looks like. 

And yet we will keep seeing Coca-Cola advertised continuously using television, radio, billboards, magazine ads, bus signs, the Internet and yes, even social media because otherwise people won’t buy it. 

About a month ago, I heard a professional public relations leader explain that his agency did what it could with the funding it was given. He remarked that it would take millions of dollars to do a national advertising campaign like major corporations do. 

OK, let’s do some basic math — it’s been 10 years since the advent of homeland security grants. Those averaged $3.2 billion per year for state and local preparedness. So we’ve spent roughly $32 billion on “stuff” and very little on disaster preparedness messaging. I fought tooth and nail to get funds allocated to that mission for my own homeland security region. We got some $2.5 million over a number of years that we translated into more than $5 million in advertising on television, radio, billboards and buses in a partnership with the Seattle Mariners baseball team. 

What if, instead of trying to get the Ad Council to support disaster preparedness messaging, we worked with the national networks to buy air time and get our disaster preparedness message to everyone in the U.S? Not for a month, but continuously. There could be major ad buys in national magazines, we could target women and children to motivate them to become prepared for disasters and to maintain a level of preparedness for their own welfare and that of their community. This isn’t rocket science — we know how to do it. We have the messages, the means and the wherewithal to make a huge impact for disaster preparedness.

We need to sell disaster preparedness like they sell Coca-Cola.

You may use or reference this story with attribution and a link to
http://www.emergencymgmt.com/disaster/Preparedness-Marketed-like-Coca-Cola.html

Monday, April 21, 2014

Call for Papers: World Congress on Stress, Trauma & Coping

World Congress on Stress, Trauma & Coping

 
Experience a whole new World Congress with more opportunities to
Engage, Learn, Share.
 
 
This theme doesn't just summarize the 13th World Congress on Stress, Trauma and Coping mission and purpose -
 
It also describes the atmosphere we're striving to create:
an environment where solutions are evolving to deal with the ongoing challenges facing crisis interventionists.
 
We invite you to share in our efforts to demonstrate the impact that enhanced quality can have on our agencies, organizations, businesses, communities, and our world. We are developing the 2015 World Congress on Stress, Trauma and Coping and are looking specifically for presentations that can integrate the conference theme with one or more of these focus areas:
Emergency Services and Public Safety
Disaster Response
Faith Based Applications
Family, Children and Schools
Healthcare Settings
Industry / Corporate / EAP
Military / Veterans
Research / Innovations
Specialty Populations
Team Development and Sustainability

 
Call for Presentations opens May 9, 2014!

Saturday, April 19, 2014

SAMHSA. The Dialogue: Disaster Behavioral Health



 

SAMHSA

 

Volume 10, Issue 2

 

We continue with this year's theme, "Response," by highlighting the work of disaster behavioral health responders. It is our hope that their stories from the field help you in your own planning, response, and recovery efforts.
Special Feature: Working Together in the Field: Traditional and Disaster Behavioral Health Response to the Shooting of Greenland, New Hampshire, Police Chief and Officers
Special Feature: Working Together in the Field: Traditional and Disaster Behavioral Health Response to the Shooting of Greenland, New Hampshire, Police Chief and Officers, an interview with Paul Deignan, M.S.W., Disaster Behavioral Health Consultant/Trainer, and Don McCullough, M.S., CMHC
We summarize an interview conducted with traditional and disaster behavioral health responders where they share their experiences responding to the fatal shooting of a police chief and the wounding of several other officers in a small, close-knit community.
The Work of a Psychiatry Disaster Responder
The Work of a Psychiatry Disaster Responder, by Margaret Tompsett, M.D., Distinguished Life Fellow of the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry
A disaster psychiatrist discusses her experience responding to several large-scale events and the importance of understanding the difference between disaster response and the traditional tasks of one's professional discipline.
West, Texas: Resiliency in Action
West, Texas: Resiliency in Action, by Chance Freeman, Disaster Behavioral Health Services (DBHS) Branch Manager; Jennifer Reid, LMSW, DBHS Response Coordinator; Dana LaFayette, LPC, LP-S, LCDC, Director of Crisis Services, Heart of Texas Region Mental Health and Mental Retardation (MHMR) Center; and Molly Howard, LMSW, Program Manager, Heart of Texas Region MHMR Center
The authors describe the disaster behavioral health response to the fatal fertilizer plant explosion in West, Texas, and share how they worked tirelessly to help survivors and responders.
Recommended Resources
Understanding Compassion Fatigue and Compassion Satisfaction: Tips for Disaster Responders
This podcast can help disaster behavioral health professionals learn about the positive and negative effects of helping disaster survivors.
The Behavioral Health Response to Mass Violence
This podcast discusses the psychological responses to mass violence and suggests strategies and interventions to provide immediate support and mitigate long-term negative mental health consequences.
Post-Disaster Retraumatization: Risk and Protective Factors
This podcast describes the concepts and signs of retraumatization and associated risk and protective factors and highlights promising treatment strategies and tips for avoiding retraumatization.
 

About The Dialogue
The Dialogue, a quarterly technical assistance journal, is an arena for professionals in the disaster behavioral health field to share information, resources, trends, solutions to problems, and accomplishments. Read previous issues of The Dialogue.

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