The Cure that Killed: Outbreak Highlights Drug Mixers’ Lack of Oversight
Stockpiles of drugs usually help alleviate public health crisis, but recently a supply of nearly 18,000 doses of a tainted steroid caused one instead. Adding insult to injury, the outbreak probably stemmed from unscrupulous practices made possible by an inconsistently regulated industry.
So far the U.S. Centers for Disease Control and Prevention estimates the outbreak has infected 247 people in 15 states and caused 19 deaths. It’s possible that the wave of meningitis cases—caused by fungal contamination—might have been avoided if the drug maker had been subject to Food and Drug Administration testing and regulation. Instead, the firm that made the suspect doses, known as a compounding pharmacy, only has to abide by state laws that regulate pharmacists.
“This incident raises serious concerns about the scope of the practice of pharmacy compounding in the United States and the current patchwork of federal and state laws,” a letter from the U.S. House Committee on Energy and Commerce states.
“Compounding pharmacies can serve an important public health function by mixing or altering medications designed to fulfill special needs of individual patients…. In other cases, however, compounders may simply provide a less expensive version of an FDA-approved product without having to adhere to the rigorous manufacturing standards required of FDA-approved versions.”
There’s some indication that the latter tack was being taken by the New England Compounding Center, which made the corrupted steroid, according to a Reuters investigation of how the company conducted business.
Most states allow compounders to create drugs in response to an individual prescription using FDA-approved materials when a commercial version isn’t available. Examples might include customizing a drug based on a patient’s physical characteristics or to avoid an allergic reaction to a binding agent. At times, doctors prefer to compound drugs because they’re less expensive than what’s commercially available.
There are more than 7,500 compounding pharmacies in the United States, according to the Associated Press. Many mix prescriptions on a case-by-case basis for local doctors or hospitals. Reuters, however, obtained NECC e-mails that indicated the company solicited large-scale orders without getting prescriptions or even the names of patients.
“This organization chose to apparently violate the licensing requirements under which they were allowed to operate," Madeleine Biondolillo of the Massachusetts Department of Public Health told Reuters.
The company is also under investigation by the FDA, possibly for manufacturing drugs and illegally importing FDA-regulated products, and could face criminal charges in the outbreak, according to the New York Times.
While the size of the tainted NECC drug lot is alarming and most likely not within the bounds of its licensure, many in the industry say the situation is not at all unheard of.
“Some of these companies are just setting up big manufacturing shops in the guise of traditional compounding and making drugs that are, for the most part, commercially available,” former FDA counsel Sheldon Bradshaw told the Times earlier this month. “Instead of making fake Rolexes, they are making fake drugs.”
While the phenomenon has been exacerbated by widespread commercial drug shortages and problems within in the drug manufacturing industry, there seems to be a lack of understanding by both doctors and patients about where the medication is coming from.
“We ask for the medication, it’s in stock, we use it,” Anders Cohen, chief of neurosurgery and spine surgery at the Brooklyn Hospital Center, told the Times. “I don’t know if it’s coming from A, B or C. This is kind of a wake-up call about where your stuff is coming from.”
Attempts by the FDA to bring compounding pharmacies under its regulatory jurisdiction were shut down by a 2002 U.S. Supreme Court ruling that found a portion of the legislation unconstitutional, according to the Wall Street Journal. That legislation has never been revived, but last week lawmakers vowed to introduce new oversight for compounding pharmacies.
“It is really unfortunate that it takes a crisis to bring this kind of change, but that is often the case,” Deborah Autor, a Food and Drug Administration deputy commissioner, told the Times.
When, in September, families of the victims of a tragic shooting at an Aurora, Colorado, movie theater became frustrated with how a compensation fund was being handled, there was perhaps only one man to call—Kenneth Feinberg. The lawyer and high-profile mediator has long been known for helping victims and victim funds move forward toward some form of resolution.
Now, not even a month later, Feinberg has again worked his magic. He announced Monday that he was able to reach a payment protocol to disperse $5 million left in the Aurora Victim Relief Fund, according to the Denver Post. The agreement mostly compensates the families of those who died or sustained lasting injuries. The remainder will help those with extended hospital stays.
While the quick resolution is a victory for families who felt the fund was misused and that payment wasn’t forthcoming when needed, it was—as usual—a small victory.
“I don't hear a lot of criticism—for one, there's resignation,” Feinberg told the Post. “People generally feel, ‘Well, he's getting the money out the door.’ Is it perfect? Absolutely not. There's not enough money. It's a horrible situation.”
As the level-headed engineer of settlements ranging from 9/11 to the Virginia Tech shootings to the BP oil spill, Feinberg is no stranger to far from perfect. Still, he’s managed to create quite a niche for himself as a special master for compensation cases. With a career spanning from a 1984 Agent Orange settlement to the upcoming case of the Penn State University victims, Feinberg remains unassuming about the skill it takes to try to bring closure for those affected by tremendous losses.
“I think I'm doing what millions of Americans would do if asked,” Feinberg told the Associated Press when he agreed to take on the Aurora case—like many of his cases—pro bono. “I've had experience doing this, so I get the call. This is not rocket science. This is trying to take a limited pot of money, distribute it as soon as you can, as quickly as you can to eligible people in sore need of this money.”
Others are not so understated about Feinberg’s skills, which often result in a high percentage of participants agreeing the settlement terms.
“Ken knows how to look at a complex problem and design a system that tends to the needs of all stakeholders, is efficient and is sensitive also to what the public might think,” Feinberg colleague Robert Bordone, the director of Harvard Law School’s negotiation and mediation clinical program, told the ABA Journal. “He’s a brilliant system designer of the next-level cutting edge for alternative dispute resolution.”
However, Feinberg isn’t everyone's golden child when it comes to mediating disputes. He’s had to slowly find his groove, making some noticeable mistakes along the way—including taking some criticism for harsh treatment of 9/11 victim’s families. And at least one person has wondered if Feinberg himself might be getting too big to fail.
“It seems we’ve moved into a new universe of problematic dispute resolution where people really are unrepresented,” Linda Mullenix, a professor at the University of Texas School of Law who knows and admires Feinberg, posited to the ABA Journal after the BP spill. “All they have is Ken Feinberg saying, ‘This is good for you; come on in and it’s in your best interest.’ As you move from each model to the next, there’s less oversight. Who’s guarding the guardian?”
Regardless of those concerns, it’s in cases like the Aurora shootings that Feinberg really shines—and the key isn’t his legal acumen or even his negotiating skills. According to him, it’s his ability to let people voice their angst and know they were heard.
“When you set up these programs, if you can do it, give every claimant the right to be heard,” he recently told NPR’s Talk of the Nation host Neal Conan. “Let the claimant vent, vent about, ‘Why me, why the loss of my brother, why the loss of my wife or my husband? That opportunity—to express, to disclaim—very, very important to the success of voluntarily signing up for the programs.”
From boardrooms to classrooms to conference rooms, resilience has been a buzz word in the disaster community for some time now. How do we incorporate resilience into disaster planning? How can resilience be measured and communicated? And the always popular mind-pretzel: When we say “resilience” what exactly do we mean?
Now, a new National Academies publication could help move the conversation from talking resilience talk to walking the resilience walk. Disaster Resilience: A National Imperative, lays out six key recommendations for integrating resilience into public and private disaster planning.
Of course, before they could do that, they had tackle defining resilience. The report ultimately labeled resilience as “the ability to prepare and plan for, absorb, recover from, and more successfully adapt to adverse events.”
The report, which aims to create “a more disaster-resilient America by 2030,” proposes ideas such as a national document database for disaster-related data sharing, cooperative risk management strategies, government-supported local and regional resilience coalitions, and the adoption of federal resilience policies and programs.
“This vision of the future requires a new national culture of disaster resilience in which everyone takes responsibility for resilience to both natural and human-induced disasters. All communities and levels of government know their roles and responsibilities in building resilience, and they act on them” states the report summary.
Notably, the report committee recommends that the Department of Homeland Security, as well as other federal, state, and local agencies, develop a National Resilience Scorecard that would measure resilience. While domestic and international organizations have created resilience measures, the United States has no consistent national standard for resilience measurement, making it difficult to collect uniform data. Given the complexity of the concept, the authors encourage a national measurement strategy that incorporates diverse components of resilience but is adaptable across communities.
The United States isn’t the only one noodling resilience lately though. It’s also been on the agenda of the European Union, Japan, and even a coalition of small Pacific islands.
Earlier this month, the European Union released a policy it hopes will increase resilience by encouraging its emergency and development arms to work more closely together, according to OOSKAnews.
According to a European press release, the policy is a game changer, particularly in terms of balancing development assistance and disaster planning.
"This is a substantial shift in mentality and practice: from distributing aid to drought-affected people in order to survive until the next drought to investing in the long-run—building irrigation systems, promoting more resistant crops, helping pastoralists manage their livestock," EU development commissioner Andris Piebalgs told The Guardian.
Resilience is not only a more sustainable approach to disaster planning, it might also be more economically sound.
The EU report found that putting four Euros toward disaster prevention saves an additional four to five Euros in post-disaster aid. An Islamic Relief report released a week before the EU policy had similar findings.
The benefits to resilience-based disaster planning are also being recognized in the Pacific. At a recent meeting on disaster risk management in Japan, a joint report released by Japan and the World Bank highlighted the importance of preventative disaster measures. According to The Japan Times Online, the event also spotlighted personal resilience stories as told by a diverse group of leaders.
Just below the equator, the Pacific Risk Resilience program is underway, reports the Solomon Times. The program targets four island nations—Fiji, Tonga, Vanuatu, and the Solomon Islands—and is designed to integrate risk management and development strategies and strengthen community resilience. It is a joint effort, backed by the UN Development Programme and the Australian Agency for International Development (AusAID).
“On top of the climate change adaptation issues all Pacific countries must face, Vanuatu, Solomon islands, Tonga and Fiji are the four countries most at risk of natural disasters in the Pacific” John Davidson, AusAID Minister-Counsellor Pacific, told the Solomon Times. “Disaster risk management and climate change adaptation share a common focus—building community resilience.”
With a common goal in sight, the disaster community from the United States to the European Union (and everywhere in between), is moving resilience forward from an abstract concept to a set of best practices. These strategies will hopefully save lives, time, and money but only if we actually collect and act on the new resilience data.
“Enhancing the nation's resilience will not be easy, nor will it be cheap,” stated Susan Cutter, chair of the committee that authored the report. “But the urgency is there, and we need to begin the process now in order to build a national ethos that will make the nation safer, stronger, more secure, and more sustainable”—Stacia Sydoriak, Contributing Writer
Call for Presentations
Disaster Resistant University Workshop
Deadline: November 2, 2012
The University of New Orleans Center for Hazards Assessment, Response, and Technology is accepting abstracts of presentations for the 2013 Disaster Resistant University Workshop to be held March 20-22 in New Orleans. Presenters should submit abstracts of 250 words or less describing the presentation and how it relates to this year’s theme of linking mitigation and resilience. Complete guidelines and a required cover sheet are available on the presentation Web page.
Call for Participation
Outdoor Warning System Survey
University of Oklahoma and Indiana University of Pennsylvania
Deadline: November 15, 2012
Drs. Bill Donner and Jerry Brotzge are requesting that emergency personnel working with outdoor warning systems complete a survey to assess the current state of technology and policy regarding warning sirens. The purpose of the survey is to understand regional variability and policy considerations in siren networks nationwide.
Call for Nominations
Board of Directors
International Association of Wildland Fire
Deadline: November 25, 2012
The International Association of Wildland Fire is accepting nominations for its Board of Directors. Terms are for three years and require a minimum time commitment of several hours per month. Candidates should be a member of IAWF and have expertise in wildland fire suppression, prevention, research, equipment, or other related subjects.
Wildland Fire Lessons Learned Center Incident Reviews
When it comes to documenting the lessons learned from wildland fires, this repository has a long memory. With downloadable documents from as far back as 1910, visitors can get a historical perspective on wildfires just as easily as they can pull up a wealth of information on recent events. Convenient search features make it easy to narrow results down to just the ones you want, while those who’ve already learned their lessons can just as easily upload them for others to read.
How Influenza Pandemics Occur
It’s coming up on the season to start battling cold and flu, so what better time to bone up on how disease spreads? This video from the National Institute of Infectious Diseases makes it easy with lots of information about pandemics and how flu mutates. You’ll even learn what the H and N stand for in the dreaded H1N1 virus, so grab some tissues and curl up for three minutes of flu-tastic education.
WWII Fire Safety Propaganda Posters
Fire Prevention Week 2012 is just behind us, but there are entire decades of Prevention Weeks past—and some are immortalized in an awesome collection of World War II posters. Check out these examples of how to keep a nation from forgetting fire safety even while a war wages in the background.
Model Act Governing Standards for the Care and Disposition of Disaster Animals
Disasters such as Hurricane Katrina have driven home how our relationship with animals impacts us before and after disasters. Leaving or losing an animal during an evacuation or disaster can be devastating and reuniting can sometimes be a challenge. That’s why this model act was created to by the American Bar Association to serve as guideline for states to create policies around the disposition of rescued animals. The model set out parameters that require a shelter to hold pets for 30 days—so they can hopefully be reunited with their owners.
Review of the Civil Defence Emergency Management Response to the 22 February Christchurch Earthquake
This review of the emergency response to the Christchurch earthquake found that, overall, emergency personnel, utility companies, and other responders to the quake did well and that policies to direct action where sound. Still, the report has 108 recommendations for making small improvements. Staffing more emergency managers and strengthening local response, giving higher priority to rebuilding jobs after a disaster, and promoting preparedness were among the top six suggestions.
[Below are some recent announcements received by the Natural Hazards Center. For a comprehensive list of upcoming hazards-related meetings, visit our Web site at www.colorado.edu/hazards/resources/conferences.html.]
October 31 to November 2, 2012
FLASH Annual Conference
Federal Alliance for Safe Homes
Lake Buena Vista, Florida
Cost and Registration: $250, open until filled
This conference will form the basis of a new online community devoted to promoting disaster safety with an emphasis on leadership, outreach, partnership, and education. Attendees will hear from multidisciplinary speakers who will apply skills such as social media, advocacy, public relations, and Web design to the work of communication risk and preparedness.
November 12-15, 2012
Southport, United Kingdom
Cost and Registration: $1,237, open until filled
This conference will help energy sector businesses create a culture of safety that weathers the uncertainties of both disasters and normal operations. Topics include learning from incidents, performance indicators and major accidents, emergency spill response, operational risk management, assessing environmental risk on offshore platforms, and the societal risks of hazardous material pipelines.
November 28-29, 2012
Second International Conference on Climate Change and Social Issues
Glasgow Caledonian University and the International Center for Research and Development
Kuala Lumpur, Malaysia
Cost and Registration: $450, open until filled
This conference will address issues related to climate change with an emphasis on the social impacts of warming. Topics include health issues, climate finance, disaster risk reduction, community development, human rights and water, climate technology, and food security.
December 3-5, 2012
Reducing Risks and Building Disaster Resilience
Center for Disaster Risk Management and Development Studies
Cost and Registration: $94, open until filled
This conference will showcase current disaster research, examine ways to build resilience and reduce disaster risk, and raise public awareness about disasters. Topics include community-based risk reduction, vulnerability and capacity building assessments, critical infrastructure, gender and disasters, climate change adaptation, early warning systems, and disaster prevention education.
December 4-6, 2012
2012 AHIMTA Conference
All-Hazards Incident Management Teams Association
Cost and Registration: $325, open until filled
This conference will familiarize attendees with best practices and lessons learned from recent incidents. Topics include the national firefighting mobilization system, incident management and emergency operation centers, coordinating public information, national frameworks, social media, and National Guard Resources. Pre- and post-conference workshops and training sessions are also offered.
January 15-17, 2013
13th National Conference on Science, Policy, and the Environment
National Council for Science and the Environment
Cost and Registration: $395 before October 26, open until filled
This conference will examine the connectedness of six themes in a series of symposia, keynote addresses, plenary sessions, and breakout workshops. Themes include: cascading disasters, the intersection of the built and natural environments, disasters as mechanisms of ecosystem change, rethinking recovery and expanding the vision of mitigation, human behavior and its consequences, and "no regrets" resilience.
Emergency Preparedness Public Information Officer
Bismark Department of Public Health
Bismark, North Dakota
Salary: $45,843 to $51,563
Closing Date: October 23, 2012
This position is responsible for creating materials to increase awareness of emergency preparedness, communicating regional disaster information, and developing communication policies. At least three years of experience or a bachelor’s in communication or a related field, effective speaking skills, and an understanding of media relations are required.
Disaster Recovery Contract Specialist
Massachusetts Emergency Management Agency
Salary: $41,184 to $59,259
Closing Date: October 24, 2012
This position is responsible for assisting during disaster recovery and coordinating applications to the Federal Emergency Management Agency’s Public Assistance Grant program. Duties include coordinating with grant recipients on necessary documentation, providing administrative support to disaster recovery programs, and acting as a liaison between FEMA and grant recipients, when necessary. A degree in business or public administration, two years of experience, and the ability to travel are required.
Emergency Response Specialist
Salary: Not posted
Closing Date: October 28, 2012
This position is responsible for developing emergency response plans and assuring fire protection for the Shell site in Convent, Louisiana. Duties include supervising emergency incidents, coordinating response teams, managing and deploying response equipment, and coordinating emergency training and exercises. A bachelor’s degree in fire science, five years of emergency response leadership experience, and NIMS certifications are required.
Fire Prevention Specialist
City of Newport Beach
Newport Beach, California
Salary: $66,851 to $94,057
Closing Date: October 31, 2012
This position is responsible for supporting the Life Safety Services Division of the Newport Beach Fire Department. Duties include code enforcement, conducting field inspections, and organizing community outreach activities. Knowledge of accepted safety standards, experience interpreting and applying safety codes, and three or more years of experience in fire and life safety are required.
Multnomah County Office of Emergency Management
Salary: $95,000 to $117,000
Closing Date: November 2, 2012
This position leads county staff as they prepare for and respond to disasters and emergencies. Duties include working with complex and highly public issues, creating strategic partnerships, and maintaining a regional approach to emergencies. A bachelor’s degree, four years of experience, and experience with emergency management principles are required. Emergency management certification is preferred.
Assistant Professor of Architectural Engineering
University of Colorado at Boulder
Salary: Not posted
Closing Date: Open until filled
This tenure-track position will serve in the structural engineering group of the Department of Civil, Environmental, and Architectural Engineering. Duties include graduate and undergraduate teaching, complementing existing research in earthquake engineering, and developing funded research programs. A PhD in engineering or a related discipline is required.
Contributions of jobs, conferences, and other content to this newsletter can be sent to firstname.lastname@example.org. Please include “for Disaster Research” in the subject line.To subscribe, visit http://www.colorado.edu/hazards/dr/ or e-mail email@example.com.