Duke Hosts the Annual Universities Allied for Essential Medicines Conference

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November 11, 2014

More than 200 students traveled from Brazil, Nepal, China, and many other countries to gather at Duke University for the 2014 Universities Allied for Essential Medicines (UAEM) conference organized by the Duke undergraduate chapter of UAEM. Throughout the two-day conference, students in fields ranging from economics to public health to law discussed the many issues related to securing access to medicine by all people, regardless of their location in the world.

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Anthony So, DGHI faculty member and director of Duke’s Program on Global Health and Technology Access, opened the conference, urging students to hold universities accountable for their influence on the pharmaceutical supply chain and to be strategic in how the knowledge their research generates becomes translated into affordable treatments to those in need.

“Access to medicine is a fundamental cornerstone to policy work in global health,” said So. “UAEM has served as a powerful voice in ensuring how research discoveries in university labs become translated into affordable products available to those in need. It was inspiring to see students from all over coming together to pave the way forward for tackling these issues.”

He also highlighted the work of Josh Sommer, a Duke undergraduate student who went on to establish the Chordoma Foundation, and by age 24, became on of Forbes 30 under 30 for his breakthrough efforts to catalzye how drugs are brought to market for neglected and rare diseases.

Beyond the numerous panel discussions and breakout sessions, Anand Grover, Former UN Special Rapporteur and Director and Co-founder of Lawyers Collective, and Marine Buizzonière, Director of Open Society Public Health Program, further encouraged students to hold key players accountable for their actions and apply pressure on the United States government, as the U.S. is in a unique position to stimulate change. Members of leading non-governmental organizations such as Jamie Love, Director of Knowledge Ecology International, Peter Maybarduk, Director of Public Citizen, and Kimberely Bonner, Research Associate with Médecins Sans Frontières (MSF) Access Campaign engaged the students throughout the weekend and instigated in-depth conversations about the role that NGO’s play on the pharmaceutical supply chain.

Since UAEM was established by a group of Yale University law students and Mèdecins Sans Frontières in 2001, it has expanded into a worldwide student organization representing over 40 universities and 18 countries. The organization believes that universities and publicly funded research institutions can be part of the solution to the problem of access; the collaboration of UAEM students and other organizations not only creates awareness of these issues but also pushes for change at the policy level, which directly impacts the priorities of policy-making entities.

Throughout their international efforts, UAEM aims to promote access to medicines and medical innovations in low- and middle-income countries, ensure that university medical research meets the needs of people worldwide, and empower students to respond to the access and innovation crisis. To learn more about UAEM’s current proposals and how you can get involved, visit their website today.

(article from http://globalhealth.duke.edu/media/news/duke-hosts-annual-universities-allied-essential-medicines-conference)

Call for Applications: 2015 Global Health Fellows

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Summer 2015 Global Health Fellows Program
Geneva, Switzerland

See Program Brochure:
2015 Global Health Fellows Brochure

We are now accepting applications for the summer 2015 Global Health Fellows Program in Geneva, Switzerland.

Overview:
The Global Health Fellows program is designed to equip students to join in the fight against HIV/AIDS, tuberculosis, malaria, and other pressing health challenges. The Program will provide students with both an academic and experiential perspective on how intergovernmental institutions, public-private partnerships, and non-governmental organizations shape global health policy. By combining internships and an intensive course on global health issues, the program is an unique opportunity to learn first-hand how global health policy is formulated and implemented. In the past, students have interned at a wide range of NGOs and intergovernmental organizations, including UNAIDS, the Special Programme for Research and Training in Tropical Diseases, UNHCR, the Global Alliance for Vaccines and Immunizations, and various offices of the World Health Organization, from the Department for Prevention of Noncommunicable Diseases to the Department of Public Health, Innovation and Intellectual Property.

What:
The summer program includes:
· An Internship in Global Health Policy of 8-12 weeks in Geneva, including an intensive, one-week course, titled “Health Policy in a Globalizing World” and
· Opportunities throughout the summer to network and socialize with other policy interns and experts in global health

The Global Health Fellows Program offers students assistance in matching to internships in Geneva-based institutions, the opportunity to learn directly from experts working to resolve some of the world’s most significant challenges in global health, and a community of fellow students from around the world.

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Who:
The Global Health Fellows program is directed by Dr. Anthony So, Director of the Program on Global Health and Technology Access at Duke University. Past program participants include students drawn nationally and abroad, from all disciplines, including law, medicine, public health, public policy, international affairs, business, environmental studies, and other graduate or professional students interested in improving global health equity through policy.

The Global Health Fellows Program is part of the Program on Global Policy and Governance. The Program is sponsored by Duke’s Sanford School of Public Policy and co-sponsored by Duke’s Global Health Institute.

When:
Typically internships take place between May and August of each summer. The course will take place in early July. There is flexibility on the start and end dates for individual students, but attendance for the course week is mandatory.

Want more Information?
Please see the accompanying brochure and visit our website for more details. Applications are due November 24, 2014 by 11:59 pm ET and require two letters of recommendation.

For questions, please contact geneva@duke.edu or 919-613-9289.

***Join us for an information webinar on Friday, October 17th at 12 pm ET. Please RSVP to Maggie Woods if you wish to attend.

Migrant Children and Health Initiative Launched

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Recently, the program partnered with groups nationwide to advocate for increased attention to and protections for migrant health. The website migrantchildrenhealth.com was launched to help spearhead the project.

Fact sheet giving an overview of situation:
Migrant Children and Health Fact Sheet

A resolution on ‘Addressing Immigrant Discrimination and Health Disparities’ introduced by Michael Rodriguez, MD, MPH and Viviana Martinez-Bianchi, MD, FAAFP and Jay W. Lee, MD, MPH, FAAFP was adopted by American Academy of Family Physicians at its annual Congress of Delegates meeting. The American Academy of Family Physicians resolution resolved that,

AAFP urge federal and state government agencies to ensure routine, evidence-based health care screening, access and treatment for newly immigrated populations; and be it further AAFP commit to stand against scaremongering, profiling and other discriminatory practices, and/or messaging that denigrates and/or depicts immigrant populations in such a light that leads towards marginalization as it relates to human rights and healthcare such as inaccurate accusations that immigrants pose major threats to public health; and be it further AAFP support policies to reduce health disparities borne by immigrants, refugees or asylees.

The American Medical Association (AMA) Resident & Fellow Section recently drafted a resolution to incorporate policies for addressing immigrant health disparities. The resolution urges U.S. federal and state agencies to ensure routine medical care access to immigrant populations, and calls for public awareness and prevention of stigma, profiling, and inaccurate accusations targeted towards immigrants in relation to their health status.

At WTO, Experts Discuss Solutions To Drugs Innovation Crisis; IP Not In The List

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03/10/2014 by Catherine Saez, Intellectual Property Watch

http://www.ip-watch.org/2014/10/03/at-wto-experts-discuss-solutions-to-drugs-innovation-crisis-ip-not-in-the-list/

The Universities Allied for Essential Medicines (UAEM) organised a panel at the World Trade Organization Public Forum this week on new approaches in university management of intellectual property. The panel gathered a diverse panel of experts giving their take on possible solutions to less innovation and higher prices of drugs, and the role of publicly-funded research.

The WTO Public Forum is taking place from 1-3 October (IPW, WTO, 2 October 2014).
Panellists at UAEM event

UAEM-WTO-PF-2-Catherine-Saez
Panelists at UAEM event

Anthony So, director of the Program on Global Health and Technology Access at the Duke University Sanford School of Public Policy, said research and development (R&D) productivity in the pharmaceutical sector has been declining, despite growing inputs.

At the same time, he said, prices of new drugs have been “alarmingly” rising. He illustrated the fact by saying that 11 of the 12 cancer drugs approved in 2012 were priced over US$100,000 per patient per year. According to So, among the top 100 drugs in the US, “the median revenue per patient rose from US$1,258 in 2010 to US$9,396 in 2014.”

Publicly-funded research institutions have long been a large contributor to innovative drugs, he said, for example to “virtually all the important innovative vaccines” that have been introduced over the past 25 years.

On the lack of availability of “priority patents,” he said that some years ago the Malaria Vaccine Initiative had a project to pull together key patents to bring a new malaria vaccine to market. The patent landscape for malaria showed 167 patent families, held by 75 different organisations. Although the Initiative narrowed its search to 39 priority patents, by the time the patent landscape was conducted, nearly half of those priority patents were no longer available for licensing, he said. Many of these patents, he added, were originally held by publicly-funded research organisations.

De-linking the cost of R&D and the price of health products is a key concept, said So. Ways of making de-linkage possible include pull mechanisms, such as advance purchase commitments and prizes. Push mechanisms, such as research grants, might also be used so that universities play a strategic role in de-linkage, he said.

Robert Don, discovery and preclinical director for the Drugs for Neglected Diseases initiative (DNDi), said the organisation was created in 2003, and in the following 10 years delivered six new treatments, and is planning to deliver 11 to 13 more by 2018.

DNDi’s founding partners include MSF, the Indian Council for Medical Research, Kenya Medical Research Institute, and the Oswaldo Cruz Foundation in Brazil.

Don presented the case of ASAQ (he put it in caps in slide) a fixed dose combination of artesunate and amodiaquine for treating malaria. The drug was developed by DNDi with public funds, and the non-patented product was licensed to Sanofi, after the World Health Organization prequalification in 2008 (IPW, Public Health, 14 April 2008).

Government Perspective

Marcela Paiva Veliz, counsellor at the Permanent Mission of Chile, said from a practical health perspective, a number of different stakeholders are important in the process, such as the private sector, universities, patients, and civil society.

Completely dissociating R&D and prices might be difficult at this stage in terms of public policy, she said, but Chile is ready to explore this matter further. Access to essential medicines is “more or less covered” through public and private funding in Chile, she said.

On the international scene, the delegate underlined two initiatives: the Medicines Patent Pool, which she said was an interesting new initiative, supported by Chile which was looking forward to MPP moving to other diseases. The MPP currently covers HIV AIDS medicines.

She also cited the PAHO (Pan American Health Organization) Revolving Fund for Vaccine Procurement. She underlined the necessity to have a balanced approach to international regulation and the use of trade flexibilities.

Current IP Paradigm Obstructs Scientific Progress Says UAEM

Lukas Fendel, executive director of UAEM Europe, said UAEM is a group of international students, young researchers, and emerging global health leaders who believe that universities are “uniquely positioned to make a difference in the global R&D crisis.”

“We are currently stuck with an innovation infrastructure that attempts to incentivise R&D mainly by granting IP rights,” he said, which results in an innovation crisis. “There is a misalignment of R&D with the actual health needs of big populations,” he added, particularly relevant to neglected diseases.

The innovation issue runs parallel to the access issue, said Fendel. Drugs are priced out of reach for the population of low and middle-income countries for infectious diseases but also chronic diseases.

“IP-centred innovation eco-systems obstruct scientific progress and innovation,” according to Fendel. The patent landscape gets ever more complex and expensive to navigate, which leads to duplication of efforts among scientists, researchers, industry and the public sector, and results in corporate secrecy, strategic patenting and patent thickets.

University and public research institutions are well positioned to address the access and innovation crisis, he said, as they are “truly innovation hubs” and have a mission to promote public welfare through creation and dissemination of knowledge. They “should strive to establish a new campus drug culture, and should be active stewards of knowledge creation and dissemination in the public interest,” he said. In particular, this should be through the creation of internal policies for global access licensing and other socially responsible licensing mechanisms.

Universities should also “fervently” support open source drug discovery mechanisms, he said, and take part in existing ones. They “should teach critical approaches in economics rather than indoctrinate students with the neo-liberal consensus on how IP should be managed and treated.”

During the Q&A session, So remarked that universities sometimes hold fast to their IP “as the last piece of gold” due to the “lottery ticket” effect created by the current innovation system. Some 30 years after the Bayh-Dole Act, he said, less than 5 percent of research revenue comes from licensing revenues in the United States, he said.

Open Source Dividend as a Solution

James Love, director of Knowledge Ecology International, advocated openness in upstream research. Society does not reward the sharing of information, he said, and provides incentives through patents and trade secret to make research closed.

An open source dividend is a proposal to fix that problem, said Love. He explained that companies selling registered drugs would have to set aside a small percentage of the sale price into a fund to pay for the open source dividend.

Taking as example a drug from Roche with sales of US$500 million per month, one percent of the sales would represent US$ 60 million a year.

Then when a product is put into the market, a jury of experts would be appointed to examine evidence determining what type of research was used by the company to develop this product, such as academic papers, databases and open libraries.

The impact would be a new financial incentive to open source medical research and would encourage third party use, allowing greater access to knowledge data, materials and technology. There would be fewer patent thickets, and it would be less expensive to acquire rights to use knowledge data, materials and technology, Love said.

Other solutions include expanding access to government funded research, and placing research paper in open archives, he said.

Image Credits: Catherine Saez

“At WTO, Experts Discuss Solutions To Drugs Innovation Crisis; IP Not In The List” by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

United States Takes Actions to Tackle Antibiotic Resistance

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On September 18, 2014, the White House announced four different actions aimed to tackle antibiotic resistance: an Executive Orders signed by President Obama, a National Strategy, President’s Council of Advisors on Science and Technology (PCAST) report on Combating Antibiotic Resistance and $20 million prize for rapid point-of-care diagnostics.

Dr. Anthony So, director of the Program on Global Health and Technology Access, served as a member of the PCAST Antibiotic Resistance Working Group and provided advisory input to the PCAST report. The PCAST report includes recommendations to appoint a White House Director for National Antibiotic Resistance Policy, tasked with ensuring inter-agency collaboration and accountability among federal agencies, as well as establishment of the Interagency Task Force and Presidential Advisory Council.  Establishing such strong federal coordination and leadership is required to tackle the rising antibiotic resistance crisis.

It’s encouraging to see the Obama Administration taking action and showing leadership to address the global public health challenge of antibiotic resistance. We are especially pleased that the PCAST report calls for White House-level coordination and innovative approaches to financing new diagnostics and drugs, from prizes for diagnostics to delinkage mechanisms. Delinkage–which refers to approaches that divorce a drug company’s return on investment from volume-based sales of the antibiotic–might be particularly useful in helping to realign economic incentives.” said Dr. So.

The four actions are summarized below:

1. The Executive Order signed by the President Obama provides the following directives:

  • Establishment of a new Task Force for Combating Antibiotic-Resistant Bacteria charged with submitting a National Action Plan to the President by February 15, 2015 to implement the National Strategy and address the recommendations made by the PCAST.
  • Establishment of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria composed of leading non-governmental experts.

2. The National Strategy provides details on actions for five goals to be achieved by 2020 in collaboration with partners from academic, public and private sectors involved in healthcare, public health, veterinary medicine, agriculture and food safety. The broad-ranging goals are to prevent the spread of resistant bacteria, strengthen national surveillance, accelerate research and development of diagnostics, vaccines and therapeutics, and improve international collaboration.

3. The PCAST Report on ‘Combating Antibiotic Resistance’  was developed in consultation with a working group of public and private sector experts spanning the human and veterinary health sectors. The report outlines a broad ranging set of actions for the US government to bring the antibiotic-resistance crisis under control.

The Executive Order signed by President Obama has not yet implemented all of the recommendations made by PCAST such as:

  • Doubling annual funding by United States to tackle antibiotic resistance from $450 million to $900 million;
  • Establishing a position for White House Director for National Antibiotic Resistance Policy (DNARP) to ensure inter-agency cooperation and accountability;
  • Establishing a national capability for pathogen surveillance based on genome analysis; or
  • Creating an Antibiotic Incentive Fund that would allow the Biomedical Advanced Research and Development Authority (BARDA) to provide financial and technical support to industry for development of new antibiotics.

4. Prize for Rapid, Point-of-Care Diagnostic Tests: The White House also announced the launch of a $20 million prize for new rapid point-of-care diagnostics. The National Institutes of Health (NIH) and Biomedical Advanced Research and Development Authority (BARDA) will cosponsor the prize for development of diagnostics to identify highly resistant bacterial infections. HHS will host a public meeting to engage public and private sector stakeholders to layout the parameters of the competition. This prize fund established by the Obama administration is higher than the £10 million Longitude Prize for diagnostics announced by the British Government, but lower than the $25 million prize fund recommended by the PCAST.

 

The full Executive Action, National Strategy, and PCAST Report are attached:

Executive Order — Combating Antibiotic-Resistant Bacteria The White House

National Strategy for Combating Antibiotic Resistance Bacteria

PCAST Report on Combating Antibiotic Resistance

Op-ed: The Meat of the Matter on Antibiotic-Resistant Infections

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Dr. Anthony So, director of Duke’s Program on Global Health & Technology Access, and Dr. David Wallinga, director of Healthy Food Action, co-authored an op-ed highlighting the dangers of overuse of antibiotics in both humans and animals. The op-ed was published in News & Observer, a local North Carolina newspaper timed with the Farm Aid event in Raleigh, North Carolina from September 9-12, 2014. The op-ed calls for limiting the animal use of antibiotics for treating diseases, not for growth promotion, and emphasizes the need for data transparency related to sales and use of antibiotics, in order to hold food producers accountable.

The Meat of the Matter on Antibiotic-Resistant Infections

By Anthony So and David Wallinga

September 12, 2014

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CHUCK LIDDY — 2002 file photo

We soon may be re-entering the medical Dark Ages. That’s no Chicken Little proclamation. In 2011, the World Health Organization warned of a return to a pre-antibiotic era “where common infections will no longer have a cure, and once again, kill unabated.”

Antibiotic-resistant infections already sicken at least 2 million Americans a year, killing over 23,000 of them. That’s far more than AIDS – or Ebola for that matter.

Reducing the huge overuse of antibiotics, both in humans and animals, is key. This overuse accelerates the development of disease-causing bacteria that are resistant to antibiotics. The Centers for Disease Control and Prevention estimates half of human antibiotics used and much of that used in food animals are unnecessary. According to data from the pharmaceutical industry, at least 70 percent of all antimicrobials sold in the U.S. are added to animal feed – typically not for treating sick animals but for promoting growth or substituting for better hygiene and infection control. These include human drugs like tetracycline and erythromycin.

The CDC has noted the strong scientific evidence that the use of antibiotics in these food animals can harm public health by transmitting these superbugs through our food supply to people.

Drastic reductions in antibiotic use on the farm are smart, and doable. Smaller family-run farms have helped create and expand the rapidly growing sector around organic and “wellness” foods, such as meats from animals raised in pastures or without antibiotics or added hormones.

But it hasn’t always been easy. Raleigh hosts Farm Aid this weekend, a benefit concert that for 28 years has focused on the challenges that continue to threaten the existence of family farms in America.

Adding antibiotics routinely to animal feed allowed larger-scale meat operations to avoid, at least in the short-term, the changes in farm practice that deter unnecessary antibiotic use. Since 1999, producers in Denmark – the world’s largest pork exporter – moved away from routinely using antibiotics in feed and instead invested in alternative practices such as better farm hygiene, infection control and vaccines. The result was 50 percent less antibiotic usage per kilogram of meat produced. The industry became both safer and more efficient, and productivity rose. Taking similar steps, the Netherlands decreased antibiotic use in agriculture by nearly 70 percent in less than half a decade.

Some of the biggest food companies in the U.S. are starting to make large-scale change as well. Perdue, the nation’s third-largest poultry producer, announced that it has now cut use of human-approved antibiotics from about 95 percent of its chickens. Retailers like Chipotle and Chick-fil-A are betting their future on meeting what they see as a consumer preference for meat raised without antibiotics.

What’s now needed are major changes in public policy and leadership among elected officials, including in North Carolina. We are home to the world’s first case of an infection resistant to carbapenem antibiotics – one of our last lines of defense against drug-resistant “superbugs.” More to the point, we host the largest swine slaughterhouse in the world – placing us second in the country among pork-producing states.

At the state level, North Carolina policymakers could offer incentives to farmers to use less antibiotics rather than the reverse. A North Carolina tax break on animal antibiotics as well as animal feed cost the state $140 million in 2011. Such a tax exemption clearly promotes rather than dissuades unnecessary antibiotic use.

In Washington, the North Carolina congressional delegation should call on the federal government to limit animal use of antibiotics for treating disease, not for growth promotion or other inappropriate reasons. We also must support farmers in introducing alternatives to antibiotics in animal production.

To hold food producers accountable, data on the sales and use of antibiotics must be transparent and publicly reported. The public deserves better monitoring of emerging drug resistance in our food supply, from farm to fork.

Read more here: http://www.newsobserver.com/2014/09/12/4145468_the-meat-of-the-matter-on-antibiotic.html?rh=1#storylink=cpy

Link to article: http://www.newsobserver.com/2014/09/12/4145468_the-meat-of-the-matter-on-antibiotic.html?rh=1