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Alzheimer's Research Uses Innovative Clinical Design, Precision Medicine Tools

September 5, 2018

Recent research has raised hopes that new drugs can help slow or reverse the symptoms of Alzheimer's disease. While promising breakthroughs abound in this arena, what distinguishes the development of one of these drugs, BAN2401, was the clinical trial's "adaptive design." That approach "ensured that when new subjects were recruited, they were more likely to be assigned to arms of the trial that showed the greatest promise," according to the Los Angeles Times. Advocates for adaptive design note it can make clinical trials more flexible, efficient and ethical because it makes effective treatments more readily available to patients. Critics are concerned that such adaptation opens the door to biased studies. To read a recent symposium on challenges to the conduct of high-quality laboratory research, click here. The other promising drug, Anavex 2-73, was developed using precision medicine approaches. "Researchers [focused on studying a small group of] Alzheimer’s patients who bear a few 'actionable genetic variants.'" These variants were identified by genomic sequencing intended to find participants most likely to have a positive response to the drugs. On Nov. 29, the Consortium is co-sponsoring a free, public conference and webcast, "Law, Genomic Medicine & Health Equity" that will discuss some of the implications of precision medicine for traditionally underserved populations; co-sponsors are the Meharry-Vanderbilt Alliance, Vanderbilt Health, and the Minnesota Precision Medicine Collaborative. The event will be held at Meharry Medical College in Nashville, TN; to learn more and register, click here

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2018 Precision Medicine Conference Will Address Pharmacogenomics

May 31, 2018

On June 22, 2018, the Institute of Personalized Medicine will present its annual conference on precision medicine, "Pharmacogenomics: Genomic Testing to Individualize Drug Therapy." Pharmacogenomics (PGx) is the science of how an individual's genetic background impacts response to medications. This event will provide education on a range of topics including cancer somatic mutations and selection of targeted therapies, emerging PGx areas such as analgesics and how to apply PGx in minority populations, clinical PGx guidelines, use of PGx in children, implementation of PGx in practice settings, insurance reimbursement, evidence for cost effectiveness and improved quality of care. Sessions begin at 8 am at McNamara Alumni Center; to learn more and register, click here

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Ramanan Laxminarayan

Global Antibiotic Use Rises, Fueled by Economic Growth

April 2, 2018

A large-scale international study has found that the use of antibiotics is increasing around the world, largely driven by improving living standards in low- and middle-income countries (LMIC). An article from the Center for Infectious Disease Research and Policy (CIDRAP), a Consortium member, describes the paper published in the Proceedings of the National Academy of Sciences, which shows that overall global antibiotic use "rose by 65% from 2000 through 2015, while the antibiotic consumption rate increased by 39%. Over that period, antibiotic consumption in LMICs more than doubled, with some LMICs having consumption rates that surpassed those of high-income countries (HICs). The increase was correlated with growth in per capita gross domestic product." One of the authors of the study is Ramanan Laxminarayan of the Center for Disease Dynamics, Economics and Policy (CDDEP), who was scheduled to be the third speaker in our lecture series on Antibiotic Resistance: Policy Challenges & Solutions; that talk was canceled because of extreme weather. A recent CIDRAP-sponsored webinar by Prof. Laxminarayan, "What Can the United Nations Do about Antimicrobial Resistance," is available for viewing here

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H. Morgan Scott

Video Available for Lecture on Agricultural Use of Antimicrobials

March 13, 2018

A lecture delivered on Feb. 28 by H. Morgan Scott, DVM, PhD, is now available for viewing via the Consortium's YouTube channel. In his talk, Prof. Scott discussed antimicrobial stewardship in the production of food animals. An article published by the Center for Infectious Disease Research and Policy (CIDRAP), a lecture co-sponsor and Consortium member, describes Scott's proposal of "an ethical framework for defining judicious use of antibiotics in animals." Last November, the World Health Organization (WHO) called for a major reduction in the use of medically important antimicrobials in food animals; according to Scott, that is "where things start to get a little tricky," since it indicates a pullback from preventive practices. Prof. Scott provided a nuanced consideration of the values shared by both sides in this contentious debate — for instance, both agree that "antibiotics enhance the health and well-being of animals and humans, that there is overuse and misuse of antibiotics in animals and humans, and that protecting the efficacy of antibiotics for future generations is a good thing." Scott was joined by Jeff Bender and Tim Johnson of the University of Minnesota College of Veterinary Medicine. In addition to CIDRAP, this lecture was co-sponsored by the Microbiota Theraputics Program. The next lecture in the series will be held on April 3, 2018 and will feature Ramanan Laxminarayan, PhD, MPH of the Center for Disease Dynamics, Economics & Policy (CDDEP) and the Princeton Environmental Institute. He will discuss policies that can increase global access to effective antimicrobials.

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CSH Will Lead $14M NIH Study of Non-drug Treatments for Low Back Pain

September 21, 2017

The Earl E. Bakken Center for Spirituality & Healing (CSH), a Consortium member, has been awarded the first phase of an $11.2 million grant from the National Institutes of Health (NIH) to study non-drug approaches to chronic low back pain, which could lead to reduced opioid use. Funding will support a Clinical Coordinating Center at the University of Minnesota and the University of Pittsburgh for a national multi-site clinical trial examining the effectiveness of spinal manipulation therapies (SMT) and supported self-management (SSM) compared to usual medical care. An additional $2.8 million was allocated for a Data Coordinating Center (DCC) at the University of Washington. “Identifying effective management and prevention strategies for back pain is a huge challenge,” said lead investigator Gert Bronfort, DC, PhD. “By examining promising, safe and accessible non-drug treatments . . . we hope to prevent acute low back pain from becoming chronic and to reduce over-reliance on medications and unnecessary surgeries.” According to the World Health Organization, low back pain is the leading cause of disability worldwide. One study of back patients in the Journal of the American Board of Family Medicine found more than half of the patients used opioids to treat pain.

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New Study Shows Trace Amounts of Drugs May Harm Fish

January 12, 2017

"Trace levels of pharmaceuticals and other chemicals may be harming fish in Minnesota rivers and lakes, according to a study released Thursday by the Minnesota Pollution Control Agency (MPCA)," reports Minnesota Public Radio. The new study confirms that such chemicals as antidepressants, insect repellent and the X-ray contrast agent iopamidol are commonly found in the state's rivers. MPCA lead scientist Mark Ferrey asserts, "Chemicals, even at those concentrations, can cause adverse effects in fish and wildlife that we're really just starting now to be able to understand." New developments in genetics allow scientists to examine the effects of this pollution. Prof. Dalma Martinovic-Weigelt of the University of St. Thomas is doing such a study, exposing fathead minnows to contaminated water and tracking the genetic response. Her research has the goal of pinpointing "what you should be worried about. Because there's so much information about these chemicals and their effect." Her study shows changes in minnow genes related to reproduction, growth and tumor formation among fish exposed to the contaminants. The entire MPR article can be found here

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CMS Head Takes Tough Stance on Rising Drug Prices

November 4, 2016

Last night, Andy Slavitt, Acting Administrator of the Centers for Medicare and Medicaid Services (CMS), addressed the annual Biopharma Congress in Washington, DC. His talk was titled "The Need to Partner on Drug Innovation, Access and Cost." In it, Slavitt addressed what he called "pervasive" cost increases, noting: "Despite all the attention it has generated this year, Mylan’s Epipen is not even on our top 20 list for either high price increases or spending overall in 2015." Rising public outcry and state-level budget crises have led to congressional hearings about the reasons behind spiraling prices; the issue has been especially prominent during the current presidential election. Slavitt cautioned conference attendees, the majority of whom work in the pharmaceutical industry, that he's no longer comfortable defending Big Pharma. He noted that in the past, "I didn’t want this industry to be defined by its worst actors. . . but the more data that’s revealed, the more bad actors you find, and I’m telling you now: it’s too many." What is to be done? According to Modern Healthcare, despite policy positions held by both major-party candidates, significant change is unlikely because of the power of the pharmaceutical industry and ideological divisions in the legislative branch.  

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Prof. Pamala Jacobson

Pamala Jacobson Named Distinguished Pharmacy Professor

October 17, 2016

Consortium collaborator Pamala Jacobson, PharmD, FCCP, has been named a Distinguished Professor under the Pharmacy Scholars program. Prof. Jacobson's appointment grants her the "Distinguished Professor" title and $10,000 a year salary augmentation for a five-year period. The principal criteria for the award are the duration and significance of the person's contributions to the development of his/her discipline, and the impact of the person's scholarly endeavors on a national and international level. Prof. Jacobson is a renowned clinician, scientist, and national leader in clinical pharmacology. In her pharmacogenomics research program, she studies how to effectively use genetic and other biomarkers to improve drug efficacy and reduce toxicity. She has been a leader in the emerging field of precision medicine, serving as director of the University's Institute of Personalized Medicine and as one of four Principal Investigators of the Minnesota Precision Medicine Collaborative (MPMC), along with Consortium Chair Susan M. Wolf, JD; Ellen Demerath, PhD; and Kingshuk Sinha, PhD. You can view video of her commentary on Rex Chisholm's 2015 lecture, "Integrating Electronic Health Records and Genomics for Discovery and Implementation: The eMERGE Experience," which was sponsored by the Consortium, here

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Consortium Chair, 3 Colleagues Awarded Grand Challenges Research Grant

September 29, 2016

Consortium Chair Susan Wolf and three Co-Investigators – Profs. Pamala JacobsonKingshuk Sinha, and Ellen Demerath – on behalf of the Working Group on Advancing Health Through Tailored Solutions, have been awarded a Grand Challenges grant from the Office of the Provost to establish the Minnesota Precision Medicine Collaborative (MPMC). This 2-year, $500,000 grant will fund creation of a transformative University-wide initiative to use 21st century technologies – including genomics, informatics, bioengineering, analysis of environmental exposures, and behavioral sciences – to tailor health care to the challenges facing individuals and their communities. This precision medicine approach will fundamentally alter our understanding of health, disease prevention, and treatment. Core to this project is partnering with citizens, patients, and healthcare providers to understand and effectively address major health problems. MPMC will create a living laboratory, starting with demonstration projects on Alzheimer’s disease, lung cancer, and depression. All three are diseases whose incidence, burden, and mortality rates reveal disturbing health disparities. This focus will enable us to leverage U of M research strengths across many disciplines and to engage with partners in the health industry and Minnesota’s underserved communities. By investing in the development and delivery of precision medicine, our university will contribute to the national effort to transform science, medicine, and public health through more precise understanding of the factors contributing to health and disease. MPMC aims to make a unique contribution through collaborative research, cutting-edge innovation, responsible policy, and sustained commitment to improving health equitably across our communities.    

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UN Tackles Antibiotic Resistance

September 22, 2016

A new declaration by the UN General Assembly is intended to slow the spread of antibiotic-resistant organisms. According to National Public Radio, the resolution "requires countries to come up with a two-year a plan to protect the potency of antibiotics. Countries need to create ways to monitor the use of antibiotics in medicine and agriculture, start curbing that use and begin developing new antibiotics that work." While concerns about "superbugs" are widespread in public health circles, it took data showing the potentially catastrophic economic implications of antibiotic resistance to spur this action. One expert, Ramanan Laxminarayan, is optimistic about the outcomes of this campaign, comparing this effort to a similar one begun by the UN about the HIV pandemic; the article notes, "since 2004, there has been a 45 percent drop in AIDS-related deaths in countries supported by global HIV campaigns."

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Drugmakers Use Legislative Strategies to Weaken Opioid Regulation

September 21, 2016

A new, in-depth investigation by the Center for Public Integrity and the Associated Press details the methods by which pharmaceutical companies and their allies weaken and defeat restrictions on opioid access. According to the article, "Deaths linked to addictive drugs like OxyContin, Vicodin and Percocet had increased more than fourfold since 1999, accounting for more fatal overdoses in 2012 than heroin and cocaine combined." Part one of the two-article series describes "a statehouse playbook of delay and defend that includes funding advocacy groups that use the veneer of independence to fight limits on the drugs," a strategy executed by "an annual average of 1,350 lobbyists in legislative hubs from 2006 through 2015." Part two focuses on similar efforts at the federal level, outlining how drug lobbies "reinforced their influence with more than $140 million doled out to political campaigns. That combined spending on lobbying and campaigns amounts to more than 200 times the $4 million spent during the same period by the handful of groups that work for restrictions on painkillers. Meanwhile, opioid sales reached $9.6 billion last year." The spike in opioid deaths has led President Obama to declare Sept. 18-24 Prescription Opioid and Heroin Epidemic Awareness Week and request $1.1 billion in new funding for treatment programs. 

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New Rules: Researchers Must Publish Results of All Clinical Trials

September 19, 2016

In a step toward greater transparency, the US Department of Health and Human Services (HHS) has announced that, going forward, researchers funded by the National Institutes of Health (NIH) must report the design and results of all clinical trials, whether successful or not. An article in Nature describes the new rules, which are designed to reduce the number of clinical trials that aren't reported; a 2013 study found that approximately half the time, trial results aren't published if they have unfavorable results. The article notes, "Under the new rule, trials must be registered on ClinicalTrials.gov within 21 days of enrolling their first patient — researchers can no longer wait for the results of their trails to report their data." For the first time, those who don't adhere to the guidelines can be penalized by having their funding withdrawn. Bioethicist Jennifer Miller of New York University’s Langone Medical Center praises the change, noting "You need a clear law so you can have clear compliance." 

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Irene Bueno gathering sediment from a river in Chile

Consortium Scholar Sheds New Light on Fish Farms’ Role in Antibiotic Resistance

September 12, 2016

In 2015, Irene Bueno was awarded a Consortium Research Grant to study aquaculture in southern Chile. Dr. Bueno is a doctor of veterinary medicine who is now pursuing her PhD at the College of Veterinary Medicine at the University of Minnesota, focusing on ecosystem health and emerging problems within the human-wildlife interface. Aquaculture is a major economic activity in Chile, and has been increasingly criticized for the extensive use of antibiotics. Dr. Bueno’s Consortium-funded research illuminates the mechanisms by which antibiotic resistant bacteria (and associated genes) are released from freshwater fish farms into the aquatic ecosystem. An interdisciplinary team led by Dr. Bueno and her advisers, Drs. Randy Singer and Dominic Travis, collaborated with Chilean researchers and governmental officials to sample and analyze antibiotic resistant bacteria in river sediment, wastewater, and to understand the antibiotic use at the farms. Among the project’s outcomes is the development of a model that can be used to assess interventions that mitigate the dissemination of antibiotic resistance from the fish farms into the watershed. Regarding her research, Dr. Bueno notes, “Characterizing the way antibiotic resistant bacteria spreads through this watershed from sources such as fish farms, will help inform decisions related to waste management at the local level. On a broader scale, the data generated will contribute to advancing our knowledge of how antibiotic resistance is disseminated, bringing us a step closer to understanding the potential health consequences for humans, animals, and the ecosystem.” To learn more about our annual Consortium Research Awards, click here

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Cancer Moonshot Announces Next Steps for Transformative Research

September 8, 2016

In his 2016 State of the Union address, President Barack Obama announced the Cancer Moonshot, an intensive research collaborative to accelerate immunotherapy as an effective treatment for cancer patients. Led by Vice President Joe Biden, doctors, patients, researchers, pharmaceutical companies, insurance companies, and technologists are striving to managing cancer as a chronic condition, like diabetes, rather than a devastating and life-threatening illness. Last June, Consortium member center Masonic Cancer Center hosted a local event that was part of the national launch of the Moonshot, which featured remarks by VP Biden and US Senators Amy Klobuchar and Al Franken. Yesterday, a Blue Ribbon Panel released its roadmap for the effort, recommending 10 transformative research approaches for achieving major strides in cancer prevention, diagnosis and treatment by 2020. The report can be read here.

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Feud Over Parkinson's Drug Trial Reveals Power of Gatekeepers

August 31, 2016

A dispute between Dr. Charbel Moussa, a scientist at Georgetown University, and the Michael J. Fox Foundation (MJFF) has exposed some challenges of conducting independent drug research in collaboration with a major advocacy group. An article in STAT outlines the conflict, noting that the MJFF-funded Phase 2 trial based on Moussa's previous research "was supposed to begin in October, but Fox and the Georgetown team had a bitter falling out, and it’s unclear whether Georgetown will be able to obtain the medicine from its manufacturer so that the study can proceed. [MJFF], meanwhile, is moving forward on its own, and has established a separate group to study the same drug." The article provides a glimpse into unusually public discord within the world of high-stakes research. In a statement, MJFF states the conflict with Dr. Moussa and his team is a result of differences of opinion regarding the design and execution of the study, citing "the limitations of open-label clinical trials in Parkinson's, which have been shown to be disproportionately affected by placebo response." Leigh Turner, a professor at Consortium member the Center for Bioethics, is quoted in the STAT article, saying funders and journal editors should "be above reproach in their handling of insider information. [Turner cautions] 'You have these gatekeeper moments, where it is possible to take advantage of positions like that, to gobble up as much information as possible, and repurpose it for your own advantage.'"

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A Brief History of TV Drug Ads

August 30, 2016

Direct-to-consumer drug ads have been legal in the US since 1985, but according to the World Health Organization, they really "took off in 1997 when the Food and Drug Administration (FDA) eased up on a rule obliging companies to offer a detailed list of side-effects in their infomercials." A new, short video on Vox.com provides a history of these ads and the regulatory and legal decisions that allow them. Those include the landmark 1976 Supreme Court ruling in Virginia State Pharmacy Board v. Virginia Citizens Consumer Council, which for the first time held that "commercial speech" is protected by the First Amendment. The video shows some of the earliest TV drug ads and outlines empirical research about their effects. The upshot? As annoying and ubiquitous as they are, these ads aren't necessarily bad for us – and in some cases they actually help. View the video here

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