Blockchain Papers

Peggy Eastman

In response to growing threats on federal funding for the National Institutes of Health (NIH), Sen. Tammy Baldwin (D-WI) and Sen. Peter Welch (D-VT) held a Senate forum on Capitol Hill with speakers, including researchers and patients. The speakers included surgical oncologist Monica Bertagnolli, MD, former Director of the NIH, former Director of the National Cancer Institute (NCI), and a cancer survivor. She stressed the dire consequences of grant freezes, disruptions in funding, staffing cuts, administrative upheaval, confusion, and a chilling effect on young investigators just beginning their scientific careers. “We are here today to sound the alarm,” Baldwin said. “This isn't efficiency; this is cruelty.” She said that “cures for Alzheimer's disease and cancer are not waste, or fraud, or abuse,” and she noted that “biomedical research can't just be turned on and off on a whim. We have heard heartbreaking stories from patients in clinical trials.” Welch noted, “It's an upside-down set of priorities; the cruelty speaks for itself. It's a lack of confidence in our nation. This is an erosion of our spirit.” Senate Minority Leader Chuck Schumer (D-NY) called cuts for NIH research “just appalling. We are going to fight this tooth and nail. The public is on our side; we must win this fight. People's lives are at stake.” The American Association for Cancer Research (AACR), which worked with Senate organizers on the forum, has reported and is fighting the freezing of new NIH grants and blockages of already approved funding; proposed the capping of indirect costs at 15 percent; canceled NIH advisory council meetings, halting final approval of peer-reviewed grants; the ordering of massive layoffs and the imposition of a hiring freeze at the NIH; and continued termination of active NIH grants despite federal court orders. The AACR is urging Americans to contact their members of Congress and tell them to reject any funding cuts to the NIH and NCI, address the instability caused by recent administrative disruptions, and preserve the progress of scientific research by ensuring that early-career scientists have the stable funding necessary to drive the next wave of medical research breakthroughs. “This is a critical time for our nation...the confusion is rampant,” Bertagnolli said. As a cancer survivor, she noted that she would not be here today without the research funded by the NIH over the past 5 decades. She termed NIH research “a great investment for the American people.” She cited the harm caused by “more than 300 grants terminated and about $1.5 billion in funding delays and barriers that are preventing the NIH's role of ensuring that funding is delivered to outstanding researchers across the nation.” Bertagnolli mentioned the case of a young researcher who trained for 16 years and could not get a job because of hiring freezes. She said this is not an isolated story and the nation is being deprived of the promising work of young investigators. Bertagnolli added there was not a day she was at the NIH that people employed there did not ask how they could make sure they were doing the most cutting-edge research. She noted that NIH research funding is the foundation for the work on which most of the new drugs that reach clinical practice are based. Scientific researchers built bridges that have allowed patients to outpace cancer, including Larry Saltzman, MD, a survivor of chronic lymphocytic leukemia diagnosed in 2010, a retired physician, and former Executive Research Director at the Leukemia & Lymphoma Society. He has been on many clinical trials and received many treatments, including CAR T-cell therapy. “Time is everything,” he said. “I am living proof of what the NIH can do. We must speak up, stand up for science,” and protect the future of medical research. Whitney Wharton, PhD, Associate Professor at Emory University and an Alzheimer's disease researcher, noted she has had two NIH grants terminated recently. She said they have been “devastating” for her research team and the patients participating in clinical trials. Wharton stressed the importance of engendering trust in people who enroll in clinical trials and who willingly donate their time and—in many cases—samples from their bodies. “It takes a long time to become a scientist,” said Wharton, and the current concerns about the stability of a scientific career may cause some young scientists to leave research altogether. Sterling Johnson, PhD, Professor of Medicine and Associate Director of the Wisconsin Alzheimer's Disease Research Center at the University of Wisconsin-Madison, agreed. He noted that Alzheimer's disease appears years, if not decades, before the onset of symptoms, and medical research has led to the development of prescription drugs to slow the progression of the disease. He said that 6.9 million Americans have Alzheimer's disease, a number projected to double by 2050 without scientific research advances. Johnson said that, just at a time when young investigators are urgently needed, growing uncertainty is discouraging early-career scientists from entering the biomedical field. “That is stopping progress,” he said. Jessy Ybarra, a veteran living with amyotrophic lateral sclerosis (ALS) and a board member of the ALS Association, noted that veterans are twice as likely to develop ALS and research is urgently needed to make ALS “a livable disease” until a cure can be found. He played a recording from his 10-year-old son at the Senate forum in which the son pleaded for support for medical research, noting, “I am not ready to say goodbye to my best friend, my dad.” Sen. Elizabeth Warren (D-MA) stated that the NIH is the largest biomedical research institution in the world and investing in it pays off financially, as well as medically. “We cannot afford to lose a generation of scientific breakthroughs and a generation of research scientists,” she stressed. Sen. Edward Markey (D-MA) agreed. “The NIH is really the national institutes of hope,” he said. “I'm going to fight for all those young researchers.” Sen. Dick Durbin (D-IL), Democratic minority whip and longtime senator from Illinois, stressed the urgent need for a bipartisan effort to support medical research, noting that what is lacking now is “support from the other side of the aisle.” He said he remembers a time in the past when the NIH received a strong increase in congressional funding due to cooperative bipartisan support. Sen. Catherine Cortez Masto (D-NV) agreed with Durbin on the need for strong bipartisan support of NIH research. “This is about saving lives,” she said. “It is not a red state or blue state issue. It touches so many of us; that's what this is all about.” Sen. Angela Alsobrooks (D-MD) noted that the NIH is in her state's backyard and “an attack on the NIH is, in fact, an attack on the state of Maryland.” She noted she is a member of the “sandwich generation” who is raising a 19-year-old daughter and caring for a mother who has Alzheimer's disease. For women caregivers like her, she said that breakthroughs from medical research are becoming increasingly important. The AACR has vowed to continue the fight to preserve the NIH as the cornerstone of biomedical research. “The administration's ongoing disruptions of and restrictions on the NIH's ability to work in partnership with the broader scientific community are jeopardizing progress and delaying innovations and treatments that are pivotal to improving patient outcomes and saving lives,” the AACR stated. “The stakes could not be higher. The decisions made today will determine whether we accelerate the fight against cancer or allow critical momentum to be lost.” The AACR's work on the Senate forum is “part of our long-standing commitment to ensuring that policymakers understand what is at stake and that they hear directly from those on the front lines.” Peggy Eastman is a contributing writer.

Maximilian Unfried

In an era marked by scientific stagnation, Decentralized Science (DeSci) challenges the inefficiencies of traditional funding and publishing systems. DeSci employs blockchain technology to address the misalignment of incentives in academic research, emphasizing transparency, rapid funding, and open-source principles. Centralized institutions have been linked to a deceleration of progress, which is acutely felt in the field of longevity science-a critical discipline as aging is the #1 risk factor for most diseases. DeSci proposes a transformative model where decentralized autonomous organizations (DAOs) facilitate community-driven funding, promoting high-risk, high-reward research. DeSci, particularly within longevity research, could catalyze a paradigm shift towards an equitable, efficient, and progressive scientific future.

Adugna Negussie, Abay Sisay, Agumas Shibabaw, Edosa Kebede · 9 authors

No abstract is available for this record.

Authors unavailable

No abstract is available for this record.

Catherine R. Lucey, Karen E. Hauer, Patricia O’Sullivan, Ann Poncelet · 6 authors

Medical Education Program Highlights In 2016, the University of California, San Francisco (UCSF) School of Medicine launched the Bridges Curriculum, developed to ensure that graduates are prepared to tackle the most complex problems of 21st-century patients and communities. The curriculum has an enduring focus on providing evidence-based, compassionate care while leveraging emerging skills in systems science and new methods of discovery. The Bridges Curriculum seeks to instill the 4 UCSF physician habits of mind: inquiry, continuous improvement, adaptive leadership, and social justice. To teach these habits of mind, the curriculum has an inquiry thread focusing on deep exploration into a scholarly area. Each step advances the learner, first to a sophisticated consumer of biomedical science, then to a producer of new knowledge. Continuous improvement skills are instilled through the clinical microsystem clerkship (CMC), a longitudinal clinical skills curriculum integrating skills in direct patient care, health systems improvement, and interprofessional collaboration. The CMC engages students in systems improvement work directly affecting the quality and safety of care. During the core clerkship phase, we offer a series of clinical immersion experiences (CIExes) electives, which provide opportunities for deeper exploration of a specialty or subspecialty. Trained and dedicated faculty “coaches” support students’ progression. The coaching program is designed to provide academic guidance for students and support professional/personal development throughout the curriculum. Curriculum Curriculum description The Bridges Curriculum is a 4-year, 3-phase curriculum: Foundations 1 (F1) is the preclerkship phase, including foundational sciences coursework and early, robust instruction and practice of health systems sciences (CMC). Foundations 2 (F2) starts in December, year 2, with six 8-week blocks for 8 core clerkships and 8 weeks of CIExes. Career launch starts in March of year 3, including a longitudinal ambulatory subinternship, dedicated time for completing scholarly projects, and advanced clinical training preparing students for their chosen career paths. Other curricular characteristics: Early, robust instruction and practice of health systems science (CMC) Incorporation of a dedicated coaching program, integrated with the CMC during the preclerkship phase, embedded in a longitudinal curriculum in assessment, reflection, coaching, and health (ARCH) across all 3 phases Deliberate instruction with dedicated time in concepts and application of inquiry in scientific domains Intentional incorporation of elements of social justice into all curricular aspects, including a planned required rotation demonstrating these principles in the community-engaged context Collaborative integration of foundational science content into clerkships Curriculum changes since 2010 The rollout of the Bridges Curriculum will be complete in May 2020, a significant evolution of our curricular content and pedagogy. Structural changes within the 4-year timeline include: A shortened preclerkship phase (ends December, year 2) Earlier start of clerkship phase (January, year 2) Longitudinal structure of the family and community medicine clerkship Shift in placement of USMLE Step 1 examination to after core clerkships (January, year 3) Earlier start of postclerkship phase (March, year 4) Over the coming year, we will also adjust delivery of foundational science content. Class size changes since 2010 In AY 2019–2020, UCSF became the sponsoring institution for the San Joaquin Valley Program in Medical Education (SJV PRIME), serving central California communities. The class size increased by 6 students for the first academic year’s entering class and will subsequently rise to 12. These students have been incorporated into class structures with minimal change required in structure or function, primarily because their clerkship and postclerkship phases take place at UCSF Fresno, where they had been placed previously for clerkships while managed by a different institution. Assessment Medical education program objectives are based on ACGME domains of competence, with the addition of interprofessional collaboration as a separate domain. See Supplemental Digital Appendix 1—Program Objectives and Assessment Methods——at https://links.lww.com/ACADMED/A959. Assessment changes since 2010 UCSF has implemented programmatic assessment in the F1 phase of the curriculum and is in the process of implementing programmatic assessment in core clerkships, F2. Implementation of programmatic assessment aims to support students’ learning across the curriculum and ensure achievement of expected competence. The assessment system emphasizes students’ development of reflection, learning, and planning skills in close coordination with their coaches throughout the 4-year curriculum. Students and coaches have ready access to performance data in an individual electronic student dashboard containing visual displays of student progress compared with expected benchmarks and class averages. The dashboard includes score reports from summative assessments and students’ reflections and learning goals. In the core clerkships, the school eliminated tiered (honors) grades in January 2019. This decision was made after a multiyear effort to explore and address concerns about accuracy, fairness, and equity of clerkship grades and the impact of grading on students’ learning and well-being. Clerkships are now graded Pass/Fail, with a new requirement for 2 weekly work-based assessments for formative feedback, completed collaboratively by a faculty/resident supervisor working with the student. Parallel curriculum or tracks UCSF has 5 parallel tracks: Joint Medical Program is a 5-year integrated MS–MD program for 16 students who begin their education at UC Berkeley and transfer to the UCSF campus for clerkships and senior year. Program in Medical Education for the Urban Underserved is a 5-year track accepting 12 students annually. Students take a year off to pursue a master’s degree in a field enhancing their leadership ability in the care of vulnerable populations. SJV PRIME is a 4-year track recruiting 12 students from the Central Valley of California committed to addressing health care disparities in this underserved area. Students participate in their preclerkship years at UCSF in San Francisco, then relocate to Fresno to complete clinical studies. The Medical Scientist Training Program is the UCSF MD–PhD program, accepting 12 students yearly into a T32 and institutionally supported combined program. The Oral Maxillofacial Surgery (OMFS) program accepts 4 students with DDS degrees into an integrated MD–OMFS residency program. Pedagogy The core curriculum and 5 parallel tracks use these pedagogical approaches: Case-based learning Clinical experience: ambulatory Clinical experience: inpatient Discussion: large group (> 12) Discussion: small group (≤ 12) Laboratory Lecture Peer teaching Preceptorship Problem-based learning Changes in pedagogy since 2010 Our work since 2010 has been in identifying the balance between instructional strategies and content to best help learners with cognitive integration, particularly in the content-dense, preclerkship phase. Clinical experiences Clinical sites represent the spectrum of communities for which we provide care, including urban and rural, primary and tertiary/quaternary, ambulatory, and inpatient sites. Required longitudinal experiences The Bridges Curriculum has numerous longitudinal experiences: Longitudinal small groups to support learning for each key element in the preclerkship phase Longitudinal delivery of the family and community medicine core clerkship 3 longitudinal integrated clerkships Longitudinal, ambulatory experience during the postclerkship phase (specialty practice ambulatory subinternship) A longitudinal curriculum (ARCH) delivered at key touchpoints across all 3 phases Clinical experience first encounter Students first enter the clinical environment in the third week of the preclerkship phase, during the CMC. This experience starts with a focus on health systems and systems improvement, gradually introducing patient care skills. Required and elective community-based rotations All core clerkship rotations have community-based sites; many clinical electives are also offered at community-based sites. The San Francisco Veterans Affairs Health System is a key affiliate, and over 75% of students rotate there at some point during medical school. Challenges in designing and implementing clinical experiences for medical students The primary limitation on students’ clinical experiences comes from increased demands placed on limited clinical sites by learners from other domestic and international institutions, and across the health care training spectrum. Curricular Governance The faculty committee with primary curricular responsibility is the Committee on Curriculum and Educational Policy (CCEP), a standing committee of, and deriving its authority from, the Council of the Faculty. The CCEP accomplishes its work through a group of subcommittees: an executive committee, subcommittees focused on operations during the 3 phases, Mapping and Integration Committee, and Student Governance Committee. Each committee has LCME standards of primary responsibility and meets monthly. The executive committee is responsible for operational management of and reporting on CQI through reviewing operations reports and program evaluation data. Decentralized curricular governance None of our governance is managed at the department level. Clerkship directors and staff are funded through a centrally managed budget for curriculum leadership. Education Staff The Medical Education Unit oversees the continuum of medical education, under the vice dean for education and associate dean for medical education (ADME). The ADME oversees all staff, including the medical student programs. The structure includes a central office under the chief of staff, which oversees accreditation, financing, staff engagement, affiliations, communications, and overall strategic support. The ADME oversees educational technology, data and analytics services, and simulation and anatomy centers. Medical student programs are organized under the associate deans for admissions, students, curriculum, and assessment. Student services provides daily support for students and career advising. The Assessment, Curriculum, and Evaluation Unit oversees curriculum support and clinical phase coordination. It also supports required scholarly activities (inquiry curriculum), student coaching program, and CQI of the curriculum under the director of program evaluation. Medical education leadership The dean provides overall leadership for the School of Medicine. Reporting to the dean is the executive vice dean and vice dean for education, responsible for the medical education continuum. There are 6 associate deans reporting to the vice dean for education: Associate dean for medical education: Responsible for staff, program development and support, communications, physical space, technology, finance Associate dean for admissions: Responsible for admissions process, student scholarships, financial aid Associate dean for students: Responsible for the medical student experience and assisting students and faculty with issues with student activities, supports, career planning, professional development Associate dean for curriculum: Responsible for the medical student curriculum, including foundational sciences, clinical and systems sciences, the inquiry curriculum, and curriculum governance and CQI Associate dean for competency assessment and professional standards: Responsible for student assessment, including competencies and milestones, and the MSPE; also oversees the coaching program, which provides nonevaluative longitudinal student support Department of Medical Education Medical education staff support the medical education continuum: outreach and postbaccalaureate preparation for medical school, admissions, medical student curriculum, GME, continuous professional development, educational technology, and simulation and anatomy-based instruction. Central staff also support multiple student support services. The Office of Medical Education includes the Center for Faculty Educators (CFE), which houses our Academy of Medical Education (AME), faculty develop programs, and educational research. The center includes faculty directors of the academy and of faculty development and educational research. Faculty Development and Support in Education Professional development for faculty as educators The CFE hosts the AME and an award-winning faculty development program, recipient of an ASPIRE to Excellence Award. Faculty can view online orientation resources for the Bridges Curriculum and coaches receive tailored faculty development. We are initiating workplace-based faculty development through the Learning and Caring Ecosystem program. Faculty can participate in “Teach for UCSF” certificates in general, clinical, simulation, interprofessional, quality improvement and patient safety, and equity and inclusion teaching as well as educational leadership. Education-focused faculty can apply to the longitudinal Teaching Scholars Program and advance to master’s and doctoral degrees in health professions education through external partners. Role of teaching in promotion and tenure Faculty must demonstrate quality teaching. Peer observation of teaching can be submitted as data for promotion and tenure application. Clinical educators must show engagement in creative activity and/or dissemination of educational scholarship and/or substantial educational leadership and can be promoted through the University of California “clinical X” series. Educators can embed a teaching portfolio into their CV. Academy for Medical Educators Since 2000, the AME has supported the educators who carryout and advance UCSF’s education mission through community, diversity, advocacy, service, and innovation. The AME currently has 163 members from medicine, dentistry, nursing, and pharmacy, selected by a rigorous application process. Programs include education grants, endowed chairs (24), teaching awards, quarterly meetings/workshops, an education showcase, teacher observation program, and UCSF-wide initiatives to address diversity/equity/inclusion, wellness, learning climate, and education finance. Regional Medical Campuses Directors of both campuses are ex officio members of the CCEP, which oversees educational programming. See Table 1—Regional Medical Campuses.Table 1: Regional Medical CampusesEducational experiences across sites Directors of each program meet quarterly with main campus associate education deans to review curriculum, assessment, student experience, and progress. Each regional campus submits an annual report to the CCEP demonstrating equivalency in student satisfaction, outcomes, and competency. Memorandums of understanding between main and regional campuses are reevaluated and renewed every 5 years.

Ganesh Rao

It has been my honor to serve as the 69th president of the Congress of Neurological Surgeons. I was humbled and excited by this opportunity to make a difference. In this address, I hope to stimulate a discussion about how we can and should practice, educate, and influence with reason. How as active voices for science and truth we can cultivate an age of reason for neurosurgery, and medicine as a whole. “A long habit of not thinking a thing wrong gives it a superficial appearance of being right.” These words, written by Thomas Paine, in the pamphlet “Common Sense”, which spurred the United States to fight for its independence, underscore the theme of this year's meeting. Paine would go on to pen The Age of Reason and the Rights of Man, which were some of the first examples of free rational inquiry and critical thinking in the United States. Today, we are living in a time of major upheaval with respect to trust in institutions, acceptance of fact, and recognition of expertise. Twenty-four hour news cycles, constant reminders to engage in social media, and a culture that rewards fame for fame's sake have all contributed to our current state of mistaking skepticism and critical thinking with denialism. Equal time is given to spurious viewpoints, which are touted as equivalent to verifiable truths. To be clear, skepticism is no vice. Suspicion of dogma is not, by itself, a crime. However, what has happened worldwide over the past several years has eroded trust in institutions and neurosurgery is no exception. Much of the loss of trust in the rigor of scientific inquiry can be traced to the deluge of information to which we are exposed. The amount of information being generated across the globe is staggering. Some 500 million tweets are sent daily for a total of 200 billion tweets per year. By the year 2020, the entire digital universe is expected to reach 44 zettabytes (that's a 1 followed by 21 zeroes). That is 40 times more bytes than there are stars in the observable universe. The ability to distinguish reputable information from misinformation is a nearly impossible task when information comes at us so quickly. One can appreciate how easily information can be manipulated. Simple things like reviews on websites can no longer be trusted. In fact, research recently published in the journal Science, has shown that on social media, false stories spread 70% faster than true ones. This phenomenon is not due to bots but rather posts by humans. Conspiracies can be easily concocted by unsubstantiated claims. Correlation is often confused with causation. Myth is reported as fact. Celebrity can now overcome a need for proof. The deluge of scientific misinformation parallels the increase in digital content. Medical journals, once a respected repository of rigorous scientific inquiry have become the source of significant misinformation and dubious peer review. InCites Journal Citation Reports now indexes more than 12 500 journals. Not all journals are equal. Even a journal with a good reputation can sometimes get it wrong. Predatory journals, a term coined only a decade ago, are now commonplace and difficult to differentiate from well-respected titles. These journals often charge a significant article processing fee, lack rigorous, if any, peer review, and take advantage of the “publish or perish” paranoia that pervades academic medicine. One might think that the accessibility of data would allow individuals to make rational choices about the information that they consume. However, there is virtually no regulation of this information. Our patients have more access than ever to the medical literature. However, the democratization of information may have actually undermined scientific trust and understanding. As neurosurgeons, we can differentiate high quality journals from low-quality ones but the public probably cannot tell the difference. Patients now arrive to our clinics armed with misinformation in the form of alternative therapies including potentially harmful supplements or ineffective treatments. This is all creating a situation we would never have imagined 20 yr ago—before the rise of the internet. And it is a sensitive issue—at a time when we are encouraged, and appropriately so, to engage more with our patients and to listen and involve them, this admirable goal has gone awry. Now our first burden is to teach them how to trust the experts, trust us, again. We must be prepared to help our patients differentiate the truth from hype. To reassure them that the treatments we use are based on the best available medical evidence, and why evidence is essential. “I have always strenuously supported the right of every man to his own opinion, however different that opinion might be to mine. He who denies to another this right, makes a slave of himself to his present opinion, because he precludes himself the right of changing it.” Paine wrote that we are entitled to our own opinions, no matter how different yours may be to mine, but we should all retain the right to change it. And we should, if persuaded by solid evidence. As physicians, we are not immune to the pitfall of holding rigidly to our biases. As science changes our practices we are often slow to adapt. Physicians in general continue to practice medicine that is contrary to the evidence. Each year JAMA publishes an update on medical overuse. How many times do you see gabapentin and its derivatives prescribed for sciatica? How about those 2 million-dollar robots your hospital is buying for kidney surgery? It turns out the evidence for their efficacy is very thin. Although neurosurgery is not immune to these hazards, to our credit, we have taken on trials of procedures that have eventually narrowed their scope of use. When a treatment shows promise, we have done the studies to verify their worth. But there may always be grey areas particularly when it comes to certain procedures. “But it is necessary to the happiness of man that he be mentally faithful to himself.” Has our judgment been clouded on occasion by economic incentives? Perhaps but we also get some things right including adopting technology knowing that the benefit will be there for our patients. Above all, when the challenge is adopting new ways of helping patients, it is incumbent on us to perform the appropriate studies when results look promising. No one else can validate or reject—that is a critical part of our responsibility as surgeons. An example from the neuro-oncology world is the EGFR variant 3 vaccine for the treatment of glioblastoma. Compared to historical controls, the vaccine showed tremendous promise but in a randomized controlled trial, it did not hold up. Neither did bevacizumab which also showed promise in Phase II trials but failed in phase III. What if we hadn’t conducted these important randomized trials? How many patients would have been exposed to harmful and useless treatments? Without firm evidence for their use, procedures and treatments can be sold and promoted to an unsuspecting public who can be swindled, or worse, harmed. When this happens, even procedures that may benefit our patients can get caught up in the fray. We need only look to the lay press to see how our profession can be sullied in ways that may seem unfair to us. Poorly investigated procedures and technology can harm our entire profession. What do we do when this misinformation reaches our patients? And they believe it because they read it somewhere? Or someone told them about it? And they come to us with their belief hardened? As Paine tells us, it is an almost impossible task to undo what has been done. To be clear, no one person, political leaning, or socioeconomic class has a monopoly on misinformation. Today we have an example that is compelling, taking place in real time, literally as we sit here today. In perhaps what is the defining misinformation campaign of our times, the link between vaccines and autism. Measles was declared eradicated in the US in 2000 by the CDC and the Americas in 2016 by the Pan American and World Health Organizations thanks to widespread vaccinations. But just a few years later, the disease is making a resurgence due to a decline in vaccinations. Not because of some new untreatable strain or forces beyond our control, or a vaccine so expensive that no one can afford it. No, the resurgence is due to a decline in vaccinations. Parents simply choosing to not vaccinate. In Europe, the numbers are even worse with the continent experiencing nearly 100 000 reported cases. Measles is a terrible disease with a death rate as high as 30% prior to the vaccine. Even today, it has a case fatality rate of 3 in 1000. Nonmedical exemptions are becoming more common and are clearly causing a spike in measles outbreaks. These exemptions are occurring across the political spectrum in communities all over the United States. In my home state of Texas, the number of nonmedical exemptions has been rising dramatically, from just about 2000 in 2002 to over 64 000 in 2019. What has not been going down commensurate with this 30-fold increase in exemptions is the rate of autism. How did we get here? The link between measles, mumps, rubella and autism, stems from an article by Andrew Wakefield in 1998. This study of just 12 children concluded that the vaccine resulted in “developmental regression in a group of previously normal children”. The cause was taken up by celebrities and others resulting in a sustained attack against the safety of vaccines. We have watched the CDC and WHO and pediatric and infectious disease experts speak out with truth and science and reason—and yet too many parents listen to celebrities and anecdotes. The scientists promoting the safety and efficacy of these vaccines get demonized. We have watched truth and reason be trumped by hype, no matter how well intended it is. The effects of this paper linger even today, all over the world, with high rates of belief that vaccines cause autism. Twelve years later, The Lancet published a retraction indicating that “several elements” of the paper were “incorrect”. By then, the damage had been largely done. Now we are experiencing outbreaks all over the country with dangerous, even intentional, exposures of our children to diseases with not insignificant consequences, including death. Change is possible though. After a measles outbreak in Disneyland in 2015, the California legislature passed Senate Bill 227 which banned non-medical exemptions in 2016. This resulted in a record high vaccination rate of over 95% of kindergartners. Medical misinformation is making its way into our hospitals and clinics like never before. We need to push back. We are the experts, and we can make a difference. When we hear something absurd, we should not be afraid to call it out. We must use our expertise to inform patients and the public. Our voices can change minds. There is no risk-free proposition. We do have data on harm from vaccines. The National Vaccine Injury Compensation Program pays out adjudicated claims and collects data from individuals harmed by vaccines. Between 2006 and 2017, 3.4 billion doses of vaccines were distributed in the US. One individual was compensated for every 1 million doses distributed. By comparison, the likelihood of being struck by lightning is 1 in 700 000. This information is rarely, if ever, mentioned in the so-called vaccine debate. Perhaps the most famous example of the harm medical misinformation can cause is the choice Apple co-founder Steve Jobs made regarding his own cancer diagnosis. Jobs was diagnosed with a pancreatic neuroendocrine tumor at age 48. He was advised to undergo potentially curative surgery, but for 9 mo he sought out alternative treatments including vegan diets, acupuncture, cleansings, and even consulted a psychic. He eventually had the surgery but according to many experts this delay almost certainly cost him his life. My wife Lorelei was diagnosed with a similar tumor not so long ago. In 2010, after years of intermittent abdominal pain attributed to reflux, while suffering with severe pain, from what we now know was acute pancreatitis, she went, on her own, to a local emergency room and insisted on getting a computed tomography. It was a shock; she was too healthy to be that sick. We discovered her tumor when our twin boys were barely a year old. We were fortunate to have the best information on how to treat her tumor and after her distal pancreatectomy and splenectomy, she has made a remarkable recovery. I would not be standing here, not as president of the CNS, not as a neurosurgeon, but as the person I am today had it not been for the love and support of my wife. Her journey reminds me that medical science has made a remarkable difference in the lives of countless human beings. What would have happened to someone with a pancreatic tumor 100 yr ago, or even 50 yr ago without the advances that we now take for granted. We are celebrating cures of stage IV cancers even in patients with brain metastases thanks to the diligence and hard work of unsung heroes in laboratories and patients willing to enroll in clinical trials. We wait to hear results of prospective randomized controlled trials because they provide us the best evidence that a treatment is going to work. And the payoff is that our patients survive to live another day, spend time with their families, and enjoy life. We are in a unique position to advocate for our patients by advancing truth, confronting misinformation, and recommending the best treatments, but also by avoiding those that do not work or have not demonstrated efficacy in a rigorous way. We should not be afraid to advise a patient that an “alternative treatment” may expose them to real harm. Choosing “alternative” medicine over standard of care therapies can lead to a significant decrease in survival for patients with cancer. Now I ask—what can we do, each of us? I want you to leave here ready to help our patients by doing something, and each of us will choose our own way. Doing something can take many forms. It is an uphill battle for sure. You will be facing the so-called Dunning-Kruger Effect in which overconfidence and a knowledge deficit go hand in hand. I had the opportunity to meet with Dr Peter Hotez, Dean for the National School of Tropical Medicine at Baylor College of Medicine, and a champion of vaccinations, he told me we need a curriculum that specifically teaches health and science verbal communication in our medical schools. We need to teach the tools to defend science and expertise. We need to speak in declarative sentences and avoid talking down to our patients. He titled his book “Vaccines Did Not Cause Rachel's Autism” in order to simplify the message. I encourage you to read this book, but do not look at the book reviews; they’ve been corrupted by the anti-vaccination movement. “The mind once enlightened cannot again become dark” To conclude, I want to encourage you to counter misinformation and dangerous recommendations in the following ways: We must all stay abreast of the latest and best studies in our field. Familiarize yourselves with ways to differentiate good studies from bad. When patients ask you about a treatment you know to be ineffective or dangerous, it is your opportunity to help that patient Check your arrogance though, our patients deserve honesty, as well as humility and respect Participate in honest and open Morbidity and mortality conferences, Review practice changing peer-reviewed literature with colleagues If misinformation is being spread—say something. We have to be actively engaged. We are the experts. Be critical, be skeptical, but remain open to changing your mind if the evidence convinces you to do so. This is what I am asking. That we are even more forceful in being the guardians of medical truth with our patients and with our communities. To quote Paine one last time: “The mind once enlightened cannot again become dark” Disclosures The author has no personal, financial, or institutional interest in any of the drugs, materials, or devices described in this article.

Sean P. Clarke

FigureEmployees in hospitals and other healthcare settings are increasingly returning to school to obtain advanced degrees. In addition to course papers, graduate programs often require a thesis or major paper; not surprisingly, students often look for projects where they can collect needed data quickly and easily. They may even desire to have a project address a job requirement and an academic requirement at the same time. This article reviews the potential advantages and pitfalls of conducting a school project in one's own workplace and offers suggestions for students, faculty, and managers when this occurs (see Suggestions for students, faculty, and managers). When a student is also an employee Students taking advanced courses may be assigned to a specific project on a unit or in a practice setting other than where they normally work. The matchmaking of students with settings can happen in two ways: Healthcare managers may reach out to professors with a project for which they need assistance or managers may be approached by professors or students asking about potential projects. The student who's either not employed or employed at another institution gets to try out the role of consultant, and there's “free labor” on both sides. The setting receives hours of student time, and the students and their programs receive free supervision—the trade-off is often well worth it on both sides. Managers don't have to pay for a staff member's time or an external consultant to work on a project; however, they'll often spend extra time explaining exactly what's expected and may need to follow the work closely. Students can try out new skills under supervision where stakes are relatively low and without needing to spend a lot of time establishing their credibility. But there are drawbacks, such as when the student's time in a course or on a placement runs out before a project is finished. Situations get more complicated when the student is also an employee on the unit or within the setting that he or she is writing about. The convenience of not having to find (or travel to) another site beyond school and work to complete a project can be appealing. From the manager's perspective, a student who's also an employee may have insider knowledge, connections, or permissions that may make a project run more smoothly and it may be easier to hold him or her accountable for project outcomes. But there can be complications. The student wants to be a good employee, but also needs to be a successful student. If the employer evaluates or is in some way a grader of the project, there's a dual role that can create problems for everyone. And if the project somehow doesn't live up to the manager's expectations, the student may feel special pressures and worry that both a grade and his or her standing in the organization are at stake. There are four basic scenarios for students in an advanced course or graduate program completing projects in their work settings for academic credit. The first, and simplest, is when the student writes a course paper to describe and analyze a clinical case or ongoing situation from his or her workplace. The primary concern here is making sure that the student doesn't openly name the institution and/or specific unit, or specific patients and staff members. Usually using pseudonyms and changing identifying details are sufficient. In most cases, the manager's interest in the paper is typically minimal and he or she may not even know about it. Things get blurrier when students are involved in a quality improvement (QI) project within their normal work setting that they write up for academic credit; for instance, for a course on healthcare quality. Almost by definition, a QI project is one where there's some level of manager or leader agreement. QI projects mostly involve analyzing data that are normally gathered in the course of delivering care and managing operations and service quality. If any new or additional data gathering, interviews, or questionnaires are involved, they need to fall within the scope of what the manager can reasonably ask of others. On the other hand, a research project aims at original knowledge discovery for potential applications beyond the management of a particular setting and often does ask more of patients and staff. Students, faculty, and managers need a sense of QI project boundaries, which normally don't require research ethics clearance; exceeding these limits and purposes can cause problems for everyone involved. (On a side note, it's sometimes recommended that Institutional Review Board [IRB] clearance be sought for QI projects that a student or team hopes to publish.) Action research—a specific kind of scholarship in graduate programs emphasizing leadership—is the third type of academic project that can be done in one's own workplace. In some fields, a dissertation or thesis can take the form of a detailed review of a work situation and efforts to change it. The scholar-leader analyzes a situation, but also usually intervenes and evaluates the workplace's responses to interventions or programs. Action researchers understand that complete objectivity as a participant and leader in a change project is impossible; coming to terms with this is a key part of the method. As appealing as action research may sound, not all academic programs allow this type of thesis or dissertation. There are many layers of planning and a whole vocabulary and toolkit of data gathering and analysis skills that must be mastered. Action research also demands political skills, including securing the permission of one's superior to engage in the project (and to use it as the basis for an academic paper), obtaining agreement of major workplace stakeholders affected by the project, and working closely with university faculty to ensure that the project and its write-up meet program requirements. Depending on the nature of interviews and other forms of information gathering, research ethics clearance can be necessary for some or all of the data collection. Such projects can be, and often are, very rewarding, but they must be a good fit for the overall program of study and approached with recognition that they involve considerable effort beyond just doing one's job within the work setting. The fourth, and most complicated, situation occurs when the student embarks on original data collection for a research project in a clinical setting. Normally, confidential information is sought or the needed time and effort of patients and/or staff is above and beyond what's typically required for clinical care, monitoring, or QI. This is often considerably beyond the information use in the student's role as an employee. In many clinical settings, staff members are encouraged to get involved in research and even run small team projects as part of their roles. Sometimes these projects involve replicating earlier clinical findings or testing an instrument to see if it applies or how a local setting compares with a sample in the literature. The motivations for doing local clinical research include a general desire for on-site research activity or unit staff members' particular interest in a specific clinical topic. Unit-based research is above and beyond the scope of this article; however, in most cases, it's done out of intellectual curiosity and for professional development rather than academic reasons or advancement as researchers. Just as in the case of QI projects, there can be a special appeal to employees and managers for running a local research project as an academic study. The ideas for the study can come from the student/employee or the organization. Prominent among the advantages of students collecting data in their work settings is time saved in finding an appropriate site and obtaining an entrée into a setting. Employers may find it attractive to have a degree-seeking employee working on a project that's an organizational priority because it's assumed that he or she will want to follow through in a timely manner and at a high level of performance. However, there are some potential complications. Research is nearly always examined and approved by some kind of ethics or IRB before data collection. For students in degree programs, this often occurs at both the educational institution and clinical facility. Whereas being known as a staff member may help obtain permissions to perform a study in a clinical facility (and some agencies actually require that at least one staff member be an investigator on any project taking place in the organization), being on staff at an institution can also add wrinkles to a project being cleared. Today, most clinical agencies and ethics review boards see a clinician or manager approaching his or her own patients or coworkers directly to ask them to participate in a research project as a conflict of interest. Subjects are likely to feel pressure to sign up for a study out of duty or obligation, or even a concern that they'll somehow disadvantage themselves if they opt out. Even when there are no special surveys, interviews, blood draws, or instrument readings involved, as in the case of secondary analysis (a form of research reusing data originally collected for other purposes), researchers typically need to have arms-length contact with any identifiable data they don't have a job-related reason to access (as in the case of patients for whom they aren't personally caring or data they don't need to carry out their jobs). Dealing with these ethics issues in a manner acceptable to all parties can lead to projects needing extra personnel or other costs. Challenges of note One of the main challenges of embarking on a research project as a student is that studies for academic credit are often extensively planned, involve careful literature reviews, and require regular consultation with a committee of research faculty advisors. Because the thesis or dissertation is the proof that the student has mastered research skills in the relevant discipline at the level required for the degree, the professor(s) involved usually pays very close attention to detail in relation to how research principles are reflected in the project and how it's written up. To the student and/or manager, having the student graduate and fulfilling a functional purpose for the organization are likely to be much more important. Between ethics issues and disagreements about project direction from academic versus practical standpoints, without careful planning, the supposed time savings of “easy access” to a setting and its patients or staff can quickly be erased and the student-employee may find him- or herself in conflicts between academic and work supervisors. It's also important to remember that actually carrying out research projects can be very unpredictable. The ethics clearance process alone can take months (being known to the institution or the IRB as an institutional employee may or may not accelerate getting approval) and subject recruitment and having subjects complete all necessary data collection tends to have a number of twists and turns. Coming to work in a clinical setting where one's managers and colleagues are well aware of slow or no progress on a study can be challenging, and may be doubly challenging when managers have a special stake in seeing the project finished. Some final cautionary notes about doing research in the workplace for degree credit relate to publishing and dissemination. Reporting results when findings aren't flattering to patients, clinicians, or care quality can be challenging under any circumstances; this is even truer when researching in one's own work setting. Keep in mind that even if the workplace's identity can be camouflaged in a written report, it often doesn't take much sleuthing to figure out identities of institutions, units, and even managers, staff members, or patients, especially because institutional affiliations are often part of the author's byline or acknowledgments. Also, depending on the student's career goals and the needs and preferences of colleagues, managers, and professors, authorship considerations, such as who becomes a named author on any publications resulting from a dissertation or thesis, may become complicated if not worked out up front. Careful consideration needed It's indeed possible for nurses to do academic research that counts for credit toward an advanced degree in the clinical settings where they work. However, this kind of involvement has to be thought through carefully on all sides. Understanding common pitfalls can be helpful in starting productive dialogues between students, faculty members, and managers. Suggestions for students, faculty, and managers Tips for students Recognize the trade-offs involved in doing research for academic credit on the job and be cautious about accepting compromises that may jeopardize your future at the organization or your ability to complete projects or courses and earn your degree. Understand the difference between QI and research in terms of the types of clearance required. Be extremely careful about naming patients, staff, or practice settings in any notes or drafts of papers and assignments, and about making unflattering comments/analyses about any setting (whether you work in it or not), particularly if you present or publish your work. Tips for educators Make sure that confidentiality issues are addressed if students are asked to write about or discuss clinical or management situations from their own workplaces. These include not only the obvious need to protect information that may lead to patients being identified, but also the privacy of care settings and those who work in and manage them. Think carefully before asking or encouraging students to do a large-scale project in their workplace and be ready to steer them to other settings. Tips for managers Recognize the risks of double roles (being both a researcher trainee or student and employee in a setting or being both a work supervisor and a preceptor/project advisor/evaluator). Pressures, stresses, and possible ethical conflicts can result. Staff members must be careful about mingling their schoolwork and paid work too closely and neglecting their job duties. Be understanding if employees and their professors decide that projects are best done in settings other than the student's own workplace. Help students from local colleges and universities, your own employees, and students employed by other local organizations network to find appropriate clinical settings for their academic work when necessary.

Thomas B. Dodson

No abstract is available for this record.

Gary Gaddis

In 2000, the first Academic Emergency Medicine consensus conference was convened. The topic, “Errors in Emergency Medicine,” was interposed between two well-known Institute of Medicine (IOM) reports of direct relevance: To Err is Human: Building a Safer Health System1 (1999) and Crossing the Quality Chasm: A New Health System for the 21st Century2 (2001). This foreshadowed the great degree of relevance and timeliness that would characterize future consensus conferences, each of which has as its primary goal the development of a research agenda that will guide the science of the topic at hand. This year, Academic Emergency Medicine convened its 11th consensus conference, “Beyond Regionalization: Integrated Networks of Emergency Care,” in conjunction with the annual meeting of the Society for Academic Emergency Medicine in Phoenix, Arizona. The proceedings will appear in the December issue of this journal. In this fashion, another timely research agenda will be developed, refined, and disseminated. These consensus conferences have not occurred in a vacuum. They have, to a demonstrable degree, had their intended effect of stimulating research. This month’s issue of the journal is the first to be devoted primarily to dissemination of research and concepts that have grown from prior consensus conferences. There is every reason to believe that a new and useful tradition has been established. The topics of the prior AEM consensus conferences have been: 2000: Errors in Emergency Medicine 2001: The Unraveling Safety Net 2002: Assuring Quality 2003: Disparities in Emergency Care 2004: Emergency Medicine Information Technology 2005: Ethical Conduct of Resuscitation Research 2006: The Science of Surge 2007: Knowledge Translation in Emergency Medicine: Establishing a Research Agenda and Guide Map for Evidence Uptake 2008: The Science of Simulation in Health Care: Defining and Developing Clinical Expertise 2009: Public Health in the Emergency Department: Surveillance, Screening, and Intervention 2010: Beyond Regionalization: Integrated Networks of Emergency Care A number of the consensus conferences have received significant financial support from Canadian, American federal, other public, and various private sources. Focusing on the conferences of 2007, 2008, and 2009 is illustrative. The 2007 conference received financial support from the Agency for Healthcare Research and Quality (AHRQ), and among the featured speakers who took time from their busy schedules to join us in Chicago was Carolyn Clancy, the director of the AHRQ since 2003. Support also came from the National Center for Research Resources, an organization promoting the Clinical and Translational Science Awards program within the United States National Institutes of Health, and the Knowledge Translation Workshops and Symposia Grant Program of the Canadian Institutes of Health.3 The 2008 conference received primary financial support from AHRQ, the Josiah Macy, Jr. Foundation, MedEdPORTAL (an electronic publication of the American Association of Medical Colleges), and the Risk Management Foundation of the Harvard Medical Institutions. Over 30 other medical organizations and academic departments nationwide provided smaller degrees of support. In addition, unrestricted educational grants were received from major manufacturers of medical simulator hardware and software.4 The 2009 conference was primarily supported by a grant from AHRQ and the National Institute on Drug Abuse of the National Institutes of Health, with secondary support from the National Institute of Mental Health; the National Institute on Alcohol Abuse and Alcoholism; the Substance Abuse and Mental Health Services Administration (SAMHSA); “Join Together” of the Boston University School of Public Health; and the Departments of Emergency Medicine of Boston University, Brown University, Emory University, George Washington University, Johns Hopkins University, the University of Maryland, the University of Michigan, and Yale University. This conference featured participation from Dr. Richard Denisco from the National Institute on Drug Abuse, Dr. Ralph Hingson from the National Institute on Alcohol Abuse and Alcoholism, Dr. Amy Goldstein from the National Institute of Mental Health, Dr. James Heffelfinger from the Centers for Disease Control and Prevention, Dr. Richard Saitz from Boston University, and Dr. Jack Stein, director of SAMHSA’s Center for Substance Abuse Treatment.5 Given the significant and continuing financial support of the agencies and foundations that have supported our consensus conferences, it seems prudent to provide them with proof that their efforts have been followed by meaningful responses to the numerous calls for research contained within the consensus conference summary statements and proceedings. In other words, this issue of our journal can be thought of as the first installment of a series of “itemized receipts” that will document how the financial support provided to enable the consensus conferences has been worthwhile. The first several consensus conferences did not enjoy such external financial support, but as the size and scope of the sessions grew, so did the need for funding. Our journal will continue to present these annual consensus conferences into the foreseeable future, and they will require the expenditure of significant resources of time and finances. To be able to document, from the pages of our own journal, that prior consensus conferences have had the desired effect of stimulating relevant research may increase the likelihood that the organizers of future conferences can continue to achieve similar external financial support. Looking forward, it is hoped that an even greater number of research efforts will be inspired by our consensus conferences and that much of that research will appear in our journal. It must be noted that not all of this month’s articles were submitted by authors who had the express intent that they appear in this special consensus conference follow-up issue. The Associate Editors and Senior Associate Editors, as well as Kathleen Seal, our Technical Editor, have referred a number of manuscripts submitted to the journal, but not submitted specifically for appearance in this issue, to the attention of the consensus conference guest editors group. In other words, our work group had to “prime the pump” somewhat. It is hoped that this will not be necessary in the future and that a greater number of manuscripts will be submitted with the goal that they appear in the consensus conference follow-up proceedings. A suggestion going forward relates to the probability that the research agendas set forth at a given consensus conference may eventually become “dated.” Toward that end, it is possible that future consensus conference follow-up issues might only accept manuscripts inspired by consensus conferences of the past 3 to 5 years. This issue contains a total of 15 manuscripts, with the following representation: 2002: one manuscript 2003: two manuscripts 2004: two manuscripts 2005: zero manuscripts 2006: two manuscripts 2007: three manuscripts 2008: one manuscripts 2009: four manuscripts I would be remiss not to thank several people without whom this edition of the journal would not have been possible. The Guest Assistant Editors, who functioned most capably as decision editors, included Gail D’Onofrio, Nicole Deiorio, Lynne Richardson, and Terri Schmidt. I am indebted to them for their efforts. It would be misleading to state that this process evolved exactly as first envisioned, and I must also thank these Guest Assistant Editors for their patience with the evolving processes. David Cone gave me the opportunity to more truly understand the extreme degree of knowledge and organization he brings to his role as Editor-in-Chief. Finally, but most importantly, I thank Kathleen Seal for her most capable guidance and patience. I have learned to an even greater degree than before what a valuable resource she is to our journal.

Wayne Richenbacher

I am both humbled and honored to have been given the opportunity to serve the American Society for Artificial Internal Organs (ASAIO) as president for this past year. As some of you know, I am a cardiac surgeon and as such, I am keenly aware that governance of a society, like open heart surgery, is best accomplished by a dedicated, experienced group of individuals. Favorable outcomes in cardiac surgery and management of a society are dependent on a successful team effort. This past year I was quite fortunate to have been surrounded by a very dedicated and actively engaged group of individuals. As many of ASAIO's presidents have done in the past, I would like to thank Karen Burke, Executive Director for her commitment to ASAIO. Karen is truly the heart and soul of our society. I would also like to thank the ASAIO Board and, in particular, the members of the executive committee: Bill Holman, David Humes, Bill Wagner, and Kurt Dasse. Their collective wisdom and vision for the society made the management task far simpler than I would have imagined and assures me that our society is in very good hands for the future. In choosing a topic for the presidential address, I felt that conflict of interest considerations are not only timely but also of particular interest to the diverse membership of our society. Given that our membership roster has representatives from clinical medicine, engineering, basic science, the federal government, and industry, I believe we are in a unique position to acknowledge the potential for conflict of interest and influence the process by which such conflicts are managed. A conflict of interest has been defined as “a set of conditions in which professional judgment concerning a primary interest (such as a patient's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain).”1 Although financial gain is the most easily recognized and readily quantified, it is only one of a number of possible secondary interests. Physician-scientists are driven to participate in clinical research out of a desire to advance knowledge thereby providing better therapeutic modalities for their patients. Academic medical centers exist to foster an environment in which such advances are made possible. A successful investigative effort oftentimes results in ongoing grant support and academic recognition.2 Academic medical centers derive nonfinancial gains from research conducted by their faculty. There is great prestige associated with recognition as a leading research institute. Personal career advancement and institutional recognition are powerful secondary interests. The common perception is that any relationship between an investigator or academic institution and industry creates doubt about the validity of an investigative effort and may jeopardize the quality of care provided to a research subject. However, the presence of a conflict of interest should not be considered evidence of misconduct on behalf of the investigator, academic institution, or industrial partner. Rather, conflicts of interest are inherent in the investigative process. The goal is to manage the conflicts of interest in an ethical manner thereby ensuring that a study is conducted with unquestionable scientific validity and that the patient's care is uncompromised. It is important to understand how human subjects research evolved to the point where conflicts of interest can occur. Public Law 96-517 known as the Bayh-Dole Act, was cosponsored by Birch Bayh of Indiana and Robert Dole of Kansas.3 This legislation was enacted on December 12, 1980, became effective in July 1981, and created a patent policy that permitted universities, for the first time, to elect title to inventions made under federal sponsorship. Universities were expected to file patents and subsequently commercialize these inventions. This piece of legislation is generally credited as the originator of academic technology transfer whereby university research, inventions, and intellectual property are transferred to private industry for purposes of commercialization. By doing so, public welfare is enhanced and industrial growth made possible, as university generated technology is developed into real world products. Currently, around 5,000 licenses and options are executed annually by universities with private industry, growth of more than 500% since 1991.4 Such tech transfer translates into $1.39 billion in annual licensing income to universities, a nearly $1 billion increase since 1995. The enhanced relationship between academic institutions and industry has led to a multitude of medical advances and the creation of biotechnology markets. However, an unintended consequence of the relationship is an academic institution's increased reliance on industrial funding to support further research. Between 1980 and 2000, industry's share of the total investment in biomedical research and development increased from 32% to 62%.5,6 Support from the federal government fell during the same period. The complex financial relationship among investigators, academic institutions, and industrial partners is well documented. Of 2,052 life science faculty at 50 US universities receiving research funding from the National Institutes of Health, surveyed in a report published in 1996, 28% received research support from industry.7 In 1984, 46% of life science companies supported academic research, whereas in 1994, 57% of firms provided such support, a number that achieves statistical significance (p = 0.05).8 In 1999, the Association of University Technology Managers reported that 124 of 183 members (68%) in the United States and Canada held equity ownership in businesses that sponsored research at the same institutions.6 Patent royalties and, to a greater extent, equity holdings by investigators and academic institutions create an entirely new dynamic in their relationship with the industrial partner.6 The creation of a new revenue model for research scientists and universities has blurred the lines between academic and commercial values. The rise in institutional entrepreneurialism carries with it a responsibility for business stewardship. Such a shift in mind set can easily portend a shift in academic mission. The potential for research bias ensues. The promise of financial rewards raises justifiable concern about the conduct, interpretation, and reporting of funded research.2 There is a well documented disparity in outcomes between industry-sponsored and nonindustry sponsored research. In one review of 332 randomized controlled trials, industry funded studies were 1.9 times more likely to report positive results, a statistically significant proindustry finding.9 Bekelman et al.6 summarized eight articles that compared the outcomes of industry-sponsored versus nonindustry sponsored research studies. These eight articles collectively evaluated 1,140 original studies. The summary odds ratio from these studies was 3.60, with the conclusion favoring industry regardless of whether the study was a randomized controlled trial or other study design. Although perhaps an overstatement, industry-sponsored research is, in general, designed to affirm a hypothesis that is anticipated to be affirmed.10 Industry studies are intended, in part, to mature a concept or product along a linear fashion, whereas government-funded studies may be designed to ask broader, more conceptual questions.10 More worrisome are potential impediments to the investigator's access to data and freedom to publish the results of industry-sponsored research studies. There are reported instances where publication of the results of research that were unfavorable to an industrial product were delayed or blocked altogether by the companies that had provided financial support for the study.11–13 In one survey of academic investigators, 19.8% of 410 respondents reported publication of their research results had been delayed for more than 6 months to slow the dissemination of undesired results and to resolve disputes over ownership of intellectual property, among other reasons.13 So, why the seeming sudden interest in recognition and management of conflicts of interest? The Joint Commission defines a sentinel event as “an unexpected occurrence involving death or serious physical or psychological injury … Such events are called ‘sentinel’ because they signal the need for immediate investigation and response.”14 The event that accelerated efforts to address the influence of conflicts of interest on the safety of research subjects occurred in 1999.15,16 Jesse Gelsinger was an 18-year-old man who suffered from a mild disorder of nitrogen metabolism known as ornithine transcarbamylase deficiency.16 On September 13, 1999, as part of a gene therapy clinical trial, he received an intrahepatic injection of adenovirus vector particles containing a gene to correct the genetic defect. He died 4 days later of what was presumed to be an immune reaction to the virus vector. This death was the first in a gene therapy trial. In the firestorm that ensued, it was alleged that investigators at the University of Pennsylvania where the death occurred held patents covering several aspects of the technology employed. In a wrongful death lawsuit, it was further alleged that James Wilson, the Director of the Institute for Human Gene Therapy at the University of Pennsylvania, and the University itself were reported to have equity holdings in Genovo, the private sector biotechnology company collaborating on the project.15,16 These conflicts of interest were allegedly never disclosed to the trial participant. The fallout from the tragedy in Philadelphia and elsewhere called into question physician–industry relationships and the impact of those relationships on the clinical investigative process. Kim et al.17 from the Psychiatry Department at the University of Rochester looked specifically at potential research participants' views of researcher and institutional financial conflicts of interest. In their article published in 2004, the authors presented seven different scenarios of financial conflicts of interest to 5,478 individuals. The majority of individuals surveyed responded that knowing conflict of interest information was “extremely” or “very” important. Sixty-four to 87% of respondents (depending on conflict of interest scenario) felt that financial conflicts of interest should be disclosed as part of the informed consent process. Although the majority of those individuals surveyed would chose to participate in a study in the face of a known financial conflict of interest, the effect of such a conflict of interest resulted in a sizeable minority to be less inclined (range, 3%–44%) to participate or would chose not to participate (range, 2%–32%). The erosion of trust was further reflected in the fact that pharmaceutical and medical technology companies paid more than $2.5 billion in healthcare fraud settlements in 2001 and 2002.10 Public trust had to be regained, and potential research participants needed assurance that clinical investigation could be conducted free of bias. The question to be answered was where to begin. On May 23, 2000, in direct response to the death of the patient in the gene therapy clinical trial, former Secretary of the Department of Health and Human Services, Donna Shalala, announced five new initiatives that were specifically designed to ensure patient safety and increase public confidence in clinical trials.18,19 Two of the five new initiatives specifically addressed conflicts of interest. The purpose of these initiatives was to “clarify and enhance the informed consent process” and specific mention was made “that any researchers' financial interest in a clinical trial be disclosed to potential participants.” A conference that specifically addressed financial conflicts of interest was held in Bethesda, MD, on August 15–16, 2000. Subsequent to that conference, a draft interim guidance document was prepared and made available for public comment on January 10, 2001. A second draft guidance document appeared in 2003, whereas the Final Guidance document entitled “Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subjects Protection” was made available in 2004.20 In part, these guidelines suggested that institutions establish a Conflict of Interest Committee to identify and address potential individual or institutional conflicts of interest. The Conflict of Interest Committee was to function in concert with the Institutional Review Board (IRB). The mandate of the latter committee is to protect the rights and welfare of human research subjects. As the Department of Health and Human Services was in the process of developing guidelines to address financial conflicts of interest in human subjects research, the Association of American Medical Colleges (AAMC) announced their own intent to examine the same process. In October 2000, the president of the AAMC, Jordan Cohen, announced the formation of a task force whose assignment was to revise and extend the AAMCs existing conflict of interest guidelines based on contemporary events and increased concern about the impact of financial conflicts of interest on public trust in the objectivity of human subjects research.21 Jordan charged this task force to address three issues: 1) To recommend upper limits of allowable financial interests that would motivate investigators to pursue the clinical research with due diligence but not raise concern that remuneration for research serve as a financial windfall for those providing oversight for the scientific process. 2) To consider inaugurating a voluntary, institution-based certification process for research faculty. The certification process would function much like board certification and would ensure that those involved with funded research were cognizant of the rules and regulations governing such research. 3) To consider additional safeguards that might be necessary to “address the potential downside of financial conflicts at the institutional level,” recognizing that institutions, as opposed to individual scientists, might also have a financial stake in the outcomes of clinical trials conducted onsite. The task force ultimately published two documents: one dealing with individual22 and the second with institutional23 financial conflicts of interest in research involving human subjects. Recommendations in these two reports also include the creation of a Conflict of Interest Committee or, in lieu of a committee, a conflict of interest official. The Conflict of Interest Committee is responsible for identifying, quantifying, and potentially reducing the financial conflict of interest of any individual conducting human subjects research. Findings from the Conflict of Interest Committee are to be made known to the IRB. Institutions were tasked with developing written policies detailing substantive prohibitions and restrictions, reporting, implementation, disclosure, monitoring, and review of financial conflicts of interest. The AAMC task force recommendations specific to managing institutional conflicts of interest make particular reference to the makeup of the Conflict of Interest Committee. The membership roster is to include only individuals who are independent of the direct line of authority for clinical research oversight within the institution. The task force further recommended the inclusion of at least one or more individuals with to the institution The institutional of Technology is to report to the Conflict of Interest Committee any licensing into by the institution that equity interest, and the reporting guidelines are recommended for institutional In potential financial conflicts of interest should be disclosed by the individual conducting the research. The should be into the patient consent and the financial interest in question should be and not to additional to the welfare of the research participants or to the of the industrial representatives also to their own of dealing with investigators and academic The Research and of developed a on with This effect on July and was in January Of greater interest to the membership of this society is the of on with Health by the Medical Technology Association is a of medical technology and the of was on January The of the into effect on July This and document such important as company conducted product and with healthcare and research and to the of the include guidelines that address with healthcare and the of companies that their of the for public review on The of have also done their part to for and the scientific of human subjects research. The two leading in the of surgery, the of and and the of that authors report any financial conflicts of interest a is for The of those have the of such conflicts on the title of the article at the of However, the of only one of a conflict of interest. To ensure that authors of research data and the freedom to publish the results of clinical research, the Committee of Medical the for to and for to of potential conflicts of interest, this document that authors potential conflicts to study participants and that they have done within the of the The document further that in reference to conflicts of interest to support should not into an that with their access to the data and their to and to and publish To ensure that investigators are for their own research, authors of a study funded by a with a or financial interest in the may also be to a to the effect that had access to the data in this study and I responsibility for the of the data and the of the data The of the of and and the of have new to their for that a policy in which a a study in which “an other than the investigator had of the data or had over might be on that Such policies serve two to research scientists in their with industrial in developing and to ensure of the have information to make an informed judgment about potential bias in the research In the since the death in the gene therapy clinical trial, significant has been made in the and management of of conflicts of interest. However, this is a process in The majority of management policies are in the of recommendations or There has been a response from institution to institution with to developing and on policies and that are a number of in which potential conflicts of interest can be and In clinical trials, investigators be involved in aspects of trial the of and In funded research, investigators of data and data The research scientists be the freedom of publication of a conflict of interest on behalf of the investigator or the institution at which funded research is should be should be in the consent document that a potential research to the presence and of a possible conflict of interest. By doing so, the potential research is made aware of the conflict and is the opportunity to an as to the impact of such a conflict on the investigative process. such written should include financial the of It has also been suggested by one that informed consent should include a of the quality of medical evidence on which recommendations are should an opportunity for between the investigator and the potential research the latter is that safety is and the study is conducted bias. of conflicts of interest is the responsibility of not only the investigator but also the institution. In to the informed consent of conflicts of interest and Institutional Conflict of Interest should be developed with a mandate to review potential conflicts of interest and ensure that such conflicts are disclosed and Conflict of Interest Committee membership should include research scientists who have conflicts with the institution, the investigators, or the clinical trial in which the faculty of the academic institution is To one or more members of the Conflict of Interest Committee should be from the institution. The Conflict of Interest Committee should be charged with developing policies for management of potential conflicts and should with the to ensure that such policies are It has been suggested that a for to AAMC guidelines might be better accomplished by the guidelines into the companies should to of should be in and an need for the and that such was for should be with and not based on the or of the business academic medical the Conflict of Interest Committee should oversight for faculty members who into The and potential research participants should be made aware of and be that such in influence the or of clinical research. A financial be it an investigator or institution should not serve as investigator or data in a clinical trial. The of a financial on industrial support or on an investigator's or institution's equity interest in an industrial have to be In for patient care should be first and in the of involved in human subjects research. To the of the scientific such investigation be conducted free of or advances in medical in general, and in particular, a relationship among academic medical and industrial In the would that may be an increased reliance on industry for financial support in the future. The of our society since has been to advance medical technology for the of our patients. To this ASAIO is with a membership that an and of to the task at The of our society is our to a clinical a to address that the new and, in and clinical trials our the complex process and more understand the process by which new technology is to the To ensure that we to be to new to the board and technology to the clinical we be open and in our management of conflicts of interest, the of our clinical research are and our to participate in the process

Michael A. Weber

Academic physicians are under attack in the United States. Federal and state politicians, the lay media, some regulatory agencies, medical journals, and even medical schools have voiced strong concerns over the relationships between academic physicians and the pharmaceutical and device industries. These industries have been accused of corrupting medical research, education, and practice; and so, by extension, academic physicians who participate in these activities have become a focus of unfriendly attention. In their clamor, critics have not been reluctant to use the pejorative and misleading term conflict of interest in describing these academic-industry relationships. Physicians are notoriously slow to react, but in the end a group of academics from diverse medical specialties met at Harvard in late July to conduct the inaugural public meeting of a new organization: The Association of Clinical Researchers and Educators (obviously now known as ACRE). And, in the interests of transparency, let me immediately state that not only do I participate in research and educational services supported by industry, but that I was one of the founders of ACRE and took part actively at the Harvard meeting. Why in the United States—and throughout much of the world, for that matter—have academic physicians and industry forged their collaborations? In reality, a large part of medical research and education in contemporary times is based on this relationship. Dr Jeffrey Flier, Dean of Harvard Medical School, acknowledged at the ACRE meeting that his school’s mission to promote medical education and research requires interaction with industry.1 Most of the major advances in recent decades in conditions such as cancer and heart disease, and their incorporation into medical practice, have resulted from this partnering between academia and industry. Academic physicians are uniquely qualified to identify unmet medical needs and, working collaboratively with industry colleagues, to devise and conduct the types of basic research and clinical trials that lead to therapeutic breakthroughs. It is not difficult to understand why our critics have come to question this relationship, including legitimate concerns about preserving the independence of academic physicians. But one of the dominant motivations for this negativity comes from the costs—admittedly, often quite high—of new developments in patient care. Government agencies with limited budgets and commercial health plans with financial obligations to investors understandably look with dismay as relatively more costly tests, procedures, and therapies are developed and made available by industry and its academic advisors. From the perspective of health plan operators, the situation only gets worse when academic physicians teach their practicing colleagues about the attributes of these new developments. ACRE’s first meeting, which played to a packed house in the Bornstein Amphitheater at the Brigham and Women’s Hospital, attracted a wide range of speakers. There were representatives of medical societies, including such disciplines as diabetes, lymphoma, myeloma, and hypertension. As well, there were representatives of patient advocacy groups passionately committed to preserving the productive academia-industry collaboration needed to address unmet needs across a broad range of serious illnesses. An important insight came from a nationally recognized medical ethicist, Lance Stell, who is a professor of philosophy and Director of the Medical Humanities Program at Davidson College. “Conflict of interest” in the medical context has a clear meaning. Specifically, it occurs when practitioners accept personal rewards (such as fees, grants, awards, or recognition) in return for actions that could violate their professional obligations. In essence, to accuse a clinician of conflict of interest would require empirical proof that, in return for a reward, an action was taken that resulted in diminished care or even harm to patients. Clearly, such occurrences are extraordinarily rare in the conduct of medical research and education activities. There are words that are more accurate and less emotive than “conflict,” and we are starting to see a preference for such terms as duality, concordance, or alignment of interests. It is ironical that another speaker at the ACRE meeting discussed how certain actions in the medical setting, which perhaps really do represent true conflicts of interest, go without criticism. For instance, some commercial health plans offer practitioners direct monetary rewards for switching their patients from more expensive to less expensive drugs, or, possibly, for reducing their use of tests, referrals, and therapies so as to minimize the insurers’ outlays. Much of the information received by practicing clinicians comes from events that are funded, directly or indirectly, by industry. Partly, this is by default. After all, who else has both the responsibility as well as the resources to provide ongoing education in the clinical sciences? Inevitably this type of sponsorship has been criticized on the grounds that industry is not providing support out of altruistic principles, but rather is more intent on marketing its products. Apart from unrestricted grants that industry can provide to medical schools or hospitals to support educational ventures of their own choosing, there are two main types of industry-supported education. The first of these comes under the heading of promotional activities, and the second is labeled as continuing medical education, or CME. Each of these has its share of critics. Promotional education programs can take place in hospitals, medical offices, or at outside venues such as restaurants and are designed to provide information directly about a company’s product. These types of activities are regulated by such agencies as the Food and Drug Administration. In the case of a pharmaceutical agent, the information presented must be balanced, providing information about risks as well as benefits, and must conform largely to what is stated about the drug in its approved product label. Claiming a desire to comply with these rules, many pharmaceutical companies have tightly scripted the content of these presentations, typically demanding that presenters faithfully use a company-provided slide set without allowing them the option to add, delete, or make any other changes. This requirement obviously creates fundamental problems for academic physicians invited to present at such events. After all, how can well-regarded experts stake their reputations, not to mention the reputations of their academic institutions, on material that has been created by unknown persons at the behest of a pharmaceutical company? Not surprisingly, some major medical schools have now instructed their faculty members not to give such lectures unless they have meaningful control over the content. For community practitioners who attend such events, this is an unfortunate development, for it deprives them of beneficial teaching interactions with true medical leaders. Some observers believe that industry lawyers, in imposing this censorship, have overreacted to regulatory requirements, and there is even a suspicion that these rules—rather too conveniently—enable companies to focus more directly on their marketing messages. Rescuing this situation and re-creating collegial educational experiences in the community will require negotiations between industry and academia and, in all likelihood, regulatory agencies as well. CME is a very demanding proposition. On the one hand, industry has a compelling obligation to facilitate high-quality educational opportunities and updates for the users of its products. But, at the same time, CME rules demand that industry has a “hands off” involvement in such events, merely serving as a provider of grants. The contents of CME programs usually are created by academic faculty and are subjected to peer review (similar to an article submitted to a journal) to ensure their objectivity. Even so, some critics still claim that industry can exert a bias on this process simply by selecting which types of programs they will support. But while it is true that pharmaceutical companies are more likely to support CME activities within their areas of medical interest, industry now goes to considerable pains to ensure that its grant decision processes are kept entirely separate from marketing activities. The opponents of industry support for CME activities still claim that, despite the firewalls, industry is still rewarded for its support of CME activities by increased sales of its products. Even if this were true, it is a not unreasonable proposition that if well-balanced data, presented in an unbiased fashion, affects the subsequent utilization of drugs or devices, this will very likely be to the benefit of patients. From the perspective of academic clinicians, rigorously conducted CME events in which they are free to select the content and ideas represent ideal opportunities to enhance practitioner knowledge and patient care. Attempts by legislators (and others who regard medical education as a health–care cost driver) to prevent or limit industry support of CME could have the effect of diminishing the quality of medical practice. Again, it is the responsibility of physicians and organizations like ACRE to argue the value to patients of cooperation between academia and industry in medical education as well as in research. Many medical societies, particularly small specialty organizations, depend on industry support. The operating costs of societies, as well as the cost of meetings, publications, patient education and other professional activities cannot be fully funded by member subscriptions. Support from industry is often essential and comes in the form of corporate memberships, sponsorship of CME or other activities at scientific meetings, exhibit fees, and journal advertising. This support has been criticized by the media as indicative of excess industry influence on professional activities. And, indeed, it might be appropriate for societies to consider whether funding from industry and income from members should be directed selectively to purposes relevant to those funding sources. It is worth noting that the mistrust between the provider of health services and the worlds of academia and industry became a major public issue in Great Britain about 4 years ago. In fact, a committee of Parliament issued a report expressing concern at the failure of the academic community and the health service to work more closely with the pharmaceutical industry to minimize inappropriate or suboptimal use of drugs in clinical practice.2 Subsequently, in a high-profile report issued early this year, the Royal College of Physicians (which represents a broad range of medical specialists) stated that the interests of patients and their clinicians are best served by close cooperation between academia, industry, and the health services.3 It is unfortunate that we have lagged behind on this side of the Atlantic. Indeed, one of the most telling statements made at the Harvard meeting came from Massachusetts State Representative Michael Rodrigues, who helped lead the opposition in the legislature to a now-enacted law that dramatically curtails interactions between physicians and industry in that state. It was particularly discouraging to hear from this representative that he and his colleagues lost their opportunity to block the legislation when local physician leaders gave up the fight and decided to remain silent. The responsibility of ACRE is to re-establish the partnership of academia, industry, clinicians, and patients in the United States. Among its initial goals is educating the lay public as well as the medical community about the value to patients of the research and educational collaborations between academia and industry. This will be no easy task, for so many negative items have already appeared in the media regarding the alleged manipulation of physicians by industry, usually with only weak rebuttals by academic or industry leaders. Indeed, one of ACRE’s main responsibilities will be to develop a public voice that gets heard and quoted when such issues arise. There already has been one such success: Dr Thomas Stossel, one of ACRE’s leaders and the chair of the Harvard meeting, was invited to testify at a high-profile US Senate hearing on CME in late July. Another of ACRE’s main tasks will be to set up codes of conduct or guidelines designed to ensure that relationships between academic physicians and industry are ethical and clearly targeted at improving outcomes for our patients. This, again, will take considerable thought and discussion. As Dean Flier pointed out, we still need to figure out how best to “strike a wise balance” and create “manageable tension” in optimizing productive interactions between academics and industry. From the perspective of the many of us involved in cardiovascular medicine, it is easy to see the dramatic improvements in patient care that have resulted from the academic-industry partnership in recent years. Major clinical events and mortality have been sharply reduced in such areas as hypertension, lipid disorders, diabetes, heart failure, acute coronary syndromes and chronic kidney disease by this collaboration. ACRE’s members, in common with most physicians, no longer find it acceptable to let others unilaterally set up the rules by which we are expected to function in performing these vital tasks. It is long overdue that we take responsibility for our professional activites in research, education, and practice. More information about ACRE can be found on its Web site: http://www.acreonline.org The site also has information about how to become a member.

Imelda Bates, Kathryn Maitland

In this issue of Clinical Infectious Diseases, Petti and colleagues [1] highlight the need for increased investment in laboratory services to avoid compromising patient care. Health care professionals are waking up to the realization that the development of new drugs and treatment strategies has far outstripped the ability of health care systems to deliver them to individuals who need them. The decision has been made by leading global health care funders that cost should not be a deterrent to providing effective treatment, even in the poorest countries. As a result, there are major drives to rapidly increase availability of antiretroviral drugs and antimalarial combination therapies. A similar and potentially stronger argument for prioritizing effectiveness over cost pertains to the provision of accurate frontline diagnostic services. Yet, as Petti and colleagues [1] illustrate, there is widespread use of “empiricism without laboratory support for diagnosing disease” in sub-Saharan Africa, which would not be tolerated in resource-plenty countries. What can be done to redress the imbalance and bring investments in diagnostics to a level that will support cost-effective deployment of available treatment regimens in sub-Saharan Africa? Let us consider how this might be achieved by exploring opportunities within the major areas of concern discussed by Petti et al. [1]: clinical misdiagnosis, inadequate health care infrastructure, and laboratory capability and diagnostic accuracy. Almost none of these opportunities can be realized by laboratory services in isolation; they depend on close partnerships between technical and clinical professionals and local and national health care managers. For many common infections in sub-Saharan Africa, including severe and nonsevere malaria and septicemia, clinical diagnosis is not adequately sensitive or specific. Because malarial and bacterial infections share similar presenting features, syndromic management [2] results in overtreatment of both conditions, increasing the expense and threatening the longevity of the limited repertoire of inexpensive antimicrobials. Often, frontline medical personnel have to make immediate clinical decisions on the basis of a limited number of diagnostic tests. Equally important are the refinement of this initial diagnosis and the targeting of therapies over the ensuing hours and days, which is greatly facilitated by good diagnostic facilities; thus, the laboratory is the most important determinant in this process. Ideally, rapid and accurate diagnostic testing would be available at the first consultation, to enable personnel to make the correct diagnosis and to avoid the waste of resources and increased ill health associated with incorrect initial diagnoses. In some cases, such diagnostic tools are available but are not in routine use, because they are considered to be too expensive or because they have not been adequately evaluated in real-life situations. Such tools include rapid dipstick malaria tests, anemia and HIV tests, and fingerprick hemoglobinometric tests. Much more investment is needed to evaluate and adapt existing tools and to develop new diagnostic approaches for common conditions. This is likely to be most effectively achieved through partnerships between researchers, policy makers, and commercial companies that are similar to the programs that have been used for drug development (e.g., Medicines for Malaria Venture). The availability of such diagnostic tools is not likely to greatly impact clinical care unless their use is underpinned by evidence-based guidelines that are implemented, supervised, audited, and embedded within local practice. The process of producing guidelines is based on the synthesis of published evidence from diverse sources and then adaptation to suit local circumstances, and it needs to involve collaboration between clinicians and laboratory professionals. A proposal to simplify the complex process of guideline development has been proposed recently by Raine et al. [3]. Laboratory services are one of the most neglected areas of health care provision in sub-Saharan Africa and are disproportionately affected by the staff shortages, poor communications, inadequate equipment, low morale, and lack of training that impinge on all those involved in delivering health care in poorer African countries. The reforms currently underway in the health care sector in many sub-Saharan African countries and the consequent decentralization of planning and financing could be used as an opportunity for laboratory services to move up on the priority list of essential services. This will only happen if laboratories represent themselves on key decision-making bodies, rather than being represented by other sections of health care services, such as pharmacy. Within top-level management, the voice of clinicians is generally much more powerful than that of laboratory professionals. Clinicians therefore have a responsibility to support and advocate for their technical colleagues in the laboratory service, to ensure that they are involved in decisions affecting the laboratory at all levels, and to promote, facilitate, and demand high-quality and responsive laboratory support for effective patient care. The fact that a test was done by a senior technician or that it was performed on a sophisticated piece of equipment in no way guarantees the accuracy of the results. Establishing, maintaining, and demonstrating the accuracy of diagnostic tests is a major challenge for most laboratories in sub-Saharan Africa. To do this, they need to have the skills and resources to institute regular internal quality checks for each test, reliable documentation processes, and access to an external reference center that is itself linked to and accredited by international quality-assessment networks. Laboratories must be able to show that they perform well in such an external quality-assessment scheme before clinicians can be confident that the results of tests they request will be accurate. The complexity and cost of setting up and maintaining such a quality-assurance system means that only a very few laboratories, almost exclusively those that are tertiary or privately owned, can provide evidence that their results are accurate. There are a few examples of innovative local schemes for simple external quality checks on key laboratory tests—for instance, sending blood samples, malaria slides, or sputum smears for tuberculosis diagnosis to neighboring laboratories and then meeting regularly to compare results and to reflect on any discrepancies. In addition, there are particularly good examples of local quality-assurance systems designed to evaluate testing in tuberculosis control programs that could be expanded to include the malaria test (another microscopy-based test) and further extended to other essential laboratory investigations, such as hemoglobin and transfusion-related tests. Even these local schemes require a high degree of motivation and organization by the laboratory staff, as well as support from clinicians and regional or national health care managers. Qualityassurance networks are one of the areas in which nongovernmental organizations and the private sector could play a much greater role, particularly in places where governmental health care systems are ineffective or dysfunctional. Outsourcing external quality assessment to such agencies would bring many mutual benefits, especially because many of the public-sector laboratory staff also work in the private sector. The current international focus on rapidly widening the access to antiretrovirals can be perceived as either a threat to or an opportunity for laboratory services in sub-Saharan Africa. It is a potential threat because strong vertical programs concerned with HIV care and management focus on the HIV-related aspects of laboratory services, thereby fragmenting the service and diverting scarce resources, particularly human resources, away from important non-HIV tests, such as those for malaria, anemia, and tuberculosis. On the other hand, if laboratory aspects of HIV programs are able to integrate into and strengthen existing systems, they will provide a unique opportunity to build the capacity of long-neglected laboratory services in sub-Saharan Africa. It is very surprising that the article by Petti et al. [1], which is wholly concerned with the provision of laboratory services in sub-Saharan Africa, does not include an African author. Is this indicative of the dearth of indigenous laboratory advocates in sub-Saharan Africa? As treatment costs for common conditions increase in poorer countries, the balance must shift away from syndromic management toward achievement of specific diagnoses. Laboratory services will have an increasingly important role to play in improving the quality and effectiveness of patient care, but, to do this, laboratories and their advocates need to be given a much louder voice on the international health care stage. Potential conflicts of interest. I.B. and K.M.: no conflicts.

James N. Weinstein

A hundred times a day I remind myself that my life depends on the labors of other men, living and dead, and that I must exert myself in order to give, in the measure as I have received and am still receiving. Albert Einstein As mere mortals we do not have the skills of Harry Potter or even the great Houdini. Authorship is an honor and a privilege and though there is something magical about scientific writing its unlikely to find a place in Hollywood or even late night television. More likely than not, as is the case in most publications, citation by others is infrequent and stardom doesn’t exist. Most write scientific papers for the pleasure of being involved in something exciting, i.e., a new treatment, technique, or process that is thought to be better than others and certainly no worse. Others write papers because they simply want to share their scientific work with their peers and defend their ideas and methods. They believe that their work will impact others in the field in a positive way. Some believe their results may actually change practice, and or change our understanding of our daily work, whether clinical or experimental. Intellectual Capital Though the efforts of authors and co-authors are not patentable and rarely bring direct monetary gain, they are generally not expended for strictly altruistic motives. The hoped for academic advancement and associated academic promotion that follows successful publication is often accompanied by increased wages. Since the dollars are usually small, the academic and collegial respect gained are often more important. Thus, the intellectual capital of the investigator(s) and author(s) is significant and quantified similarly to the way a business usually evaluates and values their employees. As academically oriented physicians and scientists, our intellectual capital is our major asset. The value of that asset may be reflected in the market by salary and benefits. Like a professional athlete, most of our value is based on our performance. Authorship is one means of evaluating academic performance based on the assumption that much of that performance is reflective of our intellectual capital. After all, there are incredible skills involved in being an author. Though not as recognized as those of an athlete, they are no less impressive. Publishing frequently or in prestigious journals demonstrates to your company (hospital, laboratory, etc.) that your intellectual capital has relative value. It could be likened to fielding percentage in baseball or field goal percentage in basketball or football. In each case you are judged by your performance. In baseball, your batting average may be the most important statistic, unless of course you are a pitcher, where number of wins may be the key performance measure and ERA (earned run average) a secondary measure. As an academic physician, authorship should be but one measure of performance. As a physician, intellectual capital must incorporate your surgical and/or medical skills as well as your diagnostic and clinical acumen. Your value to your institution and your community is a composite. The number of patients seen and/or number of surgeries performed must not be the sole performance criterion of a clinician, nor should the absolute number of experiments performed by a bench scientist. These easily quantifiable attributes would give one a skewed and under-representative sense of one’s intellectual capital. There is yet another layer of confounding added to the attempt to value intellectual capital. Performing surgery or doing the experiment is, of course, difficult, but doing it correctly and achieving the prescribed goal is more dependent on the preparation than the actual procedure. The years and years of training in the classroom, the laboratory and or the operating theater to obtain the necessary intellectual capital and skills, must not be dismissed. With any great athlete, it is the off the field work and the preparation that makes that athlete great. Of course some are born with extraordinary skills, but their work ethic is what makes them great. For example, there are many great basketball players. Why do we remember Michael Jordan? Because Michael Jordan has all the skills but it is his off the court training and work effort that make him the best. In the corresponding world of science and medicine there are also Michael Jordans, like Einstein or Salk. Authors, not unlike great athletes, are interested in having their work recognized and appreciated by those who hear it or read it in the peer reviewed literature. Authors want recognition at a level commensurate with the quality and public importance of their work. Authors who work hard in the preparation of their scientific question, employ the best scientific methods and perform excellent clinical and basic research have the opportunity to publish their work. In so doing they expose themselves to peer review and open discussions for and against their work. But the decision of who should be the lead author and co-author is not unlike that of who gets to be in the starting lineup. Unlike sports, it is not simply the best guy on the team or even the captain. Authorship is very special and needs to be understood by all. Given what’s at stake in the assignment of authorship (e.g., respect and prestige, promotion, tenure), it is an awesome responsibility. So many people contribute to scientific endeavor, at levels ranging from the administrative to the strictly conceptual, that it can be difficult to discern where the lines of authorship should be drawn. However, there have begun to be clear guidelines about who to include as author and who not to. To me, it is all about intellectual capital. Someone had the idea, did the literature search, wrote the grant, coordinated and orchestrated the project, acquired the funding, analyzed the data, interpreted the data, wrote the paper, reviewed and edited the paper (often multiple times), etc. Now it is done and the weighing of who contributed what must be put down in writing upon submission of the paper. Who is included, who is first and last? Seniorship Does Not Mean Authorship Just because you’re the boss doesn’t mean your name should go on every paper. Or just because you’re the best know person at your institution does not mean you deserve authorship (this is known as the Halo Effect). There have been many institutions wherein the most senior person has been a “guest author.” This is neither necessary nor correct. The senior author may be present but if not part of the idea and the writing, editing and/or interpretation they need not be an author. Just reading the paper is not enough. To continue with the athletic and business metaphors, Michael Jordan does not take credit for other team members’ points to make his average better. He does not ask someone else to shoot his free throws and credit those shots to himself. A business person doesn’t usually give credit to others for his/her sales or expect a bonus for work someone else did. Likewise an author can only claim authorship for work they in fact do. Authorship Depends on What You Do, Not Who You Are JAMA deputy editor Drummond Rennie MD, 1 recently modified JAMA’ s Information for Authors to correspond directly to the most recent update of the uniform requirements originally recommended in 1985 and continuously updated by the International Committee of Medical Journal Editors. 2 According to the ICMJE, authorship credit should be based only on: Substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; Drafting the article or revising it critically for important intellectual content; and Final approval of the version to be published. Conditions 1, 2, and 3 must all be met. Acquisition of funding, the collection of data, or general supervision of the research group, by themselves, do not justify authorship. Among other journal editors, Rennie was dismayed to find that these guidelines were being ignored, and decided to follow the leads of the editors of The Lancet and BMJ in requiring that authors disclose their specific contributions to the article, and that the journal actually publish them. 1,3 For simplicity, JAMA provides a list of contributions categories for authors to check off before submission. Spine Policy Authorship is all about performance and valuing intellectual capital. Spine agrees with The Lancet, BMJ, and JAMA that authors should be recognized by their specific contributions to the manuscript under review and has added this requirement to the Information to Authors section. Each author’s contribution must be specified in the submission of a new manuscript. This should be present on the title page with each author’s degrees and institutional affiliation followed by their specific contribution to the submitted manuscript (Table 1). Beginning in the spring of 2003 this information will be published in the electronic version of Spine at the end of each article.Table 1: Authorship Contributions ChecklistOrder of Authors Regarding the issue of author order, Spine recommends that the lead author be the person responsible for much of the “work” as defined by collaborators and the investigative team. In many situations there are a priori criteria established for authorship, as well as a designated person(s) or writing group responsible for making important decisions around the issues of authorship. In some cases the Principal Investigator of a large study will act as the arbiter and decision-maker when potential conflicts of authorship, order, and or attribution arise. Spine supports the concept that the senior author of a work should be last but should not be automatically conferred. Senior authors can and should be first authors when their contribution to the work warrants it. Likewise, statisticians should be authors but not simply for running the numbers. They need to be involved in the study design, data acquisition and data interpretation with the writing team. A good statistician can not work in isolation and be brought on the scene to “save” the day by contributing a “P value.” This is not the way to utilize a statistical colleague nor is it a good use of their talents. Like an athletic team, there are positions each player can identify as their primary role, i.e., goalie, wing man, guard, pitcher, quarterback, etc. In a scientific paper for Spine I would like the authors to identify their contribution to the team. Many institutions around the world now use the Scientific Citation Index (SCI) as a means of quantifying ones academic efforts and the significance of their publications. Spine is ranked 2 in Immediacy and 4 in Impact when compared to all other orthopaedic journals in SCI’s Journal Citation Report, 4 and it is the only musculoskeletal journal listed in the evidence-based medicine lists by Sackett. 5,6 To reach this level of excellence requires us to maintain the highest of standards and to have policies that respect the individual authors, reviewers and readers. We are proud of our publication policies at SPINE and hope that we have clarified any doubts about a very complicated and truly important issue of authorship. As Einstein said, “A hundred times a day I remind myself that my life depends on the labors of other men, living and dead, and that I must exert myself in order to give, in the measure as I have received and am still receiving.” To be accountable for one’s work is an expected responsibility imposed upon authors. In order to maintain the quality and integrity of one’s research and the respect of colleagues, institutions and representative societies, one’s authorship bears much of the burden of proof of one’s intellectual capital. At the same time, as an author you are more often than not dependent on the labors of others. Therefore, you must exert yourself in the contribution you make as an author so as to be deserving of the credit that is associated with authorship and the acclaim and or recognition it brings to bear on that intangible but all important intellectual capital.

David S. Jones

In the early 1970s physicians engaged in fierce debates over the most appropriate method of evaluating the efficacy of coronary artery bypass grafting (CABG). With millions of patients and billions of dollars at stake, CABG sparked fierce controversy. Skeptics demanded that randomized controlled trials (RCTs) be performed, while enthusiasts argued that they already had visual proof of CABG's efficacy. When RCTs appeared, they did not settle the controversy. Participants simply reasserted their preconceptions, defending a trial's strengths or exploiting its flaws. The debate centered on standards of knowledge for the evaluation of therapeutic efficacy. Specifically, cardiologists and cardiac surgeons struggled to assess the relevance of different measures of therapeutic success: physiological or clinical, visual or statistical. Many factors contributed to participants' decisions, including disciplinary affiliation, traditions of research, personal experience with angiography, and assessments of the history of cardiac therapeutics. Physicians had to decide whether angiography provided a meaningful representation of the disease and its treatment or whether demonstrations of therapeutic success could come only from long-term statistical evaluation of mortality data.