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CONFLICTS OF INTEREST HAVE TAKEN AN INCREASingly prominent role in politics, business, and medicine. High-profile examples of undisclosed or incompletely reported financial conflicts of interest have been well publicized. There have been recent investigations by academic centers and lawmakers into unreported conflicts of interest by physicians and recommendations for more transparent reporting of potential conflicts of interest by faculty and researchers. Despite this increased attention, episodes of unreported financial conflicts of interest continue to occur. JAMA editors take issues of undisclosed conflicts of interest very seriously and investigate such allegations rigorously. In investigating such allegations, we follow our standard policies and procedures, which involve conducting our own independent investigation and contacting the authors whose disclosures are challenged. We require the authors to verify or refute the allegations and to provide a detailed explanation to support their position. In addition, we also ask all other authors listed on the article to verify that their published disclosure information was complete and accurate. Once the investigation is complete, when appropriate (not all allegations prove to be accurate) we publish a letter in JAMA that reflects the results of the investigation, including the authors’ explanation for why the conflicts were not initially reported as well as an apology from the authors, along with a formal correction, and thereby correct the record and the medical literature. We have never hesitated to do this and have published several such letters following these same procedures. However, these investigations require due diligence to ensure that the allegations are evaluated fairly and the record is corrected as necessary. This approach is important to ensure due process and also to ensure that no one’s reputation is unfairly damaged due to inaccurate charges and at the same time to make certain that all relevant disclosures—including those that might not have been included in the original allegation—have been identified and addressed. Moreover, because of the sensitive nature of these investigations, we have conducted them confidentially and ordinarily have not revealed the identity of the individual bringing the allegations to the person being accused of failing to report conflicts of interest. The results of the investigation ordinarily are not revealed to any third parties until the letter of explanation and the formal correction are published. Clearly, with this level of diligence, these investigations into undisclosed conflicts of interest are time-intensive and require careful attention. To avoid misunderstanding about our policies and procedures, we are clarifying certain aspects regarding our approach for investigations into allegations of unreported potential conflicts of interest. JAMA requires that the individual bringing the allegations provide a written detailed explanation of the unreported conflicts of interest and provide documentation to support the allegation. We will explain to the person bringing the allegation that gaining full cooperation of all parties with knowledge of the facts is likely to be enhanced by maintaining confidentiality while the investigation is under way. This approach has proven to be vital in delicate situations, such as those requiring the assistance of deans. Furthermore, the person making the allegation will be informed about progress of the investigation and will be notified when the investigation is completed. In addition, once the investigation into unreported conflicts of interest is completed and the letter of explanation and the correction (if necessary) are finalized, those documents will be immediately posted online and linked from the article, and then subsequently published in the print journal. The duty to disclose and report potential conflicts of interest hinges on trust and patience, and a common bond among authors, deans, editors, and readers recognizing that reporting the best available biomedical science matters most. Pressures to publish rapidly, reports in the news media, and comments on blogs and advocacy sites must not overwhelm the process of thorough and fair investigation when reputations are at stake. A rush to judgment may spark heat and controversy, but rarely sheds light or advances medical discourse. JAMA has been a leader in developing and enforcing policies on conflicts of interest. We have dedicated our professional efforts to doing all we can to ensure that articles

ONCE AGAIN HEALTH CARE REFORM IS A NATIONAL priority, and President Obama has made a commitment that his administration will work to ensure health care for all US citizens. It is assumed that this includes the 47 million individuals who are currently uninsured and the other millions who have inadequate insurance because they lack the financial means to purchase adequate health care. The United States has assiduously opted not to join other developed nations by enacting a national health service, a national health insurance, or any single-payer health system, and there is little likelihood that this will occur now. Why is this the case? The United States is a nation built on commitment, certainly to freedom and to capitalism. But what has happened to the entreaty “Give me your tired, your poor, your huddled masses yearning to breathe free . . . ,” inscribed on a bronze plaque currently located inside the Statue of Liberty exhibit? Perhaps US citizens have become too tired and there are too many poor, huddled masses yearning, so the sense of community has dramatically changed. Certainly, especially in current times of great economic stress, few if any want to provide for those who can provide for themselves but will not. Commitment to community means all doing whatever they can to provide for themselves and family and then providing whatever they can to help those who, for legitimate reasons, simply do not have enough. Perhaps it is unrealistic to believe that there are enough resources in the United States to ensure that no citizen should go hungry or without shelter or health care. But knowing how the United States has prospered despite great stresses such as wars and financial depressions, it seems logical to hope that the nation can once again prosper and share that prosperity with all deserving Americans. One aspect of health care can serve as an example of how commitment to community could work. There has been a maldistribution of US physicians by specialty and geography for many decades. The solution for maldistribution by specialty rests primarily on eliminating the lack of primary care physicians and perhaps the lack of general surgeons. In 2008, only 16.9% of medical students chose the primary care specialties of general internal medicine (5.1%), family medicine (6.1%), and general pediatrics (5.7%), and only 6% chose general surgery. In addition, 87.6% of medical students graduate with loans, and 79.3% graduate with loans of more than $50 000. The mean educational debt for indebted medical school graduates is $139 517. With that degree of indebtedness, and considering the current salaries of generalist physicians, the likelihood is low that more medical school graduates will choose primary care. One peculiarity is that this is not true for general pediatricians. In this issue of JAMA, Freed and Stockman report that, over the past 3 decades, there has been a steady increase in the ratio of generalist pediatricians from 32 per 100 000 children aged 0 to 17 years to 78 per 100 000 in 2005. However, although the number of generalist pediatricians does not appear to be a problem, their geographic maldistribution remains. The current lack of primary care physicians, at least for adults, especially in underserved areas, is not a new phenomenon, and several solutions to alleviate this problem have been proposed. One attempted solution to the primary care problem was to increase the number of medical schools in the United States. A total of 41 new medical schools were opened in the United States between 1970, when there were 85 schools, and 1990, when there were 126 schools. The majority (27) of these new schools were opened in the 1970s (Henry M. Sondheimer, MD, Association of American Medical Colleges; oral communication). Graduating more physicians from more medical schools clearly did not solve the issue of specialty or geographic maldistribution. Another proposed solution centered primarily on the relatively low reimbursements to primary care physicians when compared with subspecialists. In this issue of JAMA, Baron proposes that a more substantial problem affecting primary care is the lack of capacity for generalist physicians to perform well despite their intentions. This problem is a function of both the mental models of primary care (ie, taking responsibility for advocating for and supporting patients) and the available funding to support that care. This problem is exemplified by Wu, also in this issue of JAMA, who writes about his experience with one patient in A Piece of My Mind.

Professional medical associations (PMAs) play an essential role in defining and advancing health care standards. Their conferences, continuing medical education courses, practice guidelines, definitions of ethical norms, and public advocacy positions carry great weight with physicians and the public. Because many PMAs receive extensive funding from pharmaceutical and device companies, it is crucial that their guidelines manage both real and perceived conflict of interests. Any threat to the integrity of PMAs must be thoroughly and effectively resolved. Current PMA policies, however, are not uniform and often lack stringency. To address this situation, the authors first identified and analyzed conflicts of interest that may affect the activities, leadership, and members of PMAs. The authors then went on to formulate guidelines, both short-term and long-term, to prevent the appearance or reality of undue industry influence. The recommendations are rigorous and would require many PMAs to transform their mode of operation and perhaps, to forgo valuable activities. To maintain integrity, sacrifice may be required. Nevertheless, these changes are in the best interest of the PMAs, the profession, their members, and the larger society.

THE HOLIDAY SEASON IS TRADITIONALLY A TIME FOR HOPEfulness as the new year begins. With the promise of a new administration in Washington, there is a renewed sense of optimism for health care reform and hope for better health care for all in the United States. In this Editorial, we start today by reflecting on the essence of personal health care that is based on the depth of the relationship between patient and physician so eloquently described by Peabody: “The treatment of a disease may be entirely impersonal; the care of a patient must be completely personal.” Personal care begins with establishing a sense of hope for the patient and seeking to maintain that sense throughout the course of treatment. For patients, that means a hopeful prognosis; a promise that something can be done for their illness; that they will be actively involved in their treatment; or knowledge that hospice care may provide solace for their last days if their illness is terminal. Hope begins with sincere emotional engagement with a physician who addresses the patient’s fears. The human nervous system has evolved to allow for hope. With hope, sleep is restorative, easing daytime fears as emotion is modulated while dreaming, allowing for waking more refreshed and alert to the challenges of a new day. The physician’s warm reassuring facial expression is a product of the evolution of the family unit and facilitates hopefulness. Social engagement is elicited on the most basic level when a physician asks a patient to breathe slowly and relax as the physician speaks to the patient with quiet gentle prosody to facilitate objective listening. Listening, the patient spontaneously orients to the face of the physician who seeks to engage the patient by looking into his or her face and eyes. Meaningful social encounter slows the heart, regularizes breathing, and primes the mind to listen. When fully engaged, a patient feels safe. That sense of comfort helps explain why the effect of one person on another is so potent. It also may account for elements of the placebo effect, a real physiologic response linked to reward centers in the brain, immune functioning, and possibly to the release of restorative hormones such as oxytocin. The psychological experience is that of hopefulness achieved by the balancing of mistrust and trust. Often a patient comes to a physician with a sense of disquiet and dis-ease, not knowing what to expect but hoping to be restored, while fearing the worst. Anxiety is distracting to a patient and makes it difficult for him or her to listen to what a physician has said or is saying. Worse still is despair, when a patient gives up hope completely and shuts down emotionally. How can a physician reassure a patient who is so distressed and ensure that the patient leaves with the expectation that something can be done and is hopeful about his or her condition? To illustrate the importance of this reassurance, Engel described the course of a patient in an emergency department who had a first myocardial infarction that progressed to cardiac arrest during the medical evaluation. After recovery the patient reported having felt helpless, angry, and impotent about his medical care because of the impersonal way he had been treated prior to the cardiac arrest. Engel had earlier proposed that in an interview a physician should look for signs of hopelessness. The hopelessness gesture that he so eloquently described is recognized in the midst of the interview or examination when the patient sighs and reaches out toward the examiner. This reaching out is followed by dropping the arms in resignation and flattening of the facial expression when it goes unrecognized. Like a child who reaches to be picked up and, being ignored by the parent, turns away and begins to cry, the adult too seeks support; but in the adult, reaching out for emotional support is more subtle. A physician should be alert for the hopelessness gesture and consider it a clinical sign and an opportunity to reestablish hope, attend to the patient’s disquiet, and console him or her before moving on to the next step of the interview or examination. Modern medical practice intent on completing the electronic medical record or getting to the physical examination risks sacrificing personal care when too much attention is directed to data collection and too little to the patient. To sustain hope following an encounter with a very sick patient, a physician should consider it an obligation to convene a support group of family, friends, and community members. A confiding relationship with a spouse, close family friend, community member, or physician is a potent force for a patient dealing with an illness and for sustaining hope. A close confiding relationship may reduce rates of rehos

FULFILLING THE KEY OBJECTIVE OF JAMA, “TO PROmote the science and art of medicine and the betterment of the public health,” involves publishing the most important biomedical investigations and clinical research articles possible. Rigorously conducted randomized clinical trials (RCTs) provide the highest level of scientific evidence for interventions and treatment to enable physicians and other practitioners to provide better care for patients and ultimately to improve the health of the public. Therefore, publication of high-quality, major RCTs represents a top priority for JAMA. JAMA has published a substantial number of major RCTs, including landmark trials that were immediately practice changing; major clinical trials with important practical application and implications; and innovative, cutting-edge trials that have advanced biomedical research. Although observational studies and systematic reviews also are extremely important and valuable sources of scientific and clinical information, RCTs will continue to receive the highest consideration for publication. For authors of RCTs, JAMA offers the advantages of large circulation (print circulation of more than 350 000), extensive reach (approximately 2 million Web site page views per week), high impact factor (23.2), and short time to publication (median of 81 days from submission to acceptance, and 37 days from acceptance to publication). The Instructions for Authors published in this issue of JAMA includes detailed information about manuscript preparation and submission. Many aspects of these instructions are specific for clinical trials and should be helpful for authors preparing manuscripts reporting results of RCTs. Several important features related to RCTs deserve emphasis. First, as a condition of consideration for publication, JAMA requires that all RCTs must be registered in a public trials registry that is acceptable to the International CommitteeofMedical Journal Editors (ICMJE) and that requires the minimumregistrationdatasetasdescribedbytheICMJE.For JAMA, the acceptable trial registries include the following: Australian New Zealand Clinical Trials Registry (http://www.anzctr .org.au); ClinicalTrials.gov (http://www.clinicaltrials.gov); ISRCTN Register (http://isrctn.org); the Nederlands Trial Register (http://www.trialregister.nl/trialreg/index.asp); and UMIN Clinical Trials Registry (http://www.umin.ac.jp/ctr). Clinical trials for which patient enrollment began after July 2005 should have been registered before the onset of patient enrollment. All clinical trials, regardless of when they were completed, must have been registered and these trials, as well as secondary analyses of the original trial data, must include the trial registration number in the abstract of the manuscript at the time of submission. JAMA’s requirement for trial registration differs somewhat from requirements for registration in the recently enacted Food and Drug Amendments Act of 2007; for instance, JAMA requires registration of all RCTs (except for phase 1 trials) that randomize human research participants to an intervention, not only those trials involving drugs or devices subject to provisions of the Federal Food, Drug, and Cosmetic Act. Second,authorsofclinical trialsshouldfollowtheCONSORT guidelines for reporting RCT results, including submitting a detailed patient flow diagram. For efficacy trials, the primary results should be presented based on intention-to-treat analysis, including and accounting for all randomized patients in the analysis, and if necessary, using appropriate methods toaccount formissingdata (suchas imputationmethods,baseline values carried forward, etc). Other analyses, such as “completers” or “per-protocol” analyses, may be reported, but the intention-to-treat analysis generally should be reported as the primary analysis. In addition, authors are encouraged to submit protocols of RCTs along with their manuscripts. Third, for all RCTs, data analysis must be conducted by an academic statistician. For industry-sponsored RCTs in which the data analysis is conducted only by statisticians employed by a company sponsoring the research, JAMA requires that a statistical analysis also be conducted by an independent statistician at an academic institution, such as a medical school, academic medical center, or government research institute, that has oversight over the person conducting the analysis and that is independent of the commercial sponsor. The independent statistician should review the study protocol and determine the appropriateness of the prespecified data analysis plan, should receive the entire raw data set, and should conduct an independent data analysis; the results of the independent analysis should be the results reported in the manuscript.

THE PRESSING INTEREST AND CURRENT ACTIVITY SURrounding health care access and health system reform by physicians, other health care professionals, policy makers, and the public is well justified and increasingly urgent. Health care expenditures in the United States are at an all-time high and are projected to exceed $2 trillion in 2006, with Medicare and Medicaid accounting for more than $400 billion and more than $300 billion, respectively. At the same time, the number of individuals with inadequate health insurance coverage also has reached an all-time high: nearly 47 million are uninsured and at least 16 million more are underinsured. In addition, some companies that traditionally have provided employer-sponsored health insurance are eliminating this benefit or reducing coverage and benefit levels, and many more are shifting an increasing proportion of health care costs to their insured employees. As a result, many insured individuals are responsible for an increased share of health insurance premium costs, for increased out-ofpocket costs for some medical services due to reductions in first-dollar coverage and increased individual and family deductible levels, and for increased costs and copayments for medications, due to reductions in prescription drug benefit plans. Moreover, the time in which the baby boom generation will enter Medicare is rapidly approaching, potentially threatening the financial stability and longterm viability of this major health care funding institution. Along with these alarming trends in expenditures and health insurance coverage, there are several major problems at the clinical care delivery level in the US health care system. For instance, medical care has become increasingly fragmented, and patients are often left to navigate and negotiate through a bewildering and complex system. At the same time, advances in medical science more than ever offer the possibility of reducing the morbidity and mortality associated with serious diseases, yet access, availability, and cost prevent many patients from benefiting from these latest discoveries and from receiving the quality of care that should be available. Compared with outcomes in some other industrialized countries, some broad measures of health in the United States are mediocre at best, while only in the overhead costs of running this chaotic enterprise does the United States lead the world. Perhaps most concerning, physicians continue to be increasingly frustrated by insurance company administrators and legislators making decisions that directly affect patient care and medical practice, and dictating policies that govern determining and obtaining compensation for clinical care. These and other factors make achieving meaningful reform in the US health care system, and specifically addressing the issue of access to care, critical priorities. This issue of JAMA includes a collection of articles that provide new data and thoughtful perspectives on important issues involving various aspects of access to care, as a critical component of comprehensive health system reform. Perhaps the most important factors that must be considered in any discussion of access to health care are quality of care and health care outcomes. In general, forgoing or delaying necessary medical care, including preventive interventions, diagnostic testing, or medical or surgical treatment, is associated with worse health outcomes, as shown in 2 longitudinal observational studies reported in this issue. In their multicenter study of 2498 patients hospitalized for acute myocardial infarction, Rahimi and colleagues found that self-reported financial barriers to health care services (18.1% prevalence) or medication (12.9% prevalence) were common, even among the roughly 69% of patients with health insurance. At 1-year follow-up, financial barriers to health care or to medication were associated with significantly worse recovery after myocardial infarction, manifested as higher rates of angina, increased risk of rehospitalization, and poorer quality of life. In another study, Hadley used data from sequential interviews from the national Medical Expenditure Panel Survey (1997 through 2004) to compare medical care use and health changes among uninsured and insured nonelderly individuals who experienced a “health shock” caused by an unintentional injury (15 866 individuals) or onset of a chronic medical condition (7954 individuals). Following such a health shock, those who were uninsured reported that they received less medical care, had less medication use

SINCE THE MID-1980S, JAMA AND OTHER MEDICAL JOURnals have encouraged authors to disclose conflicts of interest that they may have in the subject matter of their manuscripts. In 1989, JAMA began requiring authors to sign a statement declaring all potential financial conflicts of interest and began including all such disclosures in published articles. Since that time, the journal’s conflict of interest policy has continued to evolve with the goal of improving disclosures and transparency for all involved. For example, the policy applies to all types of manuscripts, including letters and book reviews, and to all individuals involved in the review, editorial evaluation, and publication process, including peer reviewers, editorial board members, and editors. Most recently, JAMA began requiring authors to specifically indicate if they have no conflicts of interest in the subject matter of their manuscript. The International Committee of Medical Journal Editors (ICMJE), the Council of Science Editors (CSE), and the World Association of Medical Editors (WAME) have similar policies. However, biomedical journals have a wide range of conflict of interest policies (eg, some request disclosures, some require disclosures, and some publish disclosures and some do not). Journals also define relevant conflicts of interest in different terms to include financial and nonfinancial conflicts or only financial interests, and for financial interests, may define relevance in different monetary amounts or lengths of time. Perhaps because of these different policies, some authors may not fully understand JAMA’s requirements for reporting potential conflicts of interest and might not fully disclose their conflicts of interest to JAMA at the time they submit their manuscripts. For example, some authors completely disclose all relevant conflicts of interest in the submitted manuscript, whereas other authors disclose relevant interests in a cover letter or only in the authorship form. The result is an inconsistent approach whereby for some authors, the disclosure is completely transparent to all involved in the manuscript evaluation process, including peer reviewers; but for other authors, the disclosure is made public only at the time of publication. In addition, some authors continue to misunderstand what is expected and provide inaccurate or incomplete disclosures that are discovered after publication and result in a published correction or letter of explanation. To further improve the transparency of reporting of potential conflicts of interest and to encourage more accurate and complete disclosures, an important new policy is that JAMA will begin requiring all authors to disclose all potential conflicts of interest in the Acknowledgment section of the manuscript at the time of submission. This includes specific financial interests and relationships and affiliations relevant to the subject of the manuscript. Between now and the end of 2006, JAMA will permit submissions of manuscripts in which authors’ conflict of interest information is not yet included in the manuscript, but with the understanding that this information will be obtained and submitted promptly—and definitely before any revisions are considered. Beginning January 2007, JAMA will require that complete disclosures of conflicts of interest from all authors, including declaration of no conflicts of interest, are included in the Acknowledgment section of the manuscript. JAMA’s Web-based manuscript submission system will require the corresponding author to indicate that this information is included in the manuscript at the time of submission. Authors will continue to complete and sign an authorship responsibility form that includes statements on conflict of interest as well as funding and support. Conflicts of interest in biomedical science continue to be under intense and increasing scrutiny. To help ensure transparency and complete reporting of this information, JAMA’s policies on conflicts of interest have been updated (as noted below). All authors are encouraged to read these policies carefully and to follow them completely. By doing so, peer reviewers and editors can expect full disclosure of potential conflicts of interest in manuscripts submitted to JAMA, and physicians, other health care professionals, and the public can expect complete reporting of conflict of interest information in articles published in JAMA.

THIS YEAR IT WAS MY HONOR TO HAVE BEEN THE COMmencement speaker at 3 medical schools: Drexel University, University of California, Los Angeles (UCLA), and the University of Texas at Houston. On each occasion, I felt the same euphoria that I had at my own graduation and at the other commencements in which I spoke or, as Vice Dean of Academic Affairs and Faculty at Johns Hopkins School of Medicine, helped with the proceedings. It is exhilarating to experience, up close and personally, the enthusiasm and excitement of so many new physicians who clearly sense their potential to help those who will seek their care, and who want to fulfill their dreams of doing so. One of the most touching of all moments in this year’s ceremonies occurred at UCLA. The “benediction” involved 24 graduating physicians joining the chaplain on stage to speak in the native language of their ethnic groups, no matter whether they were 1stor 10th-generation Americans. The 24 languages spoken ranged from Afrikaans through Gujarati, Hindi, Mandarin Chinese, Tigrinya, and Urdu to Vietnamese. The phrase each graduate spoke was, “May we leave here to cure when possible, and to care always.” What could be better wishes for healers to declare publicly? I wept along with most in the audience. Early the next morning, I flew to San Diego to speak at an international meeting of subspecialists; which subspecialty is unfortunately irrelevant because it could have been almost any one. The geographic distance is 111 miles; the psychological distance was an eternity. As I walked off the plane, I was greeted with several ads prominently placed in the airport inviting physicians to visit one exhibit booth or another. It’s a free country, so why not? It was too early to check into the hotel, so I went to the convention center to register. On the way I passed hundreds of people (many certainly were physicians) walking from the center with identification cards in plastic cases hung around their necks on a ribbon emblazoned with the name of a pharmaceutical company. They were also carrying cloth bags adorned with large logos of several pharmaceutical companies—oh, and also the name of the subspecialty society. I politely declined both when they were offered to me, much to the chagrin of the sweet woman who worked the registration desk. When I arrived at the room where I was to speak, a giant placard outside listed the names of the speakers and times of presentations—and the announcement by the names of several speakers that their presentations were sponsored by a particular pharmaceutical company. Of course, there were statements all over the podiums and in the rooms stating that all “sponsored” discussions involved funds from “unencumbered educational grants” that had nothing to do with the choice of speakers or topics. The spirit displayed at the conference was in such contrast to that displayed at the previous day’s commencement. What happened to the altruistic, “above all, help the patient” spirit? After completing my presentation on conflicts of interest (the conference committee apparently had a sense of irony), I returned to the hotel to register. I was handed my room key: a plastic card with the name and logo of a pharmaceutical company on one side and an invitation to “visit us at booth #1501.” Once again, I wept—this time, alone.

RESEARCH STUDIES IN BIOMEDICAL JOURNALS ARE INcreasingly scrutinized, not only for their scientific findings and clinical and public health implications, but also because of concerns related to conflicts of interest of investigators and concerns about misleading reporting of industry-sponsored research. The perception that conflicts of interest or financial concerns may have potentially detrimental effects on medical science has prompted medical journals to critically examine and more vigorously enforce policies for disclosure of potential conflicts and for reporting of relationships with industry. The need for transparency in reporting the financial conflicts of interest of authors and the relationships between investigators and funding sources has never been greater and is essential to help maintain confidence and trust in the scientific integrity of medical research articles. In this editorial, we review and update our policies for authors reporting conflicts of interest and disclosing financial support and other paid contributions for their work, as well as the requirements for reporting of industry-sponsored studies. Much of this information and the rationale for these policies have been described in previous editorials and are detailed in the current JAMA Instructions for Authors. Reporting Financial Conflicts of Interest. All authors of all manuscripts submitted to JAMA (including research reports, reviews, opinion pieces, letters to the editor, and book reviews) are required to report potential conflicts of interest, including specific financial interests relevant to the subject of their manuscript. Authors are expected to provide detailed information about any relevant financial interests or financial conflicts within the past 5 years and for the foreseeable future, particularly those present at the time the research was conducted or the paper was written and up to the time of publication. Authors also must report other financial interests that represent potential future financial gain, such as relevant filed or pending patents or patent applications in preparation. Although many universities and other institutions and organizations have established policies and thresholds for reporting financial interests and other conflicts of interest, JAMA requires complete disclosure of all relevant financial relationships and potential financial conflicts of interest, regardless of amount or value. Authors who are uncertain about what might constitute a potential financial conflict of interest should always err on the side of full disclosure and should contact the editorial office if they have questions or concerns. To report this information, each author is required to sign and submit the following disclosure statement on the JAMA authorship form: “I certify that all my affiliations with or financial involvement, within the past 5 years and foreseeable future (eg, employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, royalties) with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript are completely disclosed.” Authors may include these disclosures on the JAMA financial disclosure form or should indicate that the disclosures are included in an attachment to the form or in the manuscript. In addition, authors who have no relevant financial interests should provide a statement indicating that they have no financial interests related to the material in the manuscript. Authors will be reminded to report this information at the time they submit their manuscript via our online manuscript submission and review system. For all accepted manuscripts, each author’s disclosures of relevant financial interests or declarations of no relevant financial interests will be published. Decisions about whether financial information provided by authors should be published, and thereby disclosed to readers, are usually straightforward. Editors are willing to discuss disclosure of specific

IN THIS ISSUE OF JAMA, WE ARE PUBLISHING A LETTER OF apology from Staats for duplicate publication of data from a randomized controlled trial of ziconotide for treatment of pain in patients with cancer or AIDS. Staats is the first author of the report of this trial, which was published in JAMA in January 2004. However, most of the data from this study had been reported 4 years earlier by Mathur in a review article in another journal. Determining which article is original and which is duplicate is not a simple task. If duplication is determined by which report was published first, the article by Mathur is clearly the first publication of the data from this trial. But is it really the original report of this trial? The issue is whether to define originality by publication date vs the authorized complete report from those responsible for the conduct of the study and the collection, analysis, and interpretation of the data. By my reasoning, the article by Staats et al is a duplicate publication of the trial data, but it is the original full report of the trial from the investigators who conducted the study. This major infraction involving publication of the same data in 2 journals raises several key issues, and it might be helpful, especially for young investigators, to learn from this episode. Mathur’s article was a seminar review article that included data from 2 clinical trials of ziconotide as well as other information about the mechanism of action and pharmacologic profile of the drug. However, the reference for the duplicate data, analysis, and conclusion was an abstract reporting data only on patients with AIDS-related neuropathic pain. Only 12% of the patients in the article by Staats et al had AIDS; the other 88% were patients with malignancies. So considering that neither Staats nor any of the coinvestigators are coauthors of the article by Mathur, and that Mathur is not a coauthor or is not acknowledged on the article by Staats et al, it is unclear how Mathur obtained the rest of the data. According to the information in the publication, Mathur was a “current consultant for and past employee of Neurex Pharmaceuticals (a business unit of Elan Phamaceuticals),” the company that manufactures ziconotide. Therefore, Mathur had access to the data on file. According to Staats, “[Mathur’s] submission was sent without my permission or notification, and without citing my coauthors and me.” However, the article by Staats et al does include a citation to the article by Mathur. Neurex Pharmaceuticals apparently condoned the publication of Mathur’s article since it provided access to the data file and signed off on the article by Mathur (V. Mathur, oral communication, August 30, 2004). In addition, the physician who alerted JAMA to the duplicate publication reportedly had been given a reprint of Mathur’s article by a representative of the company soon after it was published. According to Staats, the initial draft manuscript reporting the trial results was sent to the company around 1998, but it is unclear why 5 years elapsed before the paper was submitted to JAMA (in May 2003). Such delays between study completion and manuscript preparation and submission to a journal can lead to all sorts of problems. One major problem, according to Staats, was that “in our successive revision process the reference was augmented by the citation of the article by Mathur.” Regardless of whether this reference was added by a coauthor, an undisclosed contributor, or a “ghost writer,” Staats, the lead and corresponding author, by his own admission, should have read (reread) the manuscript and all references. This episode of duplicate publication illustrates several important points. First, editors should make sure that all data in a manuscript are properly referenced except, of course, those data reported as part of an original study. Investigators should (1) make sure the agency or company funding the study agrees at the onset not to publish or release data from the study conducted by the investigators without obtaining permission or at least informing the investigators; (2) disclose the existence of all writing and editing assistance, and not use ghost writers or ghost contributors; (3) carefully read and review the original draft and all successive drafts, including the references; (4) prepare the manuscript and submit it for publication as soon as possible after completion of the study; and (5) notify the editor and provide copies of related papers or reports at the time of submission. Duplicate publication is a serious issue that raises concerns about copyright and ethical conduct. Duplicate publication also wastes valuable resources and causes problems for researchers, especially those who conduct meta

JUST 1 YEAR AGO, IN AN EDITORIAL INTRODUCING A THEME issue on “Basic Science and Translational Research in JAMA,” we stated, “The magnitude, scope, sophistication, and funding support for biomedical research are unprecedented and continue to increase dramatically.” That statement is even more true today. The National Institutes of Health funding has doubled during the past decade; the initial sequence and analysis of the human genome was published in 2001; and advances in neuroscience, molecular medicine, diagnostic radiology, robotic surgery, pharmacology, and many other areas herald the application of basic science to clinical medicine. Except for theme issues, articles reporting the results of basic science investigations or preclinical translational research have seldom been published in JAMA. However, it is important for physicians and other health care professionals to maintain an awareness of important scientific advances and promising discoveries in biomedical research. Accordingly, in this issue of THE JOURNAL, we are introducing a new section on Translational Medical Research. This section is intended to provide a forum for publication of basic science and translational research studies, with emphasis on studies of novel discoveries that advance the understanding of disease mechanisms and provide insights that may prove helpful in improving the diagnosis, treatment, and prevention of common diseases and conditions. The first article in this section illustrates a series of elegant investigations by Imai and colleagues that explore possible mechanisms underlying a highly lethal syndrome in critically ill patients. The authors began with the important clinical observation that patients with acute respiratory distress syndrome (ARDS) often experience multiple organ dysfunction and postulated that an injurious ventilatory strategy may lead to end-organ epithelial cell apoptosis and organ dysfunction. Using an in vivo animal model of aspiration, Imai et al demonstrated that an injurious ventilatory strategy increased epithelial cell apoptosis in the kidney (especially in LLC-RK1 renal tubular cells) and the small intestine and led to increased levels of biochemical markers indicating renal dysfunction. Then, in an in vitro model, the authors used plasma from the ventilated animals and induced apoptosis in LLC-RK1 renal tubular cells and found that a fusion protein that blocks soluble Fas ligand (a circulating pro-apoptotic factor) attenuated apoptosis induction. Finally, in an investigation using samples from patients previously involved in a clinical trial of a lung protective strategy, the authors found a significant correlation between changes in soluble Fas ligand and changes in creatinine in patients with ARDS. Investigations such as this and other translational research studies often reflect a “bench to bedside” or a “bedside to bench and back to bedside” approach that begins with a challenging clinical problem or observation, involves rigorous investigation with application of basic science techniques and discoveries, and brings new insights about important clinical problems back to the clinical interface, along with potential directions for the next steps in future research. Perhaps more important, most translational research studies require close collaboration between basic scientists and clinical researchers, with synergistic effects resulting from shared expertise and dedicated efforts to solve challenging problems. Although the clinical research enterprise currently is facing several important challenges, breakthrough discoveries in basic biomedical science must continue to be translated effectively to human studies to advance clinical science, expand medical knowledge, and ultimately improve patient care and health. We encourage authors to submit studies of rigorous, highquality basic science and translational research that extend along the “bedside to bench” and “bench to bedside” continuum for consideration for publication in the Translational Medical Research section of THE JOURNAL. Our goal is to encourage investigators to report their research and enable clinicians to gain broader insight about basic mechanisms of disease that will ultimately lead to better care of patients.

Importance Glioblastomas and malignant gliomas are the most common primary malignant brain tumors, with an annual incidence of 5.26 per 100 000 population or 17 000 new diagnoses per year. These tumors are typically associated with a dismal prognosis and poor quality of life. Objective To review the clinical management of malignant gliomas, including genetic and environmental risk factors such as cell phones, diagnostic pitfalls, symptom management, specific antitumor therapy, and common complications. Evidence Review Search of PubMed references from January 2000 to May 2013 using the terms glioblastoma , glioma , malignant glioma , anaplastic astrocytoma , anaplastic oligodendroglioma , anaplastic oligoastrocytoma , and brain neoplasm . Articles were also identified through searches of the authors’ own files. Evidence was graded using the American Heart Association classification system. Findings Only radiation exposure and certain genetic syndromes are well-defined risk factors for malignant glioma. The treatment of newly diagnosed glioblastoma is based on radiotherapy combined with temozolomide. This approach doubles the 2-year survival rate to 27%, but overall prognosis remains poor. Bevacizumab is an emerging treatment alternative that deserves further study. Grade III tumors have been less well studied, and clinical trials to establish standards of care are ongoing. Patients with malignant gliomas experience frequent clinical complications, including thromboembolic events, seizures, fluctuations in neurologic symptoms, and adverse effects from corticosteroids and chemotherapies that require proper management and prophylaxis. Conclusions and Relevance Glioblastoma remains a difficult cancer to treat, although therapeutic options have been improving. Optimal management requires a multidisciplinary approach and knowledge of potential complications from both the disease and its treatment.

quality care. Plaintiffs’ attorneys, physicians, and patient safety proponents need to work toward achieving their stated central motivation (ie, protecting patients from medical errors and fairly compensating the unfortunate few who nevertheless sustain avoidable injuries). Even as states continue to reform tort law and the patient safety movement makes progress toward its goals, health care generates large numbers of avoidable injuries from medical errors—most of which the legal system fails to compensate. Regardless of how fanciful this may sound in the face of entrenched contrary experience, now is the time for the disparate and opposing forces to find a way to focus together on “the large number of patients who die unnecessarily each year from medical errors” rather than a continuance of actions reflecting the visceral antipathy of many physicians and lawyers to one another.

Access to medical information via the Internet has the potential to speed the transformation of the patient-physician relationship from that of physician authority ministering advice and treatment to that of shared decision making between patient and physician. However, barriers impeding this transformation include wide variations in quality of content on the Web, potential for commercial interests to influence online content, and uncertain preservation of personal privacy. To address these issues, the American Medical Association (AMA) has developed principles to guide development and posting of Web site content, govern acquisition and posting of online advertising and sponsorship, ensure site visitors' and patients' rights to privacy and confidentiality, and provide effective and secure means of e-commerce. While these guidelines were developed for the AMA Web sites and visitors to these sites, they also may be useful to other providers and users of medical information on the Web. These principles have been developed with the understanding that they will require frequent revision to keep pace with evolving technology and practices on the Internet. The AMA encourages review and feedback from readers, Web site visitors, policymakers, and all others interested in providing reliable quality information via the Web.

In this issue of JAMA, we are publishing the names of the 3804 peer reviewers who reviewed manuscripts for JAMA in 2012

Children of mothers who smoked during pregnancy had IQ scores that were lower than the scores of children born to mothers who did not smoke. Routine use of nebulized steroids for croup can potentially reduce the need for hospitalization.

A disturbing observation is the recent increase in the use of LSD and other hallucinogens by younger adolescents. Almost 90% of high school seniors in 1992 reported some experience with alcohol in the past. In 1991, some of the highest rates of gonorrhea were among adolescents aged 15 to 19 years.