National Institutes Of Health Panel Research Articles

Dyslipidemia Screening of 9- to 11-Year-Olds at Well-Child Visits by Utah Pediatricians.

In 2011, an expert National Institutes of Health panel published the "Integrated Guidelines for CV Health and Risk Reduction in Children and Adolescents," which recommended screening all children aged 9 to 11 years for dyslipidemia. It is unknown if this guideline is being followed. We surveyed members of the Utah chapter of the American Academy of Pediatrics to determine whether they performed universal lipid screening at well-child visits (WCV) on their patients at 9,10, or 11 years and how comfortable they were with evaluating and/or managing children with dyslipidemia. Of the 118 respondents who practiced primary care, only 18 (15%) screened all children at WCV; 86 (73%) tested "some," most commonly children who were obese or had a positive family history. 18% were unfamiliar with the guidelines; 28% were familiar with the guidelines but felt they were "inappropriate;" 98 (84%) of the respondents said they were "very or somewhat comfortable" evaluating children with dyslipidemia.

An updated National Institutes of Health consensus panel on bariatric surgery.

The last time the National Institutes of Health (NIH) convenedaconsensuspanel onbariatric surgery,manyofour currentmedical studentswere still in diapers. At that time, fewer than 10 000 bariatric procedureswere done annually and the most commonly performed bariatric operations were the vertical banded gastroplasty and open Roux-en-Y gastric bypass. The landscape has changed dramatically since then. Bariatric surgery has become one of themost commonly performed general surgery procedures and it is almost exclusively performed laparoscopically, with a good safety profile. Verticalbandedgastroplastyhasbecomeobsoleteandthemost commonlyperformedbariatricprocedure is laparoscopicsleeve gastrectomy, whichwas not even on the radar screen in 1991. Despite all of these changes, decisions about who should receive bariatric surgery are still based on the 1991 NIH consensus panel. Although evidence on the effectiveness of bariatric surgery was limited at that time, the original NIH panel had a substantial impact on decisionmaking and opened the door for the dramatic growth in the field since then. In this issueof JAMASurgery, Courcoulas et al1 present the report from the second NIH consensus panel. It does not appear that the second consensus conference will have nearly the impact of the first. This appears tobebydesign, as thepanel’s chargewas largely to provide a review and summary of existing evidence. Consequently, the report by Courcoulas et al1 providesavery thoroughreviewof thesubstantialevidence insupportof theeffectivenessandefficacyofbariatric surgery,which may have the salutary effect of further legitimizing the field. This report can be used to support and inform coverage decisions to enhance access to bariatric procedures. However, the panel did not provide explicit recommendations on how coverage should change going forward. In particular, the time is ripe for lowering the body mass index (BMI, calculatedasweight inkilogramsdividedbyheight in meters squared) threshold for bariatric surgery. Evidence fromanumber of randomized clinical trials demonstrates the efficacyof bariatric surgery in the remissionof diabetesmellitusandother comorbidconditions forpatientswithclass Iobesity (BMI, 30-35).2-5 While long-term durability data are lacking for patients in this BMI range, the evidence supporting reducing the BMI threshold to 30 (with comorbidities) is substantially higher now than was the evidence for setting that threshold at 35 in 1991. Certainly, as thenewNIHpanel suggests, further studyof the long-termoutcomes of bariatric surgery, especially sleeve gastrectomy, is warranted. And such studies should include medically treatedpatients, particularlywhenexaminingquality of life and other patient-centered outcomes. But the evidence in support of bariatric surgeryvsmedical therapy in the treatmentofmorbidobesity andassociatedconditions is fairly overwhelming. However, we missed this opportunity to leverage the substantial expertise of this panel tomake recommendations about expanding coverage to these additional patients, who would very clearly benefit from it.

Comment on McIntyre. Diagnosing Gestational Diabetes Mellitus: Rationed or Rationally Related to Risk? Diabetes Care 2013;36:2879–2880

Dr. McIntyre eloquently challenges the National Institutes of Health (NIH) consensus panel conclusions that contradict the American Diabetes Association (ADA) position on the diagnosis of gestational diabetes mellitus (GDM) (1). His claims merit comment. He feels it is “most disturbing” that the panel did not address the issue of “undiagnosed type 2 diabetes.” While we agree that detecting overt type 2 diabetes early in pregnancy is important, this was not the specific question the NIH panel was charged to answer. McIntyre feels we should embrace change, but “change” and “change for the better” are not synonymous. After a rigorous review, the panel concluded that there was not enough evidence to …

Moneyball, gambling, and the new cholesterol guidelines.

“Lies, damn lies and statistics.” The old adage is emblematic of people’s distrust of statistics, yet in recent years advanced statistics have proven useful over traditional approaches in areas as varied as Nate Silver’s work in political polling and advanced statistics in sports. In November 2013, new cholesterol guidelines, initially developed by an expert National Institutes of Health panel and then endorsed and published jointly by the American College of Cardiology and the American Heart Association (ACC/AHA), took a few steps toward applying more advanced statistical techniques to medical practice.1 The fundamental change is that the ACC/AHA cholesterol guidelines base their recommendations on the best available information on an individual patient’s chance of benefitting from treatment. To achieve this, they noted that we need to stop focusing so much on low-density lipoprotein (LDL) cholesterol levels and focus more on our patient’s overall risk of having a heart attack or stroke. For primary prevention, the new guidelines propose that a statin be recommended once a person’s 10-year risk of having a heart attack or stroke is >7.5%, using a cardiovascular risk calculator developed by the original National Institutes of Health expert panel. Noting that multiple clinical trials have failed to find a significant benefit from adding a second lipid-lowering medicine to a statin, the ACC/AHA cholesterol guidelines generally recommend no additional cholesterol medications for those who tolerate a statin, even if LDL remains elevated. These guidelines have triggered a cacophony of controversy, with some cholesterol specialists suggesting that the new guidelines will lead to serious undertreatment of high cholesterol and lost lives, and others suggesting that they will lead to overtreatment of millions of Americans.2,3 The net result—utter confusion. Controversies in medicine have become a dime a dozen, but this medical controversy has a unique aspect to …

Polycystic Ovary Syndrome: What's in a Name?

Assigning names to new concepts in both general and medical knowledge is frequently problematic. Medical disorders have been primarily named after the first (or more often, the first to be recognized) individuals to describe its features (eg, Asperger’s syndrome), or perhaps after some clinical finding, now historic, and perhaps even tangential in nature (eg, systemic lupus erythematosus). Such names are frequently not intuitive and do not allow patients or their doctors to immediately understand what the disorder is all about without having to memorize the link first. But the increasing need for medical efficiency and the growing number of conditions today call for medical disorder names that are readily informative and almost instinctual in nature. And that is where we are with the disorder that we today know as the “polycystic ovary syndrome” (also known as polycystic ovarian syndrome) or PCOS, previously known as the “polycystic ovary disease” (PCOD), and even before that as the “Stein-Leventhal syndrome.” We now know that this disorder is extraordinarily common, affecting between 6 and 20% of reproductive-age women depending on the diagnostic criteria used (because there is more than one). It was originally named for the first individuals to report on symptoms associated with the syndrome (1), and then for the salient physical finding first observed (polycystic ovaries, a term coined by Stein and Leventhal). Recently, a National Institutes of Health (NIH) consensus meeting [NIH Office of Disease Prevention: Evidence-based Methodology Workshop on Polycystic Ovary Syndrome (PCOS), December 3–5, 2012] was convened to try and bring clarity to the field of study (2). Among their recommendations, members of the panel noted, “We believe the name ’PCOS’ is a distraction and an impediment to progress. It causes confusion and is a barrier to effective education of clinicians and communication with the public and research funders.” The panel further stated, “It is time to expeditiously assign a name that reflects the complex. . . interactions that characterize the syndrome—and their reproductive implications.” This investigator strongly agrees with this recommendation. As we would expect, there have been prior efforts at renaming the disorder, including the change from SteinLeventhal syndrome to PCOD and then to PCOS (because the disorder does not appear to be a specific disease). Lobo (3) proposed changing the name of the disorder to “hyperandrogenic chronic anovulation” to reflect the underlying and generally unique condition associated with the disorder—hyperandrogenism. More recently, Behera et al suggested changing the name of PCOS to “estrogenic ovulatory dysfunction” or “functional female hyperandrogenism” (4). Notably, both of these recommendations centered on naming the disorder around generalities concerning the condition itself, although paradoxically perhaps they were too general to be useful enough. And neither had the force of authority behind them—unlike the NIH panel recommendations. Name change is not new, of course. It has already occurred for a number of diseases or disorders, eg, mongolism to Down syndrome, manic depression to bipolar disorder, testicular feminization to androgen insensitivity syndrome, multiple personality to dissociative identity disorder. And a few have paradoxically changed their names to those of individuals, such as changing senile dementia to Alzheimer’s disease and leprosy to Hansen’s disease. Names have been changed for food products. The Chinese gooseberry was renamed kiwi because New Zealand

Diagnosing Gestational Diabetes Mellitus: Rationed or Rationally Related to Risk?

The much-anticipated, weather-plagued National Institutes of Health (NIH) Consensus Development Conference on Diagnosing Gestational Diabetes Mellitus, held in Bethesda, Maryland, 4–6 March 2013, led to publication of a consensus panel report (1) that essentially maintains and promotes the status quo regarding gestational diabetes mellitus (GDM) diagnosis. The panel report contradicts current American Diabetes Association (ADA) recommendations (2). This commentary addresses several areas of disagreement. The only constant is change, and this is most apparent with the demography of pregnancy. Perhaps the most disturbing omission from the NIH panel’s report (1) is the lack of clear acknowledgment of the importance of the increasing prevalence of prediabetes and undiagnosed type 2 diabetes, outside pregnancy, in women of childbearing age (2). This omission effectively precludes any strategy for early detection of these potentially serious problems in pregnancy. Much of the NIH report expresses grave concerns about the possibility of a two- to threefold increase in GDM prevalence from the current estimate of 5–6%. However, the National Health and Nutrition Examination Survey (NHANES) 2005–2008 data (3) regarding U.S. women aged 18–44 years report frank diabetes in 4.5% of participants (1.7% undiagnosed) and prediabetes in 26.4%. While the current ADA (2) criteria for the diagnosis of GDM are based primarily on considerations of fetopathy, they still have an important role in identifying women with current or future abnormalities of glucose metabolism. Given the NHANES prevalence estimates for impaired …

National Institutes of Health Panel: Reduce Colorectal Cancer Deaths by Striking Down Barriers to Screening

A National Institutes of Health (NIH) state-of-the-science panel that convened February 4–5, 2010, identified ways to further increase the use and quality of colorectal cancer screening in the United States. The 13-member conference panel included experts in the fields of cancer surveillance, health services research, community-based research, informed decision making, access to care, health care policy, health communication, health economics, health disparities, epidemiology, statistics, thoracic radiology, internal medicine, gastroenterology, public health, end-of-life care, and a public representative. Colorectal cancer is the third most common cancer and the second leading cause of cancer-related deaths in the United States. Despite evidence and guidelines supporting the value of screening for this disease, rates of screening for colorectal cancer are consistently lower than those for other types of cancer, particularly breast and cervical. “We recognize that some may find colorectal cancer screening tests to be unpleasant and time-consuming. However, we also know that recommended screening strategies reduce colorectal cancer deaths,” said Donald Steinwachs, PhD, panel chair, and professor and director of the Health Services Research and Development Center at The Johns Hopkins University. “We need to find ways to encourage more people to get these important tests.” The panel found that the most important factors associated with being screened are having insurance coverage and access to a regular health care provider. Their recommendations highlighted the need to remove out-of-pocket costs for screening tests. Given the variety of tests available, the panel emphasized that informed decisions incorporating personal preferences may help reluctant individuals determine which test's combined attributes—invasiveness, frequency, and required preparation—are preferable to them, helping them to identify and obtain the most palatable test. For example, an individual may choose a more invasive test requiring less frequent follow-up or a less invasive test requiring more frequent follow-up. Noting differences in screening rates across racial and ethnic groups, socioeconomic status, and geographic location, the panel emphasized the need for strategies that target specific subgroups. For example, compared with non-Hispanic whites, Hispanics are less likely to be screened. The panel also noted that if efforts to increase utilization are successful, there will be a greater demand for colorectal cancer screening services. Available capacity involves not only facilities and appropriately trained providers, but also support for informed decision making, resources to coordinate screening services and communicate results effectively, and enhanced monitoring practices to ensure that positive results are followed up with colonoscopy. Depending on the scale of increase in screening rates, there may be a need to increase local and national capacity. In addition to increasing first-time screening rates, the panel also identified the need to ensure that individuals return for subsequent testing at recommended intervals. A variety of colorectal cancer screening tests are available and different guidelines recommend them at different intervals. The panel's state-of-the-science statement, which incorporates comments received during a subsequent public session, is available at http://consensus.nih.gov. A list of the panel members and their institutional affiliations is included in the conference statement.

Restless legs syndrome: differential diagnosis and management with pramipexole

Restless legs syndrome (RLS) is a condition characterized by discomfort at rest and urge to move focused on the legs. RLS may occur as an idiopathic, often hereditary condition (primary RLS), or in association with medical conditions (secondary RLS) including iron deficiency, uremia, and polyneuropathy. Current understanding of the pathophysiology of RLS points to the involvement of three interrelated components: dopaminergic dysfunction, impaired iron homeostasis, and genetic mechanisms. The diagnosis of RLS is made according to the consensus criteria by a National Institutes of Health panel: 1) an urge to move the legs, usually accompanied by uncomfortable sensations; 2) beginning or worsening during rest; 3) relieved by movement; and 4) worse, or only occurring, in the evening or at night. The differential diagnosis of RLS aims to: 1) distinguish RLS from other disorders with RLS-like symptoms and 2) identify secondary forms, with investigation of underlying diseases. The treatment of RLS demands a clinical evaluation to rule out and cure causes of secondary RLS, including iron supplementation when deficient, and to eliminate the triggering factors. The presence of neuropathy should be especially investigated in nonhereditary, late-onset RLS, in view of a possible treatment of the underlying disease. The first line treatment for idiopathic RLS is represented by dopamine agonists, in particular nonergot-derived ropinirole and pramipexole, whereas ergot dopamine agonists (cabergoline and pergolide) are no longer in first-line use given the risks of cardiac valvulopathy. Although no comparative trials have been published, a meta-analysis of pramipexole versus ropinirole suggests differences in efficacy and tolerability favoring pramipexole.

Waging war on modern chronic diseases: primary prevention through exercise biology

In this review, we develop a blueprint for exercise biology research in new millennium. The first part of our plan provides statistics to support contention that there has been an epidemic emergence of modern chronic diseases in latter part of 20th century. The health care costs of these conditions were almost two-thirds of a trillion dollars and affected 90 million Americans in 1990. We estimate that these costs are now approaching $1 trillion and stand to further dramatically increase as baby boom generation ages. We discuss reaction of biomedical establishment to this epidemic, which has primarily been to apply modern technologies to stabilize overt clinical problems (e.g., secondary and tertiary prevention). Because this approach has been largely unsuccessful in reversing epidemic, we argue that more emphasis must be placed on novel approaches such as primary prevention, which requires attacking environmental roots of these conditions. In this respect, a strong association exists between increase in physical inactivity and emergence of modern chronic diseases in 20th century industrialized societies. Approximately 250,000 deaths per year in United States are premature due to physical inactivity. Epidemiological data have established that physical inactivity increases incidence of at least 17 unhealthy conditions, almost all of which are chronic diseases or considered risk factors for chronic diseases. Therefore, as part of this review, we present concept that human genome evolved within an environment of high physical activity. Accordingly, we propose that exercise biologists do not study the effect of physical activity but in reality study effect of reintroducing exercise into an unhealthy sedentary population that is genetically programmed to expect physical activity. On basis of healthy gene function, exercise research should thus be viewed from a nontraditional perspective in that control group should actually be taken from a physically active population and not from a sedentary population with its predisposition to modern chronic diseases. We provide exciting examples of exercise biology research that is elucidating underlying mechanisms by which physical inactivity may predispose individuals to chronic disease conditions, such as mechanisms contributing to insulin resistance and decreased skeletal muscle lipoprotein lipase activity. Some findings have been surprising and remarkable in that novel signaling mechanisms have been discovered that vary with type and level of physical activity/inactivity at multiple levels of gene expression. Because this area of research is underfunded despite its high impact, final part of our blueprint for next millennium calls for National Institutes of Health (NIH) to establish a major initiative devoted to study of biology of primary prevention of modern chronic diseases. We justify this in several ways, including following estimate: if percentage of all US morbidity and mortality statistics attributed to combination of physical inactivity and inappropriate diet were applied as a percentage of NIH's total operating budget, resulting funds would equal budgets of two full institutes at NIH! Furthermore, fiscal support of studies elucidating scientific foundation(s) targeted by primary prevention strategies in other public health efforts has resulted in an increased efficacy of overall prevention effort. We estimate that physical inactivity impacts 80-90% of 24 integrated review group (IRG) topics proposed by NIH's Panel on Scientific Boundaries for Review, which is currently directing a major restructuring of NIH's scientific funding system. Unfortunately, primary prevention of chronic disease and investigation of physical activity/inactivity and/or exercise are not mentioned in almost 200 total subtopics comprising t

Clinical Management of Primary Hyperparathyroidism and Thresholds for Surgical Referral: A National Study Examining Concordance Between Practice Patterns and Consensus Panel Recommendations

To determine whether 1990 guidelines established by the National Institutes of Health (NIH) for the optimal management (surgical versus nonsurgical) of patients with asymptomatic primary hyperparathyroidism (PHPT) are known and followed by endocrinologists. We surveyed endocrinologists in the United States who were randomly selected in 1998 from two endocrine societies. Endocrinologists were asked about management of asymptomatic patients with PHPT, awareness of NIH recommendations, practice demographics, and annual PHPT case volume. We classified endocrinologists into either low-volume (<12 cases of PHPT per year) or high-volume (> or = 12 cases per year) physicians. Of 374 eligible physicians, 146 (39%) responded to our survey. In comparison with nonrespondents, respondents were of similar age, sex, years in practice, and geographic location profiles; this finding suggested minimal nonresponse bias. More high-volume physicians than low-volume physicians were aware of the NIH guidelines (75% versus 50%; P<0.01). Management of asymptomatic patients was similar between volume groups; overall, 39% of patients were referred for surgical treatment. Nevertheless, considerable variation in management existed; 7% of all physicians referred > or = 90% of their asymptomatic patients for surgical treatment, whereas 31% referred < or = 10%. Adherence to monitoring guidelines for nonsurgically managed patients ranged widely, depending on the specific recommendation (from 6% of physicians obtaining creatinine clearance assessments every 6 months to 78% of physicians ordering serum calcium measurements every 6 months). Surgical referral practices also varied substantially, with 25% of all physicians referring a 40-year-old patient with PHPT when hypercalcemia was mild (< or = 1 mg/dL above normal), 39% when hypercalcemia was moderate, and 31% when hypercalcemia was severe (>1.5 mg/dL above normal). Of the responding physicians, 4% reported that hypercalcemia alone was not sufficient justification to refer a patient for surgical intervention. Higher PHPT case volume was not associated with differences in surgical referral. Suboptimal awareness of the 1990 NIH panel recommendations and the substantial variation in clinical management of PHPT indicate that newer NIH guidelines developed in 2002 must be more widely disseminated and strongly recommended if practice patterns are to be influenced and clinical outcomes improved.

James Battey profile. NIH's man in the middle of the stem cell debate.

JAMES BATTEY PROFILEJames Battey knows that he works in a fishbowl. As head of a National Institutes of Health panel managing stem cell research within the bounds established by the Bush Administration, Battey hopes to satisfy researchers who want to extend the scientific frontier without incurring the wrath of politicians who raise the specter of human embryo farms.

Past, Present, and Future of Endoscopic Retrograde Cholangiopancreatography: Perspectives on the National Institutes of Health Consensus Conference

Past, Present, and Future of Endoscopic Retrograde Cholangiopancreatography: Perspectives on the National Institutes of Health Consensus Conference

Waging war on modern chronic diseases: primary prevention through exercise biology.

In this review, we develop a blueprint for exercise biology research in the new millennium. The first part of our plan provides statistics to support the contention that there has been an epidemic emergence of modern chronic diseases in the latter part of the 20th century. The health care costs of these conditions were almost two-thirds of a trillion dollars and affected 90 million Americans in 1990. We estimate that these costs are now approaching $1 trillion and stand to further dramatically increase as the baby boom generation ages. We discuss the reaction of the biomedical establishment to this epidemic, which has primarily been to apply modern technologies to stabilize overt clinical problems (e.g., secondary and tertiary prevention). Because this approach has been largely unsuccessful in reversing the epidemic, we argue that more emphasis must be placed on novel approaches such as primary prevention, which requires attacking the environmental roots of these conditions. In this respect, a strong association exists between the increase in physical inactivity and the emergence of modern chronic diseases in 20th century industrialized societies. Approximately 250,000 deaths per year in the United States are premature due to physical inactivity. Epidemiological data have established that physical inactivity increases the incidence of at least 17 unhealthy conditions, almost all of which are chronic diseases or considered risk factors for chronic diseases. Therefore, as part of this review, we present the concept that the human genome evolved within an environment of high physical activity. Accordingly, we propose that exercise biologists do not study "the effect of physical activity" but in reality study the effect of reintroducing exercise into an unhealthy sedentary population that is genetically programmed to expect physical activity. On the basis of healthy gene function, exercise research should thus be viewed from a nontraditional perspective in that the "control" group should actually be taken from a physically active population and not from a sedentary population with its predisposition to modern chronic diseases. We provide exciting examples of exercise biology research that is elucidating the underlying mechanisms by which physical inactivity may predispose individuals to chronic disease conditions, such as mechanisms contributing to insulin resistance and decreased skeletal muscle lipoprotein lipase activity. Some findings have been surprising and remarkable in that novel signaling mechanisms have been discovered that vary with the type and level of physical activity/inactivity at multiple levels of gene expression. Because this area of research is underfunded despite its high impact, the final part of our blueprint for the next millennium calls for the National Institutes of Health (NIH) to establish a major initiative devoted to the study of the biology of the primary prevention of modern chronic diseases. We justify this in several ways, including the following estimate: if the percentage of all US morbidity and mortality statistics attributed to the combination of physical inactivity and inappropriate diet were applied as a percentage of the NIH's total operating budget, the resulting funds would equal the budgets of two full institutes at the NIH! Furthermore, the fiscal support of studies elucidating the scientific foundation(s) targeted by primary prevention strategies in other public health efforts has resulted in an increased efficacy of the overall prevention effort. We estimate that physical inactivity impacts 80-90% of the 24 integrated review group (IRG) topics proposed by the NIH's Panel on Scientific Boundaries for Review, which is currently directing a major restructuring of the NIH's scientific funding system. Unfortunately, the primary prevention of chronic disease and the investigation of physical activity/inactivity and/or exercise are not mentioned in the almost 200 total subtopics comprising t

Report of the NIH Panel To Define Principles of Therapy of HIV Infection.

Recent research advances have afforded substantially improved understanding of the biology of HIV infection and the pathogenesis of AIDS. With the advent of sensitive tools for monitoring HIV replication in infected persons, the risk for disease progression and death can be assessed accurately and the efficacy of anti-HIV therapies can be determined directly. Furthermore, when used appropriately, combinations of newly available, potent antiviral therapies can effect prolonged suppression of detectable levels of HIV replication and circumvent the inherent tendency of HIV to generate drug-resistant viral variants. However, as antiretroviral therapy for HIV infection has become increasingly effective, it has also become increasingly complex. Familiarity with recent research advances is needed to ensure that newly available therapies are used in ways that most effectively improve the health and prolong the lives of HIV-infected persons. To enable practitioners and HIV-infected persons to best use rapidly accumulating new information about HIV disease pathogenesis and treatment, the Office of AIDS Research of the National Institutes of Health (NIH) sponsored the NIH Panel To Define Principles of Therapy of HIV Infection. This Panel was asked to define essential scientific principles that should be used to guide the most effective use of antiretroviral therapies and viral load testing in clinical practice. On the basis of detailed consideration of the most current data, the Panel delineated 11 principles that address issues of fundamental importance for the treatment of HIV infection. These principles provide the scientific basis for the specific treatment recommendations made by the Panel on Clinical Practices for the Treatment of HIV Infection sponsored by the Department of Health and Human Services and the Henry J. Kaiser Family Foundation. The reports of both of these panels are provided in this supplement. Together, they summarize new data and provide both the scientific basis and specific guidelines for the treatment of HIV-infected persons. This information will be of interest to health care providers, HIV-infected persons, HIV and AIDS educators, public health educators, public health authorities, and all organizations that fund medical care of HIV-infected persons.

'Decent Research and Closure' Needed on Medical Marijuana, Says Head of NIH Panel

SCIENTISTS INTERESTED in filling in the therapeutic blanks about medicinal marijuana hope a new nonpartisan report will expedite applications for federal funds and supplies of the drug. The National Institutes of Health (NIH) released the report early last month. It was written by an independent, 9-member panel of experts who presided over a 2-day workshop on medical marijuana that the NIH sponsored last February in Bethesda, Md. The workshop was convened in response to ballot initiatives last year in which voters in California and Arizona approved marijuana for medicinal use. the report, the panel reiterated its support for further research to determine marijuana's therapeutic efficacy in 5 areas: appetite stimulation and cachexia; nausea and vomiting following anticancer therapy; neurologic and movement disorders; analgesia; and glaucoma. In order to evaluate various hypotheses concerning the potential utility of marijuana in various therapeutic areas, more and better studies would be needed, panel

NIH Panel Urges Overhaul of the Rating System for Grants

Choosing winners from among the 30,000 biomedical scientists who seek federal grants each year is a delicate task, especially when more than three-quarters of grant proposals now get rejected. But tinkering with the peer-review process by which the National Institutes of Health (NIH) picks these winners is an even more delicate proposition. An internal NIH panel has, however, just issued a set of recommendations that could result in a fundamental change in the way peer-review panels weigh scientific merit. Their recommendations are available on-line .

NIH Panel Report of 'No Flaws' in FIAU Trial at Variance With FDA Report, New Probe Planned

THE TRAGIC deaths of five patients in a National Institutes of Health (NIH) study of the experimental hepatitis drug fialuridine or fluoroidoarauracil (FIAU) were, given the circumstances, unavoidable and due to a wholly new type of unexpected and delayed liver toxicity. There were no noteworthy flaws in the conduct of the study. This is the conclusion of an exhaustive review of the situation conducted by a subcommittee of the NIH Director's Advisory Committee chaired by David R. Challoner, MD, vice president for health affairs, University of Florida College of Medicine, Gainesville, and David M. Kipnis, MD, distinguished university professor of medicine, Washington University School of Medicine, St Louis, Mo. The inquiry was conducted at the request of NIH Director Harold Varmus, MD, and the report presented at a committee meeting on June 2. This report, the second to follow the deaths, could be viewed as at variance with an earlier

Letter to the Editor

Pope et al have concerns about the American Academy of Pediatrics Committee on Infectious Diseases recommendation for using ribavirin in RSV patients who are mechanically ventilated. The Committee based these recommendations not only on the study published by Smith et al, but also on observations on individual patients in clinical situations where experienced care-takers have reported favorable clinical outcomes and safety. Sources included members of the Committee, the Food and Drug Administration, the pharmaceutical manufacturer, a National Institutes of Health panel of scientists, and reviewers and representatives from the National Institute of Occupational Safety and Health.

Vasectomy and prostate cancer.

Numerous epidemiologic studies of vasectomized men have been conducted over the last decade. The majority of the reports have been reassuring with regard to possible long-term health consequences following male sterilization. In February 1993, two articles suggesting a relationship between vasectomy and prostate cancer appeared in the literature. Following publication of these studies, the United States National Institutes of Health (NIH) organized a meeting of experts to review the most recent literature on vasectomy and prostate cancer. After considering the evidence from the aforementioned studies and the preliminary findings of three unpublished studies, the NIH panel concluded that there was insufficient evidence of a real association between vasectomy and prostate cancer. This article reviews current information concerning the relationship, and recommends that providers continue to provide vasectomy as a contraceptive option. The research community should continue to investigate the possibility of a relationship between vasectomy and prostate cancer.

Restoring hope: lifting the ban on fetal tissue transplantation research.

Chairman of the Subcommittee on Aging of the US Congressional Committee on Labor and Human Relations supports the Research Freedom Act designed to lift the ban on fetal tissue transplantation research. Transplanting fetal tissue into patients may treat Parkinson's disease and perhaps even diabetes, genetic disorders, and spinal cord injuries. In 1988, the National Institutes of Health (NIH) proposed to perform the 1st neural transplant on a patient with Parkinson's disease and underwent the required scientific and ethical reviews, but the Reagan administration forbade this procedure. It called for an independent evaluation of the moral and ethical issues of this research. The hand-picked panelists, most of whom opposed abortion, even determined that its funding was appropriate and it would not encourage women to seek abortion. Yet the Reagan administration continued the ban and the Bush administration followed suit despite the panel's results and many requests from people with progressive debilitating diseases. The Research Freedom Act heeds the recommendations of the NIH panel. Legislators include safeguards to place a firm barricade between abortion and research in the act. For example, the physician must substantiate in writing that the woman agreed to donate the fetal tissue after she decided to pursue an abortion. The Act forbids the sale of fetal tissue and assesses criminal penalties on any such exchanges. We allow transplantation of organs from murder victims even though we do not support murder. So we can condone the use of fetal tissue for life-saving research without endorsing abortions. The Act also renews the integrity of NIH's scientific review process. It can renew hope for people with diseases that fetal tissue transplantation may be able to treat. The US can either use the lifeless tissue for transplants or for other research or it can throw it away.