NEW DIAGNOSTIC IMAGING DEVICES AT THE NIH CLINICAL CENTER TO AUTOMATICALLY RECORD RADIATION EXPOSURE

It's about time we started keeping track of radiation exposure. I have seen the system fail to total up radiation exposures too many times and am fearful that there are going to be long term consequences for many people. Patients need total radiation exposure from X-rays, CT Scans, and dental X-rays tallied up each year. - BRH

NEW DIAGNOSTIC IMAGING DEVICES AT THE NIH CLINICAL CENTER TO AUTOMATICALLY RECORD RADIATION EXPOSURE

U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News
NIH Clinical Center (CC)
For Immediate Release: Monday, August 17, 2009

CONTACT: Bill Schmalfeldt, 301-496-2563,

NEW DIAGNOSTIC IMAGING DEVICES AT THE NIH CLINICAL CENTER TO AUTOMATICALLY RECORD RADIATION EXPOSURE

Radiology and Imaging Sciences at the National Institutes of Health Clinical Center has taken a significant step to further safeguard clinical research patients at the NIH Clinical Center who are exposed to radiation during certain imaging tests. Computed tomography (CT) and positron emission tomography (PET)/CT equipment purchased by the Clinical Center will now be required to routinely record radiation dose exposure in a patient's hospital-based electronic medical record.

"When a hospital or clinic patient receives a medication or a treatment, it is routinely recorded in the patient's medical record," said John I. Gallin, M.D., director of the Clinical Center, NIH's clinical research hospital in Bethesda, Md. "The Clinical Center's approach is an important first step in making it possible to more easily document and track information about a patient's exposure to radiation."

Today, electronic radiology information systems in hospitals generally do not collect or report radiation exposures. "CT and PET/ CT scanners do not currently forward data on radiation dose to our radiology information systems," said Dr. David A. Bluemke, M.D., Ph.D. Bluemke is director of Radiology and Imaging Sciences at the Clinical Center.

The risk of exposure to low doses of medical radiation from diagnostic medical-imaging tests isn't known, but very high radiation doses have the potential to cause cancer. The ability to keep track of an individual's exposure to radiation through routine imaging tests is needed so that researchers can begin to determine if these exposures pose a health risk.

"The National Council on Radiation Protection and Measurements reported recently that Americans received seven times more radiation exposure from medical tests in 2006 than was the case in the 1980s," said Ronald Neumann, M.D., chief of nuclear medicine and deputy associate director for imaging sciences at the Clinical Center. "CT and cardiac nuclear medicine studies accounted for much of this increased medical radiation exposure."

Ultimately, radiation dosage could become a standard element of a universal electronic medical record used to assess radiation risk from life-long medical testing, the Clinical Center radiologists said. "Recording radiation dose is technically possible and an ethical imperative," Neumann said.

"The NIH Clinical Center also will require that newly purchased equipment allows patients to record their radiation dose exposure in their own personal health record," Bluemke added. Online resources to help individuals organize their health information as a personal medical record are becoming more prevalent. Currently, patients can easily receive their diagnostic imaging studies records on CD-ROM, Bluemke said. The NIH Clinical Center's imaging program will work with vendors who supply Clinical Center imaging equipment to develop software tools to extract the examination type, date, and radiation dose exposure from the CD-ROM, for uploading to a personal health record. As both the American College of Radiology and the Radiological Society of North America have recommended, patients should keep a record of their X-ray history.

About 25,000 CT and 1,250 PET/CT scans are performed at the Clinical Center each year as part of NIH research protocols. The clinical research hospital currently houses five CT scanners, and two PET/CT scanners.

The NIH Clinical Center (CC) is the clinical research hospital for the National Institutes of Health. Through clinical research, physician-investigators translate laboratory discoveries into better treatments, therapies and interventions to improve the nation's health. For more information, visit .

The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit .

RISK OF PANCREATIC CANCER LINKED TO VARIATION IN GENE THAT DETERMINES BLOOD TYPE

A gene variation or gene defect has been found that increases the risk of pancreatic cancer, which is one of the deadliest of all cancers. - BRH

RISK OF PANCREATIC CANCER LINKED TO VARIATION IN GENE THAT DETERMINES BLOOD TYPE
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U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News
National Cancer Institute (NCI)
Embargoed for Release: Sunday, August 2, 2009, 1 p.m., EDT

CONTACT: NCI Office of Media Relations, 301-496-6641,

RISK OF PANCREATIC CANCER LINKED TO VARIATION IN GENE THAT DETERMINES BLOOD TYPE

Common variants of the gene that determines human blood type are associated with an increased risk of pancreatic cancer, according to a study by scientists at the National Cancer Institute (NCI), part of the National Institutes of Health, and colleagues from many universities and research institutions. The study, published online Aug. 2, 2009, in Nature Genetics, is consistent with an observation first made more than 50 years ago.

In the study, the researchers discovered that genetic variation in a region of chromosome 9 that contains the gene for ABO blood type was associated with pancreatic cancer risk. Individuals with the variant that results in blood types A, B, or AB were at an increased risk of pancreatic cancer, compared to those with the variant for blood type O. This finding is consistent with previous research, some of it dating back to the 1950s and 1960s, that had shown increased risks of gastric and pancreatic cancer among individuals of the A and B blood groups (i.e., blood types A, B, and AB). The latest results provide a genetic basis for those earlier observations.

A person's blood type depends on which form or forms of the ABO gene they inherit from their parents. The protein produced by the ABO gene determines the type of carbohydrates (complex sugars) that are present on the surface of red blood cells and other cells, including cells of the pancreas. The proteins encoded by the A and B forms of the gene transfer different carbohydrates onto the cell surfaces to make A and B blood types. The O form encodes a protein that is unable to transfer carbohydrates. Studies by other researchers have shown that ABO protein encoding in pancreatic tumor cells is different than in normal pancreatic cells.

To discover genetic variations that contribute to pancreatic cancer risk, the research team conducted a genome-wide association study (GWAS). In a GWAS, researchers analyze common variants, called single-nucleotide polymorphisms (SNPs), in the genomes of people with a disease and people without the disease. Initially, the research team studied the genomes of 1,896 patients with pancreatic cancer and 1,939 control subjects to identify SNPs with a strong association with pancreatic cancer. The team then verified its findings by studying the genomes of another 2,457 people with pancreatic cancer and 2,654 people without the disease. In the end, they identified several SNPs on the long arm of chromosome 9 that were associated with pancreatic cancer risk and mapped to the ABO gene.

"Only by working across disciplines and with more than a dozen research groups were we able to make this important discovery of the potential role of the ABO gene in pancreatic cancer risk," said co-author Patricia Hartge, Sc.D., of NCI's Division of Cancer Epidemiology and Genetics (DCEG). "Although it will take much more work, this finding may lead to improved diagnostic and therapeutic interventions that are so desperately needed."


Pancreatic cancer is the fourth leading cause of cancer death in the United States. It is difficult to detect, and in many people it is not diagnosed until after the disease has spread to other parts of the body. Less than five percent of Americans with pancreatic cancer survive five years past diagnosis. Risk factors include smoking, diabetes, race, and a family history of the disease.

"Pancreatic cancer is the newest beneficiary of so-called high-throughput genotyping that, over the past two years, has yielded scores of genetic hot-spots linked to risk for cancer and other diseases," said co-author Stephen J. Chanock, M.D., chief of NCI's Laboratory of Translational Genomics in DCEG. "As more variants are discovered and follow-up studies are conducted to examine the biological effects of these variants, a better understanding will emerge of the inherited risk factors and mechanisms that lead to the development of pancreatic cancer."

The study was part of PanScan, a GWAS of pancreatic cancer conducted by the Pancreatic Cancer Cohort Consortium, composed of 14 academic centers. The investigators are conducting whole-genome scans to identify common genetic variants that may be markers of susceptibility to pancreatic cancer.

Analyses and data from PanScan will be available through NCI's caBIG (Cancer Biomedical Informatics Grid). The summary results for similar data on breast and prostate cancer are already freely available to other researchers at this Web site.

For more information on Dr. Hartge's research, please go to .

For more information on Dr. Chanock's research, please go to .

For more information about PanScan, please go to .

NCI leads the National Cancer Program and the NIH effort to dramatically reduce the burden of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. For more information about cancer, please visit the NCI Web site at or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).

The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit .
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REFERENCE: Amundadottir L., et al. Genome-wide association study identifies ABO Blood Group Susceptibility Variants for Pancreatic Cancer. "Nature Genetics." Online August 2, 2009.

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Keywords: National Institute of Health, United States, National Cancer Institute, Genome-wide association study, United States Department of Health and Human Services, National Cancer Program, Single-nucleotide polymorphism

GENES KEY TO STAPH DISEASE SEVERITY, DRUG RESISTANCE FOUND HITCHHIKING TOGETHER

A new study finds that resistance and virulence can travel together. - BRH

GENES KEY TO STAPH DISEASE SEVERITY, DRUG RESISTANCE FOUND HITCHHIKING TOGETHER

U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News
National Institute of Allergy and Infectious Diseases (NIAID)
For Immediate Release: Friday, July 31, 2009

CONTACT: Ken Pekoc, 301-402-1663

GENES KEY TO STAPH DISEASE SEVERITY, DRUG RESISTANCE FOUND HITCHHIKING TOGETHER

Scientists studying Staphylococcus bacteria, including methicillin-resistant S. aureus (MRSA), have discovered a potent staph toxin responsible for disease severity. They also found the gene for the toxin traveling with a genetic component of Staphylococcus that controls resistance to antibiotics. The study, now online in PLoS Pathogens, shows for the first time that genetic factors that affect Staphylococcus virulence and drug resistance can be transferred from one strain to another in one exchange event.

One of the ways Staphylococcus bacteria become drug-resistant is through horizontal gene transfer, whereby resistance genes move from one bacterium to another. Staph bacteria also can exchange virulence genes using the same mechanism, but this was previously assumed to occur separately from the transfer of antibiotic resistance.

Scientists from the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health, led the study. They collaborated with researchers at the University of Tubingen in Germany and the University of Medicine and Dentistry of New Jersey.

"The discovery that bundled genes determine virulence and antimicrobial resistance suggests a new research focus for scientists trying to better prevent and treat serious staph infections," says Anthony S. Fauci, M.D., NIAID director.

The research involved more than 100 strains of S. aureus and S. epidermidis, both bacteria found on the skin of most people. In recent decades, these bacteria have become increasingly virulent, often causing severe disease that can be resistant to traditional antibiotics such as methicillin.

The studies were directed by NIAID senior investigator Michael Otto, Ph.D. In 2007, he and his colleagues found that staphylococci secrete toxins of the phenol-soluble modulin (PSM) family that are primarily responsible for attracting and killing human white blood cells called neutrophils. This process is critical for the ability of S. aureus-including community-acquired MRSA-to cause disease.

While screening S. aureus and S. epidermidis strains, Dr. Otto's group noticed that some strains produced one additional, previously unknown PSM toxin. The researchers hypothesized that the toxin was somehow connected to drug resistance. This idea surfaced because the toxin appeared in 10 percent of all MRSA strains and 68 percent of all methicillin-resistant S. epidermidis strains analyzed-whereas the researchers did not find it in strains of S. aureus or S. epidermidis that are sensitive to methicillin.

The research group confirmed its theory by identifying the specific location that encodes the toxin, which was in gene clusters that control drug resistance, known as SCCmec. The group named the new toxin PSM-mec.

"This work represents a previously unknown example of a toxin hitchhiking on staphylococcal mobile genetic elements that are primarily in charge of transferring antibiotic resistance," says Dr. Otto. He adds that the finding "should alert the research community that aggressive, drug-resistant staph can evolve more quickly than we assumed."

The research group is continuing its study of PSM-mec in S. epidermidis, where the toxin is more prevalent. Ultimately, being able to neutralize PSM-mec and other toxins that attack human defenses could lead to new treatments for S. aureus and S. epidermidis disease.

NIAID conducts and supports research-at NIH, throughout the United States, and worldwide-to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at .

The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit .

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NIH STUDY FINDS LOW SHORT-TERM RISKS AFTER BARIATRIC SURGERY FOR EXTREME OBESITY

I have never been enamored of the way side effects can be trivialized when deaths actually occur. Do patients dying really support how safe an operation is? - BRH

NIH STUDY FINDS LOW SHORT-TERM RISKS AFTER BARIATRIC SURGERY FOR EXTREME OBESITY

U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
For Immediate Release: Thursday, July 30, 2009

CONTACT: Leslie Curtis, Mary M. Harris,
301-496-3583

NIH STUDY FINDS LOW SHORT-TERM RISKS AFTER BARIATRIC SURGERY FOR EXTREME OBESITY

Short-term complications and death rates were low following bariatric surgery to limit the amount of food that can enter the stomach, decrease absorption of food or both, according to the Longitudinal Assessment of Bariatric Surgery (LABS-1). The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health. Results are reported in the July 30 issue of the New England Journal of Medicine.

Less than 1 percent (0.3 percent) of patients died within 30 days of surgery, further supporting the short-term safety of bariatric surgery as a treatment for patients with extreme obesity.

Bariatric surgery can have dramatic health benefits--such as improved blood sugar control or even reversal of type 2 diabetes. But it also carries serious risks, including death. The LABS-1 study aimed to evaluate the short-term safety of bariatric surgery to help doctors and patients understand the risks.

"Evaluating the 30-day safety outcomes of bariatric surgery in large populations is an essential step forward," according to co-author Myrlene Staten, M.D. senior advisor for diabetes translation research at NIDDK, part of NIH. "And LABS-1 data are from all patients who had their procedure performed by a surgeon participating in the study, not from just a select few patients."

Various types of bariatric surgery limit food intake, nutrient absorption or both. The major types of surgery undergone by participants in this study included laparoscopic adjustable gastric banding, laparoscopic Roux-en-Y gastric bypass and open Roux-en-Y gastric bypass. Gastric bands create a pouch around the top of the stomach to limit food intake at any one time. Gastric bypass also creates a pouch and redirects food around most of the stomach and part of the small intestine, limiting the absorption of food..

The LABS-1 consortium followed 4, 776 patients who had bariatric surgery for the first time, evaluating complications and death rates within the first 30 days after surgery. Patients were at least 18 years old and had an average body mass index (BMI) of 44, considered extremely obese. BMI measures weight in relation to height. As with most populations undergoing bariatric surgery, the majority of LABS-1 patients were white and female. The study took place over two years at 10 medical sites, with one additional center coordinating data collection and analyses.

Within 30 days of surgery, 4.1 percent of patients had at least one major adverse outcome, defined as death, development of blood clots in the deep veins of the legs or in the pulmonary artery of the lungs, repeat surgeries, or failure to be discharged from the hospital within 30 days of surgery.

Thirty day mortality was low, ranging from no deaths in the laparoscopic adjustable gastric band group, to six (0.2 percent) in the laparoscopic Roux-en-Y gastric bypass group, to nine (2.1 percent) in those undergoing open Roux-en-Y gastric bypass. The overall risk of complications also varied by procedure.

The investigators pointed out, however, that people undergoing some procedures, such as open Roux-en-Y gastric bypass, tended to be heavier and sicker than those undergoing laparoscopic adjustable gastric banding, and after adjusting for patient and center characteristics, there were no significant differences in complication risk that could be attributed to the type of procedure. There were some patient factors that increased the risk of complications, including a preoperative history of deep vein blood clots and sleep apnea. Patients with a very high BMI, a measure that relates weight to height, were also at increased risk--those with a BMI of 75 had a 61 percent higher risk of complications than those with a BMI of 53.

Currently, more than one third of U.S. adults are obese (BMI higher than 30) and an increasing number are extremely obese (BMI higher than 40), according to the U.S. Centers for Disease Control and Prevention. People who are extremely obese are potential candidates for bariatric surgery.

"There is a real need to determine safe and effective treatments for patients with extreme obesity and its associated medical conditions," said Susan Z. Yanovski, M.D., a co-author of the paper and co-director of NIDDK's Office of Obesity Research. "This study's results can help patients and physicians make informed decisions about potential risks and benefits of bariatric surgery."

LABS-1 is part of the Longitudinal Assessment of Bariatric Surgery consortium, an NIDDK-funded study launched in 2003 to examine the short- and long-term benefits and risks of bariatric surgery for adults with extreme obesity. LABS-2 will follow a subset of patients to gather longer-term information on patient characteristics, types of surgeries, medical and psychosocial outcomes and economic factors. The consortium brings together researchers with expertise in bariatric surgery, obesity research, internal medicine, endocrinology, behavioral science, outcomes research, epidemiology, and other relevant fields to collaboratively plan and conduct studies that will ultimately lead to better understanding of bariatric surgery and its impact on the health and well-being of patients with extreme obesity.

LABS-1 was conducted by researchers at the following centers:

-- Columbia University Medical Center, New York City
-- Cornell University Medical Center, New York City
-- East Carolina Medical Center, Greenville, N.C.
-- Neuropsychiatric Research Institute, Fargo, N.D.
-- Oregon Health & Science University, Portland
-- Legacy Good Samaritan Hospital, Portland, Ore.
-- Sacramento Bariatric Medical Associates, Sacramento, Calif.
-- University of Pittsburgh Medical Center
-- University of Washington, Seattle
-- Virginia Mason Medical Center, Seattle
-- University of Pittsburgh Graduate School of Public Health (Data Coordinating Center)

For more information about the LABS-1 study, search for NCT00433810 at . Information about the larger LABS study is at .

Learn more about weight control by visiting NIDDK's Weight-control Information Network at . "Bariatric Surgery for Severe Obesity" describes procedures, risks and potential benefits at .

More information about NIH's obesity research is available at .

The NIDDK, part of NIH, conducts and supports basic and clinical research and research training on some of the most common, severe and disabling conditions affecting Americans. The Institute's research interests include: diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic and hematologic diseases. For more information, visit .


The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit .

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NIH AND VA ANNOUNCE $7 MILLION PARTNERSHIP FOR SUBSTANCE ABUSE RESEARCH AMONG MILITARY PERSONNEL, VETERANS AND THEIR FAMILIES

More research for Dr. Drew.... and everyone needing to know more about substance abuse.

NIH AND VA ANNOUNCE $7 MILLION PARTNERSHIP FOR SUBSTANCE ABUSE RESEARCH AMONG MILITARY PERSONNEL, VETERANS AND THEIR FAMILIES

U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News
National Institute on Drug Abuse (NIDA)
For Immediate Release: Thursday, July 30, 2009

MEDIA CONTACT: Stephanie Older, 301-443-6245,

NIH AND VA ANNOUNCE $7 MILLION PARTNERSHIP FOR SUBSTANCE ABUSE RESEARCH AMONG MILITARY PERSONNEL, VETERANS AND THEIR FAMILIES
Research will focus on war efforts in Iraq and Afghanistan

Washington, D.C. - Two federal departments have joined forces to create a first-time collaborative funding project to support research on substance abuse and associated problems among U.S. military personnel, veterans and their families. The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, in partnership with two other NIH Institutes -- the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National Cancer Institute (NCI) -- are jointly collaborating with the Department of Veterans Affairs (VA), on a seven million dollar funding opportunity announcement for research in this area. NIH is the leading scientific agency within the U.S. Department of Health and Human Services.

There is a growing awareness that returning military personnel -- whatever their overseas role -- need help confronting a variety of war related problems including traumatic brain injury, post traumatic stress disorder, depression, anxiety, sleep disturbances, and substance abuse, including tobacco, alcohol and other drugs. Many of these problems are interconnected, and contribute to individual health and family relationship crises, yet there has been little research on how to prevent and treat the unique characteristics of wartime related substance abuse issues. The funding opportunity announcement will focus on the causes, screening and identification, prevention and treatment of substance use and abuse--including alcohol, tobacco and other drugs--and associated problems, including post-traumatic stress disorder.

"Active duty military personnel and the community of veterans have sacrificed so much for our country that we owe them nothing less than the best that research can offer," said Acting NIH Director Raynard S. Kington, M.D., Ph.D.

This funding opportunity announcement was prompted by a meeting held in January to gain a better understanding of the substance abuse intervention needs of military personnel, veterans, and their families and develop recommendations for prevention and treatment research priorities in this area. This is the first post-meeting announcement and is specific to those serving, or who have served, in Operation Enduring Freedom (Afghanistan) and/or Operation Iraqi Freedom.


"Working in collaboration with key federal agencies, we hope to learn more about how to address the array of social and emotional problems caused by the trauma of war that bring so much pain to soldiers and their families," said NIDA Director Nora D. Volkow. "Even though they are no longer in combat, many of these brave men and women are now fighting substance addiction -- another dangerous enemy."

"The transition period as soldiers withdraw from battlefield stress and face the rigors of re-adjusting to life at home can be a critical turning point," said NIAAA Acting Director Kenneth Warren. "This partnership will enhance our efforts to find solutions to the complex alcohol and substance abuse problems that plague our soldiers and their families."

The grant applications submitted will be reviewed by an NIH review panel that includes scientific expertise regarding substance abuse and associated conditions. Each agency will fund grants relevant to its mission. NIDA will fund $2 million, NIAAA $2 million, NCI $1 million and the VA $2 million.

As the research evolves, the VA will look for new tools to confront a complex cascade of problems which increasingly threaten the medical and physical health of its patients.

Dr. Joel Kupersmith, the VA's chief research and development officer, comments, "VA has long supported a strong research program for veterans, and this request for applications provides the opportunity to clearly focus on essential issues encountered by the newest generation of veterans in conjunction with federal partners."

Research questions related to all phases of the deployment cycle (i.e., pre-deployment, deployment, re-integration, and separation) and all branches of the military (e.g., Army, Navy, Marines, Air Force, Coast Guard, U.S. Military Reserves, National Guard) and veterans are of interest. The deadline for grant applications is December 22, 2009.

The Department of Veterans Affairs (VA) -- VA's Office of Research and Development (ORD) aspires to discover knowledge, develop VA researchers and health care leaders, and create innovations that advance health care for our veterans and the nation. For more information about VA Research: .

The National Institute on Alcohol Abuse and Alcoholism, part of the NIH, is the primary U.S. agency for conducting and supporting research on the causes, consequences, prevention, and treatment of alcohol abuse, alcoholism, and alcohol problems, and disseminates research findings to general, professional, and academic audiences. Additional alcohol research information and publications are available at .

NCI leads the National Cancer Program and the NIH effort to dramatically reduce the burden of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. For more information about cancer, please visit the NCI Web site at or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).

The National Institute on Drug Abuse is a component of the National Institutes of Health, U.S. Department of Health and Human Services. NIDA supports most of the world's research on the health aspects of drug abuse and addiction. The Institute carries out a large variety of programs to inform policy and improve practice. Fact sheets on the health effects of drugs of abuse and information on NIDA research and other activities can be found on the NIDA home page at . To order publications in English or Spanish, call NIDA's new DrugPubs research dissemination center at 1-877-NIDA-NIH or 240-645-0228 (TDD) or fax or email requests to 240-645-0227 or drugpubs@nida.nih.gov. Online ordering is available at .

The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit .

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SUN EXPOSURE MAY TRIGGER CERTAIN AUTOIMMUNE DISEASES IN WOMEN

More bad news for women. The sun may trigger autoimmune disease.

SUN EXPOSURE MAY TRIGGER CERTAIN AUTOIMMUNE DISEASES IN WOMEN

U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News
National Institute of Environmental Health Sciences (NIEHS)
For Immediate Release: Thursday, July 30, 2009

CONTACT: Robin Mackar, 919-541-0073,

SUN EXPOSURE MAY TRIGGER CERTAIN AUTOIMMUNE DISEASES IN WOMEN

Ultraviolet (UV) radiation from sunlight may be associated with the development of certain autoimmune diseases, particularly in women, according to a study by researchers at the National Institute of Environmental Health Sciences (NIEHS), part of the National Institutes of Health.

"This study found that women who lived in areas with higher levels of UV exposure when they developed an autoimmune muscle disease called myositis were more likely to develop the form known as dermatomyositis, which weakens the muscles and causes distinctive rashes, instead of the form called polymyositis that does not have a rash," said Frederick W. Miller, M.D., Ph.D., chief of the Environmental Autoimmunity Group, Program of Clinical Research, at NIEHS. "Although we have not shown a direct cause and effect link between UV exposure and this particular autoimmune disease, this study confirms the association between UV levels and the frequency of dermatomyositis that we found in a previous investigation," said Miller.

The study, published in the August issue of Arthritis & Rheumatism, is also the first to evaluate and find a possible UV radiation association in autoimmune diseases in women.

According to Miller, women are more likely than men to develop many autoimmune diseases, but the reasons for this have not been clear. "We only found the association between UV exposure and dermatomyositis in women and not in men, and it could be that inherent differences in how women and men respond to UV radiation may play a role in the development of certain autoimmune diseases," said Dr. Miller. Miller also noted that other researchers have shown that female mice develop more skin inflammation after UV light exposure compared to male mice and these effects may be related to the new findings in dermatomyositis.

The study was designed to determine if there was a relationship between the level of UV exposure at the onset of the disease and the type of myositis and autoantibodies that people developed. Dermatomyositis and polymyositis are the two major forms of myositis and both are considered autoimmune diseases, in which the body's immune system attacks muscle or skin and sometimes other tissues. Dermatomyositis is typically accompanied by a distinctive reddish-purple rash on the upper eyelids or over the knuckles and is often made worse with sun exposure.

To conduct the study, the NIEHS researchers collaborated with myositis centers across the country that had seen 380 patients who had been diagnosed with dermatomyositis or polymyositis and determined their autoantibodies. "Patients with autoimmune diseases make a variety of autoantibodies that are unique to different conditions. One autoantibody specifically associated with dermatomyositis is called the anti-Mi-2 autoantibody and we know from our previous research that UV radiation increases levels of the Mi-2 protein that this autoantibody binds to," said Miller.

In addition to finding an association between the level of UV radiation and the proportion of women who developed dermatomyositis compared to polymyositis, the researchers found an association between UV levels and the proportion of women with the anti-Mi-2 autoantibody. "More research is clearly needed to understand the potential links between UV radiation and the development of autoimmune diseases and autoantibodies in women," said Miller.

"While the causes of autoimmune diseases are not known, we suspect from emerging research that they develop after one or more environmental exposures in genetically susceptible people," said NIEHS Director Linda Birnbaum, Ph.D. "This study adds UV radiation to the growing list of environmental exposures possibly important in the development of autoimmune diseases."

The NIEHS supports research to understand the effects of the environment on human health and is part of NIH. For more information on environmental health topics, visit our Web site at .

The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit .
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REFERENCE: Love LA, Weinberg CR, McConnaughey DR, Oddis CV, Medsger TA, Reveille JD, Arnett FC, Targoff IN, Miller FW. "Ultraviolet Radiation Intensity Predicts the Relative Distribution of Dermatomyositis and Anti-Mi-2 Autoantibodies in Women." Arthritis & Rheumatism. August, 2009.

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SUN EXPOSURE MAY TRIGGER CERTAIN AUTOIMMUNE DISEASES IN WOMEN

U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News
National Institute of Environmental Health Sciences (NIEHS)
For Immediate Release: Thursday, July 30, 2009

CONTACT: Robin Mackar, 919-541-0073,

SUN EXPOSURE MAY TRIGGER CERTAIN AUTOIMMUNE DISEASES IN WOMEN

Ultraviolet (UV) radiation from sunlight may be associated with the development of certain autoimmune diseases, particularly in women, according to a study by researchers at the National Institute of Environmental Health Sciences (NIEHS), part of the National Institutes of Health.

"This study found that women who lived in areas with higher levels of UV exposure when they developed an autoimmune muscle disease called myositis were more likely to develop the form known as dermatomyositis, which weakens the muscles and causes distinctive rashes, instead of the form called polymyositis that does not have a rash," said Frederick W. Miller, M.D., Ph.D., chief of the Environmental Autoimmunity Group, Program of Clinical Research, at NIEHS. "Although we have not shown a direct cause and effect link between UV exposure and this particular autoimmune disease, this study confirms the association between UV levels and the frequency of dermatomyositis that we found in a previous investigation," said Miller.

The study, published in the August issue of Arthritis & Rheumatism, is also the first to evaluate and find a possible UV radiation association in autoimmune diseases in women.

According to Miller, women are more likely than men to develop many autoimmune diseases, but the reasons for this have not been clear. "We only found the association between UV exposure and dermatomyositis in women and not in men, and it could be that inherent differences in how women and men respond to UV radiation may play a role in the development of certain autoimmune diseases," said Dr. Miller. Miller also noted that other researchers have shown that female mice develop more skin inflammation after UV light exposure compared to male mice and these effects may be related to the new findings in dermatomyositis.

The study was designed to determine if there was a relationship between the level of UV exposure at the onset of the disease and the type of myositis and autoantibodies that people developed. Dermatomyositis and polymyositis are the two major forms of myositis and both are considered autoimmune diseases, in which the body's immune system attacks muscle or skin and sometimes other tissues. Dermatomyositis is typically accompanied by a distinctive reddish-purple rash on the upper eyelids or over the knuckles and is often made worse with sun exposure.

To conduct the study, the NIEHS researchers collaborated with myositis centers across the country that had seen 380 patients who had been diagnosed with dermatomyositis or polymyositis and determined their autoantibodies. "Patients with autoimmune diseases make a variety of autoantibodies that are unique to different conditions. One autoantibody specifically associated with dermatomyositis is called the anti-Mi-2 autoantibody and we know from our previous research that UV radiation increases levels of the Mi-2 protein that this autoantibody binds to," said Miller.

In addition to finding an association between the level of UV radiation and the proportion of women who developed dermatomyositis compared to polymyositis, the researchers found an association between UV levels and the proportion of women with the anti-Mi-2 autoantibody. "More research is clearly needed to understand the potential links between UV radiation and the development of autoimmune diseases and autoantibodies in women," said Miller.

"While the causes of autoimmune diseases are not known, we suspect from emerging research that they develop after one or more environmental exposures in genetically susceptible people," said NIEHS Director Linda Birnbaum, Ph.D. "This study adds UV radiation to the growing list of environmental exposures possibly important in the development of autoimmune diseases."

The NIEHS supports research to understand the effects of the environment on human health and is part of NIH. For more information on environmental health topics, visit our Web site at .

The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit .
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REFERENCE: Love LA, Weinberg CR, McConnaughey DR, Oddis CV, Medsger TA, Reveille JD, Arnett FC, Targoff IN, Miller FW. "Ultraviolet Radiation Intensity Predicts the Relative Distribution of Dermatomyositis and Anti-Mi-2 Autoantibodies in Women." Arthritis & Rheumatism. August, 2009.

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SPECIES BARRIER MAY PROTECT MACAQUES FROM CHRONIC WASTING DISEASE

More information on a prion disease. Prions still remain controversial as infectious agents among some researchers.

SPECIES BARRIER MAY PROTECT MACAQUES FROM CHRONIC WASTING DISEASE

U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News
National Institute of Allergy and Infectious Diseases (NIAID)
For Immediate Release: Wednesday, July 29, 2009

MEDIA CONTACT: Ken Pekoc, 406-375-9690,

SPECIES BARRIER MAY PROTECT MACAQUES FROM CHRONIC WASTING DISEASE

Data from an ongoing multi-year study suggest that people who consume deer and elk with chronic wasting disease (CWD) may be protected from infection by an inability of the CWD infectious agent to spread to people. The results to date show that 14 cynomolgus macaques exposed orally or intracerebrally to CWD remain healthy and symptom free after more than six years of observation, though the direct relevance to people is not definitive and remains under study. Cynomolgus macaques often are used as research models of human disease because they are very close genetically to humans and are susceptible to several forms of human brain-damaging disease. Thus, it was decided to see whether exposure to CWD could induce disease in the macaques. The study appears online in the journal Emerging Infectious Diseases.

CWD is a type of brain-damaging disease known as a transmissible spongiform encephalopathy (TSE) or prion disease. CWD primarily affects deer, elk, and moose. Other TSE diseases include mad cow disease, or bovine spongiform encephalopathy (BSE) in cattle, scrapie in sheep, and sporadic Creutzfeldt-Jakob disease (CJD) in humans. Humans are not susceptible to sheep scrapie, but BSE appears to have infected about 200 people, primarily in Europe in the 1990s. Those findings provided the rationale for the present CWD-macaque study, which began in 2003.

"We plan to continue this study for at least several more years because, although the risk to macaques so far appears to be low, we know that these diseases can take more than 10 years to develop," says Bruce Chesebro, M.D., chief of the Laboratory of Persistent Viral Diseases at Rocky Mountain Laboratories (RML) in Hamilton, Mont. RML is part of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). The RML group is leading the study with collaborators from the Colorado Division of Wildlife; State University of New York Downstate Medical Center; New York State Institute for Basic Research in Developmental Disabilities; American Red Cross; and the University of Wyoming.

The findings by the RML group support published field studies done by others in regions of Colorado and Wyoming where CWD is endemic. Between 1979 and 2001, there were no significant increases in human TSE diseases despite the likelihood that hunters in those areas were exposed to CWD through contact with infected animal tissue and contaminated hunting tools such as knives and saws. Extensive laboratory data also supports a human species barrier against CWD.

Notably, the RML study also included identical testing in squirrel monkeys, which are genetically less similar to humans than macaques. Of 15 squirrel monkeys exposed orally to CWD, two displayed disease symptoms 69 months after infection. Of 13 squirrel monkeys exposed intracerebrally to CWD, 11 displayed symptoms between 33 and 53 months after infection. In symptomatic animals, the presence of the CWD agent was confirmed in brain, spleen and lymph nodes.

The results in squirrel monkeys were not surprising because a study elsewhere in two squirrel monkeys yielded similar results. The study by the RML group was different, however, in that it tested oral exposure to CWD and also studied eight CWD samples from different areas of the country. The results in squirrel monkeys confirmed that disease progression in that species appears consistent with disease progression in deer and elk, where severe weight loss is nearly always present.

"The fact that the squirrel monkeys, like the deer and elk, suffered severe weight loss suggests that chronic wasting disease might affect a common region of the brain in different species," notes Dr. Chesebro.

NIAID conducts and supports research-at NIH, throughout the United States, and worldwide-to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at .

The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit .
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REFERENCE: Race B et al. Susceptibilities of nonhuman primates to chronic wasting disease. "Emerging Infectious Diseases." DOI: 10.3201/eid1509.090253.

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Sildenafil Stopped for Pulmonary Hypertension in Sickle Cell

Pulmonary hypertension remains a horrible disease with bad treatment options. This is more bad news....

NHLBI STOPS STUDY OF TREATMENT FOR PULMONARY HYPERTENSION IN PATIENTS WITH SICKLE CELL DISEASE DUE TO SAFETY CONCERNS

U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News
National Heart, Lung, and Blood Institute (NHLBI)
For Immediate Release: Tuesday, July 28, 2009

CONTACT: NHLBI Communications Office, 301-496-4236,

NHLBI STOPS STUDY OF TREATMENT FOR PULMONARY HYPERTENSION IN PATIENTS WITH SICKLE CELL DISEASE DUE TO SAFETY CONCERNS

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped a clinical trial testing a drug treatment for pulmonary hypertension in adults with sickle cell disease nearly one year early due to safety concerns. In an interim review of safety data from 33 participants who completed 16 weeks of treatment, researchers found that, compared to participants on placebo (dummy pill), participants taking sildenafil (Revatio) were significantly more likely to have serious medical problems. The most common problem was episodes of severe pain called sickle cell crises, which resulted in hospitalization. No deaths have been associated with the drug in the clinical trial.

Known as walk-PHaSST, the study was the first multicenter, randomized clinical trial to test the safety and effectiveness of sildenafil for pulmonary hypertension in patients with sickle cell disease, one of the most common genetic blood disorders in the United States. Pulmonary hypertension is a debilitating condition of high blood pressure in the arteries that carry blood to the lungs, which can lead to heart failure and death. Approximately 30 percent of sickle cell disease patients develop pulmonary hypertension, and even mild levels of pulmonary hypertension have been associated with sudden death in people with sickle cell disease.

"The increase in sickle cell medical problems is concern enough for us to stop this clinical trial to protect the safety of our participants," said NHLBI Director Elizabeth G. Nabel, M.D. "We will continue to look into the possible causes of these preliminary results. In the meantime, we encourage patients with sickle cell disease who are taking sildenafil for pulmonary hypertension to talk with their physicians about the potential risks and benefits of the medication and what actions they should consider, including whether to taper off this medication and how to best manage both sickle cell disease and pulmonary hypertension."

Because the medical problems experienced in walk-PHaSST were complications specific to sickle cell disease, "The findings of the walk-PHaSST study should not be applied to other groups of patients with pulmonary hypertension where the drug has been found to be safe and effective," Nabel added.

Researchers are conducting extensive analyses of the study results, which could contribute to recommendations for treating pulmonary hypertension in patients with sickle cell disease. They will prepare reports of their research for publication in peer-reviewed journals.

The NHLBI stopped the study on July 7, 2009, based on the unanimous recommendations of the Pulmonary Complications of Sickle Cell Disease Data and Safety Monitoring Board (DSMB), an independent advisory group that has been monitoring the study since it began. This DSMB is composed of experts in sickle cell disease, lung disease, statistics, and bioethics.

Participants in walk-PHaSST have discussed the preliminary findings of the study with their study clinicians. They have been instructed to taper sildenafil treatment over a period of three to seven days to minimize problems associated with immediate withdrawal from the drug, such as worsening of symptoms of pulmonary hypertension. Researchers will continue to monitor participants and conduct further analyses to assess the findings.

Walk-PHaSST was designed to determine whether sildenafil lessens the symptoms of pulmonary hypertension, such as shortness of breath, by improving heart and lung function, in individuals with sickle cell disease who develop pulmonary hypertension. The primary outcome measure was the results of a six-minute walk test, a standard indicator of a person's heart and lung function. Hence, the name walk-PHaSST reflects the primary test used to assess effectiveness of the treatment ("walk" test) for Pulmonary Hypertension and Sickle Cell Disease with Sildenafil Therapy. Researchers also evaluated the safety of the drug for sickle cell disease patients through reports of adverse effects and laboratory tests.

Sildenafil is approved by the Food and Drug Administration for use in patients with pulmonary hypertension. In general, the drug treats pulmonary hypertension by relaxing the blood vessels in the lungs to allow blood to flow more easily. Since sildenafil is not FDA-approved to treat pulmonary hypertension in patients with sickle cell disease, the walk-PHaSST study was conducted under an investigational new drug application. The FDA was notified of the termination of the study on July 14.

Walk-PHaSST began recruiting participants in July 2007 and enrolled 74 patients over the age of 19 (average age 45). Participants had sickle cell disease and mild to severe pulmonary hypertension. They were randomly assigned to receive sildenafil or placebo for 16 weeks. Participants could also receive other therapies as needed to manage sickle cell and related complications. After completing the study treatment (or placebo), participants could choose to be part of the open-label follow-up phase of the study and continue to be assessed for up to one year. In the open-label study, participants and clinicians knew that sildenafil was being taken. When the study was stopped, 33 participants had completed the clinical trial.

Researchers found that 38 percent of participants taking sildenafil had serious adverse effects -- primarily sickle cell pain crises -- compared to 8 percent of participants in the placebo group.

"Although these preliminary results are disappointing, we expect that the study's results, once fully analyzed, will provide important insights into the role of pulmonary hypertension in sickle cell disease," said Mark Gladwin, M.D., lead investigator of walk-PHaSST and director of the Vascular Medicine Institute at the University of Pittsburgh. Gladwin is also a special volunteer for the NHLBI and was formerly a senior investigator with the Critical Care Medicine Department at the NIH Clinical Center and chief of the NHLBI Pulmonary and Vascular Medicine Branch.

The design of the walk-PHaSST study was based on extensive evidence that sildenafil improves pulmonary hypertension regardless of its cause and on results of a small, open-label, nonrandomized pilot study led by Gladwin while he was at the NIH. The pilot study evaluated 12 sickle cell patients with mild or moderate pulmonary hypertension who were being treated with sildenafil and with hydroxyurea, a drug known to help reduce the numbers of episodes of sickle cell pain crises and acute chest syndrome, as well as hospitalizations and blood transfusions needed. In 2005, Gladwin and his colleagues reported that after about 6 months, sildenafil was well tolerated, decreased pulmonary blood pressure, and increased exercise capacity.

"Walk-PHaSST emphasizes the importance of multi-site, blinded, randomized clinical trials to increase our understanding of both the benefits and the potential risks of specific treatments," noted Jonathan C. Goldsmith, M.D., NHLBI project officer of walk-PHaSST. "As with all clinical studies, patient safety is paramount."

Walk PHaSST was conducted at the following locations:

-- Children's Hospital, Oakland, Calif.
-- University of Colorado, Denver
-- Howard University Hospital, Washington, D.C.
-- University of Illinois at Chicago
-- Johns Hopkins Medical Institutions, Baltimore
-- NIH Clinical Center, Bethesda, Md.
-- Albert Einstein College of Medicine, New York City
-- Columbia University, New York City
-- Children's Hospital, Pittsburgh
-- Imperial College London and Hammersmith Hospital, London, England

Rho Inc. of Chapel Hill, N.C., serves as the data coordinating center. Pfizer provided the treatment drug and placebo for the study.

Sickle cell anemia affects millions of people worldwide. An estimated 70,000 to 100,000 people in the United States have sickle cell disease, primarily African Americans and, to a lesser degree, people whose families come from South or Central America. Patients with this disease have abnormal hemoglobin molecules in their red blood cells. The abnormal molecules deform the red blood cells, causing them to clump together and block blood flow through blood vessels, leading to painful sickle cell crises, organ damage, and anemia. Life-threatening complications include infections, acute chest syndrome, stroke, and pulmonary hypertension. Painful crises are the leading cause of emergency room visits and hospitalizations of people who have sickle cell anemia.

There are currently no established guidelines for treating pulmonary hypertension in patients with sickle cell disease. Pulmonary hypertension can lead to heart failure and death as the heart must work harder to push blood into the lungs. In general, intensive management of sickle cell disease through hydroxyurea, blood transfusions, and/or bone marrow transplantation may be indicated. Other treatment options may include blood-thinning medicines, diuretics, and oxygen therapy.

"As new treatments have evolved over the past several years, sickle cell patients are living longer than in previous decades, presenting new challenges for managing chronic problems and complications such as pulmonary hypertension," noted Susan Shurin, MD, NHLBI deputy director and a hematologist. "The NHLBI continues to maintain a strong commitment to supporting research in adults as well as in children to discover new and better ways to improve quality of life and survival for patients with sickle cell disease."

Further information about this trial (NCT00492531) can be found at . To arrange an interview with an NHLBI spokesperson or Dr. Gladwin, please contact the NHLBI Communications Office at (301) 496-4236 or email . Dr. Gladwin can also be reached at .

Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at .

The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit .
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RESOURCES:

Sickle cell disease .

Pulmonary hypertension

Report of the National Heart, Lung, and Blood Advisory Council Subcommittee Review of the NHLBI Sickle Cell Disease Program, February 29, 2008

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INTENSIVE GLUCOSE CONTROL HALVES COMPLICATIONS OF LONGSTANDING TYPE 1 DIABETES

The NIH is saying that better blood sugar control in diabetes results in fewer health complications. - BRH

U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Embargoed for Release: Monday, July 27, 2009, 4 p.m. EDT

CONTACT:
Mary Harris, Joan Chamberlain, 301-496-3583,

INTENSIVE GLUCOSE CONTROL HALVES COMPLICATIONS OF LONGSTANDING TYPE 1 DIABETES
Study Finds Improved Long-Term Outlook

Near-normal control of glucose beginning as soon as possible after diagnosis would greatly improve the long-term prognosis of type 1 diabetes, concludes a study published in the July 27, 2009, issue of the Archives of Internal Medicine, which updates information about the clinical course of type 1 diabetes. The study also found that the outlook for people with longstanding type 1 diabetes has greatly improved in the past 20 years due to a better understanding of the importance of intensive glucose control as well as advances in insulin formulations, insulin delivery, glucose monitoring, and the treatment of cardiovascular risk factors.

"The demonstration that near-normal glucose control substantially lowers microvascular and cardiovascular complications has heralded a new era of type 1 diabetes care," says lead author David M. Nathan, M.D., of Massachusetts General Hospital. Nathan is also co-chair of the landmark Diabetes Control and Complications Trial (DCCT) and its follow-up study, the Epidemiology of Diabetes Interventions and Complications (EDIC), both funded by the National Institutes of Health. "The remarkable improvement in long-term outcomes achieved with intensive glucose control should encourage clinicians and patients alike to implement intensive therapy as early in the course of type 1 diabetes as possible."

The DCCT, conducted from 1983 to 1989, found that intensive glucose control was superior to conventional control in delaying or preventing the complications of type 1 diabetes. EDIC continues to follow DCCT participants to determine the long-term effects of prior intensive versus conventional blood glucose control.

The authors compared overall rates of eye, kidney, and cardiovascular complications in three groups of people diagnosed with type 1 diabetes an average of 30 years earlier. Two groups consisted of DCCT/EDIC participants--those randomly assigned to intensive glucose control or to conventional control. The third group was a subset of patients in the Pittsburgh Epidemiology of Diabetes Complications (EDC) study, who were matched to DCCT/EDIC participants by age, duration of diabetes, and degree of eye damage. The EDC, also funded by NIH, is a population-based study that has been following residents of Allegheny County, Pa., who were diagnosed with type 1 diabetes from 1950 to 1980.

After 30 years of diabetes, DCCT participants randomly assigned to intensive glucose control had about half the rate of eye damage compared to those assigned to conventional glucose control (21 percent vs. 50 percent). They also had lower rates of kidney damage (9 percent vs. 25 percent) and cardiovascular disease events (9 percent vs. 14 percent) compared to those receiving conventional glucose control. Eye damage ranged from significant damage without vision loss to blindness. Kidney damage ranged from mild kidney disease to kidney failure. Cardiovascular events encompassed heart attack, stroke, angina, and obstruction of the coronary arteries.

The intensively treated DCCT group also had lower complication rates than EDC participants, whose rates were similar to DCCT's conventional control group: eye damage (47 percent), kidney damage (17 percent), and cardiovascular disease events (14 percent).

"Better treatment of blood pressure and cholesterol is also helping to reduce complication rates. The similar event rates in the DCCT conventional control group and the EDC study suggest that the results of the DCCT trial are likely to be generally applicable to those with type 1 diabetes," said Trevor Orchard, M.D., of the University of Pittsburgh, who heads the EDC study.

Not only did intensive glucose control halve the rates of eye and kidney damage, but the rates of vision loss and kidney failure were much lower than had been seen historically. "After 30 years of diabetes, fewer than 1 percent of those receiving intensive glucose control in the DCCT had significantly impaired vision, kidney failure, or needed a limb amputation due to diabetes," noted Saul Genuth, M.D., of Case Western University, who co-chairs the EDIC study. "Tight control is difficult to achieve and maintain, but its benefits have changed the course of diabetes."

The DCCT compared intensive management of blood glucose to conventional control in 1,441 people 13 to 39 years of age with type 1 diabetes. At the time, conventional treatment consisted of one or two insulin injections a day with daily urine or blood glucose testing. Participants randomly assigned to intensive treatment were asked to keep glucose levels as close to normal as possible. That meant trying to keep hemoglobin A1c (A1C) readings at 6 percent or less with at least three insulin injections a day or an insulin pump, guided by frequent self-monitoring of blood glucose. (A1C reflects average blood glucose over the previous two to three months.)

In addition, the rates of eye damage (30 percent) and kidney disease (12 percent) in all DCCT/EDIC participants who had type 1 diabetes for 25 years were also significantly lower than the rates of eye damage (40-53 percent) and kidney disease (35 percent) reported in the medical literature for comparable patients diagnosed in the 1950s to 1970s.

"These data give clinicians a realistic description of the clinical outcomes they can discuss with their patients. When intensive therapy, now the standard of care, is implemented early in the course of diabetes, most patients with type 1 diabetes should be able to avoid the disastrous long-term complications that were so common in the past," said Nathan.

Major improvements in glucose monitoring and insulin delivery introduced in the past decade are now helping patients control their blood glucose more precisely and conveniently and reduce the risk of hypoglycemia. For example, several continuous glucose monitoring devices approved by the Food and Drug Administration give both trend and real-time information on glucose levels. Insulin pump technology is also improving, and researchers have begun testing a system that combines both technologies in patients with newly diagnosed type 1 diabetes.

In the United States, nearly 24 million people have diabetes. In adults, type 1 diabetes accounts for 5 to 10 percent of all diagnosed cases of diabetes. Formerly called juvenile-onset diabetes or insulin-dependent diabetes, type 1 diabetes develops when the body's immune system destroys pancreatic beta cells, the only cells in the body that make the hormone insulin that regulates blood glucose. This form of diabetes usually arises in children and young adults, but it can occur at any age. Management involves keeping blood glucose levels as close to normal as possible with three or more insulin injections a day or treatment with an insulin pump, careful monitoring of glucose, and close attention to diet and exercise.

Type 2 diabetes, or adult-onset diabetes, accounts for about 90 to 95 percent of all diagnosed cases of diabetes in adults. It usually begins as insulin resistance, a disorder in which the cells do not use insulin properly. As the need for insulin rises, the pancreas gradually loses its ability to produce it. Type 2 diabetes is associated with older age, obesity, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity, and race/ethnicity. African Americans, Hispanic/Latino Americans, American Indians, and some Asian Americans and Native Hawaiians or other Pacific Islanders are at particularly high risk for type 2 diabetes and its complications.

The DCCT is registered as NCT00360815, and EDIC is registered as NCT00360893 in . The DCCT/EDIC is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Eye Institute, the National Institute of Neurological Disorders and Stroke, and the General Clinical Research Centers Program, National Center for Research Resources, within the NIH. Genentech contributed to the DCCT/EDIC through a Cooperative Research and Development Agreement with the NIDDK. Lifescan, Roche, Aventis, Eli Lilly, Omnipod, Can-Am, B-D, Animas, Medtronic, Medtronic Minimed, Bayer, and Omron, contributed free or discounted supplies to the DCCT/EDIC. The EDC study is funded by the NIDDK.

NIDDK, part of the NIH, conducts and supports basic and clinical research and research training on some of the most common, severe and disabling conditions affecting Americans. The Institute's research interests include diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic and hematologic diseases. For more information, visit .

The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit .

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