FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample

The U.S. Food and Drug Administration has cleared for marketing a test that can help health care professionals determine what type of cancer cells are present in a malignant tumor.

The Pathwork Tissue of Origin test compares the genetic material of a patient’s tumor with genetic information on malignant tumor types stored in a database.

It uses a microarray technology to analyze thousands of pieces of genetic material at one time. The test considers 15 common malignant tumor types, including bladder, breast, and colorectal tumors.

"The clearance of the Pathwork test is another step in the continued integration of molecular-based medicine into standard practice," said Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health, which oversees medical diagnostics. "In the past, scientists have classified different types of cancers based on the organs in which the tumors develop. With the help of microarray technology, they will be able to classify these types of cancers in a standardized non-reader dependent manner based on the patterns of gene activity in the tumor cells."

The Pathwork Tissue of Origin test is the second in vitro diagnostic multivariate index assay (IVDMIA) device to be cleared by the FDA. In July 2007, the FDA issued a draft guidance document to address premarket pathways and postmarket requirements for IVDMIAs. IVDMIA tests combine the values of multiple variables to yield a single, patient-specific result.

Nearly every cell of the body contains a full set of chromosomes and identical genes but only a fraction of these genes are turned on or expressed in any given cell. Gene expression occurs when certain molecular information contained within DNA is transcribed to create molecules known as RNA. These molecules in turn make the proteins that perform most of the critical functions of cells.

Microarray technology can simultaneously measure gene expression levels of large numbers of genes. Small DNA fragments are placed or arrayed on a slide and then RNA, which has been extracted from the tumor tissue and labeled with a fluorescent marker, is spread over this "microarray."

Since RNA binds to its complementary DNA strand, how much binding occurs indicates how active the gene being evaluated is. This can be determined by putting the array under a scanning microscope and measuring the intensity of the fluorescent light at each point on the array.

Pathwork’s proprietary software converts the scanned image data to gene expression measurements. The gene expression patterns are compared with known gene expression patterns in the database that correspond to different tumor types.

The Pathwork Tissue of Origin test has been found to provide patterns that confirm existing tissue of origin of the 15 common tumor types using standard clinical and pathological information. This accuracy of this test is similar to that achieved by expert pathologists using current standards of practice.

PathChip, the gene expression array used in the Pathwork Tissue of Origin test, is custom-designed for Pathwork Diagnostics of Sunnyvale, Calif., by Affymetrix Inc., of Santa Clara, Calif. PathChip is the first custom Affymetrix gene expression array to be cleared for diagnostic use.

Chambliss, Isakson Applaud $5.5 Million Reimbursement for Sumter Regional Hospital

U.S. Senators Saxby Chambliss, R-Ga., and Johnny Isakson, R-Ga., today applauded the decision by the Federal Emergency Management Agency (FEMA) to provide $5.5 million in federal funding to help reimburse Sumter Regional Hospital in Americus for leased medical equipment. The hospital was severely damaged and the adjacent HealthPlex was destroyed during the storms and tornadoes that hit the area on March 1, 2007. Chambliss and Isakson toured the damage with President Bush on March 3, 2007, and have been working with local officials throughout the recovery process.

“This assistance is greatly needed,” said Chambliss. “The storms and tornadoes that hit Southwest Georgia last year took a tremendous toll on the Americus area and severely displaced a critical medical facility that so many folks in the area rely on. It is imperative that the federal government provide all the assistance it can to continue the rebuilding process and ensure that Georgians who live in this area have access to the quality health care they deserve.”

“This is welcome news for Sumter Regional Hospital,” Isakson said. “These funds are essential to the hospital’s recovery from the severe tornadoes that wreaked havoc across much of the area and will go a long way toward ensuring that residents of the region continue to receive the superior healthcare they have come to expect from Sumter Regional.”
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Doctors at Piedmont Hospital Help Pioneer New SpyGlass™ System

May Alter Diagnosis and Treatment of Patients with Liver,
Gallbladder and Bile Duct Conditions: First of its Kind in Atlanta

Local Man’s Health Scare Shows Value of New System that Provides Direct Visualization of
Patient’s Bile Ducts and May Reduce Need for Additional Testing and Repeat Procedures

When the doctor at his local hospital diagnosed Ira Crawford with bile duct cancer and said he was discharging him so he could spend his final days at home, the 82-year-old Griffin, Ga. man replied, “No, I’m going to discharge you.”

Crawford had witnessed the end stages of cancer before and knew he was not that sick. But, after 19 days in the hospital, Crawford knew something had to be done because his condition was getting worse and worse every day; his urine was black and his stool was gray. Bile duct cancer has an 80 to 90 percent mortality rate and the average patient survives six months.

Fortunately for Crawford, his regular doctor researched his condition and discovered that physicians at Piedmont Hospital were now using a new cholangioscopy technology to diagnose and treat conditions such as obstructions due to mass, strictures and stones within the biliary tract.

Using the new technology that is part of the SpyGlass™ Direct Visualization System, Roshan Shrestha, M.D., therapeutic endoscopist and medical director of liver transplantation, Piedmont Hospital Transplant Services, was able to use a miniature 6,000 pixel fiber optic probe that provides physicians with a direct view of a patient’s bile ducts, overcoming some of the visual challenges of conventional ERCP procedures. Dr. Shrestha was able to visualize the area in Ira Crawford’s liver and diagnose that it was a stone in his bile duct located deep inside the liver – a much better diagnosis than cancer.

As part of the traditional ERCP procedure undergone by almost 500,000 people in the United States annually, physicians use an endoscope – a long, flexible, lighted tube that is inserted through a patient’s mouth and directed through the stomach into the first part of the small intestine – in order to view the entrance to the biliary tract. At this point X-rays may be taken of the inside of the biliary tract. However, these X-rays are two-dimensional black and white images that often do not provide enough information to obtain a complete diagnosis. In Ira Crawford’s case, the doctor was not able to obtain an accurate image, which led to his diagnosis of cancer.

Data shows that up to 60 percent of ERCPs performed using brush cytology or fluoroscopic guidance fine needle aspiration for tissue diagnosis are inconclusive, potentially creating the need for additional testing or repeat procedures. Besides being inconvenient for patients having to return to the hospital, the procedure can take two or more hours and typically requires them not to eat or drink six to eight hours beforehand. At times to make definitive diagnosis, patients undergo unnecessary surgery which carries higher morbidity and even mortality.

The SpyGlass System, developed by Boston Scientific Corporation, provides direct visual access into a patient’s biliary duct to improve diagnosis by helping to identify stones, strictures or mass causing obstructions of the bile duct. A fiber optic probe attaches to a camera head and is inserted through a single-use catheter that can be steered in four directions. This is designed to allow the user to access and inspect all four quadrants of the examination and treatment area. As a result, physicians are able to achieve an improved diagnosis for patients.

Piedmont Hospital is one of just 25 medical centers in the nation to be selected to use the Spyglass System in the second phase of clinical release for the device and is the first of its kind in metro Atlanta.

Direct visualization of the biliary system (cholangioscopy) has been possible for more than 30 years and its benefits are well documented in numerous published studies. However, the technology has not been widely adopted due to the cost and limitations of available devices. Boston Scientific designed the SpyGlass System to help therapeutic endoscopists overcome these hurdles and to make cholangioscopy feasible for a larger number of physicians.

Studies Demonstrate Clinical Benefits of SpyGlass System

A study evaluating the clinical utility and safety of the single-operator SpyGlass System for diagnostic and therapeutic endoscopic procedures in bile ducts was performed at the University of Colorado Health Sciences Center in Denver and the Beth Israel Deaconess Medical Center in Boston. Thirty-five patients underwent procedures with the SpyGlass System. Results were published in the May 2007 issue of Gastrointestinal Endoscopy, demonstrating that a single-operator system proved clinically feasible and provided adequate samples for histologic diagnosis and successfully guided stone therapy. The procedures were deemed safe and well tolerated.

In addition, results of a preclinical study described in the February 2007 issue of Gastrointestinal Endoscopy showed that success rates for access in all quadrants were significantly higher with the SpyGlass System than with conventional systems. In addition, higher success rates were attained using the SpyGlass System to access biopsy targets and to perform simulated biopsies. The SpyGlass System permitted access to 48 of 48 biopsy targets.

“These preliminary studies along with my personal experience on more than a dozen patients suggest that the direct visualization provided by the SpyGlass System offers tremendous advantages that until now have not been possible with traditional ERCP systems,” said Dr. Shrestha. “In addition, the SpyGlass System eliminates a significant clinical staffing requirement, provides the potential to improve the efficiency of the procedure, and will allow us to improve the quality of care to our patients.”

“I can’t recommend Dr. Shrestha highly enough. He saved my life,” said Crawford. “It’s great that he and his team got in there in time because I was in bad, bad shape.”
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Federal Agents Seize more than $24 Million in Unapproved New Drugs

Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.

"American consumers are entitled to have safe and effective drugs," said Hanaway.

The seizure followed an inspection of several of the company's plants where FDA investigators found that the company was not complying with an FDA enforcement notice as well as manufacturing unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.

"The FDA is committed to taking enforcement action against firms that circumvent the drug approval process," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research (CDER). "Consumers need to be confident that the drugs and medical products they use are safe and effective, and the FDA will take the necessary measures to ensure safety and effectiveness throughout the lifecycle of the product, including keeping the product from reaching the marketplace."

In a routine inspection of KV Pharmaceutical's facilities in early 2008, the FDA found the company was violating its May 29, 2007, notice (72 FR 29517) requiring companies to stop manufacturing all timed-release drug products containing guaifenesin, including combination drug products in which guaifenesin is in immediate release form, but another ingredient in the combination drug product is in timed-release form, because they are unapproved new drugs. FDA took the action as part of its effort to ensure that all drugs marketed in the United States have the required FDA approval and that they are safe, effective, of good quality, and are appropriately labeled. For products in timed-release form, FDA approval is also necessary to make sure that the product releases its active ingredients at the correct rate. Improperly manufactured timed-release products may release the active ingredients too quickly, too slowly, or not at all, making the product unsafe or ineffective.

The FDA required companies to stop manufacturing the affected products before August 27, 2007, and to stop shipping the products before November 26, 2007. KV Pharmaceutical continued to manufacture and ship these unapproved new drugs after the cessation dates.

The inspection also exposed the company's manufacturing and distribution of other unapproved drug products. Today's action addresses numerous unapproved drug products manufactured and distributed by the company.

The following drug products were seized and will be destroyed:

• PhenaVent Capsules
• PhenaVent LA Capsules
• PhenaVent PED Capsules
• Ethezyme Papain-Urea Ointment
• Ethezyme 650 Papain-Urea Ointment
• Ethezyme 830 Papain-Urea Ointment
• Hista-Vent DA Tablets
• Meperidine/Promethazine Capsules
• Pseudovent Capsules
• Pseudovent 400 Capsules
• Pseudovent PED Capsules
• Tri-Vent DM Syrup
• Tri-Vent DPC Syrup
• Hydro-Tussin DM Liquid
• Hydro-Tussin CBX Syrup
• Hydro-Tussin DHC Syrup
• Hydro- Tussin EXP Syrup
• Hydro-Tussin HD Syrup
• Hyoscyamine Sulfate Sublingual Tablets
• Hydroquinone 4% Cream
• Hydroquinone 4% Cream with Sunscreen
• Bromfenex Extended Release Capsules
• Bromfenex PD Extended Release Capsules

The seized drugs had been held under embargo by the state of Missouri. Since the time of the embargo, KV Pharmaceutical has been cooperating with FDA officials.

"The FDA will take action against companies that continue to manufacture or market an unapproved product after the marketing or distribution cessation date," said Deborah M. Autor, director of the FDA's Office of Compliance within CDER. "When a company does not heed a cessation date relating to a specific product, the FDA will take enforcement action relating to the company's other unapproved drugs."

In June 2006, the FDA issued a guidance document titled, "Marketed Unapproved Drugs—Compliance Policy Guide (CPG)." This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective.

The FDA encourages consumers who may have these products to contact their health care professional about FDA-approved treatments and discard these products.

Note to People with Scarred and Stiffened Lungs: Monitor Your Sleep Before Severe Fatigue Sets In

Family, friends and neighbors remember Lisa Sandler Spaeth as an active mother of two in Potomac, Md., with a lot on the go, juggling her son’s baseball games and her daughter’s horseback-riding lessons with numerous committee obligations, organizing women’s activities at her local synagogue. Add to this Spaeth’s thriving home business turned wholesale supplier - making custom hair accessories for children - which she founded with her mother.

But Spaeth was also diagnosed with pulmonary fibrosis, a hard-to-treat disease that progressively damages the lungs and starves the body of oxygen. For two years after her diagnosis, until her death in May 2007, at age 44, Spaeth was beset by fatigue. Her energy levels sank as her lungs deteriorated. Breathing became difficult, and she could no longer attend many of the sporting events, trade fairs and women’s groups that filled her life.

It is with people like Spaeth in mind that researchers at Johns Hopkins and elsewhere have found what is likely to be the first evidence linking the extreme fatigue in the lung-scarring disease, which has no known cause, to the poor quality of sleep that results - as much as a 25 percent loss in body-rejuvenating R.E.M. sleep. And they have also gauged the detrimental effects this has on people’s daily lives, nearly halving test scores used to assess physical and mental quality of life.

In a report appearing this month in the journal Chest, senior study investigator and pulmonologist Sonye Danoff, M.D., Ph.D., who treated Spaeth, found more than twice the amount of nighttime sleep disturbances and double the number of daytime episodes of drowsiness among 41 men and women with so-called idiopathic pulmonary fibrosis than in people with healthy lungs.

“Physicians should strongly consider monitoring people with this scarring lung disease for sleep disorders as part of their standard care, because poor sleep has a profound effect on their quality of life,” says Danoff, an assistant professor at the Johns Hopkins University School of Medicine.

The latest study results back up previous research by Danoff and other sleep experts at Johns Hopkins, which showed that 18 of 22 people with fibrosed lungs had problems breathing while asleep. The majority of them dropped out of R.E.M. sleep during the night, losing 25 percent of total R.E.M. sleep time.

It is during the R.E.M. period that rapid eye movements occur (hence the name), that people dream and that the body recovers from the previous day and builds up energy for the next.

Pulmonary fibrosis makes people highly vulnerable to sleep problems, Danoff says, because they often breathe twice as fast to supply the body with oxygen. And just as breathing and other body functions naturally slow down at the onset of R.E.M. sleep, these people who depend on a higher rate of breathing are constantly being pushed to wake up from a lack of oxygen.

“Essentially,” she adds, “the body’s internal alarms go off as people enter the most rejuvenating part of sleep. And when people don’t get a good night’s sleep, they cannot function normally the next day. It’s a slippery slope that gets progressively worse over time.”

Also in this latest Johns Hopkins study are survey results assessing quality of life and quality of sleep, which showed that people with stiffened lungs and sleep problems have 40 percent lower scores in physical activities compared to the general U.S. population. Rated activities included basic tasks, such as going to the mailbox and walking to the car. Mental and social activities, such as carrying on a conversation with a store clerk or telephoning friends and family, were reduced 48 percent.
Sleep quality was assessed on a scale comprising 36 different sleep measurements, such as the length of time it took to fall asleep and overall time spent sleeping.

Moreover, the team’s analysis showed that sleep problems could not be predicted by other demographic factors, such as age, gender, race or weight. Nor were they linked, researchers say, with other lung function and more noticeable disease symptoms, including shortness of breath and cough.

“Because there is so much about pulmonary fibrosis that we cannot yet fix, we need to focus on what we can fix while we wait for research to catch up with treatments that can prevent or reverse the disease,” says Danoff.

Current treatments for pulmonary fibrosis are limited to steroids and other immune-system-lowering drugs that help slow down lung tissue deterioration as the thin walls of the air sacs stiffen and lose capacity to freely expand and contract.

More than 200,000 Americans suffer from pulmonary fibrosis, whose cause remains unknown. And the lung disease kills nearly 40,000 each year.

“If we had been able to treat Lisa Spaeth’s fatigue from poor quality sleep, then she might have had more time to lead her life as fully as she had been prior to getting sick,” says Danoff.

Despite Spaeth’s death, her zest for life carries on. Her mother, Froma Sandler, maintains the business. And through the encouragement of family and friends, more than a thousand people have donated to medical research in Spaeth’s honor. The largest-ever contributions arrived in May, just prior to the first anniversary of Spaeth’s death, when the Maryland-based Robert M. Fisher Memorial Foundation pledged $2 million to Johns Hopkins to help fund Danoff’s future studies into pulmonary disease.

“This research funding will lay the groundwork for a more consolidated and comprehensive look at the many factors that may improve and extend the lives of patients with pulmonary fibrosis: from rehabilitation of the lungs to the development and testing of new medications to offset losses in quality of life from fatigue,” says Danoff.

Danoff plans to use some of the funding to support studies that monitor patients with pulmonary fibrosis for problems in sleep patterns, especially in deep-sleep R.E.M. patterns, to target for treatment.

Another phase of research, she says, involves testing new devices to support breathing during sleep and to see if these devices improve quality sleep time and abate fatigue.

Funding for this latest study was provided by a fellowship grant from the CHEST Foundation, the philanthropic arm of the American College of Chest Physicians, which also publishes the journal Chest, and by The Johns Hopkins Hospital’s General Clinical Research Center.

In addition to Danoff, other Hopkins researchers involved in these studies, conducted solely in Balimore, were Vidya Krishnan, M.D.; Meredith McCormack, M.D., M.H.S.; Stephen Mathai, M.D., M.H.S.; Maureen Horton, M.D.; and Nancy Collop, M.D. Additional assistance was provided by Shikhar Agarwal, M.D., from the Johns Hopkins University’s Bloomberg School of Public Health; Brittany Richardson, from the University of Maryland; and Albert Polito, M.D., from Mercy Medical Center.

Bob Barr Criticizes Barack Obama Plan to Provide Health Insurance for Illegal Aliens

“Neither Sen. Barack Obama nor Sen. John McCain wants to talk about immigration, but the system is broken,” says Bob Barr, the Libertarian Party candidate for president. “Unfortunately, neither of them wants to take the tough steps necessary to secure America’s borders and institute a realistic policy to cut illegal immigration.”

An example of the problem is Sen. Obama’s oft-stated promise to “give health insurance to 47 million Americans who are now without coverage.” Of course, “Sen. Obama doesn’t plan on giving them coverage. He plans on making the taxpayers give them coverage. There’s a big difference,” notes Barr.

But there’s an even more fundamental issue. Approximately one-quarter of those persons who are uninsured are in America illegally. “It’s not fair to expect U.S. taxpayers to pay for health insurance for the citizens of another nation. America’s bloated welfare state is expensive enough, and even after recent reforms it still creates a disincentive to work. Handing out insurance to people who have come to America illegally will encourage even greater illegal immigration,” Barr explains. “And that, in turn, will push up government health care expenditures, creating a vicious cycle of more and more spending and more and more illegal immigration.”

“Instead of increasing the reward for violating the law and America’s borders, the federal government should move in the other direction. It must stop requiring hospital emergency rooms to provide free care for illegal aliens and the courts must stop forcing states to provide free schooling for the children of illegal aliens. This means changing the law and perhaps even the Constitution, but until we do so the government will continue to create a taxpayer-funded draw for illegal immigration,” says Barr.

“There is much to do to construct a rational immigration policy. We must start by securing the border. We should adopt a constitutional amendment, if necessary, to ensure that the children of those here illegally do not automatically become citizens; such a privilege should be accorded only those who are born in this country of parents in this country lawfully. We should also allow more highly-skilled legal immigrants, emphasizing economic productivity over family ties,” Barr explains.

“Most important, we should stop paying people to come here illegally. No more free health care. No more free education. And certainly no free health insurance,” emphasizes Barr. “It’s wrong to make Americans pay for medical treatment of other people. In fact, it’s completely counterproductive and illogical to do so. Eliminating incentives for illegal immigration will be one of the top priorities of the Barr Administration.”

Barr represented the 7th District of Georgia in the U. S. House of Representatives from 1995 to 2003, where he served as a senior member of the Judiciary Committee, as Vice-Chairman of the Government Reform Committee, and as a member of the Committee on Financial Services. Prior to his congressional career, Barr was appointed by President Reagan to serve as the United States Attorney for the Northern District of Georgia, and also served as an official with the CIA.

Since leaving Congress, Barr has been practicing law and has teamed up with groups ranging from the American Civil Liberties Union to the American Conservative Union to actively advocate every American citizen’s right to privacy and other civil liberties guaranteed in the Bill of Rights. Along with this, Bob is committed to helping elect leaders who will strive for smaller government, lower taxes and abundant individual freedom.

FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder

The U.S. Food and Drug Administration today approved the first generic versions of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches.

"Generic drugs undergo a rigorous scientific review to ensure that they will provide the patient with the same amount of high quality, safe and effective drug as the name brand product," said Gary J. Buehler, director of the FDA's Office of Generic Drugs. "This approval provides an additional treatment option for patients who suffer from epilepsy, bipolar disorder and migraines."

Generic divalproex sodium will have the same safety warnings as Depakote, including a Boxed Warning that cautions about the risk of liver damage (hepatotoxicity), including fatalities, and pancreatitis, or an inflamed pancreas, including fatal cases. The Boxed Warning also highlights the risk of birth defects (teratogenicity), including neural tube defects.

The following firms have received approval to market divalproex sodium delayed-release tablets: Sun Pharmaceutical Industries Ltd., Mumbai, India; Genpharm Inc., Ontario, Canada; Nu-Pharm Inc., Ontario, Canada; Upsher-Smith Laboratories, Maple Grove, Minn.; Sandoz Inc., Broomfield, Colo.; TEVA Pharmaceuticals USA, North Wales, Penn.; Dr. Reddy’s Laboratories, Hyderabad, India; and Lupin Limited, Mumbai, India.

American Cancer Society, National Medical Association Announce Collaboration to Reduce Cancer Disparities

PRNewswire-USNewswire/ -- The American Cancer Society and the National Medical Association today announced a three-year strategic collaboration intended to educate the general public, physicians, and other health professionals about best practices to achieve optimal outcomes in cancer prevention and early detection practices, and treatment among ethnic minority and underserved population groups. This collaboration represents a significant commitment by both organizations to target and eliminate cancer disparities specifically among racial and ethnic minorities by reducing inequalities in access to information and screening services, quality care and treatment, and end-of-life support.

Racial and ethnic minorities can often face numerous obstacles to receiving equal access to quality cancer prevention, early detection and treatment services. Many lack health insurance, live in rural or inner-city communities, have low incomes, and experience language barriers, racial bias and stereotyping. They also tend to receive lower quality health care than whites even when insurance status, income, age and severity of conditions are comparable.

"Promoting increased awareness and understanding of cancer prevention, early detection and treatment to help reduce health disparities is a nationwide priority for the American Cancer Society, said Otis W. Brawley, M.D., chief medical officer, American Cancer Society. "Collaborations with pre-eminent organizations such as the National Medical Association are central to the Society's strategy to reach racial and ethnic minorities with appropriate health information."

"Strategic partnerships with organizations like the American Cancer Society amplify the National Medical Association's ability to touch and impact lives through community action and healthcare provider education," said Nelson L. Adams, III, M.D., president, National Medical Association.

Initial goals for the collaboration include developing and distributing culturally relevant consumer and professional materials that focus on prevention, early detection, and treatment of breast, prostate, and colorectal cancer, as well as proper nutrition and physical activity. The effort will also target faculty and alumni of Historically Black Colleges and Universities, NMA clinical specialty sections, regions, states and local members, community-based organization leaders in the African-American and Hispanic/Latino communities, and large African-American and Hispanic/Latino church congregations nationwide.

This year's collaborative activities also feature a joint cancer symposium called "Collaboration in Addressing Cancer Disparities" for health professionals attending the 2008 National Medical Association Annual Convention and Scientific Assembly, July 26 to 31, 2008. This symposium will take place on Tuesday, July 29 from 9a.m. to 11a.m. ET at the Georgia World Congress Center in Atlanta, Georgia. More than 5,000 health professionals, including physicians, scientists, nurses, medical students, dietitians, and others are expected to attend. The program will provide an overview of the cancer burden facing ethnic and racial minorities and special population groups, its impact on the health of those groups, current progress being made in cancer care, and a discussion of disparities in cancer care and recommendations for addressing them.

Early-Life Nutrition May Be Associated With Adult Intellectual Functioning

• Adults who had improved nutrition in early childhood may score better on intellectual tests.
• Poor nutrition during childhood is associated with poor cognitive performance in adulthood.

ATLANTA -- Adults who had improved nutrition in early childhood may score better on intellectual tests, regardless of the number of years they attended school, according to a report in the July issue of Archives of Pediatrics & Adolescent Medicine, one of the JAMA/Archives journals.

"Schooling is a key component of the development of literacy, reading comprehension and cognitive functioning, and thus of human capital," says Aryeh D. Stein, PhD, MPH, an associate professor of global health at Emory University's Rollins School of Public Health.

Research also suggests that poor nutrition in early life is associated with poor performance on cognitive (thinking, learning and memory) tests in adulthood.

"Therefore, both nutrition and early-childhood intellectual enrichment are likely to be important determinants of intellectual functioning in adulthood," Stein says.

Between 1969 and 1977, Guatemalan children in four villages participated in a trial of nutritional supplementation. Through the trial, some were exposed to atole--a protein-rich enhanced nutritional supplement--while others were exposed to fresco, a sugar-sweetened beverage. Stein and colleagues analyzed data from intellectual testing and interviews conducted between 2002 and 2004, when 1,448 surviving participants (68.4 percent) were an average of 32 years old.

Individuals exposed to atole between birth and age 24 months scored higher on intellectual tests of reading comprehension and cognitive functioning in adulthood than those not exposed to atole or who were exposed to it at other ages. This association remained significant when the researchers controlled for other factors associated with intellectual functioning, including years of schooling.

"Nutrition in early life is associated with markers of child development in this population, and exposure to atole for most of the first three years of life was associated with an increase of 0.4 years in attained schooling, with the association being stronger for females (1.2 years of schooling)," Stein says.

Thus, schooling might be in the causal pathway between early childhood nutrition and adult intellectual functioning, says Stein. The data, which suggest an effect of exposure to an enhanced nutritional intervention in early life that is independent of any effect of schooling, provide additional evidence in support of intervention strategies that link early investments in children to continued investments in early-life nutrition and in schooling.

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In addition to Stein, study authors were Meng Wang, MS, Ann DiGirolamo, PhD, Usha Ramakrishnan, PhD, Kathryn Yount, PhD, and Reynaldo Martorell, PhD, all of the Hubert Department of Global Health, Rollins School of Public Health, Emory University; and Ruben Grajeda, MD, and Manuel Ramirez-Zea, MD, PhD of the Unit of Public Policies, Institute of Nutrition of Central America and Panama.

This study was supported by grants from the National Institutes of Health and from the National Science Foundation. The National Institutes of Health, the Thrasher Fund and the Nestle Foundation have funded the work of the INCAP Longitudinal Study since its inception. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Reference: Arch Pediatr Adolesc Med. 2008;162[7]:612-618

Transplantation of Kidneys from Black Cardiac-Death Donors Provide Black Recipients with the Best Long-Term Survival

Contrary to prevailing assumptions, Johns Hopkins researchers have shown that kidneys recovered from black donors who died from cardiac death offer the best survival rate for black recipients of a deceased-donor kidney.

This discovery, released online this week and appearing in the October 2008 issue of the Journal of the American Society of Nephrology, challenges the long-held belief that kidneys from white brain-death donors offers the best deceased-donor transplant survival rate for either black or white recipients.

“Our findings indicate that increased use of kidneys from cardiac-death donors could help reduce the organ shortage and improve outcomes for black kidney transplant recipients,” says lead author Jayme Locke, M.D., M.P.H., of the Department of Surgery at Johns Hopkins.

Locke and a team of Johns Hopkins researchers examined the outcomes of more than 25,000 black adults who received a deceased-donor kidney transplant between 1993 and 2006.

Results showed that black recipients who received a kidney from a black cardiac-death donor had a 70 percent reduction in the risk of kidney loss and a 59 percent reduction in risk for death when compared to black recipients who received a kidney from a white brain-death donor.

“Our data is consistent with the previous observation that black recipients seem to do better with kidneys from white brain-death donors than they do with kidneys from black brain-death donors or white cardiac-death donors, however, the fact that black recipients have the best outcomes with kidneys from black cardiac-death donors is significant,” says co-lead author Daniel Warren, Ph.D., of the Department of Surgery at Johns Hopkins.

He says that the exact mechanisms responsible for racial differences in outcomes after kidney transplantation are not known, however, the results suggest that the genetic background of the donor and recipient likely have a significant impact on long-term outcomes.

“We believe that an improved understanding of the molecular consequences of cardiac and brain death is critical to improving outcomes for all kidney transplant recipients and warrants further investigation,” he added.

There are currently more than 70,000 Americans waiting for kidney transplants. Only about 600 deceased-donor kidneys donated after cardiac death are currently used for transplantation versus 7,000 donated after brain death.

This discrepancy is due in part to the belief that kidneys that are exposed to cardiac death generally suffer more damage than kidneys that are exposed to brain death.

“Our results show this is not always true, and that is significant news for all patients waiting for a kidney,” says Locke.

Other researchers who worked on this study from Johns Hopkins include Robert Montgomery, M.D., Ph.D.; Andrew Cameron, M.D.; Joseph Melancon, M.D.; Dorry Segev, M.D.; Andrew Singer, M.D., Ph.D.; Christopher Simpkins, M.D., M.P.H.; Andrea Zachary, Ph.D.; Francesca Dominici, Ph.D.; Mary Leffell, Ph.D.; and Deborah McRann, B.S.N.

Chemotherapy and Radiation After Surgery Prolongs Life for Pancreatic Cancer Patients

Pancreatic cancer patients treated with a combination of chemotherapy and radiation after surgery survive approximately six months longer than those receiving surgery alone, Johns Hopkins Kimmel Cancer Center scientists report.

Previous clinical trials conducted in the 1980s and 90s in the United States established the benefit of postoperative chemotherapy and radiation. However, experts still disagree on whether to administer the treatments because results from European studies suggest the opposite effect — a decrease in survival.

“Some physicians might avoid chemotherapy and radiation if a benefit in survival is uncertain. However, without proof, I believe it is a disservice to these patients if we eliminate chemotherapy and radiation,” says radiation oncologist Joseph Herman, M.D., who led the study.

Herman and his team sought to put the issue to rest by reviewing records of 616 Johns Hopkins patients whose pancreatic cancers were surgically removed between Aug. 30, 1993, and Feb. 28, 2005. The researchers compared the survival of 345 of the patients who had only surgery with 271 who were then treated with 5-fluorouracil (FU)-based chemotherapy agents and modern types of radiation.

Patients receiving the combined chemotherapy and radiation experienced an improved median survival when compared with patients who did not (21.2 vs. 14.4 months). Two-year survival also improved (43.9 percent vs. 31.9 percent), as did five-year survival (20.1 percent vs. 15.4 percent). Results were published in the July 20 issue of the Journal of Clinical Oncology.

“The take-home message of this study is that patients who received combined chemotherapy and radiation appeared to have better survival than patients who have surgery alone, suggesting that it is safe and beneficial if it’s done carefully and properly,” says Herman, assistant professor in the Department of Radiation Oncology and Molecular Radiation Sciences.

He cautions that this is a retrospective study and that selection bias was possible as they may have selected out those patients who are healthy enough to receive the chemotherapy and radiation. “Regardless, it is still encouraging to say that many of these patients had very aggressive cancer and a lot of them are still alive several years after they received this combination therapy,” says Herman.

Because data to assess treatment toxicity were unavailable, Herman and his study team focused on survival instead. He says the majority of patients were able to complete the therapy, suggesting that they tolerated it well.

The study also identified risk factors to determine those patients most likely to benefit from combined chemotherapy and radiation. Patients who clearly benefited included those with lymph-node-positive disease and those with tumors larger than 3 centimeters (about 1.2 inches). Patients with aggressive tumors also benefited, as did those with margin-positive disease, where the surgeon was unable to remove most of the tumor.

Groups were similar with respect to tumor size, nodal status and margin status, but those receiving combined chemotherapy and radiation were younger (median 64 vs. 70 years) and less likely to present with another serious disease.

“The survival benefit is still seen regardless of high-risk tumor characteristics and after controlling for age, other concurrent diseases and surgical complications,” Herman says.

Patients in this study received about five and a half weeks of combined chemotherapy and radiation, which is referred to as concurrent therapy. The therapy begins about four to eight weeks after surgery.

Most patients also received continuous-infusion 5-FU chemotherapy. This is a form of chemotherapy that enhances the ability of radiation to damage DNA, the building block of the rapidly dividing cancer cells. Patients take four weeks off at the conclusion of their initial therapy, and then may receive maintenance chemotherapy, as prescribed, in the weeks and months ahead.

Pancreatic cancer strikes about five out of 100,000 people each year in the United States. Because pancreatic cancer often has no symptoms in its early stages, cancerous tumors often go unnoticed until the cancer advances and individuals become ill. Prognosis is poor for long-term survival, with only about 5 percent of pancreatic cancer patients surviving five years after their diagnosis.

The most aggressive and effective form of treatment for pancreatic cancer is a complicated surgery commonly known as the Whipple procedure (used in this study), in which the gallbladder, common bile duct, part of the duodenum, and the head of the pancreas are generally removed. Johns Hopkins Hospital has performed more than 3,000 Whipple surgeries over the past 25 years.

The study was funded by the Johns Hopkins Department of Radiation Oncology and Molecular Radiation Sciences.

Michael Swartz, Charles Hsu, Jordan Winter, Timothy Pawlik, Elizabeth Sugar, Ray Robinson, Daniel Laheru, Elizabeth Jaffee, Ralph Hruban, Kurtis Campbell, Christopher Wolfgang, Fariba Asrari, Ross Donehower, Manuel Hidalgo, Luis Diaz, Charles Yeo, John Cameron, Richard Schulick and Ross Abrams, also from Johns Hopkins, assisted with this study.

Piedmont Fayette Hospital Names VP of Medical Affairs

Piedmont Fayette Hospital (PFH) is pleased to announce the promotion of Frederick E. Willms, M.D., FRCPC, FACP to the position of vice president of medical affairs and chief quality officer.

Dr. Willms has been on staff at Piedmont Fayette for 10 years, serving in many roles including two terms as chief of medicine and a PFH hospitalist. He has served as assistant professor of medicine at Dalhousie University and currently is a peer reviewer for the state of Georgia’s Medical Board.

“I am excited and looking forward to continuing the many quality and patient safety initiatives begun by Dr. Mitchell,” Dr. Willms said. “I also hope to cultivate physician relationship building at Piedmont Fayette.”

Dr. Willms graduated Magna cum Laude in 1976 and earned his medical degree from the University of Ottawa in Ontario, Canada. He completed a rotating internship at the University of Toronto, Toronto Western Hospital and then completed his residency at Dalhousie University in Halifax, Nova Scotia where he served as chief resident. He is a fellow of the American College of Physicians and Alpha Omega Alpha Honor Medical Society.

He lives in the Fayette community with Wendy, his wife of 27 years.

Emory Physicians Assistant Student Only Georgian to Provide Care at Olympics

The United States Olympic Committee (USOC) has selected Harris Patel, MA, ATC, as part of its 62-member medical staff. Patel is a certified athletic trainer (ATC) currently enrolled in the Physicians Assistant Program at Emory University School of Medicine.

Patel will leave on July 28 to spend five weeks with the athletes, beginning with training camp in Dalian and then on to Beijing. Patel is the only medical professional from Georgia assigned to the USOC medical staff.

He began his career as an athletic trainer in 1998 and has been working with premier athletes since he was an undergraduate at the University of Georgia.

Patel's responsibilities at the games will include prepping U.S. athletes for practice or competition and evaluating injuries to determine the best course of action for the welfare of the athlete. He will also be involved with implementing treatment and rehabilitation programs.

"We are on call for the athletes 24/7 because they depend on us as medical professionals," says Patel. "We have to be on our feet for any medical emergency both on and off the field."

Patel's experience throughout graduate school and beyond is an impressive mixture of working on the medical staff of NFL football teams and spending his summers working with Olympic athletes.

His relationship with the USOC began in 2005 when he was selected to go to Sherbroke, Canada. for the Youth World Championships in Athletics. He interned with the USOC medical staff in Colorado Springs in 2004, working with all varieties of U.S. athletes, and traveled to Helsinki, Finland, for the 2005 World Championships in Athletics. In 2006 he traveled to Birmingham, England, for a track and field meet, and then on to the 2007 Pan Am Games in Rio de Janeiro.

"I sometimes have to look back and wonder how I got all those opportunities," he says. "I have been very blessed and very fortunate."

Patel graduates from Emory's Physician Assistant program in December 2008. He plans to stay in the field of primary care and sports medicine. He says,"God has a plan" for him and he will follow that plan -- after he passes his boards.

Scientists Identify How Gastric Reflux May Trigger Asthma

Researchers at Duke University Medical Center appear to have solved at least a piece of a puzzle that has mystified physicians for years: why so many patients with asthma also suffer from GERD, or gastroesophageal reflux disease.

Clinicians first noted a relationship between the two diseases in the mid-1970s. Since then, studies have shown that anywhere from 50 to 90 percent of patients with asthma experience some aspect of GERD. But can GERD cause asthma, or, is it the other way around? Perhaps there is some shared mechanism at the root of both disorders causing them to arise together. Physicians could make a case for each scenario, but until now, the exact nature of the relationship was not clear.

Working in laboratory experiments with mice, Dr. Shu Lin, an assistant professor of surgery and immunology at Duke, discovered that inhaling tiny amounts of stomach fluid that back up into the esophagus – a hallmark of GERD – produces changes in the immune system that can drive the development of asthma.

In the experiments, researchers inserted miniscule amounts of gastric fluid into the lungs of mice (mimicking the human process of micro-aspiration, or breathing in tiny amounts) over a period of eight weeks. They compared these animals' immune systems with those of mice that were exposed to allergens but not the gastric fluid.

The immune systems of the two sets of mice responded very differently. Those that had the gastric fluid in their lungs developed what researchers call a T-helper type 2 response, a type of immune system reaction characteristic of asthma. The other mice responded in a more balanced manner, mounting an immune reaction consisting of both T-helper type 1 and T-helper type 2 responses.

"This is the first experimental evidence in a controlled, laboratory setting linking these two very common conditions in humans," says Lin, the senior author of the study published online in the European Journal of Clinical Investigation. "These data suggest that chronic micro-aspiration of gastric fluid can drive the immune system toward an asthmatic response."

"This does not mean that everyone with GERD is going to develop asthma, by any means," says William Parker, an assistant professor of surgery at Duke and a co-author of the study. "But it may mean that people with GERD may be more likely to develop asthma. If there is an upside to this, it is that developing GERD is something we can pretty much treat and control."

Parker says poor diet, a lack of exercise and obesity all contribute to the development of GERD, and that rising rates of reflux disease are part of a "perfect storm" of environmental and behavioral factors driving escalating rates of asthma, particularly in Western cultures. "People should avoid the risk factors for GERD. We strongly believe that the rise in asthma, particularly among adults in the country, is in large measure due to lifestyle choices that can be changed."

Lin and Parker agree that much more work needs to be done to fully understand the cellular and molecular mechanisms involved in the relationship between reflux disease and asthma, but both feel their study offers new directions for developing additional treatment options for both problems.

Lin says patients who already have GERD can minimize gastric reflux – and thereby lessen their chances of developing asthma – by following a few simple guidelines: Eat smaller meals and eat several hours before going to bed; raise the head of the bed a few inches; maintain a healthy weight; and limit fatty goods, coffee, tea, caffeine and alcohol – they can relax the esophageal sphincter and make reflux more likely.

Funding for the study came from the Society of American Gastrointestinal Endoscopic Surgeons Research Grant and the Parks Protocol Memorial Fund.

Additional co-authors from Duke include lead author Andrew Barbas, Tacy Downing, Keki Balsara, Hung-Enn Tan, Gregory Rubinstein, Zoie Holzknecht, Bradley Collins and R. Duane Davis.

Diabetes Experts Recommend One-Two Punch for Treating Patients with Pre-Diabetes

BUSINESS WIRE --For the first time, a consensus of diabetes and metabolic disorder experts have recommended a comprehensive treatment regimen for patients with pre-diabetes. The recommendations call for specific guidelines on both lifestyle, and pharmaceutical intervention where appropriate. The recommendations are made in a Consensus Statement released this morning by the American Association of Clinical Endocrinologists (AACE).

Pre-diabetes is a condition defined by elevated fasting glucose levels or impaired glucose tolerance. According to the Centers for Disease Control (CDC), more than 56 million Americans currently have the condition, which leaves patients at risk, not only for developing type 2 diabetes, but also for cardiovascular complications. This is an extension of the effort to recognize and treat type 2 diabetes earlier and more aggressively.

However, at this time, there are no pharmacologic therapies that have been approved by the FDA for prevention of the conversion of pre-diabetes to diabetes. That’s why the expert panel has recommended a two-pronged approach to treating pre-diabetes. The first is intensive lifestyle management to prevent the progression to type 2 diabetes.

“As individuals and as a society, we need to address those forces which are creating the epidemic of obesity, diabetes, and pre-diabetes,” said Yehuda Handlesman, MD, FACP, FACE, Treasurer of AACE and Medical Director of the Metabolic Institute of America. “We understand the difficulties in implementing solutions, but as an association of endocrinologists we are committed to supporting community and national efforts in every way we can.”

The recommendation calls for patients to adhere to the guidelines set forth in the Diabetes Prevention Program, established by the United States government.

“Although lifestyle can clearly modify the progression of patients towards overt diabetes, it may not be sufficient,” said Alan J. Garber, MD, PhD, FACE, Professor of Medicine, Baylor College of Medicine, Houston, and Chairman of the Consensus Conference. “Medications may well be required, particularly in high risk groups.”

The second approach is to prevent the development of cardiovascular complications, and to help those patients where lifestyle modifications have been insufficient to modify cardiovascular risk factors. This requires cardiovascular risk reduction medications for abnormal blood pressure and cholesterol independent of glucose control medications.

“The data show that there is a spectrum of severity, with the most severely affected approaching the risks of people with diagnosed type 2 diabetes,” said Daniel Einhorn, MD, FACP, FACE, Vice President of AACE and Medical Director of the Scripps Whittier Institute for Diabetes in La Jolla, CA. “In these highest risk individuals, who represent a minority, pharmacologic strategies may be appropriate if intensive lifestyle therapies fail. Regardless, all individuals at risk for diabetes should be aware of the level of their risk factors and be prepared to take action.”

While the number of people with pre-diabetes in the United States exceeds 56 million, most patients with the condition have not been diagnosed. People are considered high risk if they have near diabetic levels of blood glucose, hypertension, or abnormal lipid profiles. These patients should consider working with their doctor to monitor their status.

The preliminary publication of the Consensus Statement is available at media.aace.com. The final document will be published later this year in Endocrine Practice, the Journal of the American Association of Clinical Endocrinologists.