FDA Expands Use of Approved Breast Cancer Drug

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Tykerb (lapatinib) in combination with Femara (letrozole) to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.

HER2 is a protein involved in normal cell growth. It is found on some types of cancer cells, including breast cancer cells. In hormone positive breast cancer, the presence of certain hormones contributes to breast cancer growth. In HER2-positive breast cancer, stimulation of the HER2 receptor contributes to cancer cell growth. Breast cancer is the second leading cause of death among women. More than 192,000 women will be diagnosed with breast cancer this year.

"This drug combination of Tykerb plus Femara provides women being treated for advanced breast cancer with an important treatment option. This entirely oral treatment regimen works by targeting both HER2 and the hormone receptors, thereby slowing the cancer cells' ability to grow or spread," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, in the FDA's Center for Drug Evaluation and Research.

Women with HER2-positive disease receiving the Tykerb plus Femara combination more than doubled the time they lived without the cancer progressing compared with those receiving Femara alone (35 weeks vs. 13 weeks). Women in the company sponsored study were randomized to receive Tykerb plus Femara or Femara alone. It is too early to determine whether an improvement in overall survival will be observed in the clinical trial.

Tykerb works by depriving tumor cells of signals needed to grow. Tykerb enters the cell and blocks the function of the HER2 protein.

Tykerb was initially approved in combination with a chemotherapy drug, Xeloda (capecitabine) in 2007. This combination was used to treat women with advanced breast cancer tumors with the HER2 protein who had received prior treatment with chemotherapy drugs, including an anthracycline and a taxane, and Herceptin (trastuzumab), an anti-cancer antibody used to treat HER2-positive advanced breast cancer.

Safety information from this study was consistent with previous Tykerb clinical studies in advanced breast cancer. The most commonly reported side effects of the combination were diarrhea, rash, nausea and fatigue. Treatment with Tykerb also has been associated with decreases in heart function, liver damage, and lung tissue inflammation. Fetal harm may occur if used to treat advanced breast cancer in pregnant women. Patients should talk to their health care provider about the potential side effects, drug interactions, and other medical conditions.

Tykerb is marketed by Collegeville, Pa.-based GlaxoSmithKline.

Femara is marketed by Lebanon, Pa.-based Novartis AG.

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Obama Administration issues rules requiring parity in treatment of mental, substance use disorders

/PRNewswire/ -- The U.S. Departments of Labor, Health and Human Services (HHS), and the Treasury today jointly issued new rules providing parity for consumers enrolled in group health plans who need treatment for mental health or substance use disorders.

"Today's rules will bring needed relief to families faced with meeting the cost of obtaining mental health and substance abuse services," said U.S. Secretary of Labor Hilda L. Solis. "The benefits will give these Americans access to greatly needed medical treatment, which will better allow them to participate fully in society. That is not just sound policy, it's the right thing to do."

"The rules we are issuing today will, for the first time, help assure that those diagnosed with these debilitating and sometimes life-threatening disorders will not suffer needless or arbitrary limits on their care," said Secretary of Health and Human Services Kathleen Sebelius. "I applaud the longstanding and bipartisan effort that made these important new protections possible."

"Workers covered by group health plans who need mental health and substance abuse care deserve fair treatment," said Deputy Treasury Secretary Neal Wolin. "These rules expand on existing protections to ensure that people don't face unnecessary barriers to the treatment they need."

The new rules prohibit group health insurance plans -- typically offered by employers -- from restricting access to care by limiting benefits and requiring higher patient costs than those that apply to general medical or surgical benefits. The rules implement the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA).

MHPAEA greatly expands on an earlier law, the Mental Health Parity Act of 1996, which required parity only in aggregate lifetime and annual dollar limits between the categories of benefits and did not extend to substance use disorder benefits.

The new law requires that any group health plan that includes mental health and substance use disorder benefits along with standard medical and surgical coverage must treat them equally in terms of out-of-pocket costs, benefit limits and practices such as prior authorization and utilization review. These practices must be based on the same level of scientific evidence used by the insurer for medical and surgical benefits. For example, a plan may not apply separate deductibles for treatment related to mental health or substance use disorders and medical or surgical benefits. They must be calculated as one limit. MHPAEA applies to employers with 50 or more workers whose group health plans choose to offer mental health or substance use disorder benefits. The new rules are effective for plan years beginning on or after July 1, 2010.

The Wellstone-Domenici Act is named for two dominant figures in the quest for equal treatment of benefits. The late Sen. Paul Wellstone, D-Minn., who was a vocal advocate for parity throughout his Senate career, sponsored the ultimately successful full parity act. He was joined by former Sen. Pete Domenici, R-N.M., who first introduced legislation to require parity in 1992. Champions of the legislation also included the bipartisan team of Rep. Patrick Kennedy, D-R.I., and former Rep. Jim Ramstad, R-Minn.

The issue of parity dates back more than 40 years to President John F. Kennedy, and also was supported by President Clinton and the late Sen. Edward Kennedy.

The interim final rules released today were developed based on the departments' review of more than 400 public comments on how the parity rule should be written. Comments on the interim final rules are still being solicited. Sections where further comments are being specifically sought include so-called "non quantitative" treatment limits such as those that pertain to the scope and duration of covered benefits, how covered drugs are determined (formularies) and the coverage of step-therapies. Comments are also being specifically requested on the regulation's section on "scope of benefits" or continuum of care.

Comments on the interim final regulation are due 90 days after the publication date. Comments may be emailed to the federal rulemaking portal at http://www.regulations.gov/. Comments directed to HHS should include the file code CMS-4140-IFC. Comments to the Department of Labor should be identified by RIN 1210-AB30. Comments to the Treasury's Internal Revenue Service should be identified by REG-120692-09. Comments may be sent to any of the three departments and will be shared with the other departments. Please do not submit duplicates.

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HHS Secretary and Surgeon General Join First Lady to Announce Plans to Combat Overweight and Obesity and Support Healthy Choices

First Lady Michelle Obama, U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius and U.S. Surgeon General Regina Benjamin announced plans today to help Americans lead healthier lives through better nutrition, regular physical activity, and by encouraging communities to support healthy choices. At a YMCA in Alexandria, VA, they talked directly with national and local leaders, parents and health professionals about reducing overweight and obesity in adults and children.

The First Lady recently announced that she will launch a major initiative on childhood obesity in the next few weeks and has asked HHS to play a key role. Today, HHS released The Surgeon General's Vision for a Healthy and Fit Nation. In her first release to the nation, Dr. Benjamin highlights the alarming trend of overweight and obese Americans, and asks them to join her in a grassroots effort to commit to changes that promote the health and wellness of our families and communities.

"The surge in obesity in this country is nothing short of a public health crisis that is threatening our children, our families, and our future," said First Lady Michelle Obama. "In fact, the health consequences are so severe that medical experts have warned that our children could be on track to live shorter lives than their parents. The paper released today is an incredibly important step in directing the Nation's attention to solving the obesity epidemic and we do not have a moment to waste."

The prevalence of obesity has more than doubled among adults and has tripled among children and adolescents from 1980 to 2004. Currently, two-thirds of adults and nearly one in three children are overweight or obese. Increased food intake, a sedentary lifestyle, and environments that make it difficult for people to make healthy choices but easy to consume extra calories, all contribute to the epidemic of overweight and obesity. This epidemic threatens the progress we have made in increasing Americans' quality and years of healthy life.

"Curbing the obesity epidemic requires committed people and organizations across the nation working together to take action," said Secretary Sebelius. "Today, we outline a vision for the nation that requires parents, neighborhoods, the medical community, employers, schools and individuals to take a coordinated and comprehensive approach to combating overweight and obesity."

Additionally, many racial and ethnic groups and geographic regions of the United States are disproportionately affected. For instance, African American girls and Hispanic boys are more likely to be obese compared to non-Hispanic whites. Among adults, American Indian and Alaskan native adults have the highest rates of obesity. The sobering impact of these numbers is reflected in the nation's concurrent epidemics of diabetes, heart disease and other chronic diseases. Researchers warn that if trends are not reversed, our children will be seriously afflicted with medical conditions such as diabetes and heart disease in early adulthood.

"Americans will be more likely to change their behavior if they have a meaningful reward - something more than just reaching a certain weight or dress size," said Dr. Benjamin. "The real reward is invigorating, energizing, joyous health. It is a level of health that allows people to embrace each day and live their lives to the fullest without disease or disability."

The recommendations in The Surgeon General's Vision for a Healthy and Fit Nation include:

Improving our communities - Neighborhoods and communities should become actively involved in creating healthier environments. The availability of supermarkets, outdoor recreational facilities and the limitation of advertisements of less healthy foods and beverages are all examples of ways to create a healthier living environment.

Healthy Choices and Healthy Home Environments - Change starts with the individual choices Americans make each day for themselves, their families and those around them. Reducing the consumption of sodas and juices with added sugars; eating more fruits, vegetables and whole grains; limiting television time; and being more physically active help us achieve and maintain a healthy lifestyle.

Creating Healthy Child Care Settings - It is estimated that more than 12 million children ages 0-6 receive some form of child care on a regular basis from someone other than their parents. Parents should talk with their child care providers about changes to promote their children's health.

Creating Healthy Schools - To help students develop life-long health habits, schools should provide appealing healthy food options including fresh fruit and vegetables, whole grains, water and low-fat beverages. School systems should also require nutrition standards and daily physical education for students.

Creating Healthy Work Sites - Employers can implement wellness programs that promote healthy eating in cafeterias, encourage physical activity through group classes and create incentives for employees to participate.

Mobilizing Medical Communities - Medical care providers must make it a priority to teach their patients about the importance of good health. Doctors and other health care providers are often the most trusted source of health information and are powerful role models for healthy lifestyle habits.

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Fat Tissue May Be a Source of Valuable Blood Stem Cells, Study Says

/PRNewswire/ -- Bone marrow is a leading source of adult stem cells, which are increasingly used for research and therapeutic interventions, but extracting the cells is an arduous and often painful process. Now, researchers have found evidence that fat tissue, known as adipose tissue, may be a promising new source of valuable and easy-to-obtain regenerative cells called hematopoietic stem and progenitor cells (HSPCs), according to a study prepublished online in Blood, the official journal of the American Society of Hematology.

"It's not outside the realm of possibility that a donor graft of adipose tissue-derived HSPCs might be able to partially replace the need for bone marrow transplantation within 10 years," said lead study author Gou Young Koh, MD, PhD, of the Department of Biological Sciences, Korea Advanced Institute of Science and Technology (KAIST) in Daedeok Science Town, Daejeon, South Korea.

HSPCs are powerful cells that have the ability to regenerate and develop into many different kinds of cells. With advances in technologies and understanding of cell functions, HSPCs are now used to repair damaged tissue and are being studied for their potential to treat a vast array of chronic and degenerative conditions. HSPCs are found in high quantities in the bone marrow, but a certain portion known as extramedullary tissue, found outside of bone marrow, circulate between the marrow and the peripheral blood.

Previous research has found that adipose tissue contains many different types of adult stem cells. In this study, researchers hypothesized that the adipose tissue might be a valuable alternative source of HSPCs as an extramedullary tissue but questioned whether the tissue could provide a sufficient quantity of cells to be used for research and therapeutic purposes.

"We know that adipose tissue and bone marrow tissues share similar properties, so we suspected that valuable stem cells might be found in the adipose regions, offering a unique resource for stem cells that might be easier and less costly to extract," said Dr. Koh.

Within the adipose tissue is a special cell population known as the stromal vascular fraction (SVF), which consists of other undefined stem cells as well as immune, endothelial (blood vessel lining), progenitor (undifferentiated or premature precursor cells), and stromal (connective tissue) cells. Cells in the SVF share similar properties to those in the bone marrow. Both contain a population of cells that have the ability to differentiate into several cell types. In addition, both adipose tissue and bone marrow offer similar environments for optimal stem cell growth and reproduction, including a smaller amount of circulating oxygen and specialized vascular systems as compared with other organs.

The research team characterized the HSPCs in the SVF of mouse adipose tissue with both in vitro and in vivo analyses. They studied the origin of the HSPCs to better predict their behavior and determine whether the quantity of cells could be increased by promoting more frequent HSPC movement between the bone marrow and peripheral blood using granulocyte colony-stimulating factor, or G-CSF, a growth hormone used to encourage development of stem cells. The team found that the more they could mobilize the HSPCs between the bone marrow and the peripheral blood, the more HSPCs they would find in the SVF.

The study results provide compelling evidence that the SVF derived from adipose tissue contains functional HSPCs capable of generating hematopoietic (blood-forming) cells. Importantly, researchers found that the cells were able to differentiate into a variety of hematopoietic cells when tracked for at least 16 weeks post-transplantation, which reflects long-term and permanent reconstitution of donor hematopoietic cells in recipients.

The frequency of HSPCs in the adipose tissue found in the study was significantly less than that found in bone marrow (approximately 0.2 percent of the HSPCs found in total bone marrow). Therefore, researchers wanted to determine whether the SVF might be used practically as an alternative source of HSPCs. Fortunately, according to the researchers, a vast amount of the SVF in adipose tissue can be easily obtained from patients using conventional liposuction and isolation methods that are safe and relatively pain-free.

"These study results suggest that more HSPCs might be obtained from the stromal vascular fraction through increased mobilization of these cells from the bone marrow using G-CSF," said Dr. Koh. "So once a technology can be defined to purify HSPCs from the stromal vascular fraction, we believe adipose tissue may be a good alternative and novel resource for obtaining functional and transplantable HSPCs."

The research team is actively extending their research in this area, including plans for a human clinical study. They also emphasize the need for a clinically safer and more efficient method for isolating the HSPCs from the adipose tissue.

The American Society of Hematology (www.hematology.org) is the world's largest professional society concerned with the causes and treatment of blood disorders. Its mission is to further the understanding, diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems, by promoting research, clinical care, education, training, and advocacy in hematology. ASH provides Blood: The Vital Connection (www.bloodthevitalconnection.org), a credible online resource addressing bleeding and clotting disorders, anemia, and cancer. The official journal of ASH is Blood (www.bloodjournal.org), the most cited peer-reviewed publication in the field, which is available weekly in print and online.

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Stopping Bacterial Infections Without Antibiotics

/PRNewswire/ -- New research at the A. James Clark School of Engineering could prevent bacterial infections using tiny biochemical machines--nanofactories--that can confuse bacteria and stop them from spreading, without the use of antibiotics.

A paper about the research is featured in the current issue of Nature Nanotechnology. "Engineered biological nanofactories trigger quorum sensing response in targeted bacteria," was authored by Clark School alumnus Rohan Fernandes (Ph.D. '08, bioengineering), graduate student Varnika Roy (molecular and cell biology), graduate student Hsuan-Chen Wu (bioengineering), and their advisor, William Bentley (professor and chair, Fischell Department of Bioengineering).

The group's work is an update on their original nanofactories, first developed in 2007. Those nanofactories made use of tiny magnetic bits to guide them to the infection site.

"This is a completely new, all-biological version," he says. "The new nanofactories are self-guided and targeted. We've demonstrated for the first time that they're capable of finding a specific kind of bacterium and inducing it to communicate, a much finer level of automation and control."

The new nanofactories can tell the difference between bad (pathogenic) and good bacteria. For instance, our digestive tracts contain a certain level of good bacteria to help us digest food. The new nanofactories could target just the bad bacteria, without disrupting the levels of good bacteria in the digestive tract (a common side effect of many antibiotics). Nanofactories target the bacteria directly rather than traveling throughout the body, another advantage over traditional antibiotics.

Bacterial cells talk to each other in a form of cell-to-cell communication known as quorum sensing. When the cells sense that they have reached a certain quantity, an infection could be triggered. The biological nanofactories developed at the Clark School can interrupt this communication, disrupting the actions of the cells and shutting down an infection.

Alternatively, the nanofactories could trick the bacteria into sensing a quorum too early. Doing so would trigger the bacteria to try to form an infection before there are enough bacterial cells to do harm. This would prompt a natural immune system response capable of stopping them without the use of drugs.

Because nanofactories are designed to affect communication instead of trying to kill the bacteria, they could help treat illness in cases where a strain of bacteria has become resistant to antibiotics.

"The work by Dr. Bentley is extremely exciting as he is using the ability of engineering to 'build' using nature based components," says Philip Leduc, associate professor in the Departments of Mechanical and Biomedical Engineering and the Lane Center for Computational Biology and Biological Sciences at Carnegie Mellon University. "Understanding the science of cells is wonderful, but then using these components and constructing systems that leverage biological advantages is a huge step forward. His work in this paper uses his synthetic biology approach to build new nanofactories toward new areas of antimicrobials as well as opening new findings in quorum sensing."

The nanofactories' ability to alter cell-to-cell communication isn't limited to fighting infections.

"Quorum sensing and signaling molecules are actually used to accomplish a lot of things," Bentley explains. "Sometimes disease develops because communication is not taking place--a good example is digestive disorders that involve an imbalance of bacteria in the digestive tract. In that case, nanofactories could be used to start or increase communication instead of disrupting it."

For More Information:

Read the article at Nature NanotechnologyVisit Professor Bentley's web siteSee a research overview at the Biochip Collaborative web site

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FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain

The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL.

This is the only FDA approved morphine sulfate oral solution available at this concentration. Although the use of this medicine to manage pain has been common practice for many years, this form and concentration of morphine was not FDA approved until now.

Today’s action is part of the FDA’s unapproved drugs initiative. As part of this program, the FDA has worked with the manufacturer of the now-approved product, Roxane Laboratories, to ensure that there is enough drug available for patients. The FDA will also be working with patient organizations and prescribers so that they are aware that an approved product is available, and can notify the FDA if there are any problems with availability.

“An important goal of the unapproved drugs initiative is to make sure that marketed drugs meet current FDA standards,” said Douglas Throckmorton, M.D., deputy director for the FDA’s Center for Drug Evaluation and Research. “Our action today reflects a careful balance between ensuring patient access to necessary medicines, while making sure companies comply with the law.”

One benefit of the FDA approval process is a requirement for manufacturers to provide sufficient information on how to safely prescribe and use a drug. Manufacturers may also have to establish additional safety measures to manage unique risks of a medicine. For this formulation of morphine, the manufacturer had to develop a safety program prior to approval to address the known risks of morphine misuse, abuse and overdose.

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FDA Approves New Treatment for Type 2 Diabetes

The U.S. Food and Drug Administration today approved Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults.

Victoza is intended to help lower blood sugar levels along with diet, exercise, and selected other diabetes medicines. It is not recommended as initial therapy in patients who have not achieved adequate diabetes control on diet and exercise alone.

Insulin is a hormone that helps prevent sugar (glucose) from building up in the blood. People with type 2 diabetes have difficulty making and using insulin. Victoza is in a class of medicines known as glucagon-like peptide-1 (GLP-1) receptor agonists that help the pancreas make more insulin after eating a meal.

"Diabetes is a leading cause of death and disability, with more than 1.5 million new cases diagnosed annually," said Mary Parks, M.D., director, Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. "Controlling blood sugar levels is very important to preventing or reducing the long term complications of diabetes, and Victoza offers certain patients with type 2 diabetes a treatment option for controlling their blood glucose levels."

In five clinical trials involving more than 3,900 people, pancreatitis (inflammation of the pancreas) occurred more often in patients who took Victoza than in patients taking other diabetes medicines. Victoza should be stopped if there is severe abdominal pain, with or without nausea and vomiting, and should not be restarted if pancreatitis is confirmed by blood tests. Victoza should be used with caution in people with a history of pancreatitis.

The most common side effects observed with Victoza were headache, nausea, and diarrhea. Other side effects included allergic-like reactions such as hives.

Victoza was not associated with an increased risk for cardiovascular events in people who were mainly at low risk for these events. FDA approved Victoza, however, with several post-marketing requirements under the Food and Drug Administration Amendments Act (FDAAA) to ensure that the company will conduct studies to provide additional information on the safety of this product.

In addition to a cardiovascular safety study to specifically evaluate the cardiovascular safety of Victoza in a higher risk population, the company also is required to conduct a 5-year epidemiological study using a health claims database to evaluate thyroid and other cancer risks as well as risks for seriously low blood glucose levels (hypoglycemia), pancreatitis, and allergic reactions. To specifically evaluate the risk of medullary thyroid cancer, the company is required to establish a cancer registry to monitor the rate of this type of cancer in the United States over the next 15 years.

In animal studies, Victoza caused tumors of the thyroid gland in rats and mice. Some of these tumors were cancers, which were significantly increased in rats who received excessive doses that were 8-times higher than what humans would receive.

It is not known if Victoza could cause thyroid tumors or a very rare type of thyroid cancer called medullary thyroid cancer in people. For this reason, Victoza should not be used as the first-line treatment for diabetes until additional studies are completed that support expanded use. Also, Victoza should not be used in people already at risk for medullary thyroid cancer, such as those who have medullary thyroid cancer in the family or those with a rare genetic condition known as Multiple Endocrine Neoplasia syndrome type 2.

To ensure the safe and effective use of this product, Victoza was approved with a Risk Evaluation and Mitigation Strategy consisting of a Medication Guide and a Communication Plan to help patients and providers understand the risks of Victoza and to ensure that the benefits of the drug outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid cancer.

Victoza is manufactured by Novo Nordisk of Bagsvaerd, Denmark.

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FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis

The U.S. Food and Drug Administration today approved Ampyra (dalfampridine) extended release tablets to improve walking in patients with multiple sclerosis (MS). In clinical trials, patients treated with Ampyra had faster walking speeds than those treated with an inactive pill (placebo). This is the first drug approved for this use.

MS is a chronic, often disabling, disease that affects the central nervous system—the brain, spinal cord, and optic nerves. There are about 400,000 people in the United States and 2.5 million people world-wide with MS.

The progress, severity, and specific symptoms of MS are unpredictable and vary from one person to another. Symptoms can be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision. About half of all people with MS experience cognitive impairments like difficulties in concentration, attention, memory, and judgment, although these symptoms are usually mild and are frequently overlooked. Depression also is common among MS patients.

“Trouble with walking is one of the most debilitating problems people with MS face,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.

Ampyra, when given at doses greater than that recommended (10 milligrams twice a day), can cause seizures. The most common adverse reactions reported by patients taking Ampyra in clinical trials include urinary tract infection, insomnia, dizziness, headache, nausea, weakness, back pain, balance disorder, swelling in the nose or throat, constipation, diarrhea, indigestion, throat pain, and burning, tingling or itching of skin.

Ampyra should not be used in patients with moderate to severe kidney disease. In these patients, blood levels with the drug approach those associated with the occurrence of seizures.

Ampyra will be manufactured under licenses from Elan of Dublin, Ireland, and distributed by Acorda Therapeutics Inc. of Hawthorne, N.Y.

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FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients

The U.S. Food and Drug Administration today approved the HeartMate II, a continuous-flow, left ventricular assist system as a support for severe heart failure patients who are not acceptable candidates for heart transplantation.

The HeartMate II is already FDA-approved for use in patients awaiting further, perhaps more complex treatment, such as transplants.

Heart assist devices are surgically implanted mechanical pumps that help the heart's ventricle pump blood to the rest of the body. HeartMate II consists of a small, lightweight blood pump implanted in a patient’s chest just below the heart. An electrical cable that powers the blood pump passes through the patient’s skin to an external controller worn around the patient’s waist.

A physician designates the pump’s speed based upon clinical need. The device is designed to sound an alarm upon malfunction or other potentially drastic changes that could impact the pump’s operation.

“The approval of HeartMate II provides an option for heart failure patients who cannot receive a transplant,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Its smaller size and mobility should allow more patients, including women and men of smaller stature, access to treatment.”

In a randomized clinical study of 200 participants at 38 centers, 46 percent of 134 participants with the HeartMate II were still living after two years with no disabling stroke or need for a reoperation for device replacement or repair compared with 11 percent of 66 participants in the control group. In addition, data collected in a separate registry of smaller stature women and men indicated that the device worked well in this specific population.

As a condition of the FDA’s approval, the company will conduct a post-approval study to further evaluate the device’s performance. The data will be recorded in the Interagency Registry of Mechanical Assisted Circulatory Support (INTERMACS) and made available when the post-approval study is concluded. The INTERMACS is a clinical outcomes registry managed by the FDA, the National Heart, Lung and Blood Institute at the National Institutes of Health, the Centers for Medicare & Medicaid Services and participating hospitals and companies.

HeartMate II is manufactured by Thoratec Corp. based in Pleasanton, Calif.

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FDA Commissioner Addresses Nation's Health Care Professionals on H1N1 Vaccine Safety

FDA Commissioner Margaret A. Hamburg today sent a letter to America’s health care professionals thanking them for their efforts during the 2009 H1N1 influenza outbreak and providing information on safety monitoring of the 2009 H1N1 vaccines.

“In November, I wrote to thank you for your efforts during the 2009 H1N1 influenza outbreak and to provide information about the development and FDA approval of the H1N1 vaccines,” Hamburg wrote. “I mentioned our continuing robust efforts to monitor the safety of these vaccines and now would like to reassure you that, to date, the safety assessment is very encouraging.

“As a key part of our missions, the FDA, the Centers for Disease Control and Prevention, other agencies across the Department of Health and Human Services, and other parts of the federal government, including the Department of Defense and the Department of Veterans Affairs, have enhanced and expanded our vaccine safety monitoring systems to detect and quickly investigate any unexpected, rare, or serious adverse events. These additional systems enhance our ability to determine whether any adverse events can be attributed to H1N1 influenza vaccines. A detailed description of vaccine safety efforts is available online at www.flu.gov.

“According to the January 8, 2010 update of FDA and CDC vaccine safety monitoring activities, as of December 30, 2009 the total number of doses of H1N1 vaccines distributed was 99.3 million and the vast majority (94%) of adverse events reported to VAERS were classified as "non-serious" (e.g., soreness at the vaccine injection site). Weekly updates on FDA and CDC vaccine safety monitoring activities are available through the VAERS web site http://vaers.hhs.gov/resources/h1n1update#top.”

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FDA Updates Earlier Guidance on Respiratory Treatment Spiriva HandiHaler

The U.S. Food and Drug Administration today announced that data from a recent review of the Spiriva HandiHaler, a long-acting respiratory treatment for chronic obstructive pulmonary disease (COPD), do not support an increased risk of stroke, heart attack, or death in patients using the medicine.

COPD is a serious and chronic lung disease that restricts air flow in the lungs resulting in shortness of breath. In the United States, COPD includes two main conditions – emphysema and chronic bronchitis. Spiriva HandiHaler consists of capsules and an inhalation device approved for once daily use in COPD.

A March 2008 FDA Early Communication had described data submitted by the manufacturer of Spiriva HandiHaler as suggesting a small increased risk of stroke in patients treated with tiotropium, the medicine’s active ingredient. In October 2008, an Updated Early Communication highlighted two additional publications suggesting an increased risk of stroke, heart attack, and death in patients using tiotropium.

Today’s update of those communications is based on an FDA review of the Understanding the Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) study that compared Spiriva HandiHaler with a placebo in 5,992 COPD patients. In November 2009, the FDA Pulmonary – Allergy Drugs Advisory Committee also reviewed the data and voted that findings from the UPLIFT study resolved the potential safety concerns for Spiriva Handihaler.

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CDC Foundation Launches Viral Hepatitis Action Coalition

/PRNewswire/ -- In anticipation of the release of the Institute of Medicine (IOM) report on viral hepatitis, the CDC Foundation (the independent nonprofit partner of the Centers for Disease Control and Prevention), in partnership with CDC's Division of Viral Hepatitis, recently launched the Viral Hepatitis Action Coalition. The Coalition is comprised of private-sector organizations committed to supporting high priority research, education and program evaluation projects initiated by CDC's Division of Viral Hepatitis. In addition to providing funding for specific projects, Coalition members also will support CDC by sharing research data, connecting CDC to appropriate stakeholders and networks, and providing feedback on the information and tools needed in the field to respond to the recommendations outlined in the IOM report.

Founding Viral Hepatitis Action Coalition members include: Gilead Sciences, Inc.; Merck & Co., Inc.; OraSure Technologies; and Vertex Pharmaceuticals. In addition to supporting the overall Coalition, members will have the opportunity to fund and partner with CDC on CDC-led research and education projects as priorities are identified. Two initial priority projects include a study called Birth-cohort Evaluation to Advance Screening and Testing for Hepatitis C (BEST-C) and a national hepatitis education campaign. For each project, Coalition members will reach out to other critical partners in the hepatitis community as appropriate, including partners from academia, patient advocacy and other hepatitis-related groups. Coalition members are committed to engaging the entire hepatitis community in efforts to improve screening and treatment of viral hepatitis.

The Viral Hepatitis Action Coalition is seeking additional membership, and those interested in membership should contact Leah-Lane Lowe at 404.653.0790 or llowe@cdcfoundation.org. To learn more about CDC's Division of Viral Hepatitis, please visit www.cdc.gov/hepatitis.

Established by Congress, the CDC Foundation is the independent, nonprofit partner of the Centers for Disease Control and Prevention. The CDC Foundation helps CDC do more, faster by forging effective partnerships between CDC and individuals, corporations and foundations to fight threats to health and safety. To learn more, please visit www.cdcfoundation.org.

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Mammography availability linked to breast cancer mortality rate

More women die of breast cancer in areas where mammography centers are few and far between, according to research by a Medical College of Georgia radiology resident.

Breast cancer mortality rates ranged from 34.1 per 100,000 women in counties with no mammography facilities to 27.5 in those with at least one, said Dr. Kandace Klein, a fourth-year radiology resident.

Drs. Klein and James Rawson, Warren professor and chair of the Department of Diagnostic, Therapeutic and Interventional Radiology, presented their findings at the recent annual conference of the Radiology Society of North America. Dr. Klein also received the society’s Trainee Research Prize for the project.

Researchers used mapping and statistical software to determine the relationship between the number of sites in a specific geographical area and the number of breast cancer deaths. While this phase of the research did not account for variables such as race, education or socioeconomic status, a noticeable pattern emerged.

“The number of sites within a county is related to the population,” Dr. Klein said. “Increasing access to a facility correlates with a decrease in mortality.”

Researchers could not account for mobile mammography units and any transfer cases, such as when a patient went to another county to receive mammography services. The next phase of the project will analyze other factors that could affect breast cancer mortality rates, she said.

Dr. Klein, a graduate of the Texas College of Osteopathic Medicine, will complete her residency this spring and begin an MCG fellowship in body imaging.

By Jennifer Hilliard
MCG

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FDA Approves New Drug for Rheumatoid Arthritis

The U.S. Food and Drug Administration approved Actemra (tocilizumab) on Friday to treat adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved drug classes for rheumatoid arthritis.

Actemra recommended use is limited to patients who have failed other approved therapies because of serious safety concerns that were noted in clinical studies. These safety concerns include elevated liver enzymes, elevated Low-density lipoprotein (LDL) or bad cholesterol, hypertension, and gastrointestinal perforations.

“Physicians and patients need to be aware of the risk of serious adverse effects of Actemra and make informed decisions regarding its benefits and risks in the treatment of individual patients,” said Bob Rappaport, M.D., director of the Division of Analgesics, Anesthetics and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

The FDA is requiring the sponsor to conduct a post-marketing clinical trial to further evaluate the long-term safety of Actemra. Specifically, the FDA wants to evaluate the impact of elevated LDL cholesterol and blood pressure seen in some patients in shorter-term trials on the cardiovascular health of patients treated with Actemra.

In addition, a Risk Evaluation and Mitigation Strategy (REMS) will require the drug sponsor to implement a Communication Plan for physicians informing them how to appropriately monitor their patients for liver and/or gastrointestinal side effects. The REMS will include a Medication Guide to ensure that patients are informed of the benefits and risks of Actemra.

Actemra works by blocking the action of interleukin-6, an immune system protein that is overabundant in people with rheumatoid arthritis.

The effectiveness and safety of Actemra was determined in five clinical trials in adult patients with active rheumatoid arthritis. In all of the trials, patients treated with Actemra experienced greater improvement in their tender or swollen joints than patients treated with a placebo.

The most common adverse reactions in clinical trials were upper respiratory tract infections, headache, inflammation of the nose or nasal passage, high blood pressure and increased liver enzymes. Elevations in the LDL or bad cholesterol were also seen in some patients, some of whom required the addition of lipid lowering agents.

Patients treated with Actemra are at increased risk for developing serious infections. Most patients who developed these infections in clinical trials were also taking other drugs that suppress the immune system such as methotrexate or corticosteroids.

Actemra is marketed by San Francisco-based Genentech Inc., a subsidiary of the Roche Group.

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Researcher uses federal grant to investigate West Nile Virus

Georgia State University’s Margo Brinton, a Regents’ Professor in the Department of Biology, received a $289,000 federal stimulus grant from the National Institutes of Health to continue her research on West Nile virus, which is transmitted to humans by mosquitoes.

West Nile virus causes either a mild illness characterized by short-term flu-like symptoms or no symptoms at all in most people it infects. But for some, infection results in severe illness, with the possibility of permanent neurological effects or death, according to the Centers for Disease Control and Prevention.

Specifically, this grant will focus on studies aimed at understanding how West Nile virus manipulates and commandeers cell proteins and processes to enhance its own replication.

“By gaining a detailed understanding these complicated interactions, we’re defining new targets for the development of antiviral therapies, and we’re also learning more about cell functions,” Brinton said.

Another of the projects ongoing in Brinton’s lab is focused on understanding why a small number of people infected with West Nile virus become extremely ill, even though they have normal responses to infections with other types of viruses. This work may lead to the development of a way to identify individuals who are highly susceptible to West Nile virus. These would be good candidates for vaccination with a “killed” vaccine but not a “live” one for this virus.

The idea that genetic factors could control the severity of the disease developed by individual humans after infection with West Nile virus is based in part on work done by Brinton’s lab on mice. In mice, a single, dominant gene determines whether a mouse lives or dies after a West Nile infection. Although the general location of this gene in the mouse DNA genome had been determined, the identity of the gene was not known until 2002, when Brinton’s lab compared a region of 650,000 DNA base pairs in resistant and susceptible mice and found the single change between them that made the difference.

Brinton, who first came to Georgia State in 1989, has been working on West Nile virus since the 1960s. “In the 1960s, West Nile virus was circulating primarily in Africa and the Middle East and was thought to cause only mild disease symptoms in humans,” Brinton said. One group of physicians thought that this virus was safe enough to be used to help cancer patients by generating interferon – a cell proteins made and released in response to pathogens that can act against tumors.

However, the patients – who already had weakened immune systems due to their cancer – died. Because of these human deaths, West Nile virus received a higher safety-level classification, meaning that scientists had to take more precautions when working with it. Additionally, the strain of virus that came to the United States in 1999 is more virulent than previously known strains.

Even though Brinton’s lab primarily works with less virulent strains of the virus, she and her staff take multiple precautions and work with live virus only in secure labs that are rated at Biosafety level 3, with level 4 being the highest safety rating.

For more information about West Nile virus, visit www.cdc.gov/ncidod/dvbid/westnile/index.htm.

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Drug benefit expanded to more seniors

WASHINGTON (AP) -- In case the prospect of nearly $4,000 in prescription assistance isn't enough to perk up low-income seniors, the government is using '60s singer Chubby Checker to publicize "the twist" in the Medicare drug program.
As of Jan. 1, more than 1 million low-income seniors are newly eligible for more generous prescription drug benefits under the "extra help" program. Benefiting from a new law...
http://www.washingtontimes.com/news/2010/jan/08/drug-benefit-expanded-more-seniors/

Pediatric Cancer Survivors at Risk for Chronic Illnesses that May Cause Heart Disease

Survivors of pediatric cancer are at greater risk for high cholesterol, diabetes and high blood pressure, all of which predispose them to heart disease.

These risk factors for heart disease are being found at an earlier age than in the general population, according to research published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.

Lillian R. Meacham, MD, professor of pediatrics at Emory University and medical director of the Aflac Cancer Center of Children's Healthcare of Atlanta Cancer Survivor Program, used data from the Childhood Cancer Survivor Study, which included 8,599 cancer survivors and 2,936 of their siblings.

"In data previously published from the Childhood Cancer Survivor Study, pediatric cancer survivors were found to be at almost 10-fold greater risk for cardiovascular disease than their non-survivor counterparts," says Meacham. "In this study we identified whether the predisposing risk factors for cardiovascular disease - obesity, hypertension, hyperlipidemea and diabetes - were present at higher rates compared to siblings. If the risk factors could be recognized and treated early it is hoped some of the long-term cardiac side effects could be averted."

Meacham found that cancer survivors were nearly twice as likely as their siblings to take medication for high blood pressure, 60 percent more likely to take cholesterol medication and 70 percent more likely to have diabetes.

Radiation treatment may be playing a role in the development of risk factors for cardiovascular disease, Meacham says. Total body irradiation was linked with a 5.5-fold increased risk and chest and abdomen radiation a 2.2-fold increased risk of cardiovascular risk factor clustering, which when present is associated with subsequent cardiovascular disease.

"Mechanistically, we are not yet sure why this is, but the association is definitely there," says Meacham.

Researchers examined the presence of cardiovascular risk factors and found that physical inactivity among cancer survivors was linked with a 70 percent increased risk for cardiovascular risk factor clustering. Older age at the time of the study was linked to a 8.2-fold increased risk for cardiovascular risk factor clustering among survivors compared with children who had never had cancer.

"These risk factors are manifesting at about age 32, which is much younger than a non-cancer survivor would exhibit signs of cardiovascular risk factors," says Meacham. "Some have suggested that when you are a cancer survivor there are parts of you that wear out early, so we need to be vigilant about our follow-up of these patients in order to find these late effects early and intervene."

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HHS Delivers the Nation's First Health Security Strategy

HHS Secretary Kathleen Sebelius today released The National Health Security Strategy, the nation's first comprehensive strategy focused on protecting people's health during a large-scale emergency. The strategy sets priorities for government and non-government activities over the next four years.

"As we've learned in the response to the 2009 H1N1 pandemic, responsibility for improving our nation's ability to address existing and emerging health threats must be broadly shared by everyone - governments, communities, families, and individuals," Secretary Sebelius said. "The National Health Security Strategy is a call to action for each of us so that every community becomes fully prepared and ready to recover quickly after an emergency."

National health security means that the nation and its people are prepared for, protected from, and resilient in the face of health threats or incidents with potentially negative health consequences such as bioterrorism and natural disasters. The strategy provides a framework for actions that will build community resilience, strengthen and sustain health emergency response systems, and fill current gaps.

"Events which threaten the health of the people of this nation could very easily compromise our national security. Whether it's a pandemic or a premeditated chemical attack, our public health system must be prepared to respond to protect the interests of the American people. In order to be prepared to both respond to an incident and to recover, we need a strong national health system with individuals and families ready to handle the health effects of a disaster," Secretary Sebelius said.

The National Health Security Strategy and the accompanying interim implementation guide outline 10 objectives to achieve health security:

1. Foster informed, empowered individuals and communities
2. Develop and maintain the workforce needed for national health security
3. Ensure that situational awareness so responders are aware of changes in an emergency situation
4. Foster integrated, health care delivery systems that can respond to a disaster of any size
5. Ensure timely and effective communications
6. Promote an effective countermeasures enterprise, which is a process to develop, buy and distribute medical countermeasures
7. Ensure prevention or mitigation of environmental and other emerging threats to health
8. Incorporate post-incident health recovery into planning and response
9. Work with cross-border and global partners to enhance national, continental, and global health security
10. Ensure that all systems that support national health security are based upon the best available science, evaluation, and quality improvement methods

The National Health Security Strategy also highlights specific actions that the nation - including individuals, communities, non-government organizations, and government agencies - should take to prevent, protect against, respond to, and recover from health threats.

Among the initial actions for the federal government are conducting a review to improve the system for developing and delivering countermeasures - medications, vaccines, supplies and equipment for health emergencies; coordinating across government and with communities to identify and prioritize the capabilities, research, and investments needed to achieve national health security; and evaluating the impact of these investments.

Federal, state, local, tribal, and territorial government agencies, as well as medical, public health and community-based organizations, collaborated to develop the strategy and interim implementation guide. To determine any additional issues and themes the strategy should address, the HHS solicited direct input from non-federal participants during six regional workshops. HHS also worked with the Institute of Medicine to engage the medical community.

The Pandemic and All Hazards Preparedness Act directed the HHS Secretary to develop the National Health Security Strategy with an accompanying implementation plan by 2009 and to revise the documents every four years. HHS, however, will update the implementation plan every two years to reflect advances in public health and medicine.

Because of the close relationship between health and national security, the National Health Security Strategy that complements and supports other U.S. strategies and guidelines related to security preparedness, response, and recovery.

To obtain a copy of the strategy and implementation guide, visit www.hhs.gov/disasters.

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Radio Frequency Energy Used to Shrink Fibroids and Reduce Symptoms in New Minimally Invasive Procedure

/PRNewswire/ -- Montefiore Medical Center recently became the only hospital on the East Coast to conduct the Radio Frequency Ablation procedure to shrink uterine fibroids in women 30 years and older. This minimally invasive procedure, initially used to treat liver cancer, uses a tiny needle that is inserted into the fibroid, applying low energy radio frequency electrical current, which creates localized tumor destruction by heat.

"More than 30% of all women suffer from fibroids, which can cause excessive menstrual bleeding and pain," said Erika Banks, MD, Director of the Fibroid Center at Montefiore and lead investigator of the study. "This procedure is another option for these women who wish to preserve their uterus -- an important advantage of this minimally invasive procedure."

Fibroids are benign tumors, which grow in the uterus. Fibroids are the most common tumor in the reproductive years, and are 2-3 times more common among African American women. Symptoms include heavy and or painful menstrual bleeding, a feeling of pressure in the pelvis, frequent urination, pain during intercourse, abdominal bloating and abdominal pain and/or back ache.

Montefiore is one of only five medical centers in the U.S. to test this procedure. The other centers are in California, Arizona, Michigan and Missouri. This study is currently enrolling women with fibroids and heavy bleeding who no longer desire fertility.

Treatment of 235 fibroid tumors in 70 women outside the U.S. resulted in significant reduction of symptoms and improvement in quality of life for about 90% of women, according to Dr. Banks.

Montefiore Medical Center encompasses 126 years of outstanding patient care, innovative medical "firsts," pioneering clinical research, dedicated community service and ground-breaking social activism. A full-service, integrated delivery system caring for patients in the New York metropolitan region and beyond, Montefiore is a 1,491-bed medical center that includes: four hospitals -- the Henry and Lucy Moses Division, the Jack D. Weiler Division, the North Division and The Children's Hospital at Montefiore; a large home healthcare agency; the largest school health program in the US; a 23-site medical group practice integrated throughout the Bronx and Westchester; and a care management organization providing services to 179,000 health plan members.

In 2008, The Children's Hospital at Montefiore was ranked as one of "America's Best Children's Hospitals" in US News & World Report's prestigious annual listing and also received honors in the magazine's 2009 edition. The Leapfrog Group lists Montefiore among the top one percent of all U.S. hospitals based on its strategic investments in sophisticated and integrated healthcare technology.

Montefiore is committed to meeting the healthcare needs of the future through medical education and manages one of the largest residency programs in the country. Montefiore is The University Hospital and Academic Medical Center for Albert Einstein College of Medicine and has an affiliation with New York Medical College for residency programs at the North Division.

Distinguished centers of excellence at Montefiore include cardiology and cardiac surgery, cancer care, tissue and organ transplantation, children's health, women's health, surgery and the surgical subspecialties. Montefiore is a national leader in the research and treatment of diabetes, headaches, obesity, cough and sleep disorders, geriatrics and geriatric psychiatry, neurology and neurosurgery, adolescent and family medicine, HIV/AIDS and social and environmental medicine, among many other specialties. For more information, please visit MACROBUTTON HtmlResAnchor www.montefiore.org or www.montekids.org .

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New Pediatrics Report Urges Medical Community to Address Underlying Pathologies in Patients With Autism

/PRNewswire/ -- An article published today in the journal Pediatrics confirms what parents and advocacy organizations have been saying for years: many individuals with autism suffer from gastrointestinal disease that can contribute to behaviors and symptoms associated with autism.

Evaluation, Diagnosis, and Treatment of Gastrointestinal Disorders in Individuals With ASDs: A Consensus Report is the result of expert panel study and discussion led by Dr. Timothy Buie of the Harvard Medical School Department of Pediatrics. The panel's findings point out not only the existence of underlying GI disturbances that can manifest as behavioral problems, but also notes that such medical issues have often gone undiagnosed or been ignored in the past by physicians treating patients diagnosed with autism.

"We are finally getting mainstream acknowledgement that our kids are physically sick, and not the victims of some mysterious genetic behavioral disorder," commented Lori McIlwain, National Autism Association (NAA) board chair. "With one in 110 children now diagnosed with autism, we are in the midst of a national health emergency. Physicians must address the underlying medical conditions involved in this epidemic if they are to help us find answers and relief for our children."

The panel arrived at several conclusions regarding current clinical practice guidelines and made recommendations for future medical and research priorities. These include:

-- Current treatment guidelines do not routinely consider potential
medical problems
-- Problem behaviors including self-injury, aggression, irritability,
and sleep disturbance may be manifestations of abdominal pain
-- Behavioral treatment should not substitute for medical treatment
-- Gastrointestinal symptoms should be considered an urgent indication
for medical investigation
-- Immunologic dysfunction, inflammation, metabolic dysfunction, and
allergies are all potentially associated with autism
-- Research is needed to determine the role of abnormal GI permeability
in neuropsychiatric manifestations of autism
-- Greater awareness is needed among health care providers of the
atypical manifestations of GI disorders
-- Awareness of unrecognized medical conditions in autism must become a
priority of professional societies including the American Academy of
Pediatrics
-- Diagnostics should be performed to accurately identify co-morbid
allergic disease
-- Research is needed to determine the role of immune dysfunction in
autism


"This is definitely a step in the right direction," said Ms. McIlwain. "Our kids need and deserve clinical investigation and treatment for the underlying medical conditions from which they suffer."

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St. John's Wort Not Helpful Treatment for Irritable Bowel Syndrome, Mayo Clinic Researchers Say

A Mayo Clinic research study published in the January issue of The American Journal of Gastroenterology finds that St. John's wort is not an effective treatment for irritable bowel syndrome (IBS). While antidepressants are frequently used to treat IBS, to date, no study has examined the success of using the herbal supplement St. John's wort in treating IBS.

"Our study investigated if herbal antidepressants such as St. John's wort could benefit irritable bowel disease patients," says Yuri Saito, M.D., M.P.H., a gastroenterologist and lead physician scientist on the study. "Several of the chemical neurotransmitters that are in the brain are also in the colon. Therefore, it's been thought that antidepressants may affect sensation in the colon in a similar way to how they affect sensation in the brain. Our goal was to evaluate the usefulness of St John's wort in treating IBS."

In this placebo-controlled trial, 70 participants with IBS were randomized where half the patients received St. John's wort and the other half received a placebo for three months. In all, 86 percent of the participants were women, and the median age was 42 years. After three months of observing symptoms such as stomach pain, diarrhea, constipation and bloating, Mayo researchers found that the placebo group had a better response than the group taking the herbal supplement, St. John's wort.

"Because people tend to struggle with IBS for several years, patients are really looking for inexpensive, over-the-counter treatments such as St. John's wort," says Dr. Saito. "Unfortunately, our study showed that St. John's wort was not successful in helping IBS patients."

St. John's wort is an herbal supplement derived from the St. John's wort plant. It has been shown to be helpful in several medical conditions such as depression as well as other pain syndromes. Research has shown it to be as effective as conventional, prescription anti-depressants in treating mild to moderate depression.

"The challenge with IBS is that there is no cure, no one treatment tends to be wholly effective and some treatments come with significant side effects," explains Dr. Saito. "However, well-designed studies of herbal supplements are important so that physicians and patients can make informed decisions about which supplements to recommend or try. Studies of alternative treatments are generally lacking and patients are forced to use a "trial and error" approach to over-the-counter treatments for their IBS."

IBS is a common disorder that affects the colon and commonly causes cramping, abdominal pain, bloating, gas, diarrhea and constipation. Approximately 58 million people struggle with IBS, mostly women.

Each year, Mayo Clinic physicians treat thousands of people with IBS. Read more information on treatment for irritable bowel syndrome at Mayo Clinic.

Mayo Clinic's Division of Gastroenterology and Hepatology has been ranked #1 in the U.S. News & World Report Honor Roll of Top Hospitals since the rankings began 20 years ago.

Other members of the Mayo Clinic research team included Enrique Rey, M.D.; Ann Almazar-Elder; W. Scott Harmsen; Alan Zinsmeister, Ph.D.; G. Richard Locke , M.D.; and Nicholas Talley, M.D., Ph.D.
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