FDA approves Latuda to treat schizophrenia in adults

The U.S. Food and Drug Administration today approved Latuda (lurasidone HCl) tablets for the treatment of adults with schizophrenia.

Schizophrenia affects about 1 percent of the U.S. population, ages 18 years and older, in a given year. The most prominent symptoms include hallucinations, delusions, disordered thinking and behavior, and suspiciousness. Hearing voices that other people don't hear is the most common type of hallucination. These experiences can make people with the disorder fearful and withdrawn.

“Schizophrenia can be a devastating illness requiring lifelong treatment,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. “Some patients do not respond well to certain types of drug therapy, so it is important to have multiple treatment options available.”

Latuda is included in the atypical antipsychotic class of drugs. All atypical antipsychotics contain a boxed warning alerting prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis.

Four six-week controlled studies of adults with schizophrenia demonstrated the effectiveness and safety of Latuda. In the trials, patients treated with Latuda had fewer symptoms of schizophrenia than those taking an inactive pill (placebo).

The most common adverse reactions reported by those in clinical trials were drowsiness, feelings of restlessness and the urge to move (akathisia), nausea, movement abnormalities such as tremors, slow movement, or muscle stiffness (Parkinsonism), and agitation.

Latuda is manufactured by Sunovion Pharmaceuticals Inc. of Fort Lee, N.J.

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FDA approves additional medical indication for Sprycel

The U.S. Food and Drug Administration today approved a new indication for Sprycel (dasatinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

Sprycel, an oral kinase inhibitor, is believed to inhibit the activity of certain proteins responsible for the growth of cancer cells. The action allows bone marrow to begin reproducing normal red and white blood cells.

In June 2006, the FDA granted accelerated approval for Sprycel to treat adults with CP-CML with resistant disease or who were intolerant to prior therapy, including Gleevec (imatinib). The agency converted Sprycel to a regular approval in May 2009, after 24-month follow-up data from earlier clinical studies confirmed the treatment’s safety and effectiveness.

Other FDA-approved drugs to treat various forms of CML include Gleevec, approved in May 2001, and Tasigna (nilotinib), approved in October 2007.

The FDA granted Sprycel a priority review for Ph+ CP-CML.

This is the third drug approved for Ph+ CP-CML under accelerated approval, a process allowing the FDA to approve a drug to treat a serious disease with an unmet medical need based on an endpoint thought to reasonably predict clinical benefit. A company is required to collect additional long term efficacy and safety information data confirming the drug’s benefit. The accelerated approval program provides earlier patient access to promising new drugs while confirmatory clinical trials are being conducted.

“These drugs have dramatically changed the lives of patients with CML,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Results from additional CML studies continue to demonstrate the importance of studying cancer drugs in the earlier stages of a disease.”

In CML, too many blood stem cells develop into a type of white blood cell called granulocytes. These granulocytes are abnormal and do not become healthy white blood cells. These cells can build up in the blood and bone marrow so there is less room for healthy white blood cells, red blood cells, and platelets. When this happens, infection, anemia, or unexpected bleeding may occur.

One open-label, randomized clinical trial in patients with CP-CML evaluated the safety and effectiveness of Sprycel. The trial measured complete cytogenetic response (CCyR) and cytogenetic response (MCyR), gene-based indicators of how well the malignant cells respond to the treatment. The most commonly reported side effects of Sprycel included decreased bone marrow activity resulting in fewer red and white blood cells and platelets (myelosuppression), fluid retention, diarrhea, headache, musculoskeletal pain, and rash.

Sprycel is marketed by New York City-based Bristol-Myers Squibb. Tasigna and Gleevec are marketed by East Hanover, N.J.-based Novartis Pharmaceuticals.

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National Meningitis Association Statement on Advisory Committee on Immunization Practices Vote

/PRNewswire/ -- On October 27, 2010, the CDC's Advisory Committee on Immunization Practices (ACIP) voted to expand the adolescent meningococcal vaccination recommendation to include a booster. Routine vaccination at age 11-12 years continues to be recommended with a booster dose at age 16. For adolescents who are first vaccinated between 13 and 15 years of age, a booster dose is recommended 5 years after the first dose through age 21.

NMA Statement:

The National Meningitis Association supports ACIP's decision to maintain meningococcal immunization at age 11-12 and to add a booster dose to provide increased prevention of disease among adolescents throughout their high-risk years. This is a good public health decision that will protect our children from meningococcal disease.

We looked forward to supporting this recommendation as well as the adolescent immunization platform through our education and outreach programs.

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Patients Who Survive Sepsis Infections Are More Than Three Times as Likely to Develop Cognitive Problems

/PRNewswire/ -- Older adults who survive severe sepsis are at higher risk for long-term cognitive impairment and physical limitations than those hospitalized for other reasons, according to researchers from the University of Michigan Health System.

Research to be published Oct. 27 today in the Journal of the American Medical Association showed that 60 percent of hospitalizations for severe sepsis were associated with worsened cognitive and physical function among surviving older adults. The odds of acquiring moderate to severe cognitive impairment were 3.3 times higher following an episode of sepsis than for other hospitalizations.

Severe sepsis also was associated with greater risk for the development of new functional limitations following hospitalization, says lead author, Theodore (Jack) Iwashyna, M.D., Ph.D., assistant professor of internal medicine at U-M.

Among patients who had no limitations before sepsis, more than 40% developed trouble with walking. Nearly 1 in 5 developed new problems with shopping or preparing a meal. Patients often developed new problems with such basic things as bathing and toileting themselves.

"We used to think of sepsis as just a medical emergency, an infection that you get sick with and then recover," said Iwashyna, "But we discovered a significant number of people face years of problems afterwards.

"Those problems are bigger and more common than we expected. Most older Americans suffer real brain and body problems. We need new treatments, not just for the sepsis infection, but to prevent these new disabilities afterwards."

Sepsis is an overwhelming infection that can result in failure of multiple organ systems. The initial infections are often common problems, such as pneumonia or a urinary tract infection. About 40 percent of those with severe sepsis die from the infection.

Anyone can get sepsis, but older people and those with weakened immune systems are most vulnerable. Sepsis is probably the most common cause of critical illness in the United States.

The best data available are from the 1990s, when it was estimated that 750,000 people each year were diagnosed with sepsis. Researchers believe that number has doubled each decade.

"These new data show a majority of older patients suffer with real life-changing burdens after beating sepsis. This is an underrecognized public health problem with major implications for patients, families and the health care system," Iwashyna says.

"We need to make sure families have the resources they need to care for survivors of sepsis when they go home. It's not enough just to get them through the acute episode. We need to start preparing them for the years of problems they may have afterwards."

"This research underscores the need for physicians who care for older adults to focus early on preventing infections that can lead to sepsis," says study co-author Kenneth M. Langa, M.D., Ph.D., a core investigator for the Ann Arbor Veterans Administration Health Services Research and Development Service's Center of Excellence and professor of internal medicine at U-M.

Older patients need to get their flu and pneumonia vaccines in order to decrease their risk for infections, and physicians need to be aware of the long-term risk for cognitive and physical disabilities that many patients may face, Langa said.

"In contrast to Alzheimer's disease and other forms of dementia, the cognitive impairment associated with sepsis is likely at least partially preventable through better acute care of the sepsis episode and better rehabilitation efforts afterwards," Langa says.

"We need to start working early – from the beginning of the hospitalization – to make sure patients do not develop new disability. There are innovative new ways to care for people that might help prevent this disability," Iwashyna says.

The research was supported primarily by the National Institute on Aging and the National Heart, Lung and Blood Institute.

The researchers used data from the NIA-supported Health and Retirement Study , a long-term study that collects information on the health, economic, and social factors influencing the health and well-being of a nationally representative sample Americans over age 50.

"This research makes clearer how acute medical problems in older adults may have an important lasting impact and contribute to a downward trajectory in both cognitive and physical function," says Richard Suzman, Ph.D., director of the NIA's Division of Behavioral and Social Research, which supports the HRS.

"The unique nature of the rich HRS dataset that links both survey data and Medicare administrative data made this innovative study possible and will also facilitate future studies of the long-term impact of critical illness on older adults and the family members that care for them."

The HRS, now in its 18th year, follows more than 22,000 people over the age of 50, collecting data every two years, from pre-retirement to advanced age.

The NIA leads the federal effort supporting and conducting research on aging and the medical, social and behavioral issues of older people. For more information on research and aging, go to www.nia.nih.gov.

Additional authors: E. Wesley Ely, M.D., M.P.H. of the Tennessee Valley Veteran's Affairs (VA) Healthcare System and Vanderbilt University; Dylan M. Smith, Ph.D., of Stony Brook University Medical Center.

Journal reference: Journal of the American Medical Association, 2010; 304(16): 1787-1794.

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Substantial Consumption of Fluoride Increases Chance of Mild Fluorosis

/PRNewswire/ -- Young children who consume substantial amounts of fluoride through infant formula and other beverages mixed with fluoridated water or by swallowing fluoride toothpaste have an increased chance of developing mild enamel fluorosis, according to research published in the October issue of The Journal of the American Dental Association and supported by the National Institute of Dental and Craniofacial Research. Children can continue using fluoridated water and fluoride toothpaste because fluoride has been proven to prevent tooth decay, and mild fluorosis does not negatively affect dental health or quality of life.

"Nearly all of the fluorosis in our study participants was mild. A recent review of the effects of mild dental fluorosis on oral health-related quality of life concluded that the effect of mild fluorosis was not adverse and could even be favorable," according to the study. "This suggests that concerns about mild dental fluorosis may be exaggerated. Therefore, no general recommendations to avoid use of fluoridated water in reconstituting infant formula are warranted."

According to the American Dental Association, mild enamel fluorosis appears as barely noticeable faint white lines or streaks on tooth enamel that may occur when children ingest excess fluoride while their teeth are developing.

Researchers concluded that substantial fluoride consumption from beverages with fluoridated water, including infant formula, by children between the ages of 3 to 9 months, elevates a child's prospect of developing mild enamel fluorosis. Substantial fluoride consumption from beverages with fluoridated water and from fluoride toothpaste by children between the ages of 16 to 36 months also elevates a child's probability of developing mild enamel fluorosis.

The American Academy of Pediatrics recommends breastfeeding for infants. If parents are concerned about reducing the chances of their infants developing mild fluorosis through consuming substantial amounts of infant formula mixed with fluoridated water, the researchers suggest that they consult with their family dentist or physician. The researchers also encourage parents to follow recommendations to use small (smear or pea-sized) amounts of fluoridated toothpaste and ensure proper supervision of the child's tooth brushing.

Researchers recruited mothers of newborn infants from eight Iowa hospital postpartum wards between 1992 and 1995 for their children's participation in what would become known as the Iowa Fluoride Study, an investigation of dietary and non-dietary fluoride exposures, dental fluorosis and dental cavities. Researchers sent questionnaires to the parents at regular intervals and 630 children underwent visual dental examinations using standardized techniques and portable equipment. The leader of the research team was Steven M. Levy, D.D.S., M.P.H., the Wright-Bush-Shreves Endowed Professor of Research in the Department of Preventive and Community Dentistry at the University of Iowa's College of Dentistry and Professor of Epidemiology at the College of Public Health.

Note: Although this study appears in The Journal of the American Dental Association, it does not necessarily reflect the policies or opinions of the American Dental Association.

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Medicare 'Competitive' Bidding Program for Home Medical Equipment Is Plagued by Myths; Economists Warn that the Bid System Will Fail

/PRNewswire/ -- While Medicare paints a glowing picture of the controversial "competitive" bidding program for home medical equipment and services (HME), economists and consumer groups have lined up to oppose the flawed system.

New restrictions and unsustainable prices based on this controversial bidding system are scheduled to take effect on January 1, 2011 in nine of the largest metropolitan areas including Charlotte, Cincinnati, Cleveland, Dallas-Ft. Worth, Kansas City, Miami, Orlando, Pittsburgh, and Riverside, Calif. Another 91 areas throughout the U.S. will be subjected to the bidding program starting later in 2011. The bidding system affects providers and users of home medical equipment and services such as oxygen therapy, respiratory devices, hospital beds, wheelchairs, and other medically required equipment and supplies needed by seniors and people with disabilities in Medicare.

Proponents of the bidding system have conveyed misleading information that exaggerate the benefits and ignore the severe shortcomings of the program.

MYTH #1: The bidding system improves the method setting reimbursement rates for providers of home medical equipment and services.

REALITY: 166 experts, including two Nobel laureates and numerous economics professors from leading universities, recently warned Congress and regulators that this bidding system will fail. The experts, who do not otherwise oppose competitive bidding to set Medicare prices, point out that the system has four fatal flaws:

* The bidders are not bound by their bids, which undermines the credibility of the process.
* Pricing rules encourage "low-ball bids" that will not allow for a sustainable process or a healthy pool of equipment suppliers.
* The bid design provides "strong incentives to distort bids away from costs."
* There is a lack of transparency in the bid program that is "unacceptable in a government auction and is in sharp contrast to well-run government auctions."


These concerns are not new. They have been shared with the federal Centers for Medicare and Medicaid Services (CMS), which designed the bidding system. But the agency has dismissed those concerns.

The 166 economists sent letters outlining the flaws in the bidding system to Senators Max Baucus (D-Mont.) and Charles Grassley (R-Iowa) and to Representatives Jason Altmire (D-Pa.) and Ralph Hall (R-Tex.) on October 15, 2010, and sent a letter to Rep. Pete Stark (D-Calif.) on September 26. See http://www.cramton.umd.edu/auction-papers.htm.

A September 30, 2010 New York Times' "Freakonomics" article by two of the 166 economists addresses the bidding issue. Yale University economist Ian Ayres and University of Maryland economist Peter Cramton, conclude: "The mystery is why the government has failed over a period of more than ten years to engage auction experts in the design and testing of the Medicare auctions…. We suspect the problem is that CMS initially did not realize that auction expertise was required, and once they spent millions of dollars developing the failed approach, they stuck with it rather than admit that mistakes were made." See: http://freakonomics.blogs.nytimes.com/2010/09/30/fix-medicares-bizarre-auction-program/

MYTH #2: Medicare overpays for home medical equipment, and the bidding system applies market forces to correct that.

REALITY: Proponents of the bidding system have used out-of-date reimbursement rates and false comparisons of retail costs versus Medicare costs to argue their case. For many years, CMS has set reimbursement rates for home medical equipment through a fee schedule. Over the past decade, those reimbursement rates have dropped nearly 50 percent because of cuts mandated by Congress or imposed by CMS.

The costs of delivering, setting up, maintaining, and servicing medically required equipment in the home are obviously greater than the cost of merely acquiring the equipment. But Medicare does not recognize the costs of these services. So comparing the cost of the equipment to the larger cost of furnishing the full array of required equipment, supplies, and services is false and misleading.

MYTH #3: The bidding program will make healthcare more cost-effective.

REALITY: The home is already the most cost-effective setting for post-acute care. For many years, home medical equipment providers have competed in Medicare on the basis of quality and service to facilitate in the hospital discharge process and enable patients to receive cost-effective, high-quality post-acute care at home. As more people receive quality equipment and services at home, patients and taxpayers will spend less on hospital stays, emergency room visits, and nursing home admissions. Home medical equipment is an important part of the solution to the nation's healthcare funding crisis. Home medical equipment represents less than two percent of total Medicare spending. So while this bidding program would make even more severe cuts to reimbursement rates for home medical equipment, that will ultimately result in much higher spending in Medicare and Medicaid for hospital and nursing home stays and for physician and emergency treatments.

MYTH #4: The bidding program will eliminate fraud in the home medical equipment sector.

REALITY: CMS continues to describe the bidding program as an anti-fraud tool. In reality, it is a price-setting mechanism that has nothing to do with fraud prevention. In fact, the exact opposite is true, according to the 166 market experts who warned Congress in their October 15 letters that the CMS bidding program "will lead to a 'race to the bottom' fostering fraud and corruption."

When explaining on October 14, 2010 why it has missed the deadline for announcing the bid winners, CMS raised concerns about fraud associated with the bidding program. Yet the agency said it will implement the new system on January 1, 2011. The economists' October 15 letter states, "This haste to implement results that raised many red flags with respect to program integrity seems contrary to the public interest and common sense."

The real solution to keeping criminals out of Medicare is better screening, real-time claims audits, and better enforcement mechanisms for Medicare. Two years ago, the American Association for Homecare proposed to Congress an aggressive, 13-point legislative action plan to combat fraud, and many of those provisions have been included in legislation passed in Congress. Moreover, two important anti-fraud requirements – accreditation and surety bonds – took effect more than one year ago, in October 2009.

MYTH #5: Only the home medical equipment sector opposes the bidding system.

REALITY: In addition to the 166 economists and bidding experts who have expressed grave concerns about the bidding program, many consumer and disability organizations have called for a halt to the bidding system. Those groups include the ALS Association, the American Association for Respiratory Care, the American Association of People with Disabilities, COPD/ALERT, the International Ventilator Users Network, the Muscular Dystrophy Association, the National Emphysema/COPD Association, the National Spinal Cord Injury Association, and Post-Polio Health International, among others.

These consumer groups support H.R. 3790, a bill in the U.S. House of Representatives that would eliminate the bidding program in a fiscally responsible manner. That legislation would lower reimbursement rates for durable medical equipment but would allow providers to continue competing to serve Medicare beneficiaries on the basis of service and quality. The bipartisan bill has 257 cosponsors, including more than half of the Democrats and more than half of the Republicans in the House.

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New Label Changes for Commonly Prescribed HIV Drug Invirase

The U.S. Food and Drug Administration today announced that new safety information has been added to the label for the HIV antiviral drug Invirase (saquinavir), describing potentially life-threatening side effects on the heart when used with Norvir (ritonavir), another HIV antiviral medication.

In February 2010, the agency warned patients and health care professionals that when used together, the two drugs could cause prolongation of the QT and PR intervals--indicators of heart rhythm activity seen on an electrocardiogram.

Prolongation of the QT interval may lead to a condition known as torsades de pointes, an abnormal heart rhythm. With torsades de pointes, patients may experience lightheadedness, fainting or abnormal heart beats. In some cases, torsades de pointes may progress to a life-threatening irregular heart beat known as ventricular fibrillation.

Prolongation of the PR interval may also lead to an abnormal heart rhythm known as heart block. With heart block, patients may experience lightheadedness, fainting or abnormal heartbeats.

The FDA is also requiring a medication guide for patients using Invirase that will describe these potential risks. Patients at greater risk of developing one of the serious heart events described above include those with underlying heart conditions or those that have existing heart rate or rhythm problems.

“These heart conditions could potentially be life-threatening and we want to assure that health care providers and patients are adequately informed of the risks,” said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. “Patients should talk to their doctor if they have any concerns about their treatment. Certain drugs may interact with Invirase and increase the risk of developing these side effects, so patients should be sure to tell their doctor about other medicines they may be taking, including non-prescription medicines, vitamins, and herbal supplements.”

Patients and health care professionals should report any side effects from the use of Invirase to the FDA’s MedWatch program.

Invirase is an antiretroviral medication first approved in 1995, and used in combination with Norvir and other antiretroviral medicines to treat HIV in adults. Invirase does not cure HIV infection, may not prevent development of HIV-related illnesses and may not prevent the spread of HIV to other people.

Invirase is marketed by San Francisco-based Genentech, a subsidiary of the Roche Group. Norvir is marketed by Abbott Laboratories based in Abbott Park, Ill.

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State, Justice Department Reach Agreement on Mental Health Plan

Agreement avoids direct federal control, lays out measurable benchmarks

Governor Sonny Perdue today announced that the State of Georgia and the US Department of Justice (DOJ) have reached a settlement agreement that avoids direct federal control of the state’s services for people with developmental disabilities and mental illness and adds concrete goals to Georgia’s current plans to expand services in communities. Under the agreement, the state will stop admitting people whose primary diagnosis is a developmental disability into state hospitals by July 2011 and instead place them directly into community services. By July 2015 it will attempt to place any who remain in state hospitals into community services as well. The agreement also provides for expanded community-based services for approximately 9,000 individuals with mental illness. The new agreement lays aside a DOJ lawsuit brought earlier this year under the Americans with Disabilities Act.

“We’re happy that, after long and frequent negotiations, we now have an agreement with measurable goals that preserves Georgia’s ability to make decisions on how best to serve Georgians,” said Governor Perdue. “I have always said the state needed to provide better services to our most vulnerable citizens, and the Department of Justice has played a helpful role in spurring change in Georgia. I am confident we finally have an agreement that moves us towards our common goals of recovery and independence for people with mental illness and developmental disabilities”

The new agreement is part of a series of actions that have sought to reform Georgia’s behavioral health and developmental disability services. In its 1999 Olmstead decision, the US Supreme Court found that people with mental illness and developmental disabilities in Georgia and other states have a right to receive services in community settings instead of being segregated into state hospitals. The new settlement agreement furthers the State’s commitment to comply with the Olmstead agreement, replacing and expanding upon an existing voluntary compliance agreement that was entered into in 2008. It reaffirms, and does not replace, a separate agreement that seeks to improve the safety and effectiveness of the state’s psychiatric hospitals.

“The staff members at our hospitals and regional offices have worked long and hard to make the people we serve safer,” said Dr. Frank Shelp, Commissioner of the Georgia Department of Behavioral Health and Developmental Disabilities (DBHDD). “This agreement would not have been possible without their dedication, and it’s that commitment to the people we serve that will make it a success.” In 2009, Governor Perdue and the Georgia General Assembly created DBHDD to focus solely on policies and programs for people with mental illness, developmental disabilities, and substance use disorders. In its first year of operations, the agency improved the safety and effectiveness of the seven state hospitals, expanded community-based services, built innovative partnerships with several medical schools in Georgia, and forged strong alliances with Georgia advocacy and consumer groups.
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FDA Approves Pradaxa to Prevent Stroke in People With Atrial Fibrillation

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).

Atrial fibrillation, which affects more than 2 million Americans, involves very fast and uncoordinated contractions of the heart's two upper heart chambers (atria) and is one of the most common types of abnormal heart rhythm.

"People with atrial fibrillation are at a higher risk of developing blood clots, which can cause a disabling stroke if the clots travel to the brain," said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research.

Pradaxa is an anticoagulant that acts by inhibiting thrombin, an enzyme in the blood that is involved in blood clotting. The safety and efficacy of Pradaxa were studied in a clinical trial comparing Pradaxa with the anticoagulant warfarin. In the trial, patients taking Pradaxa had fewer strokes than those who took warfarin.

"Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa," Stockbridge says.

As with other approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, was among the most common adverse reactions reported by patients treated with Pradaxa. Gastrointestinal symptoms, including an uncomfortable feeling in the stomach (dyspepsia), stomach pain, nausea, heartburn, and bloating also were reported.

Pradaxa was approved with a Medication Guide that informs patients of the risk of serious bleeding. The guide will be distributed each time a patient fills a prescription for the medication.

Pradaxa, manufactured by Boehringer Ingelheim Pharmaceuticals Inc. of Ridgefield, Conn., will be available in 75 milligram and 150 milligram capsules.

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Piedmont Fayette Hospital and Piedmont Heart Institute Physicians Partner with US AGAINST ATHERO to Educate on Heart Disease

Piedmont Fayette Hospital and Piedmont Heart Institute Physicians have teamed up with US AGAINST ATHERO, to bring the Artery Explorer experience to Piedmont Fayette Hospital at 1255 Highway 54 West in Fayetteville, Ga. In addition to this unique educational experience, visitors will have a chance to have their blood pressure checked and learn their body mass index (BMI). The event is Tuesday, October 26 from 11 a.m. to 5 p.m. and Wednesday, October 27 from 1 p.m. to 6 p.m.

As part of US AGAINST ATHERO, the Artery Explorer is touring the country to increase awareness of atherosclerosis—the dangerous buildup of plaque in the arteries. This incredible virtual experience allows viewers to surf through arteries on a journey deep inside the body. The movie demonstrates how risk factors like high levels of bad cholesterol, smoking and high blood pressure can contribute to the buildup of plaque in arteries.

Coronary heart disease and stroke kill more Americans every year than all cancers combined. Atherosclerosis, or athero for short, is often the leading cause. It is the progressive buildup of plaque in the arteries linked to about one in four deaths in the United States each year. For more information, call 770.719.6060 or visit athero.com.
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Allergy Drug Found to Clear Condition but not Symptoms of Throat Disease

(BUSINESS WIRE)--A group of Mayo Clinic (http://www.mayoclinic.org/about/) researchers conducted the first controlled trial of swallowed fluticasone nasal spray (also known as Flonase) on people with the allergic esophageal condition called eosinophilic esophagitis (http://www.mayoclinic.org/eosinophilic-esophagitis/). Research showed that the aerosolized swallowed allergy drug helped treat the cause of the throat condition, but symptoms lingered. The researchers’ findings were presented today at the Annual Scientific Meeting of the American College of Gastroenterology (http://www.acg.gi.org/) in San Antonio.

Eosinophilic esophagitis is a relatively new disease, first noticed in young people, that causes those who have the condition to feel like solid food is sticking in their throat or like they have heartburn. A steroid applied to the esophagus is often used for treatment, but its effectiveness has not been scientifically proven.

For the randomized, double-blind study, 34 adults swallowed either a placebo or aerosolized fluticasone twice a day for six weeks. Fluticasone is used in inhalers and as a nasal spray to treat inflammation in the lungs and sinuses caused by allergies. The drug is a corticosteroid that decreases irritation and swelling and, when used for asthma, allows for easier breathing.

After completing the course of medication, the research volunteers were given questionnaires to assess their symptoms and side effects of the treatment. Their throats were examined with an endoscope and then through biopsies for the presence of eosinophils -- a type of white blood cell that secretes proteins, which researchers suspect causes swallowing problems.

“We had complete histologic remission in 68 percent of the people who took the fluticasone, compared to zero for the placebo,” says Jeffrey Alexander, M.D., (http://www.mayoclinic.org/bio/13216619.html) a Mayo Clinic gastroenterologist and lead author on the study. “From this perspective, fluticasone does get rid of the eosinophils in the esophagus; however, people’s symptoms did not improve.”

Dr. Alexander attributes the lack of symptom improvement to several confounding factors. “We had a symptom response in 63 percent of the people, but we had a placebo response in 47 percent of the people, which is very high,” Dr. Alexander says. “Our experience in clinical practice is that the symptoms do get better. We suspect the lack of symptom response was related to difficulty in assessing intermittent swallowing symptoms with our questionnaire.”

The research team has multiple ongoing studies in the diagnosis, pathophysiology and treatment of eosinophilic esophagitis.

The research project was funded by the Fitterman Grant to the Mayo Division of Gastroenterology (http://www.mayoclinic.org/gi/). Mayo Clinic co-authors include Kevin Jung; Amindra Arora, M.B., B. Chir; Felicity Enders, Ph.D.; Dawn Francis, M.D.; Hirohita Kita, M.D.; Yvonne Romero, M.D.; David Katzka, M.D.; Thomas Smyrk, M.D.; and Nicholas Talley, M.D.

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American Red Cross and American Heart Association Jointly Announce Revised First Aid Guidelines

/PRNewswire/ -- The American Red Cross and American Heart Association today announced changes to guidelines for administering first aid. Among the revisions are updated recommendations for the treatment of snake bites, anaphylaxis (shock), jellyfish stings and severe bleeding. The First Aid Guidelines are being published in Circulation: Journal of the American Heart Association.

Volunteer experts from more than 30 national and international organizations joined the Red Cross and the American Heart Association in reviewing 38 separate first aid questions. Experts analyzed the science behind them and worked to reach consensus on the treatment recommendations. Last revised in 2005, these recommendations form the recognized scientific basis for most first aid training around the world.

"It is vital that the first aid community come to consensus and speak in a clear voice on these life and death issues," said David Markenson, M.D., first aid science advisor to the American Red Cross. "We are proud to help set the standard for first aid training around the globe."

"Prompt and effective first aid can save lives and prevent many medical situations from worsening, so it's important that everyone learn about the changes the American Heart Association and American Red Cross have made to the first aid guidelines," said Jeff Ferguson, M.D., American Heart Association volunteer co-chair of the first aid guidelines writing group.

In looking at the treatment of jellyfish stings, the revised guidelines reaffirm the recommendation to use vinegar to treat the sting. The vinegar neutralizes the venom and may prevent it from spreading. After the vinegar deactivates the venom, immersing the area in hot water for about 20 minutes is effective for reducing pain. The treatment for snake bites has been amended slightly to recommend applying a pressure immobilization bandage to any venomous snake bite, with pressure being applied around the entire length of the bitten extremity.

Under the revised guidelines for treating anaphylaxis, if symptoms persist after a few minutes of giving the patient an epinephrine injection from a prescribed auto-injector and medical help is delayed, the first aid provider can give a second epinephrine injection from a prescribed auto-injector. The guidelines also recommend that the general public not routinely use hemostatic agents (substances used to help stop bleeding) to control bleeding because of significant variability in effectiveness and the potential for adverse effects. Tourniquets and hemostatic agents should be considered alternatives for professional rescuers when direct pressure is not possible or fails to control bleeding.

The expert panel also reaffirmed some key first aid recommendations, including use of aspirin when helping someone experiencing persistent chest pain or discomfort associated with a cardiac emergency. Bystanders should call 9-1-1 and activate the emergency medical services (EMS) system for anyone with chest discomfort. While waiting for EMS personnel to arrive, the person being treated may be advised to chew two low dose baby aspirin or one adult (non-enteric-coated) aspirin, if they are not allergic to aspirin or have had a stroke or recent bleeding.

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FDA approves Botox to treat chronic migraine

The U.S. Food and Drug Administration today (October 15) approved Botox injection (onabotulinumtoxinA) to prevent headaches in adult patients with chronic migraine. Chronic migraine is defined as having a history of migraine and experiencing a headache on most days of the month.

“Chronic migraine is one of the most disabling forms of headache,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Patients with chronic migraine experience a headache more than 14 days of the month. This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available.”

Migraine headaches are described as an intense pulsing or throbbing pain in one area of the head. The headaches are often accompanied by nausea, vomiting, and sensitivity to light and sound. Migraine is three times more common in women than in men. Migraine usually begins with intermittent headache attacks 14 days or fewer each month (episodic migraine), but some patients go on to develop the more disabling chronic migraine.

To treat chronic migraines, Botox is given approximately every 12 weeks as multiple injections around the head and neck to try to dull future headache symptoms. Botox has not been shown to work for the treatment of migraine headaches that occur 14 days or less per month, or for other forms of headache. It is important that patients discuss with their physician whether Botox is appropriate for them.

The most common adverse reactions reported by patients being treated for chronic migraine were neck pain and headache.

OnabotulinumtoxinA, marketed as Botox and Botox Cosmetic, has a boxed warning that says the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening. There has not been a confirmed serious case of spread of toxin effect when Botox has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus, or when Botox Cosmetic has been used at the recommended dose to improve frown lines.


Botox is manufactured by Allergan Inc. of Irvine, Calif.

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FDA issues warnings to marketers of unapproved ‘chelation’ products

The U.S. Food and Drug Administration today warned eight companies that their over-the-counter (OTC) chelation products are unapproved drugs and devices and that it is a violation of federal law to make unproven claims about these products. There are no FDA-approved OTC chelation products.

The companies that received the warning letters claim that their products treat a range of diseases by removing toxic metals from the body. Some also claim to treat autism spectrum disorder, cardiovascular diseases, Parkinson’s disease, Alzheimer’s disease, macular degeneration, and other serious conditions. Some companies that received the warning letters also claim their products will detect the presence of heavy metals to justify the need for chelation therapy.

The drug products involved have not been evaluated by the FDA for treatment of these diseases, and violate the Federal Food, Drug, and Cosmetic Act (FFDCA). Despite the claims of the companies that received warning letters, the effectiveness in treating any of the diseases listed is unsubstantiated. Depending on the condition, when relying on unproven OTC chelation products to treat serious conditions, patients may delay seeking effective medical care.

In addition, there are serious safety issues associated with chelation products, which can alter the levels of certain substances in the blood. Even when used under medical supervision, these products can cause serious harm, including dehydration, kidney failure, and death.

“These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options,” said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief.”

The agency advises consumers to avoid non-prescription products offered for chelation or detoxification. The only FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as lead poisoning and iron overload. Procedures involving these agents carry significant risks and should be performed only under medical supervision.

The FDA has noted an increase in “chelation therapy” products marketed on the Internet that claim to cleanse the body of toxic chemicals and heavy metals. Although some of the products are marketed as dietary supplements, they are unapproved drugs because they claim to treat, mitigate, prevent, or diagnose disease. The products come in various dosage forms, including transmucosal sprays, suppositories, capsules, liquid drops, and clay baths.

Some of the companies also sell unapproved screening tests that claim to detect the presence of heavy metals in urine to justify the need for chelation therapy.

"FDA will seek enforcement action against companies that promote therapeutic benefits of products not yet evaluated by the agency for safety and effectiveness.” said Dara A. Corrigan, associate commissioner for Regulatory Affairs.

Under the FFDCA, companies that market products that claim to prevent, diagnose, treat or cure diseases must file an application with the FDA and provide data that demonstrate their products’ safety and effectiveness.

The companies must take prompt action to correct the legal violations cited in the warnings letters or face possible legal action, including seizure and injunction. The FDA issued warning letters to the following companies:

* World Health Products, LLC: Detoxamin Oral, Detoxamin Suppositories, and the Metal Detector test kit
* Hormonal Health, LLC and World Health Products, LLC: Kelatox Suppositories, and the METALDETECTOR Instant Toxic Metals Test
* Evenbetternow, LLC: Kids Chelat Heavy Metal Chelator, Bio-Chelat Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline Drops, NutriBiotic Grapefruit Seed Extract, Natur-Leaf, Kids Clear Detoxifying Clay Baths, EBN Detoxifying Bentonite Clay, and the Heavy Metal Screen Test
* Maxam Nutraceutics/Maxam Laboratories: PCA-Rx, PC3x, AFX, AD-Rx, AN-Rx, Anavone, AV-Rx, BioGuard, BSAID, CF-Rx, CreOcell, Dermatotropin, Endotropin, GTF-Rx, IM-Rx, Keto-Plex, Natural Passion, NG-Rx, NX-Rx, OR-Rx, Oxy-Charge, PN-Rx, Ultra-AV, Ultra Pure Yohimbe, and the Heavy Metal Screening Test
* Cardio Renew, Inc: CardioRenew and CardioRestore
* Artery Health Institute, LLC: Advanced Formula EDTA Oral Chelation
* Longevity Plus: Beyond Chelation Improved, EndoKinase, Viral Defense, Wobenzym-N
* Dr. Rhonda Henry: Cardio Chelate (H-870)

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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FDA: Possible increased risk of thigh bone fracture with bisphosphonates

The U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis. A labeling change and Medication Guide will reflect this risk.

Bisphosphonates inhibit the loss of bone mass in people with osteoporosis. Bisphosphonates have been shown to reduce the rate of osteoporotic fractures -- fractures that can result in pain, hospitalization, and surgery-- in people with osteoporosis. While it is not clear whether bisphosphonates are the cause, atypical femur fractures, a rare but serious type of thigh bone fracture, have been predominantly reported in patients taking bisphosphonates. The optimal duration of bisphosphonate use for osteoporosis is unknown, and the FDA is highlighting this uncertainty because these fractures may be related to use of bisphosphonates for longer than five years.

The labeling changes and Medication Guide will affect only those bisphosphonates approved for osteoporosis, including oral bisphosphonates such as Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and their generic products, as well as injectable bisphosphonates such as Reclast and Boniva.

Labeling changes and the Medication Guide will not apply to bisphosphonates used for Paget’s disease or cancer/hypercalcemia such as Didronel, Zometa, Skelid, and their generic products.

“The FDA is continuing to evaluate data about the safety and effectiveness of bisphosphonates when used long-term for osteoporosis treatment,” said RADM Sandra Kweder, M.D., deputy director, Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. "In the interim, it’s important for patients and health care professionals to have all the safety information available when determining the best course of treatment for osteoporosis.”

Today’s warning follows a March 10, 2010, Drug Safety Communication announcing the FDA’s ongoing safety review of bisphosphonate use and the occurrence of atypical femur fractures. The FDA has since reviewed all available data on bisphosphonate use, including data summarized in the American Society for Bone Mineral Research Task Force report. The report recommended additional product labeling, better identification and tracking of patients experiencing these breaks, and more research to determine whether and how these drugs cause the serious but uncommon fractures.

Based on the FDA’s review, the Warnings and Precautions section of all bisphosphonate products for osteoporosis will be revised, and the FDA will require the inclusion of a Medication Guide to better inform patients of the possible increased fracture risk.

The FDA recommends that health care professionals be aware of the possible risk in patients taking bisphosphonates and consider periodic reevaluation of the need for continued bisphosphonate therapy for patients who have been on bisphosphonates for longer than five years.

Patients taking bisphosphonates for osteoporosis should not stop using their medication unless told to do so by their health care professional. Those taking bisphosphonates also should report any new thigh or groin pain to their health care provider and be evaluated for a possible femur fracture. Patients and health care professionals should report side effects with the use of bisphosphonates to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling (800) 332-1088.

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Clayton State to Hold Men’s Health Fair, October 14

As part of Clayton State University’s first Men’s Awareness Week, the University’s Department of Campus Life, along with the Student African American Brotherhood is sponsoring a Men’s Health Fair on Thursday, Oct. 14.

The Health Fair will be held on Main Street on the second floor of the James M. Baker University Center and will run from 10 a.m. to 2 p.m. It is free and open to the public.

For more information, contact Lakiesa Cantey Rawlinson at lcanteyrawlinson@clayton.edu or call (678) 466-5433.

A unit of the University System of Georgia, Clayton State University is an outstanding comprehensive metropolitan university located 15 miles southeast of downtown Atlanta.

FDA Funds Pediatric Trial Testing Genetically Reprogrammed HSV to Treat Cancer

/PRNewswire/ -- A clinical trial testing a genetically reprogrammed herpes simplex virus as treatment for deadly forms of childhood cancer has received a U.S. Food and Drug Administration grant to support the research.

The Phase I trial at Cincinnati Children's Hospital Medical Center currently focuses on testing the safety of the agent HSV1716 in patients. The study includes young patients with solid tumors such as rhabdomyosarcoma or Ewing's sarcoma. These cancers have limited treatment options and survival rates under 30 percent when the cancers recur and spread to other parts of the body.

Survival curves for stubborn, metastatic childhood cancers have leveled off in the last decade, underscoring the need for new therapeutic approaches, says Timothy Cripe, M.D., Ph.D., principal investigator on the trial and a physician/researcher in division of Hematology/Oncology at Cincinnati Children's.

"We've exhausted our ability to improve cure rates with existing conventional therapies, and we need new solutions," he said. "This is why we are testing HSV. It's a potent virus that has been manipulated genetically with the intent of making it safe for the patient. When you're trying to fight fire with fire you need something that is strong."

The $600,000 grant from FDA is part of a program encouraging clinical development of "orphan drugs" as new treatments for rare diseases or conditions. The HSV1716 virus being tested in this trial was developed by Crusade Laboratories of Glasgow, Scotland.

HSV1716 is similar to other viruses now under development by Dr. Cripe and colleagues at Cincinnati Children's in that certain genes are removed so the virus does not infect healthy dormant cells or cause the disease in the recipient. Instead, the genetic manipulation is designed to prompt the virus to target, infect and degrade only rapidly dividing cancer cells.

Genetic information also can be added to HSV that programs the virus to attack cancer cells in other ways – such as activating certain types of chemotherapies in a one-two punch or destroying blood vessels that feed tumors. Research in mouse models of human cancer by Cripe's laboratory has shown oncolytic HSV agents to be effective at shrinking a variety of modeled tumor types, suggesting a possible approach for treating human disease.

"Our goal in the current HSV1716 trial is to light a fire to the cancer so that the virus replicates and spreads to the cancer cells," Dr. Cripe explained. "We have to take this one step at a time, and the initial phase of the trial focuses on making sure the virus doesn't cause adverse side effects. It has been tested in Europe in adults with brain cancer, squamous cell carcinoma and melanoma and shown in those trials to be safe."

HSV1716 has also been tested extensively for safety in animal models at Cincinnati Children's Hospital by Dr. Cripe and in Europe prior to it being tested in people.

The Phase I trial will include up to 18 patients and is expected to last three years. The optimum safe dosing for this virus is unknown, so the study will sequentially increase dosing levels in small groups of patients and observe for side effects as the trial proceeds. This earliest phase tests the lowest dose on older children and young adults with solid tumor cancers who have limited or no standard therapy options available.

The researchers plan to add younger patients with earlier stages of cancer as the trial proceeds. They will not be able to determine if the safety trial is successful until all patients have received treatment and the results analyzed. As with all clinical trials of new anticancer therapies in patients, many factors can influence the risk for severe side effects and anticancer activity. Even though HSV1716 may cause tumor shrinkage in mouse models of pediatric cancer, it may not have antitumor effect in patients.

Initial funding for the trial came from a private foundation, Solving Kids Cancer, of New York. Preclinical research that helped lead to the trial was supported by the American Cancer Society, the National Cancer Institute, the Cincinnati Children's Hospital Medical Center Translational Research Initiative and local foundations, including CancerFree Kids, teeoffagainstcancer.org, the Katie Linz Foundation, The Sarah Zepernick Foundation, the TeamConnor Cancer Foundation and money donated in memory of Katie McKenna Cappel and Zachary Heringer.

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FDA approves injectable drug to treat opioid-dependent patients

The U.S. Food and Drug Administration today approved Vivitrol to treat and prevent relapse after patients with opioid dependence have undergone detoxification treatment.

Vivitrol is an extended-release formulation of naltrexone administered by intramuscular injection once a month. Naltrexone works to block opioid receptors in the brain. It blocks the effects of drugs like morphine, heroin, and other opioids. It was approved to treat alcohol dependence in 2006.

“Addiction is a serious problem in this country, and can have devastating effects on individuals who are drug-dependent, and on their family members and society,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “This drug approval represents a significant advancement in addiction treatment."

The safety and efficacy of Vivitrol were studied for six months, comparing Vivitrol treatment to placebo treatment in patients who had completed detoxification and who were no longer physically dependent on opioids. Patients treated with Vivitrol were more likely to stay in treatment and to refrain from using illicit drugs. Thirty-six percent of the Vivitrol-treated patients were able to stay in treatment for the full six months without using drugs, compared with 23 percent in the placebo group.

Patients must not have any opioids in their system when they start taking Vivitrol; otherwise, they may experience withdrawal symptoms from the opioids. Also, patients may be more sensitive to opioids while taking Vivitrol at the time their next scheduled dose is due. If they miss a dose or after treatment with Vivitrol has ended, patients can accidentally overdose if they restart opioid use.

Side effects experienced by those using Vivitrol included nausea, tiredness, headache, dizziness, vomiting, decreased appetite, painful joints, and muscle cramps. Other serious side effects included reactions at the site of the injection, which can be severe and may require surgical intervention, liver damage, allergic reactions such as hives, rashes, swelling of the face, pneumonia, depressed mood, suicide, suicidal thoughts, and suicidal behavior.

Vivitrol should be administered only by a physician as an intramuscular injection, using special administration needles that are provided with the product. Vivitrol should not be injected using any other needle. The recommended dosing regimen is once a month.

Consumers and health care professionals are encouraged to report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

Vivitrol is manufactured by Alkermes, Inc.

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Therapeutic Benefits of Bariatric Surgery on Diabetes Translate Into Significant Economic Benefits

/PRNewswire/ -- New data presented today at Obesity 2010, the 28th annual scientific meeting of The Obesity Society, find that bariatric surgery is associated with reduced healthcare costs for diabetes patients who are morbidly obese. The study, conducted by Washington University School of Medicine in St. Louis, Universite du Quebec a Montreal (UQAM), and Analysis Group, Inc., shows that costs associated with bariatric surgery are fully recovered in two to three years post-surgery, and a significant reduction in diabetes diagnostics claims and diabetes medication claims occurs post-surgery. The study, Economic Impact of the Clinical Benefits of Bariatric Surgery in Diabetes Patients With BMI greater than or equal to 35 kg/m2, also was published in last month's online edition of Obesity ( link to abstract of study in Obesity ).

Diabetes mellitus is a major public health concern in the United States—and other parts of the world—because of its prevalence, considerable morbidity and mortality and economic burden. Diabetes is associated with serious complications, including coronary heart disease, kidney failure, neuropathy, blindness and amputation, and was the seventh leading cause of death in 2006, accounting for more than 72,000 deaths.(1)

Type 2 diabetes accounts for 90 to 95 percent of all diagnosed cases.(1) Obesity is a major risk factor for Type 2 diabetes,(2) and the risk of diabetes increases directly with body mass index (BMI).(3) Results of a 2004 meta-analysis of more than 20,000 patients who had bariatric surgery showed that diabetes was completely resolved in 76.8 percent of patients, and resolved or improved in 86 percent, following surgery.(4)

"Weight loss is an important therapeutic goal in obese patients with type 2 diabetes, because even moderate weight loss—5 percent—improves hepatic insulin sensitivity and reduces glucose production by the liver(5)," says Samuel Klein, M.D., director, Center for Human Nutrition, Washington University School of Medicine, St. Louis. "Bariatric surgery is the most effective available weight-loss therapy and has considerable beneficial effects on diabetes and other obesity-related comorbidities."

Diabetes-related costs represent a disproportionate share of healthcare costs among the obese.(6) The estimated yearly costs of managing a patient with diabetes ($13,243) are more than five times that of a patient without diabetes ($2,560), and this number is expected to reach $350 billion total by 2025. With the addition of productivity lost, this number increases to $2.6 trillion in the next 15 years.(7)

"The purpose of this study was to estimate the economic impact of the clinical benefits of bariatric surgery on medical costs and return on investment of the surgery in patients with diabetes who are morbidly obese (BMI greater than or equal to 35 kg/m2)," says Pierre Cremieux, Ph.D., a health economics expert and Managing Principal at Analysis Group. "We identified obese patients with diabetes who were treated with bariatric surgery and compared their post-surgery healthcare costs, diabetes diagnosis claims, and diabetes medication claims with matched non-surgery control patients. The data show surgical therapy to be clinically effective, and ultimately less expensive, than leaving these patients on standard therapy."

Using an administrative claims database of privately insured patients covering 8.5 million lives 1999–2007 at 40 large nationwide companies, the researchers identified obese patients with diabetes, 18 to 65 years old who were treated with bariatric surgery, using Healthcare Common Procedure Coding System codes. These patients were matched with non-surgery control patients on demographic factors, comorbidities and healthcare costs. The overall return on investment associated with bariatric surgery was calculated using multivariate analysis, and surgery and control patients were compared post-index with respect to diagnostic claims for diabetes, diabetes medication claims, and adjusted diabetes medication and supply costs. Specific findings of the study include:

* At six months post-surgery, 28 percent of surgery patients had a diabetes diagnosis, compared to 74 percent of control patients (P <0.001).
* At three months post-surgery, insulin use (among pre-index insulin users) dropped to 43 percent for surgery patients vs. 84 percent for controls (P < 0.001).
* At one month post-surgery, medication and supply costs were significantly lower for surgery patients (P < 0.001).


This research comes in the wake of Analysis Group's 2008 research, "A Study on the Economic Impact of Bariatric Surgery," which also demonstrated that healthcare costs for morbidly obese patients receiving bariatric surgery dropped while costs for morbidly obese patients who did not have surgery continued to rise. That study also provided evidence that insurers recover their costs for bariatric surgery in two to four years, depending on the type of surgery performed.

The study was co-authored by Samuel Klein, M.D., (Wash. U), Pierre Cremieux, Ph.D., (UQAM and Analysis Group), Arindam Ghosh, Ph.D., Sara Eapen, Ph.D. and Tamara J. McGavock (all of Analysis Group). The study was funded by Ethicon Endo-Surgery, Inc., a manufacturer of minimally invasive and traditional surgical devices and instruments for bariatric surgery.

Analysis Group provides economic, financial, and business strategy consulting to leading law firms, corporations, and government agencies. The firm has more than 500 professionals, with offices in Boston, Chicago, Dallas, Denver, Los Angeles, Menlo Park, New York, San Francisco, Washington and Montreal (www.analysisgroup.com).

(1) National Diabetes Fact Sheet: United States, 2007. CDC Diabetes, 2007.

(2) Ford ES, Williamson DF, Liu S. Weight change and diabetes incidence: findings from a national cohort of US adults. Am J Epidemiol 1997;146:214–222.

(3) Colditz GA, Willett WC, Rotnitzky A, Manson JE. Weight gain as a risk factor for clinical diabetes mellitus in women. Ann Intern Med 1995;122:481–486.

(4) Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA 2004;292(14):1724-37.

(5) Wing RR, Koeske R, Epstein LH et al. Long-term effects of modest weight loss in type II diabetic patients. Arch Intern Med 1987;147:1749–1753.

(6) Cawley J, Rizzo J, Gunnarsson C, Haas K. The health care cost effects of diabetes among obese and morbidly obese adults in the United States. Poster presented at International Society of Pharmacoeconomic Outcomes Research (ISPOR) 13th Annual International meeting, Toronto, ON, Canada.

(7) Campbell RK, Martin TM. The chronic burden of diabetes. Am J Manag Care 2009;15:S248–S254.

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Geron Initiates Clinical Trial of Human Embryonic Stem Cell-Based Therapy in Patients with Spinal Cord Injury

(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN) today (Octoberf 11) announced the enrollment of the first patient in the company’s clinical trial of human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells, GRNOPC1. The primary objective of this Phase I study is to assess the safety and tolerability of GRNOPC1 in patients with “complete” American Spinal Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord injuries. Participants in the study must be newly injured and receive GRNOPC1 within 14 days of the injury.

“Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies”

The patient was enrolled at Shepherd Center, a 132-bed spinal cord and brain injury rehabilitation hospital and clinical research center in Atlanta, GA. Shepherd Center is one of seven potential sites in the United States that may enroll patients in the clinical trial.

“Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies,” said Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO. “When we started working with hESCs in 1999, many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials. This accomplishment results from extensive research and development and a succession of inventive steps to enable production of cGMP master cell banks, scalable manufacture of differentiated cell product, and preclinical studies in vitro and in animal models of spinal cord injury, leading to concurrence by the FDA to initiate the clinical trial.”

“We are pleased to have our patients participating in this exciting research,” said Donald Peck Leslie, M.D., medical director, Shepherd Center. “Our medical staff will evaluate the patients’ progress as part of this study. We look forward to participating in clinical trials that may help people with spinal cord injury.”

David Apple, M.D., Shepherd Center’s medical director emeritus and principal investigator of the trial at Shepherd Center, said, “This clinical trial represents another step forward in Shepherd Center’s involvement in an attempt to find a cure for paralysis in people with spinal cord injury. Shepherd Center is an ideal place to conduct this study because of our clinical expertise and the volume of patients referred here for rehabilitation care.”

In addition to Shepherd Center, Northwestern Medicine in Chicago, IL is also open for patient enrollment. As additional trial sites come online and are ready to enroll patients, they will be listed on the Patient Information pages of Geron’s website at www.geron.com/patients/clinicaltrials/hESC.aspx and on the NIH clinical trials registry, ClinicalTrials.gov, at clinicaltrials.gov/ct2/show/NCT01217008?term=GRNOPC1&rank=1.

Further information on the criteria for patient eligibility for the study is also available on ClinicalTrials.gov.

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Abbott Laboratories Agrees to Withdraw Its Obesity Drug Meridia

/PRNewswire/ -- Abbott Laboratories has agreed to voluntarily withdraw its obesity drug Meridia (sibutramine) from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke, the U.S. Food and Drug Administration announced today.

"Meridia's continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke," said John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research (CDER). "Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs."

Meridia was approved by the FDA in November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone.

The FDA requested the market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT was initiated as part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of this drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared to another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.

"The patients in the European SCOUT trial did not have the same characteristics as the patients for the approved indication in the United States; however, these results, combined with other available safety data raised serious questions about Meridia's safety for all patient groups," said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology in CDER.

The agency's analysis of SCOUT was the subject of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee meeting on Sept. 15.

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