Monday, June 29, 2009

Study Shows Multifaceted Inpatient Psychiatry Approach Can Reduce Readmissions

According to a new study conducted by staff at Mayo Clinic and Austin Medical Center — part of Mayo Health System, patients treated at a rural hospital utilizing a multifaceted inpatient psychiatry approach (MIPA) had lower odds of readmission within 30 days.

Access to psychiatric services in rural areas, particularly inpatient psychiatric care, is limited and care may not be as comprehensive as in metropolitan areas. The purpose of the study, published in the Summer 2009 issue of The Journal of Rural Health, evaluated the impact of the MIPA approach to psychiatric inpatient care on readmission rates in a rural hospital setting.

"The primary treatments for patients who enter inpatient psychiatric hospitals include medication management, group psychotherapy and brief inpatient hospital stays. However, research has shown that this standard of care can result in high numbers of readmissions within 30 days," according to Timothy Lang, Psy.D., a clinical psychologist at Austin Medical Center and one of the study's authors. "To the extent that readmissions may be avoidable, they can be characterized as overutilization of services which can place a strain on both inpatient facility staff and the patient. Approaches like MIPA need to be explored as a practice innovation for inpatient psychiatric facilities."

The MIPA model of inpatient psychiatric care emphasizes a comprehensive diagnosis of the patient's condition with that diagnosis driving treatment and more effective interventions. Austin Medical Center incorporated many of the MIPA best practices that had been reported in the literature, including targeted psychopharmacology; psychological and cognitive testing; occupational therapy; chemical dependency evaluations, smoking cessation group therapy; dietary group therapy; family meetings; contacts with friends and/or family to provide input for improving diagnosis reliability; and relapse prevention.

The study utilized data on psychiatric inpatient readmissions data gathered from 1999 to 2005 at Austin Medical Center. The study's authors compared readmissions within 30 days for patients who were admitted to an inpatient psychiatric unit using a MIPA model of care to readmissions of a comparison group of patients admitted prior to Austin Medical Center's adoption of MIPA in July 2002.

The findings showed that prior to Austin Medical Center's implementation of MIPA, 12 of 37 patients, or 32.4 percent, were readmitted within 30 days. In contrast only seven of 147 patients, or 4.8 percent, were readmitted following MIPA implementation. In addition, significant increases in the percentage of patients' utilization of services following MIPA implementation were noted. These services include psychological testing; occupational therapy; chemical dependency evaluations; smoking cessation counseling; dietary counseling; family meetings; collateral contacts; relapse prevention and follow-up outpatient visits. While specific services that may have caused a reduction in readmission rates cannot be determined from this study, services are regarded as a bundle that is believed to have a collective impact.

"This study indicates the impact of MIPA is positive for patients," according to another study author, James Rohrer, Ph.D., Mayo Clinic Department of Family Medicine. "The results support cautious optimism that the MIPA of inpatient psychiatric care has reduced readmission rates. The implementation of this model in a rural hospital demonstrates that access to high-quality inpatient psychiatric care is achievable in rural settings."

Another study author is Pierre Rioux, M.D., medical director of Austin Medical Center's psychiatric inpatient unit and an instructor in psychiatry at Mayo Clinic.
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Saturday, June 27, 2009

Test is Accurate and Economical for Diabetes and Prediabetes Screening

A test commonly used to help identify women with diabetes during pregnancy may be an accurate, convenient and inexpensive way to screen the general population for unrecognized diabetes and prediabetes, according to Emory University researchers.

The results of the study, "Glucose challenge test screening for prediabetes and undiagnosed diabetes" will be published online and in print in the journal Diabetologia.

"Widespread use of the glucose challenge test (GCT) to screen Americans for prediabetes and diabetes could provide a major opportunity to improve the health of more than 40 million people," said lead study author Lawrence S. Phillips, MD, Emory University School of Medicine Professor of Medicine, Division of Endocrinology.

The study screened 1,573 volunteer participants who had never been diagnosed with diabetes. At a first visit, at different times of the day and without restriction of meals, participants were given a 50-gram glucose drink. Glucose was measured both before the drink (random glucose) and an hour after the drink (GCT glucose).

At a follow-up visit held in the morning after an overnight fast, participants had measurement of hemoglobin A1c (a standard test used to monitor diabetes), and a 75-gram oral glucose tolerance test (OGTT). The OGTT is the "gold standard" for diagnosing diabetes and prediabetes.

After screening, researchers found that 4.6 percent of the participants had previously unrecognized diabetes, and 18.7 percent had prediabetes.

The GCT was the most accurate screening test for these problems, significantly better than the random glucose or A1c tests. Since the good performance of the GCT was unaffected by the time of day, or times after meals, the GCT could be performed during a routine office visit. If a patient's GCT glucose level is low, he/she wouldn't need to be screened again for another two or three years, but if the GCT glucose level is high, patients would need a confirmatory oral glucose tolerance test.

This approach is similar to screening women for diabetes during pregnancy. GCT screening is almost universal for women in their sixth month of pregnancy.

The GCT provided consistent results for a diverse group of patients - old and young, normal weight and overweight, men and women, with and without a family history of diabetes, etc. The GCT also appeared to be less expensive than other screening strategies.

Early diagnosis is a benefit both for people who have diabetes or prediabetes, and for their health care teams. Regular glucose challenge test screening (GCT first, then a follow-up OGTT if the GCT glucose is high) would be a way to assure early diagnosis, according to Phillips and team.

"Glucose challenge test screening could help improve disease management by permitting early initiation of therapy aimed at preventing or delaying the development of diabetes and its complications," says Phillips.

Diabetes is a disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches and other food into energy needed for daily life.

According to the American Diabetes Association, 23.6 million U.S. children and adults, or 7.8 percent of the population, have diabetes. While an estimated 17.9 million have been diagnosed with diabetes, 5.7 million people are unaware that they have the disease.

Pre-diabetes is a condition that occurs when a person's blood glucose levels are higher than normal but not high enough for a diagnosis of type 2 diabetes. There are 57 million Americans who have pre-diabetes, in addition to the 23.6 million with diabetes.

In addition to Phillips, study authors were: David Koch, PhD, K.M. Venkat Narayan, MD, MSc, MBA, Mary Rhee, MD, Viola Vaccarino, MD, PhD, and David Ziemer, MD, of Emory University; Ranee Chatterjee, MD, of the Johns Hopkins University School of Medicine; and P. Kolm and W.S. Weintraub, of the Christiana Care Health System in Newark, Del.

The research was supported in part by the National Institutes of Health and the National Center for Research Resources, and by the Veterans' Administration. The work was presented in part at the June 2008 national meeting of the American Diabetes Association.

From Woodruff Health Sciences Center

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Friday, June 26, 2009

U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd.

U.S. Marshals, at the request of the Food and Drug Administration, today seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities. “The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Compliance with these standards prevents harm to the public.”

This action follows Caraco’s continued failure to meet the FDA’s current Good Manufacturing Practice (cGMP) requirements, which assure the quality of manufactured drugs. Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.

Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

The FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, choline magnesium trisalicylate oral tablets, which are commonly used as pain relievers. The FDA recommends in the event of a shortage, that health care providers consider alternative treatments that are safe and effective. Consumers and health care providers who are unable to obtain any of Caraco’s products should contact the FDA Drug Shortage Program by e-mail at, or by telephone at 888-463-6332 or 301-796-3400.

The FDA’s most recent inspection of Caraco, completed in May 2009, found unresolved violations of cGMP requirements. Today’s seizure is intended to lead to major changes at Caraco’s facilities.

If the FDA identifies further significant problems, which pose risks to patient safety with any Caraco drug products on the market, the agency will take appropriate additional regulatory action and immediately notify the public.

"The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements," said Michael Chappell, FDA acting associate commissioner for regulatory affairs.

Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMPs. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.

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Thursday, June 25, 2009

CDC Introduces New Website to Help Employers Combat Obesity and Reduce Health-Related Costs

The Centers for Disease Control and Prevention (CDC) today unveiled LEANWorks!, a Website designed to help businesses address obesity. LEAN stands for Leading Employees to Activity and Nutrition. The new Website was announced at a National Business Group on Health meeting in Washington, D.C.

"CDC LEANWorks! was developed in direct response to organizations asking CDC for help in addressing the obesity epidemic. Specifically they wanted to know what interventions were effective in helping employees maintain a healthy weight," said William Dietz, M.D., Ph.D., director of CDC's Division of Nutrition, Physical Activity and Obesity. "CDC has identified science-based interventions that work to prevent and control obesity. CDC LEANWorks! provides the tools that employers need to take action."

The free Website was developed particularly for small and mid-size companies, which typically have more limited resources to devote to obesity prevention efforts. However, the tools and resources available on CDC LEANWorks! can benefit companies of any size. CDC LEANWorks! can help employers calculate the cost of obesity for their organizations and develop tailored approaches to help control these costs through interventions such as fitness classes, lunchtime health education sessions, weight management programs, and more.

The Website provides a variety of resources to employers including:
-- An obesity cost-calculator where employers can input employee
demographic data to estimate the total costs associated with obesity
and determine annual obesity-related medical costs for their
-- Information and resources to help employers plan, build, promote, and
assess interventions to combat obesity.
-- Information on how employers can estimate return on investment, a
measure of the cost of an intervention compared to the expected
financial return of the intervention.

Obesity is a risk factor for high blood pressure, type 2 diabetes, stroke, and heart disease. Obese individuals spend 77 percent more money for necessary medications than non-obese persons.

"Obesity affects more than just health care costs. It also has a significant impact on worker productivity because the more chronic diseases employees have, the more likely they are to be absent from work, or less productive if they come to work sick," said Janet Collins, Ph.D., director of CDC's National Center for Chronic Disease Prevention and Health Promotion.

Because organizations do not usually publish information about their worksite programs in the scientific literature, CDC visited select businesses to identify promising worksite obesity prevention and control practices. The CDC LEANWorks! Website provides case studies from some of those businesses to provide examples of successful worksite obesity prevention programs.

"Workplace obesity prevention programs can be an effective way for employers to reduce obesity and lower their health care costs, lower absenteeism and increase employee productivity," said Dr. Dietz. Employers may also see other indirect benefits when they implement these programs such as improved employee morale, increased worker retention, and improved recruitment of new employees."

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Intercell Supports the Japanese Encephalitis Vaccination Recommendations of CDC's Advisory Committee on Immunization Practices

/PRNewswire/ -- Intercell AG (VSE: ICLL) today announced that the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to update its previous recommendations and include IXIARO, a new Japanese Encephalitis (JE) vaccine for travelers to countries in Asia where the disease is endemic, as well as Americans living in such high-risk areas.

ACIP made significant changes to their previous Japanese Encephalitis recommendations, last updated in 1993, noting that many more travelers are now visiting areas where the disease is endemic. In addition to recognizing the recent licensure of IXIARO, the committee's expanded recommendations urged clinicians to consider vaccinating travelers visiting endemic areas during the transmission season, even those on short-term visits, if they plan to spend a substantial amount of time outdoors. The panel also concluded that IXIARO, which is derived from a well-established cell line and does not contain stabilizers or preservatives, has a lower risk of vaccine-associated adverse events than older Japanese Encephalitis vaccines.

IXIARO received marketing approval from the U.S. Food and Drug Administration on March 30, 2009 on the basis of studies that showed the vaccine is highly immunogenic after only two doses. IXIARO has been shown to stimulate a long-lasting immune response and to be well tolerated. It is the only currently manufactured Japanese Encephalitis vaccine available in the United States. IXIARO was developed by Intercell AG; the rights to market and distribute the vaccine to the private sector in the United States are held by Novartis Vaccines.

"The consequences of contracting this disease can be devastating due to the high morbidity and mortality associated with the disease, making IXIARO a crucial preventive tool for those spending time in endemic areas. It is gratifying that the ACIP committee of the CDC has chosen to broaden its recommendations and to recognize the benefits of IXIARO," said Gerd Zettlmeissl, Chief Executive Officer of Intercell. "This underscores our commitment to serving the needs of the travelers' and of the military market and developing vaccines to address unmet needs."

The ACIP consists of 15 experts in fields associated with immunization who have been selected by the Secretary of the U.S. Department of Health and Human Services to provide advice and guidance on the control of vaccine-preventable diseases. ACIP develops written recommendations for the routine administration of vaccines to children and adults in the civilian population. The ACIP is the only entity in the federal government that makes such recommendations.

About Japanese Encephalitis

Japanese Encephalitis is a mosquito-borne infection that strikes 30,000 to 50,000 individuals a year, causing 10,000 to 15,000 deaths (both probably an underestimate due to underreporting and misdiagnosis). Up to 50 percent of survivors have persistent neurological sequelae. Japanese Encephalitis is the leading cause of viral neurological disease and disability in Asia and the most important viral encephalitis in Asia. The disease is most common in several developing countries in Asia, including India and China. As there is no specific treatment for JE, health care experts recommend vaccination as the only highly effective protection for the travelers and military personnel who live in or travel to areas where the virus circulates.

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Hospice Community Urges President Obama to Stop Funding Cuts

/PRNewswire/ -- Today, 3,524 hospice providers from across the country sent a letter to President Barack Obama urging him to stop cuts to the Medicare hospice benefit beginning on October 1, 2009.

The cuts threaten to jeopardize availability of the compassionate and high-quality care that 1.5 million patients and their family caregivers receive from hospice providers each year.

In addition to the letter, more than 500 providers of the hospice community submitted comments to the Centers for Medicare and Medicaid Services (CMS) on how the cuts will cause them to decrease services, reduce staffing, and in some cases, close their programs.

This follows two Congressional letters sent to President Obama by 45 U.S. Senators and 171 U.S. Representatives, demonstrating that he has strong, bipartisan support to stop the cuts in hospice funding.

The cuts come from a 2008 federal rule that eliminates a component of the Medicare hospice benefit known as the budget neutrality adjustment factor (BNAF). Members of the hospice community have been calling and emailing the Administration requesting that implementation of this rule be stopped.

"The sheer number of hospice programs represented by this letter and those recently sent by Members of Congress should send a strong message to the White House about the urgency in stopping these cuts," said J. Donald Schumacher, NHPCO president/CEO.

Earlier this year, President Obama and Congress approved a moratorium on the hospice funding cuts that expires on September 30, 2009. Without further action, hospice reimbursements will drop by 3.1 percent, leaving hospice programs, particularly smaller and rural ones, facing cutbacks in services and possible closure.

Hospice is a proven Medicare cost saver. In 2007, an independent, Robert Wood Johnson Foundation-funded study by Duke University found that hospice reduced Medicare costs by $2,300 per patient, saving more than $2 billion per year.

Hospice is considered to be the model of high-quality care at the end of life. Research from NHPCO shows that 98 percent of families served by hospice are willing to recommend its care and services to others.

For more information about NHPCO's efforts to protect hospice funding, please visit NHPCO's Advocacy Web page at: (the letter sent to President Obama is available online).

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Wednesday, June 24, 2009

FDA Approves Generic Prescription-Only Version of Plan B Emergency Contraceptive for Women Ages 17 and Under

The U.S. Food and Drug Administration today approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg. The generic product will be available by prescription only for women ages 17 and under.

Plan B was first approved in 1999 for prescription use only for women of all ages. Plan B is manufactured by Duramed Pharmaceuticals Inc., of Cincinnati.

In 2006, Plan B was approved for nonprescription use for women ages 18 and older. Plan B remained available as a prescription-only product for women ages 17 and under. Today's approval allows marketing of a prescription-only generic product for women ages 17 and under. No generic levonorgestrel product for emergency contraception can be approved for nonprescription use in women ages 18 and older until Aug. 24, 2009, when the marketing exclusivity held by Duramed for the nonprescription use expires.

The generic levonorgestrel tablets 0.75 mg are made by Watson Laboratories Inc., based in Corona, Calif.

Levonorgestrel can prevent pregnancy after unprotected intercourse or a known or suspected contraceptive failure. It is not effective in terminating an existing pregnancy and does not protect against sexually transmitted diseases, including HIV infection.

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HHS Announces Advanced Development Contract for New Way to Make Flu Vaccine

HHS Secretary Kathleen Sebelius announced today (June 23) that the department will pursue advanced development of new way to make influenza vaccine. The work will be done by Protein Sciences Corporation, Inc., of Meriden, Conn., under a new $35 million contract. The contract could be extended up to five years at a total cost of approximately $147 million.

"The technology has advanced in recent years to a point that we believe it could help meet a surge in demand for U.S.-based vaccine for seasonal and pandemic flu," Secretary Sebelius said. "We want to use the technology to help our nation respond to emerging infectious diseases."

With this new technology, known as recombinant influenza vaccine, a gene would be extracted from a flu virus and placed into an insect virus called baculovirus, which does not affect people and can multiply quickly to high levels in insect cells. The cells are purified to become
a basic part of a human vaccine.

Using this method, vaccine candidates, clinical investigational lots, and commercial-scale vaccine production may be available faster than by using traditional vaccine production methods. Because the basic cells can be frozen and stored indefinitely, manufacturing large quantities of a vaccine is also faster using this recombinant technology.

The new contract will be administered by the Office of Biomedical Advanced Research and Development Authority (BARDA) within HHS and will support Protein Sciences Corporation, Inc., in advanced development activities needed for potential Food and Drug Administration (FDA) approval to use this new technology for producing flu vaccines.

If this new technology is demonstrated to be safe and effective and the FDA licenses the new technology for flu vaccines, the contract requires the company to establish domestic manufacturing capability to provide a finished vaccine within 12 weeks of pandemic onset and to produce at least 50 million doses of pandemic flu vaccine within six months of pandemic onset.

Today's award aligns with the National Strategy for Pandemic Influenza Implementation Plan, which calls on HHS to develop and procure medical countermeasures for pandemic influenza or for potentially pandemic strains, such as the recent novel H1N1 flu virus.

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Tuesday, June 23, 2009

FDA Approves Cambia™ for Migraine

(BUSINESS WIRE)--Kowa Pharmaceuticals America, Inc. (KPA), a privately-held specialty pharmaceutical company headquartered in Montgomery, AL, announced today that the U.S. Food and Drug Administration (FDA) has approved Cambia™, a diclofenac-based non-steroidal anti-inflammatory drug (“NSAID”) combined with potassium bicarbonate, for the treatment of acute migraine with or without aura in adults.

Cambia™, formulated with KPA’s patented Dynamic Buffering Technology (DBT), was specifically developed to address widespread unmet needs among patients by offering fast and effective relief of migraine pain. In randomized clinical trials, Cambia™ was shown to be effective not only in migraine pain, but also in treating photophobia (sensitivity to light), phonophobia (sensitivity to sound), and nausea commonly associated with migraine attacks. Cambia™ was also shown to provide statistically significant onset of relief of migraine pain within 15 to 30 minutes.

“The approval is the culmination of over three years of effort from our partners at Applied Pharma Research and the internal team at Kowa,” said William Maichle, Chief Operating Officer of Kowa Pharmaceuticals America, Inc. “Patients and physicians consistently mention rapid pain relief as most important when asked about primary attributes of a migraine medication. We believe Cambia™ addresses these needs and will be a valuable addition to physicians’ migraine armamentarium.”

KPA obtained exclusive U.S. and Canadian marketing rights for Cambia™ from Applied Pharma Research (APR), a Swiss drug delivery and drug development company, in 2005. The product is currently marketed by Novartis Pharma AG, via a license from APR, under the trademarks Voltfast or Catafast in several European countries. KPA and APR have been granted patents that cover Cambia™ through 2026. KPA and APR are currently in the final stages of negotiations with a marketing partner and expect Cambia™ to launch in 4th quarter 2009.

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The Alliance for the Advancement of Adult Stem Cell Therapy and Research Announces Successful Treatment of End-Stage Heart Disease with Stem Cells

(BUSINESS WIRE)--Zannos Grekos, MD, Associate Clinical Professor at Nova Southeastern University, has announced six month follow-up results for a patient treated with adult stem cells in a clinical study of idiopathic dilated cardiomyopathy. The clinical study is a collaborative effort among physicians at Regenocyte Therapeutic, an American stem cell therapy clinic; researchers and scientists from Theravitae, a biotechnology company from Israel; and physicians from the American Institute for Regenerative Medicine, Dominican Republic.

Leonard Narracci, 71 from Venice, Florida, underwent the adult stem cell therapy in October 2008. Since being diagnosed with idiopathic dilated cardiomyopathy and congestive heart failure, Narracci's ejection fraction was severely reduced at 18% (with normal being over 55%). Within three months of the treatment, his ejection fraction improved to 40% and it is now at 51%.

“It goes against traditional theory that we should try to fix damaged heart muscle, but we are generating new heart tissue with impressive results that improve cardiac function and quality of life,” said Dr. Leonel Fernandez Liriano, Professor of Medicine at Pontifical Catholic University School of Medicine (PCUSM), and the head of the cardiology team that treated the patient with adult stem cells.

Grekos states, “After comparing this patient’s echocardiogram and MUGA nuclear scans before and after treatment, we are very pleased to see a profound increase in cardiac function.”

Regenocyte Therapeutic has treated several similar patients and they are demonstrating correlative improvements. Grekos continues, “We have had success in the ischemic heart disease patients since 2006, and it is encouraging to see that the technology can now be applied to other diseases.” Regenocyte Therapeutic is also treating patients with pulmonary hypertension, COPD, kidney disease, peripheral artery disease, and early senile dementia.

Athina Kyritsis, MD, chair of Regenocyte’s Scientific Advisory Board, says the patient results are based upon several years of Regenocyte’s clinical experience in the treatment of numerous degenerative diseases with adult stem cell therapy. “We have had consistent success in generating viable heart tissue and growing new vessels, treating diseases like cardiomyopathy and peripheral vascular disease. With the increased circulation, healing of wounds and improvement in ejection fractions, it seemed a natural progression to approach cardiomyopathy in the same manner. I believe we have only begun to discover what adult stem cells can accomplish in altering the course of diseases until now thought to be untreatable.”

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Monday, June 22, 2009

Parent Project Muscular Dystrophy Holds 15th Annual Connect Conference in Atlanta

/PRNewswire/ -- Patricia A. Furlong, Founding President and CEO of Parent Project Muscular Dystrophy (PPMD), the largest non-profit organization in the United States focused on finding a cure for Duchenne muscular dystrophy (Duchenne), announced that PPMD will be honoring United States Senator Johnny Isakson and the American Football Coaches Association (AFCA) with "Change It Champion" awards at the 2009 Connect Conference in Atlanta, Georgia on Saturday, June 27. Other award recipients include Darius Weems and Logan Smalley from the acclaimed documentary "Darius Goes West."

Researchers, scientists, and Duchenne experts from around the world travel to the Connect Conference every year to share with families the latest in muscular dystrophy research and care. Duchenne, the most common form of childhood muscular dystrophy, is a progressive and fatal muscle disorder affecting boys and young men that causes the loss of muscle function, wheelchair dependency, and a decline in respiratory and cardiac function.

Ms. Furlong is excited that PPMD's 15th anniversary will be marked in Atlanta, with what promises to be the most comprehensive and informative conference the organization has held to date. But the anniversary is bittersweet. "When we formed Parent Project Muscular Dystrophy fifteen years ago - a group of parents and grandparents frustrated by the lack of research and funds devoted to Duchenne muscular dystrophy - we hoped that we wouldn't still be around in 2009. That a cure would have been found and our desperate fight to save the lives of our sons would have ended. That this monster that had invaded our homes and our families would have been defeated. Duchenne has not been cured, but the research that is happening is incredible and the people dedicated to end Duchenne are the most passionate and determined people you could hope to have working for your child's health."

Ms. Furlong is especially proud of the reputation the Connect Conference has established over its 15 year history. "Families attend the Connect Conference, the largest international event dedicated entirely to Duchenne, because of the robust agenda and acclaimed presenters. We present state-of-the-art research, including updates on PPMD's drug discovery program Project Catalyst and the End Duchenne Grant Award Program, a program to ensure promising Duchenne research reaches translation to human studies. Experts come to debate issues surrounding optimal care, and parents reap the benefits of these discussions. PPMD's goal has always been to provide the Duchenne community with a comprehensive approach in the fight against Duchenne - funding research, promoting advocacy, broadening treatment options, and as reflected the last 15 years with the Connect Conference, uniting the community. Only this comprehensive approach will lead to the day that 100% of those diagnosed can turn to a treatment to end Duchenne."

United States Senator Johnny Isakson (R-GA), has been a Member of Congress since 1999, serving three terms in the House of Representatives before being elected to the Senate in 2004. He has helped advocate for funding for muscular dystrophy research for years. When notified of the "Change It Champion" award he will receive, Senator Isakson said, "I have devoted my life to serving the State of Georgia and our great nation. I am humbled by this award and PPMD's recognition of my work in muscular dystrophy. But we still need additional research and we still need a cure. And I will not stop working for this cause until that day comes."

PPMD is also recognizing the American Football Coaches Association for its commitment to Coach to Cure MD, a one-day, nationwide event with PPMD designed to raise awareness about Duchenne. AFCA member coaches around the country will wear armbands again this year in an effort to create media interest and public understanding of Duchenne. Last year, the AFCA helped to raise over $270,000 for Duchenne research. Says Executive Director of the AFCA, Coach Grant Teaff, "Every football coach has one thing in common - a commitment to young men. This charity partnership is a great way to show the world the great core values of our profession, and help find a cure for these young men."

Darius Weems and Logan Smalley will receive a "Change It Champion" award for their work on the critically acclaimed documentary "Darius Goes West." The film chronicles 15-year-old Darius, who lives with Duchenne, and eleven of his best friends as they set off across America with the ultimate goal of getting his wheelchair customized on MTV's Pimp My Ride. More than just entertaining or even an awareness piece about Duchenne, the film has been hailed for the attention it brings to accessibility issues in our country. Additionally, Mr. Weems and Mr. Smalley decided to sell the DVD of the film themselves so that a majority of the proceeds of each copy sold will go towards Duchenne research. Their goal is to sell one million copies in one year.

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Saturday, June 20, 2009

Top 10 Facts About House Democrats' 852-Page Government Takeover of Health Care

House Democrats today (June 19) unveiled their long-awaited health care “reform” legislation, and it’s just what the American people expected: an 852-page bureaucratic nightmare that rations care, raises taxes, and empowers government bureaucrats – not patients and doctors – to make critical medical decisions.

As House Republican Leader John Boehner (R-OH) warned middle-class families and small businesses earlier today, “This plan will make health care more expensive, reduce the quality of care for millions of families and small businesses, cost American jobs, and force untold millions of Americans off their current plans and into a government-run nightmare operated by federal bureaucrats.” As Democrats prepare to defend their government takeover of health care in a series of committee hearings next week, here are the latest Top 10 facts about the House Democrats’ health care proposal:

1. Democrats’ Government Takeover Will Cost Middle-Class Families and Small Businesses Billions. Though House Democrats don’t know (or won’t say) how much their government takeover will cost, here’s what we do know: the plan will make health care more expensive and hit the middle class particularly hard with higher taxes, rationed care, and new health care costs. As millions of families and small businesses are struggling to make ends meet while making responsible choices, this plan forces those that make responsible decisions to foot the bill for those who don’t.

2. Democrats’ Government Takeover Will Cost Tens of Millions Their Current Health Care Coverage. The House Democrats’ plan could force more than 100 million Americans out of their current health care plan and onto the government rolls, according to a Lewin Group study published earlier this year. A Congressional Budget Office report on a similar plan authored by Senate Democrats that would force at least 23 million Americans off of their current plans. According to the Associated Press, even the White House admits that the President’s promises about allowing the American people to keep their health care shouldn’t be taken literally.

3. Democrats’ Government Takeover Will Cost Millions of Americans Their Jobs. The House Democrats’ plan would impose employer mandates and cost jobs by requiring some employers – especially some small businesses – to pay a new eight percent tax to Washington. The plan would also slap employers that are unable to offer coverage the government deems adequate with another new financial burden. These two new taxes will make it more difficult than ever for small business owners to reinvest in their businesses and create and retain good paying jobs. Using the economic model of the President’s own economic advisors, an employer mandate would result in 4.7 million Americans losing their jobs.

4. Democrats’ Government Takeover Will Put Bureaucrats in Charge of Key Medical Decisions. Instead of keeping patients and doctors in charge of key medical decisions, the House Democrats’ plan will give Washington the power instead. And if you’re outraged with what Washington’s done with the bailouts, just wait until you see what Uncle Sam does with your health care.

5. Democrats’ Government Takeover Will Cost Future Generations Money They Don’t Have. The House Democrats’ bill simply shifts the burden of debt from one generation to the next. Our nation can’t sustain the Medicaid and Medicare programs now. At a time when families and small businesses already are being crushed under the weight of historic debt, a new government-run program will only further add to the bill passed along to our children and grandchildren.

6. Democrats’ Government Takeover Will Cost Seniors Key Medicare Benefits and Options. In order to expand health care benefits to some seniors, House Democrats will slash coverage millions of other seniors depend on. These benefit cuts will ultimately eliminate choices for seniors.

7. Democrats’ Government Takeover Will Place a New Mandate on Individuals. The House Democrats’ plan mandates that every American buy health insurance or pay a hefty penalty to Washington equal to almost two percent of their income. This would force more Americans into government-run system that will make health care more expensive, ration care, and put bureaucrats in charge of medical decisions.

8. Democrats’ Government Takeover Will Raise Taxes on Families, Small Businesses. Energy & Commerce Committee Chairman Henry Waxman (D-CA) readily admitted that the Democrats’ health care “reform” plan would be financed with tax hikes. The Associated Press reported that, “Democrats are considering everything from taxing soda, to raising income taxes on upper income people earning more than $200,000, to a federal sales tax.” Exactly how many new taxes will there be to bankroll this government takeover? When do Democrats plan to reveal them?

9. Democrats’ Government Takeover Is a Missed Opportunity To Reduce Health Care Costs. The House Democrats’ plan does not include even a shred of medical liability reform, missing an opportunity to drive down health care costs by reducing costly, unnecessary defensive medicine practiced by doctors trying to protect themselves from trial lawyers.

10. Democrats’ Government Takeover Harms Small Businesses, Costs Jobs. The House Democrats’ plan uses the amount of an employer’s annual payroll to define “small business,” which is troubling news for millions of Americans who depend on these engines of economic growth. Based on the Democrats’ definition of small businesses only those with, on average, less than 10 employees will be spared from new taxes through employer mandates. This leaves a huge number of small businesses to deal with the onerous and expensive mandates of the House Democrats’ government defined health benefit plan (“small businesses” are traditionally defined as employing less than 500 people). These small businesses employ 47.3 million employees and provide those employees $1.7 trillion in wages annually. The House Democrats’ new employer mandate and taxes on these businesses will make it more difficult to retain these jobs and wages.

Rationing care, raising taxes, and putting bureaucrats in charge of key health care decisions is not “reform.” There is a better way. Led by Rep. Roy Blunt (R-MO) and his Health Care Reform Solutions Group, House Republicans have outlined a plan to expand access to affordable, quality care regardless of pre-existing conditions; protect Americans from being forced into a government-run plan, making certain that medical decisions are made by patients and their doctors, not Washington bureaucrats; and let Americans who like their health care coverage keep it, while giving all Americans the freedom to choose the plan that best meets their needs. Will Democrats barrel ahead with their costly government takeover? Or will they heed the President’s words to bring all stakeholders to the table to ensure real health care reform?

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Friday, June 19, 2009

Oncology Care Quality Improvement Program Introduced by Bipartisan Coalition Dedicated to Better Cancer Care Nationwide

/PRNewswire/ -- A bipartisan group of members from the U.S. House of Representatives introduced a bill late yesterday aimed at improving oncology care in the United States by refocusing efforts towards patient-centered cancer care delivery and studying the best methods to coordinate care and extend quality of life. The "Oncology Care Quality Improvement Program of 2009" will establish a voluntary pilot program to identify major areas of potential improvement to oncology care, including error reduction, increased patient education and care coordination, and expansion of end-of-life planning and counseling services.

This groundbreaking oncology legislation, led by U.S. Representative Joseph Crowley (NY-7), has 18 original cosponsors, including lead sponsors Reps. Mike Rogers (MI-08), Lois Capps (CA-23), Anna Eshoo (CA-14) and Paul Ryan (WI-01). The bill has been endorsed by National Patient Advocate Foundation (NPAF), US Oncology, Society of Gynecologic Oncologists (SGO), Association of Community Cancer Centers (ACCC) and UPMC Cancer Centers.

"Fighting cancer is a fight we must win," said Rep. Joseph Crowley (NY-7). "This innovative demonstration project will ensure that patients and doctors have the best tools and information at their disposal. By providing our health care providers with most-up-to date information on best practices, we will ensure cancer patients are given the best and most cost-effective care. I thank Rep. Rogers, Capps, Eshoo and Ryan and colleagues from both sides of the aisle for joining me in leading this fight for oncology patients, doctors and families. We are proud to have the endorsement of the National Patient Advocate Foundation and US Oncology, our partners in working to get this program enacted swiftly."

"Cancer is one of the great health care challenges of our time," said Rep. Mike Rogers (MI-08). "Half of all men and one third of women will be diagnosed with cancer at some point in their lives and these figures are expected to skyrocket as the Baby Boom generation ages. That's why I'm proud to join Rep. Crowley to introduce this legislation, which will improve the quality of care for seniors with cancer while also creating a more efficient Medicare system."

"As researchers and clinicians work to improve cancer care in innovative ways, I'm proud to be part of this effort by Congress and CMS to evaluate the innovative use of health information technology in order to improve cancer care overall," said Rep. Lois Capps (CA-23). "The standard for oncology care in the 21st Century is about comprehensive care planning and coordination. By providing incentives to use the newest health information technology tools available, we can assist providers and patients in achieving optimal information sharing on best practices and better coordination among clinicians."

"As we begin to work on health care reform in the House, it's more important than ever that we look at every option available to help increase the quality of care while decreasing the overall cost of health care," said Rep. Anna Eshoo (CA-14). "This pilot program gives participating oncology groups the flexibility and incentives necessary to explore cost-saving measures without sacrificing the quality care their patients receive."

"Like most Americans, my family has been personally touched by cancer and personally motivated in our fight against cancer," said Rep. Paul Ryan (WI-01). "I remain committed to doing all that I can to find a cure for this disease, while working to promote innovate and compassionate improvements to oncology care. I am a proud to help introduce the Oncology Care Quality Improvement Program, and thank Rep. Crowley and my colleagues on both sides of the aisle for working on this important piece of legislation and for their leadership in the fight against cancer."

"Finally, we have a thoughtful, progressive, quality-driven program that achieves patient-centric cancer care delivery, while reducing costs at the same time. It is a win for the patient, the taxpayer and the physician," said Dr. Roy Beveridge, Chief Medical Officer, US Oncology.

National Patient Advocate Foundation (NPAF) continued, "NPAF is pleased to offer its strong support for the Oncology Care Quality Improvement Program of 2009. This legislation calls for adherence to evidence-based guidelines which will reduce variation in care for patients and help physicians make clinical decisions with evidence of proven treatment regimens. In addition, NPAF commends Rep. Crowley for addressing the importance of an adequate medical workforce as well as appropriate reimbursement which are critical in order for education and care coordination to have a meaningful impact on patients and our health care system."

Background on the Oncology Care Quality Improvement Program of 2009:

The oncology care quality improvement (OCQI) program is a cost-saving, voluntary pilot program, to be led by the Centers for Medicare and Medicaid Services (CMS) in consultation with an advisory committee of expert oncology community physician, nurse, patient organizations and industry leaders. The OCQI will evaluate the impact of provider-led approaches to improve care quality and outcomes for Medicare beneficiaries with cancer while creating greater care efficiencies to reduce costs. The OCQI aims to foster evidence-based guideline adherence to minimize variation and reduce errors in care, offers patient education and care coordination services to help patients avoid and/or address common effects of their cancers and treatments, and provides end-of-life planning and counseling services that aims to improve quality of life.

The OCQI will provide payments to participating oncology groups - based on their meeting of defined performance goals as well as per capita expenditure targets created by CMS - to be allocated from half of the program savings generated by the participating group. The other half of the program savings will be retained by the Medicare program.

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Wednesday, June 17, 2009

Former Senate Majority Leaders Baker, Daschle and Dole Release Bipartisan Framework for Comprehensive Health Reform

/PRNewswire/ -- Former U.S. Senate Majority Leaders Howard Baker, Tom Daschle and Bob Dole, members of the Bipartisan Policy Center's (BPC) Advisory Board, today released a bipartisan, budget-neutral framework for comprehensive health reform to ensure that every American has affordable, quality health coverage. The Leaders' Project on the State of American Health Care report, entitled "Crossing Our Lines: Working Together to Reform the U.S. Health System," offers realistic, bipartisan and politically-viable policy recommendations to address the delivery, cost, coverage and financing challenges facing the nation's health care system.

The report calls for refocusing the nation's health care system on a commitment to quality and value -- rather than quantity and volume -- to improve medical outcomes and constrain unsustainable cost growth. In so doing, the Leaders underscore the need to rededicate the country to prevention and wellness as a better prescription to address the flaws of our health care system. To achieve the commitment of coverage for all Americans, the report embraces the need for strong insurance reforms that require guaranteed issue; the elimination of medical underwriting for pre-existing conditions and rating limitations; new state and regional coverage options through exchanges; reforms that constrain cost growth; and financial assistance through Medicaid and tax credits.

In developing their recommendations, the Leaders addressed many politically sensitive issues, recognizing that effective agreements often require tough choices. Specifically, their budget-neutral plan calls for: a personal responsibility requirement for all Americans to purchase affordable health insurance; refundable tax credits that limit premium contributions to a percentage of income; tax credits for small businesses that offer coverage; limited fees for employers not offering or paying for health benefits; a tax exclusion linked to the value of benefits received by Members of Congress; and the establishment of an Independent Health Care Council to promote coordination among federal health care programs.

Consistent with the federal/state health reform model, the Leaders' plan provides for initial financial and technical support to states that choose to establish competing state plan options. These plans would have to compete on a level playing field. The Leaders also provide for a process that allows the President to submit a plan to Congress for a vote under expedited procedures if, after five years, the HHS Secretary has certified that the existing options do not provide for affordable coverage.

Arguing that flexibility from all sides is required to break the long stalemate over improving the health care system, the Leaders each embraced positions that have long been controversial within their own parties.

"Health reform can be achieved," said Senator Baker. "But in order for that to happen we must work beyond our points of disagreement and focus on reaching bipartisan solutions to create the health care system that the American people deserve."

Addressing the compromises the Leaders made in developing this report, Senator Daschle said, "A number of proposals would have looked different if they had been crafted by only Democrats or only Republicans. But in the spirit of our bipartisan effort, my colleagues and I agreed to this compromise in the hopes that we can begin to bridge any rifts in the debate and move forward with achieving our common goal of reforming the health care system."

Senator Dole stressed the need for preventive care and personal responsibility. "We need to improve health care delivery, while providing individuals with the knowledge, tools and choices they need to be accountable for their health," he said. "These and other reforms are needed to fix the nation's 'sick care' system."

The Leaders' Project on the State of American Health Care was launched in April 2008 with the goal of developing a comprehensive, but achievable set of policies to ensure that all Americans have quality, affordable health insurance coverage, while constraining cost growth, promoting innovative delivery of care, and focusing treatments more on the patient, and not just the illness.

The proposal reflects a series of forums that took place throughout 2008, each hosted by one of the Leaders. The events addressed four key topics, or "pillars," of health care reform: promoting high-quality, high-value care; making health insurance available, meaningful and affordable; emphasizing and supporting personal responsibility and healthy choices; and developing a workable, sustainable approach to health care financing. The project was co-directed by health care experts Chris Jennings and Mark McClellan.

To support the development of their recommendations, the Leaders sought advice and input from a broad range of health care providers, businesses, labor representatives, state and local policymakers, health plans, academics and consumer advocates through their public policy forums and targeted outreach activities. Ultimately, the Leaders' report seeks to establish a constructive center in the often polarized debate about health reform, and to advance a coherent strategy for modernizing the health care system and create a consistent source of health coverage for every American. For more information or to download a full copy of the report, "Crossing Our Lines: Working Together to Reform the U.S. Health System," please visit:

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Tuesday, June 16, 2009

FDA Advises Consumers Not To Use Certain Zicam Cold Remedies

The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.

The products are:
--Zicam Cold Remedy Nasal Gel
--Zicam Cold Remedy Nasal Swabs
--Zicam Cold Remedy Swabs, Kids Size (a discontinued product)

The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.

“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason.”

People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.

The FDA has issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval.

“Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of CDER’s Office of Compliance.

Health care professionals and consumers are encouraged to report adverse events (side effects) that may be related to the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.
--Regular Mail: use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: 800-FDA-0178
--Phone: 800-FDA-1088

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Process Begins to Define "Meaningful Use" of Electronic Health Records

Building on the historic $19 billion investment provided through the
American Recovery and Reinvestment Act of 2009 (Recovery Act), efforts
continued today to further the national adoption and implementation of
health information technology (HIT) -- an essential tool to modernize
the health care system and bring about improved health for all
Americans. The Health Information Technology (HIT) Policy Committee, a
Federal Advisory Committee (FACA) to the U.S. Department of Health and
Human Services (HHS), met today to begin the process of defining
"meaningful use" of electronic health records (EHRs). This meeting is a
first step for the department, as it investigates possible definitions
for meaningful use.

"We are moving fast to achieve the President's goal to improve the
health and well-being of every American through the on-going use of
health information technology," stated HHS' National Coordinator for
Health Information Technology David Blumenthal, M.D., M.P.P. "The work
of the policy committee is a first step toward assuring that technology
-- the electronic health record -- is used in a meaningful way to
provide better patient care."

The Recovery Act provides Medicare and Medicaid incentive payments to
eligible providers, such as physicians and hospitals, in order to
increase the adoption of EHRs. To receive the incentive payments,
providers must demonstrate "meaningful use" of a certified EHR.
Building upon the work done by the HIT Policy Committee, the Centers for
Medicare & Medicaid Services (CMS), along with the Office of the
National Coordinator for Health Information Technology (ONC), will be
developing a proposed rule that provides greater detail on the incentive
program and proposes a definition of meaningful use. CMS expects to
issue the proposed rule in late 2009, which will be followed by a
comment period.

The recommendations discussed today represent extensive work by the
Committee's Meaningful Use Workgroup to review and evaluate diverse
ideas and contributions from Workgroup members along with information
from a public hearing on meaningful use convened in April by the
National Committee on Vital and Health Statistics (NCVHS). The NCVHS
hearing brought together key healthcare and information technology
stakeholder groups. The workgroup also reviewed written comments from
additional diverse stakeholders.

A public comment period on today's recommendations will be open through
the close of business on Friday, June 26, 2009. Instructions on how to
submit public comment can be found at

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CSTE Leads Effort to Improve Blood Lead Reporting

/PRNewswire / -- Citing evidence that even a very low level of blood lead is a significant health risk at any age, the Council of State and Territorial Epidemiologists (CSTE) is recommending a change in the case definition of elevated blood lead levels in adults. In a vote at the CSTE annual conference in Buffalo, NY, State Epidemiologists approved a proposal to consider blood levels of 10 ug/dl or more in adults as "elevated" -- the same standard as currently exists for children.

Studies show that blood lead levels as low as 10 ug/dl contribute to an elevation in blood pressure and attendant health risks, including stroke. Low blood levels also are associated with an increase in mortality from heart disease, decreased kidney function and changes in cognition.

"Having this additional data will allow researchers, epidemiologists and the public to know more about the burden of lead poisoning across the age spectrum," CSTE President Mel Kohn, M.D., M.D.H. said. "While we often think of lead poisoning as a health concern in children and pregnant women, we need to address how lead poisoning is affecting adults, from exposure in the workplace and from hobbies such as target shooting."

The risk of lead poisoning is especially pronounced among workers in certain industries, including lead refining and smelting; construction work involving paint removal; manufacture of bronze and brass products such as plumbing fixtures; demolition and maintenance of outdoor metal structures such as bridges and water towers; and battery manufacturing and recycling.

Many occupational exposures are not identified because not all employers do the required occupational testing. Compounding the problem is the fact that only a fraction of known occupational cases are included in national health statistics, which currently only include counts of individuals with blood lead levels 25 ug/dl and greater.

Some states are already obtaining reports from laboratories of individuals with blood lead levels lower than 25 ug/dl and share this information with the Centers for Disease Control and Prevention/National Institute of Occupational Safety and Health Adult Blood Lead and Epidemiology (ABLES) Program. ABLES received reports of 12,935 adults with blood lead levels from 10-24 ug/dl who were tested in 2007 in 21 states, compared to reports of 5,419 adults with blood lead levels of 25 ug/dl and above in these same states. These reports are likely minimum estimates of the true magnitude of the problem.

"The current ABLES data for adults with blood lead levels of less than 25 ug/dl reflects only sporadic reporting," Dr. Kohn said. "The result is a significant underestimation of the health impact of elevated blood lead levels in the population of the United States that will be greatly alleviated by the new recommended reporting practices. With more complete reporting, we will have a clearer picture of the true scope of the problem to guide our efforts to prevent lead poisoning. This will reduce the toll of lead exposure on the health of Americans of all ages."

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Monday, June 15, 2009

FDA Requests Labeling Change for Leukotriene Modifiers

The U.S. Food and Drug Administration today provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. The FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).

Leukotrienes are chemicals the body releases in response to an inflammatory stimulus, such as when a person breathes in an allergen. Montelukast and zafirlukast are leukotriene receptor antagonists that work by blocking leukotrienes. Zileuton is a leukotriene synthesis inhibitor which works by stopping the formation of certain substances that cause swelling, tightening, and mucus production in the airways.

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Saturday, June 13, 2009

The Secret Lives of Sneezes and Coughs

Like people, coughs come in all shapes and sizes. They can be deep or shallow, long or short, or forced or stifled. Scientists who study the ways we cough and sneeze are shedding light on how viruses like influenza spread.

To follow the evolution of cough, scientists use elaborate setups that reveal how much saliva is expelled and where it goes. They ask people to cough into masks that are carefully weighed before and after the coughs. They illuminate the flows of coughs with powerful lasers and fancy photo techniques and use powerful computers to model this flow of thousands of tiny particles. They use heated manikins and cough machines in rooms filled with tiny droplets of olive oil or theatrical smoke to track how air moves, where breath goes, and how exposed we are to someone else's cough.

A typical cough starts with a deep breath, followed by a compression of air in the lungs and then a crackling burst as that air is forced out in a fraction of a second. The average human cough would fill about three-quarters of a two-liter soda bottle with air -- air that shoots out of the lungs in a jet several feet long. Coughs also force out thousands of tiny droplets of saliva. About 3,000 droplets are expelled in a single cough, and some of them fly out of the mouth at speeds of up to 50 miles per hour.

Sneezing is even worse. It starts at the back of the throat and produces even more droplets -- as many as 40,000 -- some of which rocket out at speeds greater than 200 miles per hour. The vast majority of the droplets are less than 100 microns across -- the width of a human hair. Many of them are so tiny that they cannot be seen with the naked eye.

"What happens to these droplets depends on their size," said fluid dynamicist Bakhtier Farouk of Drexel University in Philadelphia. He is working on software that models how microscopic droplets move around a room.

Most of the larger, heavier drops fall quickly to the floor under the influence of gravity. The smaller and lighter particles (those that are five microns or less across) are less affected by gravity and can stay airborne almost indefinitely as they are caught up in and dispersed by the room's airflow.

Movements in a room can cause the heavier droplets to become airborne again after they have fallen to the ground or another surface. Making a hospital bed can kick up viruses on the covers. Opening a door can dramatically alter the airflow in the room and pull up viruses on the floor. Even walking through a room can spread droplets in a person's wake.

If a person is sick, the droplets in a single cough may contain as many as two hundred million individual virus particles. The number varies dramatically and changes over the course of an infection as the immune system clears out the virus. Generally, a sick person is most infectious as soon as the first symptoms appear and less infectious as his or her immune system clears the virus.

Once airborne, viruses in these tiny droplets can survive for hours. Even if the droplets hit a surface, the viruses can survive and still spread disease if the droplets become airborne later. When a droplet lands on paper, its virus particles can survive for hours. On steel or plastic they can survive for days.

Once they are breathed in, the droplets settle onto cells at the back of the throat, where the virus attempts to enter these cells and begin replicating. This may or may not cause an infection. The body's natural defenses are designed to eliminate infections, and whether someone will fall ill depends on how much virus is breathed in and whether the person's immune system has encountered that virus previously, said Julian Tang, a clinical virologist in Singapore.

When people do get sick, the body tries to deal with the infection by bringing up mucus to help clear it. Some of this mucus is swallowed, carrying the virus down to be destroyed by stomach acid. Some viruses in the throat, though, will be expelled when we cough, and this coughing expels the mucus (and new virus) out of the body, thus beginning the whole process anew.

By Jason Socrates Bardi
Inside Science News Service

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FDA Issues Public Health Advisory Regarding Levemir Insulin

The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.

The FDA has received one report of a patient who suffered an adverse event due to poor control of glucose levels after using a vial from one of these three lots.

The agency is advising patients who use Levemir insulin to:

1. Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038. Patients can locate the lot number on the side of the box of insulin and also on the side of the vial.

2. Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your healthcare provider as another insulin product may require adjustments in dosing.

3. Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.

4. Contact the Novo Nordisk Customer Care Center at 800-727-6500 for what to do with vials from these lots or if you have any other questions.
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Thursday, June 11, 2009

FDA Alerts Patients to Medtronic Pacemaker Recall

The U.S. Food and Drug Administration is alerting patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.

Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death.

There are more than 1.7 million Kappa or Sigma pacemakers implanted in patients throughout the world. Of those, only about 21,000 pacemakers are affected by this recall, most of which have been implanted in patients for five years or longer.

Medtronic Inc. issued a letter to physicians alerting them to this problem on May 18. The company communicated with patients via letter on May 27.

The affected pacemakers are Kappa Series 600/700/900 and Sigma Series 100/200/300. Patients with these models of Kappa and Sigma pacemakers should determine if their pacemaker is part of this recall by contacting Medtronic at 800-505-4636 or going to their Web site at

Patients who have these recalled pacemakers and those who are unsure if their pacemakers are affected should follow up with their primary care physician or cardiologist.

Through standard medical device reporting requirements, the FDA became aware of possible problems and worked with the company to address them. The FDA classified this voluntary recall as Class I, indicating reasonable probability that the use of the device will cause serious adverse health consequences or death.

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FDA Approves Injectable Form of Ibuprofen

The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever.

“Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options,” said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA’s Center for Drug Evaluation and Research. “But until now there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products.”

Caldolor will be available for hospital use only. It is approved to be administered in 400 mg to 800 mg doses, over 30 minutes, every 6 hours for acute pain. To treat fever, the drug is approved in a 400 mg dose administered over 30 minutes, followed by 400 mg every 4 to 6 hours, or 100-200 mg every 4 hours, as necessary.

In a clinical trial of 319 women who had undergone an elective abdominal hysterectomy, patients were less likely to request morphine for pain on an as-needed basis when administered Caldolor.

Caldolor should be used with caution in patients with congestive heart failure, kidney impairment, at risk of blood clots and those who have a prior history of ulcers or gastrointestinal bleeding. When used in such patients, attention to using the lowest effective dose for the shortest time period is important to reduce the risk of serious adverse events. The drug has also been associated with high blood pressure, serious skin reactions, and serious allergic reactions.

The most common adverse reactions reported in the controlled clinical trials were nausea, flatulence, vomiting, and headache.

Caldolor is manufactured by Cumberland Pharmaceuticals Inc., Nashville, Tenn.

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Wednesday, June 10, 2009

Minorities, Low Income Americans More Likely to Be Sick, Less Likely to Get Care

U.S. Health and Human Services (HHS) Secretary Kathleen Sebelius yesterday released a new report on health disparities in America and participated in a White House Health Care Stakeholder Discussion on the importance of reform that reduces disparities that exist in our current health care system. The new report Health Disparities: A Case for Closing the Gap is
available at

"Minorities and low income Americans are more likely to be sick and less likely to get the care they need," Secretary Sebelius said. "These disparities have plagued our health system and our country for too long. Now, it's time for Democrats and Republicans to come together to pass
reforms this year that help reduce disparities and give all Americans the care they need and deserve."

A Case for Closing the Gap highlights some of the glaring disparities that exist in the current health system. Under the status quo:

- Forty-eight percent of all African Americans adults suffer from
a chronic disease compared to 39 percent of the general population.
- Eight percent of white Americans develop diabetes while 15
percent of African Americans, 14 percent of Hispanics, and 18 percent of
American Indians develop diabetes.
-Hispanics were one-third less likely to be counseled on obesity
than were whites -- only 44 percent of Hispanics received counseling.
- African Americans are 15 percent more likely to be obese than

The report also notes that 40 percent of low-income Americans do not have health insurance. About one-third of the uninsured have a chronic disease, and they are six times less likely to receive care for a health problem than the insured. In contrast, only 6 percent of high-income
Americans lack insurance.

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Tuesday, June 9, 2009

FDA Requires Boxed Warning for All Botulinum Toxin Products

Prompted by reports of serious adverse events, the U.S. Food and Drug Administration today announced that safety label changes, including a boxed warning, and a Risk Evaluation and Mitigation Strategy (REMS), are necessary for all botulinum toxin products.

The agency said it took the action because of reports that 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, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.

These symptoms have mostly been reported in children with cerebral palsy being treated with the products for muscle spasticity, an unapproved use of the drugs. Symptoms have also been reported in adults treated both for approved and unapproved uses.

The agency also took the action because of the potential for serious risks associated with the lack of interchangeability among the three licensed botulinum toxin products.

“Updated labels for this class of products will help health care professionals and patients better understand the risks and benefits,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Botulinum toxin products have benefits but can cause serious health problems and it is important that anyone who administers or uses these products understands these risks.”

Product Names

The products required to add the new label and a REMS are Botox and Botox Cosmetic (botulinum toxin type A), marketed by Allergan; Myobloc (botulinum toxin type B), marketed by Solstice Neurosciences; and a new FDA-approved product, Dysport (abobotulinumtoxinA), marketed by Ipsen Biopharm Ltd.

Botox, Myobloc, and Dysport are approved by the FDA for the treatment of a condition marked by repetitive contraction of the neck muscles (cervical dystonia). Botox Cosmetic and Dysport are approved by the FDA for dermatologic use in the temporary improvement in the appearance of frown lines between the eyebrows called glabellar lines. In addition, Botox is approved for the treatment of severe underarm sweating (primary axillary hyperhidrosis), crossed eyes (strabismus), and abnormal tics and twitches of the eyelids (blepharospasm).

Recommendations for Health Care Professionals

The FDA has notified the manufacturers of Botox and Myobloc that label changes and a REMS are necessary to ensure that the benefits of the product outweigh the risks. The FDA approved a REMS for Dysport as part of the product approval. The REMS for each of these products will include a Medication Guide and a Communication Plan. Medication Guides are FDA-approved handouts given to patients, or their families and caregivers, when a medicine is dispensed. The Medication Guides will contain information about the risks associated with botulinum toxin products. The FDA is also requiring the manufacturers to collect safety data in children and adults with muscle spasticity to assess the signal of risk regarding distant spread of toxin effects.

Treatment of muscle spasticity is not an FDA-approved use of botulism toxin products. The doses used in treatment of muscle spasticity are often much higher than the doses for uses described in FDA-approved product label. Symptoms consistent with spread of toxin effects have been reported at doses comparable to or lower than doses used to treat cervical dystonia.

For the FDA-approved dermatologic use of temporary improvement in the appearance of glabellar lines, the agency has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when the botulinum toxin products are used in accordance with the approved label.

The companies that make Botox and Myobloc are required to submit the requested safety label changes, including the boxed warning and the Medication Guide, to the FDA within 30 days, or to provide a reason why they do not believe such changes are necessary. If they do not submit new language, or the FDA disagrees with the language the companies propose, the Food, Drug, and Cosmetic Act provides strict timelines for discussions regarding the changes. At the end of these discussions the agency is allowed to issue an order directing the label change as deemed appropriate to address the new safety information.

Health care professionals who use botulinum toxins should do the following:

Understand that dosage strength (potency) expressed in “Units” is different among the botulinum toxin products; clinical doses expressed in units are not interchangeable from one product to another.

Be alert to and educate patients and caregivers about the potential for effects following administration of botulinum toxins such as: unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.
Understand that these effects have been reported as early as several hours and as late as several weeks after treatment.

Advise patients to seek immediate medical attention if they develop any of these symptoms.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.--Online --Regular Mail: use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787--Fax: 800-FDA-0178--Phone: 800-FDA-1088

Today’s action updates a February 2008 announcement that the FDA was conducting an ongoing safety review of botulinum toxin products.The FDA also issued a response to a citizen petition related to the risk of spread of botulinum toxin effects from the site of injection. This response provides additional detail regarding the FDA’s analysis of this safety issue. The FDA’s response to the Citizen Petition can be found at
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Monday, June 8, 2009

Rep. Lewis Commends Kidney Care Partners' Health Care Campaign to Improve Survival Rates of First-Year Dialysis Patients in Georgia

/PRNewswire / -- Kidney Care Partners announced the launch of a voluntary quality improvement campaign pledging to reduce mortality among first-year dialysis patients - those at the greatest risk - in Georgia and across the country by 20 percent by the end of 2012.

The "Performance Excellence and Accountability in Kidney Care" or PEAK Campaign ( to reduce mortality in the first year will focus on patient education and key clinical care activities to achieve its goal.

Led by Kidney Care Partners, with support from research partners at Brown University and Quality Partners of Rhode Island as well as experts in the kidney community, the PEAK Campaign will:

-- Equip health care providers with tools to help first-year dialysis
patients better transition;
-- Improve the health and survival of first-year dialysis patients;
-- Result in reduced hospitalizations, thus resulting in Medicare

The PEAK campaign has garnered support not only from a broad cross-section of the kidney community but also from policymakers. "This Congress is deeply committed to resolving the fundamental challenges of health care delivery in this country, but we cannot do it alone," said Rep. John Lewis (D-GA), sponsor of the Kidney Care Quality and Education Act of 2007, which included patient-centered education programs and linked reimbursement with quality care - provisions which were ultimately passed as part of the Medicare legislation of 2008. "We need organizations like KCP to target specific problem areas in the community and find ways to respond. Saving lives is the goal that motivates us all."

Kidney disease affects more than 26 million people nationwide. Approximately 400,000 Americans suffer from kidney failure and require dialysis or kidney transplantation to survive. Transplants are limited due to the shortage of donor organs, so most patients undergo dialysis for three to four hours, three times a week. The number of Americans with kidney disease is rising steadily due to risk factors including diabetes, hypertension, obesity and high blood pressure.

African Americans, Hispanics and other minority groups are most at-risk for developing kidney failure. And while African Americans make up just 12 percent of the general population, they account for 30 percent of people with kidney failure.

There were 3,790 new dialysis patients in 2007 in Georgia alone, a 15 percent increase since 2003, and a total of 14,086 patients on dialysis in 2007 in Georgia, a more than 20 percent increase since 2003, according to the Southeastern Kidney Council.

All too often, the onset of chronic kidney disease (CKD) is gradual and undetected, leaving patients especially vulnerable when the disease is recognized. Helping patients to understand their disease and to manage it appropriately is an essential ingredient to high quality care for newly diagnosed patients and a central component of the PEAK Campaign.

"The kidney care community has achieved considerable and measurable quality improvements in the last decade. The goal of the PEAK Campaign is to help us achieve comparable results in the next decade," said Kent Thiry, KCP Chair. "Our Campaign focuses on patients who are new to dialysis, because these patients are particularly vulnerable. One challenge is to help these patients understand and effectively manage their disease. We also will start a systematic community-wide process of identifying and sharing 'breakthrough' practices that will improve survival rates."

While the survival rate of end-stage renal disease (ESRD) patients has improved, mortality in the first year of dialysis has remained stable during the last decade. The kidney care community has recognized the need to improve the first-year mortality rate as compared to other industrialized nations.

With recommendations from our research partners, KCP will encourage providers to further improve outcomes for first-year dialysis patients in an effort to extend, even save, 10,000 lives.

"Dialysis providers already have robust quality improvement programs in place to ensure consistent delivery of high quality care. The kidney care community looks forward to undertaking this voluntary effort to take quality improvement to the next level," KCP's Thiry added.

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Three in Every One Thousand U.S. Children Diagnosed with Tourette Syndrome

The first-ever national estimate among a nationally representative sample of U.S. children revealed that 3 out of every 1000 children between the age of 6 and 17 in the United States have been diagnosed with Tourette Syndrome (TS), according to a study by the Centers for Disease Control and Prevention (CDC) released in the Morbidity and Mortality Weekly Report.

The study, “Prevalence of Diagnosed Tourette Syndrome in Children in the United States, 2007,” found that a TS diagnosis is three times more common in boys than in girls, and approximately twice as common in children between 12-17 years as those aged 6-12 years. Among children with TS, 27% were reported as having moderate or severe TS and 79% of children had also been diagnosed with at least one additional mental health or neurodevelopmental condition.

Tourette Syndrome is a neurological disorder that typically begins during early childhood, with symptoms being most severe between the ages of 10 and 12 years. TS is characterized by recurring multiple motor tics and at least one vocal tic. Tics are involuntary, repetitive, stereotyped, usually sudden and rapid movements or vocalizations that may be suppressed for short periods of time.

“TS and tic disorders have been linked to higher rates of Attention Deficit/Hyperactivity Disorder, obsessive-compulsive disorder, and impairments associated with these conditions, such as learning disabilities and problems with peer relations,” said Dr. Rebecca Bitsko, Health Scientist at the Centers for Disease Control and Prevention. “Given the high number of children diagnosed with TS who have another mental health or neurodevelopmental condition, it is necessary to further study the relation between these conditions.”

Further, the data showed that non-Hispanic white children were more than twice as likely as non-Hispanic black children or Hispanic children to have a parent-reported TS diagnosis.

“Having an estimate of the number of U.S. children who are diagnosed with TS is a first step toward understanding the overall impact of this condition in the population,” said Dr. Bitsko. “Further research must examine differences in access to health care for children with TS in different population groups, the impact of TS on the quality of life, long term outcomes for children with TS, and strategies for reducing the impact of conditions associated with TS.”

The study analyzed data from interviews with parents (or guardians) from 91,642 households from April 2007 through July 2008 collected through the National Survey of Children′s Health (NSCH). The NSCH is the first large, national, population-based survey of U.S. children up to 18 years old that included questions on TS. This random-digit-dialed telephone survey is sponsored and directed by the Health Resources and Services Administration′s Maternal and Child Health Bureau and conducted by CDC through the State and Local Area Integrated Telephone Survey program. Interviews were completed in 66.0% of identified households with children which represents a 46.7% response of all possible eligible households.

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Thursday, June 4, 2009

Clayton State Honors Students Holding Red Cross Blood Drive on June 15

The Clayton State University Honors Student Association will be holding another Red Cross Blood Drive on Monday, June 15.

The Red Cross Bloodmobile will be located in the parking lot in front of the University’s new Student Activities Center from 10 a.m. to 2 p.m.

For more information, go to or email the Honors Student Association’s Jenna Pair at

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

Wednesday, June 3, 2009

FDA Warns About Serious Liver Injury Associated With Anti-Thyroid Drug

The U.S. Food and Drug Administration today warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil (PTU) for the treatment of Graves' disease.

"After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves' disease, methimazole," said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. If PTU therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy."

PTU was approved for marketing in 1947. A total of 32 cases of serious liver injury associated with the use of PTU were reported to the FDA's Adverse Event Reporting System since that system was established in 1969 through October 2008. Of the 22 adult cases, the FDA identified 12 deaths and five liver transplants. Of the 10 pediatric cases, there was one death and six reports of liver transplant.

Graves’ disease is an autoimmune disorder that leads to overactivity of the thyroid gland. The thyroid gland, located in the front of the neck just below the Adam’s Apple, releases hormones that regulate the rate of the body’s metabolism and are critical for body temperature control, energy, weight, mood, and blood calcium levels.

PTU is considered second-line drug therapy, except in certain patients who are allergic to, or intolerant of, methimazole. Because a rare birth defect has been reported with methimazole and not with PTU, PTU may be more appropriate for patients with Graves’ disease who are in the first trimester of pregnancy.

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Roche Diagnostics notifies customers of the potential for ACCU-CHEK® Softclix 10 and/or 17 count lancets to be uncapped

Roche Diagnostics notifies customers of the potential for ACCU-CHEK® Softclix 10 and/or 17 count lancets to be uncapped which may lead to an accidental needle stick

Roche Diagnostics announced May 18 that it is notifying its customers and healthcare professionals about a potential issue with a small number of ACCUCHEK ® Softclix 10 and/or 17 count lancets that have missing caps that were distributed as samples or in the following meter kits:

Meter Kits REF Number Lancet Count Lancet Lot Numbers Affected

ACCU-CHEK® Active Meter Kit

ACCU-CHEK® Voicemate Meter

ACCU-CHEK® Aviva Meter kits that include an ACCU-CHEK® Softclix lancing device

Coaguchek XS Systems for Patient Self-Testing





M25C2, M25C5, M25C7, M32B5, N32A5
ACCU-CHEK® Compact Plus Meter Kit
M25C9, M25D2, M27D6, M32A8, M32B3

Missing caps can lead to the potential for an accidental needle stick. It is for this reason that Roche Diagnostics, in cooperation with the U.S. Food and Drug Administration (FDA), is voluntarily requesting that customers inspect their lancets prior to opening the plastic bag containing the lancets. If customers notice ACCU-CHEK Softclix 10 and/or 17 count lancets without caps do not use them. Additionally, customers should use caution while handling the lancets to avoid the potential for an accidental needle stick, dispose of them in apuncture proof container with a lid, and contact one of the following phone numbers for a replacement:

  • Diabetes Care customers: 1-800-778-7057 (ACCU-CHEK Customer Care Service Center)
  • CoaguChek customers: 1-800-778-7505 (Point-of-Care Technical Service) Customers should always use caution when handling lancets. Roche takes this issue very seriously and is taking steps to prevent this issue in the future.

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