Improving Patient Care By Designing Drugs And Their Antidotes Together

Posted by admin on Octubre 6th, 2009 under pharma industry Tags: , ,  •  No Comments

Imagine a surgical patient on a bloodthinning drug who starts bleeding more than expected, and an antidote that works immediately because the blood thinner and antidote were designed to work together. Researchers at Duke University Medical Center have engineered a way to do this for an entire, versatile class of drugs called aptamers and published their findings in Nature Medicine.

“With any anticoagulant, you are trying to reduce your chances of having clotting because it can lead to a heart attack or stroke during treatment,” said Bruce Sullenger, Ph.D., senior author and Vice Chair for Research and Joseph W. and Dorothy W. Beard Professor of Surgery. Yet bleeding is a common side effect during and after treatments that require anticoagulation therapy such as surgery or angioplasty.

These new antidotes may give doctors a way to quickly and precisely put the brakes on an anticoagulant if bleeding becomes a problem or neutralize other adverse events or toxicities.

Duke researchers have just completed a series of successful clinical trials in patients taking a bloodthinner aptamer and an antidote engineered to reverse the effects of the aptamer.

“We have shown that this type of antidote can reverse the action of any of the aptamer drugs, and there are many aptamers in development,” Sullenger said. Their approach amounts to a universal antidote to the entire aptamer family. “We predict that this advance will significantly expand the number of diseases that can be more safely treated using antidotecontrollable therapeutic agents,” he said.

The new approach, called RNAbased aptamer technology, “provides the opportunity to make safer drugs,” said Sullenger, who also directs the Duke Translational Research Institute. “And now that we can engineer a universal antidote for aptamers, we can in trustedtablets principle for the first time afford to provide additional control over drugs for patients and their physicians.”

Aptamers are oligonucelotides, short stretches of nucleic acid that bind to a specific target molecule. If a patient takes an aptamer drug, the drug is the only free oligonucleotide in the body.

The researchers studied eight aptamer drugs and showed that the antidotes they introduced could reverse the activity of any of the drugs, regardless of the sequence, shape or target of the drug.

One advantage of aptamer drugs, as opposed to antibodybased drugs, is that nucleic acids arent typically recognized by the human immune system as foreign agents. Aptamers do not generally trigger an immune response, Sullenger said.

“This technology could be applied to any oligonucleotidebased therapeutic that is free in a patients circulation,” said lead author Sabah Oney, Ph.D., formerly with the Sullenger laboratory and now a senior scientist at b3bio, a biotechnology company Sullenger helped cofound in the Research Triangle Park.

“With the everincreasing number of such drugs in clinical trials, we believe that this discovery can have very broad applications and improve the safety profile of these therapeutics,” Oney said. “This could be rapidly translated into the clinic, and lead to a whole new class of safer therapeutic agents.”

To date, one aptamer has been approved by the U.S. Food and Drug Administration, a drug for macular degeneration, a cause of blindness. Several others are being tested and developed for use in cardiovascular, hematology and cancer patients.

“This research potentially represents the next frontier of controlled therapeutics using nucleic acids as highly selective antithrombotics and neutralizing polymers,” said Richard C. Becker, M.D., Professor of Medicine in the Duke Divisions of Cardiology and Hematology and a scientist in the Duke Clinical Research Institute (DCRI) who has worked on clinical trials with the aptamer antidotes. “The translational platform for antithrombotic therapy pioneered by the Sullenger laboratory in collaboration with the DCRI underscores the unlimited potential of clinicians and scientists collaborating with purpose and commitment to advance patient care.”

“Future optimization should further improve the potency of sequestering the aptamers from circulation, which will then spur the development of many new aptamer drugs,” said Kam Leong, a James B. Duke professor of biomedical engineering and coauthor of the study.

Other authors on the paper include Ruby T. S. Lam of the Duke Department of Biomedical Engineering, Kristin M. Bompiani and Charlene M. Blake of the Duke University Program in Genetics and Genomics and the Duke Department of Surgery, George Quick of the Duke Translational Research Institute, Jeremy Heidel and Joanna YiChing Liu of Calando Pharmaceuticals, and Brendan C. Mack and Mark E. Davis of the Department of Chemical Engineering at the California Institute of Technology.

This work was supported by a grant from the National Institutes of Health, a predoctoral fellowship from the American Heart Association, and a grant from the National Cancer Institute.

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Mary Jane Gore

Survey Reveals Most Consumers Do Not Carry A Medication List

Posted by admin on Octubre 5th, 2009 under pharmacy Tags: ,  •  No Comments

A medication list can provide emergency medical personnel with lifesaving information and help prevent the nearly 1.5 million¹ people harmed by medication related errors every year. But, a recent consumer survey commissioned by the American Pharmacists Association (APhA) and conducted by Harris Interactive revealed that while a large percentage of Americans have an uptodate list of their prescription medications, only 28 percent of consumers carry the list with them at all times.

Among the people who do not have an uptodate list, 49 percent said they never thought about it and 36 percent said they have no desire or need to carry the list. Females (31%) are more likely than males (24%) to carry a list. In addition, as consumers age, the likelihood that they carry a list significantly increases.

APhA recommends that people always carry an updated list of their prescription and overthecounter medications, vitamins and herbal products. The list should include the name and dosages of the medications, as well as what conditions the medications treat and any of the patients known allergies.

“One of the most important things consumers can do to take an active role in their health care is carry a current medication list,” said Kristen Binaso pharmacist and APhA national spokesperson. “Until electronic medical records are the standard and can be shared across providers, consumers should be sharing their list with all of their health care providers to minimize the risk of improper dosing, duplicating medications, and harmful drug interactions and side effects.”

Throughout the year, but in particular during American Pharmacists Month in October, APhA is urging consumers to get to know their pharmacist through its “Know Your MEDICINE, Know Your PHARMACIST” public education campaign. The campaign underscores the link between knowing your pharmacist and the safe and effective use of medications. Improper medication use has been estimated to cost our nation $177 billion² annually in total direct and indirect healthcare costs.

The survey also found that although pharmacists are the medication experts, 77 percent of consumers do not know their pharmacists name and only 40 percent have asked their pharmacist questions about their health care needs in the past year. These statistics are troubling to pharmacists given that they are the most accessible health care providers to the public. While a large percentage of consumers do not know the name of their pharmacist, they still rank pharmacists as the second most trusted source of medication information behind doctors.

“Pharmacists are consumers ally in helping them make the best use of their medications,” said Binaso. “We have years of advanced training about how medications can work to improve health and how to help consumers use medications correctly and we are eager to become more involved with our patients health.”

To maximize the benefits from medications and minimize the potential for harmful drug interactions and side effects, APhA recommends that consumers ask these questions before taking any type of medication particularly those who take multiple medications, dietary supplements and/or OTC medications.

When and how you should I take my medication?
What should I do if I miss a dose?
Are there any potential side effects?
Will my medication(s) interact with other medications or food?
How do I safely dispose of unused medications?

Other highlights in the survey include

Those who know their pharmacists name are more likely to have an uptodate medication list.
Twothirds of consumers accept their pharmacists recommendations of OTC products at least most of the time.
Sixty percent of respondents use one pharmacy to fill prescriptions.
Fiftytwo percent of respondents are likely to ask their pharmacist a question when they receive a prescription for the first time

To download a medication list or to find tips on how to talk to your pharmacist and use medicines safely, visit pharmacist.com/APhM.

About the 2009 Know Your Medicine; Know Your Pharmacist Survey The “2009 Know Your Medicine; Know Your Pharmacist” survey was commissioned by the American Pharmacists Association and conducted in May 2009 by Harris Interactive.

Survey Objective To collect and report information about how consumers interact with and perceive their pharmacist and how their relationship with the pharmacist impacts their use of medications.

Survey Sample 1,003 qualified respondents from a nationally representative panel. The survey included a similar percentage of men and women and included respondents age 21 and over.

Statistical Confidence plus/minus 3 percent.

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Heart Attack And Stroke Prevented In Large, Diverse Population By Bundling 2 Low-Cost Heart Drugs

Posted by admin on Octubre 3rd, 2009 under diabetes Tags:  •  No Comments

A program that bundled two generic, lowcost drugs a cholesterollowering statin and a blood pressurelowering drug and gave daily doses to 68,560 people with diabetes or heart disease for two years is estimated to have prevented 1,271 heart attacks and strokes in the first year following the study period, according to a Kaiser Permanente study published online in the American Journal of Managed Care.

Kaiser Permanente developed the ALL initiative (Aspirin, Lisinopril and LipidLowering Medication) in 2003 to reduce heart attacks and strokes by aggressively enrolling patients with heart disease or patients over 55 with diabetes in a therapeutic program that included the use of a triad of medications lowdose aspirin, lovastatin and lisinopril.

The threeyear clinical observational study found that offering 40 milligrams of lovastatin and 20 milligrams of lisinopril daily for two years to people not already on both drugs reduced their risk of hospitalization for heart attack or stroke the following year by more than 60 percent. Aspirin was not part of the study because it was overthecounter and its use could not be measured through pharmacy records. However, it was separately estimated that 75 percent of study participants were already taking aspirin. The study was conducted by Kaiser Permanentes Care Management Institute in Oakland, Calif., which synthesizes knowledge on the best clinical practices to develop evidencebased care programs at Kaiser Permanente.

While previous research and clinical trials have shown that statins and angiotensinconverting enzyme inhibitors / angiotensin receptor blockers (ACEI/ARB) individually reduce heart attacks and strokes, this is the first study to evaluate whether a consistent process could be developed to deliver the combined drugs to large numbers of people with diabetes and/or heart disease in realistic settings across a health care delivery system. It is also the first study to evaluate how dramatically this program would affect clinical outcomes and hospitalization rates for heart attack and stroke.

The study followed 170,024 ethnically diverse Kaiser Permanente members in California with heart disease and/or diabetes for two years during the medication phase and for one year during the outcome monitoring phase. The study cohort was broken into three groups 21,292 members in the highexposure group who took the bundled drugs more than half of the time in 2004 and 2005 based on their prescription refill habits; a lowexposure group of 47,268 people who took the drug bundle less than half of the time during 2004 and 2005 based on their prescription refill habits, and a noexposure group of 101,464 people who either took neither or just one type of the two tracked drugs during 2004 and 2005.

The researchers found that among the study population as a whole, there were 21 heart attacks and strokes per 1,000 people in 2006. Among the 47,268 people in the group that had low exposure to the drugs, there were 726 fewer heart attacks and strokes than in the no exposure group, equivalent to a reduction of 15 heart attacks and strokes per 1,000 people. Among the 21,292 people in the high exposure group, there were 545 fewer heart attacks and strokes, equivalent to a reduction of 26 heart attacks and strokes per 1,000 people. The study estimated this effect to be a 60 percent savings of these events.

“Heart disease is the number one killer in the United States, and 23 million Americans have diabetes. This is a proven program that can be applied in many settings to reduce heart attacks and strokes, and at the same time decrease the cost of care for those events,” said the studys lead author, R. James Dudl, MD, the diabetes clinical lead at Kaiser Permanentes Care Management Institute.

These findings validate the forecasts of the Archimedes Model. The Archimedes Model simulated the pathophysiology, treatments, and outcomes of coronary artery disease and diabetes and its complications at the individual level and aggregated the results to project populationlevel effects. The model forecasted that “bundled” cardioprotective medications aspirin, lisinopril, and lovastatin would reduce the risk of heart attack and stroke in a highrisk population by 71 percent. In 2002 Kaiser Permanente researchers used the Archimedes Model to project the effects of offering the combined pharmacotherapy and to develop a simple, inexpensive method for delivering it.

The Kaiser Permanente researchers conducted this observational study of its drugbundling program as a clinical execution of the Archimedes modeling because the simulation model outcomes looked so promising, researchers said.

“The programs results confirm the Archimedes Models predictions that these treatments can save lives and reduce health care costs,” said David Eddy, MD, Ph.D., founder and chief medical officer emeritus of Archimedes, Inc.

Currently more than 256,000 Kaiser Permanente members in Hawaii, California, Oregon, Washington, Colorado, Ohio, Georgia, Maryland, Virginia, and Washington, D.C. are participating in the drug medication bundle program. Clinicians use Kaiser Permanente HealthConnect®, the worlds largest civilian electronic health records system, to find highrisk patients not already on the medications and use the health providers integrated delivery system to reach out to eligible members at every point of care.

As an example of how this program can be widely implemented in diverse populations and health care settings, this initiative has also been applied in community health centers through Kaiser Permanentes community benefit program. In underserved populations with varying levels of health literacy, the number of patients taking the bundle increased fourfold within a 12month period.

“We have long known from clinical trials that aspirin, cholesterollowering therapies such as statins, and ACE inhibitors such as lisinopril reduce the risk of future heart attacks and strokes in patients who have had a prior cardiovascular event or who have diabetes. Our primary goal here was to increase the use of the drugs,” said study coauthor Jim Bellows, Ph.D., Kaiser Permanente Care Management Institutes director of the Center for Evaluation and Innovation. Bellows helped develop the evaluation of the program to bundle and deliver the two medications.

Other authors on this study include Margaret C. Wang, Ph.D., MPH, and Michelle Wong, MPH, MPP, both of Kaiser Permanentes Care Management Institute.

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Emily Schwartz

CARD Brings Experts Together For Rochester New York Autism Conference

Posted by admin on Octubre 2nd, 2009 under autism Tags: , ,  •  No Comments

The Center for Autism and Related Disorders, Inc. (CARD) will host a one day, comprehensive CARD Rochester Autism Conference on October 28, 2009 at The Country Party House located at 321 East Linden in Rochester, New York.

“CARD has brought together six of its leading autism experts to present workshops which will deliver the most effective autism interventions, the latest in autism research and information on the most successful autism curricula to date,” says CARD Rochester Managing Supervisor Denise Rhine, MS Ed, BCBA. “We are confident that both professionals and parents will greatly benefit from this intensive conference.”

The CARD Rochester Autism Conference is designed for Board Certified Behavior Analysts (BCBAs), Board Certified Associate Behavior Analysts (BCaBAs), parents, caregivers, students, and professionals (including teachers, social workers, speech and language pathologists, and others).

The conference begins with a keynote address by world renowned autism expert, Dr. Doreen Granpeesheh and ends with a screening of RECOVERED Journeys Through the Autism Spectrum and Back, an awardwinning documentary of four children who recovered from autism.

For more information about the conference, visit centerforautism.com/autism_conference. Registration deadline is October 23, 2009.

Obstetricians Complication Rates Vary By Residency Program, Study Finds

Posted by admin on Octubre 1st, 2009 under womens health Tags: ,  •  No Comments

Obstetrics patients treated by graduates of certain residency programs have better health outcomes than others, according to a study by the University of Pennsylvanias Leonard Davis Institute of Health Economics, the New York Times reports. The study, published in the Journal of the American Medical Association, evaluated residency programs based on rates of complications among deliveries overseen by their graduates. Researchers analyzed the records of 4.9 million deliveries in Florida and New York state from 1992 to 2007, covering 4,124 obstetricians from 107 residency programs, the Times reports.

The study divided residency programs into five groups based on the graduates rates of patient complications, such as infections and bleeding, after both caesarean section and vaginal deliveries. About 10.3% of women whose infants were delivered by physicians in the top onefifth of programs experienced complications, compared with 13.6% of women treated by physicians from the other programs. David Asch, executive director of the Leonard David Institute, declined to state how specific programs fared.

Asch noted that complication rates for some other types of doctors are available on the Internet, adding, “We determined that obstetrics and gynecology residency programs also differ in the quality of the physicians they produce” (Rabin, New York Times, 9/29).

Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

Natural Products Associations Fabricant To Testify At Senate Hearing On Steroids And Sports Supplements

Posted by admin on Septiembre 30th, 2009 under complementary medicine Tags: , ,  •  No Comments

Daniel Fabricant, Ph.D., interim executive director and CEO of the Natural Products Association (NPA), will testify today before the Subcommittee on Crime and Drugs of the U.S. Senate Judiciary Committee during a hearing examining the illegal marketing of steroids as dietary supplements. Titled “Body Building Products and Hidden Steroids Enforcement Barriers,” the hearing will also include testimony from the Food and Drug Administration (FDA), Department of Justice and the United States Anti Doping Agency.

According to Fabricants testimony, NPA believes that “tougher enforcement and prosecution to the full extent of the law are the best ways to stop the criminals” responsible for selling steroids masquerading as dietary supplements. “The barriers to enforcement are simple money, manpower and will,” Fabricant said.

Fabricant also made the distinction between the “legal, safe and healthy dietary supplement industry” and the seedy, flybynight, and unsafe world of illegal steroids” and called on the FDA, DEA and other appropriate agencies to work together to enforce the law.

“We fully support the rules that already exist that ensure that whats on the label is whats in the bottle,” Fabricant said.

Fabricants complete testimony is available here.

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How Can I Connect With My Autistic Child?

Posted by admin on Septiembre 30th, 2009 under mental health Tags: ,  •  1 Comment

For fathers coming home from work and find it impossible to connect with their autistic child, it can typically be the straw that breaks the familys back. Where most children will greet Daddy with a hug, many autistic children arent capable of affectionate interactions that keep a family intact.

Emerson B. Donnell III lived that experience every day, decided to do something about it, and his research and experience has delivered results that no one could ever have thought possible. Specific strategies designed to elicit proper emotion have blossomed back into true affection. Today, Donnells son will greet him at the door with hugs, kisses and an engaging smile. The strategies to bring their world together have also helped his sons speech increase exponentially.

Donnell, author of “Dads And Autism, Learn How To Stay In The Game” from Altruist Publishing (dadsandautism.com) said that without the proper tools, developing a loving connection can be a monumental task. But getting that toehold is the seed towards healing not only the child, but the family as a whole.

Donnells approach combines tactics from a variety of proven sources, meshed with his own personal experiences. The result is a systematic program that enables fathers (and mothers) to bond and develop affection in their autistic child with specific tactics and strategies that can be exercised in the comfort of their homes.

“The new therapy that Ive applied is called Applied Affectionate Behavior Analysis (AABA),” he said. “I have also coined the term Discrete Affectionate Trials (DATs). These are specific exercises designed to elicit and develop proper emotion and affection in autistic children.”

Autism need not be a prison sentence for your child, or for your family, Donnell added.

“I can say with all certainty that if it wasnt for the specific I use at home, my son would still be a distant eyed stranger in my house,” he said. “Developing these tactics have not only saved my son, but very possibly my marriage.”

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Children Of Working Mothers Are More Likely To Lead Unhealthier Lifestyles

Posted by admin on Septiembre 29th, 2009 under fitness obesity Tags: ,  •  No Comments

Research published ahead of print in the Journal of Epidemiology and Community Health reports that children of working mothers are likely to lead unhealthier lifestyles than those whose mothers do not work.

The study suggests they are more sedentary and are more likely to be driven to school.

The research was based on more than 12,500 five year old singleton children who were part of the UK Millennium Cohort Study.

A questionnaire was handed out to the mothers about the hours they worked and their childrens diet, exercise levels, and sedentary activities.

The survey incorporated how much of sweets and crisps, sugary drinks, fruits and vegetables the child consumed. It also included questions on whether they took part in organized exercise and how they got to school.

In addition, mothers were asked how long their child spent in front of a TV or computer each day.

Factors likely to influence the results, such as maternal education and socioeconomic circumstances were taken into account. Results indicated that children whose mothers worked part, or full time, were more likely to mostly consume sugary drinks between meals than kids whose mothers had never worked.

Furthermore, these children were more likely to spend at least two hours a day in front of the TV or at a computer. They were also more likely to be driven to school rather than walk or cycle.

Children whose mothers worked full time were also less likely to mainly snack on fruit and vegetables between meals, or to eat three or more portions of fruit a day.

Those whose mothers worked flexi time were likely to have healthier lifestyles. However, once other influential factors had been taken into consideration, there was little indication that these children behaved more healthily.

In recent decades, the work patterns of dads have changed moderately. On the other hand, those of mothers have changed greatly. “Approximately 60 percent of mothers with children under five in the US and the UK now go out to work,” write the authors.

“But busy working parents may have less time to give their children healthy foods and opportunities for exercise,” say the authors. They refer to earlier research, suggesting an association between working mothers and a higher risk of obesity in their children.

“Our results do not imply that mothers should not work,” they remark. “Rather, they highlight the need for policies and programmes to help support parents” to create a healthy environment for their children.

They recommend that dietary guidelines for children in formal care (comparable to those already adopted in Scotland, for instance) should be applied in the UK.

“Examining the relationship between maternal employment and health behaviours in 5 year old British children”
S Sherburne Hawkins, T J Cole, C Law, The Millennium Cohort Study ChildHealth Group
Online First J Epidemiol Community Health 2009; doi 10.1136/jech.2008.084590
Journal of Epidemiology and Community Health

Experts Recommend New Name, More Research On Nonmalignant Breast Tumor

Posted by admin on Septiembre 28th, 2009 under womens health Tags: ,  •  No Comments

On Thursday, a panel of medical experts convened by NIH recommended that the word “carcinoma” be removed from the name of a nonmalignant breast tumor called ductal carcinoma in situ because the current terminology can mislead some women into believing they are likely to develop breast cancer, Reuters reports. DCIS is a condition in which abnormal cells have grown in the milk duct but not spread to breast tissue. The panel said more research is needed to determine the likelihood that a womans DCIS will progress into actual invasive breast cancer.

Since the start of widespread mammography in the late 1980s, DCIS diagnosis rates have increased sevenfold. By 2020, approximately one million U.S. women are expected to be living with the condition (Steenhuysen, Reuters, 9/24). More than 50,000 women are diagnosed with DCIS annually (Neergaard, AP/Baltimore Sun, 9/24).

Because DCIS is believed to be a risk factor for developing invasive breast cancer, the abnormal cells are removed, and only about 2% of DCIS patients die of breast cancer within 10 years. However, doctors have no way of knowing which women were at risk of developing invasive cancer and which would have remained healthy without treatment. In addition, there are vast differences in how the condition is treated, ranging from simple surgeries to chemotherapy or even protective removal of the opposite, healthy breast, the AP/Baltimore Sun reports (AP/Baltimore Sun, 9/24).

The panel concluded that a significant amount of new research is needed to determine which women can safely forgo intensive treatment (AP/Baltimore Sun, 9/24). “Despite having had a century of knowledge of the disease, we do not understand the natural history of DCIS, and probably never will,” according to panel Chair Carmen Allegra, an oncologist at the University of Florida (Reuters, 9/24).

The panel said that changing the name of the condition will help doctors better convey that while growth should not be ignored, there is no need for panic. While the experts did not offer an alternative name, Allegra said that the current inclusion of “carcinoma” in the name “carries with it such a disproportionate level of anxiety relative to the relatively indolent nature of the disease” (AP/Baltimore Sun, 9/24). Panel member Arnold Schwartz, a surgical pathologist at the George Washington University Hospital, disagreed with the panels recommendation to change the name. He said that many other cancers and precursor cancers include the name carcinoma in situ including those of the skin, head and neck, esophagus and bladder “without any emotional impact” (Reuters, 9/24).

Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

CIGNA Offers Assistance To Customers Affected By Georgia Floods

Posted by admin on Septiembre 26th, 2009 under aid disasters Tags: , ,  •  1 Comment

CIGNA (NYSECI) announced today that it is temporarily lifting certain medical and pharmacy restrictions in order to aid individuals impacted by severe flooding in Georgia.

People insured by CIGNA in the affected Carroll, Catoosa, Chattooga, Cherokee, Clayton, Cobb, Crawford, DeKalb, Douglas, Forsyth, Fulton, Gwinnett, Newton, Paulding, Rockdale, Stephens and Walker Counties can refill prescriptions early without prior approval and access care at any health care professional (innetwork or outofnetwork) at innetwork rates.

“The health and wellbeing of the individuals we serve is our primary concern,” said Susan Gaca, Director, CIGNA Disaster Response Team. “We hope that during times such as this, these actions will provide some relief to those impacted.”

This temporary measure is in place until September 27, 2009 and may be extended if necessary.

Customers with questions or concerns are encouraged to call the customer service phone number on their CIGNA ID card or the CIGNA nationwide customer service telephone number at 1.800.CIGNA24 (1.800.244.6224) for additional information about the waivers.

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