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Newsmaker Q&A with Thomas L. Spray, M.D.

Posted on by Charlie

Thomas L. Spray, M.D., is chief of the Division of Cardiothoracic Surgery at The Children’s Hospital of Philadelphia, director of the hospital’s Thoracic Organ Transplantation Program, and Professor of Surgery at the University of Pennsylvania School of Medicine. Community recently interviewed Dr. Spray about pediatric lung transplantation.

What are the most important considerations for parents when making decisions about pediatric lung transplants?

The fundamental issue here is that, lung transplantation is, unlike heart transplantation, not associated with as good long-term survival. In some ways it’s somewhat palliative. Five-year survival for lung transplant is about 50 percent. And despite lung transplants being around now for about 25 years, there hasn’t been a lot of improvement in survival.

The lung is an immunocompetent organ, unlike most other organ transplants. It has the disadvantages of being connected to the outside, so it’s always at risk of infection. Also, there are lymph nodes in the lungs, which probably make them more susceptible to rejection and latent chronic rejection, which is where most lung transplants eventually fail; something called bronchiolitis obliterans—scarring of the small airways of the lungs—which is thought to largely be a chronic rejection problem.

Having said that, there are isolated patients who do extremely well and do well over the long term, but if you just take the averages, the average survival is about five years. So that’s the disadvantage.

On the other hand, for many patients, especially pediatric patients, their survival is going to be measured in a matter of a year or less if they don’t get a lung transplant. So it’s successful, but it’s not perfect by any means. It’s generally very much palliative for children as well.

To what degree should the child be involved in the decision?

To what degree the child should be involved in the decision is somewhat age-dependent. When you have a lung transplant, you’re basically exchanging one disease for another one, because you then have to be on medicines to prevent rejection, and you have a certain amount of medical surveillance necessary.

Unfortunately lung transplantation is still a procedure that has a significant risk associated with it. The lungs cannot work sometimes. The outcome cannot be positive if you get a viral infection of the transplant early on—it can destroy the lungs. And that’s very hard for anyone to survive.

I can remember some patients though, with cystic fibrosis, after lung transplant, even when the lungs went bad, and they ultimately died, having said during the time they were alive, that it was worth everything just to breathe normally for a change. So you have to put it in perspective.

When you get into the teenage years, I think it’s appropriate for the child to be involved in the decision. I think it’s especially important for teenagers, who unfortunately have a fairly high risk of not being compliant with medical management, and then they reject their organs and die.

Just being an adolescent is a risk factor for transplant, it appears. It’s a difficult time. That’s why when you’re talking teenagers, it’s very important that they be involved in the decision process, so that they recognize that they have to be involved in the medical management. They have to take their medicines faithfully. They have to be seen frequently. And if they aren’t willing to do that, then it’s kind of foolish to go down that pathway.

What have been some of the advances in pediatric lung transplantation?

Patient room at The Children's Hospital of Philadelphia

Patient room at The Children’s Hospital of Philadelphia

Most of the advances in transplantation, in terms of survival, over the last 15 years, have been at the early period after transplant. In other words, we’ve been able to transplant more complex patients, who’ve had multiple previous operations, who were sicker waiting for transplant.

We’ve evolved to the point where it’s now possible to support patients on an assist device called ECMO while waiting for transplant and still have them able to be up and around and maintain their ability to breathe, so that it makes it easier after the transplant. So there are some advances, but there haven’t been any major advances in immunosuppression.

We have experience now transplanting newborns all the way up to adults. We’ve had experience with many kinds of complex congenital heart disease and lung transplants. We have experience in pulmonary hypertension. Those are the more common causes in children.

I think it’s important to note that in the pediatric world, the most common indications for transplant are considered the higher risk indications in the adult world. For example, in adult lung transplant, the most common indication is emphysema. Emphysema is a more straightforward condition to treat with lung transplant than any of the diseases that we see in children, and emphysema is virtually unheard of in children, so pediatric transplant by its very nature is a higher risk population.

What percentage of pediatric transplant patients have pulmonary hypertension?

At The Children’s Hospital of Philadelphia, at least 50 percent or more have congenital heart disease or pulmonary hypertension, and relatively fewer have cystic fibrosis. Part of that is because the management of cystic fibrosis has improved over the years such that there are relativity fewer children who require transplantation for cystic fibrosis than in the past. So, most people with cystic fibrosis can get to adulthood before they have enough lung deterioration to require transplant, and therefore get transplanted in adult centers now.

When we first started doing lung transplant in about 1990, when I was in St. Louis, cystic fibrosis was a common indication, because children under 18 with severe cystic fibrosis would come to St. Louis for transplant. In Philadelphia, we see less of that and more pulmonary hypertension and congenital heart disease.

What drew you to the lung transplantation field?

I started out as a congenital heart surgeon. Congenital heart surgeons all have to be adult heart surgeons first. I did adult and congenital heart surgery at St. Louis Children’s Hospital. I was recruited to come here to take over from William Norwood, a very well known surgeon, who went to Europe to start a new program.

When I came to Philadelphia, there wasn’t a lung transplant program in this area. So I started a pediatric lung transplant program when I came in 1994, having started the program in St. Louis in 1990.

I think my interest in lung transplant came from patients I saw in St. Louis who had no real, good option for repair of their heart, because they didn’t have good lungs to push blood into. There are certain types of congenital heart disease where that’s the case, where you could repair the heart defect if you had pulmonary arteries to pump blood into.

But children who don’t have that became progressively more cyanotic. I saw some of these children and I thought, ‘If we could just put new lungs in, we could fix the heart.’ So that’s what got me interested initially, and then that expanded to all the other potential reasons for lung transplant, of which there are many.

What are some of the differences in quality of life after a successful pediatric lung transplant?

Art therapy at The Children's Hospital of Philadelphia

Art therapy at The Childrens Hospital of Philadelphia

Quality of life depends on the patient’s condition before the transplant, but the majority in the pediatric population are extremely debilitated. They often have cystic fibrosis. They’re chronically infected. They have poor lung function. They have very little exercise tolerance. Patients with PH may have heart failure also. So the quality of life prior to transplant is very poor.

The waiting times are so long for lung transplant that most children deteriorate significantly while waiting in the hospital. They’re sometimes waiting in the hospital for a year or more.

So the quality of life after transplant, while vastly improved, takes a while for them to recuperate. I think what people often don’t realize is that if you’re sick for months and months prior to lung transplantation, there’s a lot of rehabilitation necessary. Even after a successful lung transplant, it’s not like patients are going home in a week. Many of them have to stay in the hospital for months while they’re literally recuperating and rehabilitating themselves from being chronically ill for the previous several years.

How much interaction do your patients have with the Child Life, Education and Creative Arts Therapy department at The Children’s Hospital of Philadelphia?

They have a great deal of interaction, especially while waiting. Children who are sick and in the hospital and literally waiting for sometimes months and months for organs to become available need that kind of interaction. They need to have play.

They need to have creative interactions, and that’s why the Child Life Department is so important for all the patients in the hospital, but even more important for those who are chronically in the hospital for long periods of time. They need to have that kind of stimulation. They need to be able to be involved in arts and crafts to keep them occupied, literally, to help them develop while they’re waiting.

What are some ways that families can cope with being on a waiting list?

Everyone, I think, does that differently. I think it’s always difficult for families to recognize that a waiting list is exactly that. You have no idea when organs might become available.

There are times when organs are available, and we tentatively accept them, and then they deteriorate to the point that we can’t use them. So the families have situations where their hopes are raised that they’ll have a transplant, and then it falls through, and then they’re back waiting again. So it’s a difficult thing for the families.

I think the families need to recognize that donor organs are hard to come by; they’re very scarce. The organ system is as fair and open as people can make it. It’s constantly trying to be as completely open and straightforward as possible and to not disadvantage anybody and make everybody on an equal playing field. But these are difficult things sometimes.

Transplantation in some ways is kind of a fundamentally flawed strategy, because you have to have a tragedy to have a miracle. Someone has to die for organs to be available, and as a physician and surgeon, I don’t want anyone to die. In a way, I don’t want there to be more donors.

On the other hand, I think the donors who are available should be used as maximally as possible, because there are so many children who need the organs. It’s a constant battle to try to use everyorgan you possibly can. But then some of them have problems and don’t work. That’s unfortunately the chance you take.

What programs are in place at The Children’s Hospital of Philadelphia to help families afford the cost of pediatric lung transplants?

Art therapy at The Children's Hospital of Philadelphia

Art Therapy at The Children’s Hospital of Philadelphia

There’s a whole process before someone is listed for transplantation that involves evaluating their financial situation. The hospital has many programs to try to get them into programs that will provide coverage. Because it makes little sense to do a lung transplant if you have no coverage for medications after the transplant, which happens in some crazy insurance arrangements.

The hospital sometimes will help families get Medicaid or some other government program that will at least provide them with follow-up medications and follow-up care. There’s a whole financial counseling group that works with families in relation to transplant, because you have to recognize it’s not a one-time deal. It’s like a new disease, if you will, transplantation.

What else is important to stress about how pediatric lung transplants are different from adult transplants?

The diseases are different, and they’re more complex. Many of the [pediatric] patients have had previous surgeries, which complicate the transplant significantly, in terms of bleeding and other issues.

I’ve said many times that the hardest part of transplantation is not putting the new organs in; it’s getting the old ones out. That can be extremely difficult due to the scarring and inflammation and previous infections. It can sometimes be extremely difficult just to get the old organs out without damaging other important structures. They can all be stuck together in the chest.

That’s one major challenge with lung transplant, especially in children. It’s not as common in adults. Most of the adults with emphysema have not had significant previous surgeries; they don’t have a lot of extra blood vessels.

Many of the children who need transplant are also ‘blue.’ They’re cyanotic. They don’t have normal oxygen levels. That stimulates development of blood vessels in the chest that can be very difficult to control at the time of transplant, and bleeding is much more of an issue.

Then of course we’re dealing with different sizes. In adults, they’re using mostly adult lungs and some teenage lungs. But in pediatric transplantation, we have to list patients in a very discrete size range, because we do transplants in patients all the way from newborns up to adult-size teenagers. So we have to have the ability to put very small lungs in small children.

We do occasionally use lobes or parts of lungs from adults in small children, which is something the adult world rarely, if ever does, because we have to deal with this wide size range.

All photos courtesy of The Children’s Hospital of Philadelphia

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FDA Approves SABRIL for Treating Children

Posted on by CVCAdmin
SABRIL

FOR IMMEDIATE RELEASE

Lundbeck’s SABRIL® (vigabatrin) Now Approved by U.S. FDA as an Adjunctive Treatment Option for Children 10 and older with Refractory Complex Partial Seizures

Deerfield, Ill., October 28, 2013 – The U.S. Food and Drug Administration (FDA) approved SABRIL (vigabatrin) as add-on therapy for the treatment of refractory complex partial seizures (CPS) in children 10 years of age and older who have inadequately responded to several other treatments and if the possible benefit outweighs the risk of vision loss.1 This approval expands upon the age range of SABRIL’s previous indication as adjunctive therapy for adults with refractory CPS. SABRIL is not indicated as a first-line agent for refractory CPS.

Of the more than two million Americans affected by epilepsy,2 approximately 35 percent have CPS, which originates from a single region of the brain and can cause impaired consciousness.3 Approximately 30 to 36 percent of those with CPS continue to have seizures despite trying multiple therapies, and are considered to have refractory CPS.4,5,6

“It is crucially important for people with challenging seizures like refractory CPS to not give up and continue striving for improved seizure management, and this expanded Sabril indication provides another consideration for the treatment of those ten and older with refractory CPS,” said Philip Gattone, president and CEO of the Epilepsy Foundation. “We encourage people living with such challenging seizures and their loved ones to have ongoing conversations with their doctor about available options to help manage this intractable seizure disorder.”

When SABRIL was first approved in 2009, a patient registry was established to collect information on all patients who are prescribed SABRIL. To date, more than 5,600 patients have been treated with SABRIL, a substantial number of whom have been treated for refractory CPS.7 In evaluating whether to start SABRIL, doctors, patients and their caregivers work together to assess the risk of permanent vision loss versus the benefit of seizure reduction. There are other serious risks associated with SABRIL. Please see the important safety information below for more details.

“With so many children still having seizures due to refractory CPS, we are very pleased that the FDA has approved SABRIL for patients 10 and older who may benefit from a new add-on treatment option,” said Amy Magro, Director of Epilepsy Marketing at Lundbeck. “For those caring for a child as young as 10, we hope this new indication provides encouragement to speak with their child’s doctor about the risks and potential benefits of adding SABRIL for refractory CPS.”

In addition to its refractory CPS indication, SABRIL is approved for use in babies one month to two years of age with infantile spasms if the possible benefit outweighs the potential risk of vision loss.

For more information, please visit www.SABRIL.net.

About SABRIL® (vigabatrin) 1
SABRIL is a prescription oral antiepileptic drug developed in the United States by Lundbeck. SABRIL is available in 500-mg tablets or 500-mg packets of powder for oral suspension. Because of the risk of permanent vision loss, SABRIL is available only through a restricted program under a REMS called the SHARE Program. (1-888-45-SHARE).

Use
SABRIL (vigabatrin) is a prescription medicine used with other treatments in adults and children 10 years of age and older with refractory complex partial seizures (CPS), who have not responded well enough to several other treatments, and if the possible benefits outweigh the risk of vision loss. SABRIL should not be the first medicine used to treat CPS.

SABRIL (vigabatrin) is a prescription medicine used in babies, 1 month to 2 years old, with infantile spasms (IS), if the possible benefits outweigh the possible risk of vision loss.

Important Safety Information

WARNING: VISION LOSS

See Medication Guide and full Prescribing Information for complete information

In all people who take SABRIL:

• You are at risk for vision loss with any amount of SABRIL

• Your risk of vision loss may be higher the more SABRIL you take daily and the longer you take it

• It is not possible for your healthcare provider to know when vision loss will happen. It could happen soon after starting SABRIL or any time during treatment. It may even happen after treatment has stopped.

Please see SABRIL Medication Guide, full Prescribing Information including Boxed Warning, and Instructions for Use; go to www.sabril.net, or call toll-free 1-888-45-SHARE (1-888-457-4273).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

About Lundbeck in the U.S.
A wholly owned subsidiary of H. Lundbeck A/S of Denmark, Lundbeck in the United States is headquartered in Deerfield, Illinois, and is committed to providing innovative specialty therapies that fulfill unmet medical needs of people with central nervous system (CNS) disorders, including several therapies for people with challenging seizure disorders.

With a special commitment to the epilepsy community, Lundbeck actively supports and participates in hundreds of community-based initiatives. Learn more about our epilepsy community programs at http://www.lundbeck.com/us/our-commitment/community-involvement.

About H. Lundbeck A/S
Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with brain diseases. For this purpose, Lundbeck is engaged in the entire value chain throughout research, development, production, marketing and sales of pharmaceuticals across the world. The company’s products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy, Huntington’s, Alzheimer’s and Parkinson’s diseases. Lundbeck’s pipeline consists of several mid- to late-stage development programs.

Lundbeck employs more than 5,800 people worldwide, 2,000 of whom are based in Denmark. We have employees in 57 countries and our products are registered in more than 100 countries. We have research centers in Denmark, China and the United States and production facilities in Italy, France, Mexico, China and Denmark. Lundbeck generated revenue of approximately DKK 15 billion in 2012. Lundbeck’s shares are listed on the stock exchange in Copenhagen under the symbol “LUN.” Lundbeck has a sponsored Level 1 ADR programme listed in the US (OTC) under the symbol “HLUYY.” For additional information, we encourage you to visit our corporate site www.lundbeck.com.

Sources

  1. SABRIL® (vigabatrin) full Prescribing Information, Deerfield, IL. Lundbeck. 2013.
  2. Epilepsy Foundation. About Epilepsy: Statistics. http://www.epilepsyfoundation.org/aboutepilepsy/index.cfm/statistics. Accessed 10/2/13.
  3. Carroll E. Medscape. Complex Partial Seizures. http://emedicine.medscape.com/article/1183962-overview. Accessed 10/2/13.
  4. Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000; 342:314-9.
  5. Devinsky O. Patients with refractory seizures. N Engl J Med. 1999;340:1565-70.
  6. Rielo DM. Medscape. Vagus Nerve Stimulation. 2011. http://emedicine.medscape.com/article/1186123-overview. Accessed 10/2/13.
  7. Data on File.

###

CONTACT:
Matt Flesch
847-282-1154

SABRIL is a registered trademark of Lundbeck.

VGB-B-00018

Opsumit

Actelion receives U.S. FDA approval of Opsumit (macitentan) for the treatment of pulmonary arterial hypertension.

Allschwil, Switzerland, October 18, 2013 – Actelion Ltd (SIX: ATLN) announced today that the United States Food and Drug Administration (FDA) has approved the use of the orally available endothelin receptor antagonist Opsumit® (macitentan) 10 mg once daily for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression.

Opsumit is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). Opsumit also reduced hospitalization for PAH.

Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years. Patients were treated with Opsumit® monotherapy or in combination with phosphodiesterase-5 inhibitors or inhaled prostanoids. Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%).

Dr. Vallerie McLaughlin, Director of the Pulmonary Hypertension Program in the Division of Cardiovascular Medicine at the University of Michigan, commented: “Over the past twenty years, great strides have been made in treating PAH patients. However, there has been a medical need for innovative treatments that improve long-term outcomes. Opsumit® is the first clinically proven and only oral treatment option indicated to delay disease progression and reduce the need for PAH hospitalization.”

Dr. McLaughlin concluded: “These effects were demonstrated in SERAPHIN, the first and largest PAH outcome study to date, where Opsumit® was given on average for 2 years, as a monotherapy or in combination with phosphodiesterase-5 inhibitors or inhaled prostanoids. I am very pleased that PAH patients will have this new treatment option.”

Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: “Today’s approval of Opsumit® by the FDA is providing the PAH community with a unique treatment option, the only oral PAH medicine that has proven to delay disease progression. Over the last 14 years, Actelion has worked tirelessly to first discover and then develop Opsumit® in the largest, longest and first-ever outcome study in PAH. I would like to express my gratitude to all the members of the PAH community. Without their contribution, Opsumit® would not have become a reality. We will now leverage our existing PAH expertise and infrastructure to bring Opsumit® to patients within the coming weeks.”

The US label for Opsumit® carries a Boxed Warning alerting patients and health care professionals that the drug should not be used in pregnant women because it can harm the developing fetus. Female patients can receive the drug only through the Opsumit REMS Program. All female patients must be enrolled in the program, comply with pregnancy testing requirements and be counselled regarding the need for contraception.

The most common adverse reactions (more frequent than placebo by 3% or more) observed in patients treated with Opsumit® were anemia, nasopharyngitis/pharyngitis, bronchitis, headache, influenza, and urinary tract infection.

Physicians are advised to measure hemoglobin and liver enzymes prior to initiation of Opsumit® and repeat during treatment as clinically indicated.

In the United States, Actelion expects Opsumit® to become available to patients in November. Outside of the United States, Actelion continues to work with health authorities to obtain regulatory approval for Opsumit® .

The FDA approval was based in part on data from the landmark phase III SERAPHIN study. Published in the New England Journal of Medicine in August 2013, the SERAPHIN study showed the risk of the first occurrence of a morbidity or mortality event, the primary endpoint of the study, was reduced by 45% (p<0.0001) with macitentan 10 mg compared to placebo. This effect was observed irrespective of whether or not patients were already treated with other therapies for PAH. SERAPHIN also showed a risk reduction in PAH related hospitalization and death of 50% (p<0.0001) compared to placebo. [1].

Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual. The symptoms of PAH are non-specific and can range from mild breathlessness and fatigue during normal daily activity to symptoms of right heart failure and severe restrictions on exercise capacity and ultimately reduced life expectancy.

NOTES TO THE EDITOR
ABOUT OPSUMIT® (MACITENTAN)

Opsumit® (macitentan) is a novel dual endothelin receptor antagonist (ERA) that resulted from a tailored drug discovery process with the target of developing an ERA to address efficacy and safety [3].

ABOUT THE SERAPHIN STUDY
SERAPHIN (Study with an Endothelin Receptor Antagonist in Pulmonary arterial Hypertension to Improve cliNical outcome) was the largest and longest randomized, controlled study in PAH patients to include a clearly defined morbidity/mortality primary endpoint [2]. The pivotal Phase III study was designed to evaluate the efficacy and safety of Opsumit®(macitentan) – a novel dual endothelin receptor antagonist that resulted from a tailored drug discovery process – through the primary endpoint of time to first morbidity and all-cause mortality event in patients with symptomatic PAH.

Global enrollment was completed in December 2009 with a total of 742 patients. Patients were randomized 1:1:1 to receive two different doses of macitentan (3 mg and 10 mg once daily) or placebo. Patients were allowed to receive PAH background therapy throughout the study, either PDE-5 inhibitors or oral/inhaled prostanoids. This event-driven study was conducted in 151 centers from almost 40 countries in North America, Latin America, Europe, Asia-Pacific and Africa and was completed in the first half of 2012, with 287 patients having an adjudicated event.

Dr. McLaughlin is a consultant to Actelion and was an investigator in the SERAPHIN trial.

ABOUT SERAPHIN STUDY DATA
Patients were randomized to placebo (n=250), macitentan 3 mg (n=250), or macitentan 10 mg (n=242). The primary end point occurred in 46.4%, 38.0%, and 31.4% of the patients in these groups, respectively. The hazard ratio for macitentan 3 mg versus placebo was 0.70 (97.5% CI, 0.52 to 0.96; p=0.0108) and the hazard ratio for macitentan 10 mg versus placebo was 0.55 (97.5% CI, 0.39 to 0.76; p<0.0001). Worsening of pulmonary arterial hypertension was the most frequent primary end point event. The effect of macitentan on this end point was observed irrespective of background therapy for pulmonary arterial hypertension. [1]

ABOUT THE SAFETY AND TOLERABILITY PROFILE
Opsumit is contraindicated in pregnancy because it may harm the developing fetus. Females of reproductive potential should be counselled on the use of reliable contraception and have a negative pregnancy test prior to initiating therapy and monthly thereafter.

Other ERAs have been associated with elevations of aminotransferases, hepatotoxicity, and liver failure. Liver enzyme tests should be obtained prior to initiation of Opsumit® and repeated during treatment as clinically indicated. If clinically relevant aminotransferase elevations occur, or if elevations are accompanied by clinical symptoms of hepatoxicity, discontinue Opsumit®.

Decreases in hemoglobin concentration and hematocrit occurred following administration of other ERAs and were observed in clinical studies with OPSUMIT. The decreases occurred early and stabilized thereafter. Decreases in hemoglobin seldom require transfusion. Initiation of Opsumit® is not recommended in patients with severe anemia. Hemoglobin should be measured prior to initiation of treatment and repeat during treatment as clinically indicated.

Should signs of pulmonary edema occur, consider the possibility of associated PVOD. If confirmed, discontinue Opsumit®.

Other ERAs have been associated with adverse effects on spermatogenesis. Men should be counseled about potential effects on fertility.

The use of Opsumit® with strong CYP3A4 inducers or inhibitors should be avoided.

The most common adverse reactions (more frequent than placebo by 3% or more) observed in patients treated with Opsumit were anemia, nasopharyngitis/pharyngitis, bronchitis, headache, influenza, and urinary tract infection.

ABOUT OPSUMIT® (MACITENTAN) SUBMISSIONS TO HEALTHCARE AUTHORITIES

Approval of the new drug application for Opsumit® (macitentan) was issued by the US Food and Drug Administration (FDA) on 18October 2013 for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). The need for PAH hospitalization was also reduced.

Regulatory reviews are ongoing in Europe, Canada, Switzerland, Australia, Taiwan, Korea and Mexico.

ABOUT PULMONARY ARTERIAL HYPERTENSION [9, 10]

Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual. The symptoms of PAH are non-specific and can range from mild breathlessness and fatigue during normal daily activity to symptoms of right heart failure and severe restrictions on exercise capacity and ultimately reduced life expectancy.

PAH is one group within the classification of pulmonary hypertension (PH). This group includes idiopathic PAH, heritable PAH and PAH caused by factors which include connective tissue disease, HIV infection and congenital heart disease.

The last decade has seen significant advances in the understanding of the pathophysiology of PAH, which has been paralleled with developments of treatment guidelines and new therapies. Drugs targeting the three pathways that have been established in the pathogenesis of PAH are endothelin receptor antagonists (ERAs), prostacyclins and phosphodiesterase-5 inhibitors. PAH treatments have transformed the prognosis for PAH patients from symptomatic improvements in exercise tolerance 10 years ago to delayed disease progression today. Improved disease awareness and evidence-based guidelines developed from randomized controlled clinical trial data have highlighted the need for early intervention, goal-oriented treatment and combination therapy.

In PAH, survival rates are unacceptably low and PAH remains incurable.

References

  1. Pulido T et al. Macitentan and Morbidity and Mortality in Pulmonary Arterial Hypertension. N Engl J Med 2013;369:809-18.
  2. Proceedings of the 4th world symposium on pulmonary hypertension. J Am CollCardiol 2009;54(1 Suppl).
  3. Bolli MH et al. The Discovery of N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N’-propylsulfamide (Macitentan), an Orally Active, Potent Dual Endothelin Receptor Antagonist. J Med Chem. 2012; 55:7849-61.
  4. Gatfield J, Mueller Grandjean C, Sasse T, Clozel M, Nayler O (2012). Slow Receptor Dissociation Kinetics Differentiate Macitentan from Other Endothelin Receptor Antagonists in Pulmonary Arterial Smooth Muscle Cells. PLOS ONE 7(10): e47662. doi:10.1371/journal.pone.0047662
  5. Iglarz M et al. Pharmacology of macitentan, an orally active tissue-targeting dual endothelin receptor antagonist. J PharmacolExpTher. 2008;327(3):736-45.
  6. Sidharta PN et al. Macitentan: Entry-into-humans study with a new endothelin receptor antagonist. Eur J ClinPharmacol. 2011;67(10):977-84
  7. Bruderer S et al. Absorption, distribution, metabolism, and excretion of macitentan, a dual endothelin receptor antagonist, in humans. Xenobiotica. 2012 Sep;42(9):901-10
  8. Bruderer S et al. Effect of cyclosporine A and rifampin on the pharmacokinetics of macitentan, a tissue-targeting dual endothelin receptor antagonist. AAPS J. 2012;14(1):68-78.
  9. Galiè N, Hoeper MM, Humbert M, et al; ESC Committee for Practice Guidelines (CPG). Guidelines for the diagnosis and treatment of pulmonary hypertension: the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), endorsed by the International Society of Heart and Lung Transplantation (ISHLT). Eur Heart J 2009;30:2493-537
  10. Benza RL, Miller DP, Barst RJ, Badesch DB, Frost AE, McGoon MD. An evaluation of long-term survival from time of diagnosis in pulmonary arterial hypertension from REVEAL. Chest 2012;142:448-56.

Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion’s first drug Tracleer® (bosentan), an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union, Japan, Canada, Australia and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium – the single layer of cells separating every blood vessel from the blood stream. Actelion’s over 2,300 employees focus on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index SMI®).

For further information please contact:
Roland Haefeli
Senior Vice President, Head of Investor Relations & Public Affairs
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
+1 650 624 69 36
www.actelion.com

The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

Adempas

News Release Intended for U.S. Media Only


FDA Approves Bayer’s New Class of Drug Adempas® (riociguat) tablets to Treat Adults with PAH and Persistent, Recurrent or Inoperable CTEPH First and only drug approved in U.S. to Treat Two Forms of Pulmonary Hypertension (WHO Group 1 and 4)


Whippany, N.J., October 8, 2013 – Bayer HealthCare announced today that the United States Food and Drug Administration (FDA) has approved Adempas®  (riociguat) tablets for: (i) the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (WHO*  Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class; and (ii) the treatment of adults with pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and delay clinical worsening. In PAH, efficacy was shown in patients on Adempas monotherapy or in combination with endothelin receptor antagonists (ERAs) or prostanoids (inhaled, oral or subcutaneous). Studies establishing effectiveness included predominately patients with WHO functional class II-III and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (25%). Adempas is the only treatment approved in the U.S. for use in two types of pulmonary hypertension (WHO Group 1 and 4). It is the first and only FDA-approved drug therapy for persistent/recurrent CTEPH after surgical treatment or inoperable CTEPH. It is also the only approved oral therapy in PAH with efficacy shown in monotherapy or in combination with ERAs or prostanoids. For all female patients, Adempas is available only through a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) Program.

1 World Health Organization

“CTEPH and PAH are serious and life-threatening diseases,” said Nick H. Kim, Associate Clinical Professor of Medicine, Division of Pulmonary and Critical Care Medicine; Director, Pulmonary Vascular Medicine; Director, Fellowship Program; University of California San Diego. “The approval of Adempas equips physicians with a new approach to treating PAH patients, and it gives us the first approved drug treatment for patients with inoperable CTEPH or with persistent/recurrent CTEPH after surgery. While surgery should always be considered as the first treatment option for CTEPH, the fact remains that up to forty percent of CTEPH patients are not eligible for surgery, and ten to thirty-five percent of CTEPH patients have disease that persists after surgery.” PAH is a disease characterized by elevated pressure in the pulmonary arteries. CTEPH is a form of pulmonary hypertension in which blood clots and thromboembolic occlusion of the pulmonary vessels leads to increased pressure in the pulmonary arteries. The standard treatment for CTEPH is pulmonary endarterectomy, a potentially curative surgery that clears clots and scar material from the blood vessels of the lung. “Bayer is deeply committed to bringing new treatment options to patients with life-threatening diseases. Adempas is an excellent example of this commitment, because it is the result of years of dedicated research in our Bayer laboratories into a new way of treating two forms of pulmonary hypertension,” said Pamela A. Cyrus, MD, Vice President and Head, U.S. Medical, Bayer HealthCare Pharmaceuticals. “We are pleased to bring this new class of treatment to patients with PAH or with inoperable CTEPH or persistent/recurrent CTEPH after surgical treatment.” Rino Aldrighetti, President and CEO, Pulmonary Hypertension Association added, “From a patient’s perspective, living with pulmonary hypertension remains difficult. We know that not all treatments work for all people. We get excited when there is a new treatment option for PAH patients, and we are thrilled there is finally an approved drug treatment for people living with persistent/recurrent CTEPH after surgical treatment or inoperable CTEPH.” Adempas, a stimulator of soluable guanylate cyclase (sGC), represents a new class of drug now available in the U.S. Pulmonary hypertension is associated with endothelial dysfunction, impaired synthesis of nitric oxide (NO) and insufficient stimulation of the NO-sGC-cGMP pathway. Adempas sensitizes sGC to endogenous NO by stabilizing the NO-sGC binding. Adempas also directly stimulates sGC via a different binding site independently of NO. Adempas restores the NO-sGC-cGMP pathway and leads to increased generation of cGMP with subsequent vasodialation. The most common adverse reactions occurring more frequently (>3%) on Adempas than placebo were headache (27% vs 18%), dyspepsia/gastritis (21% vs. 8%), dizziness (20% vs 13%), nausea (14% vs 11%), diarrhea (12% vs 8%), hypotension (10% vs 4%), vomiting (10% vs 7%), anemia (7% vs 2%), gastroesophageal reflux disease (5% vs 2%), and constipation (5% vs 1%). Other events that were seen more frequently in Adempas compared to placebo and potentially related to treatment were: palpitations, nasal congestion, epistaxis, dysphagia, abdominal distension and peripheral edema. About Patient Assistance Program Bayer offers patient assistance through the Adempas Aim Support Center program, which will assist with obtaining coverage and patient support of Adempas. Patients and providers may contact the program at 1-855-4ADEMPAS for additional information. IMPORTANT SAFETY INFORMATION 

WARNING: EMBRYO-FETAL TOXICITY Do not administer Adempas (riociguat) tablets to a pregnant female because it may cause fetal harm.

Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment. Prevent pregnancy during treatment and for one month after stopping treatment by using acceptable methods of contraception.

For all female patients, Adempas is available only through a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) Program.

Contraindications. Adempas is contraindicated in:

Warnings and Precautions Embryo-Fetal Toxicity. Adempas may cause fetal harm when administered during pregnancy and is contraindicated for use in women who are pregnant. In females of reproductive potential, exclude pregnancy prior to initiation of therapy, advise use of acceptable contraception and obtain monthly pregnancy tests. For females, Adempas is only available through a restricted program under the Adempas REMS Program. Adempas REMS Program. Females can only receive Adempas through the Adempas REMS Program, a restricted distribution program. Important requirements of the Adempas REMS program include the following:

Further information, including a list of certified pharmacies, is available at www.AdempasREMS.com or 1-855-4ADEMPAS. Hypotension. Adempas reduces blood pressure. Consider the potential for symptomatic hypotension or ischemia in patients with hypovolemia, severe left ventricular outflow obstruction, resting hypotension, autonomic dysfunction, or concomitant treatment with antihypertensives or strong CYP and P-gp/BCRP inhibitors. Consider a dose reduction if patient develops signs or symptoms of hypotension. Bleeding. In the placebo-controlled clinical trials program, serious bleeding occurred in 2.4% of patients taking Adempas compared to 0% of placebo patients. Serious hemoptysis occurred in 5 (1%) patients taking Adempas compared to 0 placebo patients, including one event with fatal outcome. Serious hemorrhagic events also included 2 patients with vaginal hemorrhage, 2 with catheter site hemorrhage, and 1 each with subdural hematoma, hematemesis, and intra-abdominal hemorrhage. Pulmonary Veno-Occlusive Disease. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Therefore, administration of Adempas to such patients is not recommended. Should signs of pulmonary edema occur, the possibility of associated PVOD should be considered and if confirmed, discontinue treatment with Adempas.  Most Common Adverse Reactions  The most common adverse reactions occurring more frequently (>3%) on Adempas than placebo were headache (27% vs 18%), dyspepsia/gastritis (21% vs. 8%), dizziness (20% vs 13%), nausea (14% vs 11%), diarrhea (12% vs 8%), hypotension (10% vs 4%), vomiting (10% vs 7%), anemia (7% vs 2%), gastroesophageal reflux disease (5% vs 2%), and constipation (5% vs 1%). Other events that were seen more frequently in Adempas compared to placebo and potentially related to treatment were: palpitations, nasal congestion, epistaxis, dysphagia, abdominal distension and peripheral edema. For important risk and use information, please see the full Prescribing Information, including Boxed Warning, at www.adempas-us.com. About Bayer HealthCare Pharmaceuticals Inc. Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world’s leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women’s Healthcare. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases. Bayer® and the Bayer Cross® are registered trademarks of Bayer. Intended for U.S. media only U.S. Media Contact: Marcy Funk, Communications, Bayer HealthCare Telephone: (862) 404-5385 E-Mail: marcy.funk@bayer.com Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Adempas

News Release Intended for U.S. Media Only


FDA ADVISORY COMMITTEE UNANIMOUSLY RECOMMENDS APPROVAL OF BAYER’S RIOCIGUAT IN TWO PULMONARY HYPERTENSION INDICATIONS

If approved by the FDA, riociguat will be the first treatment for inoperable CTEPH or persistent/recurrent CTEPH after surgery and a new treatment for PAH


Whippany, N.J., August 6, 2013– Bayer HealthCare today announced that the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee recommended approval for investigational riociguat, proposed trade name Adempas™, in two forms of pulmonary hypertension. The Committee voted 11 to 0 that riociguat should be approved for the treatment of pulmonary arterial hypertension [PAH] of WHO1 Group 1. The Committee also voted 11 to 0 that riociguat should be approved for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) of WHO Group 4. In February 2013, Bayer submitted a new drug application for riociguat in two indications: (i) the treatment of PAH (WHO Group 1) to improve exercise capacity, improve WHO functional class and delay clinical worsening; and (ii) the treatment of persistent/recurrent CTEPH (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class. “We appreciate the Committtee’s discussion today around the safe and appropriate use of riociguat and are pleased with the outcome of the votes,” said Pamela A. Cyrus, MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. “If approved, riociguat will offer a new treatment option for patients with PAH and will also provide the first approved non-surgical treatment option for CTEPH patients who are inoperable or who have recurrent or persistent disease. We look forward to continued dialogue with the FDA in order to make riociguat available to patients.”

1 World Health Organization

PAH and CTEPH are both life-threatening forms of pulmonary hypertension that cause significantly increased pressure in the pulmonary arteries. Riociguat is an investigational, oral medication for the treatment of adult patients with PAH or inoperable or persistent/recurrent CTEPH. If approved by the FDA later this year, it would create a new class of therapy available in the U.S. PH is associated with endothelial dysfunction, impaired synthesis of nitric oxide (NO) and insufficient stimulation of soluble guanylate cyclase (sGC). Riociguat stimulates sGC independent of NO and increases the sensitivity of sGC to NO. Data presented at today’s advisory committee meeting included results from the global Phase 3 clinical program, which enrolled 704 patients across two Phase 3 studies. Both studies met their primary endpoint by demonstrating a statistically significant improvement in the six-minute walk test (6MWT), after 16 and 12 weeks respectively. Riociguat was also associated with improvements across multiple, relevant, secondary endpoints in the studies. The most common treatment-emergent adverse events with riociguat were headache, dizziness, dsypesia, peripheral edema, nausea, diarrhea and vomiting. The advisory committee’s vote will be taken into consideration by the FDA when making its decision on the approvability of Bayer’s NDA for riociguat, which was submitted in February 2013. After acceptance of the NDA, the FDA granted riociguat priority review designation, which is given to drugs that have the potential to offer significant improvement in treatment or provide a treatment option where no adequate therapy exists. About Pulmonary Arterial Hypertension (PAH) In PAH, a rare and life-threatening disease, the blood pressure in the pulmonary arteries (the arteries that take de-oxygenated blood to the lungs from the heart) is significantly increased. PAH is characterized by morphological changes to the endothelium of the arteries of the lungs causing remodeling of the tissue, vasoconstriction and thrombosis-in-situ. As a result of these changes, the blood vessels in the lungs are narrowed, making it difficult for the heart to pump blood through to the lungs. In most cases, PAH has no known cause and, in some cases, it can be inherited. About Chronic Thromboembolic Pulmonary Hypertension (CTEPH) CTEPH is also a rare and life-threatening disease in which it is believed that thromboembolic occlusion (organized blood clots) of pulmonary vessels gradually lead to an increased pressure in the pulmonary arteries, resulting in an overload of the right heart. CTEPH may evolve after prior episodes of acute pulmonary embolism, but the pathogenesis is not yet completely understood. The standard treatment for CTEPH is pulmonary endarterectomy (PEA), a surgical procedure in which the blood vessels of the lungs are cleared of clot and scar material. However, CTEPH is inoperable in an estimated 20 to 40 percent of patients, and, in some cases, the disease persists or reoccurs after surgery. About Bayer HealthCare Pharmaceuticals Inc.Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world’s leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women’s Healthcare. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases. Bayer® and the Bayer Cross® are registered trademarks of Bayer.

Intended for U.S. media only Media Contact: Marcy Funk, Communications, Bayer HealthCare Telephone: (862) 404-5385 E-Mail: marcy.funk@bayer.com

Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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Line Dancing

Posted on by Charlie

Modern artist Paul Klee admired and was inspired by the spontaneous power of children’s art. Eva Leonard reports on Klee’s life, art, and creative perseverance as he fought the destructive forces of the Nazi party and the effects of systemic scleroderma.

One of the world’s most celebrated and influential modern artists, Paul Klee (pronounced “klay”), drew profound inspiration from the art of children. Because Klee believed that children created the purest art, he worked to make his art more child-like.

And he took very creative steps to do so. To reduce the impact of his artistic education on his art, he sometimes switched hands or closed his eyes when he drew, and he also used methods such as scraping layers of paint from his work to reveal the colors underneath. Klee also collected and studied the drawings of his son, Felix, and those of other children.

Two Heads, 1932. Paul Klee Swiss, 1879-1940. © 2013 Artists Rights Society (ARS), New York / VG Bild-Kunst, Bonn

(Above) Two Heads, 1932. Paul Klee. Swiss, 1879-1940. Encaustic, oil (?) and pencil on canvas. 31-7/8 x 33-1/2 in. (81.0 x 85.1 cm). Norton Simon Museum, The Blue Four Galka Scheyer Collection. P.1953.066 © 2013 Artists Rights Society (ARS), New York / VG Bild-Kunst, Bonn.

The influence of children’s art on his work, with its simple, bold lines, and vivid colors, is clear in his cheeky response to art critics of the time: “Those gentlemen, the critics, often say that my pictures resemble the scribbles and messes of children. I hope they do!”

Klee’s observation, “A line is a dot that went for a walk,” reflects his boundless sense of playfulness and imagination. He was prolific, producing more than ten thousand works of art, more than two thousand of which he created following the appearance of symptoms that would later be diagnosed as scleroderma. His desire to continually simplify his technique would serve him in his later years, as the symptoms of scleroderma began to limit his movement.

Born in 1879 near Bern, Switzerland, into a family of musicians, Klee first studied to become a violinist. He initially drew only in black and white, but a trip to Tunisia in 1914 awakened his sense of color and light. Klee also used elements of music, letters, numbers, and hieroglyphic-like symbols in his work, and was intrigued by the art of the mentally ill.

In 1906, he married the pianist Lili Stumpf, and the couple moved to Munich. In 1916, he joined the German army, painting camouflage on planes. Klee lectured at the Bauhaus from 1921 to 1931 and at the Art Academy in Dusseldorf until the Nazis dismissed him in 1933, when he refused to pledge allegiance to the party, and the Gestapo searched his home. He then fled Nazi Germany for Switzerland.

The Nazis declared Klee’s art “degenerate,” as they did most Modern art, including the works of Pablo Picasso, Joan Miró, and Salvador Dali, which they deemed counter to Nazi ideals. The Nazis seized more than a hundred of Klee’s works from public collections. Their so-called “Degenerate Art” exhibition in 1937 in Munich, meant to ridicule art they considered “un-German,” included 17 works by Klee.

After fleeing to Switzerland, Klee had his first exhibition in London and was visited by well-known artists, including Picasso, and Wassily Kandinsky. His star rose in the United States, where he earned kudos from artists Diego Rivera and Frida Kahlo, as well as from art dealers, collectors, and museum directors.

A line is a dot that went for a walk ...In 1936, the first symptoms of Klee’s scleroderma—heart irregularities, fatigue, weakness, chronic pneumonia, hardening of the skin, and gastrointestinal problems—became pronounced. Although he produced only 25 works of art that year, he rebounded as the disease stabilized. He also found new ways to create, using different styles and materials, creating 264 works the following year and more than twelve hundred pieces in 1939.

Klee’s scleroderma was likely diffuse systemic sclerosis, the most serious form of the disease. (There were no treatments for it at that time, and the condition went undiagnosed until after his death.) His art provided refuge and a way to express his struggles with the illness.

In his book, “Paul Klee and His Illness” (Karger, 2010), the author, Hans Suter, M.D., noted, “For Klee, drawing and painting were his personal form of meditation. It seems to me that this ability to sink into deep thought while working provided an excellent opportunity to get anxiety and distress out of his system.”

As Klee’s scleroderma progressed, it prevented him from doing two of the things he most enjoyed: hiking and playing the violin. However, he could still paint and draw, producing larger, simpler works, and using coarser materials such as burlap. Klee’s creative responses to the new limitations on his mobility and dexterity might have inspired his declaration: “He has found his style when he cannot do otherwise.”

During 1940, the year Klee died of heart failure from severe scleroderma at the age of 60, he created 366 works of art. Seventy-three years later, his art continues to inspire admirers, influencing not only visual artists, but also contemporary musicians all over the world, with its vibrant sense of rhythm, movement, imagination, and emotion.

The Norton Simon Museum in Pasadena, California, has more than fifty works by Klee, including paintings, drawings and prints, and one painting by Klee’s son, Felix, made when he was 12. Leah Lehmbeck, curator for the museum, said, “Very early on Klee recognized the value of children’s art and children’s drawings. He saw it as a sort of beginning of art.”

“Klee believed that creativity resided within. True things were drawn on from nature, and nothing was ever completely abstract. But the purest things were those that came from one’s self, and children are the best examples of that. They aren’t burdened by anything yet.

“There is also a really nice quote of how he saw himself. He considered himself ‘a child of this earth, yet also a child of the universe; the offspring of a star among stars.’”

Paul Klee Collections and Exhibitions
Paul Klee, 1879-1940, Fire at Full Moon, 1933. Museum Folkwang, Essen, Germany.The following museums have Paul Klee collections and/or exhibitions of his work scheduled. If you’re planning on visiting a museum to see its Klee collection, check to confirm that it will be on display, as art is often rotated. You can also view Klee’s works on many of the museum websites below.

The exhibition “Paul Klee: Making Visible” is on view at the Tate Modern from October 16, 2013 through March 9, 2014. www.tate.org.uk/whats-on/tate-modern/exhibition/ey-exhibition-paul-klee

Baltimore Museum of ArtGuggenheim New YorkMetropolitan Museum of ArtNational Gallery of ArtNorton Simon MuseumPhiladelphia Museum of ArtTate ModernZentrum Paul Klee

(Above) Fire at Full Moon, 1933. Paul Klee 1879-1940. Museum Folkwang, Essen, Germany.

The Paul Klee Center & Children's Museum Creaviva

Creaviva Open Studio, Zentrum Paul Klee. Photograph Miriam Loertscher © Creaviva

(Above) Creaviva Open Studio, Zentrum Paul Klee. Photograph: Miriam Loertscher. © Creaviva

In 2005, the Paul Klee Center (Zentrum Paul Klee) opened on the outskirts of Bern, Switzerland, designed by Italian architect Renzo Piano to look like a trio of rolling glass-and-steel hills, housing close to four thousand works by Klee. Among the works on display are nearly 50 hand puppets Klee made for his son, Felix. One of the center’s most popular areas is its Children’s Museum, Kindermuseum Creaviva.

Kindermuseum Creaviva Project Manager Sara Stocker said, “Paul Klee was not only a painter, musician and writer; he was also an excellent teacher. The idea for a Children’s Museum is to give children, teenagers and adults access to art and culture, and allow them to discover their own creativity on the basis of Paul Klee’s works.

“Creaviva’s workshops are its foundation. Children and adults can work in the Open Studio under the guidance of an art instructor, and participants can take home artwork they have created in the workshops. Creaviva’s ‘Klee Without Barriers’ offers workshops tailored to individual needs for people with disabilities.The interactive exhibition in Creaviva’s loft invites participation in playful discussions about art. It’s all about imagination, curiosity, the exciting journeys, and the joy that’s felt in one’s creation.

“The Children’s Museum Creaviva promotes Klee’s playful, experimental, humorous approach to art. ‘Creaviva’ was formed from the Latin words for ‘create’ and ‘lively.’ This can be translated as ‘a lively place of creativity.’ Long live creativity!” —Translation by Sabrina I. Parmelee

 

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In Your Words: Elaine Kelley

Posted on by CVCAdmin

Sixteen-year-old Elaine Kelley’s narcolepsy symptoms first appeared in July 2011, shortly before she started her freshman year of high school in Tulsa, Oklahoma.

“The first thing I noticed was the cataplexy,” she recalls. “It came on very suddenly. Laughing would make me very weak, and I thought that was strange. Then it just progressively got worse.

“I told my mom about it. Then I also started sleeping a lot during the day. We thought that was strange too.”

From from left to right: Elaine Kelley's mother, Vickie Kelley; brother, Joe Kelley; father, Marshall Kelley; and Elaine.

The cataplexy attacks first occurred at home and at her cousin’s house. Then, Elaine says, “It happened big time when we were shopping for school shoes, and I was yelling for my mom, asking her to come look.” Fortunately, Elaine wasn’t hurt when she collapsed in the shoe store, but she says, “That’s when we knew it was serious.

“One night I had a cataplexy attack, and my dad saw it for the first time. He wanted to take me to the hospital. We were just going to go to an urgent care center, but it was closed.

“The next day, we called my pediatrician, and she wanted me to check into the hospital. I checked in the next day and went through a 24-hour EKG and an EEG and spent the night there.  They couldn’t find anything. They had a recording of me having cataplexy and still couldn’t figure it out, because they had never seen it before.

“They thought it was epilepsy, anemia, or something neurological, but everything came back normal. They might have said that it could be narcolepsy, but they never said ‘cataplexy.’

Elaine explains how she ended up essentially diagnosing herself.  “I started googling ‘laughing and falling,’ and that’s when I came across cataplexy. So I looked into that because there was a story about a lady who had it.

“We called my pediatrician; she referred us to a sleep specialist, and I took the sleep test. I was lucky to figure it out pretty quickly, after a few months of the symptoms, because school had started.

Elaine did have cataplexy episodes at school, but luckily, she was in the bathroom with friends when they occurred.  “All my friends knew about it and were supportive, which was nice,” she recalls.

She describes her initial attempts to prevent the cataplexy on her own. “It took a lot of self-control to try to not let it happen. I would clench my fists really tight if I felt it coming on and tighten my body so I wouldn’t lose muscle control. I noticed that it did help a little.

“But once I got the right medication and figured all that out, the cataplexy has never gone back to the way it was when it was at its worst.

“I still have daytime sleepiness, but a 30-minute nap once a day helps that. I still notice that when I laugh, sometimes I lose control of my facial muscles a little bit.

“I’m very lucky. I have a strong support system with my friends and family. I play soccer. I like to babysit. I like spending time with my friends.

“I want to go to college. I really love history, so I want to major in that. My reach school is Brown; that’s what I’m shooting for. If not, I’ll probably go to the University of Oklahoma or the University of Kansas—somewhere close to home.

From left to right: Elaine Kelley; brother, Joe; and mother, Vickie.

“When I first was diagnosed, my dad sent out an email letting all my teachers know. They were all really curious. There was actually another kid who graduated last year who had narcolepsy, and I was able to talk to him about it.

“People ask me about it a lot. I have no problems explaining it.

There was a rumor at school that when I get excited, I fall asleep. That’s what some kids twisted cataplexy into. I set everyone straight.

Elaine says there are a couple of things she’d like people to know about narcolepsy: “I’d like to make it clear that I don’t fall asleep standing up, because a lot of people ask me that.”

She also says that if there’s one thing she’d like people to be aware of, it’s to be thankful to have a sleep cycle. “Because I sure do miss that.”

For those teens and children who’ve been diagnosed with narcolepsy, she adds, “Don’t be ashamed or embarrassed that you have it. I struggled with that. But if you’re confident about it, it makes it a lot easier.” —EL

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CVC – 10 Years of Saving Lives

Posted on by CVCAdmin

A quick look at some of the people and the passion behind Caring Voice Coalition, and their experiences over the past ten years at CVC.

 

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Patient Navigator Update

Posted on by CVCAdmin

On July 12, 2013, the Department of Health and Human Services issued a final rule announcing new requirements for “Navigators” and other advocates who will help patients use the Health Insurance Exchanges.

First, the final rule added another resource to health care reform, “certified application counselors,” which each Exchange must offer. Second, the final rule explained the differing standards for Navigators and certified application counselors.

Certified application counselors are individuals (or entities) who will engage in many of the same duties as Navigators. Like Navigators, certified application counselors will provide information regarding and facilitate enrollment in health plans offered through the Exchanges. The main difference between a Navigator and a certified application counselor is the former has a broader range of duties than the latter.

The states or Exchanges may require Navigators complete a certification process; however, as the name suggests, certified application counselors must be certified according to their Exchange’s requirements.

Similarly, training may very between Navigators and application counselors. For example, Navigator training must include: information on qualified health plan options, insurance affordability programs, eligibility, and other government regulations. Conversely, certified application counselors’ training may be more limited simply because they have fewer duties than their Navigator counterparts.

Another difference is Navigators cannot have any conflicts of interest and must maintain a plan for remaining free of such conflicts. Certified application counselors, on the other hand, may have conflicts of interest; although, they must report such conflicts to the consumers they are assisting.

Further, the final rule requires Navigators to provide culturally and linguistically appropriate services (CLAS standards), which include: maintaining knowledge about racial, ethnic and cultural groups in the Navigator’s area, communicating with consumers in their preferred language, and promoting a staff representative of the Navigator’s consumer demographic. Certified application counselors need not comply with CLAS standards.

Despite the differences between Navigators and certified application counselors, the Final Rule compels competence and accountability from both. Overall, the Final Rule reflects an intrinsic goal of health care reform: assuring improved access to health care.

—Stephanie Posuniak, CVC Health Care Attorney

[1] A “Navigator” is an individual (or entity) who receives funds from a federally-facilitated Exchange and state partnership Exchanges. “Non-navigator assistance personnel” are persons (or entities) who receive funds from the federal government to assist with state-based Exchanges. For purposes of this article, this writer will refer to Patient Navigators and non-navigator assistance personnel collectively as “Navigators.”

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Low-Intensity, High-Benefit Exercise and Movement Part 2

Posted on by CVCAdmin

Yoga

Arriving in the West from India in the late 1800s, yoga is a mind and body health program that more than 20 million Americans now practice.

Yoga Stretch flexibilityYoga’s non-competitive nature, along with its emphasis on breathing, stretching, mindfulness, relaxation, and respecting an individual’s limitations has great appeal for those who need to go slowly. Its benefits may include improvements in:

Because yoga may provide relief of symptoms and increased mobility and flexibility for scleroderma patients, the Scleroderma Foundation has released “Yoga for Scleroderma” a therapeutic video program of yoga poses. The exercises are modified for the physical limitations associated with scleroderma, and all of the poses can be performed while seated or lying down.

To purchase a copy of “Yoga for Scleroderma,” call the Scleroderma Foundation at 800-722-HOPE or go to www.scleroderma.org.

When considering practicing yoga, remember:

Wheelchair Exercise and Movement

Wheelchair Tai Chi Qi Gong Yoga

 

Wheelchair Tai Chi, Qi Gong, and Yoga

Along with yoga, tai chi, and qi gong can also have health benefits for those in wheelchairs.* Wheelchair tai chi was featured in the 2008 Beijing Olympics, but as with yoga and qi gong, you don’t have to be an athlete to do it.

“Wheelchair tai chi can be practiced seated for those needing simple, low-impact, upper-body exercise by integrating wheelchair motion with the gentle, dynamic, flowing movements of tai chi,” said Zibin Guo, a medical anthropologist at the University of Tennessee, Chattanooga, who developed the seated tai chi “13 Postures” program featured at the Olympics.

“It lifts the spirits and gives practitioners a sense of command of space,” said Guo. Wheelchair tai chi has become part of China’s national program to promote health and is gaining in popularity around the world. To see a video of Guo’s seated tai chi program, go to www.youtube.com/watch?v=jR0DbXlS4GI

The National Institutes of Health reports that qi gong may help control blood pressure and psychological health in older adults who are in wheelchairs. To view a video on seated qi gong, go to www.youtube.com/watch?v=ODc03UzQf4I

Chicago’s Loyola University Health System now offers a wheelchair yoga program to help patients with rehabilitation and healing after surgery and certain medical events. To view a video of the program, go to www.youtube.com/watch?v=_5QzTddu4KE

To learn more about wheelchair yoga poses, visit www.mayallbehappy.org/wheelchair-yoga

Wheelchair Resistance and Weight Training

Training with elastic resistance bands and light free weights can also benefit those in wheelchairs. Ask your health care provider for recommendations of routines best suited for you.

Wheeling a Manual Wheelchair

Regular daily activities, like wheeling a manual wheelchair, can also improve health. A 2011 study by the University of Tennessee, Knoxville found that a person who uses a manual wheelchair can burn up to 120 calories in half an hour while wheeling at two mph on a flat surface, which is three times as much as someone doing the same in a motorized wheelchair.

Health enhancing benefits can come from “simply wheeling their chair along while taking their dog for a walk,” said coauthor of the study, Professor David R. Bassett Jr. “You can still burn a significant number of calories.”

Remember, when considering a new activity program:

Tai-Chi* (See Part 1 of this story for more information on tai chi and qi gong.)

 

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Low-Intensity, High-Benefit Exercise and Movement Part 1

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Many believe the “No pain, no gain” exercise mantra, when, in fact, the opposite is true. Regular low-impact, low-intensity exercise, like walking, and slow, gentle, meditative movement practices, like tai chi, can have substantial health benefits including:

Advantages of many of these activities are that they:

If you’re considering starting a new type of activity, make sure to ask your physician about its:

Popular, low-impact, low-intensity, and low-cost (or no-cost) options that can be beneficial include:

Walking

It’s easy to underestimate the benefits of walking, but studies have shown that even slow walking can improve health, as can home-based walking exercise programs.

Thirty minutes of slow walking can benefit the elderly and the disabled as much as 30 minutes of more intense exercise can benefit those who are younger, suggests a Harvard University study. And you don’t have to take it outside to benefit. A recent Northwestern University study of nearly 200 participants with peripheral artery disease (PAD) found that a home-based walking program could improve pain-free walking time, physical activity, speed, and endurance.

The National Institute of Health’s Weight-control Information Network website offers info on what to know before you go walking, how to walk safely, stretches for walking, proper form for walking, and a sample daily walking program. For details, go to www.win.niddk.nih.gov/publications/walking.htm#firststep

Ask your physician if you’d like more information and recommendations on walking and on home-based walking programs.

Meditative Movement Practices

Tai Chi and Qi Gong

Tai-ChiBoth tai chi (pronounced “tai chee”) and qi gong (pronounced “chee gung”) are meditative movement practices that started in China and have become increasingly popular in the U.S. Both involve gentle movement, mental focus, deep breathing, and relaxation.

Both tai chi and qi gong can be adapted to many physical conditions and can also be practiced, sitting, standing, or lying down. Movements are slow and never forced.

Yang-style tai chi (named after Yang Lu-ch’an, the 19th century founder of the style) is the most popular style used in the U.S. Its popularity stems from its physical benefits, such as improved balance, flexibility, strength, and aerobic endurance, and psychosocial benefits, including decreased depression, anxiety, and stress.

A University of Arizona study showed that yang-style tai chi reduced falls among adult stroke survivors, helping them to achieve and maintain balance.  The results were striking: Those practicing tai chi experienced only approximately one-third as many falls as those in other groups.

During the 12-week trial, those in a group of 30 practicing tai chi reported five falls, while those in a usual care group of 28 people reported 15 falls, and those in a group of 31 participating in the SilverSneakers fitness program reported 14 falls.

Tai chi can also increase strength and flexibility, and benefit the immune system, bones, heart, nerves, muscles, and mind, suggests research by Harvard Medical School, which published The Harvard Medical School Guide to Tai Chi this year. The guide features practical tips for integrating tai chi into everyday activities, along with a simplified program, illustrated with more than 50 photographs. (It can be ordered online at barnesandnoble.com)

The National Institutes of Health is exploring the benefits of tai chi and qi gong and has produced a video, led by Adeline Ge, M.D., demonstrating and explaining both practices. To view it, go to www.nccam.nih.gov/video/taichidvd-full

Click here to read Part Two of CVC’s story on Low-Intensity, High-Benefit Exercise and Movement, featuring info on yoga, and exercises for those in manual and power wheelchairs.

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Summer Health Tips

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It’s easy to forget to protect yourself from the elements when you’re out enjoying sunny days. This handy checklist will help you remember to shield your skin and eyes, and stay hydrated, even on cold or cloudy days.

Sunscreen
The FDA recently updated regulations for sunscreen products and labeling, establishing a standard test for over-the-counter sunscreen products. Products that pass the broad spectrum test and provide protection against both UVB and UVA radiation are allowed to be labeled as “Broad Spectrum.” Use sunscreen with broad spectrum UV protection values of 15 or higher, and use a lip balm with at least 15 SPF. Apply a thick layer of sunscreen 30 minutes in advance of sun exposure. Reapply at least every two hours, and more often if you’re sweating, or in and out of the water. Watch the UV index, and learn to read the UV Index Scale on the EPA’s website http://www.epa.gov/sunwise/uviscale.html.  Talk to your doctor about the diseases and medications that can make people more sensitive to sun exposure.

Remember that no sunscreen completely blocks UV radiation, and no sunscreen is waterproof. Using sunscreen does not mean it is safe to spend more time in the sun, advises the EPA. You need additional protection. That includes:

Clothing
The CDC recommends wearing loose-fitting long-sleeved shirts and long pants made from tightly woven fabric. The best hats for summer protection are wide-brimmed. Avoid straw hats with holes that let sunlight through.
If you wear a baseball cap, also protect your ears and the back of your neck with clothing, or sunscreen with at least SPF 15. Don’t forget to apply sunscreen under bathing suit straps, jewelry, and sunglasses.

Sunglasses
Wear sunglasses that offer 99 to 100 percent UV protection against both UVA and UVB rays.
Wear wraparound sunglasses.
Wear sunglasses, even if your contacts have UV protection.
Children should wear real sunglasses with UV protection, not toy sunglasses.

Shade
Stay in the shade between 10 a.m. and 4 p.m. daylight savings time (9 a.m. to 3 p.m. standard time), advises the CDC. Like using an umbrella to complement other skin protection? An Emory University School of Medicine study found that black umbrellas were the most effective at blocking the sun. (A travel sun umbrella by Coolibar (coolibar.com) was the study’s big winner, blocking up to 99 percent of UVR rays.)

Adequate Hydration
Infants, children, the elderly, and those with chronic illnesses are at increased risk for dehydration. (For information on the range of dehydration symptoms and the stages of dehydration, go to www.mayoclinic.com/health/dehydration/DS00561/DSECTION=symptoms) Remember that water is usually the best choice for staying hydrated. The sugar and stimulants found in many energy drinks accelerate dehydration, as does drinking alcoholic beverages. Energy drinks and alcohol make an especially dangerous combo. Know the difference between energy drinks and sports drinks. While energy drinks stimulate the nervous system, sports drinks rehydrate, and replenish electrolytes. Read labels carefully to know exactly what you’re drinking.

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Recognizing, Avoiding, and Reporting Health Care Scams

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Health care scams are on the rise and can take many forms—in person, over the phone, via mail and online. New government programs have recently been put in place to help prevent, detect, and punish such scams.

However, it’s important to remember that con artists can be very creative in coming up with new ways to defraud their victims, and extremely persuasive, catching even the savviest consumers off-guard.

Here are some common health care scams to look out for, along with tips for protecting your personal information, and reporting health care fraud.

The Affordable Care Act

The Federal Trade Commission, the Better Business Bureau, and AARP warn about scams that claim association with the Affordable Care Act (ACA) and its Health Insurance Marketplace. Scammers have been taking advantage of confusion about health care reform and calling claiming to be government representatives issuing mandatory new national medical cards.

If you get a call from someone purporting to represent Medicare or the government, hang up immediately. Don’t rely on caller ID to correctly identify the caller; con artists can falsify caller ID numbers.

It’s important to know that:

Scammers try to convince you to act now, says Tracey Thomas, Attorney, Division of Marketing Practices, Federal Trade Commission, in order to get your money before you have time to stop and think.

“So remember that date: October 1, 2013. That’s the first time anyone, anywhere can sign up for health insurance through the Health Insurance Marketplace under the Affordable Care Act. Anyone who claims to be able to enroll you sooner is trying to scam you,” advises Thomas. To report anyone who claims to be able to sign you up sooner, go to www.ftccomplaintassistant.gov.

For up-to-date information on the Affordable Care Act and the Health Insurance Marketplace, go to: www.healthcare.gov/index.html

Other Common Health Care Scams

The Department of Health and Human Services, the Department of Justice, and the FBI warn that scammers are engaging in the following types of health care fraud:

Next week, look for Part Two of “Recognizing, Avoiding, and Reporting Health Care Scams” on www.caringvoice.org. We’re here to help!

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Health Care Scams, Part II

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Top Tips from the Experts

With major changes in health care prompted by the Affordable Care Act, it’s easy to get confused. That why it’s more important than ever for patients, providers, and caregivers to know how to recognize health care and health insurance scams. We’ve included tips from experts on combating and reporting fraud, including helpful questions for identifying scams.

In CVC Community magazine’s summer issue, CVC Health Care Attorney Stephanie Posuniak examines the growing health care role of patient navigators in the article “On Your Behalf.” In the article excerpt below, Posuniak outlines ways to help determine whether a patient navigator is legitimate.

How Can I Be Sure a Patient Navigator is Authentic?
Some organizations or individuals may pose as authentic patient navigators when, in fact, they intend to defraud you. How can you tell the difference between a real patient advocate and a con artist?  For official navigators (who assist with the Exchange), the first place to go is your state’s Exchange website, which should have a list of approved official navigators.

If you do not have access to the internet, contact the call center associated with your state’s Exchange.  For unofficial navigators (who are not directly associated with the Exchange), you can also consult your local Better Business Bureau’s website to verify credibility.

If you do not have access to the internet, here are five questions to ask before commissioning a patient navigator:

1) Who initiated the contact? Patient navigators rarely cold call individuals; so, be wary of external phone calls indicating that you must obtain a “national medical card” or the like.
2) Is the navigator willing to send me additional information about its organization?  Legitimate businesses understand the need for more information and will be happy to comply.  A navigator who does not want to send information about itself is suspect.
3) Will the navigator let me call her back? A patient navigator will not decline this request.  If the person tries to threaten or pressure you, something is wrong.
4) Has my doctor heard of this organization? Most health care providers are aware of well-known patient advocacy organizations.

For more on patient navigators, see Posuniak’s “On Your Behalf” in CVC’s Community magazine’s summer issue, out soon.

Preventing Medicare Fraud

To help stop Medicare fraud, the Department of Health and Human Services and the Department of Justice warn you to be suspicious of doctors, health care providers, or suppliers who:

For more information on common scams and identity theft, go to www.stopmedicarefraud.gov/preventfraud/scams-identity-theft

FBI Tips for Avoiding Health Care Fraud or Health Insurance Fraud

The FBI’s Common Fraud Schemes website www.fbi.gov/scams-safety/fraud
provides information and tips on avoiding some of the most common scams that the FBI investigates, including health care fraud, health insurance fraud and identity theft. The FBI advises:

To report suspected Medicare errors, fraud, or abuse, contact either:

HHS Office of Inspector General

Call: 800-447-8477
TTY: 800-377-4950
Online: Report Fraud Online

Or

Centers for Medicare & Medicaid Services
Call: 800-633-4227
TTY: 877-486-2048

Senior Medicare Patrols:
The Senior Medicare Patrol (SMP) are highly trained volunteers who show Medicare and Medicaid recipients how to protect against, detect, and report fraud, errors, and abuse through outreach, counseling, and education.

For information on the Senior Medicare Patrol, go to www.aoa.gov/AoA_programs/Elder_Rights/SMP/index.aspx

Most Wanted Health Care Fraud Fugitives

The Office of Inspector General (OIG)  is seeking more than 170 fugitives on health care fraud and abuse related charges. Click https://oig.hhs.gov/fraud/fugitives to view OIG’s Most Wanted Health Care Fugitives, as well as those recently captured.

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In Your Words: Matty Heenan

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In 1997, when I was 49, I got up one morning, showered, and got dressed … almost. I tried to put on my shoes, but found that my feet had swollen too much overnight to fit into any of them. I called my doctor, who thought I was retaining water, and gave me a diuretic. It didn’t help at all.

He referred me to a rheumatologist, which was a good start. Unfortunately, though, the rheumatologist was to retire in three weeks, so he wasn’t too invested in me. He told me that I definitely had some “auto-immune process” going on, which might take several months to sort out, but that the treatment would initially be the same: methotrexate. When I asked what methotrexate was, he replied that it was usually used for cancer, and told me to “take it or leave it.” I decided to leave it, and to tackle the issue holistically.

This led to my second unfortunate event: A doctor I pursued, who had received extensive media coverage, turned out to be a quack. It took me about 18 months to come to grips with the fact that I was slowly getting worse. I was now unable to step off a curb unaided, or to dress myself without assistance.

Dry, darkened, shiny, and tight skin covered my face, arms, hands, and legs up to mid-thigh. My fingers were slightly curled, and I had six finger ulcers on the three longest fingers of each hand, which made using them to do almost anything nearly impossible. Raynaud’s syndrome, one of the most frequent scleroderma symptoms, caused my fingers and feet to turn purple when the temperature changed from cool to warm, or vice versa. I experienced acid reflux so intense that I learned to fall asleep in a recliner every night.  Every joint in my body ached, and it hurt when I got into bed.

I used to teach elementary school. When I first got sick, school had been in session for about three days. I struggled to make it to winter break by taking a sick day every Wednesday, and sleeping (and eating a little) between Tuesday evening and Thursday morning. Every Thursday I would cry as I got ready for school, because I didn’t know how I could make it to the end of the week.

Finally, in February, 1999, I was referred to a great rheumatologist with a background in scleroderma. I walked into her office, and she told me as I was sitting down that I had systemic scleroderma. She started me on (you guessed it) methotrexate, as well as different medications to help relieve reflux symptoms, soften my skin, and ease the pain. I slowly started to improve. I no longer have finger ulcers, and for no apparent reason, my hands stabilized, with very little curvature to my fingers.

Because I have systemic scleroderma, all the extra collagen my body produces has to go somewhere. It goes into a lot of my other body systems—my heart, lungs, skin, and gastrointestinal tract seem to be getting a lot, judging from the assorted problems I’ve dealt with over the ensuing years. One is the facial deformities that can occur as the skin starts to relax. It can cause the lips to almost disappear and small lines to form around the mouth, often referred to as “purse-string mouth.” I’m still surprised when I see a photo of myself, as I only recognize my face through my eyes and nose.

It is estimated that approximately 25 percent of scleroderma patients will develop pulmonary hypertension. I fell into that group. I am fortunate that I am presently able to treat my PH with oral medications. Many of my fellow patients must be hooked up through a subcutaneous line to a pump that they wear 24/7. I pray I won’t ever have to experience that, but only time will tell.

I no longer teach school. My last day was that winter break in 1997. I wanted to continue being productive, so, once I felt a little better, I got a Little Sister in the Big Brother/Big Sister program. I am still in touch with her today. As she got older, I joined an adult literacy program, through which I have taught and mentored a woman from Africa for about eight years now. I am also the support group leader of the pulmonary hypertension group in Tucson, and the co-leader of the scleroderma group. Helping other people makes my struggles more worthwhile.

If you have a story that you’d like to share with CVC, email us at  http://www.caringvoice.org/2013/05/share-your-story-2/. Your words can give support to others and let them know that they’re not alone.

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Be the 1,350th new Like on CVC’s Facebook page

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Be the 1,350th new Like on Caring Voice Coalition’s Facebook page, and win a cool, colorful journal to help you think, create, and record! This premium journal, bound in Italian leatherette, features 256 ruled interior pages, a satin ribbon marker, and magnetic closure.

If you’ve already Liked CVC on Facebook, invite your friends, family, and colleagues to join CVC’s social media community, and one could be the winner!

Join the community and keep connected at www.facebook.com/CaringVoiceCoalition!

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June is Scleroderma Awareness Month

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Affecting approximately 300,000 people across the U.S., scleroderma is a chronic connective tissue disease in which the immune system attacks its own body, producing extra collagen. It is painful, often progressive, and can be fatal. Some medications and treatments can help with certain symptoms, but there is no known cure for scleroderma. Symptoms and effects can vary, and diagnosis can be difficult. Early and correct diagnosis by a qualified physician, often a rheumatologist, can help minimize progression and disability. Scleroderma can develop in any age group. It is not contagious.

From the Greek words meaning “hard skin,” scleroderma can cause a thickening and tightening of the skin, and serious damage to internal organs, including the heart, lungs, and kidneys. Early symptoms can include fingers that are very sensitive to cold, change color in response to stress or cold, and that become stiff and swollen, known as Raynaud’s phenomenon. (Although most people with scleroderma have Raynaud’s phenomenon, most people with Raynaud’s phenomenon do not develop scleroderma.)

In its fifteenth year, the Danvers, Mass.-based Scleroderma Foundation, a national nonprofit with 24 chapters and support groups across the country, provides support, education, and research about scleroderma. To boost awareness this spring, The Scleroderma Foundation and its Tri-State Chapter are running a 15-second video on a 520-square-foot digital billboard in Times Square from April 1 through June 30, 2013. Can’t make it to Manhattan? No worries: Click here to view this short, but powerful video.

In the Spring 2013 issue of CVC’s Community magazine, Scleroderma Foundation Communications Manager, Christina Relacion, describes how three women living with scleroderma empowered themselves—as well as their caregivers, friends, and family—through online support and resources: Click here to read their compelling stories and learn more about getting support through social media.

 

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Help Others by Sharing Your Story with CVC

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Would you like to share your story and how you came to Caring Voice Coalition with others who can learn from your experiences? Continue reading →

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