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CVC Offers LegalShield

Posted on February 10, 2015 by CVCinfo

Caring Voice Coalition has partnered with LegalShield to offer CVC patients discounted legal plan membership. For a small, flat monthly fee, CVC patients can become LegalShield members, with access to services including unlimited legal advice on any topic, living wills, estate planning, health care proxies, insurance coverage, and identity theft protection. With LegalShield, CVC patients have access to caring, top-quality attorneys from highly-rated law firms across the country at very low cost.

For more information, go to LegalShield’s website or contact Kimberly Ferris at 585-314-3111 or [email protected].

Posted in About Us, Diseases, Featured | 4 Comments

Help Others by Sharing Your Story with CVC

Posted on December 9, 2014 by CVCinfo

You can inspire others and let them know that they’re not alone when you share your story with the Caring Voice Coalition community. You can share what’s important for new patients, caregivers, and medical professionals to know about living with rare and chronic illness. And you can tell other patients how you came to CVC and what your experience has been.

Posted in About Us, Diseases, Featured | Leave a comment

Shop at AmazonSmile & Amazon Donates to CVC

Posted on November 17, 2014 by CVCinfo

Now, when you shop on AmazonSmile, you can donate 0.5% of the price of your eligible purchases to benefit the programs of Caring Voice Coalition. Caring Voice Coalition is dedicated to improving the lives of patients with chronic and rare diseases by offering services that provide financial, emotional and educational support.

AmazonSmile is a website operated by Amazon that lets customers enjoy the same selection of products, prices and shopping features as on Amazon.com. But when customers shop on AmazonSmile (smile.amazon.com), the AmazonSmile Foundation will donate 0.5% of the price of eligible purchases to the charitable organizations selected by customers.

To select Caring Voice Coalition as your AmazonSmile charitable organization, visit the following website http://smile.amazon.com/ch/26-0058446.

Posted in About Us, Diseases, Featured, Media Center | Leave a comment

Two New Treatments for IPF

Posted on October 15, 2014 by CVCinfo

FDA approves Esbriet to treat idiopathic pulmonary fibrosis.

October 15, 2014

The U.S. Food and Drug Administration today approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF).

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities. Current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant.

“Esbriet provides a new treatment option for patients with idiopathic pulmonary fibrosis, a serious, chronic lung disease,” said Curtis J. Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “We continue to help advance medication therapies by approving products that treat conditions that impact public health.”

The FDA granted Esbriet fast track, priority review, orphan product, and breakthrough designations. Esbriet is being approved ahead of the product’s prescription drug user fee goal date of Nov. 23, 2014, the date the agency was scheduled to complete the review of the drug application.

Esbriet acts on multiple pathways that may be involved in the scarring of lung tissue. Its safety and effectiveness were established in three clinical trials of 1,247 patients with IPF. The decline in forced vital capacity – the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible – was significantly reduced in patients receiving Esbriet compared to patients receiving placebo.

Esbriet is not recommended for patients who have severe liver problems, end-stage kidney disease, or who require dialysis. Esbriet should be taken with food to minimize the potential for nausea and dizziness. Patients should avoid or minimize exposure to sunlight and sunlamps and wear sunscreen and protective clothing, as Esbriet may cause patients to sunburn more easily.

The most common side effects of Esbriet are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, decreased/loss of appetite, gastro-esophageal reflux disease, sinusitis, insomnia, decreased weight, and arthralgia.

The FDA also today approved Ofev (nintedanib) for the treatment of IPF.

Esbriet is manufactured for InterMune, Inc., Brisbane, California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA approves Ofev to treat idiopathic pulmonary fibrosis.

October 15, 2014

The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities. Current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant.

“Today’s Ofev approval expands the available treatment options for patients with idiopathic pulmonary fibrosis, a serious, chronic condition,” said Mary H. Parks, M.D., deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Providing health care professionals and patients with additional treatment options helps enable appropriate care decisions based on a patient’s need.”

The FDA granted Ofev fast track, priority review, orphan product, and breakthrough designations. Ofev is being approved ahead of the product’s prescription drug user fee goal date of Jan. 2, 2015, the date the agency was scheduled to complete the review of the drug application.

Ofev is a kinase inhibitor that blocks multiple pathways that may be involved in the scarring of lung tissue. Its safety and effectiveness were established in three clinical trials of 1,231 patients with IPF. The decline in forced vital capacity – the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible – was significantly reduced in patients receiving Ofev compared to patients receiving placebo.

Ofev is not recommended for patients who have moderate to severe liver problems. Ofev can cause birth defects or death to an unborn baby. Women should not become pregnant while taking Ofev. Women who are able to get pregnant should use adequate contraception during and for at least three months after the last dose of Ofev.

The most common side effects of Ofev are diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, decreased weight, and high blood pressure.

The FDA also today approved Esbriet (pirfenidone) for the treatment of IPF.

Ofev is distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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InterMune Announces Expanded Access Program for Pirfenidone to Treat Idiopathic Pulmonary Fibrosis (IPF) in the United States

Date(s): 5/16/14 8:00 AM

For a complete listing of InterMune news releases, please click here

BRISBANE, Calif., May 16, 2014 /PRNewswire/ — InterMune, Inc. (NASDAQ: ITMN) today announced it will provide compassionate use of pirfenidone through a multi-center Expanded Access Program (EAP) in the United States to be conducted under InterMune’s U.S. IND. Pirfenidone is an investigational therapy in the U.S. and has not been approved by the U.S. Food and Drug Administration (FDA).

Expanded access programs provide a mechanism for early access to an investigational drug in the pre-approval period to treat patients with a serious or immediately life-threatening disease or condition that has no comparable or satisfactory alternative treatment options.

“We are pleased to offer this expanded access program for eligible patients in the U.S.,” said Jonathan Leff, M.D., Executive Vice President of Research and Development, InterMune. “This EAP provides a mechanism for eligible patients to access pirfenidone as a treatment option, following the recent successful completion of our ASCEND Phase 3 trial and prior to FDA’s final decision on the approvability of pirfenidone in the United States.”

To enroll in the EAP, a patient must meet specific clinical criteria. Eligible patients must have a clinical and radiographic diagnosis of IPF with the presence of a usual interstitial pneumonia (UIP) pattern on high-resolution computed tomography (HRCT). Additional criteria for the EAP are listed on www.clinicaltrials.gov. It is important to note that only a physician who is participating in the EAP can assess a potential patient for eligibility. The EAP protocol contains provisions for stopping enrollment of patients in the EAP upon a decision by the FDA on the approvability of a pirfenidone New Drug Application (NDA).

There are currently a limited number of sites accepting patients for enrollment to the pirfenidone EAP and InterMune expects that all sites will be participating by September of 2014. InterMune is working with the Pulmonary Fibrosis Foundation (PFF), the Coalition for Pulmonary Fibrosis (CPF) and other advocacy groups to enable patients with IPF to obtain information about the pirfenidone EAP.

For more information about the pirfenidone EAP, including eligibility criteria and participating clinical centers, contact InterMune Medical Information at 888-486-6411 or the Pulmonary Fibrosis Foundation (PFF) at 844-TalkPFF (844-825-5733) or visit www.clinicaltrials.gov.

About IPF
Idiopathic pulmonary fibrosis (IPF) is an irreversible and ultimately fatal disease characterized by progressive loss of lung function due to fibrosis (scarring) in the lungs, which hinders the ability of lungs to absorb oxygen. IPF inevitably causes shortness of breath, and a deterioration in lung function and exercise tolerance. IPF patients follow different and unpredictable clinical courses and it is not possible to predict if a patient will progress slowly or rapidly, or when the rate of decline may change. Periods of transient clinical stability in IPF, when they occur, inevitably give way to continued disease progression. The median survival time from diagnosis is two to five years, with a five-year survival rate of approximately 20-40 percent, which makes IPF more rapidly lethal than many malignancies, including breast, ovarian and colorectal cancers. IPF typically occurs in patients over age 45, and tends to affect slightly more men than women.

About Pirfenidone
Pirfenidone is an orally active, anti-fibrotic agent that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis. Pirfenidone also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.

About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases. In pulmonology, the company is focused on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive, irreversible, unpredictable and ultimately fatal lung disease. Pirfenidone is not approved for marketing in the United States. InterMune’s research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and fibrotic diseases. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.

Forward-Looking Statements
This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune’s judgment and involve risks and uncertainties as of the date of this release, including without limitation InterMune’s expectations regarding the availability of its Expanded Access Program for patients in the U.S. with IPF. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune’s actual results could differ materially from those described in InterMune’s forward-looking statements.

Other factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading “Risk Factors” in InterMune’s most recent annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 24, 2014 (the “Form 10-K”) and other periodic reports filed with the SEC, including but not limited to the following: (i) the risks related to the uncertain, lengthy and expensive clinical development process for the company’s product candidates, including having no unexpected safety, toxicology, clinical or other issues and having no unexpected clinical trial results such as unexpected new clinical data and unexpected additional analysis of existing clinical data; (ii) risks related to the regulatory process for the company’s product candidates, including the possibility that the results of the new 52-week Phase 3 clinical trial (ASCEND) having an FVC endpoint may not be satisfactory to the FDA for InterMune to receive regulatory approval for pirfenidone in the United States; (iii) risks related to unexpected regulatory actions or delays or government regulation generally; and (iv) risks related to the company’s manufacturing strategy, which relies on third-party manufacturers and which exposes InterMune to additional risks where it may lose potential revenue. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune’s other periodic reports filed with the SEC, all of which are available via InterMune’s web site at www.intermune.com.

SOURCE InterMune, Inc.

Investors: Jim Goff, InterMune, Inc., 415-466-2228, [email protected], Media: Geoff Curtis, Edelman, 312-550-8138, [email protected]

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.

• SABRIL can permanently damage the vision of anyone who takes it. The most noticeable loss is in the ability to see to the side when looking straight ahead (peripheral vision). If this happens, it will not get better. People who take SABRIL do not lose all of their vision, but some people can have severe loss and may only be able to see things straight in front of them (sometimes called “tunnel vision”), and they may also have blurry vision.
• Tell your healthcare provider right away if you (or your child): might not be seeing as well as before starting SABRIL; start to trip, bump into things, or are more clumsy than usual; are surprised by people or things coming in front of you that seem to come out of nowhere; or if your baby is acting differently than normal. These changes can mean that vision damage has occurred.
• Your healthcare provider will test your (or your child’s) vision before or within 4 weeks after starting SABRIL, and at least every 3 months during treatment until SABRIL is stopped. Vision should also be tested about 3 to 6 months after SABRIL is stopped. You (or your child) may not be able to be tested in certain situations. It is difficult to test vision in babies, but to the extent possible, all babies should have their vision tested. Your healthcare provider will determine if testing can be done. Regular vision testing is important because damage can happen before any changes are noticed.
• Vision tests cannot prevent the vision damage that can happen with SABRIL, but they do allow SABRIL to be stopped if vision has gotten worse, which usually will lessen further damage. Even these regular vision tests may not show vision damage before it is serious and permanent. Parents, caregivers, and healthcare providers may not recognize the symptoms, or find vision loss in babies, until it is severe.
• If vision tests are not done regularly, your healthcare provider may stop prescribing SABRIL for you (or your child). Some people are not able to complete vision testing. If vision testing cannot be done, your healthcare provider may continue prescribing SABRIL, but will not be able to watch for any vision loss.
• Brain pictures taken by magnetic resonance imaging (MRI) show changes in some babies after they are given SABRIL. It is not known if these changes are harmful.
• Like other antiepileptic drugs, SABRIL may cause suicidal thoughts and actions in some people. Call a healthcare provider right away if you (or your child) have any symptoms, especially sudden changes in mood, behaviors, thoughts or feelings, and especially if they are new, worse, or worry you.
• Do not stop SABRIL without first talking to a healthcare provider. Stopping SABRIL suddenly can cause seizures that will not stop.
• SABRIL can cause serious side effects such as low red blood cell counts, sleepiness and tiredness, nerve problems, weight gain, and edema. Because SABRIL causes sleepiness and tiredness, do not drive, operate machinery, or perform hazardous tasks, unless it is decided that these things can be done safely. SABRIL may make certain types of seizures worse. Tell your healthcare provider right away if seizures get worse.
• Before starting SABRIL, tell your doctor about all of your (or your child’s) medical conditions including depression, mood problems, suicidal thoughts or behavior, any allergic reaction to SABRIL, vision problems, kidney problems, low red blood cell counts, and any nervous or mental illness. Tell your doctor about all the medicines you (or your child) take.
• If you are breastfeeding or plan to breastfeed, SABRIL can pass into breast milk and may harm your baby. If you are pregnant or plan to become pregnant, it is not known if SABRIL will harm your unborn baby. You and your healthcare provider will have to decide if you should take SABRIL while you are pregnant.
• The most common side effects of SABRIL in adults include: problems walking or feeling uncoordinated, feeling dizzy, shaking (tremor), joint pain, memory problems and not thinking clearly, eye problems like blurry vision, double vision, and eye movements that cannot be controlled. The most common side effects of SABRIL in children 10 to 16 years of age include weight gain, upper respiratory tract infection, tiredness, and aggression. Also expect side effects like those seen in adults.
• The most common side effects of SABRIL in babies include: sleepiness—some babies may have a harder time suckling and feeding or may be irritable, swelling in the bronchial tubes (bronchitis), ear infection, and irritability.
• Tell your healthcare provider if you or your child has any side effect that bothers you or that does not go away. These are not all of the possible side effects of SABRIL. For more information, ask your healthcare provider or pharmacist.

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.

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CONTACT:
Matt Flesch
847-282-1154

SABRIL is a registered trademark of Lundbeck.

VGB-B-00018

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.

News Release Intended for U.S. Media Only

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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)

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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:

• Pregnancy. Adempas may cause fetal harm when administered to a pregnant woman. Adempas was consistently shown to have teratogenic effects when administered to animals. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus
• Co-administration with nitrates or nitric oxide donors (such as amyl nitrite) in any form.
• Concomitant administration with phosphodiesterase (PDE) inhibitors, including specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE inhibitors (such as dipyridamole or theophylline).

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:

• Prescribers must be certified with the program by enrolling and completing training.
• All females, regardless of reproductive potential, must enroll in the Adempas REMS Program prior to initiating Adempas. Male patients are not enrolled in the Adempas REMS Program.
• Female patients of reproductive potential must comply with the pregnancy testing and contraception requirements.
• Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive Adempas.

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: [email protected] 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.

News Release Intended for U.S. Media Only

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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

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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: [email protected]

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.

Posted in About Us, Diseases, Featured | 1 Comment

New Office Hours

Posted on August 21, 2014 by Charlie

Starting Tuesday, September 2, 2014, CVC will have new office hours, Monday–Friday, 9 a.m.–6 p.m. EST.

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Subscribe to CVC-e!

Posted on July 9, 2014 by Charlie

Subscribe to the CVC-e newsletter, your free monthly email roundup of news, tips, and more, for CVC patients and caregivers. Don’t miss a single issue of CVC-e. Sign up now!

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CVC Earns 4-Star Rating from Charity Navigator

Posted on July 2, 2014 by CVCinfo

Caring Voice Coalition is proud to announce that we have earned a 4-star charity rating, the highest possible, from Charity Navigator, the nation’s largest charity evaluator.

Charity Navigator works to help charitable givers make intelligent giving decisions by providing information on more than five thousand charities nationwide and by evaluating their financial health. It calculates each charity’s score based upon several broad criteria, including how much is spent per dollar raised, what percentage of funds goes to programs vs. administrative and fund-raising expenses, and the organization’s long-term financial health. It then assigns a rating from one to four, with four being the best rating.

To view CVC’s Charity Navigator rating page, go to http://www.charitynavigator.org/index.cfm?bay=search.summary&orgid=13506#.U7Qk4Y1dX1g

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Accessible Travel: Travel Therapy

Posted on June 30, 2014 by Charlie

Those with chronic conditions and limited mobility have more options than ever before for accessible travel. Eva Leonard talks to travelers with special needs and accessible travel experts about important considerations when planning a trip.

“Part of my job is to make vacation travel possible,” says Royal Caribbean International Manager, Access Compliance, Ron Pettit. “Many people with disabilities don’t think about traveling or taking a vacation as an option.

“They have challenges in everyday life; getting out of bed, getting out of the house, going to school, to work, going shopping, and going to the doctor. So sometimes, when they think of all their daily challenges, they think, ‘Oh my goodness—I don’t think I could go on a cruise.’

“Some folks are born with a disability, so they’ve learned how to adapt all along. But a lot of people have acquired a disability with age, or a medical issue, so they have to rethink and learn things all over again.”

Fear of the unknown can be a factor in deterring those with chronic illness from traveling, says Pettit, who has worked for the past 25 years to improve travel for the disabled, first for 17 years at Northwest Airlines, where he served as program manager for customers with disabilities, then joining Royal Caribbean in 2006.

“It’s those personal issues. ‘How do I go to the bathroom? How do I know about oxygen? How do I do these things?’ Because, while they have learned to adapt at home, or maybe when going out a little bit, the thought of going onto an airplane, or going onto a ship seems a little daunting. They ask, ‘How would I ever do this with my new limitations?’”

But many with disabilities are traveling. The U.S. Census reports that more than 38 million Americans live with disabilities, and, according to a 2005 study by the Open Doors Organization and the Travel Industry Association of America, U.S. adults with disabilities or reduced mobility spend around $13.6 billion on travel every year.

With the world’s population now at 7 billion, about ten percent require barrier-free and easily accessible facilities. “Global estimates [of people with disabilities] range from 600 million to 900 million,” says Lilian Muller, President of the European Network for Accessible Tourism.

To meet rising demand, accessible and barrier-free travel options have grown dramatically over the last two decades. Whether you opt for a leisurely Caribbean cruise, a scenic train ride through the Canadian Rockies, or something more distant and action-packed, careful research, planning and preparation can help you decide which getaway is best for you and allow you to fully enjoy the mood-boosting, stress-reducing rewards of travel.

BEFORE YOU GO
Before you start planning your trip, check with your doctor to assess what you can do, and, depending on the type of trip you plan to take, consider working with a travel agent who understands your needs. Says Pettit, “The more information you can share about your ability and needs, the better.”

Make arrangements well in advance for wheelchair, scooter, and medical device and supply accessibility and rental. Says traveler Tracy Schutt, “Since being on oxygen 24/7, traveling has become challenging, but not impossible. Making trips to Jacksonville, Florida, to visit family requires preplanning with my home care company to have oxygen supplies waiting when I get there.”

Another traveler with pulmonary hypertension suggests sending IV medication and supplies ahead by overnight service and arranging for an oxygen concentrator, so that all are in place on arrival.

Traveler Milli Washock advises, “Have a sheet handy with all pertinent medical information, medication, supplies and emergency contacts. Being on [intravenous infusion] therapy and oxygen, I have written on top [in big, bold letters], ‘Do Not Stop Pump.’ And, she adds, for devices that must be charged or plugged in, “When traveling to a foreign country, be sure to have the proper electrical adapters.”

It’s also important to get as much information as possible in advance about the availability of services you might need en route and at your destination. For example, find out what airline, hotel, rail, or cruise staff can assist you with when traveling, and if there is a medical facility specializing in your condition at your destination. If you’re planning a cruise, ask what types of onboard medical services are available, and if there is a fee.

HOTELS, RESORTS, AND THEME PARKS
Travel writer Candy Harrington has been covering accessible travel for the past 16 years and has authored books on the topic, including, Barrier-Free Travel; A Nuts and Bolts Guide for Wheelers and Slow Walkers. She also writes the barrier-free travel blog www.BarrierFreeTravels.com.

Harrington advises travelers with special needs to be very specific about their needs and ask detailed questions when booking a hotel room.

“First and foremost,” she emphasizes, “you have to understand that there are many types of accessible rooms, so you have to ask for an accessible room with the features you need. Don’t just ask for an accessible or an ‘ADA-compliant’ room.

“If you need a roll-in shower, specify that, because all accessible rooms do not have roll-in showers—some have tub/shower combinations. If you need the toilet grab bars on a specific side, you need to specify that too.

“And if bed height is an issue for you, inquire about that also. Bed height is not covered under the Americans with Disabilities Act (ADA), and you could very well end up with a 32-inch-high bed, which would make transfers very challenging.

“Don’t assume that the accessible hotel room is going to have the exact same features that your own home has, because in most cases, it won’t. Ask a lot of questions to make sure you get the access features you need.”

Some hotels are more accessible than others, and good indicators of their commitment can often be found online. Benchmark Resorts & Hotels comprises 13 properties across the United States, and the company’s website promotes Benchmark’s commitment to ADA compliance, with detailed accessibility information for each property.

Benchmark’s Turtle Bay resort on Oahu’s North Shore features 15 ADA-compliant guest rooms and one ADA-compliant cottage. Other accessible features include the resort’s swimming pools, hot tubs, fitness center, spa, restaurants, lounges, and a wide-open door-less gateway entrance.

 

A video on Turtle Bay’s website features paraplegic surfer Jess Billauer, founder of the Life Rolls on Foundation, dedicated to improving the quality of life for young people affected by spinal cord injury, as he easily wheels through the resort, surfs with an adaptive electric surfboard and describes the independence that accessibility brings.

“We do everything possible to make sure everything is accessible,” says Gary Harnist, vice president of construction and design for Benchmark. “ADA guest rooms at Turtle Bay have automatic doors. The peepholes are lower. Bathrooms have roll-in showers, and shower, temperature and lighting controls are at a reachable height. We want to make sure the balconies are accessible, so we have sliding glass doors and ramps.”

Harnist advises, “Ask questions before you arrive. Let us know what your needs are. Many times we’ve sent staff members to the store to buy a lower shower seat, or called a rental company to get the kind of wheelchair a guest needs to insure that their stay is perfect.” For more information about Benchmark Resorts & Hotels, go to www.benchmarkresortsandhotels.com/about/social_responsibility/ada_accessibility_compliance

As with hotels and resorts, when planning a trip to a theme park, checking in advance for clarity on accessibility and disability policies can be a good idea. Walt Disney World and Disneyland Resorts made headlines in October when it replaced its Guest Assistance Card (GAS) program with a Disability Access Service Card (DAS).

A Disney Parks blog post by Thomas Smith, social media director, Disney Parks, explains that guests with disabilities can now “request a DAS at Guest Relations and receive a return time for attractions based on the current wait time.” Prior to the change, which Smith said was prompted by abuse of the program, guests with disabilities had been able to go directly to the front of the lines for Disney attractions.

For more information on Walt Disney World and Disneyland Resorts, go to http://disneyparks.disney.go.com

CRUISES
A recent study by the Open Doors Organization and the U.S. Travel Association found that 12 percent of Americans with disabilities have taken a cruise in the last five years.

“Cruises are great for people who need to move slowly and take their time. You can be as active as you want and do everything, or you can do as little as you want, have a nice spot in the lounge and watch the sea,” says Royal Caribbean’s Pettit. “We’ve designed our cruise ships to be very accessible, so there are elevators, ramps, and platform lifts. We have options all over the ship for guests with limited mobility.”

Travel agents can be helpful in sorting out accessible cruise options. Says Pettit, “If you’ve never cruised before, you don’t know the questions to ask, and that’s why we recommend using a travel agent.

“There are travel agents who specialize in accessible cruises and in specific conditions. Some specialize in dialysis cruises, autism cruises, deaf cruises, blind cruises, and disability in general, and not just group cruises. They deal with individuals or families. They specialize, may have the disability themselves, and know the questions to ask. They can help walk you through making an informed decision about the right cruise line and cruise for you.”

Says traveler Milli Washock, “A few years ago, I went on a weekend cruise, with a wheelchair, room air concentrator, oxygen tanks, a portable concentrator and a BIPAP, and did quite well. The cruise line, Carnival, went out of their way to bring me [my oxygen] tanks wherever I was and made sure everything was taken care of in the cabin and with shows and dining. They even had distilled bottled water. We had a great time.”

For those cruising for the first time, Washock suggests, “Book a room with open air, a window and/or a balcony, and liberally use hand sanitizer everywhere.”

Says Pettit, “Oxygen has changed over the years. What works well for a lot of people now is the new portable oxygen concentrator, what I call’ the magic box.’ It takes ambient air and turns it into breathable oxygen on demand.

“This works well for many people who require oxygen therapy. It may not work for everyone. Some people need continuous air flow. They may need a flow rate that’s higher than what the portable concentrators can give. But for many, many people, portable oxygen concentrators have been revolutionary.

“Portable oxygen concentrators allow passengers to use the same equipment in the plane, on the ground, and on the cruise ships. We have power outlets in our staterooms, so passengers can charge overnight, and they can bring extra batteries as well.

“Technology and the ability of our staff to assist our guests go a long way to help [those with special needs] think about cruising as a possibility. We provide our staff with sensitivity training and technical training, primarily for wheelchair assistance and assisting guests on and off the ship. That’s the number one request that we get.

“We provide training about different types of disabilities and how to communicate with different types of guests. We focus primarily on people with mobility, hearing, and visual disabilities, but we do talk about guests with cognitive or developmental disabilities.

“From an identification perspective, there’s always the question of dignity in providing too much information. The more information we have, the more we can assist you. If we don’t understand your condition, we may provide inappropriate support. If we know ahead of time, it makes things easier.”

In February, Royal Caribbean was the first cruise line to be named as autism-friendly by Autism on the Seas, a agency that develops cruise vacation services for those with children with special needs.

Says Pettit, “Our products and services are accessible for guests with autism and other developmental disabilities. We have priority check in, boarding, departure, and special dietary offerings like gluten-free items. We offer modifications to our youth program onboard, like dropping down an age group if the child would be more comfortable, based on ability.

“We offer autism-friendly movies: The sound is not so loud, the lighting is a little bit lighter, and the kids are encouraged to get up and walk around during the movies. We added a social story to help families dealing with autism prepare for their cruise. Often children with autism need a little structure and preparation, [so we let them know that] when you get to the ship, this is what you’re going to see and this is what you’re going to do, so they can prepare. And really, it’s about the entire family and not just children. Many of our features are used by teens and adults with autism.

“Everybody is different. Their needs are going to be different. We can work with our guests and our travel agents to see if we can help accommodate that need. A lot of our business continues to be booked through travel agents. For many people, it’s their first time, or they may have special needs. You may need a little additional help from an expert. It makes for a much better cruise experience.”

Royal Caribbean’s Access Department is a resource center for guests and travel agents. Staff can answer questions about accommodations for guests with disabilities and can be reached at 866-592-7225 (phone); 954-628-9708 (local); 954-628-9622 (fax) or email [email protected]. Or for more information, go to www.RoyalCaribbean.com/AccessibleSeas

WHERE TO CRUISE
Pettit says that cruises that involve the United States are often preferable for those in wheelchairs or those who need to move slowly. “Alaska, Hawaii, New England, and Western Pacific coastal cruises are all great options, simply because they involve U.S. ports of call, and, generally, when you’re within the U.S., you have a much better sense of accessibility.

“There are curb cuts. There are accessible restrooms and facilities. Whenever you get outside of the U.S., while there are accessibility regulations in place, they may not always meet the same level as in the U.S.”

“The Caribbean has mixed levels of accessibility. We’ve seen progress over the years in many of our ports of call. People tend to gravitate to the Eastern Caribbean itineraries more because more of the ports of call are docked—that means you can roll on and roll off the ship with ease. When you get to the Western Caribbean, you have more ports that are tender,” says Pettit.

“We sail to more than 300 ports of call around the world, and about one third of those ports are tender. What that means is that our ships cannot dock at a pier. They have to anchor in the harbor, and so we transfer guests onto a smaller vessel, usually called a tender. They take that tender to the port and get off there. That process may pose some challenges for guests in wheelchairs and those who have difficulty walking.

“Our larger ships, like Oasis of the Seas and Allure of the Seas, are great ships for guests in wheelchairs and those with difficulty walking, because they never have to tender. They always dock.”

Bob Curley, Caribbean travel expert for About.com, notes that the U.S. Virgin Islands must comply with the ADA and that “Barbados has also made a pretty concerted effort to be compliant, as have Aruba and St. Maarten. Every cruise port in Jamaica is a non-tender port, and St. Thomas also has a dock.”

Says Pettit, “Europe is becoming increasingly accessible, although it’s mixed. A lot of our ships sail there in the summer. There are cobblestone streets, and there may not always be curb cuts. The buildings are older, so they might not always have the wider doors and accessible restrooms. It does require that our guests and our travel agents research the different ports of call to see which ones are more suited than others.

“The Mediterranean is increasingly becoming more accessible, and the more northern and the western you go, it gets more accessible. When you look at bigger ports, especially those that have hosted the Olympics, because they hold the Paralympics, they have increased accessibility over the years.

“Athens and Barcelona are recent examples, so they may have more accessible taxis and motor coaches and overall facilities for people in wheelchairs. You go to some of the smaller ports, like Santorini, and the island ports, and there are mixed levels of accessibility.

“The challenge we get with different ports of call is usually with accessible vehicles; if a guest has some ability, or a caregiver who can assist them into a regular taxi, or they can go up a few steps into the motor coach, more options become available.”

To improve accessibility for guests with more limited mobility, Pettit says that, in Europe, Royal Caribbean has created Easy Tours—a modified version of the cruise line’s panoramic city tours.

“It’s a narrated ride throughout the city on a bus, with a couple of opportunities to get off to look around. These have a motor coach with a lift, or, more often in Europe, a van with a ramp in the back. These are in about 80 ports and are a great option for guests in wheelchairs or scooters, who have limited capability.”

RAIL TRAVEL
Rail travel has its advantages for those with chronic conditions and medical devices, and train trips throughout the U.S. and Canada can be a good place to start.

Says traveler Milli Washock, “I always used to find a plug at the gate [at the airport] for last-minute charging, but I don’t fly anymore. Traveling [domestically] by train is easier in that there is a plug by every seat. It takes longer, but you have a bigger selection on dining and with movies if you plug in your laptop or device.”

With input from disability advocacy organizations, over the past five years, Amtrak has made accessibility improvements at more than 200 stations. All Amtrak trains have accessible seating and restrooms, and all long-distance trains have accessible bedrooms. Amtrak also offers a discount to passengers with disabilities and their companions.

For more information, go to www.amtrak.com/accessible-travel-services.

Other countries have also made recent improvements in rail travel accessibility. Australia, for example, offers a host of services and special deals to meet the needs of travelers with disabilities, including accessible services in most of its trains. For more information, go to www.australiaforall.com

But accessible international rail travel might be even closer than you think. “We are more accessible than flying or taking the bus,” says Jacques Gagnon, senior manager, media and community relations for Via Rail Canada, Canada’s national passenger rail service.

“When you take Via Rail, you can enjoy traveling while looking out the window and seeing scenic portraits of cities, prairies, and the Rockies, while being comforted by having a quiet time.

“It’s spacious. We have invested in making cars accessible, roomy, and user-friendly for people with limited mobility and special conditions. We also cater to gluten-free and other special dietary needs, with advance notice.

“Canadian laws and regulations provide ample services for people with limited mobility. It’s part of the fabric of Canada to provide accessibility to its citizens and to travelers.

“At various stations we have lifts to allow people with wheelchairs to board the train. We have a dedicated area where the person will anchor his or her wheelchair safely.

“We also allow someone, or a service animal, to accompany that person and ride at no additional cost. We ask to receive 24-hour, or ideally, 48-hour advance notice that someone with a specific condition will be boarding the train so the attendants can recognize and attend to their needs.”

For those interested in viewing gorgeous vistas while riding the rails, Gagnon says, “There are two long-haul routes—one is The Ocean—a 22-hour journey from Montreal to Halifax. The train travels along shorelines of the Atlantic Ocean and has a panoramic car.

“The other one is The Canadian, between Toronto and Vancouver, through the Canadian Rockies and the prairies. It‘s a very scenic three-and-a-half-day journey. The track goes across terrain where there are no highways and roads. It’s very unique—even in the summer time, the Rockies are covered with snow. It’s a very elevated, beautiful terrain, with views of the Pacific Ocean.” For more information on Via Rail, go to https://www.viarail.ca/en/travel-info/special-needs/accessibility

AIR TRAVEL
Getting as much information as possible and alerting the airline to your needs in advance, as well as allowing time for delays, are critical when traveling by air. Be sure to factor in potential traffic issues, lengthy distances between gates, crowds, long lines and flight delays when connecting. And don’t be hesitant to ask for assistance, such as wheelchairs or electric carts, experienced travelers advise.

One flyer says, “My husband has Huntington’s disease, and for him, we found going on the plane with assistance has given him more time to get to his seat without people pushing and being impatient. Also, we request wheelchair assistance at all airports.

“If you’ve ever been to Jamaica, Miami, or Atlanta airports, then you know it’s like walking a mile from one point to another. Imagine if you only have half an hour to get from one gate to the other. Always ask for assistance when needed. Most of the people who work at airports are only to happy to help.”

Traveler Keti Galanos says, “Panic attacks are commonplace for those of us afflicted. I am at the near norm readings for PAH, yet will take medication for the next year. I request a wheelchair, as I cannot run between gates in the airport, and I always panic and am out of breath.”

Traveler Cheryl Kneal recalls, “I traveled to Chicago from Orlando over Christmas. I had my portable oxygen concentrator and had the airline take me to the gate for departure, and then, when we arrived, to where I was picked up, to conserve energy.”

Kneal adds that, to deal with stress and panic attacks about running out of oxygen, she meditated frequently during the two-hour flight.

For those with limited mobility, addressing needs step-by-step ahead of time is key to alleviating stress and making travel as hassle-free as possible. When making your airline reservation, let the agent know if you’ll be traveling with a wheelchair or scooter, if you’ll need one at the airport, and if you’ll need to transfer to one of the airline’s aisle wheelchairs (a narrow wheelchair designed to fit aircraft aisles) to help you board or deplane. Also ask if you can use the aisle wheelchair during the flight to get to the bathroom.

Ask to keep your wheelchair until you get to the gate, check it there, and have it returned to you at the gate on arrival. (Depending on the type of wheelchair you have and space available, it will either be stored in the cabin or in the baggage hold during the flight.)

Flight attendants can help passengers use the aisle wheelchair to get to the restroom, but not in the restroom, and many onboard restrooms are not wheelchair accessible. Flight attendants are also not required to lift or carry passengers. Some fliers with limited mobility limit fluid intake before and during a flight to prevent the need to use the restroom, however doing so can present the risk of dehydration and other medical problems.

Flying can also be unpredictable. Air traffic and weather delays can mean the plane is stuck on the runway before takeoff or circling for an extra hour before landing. If you have limited mobility, it might be advisable to consider flying with someone who can help you in the restroom, or catheterization, rather than limiting fluids.

AIRPORT SECURITY
Candy Harrington advises those who have concerns about navigating airport security in wheelchairs and with medication and medical devices to check the TSA guidelines beforehand.

“Although the TSA is exempt from the ADA and the ACAA, they have developed specific guidelines for dealing with disabled passengers. They list these guidelines on their website, so it’s a good idea to familiarize yourself with them, so you will know what to expect.”

Traveler Ruth Cozad says that she was pleasantly surprised with her TSA experience. “We went to Hawaii with both oxygen and CPAP machines and had an amazing trip. Going through security was my big worry, and it went so smoothly.” For more information on TSA guidelines, go to www.tsa.gov/traveler-information/travelers-disabilities-and-medical-conditions or call the TSA Cares hotline at 855-787-2227 with any access-related questions prior to travel.

DRIVING
For some travelers with chronic conditions, especially those traveling with oxygen, driving can provide the most stress-free journey, and help them slowly ease into travel. Taking short trips from one central location can also help to conserve energy and get the most out of a trip.

Cozad suggests, “My advice would be to stay in one location and take day trips, instead of moving each day. We often take driving trips that last several weeks, and those are easy enough, with my husband unloading and reloading oxygen and CPAP equipment, plus our luggage.”

Milli Washock says, “A lot of people are using the Inogen One portable oxygen device, and it’s nice to go on a plane or a ship. I find it great for long-distance auto travel.”

A potential problem, though, says Washock, is that the device does not have a HEPA filter. She recalls that once, while she was dining out, “a man was smoking a cigar in the nearby bar, and suddenly I was ‘smoking a cigar’ and could not breathe.”

In this case, Washock found that traveling by car had benefits. “Thankfully, I had an oxygen E tank in the car and did not have to permanently abandon my dinner, but it gave me something to think about.”

Despite such challenges, Washock says, “It is good to travel if you can. Just because our bodies do not cooperate the way we want does not mean our brains and lives have to shut down. And, she notes, travel, no matter the distance, can be enhanced by state of mind. “Take it slowly, and enjoy the world around you, whether traveling to your porch or across the world. Each day is a new day.”

 

See Part 2 of our accessible travel story, highlighting some of Washington, D.C.’s top accessible attractions!

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Help Others by Sharing Your Story with CVC

Posted on June 1, 2014 by CVCinfo

You can inspire others and let them know that they’re not alone when you share your story with the Caring Voice Coalition community. You can share what’s important for new patients, caregivers, and medical professionals to know about living with rare and chronic illness. And you can tell other patients how you came to CVC and what your experience has been.

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In Your Words: Carrie Beth and Asher

Posted on May 28, 2014 by Charlie

Carrie Beth Pretto’s son Asher’s infantile spasms (IS) were diagnosed two years ago. A year after brain surgery, multiple medications and doctors’ visits, he is now seizure-free. Pretto describes the challenges they’ve overcome, and still face, and offers advice on finding support, treatment, and resources for IS.

Asher was diagnosed with infantile spasms on November 11, 2011. He was six months old.

A week prior to his diagnosis, Asher began having unusual eye patterns and jerking body movements. He would lean forward and then throw his head back and arms out wide.

As we began to notice this wasn’t just a one-time occurrence, we became concerned. Over a week’s time, the jerking motions and eye rolling developed into clusters, occurring more often throughout the day.

I made a call to our pediatrician, who immediately ordered us to have an EEG performed. While there, I overheard nurses comment, “This is classic IS,” not knowing the least bit about what they were referring to.

Within hours, we were sent to a local pediatric neurologist. I can still see the look on the doctor’s face when she walked into the room. It was not your usual first greeting from your doctor. Her face was filled with sadness and disappointment.

After examining Asher and reviewing the EEG, she diagnosed him with infantile spasms. The doctor stressed the need for starting treatment immediately to prevent prolonged damage to Asher’s brain and the associated developmental delays.

Although we knew nothing about IS, we could sense this was a serious matter and obediently agreed to any recommended treatment. The first step was to stop the spasms, and then continue trying to diagnose the cause of the spasms via MRI and other methods.

We were told the best case was that nothing abnormal would be found, and in that case, he’d likely grow out of the IS. The neurologist kept commenting that she hoped it wasn’t tuberous sclerosis complex (TSC). Again, something we had never heard of before.

The doctor prescribed a very expensive medication that was made-to-order out of Chicago and wouldn’t be released to us until a nonprofit organization agreed to assist with the co-pay. Within three days, we received the medication and began administering it via injections twice a day for 60 days. A nurse administered the first injection, but I was left to provide the injections from then on in his poor little thighs.

Again, step two was to determine what was causing the IS, so throughout his period of treatments, Asher underwent numerous tests such as MRI, ultrasounds, cardiology exams, blood work—it seemed endless. During this time, our poor son ballooned from the steroids, going from 15 to 20 pounds in only seven weeks.

The medication stopped the IS within three days of the first injection, but while weaning him off the treatment in the final weeks, we observed a different type of seizure develop, one in which he lost emotion while looking up and away. The neurologist prescribed new medications in various combinations and doses to stop the seizures, each unsuccessful.

Approximately two months after Asher was first diagnosed with IS, the neurologist delivered a diagnosis of tuberous sclerosis complex, based on the findings on the MRI. Tuberous sclerosis complex (TSC) is a genetic disorder in which the DNA lacks either one or both of the genes that suppress tumor growth in many of the major organs.

Currently Asher is only showing the TS characteristics of tumor growth on his skin and brain, which account for his uncontrolled epilepsy and developmental delay.

From this point, we were referred to the TSC clinic at UT Medical Center in Houston, Texas, for further treatment. There, we met with multiple neurologists and a geneticist, who prescribed another round of medications to control the seizures.

Finally, on November 5, 2012, Asher underwent an occipital resection on the left hemisphere of his brain to remove the largest tuber, [occupying] roughly 10 percent of his brain, that was causing his epilepsy.

With our weekly schedule of occupational, speech, physical and autism therapy, Asher is thriving, despite the setbacks that we have faced over the past two years.

After two years of multiple medications and doctors’ visits, Asher has now been seizure-free since his brain surgery just over a year ago. It is such a blessing that we can now say our little guy, at the age of two and a half, is actively catching up and accomplishing new milestones everyday.

Asher is a busy little guy. When not at therapy, some of the things he enjoys are swinging, going for wagon rides, running outside, doing puzzles, listening to sing-a-long songs, anything to do with shapes, playing peek-a-boo, coloring, jumping on the bed, and airplane on daddy’s feet, and he loves tubby time (bath time).

Some of the biggest challenges have been his lack of and delays in ability to communicate and show emotions and expressions of love, public outings, such as shopping and restaurants, tending to another child while home, what kind of care to give him and how to get it, as well as therapy, treatment plans for long-term care, limited medical coverage for behavioral therapy, rareness of the disorder and limitations of knowledgeable staff close to home.

For the parents of those who are newly diagnosed, it’s important to educate yourself quickly through only credible resources—the internet can be very misleading—and to find a neurologist who is knowledgeable in diagnosing and treating IS. Technology is also very important—they must have the right and most up-to-date tools.

Be prepared to make difficult decisions, whether it is in regards to medications and their harmful side effects, or the onset of developmental delays. Nonprofit companies are available to help you when in need. Support groups are out there … you are not alone.

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We Can Be Heroes: Patricia George, M.D.

Posted on May 18, 2014 by Charlie

Patricia George, M.D., spoke with Community about her work in pulmonary transplant medicine, her HIV-PAH research, and her motivation as a member of PHA’s four-woman Team PHenomenal Hope in the nine-day 2014 Race Across America.

Going into medical school, I had passion for and experience in immunology research, so transplantation was something in which I was always interested. And like many who go into pulmonary medicine, I was initially drawn to it through my medical school and residency rotations in the medical intensive care unit. I enjoyed pulmonary physiology, and the work and pace of critical care medicine.

In addition, as a medical student, I met a patient with cystic fibrosis awaiting a lung transplant in the medical intensive care unit. I got to know her and her mom, and some of her life story, and wanted to be able to help people like her with lung disease. So that led me to pulmonary medicine and pulmonary transplant medicine.

My research involves looking at the mechanisms of HIV-associated pulmonary arterial hypertension (HIV-PAH). Pulmonary arterial hypertension is quite rare, however in patients with HIV, it affects at least 0.5 percent, and perhaps more, according to recent studies. That’s at least one in [every] 200 patients!

Advances in HIV care have changed the landscape for people with HIV, and many now label HIV a chronic disease. So medical complications, like HIV-PAH, become extremely important to study and hopefully help people live longer and live better.

Team PHenomenal Hope came together with people passionate about cycling and raising awareness. As an avid cyclist, it had long been a dream to someday race in the Race Across America (RAAM).

Stacie Truszkowski, one of my close friends in the cycling community, also shared this dream. So, in 2011 and 2012, Stacie and I reached out to our endurance cycling friends whom we thought might be crazy—er—passionate—enough to do this as well, and in 2012, with the addition of Anne-Marie Alderson, Ryanne Palermo, and Kate Bennett as our crew chief, our four-woman cycling team was born.

We organized this Pittsburgh-based team, met with our friends at PHA, as well as our earliest sponsors, and formed Team PHenomenal Hope. Later that summer, we added to this group Greta Daniels, assistant crew chief and alternate racer, and Sara Harper, alternate racer and crew.

Our mission is to dedicate our training and racing to those who live with pulmonary hypertension, to raise public awareness about the disease, and to raise funds to find a cure.

I started biking during pulmonary fellowship. I wanted to get back in shape, and a new women’s cycling team called Steel City Endurance was forming. I joined them in the inaugural year, and became totally enamored with biking and bike racing and met a lot of really neat people.

I enjoy being outside, escaping the stresses of my sometimes hectic lifestyle. As for endurance cycling, I enjoy pushing my body and mind to some sort of limit. It allows you to lose yourself in the present—how you’re feeling at that time.

We’re working with our team coach, who’s helping coordinate our training schedules so that they build and peak at the right time. Training is about consistency—getting the workouts in, getting stronger every day (except rest days). Eating healthy and getting enough sleep are crucial too.

As a team, we’re racing the whole race as a relay. To make the time cut-off and make it to the finish line as fast as we can, we divide up the ride into 20-to-30-minute segments.

On a four-person team, typically two riders will be out on the road, trading places in 20-to-30-minute pulls (one riding, the other in a support vehicle leapfrogging ahead for the exchange to happen). This pair of the four-woman team will ride for four to six hours, while the other pair rests, eats, sleeps, and recovers. It goes 24/7, from the time the gun goes off until we cross the finish line.

From what I hear, mental toughness will be one of the biggest challenges during RAAM. Those who have done it say that, at about day four or five, the sleep deprivation kicks in, and the reality of the Midwest flatlands also hits you. I know there is beauty in rolling plains, but at that point in the race, it may be tough to see it.

During RAAM, the crew is the essential group of people that will get us from Oceanside, California, to Annapolis, Maryland. The crew chief, Kate Bennett, is in charge of coordinating the drivers, navigators, medics, mechanics, nutrition, making sure we’re on course, and that people— including crew—are getting enough sleep, food, etc. A race with this relay between four racers, moving across the country with an RV, two support vehicles, and 13 crewmembers is quite an undertaking.

The greatest source of inspiration is the PH community. When I think about how hard it may be to be on the bike, mentally or physically, I think about what my patients go through on a daily basis.

I get to choose to ride my bike, to push myself through discomfort. My patients don’t have such a choice. They wake up and live with pulmonary hypertension every day, and face whatever that day may bring, and many do so with such grace. So when I’m feeling less than motivated, I often think of people I know living with PH, and it motivates me to get this job done.

Likewise, in my practice, I am regularly reminded of the need for a cure. I often evaluate patients with pulmonary hypertension in need of a lung transplant. For this group of patients, they often no longer are responding to medications. It is a reminder that, while we have come so far, and many patients do respond to medical therapies, we still need a cure.

In my job, I also conduct PH research, and know firsthand how important funding is to exploring the frontiers in science. It makes it all the more important to me that Team PHenomenal Hope is raising money for PHA to fund grants and help other scientists have funds needed to find a cure.

We have something truly special with our partnership with the Pulmonary Hypertension Association. PHA launched a Race of Our Lives campaign, and we have been amazed how people in the community have organized their own Unity events, walking, riding their bikes, doing whatever they can to raise awareness about PH and join us in raising funds to find a cure.

Team PHenomenal Hope is bigger than four of us on bikes, or the 17 of us crossing the country. This is actually a huge team that spans coast-to-coast.

Pulmonary hypertension is a rare disease that can affect anyone, from children to adults, men and women, and people of all races and ethnic backgrounds. Initially, it is often misdiagnosed as another pulmonary condition, taking on average over a year to make the correct diagnosis and get the proper treatment.

Although it is a rare disease, it is important for doctors to at least think about pulmonary hypertension in their differential diagnosis when faced with a patient with shortness of breath, because without considering it, the diagnosis won’t be made.

Fortunately there are many medical treatments on the market, changing the prognosis for many who have this disease; however there still are people who do not respond to therapy, and to date there is no cure. Team PHenomenal Hope is working with PHA to do something to try to change that.

 

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We Can Be Heroes: Shana Verstegen

Posted on May 7, 2014 by Charlie

Six-time log rolling and boom-running champion Shana Verstegen (née Martin) has been featured on ESPN, The Travel Channel, and Outdoor Life Network. Verstegen’s sports of choice demand a daunting blend of strength, balance, endurance, and agility.

The physical state that allows the 34-year-old athlete and fitness trainer to stay atop logs that are bobbing in water while spinning them with her feet, and win by making her competitor lose her balance is complemented by her training in pole vaulting, gymnastics, and karate.

In 1986, Verstegen’s mother, Deborah Martin, was diagnosed with Huntington’s disease. Martin succumbed to respiratory complications from the disease in March 2013. Verstegen, who married her husband, Peter, in November 2013, has not been tested for Huntington’s. Community spoke to Verstegen about her plans for the future, her mother’s legacy of strength and determination, and the freedom Verstegen finds in log-rolling.

I first learned about Huntington’s disease in our hotel room at the Mayo Clinic. My dad set out a bunch of materials provided by the Huntington’s Disease Society of America (HDSA) about what Huntington’s disease is, what to expect, and caregiving.

My parents sat down and explained to me exactly what to expect over the next several years, and how my mom would lose her ability to walk, talk, and care for herself. But they also showed me all the research that was happening.

My dad said, ‘All these people are working really hard to make sure that your mom gets better.’

And then my dad flipped a coin.

He said, ‘These are your chances of also having Huntington’s disease.’

My question was, ‘Well, which one is it? Heads or tails?’ He said, ‘I can’t tell you that.’ But… he always went right back to: ‘All this research is happening.’

He truly believed they would have a cure before it came to my time. Unfortunately, they don’t yet.

I began log rolling at the YMCA swimming pool. I loved the fact that it was so unique and fun! Log rolling has always been my escape. As a child, when I showed up for practice, nothing else in the world, not even how sick my mother was, bothered me. It was my time to have fun with friends and do something I love. It still is!

What I think is most important for caregivers and those newly diagnosed with Huntington’s disease to know is that life is not over upon diagnosis. No matter what challenge we face, we all need to live life to the fullest and love and appreciate those closest to us.

With my career as a fitness professional and all of my athletic competitions throughout the year, daily workouts are part of my life. I don’t think of [the possibility of ] delaying Huntington’s disease while I exercise, just about having fun and performing well. If I do have the disease, of course, a delayed onset would be a wonderful benefit.

After my mom had to move into a nursing home for safety reasons in 1993, my dad and I made a promise to spend time with her at least once every week. This became our ‘family day.’

While she was still mobile, we would go on various adventures around southern Wisconsin and out to eat. When she was no longer able to leave the nursing home, we would spend time there, telling her about what was new in our lives and watching movies. After her passing in March of 2013, my dad and I continue this weekly tradition of family day.

My mother used her battle with Huntington’s disease to teach some very important lessons. She taught us to smile, to give, to be strong and independent and stubborn—to fight for what we believe in, to love unconditionally, embrace family, live every day to the fullest, and to sing.

My life is absolutely amazing now, and part of it is because I can hold onto hope. I fear a positive test result will take that hope away from me. But through my involvement with HDSA, I’ve met so many people who are positive with Huntington’s disease and are living their lives just as fully as I live mine.

This year may mark a change in my decision to not be tested, but that is a decision my husband and I will have to make after much thought.

As for the future, I will continue packing 30 hours into each 24-hour day, and working my hardest to do my part to find a cure for Huntington’s disease. I also, more than anything, want to become a mom.

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We Can Be Heroes: Nicole Murray

Posted on April 28, 2014 by Charlie

Nicole Murray talks to Community about pairing her love of running with raising awareness and funding for her son Ronan’s infantile spasms (IS) and offers advice for parents of children who’ve been recently diagnosed with IS. Murray ran in the 2013 Philadelphia Marathon as an Epilepsy Foundation Athlete vs. Epilepsy.

Ronan was officially diagnosed in late April 2012, at four months old, via video EEG, though he was having clinical spasms in March. It took nearly five weeks for his clinical spasms to evolve to infantile spasms and hypsarrhythmia on the EEG.

The moment he started having them, I knew they were IS. I had read about IS when I joined an epilepsy parent support group and had seen videos of children having IS, so I knew. It’s very different than other seizure types; they don’t look all that terrible, but they are incredibly catastrophic.

I’ve always been a runner. It has always been a great stress reliever for me. I knew that I could pair my love of running with raising awareness for Ronan’s condition, and that’s why I chose to run for the Epilepsy Foundation.

Ronan is defying the odds and breaking the rules. At ten and a half months old, he was not sitting, not babbling, and not self-feeding. He was having anywhere from five to 50 seizures daily. Since the morning of October 23, he has not had one seizure!

He had surgery three months ago, and he’s sitting unassisted, babbling, self-feeding, plus, starting to really bear weight on his legs. His development has taken off, and he’s so happy and alert, despite still being on two seizure meds.

The surgery did leave him with deficits, some of which will be permanent. Some of which, we’ll hope to overcome with intensive therapy.

He does have significant weakness/unawareness on his right side, as his entire left-brain hemisphere is now disconnected/removed, but he’s showing steady progress with arm recovery. His leg has recovered very well. He will have a permanent visual field cut. The right visual field of both eyes will never return.

Right now, we are working hard with seven-plus therapy appointments per week, and celebrating in each and every inch and milestone he’s making.

I’m now back to work, and his therapy schedule (and our other son) keep us very, very busy. I try to get out [to run] at least three, ideally four times a week.

Running helps me feel strong, both physically and mentally. I also never take for granted that I have the physical abilities to run, as I’ve met many children now who cannot.

I don’t know [what marathons I’m running next]! I think I’ll probably be more inclined to sign up for a half marathon first. Training for a full marathon is a serious time commitment. Perhaps Philly again.

Regrettably, I have not been involved with the Epilepsy Foundation beyond raising money via the marathon. Eventually, I’ll become more involved, but right now, Ronan’s therapy and needs are intense. I am involved with several online support groups for infantile spasms and polymicrogyria, and the Hemispherectomy Foundation, among others.

You can follow Ronan’s journey and progress here: https://www.facebook.com/RonanRobertsFanClub

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We Can Be Heroes: Nicole Jeray

Posted on April 23, 2014 by Charlie

LPGA golfer Nicole Jeray details her five-year search for an accurate narcolepsy diagnosis and how managing her narcolepsy has improved her game.

I first experienced symptoms of narcolepsy in college. I fell asleep in all my classes. My notes were a scribbled mess because I was asleep. I was fighting so hard to stay awake and listen to lectures.

I also fell asleep while driving. I took a special class in Chicago that was an hour-and-15-minute drive from campus, and I’d fall asleep every single time I drove back. I’d take the wrong exit and get lost going back to campus.

I fell asleep in the summertime driving to far away golf tournaments. I thought it was the exhaust from my old car. I’d roll the windows down and turn the music on high to help me stay awake. I guess I got used to being sleepy and fighting it—it just became a part of life. I had very vivid dreams and sleep paralysis in college. I thought this was normal, and my friends enjoyed hearing about my wild dreams.

I played lots of sports as kid. I was very athletic and had excellent hand-eye coordination. Golf was just another sport at first. When I was 15, I started working at a golf course, and it was then that I became addicted to the game.

It was five years between the onset of symptoms and an actual narcolepsy diagnosis, and I was only diagnosed because I developed severe cataplexy. In those five years, I went to several doctors looking for answers. ‘Overworked’ was the only diagnosis I received. I took vitamins and even became a strict vegan in an attempt to find more energy.

After a year and a half of eating this way, my symptoms never improved, and I developed severe cataplexy. I was lucky to see a doctor who listened to me and researched further to find an answer. Finally I heard the word ‘narcolepsy.’ One week later, I saw a neurologist and did a sleep study and found that I had a classic, textbook case of narcolepsy.

I was relieved that there was a name, and that I was not going to die. I would be able to continue to pursue my golf career. Little did I know, that day was only the beginning of a long roller coaster ride and a terrific education on life.

I have to force my mind to think about something else to try to prevent cataplexy. It stinks though, to not be able to enjoy the excitement like you want. I became quite good at remaining even-keeled, never too angry and never too excited. It’s built into my personality now.

Sometimes I picture that little kids might be watching, and I don’t want to scare them. It’s pretty traumatic watching someone suddenly become totally limp and fall to the floor. Becoming the center of attention and ruining a fun moment for people is no fun. It happened a lot, but diverting my attention would help.

Having narcolepsy taught me to appreciate each waking moment! I learned to set priorities. Important things must come first—when I have the energy.

I also learned how to say ‘no.’ I used to do everything that was asked of me, and more. Now, I do things that I actually enjoy and the things I want to do. Life is much happier and easier. Funny, it took getting narcolepsy to learn this.

I like that I’m more even-keeled. It’s less stressful, and less dramatic. I watch other people get so uptight about things, or make such a big deal over nothing. It seems unhealthy, and it drains energy.

My visualization skills have also improved. I must visualize and believe that I’m going to hit that shot just right. This way, when I do hit a great shot, it’s no surprise, and I don’t get so excited and have full cataplexy.

Narcolepsy also taught me how to take care of myself. When I do, my symptoms are much better. I drink plenty of water, eat the right things, maintain a sleep routine, good friends, and healthy relationships. It now baffles me that I didn’t do all these things before. Why does it take a life-changing disorder to figure out what the important things are in life?

I finished 113 on the LPGA money list in 2013—it’s the best I’ve finished on the LPGA since being diagnosed with narcolepsy in 1996. This position will get me into between 10 and 17 events in 2014. I’m also doing the Swinging for Sleep online fundraising campaign again in 2014 to promote narcolepsy awareness, research and patient support.

I care so much about my career that I must take extra care when it comes to managing narcolepsy. I must be extremely aware of how my body and brain feel so I can perform my best. I pay attention to the things that make me sleepier or more alert.

Golf helps narcolepsy in many ways. I’m outside and in sunlight, golf is active, and I set my own schedule. The longest I generally have to be alert and awake is about six to seven hours—which used to be extremely challenging before my latest medication change. I spend a lot of time in the gym because of golf. This has to help my narcolepsy.

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We Can Be Heroes: Michael Poole

Posted on April 21, 2014 by Charlie

Community spoke with 22-year-old New Zealand champion triathlete Michael Poole about his sport, his love of adventure, and his discipline in dealing with epilepsy.

My epilepsy was first diagnosed when I was 17 or 18 years old. I was in two situations where I had grand mal seizures about 13 weeks apart.

It was a difficult time, as my sport involves activities (swimming and cycling) that have risk attached, but I had good doctors and great advice that I’ve followed very closely. The medication I’m on appears to have worked well too.

Growing up in New Zealand, there is every opportunity to be active. I played a lot of soccer early, but also loved running races. At 13, I started cycling and then did a couple of triathlons and realized I had to learn to swim a lot better.

Through some great coaching and lots of hard work, by the time I had left high school in New Zealand, I had won national titles in triathlon, duathlon, multi-sport, cycling, cross-country running, and road running. I had also represented New Zealand internationally in both cycling and triathlon.

For those newly diagnosed, I think it’s important to get as much accurate information as you can from experts. Don’t panic. Follow advice really closely. Don’t put aside ambitions. Talk about things when you are ready.

Some of the most important things I’ve learned from being an athlete are that it’s really hard work on a daily basis, and you have to take things one day at a time. I’ve been able to travel to a range of countries—China, South Korea, Japan, New Caledonia, Australia, Costa Rica, and Barbados, and to 20 cities in the U.S.—you learn a lot about people and places.

Being disciplined around my risk factors is hard—sleep, diet, remembering to take meds. Being concerned about misunderstandings can be hard too. I have to declare my condition on race entries, but so far organizers have been really good and low-key. When we were first working through that, it was hard, as the restrictions placed on me the first six to 12 months after diagnosis were strict for driving, cycling, and swimming.

I’m a full-time chemical engineering student at the University of South Florida. I have high expectations and work very hard. To be a full-time student, full-time athlete living in a country I did not grow up in has real challenges.

I race often. On January 19, I raced in a world-class field in Auckland over a half-iron man distance. I then have more races in New Zealand and one in Australia before heading back to the U.S. in mid-February.

I will then look to race approximately 20 times across the U.S. during the year. It’s always challenging, as many world-class athletes come to the U.S. to race, but lots of learning and development are available. Financially things are also tough—I pay full international fees, plus away-from-home living costs. Triathlon is an expensive sport in many ways—getting sponsorship is tough—and the major results do not come until your mid to late twenties. So a week-by-week challenge is finding enough financial backing just to keep moving forward as a student and an athlete.

What is most rewarding about being a triathlete are the challenges of continuous improvement and the overcoming of all the strategic life problems that go with the sport. It is a very difficult sport.

I offered my profile to the Epilepsy Foundation to assist in any way they saw fit, and their Athletes vs. Epilepsy initiative fits really well. If I can in some way encourage people with epilepsy to be out and be active, it can only be a good thing. People are very welcome to contact me through: www.facebook.com/michaelpooleprofessionaltriathlete

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