Headlines — Lung Cancer, MS, Harry Potter, Hearing Loss

Circa 2005

LUNG CANCER

CELEBREX GETS SECOND LOOK

After a lengthy re-evaluation process and the addition of new monitoring guidelines, The University of Texas M. D. Anderson Cancer Center has reactivated a lung cancer chemoprevention trial studying celecoxib, an anti-inflammatory medication also known as Celebrex.

In the wake of preliminary research elsewhere suggesting celecoxib might slightly increase the risk for stroke or cardiac events, M. D. Anderson voluntarily suspended the trial of the popular medication last December at the request of Pfizer, the maker of the drug, and the National Cancer Institute, the funding source for the study, until further data on the drug could be analyzed. In February, advisors to the Food and Drug Administration (FDA) recommended that celecoxib continue to be studied in the treatment and prevention of cancer. The investigators at M. D. Anderson have added stringent guidelines to reduce risk to participants and insure the drug will be safe.

“At this point, there is nothing available to deter lung cancer in smokers, even in those who have quit,” said Jonathan M. Kurie, MD, principal investigator and professor in the Department of Thoracic/Head and Neck Oncology. “In looking at the data, we believe the potential benefit to the patient is greater than the risk. We continue to believe this drug has potential to reduce the risk of lung cancer, and that is a tremendous opportunity not to be overlooked.”

Lung cancer is the leading cause of cancer mortality in both men and women, accounting for 28 percent of all cancer deaths in the United States, according to the American Cancer Society. There are bout 173,000 new cases of lung cancer diagnosed in this country each year, about 90 percent occurring in current or former smokers.

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WALKING DRUG

MS TREATMENT ENTERS PHASE III TEST

Acorda Therapeutics has announced that it has initiated a pivotal, phase III clinical trial of FampridineSR, a sustained-release tablet formulation of the investigational drug Fampridine (4-aminopyridine or 4-AP). The study, which is based on a Special Protocol Assessment issued by the FDA, will evaluate the safety and efficacy of Fampridine-SR in improving walking ability for people with multiple sclerosis (MS).

The primary outcome measure for the study will be an improvement in walking ability; secondary outcomes will include measurements of leg strength and muscle spasticity.

“Today’s MS therapies act to prevent relapses and slow the progression of the disease but do not address the considerable loss of function experienced by these patients,” said Andrew Goodman, MD, director of the MS Center at the University of Rochester Medical School and chairman of Acorda’s MS advisory group.” A drug that could improve walking ability would be a significant and complementary addition to the current array of available therapies.” According to the North American Research Committee on Multiple Sclerosis patient registry, approximately 80 percent of people with MS experience some degree of walking impairment. Additionally, mobility issues tend to worsen over time and seem to be independent of the type of MS diagnosed.

The most recent multi-center, phase II clinical trial of Fampridine-SR enrolled 211 patients with MS. The results showed a positive trend for improvement in average walking speed as measured by the Timed 25-Foot Walk, and a statistically significant improvement in leg muscle strength as measured by the Lower Extremity Manual Muscle Test. These data are consistent with the results of earlier phase II trials.

Adverse events seen in previous clinical studies have generally been rated as mild to moderate and have included insomnia, paresthesias (numbness/tingling in the limbs), dizziness and nausea. Seizures were reported in a small number of patients, at higher doses than are currently being evaluated. As Fampridine-SR is an investigational drug, safety and efficacy have not been fully determined.

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BRAILLE BOOKS

TRANSCRIBERS ON THE WAY

Verizon Communications has awarded the American Foundation of the Blind (AFB) a $200,000 grant to promote the new career of Braille Textbook Transcriber and improve literacy for blind and low-vision schoolchildren.

The funds will launch online community college-level courses designed to train transcribers to produce textbooks and instructional materials in braille. AFB is working on this effort in collaboration with Northwest Vista College in San Antonio, Texas; the Texas Education Agency; and 35 of the leading national organizations and associations in education, literacy and service to the blind and low-vision population.

“The online curriculum is a critical step toward meeting the needs of blind and low-vision schoolchildren across America, who currently wait months to receive textbooks and instructional materials in braille,” said Carl R. Augusto, president and CEO of AFB. “We are deeply appreciative of Verizon’s commitment to continuing this partnership and its long-standing dedication to championing literacy in America.”

It is estimated that the U.S. needs 380 full-time transcribers now, will need 735 additional transcribers in five years, and will need 1,020 additional transcribers in 10 years. Current transcribers are dedicated but unpaid volunteers who cannot meet the demand for brailled textbooks and learning materials.

Since 2002, AFB’s partnership with Verizon has propelled the lack of timely and appropriate textbooks and instructional materials for schoolchildren with vision loss into the forefront of education and policy discussion. This national effort has forced policymakers to look at what access truly means for students who are blind or low-vision.

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HARRY POTTER

WEBSITE USES ACCESSIBLE TECHNOLOGY

The official website of Harry Potter author J.K. Rowling is new—and very much improved for fans with disabilities. Lightmaker, the site’s designer, has worked closely with the Royal National Institute of the Blind (RNIB) and Macromedia to pioneer a fully accessible site. The website is navigable by keyboards without the need for a mouse, and the homepage contains an accessibility menu so users can quickly gain access to features that enlarge webpage text, turn off background noise, pause onscreen movements and add captions to sound.

Rowling said, “www.jkrowling.com allows me the opportunity to be able to communicate directly with as many Harry Potter fans as possible. I am therefore delighted that [fans with disabilities] can now be a part of this.”

Lightmaker designers have managed to create an accessible version of the site that includes visual elements, links, images and text, while still maintaining a rich visual experience for fans without disabilities. To do this, the site relies heavily on Macromedia Flash technology.

“The website is the best example of accessibility and design in rich media on the web today,” said Bob Regan, senior product manager with Macromedia. “The site shows that great designs and accessibility in multimedia content are not mutually exclusive and creates a unique and playful experience for all fans of J.K. Rowling’s work, regardless of disability.”

www.jkrowling.com

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HEARING HELP

DEAFNESS ON THE RISE

More and more Americans are finding it difficult to hear without using a hearing aid, according to a new survey by the Better Hearing Institute (BHI).

The BHI MarkeTrak survey, the most comprehensive of its kind, found that 1 in 6 baby boomers (ages 41- 59) has experienced a degree of hearing loss, and most people with hearing loss are younger than 65 and still in the workforce. Furthermore, the study revealed that 1 in 14 Generation Xers (ages 29-40) already have hearing loss, and at least 1.4 million children (aged 18 or younger) have hearing loss. Yet, despite the rising incidence of hearing loss, only about 1 out of 4 people with this problem use hearing instruments, and more than a million children with hearing loss are not getting treated.

BHI researchers found that for the 24 million Americans with untreated hearing loss, the impact of doing nothing about this problem equates to at least $100 billion in lost income per year. On average, the income decline is cut in half for hearing aid owners.

“People are still embarrassed to admit they have hearing loss and get hearing aids. But the price of their vanity is lost earnings for the rest of their lives, a diminished ability to communicate effectively, family problems and a host of other troubles,” said Sergei Kochkin, PhD, executive director of the not-for-profit BHI and the principal MarkeTrak researcher.

Once people try hearing aids, the vast majority feel their lives have improved, according to survey findings. Overall consumer satisfaction with new digital hearing instruments is 77.5 percent, an increase of more than 14 percentage points since 2000. “With the increase of Bluetooth for cell phones and the growth of MP3 players with earphones, there is greater acceptance of devices for the ear,” said Dr. Kochkin. “We hope this trend helps people overcome their anxieties about using instruments to aid hearing.”

The BHI’s MarkeTrak survey utilized 53,000 members of the National Family Opinion panel to track the incidence of identified hearing loss in the United States. It is the seventh MarkeTrak survey to be released since 1990.

www.betterhearing.org

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