Circa 2005
DRUG THERAPY
NEW DNA TEST IMPROVES RESULTS
Through most of medical history, doctors have had to determine the correct dose of medication for an individual patient by trial and error. Because of genetic differences in the level of enzymes that activate and break down medications in the body, some patients need very high doses to get good effect, whereas others develop side effects at unusually small doses. A new blood test recently approved by the Food and Drug Administration (FDA) will help doctors personalize some drug treatment decisions for individual patients.
The Invader UGT1A1 Molecular Assay, manufactured by Third Wave Technologies, detects variations in a gene that produces the enzyme UDP-glucuronosyltransferase. This enzyme is active in the metabolism of certain drugs, such as Camptosar (irinotecan), a drug used in colorectal cancer treatment. Variations in the UGT1A1 gene can influence a patient’s ability to break down Camptosar, which can lead to increased blood levels of the drug and a higher risk of side effects or toxicity.
The Invader assay joins a growing list of genetic tests available to physicians to personalize treatment decisions, including the Roche AmpliChip, used to individualize dosage of some psychiatric, cardiac and chemotherapy drugs, and the TRUGENE HIV-1 Genotyping Kit, used to detect variations in the HIV virus that make it resistant to some anti-retroviral drugs.
“This test represents the power of DNA-based testing to provide individualized medical care,” said Daniel Schultz, MD, director of the FDA’s Center for Devices and Radiological Health. “These technologies can significantly improve patient management and reduce the risk of ineffective or even harmful drug therapy.”
The Invader assay is intended to aid a physician in making individualized patient treatment decisions, but it is not a substitute for a physician’s judgment and clinical experience. Other important factors that may affect dosing should be considered, such as the patient’s liver and kidney function, age and other medications.
THIRD WAVE Molecular Diagnostics
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iBOT 4000
HIGH-TECH WHEELCHAIR
Independence Technology, a Johnson & Johnson company, has launched the iBOT 4000, a new version of its already-popular iBOT Mobility System, which in just two years has become the Cadillac of power wheelchairs. The iBOT 4000’s combination of innovative functions allows users to climb curbs; go up and down stairs; raise themselves to standing height to address others at eye level; and travel with ease and stability over sand, gravel, grass and other uneven terrains.
Based on the designs of inventor Dean Kamen, the iBOT 4000 utilizes the patented iBALANCE technology, an integrated combination of sensors, software components and multiple computers that work in conjunction with motion sensors called gyroscopes. This electronic balance system is custom-programmed and calibrated to each user’s center of gravity, continually realigning and adjusting wheel position in response to subtle movements. When people reach forward to shake hands, their iBOTs move with them; when they lean back, their iBOTs move away as well.
Not everyone who uses a wheelchair will be able to use the iBOT 4000, but an estimated 70 percent of people who use wheelchairs in the U.S. may qualify to have the iBOT prescribed for them. Users need to meet certain weight and flexibility requirements and must have sufficient hand function to dial a push-button telephone or use a hand-operated joystick. Some medical conditions such as brittle bones may preclude safe use of the iBOT.
Independence Technology is on contract with the Veterans Health Administration (VA) for the iBOT Mobility System. The veteran must qualify medically and be registered with the VA. More information about the VA contract and reimbursement possibilities with other insurers is available from reimbursement counselors at Independence Technology’s Customer Zone phone number.
Customer Zone 866.813.0788
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HURRICANE RELIEF
RESOURCES AND PROGRAMS FOR PEOPLE WITH DISABILITIES
Millions around the world have watched the unfolding stories from the hurricane-ravaged Gulf Coast. Entire cities of people have been displaced and hundreds of lives have been lost. Some of those most affected by the huricanes are people who have illnesses or disabilities, from the young to the elderly. Biloxi, Mississipi, for example, was home to 10,700 people with disabilities—nearly 26 percent of the population; Mobile, Alabama, to 43,000; and New Orleans to 102,000.
As residents take the necessary steps to rebuild their lives, people with disabilities remain at risk, as their needs for basic necessities are compounded by chronic health conditions and functional impairments. Nevertheless, the situation is not hopeless. An overwhelming outpouring of community, organizational, corporate and federal support has occurred. Following is a brief list of helpful resources:
• For a comprehensive listing of agencies, services, programs, special needs shelters and accessible housing accomodations.
• There is a wide range of federal assistance available, but individuals with disabilities or chronic health care needs must register to receive services. To register with FEMA (Federal Emergency Management Agency), call 800.621.FEMA or 800.462.7585 (TDD) or visit www.fema.gov/about/process for online registration.
• United Cerebral Palsy (UCP) has set-up a Hurricane Disaster Relief Fund to provide services to people with disabilities affected by the hurricanes and to assist UCP affiliates throughout the region in restoring their operations as quickly as possible. To make an online donation, visit www.ucp.org/donate
• Because the United States Postal Service (USPS) has suspended mail service in some hurricane-damaged areas, USPS has been establishing temporary mail delivery stations where Social Security recipients can pick up their checks. To find these locations, search the term Social Security on the www.usps.com website. To help prevent identity fraud, USPS will ask for photo ID. Social Security payments received by direct deposit will be unaffected. Recipients can also go to any open Social Security office to request immediate payment.
• Most pharmaceutical companies offer patient assistance programs, which provide free medications to people with limited resources who qualify. Several websites now offer comprehensive access to downloadable applications from nearly all the pharmaceutical companies, covering more than 1,000 brand-name drugs. To learn more visit www.needymeds.com
• The Centers for Medicaid and Medicare have announced a waiver among all of the states housing hurricane survivors who were already receiving Medicaid to have their Medicaid accepted in their current location. There will also be an expedited process for Medicaid eligibility for those who may now be eligible due to their hurricane-related situation.
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PARALYSIS
NEW TREATMENT GETS FDA CLEARANCE
In the treatment of neurological damage, an important part of rehabilitation is maintaining the health of muscles that were previously exercised through voluntary movement. To this end, Restorative Therapies, a designer and supplier of medical devices, has received FDA clearance of the RT300-S, a cycling machine that activates muscles through an external process called functional electrical stimulation (FES).
The RT300-S can be used right from a wheelchair, with no transfer required. A computer delivers electrical currents to activate the quadriceps, hamstring and gluteal muscles, enabling the legs to move through a regular pattern of physical activity. “Studies reveal that such activity improves patients’ quality of life by promoting overall physical integrity: improving cardiovascular health, preventing skin breakdown, and reducing the incidence of osteoporosis and other secondary complications resulting from prolonged immobility,” says John McDonald, MD, PhD, founder of Restorative Therapies and director of the International Center for Spinal Cord Injury at the Kennedy Krieger Institute in Baltimore. “As an important activity in the lives of those with neurological impairment, this is a therapy that individuals, especially children whose nervous systems are still developing, can do now to promote their general health and physical well-being.”
According to Restorative Therapies, anecdotal experience suggests repetitive stimulation from the RT300-S not only helps muscles, but may also promote nerve cell growth and help the central nervous system become more functional. Controlled clinical trials are underway.
A pediatric model designed for children aged 4 to 12 years is also available for clinical use in the United States. “Until now, children with spinal cord injuries have not had the opportunity to cycle with FES,” says Therese E. Johnston, MSPT, research specialist at the Shriners Hospital for Children in Philadelphia, Pennsylvania. “This device provides unique opportunities for children as they are still growing and changing, potentially allowing for even greater benefits.”
Restorative Therapies Inc.
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MEDICARE
NEW DRUG PROGRAM TO ROLL OUT
For most of its 40-year history, Medicare—the federal health insurance program for people over age 65, people younger than 65 with certain disabilities, and people with end-stage renal disease—has not paid for outpatient prescription medications. But the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 established that as of January 1, 2006, Medicare would include a prescription drug benefit called Medicare Part D. Enrollment is not automatic; people have to select a participating health plan and sign up.
The Medicare drug benefit is optional. However, there is a penalty for those who wait to join past the initial enrollment period (November 1, 2005, through May 15, 2006, for current beneficiaries, or at the time of Medicare enrollment for those who become eligible in the future). Beneficiaries who decide to enroll in Part D later will pay a one percent penalty for each month of delay unless they have comparable coverage from another source.
Under Part D, beneficiaries pay an extra premium each month and choose between at least two plans that offer drug coverage in their area. All plans include many brand-name and generic drugs, but the specific drugs covered may differ from plan to plan. The percentage of drug costs the plan pays varies with the total medication costs accumulated so far that year, after payment of a $250 deductible. According to the Centers for Medicare and Medicaid Services, in a typical plan, Medicare will pay 75 percent of drug costs from $0 to $ 2,250; then the beneficiary will pay 100 percent of drug costs from $2,250 to $3,600; after that, Medicare pays 95 percent and the beneficiary 5 percent.
Some people with limited income are eligible for extra help and may end up with little or no out-of-pocket costs. Beneficiaries will automatically be enrolled for the extra help if they also receive Medicaid (the federal health insurance for some people with low income); receive Supplemental Security Income (SSI) payments from Social Security; or are enrolled in a Medicare Savings Program (special programs that help some people with low income pay for copayments and deductibles). Unlike most beneficiaries, these recipients will be automatically enrolled in a drug plan if they do not choose one on their own. Anyone with limited resources can investigate eligibility for extra help by contacting a local Social Security or Medicaid office for an application.
1.800.MEDICARE
877.486.2048 (TDD)
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OVARIAN CANCER
REPORT ON EARLY SYMPTOMS
Ovarian cancer has generally been thought of as a silent disease because it doesn’t cause severe symptoms until it has reached an advanced stage. A new study from the journal Cancer, however, finds that abdominal swelling, pain and gastrointestinal complaints are common up to six months before ovarian cancer is diagnosed.
“Some patients with ovarian cancer do report symptoms many months before their ultimate diagnosis, and some ovarian cancer patients could have had an earlier diagnosis if pelvic imaging was included in their workup,” said Dr. Lloyd H. Smith, of the University of California at Davis.
Smith and his colleagues used data from the National Cancer Institute’s Surveillance, Epidemiology and End Results Program and from Medicare claims for California women who developed ovarian cancer to investigate whether symptoms preceded a diagnosis of ovarian cancer and whether an earlier clinical diagnosis is possible in patients with ovarian cancer.
Data for 1,985 women with ovarian cancer were compared to data from two control groups: 10,941 women with breast cancer and 6,024 without cancer. As early as 12 months before diagnosis, women with ovarian cancer were at least twice as likely to present to a physician with abdominal swelling or pelvic pain. As early as nine months before diagnosis, women with ovarian cancer were also more likely to complain of abdominal pain. Overall, about 40 percent of these women had one or more physician visits for abdominal or pelvic symptoms more than four months before their ovarian cancer was discovered.
“Our findings suggest that ovarian cancer could be diagnosed earlier in some patients whose diagnosis currently is delayed by at least four months, because physicians order abdominal imaging or perform gastrointestinal procedures before they order a test that is more likely to diagnose ovarian cancer,” the researchers concluded. Tests more likely to diagnose ovarian cancer include imaging of the pelvis and blood tests for cancer markers like CA-125. “If routine medical evaluation fails to explain the symptoms and they persist, then testing for ovarian cancer should be considered,” said Smith.
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