• FDA reviews antiviral drug Ampligen® for the treatment of CFS/ME
• Labor Day
• Speed of Mental Operations in Fibromyalgia: A Selective Naming Speed Deficit
• Service Dogs for The Disabled
• New Drug Application for Remoxy
• Choosing A Good Disability Attorney
• Pain Management in Fibromyalgia
• Rosh Hashanah

A new drug application for Ampligen has been submitted to the United States Food and Drug Administration (FDA) for the treatment of chronic fatigue syndrome (CFS/ME). Hemispherx Biopharma, Inc. is the Philadelphia-based technology company that has been developing and testing Ampligen for more than 30 years.

Ampligen (a double-stranded RNA drug product) is an experimental, unapproved drug in human clinical development for the treatment CFS/ME, HIV, renal cell carcinoma and malignant melanoma. The drug is administered intravenously, typically twice weekly over a year or more. Ampligen has been available in Belgium and Canada for ME/CFS and HIV treatment since 1996.

Ampligen was originally discovered and developed at Johns Hopkins University and later licensed to Hemispherx. The clinical trial data submitted to the FDA included 1,200 study participants and about 90,000 dose administrations.

Labor Day is a United States federal holiday observed on the first Monday in September. The holiday originated in 1882 as the Central Labor Union (of New York City) sought to create "a day off for the working man".

Labor Day was outlined in the first proposal of the holiday as:

"a street parade to exhibit to the public 'the strength and esprit de corps of the trade and labor organizations', followed by a festival for the workers and their families."

Congress made Labor Day a federal holiday in 1894. Speeches by prominent men and women were introduced later, as more emphasis was placed upon the economic and civil significance of the holiday. Still later, by a resolution of the American Federation of Labor convention of 1909, the Sunday preceding Labor Day was adopted as Labor Sunday and dedicated to the spiritual and educational aspects of the labor movement.

Today, Labor Day is often regarded as a day of rest and, compared to the May 1 Labour Day celebrations in most countries, parades, speeches or political demonstrations are more low-key. Forms of celebration include picnics, barbecues, fireworks displays, water sports, and public art events. Families with school-age children take it as the last chance to travel before the end of summer. FM/CFS/ME RESOURCES wishes you and your family a Happy Labor Day!

Leavitt F, Katz RS.

OBJECTIVE: Abnormal processing of information in fibromyalgia may hold clues to brain abnormalities in this illness. The purpose of this study is to examine the speed of mental operations in people with the fibromyalgia (FM) under the pressure of time. The central question addresses whether FM is associated with processing speed deficits across a spectrum of speeded tasks.

METHOD: Sixty-seven patients with fibromyalgia with a history of memory complaints and 51 controls presenting with complaints of memory loss completed 10 timed cognitive measures of processing speed. Controls were patients with memory complaints who did not have FM.

RESULTS: The majority of FM patients (>70%) performed within 1 standard deviation of the norm on 7 or more of 10 speeded measures. However, more than 49% of FM patients tested as impaired (>1.67 SD below normative mean) on 2 specific validated speed tasks (reading words and naming colors). Compared with controls, the number of FM patients showing impairment was 2.0 times greater for reading speed, and 1.6 times greater for color naming speed. A mean time delay of 203 milliseconds was recorded for reading words and 285 milliseconds for naming colors in the FM impaired sample. A 203 milliseconds delay in reading words represents a 48% (203/417) time increase over the normal time for reading the same stimulus word.

CONCLUSION: Abnormalities in naming speed are an unappreciated feature of FM. Selective deficits in naming speed in association with otherwise well preserved global processing speed set patients with FM apart from controls with memory complaints. Clinicians would be wise to specifically request adding a rapid naming test such as the Stroop Test to the cognitive battery; to document cognitive dysfunction in FM patients who otherwise appear to test normally, despite often intense complaints of memory and concentration difficulties that can affect job performance and increase disability.

__________________

Source(s):

* National Center for Biotechnology Information: PMID #18636019
* Department of Behavioral Sciences; and Department of Internal Medicine, Section of Rheumatology, Rush Medical College, Chicago, IL.

Service dogs that are trained to assist the individual needs of a person with a disability can provide the amount of physical and/or psychological support necessary to help that person lead a more functional and independent life. Many service dogs are cross-trained to perform more than one category of work, such as guide and mobility for a person who is blind and has severe arthritis.

Service Animals:

Are animals legally defined (Americans With Disabilities Act, 1990) and are trained to meet the disability-related needs of their handlers who have disabilities. Federal laws protect the rights of individuals with disabilities to be accompanied by their service animals in public places. Service animals are not considered "pets."

Therapy Animals:

These animals are not legally defined by federal law, but some states have laws defining therapy animals. They provide people with contact to animals, but are not limited to working with people who have disabilities. They are usually the personal pets of their handlers, and work with their handlers to provide services to others. Federal laws have no provisions for people to be accompanied by therapy animals in places of public accommodation that have "no pets" policies. Therapy animals usually are not service animals.

Companion Animal:

These animals are not legally defined, but are accepted as another term for pet.

Social/Therapy Animals:

Likewise, these animals have no legal definition. They often are animals that did not complete service animal or service dog training due to health, disposition, trainability, or other factors, and are made available as pets for people who have disabilities. These animals might or might not meet the definition of service animals.

Tasks Performed by Service Dogs

Service dogs are versatile, reliable assistants for people with disabilities. No longer limited to guiding people with visual impairments, service dogs perform a wide variety of tasks suitable as intervention for an equally wide assortment of limitations.

Service dogs can be trained to reliably perform many tasks, some of which are:

• Leading a person who has a visual impairment around obstacles, to destinations (seating, across street, to/through door, to/into elevator, etc.).


• Sound discrimination to alert a person with a hearing impairment to the presence of specific sounds, such as:

  • Smoke/fire/clock alarms
  • Telephone
  • Baby crying
  • Sirens
  • Another person
  • Timers buzzing
  • Knocks at door
  • Unusual sounds (things that go bump in the night, etc.)

• General assistance, including:
  • Mobility (helping person balance for transfer/ambulation, pulling wheelchair, helping person rise from sitting or fallen position).
  • Retrieval (getting items that are dropped or otherwise out of reach, carrying items by mouth).
  • Miscellaneous (e.g., open/close doors and drawers, help person undress/dress, carry items in backpack, act as physical buffer to jostling by others, put clothes in washer/remove from dryer, bark to alert for help).

• Sense and alert owners to oncoming seizures. It is currently unknown why or how some dogs are able to do this, but a number of dogs have demonstrated the ability to warn their owners of oncoming seizures, enabling the owners to position themselves safely.

Qualifying & Applying For A Service Dog

Trainers and organizations that have service animals establish their own qualifying criteria. Ask for a copy of their qualification criteria in writing. Some organizations require documentation of a particular degree of disability. Other organizations will not accept you unless you live alone or have no pets. Many organizations have online application forms.

When researching service animal organizations remember to ask what your cost will be. Many organizations offer dogs to patients free of charge, others require you to pay a fee of up to $20,000. For help in paying for a service animal visit Assistance Dog United Campaign. They have programs that offer assistance to people needing a service animal.

Where To Apply

Here are just a few places we've found that provide service animals. Be sure to research all organizations fully so you won't be surprised in the end.

• NEADS - Dogs For Deaf and Disabled Americans
• Canine Companions for Independence
• Paws'itive Teams
• Puppies Behind Bars
• Susquehanna Service Dogs
• Paws With A Cause
• Service Dog Project
• Texas Hearing & Service Dogs
• Paws With Purpose

SAN MATEO, Calf. and BRISTOL, Tenn. – Pain Therapeutics, Inc. and King Pharmaceuticals, Inc. have announced that a New Drug Application (NDA) for Remoxy has been submitted to the U.S. Food and Drug Administration (FDA). Remoxy, a unique long-acting formulation of oral oxycodone for moderate to severe chronic pain, is designed to resist common methods of prescription drug misuse and abuse.

Pain Therapeutics and King believe the NDA for Remoxy benefits from years of rigorous and independent scientific and clinical testing. The NDA includes animal and human data from extractability, pharmacokinetic, toxicology and clinical studies. If approved, the Companies believe Remoxy could be the first oxycodone on the market that is designed to reduce the risk of misuse and abuse.

"Our vision is to develop a line of opioid painkillers that minimizes the risk of misuse, abuse or diversion," said Remi Barbier, Pain Therapeutics' chairman, president and chief executive officer. "We believe the integrity of such drugs can deliver peace of mind to physicians, pharmacists and patients."

Brian A. Markison, King's chairman, president and chief executive officer, stated, "The NDA submission for Remoxy is an important advance in meeting the pain management needs of patients and prescribers concerned with addressing the risks of prescription pain medicine misuse and abuse within our communities."

If you've got FM and/or CFS/ME chances are you're going to think about applying for Social Security Disability at some point in time. Applying for disability is a long, often frustrating experience. However, having a lawyer who specializes in Social Security, disability law or FM/CFS/ME will make this process much easier! Here are some qualities good lawyers should have:

Integrity

Many lawyers will offer you a free half hour consultation, during this time you will be able to give the lawyer a brief insight into your particular problem. Once presented with the facts a good lawyer will always tell you up front what they think your chances of winning the case are.

Background History

You should feel comfortable in the lawyer's presence. A good honest lawyer will have nothing to hide when it comes to asking about previous cases that they have won or lost. Obviously they may not be able to go into great detail but they should be able to give you an idea of how many cases they have succeeded in winning and if any of those cases were similar to yours.

Special knowledge

A good lawyer will be knowledgeable about the area of law in which they practice. If you're attempting to get SSD or SSI you'll want an attorney who specializes in social security or disability law. They will have expertise explaining your disabilities in terms of work limitations. Disability law is a specialty and therefore you are better off with a lawyer who just specializes in disability law as they will have more experience and knowledge.

Thoroughness

A good lawyer must be able to listen to you with an open mind, to understand the changes you have suffered since your disability. A good lawyer will look for what has motivated you throughout your career, and what barriers you now face. It is this attention to detail that helps make a convincing case for court.

Good judgment

Because the practice of law involves real people interacting with often complex legal principles, good lawyers must exercise good judgment. This involves being able to see the big picture. A good lawyer will ask whether all of the pieces really fit together to make a single cohesive whole. Chasing after weak claims can sometimes weaken a strong claim. So a good lawyer must decide what claims are credible and what claims are not. Then they must work with you to build a case which can stand up to serious scrutiny.

Trial skill

A good lawyer must be willing to take a case all the way through a trial and have a good track record in court. Although few cases may actually go to trial, the quality of a settlement often depends on the defense team's assessment of how well the lawyer might do in court.

Crofford LJ.

PURPOSE OF REVIEW: Pain is the primary presenting symptom in the vast majority of inflammatory and non inflammatory rheumatic diseases. Patients tell us that improved pain relief is a principal concern. Many pain complaints respond incompletely to the treatment of the primary rheumatic disorder and pain syndromes such as fibromyalgia do not respond to traditional analgesic medications. Therefore, proper management requires consideration of additional medications for symptomatic relief. This review addresses newer strategies for the treatment of pain in patients with fibromyalgia that may be also useful in patients with other rheumatic diseases.

RECENT FINDINGS: New medications have been developed with a better understanding of chronic pain mechanisms that principally address pain neurobiology at the levels of the spinal cord and the brain. Clinical studies demonstrate the effectiveness of the alpha-2-delta ligands (gabapentin and pregabalin) and the norepinephrine/serotonin reuptake inhibitors (duloxetine and milnacipran) in fibromyalgia.

SUMMARY: Patients with chronic pain, best classified as fibromyalgia, either primary or in association with other rheumatic disorders, may experience benefit from new therapies targeting central pain mechanisms.

__________________

Source(s):

* National Center for Biotechnology Information: PMID #18388513
* Current Opinion in Rheumatology. 2008 May; 20(3):246–50

Rosh Hashanah (literally, "Head of the Year") refers to the celebration of the Jewish New Year. The holiday is observed on the first day of the Hebrew month of Tishrei, which falls in September this year, and marks the beginning of a ten-day period of prayer, self-examination and repentance, which culminate on the fast day of Yom Kippur. These ten days are referred to as Yamim Noraim, the Days of Awe or the High Holy Days.

While there are elements of joy and celebration, Rosh Hashanah is a deeply religious occasion. The customs and symbols of Rosh Hashanah reflect the holiday's dual emphasis, happiness and humility. Special customs observed on Rosh Hashanah include; the sounding of the shofar, using round challahs, eating apples and honey (and other sweet foods) for a sweet new year.

S'lichot is a customary service observed before Rosh Hashanah. S'lichot, meaning forgiveness, refers to the penitential prayers recited by Jews prior to the onset of the High Holiday season. It is a solemn and fitting preparation for ten days of reflection and self-examination.

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