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New Location

Our new location will be at Durant Road and Falls of Neuse in north Raleigh.

11/2006

Primary Stroke Center Certification Awarded

On Friday, September 1, WakeMed was officially awarded with The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Primary Stroke Center Certification. This certification demonstrates that our program follows national standards and guidelines proven to significantly improve outcomes for stroke patients. Congratulations to WakeMed's entire Stroke Team for helping us earn this worthy distinction. The team is led by Stroke Program Coordinator Kimberly Elks, RN, and Stroke Program Medical Director Keith Hull, MD, (above) Raleigh Neurology Associates.

Reorganizing the Quality Council

WakeMed is always striving to improve the quality of care delivered to our patients. With that being said, how do we prioritize performance improvement initiatives to ensure the ones we pursue are aligned with our strategic plan, and, most importantly represent the best interests of our patients?

In the past, the WakeMed Quality Council has served as the focal point for several valuable teams designed to establish and implement quality improvement initiatives. Over the years, the number of teams, committees and steering groups throughout the system with similar goals has increased, which is an excellent indicator of our organizational dedication and commitment to quality. With more groups focused on quality, it has become more important than ever to identify a single team to help lead the Continuous Quality Improvement (CQI) charge.

For this reason, the Quality Council is being reorganized to bring together a team of administrative and physician leaders to help set the course for WakeMed's continuous quality improvement. The new Quality Council will play a key role in identifying solutions to improve the way we deliver patient care here at WakeMed, and will serve as the steering body for all CQI projects throughout the system.

Over the past several months, we've evaluated the Quality Council membership to identify the ideal blend of clinical, physician and administrative leaders. Several new members, including five additional physicians, have been added to the group. As it relates to patient safety and quality, physician leadership is invaluable to the Quality Council.

These changes will ensure that our physicians are equally engaged in CQI initiatives so we are all working together to make quality improvements. As we continue to focus on continuous JCAHO readiness and improving our publicly reported data measures, we believe the new Quality Council will allow us to achieve more together in the best interest of our patients.

— Stethoscope News, November 2006

06/2006

UPDATE: Biogenidec and Elan Pharmaceuticals announced that the FDA has granted approval for the reintroduction of Tysabri for patients with relapsing remitting multiple sclerosis

At this time, the companies and the FDA are finalizing the details of what is called the TOUCH program which will be used to monitor the safety of Tysabri. Commercial availability of Tysabri is dependent upon the completion of the details of this risk management program. Further details can be found at the following websites:

www.fda.gov
www.nmss.org
www.biogenidec.com
www.elan.com

We will update the Raleigh Neurology website as more information becomes available to us.

03/2006

UPDATE: FDA Advisory Panel Recommends Tysabri's Return To Market For Relapsing MS

UPDATE - March 22, 2006 - The FDA has extended the regulatory review period for the reintroduction of Tysabri®  (natalizumab) for another 90 days. The FDA is primarily reviewing the risk management plan which Biogenidec and Elan have developed to monitor patients for whom Tysabri may be prescribed. The drug is therefore not immediately available. Biogenidec and Elan anticipate a final decision from the FDA on or before June 28, 2006.

GAITHERSBURG, MD - March 8, 2006 - Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today that the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously to recommend reintroduction of TYSABRI® (natalizumab) as a treatment for relapsing forms of multiple sclerosis (MS).  

The Committee's recommendation is advisory to the FDA, and the agency is not bound by this recommendation. The FDA has designated TYSABRI for Priority Review, a status for products that are considered to be significant therapeutic advancements over existing therapies that address an unmet medical need. Biogen Idec and Elan will continue to work closely with the FDA in the weeks ahead with the goal of making TYSABRI available. Discussions with FDA will include, among other things, finalizing the details of the TYSABRI risk management plan. The companies anticipate action by the FDA by March 29, 2006.

For more information on this announcement, please go to: http://www.nationalmssociety.org/tysabri_march8.asp

Raleigh Neurology was honored on February 5, 2005 at an awards ceremony with recipients of the Employee Support of the National Guard and Reserves Above and Beyond Award, given to outstanding employers of members of the US National Guard and Reserves. The prestigious award was given to only 80 recipients out of over 500 entries.

Major Ronnie Baugh, a reservist, was called to action last year in Afghanistan and his wife, Erin Baugh, a business office employee of RNA, was going to have to quit her job to stay at home and care for their infant child. Steve Smith, Administrative Manager of Raleigh Neurology, realized that if she had a computer and a high-speed Internet connection at home she could continue to do her job. Raleigh Neurology set up everything for Erin and paid for her Internet connection for the 12 months that Ronnie served in Afghanistan. Of course, Ronnie was comforted to know that his wife could not only give care to their child during this difficult period, but also be able to maintain her job at Raleigh Neurology.

For this act of employee humanitarianism and innovation, Steve Smith was given this award on behalf of Erin and Ronnie Baugh. We congratulate Steve for his creative insight in setting up work programs that not only benefit our company, but also help our employees.

Erin Baugh is a payment posting representative in the business office and is still working from home.

Pictured above: Mr. Craig Duehring - Principal Deputy Assistant Secretary of Defense for Reserve Affairs,
Mr. Bud Brown, Steve Smith, Ronnie Baugh and General William E. Ingram, Jr.

03/2005

Biogen Idec and Elan Pharmaceuticals have announced a voluntary suspension in the marketing of TYSABRI (natalizumab) for the treatment of multiple sclerosis. Although TYSABRI was recently approved for use by the Food and Drug Administration (FDA) in relapsing MS, the drug has been suspended for use pending further investigation of two patients who had serious adverse events potentially linked to TYSABRI.

One patient developed a fatal, confirmed case of a rare demyelinating disorder called progressive multifocal leukoencephalopathy (PML). A second patient is suspected as having PML but the diagnosis has not yet been confirmed. PML is a rare disorder ordinarily seen in patients with severely compromised immune systems.

So far approximately 3000 patients have been treated with TYSABRI in clinical trials of multiple sclerosis, Crohn's disease, and rheumatoid arthritis. Approximately 1100 patients have received TYSABRI treatment for over 2 years. The two cases reported are the only reports to date in MS in patients treated with TYSABRI in combination with AVONEX. There are no reports of PML in patients receiving either AVONEX alone or TYSABRI alone. No patients receiving TYSABRI for conditions other than MS have been described.

It should be emphasized that the two patients reported had both received TYSABRI for an extended period of time. The first patient had received 37 doses of TYSABRI and the second patient 28 doses. Both received weekly AVONEX. There have been no reports of PML in patients receiving only a dose or two of TYSABRI.

Furthermore, the exact relationship of PML to TYSABRI and AVONEX has not been clearly established as of yet. Biogen Idec and Elan are exercising caution by voluntarily suspending the use of TYSABRI until there is enough information available to determine the safety of TYSABRI either as monotherapy or as therapy in combination with other agents such as AVONEX.

While we are all disappointed at this turn of events, we remain optimistic for our patients with MS. If further review of all of the available suggests that there is a safe role for TYSABRI in the therapy of MS we will proceed cautiously with treatment. If the data suggests this is not an appropriate option for our patients we will continue to do the best we can with the treatments currently available. Please contact your neurologist at RNA to make decisions about current therapy. TYSABRI will not be available until further notice.

We will continue to make use of this website as a resource to keep our patients informed on all of the latest developments in this arena.

For updated information on this and other announcements, please go to:

US Food & Drug Administration or The National MS Society

Raleigh Neurology is currently enrolling patients in a study investigating the issues of excessive daytime sleepiness and nighttime sleep disruption in Parkinsonism. This study is being done in collaboration with neurologists at Baylor University in Houston Texas and the University of Colorado Medical Center in Denver. RNA is one of three sites nationally participating in this clinical trial. Further details of the study can be found on our website on the Research page.

Volunteer Hall of Fame Award

The National Multiple Sclerosis Society is pleased to announce the 2004 Eighth Annual Volunteer Hall of Fame, a very special group of volunteers from chapters and the home office. These individuals have actively supported the efforts of the MS Society over many years and have had a powerful influence within their communities in advancing awareness, support and leadership for the mission. Congratulations to Jill Beavin and thanks to all the Volunteer Hall of Fame members for their generous contribution of time, talent, leadership and commitment to our mission.

Jill K. Beavin, RN
Client Programs
Eastern North Carolina Chapter

Jill Beavin began her involvement with the Eastern North Carolina Chapter in 1995. Her degree in nursing and her years of experience with neurology patients have positioned her as a vital volunteer for the chapter. She is an active member of the MS Programs Committee and has served in numerous capacities in her nearly ten years of involvement, creating new programs and assisting with health care professional education.

MDS: Intermittent Apomorphine Helps Reduce Motor Fluctuations in Parkinson's Disease

By Paula Moyer

ROME, ITALY - June 18, 2004 - Patients treated with intermittent apomorphine experience significant improvements in motor fluctuations, according to findings presented here at the 8th International Congress of the Movement Disorder Society.

"We saw significant improvement, within a few minutes, of several motor symptoms of Parkinson's [patients] over placebo," said principal investigator Keith L. Hull, Jr, MD, cofounder and partner, Raleigh Neurology Associates, Raleigh, North Carolina.

To determine whether injections of intermittent subcutaneous apomorphine would help rescue patients rapidly from the bothersome so-called "off" episodes of motor fluctuations that occur despite optimized treatment with currently available antiParkinson's medications, they recruited 62 patients with idiopathic Parkinson's disease.

The randomized, double-blind, parallel-group, single-dose, placebo-controlled study involved 45 men and 17 women, who averaged 65.5 years old and had their disease for an average of 14.7 years. All patients had motor complications despite optimum treatment with levodopa/carbidopa plus at least one oral dopamine agonist. Patients had received apomorphine for at least 3 months before entering the study; the average use duration was 434 days.

Patients were assigned to 1 of 4 treatment groups receiving a single dose of the patient's typically effective dose of apomorphine; the typically effective dose of apomorphine plus an additional 2.0 mg; a placebo injection at the volume equal to the patient's typically effective dose; or placebo at a volume equal to the typically effective dose plus 0.2 mL.

The primary efficacy parameter was a change from the predose assessment using the Unified Parkinson's Disease Rating Scale (UPDRS) motor score measured at 10, 20, and 90 minutes after treatment. The investigators also used the Webster's Step Seconds Test (WSS) at 2.5, 5, 7.5, 10, 15, 20, and 40 minutes after treatment.

The findings show significant improvement in WSS scores 7.5 minutes after treatment. This improvement, a decrease of 200 seconds in comparison with the placebo group, continued for at least 40 minutes after treatment. The investigators also observed significantly superior UPDRS motor scores following the apomorphine injection in comparison with placebo at 10 minutes, a mean reduction of 19.9 compared to 5.6 in placebo (P =.0001). The difference at 20 minutes was a decrease of 24.2 in the treatment group compared to 7.4 in placebo (P =.0001).

No significant improvements were detected in UPDRS and WSS scores with apomorphine at the typically effective dose plus 2.0 mg in comparison with the typically effective dose.

There were no overall significant differences in the rates of adverse effects between the placebo and treatment groups. A slightly higher rate of adverse events occurred in the group getting the typically effective dose of apomorphine plus 2.0 mg, but the difference was not statistically significant.

[Presentation title: Onset of Action of Intermittent Subcutaneous Apomorphine in the Treatment of "Off" Episodes in Patients With Advanced Parkinson's Disease. Abstract P607]

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