Real People, Great Record Release Party!

SILVER SPRING, MD – December 8, 2023 – On December 8^th, the U.S. Food and Drug Administration (FDA) approved 2 gene therapies for the treatment of sickle cell disease in patients 12 years and older. Each treatment is approved for patients with a history of recurrent episodes of blocked blood vessels from misshapen red blood cells. The gene therapy techniques are Casgevy and Lyfgenia. These are the first approved treatments using a genome editing system in the U.S. The only FDA-approved treatments for sickle cell disease until now include a bone marrow or stem cell transplant from donors, a medicine that can prevent the red blood cells from becoming misshapen, and a medicine that can prevent misshapen cells from adhering to blood vessels.

Sickle cell disease is an inherited blood disorder that affects about 100 thousand Americans and 20 million people in the world. Most people with sickle cell disease in the U.S. are African Americans. The disease affects red blood cells that become misshapen (resembling a sickle) and block blood flow to specific areas of the body. This can result in severe painful crises, infection, loss of vision, or a stroke. The misshapen red blood cells can die early, resulting in severe anemia with symptoms of feeling tired.

With each technique, the patient’s blood stem cells are removed and modified by the CRISPR gene editing technique (which has been derived from naturally occurring gene editing systems found in bacteria). Once the stem cells are collected, the remainder of the bone marrow cells are removed with high-dose chemotherapy. Then the modified stem cells are transfused back to the patient. They attach and multiply within the bone marrow. The genetically modified stem cells produce red blood cells that keep their normal shape.

The FDA reported a study of 31 patients with at least 2 episodes of severe blood flow crises a year for 2 consecutive years prior to entering Casgeny treatment. After 24 months of follow-up, over 90% of the patients had at least 12 consecutive months without a severe blood flow crisis.

The FDA reported a study of 32 patients, ages 12 to 50, with a history of severe blood flow crises prior to entering Lyfgenia treatment. After 24 months of follow-up, almost 90% of the patients had no severe blood flow crisis between 6 and 18 months after treatment.

As quoted in the December 8^th FDA news release, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research said, “These approvals represent an important medical advance with the use of innovative cell-based gene therapies to target potentially devastating diseases and improve public health. Today’s actions follow rigorous evaluations of the scientific and clinical data needed to support approval, reflecting the FDA’s commitment to facilitating development of safe and effective treatments for conditions with severe impacts on human health.”

Each of the gene therapy treatments enable patients to use their own blood stem cells rather than have a transfusion of donor cells, in theory, reducing the risk of complications and failure.

Listen to the full report below:

Contact: Dr. Dick Needleman, Health reporter, 103.3 AshevilleFM, [email protected]

BUNCOMBE COUNTY, NC – December 13, 2023 – The creation of the Mobile Vaccination Team in 2022 was one of the highlights of Buncombe County Health and Human Services and the Public Health Department during the COVID-19 pandemic. It has quickly become one of the most important new public health interventions to reach underserved rural communities and populations.

As a result of the COVID-19 pandemic, there has been additional federal funding for public health in Buncombe County. The Department used some of these funds to purchase a customized mobile van and hire a team of nurses and emergency medical technicians. (The van has been on back order for more than one year.) The Team started with mobile COVID-19 vaccination clinics and soon expanded to mpox vaccination clinics in the fall 2022 during the mpox epidemic. The Mobile Team even partnered with our station AshevilleFM and the Getaway River Bar to offer vaccinations for mpox and COVID-19 on September 14, 2022.

The BC Public Health Outreach Team is headed by the Director of Nursing Amparo Oviero Acosta. It is still currently funded with COVID appropriations, although additional funding may be needed for its sustainability and expansion.

The Mobile Vaccination Team has evolved into a Mobile Outreach Team. According to Its website, the Team’s mission is  “To partner with our community to increase equitable access to public health services, focusing on historically underserved by the healthcare system, low-income areas and rural communities.” Its values are to build access, community trust, and improve health outcomes.

The Mobile Team’s current services include:

• Vaccinations for COVID, hepatitis A/B, flu, shingles, and tetanus
• Vaccine record review
• Testing for HIV, Hep C, and sexual transmitted infection (STI)
• Treatment of STI
• Harm reduction resources, education and treatment for opioid use disorder with Naloxone
• Community resource navigation
• Health education

Its future services will include:

• Pregnancy testing
• Reproductive health
• Syringe exchange
• Applications for Medicaid, food services, and social work
• STI education

The BC Mobile Team can partner with a community or organization that is hosting an event. Requests to host an event can be submitted online at buncombecounty.org Under the county services tab, click on Departments & Agencies, then on public health, and then mobile team or contact Sarah Smith at 828-250-5716. The mobile van currently delivers services at the same location and during the same hours of many food pantries throughout Buncombe County.

Here are some of its future events: December 15 @ ABCCM West Food Distribution; December 18 @ Deaverview Community Engagement Market; and December 19 @ Big Ivy Community Center for food distribution

Listen to the full report below:

Contact: Dr. Dick Needleman, Health reporter, 103.3 AshevilleFM, [email protected]

ASHEVILLE, NC –  December 13, 2023 – The COVID-19 metrics are on the CDC’s COVID Dashboard. For the week ending on December 2^nd

• Hospital admission levels are low in 97 of 100 counties in North Carolina, including Buncombe County, and about 75% of the counties in the U.S. However, they have increased in North Carolina and increased in Buncombe County from the previous week.
• Between 2.0 to 4.0% of the deaths in North Carolina were due to COVID, the 3^rd lowest level of 6 groups and increased from last week.
• Emergency room visits for COVID-19 are low in North Carolina. This represents about 2.0% of all ER visits, the 2^nd lowest of 5 levels and stable from the previous week.

Wastewater monitoring can be used to provide early warning for COVID outbreaks. The Buncombe & Henderson counties wastewater data for the week ending on November 29^th and updated on December 6^th is on the North Carolina COVID Dashboard.

• The number of viral gene copies in each water sample is at a red level representing the highest level of 5 groups, currently between the 80^th and 100^th percentile relative to the past level measured at the same site.
• The 15-day rate of change of the number of viral gene copies in each water sample has decreased from the previous week, at -99% to -10%, the lowest level of 2 groups for a negative rate of change.

Listen to the full report below:

Contact: Dr. Dick Needleman, Health reporter, 103.3 AshevilleFM, [email protected]