health and wellness
FDA Provides Update on Agency Response to Monkeypox Outbreak
Today, the U.S. Food and Drug Administration is providing an update on its multipronged response to monkeypox in the United States, including its efforts in the areas of diagnostics, vaccines and therapeutics. The agency has also established a dedicated website to provide important information about the FDA’s ongoing regulatory activities related to monkeypox along with frequently asked questions. The FDA will provide updates as developments occur and will continue to work with federal public health partners and industry to ensure timely access to all available medical countermeasures.
“The FDA has been closely tracking reports of monkeypox transmissions in the United States with our federal public health partners and coordinating preparedness efforts accordingly,” said FDA Commissioner Robert M. Califf, M.D. “We understand that while we are still living with COVID-19, an emerging disease may leave people feeling concerned and uncertain, but it’s important to note that we already have medical products in place, specifically an FDA-approved vaccine for the prevention of monkeypox disease and an FDA-cleared diagnostic test. The FDA is using the full breadth of its authorities to make additional diagnostics and treatments available. We will continue to collaborate with our partners across all sectors to expand accessibility to countermeasures and bolster the tools in our arsenal as appropriate.”
The monkeypox virus is part of the same family of viruses as variola virus, the virus that causes smallpox (a virus that has been eradicated globally). Both monkeypox and smallpox fall into the category of “orthopoxviruses.” Monkeypox is generally not fatal and typically resolves on its own without treatment. The current outbreak in the U.S. usually presents as a rash on the body, face or genital area. Although there is a very low risk of dying, there have been reported complications including severe pain, at times requiring hospital admission.
Diagnostics
Since the first case of monkeypox in the U.S. was detected, the FDA has been working with commercial laboratories and manufacturers to make monkeypox tests more readily available to consumers who need them. The Centers for Disease Control and Prevention (CDC) has an FDA-cleared non-variola orthopoxvirus test that can detect monkeypox by a swab from a monkeypox lesion (rash or growth). At this time, this is the only FDA-cleared test. The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox virus testing. In July 2022, the FDA issued a safety communication advising people to use swab samples taken directly from a lesion when testing for the monkeypox virus.
The FDA-cleared monkeypox test is being offered by the CDC and throughout many laboratories that include the CDC’s public health Laboratory Response Network. In addition, federal public health authorities have worked with industry to make the test available through five large commercial laboratories. The agency is working closely with the CDC to increase production of its FDA-cleared test and the FDA has cleared the use of additional reagents and instruments to increase the throughput of the CDC test.
The FDA will continue to work with the diagnostic community to augment access to accurate testing to support the response.
Vaccines
In 2019, the FDA approved the JYNNEOS Vaccine for the prevention of smallpox and monkeypox in adults 18 years of age and older determined to be at high risk of infection. JYNNEOS is the only vaccine approved for the prevention of monkeypox in the United States. Although clinical trials and data are limited because of the small number of cases until now, the immunological response to vaccine administration is consistent with effective prevention of the disease.
Following the emerging public health crisis closely, the FDA was aware that there were close to 800,000 doses of this vaccine pending release this fall following approval of additional manufacturing capabilities at one of the plants where the vaccine is made. With this in mind, the agency worked with HHS partners and expedited the submission of the required application for the company’s manufacturing changes in order to make these doses available to those in need. After accelerating the timeline for an inspection of the plant from fall to earlier this month, the FDA has finished its evaluation of the required information to validate product quality and has determined that the vaccine meets its quality standards.
On July 26, the agency approved a supplement to the biologics license for the JYNNEOS Vaccine, to allow for additional manufacturing capabilities at the facility. Given the emerging public health need, the FDA previously facilitated the shipment of manufactured doses to the U.S. so that they would be ready to be distributed once the manufacturing changes were approved. With the supplement approval, those manufactured doses may now be further distributed and administered. Additional doses manufactured at this plant can help address the need for this vaccine moving forward.
Therapeutics
There is no FDA-approved or authorized medicine for the treatment of monkeypox disease; however, TPOXX (tecovirimat), an antiviral medication, is being made available through the CDC under an FDA authority called Expanded Access or “compassionate use.” The FDA continues to work with the CDC to streamline their Expanded Access Program for monkeypox to facilitate access.
There are currently no human data demonstrating the efficacy of TPOXX for the treatment of monkeypox, or the safety and pharmacokinetic profile (which helps us understand what the human body does to a drug). Although expanded access program is available, conducting randomized, controlled trials to assess TPOXX’s safety and efficacy in humans with monkeypox infections is essential.
The FDA has more information on TPOXX’s approval for smallpox under the “Animal Rule” regulations on its monkeypox webpage.
Source: FDA
Food and Beverage
Controle su presión arterial: 7 cambios para controlar su salud


(Family Features) Lo que usted come y bebe, así como su nivel de actividad y sus hábitos, afectan la salud de su corazón y cerebro y son esenciales para controlar la presión arterial, el colesterol y más. La presión arterial alta (lecturas consistentemente superiores a 130/80 mm Hg) es una de las principales causas y un factor de riesgo controlable de enfermedades cardíacas y ataques o derrames cerebrales, así como de otros problemas como insuficiencia renal, pérdida de visión y problemas sexuales.
De hecho, casi la mitad de todos los adultos estadounidenses tienen presión arterial alta (hipertensión), según los Centros para el Control y la Prevención de Enfermedades, pero es posible que muchos ni siquiera se den cuenta de que la tienen a menos que experimenten otras complicaciones. Es más, el origen étnico también puede influir en sus factores de riesgo.
Las mujeres negras en edad fértil tienen más del doble de probabilidades de tener presión arterial descontrolada que las blancas, según una investigación presentada en una edición especial Go Red for Women del “Journal of the American Heart Association”. Además, la inseguridad alimentaria o la falta de acceso a alimentos saludables adecuados, que es uno de los factores sociales que pueden afectar el riesgo de presión arterial alta, es mayor entre las mujeres hispanas y negras en comparación con las mujeres blancas.
Para ayudar a mantener la presión arterial por debajo de 120/80 mm Hg y controlar los factores de riesgo, la American Heart Association, con el apoyo nacional de Elevance Health Foundation, recomienda estos cambios en el estilo de vida.
Mantener un peso saludable. Si tiene sobrepeso o es obeso, tiene un mayor riesgo de sufrir presión arterial alta. Perder tan solo 10 libras (o entre el 3 y el 5 % de su peso corporal) puede brindar beneficios para la salud, incluida la reducción o prevención de la presión arterial alta. Hable con su proveedor de cuidados de salud sobre un enfoque saludable para perder peso, incluida la ingesta calórica y las actividades que pueden ayudar tanto a perder como a mantener el peso.
Comer más saludable. Comer frutas y verduras, como mangos, aguacates y arándanos, puede reducir la presión arterial con el tiempo. Otras opciones inteligentes incluyen nueces y semillas, cereales integrales, lácteos bajos en grasa, proteínas magras y pescado. El plan de alimentaciónEnfoques dietéticos para detener la hipertensión (Dietary Approaches to Stop Hypertension) o DASH, está orientado a reducir la presión arterial y ayuda a crear un estilo de alimentación saludable para el corazón.
Reducir el sodio. Los estadounidenses consumen hasta el 75 % de su sodio de alimentos procesados como sopas, salsa de tomate, condimentos y productos enlatados. Para reducir el consumo, lea las etiquetas cuando compre y elija versiones bajas en sodio de sus comidas favoritas, omita la sal de mesa y considere especias y hierbas como alternativas de condimento.
Controlar el estrés. Se sabe que el estrés contribuye a los factores de riesgo de presión arterial alta, como la mala alimentación y el consumo excesivo de alcohol. Practicar técnicas de relajación, como el yoga o la respiración profunda, practicar la gratitud y hacer cosas que disfrute, pueden ayudar a reducir el estrés.
Estar activo. La actividad física no solo ayuda a controlar la presión arterial alta, sino que también ayuda a controlar el peso, fortalece el corazón y reduce los niveles de estrés. La American Heart Association recomienda al menos 150 minutos por semana de actividad física de intensidad moderada, como caminar a paso ligero.
Limitar el alcohol. Beber demasiado alcohol puede aumentar la presión arterial. Si bebe, limite su consumo a no más de dos tragos por día para los hombres y un trago por día para las mujeres.
Dejar de fumar. Cada vez que fuma, provoca un aumento temporal de la presión arterial. Tanto fumar como exponerse al humo del tabaco ajeno también aumentan el riesgo de acumulación de placa dentro de las arterias, un proceso que se sabe que acelera la hipertensión.
Encuentre más consejos para controlar su presión arterial en Heart.org/highbloodpressure.
Fotos cortesía de Getty Images
SOURCE:
American Heart Association
actors & performers
Al B. Sure! & Rev. Al Sharpton: Championing Health Equity in Transplantation
Al B. Sure! and Rev. Al Sharpton unite to oppose Medicare cutbacks, advocating for health equity in transplantation to benefit minority communities.
In a powerful display of solidarity and determination, music legend Al B. Sure! and global civil rights leader Rev. Al Sharpton have come together to announce the formation of the “Health Equity in Transplantation Coalition.” This coalition aims to oppose the recent Medicare cutbacks for transplant patient blood tests that detect early signs of organ rejection, particularly affecting minority and underserved communities. With their shared commitment to justice and equality, Al B! will serve as the Executive Chairman, while Rev. Sharpton will play a vital role as the Senior Advisor.
The Impact of Medicare Coverage Restrictions:
On March 2, 2023, a private contractor known as a “Medicare Administrative Contractor” (MAC) announced restrictions on Medicare coverage for transplant patient blood tests. These tests, essential for detecting early signs of organ rejection, have been instrumental in safeguarding the health of transplant patients since 2017. However, the sudden change linking coverage to invasive surgical biopsies has caused confusion, delays, and cancellations, primarily affecting Black, Hispanic, Latino, and underserved transplant communities.
The Voice of Al B!:
As a successful organ transplant recipient and advocate for the transplant patient community, Al B! understands the importance of these blood tests firsthand. Having received a life-saving liver transplant in 2022, he emphasizes the need for accessible and non-invasive blood tests that can be conducted at home. Al B! believes that tying Medicare coverage to invasive biopsies places an undue burden on underserved transplant recipients, necessitating expensive travel, time off work for patients and caregivers, and hospital procedures.
The Support of Rev. Al Sharpton and Newt Gingrich:
Rev. Al Sharpton, renowned for his tireless work in defending the rights of minority communities, welcomes the support of former Republican Speaker Newt Gingrich in restoring Medicare coverage for surveillance blood tests. Their alignment, along with a broad bipartisan group of transplant patients, physicians, and members of Congress, highlights the urgent need to reverse these detrimental rollbacks. Rev. Sharpton emphasizes that these non-invasive tests provided a lifeline to Black, Hispanic, Latino, and underserved communities, and it is essential to expand access to better tools, not restrict them.
Addressing Disparities in Transplant Care:
Transplant care plays a critical role in the lives of Black, Hispanic, and Latino Americans, who account for 40% of transplants in the United States, exceeding their representation in the general population. The battle against organ rejection is a daily struggle, with half of all kidney transplants failing within ten years. The issue is further compounded by the severe organ shortage, disproportionately affecting these communities. Approximately 50% of individuals on the transplant waiting list are Black or Hispanic/Latino, highlighting the urgent need for equitable post-transplant care and access to transplantation.
Broad Support and National Attention:
The coalition led by Al B! and Rev. Sharpton has garnered widespread support from transplant patients and the medical community. Leading national professional transplant medical associations, including the American Society of Transplant Surgeons and the American Society of Transplantation, have expressed opposition to the Medicare coverage restrictions. Additionally, a bipartisan group of representatives in Congress, along with grassroots transplant patient group “Honor the Gift coalition,” have raised concerns and demanded answers from CMS regarding the rollbacks.
Looking Ahead:
Al B! and Rev. Sharpton express hope that the House Congressional Black Caucus and other influential bodies will join their efforts to restore Medicare coverage for these vital blood tests. To amplify their cause, hundreds of transplant recipients will gather in Washington, D.C., from December 4-6 for a series of activities, including meetings with congressional leaders and a press conference. The ultimate goal is to ensure that all transplant recipients, regardless of their background or socioeconomic status, have access to the necessary tools and care for a healthier future.
The formation of the “Health Equity in Transplantation Coalition” led by Al B. Sure! and Rev. Al Sharpton marks a significant step toward addressing the disparities faced by minority and underserved communities in transplant care. By opposing the Medicare cutbacks for transplant patient blood tests, this coalition strives to ensure that all transplant recipients have access to early detection of organ rejection, regardless of their background. Through their collective efforts, they aim to build a more equitable and inclusive healthcare system for all.
https://stmdailynews.com/category/the-bridge/
Health
Nutrient found in beef and dairy improves immune response to cancer
Newswise — Trans-vaccenic acid (TVA), a long-chain fatty acid found in meat and dairy products from grazing animals such as cows and sheep, improves the ability of CD8+ T cells to infiltrate tumors and kill cancer cells, according to a new study by researchers from the University of Chicago.
The research, published this week in Nature, also shows that patients with higher levels of TVA circulating in the blood responded better to immunotherapy, suggesting that it could have potential as a nutritional supplement to complement clinical treatments for cancer.
“There are many studies trying to decipher the link between diet and human health, and it’s very difficult to understand the underlying mechanisms because of the wide variety of foods people eat. But if we focus on just the nutrients and metabolites derived from food, we begin to see how they influence physiology and pathology,” said Jing Chen, PhD, the Janet Davison Rowley Distinguished Service Professor of Medicine at UChicago and one of the senior authors of the new study. “By focusing on nutrients that can activate T cell responses, we found one that actually enhances anti-tumor immunity by activating an important immune pathway.”
Finding nutrients that activate immune cells
Chen’s lab focuses on understanding how metabolites, nutrients and other molecules circulating in the blood influence the development of cancer and response to cancer treatments. For the new study, two postdoctoral fellows, Hao Fan, PhD and Siyuan Xia, PhD, both co-first authors, started with a database of around 700 known metabolites that come from food and assembled a “blood nutrient” compound library consisting of 235 bioactive molecules derived from nutrients. They screened the compounds in this new library for their ability to influence anti-tumor immunity by activating CD8+ T cells, a group of immune cells critical for killing cancerous or virally infected cells.
After the scientists evaluated the top six candidates in both human and mouse cells, they saw that TVA performed the best. TVA is the most abundant trans fatty acid present in human milk, but the body cannot produce it on its own. Only about 20% of TVA is broken down into other byproducts, leaving 80% circulating in the blood. “That means there must be something else it does, so we started working on it more,” Chen said.
The researchers then conducted a series of experiments with cells and mouse models of diverse tumor types. Feeding mice a diet enriched with TVA significantly reduced the tumor growth potential of melanoma and colon cancer cells compared to mice fed a control diet. The TVA diet also enhanced the ability of CD8+ T cells to infiltrate tumors.
The team also performed a series of molecular and genetic analyses to understand how TVA was affecting the T cells. These included a new technique for monitoring transcription of single-stranded DNA called kethoxal-assisted single-stranded DNA sequencing, or KAS-seq, developed by Chuan He, PhD, the John T. Wilson Distinguished Service Professor of Chemistry at UChicago and another senior author of the study. These additional assays, done by both the Chen and He labs, showed that TVA inactivates a receptor on the cell surface called GPR43 which is usually activated by short-chain fatty acids often produced by gut microbiota. TVA overpowers these short-chain fatty acids and activates a cellular signaling process known as the CREB pathway, which is involved in a variety of functions including cellular growth, survival, and differentiation. The team also showed that mouse models where the GPR43 receptor was exclusively removed from CD8+ T cells also lacked their improved tumor fighting ability.
Finally, the team also worked with Justin Kline, MD, Professor of Medicine at UChicago, to analyze blood samples taken from patients undergoing CAR-T cell immunotherapy treatment for lymphoma. They saw that patients with higher levels of TVA tended to respond to treatment better than those with lower levels. They also tested cell lines from leukemia by working with Wendy Stock, MD, the Anjuli Seth Nayak Professor of Medicine, and saw that TVA enhanced the ability of an immunotherapy drug to kill leukemia cells.
Focus on the nutrients, not the food
The study suggests that TVA could be used as a dietary supplement to help various T cell-based cancer treatments, although Chen points out that it is important to determine the optimized amount of the nutrient itself, not the food source. There is a growing body of evidence about the detrimental health effects of consuming too much red meat and dairy, so this study shouldn’t be taken as an excuse to eat more cheeseburgers and pizza; rather, it indicates that nutrient supplements such as TVA could be used to promote T cell activity. Chen thinks there may be other nutrients that can do the same.
“There is early data showing that other fatty acids from plants signal through a similar receptor, so we believe there is a high possibility that nutrients from plants can do the same thing by activating the CREB pathway as well,” he said.
The new research also highlights the promise of this “metabolomic” approach to understanding how the building blocks of diet affect our health. Chen said his team hopes to build a comprehensive library of nutrients circulating in the blood to understand their impact on immunity and other biological processes like aging.
“After millions of years of evolution, there are only a couple hundred metabolites derived from food that end up circulating in the blood, so that means they could have some importance in our biology,” Chen said. “To see that a single nutrient like TVA has a very targeted mechanism on a targeted immune cell type, with a very profound physiological response at the whole organism level—I find that really amazing and intriguing.”
The study, “Trans-vaccenic acid reprograms CD8+ T cells and anti-tumor immunity,” was supported by the National Institutes of Health (grants CA140515, CA174786, CA276568, 1375 HG006827, K99ES034084), a UChicago Biological Sciences Division Pilot Project Award, the Ludwig Center at UChicago, the Sigal Fellowship in Immuno-oncology, the Margaret E. Early Medical Research Trust, the AASLD Foundation a Harborview Foundation Gift Fund, and the Howard Hughes Medical Institute.
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