Drinking water crisis, breeding ground for gastrointestinal diseases
Humans cannot deny the importance of water as a resource for life, which serves for hydration, daily hygiene, cooking food, and other uses such as irrigation, recreational purposes, and even energy production.
However, when water is contaminated by parasites, it can cause various diseases, especially in the digestive tract.
Humans cannot deny the importance of water as a resource for life, which serves for hydration, daily hygiene, cooking food, and other uses such as irrigation, recreational purposes, and even energy production.
However, when water is contaminated by parasites, it can cause various diseases, especially in the digestive tract.
In the Dominican Republic, it is not uncommon for diarrhea to be caused by parasitic agents detected through stool culture.
“We live with parasites. It is very common in our country that a patient who comes with diarrhea and fever turns out to have a parasitic infection,” said gastroenterologist María Alonzo.
This is due, to a great extent, to four fundamental reasons: impurities that were not eliminated in the source at the moment of drinking water; lack of chlorine; deficient systems of storage of the liquid, and bad hygiene habits on the part of the citizens.
“Many of the pictures we see in the gastro consultation have to do with water that has not been properly processed and transmit parasites, bacteria and viruses,” she added.
According to the specialist at the Center for Advanced Gastroenterology, the most common parasite reports she sees in her practice are from patients infected with amoeba and giardia.
Dr. Maria Alonzo (EXTERNAL SOURCE).
These microscopic agents can cause acute gastroenteritis, consisting of diarrhea with nausea, vomiting, fever, and general malaise.
Alonzo clarifies that it is important to identify which parasitic agent is causing diarrhea, since “each one has a specific type of treatment.” Self-medication is ruled out.
“We cook or clean with non-potable water, thus contaminating the food and then we ingest it. Also, people who do not wash their hands properly, when interacting with food, in the end it is transmitted orally,” the doctor explained about the transmission cycle.
The gastro pointed out that children and elderly people are the most at-risk population, reminding that in case of diarrhea, the main thing is to keep the patient hydrated until he/she receives the corresponding treatment, otherwise, it could lead to renal failure.
More hand washing
Although it may seem a reiterative measure, Alonzo called for more emphasis on hand washing education, a simple action with proven results for the benefit of health.
“The Covid pandemic reminded us of this, but we are becoming increasingly lax. People no longer last the 20 seconds they should be soaping each hand. Only good hygiene prevents these cases (of parasitosis),” she said.
Water crisis
At present, the country is experiencing a water shortage as a consequence of the drought, aggravating the factors that lead to a lack of sanitation, which may cause, in addition to gastroenteritis, an increase of dengue, malaria, and chikungunya due to the storage of water in tanks and gallons that end up becoming mosquito breeding places if they are not hermetically sealed.
Another disease that spreads rapidly due to lack of water is cholera since its transmission is entirely linked to poor hygiene and sanitation habits. It is important to note that cholera cases have decreased and in the last few weeks, Public Health has not reported any new infections.
A direct consequence of the low rainfall is that the Santo Domingo Aqueduct and Sewerage Corporation (Caasd) has stopped producing about 25% less water than it used to, for a deficit of 139 million gallons per day in Greater Santo Domingo.
1 year 11 months ago
Health, Local
Levonorgestrel IUD reduces blood loss by more than 90% in those with heavy menstrual bleeding
BALTIMORE — Patients with heavy menstrual bleeding who received the levonorgestrel 52 mg intrauterine device experienced significant and rapid decreases in uterine bleeding after placement, a researcher reported here.Blood loss was reduced by more than 90% over 6 months after placement of the Liletta levonorgestrel-releasing intrauterine system (AbbVie/Medicines360) compared with baseline for m
ost with heavy menstrual bleeding, according to Mitchell D. Creinin, MD, professor in the department of obstetrics and gynecology at University of California Davis Health System in Sacramento.“The
1 year 11 months ago
What to keep in your first aid kit
I have been asked many times why I wear a medic alert bracelet. The answer is that I suffer from many allergies — foods and insect bites.
In fact, I was once stung by a bee and developed an anaphylactic reaction. Whoa! What's that? A very serious allergic reaction! I stopped breathing and had to be resuscitated (just like on the medical TV shows). What saved my life was my obsession with having certain medications easily available at home. These medications included injectable drugs which were used by a neighbour to save my life.
I mention my case to illustrate the importance of having a first aid kit at home. Of course, most people will not have injectable medications at home and if someone developed a bad allergic reaction, that person would need to be rushed to the nearest medical facility for appropriate treatment. However, some action could be taken as soon as symptoms developed. Assuming that the affected person is conscious, he or she could be given an antihistamine (for example — diphenhydramine — DPH) before being rushed off to the nearest medical facility. Quick action in emergency and non-emergency situations can be facilitated by having a first aid kit that is readily accessible to each household member.
The following are items that are suitable for a home first aid kit.
1. Disinfectant
2. Antibiotic ointment (for minor cuts, wounds)
3. Ointment for burns
4. Rubbing alcohol
5. Antihistamine liquid or tablets (for allergic reactions, runny nostrils, itching of the skin)
6. Pain relieving ointment/gel
7. Pain relieving liquid/tablets
8. Oral rehydration salts (for the treatment of dehydration in cases of vomiting and/or diarrhoea)
9. Sundry items — cotton swabs, gauze pads, band-aid, elastic bandage, tape, gloves
10. A small pair of scissors
11. A disposable razor (helps in removing hair from wounds)
12. Tweezers ( can be used to remove splinters from wounds. I have had to use my tweezers to remove prickles from my fingers)
13. Olive oil (can be placed in the ear to aid in the removal of wax)
14. Flashlight
15. Thermometer
16. Ice pack
17. Hot water bottle
A great substitute for an ice pack is an ice filled plastic bag wrapped with a small towel. Similarly, a good substitute for a hot water bottle is a small plastic bottle filled with hot water and wrapped in a towel.
I keep my first aid items in a carton box which is kept in a cupboard. The location of the box is known to all members of the household. You can vary the contents of your kit based on your family's needs. For example, if there are children in the household, you should have oral rehydration salts, paracetamol (for fever), an antihistamine (for example, DPH for runny nostrils) in your first aid kit. I suggest that you purchase the smallest size tubes/bottles of medications and regularly check the expiration dates of the medications that you purchase.
The contents of your first aid kit can be expanded if any household member is diabetic or hypertensive. Those persons need ready access to a glucometer to check the blood glucose levels and a sphygmomanometer (blood pressure measuring machine). Diabetics can obtain a glucometer from the National Health Fund. Many pharmacies sell blood pressure measuring machines. It is very important that everyone is familiar with rendering first aid. Knowledge of first aid can help to alleviate suffering and save lives. We all need to know CPR (cardiopulmonary resuscitation), what to do if someone is choking, ways to stop bleeding, clean wounds, lower a fever, relieve pain, and treat dehydration.
Please remember to keep all medicines out of the reach of small children. If you do not have a first aid kit at home, please start acquiring the contents as soon as possible. This kit may save your life.
Dr Jacqueline E Campbell is a family physician and radio show host. She is the author of the book "A patient's guide to the treatment of diabetes mellitus." Email:drjcampbell14@yahoo.com and IG: dr.jcampbell
1 year 11 months ago
How telemedicine supports the health needs of growing teens
TECHNOLOGY is taking over and telemedicine is just one way that the health-care sector has taken advantage of this phenomenon.
Many conversations around telemedicine underscore the benefits of it for adult patients; however, teens can also gain large benefits from the offerings of telemedicine platforms such as MDLink.
TECHNOLOGY is taking over and telemedicine is just one way that the health-care sector has taken advantage of this phenomenon.
Many conversations around telemedicine underscore the benefits of it for adult patients; however, teens can also gain large benefits from the offerings of telemedicine platforms such as MDLink.
A teenager is any person between the ages of 13-19, this period may also be referred to as adolescence as it represents the onset of puberty. During puberty, the body undergoes several changes preparing it for reproductive maturity. This period may feel unsettling for the growing teen, but also for the parents who are not sure how to guide and support them through this time. Telemedicine offers remote support for teens who may need health-care treatment for physical, emotional and mental challenges.
The following are a few ways teens can take advantage of telemedicine:
• Support through general health concerns. Whether it be a cold, a rash or even pains such as girls' menstrual cramps, teens can take advantage of telemedicine services as much as adults can. Teens can talk one-on-one with their doctors through the offerings of telemedicine such as voice call, text or video call, with permission from their parents. Parents may still offer input if necessary or teens may talk to their doctors on their own — whichever makes both child and parents most comfortable. They may find a safe space, use their headphones, and discuss with their doctor any health issues they may be having. Tech-savvy teens may find comfort in using the Internet for their treatment. Additionally, those with busy parents can get treatment without having to fit an in-person appointment into their busy schedules.
• Teens gain access to health care in rural areas. While many rural areas may not have access to specialist paediatricians or any state-of-the-art health-care facility for miles, many teens do have access to smart devices and the Internet. Therefore, teens will be able to use the technology they use every day to take care of their health and possibly even help members of their families that aren't too keen on using technology. This eliminates travelling long distances as well as long waits to get in-person visits from specialists.
• Easy and relatable access to mental health services. Teens may not only need support through physical changes but with anxiety and stress stemming from school, home life and general insecurities, including self-confidence, that come with growing up. Giving teens the opportunity to have a trained mental health physician they can talk to virtually provides key support to those that need it. They need only to find a safe and private area where they can discuss their problems and receive the recommended treatment and guidance to overcome their challenges.
• Support and advice through the changes of adolescence. Parents and teens alike may find it uncomfortable to discuss the changes happening in adolescence. This may include physical and hormonal changes. Helping teens understand how to prepare is important for managing this period of their lives. Additionally, your doctor can discuss with them about their reproductive health and offer sex education to ensure they transition through this period safely and carefully. Telemedicine provides a safe space to educate and encourage growing teens to make knowledgeable decisions about their health. It may, in turn, help teens feel more comfortable discussing their health with medical professionals and their parents. Ultimately, it ensures that teens understand there is nothing for them to worry about as they go through the phases of adolescence.
As the world changes the needs of the next generation also change. Therefore, offering more varied means to access health care is of prime importance. Telemedicine allows health care to meet teens halfway and have their needs met in a way that they find accessible and convenient. Encouraging the use of telemedicine by teens will not only support its use and importance as they get older, but provides a fundamental form of support and quality health care during a fundamental period. For parents, if you are unsure how your child can benefit from telemedicine or how you should guide them using this, you may reach out to your doctor and discuss with them the possibilities.
Dr Ché Bowen, a digital health entrepreneur and family physician, is the CEO & founder of MDLink, a digital health company that provides telemedicine options. Check out the company's website at www.theMDLink.com. You can also contact him at drchebowen@themdlink.com.
1 year 11 months ago
Children's cancer research fund backs cutting-edge leukaemia research at UVA
CHARLOTTESVILLE, United States – The Children's Cancer Research Fund (CCRF) has awarded US$250,000 to an innovative new approach to treating leukaemia (blood cancer) being developed at the UVA Cancer Center.
The grant to John H Bushweller, PhD, of the University of Virginia School of Medicine, is part of the national non-profit's efforts to accelerate the development of new and better treatments for difficult-to-treat cancers.
"This funding makes it possible to continue developing a novel approach to treatment for a form of paediatric leukaemia with a very poor prognosis," said Bushweller of UVA's Department of Molecular Physiology and Biological Physics. "For paediatric cancers in particular, the development of highly targeted approaches that directly inhibit the protein that drives the cancer has the potential to be more effective and to limit the substantial toxicity of current approaches, vastly improving outcomes for these patients. This is exactly the approach we are pursuing with the support of CCRF."
Bushweller and his team are developing drugs to block the effect of an abnormal protein that is formed when the protein MLL becomes fused to other proteins and alters the cell, resulting in either acute myeloid leukaemia or acute lymphocytic leukaemia. Bushweller and his team found in their lab models that blocking the ability of these abnormal proteins to bind to DNA completely prevented them from causing leukaemia. Based on those results they are working to develop drugs that disrupt this DNA binding, as a novel approach for treatment.
Based on the promising results so far Bushweller believes his new approach could be both more effective and less toxic than existing options for treating leukaemia. Further, he hopes that the new approach can be combined with existing drugs to provide unique benefits for patients.
"The potential benefits to patients include improved efficacy, leading to better outcomes; and much-reduced toxicity, leading to [a] far better quality of life and reduced long-term health effects from the treatment," he said.
Children's Cancer Research Fund is a national non-profit dedicated to ending childhood cancer. It backs promising research from top scientists across the country, funding projects that could make the greatest impact for children battling cancer. Since 1981 the group has contributed more than US$200 million to research, support programmes for children and their families, and towards cancer awareness and education outreach efforts.
"At Children's Cancer Research Fund we select and fund the best and most innovative research to advance breakthrough treatments for children's cancer, and we are excited about Dr Bushweller's promising results," said Jean Machart, chief operating officer and interim chief executive officer at CCRF.
1 year 11 months ago
Health-care financing options for informal sector operators
THE informal sector plays an outsized but unappreciated role in our economic development.
According to the Statistical Institute of Jamaica, as of July 2020 approximately 12.3 per cent of the employed labour force in Jamaica was engaged in the formal sector, while around 50.7 per cent were employed in the informal sector. The remaining portion consists of self-employed individuals without paid employees and unpaid family workers. The informal sector in Jamaica includes various types of employment, such as creative arts, music and entertainment, street vending, informal manufacturing, agriculture, self-employed contractors, and domestic work, among others. These workers often face challenges in accessing social protection, including health-care coverage and other benefits provided with employment in the formal sector.
Many times, individuals in the informal sector lack access to traditional health-care financing options, thereby limiting their choices when an unpredictable health-care crisis occurs. For many, the lack of access to traditional health insurance and unpredictable and irregular income streams impairs their ability to access needed health care, especially when the level of care needed is unavailable within the public health-care system.
It is necessary, therefore, to have alternative health-care financing options for this large pool of workers to ensure more reliable access to appropriate health care. Because of lack of risk pooling and limited financial protection, traditional health insurance may leave many informal sector individuals with significant out-of-pocket expenses, deductibles, or co-payments, which can be unaffordable for low-income individuals. This limitation undermines the financial protection that insurance is intended to provide and ultimately undermine health equity.
The traditional health insurance model may not be the most suitable option for our informal sector workers due to several reasons:
1) Affordability: Traditional health insurance premiums can be costly and exceptionally so for individuals outside of a group or risk pool. Informal sector workers are often not within a formal group and tend to have unpredictable or low incomes. Paying regular insurance premiums may impose a significant financial burden on them, making it difficult to afford and sustain coverage.
2) Absence of mandatory health insurance coverage laws or provisions to protect the poor.
Insurance companies have no legal mandates to provide mandatory low-cost coverage for the poor and less financially secure. In the more established economies, governments step in to fill the void to expand access to patients. The Affordable Care Act (ACA) in the USA, also known as Obamacare, introduced certain regulations and provisions, including subsidies and tax credits to lower-income families and individuals, aimed at expanding access to affordable health insurance. Additionally, certain government programmes like Medicaid, Medicare, and the Children's Health Insurance Program (CHIP) provide affordable or free health insurance to eligible individuals and families with limited income. Such options do not exist in Jamaica currently.
3) Irregular Income and Unpredictable Healthcare Expenses: Informal sector workers typically experience irregular income streams and face unpredictable health-care expenses. Traditional health insurance plans often require regular premium payments, which may not align with the income patterns of informal sector workers. Additionally, these plans may have deductibles, co-payments, or coverage limitations that can be challenging for workers with unpredictable income and health-care needs.
4) Limited Coverage for Informal Sector Needs: Traditional health insurance models often focus on formal sector employments or affinity groups both of which more likely do not include informal sector workers. Furthermore, informal sector workers may have unique occupational health services that may not be covered in traditional plans.
5) Lack of Risk Pooling: In low-income countries with a large informal sector, traditional health insurance models may struggle to achieve sufficient risk pooling to accommodate many informal sector workers making it difficult to establish stable insurance pools.
6) Lack of Inclusive Provider Networks: Traditional insurance models often have limited networks of health-care providers. In low-income countries, where health-care infrastructure and provider capacity can be limited, insurance networks may not adequately cover essential services or specialists, further restricting access to care.
7) Administrative Challenges: Informal sector workers may face difficulties in navigating the cumbersome administrative processes associated with traditional health insurance. Filling out forms, submitting claims, and meeting documentation requirements can be burdensome, particularly for those with limited literacy or access to administrative resources.
8) Fragmented Health Care Access: Informal sector workers often face challenges in accessing health-care services due to factors such as geographic location, limited provider networks, or other socio-economic barriers.
Considering these challenges, alternative health-care financing models may be more suitable for informal sector workers. These models can be designed to accommodate the irregular income patterns, specific health-care needs, and administrative capacities of informal sector workers, providing them with more accessible and affordable health-care coverage. It's important to tailor the health-care financing approach to the unique circumstances and requirements of the informal sector.
Addressing the limitations of traditional health insurance requires innovative approaches to health-care financing and delivery that are contextually appropriate for Jamaica. It may involve exploring alternative models, such as community-based health financing, social health protection programmes, or public-private partnerships to overcome these challenges and ensure equitable and inclusive access to quality health-care services in Jamaica.
In future columns we will explore specific alternative health-care financing mechanisms that may be more suitable for the large pool of informal sector workers in Jamaica to ensure a more inclusive and equitable health-care environment.
1 year 11 months ago
5 diseases under surveillance
During the first three months of this year, the country registered more cases of dengue, malaria, leptospirosis, diphtheria, tetanus, and pertussis than those reported last year in the same period.
According to epidemiological surveillance records of notifiable diseases, as of March 25, the system had captured 1,331 cases of dengue, 31% more than last year; 66 of malaria, 24% more and 100 of leptospirosis, 107% more (including 10 deaths).
Also, they report 14 cases of diphtheria, with one death; 12 cases of tetanus in non-neonatal ages, with seven deaths, and two cases of pertussis, including one death from that cause.
While the records for the year 2022 up to the same period, reported 1,007 cases of dengue fever captured by the system; 53 cases of malaria, 48 of leptospirosis and eight deaths; six cases of diphtheria and one death; eight cases of tetanus in non-neonatal age with one death and one case of pertussis.
The data are contained in epidemiological bulletin number 12 of the General Directorate of Epidemiology of the Ministry of Public Health.
The report details that in epidemiological week 12, which ended last March 25, 62 probable cases of dengue were reported, 21% of the cases are distributed in the province of Santo Domingo, and 303 cases were reported during the last four weeks of registration.
In relation to malaria, the accumulated cases as of that date were 66, of which 50% came from the outbreak in the province of Azua.
During week 12, the report indicates that five suspected cases of leptospirosis were reported, in three men residing in María Trinidad Sánchez, Peravia, and Santiago Rodríguez provinces, and one woman in Hermanas Mirabal province.
The provinces with the highest cumulative incidence of this disease, transmitted to humans through contact with the urine of infected animals, especially rats, are Santiago Rodriguez, Peravia, Azua, La Romana, and Monseñor Nouel.
SANITARY PANORAMA
On 10 April, Listín Diario reported that the first three months of this year, between medical protests, cholera outbreak, dengue cases, Covid-19 surveillance, and epidemiological alert for the presence of chikungunya in the region, were the topics that occupied the most attention in the sanitary field in the country. While the health system maintains important challenges aimed at maintaining a low incidence of other diseases.
1 year 11 months ago
Health, Local
Medical News, Health News Latest, Medical News Today - Medical Dialogues |
AbbVie gets USFDA nod for EPKINLY to treat adult patients with relapsed or refractory Diffuse Large B-Cell Lymphoma
North Chicago, Ill.: AbbVie has announced that the U.S.
Food and Drug Administration (FDA) has approved EPKINLY (epcoritamab-bysp), as the T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma (HGBL), after two or more lines of systemic therapies.
EPKINLY is approved under the FDA's Accelerated Approval program based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. EPKINLY is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration.
DLBCL is a type of aggressive, fast-growing non-Hodgkin's lymphoma (NHL), a cancer that develops in the lymphatic system and affects B cells, a type of white blood cell. DLBCL is the most common type of NHL, comprising of an estimated 30,400 U.S. cases in 2022 and 150,000 new cases each year globally. DLBCL patients are typically treated with chemoimmunotherapy-based regimens. For R/R patients, several targeted therapies including T-cell mediated treatments have recently emerged. However, single agent and ready-available or off-the-shelf treatment options are limited.
"DLBCL is an aggressive cancer type that can rapidly progress and resist treatment. The FDA approval of EPKINLY represents a new treatment mechanism of action for third line DLBCL patients. As a non-chemotherapy, single-agent treatment for DLBCL patients, we hope that EPKINLY can effectively treat this aggressive cancer type and can be used for patient care quickly and in an off the shelf form for physicians," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "The approval is just the first step, with our partner Genmab, towards a shared goal of developing a core therapy for patients with B-cell malignances."
EPKINLY marks the third approved blood cancer treatment available as part of AbbVie's growing oncology portfolio.
"Patients with DLBCL who relapse or are refractory to currently available therapies have limited options. Generally, the prognosis for these patients is poor and management of this aggressive disease can be challenging," said Tycel Phillips, M.D., City of Hope Associate Professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation. "Epcoritamab is a subcutaneous bispecific antibody that offers an additional treatment option for this patient population. With this approval, patients who are in need of additional therapy may have the opportunity to receive epcoritamab after failure to respond or relapse after two or more systemic therapies."
"The FDA approval of EPKINLY represents a new treatment for diffuse large B-cell lymphomas among patients who have relapsed or have refractory disease and are looking for a new medication," said Meghan Gutierrez, chief executive officer, Lymphoma Research Foundation.
1 year 11 months ago
News,Industry,Pharma News,Latest Industry News
PAHO/WHO | Pan American Health Organization
Urgent action needed to tackle stalled progress on health-related Sustainable Development Goals
Urgent action needed to tackle stalled progress on health-related Sustainable Development Goals
Cristina Mitchell
19 May 2023
Urgent action needed to tackle stalled progress on health-related Sustainable Development Goals
Cristina Mitchell
19 May 2023
1 year 11 months ago
Paper Strip Tests for Hypothyroidism
Student researchers at Rice University have developed a paper strip test for hypothyroidism, similar to those that are commonly used for COVID-19 testing. Babies with congenital hypothyroidism require prompt diagnosis and treatment, but in many parts of the world a lack of healthcare resources can mean that the condition can go undiagnosed for long periods, affecting a child’s development. This paper-based device may be well suited for large screening programs in such countries, as it is inexpensive and easy to use, requiring just a small drop of blood. The device consists of a wicking pad that is impregnated with antibodies against thyroid-stimulating hormone (TSH), providing a clear strip that can be assessed visually in the case of high levels of TSH, a hallmark of hypothyroidism.
Thyroxine, a thyroid hormone, is crucial for childhood development, but some children are born with an underdeveloped or completely absent thyroid gland. Identifying this early is important in avoiding lifelong developmental issues, but many low-resource countries lack a routine screening program.
“Thyroxine (T4) is responsible for the development of all body systems, including brain development, muscle development and so on,” said Alison Maniace, a researcher involved in the study. “A lack of T4 early in life will cause irreversible developmental delays if left untreated, which is why early-life diagnosis is so crucial.” “At birth, babies with congenital hypothyroidism look normal, there’s no obvious sign of this disorder, so the main roadblock to treatment in low-resource settings is the lack of widespread screening programs,” added Vanshika Jhonsa, another researcher involved in the project.
As the thyroid gland is impaired in those with hypothyroidism, leading to a lack of thyroxine, the body produces high levels of TSH in an attempt to compensate. This was the target of these student researchers, who took inspiration from at-home COVID-19 tests to develop a similar technology to detect TSH in small blood samples.
Their test strip device consists of a 3D printed case around a nitrocellulose wicking strip that has been studded with antibodies against TSH, providing a clear line that can be observed with the naked eye if the hormone is present at high levels.
The researchers have described the technology as having “the potential to impact the lives of thousands of people every year, especially in low-resource areas, allowing for early treatment and preventing the permanent disabilities that can result from untreated congenital hypothyroidism.”
More info here from the test designers: Test TSH…
Via: Rice University
1 year 11 months ago
Diagnostics, Medicine, Pediatrics, riceuniversity
Medical News, Health News Latest, Medical News Today - Medical Dialogues |
FDA approves Upadacitinib for Crohn's disease in adults
The U.S. Food and Drug Administration (FDA) has approved Upadacitinib for treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers.
This is the seventh FDA approval for RINVOQ across rheumatology, dermatology, and gastroenterology, where it is now indicated in both ulcerative colitis and Crohn's disease.
"AbbVie recognizes the need for more treatment options for Crohn's disease that can help address both rapid relief of symptoms along with the visible reduction of intestinal lining damage," said Thomas Hudson, M.D., senior vice president of research and development, chief scientific officer, AbbVie. "We're pleased that RINVOQ may provide this relief and is now available to treat Crohn's disease."
Endoscopic Response and Clinical RemissionThe approval is supported by data from two induction studies, U-EXCEED and U-EXCEL, and the U-ENDURE maintenance study.1 Statistical significance was achieved for the co-primary endpoints and key secondary endpoints with RINVOQ 45 mg in the induction studies and RINVOQ 15 mg and 30 mg in the maintenance study compared to placebo.
- Endoscopic response: In the two induction studies, 34% and 46% of patients treated with RINVOQ 45 mg achieved endoscopic response (defined as a decrease of greater than 50% from the baseline Simplified Endoscopic Score for CD [SES-CD] or for patients with isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline) at week 12, respectively, compared to 3% and 13% of patients receiving placebo.1 In the maintenance study, 28% and 41% of patients treated with RINVOQ 15 mg and 30 mg achieved endoscopic response at week 52, respectively, compared to 7% of patients receiving placebo.
- Clinical remission: In the two induction studies, 36% and 46% of patients treated with RINVOQ 45 mg achieved clinical remission (defined as a Crohn's Disease Activity Index [CDAI] of less than 150) at 12 weeks, respectively, compared to 18% and 23% of patients receiving placebo. Additionally, in the maintenance trial, 42% and 55% of patients treated with RINVOQ 15 mg and 30 mg achieved clinical remission at 52 weeks, respectively, compared to 14% of patients receiving placebo.1
"Symptoms of moderately to severely active Crohn's disease can be disruptive and uncomfortable for patients, so relief as early as possible is key. Given the progressive nature of the disease, endoscopic response is just as important," said Edward V. Loftus, Jr., M.D., professor of medicine in the division of gastroenterology and hepatology at Mayo Clinic in Rochester, Minnesota and U-EXCEL study investigator.* "Based on the clinical trial results, treatment with RINVOQ shows both early and long-term symptom relief along with evidence of a visible reduction of damage to the intestinal lining caused by excess inflammation."
"I started feeling better within a couple weeks. My symptoms lessened – less cramping, firmer stools, and the bleeding stopped. When I stopped bleeding, I had more energy," said Danielle, who is living with Crohn's disease and received RINVOQ in an open-label treatment arm in one of the clinical trials.
Rapid Clinical Response and Corticosteroid-free Clinical Remission
- Onset of clinical response based on CDAI was observed as early as two weeks in U-EXCEED and U-EXCEL, with a greater proportion of patients achieving clinical response at week 2 in RINVOQ-treated patients compared with placebo.
- This is the first clinical program of an approved moderate-to-severe Crohn's disease treatment to require steroid taper during the induction period, with a corticosteroid taper regimen initiated at week 4. Corticosteroid-free clinical remission (defined as discontinuation of steroid and achievement of clinical remission per CDAI [CDAI less than 150]) among patients on steroid at baseline was achieved at week 12 by more patients treated with RINVOQ in U-EXCEED and U-EXCEL (30% and 40%, respectively) compared to placebo (11% and 13%, respectively). In U-ENDURE, corticosteroid-free remission (defined as no corticosteroids for 90 days prior to week 52 and achievement of clinical remission) was achieved by more patients treated with RINVOQ 15 mg and 30 mg (42% and 53%, respectively) compared to 14% with placebo.
RINVOQ Safety Considerations
- Overall, the safety profile observed in patients with Crohn's disease treated with RINVOQ was consistent with the known safety profile for RINVOQ in other indications.
- RINVOQ may cause serious side effects, including:
- Serious infections. RINVOQ can lower ability to fight infections. Serious infections, some fatal, occurred, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses.
- Increased risk of death in people age 50+ with at least 1 heart disease risk factor.
- Cancer and immune system problems. Increased risk of some cancers, including lymphoma and skin. Current or past smokers have higher risk for lymphoma and lung cancer.
- Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50+ with at least 1 heart disease risk factor, especially in current or past smokers.
- Blood clots, some fatal, in veins of the legs or lungs and arteries. This occurred more often in people 50+ with at least 1 heart disease risk factor.
- Serious allergic reactions. Do not take if allergic to RINVOQ or its ingredients.
- Tears in the stomach or intestines; changes in certain laboratory test results.
1 year 11 months ago
Gastroenterology,Medicine,Gastroenterology News,Medicine News,Top Medical News
Health & Wellness | Toronto Caribbean Newspaper
Will you continue to embrace the false belief of Black people not needing therapy?
BY TRISHA SMITH “I’m not telling any White people my business!” This was my response to my aunt after a year of being in an abusive relationship in my early 20’s. I didn’t know where that response came from, or why I said it, all I knew was that Black people didn’t go to therapy, […]
The post Will you continue to embrace the false belief of Black people not needing therapy? first appeared on Toronto Caribbean Newspaper.
1 year 11 months ago
Spirituality, #LatestPost
AbbVie’s Rinvoq Lands FDA Approval as First Oral Drug for Crohn’s Disease
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BioPharma, Daily, Pharma, Top Story, AbbVie, biopharma nl, Clinical Trials, Crohn's disease, FDA, North Chicago, Rinvoq
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FDA approves Rinvoq as first oral therapy for moderate to severe Crohn’s disease
The FDA has approved AbbVie’s Rinvoq as a once-day pill intended for the treatment of adult patients with moderate to severe Crohn’s disease who are intolerant, or have had an inadequate response, to one or more TNF inhibitors.Upadacitinib (Rinvoq, AbbVie)v is now indicated for both Crohn’s disease and ulcerative colitis.
Additionally, this decision marks the drug’s seventh FDA approval across gastroenterology, dermatology and rheumatology.“AbbVie recognizes the need for more treatment options for Crohn’s disease that can help address both rapid relief of
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The Abortion Pill Goes Back to Court
The Host
Julie Rovner
KFF Health News
Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.
The fate of the abortion pill mifepristone remains in jeopardy, as an appellate court panel during a hearing this week sounded sympathetic to a lower court’s ruling that the FDA should not have approved the drug more than two decades ago. No matter how the appeals court rules, the case seems headed for the Supreme Court.
Meanwhile, in the partisan standoff over raising the nation’s debt ceiling, a key sticking point has emerged: whether to add a work requirement to the state-federal Medicaid program. Republicans are adamant about adding one; Democrats point out that, in the few states that have tried them, red tape has resulted in eligible people wrongly losing their health coverage.
This week’s panelists are Julie Rovner of KFF Health News, Sandhya Raman of CQ Roll Call, Rachel Roubein of The Washington Post, and Victoria Knight of Axios.
Panelists
Sandhya Raman
CQ Roll Call
Rachel Roubein
The Washington Post
Victoria Knight
Axios
Among the takeaways from this week’s episode:
- Hopes among abortion rights advocates for continued access to mifepristone dimmed as the three judges on the 5th Circuit Court of Appeals signaled they are skeptical of the FDA’s decades-old approval of the drug and of the Biden administration’s arguments defending it. Lawyers debated whether the Texas doctors challenging the drug had been harmed by it and thus had standing to sue. If the original ruling effectively revoking the drug’s approval is allowed to stand, the case could open the door to future legal challenges to the approval of controversial drugs.
- Two more states in the South are moving to restrict abortion, further cutting access to the procedure in the region. In North Carolina, a new Republican supermajority in the state legislature enabled the passage this week of a new, 12-week ban, as lawmakers in South Carolina consider a six-week ban.
- In Congress, the top Senate Republican said he will not back one senator’s months-long effort to hold up Pentagon nominations over a policy that supports troops and their dependents who must travel to other states to obtain an abortion.
- Envision Healthcare — which spent big in 2019 to fight legislation prohibiting some surprise medical bills — has filed for bankruptcy protection more than a year after the law took effect and cut into its bottom line. But a federal lawsuit from a group of emergency room physicians against Envision may move forward. The lawsuit claims the private equity-backed company is in violation of a California law banning corporate control of medical practices, and it could carry major consequences for the growing number of practices backed by private equity firms across the country.
- Monica Bertagnolli has been nominated to lead the National Institutes of Health. Currently the director of the National Cancer Institute, she will need to be confirmed by the Senate, which hasn’t confirmed an NIH chief since before the passage of the Affordable Care Act in 2010. Meanwhile, Sen. Bernie Sanders’ stewardship of a key health committee is causing delays on even bipartisan efforts.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: The Washington Post’s “A 150-Year-Old Law Could Help Determine the Fate of U.S. Abortion Access,” by Dan Diamond and Ann E. Marimow.
Victoria Knight: The New York Times’ “World Health Organization Warns Against Using Artificial Sweeteners,” by April Rubin.
Rachel Roubein: CBS News’ “Thousands Face Medicaid Whiplash in South Dakota and North Carolina,” by Arielle Zionts of KFF Health News.
Sandhya Raman: CQ Roll Call’s “A Year After Dobbs Leak, Democrats Still See Abortion Driving 2024 Voters,” by Mary Ellen McIntire and Daniela Altimari.
Also mentioned in this week’s episode:
KFF Health News’ “ER Doctors Vow to Pursue Case Against Envision Despite Bankruptcy,” by Bernard J. Wolfson.
click to open the transcript
Transcript: The Abortion Pill Goes Back to Court
KFF Health News’ ‘What the Health?’
Episode Title: The Abortion Pill Goes Back to Court
Episode Number: 298
Published: May 18, 2023
[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]
Julie Rovner: Hello and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent at KFF Health News. And I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, May 18, at 10 a.m. As always, news happens fast and things might have changed by the time you hear this. So here we go. We are joined today via video conference by Rachel Roubein of The Washington Post.
Rachel Roubein: Hi. Thanks for having me.
Rovner: Victoria Knight of Axios.
Victoria Knight: Hi. Good morning.
Rovner: And Sandhya Raman of CQ Roll Call.
Sandhya Raman: Hi, and good morning, everyone.
Rovner: Lots and lots of health news this week, so we will dive right in. We’re going to start with abortion because there is so much breaking news on that front. On Wednesday, a three-judge panel of the 5th Circuit Court of Appeals in New Orleans held a hearing on the Biden administration’s appeal of a Texas ruling that the FDA was wrong when it approved the abortion pill mifepristone more than 22 years ago. The panel, which was randomly chosen from an already pretty conservative slate there in the 5th Circuit, appeared to be even more anti-abortion than most of the judges on that bench. So, Sandhya, you listened to this whole thing. What, if anything, did we glean from this hearing?
Raman: I think we gleaned a lot of things and a lot of things I think we have predicted from the start. I think going into this, looking at the various judges’ records, they have ruled on anti-abortion cases in the past in the favor of that. You take that in with a grain of salt. And from watching the arguments, it seemed like they were fairly skeptical of the challenge and FDA’s approval of mifepristone and the subsequent regulations. You could kind of see through the questioning the kinds of things that they were asking and just pretty skeptical of just a lot of the things that were being said by DOJ [the Department of Justice] and by Danco there yesterday. So —
Rovner: Yeah, we should say that the lawyer for the FDA had one sort of round of presentation and questions. And then the lawyer from Danco, the company that makes mifepristone, had another. And they were pretty tough on both of them.
Raman: Yeah, and I thought it was interesting because when we were listening to the arguments, the DOJ lawyer and the Danco lawyer were kind of arguing a lot of the time just that there shouldn’t be standing, that there isn’t necessarily proof in any of the filings that any of the doctors that that were suing have really had harm due to the FDA’s role. It was kind of down the road. I think one thing that Harrington, the judge for the DOJ, had said, that was the FDA approving a drug does not mean that anyone has to prescribe it, it does not mean anyone has to take it, that the fact that if you were treating someone after the fact, that’s a few steps down the line. And so that was kind of like a messaging thing that they were doing kind of over and over again. And then when we got to the Alliance Defending Freedom, which is representing the conservative doctors, Erin Hawley had said, you know, they are affected both physically and she said emotionally, which was interesting, kind of looking at that. And so it’ll depend on how the judges rule. I think that there were definitely some signs throughout the arguments about this not being as unprecedented and that the FDA is not untouchable in terms of the courts weighing in on regulation.
Rovner: If you were just listening to it, you didn’t sort of know all of this. And remember, these were two Trump-appointed judges and a George W. Bush-appointed judge who has a history of ruling in favor of anti-abortion efforts. But they were saying that, “Well, people sue the FDA all the time. You know, what’s the difference here?” Well, the difference here is nobody has ever sued the FDA saying that they were wrong to approve something 20 years ago. Nobody’s ever tried to get a drug taken off the market that way. There’s obviously lots of litigation against the FDA for the way it does some of its thing. I mean, it’s often little things and then people sue each other with the FDA caught in the middle — drugmakers and lots of patent suits. I was surprised that the appeals court judges took issue with what everybody I think acknowledges is a correct claim that this is unprecedented and this could open the door to other challenges to other drugs for any reason — you know, someone doesn’t like them. I mean, these doctors are not saying that they’ve prescribed this drug and women have taken it and had bad reactions. They’re saying that possibly, if someone takes it and has a bad reaction, that they would have to treat that person and that that would harm their conscience, even though, as the lawyers made it clear, no one has ever forced these doctors to take care of anyone against their conscience because there are already laws that protect against that. So it was very roundabout in a lot of ways.
Raman: I think one thing that they had mentioned was that, you know, some of the cases cited in the filings were, you know, someone had taken an imported version of a mifepristone, not the one that Danco made, and then someone else had been recommended not to take the drug but still took the drug and then had side effects related to that. But there is another thing that kind of stuck out to me, was when Judge [James] Ho had asked would the FDA adhere to whatever the final court decision was? And that was a little striking to me. And then the FDA had said, you know, we will. And they cited that they had signed an affidavit last year saying that they’re going to agree to whatever the final decision is. But there were a lot of parts of the case that were just very unusual compared to the other cases that I have watched on this or any other part of health care, I think.
Rovner: Although in fairness to the judges, I mean, there was — a lot of legal experts were saying that the FDA does have enforcement authority to determine what it’s going to enforce and what it isn’t. And Justice [Samuel] Alito, when he actually challenged the Supreme Court’s stay of the original ruling — Justice Alito questioned about whether FDA would even follow if this drug was deemed unapproved. So that’s at least been coming up as a discussion. Let’s move on because it could be weeks or even months before we hear back from this panel, and we will obviously keep watching it. There’s been plenty of action in the states, too, this week — not that surprising because it’s May and lots of state legislatures are wrapping up their sessions for the year. But we should point out that particularly North and South Carolina are acting on abortion because they’ve been two of the last states in the South where abortion had remained both legal and pretty much broadly available. That’s changing as of this week, though, isn’t it?
Roubein: That’s changing in North Carolina, for sure, after this week. The Republicans there have supermajorities as of April; a Democrat in the House switched to the Republican Party. And what they did there is they overrode a veto from Democratic Gov. Roy Cooper. And this new bill, which the main provisions go into effect July 1, will restrict abortions at 12 weeks in pregnancy. And now in South Carolina, it’s still a little bit to be determined. The House passed a bill last night which would restrict abortions after fetal cardiac activity’s detected — roughly six weeks. Now they’re sending that bill back to the Senate, which had already passed it. But they made some changes. And it’s not clear whether some of the Republican female senators who oppose a near-total ban will be in favor of these changes. So that one’s a bit up in the air.
Rovner: And obviously, the 12 weeks in North Carolina is going to be important because there are a lot of women coming from other states now to North Carolina and clinics are getting backed up. It is a time thing for women to sort of be able to get themselves together, often get child care, get time off from a job, have to find a hotel in most cases, and go to another state. So it’s going to turn out to be an issue.
Roubein: I think one of the provisions abortion rights groups are pointing to there is, because this is a 12-week ban, so roughly 90% of abortions are allowed to continue, but what Democrats really pointed out was that the bill requires an in-person visit 72 hours before obtaining an abortion. So that could kind of restrict people, as you mentioned, Julie, from being able to take that time and come in from out of state in North Carolina, which has become a destination for abortions.
Rovner: All right. Well, I want to circle back to something that’s been going on for a while in the U.S. Senate. We talked about it back in March. Alabama Republican Sen. Tommy Tuberville is single-handedly holding up many military promotions to protest a Biden administration policy that allows members of the military in states with abortion bans both time off and travel funds to obtain an abortion in another state. Defense Secretary Lloyd Austin says that this — the delayed promotions — is starting to impact the nation’s readiness. Is there any resolution to this in sight? It’s now been going on for, what, a month and a half.
Raman: I think that, you know, we’re getting somewhat closer to it, but it’s hard to tell. I mean, we’ve had Mitch McConnell say that he’s not supporting what Tuberville is doing with the blockade of military nominations, so that could be a little bit more pressure compared to anyone else in the caucus putting that pressure. But I think the other thing that had come up is that there had been a report this week that the administration was going to delay on deciding if Space Force Command was going to move from Colorado to Alabama because of Tuberville. And so I think that, if that is the case — two different pressure points — there might be movement. But it’s been happening for a long time. We’ve had hundreds of nominees delayed. And I think the pushback has not necessarily been fully partisan. Even before we had McConnell speak out, we’ve had other members of — Republican senators kind of say, you know, this is maybe not the best move to do this, so —
Rovner: I mean, given how important Republicans take the military, I get why he’s doing this. It’s a pressure point because it’s a DOD [Department of Defense] policy. But still, it looks funny for a Republican to be holding up something that’s really important to the military.
Raman: Earlier this year, I think it was last month, you know, the Senate had done their procedural vote on a Tuberville resolution on something that was kind of similar, when they had the VA [Department of Veterans Affairs] rule that allows them to provide abortions for, you know, the Hyde exceptions, so rape, incest, life of the mother. And, you know, that didn’t pass on a procedural vote. So maybe something like that could be, like, a bargaining point. But it would require Democrats to say, “Yes, we do want to vote on this.” And I think that the last comments that Tuberville had even said were that, you know, “Until this policy is gone, I don’t want to waiver.” So it might not be a solution, but it could be something.
Rovner: Well, speaking of things that are proving difficult to resolve, let’s talk about the debt ceiling talks. As of today, Thursday, there’s no agreement yet, although President Biden is going to cut his overseas trip short after Treasury Secretary Janet Yellen warned that the so-called x-date, when the Treasury can no longer pay its bills, could really happen as soon as June 1. One of the big sticking points appears to be work requirements for programs aimed at low-income Americans, which Republicans are demanding and Democrats are resisting. Welfare, now called Temporary Aid to Needy Families, already has work requirements, as does SNAP [Supplemental Nutrition Assistance Program], the current name for food stamps, which leaves Medicaid, which has been a particular sticking point over the last few years. I guess we were all right back in February when Biden and the Republicans seemed to take Medicare and Social Security off the table, and we all predicted the fight would come down to Medicaid. So here we are, yes?
Knight: Yep, we’re at Medicaid. But it does seem like we’re really going back and forth on it. I think the sentiment at first was kind of that this would be the first thing to fall out of a potential deal between Democrats and Republicans because Democrats are really opposed to this. But I don’t know. This week, President Biden made some comments that were a little confusing. It kind of made it sound like he was potentially open to the idea. And then the White House kind of walked that back this week and sent some press releases out that were like, We don’t want to touch Medicaid. And then I believe it was sometime yesterday, on Wednesday, the president said, “Maybe, but nothing of consequence,” when talking about work requirements. And Congress is leaving today. So I think it’s kind of still up in the air, but the door still seems to be open, I guess is kind of the takeaway.
Rovner: There seems to be some concern from Democrats on Capitol Hill that President Biden may give too much away in trying to avoid a debt default. I mean, he’s already sort of after, you know, “We will not negotiate on the debt ceiling, we will not negotiate on the debt ceiling” — I mean, the administration says they’re negotiating on the budget, but they’re negotiating on the debt ceiling, right?
Knight: Yeah. I mean, and it seems that President Biden, the administration, may be open to budget caps as well or cutting spending. And that was kind of something that it seemed like Democrats at first were not open to doing at all. I talked to some appropriators this week, and they’re pretty upset about — Democratic appropriators — they’re pretty upset because they want the debt ceiling and appropriations to be a separate process, and they’re being tied together right now. Yeah, I think they’re somewhat concerned with how the president is negotiating right now.
Rovner: Well, it’s May 18. There’s been no talk yet of a temporary — although I assume at some point we’re going to say, let’s just extend this out a few days, and let’s extend it out a few more days, and we’ll extend it out a few more days. So obviously, we will watch this space. So the mifepristone case is not the only judicial news this week. In that other case out of Texas, challenging the preventive health services part to the Affordable Care Act, the 5th Circuit Court of Appeals — lots of news out of New Orleans this week — temporarily stayed the ruling by Judge Reed O’Connor that the ACA unconstitutionally deputized the U.S. Preventive Health Services Task Force from deciding which preventive services should be provided without copays. Long sentence. I hope it makes sense. Reed O’Connor, of course, being the judge who tried unsuccessfully to declare the entire ACA unconstitutional in 2018. What happens now in this case? Nothing changes until it gets resolved, right?
Roubein: Right. Right now I think that just through that, this means that insurers will be required to continue covering services recommended by the U.S. Preventive Services Task Force without cost sharing in care.
Rovner: And that includes PrEP for HIV, which is what’s really at issue with these doctors who are suing the FDA — or actually I guess they’re suing HHS [the Department of Health and Human Services] in general — saying that they don’t want to be required to provide these drugs.
Roubein: Yeah, it does include PrEP.
Rovner: So that will continue. I imagine that will also find its way to the Supreme Court. Finally, in not really judicial but court-related news, Envision, the private equity-backed physician staffing firm, filed for Chapter 11 bankruptcy this week, presumably because the emergency room physician practices it owns can no longer send patients most surprise medical bills. ER bills were among the most common types of surprise bills, when patients would specifically take their emergency to an in-network hospital, only to find that the doctors in the emergency room were all out of network. Is this one small step towards taking some of the profit motive out of health care? I don’t see anybody, like, shedding a lot of tears for Envision declaring bankruptcy here.
Raman: I think the second part, that the lawsuit by the ER doctors against Envision, despite them filing for bankruptcy, is going forward is interesting, and it seems unusual to me, because they’re not asking for monetary damages, but they want, like, a legal finding that the way that the company’s business structure — ownership of the staffing groups — is illegal, and if, like, winning that would ban the practice in the state of California. And so I think if you’re looking at it in terms of, like, things that would happen over the course of time, policywise, that could be something interesting to kind of watch there.
Roubein: I just wanted to hearken back real quick to, like, 2019. In the middle of the surprise billing debate, Envision and another major doctor staffing firm spent significant sums of money to try and sway the surprise billing legislation that the House and the Senate were hashing out.
Rovner: Yeah, they made CNN and MSNBC very rich with their ads.
Roubein: Millions of them.
Rovner: In the ’90s, I covered, you know, this whole corporate practice of medicine thing because I think it’s every state has a law that says that corporations can’t practice medicine; only licensed health professionals can practice medicine. So I’ve always wondered about, you know, what this lawsuit is about anyway. How are these companies actually getting away with doing this? And the answer is maybe they’re not or maybe they won’t. It’s going to be interesting. There’s now so much profit motive and private equity in health care because there’s a lot of money to be made that it’s, I think somebody is actually starting to, you know, call on it. We will definitely see how this plays out. We may not have a “This Week in Private Equity” anymore. Well, let us go back to Capitol Hill, where we finally have a nominee to head the National Institutes of Health, current National Cancer Institute chief Monica Bertagnolli, who is also, ironically, a cancer patient at the moment, although her prognosis is very good, we are told. There hasn’t been a confirmed head of the NIH since Francis Collins stepped down at the end of 2021. Congress hasn’t had to confirm a new head of the NIH since before the passage of the Affordable Care Act. I imagine that Dr. Bertagnolli is going to have to navigate some pretty choppy confirmation waters, even in a Senate where Democrats are nominally in the majority, right?
Knight: Yeah, I spent some time talking to HELP [Health, Education, Labor and Pensions] Committee Republicans last week and this week, and they definitely have some things they want to see out of a new NIH director. They’re definitely concerned about gain-of-function research, potential funding of that type of research, which is supposed to, hypothetically, make viruses more virulent. So several of them said, you know, “We don’t want to see the agency funding that kind of research,” or, “We want restrictions around that kind of research.” They also are concerned with the agency giving a grant to an organization called EcoHealth, which was supposed to have done research in Wuhan that was around gain-of-function-type things. And I think they also, in general, are just concerned with how the NIH and the CDC [Centers for Disease Control and Prevention] responded to the covid pandemic, and they aren’t happy with some of the decisions they made, what they felt like were mandate — top-down mandates. And so I do think we will see, if we actually get a HELP confirmation hearing any time soon, we’ll see — I think it’s going to be pretty contentious possibly. And as you referenced, I kind of looked into this when I was writing my story, and there really has not been a contentious hearing in a long time. Francis Collins went through a unanimous voice vote when he was confirmed. And then the two previous NIH directors, they kind of sailed through their HELP confirmation hearings. And if you think about it, Francis Collins also has served under both Republican and Democratic presidents. And I wonder if we are coming to a point where that won’t happen anymore with NIH directors.
Rovner: Back when I first started covering the NIH, it was contentious because they were talking about fetal tissue research and stem cell research and stuff that was really controversial. But then Newt Gingrich, when he became speaker of the House, declared that, you know, he wanted the 21st century to be, you know, the century of biomedicine. And he vowed to double the funding for the NIH, which the Republicans did, you know, with the Democrats’ help. So NIH has been this sacred cow, if you will, bipartisanly for at least two decades. And now it’s sort of coming back to being a little bit controversial again. In talking about the debt ceiling and possible budget cuts, I mean, NIH has usually been spared from those. But I’m guessing that if there’s budget caps, NIH is going to be included in those places where we’re going to cut the budget, right?
Knight: Yeah, absolutely. I have been talking to a Republican House appropriator over the NIH. Robert Aderholt told me that, yes, they expect a cut in their budget because Defense and NIH, Labor, HHS are usually the biggest bills. And he told me Defense probably isn’t getting cut very much, so we’re expecting to get cut. So obviously, you know, it’s a messaging bill in the House, but I think the expectation is that they’re going to propose that. The Senate seemed pretty set on keeping NIH funding what it was. They had an NIH appropriations hearing recently. So, I mean, there’s going to be some difference between those two chambers. But I think it does seem likely, especially with all the debt ceiling stuff, that cuts are possible.
Rovner: So that’s NIH. In the meantime, now we have an opening at the CDC because Rochelle Walensky announced her resignation. Have we heard any inklings about who wants to step into that very hot seat?
Roubein: I can point to some reporting from my colleagues at the Post, Dan Diamond and Lena H. Sun. At the time, the day that Walensky announced that she’d be stepping down June 30, they had wrote that White House officials had, you know, been preparing for a little while for a potential departure and had begun gauging interest in the position. And some people that Dan and Lena named that the administration had approached is former New York City Health Commissioner Dave A. Chokshi, former North Carolina Health Secretary Mandy Cohen, and the California health state secretary. Now, we don’t know ultimately what the White House, President Biden, is going to do. I do think it’s worth pointing out that the new CDC director won’t have to be Senate-confirmed; that was passed in the big sweeping government funding bill, that a CDC director would need to be confirmed, but starting January 20, 2025. So, you know, sounds like something, you know, Democrats might have been interested in doing, kind of pushing that out. So, yeah.
Rovner: The CDC is, you know, sort of the one big Department of Health and Human Services job that does not come up for Senate confirmation. Obviously, that is being changed, but it’s not being changed yet. Well, both of these confirmations, mostly the NIH one at this point, comes up before the Senate HELP Committee, Victoria, as you pointed out. Chairman Bernie Sanders there is having — what shall we call them? — some growing pains as chairman of a committee with a heavy legislative workload. What’s the latest here? He’s still kind of working on getting some of these bipartisan bills through, isn’t he?
Knight: Yeah, there is a little bit of a snafu at a recent HELP Committee hearing where Ranking Member Bill Cassidy was not happy that Sen. Sanders was bringing up some amendments that he wasn’t aware of or that they had kind of agreed to table at some point and then he brought them back up during a hearing or during a markup, and so they ended up having to delay the markup itself and do it the next week. And these were bipartisan bills. So it was really just a process issue; it wasn’t so much the subject of the bills. And they kind of worked it out and were able to pass the bills out of the committee, or most of the bills out of the committee, the next week after that happened. So I think that Sen. Sanders is figuring out how to run the HELP Committee. What I’ve kind of heard is that he is somewhat more interested in labor issues than health, and so his focus is not maybe as much on health. And I think you can see that sometimes. Also, when you talk to Sen. Sanders, he’s very much a big-picture guy and isn’t so much in the process weeds often, whereas Sen. Cassidy loves the process.
Rovner: So we’re noticing.
Knight: Yeah, Sen. Cassidy loves the process. So they’re an interesting duo, I think.
Rovner: Yeah, I mean, I was interested that this week, you know, Sen. Sanders was among those there reintroducing the “Medicare for All” bill that obviously has no future in the immediate future. But at the same time, community health centers are up for reauthorization this year. And that has always been a pet issue, even when he was House member, you know, Rep. Sanders. This is one of the issues that I know he cares a lot about. And now he’s in charge of making sure that it gets reauthorized. So he’s got sort of these competing big-picture stuff and, not smaller, but smaller than the big-picture stuff that he really cares about. I’ll be curious to see what he’s able to do on that front. I assume there’s no word on that yet, even though the authorization ends Sept. 30, right?
Raman: The sense that I’ve gotten from talking to folks is that community health centers is higher up the totem pole than some of the other issues on the must-pass list. I mean, we still have to deal with the debt ceiling and everything related there. But I think that there has been a little bit more progress then. I mean, this week, at least in the House, Energy and Commerce had marked up their bill that had community health center funding in there. So I think there’s a little bit more push on that end because they’re, you know, fairly bipartisan, have seen interest across the board on that. So I think that they are making some progress there. It’s just that there’s so many other factors right now, and that makes it pretty tricky.
Rovner: The ironic thing about Congress — it’s summertime when everybody else sort of kicks back. — that’s when Congress kicks into gear. So a lot, I imagine, is going to happen in June and July. All right. That is this week’s news. Now it is time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Victoria, why don’t you go first this week?
Knight: Sure. My extra credit this week is called “World Health Organization Warns Against Using Artificial Sweeteners.” It was published in The New York Times. Basically, the WHO said this week that artificial sweeteners aren’t effective in reducing body fat and could actually increase the risk of Type 2 diabetes and cardiovascular diseases. They looked at the available evidence, and it’s just a set of guidelines that they’re issuing. It’s not binding to anything. You know, every country can kind of make their own decision based on this. But I think it was an interesting marker. If you look at the influx of all these artificial sweeteners over time that have kind of become a mainstream part of our diet, they’re available in a bunch of different things that you can get at the store, and people often turn to them when they’re trying to reduce sugar. And now this large body is saying they may actually worsen your health, not help you, and not even reduce fat. So I think that was just kind of interesting. The FDA did not respond to The New York Times’ request for the story, so I’m not sure their stance on this, but just something to note.
Rovner: I was interested that the WHO did that. It seemed sort of very not WHO-ish, but also interesting. Sandhya, why don’t you go next.
Raman: All right, so my extra credit this week is called “A Year After Dobbs Leak, Democrats Still See Abortion Driving 2024 Voters.” And it’s from my colleagues “What the Health?” alum Mary Ellen McIntire and Daniela Altimari. And they take a look at how Democrats are kind of seeing how abortion messaging isn’t fading a year after — almost — the Dobbs decision, are kind of doubling down on focusing on that. President Biden and Vice President Harris were both at the EMILYs List gala this week honoring Nancy Pelosi. And it also comes amid a lot of the state action we talked about earlier of a lot of abortion bans going into place. And so they have a good look at that that you can read.
Rovner: Rachel.
Roubein: My extra credit is called “Thousands Face Medicaid Whiplash in South Dakota and North Carolina,” by Arielle Zionts from KFF Health News. And she takes a look at the unwinding of keeping people on the Medicaid program, particularly in South Dakota and North Carolina, where the dynamic is really interesting, because both states have recently passed Medicaid expansion. So officials are kind of going through the Medicaid rolls beforehand. So some people who could be eligible soon may be getting kicked off, only to need to reapply, or officials need to tell them that they can reapply. So I thought it was a really interesting look on how this is playing out.
Rovner: Yeah, it is. I mean, talk about head-explodingly confusing for people; it’s like, “You’re not eligible now, but you will be in three weeks. So just kind of sit tight and don’t go to the doctor for the next couple of weeks,” basically where they are. Well, my story is from The Washington Post, and it’s called “A 150-Year-Old Law Could Help Determine the Fate of U.S. Abortion Access,” by Dan Diamond and Ann Marimow. And it’s about the Comstock Act, which we have talked about before. It’s a Reconstruction-era law pushed through Congress by an anti-vice crusader, Anthony Comstock, who I learned this week was not actually a member of Congress. He was just an interested party. The law purports to ban the mailing of all sorts of lewd and lascivious items, including those intended to be used for abortion. Abortion opponents are trying to resurrect the law, which has never been formally repealed. But it turns out that Comstock wasn’t actually all that anti-abortion. In a newly resurrected interview that Comstock did with Harper’s Weekly in 1915, he said he never intended for the law to interfere with the practice of medicine by licensed doctors, including for abortion. Quote, “A reputable doctor may tell his patient, in his office what is necessary, and a druggist may sell on a doctor’s written prescription drugs which he would not be allowed to sell otherwise.” That’s how Comstock is quoted as saying. Um, wow. It’s just another weird twist in an already very twisty story. But let’s keep track of the Comstock Law going forward. All right. That is our show for this week. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us too. Special thanks, as always, to our ever-patient producer, Francis Ying. Also as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me. I’m still there. I’m at @jrovner. Sandhya?
Raman: @SandhyaWrites.
Rovner: Rachel.
Roubein: @rachel_roubein.
Rovner: Victoria.
Knight: @victoriaregisk.
Rovner: We will be back in your feed next week. Until then, be healthy.
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1 year 11 months ago
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Skin cancer is seen more frequently in the Dominican Republic
Santo Domingo.- The rising rates of skin cancer in the country can be attributed to several factors, including inadequate skin care, delayed intervention, and the failure to use sunscreen. This year alone, the Dominican Dermatological Institute (IDCP) has received 605 consultations resulting in diagnoses of cancerous skin lesions.
Santo Domingo.- The rising rates of skin cancer in the country can be attributed to several factors, including inadequate skin care, delayed intervention, and the failure to use sunscreen. This year alone, the Dominican Dermatological Institute (IDCP) has received 605 consultations resulting in diagnoses of cancerous skin lesions. This number is alarmingly close to the previous year’s report, which documented 1,168 cases of cancer detection.
Luisa Gonzalez, the head of the center’s Surgical Units, highlighted the increase in the incidence of skin cancer and attributed it to various factors such as environmental pollution, dietary habits, and lifestyle changes. These factors have collectively contributed to a higher prevalence of skin cancer among the population.
Out of the 600-plus consultations received, 111 patients required surgical procedures for skin cancer treatment. This number is significantly higher compared to the previous year when 400 patients underwent surgery, indicating an increasing trend.
The IDCP plans to conduct a national awareness campaign called “Choose to Take Care of Yourself” from the 25th of this month to June 25th. The campaign aims to raise awareness about skin cancer prevention. The medical professionals at the dermatological institute emphasized that the incidence of malignant melanoma in the Dominican Republic differs from the global trend.
Contrary to global statistics, it was observed that women in the Dominican Republic are more proactive in seeking early medical attention for any changing or emerging skin lesions. This may be due to better education and awareness among women compared to men.
Previously, the institute received visits from 30 patients with advanced malignant melanoma in a year, but last year alone, the number increased to 170 patients.
Specialists emphasize the importance of early detection of malignant melanoma, as each case of skin cancer is unique. The institutional focus has always been on raising awareness, as timely prevention measures can significantly reduce the impact of the disease.
Early diagnosis and biopsy are crucial in determining the appropriate course of treatment, as different types of skin cancer exhibit varying behaviors. The Dominican Dermatological Institute follows a protocol for skin cancer patients, including triage, evaluation, surgery, and post-operative follow-ups at regular intervals over several years. This comprehensive approach aims to ensure optimal care and monitoring for patients.
1 year 11 months ago
Health