AHA urges legislation refinements for laboratory-developed tests
The VALID Act is included in the Food and Drug Administration Safety and Landmark Advancements Act.
“The AHA is concerned that, if enacted in its current form, the VALID Act could lead to a loss of patient access to many critical tests and could dramatically slow down advances in hospital and health system laboratory medicine,” AHA said in a letter to leaders of the Senate HELP Committee. “Given the value of these tests to caregivers and patients, any framework for regulatory oversight of LDTs must ensure that the technological and clinical innovation that is essential to their development remains unrestricted; that quality and reliability are maintained at the highest levels possible; and that they continue to be widely accessible to patients. In contrast, we believe the provisions in the VALID Act could cause confusion and delays that could hinder the achievement of these goals and possibly prevent hospital and health system laboratories from continuing to develop cutting-edge LDTs in response to immediate clinical care needs.”
COVID-19 antibodies last up to 500 days after infection
Adults infected with COVID-19 develop circulating antibodies that last for nearly 500 days, according to a new study led by researchers at UTHealth School of Public Health.
The findings were published in The Journal of Infectious Diseases.
Researchers examined data from over 57,000 volunteers across the state of Texas over the age of 20 who were enrolled in the Texas CARES survey, which began in October of 2020 with the goal of assessing COVID-19 antibody status over time among a population of adults and children in Texas.
“These results are promising because we now have a good estimate of how long antibodies last after a COVID-19 infection,” said Michael Swartz, PhD, Associate Professor and Vice Chair of Biostatistics at UTHealth School of Public Health and corresponding author on the study. “Our research shows that the level of antibodies in those previously infected increases for the first 100 days post-infection and then gradually declines over the next 500 days and beyond.”
Researchers used blood draw samples from Oct. 1, 2020, to Sept. 17, 2021. Most volunteers self-reported a COVID-19 infection before October of 2020. The results differed from person to person based on their age, body mass index (BMI), smoking or vaping use, and the severity of infection; however, all volunteers showed a similar decrease in antibodies.
The results of this study are just another step in understanding the virus’s impact, and although antibodies after infection can last for almost a year and half, Swartz says it’s important to understand that being vaccinated against the virus offers the best protection against infection, reinfection, or hospitalization.
“Vaccines are a great source of protection. We know that the rates of reinfection or hospitalization after being vaccinated are a lot lower than not being vaccinated, especially against other variants like we saw with Delta and Omicron. So, if you haven’t been vaccinated, now is the time to do it,” Swartz said.
Dangerous pairing of breast cancer and diabetes
University of California San Diego study describes mechanism by which breast cancer suppresses insulin production, impairing blood sugar regulation and causing diabetes, which, in turn, promotes tumor growth, according to a news release.
Breast cancer and type 2 diabetes would seem to be distinctly different diseases, except for their commonality. Breast cancer is the second most diagnosed malignancy after some types of skin cancer; approximately 1 in 8 U.S. women will develop invasive breast cancer over the course of their lifetime. More than 10% of the U.S. population has diabetes, with an estimated 2 in 5 Americans expected to develop the chronic disease during their lifetime.
However, past research has uncovered associations between the two diseases. Women with diabetes, for example, have a 20 to 27% increased risk of developing breast cancer. Insulin resistance — a key characteristic of diabetes — has been associated with breast cancer incidence and poor survival. Population studies suggest diabetes risk begins to increase two years after a breast cancer diagnosis, and by 10 years post-diagnosis, the risk is 20% higher in breast cancer survivors than in age-matched women without breast cancer.
But these epidemiological linkages are not clear-cut or definitive, and some studies have found no associations at all. In a paper in Nature Cell Biology, a research team led by scientists at University of California San Diego School of Medicine describe a possible biological mechanism connecting the two diseases, in which breast cancer suppresses the production of insulin, resulting in diabetes, and the impairment of blood sugar control promotes tumor growth.
“No disease is an island because no cell lives alone,” said corresponding study author Shizhen Emily Wang, PhD, Professor of Pathology at UC San Diego School of Medicine. “In this study, we describe how breast cancer cells impair the function of pancreatic islets to make them produce less insulin than needed, leading to higher blood glucose levels in breast cancer patients compared to females without cancer.”
Wang said the study was inspired by early work and guidance from Jerrold Olefsky, MD, Professor of Medicine and Associate Dean for Scientific Affairs in the Division of Endocrinology and Metabolism at UC San Diego School of Medicine and co-senior author of the study with Wang.
The culprit, according to Wang and Olefsky, are extracellular vesicles (EV) — hollow spheres secreted or shed by cells that transport DNA, RNA, proteins, fats and other materials between cells, a sort of cargo communication system.
In this case, the cancer cells were found to be secreting microRNA-122 into the vesicles. Wang said when vesicles reach the pancreas, they can enter the islet cells responsible for insulin production, dispense their miR-122 cargo and damage the islets’ critical function in maintaining a normal blood glucose level.
“Cancer cells have a sweet tooth,” Wang said. “They use more glucose than healthy cells in order to fuel tumor growth, and this has been the basis for PET scans in cancer detection. By increasing blood glucose that can be easily used by cancer cells, breast tumors make their own favorite food and, meanwhile, deprive this essential nutrient from normal cells.”
The researchers found that slow-releasing insulin pellets or a glucose-lowering drug known as an SGLT2 inhibitor restored normal control of glucose in the presence of a breast tumor, which in turn suppressed the tumor’s growth.
“These findings support a greater need for diabetes screening and prevention among breast cancer patients and survivors,” said Wang.
Post–COVID conditions continue to rise among U.S. adult COVID-19 survivors
As more persons are exposed to and infected by SARS-CoV-2, reports of patients who experience persistent symptoms or organ dysfunction after acute COVID-19 and develop post-COVID conditions have increased, according to a news release.
COVID-19 survivors have twice the risk for developing pulmonary embolism or respiratory conditions; one in five COVID-19 survivors aged 18–64 years and one in four survivors aged ≥65 years experienced at least one incident condition that might be attributable to previous COVID-19.
Implementation of COVID-19 prevention strategies, as well as routine assessment for post-COVID conditions among persons who survive COVID-19, is critical to reducing the incidence and impact of post-COVID conditions, particularly among adults aged ≥65 years.
A growing number of persons previously infected with SARS-CoV-2, the virus that causes COVID-19, have reported persistent symptoms, or the onset of long-term symptoms, ≥4 weeks after acute COVID-19; these symptoms are commonly referred to as post-COVID conditions, or long COVID. Electronic health record (EHR) data during March 2020–November 2021, for persons in the United States aged ≥18 years were used to assess the incidence of 26 conditions often attributable to post-COVID (hereafter also referred to as incident conditions) among patients who had received a previous COVID-19 diagnosis (case-patients) compared with the incidence among matched patients without evidence of COVID-19 in the EHR (control patients).
The analysis was stratified by two age groups (persons aged 18–64 and ≥65 years). Patients were followed for 30–365 days after the index encounter until one or more incident conditions were observed or through October 31, 2021 (whichever occurred first). Among all patients aged ≥18 years, 38% of case-patients experienced an incident condition compared with 16% of controls; conditions affected multiple systems, and included cardiovascular, pulmonary, hematologic, renal, endocrine, gastrointestinal, musculoskeletal, neurologic, and psychiatric signs and symptoms. By age group, the highest risk ratios (RRs) were for acute pulmonary embolism (RR = 2.1 and 2.2 among persons aged 18–64 and ≥65 years, respectively) and respiratory signs and symptoms (RR = 2.1 in both age groups). Among those aged 18–64 years, 35.4% of case-patients experienced an incident condition compared with 14.6% of controls.
Among those aged ≥65 years, 45.4% of case-patients experienced an incident condition compared with 18.5% of controls. These findings translate to one in five COVID-19 survivors aged 18–64 years, and one in four survivors aged ≥65 years experiencing an incident condition that might be attributable to previous COVID-19. Implementation of COVID-19 prevention strategies, as well as routine assessment for post-COVID conditions among persons who survive COVID-19, is critical to reducing the incidence and impact of post-COVID, particularly among adults aged ≥65 years.
A retrospective matched cohort design was used to analyze EHRs during March 2020–November 2021, from Cerner Real-World Data, a national, deidentified data set of approximately 63.4 million unique adult records from 110 data contributors in the 50 states. Case-patients (353,164) were adults aged ≥18 years who received either a diagnosis of COVID-19 or a positive SARS-CoV-2 test result (case-patient index encounter) in an inpatient, emergency department, or outpatient settings within a subset of health care facilities that use Cerner EHRs. Control patients (1,640,776) had a visit in the same month as the matched case-patient (control index encounter) and did not receive a COVID-19 diagnosis or a positive SARS-CoV-2 test result during the observation period. Controls were matched 5:1 with case-patients. All patients included in the analysis were required to have at least one encounter in their EHR during the year preceding and the year after the index encounter.
Patients were followed for 30–365 days after the index encounter until the first occurrence of an incident condition or until October 31, 2021, whichever occurred first. Case-patients or control patients with a previous history of one of the included conditions in the year before the index encounter were excluded (478,072 patients). The analysis was stratified by age into two groups: adults aged 18–64 and adults aged ≥65 years. Incidence rates per 100 person-months, and RRs with 95% CIs, were calculated. The number of COVID-19 case-patients having experienced an incident condition was also estimated by age group. Nonoverlapping CIs between age groups were considered statistically significant.
Analyses were performed using RStudio Workbench (version 3.0). This activity was reviewed by the CDC and was conducted consistent with applicable federal law and CDC policy.
Among all patients aged ≥18 years, 38.2% of case-patients and 16.0% of controls experienced at least one incident condition. Among persons aged 18–64 years, 35.4% of case-patients and 14.6% of controls experienced at least one incident condition. Among persons aged ≥65 years, 45.4% of case-patients and 18.5% of controls experienced at least one incident condition. The absolute risk difference between the percentage of case-patients and controls who developed an incident condition was 20.8 percentage points for those aged 18–64 years and 26.9 percentage points for those aged ≥65 years. This finding translates to one in five COVID-19 survivors aged 18–64 years and one in four survivors aged ≥65 years experiencing an incident condition that might be attributable to previous COVID-19.
The most common incident conditions in both age groups were respiratory symptoms and musculoskeletal pain. Among both age groups, the highest RRs were for incident conditions involving the pulmonary system, including acute pulmonary embolism (RR = 2.2 [patients aged ≥65 years] and 2.1 [patients aged 18–64 years]) and respiratory symptoms (RR = 2.1, both age groups). Among patients aged ≥65 years, the risks were higher among case-patients than among controls for all 26 incident conditions, with RRs ranging from 1.2 (substance-related disorder) to 2.2 (acute pulmonary embolism). Among patients aged 18–64 years, the risks were higher among case-patients than among controls for 22 incident conditions, with RRs ranging from 1.1 (anxiety) to 2.1 (acute pulmonary embolism); no significant difference was observed for cerebrovascular disease, or mental health conditions, such as mood disorders, other mental conditions, and substance-related disorders.
The findings from this analysis of a large EHR-based database of U.S. adults indicated that COVID-19 survivors were significantly more likely than were control patients to have incident conditions that might be attributable to previous COVID-19. One in five COVID-19 survivors aged 18–64 years and one in four survivors aged ≥65 years experienced at least one incident condition that might be attributable to previous COVID-19. Independent of age group, the highest RRs were for acute pulmonary embolism and respiratory symptoms.
As the cumulative number of persons ever having been infected with SARS-CoV-2 increases, the number of survivors suffering post-COVID conditions is also likely to increase. Therefore, implementation of COVID-19 prevention strategies, as well as routine assessment for post-COVID conditions among persons who survive COVID-19, is critical to reducing the incidence and impact of post-COVID conditions, particularly among adults aged ≥65 years. These findings can increase awareness for post-COVID conditions and improve post-acute care and management of patients after illness. Further investigation is warranted to understand the pathophysiologic mechanisms associated with increased risk for post-COVID conditions, including by age and type of condition.
Prostate cancer medications may be less safe than previously
Men taking either of the two most common oral medications for advanced prostate cancer who had also undergone hormone therapy to treat their disease were at higher risk of serious metabolic or cardiovascular issues than patients who were only receiving hormone therapy, Michigan Medicine researchers found, according to a news release.
Patients taking abiraterone had 1.77 times the risk of being admitted to the emergency room or the hospital due to diabetes, hypertension or heart disease compared to those who were only on hormone therapy. Those receiving enzalutamide were at 1.22 times the risk of these issues.
Compared to patients not receiving abiraterone, those taking abiraterone were also more likely to need an outpatient visit with their physician related to at least one of these health conditions. That was not the case if the man was taking enzalutamide.
Abiraterone and enzalutamide were both found to be relatively safe in clinical trials, but concerns that the population of patients who participated in the trials was different than those in real-life settings prompted the researchers to take another look at the effects of the drugs.
For instance, this research exclusively analyzed patients with Medicare health insurance, and the majority of men studied were significantly older than those in the drugs’ clinical trials.
“Patients enrolled in clinical trials tend to be highly selected and often times do not reflect the patient population in day-to-day practice,” said Lillian Y. Lai, MD, MS, a National Institutes of Health T32 Urologic Oncology Research Fellow at Michigan Medicine and the first author of the study. “Trial participants also undergo stringent safety evaluations that some of our patients do not have access to. By studying adverse events in real-life settings, we can better understand the risks of these life-prolonging cancer treatments and help clinicians and patients make informed decisions regarding treatment.”
Since metabolic and cardiovascular conditions tend to be under the purview of primary care providers, Lai and her fellow authors recommend team-based care that involves PCPs for patients with advanced prostate cancer as a way to manage these higher risks.
“With continued expansion of the indications for abiraterone and enzalutamide to earlier stages of the disease, increasing numbers of men will be receiving these therapies for longer periods of time,” Lai said. “This will potentially amplify the scope of men affected and increase the magnitude of the risks of adverse events, making careful attention to management of these issues crucial.”
