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Medscape
03-06-2025
- General
- Medscape
Systemic Psoriasis Therapy Linked to Less Dementia
SAN DIEGO — While psoriasis is linked to higher rates of dementia, a new study suggested that older patients with psoriasis on systemic treatments may have a much lower risk than those not treated systemically. In fact, the research hints — but doesn't prove — that the medications could lower the dementia risk even below that of the general population. The study, which retrospectively evaluated US medical records of people aged 65-95 years from 2004 to 2024, found that patients with psoriasis on systemic therapies (n = 14,679) had a lower risk of developing dementia than those not on systemic treatment (n = 39,601) and lower than a matched general population group (5.77 million). The adjusted odds ratios (aORs) for the treated psoriasis group vs the untreated group were 0.49 (0.39-0.61) for Alzheimer's disease, 0.65 (0.51-0.83) for vascular dementia, and 0.60 (0.53-0.68) for nonvascular dementia. For the treated group vs the matched general population, the aORs were 0.69 (0.54-0.86), 0.85 (0.65-1.10), and 0.85 (0.75-0.97), respectively. The findings, presented at the Society for Investigative Dermatology (SID) 2025 Annual Meeting, are too preliminary to affect clinical practice. But the study does add to 'a growing body of evidence linking chronic inflammation to neurodegeneration,' study lead author Madison Olexson, a dermatology research fellow at Eastern Virginia Medical School, Norfolk, Virginia, told Medscape Medical News . 'It reinforces [how] treating systemic diseases like psoriasis may not only improve cutaneous symptoms but may have extra-cutaneous benefits as well,' she said. Sparse Data on Systemic Treatments and Psoriasis Several international reports have linked psoriasis with dementia, including a 2019 study that found an elevated risk associated with the skin disease and vascular dementia (hazard ratio [HR], 1.73; 95% CI, 1.21-2.47) and a 2023 study that identified an increased risk for dementia (HR, 1.24; 95% CI, 1.14-1.35). Also, a 2019 study linked dementia to a higher risk for psoriasis (OR, 1.46). Other autoimmune disorders such as rheumatoid arthritis and inflammatory bowel disease have also been linked to higher incidence and risk for cognitive impairment and dementia, Olexson said. 'This is believed to be linked to systemic inflammation and the sustained activity of proinflammatory cytokines such as [tumor necrosis factor] TNF alpha and [interleukin 17] IL-17, which can affect the brain and potentially lead to neurodegeneration. However, the exact mechanisms remain unclear.' She added that 'it's still a mystery whether psoriasis alone drives the development of dementia or if the increased likelihood is due to shared comorbidities or overlapping inflammatory pathways. Furthermore, we don't yet fully understand whether treatments provide direct cognitive protection or how long treatment needs to continue for maximal benefit.' Biologics and Non-Biologics Both Linked to Benefit The researchers launched the new study 'to address the limited and inconsistent data on whether psoriasis associates with dementia outcomes and systemic treatments for psoriasis could influence the likelihood of developing dementia,' Olexson said. The study retrospectively tracked patients via the TriNetX research network database. Before propensity score matching, the mean age was 66.6 ± 8.9 years for non-treated patients and 67.8 ± 9.0 years for the general population. Respectively, the groups were 42.8% and 51.7% women and 65.9% and 72.6% White. Data for the treated psoriasis group were not provided, but Olexson said their characteristics were similar. The study included both biologic medications, which target specific immune pathways, and non-biologic systemic treatments. Patients were treated for a median of 4 years (for both). The biologics were adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, secukinumab, ixekizumab, and brodalumab. The non-biologic treatments were methotrexate, apremilast, acitretin, and ultraviolet phototherapy. Both drug classes were linked to lower risks for dementia at roughly the same rates, but it was not clear if specific medications may have greater effects. Less Inflammation May Protect Against Dementia The adjusted incidence rates of Alzheimer's disease were 1.9% vs 1.2% in the non-psoriasis group vs the treated psoriasis group. For vascular dementia, the rates were 1.2% vs 0.74%, respectively. For nonvascular dementia, they were 5.4% vs 3.7%, respectively. For untreated patients with psoriasis vs treated patients with psoriasis, the adjusted incident rates were 1.7% and 0.84% for Alzheimer's disease, 1.1% and 0.72% for vascular dementia, and 5.1% and 3.1% for nonvascular dementia, respectively, which Olexson reported were statistically significant differences. 'Systemic therapies likely reduce neuroinflammation by suppressing inflammatory cytokines like TNF alpha and IL-17, both of which have been implicated in neurodegenerative processes,' Olexson said. 'These cytokines can disrupt the blood-brain barrier, promote amyloid beta accumulation, and impair neuronal function. By modulating this inflammatory cascade, systemic treatments may protect against or slow the onset of dementia.' Findings Are 'Intriguing' but Not Definitive Asked to comment on the results, Steven R. Feldman, MD, PhD, professor of dermatology, Wake Forest University, Winston-Salem, North Carolina, who was not involved in the study, noted that while the findings are 'intriguing,' they come with caveats because of the observational study design. 'If patients with dementia aren't bothered by their psoriasis or aren't given biologics for that or some other reason, getting a biologic might be associated with less dementia,' he said in an interview. 'It may be that having or not having dementia determines to some degree who gets a biologic, not that taking a biologic determines who gets dementia.' Olexson agreed that the observational design has limitations. While cohorts were matched by demographics, body mass index, and several comorbidities, she said other factors such as disease severity, socioeconomic status, and access to care could play a role in the findings. What's next? Moving forward, Olexson said, 'We have plans to conduct prospective studies related to psoriasis and cognitive health at our institution.'
Medscape
23-05-2025
- Health
- Medscape
‘Seismic' Shifts May Be Ahead in GI Care
This transcript has been edited for clarity. Hello. I'm Dr David Johnson, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School and Old Dominion University in Norfolk, Virginia. Welcome back to part 2 of my highlights from Digestive Disease Week (DDW) 2025. I've selected another 10 presentations for you, in addition to the 10 presented in part 1 of this series. If you've registered for DDW 2025, you can access these abstracts or presentations at the conference website. If you haven't, you'll need to wait for the published manuscripts, which hopefully will arrive not too long from now. Secondary Spontaneous Bacterial Peritonitis Prophylaxis The standard of care for prior spontaneous bacterial peritonitis (SBP) is to place patients on an antibiotic, typically a quinolone. In this analysis,[1] researchers looked at the Veterans Affairs database of nearly 5200 patients with a first episode of SBP. Within this cohort, they identified those on secondary SBP prophylaxis with quinolone or Bactrim, as defined as continuous use with at least one documented refill. They observed that patients on secondary prophylaxis had strikingly higher rates of SBP recurrence as well as any non-SBP infections. This raises the important question of whether we are doing more harm than good with this treatment approach owing to bacterial resistance patterns and the risks of repeated exposure to quinolones, which is associated with the potential for tendon rupture and other complications. It also challenges the recommendations put forward in national guidelines. However, we'll need to wait and see how this plays out with further analysis before we consider revisiting those guidelines. Early TIPS for Acute Variceal Bleeding The results from the second study[2] I'd like to highlight were described at DDW 2025 as being potentially 'seismic.' Current guidelines recommend early transjugular intrahepatic portosystemic shunts (TIPS) in patients with variceal hemorrhage, although this is rarely practiced. Researchers performed a systematic review and meta-analysis of randomized controlled trials to determine whether early TIPS actually improves outcomes in this setting. They analyzed trials with 689 patients, approximately half of whom received early TIPS and the remainder standard therapy. They observed no difference in all-cause mortality between these groups. However, the difference for the risk for rebleeding was striking — it was 80% lower in patients who underwent early TIPS. Surprisingly, early TIPS was not associated with an increased risk for hepatic encephalopathy and new or worsening ascites. These results suggest that when we treat patients with acute variceal bleeding, we really should consider early TIPS. Portal Hypertension Guidance DDW 2025 featured a great discussion led by Dr David Kaplan,[3] the primary author of the recent guidance on risk stratification and management of portal hypertension and varices in cirrhosis from the American Association for the Study of Liver Diseases (AASLD). Kaplan did a bang-up job, and I wanted to highlight a couple of crucial points. Firstly, he noted that if you have a patient with compensated cirrhosis, it should be the standard of care to assess them for clinically significant portal hypertension, defined as portal pressure gradient ≥ 10 mm. You'll want to ensure you can adequately evaluate for it in your locale. If you determine that the patient does have clinically significant portal hypertension, the new AASLD guidance endorses using carvedilol as prophylactic treatment. The use of pharmacotherapy precludes the necessity of screening endoscopy for most patients. This is another seismic shift, as we certainly have not been practicing that way. However, certain patients may have risks that do not make them eligible candidates for beta-blockers like carvedilol. In these instances, patients will require endoscopic intervention and evaluation. Kaplan also noted that the AASLD guidance discusses evaluating patients for whether they are candidates for preemptive placement of TIPS. Given that the 6-week mortality for acute variceal hemorrhage is in the 10%-15% range, this is something that we really need to be doing a better job at addressing. Predicting MASLD Earlier Another noteworthy study was presented in the liver population,[4] this one on the topic of predicting metabolic dysfunction–associated steatotic liver disease (MASLD), formerly known as nonalcoholic fatty liver disease. A team of researchers from China analyzed proteomics data from UK Biobank participants. They looked at approximately 2700 proteins, identifying five that were highly accurate in predicting MASLD. These proteins had an approximate prediction accuracy of 86% at 5 years from onset and 76% at 16 years. Their predictive performance was improved when augmented with clinical biomarkers, such as body mass index and daily exercise, which increased the accuracy to approximately 90% at 5 years and 82% at 16 years. It should be noted that this study did not set out to establish causality between MASLD and how these proteins interacted. For that, we'll need to await further analysis. The researchers did externally validate their results in populations in China. While we'll need to see what the eventual published manuscript reports, these data do indicate that promising new MASLD predictors may be on the horizon. GLP-1 Receptor Agonists for MASLD Glucagon-like peptide 1 (GLP-1) receptor agonists have recently emerged as an alternative to bariatric surgery for managing obesity. In this study from Stanford Medicine, Beth Israel, and the Allegheny Health Network,[5] researchers retrospectively analyzed a cohort obtained from the TriNetX database over a 6-year period. They compared outcomes in patients with MASLD receiving either GLP-1 receptor agonists or bariatric surgery. Surprisingly, they found that patients who received GLP-1 receptor agonists had significantly lower rates of major adverse liver outcomes (0.6% vs 1.2%) and all-cause mortality (0.3% vs 1.4%). If patients are willing and able to undergo medical therapy with GLP-1 receptor agonists, then we may want to consider revisiting how we approach metabolic liver disease. We need a multicenter prospective trial to evaluate this, but I'm certainly relieved to see this may make a difference in eligible patients. Timing Matters in Biliary Necrotizing Pancreatitis Patients with biliary necrotizing pancreatitis are expected to undergo cholecystectomy. The axiom is to wait for 6 weeks if they have had complications, particularly a pseudocyst. We're already familiar with using this intervention earlier in patients who present with uncomplicated pancreatitis or cholecystitis. In this study,[6] researchers conducted a retrospective analysis of a cohort of patients with biliary necrotizing pancreatitis, using data obtained from TriNetX. Their results suggested that it's better to delay cholecystectomy to beyond 16 weeks, given that it reduces the risk for adverse events without increasing mortality. Obviously, these patients still face the risk for recurrent biliary events, but delaying this surgery may be warranted in complicated biliary pancreatitis. 3D Tech Comes Up Short for Cancer Detection There was a study whose negative findings I think are worth mentioning. In it, researchers analyzed wide-angle transepithelial sampling with 3D analysis (WATS3D) as an adjunct to random forceps biopsies in patients with Barrett esophagus.[7] The technology has been suggested to have clinical benefit for detecting dysplasia and adenocarcinoma. This study from Europe, led by Jacques Bergman and colleagues, is the largest conducted to date on the topic. They found no significant diagnostic advantage for using WATS3D, which caught my attention given that guidelines have also not been able to fully endorse this technology based on existing evidence. During the 3-year follow-up, there were no cases of high-grade dysplasia or early adenocarcinoma confirmed by WATS3D that hadn't already been identified as at-risk via random forceps biopsies. This is a wake-up call that we should scrutinize its utilization. The juice may not be worth the squeeze. Microbiome Alterations in Esophageal Disorders The esophageal microbiome is a topic of particular interest to me. Therefore, I was pleased to see this study from Dr Mark Pimentel and his group at Cedars-Sinai,[8] who analyzed the small-bowel microbiome in patients with and without gastroesophageal reflux disease or Barrett esophagus. They found that there was a significant alteration in small-bowel microbiome changes in patients with these conditions, particularly linked with hydrogen sulfide–producing species. Anxiety/Hypervigilance Associated With Laryngopharyngeal Symptoms The next study[9] also relates to the esophagus, specifically to those patients with laryngopharyngeal symptoms who are often referred to us by our ENT colleagues. In this retrospective analysis, researchers evaluated adult patients presenting with both typical esophageal and laryngopharyngeal symptoms for symptom-specific anxiety and hypervigilance using patient-reported outcome measures. Patients with laryngopharyngeal presentation had a higher systemic burden as compared to those without this condition, particularly for hypervigilance. When treating these patients, I find it helpful to have them do diaphragmatic breathing. There are also emerging interventions in the form of virtual reality and gut-brain axis interventions, which may be worth considering in your practice. Extrapancreatic Cancer Risk in Chronic Pancreatitis Although we know patients with chronic pancreatitis are at an increased risk for pancreatic cancer, there have been few studies on extrapancreatic cancer. This provocative evaluation[10] comes to us from researchers at Johns Hopkins University, who looked at nearly 500 patients with chronic pancreatitis. They found that these patients had a threefold increase in the incidence of extrapancreatic cancers, in addition to an increased risk for pancreatic cancer. The most common extrapancreatic cancers were in the lung; however, bladder cancer, esophageal cancer, and a range of gastrointestinal cancers, including colon cancer, were observed as well. Smoking was associated with an almost three times greater incidence of extrapancreatic cancers. Among smokers, pack-year history was significantly higher in those who developed cancer. These results should encourage us providers who are entrusted with taking care of patients with chronic pancreatitis to do a better job. The delay between diagnosis of chronic pancreatitis and extrapancreatic cancers and pancreatic cancer was approximately 8 and 6 years, respectively. We need to improve our monitoring of these patients following their chronic pancreatitis diagnosis. This year's DDW was as exciting as ever, with important new information. We'll look forward to reviewing the manuscripts for these studies when they arrive. But, hopefully, these abstract highlights provide you with some actionable guidance now that you can apply to your clinical management. I'm Dr David Johnson. Thanks again for listening.
Medscape
16-05-2025
- Health
- Medscape
10 Actionable, Easy Interventions for GI Conditions
This transcript has been edited for clarity. Hello. I'm Dr David Johnson, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School and Old Dominion University in Norfolk, Virginia. I've just returned from Digestive Disease Week (DDW) 2025 in San Diego, California, and want to give you the highlights. I selected several noteworthy abstracts, which I'm going to cover in two separate presentations. If you registered for DDW 2025, you can access these abstracts on the conference website. However, if you didn't register, you'll need to wait for them to come out in publication. Inulin: A Promising Prebiotic The first abstract I'd like to highlight comes from a translational study,[1] which offered important data related to the use of inulin, a prebiotic that enhances short-chain fatty acid production. In previous studies, the team of researchers from Montreal, Canada, demonstrated inulin-enhanced anastomotic healing in mice as part of testing its efficacy for preventing leaks following colorectal surgery. In this current study, they assessed inulin's ability to hinder colorectal cancer cell growth in mice 'humanized' with microbiota. They found that inulin had a dramatic effect in the form of decreased dissemination of liver metastasis and subcutaneous growth of colorectal cancer cells. Mechanistically, they ascribed this to activation of the peroxisome proliferator-activated receptor pathway in the gut, which seems logical. Inulin is a naturally occurring dietary fiber, found in many plant species including chicory root, and is readily available commercially. There's no known risk associated with inulin, which makes these results actionable now. In a separate study,[2] researchers at the Children's Hospital of Philadelphia conducted a double-blind randomized trial looking at inulin's effects in children with subclinical active inflammatory bowel disease (IBD). They showed that inulin supplementation was associated with a reduction in fecal calprotectin levels, as well as improvements in the relative abundance of Bifidobacterium . These findings indicate that shifts in microbial health and reduced inflammation can be achieved in children with IBD using supplements with this naturally occurring oligosaccharide. Inulin is simple to implement. While I'm not sure about its use in adults, I plan on immediately using it as an intervention for the populations identified in these studies. It seems to be a no brainer. Alternatives to FMT for Clostridioides difficile In December 2024, gastroenterologists faced a conundrum following the news that fecal microbiota transplantation (FMT) would no longer be available from OpenBiome. A real-world study,[3] presented at DDW 2025, sheds some light on possible alternatives to standard FMT by comparing it with the US Food and Drug Administration-approved treatments of Rebyota (fecal microbiota, live-jslm), which is usually administered via enema, and Vowst (fecal microbiota spores, live-brpk), which is administered via oral capsules. Researchers assessed C difficile recurrence within 8 and 24 weeks, with stratification of results based on the presence of other relative risks like bezlotoxumab and presence of IBD. At 8 weeks, there was a significantly lower risk of recurrent C difficile following treatment with Rebyota and Vowst, which were approximately 20% better when compared with standard FMT, a difference that was maintained out to 24 weeks. Although we no longer have access to OpenBiome, these other therapies seem to offer a comparable — and perhaps superior — intervention. The only caveat is that the improvement was statistically superior when Rebyota was administered via colonoscopy, which was more frequently done than via enema in this study, although the latter administration method showed improvement. This may simply be due to the larger number of people who received it via colonoscopy, but we'll have to wait and see. However, I don't think we need to step back from treatment for C difficile , given that we have these commercially available products. AI in Adenoma Detection We're all aware that artificial intelligence (AI) is being used in many gastrointestinal (GI) indications of late and showing how it can improve outcomes. This was proven again in a study[4] from King's College London, where researchers performed a randomized, open-label trial using GI Genius, an AI module. They analyzed the adenoma detection rate (ADR) among colonoscopists classified as either non-expert or expert, categories defined as having performed less than or more than 2000 lifetime colonoscopies, respectively. Furthermore, the experts had an ADR > 40%, which is within the range of typical standards. The American Society for Gastrointestinal Endoscopy (ASGE)/American College of Gastroenterology Quality Task Force recommends an ADR of at least 35%, so the experts on this study really were. Colonoscopies were performed at eight sites by 34 endoscopists, with an approximately 2:1 ratio for non-experts to experts. The findings showed that the ADR was improved by 9.5% when using the AI module. Interestingly, the experts' ADR actually decreased with the use of the AI module, and it seemed most beneficial for those with lower detection rates. There were three guidelines produced in 2025 regarding the use of computer-assisted detection colonoscopy. One says we should use AI, one says we shouldn't, and the third— from the American Gastroenterological Association — says that we don't have enough evidence to support it yet. All in all, the recommendations are very conflicting. However, for me, the evidence seems to clearly indicate that lower-end ADR is considerably improved with AI and makes a difference. Motivating Patients With Wearable Technology There were a pair interesting studies around the use of technological tools in GI indications. The first study[5] comes from Lynn Chang's brilliant research group, who analyzed outcomes in patients with irritable bowel syndrome wearing a Fitbit, a popular device used by approximately 38.5 million people. The researchers used the Fitbit to capture participants' daily step count and sleep data. It should be noted that there are data indicating that a Fitbit seems relatively comparable with polysomnography, which is the gold standard for monitoring sleep efficiency. The team found that increased daily step count and median hours of sleep were associated with lower irritable bowel syndrome severity. In the next study,[6] researchers from Cedar-Sinai Medical Center in Los Angeles, California, conducted a prospective study with the Garmin vivofit, another activity tracker. The study essentially performed the same analysis, focusing on sleep and physical activity. However, in this case, they looked at preoperative and postoperative outcomes in patients with ulcerative colitis and Crohn's disease undergoing colorectal surgery. Once again, researchers found that increased physical activity and optimal sleep efficiency improved outcomes. Specifically, they were associated with fewer surgical complications and decreased length of stay. As with some of the previously mentioned interventions, these wearable devices are commercially available. Together, the findings from these two studies indicate that wearable devices could be a very valuable self-management tool to encourage patients to monitor themselves, strive for improvement, and do so at a negligible cost. Immune Checkpoint Inhibitors Two studies offered important findings on the use of checkpoint inhibitors, which are being used more frequently for GI complications. In fact, GI immune-related adverse events account for up to 41% of adverse events in patients with IBD. The first study[7] comes from Memorial Sloan Kettering Cancer Center in New York City. Researchers looked at a retrospective cohort of patients with IBD treated with immune checkpoint inhibitors over an 11-year period, assessing for a variety of outcomes related to GI toxicity. They found that GI toxicity led to immune checkpoint inhibitor discontinuance in 72% of patients. Discontinuation was more common in patients with active IBD at treatment initiation and among those whose pre-treatment disease was more severe. This finding suggests how important it is to receive consultation and disease assessment from an IBD specialist. They can help proactively determine how to optimize immune checkpoint inhibitor therapy before it begins. Treating these high-risk patients really does call for a multidisciplinary care team. The second study[8] caught my attention because I was unfamiliar with the topic: immune checkpoint inhibitor-related esophagitis. Researchers conducted a retrospective study with a 15-year follow-up on patients who underwent esophagogastroduodenoscopy with biopsy after receiving at least one dose of an immune checkpoint inhibitor. A diagnosis of immune checkpoint inhibitor-related esophagitis was confirmed by an expert GI pathologist. They identified 13 patients with symptoms, which were variable and included weight loss, dysphagia, anorexia, and nausea. Of the 13 patients, 54% had abnormalities on endoscopy. The takeaway is that we must perform biopsies when evaluating these patients. There are treatments available for esophageal toxicity. In this particular study, patients responded to proton pump inhibitors and budesonide, and some required an immunosuppressant medications such as biologics and systemic corticosteroids. Esophageal Complications With GLP-1 Receptor Agonists Another noteworthy study[9] delved into drug-related GI and esophageal-specific complications, in this case resulting from treatment with GLP-1 receptor agonists. We see GI motility and anesthesia issues related to these agents, but this complication concerns the effect on esophageal dysmotility. Researchers from the Mayo Clinic assessed the association of GLP-1 receptor agonist exposure on high-resolution manometry findings obtained over a 10-year period. They identified 447 patients who had been exposed to these medications, with a final comparison cohort of 84 cases and 84 controls. They found very specific, integrated relaxation pressures were statistically different in the patients taking GLP-1 receptor agonists. Distal contraction intervals were greater, as were the number of hypercontractile supine swallows, the incidence of hypercontractile esophagus, and the incidence of esophagogastric junction outflow obstruction. It's important to recognize this risk when performing manometry evaluations, and to be aware of the potential for new GI complications resulting from treatment with GLP-1 receptor agonists. Ergonomics and Endoscopy The final study[10] in this video relates to endoscopy. I thought this was important, given the ASGE guideline on ergonomics for preventing endoscopy-related musculoskeletal issues. This study comes from a team of researchers in South Korea. Using a variety of monitors, they assessed the ergonomics of endoscopists, who tend to hold static and repetitive upper limb postures. They found that 52% of endoscopists' postures fell into the high-risk category. The wrist and lower arm segments were most affected, with notable strain also placed in the head and torso regions. Fellows were more likely to be at risk, which makes sense since they're less experienced. These findings indicate that ergonomic challenges persist, despite current recommendations that we need to do better. Ensuring a robust system and emphasizing robotic ergonomic training and monitoring are important for self-preservation as we get older and further along in our endoscopy career. Stay tuned for part two of my highlights from DDW 2025, which offers exciting new findings that you won't want to miss. I'm Dr David Johnson. Thanks for listening.
Yahoo
08-04-2025
- Health
- Yahoo
USDA issues warning to Norfolk-based medical school over animal testing
The United States Department of Agriculture has sent a warning to the Eastern Virginia Medical School at Old Dominion University alleging research done in years prior using animals violated the Animal Welfare Act. Specifically, the warning notes issues in past research using chinchillas and monkeys. The USDA's warning alleges that researchers at the school, formerly known as Eastern Virginia Medical School, modified their research without proper approval. In animal research, the Institutional Animal Care and Use Committee must approve the study or experiment's plan or protocol, and if any modifications are needed, researchers must consult with the IACUC. Though the March 11 letter is not a final action from the department, it warns any further infractions may result in more serious consequences such as a civil penalty or criminal prosecution. According to the warning, several chinchillas were kept on a study despite 'passing humane endpoints' during research performed from in 2020. The Virginian-Pilot previously reported on USDA reports that detailed some of the experiments. For one experiment, the IACUC approved that the chinchillas could lose up to 20% of their body weight before researchers were required to remove them from the study. The USDA found that the chinchillas lost 25% to 30% of their body weights, but researchers never took the animals off the study. The USDA also found the approved protocol planned for the chinchillas to be on the study for 21 weeks. However, medical records showed that some of the animals remained on the study for 21 months, from March 2020 to November 2021. Three of the chinchillas were euthanized during the experiment, and another died. Eastern Virginia Medical School and Old Dominion University merged last year, forming the largest health sciences center in Virginia. The Macon and Joan Brock Virginia Health Sciences at Old Dominion University did not respond to a request for comment Monday about the USDA warning. In response to previous reporting, EVMS said restrictions during the coronavirus pandemic had hampered access to the facilities where the chinchillas were housed and that EVMS had been contracted to provide the facility for the chinchilla research by another company. In a different study in 2022 using rhesus macaques, a kind of primate more often known as a rhesus monkey, researchers administered insulin through an IV to anesthetize the animals. The USDA found that two of the male macaques were older than the protocol that IACUC approved, and five female macaques were underweight. The primates were also given, in some cases, more than double the amount of 'sweetened beverage' used in the study, and some of the macaques were on the study longer than approved. USDA inspectors also found that the researchers 'failed to utilize appropriate methods' to treat medical issues during the experiments. Issues arose during IV insulin procedures, such as the death of one monkey and unresolved low blood sugar in others. One of the macaques was under anesthesia for more than four hours and did not receive medical care despite showing signs of hypoglycemia. Researchers later euthanized the animal, and 11 primates took an 'excessive amount of time' to recover. EVMS previously said that medical intervention did occur, but it was not documented. Female baboons were used during pregnancy studies, and the USDA claims that protocols approved by the IACUC were also not followed. Five baboons were not weighed as frequently as needed, and inspectors found a lack of documentation in how much blood had been drawn from the animals. One of the baboons was found unresponsive, and the USDA found no documentation or records on what treatment followed the discovery. 'The only entry is from the (attending veterinarian) stating the animal was found unresponsive at 6 a.m., but by the time the (attending veterinarian) arrived, the animal had consumed apple, was awake, quiet, alert and responsive,' the warning states. The school, however, has maintained that the animals were always cared for, and the research is vital. 'Taxpayers should not foot the bill for this deeply troubling pattern of mistreatment of animals, and PETA calls on the National Institutes of Health to cut funding immediately,' said Daphna Nachminovitch, senior vice president for animal rights group PETA. Last year, PETA filed a complaint against the school, alleging abuse against baboons that went through Caesarian sections for pregnancy research. In 2021, the USDA sent an official warning for those studies, as well. Dr. Alfred Abuhamad, executive vice president for Health Sciences and dean of EVMS, said in a statement last year that 'attacks' about the pregnancy research have been unfair. He said the on-site veterinarian at the school provides 'utmost reverence and care.' 'My colleagues and I hope that the time will come when enough is learned so that the vital research being conducted is no longer necessary, so that the millions of families who are affected by preeclampsia can be spared the hardship and heartache that often accompany it,' Abuhamad said. 'Until that time arrives, we are committed to participating in this crucial research, part of a larger effort to close the 'women's health gap.'' Eliza Noe,
Associated Press
18-02-2025
- Health
- Associated Press
Trump has signed an executive order on IVF. Here's what you should know about the procedure
President Donald Trump on Tuesday signed an executive order aiming to reduce the costs of in vitro fertilization, a medical procedure that helps people facing infertility build their families. 'Americans need reliable access to IVF and more affordable treatment options, as the cost per cycle can range from $12,000 to $25,000,' the order said. 'Providing support, awareness, and access to affordable fertility treatments can help these families navigate their path to parenthood with hope and confidence.' The order instructed the assistant to the president for domestic policy to give Trump a list of policy recommendations on protecting IVF access and 'aggressively reducing out-of-pocket and health plan costs for IVF treatment' within 90 days. IVF became a talking point during the 2024 presidential campaign when Alabama agreed to protect in vitro fertilization providers from legal liability a couple of weeks after the state Supreme Court ruled that frozen embryos can be considered children under state law. In 2018, assisted reproductive technology, including IVF, contributed to 2% of all infants born in the United States, according to a report by the U.S. Centers for Disease Control and Prevention. Here's what to know about this increasingly common fertility treatment. What is IVF? The procedure offers a possible solution when a woman has trouble getting pregnant, and it's normally tried after other, less expensive fertility treatments have failed. It involves retrieving the woman's eggs and combining them in a lab dish with a man's sperm to create a fertilized embryo, which is then transferred into her uterus in an attempt to create a pregnancy. IVF is done in cycles and may take more than one. The procedure can use a couple's eggs and sperm or those from a donor. Does insurance cover the procedure? Insurance coverage of IVF and other fertility treatments can be patchy and depends on who provides insurance for the patient. More large employers are offering the coverage to attract and keep workers. Many businesses also are extending coverage beyond those with an infertility diagnosis, making it accessible to LGBTQ+ couples and single women. Government-funded programs such as Medicaid largely limit fertility treatment coverage. Coverage is less common among smaller employers. Critics have said the lack of widespread coverage creates a divide, limiting treatments mainly to people who can pay thousands of dollars out of pocket. What is the history of IVF? The first baby conceived through IVF was born in 1978 in England. But the first in the U.S. was in 1981 in Norfolk, Virginia, with the birth of Elizabeth Carr. Her mother, Judith Carr, had had three abnormal pregnancies, forcing the removal of her fallopian tubes. She and her husband sought treatment from Howard and Georgeanna Jones, doctors who opened a fertility clinic at Eastern Virginia Medical School. The Norfolk clinic faced resistance before it even opened. When it sought a required state certificate in 1979, more than 600 people jammed into a public hearing. Several women voiced support for IVF and testified about wanting to start a family, while anti-abortion groups raised concerns about doctors interfering with human conception and embryos being discarded. Despite proposed state legislation to stop the clinic, it opened in 1980, with others following soon afterward in California, Tennessee and Texas. By 1988, at least 169 in vitro centers were operating in 41 states. The use of IVF continued to grow, but sentiments against it never really went away in the American anti-abortion movement, said Margaret Marsh, a history professor at Rutgers University in New Jersey. Many abortion opponents had made an uneasy peace with the technology as a treatment for infertility, Marsh said. But opposition to IVF has gained momentum since the overturn of Roe v. Wade in 2022. 'Not everyone in the anti-abortion movement opposes these reproductive technologies, but many do,' she said. How are embryos made? The treatment often uses hormones to trigger ovulation so multiple eggs are produced and a needle is used to remove them from the ovaries. Eggs can be fertilized by adding the sperm to the eggs in a lab, or a single sperm can be injected into each egg. The fertilized egg is cultured over about five to six days to create the blastocyst — the early stage of an embryo — and is either transferred or stored for future use, said Dr. Jason Griffith, a reproductive endocrinologist in Houston. Griffith said that on day three after fertilization, an embryo is anywhere from six to 10 cells. By day six, it's between 100 and 300 cells. In comparison, he said, a person contains more than 1 trillion cells. How are embryos frozen and stored? Frozen embryos can be used for future pregnancies, and the vast majority survive the thawing process. The freezing process involves replacing the water in embryo cells with a protectant fluid and flash-freezing with liquid nitrogen, according to Johns Hopkins Medicine. Frozen embryos are stored in tanks containing liquid nitrogen at hospital labs or reproductive medicine centers. Griffith said they can also be kept in storage facilities contracted by health care facilities, especially when they are stored for many years. Frozen embryos can be safely preserved for a decade or more. Griffith said conditions are monitored in these facilities and there are physical security mechanisms to safeguard the tanks and backup generators in case of power outages. ___ ___
