Month: March 2022

Categories : HIV Medical IndustryTags :

Generic Options for HIV Prophylactic Cabotegravir Locked Out, MSF Warns

On By ModernMedia
Image of a syring for vaccination
Photo by Mika Baumeister on Unsplash

Médecins Sans Frontières (MSF) has warned that pharmaceutical company ViiV’s recent decision not to pursue voluntary licensing for the long-acting HIV prophylactic cabotegravir (CAB-LA) means that lower cost generic production in low- and middle-income countries (LMICs) is effectively locked out for countries like South Africa.

CAB-LA was approved for the prevention of HIV infection by the USFDA in December 2021, and ViiV currently charges $3700 (R55 000) per vial in the US ($22 200/R333 000 annually per person). The Clinton Health Access Initiative (CHAI) has shown that generic manufacturers could produce this drug for around $2.60 (R39) per vial (less than $20/R3000 per person per year). Although ViiV has publicly said they would provide CAB-LA for their at-cost price in many LMICs, they have yet to announce what that price is.

According to MSF, generic manufacturer prices are often much lower than the patented drug – and they can even produce complicated formulations like CAB-LA.  The generic equivalent [PDF] of ViiV’s paediatric formulation of the HIV drug dolutegravir costs 22 times less.

Amanda Banda, Infectious Diseases Policy and Advocacy Advisor of the MSF Access Campaign, said: “What good is HIV prevention if the people who need it can’t afford it? This is the most effective form of HIV prevention for vulnerable and marginalised communities and yet ViiV is delaying the ability of generic manufacturers to supply the drug, meaning that many people across low- and middle-income countries who would benefit from the medicine to prevent HIV infection won’t be able to access it. CAB-LA will need to be available at a price that is comparable to currently available oral PrEP if country treatment programs and donors are expected to scale up its use to the levels needed – and it’s hard to imagine that ViiV will make CAB-LA available at less than $40 (R600) per year.  ViiV needs to immediately sign a licensing deal with the Medicines Patent Pool so that more affordable generics can be produced, and more lives can be saved.”

Dr Tom Ellman, Head of MSF’s South African Medical Unit said: “We want to urgently make this drug available for people at high risk of HIV infection in our programs in sub-Saharan Africa – we don’t want a donation with many strings attached from the corporation; it is not the role of ViiV to control the use of a drug that is approved by the USFDA. We want ViiV to sell us this drug at an affordable price.”

Source: MSF

Categories : Injury & TraumaTags :

Over 70% of TBI Patients Report More Symptoms a Year On

On By ModernMedia
Source: Pixabay

More than 70% of patients with traumatic brain injury (TBI) reported at least one problematic symptom at one year of follow-up that was new or worse than before injury according to a study published in the Journal of Neurotrauma. Half of the patients reported three or more such symptoms after a year.

Joan Machamer, from the University of Washington, Harborview Medical Center, and colleagues representing the TRACK-TBI Investigators, compared the frequency and persistence of symptoms in patients with TBI to two control groups: patients with orthopedic trauma and friend controls. The groups were evaluated at 2 weeks, and 3, 6, and 12 months after injury.

Physical symptoms such as headache, fatigue, and dizziness tended to occur earlier, according to the researchers, with cognitive symptoms becoming dominant later. While physical symptoms declined noticeably over time, cognitive symptoms remained more constant over time.

“Clinicians should inquire about symptoms in patients who have had a TBI, reassure them that experiencing symptoms is common, and direct them to seek treatment for symptoms that are disrupting their lives,” the researchers said.

Commenting on the study, David L. Brody, MD, PhD, Editor-in-Chief of Journal of Neurotrauma noted that is remarkable for several reasons. “First, it is among the largest studies of its type, with over 2,000 participants. Second, it confirms what many of us who practice brain injury medicine have observed for many years– a wide variety of symptoms can be very persistent and very troubling to our patients even after so-called ‘mild’ TBI. Third, the investigators used the right controls; people with orthopedic injury as well as friends of the patients with TBI. Symptoms in patients with TBI were substantially more common and more severe than in both control groups.”

Source: Mary Ann Liebert, Inc.

Categories : COVIDTags :

COVID Battle not Over as Many Countries Continue to Struggle

On By ModernMedia
Image by Quicknews

Two years into the pandemic, and the COVID battle is not over for much of the world, warns the International Federation of Red Cross and Red Crescent Societies (IFRC). Many countries lack the capacities to transition to ‘a new normal’: high vaccination coverage, strong healthcare systems or testing capacities. The crisis will not be over until everyone has the same access to these tools, the IFRC says.

Francesco Rocca, IFRC President, said: “’Living with the virus’ is a privilege that many countries and communities around the world cannot enjoy. Ensuring equitable access to vaccines, diagnostics and treatments will not only save lives, but will also protect the world against the emergence of new and more dangerous variants. It is the only path to normalcy. None of us is safe until we all are.”

Red Cross Red Crescent staff and volunteers are constantly working to close the equity gap, ensuring that vaccines make it to the vulnerable individuals and communities that desperately need them. Their role is crucial, not only in vaccination but in informing communities, building trust, and dispelling COVID vaccine misinformation. They have now reached over 300 million people through immunisation activities.

In countries like Zambia, where health systems are fragile and rumours around vaccines are spreading fast, vaccine supply is just one of numerous obstacles. The Zambia Red Cross Society’s mobile COVID vaccination campaign takes vaccines directly to people in hard-to-access areas. Volunteers mobilise communities for vaccination, raise awareness about the mobile vaccination centres, provide information about vaccines and engage local leaders as advocates for healthy behaviour change.

Afghanistan’s health system is struggling as a new wave of COVID infections hits. Afghan Red Crescent is ramping up services at its health clinics across the country and its COVID hospital in Kabul, while supporting nationwide vaccination efforts and running information campaigns on preventing the spread of the virus.

A record surge of infections in the Pacific region is threatening to overwhelm hospitals and health systems which, until now, have largely avoided the worst of the pandemic. In countries like Fiji and Vanuatu, with more than 165 inhabited islands, Red Cross volunteers have been travelling by car, boat and foot to reach remote communities to increase awareness about COVID and get people vaccinated.

COVID not only thrives on inequality but deepens it. Women, urban communities and migrants have been disproportionately affected by the devastating socioeconomic impacts. More than 5 million children have also lost a parent or another caregiver to COVID. Psychosocial support has been at the centre of Red Cross Red Crescent work, and volunteers are seeing a significant rise in mental health support needs.

Source: International Federation of Red Cross and Red Crescent Societies (IFRC)

Categories : Medical Research & TechnologyTags :

Study Implicates High Leptin Levels in Androgen Deficiencies

On By ModernMedia
Source: National Cancer Institute on Unsplash

Researchers have uncovered new clues about the cellular processes that can lead to androgen deficiencies, in which high leptin levels appear to play a role. The findings are published in the journal Cell Death & Disease.

Symptoms of testosterone deficiency include low sex drive, erectile dysfunction, depression, and fatigue. TD afflicts approximately 30% of men aged 40-79 years, with an increase in prevalence strongly associated with ageing and common medical conditions including obesity, diabetes, and hypertension.

“Although testosterone deficiency may be present in one in five men 40 years or older, the driving factors remain largely unknown,” said Himanshu Arora, PhD, assistant professor of urology.

Dr Arora’s lab examined the effect of different concentrations of leptin on the microenvironment of the testes. The research builds on prior studies of how Sertoli and peritubular myoid cells (PMC) in the testicular microenvironment help drive Leydig stem cell differentiation via the cellular desert hedgehog signalling pathway, which transmits information to embryonic cells that guides proper cell differentiation.

The researchers extracted cellular samples from men undergoing testes biopsies for sperm retrieval. When the testes microenvironment secreted leptin in low doses, they found that Leydig stem cells differentiated into adult Leydig cells producing normal levels of testosterone. Higher doses of leptin were observed to depress testosterone levels.

“Our findings identify leptin as a key factor within the testes microenvironment,” said Dr Arora, adding that the insight “holds important implications for androgen deficiency and could have further application in prostate cancer research.”

Noting that leptin is already used in treating patients for obesity, “Preclinical studies could indicate whether adjusting levels of this hormone would be helpful in patients with testosterone deficiency,” said Ranjith Ramasamy, MD, study co-author and associate professor and director of the Miller School’s Reproductive Urology Program.

Source: University of Miami Health System, Miller School of Medicine

Categories : Environmental EffectsTags :

Climate Change Will Increase Deaths Linked to Extreme Temperatures

On By ModernMedia
Heat cracked earth
Photo by Joshua Woroniecki on Unsplash

The death rate linked to extreme temperatures will increase significantly under global warming of 2°C, with even steeper rises for each degree of warming, finds a report published in Environmental Research Letters.

With a warming scenario of just 2°C from pre-industrial levels, temperature-related mortality in England and Wales during the hottest days of the year will increase by 42%. This means an increase from present-day levels of around 117 deaths per day, averaged over the 10 hottest days of the year, to around 166 deaths per day. The findings underline the importance of keeping global warming levels to below 2°C.

At current global warming levels of around 1.21°C there would be a slight decrease in temperature-related mortality in winter and a minimal net effect in summer, meaning that overall, at this level of warming we see a slight decrease in temperature-related mortality rate.

The researchers assessed the impact of climate change on mortality rates England and Wales, specifically risk from heat in summer and cold in winter. They found that as the global mean temperature increases, temperature-related mortality in summer will increase at a much faster, non-linear rate.

The rate of increase particularly speeds up at 2°C of warming, with a much higher risk appearing beyond 2.5°C. The researchers say that 3°C warming could lead to a 75% increase in mortality risk during heatwaves.

The relationship between temperature and mortality on a graph is roughly U-shaped, meaning that at extremely high temperatures, mortality risk increases sharply for each degree rise of daily mean temperature.

The rate in winter will continue to decrease, although this leaves out extreme weather events such as storms.

Lead author Dr Katty Huang said: “The increase in mortality risk under current warming levels is mainly notable during heatwaves, but with further warming, we would see risk rise on average summer days in addition to escalating risks during heatwaves. What this means is that we shouldn’t expect past trends of impact per degree of warming to apply in the future. One degree of global warming beyond 2°C would have a much more severe impact on health in England and Wales than one degree warming from pre-industrial levels, with implications for how the NHS can cope.”

In England and Wales, temperature is associated with around 9% of total population mortality, meaning that 9% of all deaths during 2021 could be associated with the temperature. Most of those deaths are related to the side effects of cold weather.

The team analysed the 2018 UK Climate Projections (UKCP18) with data on present-day temperature and mortality in order to predict changes in temperature-related mortality relative to degrees of global warming.

In order to isolate the effects of global warming on mortality risk, the researchers looked at the potential impact for the current population, and not attempting to predict future age distributions and medical conditions.

Project lead Professor Andrew Charlton-Perez said: “As the Intergovernmental Panel on Climate Change impacts report recently showed, it is increasingly common to examine how different levels of mean global warming raise the risk of significant harm to people and society. Our study shows that because death rates will go up significantly if countries experience very high temperatures, limiting the average global rise in temperatures is likely to have substantial benefits for the overall health of the population.”

Source: University College London

Categories : CancerTags :

Completion Lymph Node Dissection Shows no Benefit in Advanced Melanoma

On By ModernMedia
Melanoma cells. Source: National Cancer Institute.

A review of data, published in Annals of Surgical Oncology, shows that completion lymph node dissection surgery for patients with stage III melanoma confers no benefit. This is especially true given that immunotherapy has shown success in treating metastases.

For years, surgery for patients with stage III melanoma, where the cancer had metastasised into lymph nodes, involved removing them along with the primary tumour. Known as completion lymph node dissection (CLND), the surgery was meant to ensure that no cancer remained after surgery.

More recently, however, cancer surgeons have discovered that CLND has the potential to cause more problems than it solves. In most cases, patients do better on immunotherapy alone than they do when their surgery involves removal of the lymph nodes, due to potential complications from lymph node surgery.

To address this, researchers reviewed their patient data to determine if immunotherapy alone resulted in better outcomes than CLND.

“In the few years prior to immunotherapy being available, some surgical trials were done asking if regional node dissection by itself improves overall survival for the patients,” said Martin McCarter, MD, a professor of surgical oncology at the University of Colorado (CU). “And the answer came back: no, it did not improve survival. That had been the standard forever, because we didn’t have other effective therapies, but once the definitive trials were done, we learned that CLND wasn’t helping, it wasn’t improving survival. Subsequent trials demonstrated that immunotherapy can improve survival in metastatic melanoma.”

For the study, the researchers looked at data on 90 patients who underwent sentinel lymph node biopsy (a procedure to determine if a skin melanoma has spread microscopically) only for stage III melanoma but did not undergo CLND. Of those patients, 56 received immunotherapy and 34 did not. Those who received immunotherapy had better rates of distant metastasis-free survival, meaning their cancer was less likely to come back.

“As treatments for melanoma have evolved, the standard of care may be evolving as well,” Prof McCarter said. “This study took a look at the patients who had a sentinel lymph node biopsy, so we knew the patient had a positive melanoma metastasis to their regional node. Those folks historically used to go on and get the completion lymph node dissection, but recently, people started to forego doing that lymph node dissection, which did not improve survival, and instead moved directly to immunotherapy, which did improve survival in other clinical trials. We proved that this is acceptable, that we’re not causing more harm to patients by doing it, and that those who do go on to get the immunotherapy seem to benefit from it.”

Forgoing CLND is part of a recent movement in cancer treatment known as de-escalation (or de-implementation) — performing only absolutely needed surgery. It’s especially important when it comes to lymph node surgery, Prof McCarter said, as in addition to the usual surgical risks, CLND has a 20% to 30% risk of permanent lymphoedema.

“If you could avoid that complication and not compromise a patient’s survival, that would be beneficial,” McCarter said. “That’s what we guessed was happening outside of definitive clinical trial evidence, and that’s what we were able to show. We know that we often overtreat patients, and this fits in that paradigm of finding ways to de-escalate unnecessary therapies, which has been done in breast cancer and other cancers as well.”

The researchers hope the findings will sway surgeons for whom CLND is still routine, despite the earlier studies showing that the additional surgery was not improving survival.

“Previous clinical trials with the use of adjuvant immunotherapy for melanoma had required a CLND,” Prof McCarter explained. “This study used real-world data from our stage III melanoma patients who were treated with immunotherapy without having a prior CLND.

“It takes years to change people’s practice patterns. I still have conversations with community surgeons who treat melanoma, asking me, ‘Should I be doing these regional node dissections?’ even though this data has been out for five to 10 years now,” Prof McCarter continued. “They’re afraid to give up what they used to do, and they’re afraid that they are doing a disservice to the patients or not giving them the best chance, when in reality, our understanding of cancer biology has evolved. We now have effective immunotherapy, which is overcoming some of the limitations of surgery while improving outcomes.”

Source:  University of Colorado

Categories : CancerTags :

Taller Adults Have a Greater Colorectal Cancer Risk

On By ModernMedia
Photo by Monstera from Pexels

Taller adults may be more likely than shorter ones to develop colorectal cancer or precancerous colon polyps, according to a new meta-analysis published in Cancer Epidemiology, Biomarkers & Prevention. While the association between taller height and colorectal cancer has been previously investigated, the researchers say those studies offered conflicting results, used inconsistent measures of height and did not include the risk of adenomas.

“This is the largest study of its kind to date. It builds on evidence that taller height is an overlooked risk factor, and should be considered when evaluating and recommending patients for colorectal cancer screenings,” said Associate Professor Gerard Mullin, MD. Greater height is still not proven to be causative, nor is it a great a risk factor as genetics, he and his team cautioned. However, it does add to long-standing evidence linking height to colorectal cancer risk.

“One possible reason for this link is that adult height correlates with body organ size. More active proliferation in organs of taller people could increase the possibility of mutations leading to malignant transformation,” said co-first author Elinor Zhou, MD.

The researchers first identified 47 international, observational studies involving 280 660 cases of colorectal cancer and 14 139 cases of colorectal adenoma. They also included original data from the Johns Hopkins Colon Biofilm study, which recruited 1459 adult patients undergoing outpatient colonoscopies to investigate the relationship between cancer and biofilm on the colon.

Because the definition of tallness differs around the world, the researchers compared the highest versus the lowest height percentile of various study groups. “The findings suggest that, overall, the tallest individuals within the highest percentile of height had a 24% higher risk of developing colorectal cancer than the shortest within the lowest percentile. Every 10-centimeter increase (about 4 inches) in height was found to be associated with a 14% increased risk of developing colorectal cancer and 6% increased odds of having adenomas,” said A/Prof Mullin.

In the US, the average height for men is 175.3cm, and for women it is 162.6 inches. This means men who are 185.4cm and women who are 172.7cm (10cm above the average US height) or taller are at a 14% increased risk of colorectal cancer and a 6% increased risk of adenomas.

The percentage results were adjusted for known risk factors of colorectal cancer, including non-modifiable factors such as age, familial colorectal cancer history and a personal history of chronic inflammatory bowel disease. Though not directly comparable due to differences in measurement scale, tallness may impart an order of magnitude of colorectal cancer risk similar to better-known modifiable factors such as cigarette smoking, moderate alcohol consumption and high processed red meat intake. At present, gastroenterologists focus on genetic and age-related risks for colorectal cancer screenings recommendations.

While colorectal cancer is the third most common cancer in both men and women in the US, fewer people are diagnosed with colorectal cancer each year has dropped overall since the mid-1980s, mainly due to prevention and screening. However, the downward trend is mostly in older adults. Among adults under 50, colorectal cancer deaths have increased 2% per year from 2007 to 2016, an as yet unexplained phenomenon.

“Greater awareness by the public and government will help promote more interest and funding for more research, which ultimately could change guidelines for physicians to consider height as a risk for cancer,” said A/Prof Mullin. “There are well-known modifiable dietary associations for colorectal cancer, such as processed red meats and smoking, but guidelines currently are fixated on family history, and height is clinically neglected when it comes to risk screening.”

Dr Zhou says more research is needed to define particular taller populations at risk for colon cancer. “For instance, tall athletes and individuals with inherited tallness, such as those with Marfan syndrome, could be screened earlier and the impact of height further explored,” she said. “We need more studies before we can definitively say at what height you would need earlier colorectal cancer screening.”

Source: John Hopkins Medicine

Categories : Cardiovascular Disease Lab Tests and ImagingTags :

Comprehensive Bloodstream Lipid Level Test Can Predict CVD Decades Early

On By ModernMedia
Source: Pixabay CC0

Lipidomics, measuring many different bloodstream lipid levels, can predict the risk of developing type 2 diabetes (T2D) and cardiovascular disease (CVD) years in the future, according to a new study in PLOS Biology. Such early prediction through lipidomic profiling may provide the basis for recommending diet and lifestyle interventions before disease develops.

At present, patient history and current risk behaviours are the main predictors for T2D and CVD, along with high- and low-density cholesterol ratios and levels. But there are over one hundred other types of lipids in the blood, which are thought to at least partially reflect aspects of metabolism and homeostasis throughout the body.

Nowadays, it is possible to measure thousands of individual lipids that make up the lipidome. Nuclear magnetic resonance spectrometry (NMR) metabolomics is also being increasingly used in large cohort studies to report on total levels of selected lipid classes, and relative levels of fatty acid saturation.

To find out if detailed lipid profiles could be better predictors, the authors drew on data and blood samples from a longitudinal health study of over 4000 middle-aged participants, first assessed from 1991 to 1994, with follow-up to 2015. Using baseline blood samples, the concentrations of 184 lipids were assessed. During the follow-up period, 13.8% of participants developed T2D, and 22% developed CVD.

The authors performed repeated training and testing on the data to create a risk model. Once the model was developed, individuals were clustered into one of six subgroups based on their lipidomics profile.

Compared to the group averages, the risk for T2D in the highest-risk group was 37%, an increase in risk of 168%. The risk for CVD in the highest-risk group was 40.5%, an increase in risk of 84%. Significant reductions in risk compared to the averages were also seen in the lowest-risk groups. The increased risk for either disease was independent of known genetic risk factors, and independent of the number of years until disease onset.

Rsk could be individually defined decades before disease onset, possibly in time to take steps to avert disease. Lipidomics could be combined with genetics and patient history to provide new insights into the beginnings of the disease. Additionally, new drug candidates could be identified from the lipids  contributing the greatest risk.

“The lipidomic risk, which is derived from only one single mass-spectrometric measurement that is cheap and fast, could extend traditional risk assessment based on clinical assay,” said lead researcher Chris Lauber of Lipotype. “In addition, individual lipids in blood may be the consequences of or contribute to a wide variety of metabolic processes, which may be individually significant as markers of those processes. If that is true, Lauber said, “the lipidome may provide insights much beyond diabetes and cardiovascular disease risk.”

Lauber added: “Strengthening disease prevention is a global joint effort with many facets. We show how lipidomics can expand our toolkit for early detection of individuals at high risk of developing diabetes and cardiovascular diseases.”

Source: EurekAlert!

Categories : Diseases, Syndromes and ConditionsTags :

For Reducing Health Risk Behaviours, Seeing is Believing

On By ModernMedia
Doctor shows an X-ray of a foot
Photo by Tima Miroshnichenko on Pexels

It is said that seeing is believing, and researchers have found that using patients’ own medical imaging such as CT scans may discourage risk-related behaviours more than non-visual information. The meta-analysis, which appears in PLOS Medicine, found that when patients see imaging results about their risk of disease, they may be more likely to reduce risky behaviours.

Modifiable behaviours such as smoking, poor diet and physical inactivity are linked to non-communicable disease. Encouraging behavioural changes can help reduce the global burden of such diseases, which account for two-thirds of deaths around the world. The investigators were interested to see whether the growing use of medical imaging technologies could help.

Gareth Hollands and University of Cambridge colleagues conducted a meta-analysis of 21 randomised controlled trials involving over 9000 adult participants. Participants were either shown visual examples of personalised risk information following an imaging procedure, such as computed tomography, ultrasound, or radiography, in addition to health information or advice, or they received health information or advice with no visual feedback. The trials reported on behaviours such as smoking, medication use and levels of physical activity.

The strongest evidence was for smoking reduction, a healthier diet, increased physical activity, and increased oral hygiene behaviours. Single studies also reported increased skin self-examination and foot care following visualised feedback. Improvement in other behaviours examined were not statistically significant. The authors conclude that the growth of medical imaging technology could be capitalised on to help people modify their lifestyles and reduce disease risk.

Hollands said: “Medical imaging scans are used ever more widely by healthcare professionals. By gathering together the existing research, this study suggests that showing the scan results to patients to highlight the state of their health could motivate them to behave in a healthier way.”

Source: Science Daily

Categories : COVID HospitalsTags :

Cohorting an Effective Response for an Emerging Pandemic

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Phot by Artem Podrez on Unsplash

During the extenuating circumstances of an emerging pandemic, grouping patients together in one area or facility, a practice known as cohorting, was successful in providing high-quality care and containing infectious patients, according to a new study published in JAMA Open.

The University of Minnesota Medical School researchers reported that cohorting was implemented by M Health Fairview early in the pandemic when there was little known about how to effectively treat patients with COVID.

“This study highlights the academic and clinical expertise of the M Health Fairview system to deliver outstanding medical care to the people of Minnesota,” said Dr Greg Beilman, a critical care surgeon at the U of M Medical School and was a co-lead of the M Health Fairview COVID response team. “In this study we demonstrated our ability to rapidly bring new developments in science to the patient’s bedside and improve outcomes for patients affected by this frequently dire disease.”

Because every person being treated in the cohorts had COVID, frontline healthcare workers quickly gained experience in COVID care. These experienced specialists worked side by side with academic physicians who were translating the latest medical research into new solutions they could apply in real time to patient care. COVID patients had access to leading-edge clinical trials, internal COVID testing capabilities, and innovative technology.

The study found that dedicated COVID units in Minnesota were associated with a 2% overall improvement in in-hospital survival rates when patients were properly matched for severity of illness. Complications associated with COVID were significantly better in this group as was the swift implementation of new care processes by health care providers.

“The opportunity to care for patients at our COVID cohort hospitals was a shining light in a dark time for many of us,” said Dr Andrew Olson, medical intensivist at the U of M Medical School and medical director of COVID hospital medicine at M Health Fairview. “We watched our colleagues develop expertise, conduct research and care for one another while staying healthy in a challenging time.”

The research team hopes the cohorting method could be implemented during other infectious disease outbreaks, like viral pneumonia. The framework helps provide infectious patients the best care during times of rapid learning in scientific research.

“As the pandemic progressed, we had broad availability of personal protective equipment, vaccinations, and more health care workers developed familiarity with treatment of COVID,” said Dr Beilman. “These developments combined with the fact that the incidence of COVID decreased last year – this care model was no longer necessary.”

Researchers plan to further investigate which patients benefit most from care at such facilities, as well as evaluate the experience for those healthcare professionals who work in them.

Source: University of Minnesota Medical School