Tag: USA

US Sees Surge in Hypertension Hospitalisations

Photo by Camilo Jimenez on Unsplash

The number of people hospitalised for a hypertensive crisis in the US more than doubled from 2002 to 2014, according to researchers from Cedars-Sinai Medical Center. Possible causes included socioeconomic factors such as reduced access to healthcare.

A hypertensive crisis is an acute, marked elevation in blood pressure that is associated with signs of target-organ damage. This increase in hypertensive crises happened at a time when some studies reported overall progress in blood pressure control and a decline in related cardiovascular events in the US. The findings are published in the Journal of the American Heart Association.

“Although more people have been able to manage their blood pressure over the last few years, we’re not seeing this improvement translate into fewer hospitalisations for hypertensive crisis,” said first author Joseph E. Ebinger, MD, a clinical cardiologist and director of clinical analytics at the Smidt Heart Institute

Dr Ebinger said there could be a number of explanations for the incrrease. More people may be unable to afford hypertension medications or are taking inadequate doses of these drugs. Socioeconomic factors may also make it difficult for people to avoid unhealthy behaviours that can contribute to hypertension, such as smoking, as well as having limited access to health care and other concerns.

“We need more research to understand why this is happening and how clinicians can help patients stay out of the hospital,” Dr Ebinger said.

For their study, the investigators used data from the National Inpatient Sample, which is a publicly available database. The data include a subset of all hospitalisations across the US, providing a picture of nationwide trends. They found that annual hospitalisations for hypertensive crises more than doubled over a 13-year period. Hospitalisations related to hypertensive crises accounted for 0.17% of all admissions for men in 2002 but 0.39% in 2014, and represented 0.16% of all admissions for women in 2002 but 0.34% in 2014.

The mortality risk for hypertensive crisis, however, did decrease slightly overall during the studied time period. Women died at the same rate as men, even though they had fewer health issues than men who also were hospitalised for a hypertensive crisis.

“These findings raise the question: Are there sex-specific biologic mechanisms that place women at greater risk for dying during a hypertensive crisis?” said senior study author Susan Cheng, MD, MPH, director of the Institute for Research on Healthy Aging in the Department of Cardiology at the Smidt Heart Institute. “By understanding these processes, we could prevent more deaths among women,” she added.

Source: Cedars-Sinai Medical Center

Omicron Not ‘Mild’ for US, Experts Say

In stark contrast to South Africa’s approach to COVID and the country’s experts characterising Omicron as “mild”, US experts have said that calling it “mild” ignores the harsh situation their country faces: record hospitalisations, sick children, other conditions being worsened by COVID, and staff shortages.

While Omicron’s odds of causing a person’s hospitalisation or death are lower, US numbers suggest that Omicron is, in fact, serious on a population level.

“What’s mild about hospitals at or near the breaking point? What’s mild about hundreds of healthcare workers per hospital out ill with COVID? What’s mild about 1.3 million cases in the U.S. just yesterday? What’s mild about the rising titer of burnout? What’s mild about an unprecedented number of children now ill and hospitalised with COVID?” Clyde Yancy, MD, chief of cardiology at Northwestern University’s Feinberg School of Medicine in Chicago, wrote in an email to MedPage Today.

“I think prudence would suggest that we reframe ‘mild’ and think more about ‘self-limited,'” he added. “We are likely at or near a plateau but how long will it last and how much more agony awaits?”

Americans were hospitalised in record numbers last week. “When there are many more people sick in large numbers – in millions – even if it’s a smaller percentage that’s going to be severely sick, that is going to result in large numbers in the hospitals,” said Biykem Bozkurt, MD, PhD, a cardiologist at Baylor College of Medicine in Houston.

While Omicron is still a threat for those unvaccinated or without previous infection, its high breakthrough rate is a cause for concern, especially in vulnerable people.

“Individuals who have breakthroughs after being vaccinated, including the elderly who have comorbid heart disease, are now flooding our emergency departments with decompensated cardiovascular diagnoses and a positive coronavirus test,” said cardiologist Jim Januzzi, MD, of Massachusetts General Hospital and Harvard Medical School in Boston.

As well as buckling healthcare systems, vulnerable and overlooked populations are being affected by Omicron even more.

Paediatric hospitalisations in the US reached a new peak in mid-January, with 20% of the entire pandemic’s hospitalisations of children happening in just two weeks in January. Over 1000 children have died from COVID by the CDC’s numbers, including 359 under five.

Moreover, patients on immunosuppressive medications may be less protected by the vaccines. “The labelling of the Omicron infection as ‘mild’ overlooks the important features and the messaging to the public,” rheumatologist Vaidehi Chowdhary, MBBS, MD, DM, of Yale School of Medicine in New Haven, Connecticut, wrote in an email to MedPage Today.

“Some patients who are on strong immunosuppressive medications do not have adequate vaccine titers and remain vulnerable,” she said, pointing out that there’s a shortage of monoclonal antibodies and antivirals, which means that this group must take extra precautions to ensure they aren’t infected in the first place.

Omicron’s impact on those who are immunosuppressed or have long COVID is not yet known, Dr Chowdhary noted. “For immunosuppressed patients, to minimise infections, many in-person appointments have been converted to telehealth or elective procedures deferred. The impact of these practices and their impact on overall patient health are not known.”

People living with disabilities and chronic illnesses continue to be faced with worsened infections, delaying consultations and difficulty accessing healthcare.

Then there are those whose infection has exacerbated their condition, whatever it may be. Omicron could be the thing that tips them over the edge, or that keeps them in the hospital for longer, experts have said. Examples seen include patients with blood clots having those clots exacerbated by COVID, and COVID-positive trauma patients having complications and longer recovery times.

Healthcare workers falling ill due to Omicron has seriously stressed US healthcare, with staff shortages have been reported in almost 20% of the country’s hospitals, leaving their already overworked colleagues to work extra.

Dr Januzzi’s hospital has been “completely full, with a huge number of individuals with COVID. So, we’re really at a breaking point where staff are getting sick. Patients and physicians alike are exhausted … the hope would be that we can get through this time and get to the other side of this.”

Source: MedPage Today

Politics Makes People Sick – Literally

Photo by Andy Feliciotti on Unsplash

According to a new US study, all the political jockeying is harmful to our health, has been for some time, and even a change in party power didn’t help.

Political scientist Kevin Smith followed up a landmark 2017 survey study where he measured the effects of the political climate on Americans’ physical, social, mental and emotional health. Smith repeated the same 32-question survey twice in 2020 – two weeks prior to the election, and two weeks after. The 2020 findings mirrored the 2017 results, and again found that a large proportion of American adults blame politics for causing them stress, loss of sleep, fractured relationships and more.

Similar to the 2017 findings, the results of the 2020 surveys, published in PLOS One, showed that an estimated 40% of Americans identified politics as a significant source of stress. Between a fifth and a third of US adults also blamed politics for causing fatigue, feelings of anger, loss of temper and triggering compulsive behaviours. About a quarter of adults reported they’d given serious consideration to moving because of politics.

That the results remained mostly stable after nearly four years is cause for alarm, Smith said.

“This second round of surveys pretty conclusively demonstrates that the first survey was not out of left field – that what we found in that first survey really is indicative of what many Americans are experiencing,” Smith, chair and professor of political science, said. “It’s also unpleasant to think that in that span of time, nothing changed. A huge chunk of American adults genuinely perceive politics is exacting a serious toll on their social, their psychological and even their physical health.”

Smith repeated the survey with the same group of people both before and after the election to see if the election’s outcome would recast people’s perceptions.

“We wondered if a change in presidency, which indeed was the case, would shift attitudes, and the short answer is no,” Smith said. “If anything, the costs that people perceive politics is exacting on their health increased a little bit after the election.”

Smioth was most surprised at the repeated finding that 5% of Americans blame politics for having suicidal thoughts.

“One in 20 adults has contemplated suicide because of politics,” Smith said. “That showed up in the first survey in 2017, and we wondered if it was a statistical artifact. But in the two surveys since, we found exactly the same thing, so millions of American adults have contemplated suicide because of politics. That’s a serious health problem.”

Those most likely to be negatively affected by politics were younger, more often Democratic-leaning, more interested in politics and more politically engaged.

“If there’s a profile of a person who is more likely to experience these effects from politics, it’s people with those traits,” Smith said.

This could mean problems for democracy if this trend continued. Smith suggested investigating whether civic education had a positive effect, as those who were more knowledgeable about politics seemed to be less affected.

Source: University of Nebraska

Sharply Increased Fatality Rate Estimated for Iota Variant

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study available on the medRxiv preprint server has estimated the increases of the SARS-CoV-2 Iota (B.1.526) variant for transmissibility, immune escape ability, and infection fatality rate in New York.

The study findings revealed that the Iota variant has considerably higher transmissibility and immune escape potential than previously circulating variants and that it can increase the infection fatality rate by 62%-82% among older adults.

Iota variant emerges in New York
The lota variant, was first identified in New York City in November 2020 and then spread across the US and to 27 countries.

According to one lab study, the Iota variant modestly resists neutralisation by therapeutic monoclonal antibodies and vaccine/infection-induced antibodies. Fortunately however, evidence indicates that the variant does not increase the risk of breakthrough infections in vaccinated or previously infected individuals.

Study design
For the study, the scientists analysed multiple epidemiological and population datasets collected in New York City and, with mathematical modeling, estimated the transmission rate, immune evasion ability, and infection fatality risk of the Iota variant.

The prevalence of SARS-CoV-2 was estimated at 16.6% at the end of the first wave, and 41.7% at the end of the second wave. Infections in all age groups were seen with the second wave, compared to mostly older age groups in the first.

Transmissibility and breakthrough
A rapid increase in Iota-infected cases was observed during the second pandemic wave. Before the variant was first discovered in a neighbourhood in early November 2020, a rise in cases was seen in that same neighborhood, which remained higher than other neighbourhoods until Iota became prevalent and raised the baseline.

The researchers estimated that Iota is 15–25% more transmissible than previously circulating variants, with breakthrough infections in 0–10% of the population. These increases made the Iota variant become dominant in New York City from November 2020 to March 2021. Afterward, with the surge of more infectious variant B.1.1.7 (Alpha), Iota prevalence fell.

Despite a reduction in mortality rate following mass vaccination, infection fatality rate was seen to increase in New York City during the second pandemic wave. The researchers estimated that the Iota variant increases the infection fatality rates by 46% for 45–64 year olds, 82% (65–74), and 62% (75+). Compared to previously circulating variants, the Iota variant, overall, caused a 60% increase in infection fatality rate, comparable to that estimated for the Alpha variant.

Source: News-Medical.Net

Infant with COVID Airlifted Out as Texas Hospitals Fill Up

Photo by Fas Khan on Unsplash
Photo by Fas Khan on Unsplash

An 11-month-old girl in Houston, Texas, had to be airlifted to a hospital in a different city because no paediatric hospitals in Houston would accept her as a transfer patient.

“She needed to be intubated immediately because she was having seizures,” said Patricia Darnauer, the administrator for LBJ Hospital. “We looked at all five major paediatric hospital groups and none [had beds] available.”

The little girl will be receiving treatment at Baylor Scott & White McLane Children’s Medical Center some 220 kilometres away.

The situation is sad but not surprising for Dr Christina Propst, who is one of the most outspoken pediatricians in Houston. Ever since the pandemic began in the US, Dr Propst has encouraged masking, social distancing, and being cautious to anyone who would listen.

“The emergency rooms at the major children’s hospitals here in Houston, the largest medical center in the world, are extremely crowded,” said Dr Propst. “They are filling, if not full, as are the hospitals and intensive care units.”

Delta variant infecting more children
Dr Propst and other clinicians ascribed the scarcity of paediatric beds, to the delta variant of COVID noticeably affecting more children, as well as being more transmissible. Texas Children’s Hospital has 30 children and adolescents hospitalised with COVID, compared to their January peak of 40.

However, the problem is worsened by widespread cases of Respiratory Syncytial Virus (RSV) in children. This is all taking place during the summer break for US schools, where doctors are used to injuries from playing outdoors.

Darnauer spoke of high numbers of patients at her hospital. “We are back beyond our pre-pandemic volumes at LBJ.”

Dr Propst advises mask wearing for those children not old enough for the vaccine, and she would also like to see Texas once again allow public schools to mandate masks. Unlike many other countries, COVID health regulations are largely up to individual states.

“If children are not masking in schools, it will be a major problem,” said Dr Propst.

She added that, even in normal times, the start of the school year generally causes a lot of germs to spread.

“It is typical that two weeks after school we see a great surge of strep and other sources of infection. We are bracing ourselves, not a question of when, it will be bad,” she said.

Source: ABC13

Trump Encouraged to Urge Followers to Take Vaccine

As US polls show that half of Republicans voters are reluctant to get a COVID vaccine, two former senior Trump administration officials have said that former US President Donald Trump is being encouraged to urge his followers to get the jab. 

The officials stressed that herd immunity could be threatened by Republican vaccine hesitancy, and that Trump’s followers will listen to him and him alone.

“Vaccines are widely regarded as one of Trump’s greatest accomplishments, and Trump understands that this legacy is at risk because half of his supporters are not taking the vaccine,” one of the officials told CNN. “It’s just not clear yet if he understands that he’s the only one who can fix this.”

The other official concurred. “In Trump country, if you want to call it that, there are still significant numbers of people who aren’t sure [COVID] is a real thing, despite folks getting sick, and there are lots of suspicions about the vaccine,” the source said. “They have literally said to me, ‘I want to hear from the president about this.’ I don’t think they’re going to listen to anyone else.”

Trump told Fox News last week that he would make a “commercial” about the vaccine, but did not make a firm commitment.
However, a person close to Trump disagreed he should take this approach. “He shouldn’t be pushing these vaccines. His posse isn’t exactly vaccine-approving and it could backfire,” the person said.

All the living former presidents save for Trump, and their wives, appeared in an ad campaign started last month encouraging vaccination – though Trump’s team denied he was approached to participate. This was because the team that organised the PSA did not think it was likely he would participate, according to a source close to that project.

In the Fox interview, Trump said, “I encourage them to take it. I do,” referring to his supporters, but has only spoken out a few times about vaccination.

Fifty-four percent of Republicans are either hesitant about or opposed to getting a COVID vaccine, according to a March survey by the Kaiser Family Foundation, and 29% said they would not get a vaccine under any circumstances.

The number of people 18 and over with at least one vaccine dose, the top 10 states are all states President Joe Biden won last November. Trump won 9 out of the bottom 10 states for vaccination.

A third former Trump official confided that as early as last summer, there were already concerns over Republican vaccine refusal.

“On Facebook I saw a ton of hesitancy for that group — just insane amounts of hesitancy already and we knew it was just going to get worse,” the official said.

That official said Trump ally Michael Caputo briefly mentioned to Trump last fall that it would be good for the president to do a vaccine PSA after the election.

One of the other former officials noted that recently, Caputo “in particular has been active in discussing” the possibility of doing a PSA with the Trump team.

“Michael takes this very seriously and sees this as a big public health problem,” said the source. “His stepping out, because he’s so connected to the president, is really going to be forceful and incredibly helpful.”

Mr Caputo served as assistant secretary for public affairs at the US Department of Health and Human Services, leaving after being diagnosed with throat cancer and a rant at heath scientists saying they were undermining Trump.

Mr Caputo confirmed to CNN that he met with Trump and the two men “spoke about vaccine hesitancy and what can be done about it.”

Trump’s final year in office will define his legacy, according to historians, which was marred by the failure to contain COVID and his incitement of a mob that stormed the US Capitol.

The former  officials said they don’t want to see the vaccine development that Trump pushed undone by vaccine hesitancy, including among his own supporters.

“I see Operation Warp Speed tipping towards failure, and it really concerns me,” one of the senior officials warned. “If we don’t move half those people into the vaccinated column, we’re most likely not going to reach community immunity, and if we don’t reach it, then the president’s vaccine legacy is dead.”

The other senior official said Trump supporters would respond positively to the former president “taking ownership of Operation Warp Speed” and mentioning that he and his wife were both vaccinated.

“He could talk about how [vaccine uptake] is the way to get the country back to where it needs to be economically and socially, using his language that he uses with his supporters. I think that would be really powerful,” said the source.

Source: CNN

Black Barbershops with Pharmacist-led Care can Combat Hypertension

Black and white image of a black man getting a haircut at a barbershop. Credit: BariKive from Pexels.

Black barbershops with pharmacist-led blood pressure (BP) care for their clients, have been shown to be cost effective, with the high initial costs offsetting reduced cardiovascular events later in life.

The study cost simulations were based on the original  Los Angeles Barbershop Blood Pressure Study (LABBPS). In that study, intervention consisted of a trial with men being assigned either to barbershops where barbers encouraged patrons to meet with pharmacists who prescribed drug therapy under an agreement with the participants’ doctors, with the control group being men assigned to barbershops where the barbers only promoted lifestyle modification and physician visits. This intervention resulted in a mean BP drop of 27.0mmHg compared to the control group which fell by 9.3mmHg.

In a 1-year intervention based on costs for the LABBPS, on average, $2356 more per participant than the controls and was associated with a gain of 0.06 quality-adjusted life years (QALYs) over a 10-year horizon, according to Brandon Bellows, PharmD, MS, of Columbia University in New York City, and colleagues.

Thus, in computer simulations,  the LABBPS intervention was associated with 10-year projected total healthcare costs averaging $42 717 per QALY gained, reported the researchers.

“One concern raised as a potential barrier to widespread LABBPS implementation is the specialty training of clinical pharmacists. In this analysis, the cost of specialty training and certification was included; the results suggest that long-term health benefits and avoided healthcare costs of the LABBPS offset these upfront training costs,” the researchers wrote.

The team reported that the cost effectiveness of the intervention could be increased under various various scenarios:

  • Only using generic drugs: $17 162 per QALY gained
  • Shortening intervention to 26 weeks: $18 300 per QALY gained
  • Implementing optimal savings from less time spent on intervention tasks, lower equipment costs, only using generics, and no participant incentive costs: intervention becomes dominant (both less expensive and more effective than control)

However, if pharmacists were less likely to intensify antihypertensive medications when systolic BP was ≥ 150 mm Hg, or if pharmacists took longer to get to the barbershops, the cost of the LABBPS intervention would exceed $50 000 per QALY gained.

“Hypertension care delivered by clinical pharmacists in Black barbershops is a highly cost-effective way to improve BP control in Black men,” the authors concluded.  

The LABBPS has received praise for demonstrating that Black men with uncontrolled hypertension had better BP control after 6 months with barbershop visits by specialty pharmacists than with regular physician visits. Extending the intervention to 1 year did not change the results.

Researchers previously reported that a telemedicine component could bring down cost and maintain efficiency of the LABBPS program.

“Hypertension prevalence remains higher among non-Hispanic Black men than in any other racial or ethnic group in the US. Hypertension awareness and treatment have plateaued in the US since 2010, and Black men continue to have worse BP control and higher hypertension-related cardiovascular disease mortality rates compared with other groups,” the investigators wrote.

The researchers assumed that after the one-year intervention period, processes of hypertension care management returned to standard care, which was a major limitation of the study.

“These findings may also be somewhat limited in scope as a healthcare sector perspective was used, which only considers direct healthcare costs, rather than a societal perspective, which may include indirect costs such as improvements in productivity,” noted Bellows and co-authors. “Finally, cost-effectiveness estimated for the LABBPS may not be generalizable to other U.S. communities, as it was specific to Los Angeles County and was driven in part by the high underlying risk of cardiovascular disease in Black men.”

Source: MedPage Today

Journal information: Bryant KB, et al “Cost-effectiveness of hypertension treatment by pharmacists in black barbershops” Circulation 2021; DOI: 10.1161/CIRCULATIONAHA.120.051683.

FDA and CDC Justify J&J Vaccine Pause

FDA and CDC officials recommended pausing administration of the Johnson & Johnson COVID vaccine “out of an abundance of caution,” and mainly for the benefit of clinicians to respond to associated serious events.

This comes after six cases of cerebral venous sinus thrombosis (CVST) combined with thrombocytopenia were reported in the US, all among women ages 18-48. With approximately 6.8 million doses administered in the U.S., it suggests a one-in-a-million risk. 

J&J has halted distribution of its vaccine in Europe, reportedly taking officials there by surprise. South Africa has also paused the vaccine rollout.

At a media briefing, when asked whether pausing administration of the vaccine was an “overreaction,” Acting FDA Commissioner Janet Woodcock, MD, said the aim was to provide “time for the healthcare community to learn what they needed about how to diagnose, treat, and report” such events.

FDA’s director for the Center for Biologics Evaluation and Research, Peter Marks, MD, PhD, noted that the condition involves a rare blood clot for which heparin or related anticoagulants is not the standard treatment.

“The issue with these types of blood clots is if one administered standard treatment, one can actually cause tremendous harm or the outcome can be fatal,” he said. “One needs to make sure providers are aware if they see people with low blood platelets or blood clots, to inquire about recent vaccination and act accordingly.”

The background rate of CVST is 2-14 per million in the setting of a normal platelet count, but thrombocytopenia together with abnormal clotting makes it a “pattern.” CVST symptoms also include severe headache, abdominal pain, leg pain, and shortness of breath.

Marks noted that vaccination-related headaches tend to resolve within a few days, whereas CVST symptoms could manifest over a week post-vaccination, and closer to a patient presenting to the emergency department with severe headache. No such rare events have been seen more than 3 weeks post-vaccination.

Dr Marks also said that this pause is a recommendation but does not prevent healthcare providers from providing the J&J vaccine to their patients should benefits of vaccination outweigh the risks.

“We’re not going to stop a provider from administering a vaccine,” he added. “The benefit/risk will be beneficial overall to that individual in a large majority of cases.”

Dr Marks said that while they don’t have a “definitive cause” for the adverse reactions, data from AstraZeneca on similar events in Europe, it is likely a “similar mechanism” with the J&J vaccine. An autoantibody against platelet factor 4 has recently been identified as the trigger for the reaction.
“The immune response occurs rarely after some people receive the vaccine, and that immune response leads to the activation of platelets and extremely rare blood clots,” he said.

However, Marks stopped short of calling it a “class effect,” meaning it was related to the viral vector vaccine itself. He said he wasn’t ready to make a “broad statement yet,” but “obviously it’s from the same general class of viral vectors.”

The AstraZeneca, J&J and Sputnik V vaccines all use adenovirus vectors to deliver antigens. The rate CVST for AstraZeneca was estimated by European officials to be about 5 per million doses. Though Sputnik V has no confirmed CVST cases, a recent report suggests a possibility.

Besides these, the Ebola vaccines are the only other ones to use adenovirus vectors.
Woodcock said that all US cases were in women of reproductive age, with one death and one hospitalisation, but Marks said it was not clear there was any association with hormonal contraception, which also carries a small thrombosis risk. The cases did not have any preexisting conditions which could have explained the events.

The American College of Obstetricians and Gynecologists (ACOG) noted there is no “clear phenotype” for women who may experience this complication.

“Until there is a better understanding of the frequency and impact of this finding, it will be important to encourage pregnant and postpartum women who wish to be vaccinated to receive the mRNA vaccines: Pfizer or Moderna,” said Christopher Zahn, MD, vice president for practice activities at ACOG, in a statement.

“If venous thrombosis is noted in the setting of thrombocytopenia, treatment includes intravenous immunoglobulin and other supportive care,” Dr Zahn added.

Source: MedPage Today

US Hits Pause on J&J Vaccine

Reacting to reports of potentially dangerous blood clots, the US is recommending a “pause” in immunisations with the single-dose Johnson & Johnson COVID vaccine in order to perform investigations.

The Centers for Disease Control and Prevention and the Food and Drug Administration said in a joint statement that they were investigating blood clots in six women that occurred 6 to 13 days after vaccination. The clots, seen in the sinuses of the brain, also had lowered platelet counts. This renders the use of heparin, the standard treatment for blood clots, potentially dangerous.

Out of 183.5 million vaccine doses administered in the US, over 6.8 million doses are the J&J vaccine — the overwhelming majority without serious side effects. The rest is made up by the two other authorised vaccines, from Moderna and Pfizer.

Use of the J&J shot will be paused in US federal distribution channels, including mass vaccination sites, with states and other providers being expected to follow.

CDC’s Advisory Committee on Immunization Practices will meet Wednesday to discuss the cases and the FDA has also launched an investigation into the cause of the clots and low platelet counts.

“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr Anne Schuchat, principal deputy director of the CDC, and Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a joint statement.

They recommend that people who received the J&J vaccine and are experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the jab contact their health care provider.

Officials say that they want to bring healthcare providers up to speed on the blood clot’s “unique treatment” .

Meanwhile, Johnson & Johnson had said it was aware of the blood clot reports, but no association with its vaccine had been established.

“We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines,” the company said in a statement. “At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine.”

In late February, the FDA  granted emergency use authorisation to the J&J vaccine, with hopes that its single-dose and relatively simple storage requirements would speed vaccinations across the country. However, only a fraction of the vaccines administered in the US are the J&J shot. The company has been beset by production delays and manufacturing errors at a contractor’s plant. 

The pharmaceutical company took over the facility to ramp up production to make good on its promise to the US government of 100 million doses by the end of May. Only about 9 million of the company’s doses have been delivered to states and are awaiting administration, according to CDC data.
Previously, concern over the blood clots was confined to AstraZeneca’s vaccine, with European regulators saying last week they found a possible link between the shots and an exceedingly rare type of blood clot presenting with low platelets, a situation found more commonly in young people.

Nevertheless, the European Medicines Agency emphasised that the benefits for the vaccine outweigh the risks. Despite this, several countries imposed restrictions on vaccine eligibility and some such as Britain and Greece recommending that people under a certain age be offered alternatives.

Unlike the Pfizer/BioNTech and Moderna vaccines which use mRNA to train the immune system to recognise the SARS-CoV-2 spike protein, the J&J and AstraZeneca vaccines use an adapted adenovirus to introduce the spike protein antigen into the body. Adenoviruses were first identified in the 1950s as a family of similar disease-causing viruses. AstraZeneca’s vaccine uses a chimpanzee adenovirus while the J&J uses a human one.

Source: Medical Xpress

High Melanoma Rates Reported in Sunny US State

A study reports that melanoma mortality among people in Utah, a sunny, high-altitude state, outpaced that of the rest of the country over 1975 to 2013.

This runs counter to the falling melanoma death rates in recent years in both Utah and the United States, a trend likely due to improved treatments such as immunotherapy. It is still the deadliest skin cancer type, with melanoma diagnosis rate in Utah the highest in the US.

Motivation for the research was recent evidence showing that for most of the 1990s and 2000s, even as melanoma mortality in the United States remained constant, incidence increased six-fold. This increasing incidence without accompanying mortality rise indicates overdiagnosis, ie false cancer diagnoses. 

In the case of melanoma, overdiagnosis may result from increased scrutiny, where increasing numbers of biopsies may find a benign lesion that would have gone undetected.

Since Utah has the highest melanoma incidence, a team from Huntsman Cancer Institute (HCI) at the University of Utah set out to evaluate the state’s melanoma diagnosis and death rate data. Biostatistician Kim Herget analysed data from the Utah Cancer Registry, a National Cancer Institute Survival, Epidemiology, and End Results (SEER) database, and the researchers found that in contrast to the rest of the country, melanoma mortality in Utah rose 0.8% per year from 1975 to 2013. Even though Utah’s melanoma death rates have been falling in recent years, they are still higher than the rest of the country.

“Although we agree that overdiagnosis of melanoma is a growing problem, the sustained increase in melanoma mortality in Utah suggests that at least some fraction of the increasing incidence is real and cannot be attributed solely to overdiagnosis,” said Doug Grossman, MD, PhD, who co-leads the HCI melanoma and skin cancer centre at HCI and serves as professor of dermatology at the University of Utah. “Our research underscores an increased risk for Utahns, and so we must remain vigilant about melanoma. For doctors, this means regular conversations with patients about their skin health and family history. For patients, this means practicing sun-safe behaviors like diligent sunscreen use, wearing sun-protective clothing, and monitoring their skin at home on a monthly basis to reduce risk of skin cancer and optimize early detection.”

Future studies should determine whether this trend in people living in Utah results from increased ultraviolet exposure in a mostly fair-skinned population living in a sunny, high-altitude climate or if it is associated with other factors such as environment or genetics. Melanomas are also found at higher rates in immune compromised patients.

Source: Medical Xpress

Journal information: Doug Grossman et al, The Rapid Rise in Cutaneous Melanoma Diagnoses N Engl J Med 2021; 384:e54 DOI: 10.1056/NEJMc2101980