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Missed Visits During Pandemic Cause ‘Detrimental Ripple Effects’ Missed Visits During Pandemic Cause ‘Detrimental Ripple Effects’

More than one third of adults aged 18-64 years in the United States delayed or went without medical care because of efforts by patients or providers to reduce the spread of COVID-19, according to a new report from the Urban Institute.

Among the adults who postponed or missed care, 32.6% said the gap worsened one or more health conditions or limited their ability to work or perform daily activities. The findings highlight “the detrimental ripple effects of delaying or forgoing care on overall health, functioning, and well-being,” researchers write.

The survey, conducted among 4007 US adults aged 18-64 in September, found that adults with one or more chronic conditions were more likely than adults without chronic conditions to have delayed or missed care (40.7% vs. 26.4%). Adults with a mental health condition were particularly likely to have delayed or gone without care, write Dulce Gonzalez, MPP, a research associate in the Health Policy Center at the Urban Institute, and colleagues.

Doctors are already seeing the consequences of the missed visits, says Jacqueline W. Fincher, MD, president of the American College of Physicians.

Two of her patients with chronic conditions missed appointments last year. By the time they resumed care in 2021, their previsit lab tests showed significant kidney deterioration.

“Lo and behold, their kidneys were in failure…One was in the hospital for three days and the other one was in for five days,” said Fincher, who practices general internal medicine in Georgia.

Fincher’s office has been proactive about calling patients with chronic diseases who missed follow-up visits or laboratory testing or who may have run out of medication, she said.

In her experience, delays mainly have been due to patients postponing visits. “We have stayed open the whole time now,” Fincher said. Her office offers telemedicine visits and in-person visits with safety precautions.

Still, some patients have decided to postpone care during the pandemic instead of asking their primary care doctor what they should do.

“We do know that chronic problems left without appropriate follow-up can create worse problems for them in terms of stroke, heart attack, and end organ damage,” Fincher said.

Lost Lives

Future studies may help researchers understand the effects of delayed and missed care during the pandemic, said Russell S. Phillips, MD, director of the Center for Primary Care at Harvard Medical School in Boston.

“Although it is still early, and more data on patient outcomes will need to be collected, I anticipate that the…delays in diagnosis, in cancer screening, and in management of chronic illness will result in lost lives, and will emphasize the important role that primary care plays in saving lives,” Phillips said.

During the first several months of the pandemic, there were fewer diagnoses of hypertension, diabetes, and depression, Phillips said.

“In addition, and most importantly, the mortality rate for non-COVID conditions increased, suggesting that patients were not seeking care for symptoms of stroke or heart attack, which can be fatal if untreated,” he said. “We have also seen substantial decreases in cancer screening tests such as colonoscopy, and modeling studies suggest this will cost more lives based on delayed diagnoses of cancer.”

Vaccinating patients against COVID-19 may help primary care practices and patients get back on track, Phillips suggested.

In the meantime, some patients remain reluctant to come in. “Volumes are still lower than prepandemic, so it is challenging to overcome what is likely to be pent-up demand,” he told Medscape Medical News in an email. “Additionally, the continued burden of evaluating, testing, and monitoring patients with COVID or COVID-like symptoms makes it difficult to focus on chronic illness.”

Care Most Often Skipped

The Urban Institute survey asked respondents about delays in prescription drugs, general doctor and specialist visits, going to a hospital, preventive health screenings or medical tests, treatment or follow-up care, dental care, mental health care or counseling, treatment or counseling for alcohol or drug use, and other types of medical care.

Dental care was the most common type of care that adults delayed or did not receive because of the pandemic (25.3%), followed by general doctor or specialist visits (20.6%) and preventive health screenings or medical tests (15.5%).

Black adults were more likely than White or Hispanic/Latinx adults to have delayed or forgone care (39.7% vs. 34.3% and 35.5%), the researchers found. Compared with adults with higher incomes, adults with lower incomes were more likely to have missed multiple types of care (26.6% vs. 20.3%).

The report by the Urban Institute researchers was supported by the Robert Wood Johnson Foundation. Phillips is an advisor to two telemedicine companies, Bicycle Health and Grow Health. Fincher has disclosed no relevant financial disclosures.

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Words from the Wise about Covid and the Heart

Satjit Bhusri, MD, is worried about heart health, his own, and yours. A long-time New York City cardiologist, he is now treating the aftereffects of Covid-19. “What’s unusual about COVID…is that it is extremely inflammatory. That means the body attacks [the virus], and [the immune system] kind of goes overboard,” he said.

What is unnerving is that the cardiovascular damage often appears after the virus has been shed.

If the Covid-19 heart connection seems surprising, it was news to doctors too, because Covid is considered a respiratory disease. But Covid patients began showing vascular problems.

“Patients were showing blood clots forming in their legs,” he said,  And the detective work began. “What’s going on with the vascular system?”

 It is the effects of the virus that get at the heart. “It interacts and interferes with the inner lining of your blood vessels,” said Dr. Bhusri. This can lead to serious side effects. The inflammation inside the blood vessels can lead to blood clots, and these in turn can lead to heart attacks and strokes. “It also looks like it directly infiltrates the muscle of the heart and it can cause heart failure, as well as arrhythmias or dangerous heart rhythms.” 

Dangerous heart rhythms sound pretty scary. So, should people be worried? In this Covid-19 world where the CDC estimates that 83.1 million people have had Covid, many of those people without any symptoms, should we all be worried about our hearts, both those who’ve had Covid and those who haven’t?

Doctors are still investigating the full extent of Covid-19. “This is not just a simple virus, this is an animal that I strongly feel will have its own subspecialties,” said Dr. Bhusri, explaining that scientists and doctors are still studying viruses like ebola, HIV, and even the Spanish flu. He thinks research into Covid-19 is here to stay as doctors and researchers try to understand this new viral player. “The organs that we’re seeing affected and the long-term effects, we’re just starting to understand,” he explained

Others share his opinion.

David Baran, MD, the director of Advanced Heart Failure and Transplantation at Sentara Health System in Virginia spoke at a cardiovascular conference in 2020. “We are literally learning as we go along,” he said,  “One of the problems is that COVID is a shapeshifter. Just when you think you understand what you are dealing with it changes.” His remarks were reported in Diagnostic and Interventional Cardiology.  

But, back to the question at hand, should you worry about heart health? The short answer is maybe. Steven Erickson, MD, medical director for Banner University Sports Medicine in Phoenix, AZ, cautioned that people who have had Covid shouldn’t return to old levels of activity “You don’t get sick with COVID-19 and stay home from school for a week and the next day go back and play two hours of soccer,” he said in comments to the Arizona Republic. 

According to a report from The Perelman School of Medicine at the University of Pennsylvania, doctors now routinely check heart health when Covid-19 is suspected. There is no magic way to know who might have heart complications from Covid-19. Some people recover with no ill effects and others don’t. In August 2020 The Lancet discussed a case study of an 11-year-old who developed heart failure.   According to the American Heart Association, about a quarter of people hospitalized show cardiovascular conditions, and they are thought to contribute to 40% of Covid-19 related deaths.

Checking out the house 

Inside the clinic, Dr. Bhsuri has seen patients who had asymptomatic Covid, with no symptoms related to the initial virus, who went on to develop heart conditions. For those patients, the best thing is preventive testing. Dr. Bhsuri likes to think of the heart as a house, with a structure (the heart muscle), electricity, and plumbing. All of these parts can contribute to different conditions like a heart rate that is irregular, too slow or too fast, or heart disease. Dr. Bhsuri described a few cases where he’s found Covid-19 patients with new-onset heart failure, heart disease, or arrhythmias. “For thoroughness, for patients who were COVID positive no matter where they were in the spectrum of the disease, they should definitely get screened for cardiovascular disease,” suggested Dr. Bhsuri. 

Dr. Bhusri has a personal connection to his work.  In 2015 he experienced cardiac shock and was hospitalized in an ICU. During the pandemic, he ran a Covid-19 unit, quarantining away from his family. To him, this was one of the hardest things in his life, second only to his heart condition. People like Dr. Bhusri, because of the impact that Covid-19 can have on the heart and cardiovascular system, are at high risk. 

An ounce of prevention …

As for people who don’t have any pre-existing risks, Dr. Bhusri’s advice focuses on lifestyle to protect good heart health. He emphasized a good diet, preferably the Mediterranean diet, and exercise.  “Wherever you are…you have got to keep moving.” 

Avoiding heart issues, and receiving regular monitoring of your heart’s health, are the best ways to keep it healthy. And during this pandemic, following established habits — always staying masked in public, avoiding close contact, and so on — can only help that goal.

Sabrina Emms is a science journalist. She got her start as an intern at a health and science podcast out of Philadelphia public radio. Before that she worked as a researcher, looking at the way bones are formed. When out of the lab and away from her computer, she’s moonlighted as a pig vet’s assistant and a bagel baker.
Medically reviewed by Yvonne Stolworthy, MSN, RN

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Late-Window Stroke Thrombolysis Not Linked to Clot Migration Late-Window Stroke Thrombolysis Not Linked to Clot Migration

In patients with acute ischemic stroke, the use of thrombolysis in the late window of 4.5 to 9 hours after symptom onset was not associated with an increase in clot migration that would cause reduced clot accessibility to endovascular therapy, a new analysis from the EXTEND trial shows.

“There was no significant difference in the incidence of clot migration leading to clot inaccessibility in patients who received placebo or [intravenous (IV)] thrombolysis,” the authors report.

“Our results found no convincing evidence against the use of bridging thrombolysis before endovascular therapy in patients with acute ischemic stroke who present outside the 4.5-hour window,” they conclude.

“This information is important because it provides some comfort for neuro-interventionists that IV thrombolysis does not unduly increase the risk of clot migration,” senior author, Bernard Yan, DMedSci, FRACP, told Medscape Medical News.

The study was published online in Stroke on February 16.

The Australian researchers explain that endovascular thrombectomy is the standard of care in patients presenting with acute ischemic stroke caused by large vessel occlusion, and current treatment guidelines recommend bridging thrombolysis for all patients receiving thrombectomy within the 4.5-hour time window.

While thrombectomy is also recommended in selected patients up to 24 hours postonset of symptoms, it remains unclear whether thrombolysis pretreatment should be administered in this setting.

One of the issues that might affect use of thrombolysis is distal clot migration. As proximal clot location is a crucial factor determining suitability for endovascular clot retrieval, distal migration may prevent successful thrombectomy, they note.   

“Clot migration can happen any time and makes life more difficult for the neuro-interventionist who performs the endovascular clot retrieval,” added Yan, who is a neurologist and neurointerventionist at the Royal Melbourne Hospital, Australia.

In the current paper, the researchers report a retrospective analysis of data from the EXTEND trial of late thrombolysis, defined as 4.5 to 9 hours after symptom onset, to investigate the association between thrombolysis and clot migration leading to clot irretrievability.

The analysis included a total of 220 patients (109 patients in the placebo group and 111 in the thrombolysis group).

Results showed that retrievable clot was seen on baseline imaging in 69% of patients in the placebo group and 61% in the thrombolysis group. Clot resolution occurred in 28% of patients in the placebo group and 50% in the thrombolysis group. 

No significant difference was observed in the incidence of clot migration leading to inaccessibility between groups. Clot migration from a retrievable to nonretrievable location occurred in 19% of the placebo group and 14% of the thrombolysis group, with an odds ratio for clot migration in the thrombolysis group of 0.70 (95% confidence interval, 0.35 – 1.44). This outcome was consistent across subgroups.

The researchers note that, to their knowledge, this is the first randomized controlled study to assess the effect of thrombolysis on clot migration and accessibility in an extended time window.

They acknowledge that a limitation of this study is that they only assessed clot migration from a retrievable to a nonretrievable location; therefore, the true frequency of any clot migration occurring was likely to be higher, and this could explain why other reports have found higher odds ratios of clot migration.

But they point out that they chose to limit their analysis in this way specifically to guide decision-making regarding bridging thrombolysis incorporating endovascular therapy in the extended time window.

“The findings of this study are highly relevant in the current clinical environment where there are multiple ongoing trials looking at removing thrombolysis pretreatment within the 4.5-hour time window in thrombectomy patients,” the authors write.  

“We have demonstrated that thrombolysis in the 4.5- to 9-hour window is not associated with reduced clot accessibility, and this information will be useful in future trial designs incorporating this extended time window,” they add.

Commenting on the study for Medscape Medical News, Michael Hill, MD, University of Calgary, Canada, said: “Thrombus migration does happen and is likely part of the natural history of ischemic stroke which may be influenced by therapeutics such as thrombolysis. This paper’s top-line result is that thrombus migration occurs in both treated and untreated groups — and therefore that this is really an observation of natural history.”

Hill says that, at present, patients should be treated with thrombolysis before endovascular therapy if they are eligible and these results do not change that recommendation. 

“The results of the ongoing trials comparing direct thrombectomy with thrombolysis plus thrombectomy will help to understand the potential clinical outcome relevance of this phenomenon,” he added.

The EXTEND trial was supported by grants from the Australian National Health and Medical Research Council of Australia and the Commonwealth Scientific and Industrial Research Organization Flagship Program.

Yan reported no relevant financial relationships.

Stroke. 2021. Published online February 16. Abstract.

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This Trial Allows for Medical Abortion Via the Mail

In December, the Supreme Court reversed a lower court ruling that had allowed abortion medications to be sent by mail. Since then, women looking to terminate a pregnancy with the combination medications packet containing mifepristone and misoprostol now must go, in person, to a medical provider.

But this in-person requirement is not necessary in many states and Washington, D.C.  Since March 2016, a study has been underway to follow participants who have used the drugs and to assess the drugs’ safety and tolerability. The trial’s sponsor is Gynuity Health Projects; the trial’s listed completion date on clinicaltrials.gov is June 2022. The participating states are listed here.

This medical abortion clinical trial is called TelAbortion.  Tara Shochet, project director, told Medical Daily that “ TelAbortion is an FDA-approved study to evaluate the safety, efficacy, and feasibility of providing medical abortion using telemedicine and mail. The study operates under an [investigational new drug] with the FDA, which allows study sites to mail the medications to study participants.”

The safety data from the TelAbortion study might support removing mifepristone from the FDA’s dangerous drugs list called REMS. A drug that lands on the REMS, or Risk Evaluation and Mitigation Strategy, does so because it is suspected of causing serious harm. 

Because of REMS mifepristone is not available at any retail pharmacy in the US.  It is only available through a certified provider at a clinic, medical office or hospital. Although some states would permit mifepristone to be sent through the mail, drugs on the REMS list are subject to federal law.

 Providers who participate in the trial must be licensed to practice according to their state’s laws. Ms. Shochet stressed that TelAbortion does not violate the Supreme Court’s recent decision.  She explained that “ Providers cannot sign up to join the study, and the FDA restriction that forbids mailing of mifepristone is for the entire country.”  

TelAbortion has  9 site partners who provide the TelAbortion services in 17 states and Washington, DC.  She added that TelAbortion does not provide services in any state outside of those within the study’s approved locations. 

Disproving a REMS listing

The FDA put mifepristone on its REMS list when it was first approved in 2000. A look at studies from that time on seems to suggest taking this combination any later than 9 weeks’ gestation  not only reduced efficacy, but caused serious medical issues. A 2005 study that looked at adverse events discussed viability during the second trimester, which begins well after the fewer than 10 weeks’ cut-off currently prescribed.  It did not have breakdowns as to when the adverse events took place.

However,  a 2015 study of 13,373 women, which did not go beyond 63 days gestation, or 9 weeks, said the rates of women with infection that required hospitalization was 0.01%; for transfusions, 0.03%. The 2005 study, which involved 607 events involving mifepristone over a four-year time period, listed 513 cases needing surgery and 43 cases needing parenteral antibiotics.

In 2016, the FDA amended the original approval indication for mifepristone by decreasing the gestational age for its use and changing the dosing allowance. 

Today many providers believe that REMS is unnecessarily restrictive as there are now more than 20 years of data. Daniel Grossman, MD, director, Advancing New Standards in Reproductive Health at the Bixby Center, University of California, San Francisco, told Medical Daily “there is no medical reason to require patients to come in person to a clinic to receive the pills for medication abortion—especially because patients are not required to take the medication in the office. This requirement creates an obstacle to care and increases the risks of coronavirus transmission during the pandemic.”An article in the NEJM reported that by 2016 mifepristone had been used by more than 3 million women in the US with 19 deaths reported to the FDA. Meanwhile pregnancy-related deaths in the US are 14 times that figure.  In 2018, there were 17 maternal deaths for every 100,000 live births — almost 32% of all deliveries in 2018 were by cesarean section.

The breakdown of pregnancy-related deaths in 2018:

  • Almost 33% occurred during pregnancy
  • 17% occurred on the day of delivery
  • 52% occurred after delivery caused by infection, hemorrhaging, and so on

Trial participation

For a woman to qualify as a participant,  the pregnancy must be less than 10 weeks along and verified by ultrasound, which can be done locally.  There is a video appointment between patient and provider. Then, if the woman is approved as a trial participant, the pills are mailed and must be taken while the pregnancy is less than 10 weeks along.

Ms. Shochet said the pills have been mailed to approximately 1500 study subjects since the project began in 2016.  

There are a few reasons why someone would choose medical abortion, especially during the pandemic. P rivacy and controlling the timing of the abortion are two reasons women seek medical abortions.

Current information suggests that health risks related to pregnancy and childbirth outweigh the risk of medical abortion.   Removing mifepristone from REMS has the potential to increase access to a safe and effective early-abortion alternative when an unplanned pregnancy occurs. 

Planning for an appointment with an abortion provider often includes arranging for time off from work and child care. Other barriers mentioned in obtaining a medical abortion include transportation and travel expenses.

Yvonne Stolworthy MSN, RN graduated from nursing school in 1984 and has spent many years in critical care and as an educator in a variety of settings, including clinical trials. 

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Tree Resin Compound Defeats Drug-Resistant Bacteria in Lab Tests Tree Resin Compound Defeats Drug-Resistant Bacteria in Lab Tests

A new compound made from tree resin kills almost 100% of drug-resistant bacteria without harming healthy tissue, laboratory studies suggest.

Made into a film, this nanocellulose could be used as a wound dressing or as a protective surface on medical implants.

Researchers have been surprised by its efficacy in the studies so far. “It was like a wonder,” Ghada Hassan, a doctoral student in pharmacy at the University of Helsinki in Finland, told Medscape Medical News. She and her colleagues published their findings in Applied Bio Materials .

Bacteria are able to evolve resistance to new antibiotics sometimes within only a few years. Infection by methicillin-resistant Staphylococcus aureus (MRSA) is a particular problem in pressure ulcers and wounds from prosthetic, plastic, and reconstructive surgery.

In search of a medicine that could retain its efficacy against these difficult-to-treat bacterial strains, Hassan noticed in Finnish pharmacies a traditional treatment for small wounds made from the resin of conifers. References to resin as a wound dressing date back 500 years in Finland, and there are many favorable anecdotal reports, she said.

Trees produce the resin when injured to protect themselves from infection. As the resin has maintained its effectiveness for millions of years, Hassan reasoned that bacteria could not easily evolve resistance to it.

However, raw tree resin would be difficult to use in many medical procedures. “For implants you cannot open the patient and pour in some resin there and then close the patient and hope it will be well,” she said.

Using dehydroabietic acid derivatives, Hassan and her colleagues modified the resin, creating a film that could be used both in wound dressings and as a coating for implants.

In an early test, they applied MRSA directly to sheets of the modified nanocellulose and found that 99.999% of the bacteria died.

In a second experiment, they created an artificial dermis containing horse plasma on which they cultivated MRSA. They then applied a film made up of the experimental nanocellulose and found that it was highly effective in killing the bacteria.

In a third experiment they placed human erythrocytes directly on sheets of the modified nanocellulose and found that most of the erythrocytes survived, as did skin fibroblasts in similar experiments.

In further experiments, they found that the nanocellulose could kill multiple strains of S. aureus, as well as Escherichia coli.

The novel compound seems to damage bacteria through multiple mechanisms, making it more difficult for the organisms to evolve resistance, Hassan said.

Early, but Good Potential

The research suggests a lot of potential for the new compound, said Aaron Glatt, MD, a professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City and a spokesperson for the Infectious Diseases Society of America. But it must undergo clinical trials before it can realize that potential, he told Medscape Medical News.

“This paper is certainly no indication that it will become the definitive answer,” he said. “What looks good in a laboratory, what looks good in a test tube, let’s put it to the test in real life.”

In addition, even if it passes muster in clinical trials, it will have to show cost-effectiveness, said Barry Kreiswirth, PhD, adjunct faculty member of the department of medicine at New York University in New York City.

“As an example, we know that using copper bed rails and other copper products in a hospital setting reduces infections, but no one is willing to pay the extra cost to copperize a hospital bed,” he told Medscape Medical News in an email.

That said, the modified nanocellulose is less expensive and less toxic than copper and silver, which are also being tested as a coating for implants, Hassan said. “Cellulose is the most abundant polymer on Earth,” she said. And unlike some other material under consideration, its bacteria-killing ingredients don’t leach out into the environment, so it may stay effective for a longer time, she said.

Her laboratory is currently closed as a protection against COVID-19, but when it opens she would like to next test the material against pathogenic fungi and viruses.

ACS Appl. Bio Mater. 2020;3:4095−4108. Full text

Hassan, Kreiswirth, and Glatts reported no relevant financial relationships.

Laird Harrison writes about science, health, and culture. His work has appeared in national magazines, in newspapers, on public radio, and on websites. He is at work on a novel about alternate realities in physics. Harrison teaches writing at the Writers GrottoVisit him at www. lairdharrison.com or follow him on  Twitter: @LairdH

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The Do’s and Don’ts on Social Media for Vaccine Haves and Have-Nots

Posting about their day is a regular practice for Generations Y and Z, especially when they have something novel or exclusive to share. So, in the thick of a global pandemic, and with the shaky rollout of covid vaccines making them somewhat of a holy grail, it’s no surprise selfies featuring the coveted shot are infecting social media timelines.

It might engender envy, even outrage, especially if the person posting seems to have cut the line. But what if the intention was to encourage others to also get the shot? Does that make it OK?

Since the pandemic began, people around the world are increasingly living out significant portions of their lives online. But with 72% of the American public using some type of social media, according to the Pew Research Center, who sets the rules for proper social media etiquette?

“This is a totally new type of world to have a pandemic in,” said Catherine Newman, the etiquette columnist at Real Simple and author of the book “How to Be a Person.” One advantage of using social media, she said, is that people can create waves of public opinion from which everyone can benefit. Newman, who also volunteers at a hospice, was vaccinated and posted a selfie. She said the selfies can help address some of the public health mistrust issues that have contributed to vaccine hesitancy.

“I don’t want to see a picture of your yacht on social media,” she said. She’d rather see covid vaccine selfies but cautions users to be mindful of the caption they choose.

After all, nearly 500,000 American lives have been lost in the pandemic and stark disparities have emerged in vaccination rates — especially among communities of color and older adults who are in the highest risk categories.

It raises the question: Is posting a vaccine selfie on your social media account a faux pas or still par for the course?

Elaine Swann, a lifestyle and etiquette expert, a certified mediator in the state of California and the founder of the Swann School of Protocol in Carlsbad, California, echoed those precautions. “RNs and front-line workers have a very different story to tell than a 20-something-year-old who got vaccinated for some obscure reason,” she said.

At the same time, she said, it’s not necessarily clear how someone came to be eligible for the vaccine. A person could present young and healthy at first glance but could have a health condition or other qualifying criteria. “We don’t know,” she said. She advises that posters follow what she calls the three core values of manners: respect, honesty and consideration.

And the same goes for people reacting to the posts.

George Francois, 35, a center director at Children’s National Hospital in Washington, D.C., chronicled his covid vaccination on Facebook. Looking at the overall death and infection rates in the African American community, he considered his post a public service. “I could inspire others to get it without having to talk to them directly,” he said.

It’s a sentiment shared by J. Shawn Durham, 44, an actor in Washington, D.C., and an unintentional “vaccine vulture.” He got a call from a friend of a friend to get vaccinated after a scheduled patient missed their appointment — leaving a critical dose that otherwise might have gone to waste. “I am healthy. I am Black. I am scholastic, so I know about our history and the Tuskegee experiments,” he said. And, given that history, Durham posted his selfies to “lead by example,” he added. “The white and the wealthy are getting vaccinated. I want Black people to want to get vaccinated too.”

Francois didn’t receive any backlash from his post and didn’t think it was a big deal. “A lot of people post their HIV and covid test results,” he said.

Bottom line: It’s common among younger adults to publicly share things some older adults may consider to be far too personal.

“It’s kind of tacky sometimes, I think, but there’s a lot of misinformation out there,” said Emilio Delgado, 31, who was born in Puerto Rico and now lives in D.C. He posted in part to foster confidence in the vaccine — to let his connections “see that someone they knew has taken it and didn’t grow a third eyeball,” he said of his hesitant followers. For that reason, he added, it was worth it.

Delgado, a local actor and patient instructor at the George Washington University School of Medicine and Health Sciences, had access to the vaccine because in this role of “standardized patient” he is often called in to role-play ultrasounds with fourth-year medical students. He makes the bulk of his income through such patient instruction and is frequently at the hospital — a place generally considered high-risk — so he’d rather be vaccinated.

For Signe Hawley, 34, a researcher and volunteer firefighter in the foothills of northwestern Boulder, Colorado, getting the vaccine — and posting about it — was an emotional experience.

Earlier in the pandemic, she made the difficult decision to pull back from her volunteer duties to protect her wife and 2-year-old daughter. But because she had been a first responder in her community, she became eligible for the vaccine sooner than expected. “I wouldn’t cut the line,” said Hawley. “But when given the opportunity, I wouldn’t pass it up either.”

For Hawley, the hardest side effect she faced after getting the vaccine was the depth of grief and sadness that surfaced surrounding the loss of her father, along with thoughts of all of the other lives lost “in the mismanagement of this,” she said.

Her father, Joe Hawley Sr., 67, died in early April from complications of covid-19 at Norwalk Hospital in southwestern Connecticut. His family was not allowed into the intensive care unit at any time during his bout with covid. And her interest in volunteerism and service is something she inherited from her father, a “humanitarian at heart,” who was involved and committed to the New England community where he lived.

“To be vaccinated for something that my father died from is so surreal,” she said, her voice breaking. Sharing her story and the vaccine photo was a way to honor her father. “This is one step to lessening the impact of death and severe health complications with covid, but it’s not the end of it,” she said.

Ultimately, she said, the more people vaccinated the better off we all are.

“We’re all posting this hoping to get buy-in,” said national etiquette expert Diane Gottsman, an author and founder of the Protocol School of Texas, a company specializing in corporate etiquette training based in San Antonio. Know your audience, she advised. And another important reminder: Follow Federal Trade Commission guidelines, which advise against posting vaccination cards containing identifying information that could expose you to identity theft.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Abandoned Cardiac Device Leads Don’t Rule Out MRI Abandoned Cardiac Device Leads Don’t Rule Out MRI

Data from an observational cohort study suggest that the presence of abandoned leads in patients with cardiac implantable electronic devices (CIEDs) should no longer be an absolute contraindication to MRI.

In the study, which spanned 7 years and included 139 consecutive patients, adverse events were few, mild, and transient. The results were published online February 17 in JAMA Cardiology.

Dr Robert Schaller

Evidence is growing that MRI can be done safely in the presence of abandoned leads, thus calling into question the need to make them an absolute contraindication, lead author Robert D. Schaller, DO, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, told theheart.org | Medscape Cardiology.

Protocols for MRI have been in place for patients with MRI-conditional devices, and recent data suggest that scanning patients with nonconditional or legacy devices is safe. This has led to changes in Centers for Medicare & Medicaid Services (CMS) reimbursement policies for MRI in patients with legacy CIED systems, Schaller said.

However, abandoned leads have been thought to act as antennae that result in tissue heating and arrhythmia induction, and they have been excluded from CMS reimbursement due to a paucity of safety data.

An earlier study from researchers at the Mayo Clinic, Rochester, Minnesota, showed no evidence of myocardial injury, as measured by cardiac troponin T, in 80 patients who underwent 97 MRI scans with 90 abandoned leads in place during the scans.

“We are the second paper, the largest one, so I think there’s enough data now for more programs to open up in order to replicate our data, with the eventual goal being for government regulators like the CMS and medical societies to finally question whether or not this is an absolute contraindication,” Schaller said.

“We felt that abandoned leads were probably safe, the risk was overblown, so in certain situations, when the patient really needed an MRI, we would go ahead and do it, informing the patient there is enhanced risk but we don’t know for sure, and they would be part of our registry. Every time we did it, nothing bad happened, so eventually we started doing it in all comers who needed an MRI and there were no safety issues,” he said.

The current cohort study included 139 consecutive patients (110 men, mean age 65.6 years) who underwent 1.5-T MRI with at least 1 abandoned lead between January 2013 and June 2020.

In all, 200 MRIs of various anatomic regions including the thorax were performed.

There was a total of 243 abandoned leads, with a mean of 1.22 per patient; the mean number of active leads was 2.04, and 64 patients (46%) were pacemaker dependent.

A transmit-receive radiofrequency coil was used in 41 patients (20.5%), all of whom underwent MRI of the brain.

There were no abnormal vital signs or sustained tachyarrhythmias, no changes in battery voltage, power-on reset events, or changes of pacing rate noted.

Decreased right atrial sensing in four patients and decreased left ventricular R-wave amplitude in one patient were transiently observed, and one patient reported sternal heating that subsided when the MRI was stopped.

“We tell patients to tell us if they feel anything abnormal. There was one patient who felt a little bit of burning in her chest, so we stopped the scan right away and the burning went away. It didn’t really make sense where the patient felt it so we’re still not sure, and it probably was not associated with the MRI, but this illustrates that you need to maintain audio and visual contact with the patient throughout the MRI,” Schaller said.

“The bottom line is, every time we did it, it was safe, nothing bad happened,” he said.

In an invited commentary, Robert J. Russo, MD, PhD, of The Scripps Research Institute, La Jolla, California, writes that this report “represents an important contribution to the literature that addresses MRI with abandoned pacing leads, the last remaining obstacle to the performance and CMS coverage for MRI in patients with an implanted cardiac device.”

“There should be very few obstacles for patients with pacemakers or defibrillators to gain access for a clinically indicated MRI,” Russo told theheart.org | Medscape Cardiology.

Dr Robert Russo

“In today’s world, the only obstacle I can think of is when the device generator battery is close to the end of its life. That is when it is most vulnerable for changes that occur in the MRI scanner, but as long as it isn’t close to that point, we can scan basically everyone. And you could still scan that patient, but you need to be aware of the potential changes that can occur,” he said.

Russo concludes with the hope that future registry data will be sufficiently compelling to prompt CMS to further revise the existing National Coverage Determination (NCD) and to remove the coverage restriction for patients with an abandoned lead undergoing MRI with or without a pacemaker or defibrillator generator.

“The body of research to date has clearly demonstrated that no patient with a non-MRI-conditional system or an abandoned pacing lead should ever be exposed to the risks associated with pacing lead extraction, nor should access or coverage be denied to clinically indicated MRI for these patients, owing to an overestimation of risk of an appropriately performed and monitored scan,” he said.

The study was funded in part by the Richard T. and Angela Clark Innovation Fund. Schaller and Russo have disclosed no relevant financial relationships.

JAMA Cardiol. Published online February 17, 2021. Abstract, Editorial

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FDA Warns About Potential Inaccuracies With Pulse Oximeters FDA Warns About Potential Inaccuracies With Pulse Oximeters

Pulse oximeters have become popular during the COVID-19 pandemic for people to track their oxygen saturation, but they may not always be accurate, the FDA cautioned in new guidance released Friday.

Several factors can affect the accuracy of pulse oximeters, including poor circulation, skin temperature, skin thickness, current tobacco use, use of fingernail polish, and dark skin pigmentation, the FDA said. A recent report in the New England Journal of Medicine shows that Black patients may not receive accurate readings from some oximeters.

“While pulse oximeters may be useful for estimating blood oxygen levels, these devices have limitations that can result in inaccurate readings,” William Maisel, MD, director of the FDA’s Office of Product Evaluation and Quality, said in a statement.

Maisel encouraged people to pay attention to all of their health symptoms, especially if they experience signs of low oxygen saturation levels, such as shortness of breath or bluish coloring on their face, lips, or nails.

“Patients with conditions such as COVID-19 should not rely solely on pulse oximeter measurements to monitor their health at home as they are not a substitute for a medical diagnosis by a health care provider,” he said.

A pulse oximeter, which is typically placed on the fingertip, uses infrared light beams to estimate the amount of oxygen in the blood and the pulse rate. Typical oxygen saturation levels vary between 95% to 100% and can be somewhat lower in people with lung problems. Health care providers and consumers have monitored oxygen saturation during the pandemic because COVID-19 can cause levels to drop, with lower than 90% being a cause for concern.

Consumers can buy over-the-counter oximeters in stores or online, but they’re not intended for medical use and don’t undergo FDA review, according to the FDA alert. Prescription oximeters undergo agency review and are typically used in hospitals and doctor’s offices, though sometimes patients receive a prescription to use one at home.

The FDA guidance gives tips to help patients and caregivers take an accurate reading and interpret the results correctly. Importantly, changes or trends in measurements are more meaningful than a single measurement, according to the guidance. If patients are concerned about a pulse oximeter reading, they should contact their healthcare provider, especially if their symptoms become worse or they think they may have COVID-19.

The FDA is evaluating the current research about pulse oximeter accuracy, particularly with a focus on studies that evaluate whether the products are less accurate for people with darker skin. Based on new findings, the FDA may update its pulse oximetry guidance and will inform the public if new information becomes available. The FDA also encourages consumers to report any pulse oximeter issues through the MedWatch Voluntary Reporting Form.

Sources

FDA, “Pulse Oximeter Accuracy and Limitations: FDA Safety Communication.”

FDA, “FDA In Brief: FDA warns about limitations and accuracy of pulse oximeters.”

FDA, “MedWatch Online Voluntary Reporting Form.”

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Smell something funny? Warnings and recalls for fish, cheese, medicine

It’s time for a Food and Drug Administration recall update, a chance to check your pantry, fridge, medicine cabinet for offending products. 

There have been 34 recalls so far in 2021, everything from salad kits to nasal spray. Sometimes a recall emanates from the manufacturer because a product has been mislabeled. Other times, like when a product is making people sick, the FDA does the honors.

Dangerously cheesy  

One such case is queso fresco, a soft fresh cheese often used in Mexican food. On February 17 th , the FDA announced that its investigation into seven cases of Listeria had zeroed in on the cheese as a possible source of the bacteria, “Although the investigation is ongoing, CDC’s analysis of epidemiologic information indicates that Hispanic-style fresh and soft cheeses are the leading hypotheses for the cause of the illnesses,” the FDA explained in a press release. 

Listeria is a type of food poisoning caused by the bacteria Listeria monocytogenes and that can be especially dangerous for pregnant women, people 65 and older or with a preexisting condition that weakens the immune system. 

The FDA reported that not only had three of the people who got sick remembered eating queso fresco, but that samples of the cheese also showed Listeria monocytogenes. More genetic testing is needed to prove that the cheese, and which specific brand, may have caused the outbreak. “At this time, there is not enough evidence to determine if this outbreak is linked to El Abuelito Queso Fresco,” read the FDA statement.

Until there is an official recall, the FDA is warning consumers and restaurants that they should not purchase, consume, or serve El Abuelito Queso Fresco cheese and should avoid “Hispanic-style fresh & soft cheeses” until further information is available. In general, the FDA suggests buying queso fresco made with pasteurized milk to lessen the risk of bacterial contamination.

Something fishy 

While the cheese investigating cures, other cases are more cut and dry. L itehouse Inc. and Russ Davis Wholesale have issued voluntary recalls of products for not properly disclosing anchovies contained in their products.

Litehouse Inc., recalled its Brite Harbor Caesar Dressing packets, called pillows, due to undisclosed anchovies. Russ Davis did the same for its Buffalo Cauliflower Bites with Kowalski’s Steakhouse Blue Dressing because of anchovies in the blue cheese dressing.

Anchovies, a small fish, pose a significant allergy risk. Fish is one of the eight most common allergies, alongside tree nuts, shellfish, milk, eggs, soy, peanuts, and wheat  When left unmarked, there is a chance that people with allergies could unintentionally consume the product.

A dangerous secret

Food items aren’t the only recent recalls. Adam’s Secret issued a voluntary recall for its Extra Strength 1500 and 3000 capsules. What, you ask, is Adam’s Secret? The male enhancement pills claim to “help stimulate activity ” using a blend of herbs like Ginkgo Biloba and Maca.

The FDA prompted the recall after lab testing found that, mixed in with the blend of herbs the pills contained sildenafil, the generic name for Viagra. So Adams’ real secret is that along with all those natural herbs and supplements, there is a little bit of all-natural phosphodiesterase type 5 (PDE5) inhibitor, the special drug name for erectile dysfunction medication.  

Sildenafil is a safe and legitimate drug. But it requires a prescription. Adding it without telling consumers could lead to dangerous side effects. In its recall alert, the FDA warned that “ Consumers with underlying medical issues who take Adam’s Secret Extra Strength 1500 or Adam’s Secret Extra Strength 3000 capsules…may experience serious health risks.”

The FDA explained that prescription drugs for diabetes, high blood pressure, or heart disease could interact with Adam’s Secret. As of yet, no consumer injuries have been reported.

Sabrina Emms is a science journalist. She got her start as an intern at a health and science podcast out of Philadelphia public radio. Before that she worked as a researcher, looking at the way bones are formed. When out of the lab and away from her computer, she’s moonlighted as a pig vet’s assistant and a bagel baker.

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COVID-19 Vaccines Were Rushed, but ‘All Steps Taken’ COVID-19 Vaccines Were Rushed, but ‘All Steps Taken’

Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

Yes, the vaccines already authorized for emergency use against SARS-CoV-2 infection were developed relatively quickly. However, speediness does not equal sloppiness, and all necessary steps were taken in the process, experts said this week.

Dr Matthew Zahn

“The speed with which safe and effective vaccines have been developed is really a tribute to medical science in this country. At the same time, that speed understandably raises concerns about the process of developing and assessing these vaccines,” Matthew Zahn, MD, said during a February 18 media briefing sponsored by the Infectious Diseases Society of America (IDSA).

Dr Dial Hewlett Jr

Regarding development of the two mRNA vaccines, “although a lot of people will say this was rushed and that we didn’t do everything we would ordinarily do, actually, everything was done” according to FDA and CDC Advisory Committee on Immunization Practices (ACIP) guidelines, said Dial Hewlett Jr, MD, medical director of the Division of Disease Control, Westchester County Department of Health, White Plains, New York, during the IDSA briefing.

“I am very confident in the safety and efficacy of these vaccines,” said Zahn, medical director at the Division of Epidemiology and Assessment, Orange County Health Care Agency, Santa Ana, California.

The vaccine development process was compressed into a shorter time period because there was a heightened focus during the pandemic and a lot of additional resources, Hewlett said. “The result was the development of two vaccines rather rapidly, which have been shown to be safe and effective — the mRNA vaccines.”

“And there are other vaccines and other platforms we believe will also be safe and effective,” Hewlett added.  

“The point cannot be emphasized enough: There was increased velocity of development bringing these vaccines to evaluation by the FDA and ACIP, but this did not involve skipping steps,” Zahn said. 

Zahn has attended ACIP meetings for more than a decade as a liaison on behalf of the National Association of County and City Health Officials. Instead of meeting every 3 months as normal, ACIP has met at least once a month over the past year to review emerging data, he said.

The Hazards of Hesitancy

Fears that the mRNA vaccines were rushed contributes to an overall issue of vaccine hesitancy. There is a real public health and individual risk, Zahn said.

“We always worry about vaccine hesitancy from a public health standpoint,” he said. “People’s fears during the pandemic that these vaccines are not safe or do not work will result in unnecessary disease and unnecessary death.”

Hewlett added, “We as scientists and physicians feel these vaccines are quite safe and effective. And we’re encouraging people to utilize these vaccines…once they are eligible.”

Lessons Learned So Far

When asked what experts have learned about vaccines over the past year, Zahn said that “one of the takeaways from the public health side is the safety and effectiveness of mRNA vaccines.”

“The thing we can learn from this experience,” Hewlett added, “is that the science was done extremely well, very effectively, and very thoroughly.”

However, with distribution, “there is a lot of room for improvement,” Hewlett said. “In the future, having a centralized plan for the mass production and the distribution of vaccines will be extremely important and extremely helpful.”

Damian McNamara is a staff journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology, and critical care. Follow Damian on Twitter:  @MedReporter.

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