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I’m part of a COVID-19 vaccine trial in New Jersey

On the afternoon of Sept. 22, I became a data point in the search for a vaccine to prevent COVID-19.

That’s when I received the first of two shots in a clinical trial to develop a vaccine, and became one of 30,000 volunteers to take a needlestick for science.

Why am I doing it? A combination of altruism, curiosity, and a sense of duty as a journalist. But more on that later.

Aside from the nurse who injected me and the hospital pharmacy that supplied her with the injection, no one else knows whether I received a placebo or the would-be vaccine. Not me. Not even Dr. Bindu Balani, the principal investigator in the trial at Hackensack University Medical Center, one of 89 study sites around the country.

This is called a double-blind study because both the researchers and the participants are blind to what was inside that syringe.

I admit, I have a hunch. But I won’t share it, in case the team monitoring me reads this.

A participant in Moderna’s clinical trial of a vaccine for COVID-19 receives an injection. Half of the participants received the vaccine, and half received a placebo. (Photo: Lindy Washburn)

The vaccine being tested was developed as part of America’s Operation Warp Speed by ModernaTX, a decade-old Cambridge, Massachusetts biotech company. Moderna has been awarded $955 million in government funding for the project, although it has never brought a vaccine to market. If this vaccine is shown to be safe and effective, the federal government has contracted to buy 100 million doses, with an option for 400 million more.    

For seven days after my injection, I took my temperature each evening, measured the size of the mosquito-bite-sized bump on my arm as it faded away, and noted that at first my arm hurt a little, but “not enough to affect daily activities.” I recorded this and other information — including my lack of headaches, fatigue, muscle aches and nausea — on a secure phone app that sends the data to Moderna.  

Weighing the pros and cons

My journey to the curtained cubicle where I received the first injection began on the job. I’m a health care reporter, and I had been covering the pandemic for six months when I wrote a story about clinical trials for the vaccine starting in New Jersey.   

I wanted to do something to help, and was fascinated by how a vaccine could be developed and brought to market so rapidly amid a pandemic. I thought a first-person account of what it’s like to be a guinea pig these days might make a good story. 

So I completed an online questionnaire declaring my interest in volunteering. A few weeks later, a nurse followed up with a phone call.

Her enthusiasm was contagious. She and other nurses had volunteered to work weekends to recruit volunteers, she said. She was excited to be part of a project to bring an end to the pandemic. 

Chances were 50-50 I’d get a placebo,

The New England Journal of Politics, Part II

The entrance to the editorial offices of the New England Journal of Medicine in Boston.



Photo:

AP

The New England Journal of Medicine (NEJM) his week published an editorial denouncing “dangerously incompetent” leadership in Washington on the pandemic and all but endorsing Joe Biden for President. This will go down well in all the right precincts. But then please don’t complain if half of America suspects that science is increasingly politicized.

The editorial recites the government’s well-known failures in managing the coronavirus, such as the initial struggles to roll out testing and hand out enough protective equipment. We can’t disagree with that, but the editors go on to extol China’s virus management, conveniently ignoring its early cover-up and manipulation of the World Health Organization. Why are American elites so enamored of authoritarian command and control? The editors then hit the U.S. for late and inconsistent quarantines, without taking into account the public-health and economic costs of lockdowns.

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You might say “the New England Journal is joining the ranks of academic publications risking their reputations as non-partisan arbiters of good science in order to rumble in the political tarpits.” That’s a line from our 2006 editorial “New England Journal of Politics” describing how the NEJM had waded into a legal dispute over Merck’s painkiller Vioxx. The NEJM also appeared in these pages in 2007 for working to tank a diabetes drug and help Democrats in Congress to regulate treatment approvals more tightly.

Our contributor Scott Gottlieb noted at the time that medical journals have “historically played a special role in helping to define medical practice standards. Even decisions they make on how prominently to place a study, let alone how they editorialize about it, are seen as strong signals to clinicians on how doctors should weigh the evidence. So when editors pursue a political agenda, it’s public health that pays a price.”

Another prominent medical journal, The Lancet, has its own history of political incursions, such as a study on Iraq war casualties funded by anti-George W. Bush partisans. The NEJM’s latest editorial laments that “current leaders” have “undercut trust in science.” The irony is that much of the public distrust of expertise derives from years of scientists behaving like politicians.

Wonder Land: Leading epidemiologists have come together to write “The Great Barrington Declaration,” which urges a “Focused Protection” strategy in managing the coronavirus, and has already been signed by thousands of scientists. Images: Getty Composite: Mark Kelly

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Personal resilience plays big part in heart health for Black Americans

Black people who have a strong sense of psychological well-being may have better heart health, a new study indicates.

It suggests that feelings of optimism and a sense of purpose and control — hallmarks of psychosocial resilience — are more important to heart health than where people live, researchers said.

Lead researcher Tené Lewis, an associate professor at Emory University’s Rollins School of Public Health in Atlanta, noted that differences in heart health between Black and White Americans have been documented for decades. But individual factors affecting Black Americans have not been well understood.

“Almost everything we know about Black Americans and their health focuses on deficits, yet we really need to begin to identify strengths,” she said. “Understanding which strengths matter most for Black Americans — and under which contexts — will allow us to develop the most appropriate and applicable public health interventions for this group.”

For the study, the researchers recruited nearly 400 Black volunteers between the ages of 30 and 70. They investigated whether the American Heart Association’s Life’s Simple 7 metrics were linked to better heart health among them. The seven measures include smoking, physical activity, diet, weight, blood sugar, cholesterol and blood pressure.

Participants also completed standard questionnaires gauging their psychosocial health.

This information was then compared with neighborhood data on heart disease and stroke and death rates.

In neighborhoods with high rates of heart disease and stroke, Black adults with higher psychosocial resilience had a 12.5% lower risk of heart disease than those who were less resilient, the researchers found.
The findings were published Oct. 7 in the journal Circulation: Cardiovascular Quality and Outcomes.

“We assumed that being both high on psychosocial resilience and living in a resilient neighborhood would be the most beneficial for cardiovascular health, yet what we found was that psychosocial resilience demonstrated the most robust association regardless of the neighborhood resilience measure,” Lewis said in a journal news release.

She said more studies like this one are needed to fully understand and respond to factors that promote better health for Black Americans.

More information

For more on mental health and heart health, head to the American Heart Association.

Copyright 2020 HealthDay. All rights reserved.

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Americans part of hepatitis C virus discovery

David Keyton, Frank JOrdans, Associated Press
Published 6:12 a.m. ET Oct. 5, 2020

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Thomas Perlmann, far right, Secretary of the Nobel Assembly announces the 2020 Nobel laureates in Physiology or Medicine during a news conference at the Karolinska Institute in Stockholm, Sweden, Monday Oct. 5, 2020. (Photo: Claudio Bresciani, AP)

STOCKHOLM — Americans Harvey J. Alter and Charles M. Rice, and British scientist Michael Houghton were awarded the Nobel Prize for Medicine or Physiology on Monday for the discovery of the hepatitis C virus.

Announcing the prize in Stockholm on Monday, the Nobel Committee noted that the trio’s work helped explain a major source of blood-borne hepatitis that couldn’t be explained by the hepatitis A and B viruses. Their work make possible blood tests and new medicines that have saved millions of lives, the committee said.

“Thanks to their discovery, highly sensitive blood tests for the virus are now available and these have essentially eliminated post-transfusion hepatitis in many parts of the world, greatly improving global health,” the committee said.

“Their discovery also allowed the rapid development of antiviral drugs directed at hepatitis C,” it added. “For the first time in history, the disease can now be cured, raising hopes of eradicating hepatitis C virus from the world population.”

The World Health Organization estimates there are over 70 million cases of hepatitis worldwide and 400,000 deaths each year. The disease is chronic and a major cause of liver inflammation and cancer.

The prestigious Nobel award comes with a gold medal and prize money of 10 million Swedish kronor (over $1,118,000), courtesy of a bequest left 124 years ago by the prize’s creator, Swedish inventor Alfred Nobel.

The medicine prize carried particular significance this year due to the coronavirus pandemic, which has highlighted the importance that medical research has for societies and economies around the world.

The Nobel Committee often recognizes basic science that has laid the foundations for practical applications in common use today.

The award is the first of six prizes being announced through Oct. 12. The other prizes are for outstanding work in the fields of physics, chemistry, literature, peace and economics.

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Trump receiving remdesivir antiviral drug as part of experimental treatment

President Donald Trump is receiving an experimental antiviral for Covid-19 called remdesivir as he remains hospitalized at Walter Reed National Military Medical Center in Bethesda, Maryland. The drug is being given as part of a double-barreled treatment plan that includes an antibody cocktail meant to give the president’s immune system a boost to fight off the coronavirus.

The president was given the first dose of remdesivir Friday evening and will be on a five-day course of the IV drug, his physician, Dr. Sean Conley, said during a news conference Saturday.

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Remdesivir, manufactured by Gilead Sciences, works by lowering the amount of virus in the body. Clinical trial data published in May found that the drug reduced patients’ length of hospital stay by about four days, from 15 days to a median of 11 days.

In July, additional data showed remdesivir may reduce deaths.

“It’s not really a treatment in the sense that it’ll cure people,” Dr. Irwin Redlener, director of the Pandemic Resource and Response Initiative at Columbia University’s National Center for Disaster Preparedness, said Saturday on MSNBC. “It will just hopefully reduce the fatality rate and reduce the course of the illness.”

Remdesivir is generally used for patients who need supplemental oxygen, although Conley said Trump did not need help breathing Saturday morning. When pressed during the briefing about whether the president had ever received supplemental oxygen, Conley persistently said the president had not received oxygen on Thursday or while at Walter Reed on Friday and Saturday.

It was unclear whether the president needed oxygen at another time.

Conley told reporters Saturday that Trump is doing “very well” but the coming days will be critical to the president’s recovery.

“With the known course of the illness, day seven to 10, we get really concerned about the inflammatory phase, phase two,” Conley said. “Given that we provided some of these advanced therapies so early in the course, a little bit earlier than most of the patients we know and follow, it’s hard to tell where he is on that course.”

Not the usual care

In addition to remdesivir, the president has received a combination antibody treatment. It’s a cocktail of two monoclonal antibodies. Antibodies act by recognizing specific germs — in this case, SARS-CoV-2, the virus that causes Covid-19 — and harnessing the immune system to fight them off.

“We are maximizing all aspects of his care, attacking this virus with a multi-pronged approach,” Conley said. “He’s the president, and I didn’t want to hold anything back. If there was any possibility that it would add value to his care and expedite his return, I wanted to take it.”

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The double-barreled approach is not usual care for patients in the president’s condition, especially since both treatments are still in clinical trial.

But in theory, the two would work “synergistically,” said Dr. Hugh Cassiere, director of critical care services for

Maryland allows child care centers to expand capacity as part of economic recovery plan

The Maryland State Department of Education announced Thursday it will allow child care centers to operate at the capacity for which they are licensed, easing restrictions previously meant to help mitigate the spread of the coronavirus in an effort to support the state’s economic recovery.

Since May, Gov. Larry Hogan, a Republican, has gradually lifted capacity restrictions promoting social distancing inside “high-risk locations” such as restaurants, brick-and-mortar retail shops and places of worship. Now, almost all businesses have reopened in some fashion, though most still have restrictions such as capacity limits, face covering requirements and temperate checks.

The expansion of child care comes as a relief to both providers that operate on tight margins and parents who have struggled to find quality care while public schools continue to operate remotely.

“It’s a game changer,” said Rich Huffman, CEO of the Celebree day care and education program, which runs child care programs for multiple age groups throughout Maryland. “It allows for us to do what we do best, and it allows more parents to go back to work. It’s going to be a huge part of the state’s recovery.”

Child care centers can now have as many as 30 school-aged students in the same room with a ratio of one teacher for every 15 students.

Since July, child care centers have been limited to no more than 15 people per classroom. In March, the state closed child care centers except for the children of essential workers as the pandemic swept into the state.

State schools superintendent Karen B. Salmon said at an Annapolis news conference that more than 82% of licensed child care centers have reopened since March. But they have remained financially hindered due to the shutdown and capacity limits, she said, forcing many parents to turn to unlicensed providers who don’t meet state standards to care for children.

“Hopefully this action will assist in limiting the many unregulated and illegal operators that have sprung up in recent months, ” Salmon said. “There are no criminal background checks, no oversight, and parents can not be sure that their children are in a safe environment.”

Maryland Family Network deputy director Steve Rohde said the increased slots made available to families will mean greater protections for children. In the current situation, he said, there are fewer adults to help children wash hands and adhere to other health protocols.

While the extra slots will help some families who are on waiting lists at their day care centers, he said there are many centers that currently have openings.

“Parents are in a real quandary right now in terms of school and child care and their comfort level,” he said. “Getting back to the child care ratios in place before COVID is a good step.”

Some parents with young children had already secured temporary child care services to fill the gaps caused by the state’s restrictions. It’s unclear how many of them will switch back to licensed child care centers and providers.

Christina

Congress may limit Medicare Part B premium increase for 2021

Congress may be poised to head off a potential premium spike for some Medicare beneficiaries.

As part of a short-term government funding bill passed by the House last week and expected to be considered by the Senate on Wednesday, any increase in Medicare Part B premiums for 2021 would be capped.

While it’s still uncertain what the standard premium would be for 2021 — it is based on an actuarial formula and typically revealed in early November for the next year — estimates have proved tricky this year due to economic upheaval from the coronavirus pandemic.

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“One thing that’s really hard about this year is that there’s been increased costs from treating Covid, but decreased cost from people delaying care or avoiding being in hospitals or doctors offices,” said Casey Schwarz, senior counsel for education and federal policy at the Medicare Rights Center.

“Normally, we’d pretty much know by this time what the premium will be,” Schwarz said.

Although the Senate could seek changes to the House-approved funding bill — which keeps the government going through Dec. 11 — the measure passed with bipartisan support in the House. Additionally, Senate Republicans had included a provision to mitigate a possible Part B premium spike in their most recent stimulus bill, proposed in July.

If the House provision makes it into the final funding bill, any increase to the Part B premium would be capped at 25% of what it otherwise would be for 2021.

Normally, we’d pretty much know by this time what the premium will be.

Casey Schwarz

Senior counsel for education and federal policy at the Medicare Rights Center

Part B covers outpatient care, medical equipment and certain other medical services. Part A, which has no premium and is funded separately by a trust fund, provides hospital coverage. Together, those parts comprise basic Medicare.

The Medicare trustees forecasted in April that the standard 2021 Part B premium would rise to $153.30 in 2021 from $144.60 this year ($8.70 more monthly, or a 6% increase). However, the trustees’ report noted that the impacts of Covid-19 were unknown and therefore could not be factored into the estimates.

While many of Medicare’s 62.7 million beneficiaries are protected from large Part B premium hikes, others are not. And, higher-income beneficiaries already pay extra each month.

Part of the issue is how those premiums interact with Social Security benefits and the associated annual cost of living adjustment, or COLA.

If a Part B premium increase would eat up more than a Social Security recipient’s COLA in any given year, the person is “held harmless” and won’t see their Social Security benefits go down. (Their Part B premiums generally are withheld from their Social Security payments.)

“People who are held harmless can see a premium increase, but it can’t be larger than their