Archive For April 16, 2021

Here’s What You Should Know About Biden’s New Rules For Fetal Tissue Research

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Here’s What You Should Know About Biden’s New Rules For Fetal Tissue Research

Fetal tissue is uniquely valuable to medical researchers – useful for developing treatments and better understanding diseases like HIV, Parkinson’s, and COVID-19.

But many anti-abortion rights groups oppose it on moral or religious grounds.

Now, Health and Human Services Secretary Xavier Becerra says he’s reversing several restrictions on fetal tissue research put in place during the Trump administration.

Human fetal tissue (stock photo)

Ed Reschke/Getty Images

Ed Reschke/Getty Images

Here’s what you need to know:

What is fetal tissue research – and why do many scientists say it’s necessary?

Fetal tissue is uniquely adaptable and useful for many types of scientific inquiry.

Lawrence Goldstein, a Distinguished Professor at the University of California San Diego School of Medicine, said because these cells are not fully developed they can be useful for many things – like trying to develop replacement organs.

“So for example if you’re trying to make a kidney from stem cells you’d like to know that as the cells begin going down the kidney development path that they’re doing it normally,” Goldstein said. “And so comparison to early fetal kidney cells that are doing it normally tells you that you’re on the right track or not.”

There are ethical requirements for tissue obtained from elective abortions: patients have to understand what they’re doing and consent to it. Doctors involved have to attest that they received consent to collect the tissue after a patient had already decided to have an abortion.

But people opposed to abortion rights often oppose this kind of research, and social conservatives held significant influence in the Trump administration.

What was the Trump administration policy on fetal tissue research – and what’s changing now?

The Trump administration took a couple of actions in 2019.

The first was a ban on NIH funding for what’s known as intramural research (essentially programs within the agency) involving newly obtained fetal tissue from abortions. Second, a requirement that external applicants for NIH funds who wanted to use fetal tissue had to go through an Ethics Advisory Board review process. The board was convened by the Trump administration, and, as critics noted, most board members were publicly opposed to abortion rights.

Lawrence Goldstein, at UCSD School of Medicine, was on that board – although he was in the minority because of his support for fetal tissue research.

“It was an incredibly unpleasant experience because highly meritorious research projects that had already been through multiple layers of review, both scientifically and ethically, went to this board to be killed,” he said.

What does this mean for the larger battle over reproductive rights?

In a statement, Marjorie Dannenfelser of the anti-abortion rights group the Susan B. Anthony List said this decision will “force Americans to be complicit in barbaric experiments.” She also said this is another step toward reversing “pro-life progress” under Trump and Pence.

This action is part of something larger – the anti-abortion rights movement is finding itself on the losing side of a lot of policy battles at the federal level. Just this week, the Biden administration announced steps to reverse changes to the Title X family planning program that had effectively cut significant funding to groups like Planned Parenthood. That news came after the FDA announced it will temporarily loosen restrictions on abortion pills, during the pandemic.

So, expect many more political fights over issues related to abortion rights in the years to come; at the same time that Biden is taking these actions at the federal level, conservatives still hold a lot of power – in state legislatures and the U.S. Supreme Court.

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The Ramifications Of The Johnson & Johnson Vaccination Halt Are Global

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The Ramifications Of The Johnson & Johnson Vaccination Halt Are Global

The U.S. Food and Drug Administration’s decision to temporarily halt the use of the Johnson & Johnson COVID-19 vaccine is having ramifications globally.


AILSA CHANG, HOST:

The decision by the federal government to halt the use of the Johnson & Johnson COVID vaccine in the U.S. over a possible link to rare blood clots has had ramifications for other countries, too. Many of them, especially in Europe, were on the verge of starting vaccination campaigns with the J&J product. NPR’s Jason Beaubien reports.

JASON BEAUBIEN, BYLINE: Most of the Johnson & Johnson vaccine that’s been administered so far has been in the U.S. But globally, Johnson & Johnson has made commitments to provide nearly a billion doses abroad. Large orders have been placed by the African Union, Colombia and the Philippines, yet most of those doses haven’t yet been delivered.

The pause in the U.S. led to the suspension of a rollout of the jab in Europe. South Africa also announced that it was halting the use of Johnson & Johnson. This comes after South Africa abandoned plans for a nationwide vaccination campaign with the AstraZeneca vaccine when it appeared that AstraZeneca wasn’t effective against the dominant variant in the country. South Africa has so far immunized less than 1% of its population and is hoping to be able to resume inoculations with the Johnson & Johnson product soon. But if that doesn’t happen, they’re going to have to switch to a third vaccine, which they hope will be Pfizer.

Meanwhile, Spain says it still plans to start using Johnson & Johnson once it gets doses of the product early this summer, but it will only give them to people in their 70s. France says it will use a shipment that just arrived this week, but only in people 55 and older.

All of the reported blood clots for J&J and similar clots with AstraZeneca have been in people under the age of 50. Most of them have been women in their 20s and 30s. Rebecca Weintraub is a doctor at Brigham and Women’s Hospital in Boston, and she’s working on research on global COVID vaccine delivery programs. Weintraub says the current pause on the Johnson & Johnson shot by the U.S. and other countries is appropriate and a normal part of rolling out a huge new vaccination program.

REBECCA WEINTRAUB: This is standard practice. We expected a set of adverse reactions to a vaccine that – not only because it was new, but this happens with any routine vaccination process.

BEAUBIEN: The World Health Organization says the current halt of the Johnson & Johnson vaccine by the U.S. shows that the systems put in place to catch rare side effects and address them are working. The WHO notes that this is simply a pause while the reports of side effects are reviewed and that the Johnson & Johnson vaccine is still authorized for use, and they expect immunizations with it will resume soon. Jason Beaubien, NPR News.

(SOUNDBITE OF JOHN METCALFE’S “GOLD, GREEN”)

Copyright © 2021 NPR. All rights reserved. Visit our website terms of use and permissions pages at www.npr.org for further information.

NPR transcripts are created on a rush deadline by Verb8tm, Inc., an NPR contractor, and produced using a proprietary transcription process developed with NPR. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of NPR’s programming is the audio record.

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Senators Urge Biden To Shut Down Guantánamo, Calling It A ‘Symbol Of Lawlessness’

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Senators Urge Biden To Shut Down Guantánamo, Calling It A ‘Symbol Of Lawlessness’

In a letter to the White House, 24 senators said the U.S. military prison at Guantánamo Bay, Cuba “has damaged America’s reputation, fueled anti-Muslim bigotry, and weakened the United States’ ability to counter terrorism and fight for human rights and the rule of law around the world.”

Maren Hennemuth/picture alliance via Getty Images

Maren Hennemuth/picture alliance via Getty Images

Calling the U.S. military prison in Guantánamo Bay, Cuba, a “symbol of lawlessness and human rights abuses,” two dozen U.S. senators are urging President Biden to shut it down quickly and find new homes for the 40 men remaining there. Many of the detainees have been confined at Guantánamo for nearly two decades without being tried or charged, and some have been cleared for release but are still being held.

In a letter sent to Biden on Friday and reviewed by NPR, Senate Judiciary Committee Chairman Dick Durbin and 23 of his Democratic-voting colleagues outlined immediate steps they believe the administration should take to close the secretive, deteriorating island detention facility. Among them:

  • Reestablish the State Department office, dismantled by the Trump administration, that negotiates with foreign governments to transfer Guantánamo prisoners to other countries.
  • Begin negotiating overseas transfers for the six men already approved for release as well as for any detainees who will not be charged with crimes.
  • Use the U.S. federal courts to pursue plea agreements with detainees who can be federally charged and let them serve any remaining prison time overseas.
  • Have the Justice Department conduct plea agreements remotely via videoconference since current federal law prohibits Guantánamo prisoners from entering the U.S. for any reason.

The senators said in the letter that Guantánamo “has damaged America’s reputation, fueled anti-Muslim bigotry, and weakened the United States’ ability to counter terrorism and fight for human rights and the rule of law around the world.” As a result, they wrote, “it is past time” to shutter the prison, which opened in 2002, and “end indefinite detention.”

Biden’s likelihood of success at closing Guantánamo is unclear. His efforts are applauded by human rights groups but criticized by several Senate Republicans, who say releasing the prisoners would endanger the country. Former President Barack Obama never fulfilled his pledge to shut down Guantánamo due to vehement Republican opposition.

In their letter, the senators described Guantánamo’s military court, which has finalized only one conviction in almost 20 years, as “thoroughly failed and discredited.” The court has been perpetually problem-plagued, and legal proceedings there have been at a virtual standstill since February 2020 when the pandemic drastically limited access to the island.

Guantánamo’s highest-profile legal matter — the 9/11 death penalty case involving five defendants — has not gone to trial even though the 20th anniversary of the attacks is fast approaching, and at this point few Guantánamo lawyers believe it ever will. The case has repeatedly been delayed by ongoing setbacks, including a sort of musical chairs of judges, one of whom quit last fall after two weeks on the job.

To date, according to an NPR investigation, Guantánamo’s military court and prison have cost the U.S. more than $6 billion, money the senators called “wasted taxpayer dollars.”

The 24 lawmakers — 23 Democrats and one independent — who signed the letter include Sens. Cory Booker of New Jersey, Kirsten Gillibrand of New York, Mazie Hirono of Hawaii, Amy Klobuchar of Minnesota, Patrick Leahy and Bernie Sanders of Vermont, Dianne Feinstein and Alex Padilla of California, and Ed Markey and Elizabeth Warren of Massachusetts. The letter was also sent to Defense Secretary Lloyd Austin, Secretary of State Antony Blinken and Attorney General Merrick Garland.

In February, the White House said it would review Guantánamo’s prison with the goal of closing it permanently but provided few details. A National Security Council spokesperson said the review would involve the NSC, Congress and the departments of Defense, State and Justice.

Meanwhile, many of the prisoners are aging, as well as weakened by their past CIA torture. And in a rare development in December, a “forever prisoner” who has been held at Guantánamo for more than 18 years despite never being criminally charged was cleared for release after a parole-like board concluded he is no longer a significant threat to the United States. However, it is unclear when he may leave Guantánamo and where he would go, because his home country of Yemen is in a state of collapse.

And Guantánamo’s facilities are rapidly decaying. Earlier this month, alleged 9/11 mastermind Khalid Sheikh Mohammed and other so-called high-value detainees were moved from a crumbling secret detention facility to a main prison area, a move the military said would cut expenses.

In recent years, about 1,800 troops — mostly National Guard members — have overseen Guantánamo’s 40 remaining detainees, costing an estimated $13 million per prisoner per year. That guard force now numbers about 1,500. Almost 800 detainees have passed through the prison since it opened in the aftermath of the Sept. 11 attacks.

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Oath Keepers Member Is 1st To Plead Guilty In Capitol Riot Investigation

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Oath Keepers Member Is 1st To Plead Guilty In Capitol Riot Investigation

Rioters clash with law enforcement as they attempt to enter the U.S. Capitol building on Jan. 6.

Eric Lee/Bloomberg via Getty Images

Eric Lee/Bloomberg via Getty Images

A heavy metal musician and founding member of the Oath Keepers extremist group pleaded guilty Friday to charges connected to the storming of the U.S. Capitol and agreed to cooperate with investigators — a first in the massive probe into the deadly Jan. 6 assault.

Jon Schaffer, a guitarist and songwriter for the heavy metal band Iced Earth, entered his plea during a hearing in federal court in Washington, D.C. The plea agreement, which comes 100 days after a mob of Trump supporters violently overran the Capitol, marks a significant step for prosecutors in the case.

Schaffer, who originally faced six counts, pleaded guilty to two charges — obstructing an official proceeding and entering restricted grounds with a dangerous weapon.

In his plea deal, Schaffer acknowledged that on Jan. 6 he was among the first people to force their way through police lines and into the Capitol. He also acknowledged wearing a tactical vest and carrying bear spray as he did so.

At Friday’s hearing, U.S. District Court Judge Amit Mehta walked Schaffer through the plea agreement and the charges.

“Are you pleading guilty, Mr. Schaffer, because you are in fact guilty, sir?” Mehta asked.

“Yes,” Schaffer replied.

Mehta said the agreement stipulates that Schaffer fully cooperate with investigators, including providing testimony and witness interviews.

It is unclear what Schaffer may be able to tell investigators, but authorities are working to understand what exactly transpired on Jan. 6 and whether it was an organized and coordinated assault.

The FBI is closely scrutinizing the Oath Keepers and Proud Boys as they seek to answer that question.

Prosecutors have brought conspiracy charges against both groups in connection with Jan. 6. The biggest of those cases so far is against a dozen members or associates of the Oath Keepers who are accused to coordinating their actions on Jan. 6 to try to disrupt the certification of the Electoral College count.

Schaffer was arrested in mid-January after turning himself in to the FBI in Indiana. He’s been in government custody since then.

The two charges against him carry a maximum sentence of 20 years and 10 years, respectively, although Judge Mehta said that — in light of the plea agreement — Schaffer is facing from 3 1/2 to four years under sentencing guidelines.

No sentencing date has been set.

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Biden Administration To Spend $1.7 Billion Track Spread Of Coronavirus Variants

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Biden Administration To Spend $1.7 Billion Track Spread Of Coronavirus Variants

Lab Assistant Tammy Brown dons PPE in a lab where she works on preparing positive COVID tests for sequencing to discern variants that are rapidly spreading throughout the U.S. at the University of Maryland School of Medicine in Baltimore, Maryland.

Michael Robinson Chavez/The Washington Post via Getty Im

Michael Robinson Chavez/The Washington Post via Getty Im

The Biden administration will send $1.7 billion to the Centers for Disease Control and Prevention and local and state governments and other research efforts early next month to find and track coronavirus variants lurking in the U.S. Already, the more contagious UK variant B.1.1.7 is now the dominant strain in this country, fueling surges in Michigan and the Northeast.

“Our goal is to get that money out as fast as possible to help states in all the many ways that they need to be able to expand their own sequencing capacity,” said Carole Johnson, the White House COVID-19 testing coordinator, in an interview with NPR.

The U.S. has been flying blind in the race between vaccination efforts and the spread of new coronavirus variants that could potentially spark another deadly nationwide surge and reduce effectiveness of the vaccines. U.S. public health officials have been operating with incomplete information because of an inadequate viral genomics surveillance system.

Friday’s announcement details how the funds — which were part of the $1.9 trillion COVID-19 relief bill passed last month — will be distributed. The largest share of funds — $1 billion — will go to the CDC, states and cities to bolster their existing surveillance efforts.

The rest will go to longer-term initiatives, including $400 million to create “Innovative Centers of Excellence in Genomic Epidemiology” which will be research partnerships between state health departments and academic institutions. An additional $300 million will go to build a “national bioinformatics infrastructure” to handle the flood of data.

Before the coronavirus, genomic sequencing of viruses in the U.S. was aimed largely at tracking food-borne illnesses. The value of genomic sequencing was a “lesson learned” from COVID-19, said Johnson. The pandemic has forced that U.S. system to adapt and the funding approved by Congress should build up the scientific infrastructure to deal with whatever comes next, she added.

“This is both about today and about building for the long term,” said Johnson. “Today’s investment … is about helping us fight COVID but is also about helping us continue to transform how public health works to combat outbreaks of all kinds going forward.”

When the U.K. variant first emerged, the viral surveillance system in the U.S. was woefully under-resourced, especially compared to other countries. In early February, U.S. laboratories were only sequencing perhaps 5,000 to 8,000 coronavirus samples per week. The CDC says the agency has now boosted that to close to 15,000 per week. But many experts estimate the country should be sequencing at least 25,000 per week.

Public health experts welcomed Friday’s announcement.

“The Biden plan makes sense and is practical,” Scott Becker, executive director of the Association of Public Health Laboratories, wrote in an email to NPR. Not only does it boost surveillance capacity, he says, but it also “looks towards building partnerships across sectors to foster innovations so that we can keep pace with science and technology. “

Others agree.

“What I was most worried about in the beginning of this process was that some new entity was going to be created that would analyze genomic information but would be not directly connected to CDC,” says Gigi Gronvall, a senior school at the Johns Hopkins University Center for Health Security. “That entity would probably fail but take a while and a lot of money with it in the process. This is the time to modernize and strengthen public health, and that begins with strengthening CDC.”

But some say even this boost in funding is not coming fast enough, especially with cases surging in many places and variants spreading quickly.

“With the money going out in May, I’d like to see a timeline of expectations for how quickly sequencing is going up,” says Heather Pierce, senior director for science policy at the Association of American Medical Colleges. “There is an urgent need to increase the sequencing by several fold in places where cases are high and rising (like Michigan), and a month or two ramp up period will put us behind where we needed to be months ago.”

Pierce noted that “one area that needs immediate attention is the sequencing of every “breakthrough” case,” which are cases in which people get infected even though they have been vaccinated. The CDC says at least 5,800 such “breakthrough infections” have been reported so far.

“We need to know whether infection after vaccination is the result of the vaccines, the variants, or some characteristic of the individuals who become infected,” Pierce wrote in an email to NPR.

Others say sequencing needs to be focused strategically.

“More is better — but in addition to random sampling we need to do targeted sequencing of hospitalized people, immune-compromised and previously vaccinated people,” says Mara Aspinall, a professor of medical practice expert at Arizona State University. “And we have to work globally on this issue.”

Some also say it’s important that these kinds of efforts continue to receive support going forward.

“For this to work, there will need to be sustained funding,” says Jennifer Nuzzo, a senior scholar at the Johns Hopkins Center for Health Security. “I am concerned about building up an infrastructure using emergency funds. We have seen over and over again that capacities require sustained investment.”

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