Medical ethics in pandemic times

https://www.axios.com/medical-ethics-clinical-trials-pandemic-eb77f819-76f1-45b0-af8a-cf181bc1607b.html

The Importance of Medical Ethics | Medical Ethics – theMSAG

The COVID-19 pandemic is rife with scientific and medical uncertainty, including debates about the ethics of using experimental treatments.

The big picture: As the global pandemic continues, the tension between providing the best available care for patients and performing trials to determine whether that care is effective risks complicating the medical response.

The big question: Is it unethical to withhold a possible treatment from someone who instead receives a placebo, or to continue to administer that treatment without having collected data on whether it works?

Driving the news: President Trump received an experimental monoclonal antibody cocktail via expanded access or “compassionate use,” which allows someone to access a treatment outside of a clinical trial before it is approved, provided their doctor, the drug company and the FDA agree.

  • Experts say his subsequent claims of the treatment being a cure risks reducing enrollment in clinical trials, flooding companies with requests for access to a limited number of doses and creating false hope for patients.
  • And the president’s treatment raised questions about fairness — would other COVID-19 patients have similar access?
  • “It’s important that we not say the president got access to a beneficial experimental intervention because we don’t know if it is beneficial or if there are adverse events associated with it, says Alex John London, director of the Center for Ethics and Policy at Carnegie Mellon University. 

He and other ethicists say the president’s treatment highlights a broader question about the ethical obligation doctors have to the science needed to determine if those treatments are effective.

Between the lines: Offering patients experimental COVID-19 drugs via emergency use authorizations, expanded access programs and compassionate use can slow needed clinical trials.

  • Researchers have struggled to enroll people in clinical trials in which they may receive a placebo if patients can access a drug directly.
  • One example: “There’s been some hiccups with the expanded access use for convalescent plasma, because it was something that precluded people from enrolling in a randomized control trial, so it took longer, and we still don’t quite know how well convalescent plasma works,” says Amesh Adalja, an infectious disease physician and senior scholar at the Johns Hopkins Center for Health Security.

More than 100,000 COVID-19 patients at almost 2,800 U.S. hospitals received convalescent plasma from people who survived the virus and developed antibodies to it.

  • “It’s easy for people to say you enrolled 100,000 people, there should have been a trial. But a small number of those 2,800 hospitals would have been capable of doing those trials,” says the Mayo Clinic’s Michael Joyner, who leads the program.
  • There are now smaller trials taking place to answer questions about the effectiveness of plasma in treating the disease in different stages.
  • But if this happens again, Joyner says programs at academic medical centers should be peeled off earlier to form clinical trials run in parallel.

The gold standard for determining whether a treatment works is through randomized controlled trials in which people are randomly assigned to receive a treatment or to be in a control group.

  • In the uncertainty and urgency of a pandemic, some physicians argue randomizing people to receive a placebo goes against physicians’ ethics and that it is better to do something to help patients than do nothing.
  • “That’s a false dichotomy because the question is, what should we do?” says London.

From a doctor’s perspectiveit’s important to weigh the collective value of theearly drug data and the individual needs of the patient, Adalja says.

  • “I do think you have to be extra careful when you’re thinking about drugs that you don’t have strong randomized control trial data for, or the data is incomplete or inconclusive,” he adds.
  • “What people have to ask themselves is what constitutes evidence or proof and where do you want to make the bets in a pandemic?” says Joyner.
  • “There is a moral, legal and public health obligation to do those trials before people use those products,” says Alison Bateman-House, a professor of medical ethics at NYU’s Grossman School of Medicine who co-chairs an international working group on pre-approval access to treatments.
  • She says she understands the emotional pull on doctors to help patients whose health is quickly deteriorating, “but it is not evidence-based medicine.”

“There is no ethical obligation to give anyone an unproven substance.”

Alison Bateman-House, NYU Grossman School of Medicine

In a forthcoming paper, London argues that when medical professionals don’t have the knowledge they need to treat patients, it is their responsibility “to band together and run studies to get evidence to discharge [their] very ancient medical obligation.”

  • Medical ethics should be updated to include a responsibility to learn in the face of uncertainty, says London, who was part of a committee that called for research to be incorporated into the response to the Ebola outbreak in West Africa in 2014.
  • The U.K.’s large randomized RECOVERY trial is based in part on the Ebola experience, says London. “Because of it, we know dexamethasone is effective and hydroxychloroquine is not.”

What to watch: How the FDA’s handling of treatments during the pandemic influences other drugs and diseases once the pandemic ends.

The bottom line: “Medicine doesn’t have a good handle on uncertainty, and that is a problem,” says London.

The Misguided Rush to Throw the School Doors Open

https://www.governing.com/now/The-Misguided-Rush-to-Throw-the-School-Doors-Open.html?utm_term=READ%20MORE&utm_campaign=The%20Misguided%20Rush%20to%20Throw%20the%20School%20Doors%20Open&utm_content=email&utm_source=Act-On+Software&utm_medium=email

With the COVID-19 pandemic raging across much of America, a return to full-scale classroom instruction poses too grave a risk to students, teachers, school staff, parents and their communities.

Across the country, many of the public schools that are scheduled to open their doors within the next few weeks are still in limbo as to whether they should open on time and how they should operate — with full-scale in-person classroom instruction, with online learning only, or with some hybrid of the two. But the right call is becoming clearer by the day: It’s too soon to bring students and teachers back into the classroom.

Most communities are not ready to reopen their schools for traditional classes because neither government leaders nor the public have done nearly enough to curb the spread of the coronavirus or make the necessary preparations that would be required to operate schools safely.

Tens of thousands of new cases of COVID-19 are being reported every day and the death toll is averaging more than a thousand daily, with Sun Belt states seeing most of the biggest surges. It’s becoming ever clearer that this grim tally will continue until an effective vaccine is available. Until then, the possibility that students, their parents, teachers and school staff could become infected with the coronavirus and spread it widely to their communities should gravely concern every public official. The danger is hardly speculative: Schools that are among the earliest to reopen are already seeing positive cases.

The arguments that students learn better in a classroom setting, that they are suffering psychologically from social isolation, and that school closures have been particularly hard on working families are all legitimate. But are we really prepared to further risk the health of our children and of our communities by putting them in an environment where most of the practices to curb the virus will be difficult, if not impossible, to consistently follow?

And the danger to school staff members if they are forced to return to work should not be underestimated. According to the Kaiser Family Foundation, 25 percent of teachers are at risk of serious illness if they become infected with COVID-19, either because of their age — 65 or older — or their underlying health conditions.

The rush to reopen fully for in-person instruction has been driven in part by President Trump and Education Secretary Betsy DeVos, whose demands have been accompanied with threats of losing federal funds. Those demands appear to run afoul of guidelines issued by the Centers for Disease Control and Prevention a few weeks ago: Among other things, the CDC counseled going with small, socially distanced class sizes, emphasizing hand hygiene and respiratory etiquette, and requiring cloth face coverings — common-sense precautions the president said were too strict and many school officials say will be difficult to implement.

The political pressure has been so intense that the CDC issued a new set of “resources and tools” for school reopening, with CDC Director Robert Redfield saying that “the goal line is to get the majority of these students back to face-to-face learning,” a stance that was seen by many as a capitulation after the president criticized the earlier guidelines. Clearly this is not what most Americans expect of our top health officials. The public must feel confident that decisions to reopen schools are based on the best scientific evidence available and the professional advice of educators.

Despite the threats and pressure, many school officials are still doing the right thing by listening to local health experts and deciding for themselves when and how best to reopen. I see this in my own state of Georgia, where, according to a recent Atlanta Journal-Constitution article on how Georgia schools plan to start the school year, most school official are delaying opening and say that when they do open they plan to implement a hybrid approach to instruction. “Teachers will check in virtually — via some video conferencing software allowing them to see the dozens of children they would normally engage with through rows or groups of desks,” the newspaper reported.

The larger school districts in metropolitan Atlanta recently reversed themselves from offering parents an option to send their children to school traditionally or attend virtually, opting to go all-virtual because of the spikes in the virus. Other schools in the state plan to meet on campus a few days a week and do virtual learning on other days. Then there are superintendents who plan to prioritize on-campus learning but restrict it to students with special learning needs, such as those who have autism. Many of these options are complex and carry with them implications difficult to foresee, but they all prioritize the health of students.

The ultimate decider of when schools will fully reopen will undoubtedly be parents, at least those who have the freedom and budgets to stay home and monitor their children’s academic progress and assist with their homework. As a caring society, we must ensure that the option to telework is given to as many parents as possible, so that the decision to send one’s children to school and possibly expose them to the coronavirus is not based on family income and social status.

We are still in an existential fight with the coronavirus, and we do not know precisely how or when this battle will end. We do know the virus is apolitical and knows no local or state boundaries. There are no quick or easy solutions. One can only pray that public officials learned something from reopening our economy too soon. We do not want this to happen again by prematurely reopening schools.

Much of what our children lose in a semester or two of distance learning can be made up in time, but a lost life is forever.

 

 

 

 

A Mississippi town welcomed students back to school last week. Now 116 are home in quarantine.

https://www.washingtonpost.com/nation/2020/08/06/school-coronavirus-outbreak-mississippi/?utm_campaign=wp_main&utm_medium=social&utm_source=facebook&fbclid=IwAR058o-kJ0UCs1SRJFdJ-bWJylbuVn1Q2QkYnhMpmWH4s6NVx9yN2CA6lNE

Over 100 students quarantined in Mississippi school district after ...

Last week, schools in Corinth, Miss., welcomed back hundreds of students. By Friday, one high-schooler tested positive for the novel coronavirus. By early this week, the count rose to six students and one staff member infected. Now, 116 students have been sent home to quarantine, a spokeswoman for the school district confirmed.

Despite the quick fallout, the district’s superintendent said he has no plans to change course.

As districts around the country debate the merits of in-person classes vs. remote learning amid an escalating novel coronavirus pandemic, the Corinth School District’s early experience shows how quickly positive tests can lead to larger quarantines.

Other districts that have welcomed teachers or students back have faced similar challenges. After teachers returned to plan lessons in Georgia’s largest district, 260 district employees were barred from reentering schools because of either testing positive for the coronavirus or being in close contact with someone who had. In southeast Kansas, six school administrators tested positive after attending a three-day retreat. And within hours of opening, a school in Greenfield, Ind., was informed by the health department that a student had the virus.

Some health officials in the Trump administration, which has pushed for schools to fully reopen, are now urging communities with high rates of the virus to rethink in-person classes. On Sunday, Deborah Birx, the White House’s top coronavirus coordinator, said on CNN’s “State of the Union” that in hard-hit areas, “we are asking people to distance-learn at this moment so we can get this epidemic under control.”

Mississippi has been among the hardest-hit states in the South and could overtake Florida as the top state for cases per capita, according to researchers at Harvard University. The state has had more than 63,000 coronavirus cases and more than 1,800 deaths to date.

On Tuesday, Gov. Tate Reeves (R) said in a Facebook post that he would delay school opening for seventh to 12th grades in hot spots. The governor also mandated masks in schools and ordered a two-week mask requirement for public gatherings.

In Corinth, the school district gave families an option of either sending their children to school buildings or doing distance learning from home.

“We made the decision that even though we had seen a spike in those numbers, that schools needed to reopen and at the same time, schools need to remain open,” Childress said in the Facebook Live broadcast.

According to the district’s reopening plan, students and teachers are screened daily, with their temperatures taken upon arrival at school and checked for symptoms including coughing, difficulty breathing, and loss of taste and smell. Childress said that the district will start midday temperature checks.

When the schools learned of positive coronavirus cases, they used contact tracing and notified students who had been “within 6 feet of an infected person for 15 minutes or more,” said a memo posted Wednesday on Facebook informing the community of the cases. Seating charts helped the school determine who needed to quarantine, Childress said in the Facebook Live broadcast.

Those students will have to self-quarantine for 14 days and continue school online.

Despite the positive tests and quarantines, Childress said he remained optimistic about the school district’s plans. He encouraged the families to wear masks, and he urged everyone with children in quarantine to stay home until getting their test results.

“We’ve had a good start of school,” Childress said. “We’re going to have some more positive cases. We know that. We know it will happen. We’re going to have to deal with it, and I can assure that we will deal with it and when we impose quarantines on students and staff, we are doing that for a reason.”

 

 

 

 

Inside the epic White House fight over hydroxychloroquine

https://www.axios.com/coronavirus-hydroxychloroquine-white-house-01306286-0bbc-4042-9bfe-890413c6220d.html

Huge fight breaks out among White House coronavirus task force ...

The White House coronavirus task force had its biggest fight yet on Saturday, pitting economic adviser Peter Navarro against infectious disease expert Anthony Fauci. At issue: How enthusiastically should the White House tout the prospects of an antimalarial drug to fight COVID-19?

Behind the scenes: This drama erupted into an epic Situation Room showdown. Trump’s coronavirus task force gathered in the White House Situation Room on Saturday at about 1:30pm, according to four sources familiar with the conversation. Vice President Mike Pence sat at the head of the table.

  • Numerous government officials were at the table, including Fauci, coronavirus response coordinator Deborah Birx, Jared Kushner, acting Homeland Security Secretary Chad Wolf, and Commissioner of Food and Drugs Stephen Hahn.
  • Behind them sat staff, including Peter Navarro, tapped by Trump to compel private companies to meet the government’s coronavirus needs under the Defense Production Act.

Toward the end of the meeting, Hahn began a discussion of the malaria drug hydroxychloroquine, which Trump believes could be a “game-changer” against the coronavirus.

  • Hahn gave an update about the drug and what he was seeing in different trials and real-world results.
  • Then Navarro got up. He brought over a stack of folders and dropped them on the table. People started passing them around.
  • “And the first words out of his mouth are that the studies that he’s seen, I believe they’re mostly overseas, show ‘clear therapeutic efficacy,'” said a source familiar with the conversation. “Those are the exact words out of his mouth.”

Navarro’s comments set off a heated exchange about how the Trump administration and the president ought to talk about the malaria drug, which Fauci and other public health officials stress is unproven to combat COVID-19.

  • Fauci pushed back against Navarro, saying that there was only anecdotal evidence that hydroxychloroquine works against the coronavirus.
  • Researchers have said studies out of France and China are inadequate because they did not include control groups.
  • Fauci and others have said much more data is needed to prove that hydroxychloroquine is effective against the coronavirus.
  • As part of his role, Navarro has been trying to source hydroxychloroquine from around the world. He’s also been trying to ensure that there are enough domestic production capabilities inside the U.S.

Fauci’s mention of anecdotal evidence “just set Peter off,” said one of the sources. Navarro pointed to the pile of folders on the desk, which included printouts of studies on hydroxychloroquine from around the world.

  • Navarro said to Fauci, “That’s science, not anecdote,” said another of the sources.

Navarro started raising his voice, and at one point accused Fauci of objecting to Trump’s travel restrictions, saying, “You were the one who early on objected to the travel restrictions with China,” saying that travel restrictions don’t work. (Navarro was one of the earliest to push the China travel ban.)

  • Fauci looked confused, according to a source in the room. After Trump imposed the travel restrictions, Fauci has publicly praised the president’s restriction on travel from China.
  • Pence was trying to moderate the heated discussion. “It was pretty clear that everyone was just trying to get Peter to sit down and stop being so confrontational,” said one of the sources.
  • Eventually, Kushner turned to Navarro and said, “Peter, take yes for an answer,” because most everyone agreed, by that time, it was important to surge the supply of the drug to hot zones.
  • The principals agreed that the administration’s public stance should be that the decision to use the drug is between doctors and patients.
  • Trump ended up announcing at his press conference that he had 29 million doses of hydroxychloroquine in the Strategic National Stockpile.

Between the lines: “There has never been a confrontation in the task force meetings like the one yesterday,” said a source familiar with the argument. “People speak up and there’s robust debate, but there’s never been a confrontation. Yesterday was the first confrontation.”

  • In response to a request for comment on Axios’ reporting, Katie Miller, a spokesperson for the vice president, said: “We don’t comment on meetings in the Situation Room.”

The bottom line: The way to discuss the drug’s potential has become a fraught issue within the Trump administration.

  • Most members of the task force support a cautious approach to discussing the drug until it’s proven.
  • Navarro, on the other hand, is convinced based on his reading that the drug works against the coronavirus and speaks about it enthusiastically.
  • Some of Trump’s favorite TV hosts, including Fox’s Sean Hannity, and friends including Rudy Giuliani, have also been touting the malaria drug for the coronavirus. Trump has made no secret who he sides with.
  • “What do you have to lose? Take it,” the president said in a White House briefing on Saturday. “I really think they should take it. But it’s their choice. And it’s their doctor’s choice or the doctors in the hospital. But hydroxychloroquine. Try it, if you’d like.”