Show an ad over header. AMP

Medical ethics in pandemic times

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 perspective, it'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.

Trump's legacy is shaped by his narrow interests

President Trump's policy legacy is as much defined by what he's ignored as by what he's involved himself in.

The big picture: Over the past four years, Trump has interested himself in only a slim slice of the government he leads. Outside of trade, immigration, a personal war against the "Deep State" and the hot foreign policy issue of the moment, Trump has left many of his Cabinet secretaries to work without interruption, let alone direction.

Keep reading... Show less

Ipsos poll: COVID trick-or-treat

Data: Axios/Ipsos poll; Note ±3.3% margin of error for the total sample size; Chart: Andrew Witherspoon/Axios

About half of Americans are worried that trick-or-treating will spread coronavirus in their communities, according to this week's installment of the Axios/Ipsos Coronavirus Index.

Why it matters: This may seem like more evidence that the pandemic is curbing our nation's cherished pastimes. But a closer look reveals something more nuanced about Americans' increased acceptance for risk around activities in which they want to participate.

Keep reading... Show less

Dunkin' Brands agrees to $11B Inspire Brands sale

Dunkin' Brands, operator of both Dunkin' Donuts and Baskin-Robbins, agreed on Friday to be taken private for nearly $11.3 billion, including debt, by Inspire Brands, a quick-serve restaurant platform sponsored by Roark Capital.

Why it matters: Buying Dunkin’ will more than double Inspire’s footprint, making it one of the biggest restaurant deals in the past 10 years. This could ultimately set up an IPO for Inspire, which already owns Arby's, Jimmy John's and Buffalo Wild Wings.

Keep reading... Show less

Federal judge halts Trump administration limit on TikTok

A federal judge on Friday issued an injunction preventing the Trump administration from imposing limits on the distribution of TikTok, Bloomberg reports. The injunction request came as part of a suit brought by creators who make a living on the video service.

Why it matters: The administration has been seeking to force a sale of, or block, the Chinese-owned service. It also moved to ban the service from operating in the U.S. as of Nov. 12, a move which was put on hold by Friday's injunction.

Keep reading... Show less

Podcast: How hospitals are prepping for the new COVID-19 surge

Coronavirus cases and hospitalizations are surging, particularly in areas that had been largely spared in the spring. One big question now is if hospitals are better prepared for this new wave, including if they'll be able to continue providing elective services.

Axios Re:Cap digs into what hospitals have, and what they still need, with Lloyd Dean, CEO of CommonSpirit Health, one of America's largest operators of hospitals and health clinics.

Belgium imposes lockdown, citing "health emergency" due to influx of COVID-19 cases

Belgium is enforcing a strict lockdown starting Sunday amid rising coronavirus infections, hospital admissions and a surge of deaths, Prime Minister Alexander De Croo announced on Friday.

Why it matters: De Croo said the government saw no choice but to lock down "to ensure that our health care system does not collapse." Scientists and health officials said deaths have doubled every six days, per the Guardian.

Keep reading... Show less

First look: Reid Hoffman launches $1M ad urging election patience

Billionaire and LinkedIn co-founder Reid Hoffman, one of Democrats' biggest donors, tells Axios he's launching a $1 milliondigital ad campaign in battleground states urging voters to be patient with election results and prepare for no winner to be known on Nov. 3, no matter what "some people" may prematurely declare via Twitter.

Driving the news: The three-minute ad, titled "We Count! A Patriotic Musical Extravaganza," features the voice of "The Big Bang Theory's" Jim Parsons and Broadway star Barrett Doss. The spot will appear on Facebook targeting voters in the swing states of Arizona, Florida, Iowa, Michigan, North Carolina, Ohio, Pennsylvania and Wisconsin.

Keep reading... Show less

2020 early voting has already reached 61% of 2016's total turnout

Early voting in the 2020 election across the U.S. on Friday had already reached 61% of 2016's total turnout, according to state data compiled by the Elect Project.

Why it matters: The coronavirus pandemic and its resultant social-distancing measures prompted a massive uptick in both mail-in ballots and early voting nationwide, setting up an unprecedented and potentially tumultuous count in the hours and days after the polls close on Nov. 3.

Keep reading... Show less

Insights

mail-copy

Get Goodhumans in your inbox

Most Read

More Stories