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Halted clinical trials put focus on COVID-19 vaccine transparency

Halted clinical trials put focus on COVID-19 vaccine transparency
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Two pharmaceutical giants this week became the latest drug companies to halt clinical trials into potential COVID-19 vaccines and treatments because of potential safety concerns, putting a renewed focus on transparency and public confidence.

Johnson & Johnson announced on Monday that a late-stage trial of its vaccine candidate had been paused because of a potential vaccine-linked illness in a participant.

A day later, Eli Lilly hit the brakes on its government-sponsored trial of a monocolonal antibody drug to treat hospitalized coronavirus patients due to a safety concern.

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Experts said the public should be reassured by those decisions because it means the vaccine trial system is working to protect patient safety as intended.

During a Wednesday interview with NBC’s “Today Show,” Ashish Jha, dean of the Brown University School of Public, said he was "heartened" by the news that the companies had hit speed bumps.

"I'm really heartened by these things. We've been racing so fast to develop therapies, vaccines, and we want to make sure the safety guardrails we usually have are in place," Jha said.

"Seeing these pauses reminds me that the system is working, and when it gets through we're going to be confident these things are safe," Jha added.

It's not unusual for large clinical trials to be halted. Adverse events, whether an illness or an accident or something else, are expected along the way.

The halts are meant to allow an independent board of experts to sort through the data and determine if the event was related to the treatment, and then make a decision about restarting the trial.

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"This should be very reassuring. These are the types of independent controls the industry builds into all of our work," Eli Lilly's CEO David Ricks said on “NBC Nightly News.”

"Those have been built into COVID development, and we are committed to making sure that our COVID therapies are as safe and effective as any other therapy we've developed in the past," Ricks added.

But the monitoring board is cloaked in secrecy, and neither the companies nor the federal government have been forthcoming about the specific reasons for pausing the trials.

Johnson & Johnson on Monday said the trial was paused "due to an unexplained illness in a study participant," but declined to give further details.

“We must respect this participant’s privacy,” the company said in a statement. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information."

The Johnson & Johnson announcement came one month after AstraZeneca halted enrollment in its COVID vaccine trial after a British participant was reported to have neurological symptoms.

But while other countries quickly restarted the trial, it is still on pause in the U.S. as the Food and Drug Administration (FDA) investigates further. AstraZeneca has refused to give more details about the safety issue, and the FDA hasn’t provided any specifics.

The ongoing pandemic means there is intense public scrutiny around developing a vaccine and treatment for COVID-19, and there's some concern that lack of transparency could backfire and turn to public distrust, especially given the pressure being exerted on the companies and regulators from the White House.

When Johnson & Johnson first announced the beginning of Phase 3 trials at the end of September, President TrumpDonald John TrumpTrump admin to announce coronavirus vaccine will be covered under Medicare, Medicaid: report Election officials say they're getting suspicious emails that may be part of malicious attack on voting: report McConnell tees up Trump judicial pick following Supreme Court vote MORE tweeted at the FDA to move quickly to approve it.

Eric Topol, a clinical trials expert at the Scripps Research Institute, said the level of public interest in the trials of pharmaceutical companies is unprecedented.

"They are operating in a global fishbowl of interest. There has never been this type of interest and scrutiny, because you weren't talking about hundreds of millions, billions of people that could be affected by the results of these trials," he said.

Topol went on to say that he was surprised by Lilly's announcement about its antibody drug, because the trial had reached a predetermined stopping point when it enrolled 300 people.

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In a statement, the National Institutes of Health, which is sponsoring the trial, said the data safety monitoring board noticed an "overall difference in clinical status" between the group that received antibodies and the group that received a placebo.

As part of the study, all of the participants also received remdesivir, an experimental antiviral drug that has been commonly used to treat patients with severe COVID-19 cases.

Eli Lilly has applied for emergency authorization for the drug, based on preliminary data that showed it helped people recently diagnosed with mild or moderate COVID-19 cases. So even if the treatment doesn't work for severe patients in the hospital, it still could hold promise if administered to people who were recently infected.

Topol said he suspects the trial was stopped because of "futility," meaning the treatment was determined to have a very low chance of working based on the data.

"My guess is futility, but I don't know because they're not being transparent," Topol said. "Why not just tell us straight away? What's the difference if it comes out one day or two weeks later? So it's just silly for them to not give us the information that is helpful."