Tag: massive

 

Doctors question results of massive WHO remdesivir study

A huge, global study of potential medications to treat Covid-19 suggests remdesivir — one of the few available drugs for the virus — may offer no real benefit to the sickest patients. But doctors on the front lines of treating severe cases advise caution when interpreting the findings.

“We already knew that in sicker populations, it didn’t really change outcomes,” said Dr. Ken Lyn-Kew, a pulmonologist in the critical care section at National Jewish Health in Denver.

That does not mean remdesivir — which was granted an emergency use authorization by the Food and Drug Administration in May — is not useful against Covid-19, however.

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The new study — which included data from more than 11,200 people in 30 countries — is the result of the World Health Organization’s Solidarity trial. It was published online Thursday on the preprint server medRxiv, meaning it has not been peer-reviewed.

Remdesivir wasn’t the only treatment given to patients in the trial. Some received hydroxychloroquine (which has since been shown to be ineffective in treating Covid-19), lopinavir (an antiviral used in HIV treatment) and interferon (another antiviral). Some received a combination of the drugs. Others got just one. Still others received no treatment.

The trial found that overall, remdesivir did not reduce deaths and did not help patients with severe Covid-19 get out of the hospital more quickly.

Related: Supplies of the drug remdesivir have run short more than once. But despite disappointing WHO trial results, European doctors still plan on using it – for now.

The latter finding contradicts a large National Institutes of Health-funded trial on the drug, which found that remdesivir reduced the amount of time it took for adults hospitalized with Covid-19 to be discharged from hospital.

Dr. Andre Kalil, a principal investigator for the NIH trial at the University of Nebraska Medical Center in Omaha, said the Solidarity trial lacked some of the basics critical to scientific research: “No data monitoring, no placebo, no double-blinding, no diagnostic confirmation of infection.”

“Poor-quality study design cannot be fixed by a large sample size, no matter how large it is,” Kalil told NBC News.

Outside experts also said it’s no surprise that the drug didn’t appear to benefit the sickest patients. Remdesivir is an antiviral medication. Like Tamiflu for influenza, antivirals generally are more effective when given early in the course of illness.

“We knew that in sicker populations, it didn’t really change outcomes,” Lyn-Kew said. “This study just reinforces that it’s not a miracle drug.”

One potential stumbling block to early treatment with remdesivir is that it’s administered intravenously. It cannot be prescribed in pill form for newly diagnosed patients to take at home. However, Gilead Sciences, which makes remdesivir, has begun to study the effect of an inhaled version of the drug. If safe and effective, it could be used at home, before the body’s inflammatory process takes over.

That inflammatory process, rather than the acute viral infection, is responsible for the more severe

Taxpayers, not company, will pay for massive Exide toxic cleanup, under plan OK’d by court

A bankruptcy court ruled Friday that Exide Technologies may abandon its shuttered battery recycling plant in Vernon, leaving a massive cleanup of lead and other toxic pollutants at the site and in surrounding neighborhoods to California taxpayers.



a train is parked on the side of a building: Portions of the shuttered Exide Technologies facility, in Vernon about 5 miles outside of downtown Los Angeles, are wrapped in white plastic to prevent the release of lead and other harmful pollutants. (Al Seib/Los Angeles Times)


© (Al Seib/Los Angeles Times)
Portions of the shuttered Exide Technologies facility, in Vernon about 5 miles outside of downtown Los Angeles, are wrapped in white plastic to prevent the release of lead and other harmful pollutants. (Al Seib/Los Angeles Times)

The decision by Chief Judge Christopher Sontchi of the U.S. Bankruptcy Court District of Delaware, made over the objections of California officials and community members, marks the latest chapter in a decades-long history of government failures to protect the public from brain-damaging lead, cancer-causing arsenic and other pollutants from the facility.

The plan’s confirmation only deepens a fiasco that has subjected working-class Latino communities across southeast Los Angeles County to chronic and dangerous levels of soil contamination and made the area a poster child for environmental injustice.

Community groups have fought for years with the company and its environmental regulators to restrict harmful pollution, shut down illegal operations and clean up the toxic mess. The property’s abandonment compounds the challenges of addressing ongoing health risks to young children and others living nearby, where thousands of yards remain riddled with lead, a powerful neurotoxin with no safe level of exposure.

The decision followed a two-day court hearing with testimony from environmental regulators, company consultants and officers and health experts, much of it about the threats to the environment and the public from abandoning a hazardous facility with the remediation unfinished. The recycling operation, located about 5 miles from downtown Los Angeles, has not been fully demolished and remains partially enclosed in a temporary, tent-like structure designed to prevent the release of lead and other toxic pollutants.

In his verbal ruling, Sontchi concluded it is not an imminent threat to the public.

“The entire property is not sort of a seething, glowing toxic lead situation,” Sontchi said.

“We have a very dangerous element that will cause long-term health effects” and takes time to accumulate, he said. “I don’t think any of that indicates there’s an imminent, immediate harm to the general public if this property is abandoned.”

State officials blame decades of air pollution from the plant, which melted down used car batteries until its closure five years ago, for spreading lead dust across half a dozen communities, including Boyle Heights, East Los Angeles, Commerce and Maywood. The area contains more than 100,000 people.

A state-led cleanup has so far removed contaminated soil from 2,000 residential properties, as well as as well as parks, day-care facilities and schools. But thousands more have yet to be cleaned in the largest remediation project of its kind in California.

The Trump administration, through the U.S. Department of Justice and the Environmental Protection Agency, supported Exide’s plan, which also leaves behind toxic sites in several other states. Those sites too remain a threat to public health and