‘Tinkering’ to Find COVID Origins; Monkeypox Paperwork; Dialysis Patient Harm?

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

‘Tinkering’ to Find COVID Origins

Researchers in a high-security laboratory in Paris have been studying a bat virus in the hopes of discovering how its cousin, SARS-CoV-2, became a global threat that has killed millions of people, the New York Times reported. However, lab experiments like this one “rekindle a longstanding debate among scientists about the wisdom of tinkering with viruses that are so closely related to a known pathogen,” the article stated.

Proponents say such experiments and the data they yield are critical to understanding and preventing pandemics, the Times reported. But critics argue that researchers shouldn’t run experiments that might make viruses better able to spread among people, due to a small chance that altered pathogens could infect lab workers and escape into the world.

“Our motivation was to try to give some insight regarding the origin of Covid,” Marc Eloit, DVM, PhD, a virologist at the Pasteur Institute in Paris who is leading the effort there, told the Times.

An area of focus for Eloit and his team has been a shape-shifting region of the spike protein known as the furin cleavage site, which has been critical to the success of SARS-CoV-2. “When scientists have engineered viruses lacking this site, the mutants struggle to replicate in the lungs of lab animals or spread to new hosts,” the Times wrote.

Eloit and his team have run lab experiments, such as transferring viruses from mouse to mouse and infecting a dish of human intestinal cells, aimed at giving the virus they have been studying a chance to evolve new traits, such as a furin cleavage site, the Times reported. But they have stopped at a certain point.

“From a purely scientific point of view, we wanted to do more than six passages,” Eloit told the Times. “But we did not want to open the risk to adapting a bat virus to humans.”

Though so-called serial passage experiments have been around for more than a century, they have been met with controversy, the Times noted. The U.S. previously halted such experiments to develop a new process for judging their safety. But some have started up again in recent years. As the debate continues, some scientists hold that regulations currently in place aren’t transparent enough, the Times reported.

Doctors Treating Monkeypox Patients Say the Paperwork is Weighing Them Down

Doctors like Roy Gulick, MD, want to give their monkeypox patients the best possible care, but Gulick and other physicians are finding they don’t have enough hours in the day, the Washington Post reported.

The time crunch they’re facing stems from struggling to “complete dozens of pages of paperwork every time they need to pry medicine out of the Strategic National Stockpile,” the Post wrote.

“It’s been a very daunting task,” Gulick, chief of the Division of Infectious Diseases at New York Presbyterian/Weill Cornell Medicine, told the Post. “There’s a ton of paperwork, there’s a ton of assessments that are required, there’s a tremendous amount that one has to do to be able to administer this drug to someone.”

The difficulty physicians are seeing when it comes to prescribing tecovirimat (TPOXX), an antiviral approved to treat smallpox, has been compounded by other issues in the fight against the spread of monkeypox, including those related to testing and vaccination, the Post reported.

“Some worry that the window is closing to prevent the virus from becoming permanently entrenched in this country, with more than 1,400 confirmed infections across 42 states — and hundreds or thousands of additional infections suspected, predominantly in the gay and bisexual community,” the Post wrote.

And lagging efforts resemble the early days of the COVID-19 pandemic, the Post reported.

Accordingly, physicians and experts have called for relaxing barriers — such as collecting multiple specimens and photographs from each patient, and scheduling four visits — that have limited tecovirimat prescriptions, the Post reported. The antiviral was “tested on animals, narrowly approved by the FDA and stored in the national emergency stockpile,” the Post noted. And CDC officials imposed restrictions in part so that it could study rare cases until the treatment might be needed.

“Making every physician for every patient go through hours and hours of paperwork and back and forth with the agencies, that’s just not a sustainable approach,” Amanda Jezek, senior vice president of public policy and government relations at the Infectious Diseases Society of America, told the Post. “We know that there are a lot of patients that are missing out entirely on treatment, or getting serious delays in treatment as a result.”

Unnecessary Procedures for Dialysis Patients?

The United States has filed a civil complaint against Fresenius Vascular Care alleging that the company performed unnecessary procedures on dialysis patients at nine centers across New York City and Long Island, the DOJ announced.

The complaint alleges that Fresenius billed the procedures to Medicare, Medicaid, the Federal Health Benefits Program and TRICARE, the DOJ said.

“The conduct alleged in this case is egregious, as Fresenius not only defrauded federal healthcare programs but also subjected particularly vulnerable people to medically unnecessary procedures,” Breon Peace, JD, United States Attorney for the Eastern District of New York, said in a statement. “This Office will hold medical providers accountable for practices that needlessly expose patients to harm for financial gain at taxpayer expense.”

Specifically, the complaint alleges that, from around January 1, 2012 through June 30, 2018, Fresenius regularly performed certain procedures on patients with End Stage Renal Disease (ESRD) without sufficient clinical indication that they needed the procedures, the DOJ said.

The interventions allegedly included fistulagrams — in which dye is injected into a patient’s vein or artery to visualize the port and surrounding blood vessels — as well as angioplasties, in which wires and balloons are inserted into veins or arteries that have narrowed to restore the patient’s blood flow, the DOJ said.

“Fresenius knowingly subjected ESRD patients — who included elderly, disadvantaged minority, and low-income individuals — to these procedures to increase its revenues,” the DOJ stated.