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Former Theranos CEO Elizabeth Holmes (C) arrives in federal court with her mother Noel Holmes (L) and father Christian Holmes in San Jose, California, September 01, 2022.

Justin Sullivan | Getty Images

Elizabeth Holmes failed to pay back more than $25 million to creditors at her former company Theranos as she tries to extend her 11-year sentence, according to a lawsuit.

Theranos ABC, a corporation formed on behalf of its creditors, alleges in a lawsuit filed in the Superior Court of California in Santa Clara County that “Holmes failed to make payment on any of the promissory notes.”

The lawsuit was filed in December 2022 but only came to light on Friday when Holmes appeared in court.

According to the breach of contract lawsuit, Holmes executed three promissory notes while she was CEO of the failed blood testing company. According to the lawsuit, the promissory notes read as follows:

August 2011 in the amount of $9,159,333.65.

December 2011 in the amount of $7,578,575.52.

December 2013 of $9,129,991.10.

According to the complaint, “Theranos ABC demanded payment of Promissory Note #1 and Promissory Note #2 from Holmes, but Holmes failed to pay any amounts pursuant to the Promissory Note.”

Theranos ABC’s attorneys did not immediately respond to a request for comment.

Two of the promissory note payments were due for the first time in 2016 and the third in 2018. In July 2016, the board of directors of Theranos, which then included Holmes, former Secretary of Defense James Mattis, attorney David Boies, and former Bechtel Group CEO Riley, amended terms to include Bechtel and former Wells Fargo CEO Richard Kovacevich to extend the bonds by five years. The first two notes are overdue and the third is due in December, the lawsuit said.

Holmes returned to federal court in San Jose, Calif., on Friday, asking that her report date next month in prison be postponed while she appeals her conviction. A man leading the lawsuit approached Holmes at her lawyers’ table in the courtroom. The man, who was becoming increasingly upset, was taken away by marshals. It could not be immediately confirmed if he was a bailiff trying to serve Holmes with the lawsuit.

In January 2022, a jury found Holmes guilty on four counts of wire fraud and conspiracy. Holmes was ordered to turn herself in to begin her sentence on April 27, 2023. Her attorneys have signaled their intention to appeal Holmes’ case to the Ninth Circuit Court of Appeals.

Following her guilty verdict last year, Holmes became pregnant and gave birth to a second child.

A lawyer for Holmes gave several reasons why she poses no risk of escaping, including her young children, and that she has been out on bail without escaping for more than a year.

However, the government pointed to a one-way ticket that Holmes and her partner Billy Evans booked to Puerto Vallarta, Mexico days after their conviction.

Holmes is also at odds with prosecutors over how much compensation she should pay. Prosecutors want her to pay nearly $900 million, while Holmes argues the government failed to prove investors relied on her allegations.

US District Court Judge Edward Davila plans to rule on both applications in early April.

Holmes founded Theranos in 2003 after dropping out of Stanford with a promise to revolutionize the healthcare industry. The company shut down in 2016 after a series of failed regulatory inspections and articles by then-Wall Street Journal reporter John Carreyrou.

A man wearing a face mask as a preventive measure against Covid-19 walks past a Communist Party flag in Wuhan, China, March 31, 2020.

Noël Celis | AFP | Getty Images

The World Health Organization on Friday urged China to release new data linking the origins of the Covid pandemic to animal samples in the Wuhan market, after the country recently halted research.

The agency said China’s Center for Disease Control and Prevention uploaded data to the public virus tracking database GISAID in late January relating to samples taken at Wuhan’s Huanan Market in 2020.

Researchers from several countries downloaded and analyzed the data before removing it, presenting their findings to the WHO last weekend. The researchers found molecular evidence that raccoon dogs and other animals susceptible to Covid were being sold at the market, consistent with hypotheses about the virus spilling over from a wild animal to humans.

The new data doesn’t provide a conclusive answer as to how the pandemic began, “but it does provide more clues” to a potential host of the virus that transmitted it to humans, said Maria Van Kerkhove, the WHO’s technical lead for Covid-19 . She urged China to release the data publicly so the WHO and other researchers can further analyze it and get closer to understanding the origins of a pandemic that has killed millions of people worldwide.

“The big problem right now is that this data exists and is not readily available to the international community,” said Van Kerkhove. “First and foremost, this is absolutely critical, not to mention that it should have been available years earlier, but that data needs to be made available for people to access, analyze and discuss with one another. “

The WHO call comes as the debate over the origin of Covid intensifies. Researchers bicker over competing theories and governments stake out positions on what to do next.

The New York Times reported the new data earlier Thursday. Researchers told the Times that starting in January 2020, the molecular data was collected from swabs taken from walls, floors, metal cages and carts in and around the market. At that point, the Chinese government had already closed the market on suspicion of a link to the Covid outbreak.

The researchers added that large amounts of the data were no match for raccoon dogs.

Van Kerkhove stressed that the data does not necessarily prove that a raccoon dog or other animal was infected with the virus and transmitted it to humans. But she said it is found that animals capable of transmitting Covid have been sold at the market which is ‘new information’.

It is not known where the animals came from and whether they were wild or domesticated, she added. According to Van Kerkhove, the WHO is pushing for studies to be conducted in other markets in Wuhan and across China. It also looks for serological tests, which measure antibodies, for people who have worked in the markets.

Van Kerkhove also noted that “all the hypotheses” about how Covid entered the human population are still on the table. She said further investigation is needed into possible biosecurity breaches by a lab or whether the virus originated in a bat before spreading to humans.

“We don’t have all the information in front of us and we need to be able to look at all these different hypotheses. We have to look at all the data that is needed to evaluate each and every one of them so we can say that this may have happened, this may not have happened,” she said.

She added that the WHO “will not be able to remove various hypotheses” until China uploads its data again.

FBI Director Christopher Wray said earlier this month that the FBI believes Covid most likely originated in a Chinese government-controlled laboratory.

In February, the Department of Energy assessed “with low confidence” that Covid had leaked from a lab.

About 44% of US adults believe the virus leaked from a virology lab in Wuhan, China, according to a Morning Consult poll released last month, while 26% say it passed naturally from animals to humans .

The pill Paxlovid, used to treat coronavirus disease (COVID-19), is seen in boxes at the Misericordia hospital in Grosseto, Italy, February 8, 2022.

Jennifer Lorenzini | Reuters

The Food and Drug Administration’s independent advisory panel on Thursday recommended full approval of Pfizer’s Covid-19 antiviral pill Paxlovid for high-risk 16-1 adults, but pointed to potentially harmful drug interactions.

Treatment is recommended for people over 50 or those suffering from a variety of conditions, such as high blood pressure or diabetes, that put them at higher risk of ending up in hospital or dying from Covid.

The FDA first made Paxlovid available for emergency use in high-risk individuals ages 12 and older in December 2021. Pfizer submitted an application for full approval of the drug in June 2022, but the FDA extended its review deadline for the application in December 2022.

The agency generally follows the advice of its advisory committees, but is not obliged to do so. A final decision will be made in May.

“I would say that along with oxygen, Paxlovid has probably been and continues to be the most important treatment tool during this epidemic,” said Richard Murphy, chief of infectious diseases at Veterans Affairs White River Junction Medical Center.

The panel relied on three of Pfizer’s mid- to late-stage clinical trials of Paxlovid, which enrolled more than 6,000 patients in 21 countries.

86% effective

A study called EPIC-HR looked at high-risk adults who were unvaccinated and had no prior Covid infection. The study found that Paxlovid reduced the risk of hospitalization or death by 86% in adults treated within five days of symptom onset and by 89% in those treated within three days of symptom onset, such a review of the company’s data by the FDA.

“I found the efficacy data clear and compelling,” said Dr. Sankar Swaminathan, chief of the Department of Infectious Diseases at the University of Utah School of Medicine.

However, the advisors agreed that serious side effects due to drug-drug interactions or DDIs are an important safety issue with Paxlovid.

Photo taken on July 31, 2022 shows a health worker taking a swab sample from a woman to test for the Covid-19 coronavirus at a swab collection center in Guangzhou, southern Guangdong province. About a third of people with Covid will experience recovery in their symptoms regardless of whether they have been treated with the antiviral Paxlovid, according to a study published online on Tuesday.

St. | AFP | Getty Images

“I just want to emphasize that we underscore the importance of risk reduction for the prescriber, primary care provider, physician and other prescribers in relation to drug-drug interactions,” said Dr. David Hardy, associate clinical professor of medicine at the University of Southern California.

“That’s where I think we could get in trouble, I should say where they would get in trouble if they prescribe this drug without knowing well what ritonavir does to other drugs,” he said. Paxlovid consists of two antiviral drugs, ritonavir and nirmatrelvir.

Interactions with other drugs

More than half of Paxlovid-eligible Medicare and Veterans Affairs patients take medications that have drug-drug interactions with Paxlovid, according to an FDA review of safety surveillance data. About 74% of Paxlovid prescriptions came from adult primary care physicians who may not have experience managing possible adverse drug interactions, the FDA review added.

The FDA said its Office of Surveillance and Epidemiology had recorded 271 reports of serious adverse events potentially related to drug-drug interactions with Paxlovid through the end of January, including 147 hospitalizations. The most common drugs causing problems are immunosuppressants, which are commonly used to treat HIV and organ transplant patients, according to the FDA.

But Swaminathan noted that drug interactions should be “responsive and minimized.” FDA officials said at the beginning of the meeting that they could potentially be addressed by adjusting the dose of certain drugs, increasing patient monitoring, and ensuring product labeling informs prescribers and patients about potential drug interactions.

Paxlovid consists of two separate medicines packaged together and is designed to reduce the risk of hospitalization or death from Covid. Nirmatrelvir blocks a key enzyme the Covid virus needs to replicate, while ritonavir boosts the first drug’s ability to fight infection.

Patients take Paxlovid within five days of onset of Covid symptoms to reduce the risk of hospitalization or death. To complete a full cycle of the drug, patients must take three Paxlovid pills twice a day for five days.

According to federal data, more than 12 million cycles of Paxlovid have been shipped to pharmacies in the United States, and 1.3 million doses are available nationwide. About 10 million patients in the US and 14 million worldwide have been treated with the drug, according to Jim Rusnak, Pfizer’s chief development officer for internal medicine.

Paxlovid’s sales rose to $18.9 billion in 2022, the first year it was available, but Pfizer expects sales to fall 58% this year to $8 billion.

rebound cases

The only vote against Paxlovid came from Terry Gillespie, a patient advocate from Plainfield, Illinois. Gillespie expressed concern that doctors didn’t know when to prescribe the drug, noting they had had Covid infection four to five times, “but never once” Paxlovid was offered.

“I don’t feel like doctors really know how to use it,” Gillespie said.

After the vote, Swaminathan also noted that he has a “worryingly large number of patients” whose doctors are advising them not to take Paxlovid for fear of renewed Covid cases. Then patients see their Covid symptoms or a positive test after initially recovering.

“I am concerned that there is not a good understanding in the medical community and patients are actually being discouraged from taking an effective drug that could save their lives,” he said

Reports of these cases surfaced shortly after Paxlovid launched in 2021, with President Joe Biden and his former chief medical adviser Dr. Anthony Fauci appeared to have recovered from Covid after taking the antiviral cocktail before testing positive again.

Swaminathan said there is “dramatic acceptance” in the media that Paxlovid causes rebound cases and is “potentially worse” than what you had before taking the drug, although there is a lack of data to support this belief.

dr Lindsey Baden, the panel chair and director of Brigham and Women’s Hospital, added that new data suggests the rebound cases caused by Paxlovid “are not the biology of what’s going on.”

“Until recently, even some of the data shared today helped me understand what that means. So we’re seeing real-time data that’s systematic and informative,” Baden said.

An FDA review of Pfizer’s clinical trials found that overall rebound rates ranged from 10% to 16%, “with no evidence of a higher rate of symptom rebound or moderate symptom rebound” in patients taking Paxlovid compared were given a placebo. This is also independent of the patient’s risk of serious illness or whether the Omicron variant or an earlier strain is dominant, according to the agency’s staff.