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‘Underwhelming’: NIH Trials Fail to Test Meaningful Long-COVID Treatments — After 2.5 Years and $1 Billion
More than 2.5 years after the National Institutes of Health received a $1 billion mandate from Congress to study and treat long COVID, the agency has finally launched clinical trials for the often-debilitating condition. But both scientists who study long COVID and patients who have struggled with it say the trials are unlikely to deliver meaningful treatments, suggesting the federal government’s landmark COVID research effort may have been wasted.
Millions of Americans have suffered symptoms ranging from debilitating fatigue to heart issues, some still sick after initial coronavirus infections in the pandemic’s first wave. Congress provided the NIH with $1.15 billion to help patients in December 2020 — and the agency has now spent most of that funding, according to a detailed new budget breakdown shared with MuckRock and STAT, with the majority going towards observational research rather than clinical trials.
Among the trials announced so far, the NIH’s long-COVID initiative, called RECOVER, is studying only a handful of pharmaceutical treatments, along with several behavioral options. These treatments will not address the underlying biological issues of long COVID, say scientists and patient advocates who reviewed the newly public details about the studies.
Scientists also expressed concerns about how the RECOVER studies will measure the way the treatments affect patients. Without study designs that account for unique long-COVID symptoms, such as delayed fatigue after exertion, the trials may miss positive impacts — or harmful side effects — of the treatments. Potential errors in the trials could have been avoided through transparency and better engagement with patients, experts and advocates say.
Michigan Judge Denies Drug Manufacturer’s Immunity in Case of Contaminated COVID Medication
A Michigan judge has ruled for the first time that a drug manufacturer is not protected by the Public Readiness and Emergency Preparedness (PREP) Act in a case where a man suffered two strokes and a leg amputation after receiving a COVID-19 medication contaminated with glass particles.
The PREP Act was declared by the U.S. Department of health and Human Services for emergency use, and shields manufacturers, administrators and distributors of vaccines from liability claims of loss caused by a drug.
The case, filed by Ven Johnson Law on behalf of Dan Nowacki, focuses on how Nowacki suffered a stroke after receiving Remdesivir that was contaminated with glass particles. Two lots containing 55,000 vials of the drug were recalled after it was found they were contaminated with glass particles.
In November 2021, Nowacki was admitted to St. Joseph Mercy Hospital in Chelsea with COVID-19. During his stay, he was administered five doses of Remdesivir and at least two of those doses belonged to the contaminated lot, the lawsuit states. Days later, he suffered a massive stroke and other serious complications.
Lilly Brushes Off Liver Tox Concerns After Pfizer Drops an Obesity Candidate
Pfizer’s decision to drop an obesity candidate on liver toxicity concerns in June raised a red flag for the analyst community. Could Eli Lilly’s thriving obesity portfolio have similar issues?
Pfizer let go of lotiglipron because of phase 1 and 2 data that showed elevated transaminases, a type of enzyme that can be an indicator of liver dysfunction. The New York-based Big Pharma had been hoping to raise up lotiglipron over more advanced candidate danuglipron because it allowed for once a day dosing — which could have been a bigger threat to Lilly and Novo Nordisk’s offerings.
But the safety data took lotiglipron out of the running, leaving the twice-daily danuglipron, which requires a higher dose, as Pfizer’s lead horse heading toward the competitive obesity market.
Lilly, meanwhile, has posted weight-loss results for orforglipron showing an astounding 14.7% weight loss at 36 weeks in a phase 2 study published in the New England Journal of Medicine in June. In a second quarter earnings call Tuesday, Lilly Chief Scientific and Medical Officer Dan Skovronsky, M.D., Ph.D., acknowledged a few cases of liver toxicity in the studies for orforglipron. The company had previously said that safety was comparable to other incretin-based therapies.
Lilly is advancing orforglipron to phase 3 in obesity and diabetes. Another candidate, retatrutide, also slid into the queue for late-phase testing in the second quarter.
WHO Flags India-Made Syrup in Latest Warning Over Contaminated Drugs
The World Health Organization on Monday flagged a batch of contaminated common cold syrup, manufactured by an Indian company, the latest in a series of warnings by the agency about substandard medicines from the country.
The United Nations agency said the batch of the syrup, branded Cold Out, found in Iraq was manufactured by Fourrts (India) Laboratories for Dabilife Pharma, and had higher than acceptable limit of contaminants diethylene and ethylene glycol.
The batch had 0.25% of diethylene glycol and 2.1% of ethylene glycol, when the acceptable safety limit for both is up to 0.10%, WHO said in its medical product alert. The agency added the manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product. The companies did not immediately respond to Reuters’ requests for comments outside of business hours.
Cough syrups made in India were linked to deaths of at least 89 children in Gambia and Uzbekistan last year. Indian authorities also found violations at Riemann Labs, whose cough syrup were linked to deaths of children in Cameroon.
Purdue Asks Supreme Court Not to Block Opioid Settlement During U.S. Appeal
Oxycontin maker Purdue Pharma on Friday asked the U.S. Supreme Court to reject the U.S. Department of Justice’s request to delay its multi-billion-dollar bankruptcy settlement resolving thousands of lawsuits against it over the opioid epidemic.
The department’s bankruptcy watchdog last week asked the Supreme Court to pause the settlement, which would shield the company’s Sackler family owners from opioid lawsuits in exchange for a $6 billion contribution to a broader settlement with states, local governments and victims of addiction.
The Department of Justice (DOJ) asked the high court to put the deal on hold after a federal appeals court rejected a proposed delay. Purdue on Friday argued a delay would be destructive, imperiling a settlement that has the support of all major stakeholders, including state attorneys general and people affected by the opioid crisis.
The DOJ’s position would “take billions of dollars out of opioid abatement programs that are sorely needed” and potentially “deprive victims of any meaningful recovery” if the deal falls apart, Purdue’s lawyers wrote.
Drug-Resistant Killer Bugs Linked to Air Pollution, Top Scientists Say
As if air pollution wasn’t deadly enough. Now new research suggests tiny airborne pollutants may be linked to higher rates of drug-resistant lethal bacteria.
In the study, researchers from Zhejiang University, China and the University of Cambridge, England, concluded that air pollution is one of the leading factors driving antimicrobial resistance (AMR) after compiling data from 116 countries between 2000 and 2018, with more than 11.5 million lab test results covering nine bacterial pathogens and 43 types of antibiotics.
The world is battling to combat the growing threat of antimicrobial resistance — a phenomenon caused by bugs such as bacteria, fungi and parasites evolving to survive against drug treatments. Without effective antibiotics, routine operations and previously minor infections, for example, could once again turn deadly.
“Our analysis presents strong evidence that increasing levels of air pollution are associated with increased risk of antibiotic resistance,” said the authors of the study, published Tuesday in The Lancet Planetary Health.
Obesity Drugs Take Brakes off Big Pharma’s Growth
It’s astonishing to see a pharmaceutical giant growing its revenue at the rate of a technology startup. That’s what Eli Lilly (LLY.N) did in the second quarter, thanks to demand for its diabetes and weight loss drug Mounjaro. Even so, the $500 billion company and Danish rival Novo Nordisk (NOVOb.CO) are likely to expand at an even faster pace in coming quarters as supply constraints ease and governments and insurers decide to foot the bill for obesity treatments.
Lilly said on Monday its top line bulged by 28% to $8 billion in the three months to June, as the firm sold nearly $1 billion worth of Mounjaro. That’s almost twice as much as the drug brought in the first quarter of the year. Though the company led by David Ricks is ramping up production, it expects supply to remain tight for the next few quarters.
Two factors are set to provide a further lift. While regulators have approved Mounjaro for treating patients with diabetes, the U.S. Food and Drug Administration has yet to give its official blessing for the drug to help people lose weight. That’s likely to come late this year.
Certain Medications Tied to Post-COVID Pulmonary Fibrosis — Rituximab and Chemotherapy Singled Out in U.S. Dataset
Pre-infection exposures to rituximab (Rituxan) or chemotherapy were associated with an increased incidence of pulmonary fibrosis in adults hospitalized for COVID-19, a nationwide cohort study suggested.
The incidence of a new pulmonary fibrosis diagnosis at 60 days was significantly higher in both rituximab-exposed patients (incidence rate ratio [IRR] 2.5, 95% CI 1.2-5.1) and chemotherapy-exposed patients (IRR 1.6, 95% CI 1.3-2.0) when compared with matched COVID-hospitalized controls who did not receive these drugs, reported Ayodeji Adegunsoye, MD, of the University of Chicago, and colleagues.
In the U.S., new cases of pulmonary fibrosis have been increasing in recent years and patients hospitalized for severe COVID-19 may be at particular risk, according to the researchers. One study showed that up to 11% of patients hospitalized for COVID have lung abnormalities in the months after being discharged.
This isn’t the first time rituximab has been linked with poor outcomes in COVID-19. Prior studies during the pandemic have shown an increased risk for severe COVID-19 for patients taking the anti-CD20 antibody for cancer, rheumatoid arthritis, and multiple sclerosis.
SK Bioscience Helps Keep Novavax Afloat, Buying 7% Stake in Vaccine Maker for $85 Million
After striking out in the pandemic phase of COVID-19 with its belated vaccine, Novavax seeks to recover in the endemic phase. And a big part of the company’s plan centers around enhancing its partnership with SK Bioscience.
The South Korean manufacturer has acquired a 7% stake in Novavax, paying $85 million for 6.5 million shares. The $13 price per share is a 59% premium over Novavax’s volume-weighted average price over the previous 90 days.
In addition, SK gains exclusive commercial rights to the updated Novavax COVID vaccine in South Korea until February 2029 and nonexclusive rights in Thailand and Vietnam until June 2028. The deal also provides a $4 million milestone payment to Novavax, plus royalties on future product sales.
The agreement also settles $195 million in Novavax’s manufacturing liabilities to SK. Overall this year, Novavax has reduced its liabilities by more than $1 billion, the company said Tuesday in presenting its second-quarter financials.
