Jan 26 (Reuters) – New data from one U.S. Centers for Disease Control and Prevention (CDC) database shows a possible stroke risk link for older adults who received an updated Pfizer (PFE.N)/BioNTech (22UAy.DE) COVID-19 booster shot, but the signal is weaker than what the agency had flagged earlier in January, health officials said on Thursday.
U.S. Food and Drug Administration officials said they had not detected a link between the shots and strokes in two other safety monitoring databases.
The new data was presented at a meeting of outside experts that advise the FDA on vaccine policy.
Earlier this month, U.S. health officials said they had detected the possible link to ischemic strokes in people over age 65 who received the newer booster shots in its Vaccine Safety Datalink (VSD) database. They said at the time it was very unlikely to represent a true clinical risk.
Dr. Nicola Klein of healthcare company Kaiser Permanente, which maintains VSD data for the CDC, said the rate of strokes observed in the database had slowed in recent weeks, but the signal was still statistically significant, meaning likely not by chance.
Most of the confirmed cases had also received a flu vaccine at the same time, which might be a factor, she said.
FDA scientist Richard Forshee said the agency plans to study whether there is any increased risk of stroke from receiving the two shots at the same time.
Both agencies still recommend older adults receive the booster shots, now tailored to target Omicron variants as well as the original coronavirus.
Dr. Walid Gellad, professor of medicine at University of Pittsburgh, said the issue required further investigation.
“Sometimes signals are not clear,” Gellad said in an email. “It makes sense to look into it more, and it doesn’t make sense to change practice given the known benefits (of getting the booster) in this age group.”
(This story has been corrected to fix the name to Nicola from Nicole in paragraph 5)
Reporting by Michael Erman; Editing by Bill Berkrot
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Jan 7 (Reuters) – The U.S. Food and Drug Administration on Friday approved the Alzheimer’s drug lecanemab developed by Eisai Co Ltd (4523.T) and Biogen Inc (BIIB.O) for patients in the earliest stages of the mind-wasting disease.
Eisai and Biogen said on Saturday the Japanese drugmaker had applied for full FDA approval of the drug.
The drug, to be sold under the brand Leqembi, belongs to a class of treatments that aims to slow the advance of the neurodegenerative disease by removing sticky clumps of the toxic protein beta amyloid from the brain.
Nearly all previous experimental drugs using the same approach had failed.
“Today’s news is incredibly important,” said Dr. Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation. “Our years of research into what is arguably the most complex disease humans face is paying off and it gives us hope that we can make Alzheimer’s not just treatable, but preventable.”
Eisai said the drug would launch at an annual price of $26,500. Biogen shares, which had been halted, were up 3% at $279.40.
The Japanese company said it also plans to apply for marketing authorization for Leqembi in Japan and the European Union by the end of its business year on March 31.
Eisai estimated the number of U.S. patients eligible for the drug would reach around 100,000 within three years, increasing gradually from there over the medium to long term.
Dr. Erik Musiek, A Washington University neurologist at Barnes-Jewish Hospital, said he was “pleasantly surprised” by the drug’s price.
“Considering the marketplace and the fact that we have no other good disease-modifying treatments, I think it’s in the ballpark of what I would expect,” he said.
Initial patient access will be limited by a number of factors including reimbursement restrictions by Medicare, the U.S. government insurance program for Americans aged 65 and older who represent some 90% of individuals likely to be eligible for Leqembi.
“Without Centers for Medicare & Medicaid Services (CMS) and insurance coverage … access for those who could benefit from the newly-approved treatment will only be available to those who can pay out-of-pocket,” the Alzheimer’s Association said in a statement.
Leqembi was approved under the FDA’s accelerated review process, an expedited pathway that speeds access to a drug based on its impact on underlying disease-related biomarkers believed to predict a clinical benefit.
“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s instead of only treating the symptoms of the disease,” FDA neuroscience official Billy Dunn said in a statement.
CMS said on Friday that current coverage restrictions for drugs approved under the accelerated pathway could be reconsidered based on its ongoing review of available information.
If the drug receives traditional FDA approval, CMS said it would provide broader coverage. Eisai officials have said the company plans to submit data from a recent successful clinical trial in 1,800 patients as the basis for a full standard review of Leqembi.
The CMS decision was largely in response to a previous Alzheimer’s treatment from Eisai and Biogen. Aducanumab, sold under the brand name Aduhelm, won accelerated approval in 2021 with little evidence that the drug slowed cognitive decline and despite objections by the FDA’s outside experts.
Biogen initially priced Aduhelm at $56,000 per year before cutting the price in half. With limited acceptance and insurance coverage, sales were only $4.5 million in the first nine months of 2022.
Lecanemab is intended for patients with mild cognitive impairment or early Alzheimer’s dementia, a population that doctors believe represents a small segment of the estimated 6 million Americans currently living with the memory-robbing illness.
To receive the treatment, patients will need to undergo testing to show they have amyloid deposits in their brain – either through brain imaging or a spinal tap. They will also need to undergo periodic MRI scans to monitor for brain swelling, a potentially serious side effect associated with this type of drug.
The medicine’s label says doctors should exercise caution if lecanemab patients are given blood clot preventers. This could be a safety risk, according to an autopsy analysis published this week of a lecanemab patient who had a stroke and later died.
In the large trial of lecanemab, which is given by infusion, the drug slowed the rate of cognitive decline in patients with early Alzheimer’s by 27% compared to a placebo. Nearly 13% of patients treated with Leqembi in the trial had brain swelling.
Dr. Babak Tousi, a neuro-geriatrician at the Cleveland Clinic, said the approval will make a “big difference” in the field because it is based on biomarkers rather than just symptoms.
“It’s going to change how we make a diagnosis for Alzheimer’s disease, with more accuracy,” he said.
Tousi acknowledged that the benefit of the drug will likely be modest. “Still, it is a benefit that we were not able to achieve” before this approval.
Reporting by Deena Beasley in Los Angeles and Bhanvi Satija in Bengaluru, additional reporting Jaiveer Shekhawat; Editing by Bill Berkrot, David Gregorio and William Mallard
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CHICAGO, Oct 18 (Reuters) – Lauren Nichols, a 34-year-old logistics expert for the U.S. Department of Transportation in Boston, has been suffering from impaired thinking and focus, fatigue, seizures, headache and pain since her COVID-19 infection in the spring of 2020.
Last June, her doctor suggested low doses of naltrexone, a generic drug typically used to treat alcohol and opioid addiction.
After more than two years of living in “a thick, foggy cloud,” she said, “I can actually think clearly.”
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Researchers chasing long COVID cures are eager to learn whether the drug can offer similar benefits to millions suffering from pain, fatigue and brain fog months after a coronavirus infection.
The drug has been used with some success to treat a similar complex, post-infectious syndrome marked by cognitive deficits and overwhelming fatigue called myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
Drawing on its use in ME/CFS and a handful of long COVID pilot studies, there are now at least four clinical trials planned to test naltrexone in hundreds of patients with long COVID, according to a Reuters review of Clinicaltrials.gov and interviews with 12 ME/CFS and long COVID researchers.
It is also on the short list of treatments to be tested in the U.S. National Institutes of Health’s $1 billion RECOVER Initiative, which aims to uncover underlying causes and find treatments for long COVID, advisers to the trial told Reuters.
Unlike treatments aimed at addressing specific symptoms caused by COVID damage to organs, such as the lungs, low-dose naltrexone (LDN) may reverse some of the underlying pathology driving symptoms, they said.
Naltrexone has anti-inflammatory properties and has been used at low doses for years to treat conditions such as fibromyalgia, Crohn’s disease and multiple sclerosis, said Dr. Jarred Younger, director of the Neuro-inflammation, Pain and Fatigue Laboratory at the University of Alabama at Birmingham.
At 50 milligrams – 10 times the low dose – naltrexone is approved to treat opioid and alcohol addiction. Several generic manufacturers sell 50mg pills, but low-dose naltrexone must be purchased through a compounding pharmacy.
Younger, author of a scientific review of the drug as a novel anti-inflammatory, in September submitted a grant application to study LDN for long COVID. “It should be at the top of everyone’s list for clinical trials,” he said.
Still, the drug is unlikely to help all patients with long COVID, a collection of some 200 symptoms ranging from pain and heart palpitations to insomnia and cognitive impairment. One 218-patient ME/CFS study found 74% had improvements in sleep, reduced pain and neurological disturbances.
“It’s not a panacea,” said Jaime Seltzer, a Stanford researcher and head of scientific outreach for the advocacy group MEAction. “These people weren’t cured, but they were helped.”
‘HUMAN AGAIN’ Dr. Jack Lambert, an infectious disease expert at University College Dublin School of Medicine, had used LDN to treat pain and fatigue associated with chronic Lyme disease.
During the pandemic, Lambert recommended LDN to colleagues treating patients with lingering symptoms after bouts of COVID.
It worked so well that he ran a pilot study among 38 long COVID patients. They reported improvements in energy, pain, concentration, insomnia and overall recovery from COVID-19 after two months, according to findings published in July.
Lambert, who is planning a larger trial to confirm those results, said he believes LDN may repair damage of the disease rather than mask its symptoms.
Other planned LDN trials include one by the University of British Columbia in Vancouver and a pilot study by Ann Arbor, Michigan-based startup AgelessRx. That study of 36 volunteers should have results by year-end, said company co-founder Sajad Zalzala.
Scientists are still working on explaining the mechanism for how LDN might work.
Experiments by Dr. Sonya Marshall-Gradisnik of the National Centre for Neuroimmunology and Emerging Diseases in Australia suggest ME/CFS and long COVID symptoms arise from a significant reduction in function of natural killer cells in the immune system. In laboratory experiments, LDN may have helped restore their normal function, a theory that must still be confirmed.
Others believe infections trigger immune cells in the central nervous system called microglia to produce cytokines, inflammatory molecules that cause fatigue and other symptoms associated with ME/CFS and long COVID. Younger believes naltrexone calms these hypersensitized immune cells.
Dr. Zach Porterfield, a virologist at the University of Kentucky who co-chairs a RECOVER task force looking at commonalities with other post-infectious syndromes, said it has recommended LDN be included in RECOVER’s treatment trials.
Other therapies under consideration, sources said, were antivirals, such as Pfizer Inc’s (PFE.N) Paxlovid, anti-clotting agents, steroids and nutritional supplements. RECOVER officials said they have received dozens of proposals and could not comment on which drugs will be tested until trials are finalized.
Dr. Hector Bonilla, co-director of the Stanford Post-Acute COVID-19 Clinic and a RECOVER adviser, has used LDN in 500 ME/CFS patients, with about half reporting benefits.
He studied LDN in 18 long COVID patients, with 11 showing improvements, and said he believes larger, formal trials could determine whether LDN offers a true benefit.
Nichols, a patient adviser to RECOVER, was “ecstatic” when she learned LDN was being considered for the government-funded trials.
While LDN has not fixed all her COVID-related problems, Nichols can now work all day without breaks and have a social life at home.
“It has made me feel like a human again.”
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Reporting by Julie Steenhuysen in Chicago; Editing by Caroline Humer and Bill Berkrot
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Sept 27 (Reuters) – Eisai Co Ltd (4523.T) and Biogen Inc (BIIB.O) on Tuesday said their experimental Alzheimer’s drug significantly slowed cognitive and functional decline in a large trial of patients in the early stages of the disease, marking a rare win in a field littered with failed drugs.
The drug, lecanemab, slowed progress of the brain-wasting disease by 27% compared with a placebo, meeting the study’s main goal, and potentially offering hope for patients and their families desperate for an effective treatment.
“It’s not a huge effect, but it’s a positive effect,” said Ronald Petersen, director of the Mayo Clinic Alzheimer’s Disease Research Center in Rochester, Minnesota.
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Eisai, leader of the 50-50 partnership’s lecanemab program, is seeking FDA approval under an accelerated pathway, with a decision expected in early January. On Tuesday the Japanese drugmaker said it will use the new efficacy results to submit lecanemab for traditional FDA review as well.
The company said it will also seek authorization in Japan and Europe during its current fiscal year, ending March 31.
Eisai said results from the 1,800-patient trial prove the longstanding theory that removal of sticky deposits of a protein called amyloid beta from the brains of people with early Alzheimer’s can delay advance of the debilitating disease.
“This means that treating amyloid is a step in the right direction,” Petersen said.
Shares of Biogen and Eisai were halted, but shares of Eli Lilly & Co , which is also developing an Alzheimer’s drug, rose as much as 6.7% in after hours trade.
The lecanemab data suggest “a potentially new multi-billion dollar franchise,” Jefferies analyst Michael Yee said in a research note.
Lecanemab, like the partners’ previous drug Aduhelm, is an intravenous antibody designed to remove amyloid deposits. Unlike Aduhelm, lecanemab targets forms of amyloid that have not yet clumped together.
“If you can slow a disease by almost 30% that’s fantastic. This is what we have been looking for,” said Dr. Jeff Cummings, director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada Las Vegas.
The so-called amyloid hypothesis has been challenged by some scientists, particularly after the U.S. Food and Drug Administration’s controversial approval of Aduhelm in 2021 based on its plaque-clearing ability rather than proof that it helped slow cognitive decline. The decision came after the FDA’s own panel of outside experts had advised against approval.
Aduhelm was the first new Alzheimer’s drug approved in 20 years after a long list of high-profile failures for the industry. read more
Patient advocacy groups hailed the news of positive lecanemab trial results.
“This is important because it demonstrates that each of these drugs is different … I would hope that the FDA approves the drug in January,” USAgainstAlzheimer’s Chairman George Vradenburg told Reuters.
The Phase III trial evaluated the drug’s ability to reduce cognitive and functional decline based on the Clinical Dementia Rating-Sum of Boxes (CDR-SB), a numerical scale used to quantify the severity of dementia in patients in areas such as memory, orientation, judgment and problem solving and personal care.
BRAIN SWELLING
The rate of a brain swelling side effect associated with anti-amyloid treatments was 12.5% in the lecanemab group, versus 1.7% in the placebo group. But many cases did not cause symptoms, with symptomatic brain swelling seen in 2.8% of those in the lecanemab group, the companies said.
Micro hemorrhages in the brain occurred at a rate of 17% in the lecanemab group, and 8.7% in the placebo group.
Petersen said the side effect rate was much less than with Aduhelm and “certainly tolerable.”
Aduhelm’s approval was a rare bright spot for Alzheimer’s patients, but critics have called for more evidence that amyloid-targeting drugs are worth the cost.
The controversy and reluctance by some payers to cover Aduhelm led Biogen to slash the drug’s price to $28,000 per year from an initial $56,000.
But Medicare, the U.S. government health plan for people 65 and older, this year said it would only pay for Aduhelm and other similar drugs if patients were enrolled in a valid clinical trial, which sharply curtailed the medication’s use. Since Alzheimer’s is a disease of aging, an estimated 85% of patients eligible for the drug are covered by the government plan.
Michael Irizarry, Eisai’s deputy chief clinical officer, said on a conference call that the company will have discussions with the Medicare agency regarding coverage of lecanemab.
The number of Americans living with Alzheimer’s is expected to rise to around 13 million by 2050 from more than 6 million currently, according to the Alzheimer’s Association. Globally, that figure could rise to 139 million by 2050 without an effective treatment, according to Alzheimer’s Disease International.
Other plaque-targeting antibodies in late-stage development for Alzheimer’s patients include Roche Holding AG’s (ROG.S) gantenerumab and Eli Lilly’s donanemab.
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Reporting by Deena Beasley in Los Angeles and Julie Steenhuysen in Chicago; Editing by Bill Berkrot and Richard Pullin
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Pennsylvania Lieutenant Governor and U.S. Senate candidate John Fetterman delivers remarks as he attends a Labor Day celebration with U.S. President Joe Biden at the United Steelworkers of America Local Union 2227 in West Mifflin, Pennsylvania, U.S., September 5, 2022. REUTERS/Elizabeth Frantz
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PHILADELPHIA, Sept 11 (Reuters) – Democratic U.S. Senate candidate John Fetterman on Sunday sought to allay concerns about his health after suffering a near-fatal stroke earlier this year, at a campaign rally focused on abortion rights in suburban Philadelphia.
Speaking at times in a halting and clipped fashion, Fetterman took aim at his Republican opponent in Pennsylvania’s Senate race, celebrity physician Mehmet Oz, for questioning his fitness to serve. “Unfortunately,” he said, “I have a doctor in my life doing that.”
He spoke for about 10 minutes before moving slowly off the stage. He walked into the crowd, shaking hands, greeting people and smiling for selfies as AC-DC’s “Back in Black” played.
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Fetterman, Pennsylvania’s lieutenant governor, has largely kept off the campaign trail since a stroke in May that he said almost killed him. Oz has seized on the issue, suggesting Fetterman’s health would prevent him from carrying out his duties if elected.
Polls show Fetterman leading Oz in a race that will help determine whether President Joe Biden’s Democrats hold onto their razor-thin margin in the U.S. Senate. The race for the seat held by retiring Republican Pat Toomey is important enough that both Biden and former President Donald Trump have traveled to the state in recent weeks to promote their parties’ candidates.
Speaking on condition of anonymity to discuss their concerns, five state Democratic Party officials interviewed in the past two weeks expressed worries about Fetterman’s health and whether Republican attacks were swaying voters.
“It’s important for people to see John Fetterman out on the campaign trail and to see for themselves that he’s all right. In a state where one (percentage) point can decide an election, it matters,” said Joe Foster, a state Democratic committeeman from the Philadelphia suburbs.
Fetterman held his first public event after his stroke in August, and has made a handful of campaign appearances since, including at a Labor Day parade in Pittsburgh. His campaign confirmed he relies on closed captions to conduct interviews due to hearing damage. He has said the symptoms are temporary.
Fetterman campaign spokesman Joe Cavello said he is up to the job.
“John marched for over two hours in the rain in Pittsburgh’s Labor Day parade, and spoke at two other events afterwards,” Cavello told Reuters on Friday. “Anyone who’s seen John speak knows that while he’s still recovering, he’s more capable of fighting for PA than Dr. Oz will ever be.
Fetterman rallied with abortion-rights advocacy group Planned Parenthood in Philadelphia’s largest suburban county as he seeks to fire up women voters concerned about the U.S. Supreme Court’s decision in June to end the nationwide right to abortion.
“Women are the reason we can win,” Fetterman said.
The stakes are high in Pennsylvania, where the governor’s race will decide whether women will maintain their access to abortions. Fetterman has vowed to help protect that access, while Oz says he’s “100% pro-life” but supports exceptions in cases of rape or incest or if the life of the mother is at risk.
Christopher Borick, a political science professor at Pennsylvania’s Muhlenberg University, said bread-and-butter campaign events like Sunday’s take on added meaning following the stroke.
“He doesn’t have to be pre-stroke John Fetterman, but people need to see that he’s capable,” Borick said.
Oz used an initial refusal by Fetterman to debate to argue that his rival was either afraid of him or concealing the scope of the damage done by the stroke.
“John Fetterman is either healthy and he’s dodging the debate because he does not want to answer for his radical left positions, or he’s too sick to participate,” Oz told reporters last week, according to media accounts.
Fetterman has now agreed to debate in October, but his campaign is looking at the possibility of using a closed captioning monitor for the event so that he does not miss any words as he continues to recover from his stroke.
“Let’s be clear, this has never really been about debates for Dr. Oz,” Fetterman said in a statement. “This whole thing has been about Dr. Oz and his team mocking me for having a stroke because they’ve got nothing else.”
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Reporting by Jarrett Renshaw, Additional reporting by James Oliphant; Editing by Scott Malone and Daniel Wallis
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WASHINGTON, July 27 (Reuters) – The U.S. Justice Department has opened a criminal investigation into Cassava Sciences Inc (SAVA.O) involving whether the biotech company manipulated research results for its experimental Alzheimer’s drug, two people familiar with the inquiry said.
The Justice Department personnel conducting the investigation into Austin, Texas-based Cassava specialize in examining whether companies or individuals have misled or defrauded investors, government agencies or consumers, according to the sources, who spoke on condition of anonymity. The sources did not provide details of the focus of the probe and whether the department was looking into any specific individuals.
As in any Justice Department investigation, this one could lead to criminal charges or be closed without any charges being brought.
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In an emailed statement, Kate Watson Moss, a lawyer representing Cassava, neither confirmed nor denied the existence of the Justice Department criminal probe.
“To be clear: Cassava Sciences vehemently denies any and all allegations of wrongdoing,” Watson Moss said, adding that the company “has never been charged with a crime, and for good reason – Cassava Sciences has never engaged in criminal conduct.”
Watson Moss added that Cassava Sciences has received confidential requests for information from government agencies, but declined to identify those agencies. Watson Moss said that “Cassava Sciences has provided information in response to these requests in full satisfaction of its legal obligations.” Watson Moss added that no government agency has accused the company of wrongdoing.
A Justice Department spokesperson declined to comment.
The company already was facing scrutiny from the U.S. Securities and Exchange Commission and investors after two physicians from outside Cassava last year made allegations of data manipulation and misrepresentation involving research underpinning the company’s Alzheimer’s drug, called simufilam.
Cassava, a small company with about two dozen employees, in a statement last year called the allegations of data manipulation and misrepresentation “false and misleading.”
Cassava on its website describes simufilam as taking an “entirely new approach” to treating Alzheimer’s, the most common form of dementia and a progressive brain disorder that affects nearly 6 million Americans. The oral medication restores the normal shape and function of a key protein in the brain, the company said.
A PETITION TO THE FDA
The criminal investigation began, according to the sources, sometime after a petition was filed in August 2021 with the U.S. Food and Drug Administration by a lawyer on behalf of two physicians asking the agency to halt clinical trials of simufilam. The physicians are David Bredt, a neuroscientist formerly at Johnson & Johnson’s Janssen, and Geoffrey Pitt, a cardiologist who serves as director of Weill Cornell Medicine’s Cardiovascular Research Institute in New York.
The petition filed by Jordan Thomas, a New York-based lawyer representing both doctors, said Cassava’s published studies on clinical trials involving simufilam in various journals contained data misrepresentation and images of experiments that appeared to have been manipulated by photo-editing software. The FDA denied the petition and let the trials proceed.
Bredt and Pitt disclosed last November in an article published by The Wall Street Journal that they shorted Cassava’s stock, betting that the price would go down once investors learned of the manipulation they alleged. They later told The New Yorker magazine that they no longer have a short position in Cassava, a claim Reuters could not independently verify.
The short-selling represents “a major conflict of interest,” Watson Moss said in her statement to Reuters.
“Cassava Sciences is interested in helping those with Alzheimer’s disease, not an easy payday,” Watson Moss added.
STOCK DROP
Cassava’s stock fell precipitously following the petition filed with the FDA by Thomas, presenting an opportunity for Bredt and Pitt to profit on their bet against the company.
Thomas declined to comment on the matter.
The FDA in February said the so-called citizen petition filed by the two physicians urging it to launch an investigation into simufilam was not a proper avenue for such a request. Requests for the FDA to initiate an enforcement action, meanwhile, are “expressly excluded from the scope of the FDA’s citizen petition procedures,” the agency said, adding that it exercises its own discretion on such matters.
An FDA spokesperson declined to comment.
Cassava shares rose on Nasdaq from around $7 in January 2021 to above $135 in July 2021 on investor hopes that the company was on the verge of a breakthrough in treating Alzheimer’s. The stock plunged weeks later following word of the petition questioning Cassava’s research results.
The company’s shares closed at $21.72 on Tuesday.
Cassava has received more than $20 million from the U.S. National Institutes of Health to support developing simufilam.
The NIH told Reuters it does not discuss potential cases of research misconduct related to grants but that officials “take research misconduct very seriously. Research misconduct may distort NIH funding decisions, the overall integrity of the research we support and the public’s trust in science and resulting outcomes.”
Cassava also is facing the SEC investigation, the sources said. The Wall Street Journal last November first reported on the SEC probe, saying the agency was examining the claims made in the FDA petition. Reuters was unable to determine what specific claims, if any, drew the agency’s scrutiny.
An SEC spokesperson said the agency “does not comment on the existence or nonexistence of a possible investigation.”
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Reporting by Marisa Taylor in Washington and Mike Spector in New York; Editing by Will Dunham and Michele Gershberg
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Two long COVID patients recover after Paxlovid treatment
Side effects, safety issues need to be studied
CHICAGO, April 18 (Reuters) – Reports of two patients who found relief from long COVID after taking Pfizer Inc’s (PFE.N) antiviral Paxlovid, including a researcher who tested it on herself, provide intriguing evidence for clinical trials to help those suffering from the debilitating condition, experts and advocates say.
The researcher said her chronic fatigue symptoms, which “felt like a truck hit me,” are gone after taking the two-drug oral therapy.
Long COVID is a looming health crisis, estimated to affect up to 30% of people infected with the coronavirus. It can last for months, leaving many unable to work. More than 200 symptoms have been associated with the condition, including pain, fatigue, brain fog, breathing difficulty and exhaustion after minimal amounts of physical activity.
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Dr. Steven Deeks, a professor of medicine at the University of California, San Francisco (USSF), and an expert in HIV cure research, said drug companies tend to discount single-patient case studies. But such instances have helped drive HIV cure research, and Deeks thinks these Paxlovid cases could do the same for long COVID.
“This provides really strong evidence that we need to be studying antiviral therapy in this context as soon as possible,” said Deeks, adding that he has heard of yet another anecdotal case at UCSF in which a long COVID patient’s symptoms cleared after taking Paxlovid.
Scientists caution that these cases are “hypothesis-generating only” and not proof that the drug caused relief of lingering symptoms. But they lend support to a leading theory that long COVID may be caused by the virus persisting in parts of the body for months, affecting patients’ daily lives long after acute symptoms disappear.
The best evidence so far comes from a National Institutes of Health (NIH) study, currently under peer review, in which researchers conducted autopsies in 44 people who died of COVID-19 or another cause but were infected with COVID. They found widespread infection throughout the body, including in the brain, that can last more than seven months beyond the onset of symptoms.
Paxlovid, which combines a new Pfizer pill with the old antiviral ritonavir, is currently authorized for use in the first days of a COVID infection to prevent severe disease in high-risk patients.
Pfizer spokesman Kit Longley said the company does not have any long COVID studies underway and did not comment on whether it would consider them.
The drugmaker has two large clinical trials testing whether Paxlovid can prevent initial COVID infection. That “may provide us with relevant data to help inform future studies,” Longley said.
Patients who have been suffering for months are growing frustrated with the lack of pharmaceutical research for their condition.
There are currently fewer than 20 clinical trials led by individual researchers or small drugmakers testing treatments for long COVID, only a handful of which have moved beyond early stages, a Reuters review found. read more
Diana Berrent, founder of grassroots COVID advocacy group Survivor Corps, has been lobbying the Biden Administration to fund large long COVID clinical trials.
“We shouldn’t be doing our research based on anecdotal reports,” she said. “That’s not good enough.”
‘BACK TO NORMAL’
In one of the case reports, published as a preprint ahead of peer review, a previously healthy and vaccinated 47-year-old woman became infected with COVID in the summer of 2021. Most of her acute symptoms dissipated within 48 hours, but she continued to have severe fatigue, brain fog, exhaustion after exercise, insomnia, racing heartbeat and body aches severe enough that she could no longer work.
About six months after her initial infection, she was reinfected, likely with COVID, and many of her acute symptoms also returned. Her doctor prescribed a five-day course of Paxlovid.
On day 3, she noticed a rapid improvement of long COVID symptoms. “She’s back to normal,” said Dr. Linda Geng, co-director of Stanford Health Care’s long COVID clinic and author of the case report posted on Research Square.
In the second case, Lavanya Visvabharathy, 37, an immunologist working at Northwestern Medicine’s long COVID clinic, was infected in December 2021.
Her initial symptoms were mild, but she later experienced chronic fatigue, headaches and sleep disturbances for four months after infection. She also kept testing positive on rapid antigen tests, a sign of viral persistence
Visvabharathy was aware of the NIH study and the Stanford case, and decided to try Paxlovid to see if it could clear any lingering virus. Toward the end of the five-day course, her fatigue and insomnia had improved, and her headaches were less frequent. Two weeks after treatment ended, her fatigue was gone. “That’s 100% fixed,” she said.
But to prove Paxlovid provides that kind of relief would require carefully controlled clinical trials, Visvabharathy said.
Dr. Igor Koralnik, who heads Northwestern Medicine’s clinic focused on the neurological effects of long COVID, noted the long list of widely-used medications that are affected by ritonavir and said Paxlovid “can’t be used willy nilly.”
“Paxlovid is not a benign medication,” he said. “There should be studies.”
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Reporting by Julie Steenhuysen
Editing by Michele Gershberg and Bill Berkrot
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Feb 4 (Reuters) – The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.
Alzheimer’s-like changes seen in COVID-19 patients’ brains
People who die of severe COVID-19 have brain abnormalities that resemble changes seen in Alzheimer’s disease – accumulation of a protein called tau inside brain cells, and abnormal amounts of the protein beta-amyloid that accumulates into amyloid plaques – small studies have found.
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At Columbia University, Dr. Andrew Marks and colleagues studied the brains of 10 COVID-19 patients and found defects in proteins called ryanodine receptors that control the passage of calcium into cells. In Alzheimer’s disease, defective ryanodine receptors are linked to accumulation of tau into so-called neurofibrillary tangles. These tangles were present in high levels in the COVID-19 patients’ brains, the Columbia team reported on Thursday in Alzheimer’s & Dementia. Other research teams have looked for – and found – abnormal amyloid levels in brains of COVID-19 patients, according to reports posted online ahead of peer review on bioRxiv and on The Lancet’s preprint server.
In all the studies, patients had experienced the most severe forms of COVID-19. If similar changes are occurring in the brains of patients with milder illness, that might help explain the “brain fog” associated with long COVID, Marks said. Patients with severe COVID-19 might be at higher risk for dementia later in life, but it is too soon to know, he added. His advice: Get a booster vaccine and avoid the virus. “If you get COVID-19, you probably won’t die, but we still don’t know a lot about the long-term effects.”
Seniors can get flu shot, mRNA COVID-19 booster together
Seniors can safely get the high-dose flu vaccine and an mRNA COVID-19 booster dose at the same time, a new study confirms.
The study’s 306 participants, all older than 65, were randomly assigned either to receive Sanofi’s (SASY.PA) Fluzone High-Dose Quadrivalent influenza vaccine and a third shot of Moderna’s (MRNA.O) mRNA vaccine at the same time, or either of the vaccines alone. Blood samples obtained before and 21 days after vaccination showed that giving the two vaccines together did not affect the resulting immune response, with similar antibody levels generated in participants in each of the three groups, according to a report published on Tuesday in The Lancet Respiratory Medicine.
A spokesperson for Sanofi said combined administration of the COVID-19 and influenza vaccines “did not raise any safety concerns and the study team is continuing to follow study participants through 6 months after vaccination.”
Fluid in some rapid COVID tests could be deadly for kids
In some COVID-19 rapid test kits, the small bottle of “reagent” fluid contains sodium azide, a powerful poison that is particularly dangerous for small children, experts warn.
In adults, small amounts can quickly cause dangerously low blood pressure, dizziness, fainting, or even heart attacks or strokes, said Dr. Kelly Johnson-Arbor, Co-Medical Director of the National Capital Poison Center in Washington, D.C. Higher doses can be fatal, she and her colleagues wrote in The American Journal of Emergency Medicine. Sodium azide levels in COVID-19 rapid test kits are not always high enough to cause low blood pressure in adults, and the iHealth kits being sent out by the U.S. government do not contain any sodium azide at all, Johnson-Arbor said. “However… since children are typically much smaller than adults, they are at a higher risk of experiencing poisonous effects after swallowing any amount,” she said.
Poison control hotlines have been getting reports of accidental exposures to the reagent fluid. “Some people have swallowed the solution, some have spilled it onto their skin, and others have put it in their eyes,” mistaking the bottle for eye drops, Johnson-Arbor said. “If you or a loved one swallows the reagent fluid or gets the fluid in their eyes or on the skin, contact Poison Control right away.” (In the U.S., at www.poison.org or 1-800-222-1222; in the UK at https://www.npis.org/).
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Reporting by Nancy Lapid; Editing by Bill Berkrot
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A health care worker fills up a syringe with a dose of Moderna’s COVID-19 vaccine for a booster shot at the vaccination reference center at the Epidemiology, Biostatistics and Prevention Institute (EBPI) in Zurich, Switzerland November 17, 2021. REUTERS/Arnd Wiegmann
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Dec 1 (Reuters) – The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.
Brain problems seen in 1% of hospitalized COVID-19 patients
Roughly one in every 100 patients hospitalized with COVID-19 will likely have central nervous system complications, researchers reported on Tuesday at the annual meeting of the Radiological Society of North America. Among nearly 38,000 patients hospitalized with COVID-19 in the United States and Europe, symptoms led doctors to suspect brain complications in about 11%. Magnetic resonance imaging (MRI) and computed tomography (CT) exams confirmed central nervous system abnormalities that were most likely associated with the virus in 10% of those patients, for an overall incidence of 1.2%. The most common finding was stroke due to clogged arteries, but the researchers also saw bleeding in the brain, inflammation of the brain, and other potentially fatal complications. Study leader Dr. Scott Faro of Thomas Jefferson University in Philadelphia said in a statement that while the lung problems related to COVID-19 are well recognized, “Our study shows that central nervous system complications represent a significant cause of morbidity and mortality in this devastating pandemic.”
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Moderna vaccine effectiveness not limited to clinical trials
Moderna’s (MRNA.O) mRNA COVID-19 vaccine is proving effective in the real world, according to doctors at Kaiser Permanente in California who have been tracking nearly 706,000 adults, half of whom had received the vaccine. Five months after the second dose, the vaccine was still 87% effective against SARS-CoV-2 infection, 96% effective against COVID-19 hospitalization, and 98% effective against COVID-19 death, researchers reported in The Lancet Regional Health – Americas. Despite a wide range of chronic diseases among those in the study, the vaccine’s effectiveness against infection ranged from 83% to 92% across age, sex, racial, and ethnic subgroups, researchers said. Immunologist E. John Wherry of the University of Pennsylvania, who was not involved in the Kaiser study, said it is “highly unlikely” that the Omicron variant of the virus can completely evade all of the immune defenses induced by the vaccines and that current boosters will likely “provide increased protection against this variant.”
COVID-19 at childbirth linked with higher risks; antibody drugs appear to be safe
Pregnant women with COVID-19 face higher risks of childbirth complications than those who are not infected by the coronavirus, a new study found. A separate study suggests mildly or moderately ill pregnant women with COVID-19 can safely be treated with monoclonal antibody drugs such as those from Regeneron Pharmaceuticals (REGN.O). The analysis of childbirth complications included 244,645 births, 874 of which were in infected women. Researchers reported on Tuesday in PLOS Medicine that miscarriage and stillbirth rates did not differ between the groups. But after accounting for women’s risk factors, researchers found that those with COVID-19 had 80% higher odds of having too much amniotic fluid, doubled odds of dangerously high blood pressure, more than doubled odds of amniotic infection, nearly tripled odds of hemorrhage during delivery, and nearly doubled odds of hemorrhage afterward. They were also at higher risk for preterm delivery. “Pregnant women and those who plan to conceive… are strongly encouraged to be vaccinated,” said study leader Dr. Sylvie Epelboin of the University of Paris. Meanwhile, doctors at the Mayo Clinic in Rochester, Minnesota treated 51 pregnant patients with mild-to-moderate COVID-19 with one of several monoclonal antibody treatments. “No adverse effects were reported, and no patient required COVID-19 related hospitalization,” they reported on Sunday on medRxiv ahead of peer review. So far, 29 of the women have delivered healthy babies. There was one miscarriage due to a congenital defect not related to the medication. The investigators note that while the infusions were well tolerated, the study was a small one. Further research is recommended to fully assess safety and efficacy in pregnancy, they said.
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Reporting by Nancy Lapid; Editing by Bill Berkrot
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Bottles of alcoholic beverages are seen for sale in a shop in Glasgow, Scotland, Britain, May 1, 2018. REUTERS/Russell Cheyne/File Photo
July 26 (Reuters) – EMBARGOED UNTIL 8:00 PM ET
Light-to-moderate alcohol consumption is linked to a reduced risk of heart attack, stroke and death among those with heart disease, according to a study published in the journal BMC Medicine on Monday.
The largest benefit – a 50% reduction in risk compared with non-drinkers – was seen in people with heart disease who drank an average of 6 grams of alcohol per day. (A standard “unit” of alcohol is 8 grams in the UK, whereas the average drink in the United States contains 14 grams.)
People who averaged 8 grams per day had a 27% lower risk of death from heart attack, stroke or angina, compared with those who did not drink. Those who drank 7 grams per day had a 21% lower risk of death due to any cause.
Drinking higher amounts, up to an average of 15 grams of alcohol daily, were linked with smaller reductions in risk. https://bit.ly/3kV2xN9
“Our findings suggest that people with CVD (cardiovascular disease) may not need to stop drinking in order to prevent additional heart attacks, strokes or angina, but that they may wish to consider lowering their weekly alcohol intake,” said study coauthor Chengyi Ding, a research student at University College London. She noted, however: “Alcohol consumption is associated with an increased risk of developing other illnesses.”
Ding cautioned that non-drinking individuals should not be encouraged to take up light drinking because of known adverse effects on other health outcomes, such as cancers.
The researchers, who assessed more than 48,000 patients with heart disease, found that higher alcohol consumption, up to 62 grams per day, was not associated with increased risks of recurrent heart attack or death compared with no alcohol consumption.
Overall, the alcohol amounts that were linked with benefit are lower than those recommended in most current guidelines. For example, the American Heart Association’s guidelines for heart patients recommend up to 2 U.S. drinks per day for men and 1 per day for women.
A 2019 study found older people with heart failure who consume up to seven drinks a week may live longer than those who completely avoid alcohol. (https://reut.rs/3y5VwwH)
However, researchers in the past have found that heavy drinking was associated with increased levels of blood biomarkers that indicate damage to the heart.
The new study analyzed data from the UK Biobank, the Health Survey for England, the Scottish Health Survey and from 12 previous studies.
The researchers caution that their findings may overestimate the reduction in risk for moderate drinkers with heart disease due to the under-representation of heavy drinkers and categorization of former drinkers who may have quit.
Reporting by Dania Nadeem in Bengaluru; Editing by Nancy Lapid and Dan Grebler
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