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An Old Drug with New Tricks: Hydroxychloroquine

The AHA! Team — Tue, 04 Feb 2025 06:24:47 +0000

Medical University of South Carolina via EurekAlert! – The anti-malarial drug hydroxychloroquine shows promise against cancer, but cancer cells often develop resistance. A new study from MUSC Hollings Cancer Center researchers discovered how, setting the stage for new combination therapies As the hunt for effective cancer therapies intensifies, some scientists are turning back to look at old drugs in a new light. The anti-malarial hydroxychloroquine is one such drug that has been “repurposed” to fight cancer. Despite its effectiveness at blocking the resupply of needed resources to cancer cells, clinical trial results have been disappointing, in part because cancer cells eventually become resistant to the drug. A Medical University of South Carolina Hollings Cancer Center team led by Joe Delaney, Ph.D., reports in Cell Cycle that resistance to hydroxychloroquine occurs not by restoring the cancer cells’ recycling ability, as had been expected. Rather, resistance develops due to changes in the division, metabolism and export pathways of cancer cells. These findings open the door for new combination treatments, as drugs targeting these newly identified resistance mechanisms can be administered along with hydroxychloroquine to improve outcomes. The promise of repurposed drugs Repurposing old drugs for new treatments is not a new concept. Aspirin was originally used as a painkiller, but after the discovery of its anti-coagulant properties, it was repurposed as a blood thinner to treat heart disease. Thalidomide, the infamous anti-nausea medication, has been recently repurposed as a treatment for certain types of cancer and even leprosy. As cancer therapy moves increasingly toward specific single-protein targets, some scientists, like Delaney, are swinging back to look at preexisting drugs to find robust, multi-target effects. “Targeting single proteins can be extremely effective to treat cancer,” said Delaney. “However, the more specific the treatment becomes, the more likely resistance is to occur.” Imagine a hotel hallway, and behind each door is a route for cancer development. Targeting single proteins is like welding one of the doors shut. It’s impossible to get through that door, but it’s just a matter of time before cancer picks the lock on another door and gets in. That’s why these old drugs are so promising, said Delaney – their breadth of targets padlocks several doors at once, making it that much harder for a cancer cell to work around them. “These older molecules usually work because they have many, many targets within the cell,” he said. “If we can figure out how to use them correctly, it’s harder for cancer cells to mutate all those different points that they are acting on.” The cancer-fighting promise and limitations of hydroxychloroquine Originally used as a treatment for malaria, hydroxychloroquine began to be explored as a cancer therapy in the mid-2000s. The drug is known to block autophagy, a process that essentially acts as a cell’s clean-up crew. Autophagy literally means “self-eating.” It enables cancer cells to gather up old or damaged cellular machinery and send it off either to be thrown out or recycled. “When we think of cancer, we think of uncontrolled dividing cells,” said Delaney. “Autophagy is one of those processes that really enables a cancer cell to do just that by resupplying it with resources needed for survival and division.” Despite the drug’s promise of killing cancer cells by blocking cellular recycling, most clinical trials using the drug have been disappointing. “What we don’t know is why so many of these clinical trials have failed,” said Delaney. “We’re trying to figure out why hydroxychloroquine works or doesn’t work in certain situations in cancer.” A surprising finding about resistance to hydroxychloroquine To answer these questions, researchers in the Delaney Lab embarked on a multi-omics exploration into hydroxychloroquine’s effect on ovarian and colorectal cancer cells. They treated cells with hydroxychloroquine and then used two different whole-genome screens to identify exactly what the cells were doing to evade hydroxychloroquine attacks. With these approaches, they were able to observe how cells activated or deactivated different cellular pathways in response to continued hydroxychloroquine exposure. “By using two completely different methods, we were able to home in on the true biological players in the system,” said Delaney. The researchers were surprised to find that cells weren’t modifying autophagy to survive –the door that was expected to be opened really wasn’t touched at all. Instead, cancer cells were surviving hydroxychloroquine by changing their metabolism, division and export pathways. “We thought the main interaction of hydroxychloroquine with cancer was this process of autophagy, but it appears instead that processes unrelated to autophagy may be the most important for cancer cells to survive this therapy,” said Delaney. Setting the stage for novel combination therapies With this discovery, the Hollings team hopes to identify drugs that could be administered along with hydroxychloroquine to prevent the cancer cells from becoming resistant to this therapy. “Our study has identified the potential mechanisms that we will need to target with a second drug to prevent resistance against hydroxychloroquine,” said Delaney. Combining hydroxychloroquine with drugs that affect cell division, metabolism or export could increase the effectiveness of the treatment. Additionally, using hydroxychloroquine to treat patients with cancers that already have defects in one of these newly identified pathways could be a very powerful intervention. Finally, patients without these defects could be directed to potentially more effective, less resistant treatments. “We certainly want to understand which patients would see the most benefit to get the best result from these trials,” Delaney said. Ultimately, these results from the Delaney Lab shed light on how repurposed drugs like hydroxychloroquine can be used to fight cancer more effectively. Specifically, they show that cancer cells resist hydroxychloroquine in unexpected ways. By using such information, scientists can create more effective combination treatments against cancer. # # # About MUSC Hollings Cancer Center MUSC Hollings Cancer Center is South Carolina’s only National Cancer Institute-designated cancer center with the largest academic-based cancer research program in the state. With more than 150 faculty cancer scientists and 20 academic departments, it has an annual research funding portfolio of more than $50 million and sponsors more than 200 clinical trials across the state. Hollings offers state-of-the-art cancer screenings, diagnostic capabilities, therapies and surgical techniques within its multidisciplinary clinics to provide the full range of cancer care. Dedicated to preventing and reducing the cancer burden statewide, the Hollings Office of Community Outreach and Engagement works with community organizations to bring cancer education and prevention information to affected populations. For more information, visit hollingscancercenter.musc.edu Journal Cell Cycle DOI 10.1080/15384101.2024.2402191 To read the original article click here.

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Breakthrough UC San Diego Brain Recording Device Receives FDA Approval for a Clinical Trial

The AHA! Team — Fri, 02 Aug 2024 08:21:00 +0000

University of California San Diego via Newswise – The Federal Drug Administration approved a clinical trial to test the effectiveness of an electronic grid that records brain activity during surgery, developed by engineers at the University of California San Diego. The device with nanoscale sensors records electrical signals directly from the surface of the human brain in record-breaking detail. The grid’s breakthrough resolution could provide better guidance for planning and performing surgeries to remove brain tumors and treat drug-resistant epilepsy. The grid’s higher resolution for recording brain signals could improve neurosurgeons’ ability to minimize damage to healthy brain tissue. During epilepsy surgery, the novel grid could improve the ability to precisely identify the regions of the brain where epileptic seizures originate for safe and effective treatment. The new brain sensor array, known as platinum nanorod grid (PtNRGrid) features a densely packed grid of a record-breaking 1,024 embedded electrocorticography (ECoG) sensors. The device rests on the surface of the brain and is approximately 6 microns thin–smaller than one tenth of the human hair–and flexible. As a result, it can both adhere and conform to the surface of the brain, bending as the brain moves while providing high-quality, high-resolution recordings of brain activity. In contrast, the ECoG grids most commonly used in surgeries today typically have between 16 and 64 sensors. These grids are rigid, stiffer and more than 0.5 mm in thickness and do not conform to the curved surface of the brain. The PtNRGrid was invented by Shadi Dayeh, a Professor in the Department of Electrical and Computer Engineering at the University of California San Diego and members of his team. Over the years, the team developed the PtNRGrid technology in collaboration with neurosurgeons and medical researchers from UC San Diego, Massachusetts General Hospital (MGH) and Oregon Health & Science University (OHSU). “This accomplishment ushers in a new era of clinical neuroscience and neuromonitoring,” Dayeh said. “We are very excited to receive the FDA approval to apply our groundbreaking PtNRGrid in a clinical setting. It is a credit to the hard work of my team members who worked tirelessly to meet the quality criteria mandated by the FDA. I am also grateful to my clinical partners, the support of the NIH, and to the campus leadership that fostered an impactful ecosystem across engineering and medicine to transform the future of healthcare.” The FDA approved an investigational device exemption (IDE) for a “pivotal study [titled] “Systematic Evaluation of Platinum Nanorod Grids (PtNRGrids) for Intraoperative Mapping and Neurophysiological Monitoring (IONM) During Brain Surgeries.” Specifically, the clinical trial is designed to demonstrate the effectiveness of the PtNRGrid device to map both normal and pathological brain activity. During the trial, UC San Diego engineers will partner with clinician-scientists: Drs. Sharona Ben-Haim and Eric Halgren at UC San Diego, Dr. Sydney Cash at MGH, and Dr. Ahmed Raslan at OHSU. In a first phase, surgeons will implant the PtNRGrid in 20 patients, then measure and compare the grid’s performance with the present state-of-the-art. The PtNRGrid will be deployed in surgeries to remove brain tumors and to remove tissue that causes epileptic seizures. Record-breaking density Dayeh’s team has pioneered human brain and spinal cord mapping with thousands of channels since 2019, and has reported early safety and efficacy results in a series of articles published in Science Translational Medicine in 2022 in human subjects. PtNRGrid is the only device with thousands of channels to demonstrate in peer-reviewed publications that it can map motor and language brain activity, as well as epileptic discharges, by producing panoramic videos of brain waves over 10 square centimeters of the brain’s cortex while maintaining resolution at a microscopic level. Currently, Dayeh’s research group holds the world record of recording brain activity from a single cortical grid with 2,048 channels on the surface of the human brain published in Science Translational Medicine in 2022. The device was used in the operating room of Dr. Ahmed Raslan of the OHSU. Since then, the team has increased the number of recording channels to 4,096 and continues to work on increasing the number of channels in the grid to monitor brain activity in even higher resolution. Pending success of this staged trial, the team will transition to the next crucial step of making the PtNRGrid available for commercial use at scale. Demonstrating that ECoG grids with sensors in the thousands of channels record brain activity with high fidelity also opens new opportunities in neuroscience for uncovering a deeper understanding of how the human brain functions. Basic science advances, in turn, could lead to improved treatments grounded in enhanced understanding of brain function. “Our goal is to provide a new atlas for understanding and treating neurological disorders, working with a network of highly experienced clinical collaborators at UC San Diego, MGH, and OHSU,” Dayeh said. Dayeh’s work toward the FDA approval is supported by an NIH BRAIN® Initiative award # UG3NS123723. To read the original article click here.

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Antibody Shows Promise for Preventing Organ Rejection After Transplantation

The AHA! Team — Wed, 12 Jun 2024 04:30:14 +0000

Duke Health – DURHAM, N.C. – A man-made antibody successfully prevented organ rejection when tested in primates that had undergone a kidney transplant, Duke Health researchers report. The finding clears the way for the new monoclonal antibody to move forward in human clinical trials. Results of the study appear online Aug. 30 in the journal Science Translational Medicine. “Current medications to prevent organ rejection are good overall, but they have a lot of side effects,” said lead author Imran J. Anwar, M.D., a surgical research fellow in Duke’s Department of Surgery. “These therapies suppress the immune system, putting patients at risk of infections and organ damage, and many cause non-immune complications such as diabetes and high blood pressure. “The push over the last decades has been to develop new, less toxic drugs,” Anwar said. “We are hopeful this antibody moves us closer to that goal.” Anwar and colleagues, including co-senior author Allan Kirk, M.D., Ph.D., chair of the Department of Surgery, focused on a monoclonal antibody identified as AT-1501. It was engineered to minimize the risk of blood clots, which had become problematic for an earlier version of this therapy. In studies using primates that had undergone kidney transplantation, AT-1501 prevented rejection without the need for additional immunosuppressive drugs or promoting blood clots, confirming its immunosuppressive potential. In animals that had undergone islet transplantation, AT-1501 alone did not lead to uniform rejection control, but it was effective in combination with existing immunosuppressive agents. The combination therapies in islet transplantation led to uniform islet graft survival without weight loss or infections that can typically arise. The islet transplants were performed by Norma Kenyon, Ph.D., co-senior author and professor at the University of Miami. “These data support AT-1501 as a safe and effective agent to promote both islet and kidney transplant survival and function and allow us to advance into clinical trials right away,” Kirk said. “This less toxic approach has been pursued for over 20 years, and I think we are finally at a turning point. This could be a great advance for people in need of organ transplants.” In addition to Kirk and Anwar, study authors include Dora M. Berman, Isabel DeLaura, Qimeng Gao, Melissa A. Willman, Allison Miller, Alan Gill, Cindy Gill, Steve Perrin, Camillo Ricordi, Philip Ruiz, Mingqing Song, Joseph M Ladowski, and Norma S. Kenyon. The study received funding support from the National Institutes of Health (U19-AI051731), the Diabetes Research Institute Foundation, and Anelixis Therapeutics, now Eledon Pharmaceuticals, which is developing AT-1501 for kidney and islet cell transplant. To read the original article click here.

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Study Reveals Protein Structure Similarities in Alzheimer’s & Down Syndrome

The AHA! Team — Wed, 29 May 2024 08:12:33 +0000

Indiana University School of Medicine via News-Medical – More than 90% of people with Down syndrome, the most common chromosomal disorder in humans and the most frequent genetic cause of intellectual disability, are diagnosed with Alzheimer’s disease by ages 55-60. More than 90% of people with Down syndrome, are diagnosed with Alzheimer’s disease by ages 55-60. A new study recently published in Nature Structural and Molecular Biology uses leading-edge cryo-electron microscopy imaging technology to determine whether differences exist between the protein structures in those with Alzheimer’s disease and those with both Alzheimer’s disease and Down syndrome. Just like in Alzheimer’s disease, the neuropathological phenotype in those with Down syndrome and Alzheimer’s disease is characterized by the presence of amyloid β (Aβ) and by abnormal accumulation of tau protein. The structures of Aβ and tau filaments in Down syndrome have not been previously investigated, and it is unknown whether they are different from those of Alzheimer’s disease.” Ruben Vidal, PhD, the Luella McWhirter Martin Professor of Clinical Alzheimer’s Research at the Indiana University School of Medicine and lead investigator of the study Researchers studied images of Aβ and tau filaments, which occurs in individuals with Down syndrome, and compared with those seen in the most common form of Alzheimer’s disease. They found that the protein structures of Aβ and tau filaments in people with both Down syndrome and Alzheimer’s disease have similarities to those found in Alzheimer’s disease. Vidal said their findings may lead to better treatments for Alzheimer’s disease patients and individuals with Down syndrome. “This study is the first comparison at the near atomic level of Aβ and tau filaments between individuals with both Down syndrome and Alzheimer’s disease and individuals with only Alzheimer’s disease,” Vidal said. “Importantly, the study found variations in the structure of Aβ, but no substantial variation in the structure of tau filaments between individuals with Alzheimer’s disease and both Down syndrome and Alzheimer’s disease. This supports the notion of common mechanisms operating in people with sporadic Alzheimer’s disease and in people with both Down syndrome and Alzheimer’s disease. This knowledge is crucial for understanding Alzheimer’s disease in people with Down syndrome and assessing whether adults with both conditions could be included in Alzheimer’s disease clinical trials. People with Down syndrome are living longer than ever, but almost all of them are dying of Alzheimer’s disease when they get older” Vidal, also an investigator in IU School of Medicine’s Stark Neurosciences Research Institute, said the research team used cryogenic electron microscopy to get a close-up, 3D view of the structure of Aβ and tau filaments in two individuals with both Down syndrome and Alzheimer’s disease. The study revealed two novel types of Aβ filaments in the vascular compartment with structures different from those previously reported in Alzheimer’s disease. Vidal said the study’s findings show it is important to include people with both Down syndrome and Alzheimer’s disease in clinical trials targeting the Aβ or tau filaments. He said there are similarities between the mechanisms at play in amyloid aggregation, but more research is needed to determine whether the differences observed in vascular Aβ deposition are unique to those with Down syndrome. “We are thrilled that our cryo-EM imaging and 3D modeling techniques have facilitated the determination of the atomic structures of amyloid beta and tau fibrils in individuals with Down syndrome, shedding light on the connection between Down syndrome and Alzheimer’s disease,” said Wen Jiang, PhD, professor of biology at Purdue University and co-corresponding author of the study. “We are fortunate to have the Purdue Cryo-EM Facility, which provides exceptional resources and services that have made this research possible. We are grateful to the patients who donated their brains to the research and thankful to the NIH for funding our work.” Other study authors include co-corresponding author Bernardino Ghetti, Anllely Fernandez, Grace Hallinan, Kathy Newell and Holly Garringer, all from the IU School of Medicine; and Rejaul Hoq, Daoyi Li, Sakshibeedu Bharath, Frank Vago, Xiaoqi Zhang and Kadir Ozcan, all from Purdue University. This research was funded by the National Institutes of Health and the IU School of Medicine Department of Pathology and Laboratory Medicine. Source: Indiana University School of Medicine Journal reference: Fernandez, A., et al. (2024). Cryo-EM structures of amyloid-β and tau filaments in Down syndrome. Nature Structural & Molecular Biology. doi.org/10.1038/s41594-024-01252-3. To read the original article click here.

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Research Underway on Young Adults Experiencing Myocarditis After COVID Vaccine

AHA Publisher — Mon, 05 Dec 2022 08:00:17 +0000

Steve Warren via CBN News – Researchers are looking into cases of serious side effects occurring in some young adults after they received a COVID-19 vaccination, including the possibility of myocarditis, an inflammation of the heart muscle. In the U.S. since late 2020, there have been around 1,000 known reports of vaccine-related myocarditis or pericarditis in children under age 18, primarily young males, according to the Centers for Disease Control and Prevention (CDC). But the CDC does not have data on the number of cases of young adults in their 20s, which has become an age group of particular concern. NBC News was the first mainstream media outlet to admit last month to the possible link between the COVID vaccines and myocarditis in young adults. The first research trials are finally underway in the U.S. to monitor these side effects. Both drugmakers who developed the COVID-19 vaccines, Moderna and Pfizer are involved. Moderna has already started two studies. Pfizer is preparing to launch another in the next couple of months that will include up to 500 teens and young adults under age 21, according to NBC News. The Food and Drug Administration has now made the studies compulsory for the companies to weigh the possible long-term effects of myocarditis. Early research conclusions could be published next year, the outlet reported. An FDA official told NBC News the chance of having myocarditis occur following vaccination is “very low.” Other Instances of Vaccine Complications Newly released data obtained from the CDC also shows the first people to receive the COVID-19 vaccines, like healthcare workers, did report a high rate of serious complications after receiving the shot. Just the News reports among the 10 million-plus users of the agency’s v-safe active monitoring smartphone app through July — 8.5 million of whom signed up between December 2020 and April 2021, before all adults were eligible for COVID vaccines — nearly 8% said they required medical care after receiving the vaccines. The data was acquired by the Informed Consent Action Network. It received the information after filing a Freedom of Information Act lawsuit against the CDC. According to the Department of Health and Human Services, more than 7,500 claims have been filed alleging serious injury from the COVID-19 vaccines as of Nov. 1. There may also be a problem with vaccine booster shots as well. Last January, an original study published in the Journal of the American Medical Association (JAMA) reported about the risk of myocarditis after mRNA-based COVID-19 vaccination. “Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men,” the study said. As CBN News reported in October, Florida’s Surgeon General, Dr. Joseph A. Ladapo issued new guidance regarding mRNA shots, warning they are associated with an 84% increase in cardiac-related adverse events among males 18-39 years old. While the Florida study wasn’t published in a peer-reviewed journal, Ladapo contends the study, along with other peer-reviewed research that points to similar results, indicates young males in this age range could be at risk from those types of vaccines. Symptoms of myocarditis include: Chest pain Shortness of breath Feelings of having a fast-beating, fluttering or pounding heart To read the original article click here.

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New COVID-19 Drug Passes Phase 2 Clinical Trial

AHA Publisher — Thu, 20 Jan 2022 08:00:34 +0000

Sanford Burnham Prebys via Newswise – LA JOLLA, CALIF. – Jan 18, 2021 – In a phase 2 clinical trial conducted by Avalo Therapeutics and supported by researchers from Sanford Burnham Prebys, a significantly higher proportion of hospitalized patients with COVID-19 remained alive and free of respiratory failure for 28 days after receiving treatment with a new antibody called CERC-002. Unlike other experimental COVID therapies, CERC-002 does not target the virus itself, instead targeting the immune response associated with the virus to stop the disease from progressing before it becomes fatal. “At the beginning of the pandemic we thought vaccines were going to be all we really needed. But with variants like omicron, we’re going to have more people that progress to serious illness even with the vaccine,” says study coauthor Carl F. Ware, Ph.D., director of the Infectious and Inflammatory Diseases Center at Sanford Burnham Prebys. “We need treatments to stop the progression to severe disease and death.” The findings were published December 6 in the Journal of Clinical Investigation. COVID-19: a Continuing Crisis In the United States, over 800,000 people have died from COVID-19. A large proportion of these deaths have been among the elderly or those who are immunocompromised due to a preexisting condition. And while three quarters of the population has received at least one dose of the COVID-19 vaccine, many remain unvaccinated. “A lot of us feel safer now that we’ve gotten our shots,” Ware says, “but the threat of the pandemic has not gone away, even for vaccinated people.” Most people with COVID-19 experience few to no symptoms. However, elderly individuals, people with a concurrent health condition or those who are immunocompromised are susceptible to a condition called cytokine storm, in which their own immune molecules called cytokines flood the body in higher concentrations than usual. Rather than helping fight the virus, these extra immune molecules wreak havoc, causing patients to develop the deadly respiratory failure characteristic of severe COVID disease. “The COVID virus gets the immune system amped up by producing these molecules, which is normally how the immune system fights diseases,” says Ware. “But when there are too many cytokines and they’re not doing their job, it can lead to severe damage.” Neutralizing the Cytokine Storm The new treatment, CERC-002, is a cytokine neutralizer—an immune molecule that recognizes and deactivates a cytokine known as LIGHT, which is elevated in patients with COVID-19. Cytokine neutralization drugs are currently being tested in the clinic, but they are mainly effective in severely ill patients who are already on a ventilator or other organ support. “There is a critical need for drugs to stop milder cases from progressing to severe,” says Ware. “This treatment targets the cytokine immune response early enough to stop it in its tracks, which no other treatment does right now.” 83 COVID patients were enrolled in the study, half receiving the treatment, and half receiving a placebo. All patients were hospitalized with mild-to-moderate respiratory distress and were also receiving standard-of-care therapy during the trial. They found that 83.9% of patients who received a dose of CERC-002 on top of standard of care remained alive and free from respiratory distress for 28 days. For patients receiving placebo, the number was only 64.5%. Looking Ahead As a phase 2 clinical trial, the purpose of this study was to test whether the compound has therapeutic potential in a small number of patients. Now that the drug has proven successful at a small scale, it can be tested on a larger number of patients to ensure its benefits are consistent across the population. Additionally, because CEC-002 targets the immune response in COVID cases rather than the virus itself, the compound may have applications that extend beyond COVID. “Cytokine storm is not unique to COVID. It occurs in other infections—even in autoimmune diseases with no active infection, so this treatment may have some utility in these other diseases as well.” While there is more work to be done before CERC-002 becomes widely available, it does offer a glimmer of hope during a pandemic that seems never-ending. “We have made a lot of progress in controlling the pandemic with vaccines and other new therapies, but it’s not over yet,” says Ware. “Treatments like this may bring physicians an option to protect infected people from severe illness. To read the original article click here.

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FDA: Merck COVID Pill Effective, Experts Will Review Safety

AHA Publisher — Wed, 01 Dec 2021 08:00:16 +0000

Matthew Perrone via CBN News – Federal health regulators say an experimental COVID-19 pill from Merck is effective against the virus, but they will seek input from outside experts on risks of birth defects and other potential problems during pregnancy. The Food and Drug Administration posted its analysis of the pill ahead of a public meeting next week where academic and other experts will weigh in on its safety and effectiveness. The agency isn’t required to follow the group’s advice. The FDA scientists said their review identified several potential risks, including possible toxicity to developing fetuses and birth defects that were identified in studies of the pill in animals. Given those risks, the FDA will ask its advisers next Tuesday whether the drug should never be given during pregnancy or whether it could be made available in certain cases. Under that scenario, the FDA said the drug would carry warnings about risks during pregnancy, but doctors would still have the option to prescribe it in certain cases where its benefits could outweigh its risks for patients. Given the safety concerns, FDA said Merck agreed the drug would not be used in children. Other side effects were mild and rare, with about 2% of patients experiencing diarrhea. Regulators also noted that Merck collected far less safety data overall on its drug than was gathered for other COVID-19 therapies. “While the clinical safety database was small, there were no major safety concerns identified,” FDA reviewers concluded. Additionally, the FDA flagged a concern that Merck’s drug led to small changes in the coronavirus’ signature spike protein, which it uses to penetrate human cells. Theoretically, FDA cautioned, those changes could lead to dangerous new variants. FDA will ask its independent advisers to discuss all those issues and then vote on whether the drug’s overall benefits outweigh its risks. All COVID-19 drugs currently authorized by the FDA require an injection or IV and can only be given by health professionals. If authorized, Merck’s drug would be the first that U.S. patients could take at home to ease symptoms and speed recovery. It is already authorized for emergency use in the U.K. The meeting marks the first time regulators have publicly reviewed a new drug for COVID-19, reflecting the intense interest and scrutiny of a pill that could be soon used by millions of Americans. The drug, molnupiravir, has been shown to significantly cut the rate of hospitalizations and deaths among people with mild-to-moderate coronavirus infections. Merck’s drug uses a novel approach to fight COVID-19: it inserts tiny mutations into the coronavirus’ genetic code to stop the virus from reproducing. But that genetic effect has raised concerns that in rare cases the drug could cause birth defects or even spur more virulent strains of the virus. Pregnant women were excluded from Merck’s study, and both women and men in the study were instructed to use contraception or abstain from sex. For its part, Merck says results from two company studies in rodents show the drug does not cause mutations or damage to DNA at the doses studied. FDA reviewers also confirmed previously reported interim results from Merck that the pill cut the rate of hospitalization and death by about half among patients with early symptoms of COVID-19 who faced increased risk due to health problems. However, on Friday morning Merck announced updated results from the same study that showed a smaller benefit from the drug. The FDA said it is still reviewing the updated data and would present a new assessment of the drug’s effectiveness next Tuesday. Among more than 1,400 adults in a company study, molnupiravir reduced the combined risk of hospitalization and death by 30%, less than the 50% initially reported based on incomplete results. Nearly 7% of patients who received Merck’s drug within five days of COVID-19 symptoms ended up in the hospital and one died. That compared to 10% of patients hospitalized who were taking the placebo and nine deaths. Merck didn’t study its drug in people who were vaccinated for COVID-19. But the FDA will ask advisers to recommend which patients may stand to benefit the most from the drug, based on vaccination status and underlying health problems. While Merck’s drug is likely to be the first pill for coronavirus in the U.S., more are expected to follow. Rival drugmaker Pfizer has submitted its own antiviral for FDA review after initial study results showed it cut the combined rate of hospitalization and death by nearly 90%. Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns that have been raised with Merck’s drug. To read the original article click here.

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Nebraska AG Allows Ivermectin and HCQ Prescriptions as Off-Label Medicines to Fight COVID

AHA Publisher — Wed, 20 Oct 2021 07:00:31 +0000

Steve Warren via CBN News – Nebraska’s attorney general has said he will not discipline or prosecute physicians who prescribe controversial, off-label drugs in order to treat and prevent COVID-19 infections if they have patient consent. KETV reported Attorney General Doug Peterson issued his 48-page opinion Friday after receiving a question from Nebraska Department of Health and Human Services CEO Dannette Smith. She asked if doctors could face discipline or legal action under Nebraska’s Uniform Credential Act (UCA) if they prescribed medications like Ivermectin and Hydroxychloroquine to fight COVID-19 in their patients. “After receiving your question and conducting our investigation, we have found significant controversy and suspect information about potential COVID-19 treatment,” Peterson wrote. He also cited numerous medical journals’ articles and case studies. “We emphasize… our office is not recommending any specific treatments for COVID-19. That is not our role,” the attorney general continued. “Rather, we address only the off-label early treatment options discussed in this opinion and conclude that the available evidence suggests they might work for some people,” Peterson wrote. “Allowing physicians to consider these early treatments will free them to evaluate additional tools that could save lives, keep patients out of the hospital, and provide relief for our already strained health care system.” The FDA has cautioned against using hydroxychloroquine (HCQ) to treat COVID. Former President Trump took HCQ early in the pandemic to prevent a COVID-19 infection, then he stopped using it in May of 2020. Other famous people said the drug worked for them. Actor Tom Hanks and his wife Rita Wilson said HCQ was useful in their recovery from the coronavirus. Actor Daniel Dae Kim (Lost & Hawaii Five-0) claimed HCQ was the “secret weapon” that helped in his recovery from the disease. Last year, Pastor A.R. Bernard of the Christian Cultural Center in Brooklyn, NY, talked about his harrowing bout with COVID-19 and how the drug cocktail with hydroxychloroquine and the antibiotic azithromycin saved his life. Families Filing Lawsuits Against Hospitals, Seeking Alternative COVID Treatments for Loved Ones At least two dozen lawsuits have been filed around the U.S., many in recent weeks, by people seeking to force hospitals to give their COVID-stricken loved ones ivermectin, a drug for parasites that has been promoted as a treatment despite a lack of conclusive evidence that it helps people with the virus. Interest in the drug started rising toward the end of last year and the beginning of this one, when studies – some later withdrawn, in other countries – seemed to suggest ivermectin had some potential in the fight against COVID-19. But some medical experts suggest having a court step in is not the way to practice medicine. “The way medicine works is, they are the experts, the doctors and… the hospitals,” Arthur Caplan, professor of bioethics at New York University’s Grossman School of Medicine told the Associated Press. “When you go there, you’re not going to a restaurant. You don’t order your own treatments.” “You can’t have a medical field that’s subjected to having to practice according to patient demand backed up by court orders. That is positively horrible medicine,” Caplan said. Ralph Lorigo doesn’t see it that way. The attorney from Buffalo, New York, filed his first of several ivermectin lawsuits in January after being approached by the family of an 80-year-old woman who was in the hospital on a ventilator. His second case was later that month, for a hospitalized 65-year-old woman. In both cases, judges ordered hospitals to allow the women to take ivermectin as their families wanted. Both women survived their hospitalizations, according to the AP. Lorigo, who has taken on numerous cases since is adamant that ivermectin works. Health experts and federal agencies say that any evidence of it being effective against COVID-19 is slim and more research needs to be done. Studies are currently underway. Israeli Clinical Trials Show Positive Results with Ivermectin As CBN News reported earlier this month, a top Israeli doctor was asked by Israel’s government to research treatments for COVID. His studies indicated positive results with ivermectin in clinical trials. Dr. Eli Schwartz, M.D. is the founder of the Center for Travel Medicine and Tropical Diseases at the Sheba Medical Center in Israel. It’s considered one of the world’s top hospitals. Dr. Schwartz is also a professor at Sackler Faculty of Medicine, Tel Aviv University. For decades, Schwartz has traveled the world fighting outbreaks like Dengue Fever and Ebola. At the beginning of the pandemic and months before any vaccine was available, Israel’s Defense Ministry assigned Schwartz to find a medical solution for COVID-19. “Since Ivermectin is one of the drugs that we are using in daily life in the Tropical Institute, I knew it. I know the safety profile of it. And since there was some hints of in-vitro studies, which show the efficacy against specifically, even against COVID-19, we decided to go for it,” he said. That meant putting the drug through a clinical trial that lasted 10 months. “Our study, which was done here, it’s a randomized controlled trial, double-blind. It’s really, I would say, this is the best method that you are doing studies. And our conclusion is that it really has antiviral activities,” Schwartz told CBN News. From his international experience in the field, Schwartz knew Ivermectin targeted parasites. Since its development in 1987, nearly 4 billion doses with few side effects and at low cost have protected millions of people from insidious parasitical diseases like River Blindness and Elephantiasis. That success won its developers the Nobel Prize for medicine in 2015. Schwartz’s study made headlines in Israel when his trial showed Ivermectin to also be anti-viral. “This is the first drug to show antiviral activity,” the doctor explained. “And then, I think, there’s a good reason to continue with a much more thorough investigation to see, for example, whether people who are at high risk, may not deteriorate to be hospitalized, to be mechanically ventilated, or to death.” Schwartz’s clinical study found that by day four, 86% of his patients who took ivermectin recovered. By day six, 94% recovered. “The bottom line is… Ivermectin decreased faster the viral load, and also sterilized the culture much better compared to the placebo,” he noted. Schwartz explained to CBN News this means Ivermectin killed the virus and his patients became non-infectious. He said this development could save lives and reduce quarantines by days. “It’s a huge change in life. It’s a huge change for the patient. It’s a huge change for his family. And from the economical point of view, it’s a dramatic change. You know, it’s how much money you can save for the economy of the country if you can shorten the isolation time,” he said. Use Not Accepted by Global Heath Professionals But ivermectin is not accepted by the global health establishment. A major FDA concern is that a number of people have tried to self-medicate using a form of the drug intended for livestock. “Don’t do it. There’s no evidence whatsoever that it works and it could potentially have toxicity…with people who have gone to poison control centers because they’ve taken the drug at a ridiculous dose and wind up getting sick,” said Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases. The World Health Organization advises “that Ivermectin only be used be used to treat COVID-19 within clinical trials.” The National Institutes of Health said, “Ivermectin is not approved by the FDA for the treatment of any viral infection” and that “well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.” For studies to be accepted by the broader medical community, it must be peer-reviewed and published in a medical journal. That’s where Prof. Schwartz hit a roadblock. Several journals turned him down, but one is currently reviewing his study. Schwartz added that while many health agencies want better studies, no large-scale trials on ivermectin happened until Oxford University began one in June of this year. “I mean, it took them 18 months from the beginning of the pandemic to try to do it. I mean, people dying all over the world. And you have drug under your hand and you have to wait so long until you get any conduction of a good study,” he said. ‘We Are in the Arms of Pharma, and the Pharma Is Looking for New Drugs’ Now, the pharmaceutical company Merck, which developed ivermectin, and Pfizer are in a race to produce an oral anti-viral drug for COVID that some believe is what ivermectin could do already. “In my view, the whole story of Ivermectin is much beyond Ivermectin. It’s even beyond the corona. The problem is that we are in the arms of the pharma and the pharma is looking for new drugs. And, therefore, all old drugs which might be with a good potential to use it for whatever you’re looking for, there’s not any parents to push for it,” Schwartz claimed. Prof. Schwartz advocates the use of ivermectin but also believes in the vaccine. “Most of the world, still vaccine is not available. So, if we have a medication that can try to reduce the magnitude of the pandemic in the meantime, that’s absolutely needed, but when, if I have to compare the vaccine and Ivermectin for prevention, no doubt the vaccine. This is the solution, the international solution,” he said. Schwartz hopes more research will prove the drug can help fight the pandemic and that it will eventually be allowed to treat patients on a widespread basis and not just within clinical trials. To read the original article click here.

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New Merck Pill Called a ‘Gamechanger’ in COVID Fight, Cuts Deaths and Hospitalizations in Half

AHA Publisher — Mon, 04 Oct 2021 07:00:37 +0000

Tara Mergener via CBN News – There’s a possible breakthrough in the fight against COVID-19. Pharmaceutical company Merck says new data on Molnupiravir shows a reduced risk of hospitalization or death by up to 50 percent in clinical trials. “You can take it home and it will significantly reduce the risk that you either ultimately are hospitalized or more importantly that you would ever face the unfortunate outcome of death,” said Rob Davis, CEO of Merck. The anti-viral treatment would be given as a series of pills within five days of testing positive for COVID. It is believed to also be effective against the Delta, Gamma and Mu variants. Through 29 days of trials, no deaths were reported in patients who received the drug compared to 8 deaths in patients who got the placebo. Merck will ask the FDA for emergency use authorization. The news comes amid vaccine mandate showdowns happening across the country, including staff in New York City schools. On Friday, California even announced it will mandate vaccines from all schoolkids once the FDA approves them. “I will continue to advocate against these mandates, but obviously I’m going to need to figure out how I’m going to pay my bills and support my son,” said New York teacher Stephanie Edmonds. Late Thursday, a Federal Appeals Court blocked the firing of New York health care workers who are claiming a religious exemption, pending the outcome of a court hearing next month. In Colorado, some healthcare facilities are bracing for staffing shortages with many employees there also refusing the shot. “We’ve had a lot of pushback from staff, there are certainly a lot of folks that just absolutely do not want it,” said Leeah Key of Eastern Colorado Services. Meanwhile, the numbers show hospital admissions for COVID are down by 27,000 in recent weeks. And health officials say the overall COVID infection rate is significantly down for the first time in three months. Still, the Biden administration was doubling down on its vaccine message Friday. “COVID vaccinations are safe, effective, convenient, free. They protect you, your loved ones, your community,” said Dr. Anthony Fauci of the COVID response team. To read the original article click here.

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