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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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