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Keyword: offlabel

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  • The drug sacrificing the health of a generation of children (Lupron-puberty blocker)

    12/30/2023 6:00:26 PM PST · by NetAddicted · 8 replies
    Wrong Speak Publishing ^ | 12/22/2023 | Josh Walkos
    Drug maker Abbvie recently won a court case in which they sued Takeda Pharmaceutical, the company responsible for the production of their drug Lupron. In the case, Abbvie alleges that Takeda created a shortage of the drug by intermittently shutting down one of its plants. A judge found that Takeda Takeda was in breach of its contract with Abbvie and has ordered the to pay most of the $480.6 million it sought. Lupron may sound familiar to you because it has been at the center of the debate art whether or not children should be allowed to suppress puberty to...
  • Fifth Circuit Rebukes FDA for Banning Ivermectin for Covid-19

    09/15/2023 5:03:31 AM PDT · by MtnClimber · 64 replies
    American Thinker ^ | 15 Sep, 2023 | Jerome R. Corsi
    The strong rebuke should end the government’s commitment to “treatments” that make its bureaucrats money, but only if the American people wise up. The U.S. Court of Appeals for the Fifth Circuit issued a unanimous three-judge decision on September 1, 2023, holding that the Federal Drug Administration (FDA) overstepped its statutory authority by attempting to ban using ivermectin to treat COVID-19. In Apter v. Department of Health and Human Services, court concluded, “FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise.” Writing for the three-judge panel, Circuit Judge Don R....
  • Researchers show multiple sclerosis drug can be used as Alzheimer's therapy (Available Ponvory reprograms cells to clean up the brain)

    09/03/2023 8:12:30 PM PDT · by ConservativeMind · 4 replies
    Medical Xpress / University of Kentucky / eBioMedicine ^ | Sept. 1, 2023 | Lindsay Travis / Zhihui Zhu et al
    A team of researchers has found that a drug used to treat multiple sclerosis (MS) is potentially effective as a therapy for Alzheimer's disease. The team studied ponesimod, an oral medication that the U.S. Food and Drug Administration (FDA) has approved to treat relapsing forms of MS. The medication reduces inflammation in the brain by targeting a specific receptor in the immune system to help regulate the body's response and prevent it from attacking the central nervous system. This receptor is activated by a lipid termed sphingosine-1-phosphate. Said Bieberich. "Since this drug is already in clinical use for therapy of...
  • Genetic discovery could help prevent irreversible blindness in people with glaucoma (Metformin may help)

    07/05/2023 9:40:18 PM PDT · by ConservativeMind · 3 replies
    International research led by QIMR Berghofer has found hundreds of new genes linked to a person's risk of developing glaucoma, including key genetic targets that could, for the first time, pave the way for treatments that prevent the retinal damage that causes blindness. The findings, from the largest-ever global genetic study of the degenerative eye disease, have been published in Nature Genetics. The research significantly advances our understanding of the genetics of glaucoma, building on a previous 2021 study to identify another 185 previously unknown genes linked to glaucoma risk, bringing the total number to 312 genes. "Existing treatments focus...
  • Study: Using a diabetes medication after testing positive for SARS-CoV-2 reduces risk of developing long COVID by 40% (Metformin)

    06/12/2023 7:26:43 AM PDT · by ConservativeMind · 17 replies
    Medical Xpress / Lancet / The Lancet Infectious Diseases ^ | June 8, 2023 | Dr. Carolyn Bramante et al
    Taking a two-week course of metformin, a safe and affordable diabetes medication after testing positive for SARS-CoV-2 leads to 40% fewer long COVID diagnoses over the following 10 months, compared to individuals taking a placebo, finds a study. The long-term symptoms some people experience after SARS-CoV-2 infection, known as long COVID, are an emerging chronic illness potentially affecting millions of people around the world. Currently there are no proven treatments or ways to prevent long COVID, other than reducing the risk of infection in the first place. This is the first phase 3 randomized controlled trial of a treatment for...
  • Pharmacists call for approval of controversial horse de-worming drug ivermectin as it could be a new weapon in war on resurgent scabies

    06/11/2023 1:06:59 AM PDT · by Libloather · 56 replies
    Daily Mail ^ | 6/10/23 | Jo Macfarlane
    Pharmacists are urgently calling for the Government to approve controversial 'horse de-wormer' drug ivermectin to treat a mite infection of the skin amid reports of rising cases and widespread treatment shortages. The highly contagious condition, scabies, causes intense itching, a raised rash and is easily spread in close contact with others. There has been a spike in outbreaks over the past year, particularly among the elderly in care homes and young adults at university. Experts now warn some cases are becoming harder to treat. High Street chemists say that the main drugs used for the skin condition – creams which...
  • Need help to quit smoking? A known drug might help reduce nicotine cravings (Available liraglutide)

    06/02/2023 8:19:01 AM PDT · by ConservativeMind · 20 replies
    A drug that was originally developed to treat diabetes and severe overweight might also help people with nicotine dependence, concludes new research. Smoking is one of the greatest threats to public health. And 75% of smokers want to quit. So why don't they? The answer is: nicotine. It is one of the most addictive known substances. Unfortunately, there is no treatment for nicotine cravings. But new research might be able to change that. "In connection with a mouse study focusing on overweight, we discovered, more or less by accident, that a well-known drug, liraglutide, used to treat diabetes and overweight,...
  • The FDA Wants to Interfere in the Practice of Medicine

    02/25/2023 3:34:54 PM PST · by george76 · 14 replies
    WSJ Opinion ^ | Jan. 12, 2023 | Joel Zinberg
    A little-noticed provision of the omnibus spending bill could give the agency power to ban off-label use of approved therapies.. Secreted within the 2023 omnibus appropriations bill—4,155 pages, spending $1.7 trillion—is a 19-line section that could change the way medicine is practiced. Physicians routinely prescribe drugs and employ medical devices that are approved and labeled by the Food and Drug Administration for a particular use. Yet sometimes physicians discern other beneficial uses for these technologies, which they prescribe for their patients without specific official sanction. The new legislation amends the Food, Drug and Cosmetic Act, or FDCA, to give the...
  • Not just ivermectin: New FDA authority to ban off-label uses alarms doctors

    02/23/2023 8:24:13 AM PST · by Twotone · 56 replies
    Just The News ^ | February 22, 2023 | Greg Piper
    Doctors are speaking out against a new law that arguably paves the way for the FDA to prohibit treatments for purposes it hasn't expressly authorized, going far beyond highly politicized subjects such as treating COVID-19 with ivermectin. The authority to ban off-label uses was buried on page 3,542 of the 4,155-page omnibus appropriations bill signed into law at year's end, though it's specifically applied to "banned devices." The FDA requested this "very unprecedented" update after a string of court losses, Endpoints News senior editor Zachary Brennan told WBUR earlier this month, while cautioning that it's not clear whether the agency...
  • Florida to Allow Doctors to Use Off-Label Drugs for Early Treatment of COVID-19: Repurposed drugs that have been shown to prevent or treat COVID-19 may be prescribed by physicians

    03/04/2022 9:42:52 PM PST · by SeekAndFind · 36 replies
    Epoch Times ^ | 03/04/2022 | Meiling Lee
    Repurposed drugs that have been shown to prevent or treat COVID-19 may be prescribed by physicians, the Florida Department of Health said in its new COVID-19 guidance for health care practitioners.The guidance, published on Feb. 24, says that health care practitioners are encouraged to provide early treatment for COVID-19 patients with federally approved generic drugs that they find will work. That’s in addition to the outpatient treatments granted emergency authorization usage (EUA) for people at risk of developing a serious illness.“When recommending COVID-19 treatment options for patients’ individualized health care needs, physicians should exercise their individual clinical judgment and expertise...
  • COVID-19 patients have severely increased levels of oxidative stress and oxidant damage, and glutathione deficiency (Glycine with NAC may help)

    01/02/2022 10:59:01 AM PST · by ConservativeMind · 12 replies
    Medical Xpress / Baylor College of Medicine / Antioxidants ^ | Dec. 27, 2021 | Homa Shalchi / Dr. Rajagopal Sekhar et al
    Researchers have investigated the effect of infection with COVID-19 on the levels of oxidative stress, oxidant damage and glutathione, the most abundant physiological antioxidant. Compared to healthy age-matched individuals whose samples were taken before the pandemic started in 2019, patients hospitalized with COVID-19 had significantly increased levels of oxidative stress and oxidant damage, and markedly reduced levels of glutathione. The results suggest that supplementation with GlyNAC, a combination of glutathione precursors previously shown to reduce oxidative stress and oxidant damage and increase glutathione as well as improve health indicators such as inflammation, might be beneficial to COVID-19 patients. However, GlyNAC...
  • Why all the fuss about Ivermectin?

    09/03/2021 2:43:41 AM PDT · by Kaslin · 59 replies
    American Thinker.com ^ | September 3, 2021 | Brian C. Joondeph
    First hydroxychloroquine, now ivermectin, is the hated deadly drug de jour, castigated by the medical establishment and regulatory authorities. Both drugs have been around for a long time as FDA-approved prescription medications. Yet now we are told they are as deadly as arsenic. As a physician, I am certainly aware of ivermectin but don’t recall ever writing a prescription for it in my 30+ years’ medical career. Ivermectin is an anthelmintic, meaning it cures parasitic infections. In my world of ophthalmology, it is used on occasion for rare parasitic or worm infections in the eye. Ivermectin was FDA approved in...
  • Marijuana legalization bill inches closer to approval in NJ

    New Jersey voters approved a measure in November to legalize recreational marijuana. More than three months later, Gov. Phil Murphy still hasn't signed a bill to make it happen... The purported holdup has been Murphy's concern that the proposed law hasn't specified uniform penalties for underage users. Last week, state Sen. Nilsa Cruz-Perez, D-Camden, and state Sen. Nick Scutari, D-Union, introduced a "cleanup" bill to address Murphy's concerns... The cleanup bill is slated to be heard in committee in Trenton on Monday. It must pass both the Assembly and the Senate — and there is no guarantee it will —...
  • Australian Professor: Ivermectin 'Amazingly Successful' in Killing Coronavirus

    08/09/2020 10:22:32 AM PDT · by yoe · 73 replies
    News Max ^ | August 8, 2020 | Tauren Dyson
    An Australian drug known as Ivermectin, which is already in use throughout the world to treat parasitic conditions, is showing great results in killing coronavirus in studies involving patients, (according to Sky News.)"Because I'm involved in developing these in the U.S. where all the patients are, there are a number of studies that are amazingly successful. We're talking close to 100%. In fact, we haven't seen a result yet under 100%. It looks like corona is very simple to kill," Professor Thomas Borody, medical director of Australia's Center for Digestive Disease. "It's available as a prescription medication. You wouldn't use...
  • Clinical Trials, the FDA and “Label”

    04/06/2020 9:14:03 AM PDT · by FlipWilson · 7 replies
    Me | 4/6/20 | FlipWilson
    This gem from the AP last night was posted here: https://apnews.com/a04cb47fc2fd9dff61118e5086aabb0e One doesn’t realize the absolute ignorance of our media until they report on an area where one has expertise. You also realize the degree to which the media relies on the public’s ignorance. The conflation of FDA approval of an expanded use of an approved drug or drugs and efficacy for that expanded or new use in the above article is astounding. Everyday, a physician somewhere prescribes a drug for a use for which it was not originally approved. Everyday. But just because the drug is not approved for...
  • Report: Children Given Viagra for Lung Disease

    07/23/2002 3:54:10 PM PDT · by anymouse · 27 replies · 534+ views
    Reuters ^ | Tue Jul 23, 1:30 PM ET
    Doctors are giving infants and babies the anti-impotence drug Viagra to save them from a life-threatening lung condition even though it has not been tested on children, a magazine said Tuesday. The drug, produced by U.S. pharmaceutical giant Pfizer, has already been used to treat a small number of children with pulmonary hypertension (PHT) in India, the United States, Canada and Britain with promising results. "Critics have expressed serious concern at the fact that no clinical trials have taken place for this use of the drug and at the wide variation in doses used," New Scientist magazine said in its...