Strongyloidiasis

Earlier this month, three physicians filed a lawsuit against the Department of Health and Human Services (HHS), HHS Secretary Xavier Becerra, the U.S. Food and Drug Administration, and FDA Commissioner Robert M. Califf in a Texas court. They allege the FDA acted outside its authority and “illegally interfered with their ability to practice medicine” by discouraging the use of ivermectin to treat COVID-19. The physicians are Dr. Robert L. Apter, M.D., Dr. Mary Talley Bowden, M.D. and Dr. Paul E. Marik, MBBCh, MMed. Bowden is an ear, nose and throat specialist in the Houston area. Marik is an internist and critical care physician board-certified in the U.S., Britain, Canada and South Africa. Apter is licensed to practice medicine in Arkansas and Washington. The complaint argues that the FDA approved ivermectin for human use in 1996 for several diseases, but after the beginning of the COVID-19 pandemic, the regulator published documents and social media posts saying the drug was dangerous for use with people. That’s something of an oversimplification, in that there were well-reported cases of people using a veterinary-grade version of the drug to self-treat COVID-19. Ivermectin is approved by the FDA to treat intestinal strongyloidiasis and onchocerciasis, both caused by parasitic worms. The drug is also approved for veterinary use to prevent heartworm and other parasites, but these are different products and are not safe for people. Ivermectin does have anti-inflammatory properties but is not generally classified as an anti-viral medication. It has also been approved for use as a topical treatment for head lice. Because of its anti-inflammatory properties and because it was cheap and available, some researchers and physicians around the world began using or testing it to treat COVID-19. Some early studies suggested it was helpful, but others did not, with some even suggesting it made the disease worse. The drug became a political flashpoint as former President Donald Trump recommended it, as well as malaria drug hydroxychloroquine and other unproven approaches such as light therapy. Ivermectin gained a fervent following by Trump supporters and similar politicians, such as Rep. Marjorie Taylor Green (R-Ga.), who tweeted in December 2020, "Ivermectin, monoclonal antibodies & other treatments are saving lives." In the spring of 2021, the FDA launched an ongoing webpage titled, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” There were four primary points: one, it is not approved for COVID-19 in humans and is not an anti-viral drug; two, taking large doses is dangerous and can cause serious health issues; third, if you have the drug via prescription for an FDA-approved use, get it from a legitimate source and take as prescribed; and four, don’t use drugs intended for animals. In March 2021, the World Health Organization reported that evidence on ivermectin’s use against COVID-19 was inconclusive and recommended it only be used to treat the disease within clinical trials. A study published in The New England Journal of Medicine in May concluded that “The efficacy of ivermectin in preventing hospitalization or extended observation in an emergency setting among outpatients with acutely symptomatic coronavirus disease 2019 (Covid-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), is unclear.” The authors based it on a randomized, control trial of 3,515 patients, 679 who received ivermectin, 679 who received a placebo and 2,157 who received something else. Patients receiving ivermectin did not have a lower incidence of medical admission to a hospital from disease progression. In a press release, Bowden said, “Since the pandemic began, I have had one mission - help my patients. I provided access to testing when testing was hard to find. I provided treatment when other doctors told my patients to stay home. I have kept over 3,900 patients out of the hospital, but it hasn’t been easy. Sadly, fighting the system has been a much bigger challenge than fighting the disease. Despite my excellent track record treating COVID patients, the FDA’s smear campaign against ivermectin continues to be a daily hurdle to overcome. I am fighting back - the public needs to understand what the FDA has done is illegal, and I hope this suit will prevent them from continuing to interfere in the doctor-patient relationship.” Marik, whose degrees (MBBch, MMed) are from the University of the Witwatersrand, Johannesburg, South Africa, stated, “The FDA’s public statements on ivermectin have been misleading and raised unwarranted concern over a critical drug in preventing and treating COVID-19. The agency felt compelled to use language to discourage any discourse and interest in using ivermectin as a front-line treatment of COVID-19. To do this is to ignore both statutory limits on the FDA’s authority and the significant body of scientific evidence from peer-reviewed research, over 80 medical trials, and results from ivermectin’s use in medical settings worldwide, showing the safe and effective use of the drug in fighting COVID-19.” The Texas Department of State Health Services had issued poison warnings about the drug. In 2020 the Texas State Board of Pharmacy also tried to prohibit prescriptions for hydroxychloroquine dispensed without a diagnosis, but that only lasted six weeks. Apter indicates she is being investigated by three state medical boards, “each threatening my medical license based on complaints from pharmacists that I have prescribed ivermectin for COVID-19. In all these cases the patients did very well.” Bowden has received complaints about her use of ivermectin as well. Marik has a reputation for being outspoken in a number of areas. In a January 2017 Letter to the Editor at Emergency Medicine News titled, “Dr. Marik’s Views Should Not be Taken Serious,” Dr. Anthony O. Cruz, M.D., a physician with Henry Ford Hospital in Detroit, responded to an article by Marik, saying, “…I was stunned by the overtly contrary perspectives presented in this article…. This is especially true for those who are, like I was, not entirely familiar with the author and his reputation as an outspoken skeptic. This article [“Humans Are Not Yeast”] flies in the face of our current mainstream understanding of pathophysiology with respect to acidosis, lactate physiology, and oxygen utilization dynamics, and delivers harsh criticism of sepsis treatment strategies.” The lawsuit is being represented by Boyden Gray, an attorney who worked for the Reagan and George H.W. Bush administrations and served as the U.S. Ambassador to the European Union during the George W. Bush administration.

OTTAWA, ON, Aug. 31, 2021 /CNW/ - Summary Product: Ivermectin (veterinary or human versions), an antiparasitic agent (tablets, paste, oral solution, injectable solution, medicated premix or topical). Issue: Consumers, are purchasing veterinary ivermectin to prevent or treat COVID-19. What to do: Do not use veterinary ivermectin for the prevention or treatment of COVID-19. If you have purchased ivermectin for this purpose, discard it immediately. Consult a healthcare professional if you have used this product and have health concerns. Issue Health Canada has received concerning reports of the use of veterinary ivermectin to prevent or treat COVID-19. Canadians should never consume health products intended for animals because of the potential serious health dangers posed by them. In this light, Health Canada is advising Canadians not to use either the veterinary or human drug versions of Ivermectin to prevent or treat COVID-19. There is no evidence that ivermectin in either formulation is safe or effective when used for those purposes. The human version of ivermectin is authorized for sale in Canada only for the treatment of parasitic worm infections in people. The veterinary version of ivermectin, especially at high doses, can be dangerous for humans and may cause serious health problems such as vomiting, diarrhea, low blood pressure, allergic reactions, dizziness, seizures, coma and even death. Ivermectin products for animals have a higher concentrated dose than ivermectin products for people. The Department is aware of multiple reports of patients in the U.S. who have required medical support and been hospitalized after using ivermectin intended for horses. Health Canada is closely monitoring all potential therapeutic treatments for COVID-19, including treatments being studied in international clinical trials. To date, Health Canada has not received any drug submission or clinical trial application for ivermectin for the prevention or treatment of COVID-19. For drugs that have the potential to be helpful in treating COVID-19, Health Canada encourages drug manufacturers to conduct clinical trials. This would provide an opportunity for the healthcare community to collect information on the effectiveness of the treatment and its associated risks. Should a manufacturer provide a submission to Health Canada related to the use of ivermectin to prevent or treat COVID-19, Health Canada would conduct a scientific evaluation of the evidence to determine the drug's quality, safety and effectiveness. Health Canada will continue to monitor the situation and will take appropriate and timely action should new information become available, including any information regarding the illegal advertising or sale of ivermectin. Health Canada will also communicate any new safety information to healthcare professionals and consumers. Health Canada has previously warned Canadians about products making false and misleading claims to treat or cure COVID-19. For information on Health Canada authorized vaccines and treatments, visit Canada.ca. Background Ivermectin, a prescription drug product, is authorized for sale in Canada for the treatment of parasitic worm infections in humans, specifically intestinal strongyloidiasis and onchocerciasis, and should only be used for this purpose, under the supervision of a healthcare professional. A veterinary version of this medication is available to treat parasitic infections in animals. People should never use the veterinary version of this product. What you should do: If you have purchased ivermectin for the prevention or treatment of COVID-19, stop using it and discard it: Follow municipal or regional guidelines on how to dispose of chemicals and other hazardous waste; or Return the product to the point of sale for proper disposal. Consult a healthcare professional if you have used ivermectin and have health concerns. Report any side effects from this product directly to Health Canada. Submit a complaint to Health Canada should you have any information regarding the illegal advertising or sale of ivermectin or any other health product using its online complaint form. SOURCE Health Canada

There appears to be a spiking interest in Ivermectin to treat COVID-19 for humans. Ivermectin is a drug usually used to prevent or treat animals with parasites. However, some forms of Ivermectin are used to treat humans with parasitic worms, head lice, and rosacea. Several reports have been received by the Food and Drug Administration (FDA) with people getting hospitalized and requiring medical attention after self-medicating with the controversial drug meant for animals. RELATED: Covid-19: MedinCell Presents Positive First Results From the Clinical Trial Aiming at Validating the Safety of Continuous Administration of Ivermectin What is Ivermectin? Ivermectin is an FDA-approved drug used to treat humans with onchocerciasis and intestinal strongyloidiasis -- two health conditions brought by parasitic worms. Additionally, there is a topical form of Ivermectin approved to use for external parasites including head lice and for rosacea, a skin condition causing redness in a person’s face. The drug is most commonly used in veterinary medicine to prevent or treat heartworm disease and particular external and internal parasites in various animal species. It is crucial to understand that Ivermectin used for humans is different from those used for animals. Why is Ivermectin Controversial? Early in 2020, a research was published (prior to scientists reviewing it) showing Ivermectin could suppress the spread of SARS-CoV-2 -- the virus causing COVID-19 -- under laboratory conditions. However, this claim was later retracted. Since the published paper, there have been various researches regarding how Ivermectin can be a possible treatment for COVID-19. In late 2020, a research group based in India summarized the results of four Ivermectin small studies as an additional treatment for COVID-19 sufferers. The group’s review displayed a notable improvement in patient survival who received the drug, supplementing other treatments. However, the authors clearly stated that there is a low quality of evidence and their findings should be taken with caution. Additionally, the authors suggested further trials should be done in order to establish the clinical effectiveness of Ivermectin. What are the dangers in using Ivermectin for humans? While Ivermectin has been approved by the FDA for both humans and animals, the controversial drug is not approved to treat or prevent COVID-19. Medicines not prescribed by a healthcare provider and obtained from a legal source should not be taken. There are various side effects from taking Ivermectin including diarrhea, facial or limb swelling, hepatitis, nausea, neurologic adverse events (confusion, dizziness, seizures), skin rash, stomach pain, sudden blood pressure drop, and vomiting. In addition, laboratory test abnormalities can be formed such as elevated liver tests and drop in white cell count. Why should I not use Ivermectin to treat COVID-19? As mentioned earlier, Ivermectin has not been approved by the FDA for preventing or treating COVID-19 for humans. Additionally, Ivermectin is not an antiviral drug -- meaning it is not meant to treat viruses. The safety and benefits of using Ivermectin for humans to treat or prevent COVID-19 has not been established. Further clinical trials are needed to ascertain the effectiveness and safety of using Ivermectin in treating COVID-19. Until then, the use of this controversial drug for COVID-19 treatment must be avoided. RELATED: Lab Tests Show a Treatment for Head Lice Could be Effective Against COVID-19 What do health organizations say about using Ivermectin for humans? Several health organizations gave profound statements regarding the use of Ivermectin in treating COVID-19. The FDA strongly stated they have not approved or authorize the use of the controversial drug to treat or prevent COVID-19. The World Health Organization (WHO) and the National Institutes of Health (NIH) said the evidence in using Ivermectin for COVID-19 treatment is still inconclusive. Until further data become available, Ivermectin should be used only within clinical trials. The Infectious Diseases Society of America (IDSA) does not recommend as well the use of Ivermectin to treat COVID-19 outside clinical trial context. Ivermectin manufacturer, Merck, also stated clearly the usage of the drug in treating or preventing COVID-19 has not been established. Merck issued an official statement saying the controversial drug has “no scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies; no meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and; a concerning lack of safety data in the majority of studies. We do not believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information.” Is the FDA taking action to protect people from fraudulent COVID-19 products? The FDA has organized a task force responsible for closely monitoring fraudulent COVID-19 products. In addition, the organization asked for the help of major retailers in keeping an eye on fraudulent COVID-19 products in online marketplaces. COVID-19 products that are sold are subject to investigation by the FDA. Furthermore, an enforcement action is also done if a product claims to cure, diagnose, prevent, or treat COVID-19 and have not exhibited effectiveness and safety. The assigned task force has been working closely with retailers to pull out listings of these types of COVID-19 products online. The FDA, along with the Federal Trade Commission (FTC), furnished warning letters to violators of the federal law and caused crucial risks to the health of a patient by selling unapproved and unauthorized products with fraudulent claims in treating or preventing COVID-19. The world has been dealing with COVID-19 for quite some time now. Given the fatality rate from the pandemic, it is unsurprising that people have been finding alternative treatments -- even those that are not approved and authorized by the FDA. While this is foreseeable, the public must be cautious. The FDA, along with the other health organizations, are doing their job to evaluate all the scientific data on any COVID-19 product to ensure the safety and effectiveness of each product, then determine as to whether they will approve or authorize it. Making use of any unapproved or unauthorized COVID-19 product by the FDA may result in grave harm.