Category:

Peru is emerging as a leader in using an anti-parasitic drug to treat COVID-19 patients...doctors...are employing the use of ivermectin in the fight against the coronavirus...As word spread in the medical community that ivermectin was showing promise in successfully treating people afflicted with COVID-19, the Peruvian government approved its use for the disease in early May — without conducting any trials or having direct, firsthand evidence of its success. TrialSite News reported that Peru is now attempting to secure almost 500,000 treatments of the drug that's normally used to kill head lice and other parasites...READ MORE

With little still known about the novel coronavirus and its treatments, some shady websites are grabbing coronavirus-related URLs to push unproven products to consumers...The Food and Drug Administration has issued more than 20 warning letters since mid-May to websites selling unproven COVID-19 treatments. These online retailers are selling products like hydroxychloroquine, essential oils and alternative sanitizers that claim to treat COVID-19 or kill the virus on surfaces...The FDA took action against these websites, requiring that they remove claims that certain products will treat COVID-19 and stop selling drugs like chloroquine for unapproved uses...READ MORE

The Department of Health and Human Services will dole out another $25 billion in funding targeted at healthcare providers that primarily serve Medicaid and low-income patients...The agency will distribute $15 billion to providers that participate in Medicaid and CHIP programs, and another $10 billion to safety-net hospitals...The funds are intended to help hundreds of thousands Medicaid providers that did not receive funding through the general distribution that went out to providers in April and May...Safety-net hospitals, which provide a significant proportion of care to uninsured and low-income patients, will be able to receive between $5 million and $50 million. HHS said it plans to distribute the funds to hospitals this week...READ MORE

...the U.S. government has shelled out big money for a stable and reliable supply of key drugs made on U.S. soil. For drugmakers accustomed to offshore manufacturing in cheaper countries, does it make any sense to onshore production to meet U.S. demand?...One company has a compelling argument, and it's taking big risks—and government funding—to test its hypothesis...Paratek Pharmaceuticals, maker of antibiotic Nuzyra, is kick-starting a three-year plan to build a government-funded, second supply chain in the U.S. in an effort to flesh out the nation's strategic supply of pandemic response drugs...The U.S. government, through its Biomedical Advanced Research and Development Authority, has dumped more than $300 million combined into helping Paratek build the U.S. supply line, which will stand apart from its current manufacturing network in Europe...READ MORE

How accurate are the coronavirus tests used in the U.S.?...Months into the outbreak, no one really knows how well many of the screening tests work, and experts at top medical centers say it is time to do the studies to find out...The FDA said in a statement that it has already asked multiple test makers to do follow-up accuracy studies, although it didn’t say for how many of the more than 110 authorized screening tests. The agency also said it is tracking reports of problems. Accuracy has also been an issue with blood tests that look for signs of past infections...the FDA warned doctors of a potential accuracy problem with Abbott Laboratories’ rapid ID Now test, which delivers results in roughly 15 minutes...READ MORE

On June 4...The Lancet, a venerable British medical publication, formally retracted a thoroughly flawed study on the drug hydroxychloroquine, originally published on May 22...The key findings of the study were stunners: most critically, that the use of HCQ led to a substantial increase in mortality rates—around 30 percent—and the occurrence of cardiac arrhythmias in these COVID-19 patients...Many experts immediately promoted the study...the initial burst of favorable publicity did not prevent a large cadre of researchers in the field from questioning its findings...pointing out multiple defects...The retraction brings into question The Lancet’s editorial process. All of the defects pointed out in the open letter should have been evident to the editors before the study was published, yet at no point did The Lancet’s retraction explicitly acknowledge any breakdown in its internal procedures. It has been hinted more than once that The Lancet took its hasty position in part because of its own visceral distaste for President Donald Trump, who has long been derided for his advocacy of HCQ to ward off the virus. Indeed, on May 16, 2020, The Lancet published an editorial calling for his defeat in the 2020 Presidential election...READ MORE

Unfortunately, there are a lot of assertions floating around that tell a misleading story about pharmaceutical manufacturing, diminishing America’s leadership and suggesting our reliance on other countries has put us at risk of potential shortages. In reality...the biopharmaceutical industry supports more than 4 million jobs across the United States, directly employing more than 811,000 Americans. Of those jobs, nearly 120,000 are high-wage manufacturing jobs, which is double the percentage of manufacturing jobs compared to the private sector overall...Discussions about enabling more manufacturing in the United States are important, but let’s not forget that the United States already sustains a substantial manufacturing presence that is part of a larger global network. We cannot replace all global manufacturing with solely U.S. manufacturing without upsetting the entire biopharmaceutical supply chain to the detriment of patients...READ MORE

U.S. regulators on Monday revoked emergency authorization for malaria drugs...amid growing evidence they don’t work and could cause serious side effects...The Food and Drug Administration said the drugs hydroxychloroquine and chloroquine are unlikely to be effective in treating the coronavirus. Citing reports of heart complications, the FDA said the drugs’ unproven benefits “do not outweigh the known and potential risks.”...The move means that shipments of the drugs obtained by the federal government will no longer be distributed to state and local health authorities for use against the coronavirus. The drugs are still available for alternate uses, so U.S. doctors could still prescribe them for COVID-19 — a practice known as off-label prescribing...READ MORE

Professional burnout among pharmacists, already a growing concern in the United States, could be exacerbated by the coronavirus disease 2019 crisis. The current pandemic strains pharmacy capacity and exposes persistent underlying problems, according to 3 experts on pharmacy burnout...A national survey of more than 4700 pharmacist concluded that, although more than half (54.2%) of respondents reported meaningful work, 32% and 33% also said they felt “a lot” or “totally” emotionally and physically exhausted. Community pharmacists demonstrated higher rates of work exhaustion and interpersonal disengagement, as well as lower levels of professional fulfillment, compared with those practicing in hospitals and other work settings...READ MORE

With the novel coronavirus continuing its global spread and a second wave threatening the United States later this year, experts worry an influx of influenza patients and COVID-19 patients will hit U.S. hospitals at the same time...pharma's working to ramp up not only for the increased demand but also for the logistical challenges of vaccinating millions of people during a pandemic...Manufacturers distributed about 170 million flu vaccine doses to the U.S. last year. This year, they're aiming to increase that by about 20 million...Vaccine makers are already producing their doses, with plans to start shipping later this summer...READ MORE