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The U.S. reported 2,473 deaths caused by COVID-19 on Tuesday, the highest number of deaths linked to the virus in a single day since the height of the pandemic in May.According to the COVID Tracking Project, the nearly 2,500 deaths are the most the U.S. has seen since May 7 — the deadliest day of the pandemic thus far, when 2,769 COVID-19 deaths were reported.Tuesday also marked the sixth-deadliest day since the pandemic began.Deaths linked to COVID-19 have been on the rise since October — though the 7-day rolling average of deaths linked to the virus has dipped in recent days, likely due to a lack of reports from the Thanksgiving holiday. From Oct. 1 to Dec. 1, the 7-day average of reported COVID-19 deaths has more than doubled from 705 to 1,520. The rise in deaths mirrors a frightening rise in COVID-19 cases. According to the COVID Tracking Project, the U.S. has recorded at least 100,000 new cases of the virus every day since Nov. 3. Since that time, the rolling 7-day average of new cases has nearly doubled from about 85.000 a day to about 159,000 a day.And health experts expect deaths and caseloads to further increase in the coming weeks. Dr. Deborah Birx, a member of the White House coronavirus task force, says the U.S. finds itself in a "very dangerous place" following the Thanksgiving holiday. She says anyone who attended a Thanksgiving gathering last week should assume they are infected with COVID-19 and take appropriate precautions. With more than a million Americans boarding airplanes on Sunday alone following the Thanksgiving holiday, health experts fear cases will skyrocket in the coming days.They also expect hospitals — already overtaxed by current COVID-19 caseloads — to admit even more patients with the virus. Currently, the COVID Tracking Project reports that 99,000 Americans are hospitalized with the virus, forcing some facilities to institute overflow areas. 1925
The US Food and Drug Administration has raised alarm about one way people might access opioids to misuse and abuse: their pets.As America's opioid epidemic rages, some pet owners could be stealing pain medications intended for their furry friends, according to a statement from FDA Commissioner Dr. Scott Gottlieb."We recognize that opioids and other pain medications have a legitimate and important role in treating pain in animals -- just as they do for people," Gottlieb said in Wednesday's statement."But just like the opioid medications used in humans, these drugs have potentially serious risks, not just for the animal patients, but also because of their potential to lead to addiction, abuse and overdose in humans who may divert them for their own use," he said.Gottlieb also said there hasn't been much information about responsible opioid prescribing for veterinary medicine professionals, and so the FDA developed a resource guide on what veterinarians need to know.The resource includes information on state and federal regulations, alternatives to opioids and how to properly safeguard and store opioids, as well as how to identify if a client or employee may be abusing opioids and take action with a safety plan."While each state creates its own regulations for the practice of veterinary medicine within its borders, including regulations about secure storage of controlled substances like opioids, veterinarians should also follow professional standards set by the American Veterinary Medical Association in prescribing these products to ensure those who are working with these powerful medications understand the risks and their role in combatting this epidemic," Gottlieb said."Veterinarians are also required to be licensed by the Drug Enforcement [Administration] to prescribe opioids to animal patients, as are all health care providers when prescribing for use in humans," he said."These measures are in place to help ensure the critical balance between making sure animals can be humanely treated for their pain, while also addressing the realities of the epidemic of misuse, abuse and overdose when these drugs are diverted and used illegally by humans."The FDA statement came one week after a perspective paper in the American Journal of Public Health called for the veterinary, public health, pharmaceutical and regulatory communities to dedicate time and resources to addressing the issue of prescription opioid diversion in veterinary medicine."I was thrilled to see the FDA commissioner make a statement that not only validated our findings but also demonstrates why research is so important for good policy," said Liliana Tenney, a senior instructor with the Colorado School of Public Health at the University of Colorado Anschutz Medical Campus and deputy director of the Center for Health, Work & Environment, who was a co-author of the paper.Tenney was unaware of the FDA statement until CNN contacted her for an interview, she said.The paper included data from a 24-item online survey that 189 veterinarians in Colorado completed in collaboration with a local veterinary society. The survey, which was about the possible abuse and misuse of opioids by pet owners and the role veterinarians play in prevention, was administered in summer 2016, Tenney said.The survey results showed that 13% of the veterinarians were aware that an animal owner had intentionally made an animal ill or injured -- or seem to be ill or injured -- to obtain opioid medications."This is significant for two reasons. These providers want to ensure the treatment of pets," Tenney said. "If this is truly the case and pet owners are intentionally harming animals, that's an animal rights issue. If opioids are being prescribed and aren't getting to the pets that need them because these drugs are being diverted, that's a public health issue."The survey results also showed that 44% of the veterinarians were aware of opioid abuse or misuse by either a client or a veterinary practice staff member, and 62% believed that they had a role in preventing opioid abuse and misuse."We recognize that this ... sample, representing 10% of the society's members, has limited generalizability and cannot be used to extrapolate to all practices. Nonetheless, these data are sufficient to warrant immediate action," the authors wrote.American Veterinary Medical Association spokesman Michael San Filippo emphasized in a statement Wednesday that the association has provided resources for veterinary staff to help combat this issue and the association will continue to monitor the situation."Though our animal patients are not the ones struggling with opioid addiction, concerns about misuse and diversion are top-of-mind for the veterinary profession, and the AVMA is actively involved in providing resources to practitioners describing alternative ways to treat pain and minimize opioid use," the statement said."While the limited data available suggests diversion from veterinary practices isn't a widespread problem, that doesn't mean we should pretend it doesn't exist," it said. "In fact, AVMA policy calls for further research to determine the prevalence of veterinary drug shoppers and to further clarify the degree to which veterinary prescriptions are impacting, or not, the human opioid epidemic."? & ? 2018 Cable News Network, Inc., a Time Warner Company. All rights reserved. 5456

The state of Michigan has agreed on a 0 million settlement in lawsuits regarding the Flint Water Crisis, Attorney General Dana Nessel announced Thursday.The settlement will be given to parties who claim they were affected by the city of Flint's 2014 transition of its public water supply to the Flint River; the majority of the money will be going to settle claims filed on behalf of children.The settlement was reached by the state parties and legal counsel after 18 months of negotiations.“Providing relief for the people of Flint and resolving these long-standing legal disputes has been a top priority for me since taking office,” Nessel said in a press release. “Flint residents have endured more than most, and to draw out the legal back-and-forth even longer would have achieved nothing but continued hardship. This settlement focuses on the children and the future of Flint, and the State will do all it can to make this a step forward in the healing process for one of Michigan’s most resilient cities. Ultimately, by reaching this agreement, I hope we can begin the process of closing one of the most difficult chapters in our State’s history and writing a new one that starts with a government that works on behalf of all of its people.”The preliminary agreement specifies that about 80 percent of the net settlement fund will be spent on claims of children who were minors when first exposed to the Flint River water, with a large majority of that amount to be paid for claims of children age 6 and younger, and earmarking 2 percent to go to special education services in Genesee County. Another 18 percent of the net settlement funds are to be spent on claims of adults and for property damage. Roughly 1 percent will go toward claims for business losses.If the settlement receives final court approval, it is likely to be the largest in Michigan state government history, affecting tens of thousands of people and resolving more than a hundred cases in state and federal trial and appellate courts."Protecting all Michiganders and their access to clean water is a priority for my administration to make sure nothing like this ever happens again," Governor Gretchen Whitmer said in a press release. "What happened in Flint should have never happened, and financial compensation with this settlement is just one of the many ways we can continue to show our support for the city of Flint and its families.""We acknowledge that this settlement may not completely provide all that Flint needs, and that many will still feel justifiable frustration with a system and structure that at times is not adequate to fully address what has happened to people in Flint over the last six years. We hear and respect those voices and understand that healing Flint will take a long time, but our ongoing efforts and today’s settlement announcement are important steps in helping all of us move forward."View a summary of the settlement below:Terms of Settlement 699810 7 by WXYZ-TV Channel 7 Detroit on Scribd This story was first reported by WXYZ in Detroit, Michigan. 3079
The Supreme Court on Tuesday rejected a challenge to a controversial Arkansas abortion law blocking medication-induced abortions.The law, passed in 2015, says that any physician who "gives, sells, dispenses, administers, or otherwise provides or proscribes the abortion-inducing drug" shall have to have a contract with a physician who has admitting privileges at a nearby hospital.The order, issued without comment, clears the way for the law to go into effect in mid-July if no other legal action is taken. Planned Parenthood is expected to make another challenge to the law in US district court."The Arkansas restriction, which was enacted supposedly to protect women's health, is medically unnecessary," lawyers for Planned Parenthood argued in court papers. They say it is unconstitutional because it places an undue burden on a patient's right to choose abortion.Medication abortion — available only early in a pregnancy — involves the combination of two pills called mifepristone and misoprostol.Lawyers for Arkansas say the law is a "commonsense requirement" that "merely requires medication abortion providers to have a contractual relationship (to ensure follow-up treatment if needed) with a physician that has admitting privileges.The-CNN-Wire 1263
The U.S. regulators who will decide the fate of COVID-19 vaccines are taking an unusual step: Asking outside scientists if their standards are high enough.The Food and Drug Administration may have to decide by year’s end whether to allow use of the first vaccines against the virus. Thursday, a federal advisory committee pulls back the curtain on that decision process, debating whether the guidelines FDA has set for vaccine developers are rigorous enough.“We will not cut corners, and we will only use science and data to make that determination,” FDA Commissioner Stephen Hahn pledged at a meeting of the Milken Institute Wednesday.Exactly how much data his agency needs to be sure a vaccine is safe and effective is a key question for the advisers. An even bigger one: If the FDA allows emergency use of a vaccine before final testing is finished, will that destroy chances of ever learning just how well that shot -- and maybe competitors still being studied -- really work?“We can’t lose sight of the fact that it is in our societal interest to see these trials to completion,” said Dr. Luciana Borio, a former FDA acting chief scientist who will be watching the advisers’ debate.Plus, multiple vaccines are being studied -- shots made with different technologies that each have pros and cons.“The first vaccine is not necessarily the best vaccine,” cautioned Dr. M. Miles Braun, a former FDA scientist now with Georgetown University School of Medicine. If the trials aren’t allowed to finish, it may be difficult or impossible to ever know for sure.It’s a critical moment in FDA’s 114-year history. The government has spent billions to race a vaccine through a research process that usually takes years, and FDA faces unprecedented pressure from the Trump administration, fueling public skepticism that politics could overrule science.Interest is so high, FDA is airing the meeting on YouTube. Here are some key issues the committee will discuss:HOW MUCH EVIDENCE IS NEEDED?FDA is requiring manufacturers to do studies of at least 30,000 people to prove if a vaccine protects and how safe it is. Those studies must include adequate numbers of people at highest risk from COVID-19 -- older adults, minorities and anyone with underlying health problems.FDA has made clear that any vaccine must be at least 50% effective. And while the studies are designed to run for two years, companies may get enough evidence the shots are protective -- in at least some people -- to stop the trials early and seek what’s called an “emergency use authorization” for wider vaccinations.Despite White House objections, the FDA told vaccine makers earlier this month not to seek that speedier review until they’ve tracked at least half their trial participants for two months. With other vaccines, that’s about the amount of time when major side effects crop up.That’s not long enough, said the head of the non-profit ECRI Institute, which reviews medical technology for hospitals and insurers. In comments submitted to the advisory committee, ECRI’s Dr. Marcus Schabacker said FDA should require six months of follow-up.“Doing any less would simply risk too much, and the consequences may be severe,” he wrote. “A weak vaccine that loses public trust could poison the well for epidemic control for many years.”WOULD EMERGENCY USE DERAIL FULL ANSWERS ABOUT VACCINES?Normally when a study ends because of evidence that a vaccine is working, the participants who got dummy shots are offered the real thing.But if FDA allows emergency use of a COVID-19 vaccine, that’s not the same as having full proof the shot works, Borio cautioned.And if the participants in the placebo group are immediately offered the real shot, researchers may not be able to get answers about all the high-risk groups in the study — or tell how long the vaccine’s protection lasts, a process expected to take many more months.But Pfizer Inc., which with Germany’s BioNTech is developing one of the leading candidates, told FDA that if it’s granted emergency use authorization, it “would have an ethical obligation” to alert study participants who got a placebo and allow them vaccine access. The company wants FDA to look into “other scientifically and statistically sound methods” to determine long-term safety and effectiveness.Pfizer’s stance is likely to face pushback. The Infectious Diseases Society of America states that FDA’s panelists “should insist” that vaccine developers “present a compelling case” for how they will complete their trials if FDA grants early authorization of their vaccine.Clearing a vaccine based on premature or faulty data “could cause more harm” by “further eroding public confidence in all vaccines,” the group said.It’s an unprecedented dilemma. The FDA has previously allowed emergency use of only one vaccine, a decades-old shot that in 2005 was authorized to prevent anthrax poisoning.This time around, multiple COVID-19 vaccines are in the pipeline. Pfizer competitor Johnson & Johnson cautioned that early FDA clearance of one vaccine could “jeopardize integrity” of other ongoing trials if patients decide to drop out to seek the first cleared shot instead.The company asked regulators to explain what options are available to ensure completion of all ongoing COVID-19 vaccine trials.WHAT ABOUT LONG-TERM SAFETY MONITORING?Even a study of 30,000 people cannot spot a side effect that only strikes 1 in 100,000. So the government is planning extra scrutiny of every COVID-19 vaccine to hit the market.At first there will be limited doses given to just certain high-risk people -- and those early recipients are to get text messages daily for the first week after vaccination, and then weekly out to six weeks, asking how they’re feeling.FDA also will be checking databases of electronic health records and insurance claims, looking for any red flags.“There’s a kind of tracking that has to take place here on a massive basis that hasn’t taken place before,” said Dr. Jesse Goodman of Georgetown University, a former director of the FDA’s vaccine and biologics center.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. 6274
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