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Health Headlines

    U.S. regulators warned a leading marijuana company for making unproven health claims about CBD, the trendy ingredient that's turning up in lotions, foods and pet treats. The Food and Drug Administration announced Tuesday it warned Curaleaf Inc., of Wakefield, Massachusetts, for illegally selling unapproved products. Curaleaf's claims could lead people to delay medical care for serious conditions like cancer, the agency said. 'Consumers should beware of purchasing or using any such products,' said Acting FDA Commissioner Ned Sharpless in a statement. The FDA has issued similar warning letters to smaller businesses, but this is the first since the agency began studying how it regulates CBD. The agency plans to report in the fall on its regulatory approach after holding a public hearing and receiving nearly 4,500 comments. The agency is exploring 'potential regulatory pathways' for some CBD products to be lawfully marketed, Sharpless said. Curaleaf, which operates in 12 states, said it will work with the FDA to resolve the issues mentioned in the warning letter . The company's shares fell more than 7% on the news, and some other cannabis stocks lost ground. The company 'is fully committed to complying with FDA requirements for all of the products that it markets,' Curaleaf said in a statement. CBD is a compound found in marijuana that doesn't cause a high. Its skyrocketing popularity has attracted mainstream retailers despite little evidence of its health claims. Curaleaf's website and social media accounts show the company is illegally selling unapproved new drugs, the FDA said, specifically its CBD lotion, a pain-relief patch, several tinctures and disposable vape pens. The company's Bido CBD for Pets products are unapproved new animal drugs, the FDA said. The FDA cited claims the company made for CBD's effectiveness in treating chronic pain, anxiety, attention deficit disorder, Alzheimer's disease, Parkinson's disease, cancer and opioid withdrawal. Curaleaf said all its CBD products come from hemp, a version of the cannabis plant that is low in THC, the part of cannabis that gives pot its high. Hemp gained new status as an agricultural crop late last year when President Donald Trump signed the farm bill. The CBD industry hoped the legislation would allow broad sales of the ingredient. But the FDA still regulates pharmaceutical products. Since CBD is the active ingredient of GW Pharmaceuticals' Epidiolex, approved by the FDA last year, the agency has said it can't be added to food or marketed to treat health conditions without going through the FDA's established processes. ___ Follow AP Medical Writer Carla K. Johnson on Twitter: @CarlaKJohnson ___ 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.
  • Advanced brain scans found perplexing differences in U.S. diplomats who say they developed concussion-like symptoms after working in Cuba, a finding that only heightens the mystery of what may have happened to them, a new study says. Extensive imaging tests showed the workers had less white matter than a comparison group of healthy people and other structural differences, researchers said. While they had expected the cerebellum, near the brain stem, to be affected given the workers' reported symptoms — balance problems, sleep and thinking difficulties, headaches and other complaints — they found unique patterns in tissue connecting brain regions. Ragini Verma, a University of Pennsylvania brain imaging specialist and the lead author, said the patterns were unlike anything she's seen from brain diseases or injuries. 'It is pretty strange. It's a true medical mystery,' Verma said. Co-author Dr. Randel Swanson, a Penn specialist in brain injury rehabilitation, said 'there's no question that something happened,' but imaging tests can't determine what it was. An outside expert, University of Edinburgh neurologist Jon Stone, said the study doesn't confirm that any brain injury occurred nor that the brain differences resulted from the strange experiences the diplomats said happened in Cuba. Cuba has denied any kind of attack, which has strained relations with the United States. The results were published Tuesday in the Journal of the American Medical Association. A journal editorial says the study may improve understanding of the reported symptoms, but that the relevance of the brain differences is uncertain. In a statement, the U.S. State Department said it 'is aware of the study and welcomes the medical community's discussion on this incredibly complex issue. The Department's top priority remains the safety, security, and well-being of its staff.' Between late 2016 and May 2018, several U.S. and Canadian diplomats in Havana complained of health problems from an unknown cause. One U.S. government count put the number of American personnel affected at 26. Some reported hearing high-pitched sounds similar to crickets while at home or staying in hotels, leading to an early theory of a sonic attack. The Associated Press has reported that an interim FBI report found no evidence that sound waves could have caused the damage. Dozens of U.S. diplomats, family members and other workers sought exams. The new study reports on 40 of them tested at the University of Pennsylvania. A group analysis of results from advanced MRI scans found brain differences in the diplomat group compared with 48 healthy people with similar ages and ethnic background. Workers had MRI tests about six months after reporting problems, but because their brains were not scanned before their Cuba stints they can't know if anything changed in their brains, a drawback of the study that the researchers acknowledge. The University of Edinburgh's Stone said the new study has several other limitations that weaken the results, including a comparison group that wasn't evenly matched to the patients. 'If you really want to suggest that something fundamentally different happened in Cuba ... then the best control group would be 40 individuals with the same symptoms who hadn't been to Cuba and had no history of head injury,' Stone said. The latest study builds on earlier preliminary reports involving 21 U.S. workers who got brain scans showing less detailed white matter changes. The new study includes 20 of those workers. A previous study from the University of Miami found inner-ear damage in some workers who complained of strange noises and sensations, but it also lacked any pre-symptom medical records. Although some workers have persistent symptoms, most have improved with physical and occupational therapy, are doing well and have returned to work, Swanson said. As more time passes, he said, 'It's going to be harder and harder to figure out what really happened.' ___ Follow AP Medical Writer Lindsey Tanner at @LindseyTanner. ___ 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.
  • Two senior senators — a Republican and a Democrat — unveiled compromise legislation Tuesday to reduce prescription drug costs for millions of Medicare recipients, while saving money for federal and state health care programs serving seniors and low-income people. Iowa Republican Charles Grassley and Oregon Democrat Ron Wyden said the bill would for the first time limit drug copays for people with Medicare's 'Part D' prescription plan , by capping patients' out-of-pocket costs at $3,100 a year starting in 2022. They're hoping to have it ready soon for votes on the Senate floor. The legislation would also require drugmakers to pay a price-hike penalty to Medicare if the cost of their medications goes up faster than inflation. Drugs purchased through a pharmacy as well as those administered in doctors' offices would be covered by the new inflation rebates. Political compromises over health care are rare these days. The bill reflects efforts by lawmakers of both parties to move beyond the rancorous debates over the Obama-era Affordable Care Act and focus on ways to lower costs for people with health insurance. Separate legislation to address 'surprise medical bills' has already cleared the Senate Health, Education, Labor and Pensions committee. The senators said preliminary estimates from the Congressional Budget Office show that the Medicare program would save $85 billion over 10 years, while seniors would save $27 billion in out-of-pocket costs over the same period, and $5 billion from slightly lower premiums. The government would save $15 billion from projected Medicaid costs. CBO also projected that Medicare's inflation rebate would have ripple effects, leading to prescription drug savings for private insurance plans sponsored by employers or purchased directly by consumers. The senators announced a Thursday vote on the package by the Finance Committee, which oversees Medicare and Medicaid. Grassley is the panel's chairman, while Wyden serves as the senior Democrat. 'Pharmaceutical companies play a vital role in creating new and innovative medicines that save and improve the quality of millions of American lives, but that doesn't help Americans who can't afford them,' Grassley and Wyden said in a joint statement. 'This legislation shows that no industry is above accountability.' The White House encouraged the Senate negotiations, and spokesman Judd Deere said the Trump administration stands ready to 'work with senators to ensure this proposal moves forward and advances the president's priority of lowering drug prices.' Democrats controlling the House want to go farther by granting Medicare legal authority to directly negotiate prices with pharmaceutical companies. Direct negotiations are seen as a nonstarter in the Republican-controlled Senate, but the bill's drug price inflation penalty may yet find support among Democrats in the House. Grassley's office said the bill will force drugmakers and insurers to take greater responsibility for keeping Medicare prescription prices in line, instead of foisting increases on taxpayers and beneficiaries. The lack of a cap on out-of-pocket costs for Medicare's popular prescription benefit has left some beneficiaries with bills rivaling a mortgage payment. That's because with Medicare's current protection for catastrophic costs, patients taking very expensive drugs are still responsible for 5% of the cost, with no dollar limit on what they pay. For example, 5% of a drug that costs $200,000 a year works out to $10,000. The Grassley-Wyden bill does not directly address the problem of high launch prices for new medications, but its inflation rebates could put the brakes on price hikes for mainstay drugs such as insulin. The bill drew a rebuke from the pharmaceutical industry, while AARP praised Grassley and Wyden. Other provisions of the legislation would: — Change an arcane Medicaid payment formula through which drugmakers can avoid paying rebates on certain drugs, depending on fluctuations in prices. — Allow state Medicaid programs to pay for expensive gene therapy treatments on the installment plan, spreading out the costs over several years. — Require drugmakers to provide public justification for new high cost drugs or steep hikes in the prices of existing medications. — Require middlemen known as pharmacy benefit managers to disclose details of the discounts they are negotiating and how much they are passing on to consumers. The benefit managers negotiate with pharmaceutical companies on behalf of insurers and consumers. — Provide doctors with new computer tools they can use to estimate out-of-pocket medication costs for patients with Medicare.
  • Opponents of a Georgia law that bans most abortions on Tuesday asked a judge to keep it from taking effect while their legal challenge plays out. The law is set to become enforceable Jan. 1. Lawyers with the American Civil Liberties Union, Planned Parenthood and the Center for Reproductive Rights sued on behalf of Georgia advocacy groups and abortion providers last month to challenge the measure. A spokeswoman for the state attorney general's office, which is defending the law, declined to comment on Tuesday's filing, citing the pending litigation. Georgia Gov. Brian Kemp, a Republican, acknowledged when he signed the law in May that it would likely face legal challenges but said the state wouldn't back down. The so-called heartbeat law bans abortion once a fetal heartbeat can be detected, which can occur as early as six weeks, before many women know they're pregnant. It's one of a spate of laws passed recently by Republican-controlled legislatures in an attack on the U.S. Supreme Court's 1973 Roe v. Wade ruling that legalized abortion nationwide. The Georgia legislation makes exceptions in the case of rape and incest, if the woman files a police report first. It also allows for abortions when the life of the woman is at risk or when a fetus is determined not to be viable because of a serious medical condition. Additionally, it declares an embryo or fetus a 'natural person' once cardiac activity can be detected, saying that is the point where 'the full value of a child begins.' The court filing Tuesday argues that viability, or the likelihood that a fetus can survive outside the womb, doesn't occur until several months into a pregnancy. That means Georgia's law directly contradicts the precedent set by the Supreme Court, which 'has repeatedly and unequivocally held that a state may not ban abortion at any point prior to viability,' the filing says. 'This case is pretty straightforward,' ACLU of Georgia legal director Sean Young said at a news conference. 'This law is blatantly unconstitutional under 50 years of Supreme Court precedent, and we are eagerly hoping that the judge will act before January.' Dr. Lisa Haddad, one of the plaintiffs, said at the news conference that the law could damage the trust between women and doctors and hinder women's access to vital treatment. 'How will Georgia's women of child-bearing age be able to obtain the health care they need and deserve when this law could prevent doctors like me from providing patient-centered, evidence-based medicine that we have gone to school to practice and provide?' she said. Louisiana , Kentucky , Mississippi and Ohio have passed similar 'heartbeat' bills. Missouri's governor signed a bill approving a ban on abortion at eight weeks, with exceptions only for medical emergencies. A new Alabama law bans virtually all abortions, even in cases of rape or incest, and makes performing an abortion at any stage of pregnancy a felony punishable by 10 to 99 years or life in prison for the provider. None of the bans has taken effect, and abortion remains legal in every state. Some of the laws have already been blocked, and courts are expected to put the others on hold as they consider legal challenges.
  • Millions of people who take aspirin to prevent a heart attack may need to rethink the pill-popping, Harvard researchers reported Monday. A daily low-dose aspirin is recommended for people who have already had a heart attack or stroke and for those diagnosed with heart disease. But for the otherwise healthy, that advice has been overturned. Guidelines released this year ruled out routine aspirin use for many older adults who don't already have heart disease — and said it's only for certain younger people under doctor's orders. How many people need to get that message? Some 29 million people 40 and older were taking an aspirin a day despite having no known heart disease in 2017, the latest data available, according to a new study from Harvard and Beth Israel Deaconess Medical Center. About 6.6 million of them were doing so on their own — a doctor never recommended it. And nearly half of people over 70 who don't have heart disease — estimated at about 10 million — were taking daily aspirin for prevention, the researchers reported in Annals of Internal Medicine. 'Many patients are confused about this,' said Dr. Colin O'Brien, a senior internal medicine resident at Beth Israel who led the study. After all, for years doctors urged people to leverage aspirin's blood-thinning properties to lower the chances of a first heart attack or stroke. Then last year, three surprising new studies challenged that dogma. Those studies were some of the largest and longest to test aspirin in people at low and moderate risk of a heart attack, and found only marginal benefit if any, especially for older adults. Yet the aspirin users experienced markedly more digestive-tract bleeding, along with some other side effects. . In March, those findings prompted a change in guidelines from the American Heart Association and American College of Cardiology: —People over 70 who don't have heart disease — or are younger but at increased risk of bleeding — should avoid daily aspirin for prevention. —Only certain 40- to 70-year-olds who don't already have heart disease are at high enough risk to warrant 75 to 100 milligrams of aspirin daily, and that's for a doctor to decide. Nothing has changed for heart attack survivors: Aspirin still is recommended for them. But there's no way to know how many otherwise healthy people got the word about the changed recommendations. 'We hope that more primary care doctors will talk to their patients about aspirin use, and more patients will raise this with their doctors,' O'Brien said. ___ 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.
  • The U.S. Food and Drug Administration has approved the first generic copies of a popular, pricey pill for nerve pain. The agency on Monday said it approved nine generic versions of Pfizer Inc.'s Lyrica. It is also used for seizures and fibromyalgia, a condition that causes chronic, widespread pain. Lyrica, approved in 2004, is Pfizer's second bestseller, with sales last year of $4.6 billion. The heavily advertised drug costs about $460 to $720 per month without insurance, depending on the pharmacy. Prices can vary widely. Prices for generic versions range from about $140 to $370 per month, according to the drug price comparison site GoodRx . Common side effects include dizziness, blurred vision and sleepiness. Serious side effects include allergic reactions and life-threatening breathing problems.
  • Dr. Raeford Brown was uniquely positioned to help the U.S. government answer a critical question: Is a new version of the painkiller OxyContin helping fight the national opioid epidemic? An expert in pain treatment at the University of Kentucky, Brown led a panel of outside experts advising the Food and Drug Administration on opioids that have been reformulated to deter snorting and injecting. There's just one problem: Neither the company that makes OxyContin nor the FDA has allowed the experts to see data on whether it reduces abuse. 'We asked for that data probably 40 or 50 times in last four or five years and were denied every time,' said Brown, whose term as an FDA adviser ended in March. Nearly a decade ago, the FDA approved reformulated OxyContin and told the company, Purdue Pharma, that it would be evaluated on whether the new version decreased cases of addiction, overdose and death. The data submitted by Purdue to answer that question remains secret. 'It's in the public interest that we all know what these drugs are doing and yet none of us can see it, which is really terrifying when you think about it,' Brown told The Associated Press. In 2015, Brown and his colleagues were supposed to review follow-up data on OxyContin at a meeting in Washington, but the FDA canceled it only days before. Purdue had pulled its application to update OxyContin's label with new information on abuse, saying it wanted more time to analyze the data. Such meetings are typically planned months in advance and are almost never canceled. A Purdue spokesman said the Stamford, Connecticut-based company has been working to complete four updated study requirements assigned by the FDA in 2016. The company said it has submitted three of the FDA-mandated studies and expects to submit the final one by October. 'Once all of the studies are completed and FDA has had the opportunity to review the results, we will evaluate options to disseminate this important data to the scientific community,' said Bob Josephson, in a statement. But the FDA's top staffer for opioids said at a public meeting last year that the agency expected the information to become available 'years ago.' 'They have it, but it's hard for us to force them to submit it,' said Sharon Hertz, FDA's division director for pain medications. The unreleased OxyContin data highlights the FDA's precarious role as both a public health agency and close confidante of industry. While the agency can order a drugmaker to research important questions, the information itself still belongs to the company and is deemed 'confidential commercial information.' An FDA spokeswoman said in an email that it would be 'premature' to comment on Purdue's results before they have been fully submitted and reviewed. The agency noted that the company's final OxyContin study has been delayed. FDA staffers expect the studies 'will help us understand the real-world impact of OxyContin's reformulation on abuse,' said Lyndsay Meyer. OVERDOSE DEATHS If OxyContin has reduced overdose deaths, federal statistics don't show it. OxyContin remains the best-selling opioid brand in the country, but it accounts for less than 2 percent of U.S. opioid prescriptions, potentially limiting its impact on national trends. (Most opioids prescribed are low-priced generic pills.) Since the new formulation was approved in 2010, fatal overdoses involving prescription opioids including OxyContin, Percocet and generic pills have risen more than 30 percent to about 14,500 in 2017, the most recent year for which complete data is available. Preliminary figures released last week suggest drug-related deaths likely fell last year for the first time in decades. Some researchers have suggested reformulated OxyContin, combined with tighter prescribing and other measures, accelerated the nationwide shift toward heroin and fentanyl. Those drugs were involved in more than 43,000 overdose deaths in 2017, nearly three times the number as prescription opioids. The FDA has now approved seven opioids, including OxyContin, with labeling that they are 'expected' to discourage abuse. Those pills are intended to be difficult to crush, break or dissolve, but they can still be misused when simply swallowed. And the drugs carry the same addiction risks. 'The real problem with opioids from the public health perspective is addiction,' said Dr. Lewis Nelson, a Rutgers University emergency medical specialist who also serves as an FDA adviser. 'These pills in the reformulated version don't do anything to reduce the likelihood or magnitude of addiction.' Purdue has published preliminary information on reformulated OxyContin in peer-reviewed journals, but the studies are clouded by potential biases and limitations. Many are written by Purdue scientists or researchers whose work is funded by the company. In most cases, the data comes from a network of specialized sources, including poison control centers, law enforcement records and drug rehabilitation clinics. Those sources show a positive picture for OxyContin's performance, with key indicators like emergency calls, law enforcement reports and rates of patients seeking prescriptions from multiple prescribers — known as doctor shopping — dropping. But even the study authors acknowledge that those measures don't necessarily reflect what's happening across the country. Only a small segment of people misusing opioids ever enter rehabilitation, for instance. When FDA researchers decided to independently examine OxyContin abuse in a study using a much larger dataset — a federal government annual survey — they found a different picture. Among people with a history of misusing prescription opioids, rates of OxyContin abuse were similar or higher three years after the drug was reformulated. 'If you were going to see an impact, this is the population where you should see it. And we didn't see anything,' said Dr. Christopher Jones, who co-authored the 2017 paper and now works at the Centers for Disease Control and Prevention. The paper's findings square with survey results suggesting less than 5 percent of long-term abusers gave up OxyContin after it was reformulated. Garrett Hade of Los Angeles said that when he was addicted to opioids it would take him only a few minutes in his kitchen to prepare OxyContin for injecting. 'It just became a matter of 'this is what you have to do today because you have abuse-deterrent OxyContin,'' said Hade, 32, who is in recovery. THE CONTINUING COST OF OXYCONTIN First launched in 1996, the original OxyContin helped spark a wave of abuse as some people quickly learned to crush the long-acting pills to release a massive opioid dose. Under pressure from regulators, politicians and law enforcement, Purdue reformulated the painkiller in 2010. Government data unveiled last week showed Purdue and other drugmakers flooded the U.S. with more than 76 billion opioid pills between 2006 and 2012. Areas that received the most pills also had the highest overdose rates. Today, Purdue faces some 2,000 local and state lawsuits alleging its aggressive marketing contributed to the opioid epidemic by downplaying OxyContin's addiction risks and promoting the drug for common pain ailments. The lawsuits have pushed the company to publicly discuss bankruptcy . The reformulation has been good for business. The patent on original OxyContin would have expired in 2013, allowing lower-priced generics to gobble up Purdue's market share. By reformulating the drug, Purdue was able to extend its patent until 2030. Since 2010, OxyContin has generated more than $21 billion in U.S. sales, according to pharmaceutical tracking service IQVIA. Purdue viewed the anti-abuse reformulation as a 'key driver' of new prescriptions and stressed the features in promotions to doctors, according to its marketing materials. Purdue stopped promoting OxyContin directly to doctors last year amid mounting scrutiny. Meanwhile Purdue has steadily increased OxyContin's price more than 95 percent, to $22 per pill for the drug's highest dose, according to data firm Elsevier. Whether the drug's anti-abuse features warrant those costs has been debated. The nonprofit group Institute for Clinical and Economic Review has found mixed evidence for OxyContin's ability to fight abuse. Dr. Peter Lurie, a former FDA senior official, co-authored the 2017 paper that found OxyContin misuse was essentially unchanged among long-term users. Now president of the nonprofit Center for Science in the Public Interest, Lurie notes that OxyContin is by far the most prescribed and most studied abuse-deterrent opioid. 'If we can't prove it for OxyContin, how are we going to show it for anything else?' he asked. ___ Follow Matthew Perrone on Twitter: @AP_FDAwriter ___ 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.
  • Sen. Kamala Harris is introducing legislation designed to ensure all Americans, particularly those in at-risk communities, have access to safe, affordable drinking water, the latest response to burgeoning water crises across the country. The California Democrat and presidential candidate's 'Water Justice Act' would invest nearly $220 billion in clean and safe drinking water programs, with priority given to high-risk communities and schools. As part of that, Harris' plan would declare a drinking water infrastructure emergency, devoting $50 billion toward communities and schools where water is contaminated to test for contaminants and to remediate toxic infrastructure. The legislation, being introduced on Monday, also would establish a $10 billion program to allow states to offset the cost of water bills in low-income communities and environmentally at-risk households. Additionally, Harris would invest $20 billion in a variety of sustainable water supply, recycling and conservation programs. Harris is focusing on the issue as she and other 2020 Democratic presidential candidates turn their sights on Michigan, where the city of Flint has faced a major water crisis . Harris, who launched her campaign in January, is among the party's candidates speaking at the NAACP's national convention in Michigan this week. And 20 candidates seeking their party's nomination will take the stage for the party's second set of presidential debates in Detroit on July 30-31. Harris is partnering with Michigan Reps. Dan Kildee, who represents Flint, and Brenda Lawrence. While Flint has dealt with lead that leached into some homes after officials tapped into the Flint River in 2014, the problems also are dire in Harris' home state, where 1 million of its nearly 40 million residents don't have access to clean drinking water because of pollution from humans or natural causes. 'Every American has the right to clean water, period,' Harris said. 'We must take seriously the existential threat represented by future water shortages and acknowledge that communities across the country — particularly communities of color — already lack access to safe and affordable water. Achieving true justice in our nation will require us to recognize the precious nature of water and take bold action to invest in long-term, sustainable solutions to ensure it is accessible for all.' Harris is not the only presidential candidate to focus on the water crisis plaguing communities around the country. Among them are former Housing and Urban Development Secretary Julián Castro, who earlier this year visited Flint and released a plan to combat lead exposure, and Sens. Bernie Sanders of Vermont and Cory Booker of New Jersey, who traveled to Denmark, South Carolina , where residents have struggled with tainted water.
  • German pharmaceutical and chemical company Bayer AG says U.S. investment firm Yellow Wood Partners will buy its Dr. Scholl's foot care business for $585 million. Bayer said Monday that the sale will enable it to 'focus on building its core over-the-counter brands.' It said that Yellow Wood Partners, based in Boston, will create a stand-alone company and plans to invest in all aspects of the business. The transaction, which requires approval from competition authorities, is expected to close in the fourth quarter. Dr. Scholl's, which had sales of $234 million last year, makes insoles, inserts and a variety of foot care and treatment products.
  • U.S. government hospitals put Native American patients at increased risk for opioid abuse and overdoses, failing to follow their own protocols for prescribing and dispensing the drugs, according to a federal audit made public Monday. The report by the U.S. Department of Health and Human Services' Office of Inspector General does not say whether patients suffered because of the hospitals' practices. But all five Indian Health Service hospitals that were reviewed had patients who were given opioids in amounts exceeding federal guidelines, the report said. 'There are vulnerabilities with this particular population in the opioid prescribing and dispensing practices,' said Carla Lewis, one of the auditors. The overdose epidemic that has killed more people than any other drug epidemic in U.S. history has hit indigenous communities hard. Native Americans and Alaska Natives had the second-highest rate of opioid overdose out of all U.S. racial and ethnic groups in 2017, according to the federal Centers for Disease Control and Prevention. Navajo Nation President Jonathan Nez called the audit's findings 'very concerning' and said the tribe plans to reach out to its congressional members and the Indian Health Service to ensure the recommendations are addressed. New Mexico Sen. Tom Udall, vice chairman of the Senate Indian Affairs Committee, said the report 'is a deeply troubling indication that structural issues at the IHS are potentially worsening the opioid crisis in Indian Country.' The report made more than a dozen recommendations to the Indian Health Service to better track patients' health records and pain management, ensure opioids are stored under tighter security and update its information technology systems. The agency agreed on every point and said changes are coming. The Indian Health Service, the federal agency that administers primary health care for Native Americans, has put an increased focus on opioids lately with a new website and the creation of a committee focused on decreasing overdose deaths, promoting culturally appropriate treatments and ensuring that communities know how to respond. The audit covered five of the 25 hospitals directly run by the Indian Health Service: the Phoenix Indian Medical Center in Phoenix; Northern Navajo Medical Center on the Navajo Nation in Shiprock, New Mexico; the Lawton Indian Hospital in Lawton, Oklahoma; the Cass Lake Indian Hospital on the Leech Lake reservation in Cass Lake, Minnesota; and the Fort Yates Hospital on the Standing Rock Sioux reservation in Fort Yates, North Dakota. Auditors considered the amount of opioids each hospital dispensed and the percentage increase over three years when deciding which ones to review. They looked at 30 patient records at each hospital, visited the facilities and interviewed staff. The auditors found that the hospitals strayed from guidelines in the Indian Health Manual in reviewing treatment for patients and their causes of pain every three months. Patients also must sign a written consent form and an agreement to treat chronic pain with opioids so they know the risks and benefits, as well as the requirement for drug screenings. More than 100 patient records did not include evidence of informed consent, and dozens did not have evidence that providers adequately educated patients. The Centers for Disease Control recommends that patients be prescribed no more than 90 morphine milligram equivalents per day, a measure used to compare an opioid dose with morphine. The audit found that each hospital met or exceeded that amount at times. At the Shiprock hospital, the daily dosage was more than four times as high. The auditors also found some patients were prescribed opioids and benzodiazepines — commonly used to treat anxiety and insomnia —at the same time, which 'puts patients at a greater risk of a potentially fatal overdose.' The Indian Health Service said all of its facilities now submit that data so the agency's top leadership can track it. Among the report's other findings: —More than two dozen records showed no evidence patients were screened for drugs with urine tests when they started opioid treatment and periodically after. Providers did not have an alert system to know when patients were due for the urine tests. The Phoenix hospital has since implemented one. —Pharmacists are supposed to review patients' files before filling prescriptions from an outside provider, but that was not done at four of the hospitals. In one case, Fort Yates filled a prescription from an outside provider despite the hospital discontinuing treatment because the patient violated a pain management agreement. The Indian Health Service said it would issue a directive in December for prescribers to track that information. —Only the Lawton hospital had opioids secured in a storage cabinet requiring employee authentication for access. One photo attached to the report showed the combination to a safe listed on the safe itself. The Indian Health Service said it has revised its manual to require opioids awaiting pickup to be locked up. —Agreements with their states require that hospitals report daily on opioid prescriptions that are filled so patients do not seek the drugs from multiple providers at the same time. Fort Yates and Phoenix now are complying. The Indian Health Service said the reporting would be automated by June 2020. At all hospitals, auditors noted that providers did not always review the data before seeing new patients or during the time patients were on opioids for pain. 'Part of it is to ensure the holistic approach of providing care,' Lewis said. Hospital officials and providers often said they were overwhelmed by the number of patients or could not control how regularly they came in — sometimes due to the long distances between patients' homes and the hospitals. Lewis said auditors try to be reasonable in their requests. 'We try to make recommendations that are going to be actionable and cost-effective for an organization,' she said.

Local News

  • There are reports of a homicide on Athens’ east side: the victim is said to be a pregnant woman, 24 years old, killed in Carriage Court off Barnett Shoals Road. Athens-Clarke County Police say the shooting happened around 9:30 Monday night. The victim is identified this morning as Auriel Callaway. She died after being taken to an Athens hospital. Callaway was four months pregnant with a fetus that did not survive. A 2 year-old who was in the home at the time of the shooting is being taken care of by other family members. There are reports that the boy’s mother was the shooting victim and that she was holding his hand at the time of the homicide. There is no word yet on suspects or motive.  Police say they are questioning possible witnesses and other persons of interest.    Athens-Clarke County Police say someone apparently stole upwards of $20,000 from a pizza restaurant on Hull Road, theft of cash from the restaurant that has taken place over the past year. Police investigators say they are looking at restaurant employees as suspects.    Franklin County Sheriff’s deputies say they have found and arrested the man who ran away from a car on I-85, leaving the scene of a traffic stop and leaving a child inside the car. Franklin County Sheriff Stevie Thomas says the child is safe, turned over first to DFACS and then to a grandmother in Atlanta. The suspect was spotted and arrested Monday afternoon, walking along the Interstate in Banks County.  An 8 year-old boy from Hartwell is in the burn unit of a hospital in Greenville South Carolina: the boy was injured in an explosion at a home in Gillsville. Banks County EMS says the boy suffered burns on his face and arms when someone tossed a plastic bottle filled with flammable liquids into a burn pile.    The GBI is releasing more details about an officer-involved shooting in Dalton. A police officer was called to an intersection where a man was jumping on cars and running in and out of traffic. The suspect attacked the officer, who uses a taser on 32 year-old David Schmitt. Schmitt took the taser away and tried to use it on the officer. That’s when Schmitt was shot. He went to the hospital in Dalton with what are said to be non-life-threatening wounds. The officer suffered minor injuries. 
  • — Four former Georgia Bulldogs – Kenny Gaines, Albert Jackson, Travis Leslie and Charles Mann – will participate in the 2019 edition of “The Basketball Tournament,” which tips off on Friday. Known more commonly as simply the “TBT,” a 64-team bracket is competing for $2-million in winner-take-all prize money.   Interestingly, three of those Bulldogs will face off in one of the opening games of the tournament’s Lexington Regional. On Friday at 3:00 p.m. ET, Leslie and the “Ft. Wayne Champs” will face “Showtime,” the team for which Jackson and Mann are playing. That contest is set to be streamed on ESPN3.   Leslie was an All-SEC performer for the Bulldogs in 2011 and scored 1,099 points in three seasons with the Bulldogs before declaring for the NBA Draft. He was drafted by the L.A. Clippers in the second round of the 2011 Draft and has played primarily in France during his professional career. Last season, Leslie averaged 12.9 points, 5.9 rebounds, 2.2 assists and 1.1 steals per game for Boulazac.   Jackson was a four-year letter winner from 2006-10 who moved into the Bulldogs’ starting five late during the 2008 campaign. Jackson had a pair of double-digit outings in Georgia’s improbable run to the 2008 SEC Tournament title when the Dogs won four games in four days – including two in one day – to secure an NCAA Tournament bid.   Mann was a SEC All-Freshman selection in 2013 and an All-SEC performer in 2014. He started 106 games for the Bulldogs, including 98 of 100 games during his sophomore, junior and senior seasons. He has since played professionally in Europe, Canada and the G-League. Mann ranks No. 15 among Georgia’s career scoring leaders with 1,411 points. Much of those came at the free throw line, where he is the Bulldogs’ all-time leader in attempts (896) and makes (618). In fact, he ranks second to only Pete Maravich in SEC history in trips to the free throw line.   Gaines will play for “Jimmy V,” competing in the Syracuse Regional beginning next Friday. They will face “Brotherly Love” on July 26 at 1:00 p.m. The “Jimmy V” team is competing in an effort to raise proceeds for The V Foundation for Cancer Research.   Gaines also was named All-SEC in 2014, and he ranks No. 21 on the Bulldogs’ career scoring leaders ledger with 1,324 points. Among Georgia’s career statistical leaders, Gaines also ranks No. 4 in 3-pointers (213), No. 5 in 3-point attempts (569) and No. 7 in 3-point percentage (.374). Since graduating from UGA, Gaines has played professionally in France and Lithuania. He recently signed to play in Italy during the 2019-20 season.   'We are honored to work with the V Foundation in this year’s TBT,” said Alex Neumann, the team’s general manager. “To be able to play for such an incredible organization that does the kind of work for cancer research that they do is a special opportunity for us. We’ve seen teams participate in TBT in past years for great causes, and it’s an inspiration to see the way people can rally around them. We’re hoping to garner that kind of support playing for Jimmy V this year. We are excited about the roster that we have constructed and can’t wait to start turning some heads in July and for years to come.'   About The Basketball Tournament TBT is a 64-team, single elimination summer tournament airing on ESPN where the winning team takes home $2 million. TBT’s 2019 format divides a 64-team field into eight regions for Rounds 1-3, with each region seeded 1-8. The last team standing will claim a winner-take-all prize of $2 million and the champion of each regional will receive a cash prize equal to 25% of the ticket sales of that particular region. 
  • The Athens-Clarke County Water Conservation Office says there is a new tool to help local residents better manage their water use. City Hall says the Water Smart Portal is an online resource that allows water customers to set up leak notifications and monitor water bills.    From the ACC Government website… Water customers now have access to a free, online tool to manage their water use. Athens-Clarke County (ACC) Public Utilities Department is introducing the WaterSmart AMI Portal, an online tool that allows residents to set up leak notifications and monitor their water bill.The WaterSmart system has the potential to save residents money and protect the local water supply through leak detection. By creating a WaterSmart account, customers can receive leak alerts and other notifications by text, voice, and email. Customers also have the ability to track their water use in near real-time, allowing residents to find and resolve leaks more quickly with careful monitoring.Other WaterSmart features include water-efficiency tips, water use and bill forecasting, and comparisons of home water usage to similar ACC households. To take advantage of these online tools, ACC Public Utilities Department (PUD) water customers can enroll for WaterSmart by visiting www.accgov.com/WaterSmart.The recent PUD upgrades to the water meters throughout the county provide the means to offer this service to customers. Using the same positive displacement meters the PUD has relied on for years to measure water use, the new Advanced Metering Infrastructure (AMI) changed the way meters are read. Instead of manually reading meters on a monthly basis, the AMI System now remotely sends water usage data daily. The consumption history is then made available to customers in easy to read graphs with WaterSmart technology.The PUD values customer feedback. A frequent request from customers is for the ability to pay water bills online with the use of a credit card. The PUD is currently evaluating options to offer this feature on the WaterSmart platform in the near future. Sign up for a WaterSmart AMI Portal account to receive notification of when this feature is available.For questions about how to register for your free WaterSmart account or to schedule a presentation, please contact Laurie Loftin at 706-613-3729 or visit www.accgov.com/WaterSmart.
  • Falcons safety J.J. Wilcox, who signed with the team in the offseason, went down with a right knee injury about an hour into the first practice of training camp on Monday. “I don’t have an injury updates from today,” Falcons coach Dan Quinn said after practice. “I’ll follow up with anything tomorrow. Nothing from the training staff today that I can share.” Before Quinn could follow up, it was reported by NFL Media that Wilcox is out for the season with a torn ACL.  However, a source familiar with the injury, would not confirm the torn ACL, but said that Wilcox will get a second option on the injury this week.  Also, reserve defensive tackle Michael Bennett suffered a broken ankle, according to NFL Media.  Wilcox, 28, who played at Georgia Southern and Cairo High, was working his way to the ball as a runner was getting down the field when he went to the ground. Wilcox was escorted to the sideline by defensive backs Damontae Kazee and Keanu Neal. He couldn’t put any pressure on the leg and was immediately attended to by the two members of the training staff.
  • The University of North Georgia campus in Dahlonega is hosting today’s Georgia Chamber of Commerce Rural Prosperity Forum. It’s underway at 8 o’clock this morning in the University’s Convocation Center.From the Ga Chamber of Commerce… The Georgia Chamber of Commerce will be hosting the first-ever Rural Prosperity North Georgia Forum on July 23 from 8 a.m. to 2 p.m. at the University of North Georgia Convocation Center.  Following the widely successful annual Rural Prosperity Summit in Tifton, the newly introduced North Georgia Forum focuses on the unique aspects of rural communities in North Georgia and seeks to bring solutions that cultivates prosperity for these portions of our state. For the first time in the North Georgia community, guests will have the opportunity to hear from speakers about the local challenges and solutions that are often faced. There will be networking opportunities for attendees, local business owners, and industry leaders to make meaningful connections and build relationships that could strengthen their business.    The honorable Senator Steve Gooch and Representative Rick Jasperse will discuss the legislative outlook on rural revitalization. There will also be a North Georgia regional speaker, Chuck Reece, who is the Editor of The Bitter Southerner. Additional speakers include representatives from the Office of Attorney General of Georgia, Georgia Department of Community Affairs, Georgia EMC, Paladin Wireless, Hart County IBA and many more.    “The Georgia Chamber works diligently with our statewide partners to address the challenges that face rural Georgia. The Rural Prosperity North Georgia Forum is an opportunity for attendees to hear from industry leaders, government officials, business owners, and key community partners about new concepts to help our rural communities grow,” said Chris Clark, President and CEO of the Georgia Chamber. “We are invested in finding real solutions for Georgia and believe that this Forum is an important part of that process.”

Bulldog News

  • ATHENS, Ga. The SEC Media Days voters have spoken, making their (Alabama) picks, and scattering brad crumbs around the rest of the league. To be the best, you have to beat the best, they say, and so previously little attention or credit is doled out to other schools when it comes to preseason All-SEC selections. RELATED: Six biggest Georgia snubs on preseason All-SEC team The Crimson Tide's dominance on the first team (11 to Georgia's 4) has been well-documented, with much of this year's voting based on last season's results. The Bulldogs, however, have several players with All-SEC ability who have yet to put up the stats or turn enough heads outside of Athens to have been noticed. Here are 12 All-SEC candidates from Georgia who did not make the first, second or third- All-SEC preseason teams, a couple of them having already been nominated on the 'biggest snubs' list: James Cook Out of the backfield, in the slot or as a return man, Cook possesses the game-breaking speed and cutback ability to score from anywhere on he field. Demetris Robertston One year bigger, stronger and tougher after his transfer from Cal, look for D-Rob to take the top off defenses and make plays whether outside or in the slot at receiver. Eric Stokes A sticky cover cornerback who produced when called upon, Stokes is also adequate in run support. Tyson Campbell Toasted early but seasoned late, there's a reason Kirby Smart started Campbell on the corner as a true freshman. Malik Herring NFL frame, good quickness and strength and a desire to live up to his head coach's expectations bode well for Herring on the D-Line. Tae Crowder Converted running back will be reacting more than thinking from inside linebacker this season, already on NFL scouts radar Trey Hill Sophomore takes to the center position naturally, teammates refer to his legs as 'tree trunks' Brian Herrien Hungry and durable, 1,000-yard season could be in reach depending on D'Andre Swift and Zamir White workloads. Tyler Simmons Simmons is all about speed and toughness, a committed team player who competed most of last season wearing a shoulder brace at receiver. Jordan Davis The first of the three players that follow in this article off the 'snubs' list, Davis was an FWAA Freshman All-American defensive tackle who dominated at times. Monty Rice Perhaps the biggest snub of all, Smart has earmarked Rice for greatness, and certainly, a captain role in the linebacker corps. Lawrence Cager The Miami transfer receiver is a 6-foot-5 former high school high jump champion with a 40-inch vertical, and while speed is a question, catch radius is not. DawgNation from SEC Media Days Kirby Smart says no emotion figures into Jacksonville talks Vanderbilt coach Derek Mason: Kirby Smart is 'like a brother' South Carolina weighs in on Georgia-Clemson toughness debate Alabama players agree, Georgia toughest team' they faced The unbelievable story of how Herschel Walker chose Georgia Kirby Smart puts breaks on recruiting trail SEC Network analyst: I love Georgia this year' Outland Trophy favorite Andrew Thomas locked into junior year Florida says playing UGA in Jacksonville a home game' Gators believe they're closer to Georgia than scores indicate Georgia football offensive line, by position Podcast: 3 overlooked Georgia football topics from media days The post 12 Georgia football players with All-SEC potential not on preseason lists appeared first on DawgNation.
  • CBS officially announced that Georgia and Notre Dame will be played under the lights in primetime at 8 p.m. ET on Sept. 21. Brad Nessler, Gary Danielson and Jamie Erdahl will be on the call for CBS. This will be the first time Georgia has hosted Notre Dame and only the third time these two historic programs have ever faced each other. The Bulldogs are 2-0 in the series against the Fighting Irish with a 17-10 victory in the 1981 Sugar Bowl and a 20-19 victory at Notre Dame Stadium in 2017.
  • HOOVER, Ala. There were many questions posed to Jake Fromm during one single whirlwind day at SEC Media Days last month. He took at least three hours of questions. Give or take a photo opp or a sunglass pose or two. Alabama? Yes. Mock draft white noise? Yep. Fish or hunt? Yes. Duck hunt or play football? Yessir. DawgNation wanted to know the answer to a specific question: How does he rate his performance after games? When he turns on the film, what is he looking for? Fromm, the quarterback known for having the clear head at all times due to immense preparation, shared a little insight into his work behind the scenes with that one. 'It kind of starts [number] one with decisions,' Jake Fromm said. 'Do we make the right decisions? The right checks? Pre-snap? Before the play? Do we make the right decision after? Did I try to force a ball? Did I check it down too soon? Are my eyes in the wrong spots? So a lot of different things, you know.' 'Really just kind of seeing what kind of throws did we make. The kind of errors. Did we make really bad errors? Did we make small ones and really did we move the ball on third down? There are a lot of different things we are looking at. Really trying to critique decisions. Then we will kind of go into physically like Hey is my foot off a little bit? Is my shoulder off? Am I not getting my elbow up when I throw?' so a lot of different little things.' 'You kind of watch it once or twice. Sometimes three times and see what you see and you see something different every single time.' Grading Jake Fromm: What does he see as his best games? Media can point to a stat line. The metric followers can pour over his QB rating and its intricate formulas. There can be a highlight-worthy throw that goes viral everywhere. The trifecta: ESPN. SEC Network. Social media. But that's how Joe Media or Joe Fan gauges a good game for the Georgia QB. Which games did Fromm feel he was at his best? The junior All-American candidate said he was closest to his standard (a likely unattainable one) at the end of the 2018 season. 'Gosh, I think the last two,' Fromm said. 'The Georgia Tech game and the Alabama game last year. Kind of finished the season and kind of thought I was playing at a high level. Thought I was making really good decisions moving the ball. Those are the two that kind of jump out to me right at the moment.' 'Just moving the ball. Making good decisions and making the big-time throws when they were needed.' Here is how Fromm fared in those games: Fromm versus Georgia Tech: 13-for-16, 175 yards, 4 TDs, O INTs Fromm versus Alabama: 25-for-39, 301 yards, 3 TDs, O INTs The first game he played in 2018 was pretty strong, too. Fromm versus Oklahoma: 20-for-29, 210 yards, 2 TDs, O INTs The junior from Warner Robins actually finished his 2018 season on a surge which saw him throw for 17 touchdowns against two interceptions. That was coming off a poor performance for the entire team, including Fromm, at LSU. This year he is the clear starter and a team leader. There is no other 5-star peer on the depth chart to compete with for starting reps under center. This is his team. Fromm's name will be in the lineup every day in the same vein that a Freddie Freeman or a Mike Trout knows that one off night won't cost him a start. Fromm will still put in the exact same work in the film room regardless. Does he see that helping him to get better and play better in 2019? 'That kind of allows me to get back to [my] high school days and have a little more fun in practice,' Fromm said. 'Really go out and try different things. For me, in high school, there's a lot of kind of trial and error in what I did. It didn't always make [my] coach happy, but it really kind of helped me play. Do you know? Hey, this is what I can and this is what I can't do.' 'I'm going to have a little more fun at practice and go out and try to make some more plays and see what happens.' The post Fromm talk: How does Jake Fromm grade himself after a game? appeared first on DawgNation.
  • HOOVER, Ala. Jake Fromm and Jake Bentley go way back and have stayed friends throughout their careers at Georgia and South Carolina. So much so that Bentley said the quarterbacks might even meet up in Greenville, S.C., and go on a double date. ' I told some guys earlier, he dates a volleyball player, so do I,' Bentley said, 'so we were going to go double date up in Greenville at some point and time before the season starts, so that would be pretty cool.' WATCH: Carolina QB Jake Bentley compares Georgia to Clemson Bentley said he has been impressed working beside Fromm in the offseason. ' You watch Jake (Fromm), and he's just very consistent as far as how he plays, he doesn't miss many throws,' Bentley said. 'He's very detail oriented, just sitting with him in the meeting room, and how he goes about his business is very professional.' NFL scouts have noticed both Fromm and Bentley, both of whom could be in the 2020 NFL Draft class. The quarterbacks have both been trained at QB Country in Mobile, Ala., by David Morris. RELATED: Morris breaks down Jake Fromm Bentley, who led South Carolina to a bowl win over Michigan his freshman season, impressed at the Manning Camp. Jim Nagy, a former NFL scout with four Super Bowl rings who's now executive director of the Senior Bowl, heaped praise. ' Walked away from Manning Passing Academy last Friday night impressed with @GamecockFB QB Jake Bentleyand that was before he won 'Air It Out' competition,' Nagy said . 'Ball was coming out quicker and cleaner than past years.' Walked away from Manning Passing Academy last Friday night impressed with @GamecockFB QB Jake Bentleyand that was before he won 'Air It Out' competition. Ball was coming out quicker and cleaner than past years. Could mean a big year for @Edwards_Bryan4. #thedraftstartsinMobile pic.twitter.com/IFAO38Vs8t Jim Nagy (@JimNagy_SB) July 1, 2019 Kirby Smart also had positive things to say about Bentley, who the Bulldogs will play host to in Sanford Stadium on Oct. 12. 'He's a leader, he's a guy who has played,' Smart said of Bentley. 'Any time you're playing a guy with that kind of experience, it's very similar to Jake (Fromm), except he's got one whole year on top of that, and they've got some good wideouts coming back with them.' Smart, of course, loves his Jake, too. 'This guy (Fromm) is the epitome of what college football is all about,' Smart said. 'Number one, he stands up for the right things, he's very strong in his faith, he lives it. 'I have a lot of respect for his ability to be who he is, be confident in who he is and still lead our team and not create any jealousy while he's doing it.' Jake Bentley Comparing the Jakes DawgNation from SEC Media Days Vanderbilt coach Derek Mason: Kirby Smart is 'like a brother' South Carolina weighs in on Georgia-Clemson toughness debate Alabama players agree, Georgia toughest team' they faced The unbelievable story of how Herschel Walker chose Georgia Kirby Smart puts breaks on recruiting trail SEC Network analyst: I love Georgia this year' Outland Trophy favorite Andrew Thomas locked into junior year Florida says playing UGA in Jacksonville a home game' Gators believe they're closer to Georgia than scores indicate Georgia football offensive line, by position Podcast: 3 overlooked Georgia football topics from media days The post WATCH: South Carolina QB Jake Bentley suggests double date with Jake Fromm appeared first on DawgNation.
  • Aaron Schunk was one of the most consistent hitters at Georgia throughout his three years with the Bulldogs. During his time wearing the red and black, Schunk had a career .312 batting average with 19 home runs and 114 runs-batted-in.  Schunk has not skipped a beat with the Boise Hawks throughout his first 32 games. During those 32 games, Schunk is slashing .311/.380/.500 with an .880 OPS. He has recorded three home runs, 12 RBI, 12 bases-on-balls and only 16 strikeouts in the Northwest League.  On July 20, Schunk recorded his first “perfect game” with the Hawks going 4-for-4 with a walk, one RBI and three runs scored.