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Health Med Fit Science

    The Senate's top Democrat is calling on the Food and Drug Administration to examine a report that found dozens of baby food products contaminated with lead and other metals. Sen. Chuck Schumer says Sunday the FDA must take more action to regulate the baby food industry. A study by Healthy Babies Bright Futures found the presence of heavy metals in 95% of the 168 baby foods that were tested. The study found 95% of the food tested contained lead, arsenic, mercury or cadmium. It found one in four baby foods that were tested contained all four metals. The New York senator says consumers 'rightfully expect those foods to be undeniably safe, appropriately regulated and nutritiously sustaining.' He says federal regulators should examine the study and release a public statement of their findings.
  • They call it the Cosmic Crisp. It's not a video game, a superhero or the title of a Grateful Dead song. It's a new variety of apple, coming to a grocery store near you Dec. 1 Cosmic Crisp is the first apple ever bred in Washington state, which grows the majority of the United States' apples. It's expected to be a game changer. Already, growers have planted 12 million Cosmic Crisp apple trees, a sign of confidence in the new variety. While only 450,000 40-pound (18-kilogram) boxes will be available for sale this year, that will jump to more than 2 million boxes in 2020 and more than 21 million by 2026. The apple variety was developed by Washington State University. Washington growers, who paid for the research, will have the exclusive right to sell it for the first 10 years. The apple is called Cosmic Crisp because of the bright yellowish dots on its skin, which look like distant stars. 'I've never seen an apple prettier in the orchard than these things are,' said Aaron Clark of Yakima, whose family owns several orchards in central Washington and has planted 80 acres of Cosmic Crisps. The new variety keeps for a long time in storage and in the refrigerator, said Kate Evans, who runs the breeding program at Washington State University. And it's an exceptionally good 'eating apple,' she said. 'It's ultra-crisp, very juicy and has a good balance of sweetness and tartness.' Cosmic Crisps are a cross between the disease-resistant Enterprise and the popular, crunchy Honeycrisp varieties. The Honeycrisp, nicknamed 'Moneycrisp' by some growers, was the latest apple to spark a big buzz in the United States when it was introduced a couple of decades ago. It was developed by the University of Minnesota. 'This apple (Cosmic Crisp) has a good opportunity to be a hit with a lot of people,' said Clark, a vice president of Price Cold Storage, a company with orchards and fruit warehouses throughout central Washington. 'It better be, because we are going to have a lot of them.' Apples are a $2.5 billion a year business in Washington, which grows about 60% of the nation's supply, or nearly 140 million boxes. The top varieties are Gala (23, Red Delicious (20%) and Fuji (13%). Apples are grown in the arid valleys and brown hillsides of central Washington, a few hours east of Seattle, and watered by irrigation projects. The state has around 1,500 apple growers and 175,000 acres of orchards. About 50,000 people pick some 12 billion apples by hand each fall. The fruit is exported to 60 countries. With so much success, why was a new apple variety needed? 'A new apple brings excitement,' said Toni Lynn Adams, spokeswoman for the Washington Apple Commission, which markets apples internationally. 'A new variety can reinvigorate a market and industry.' Washington growers, who had watched the market share for sometimes mushy Red Delicious apples plummet over time, were looking to replicate the success of the Honeycrisp, Adams said. 'It's going to shake things up in a great way,' Adams said. 'We're expecting it to increase in volume rapidly.' Adams could not speculate on how much Cosmic Crisp apples will cost per pound. 'Better quality makes for better returns,' said Clark, the grower. 'This is a for-profit deal, man. We're trying to make some money with it.' Remarkably, this is the first apple variety developed in Washington state, which has been known for apples for more than a century. Scientists at WSU's Tree Fruit Research Center in Wenatchee spent 20 years breeding the desired apple tree seeds. In addition to helping pay for that research, apple growers need a license to buy the trees and pay a royalty on sales of the fruit. The trees take three years to produce a crop, said Kathryn Grandy, a member of the team marketing the apple. 'This will be the largest launch of a single variety ever, globally,' she said, and it's backed by a $10.5 million marketing budget. Consumers will not have trouble finding the variety, said Grandy, who works for a company called Proprietary Variety Management and is based in the town of Chelan, in the heart of apple country. Work on developing the variety began in 1997, said Evans, of Washington State University. The process of cross-hybridization has been used to breed plants for hundreds of years, Evans said, and is quite different from the more controversial genetic modification methods. 'The goal, in my opinion, is to get more consumers eating apples,' she said. 'Ultimately that is the goal of any plant breeder.
  • Matt Every was suspended for 12 weeks Friday for what the PGA Tour said was a violation of its conduct policy on drugs of abuse. Every said it was legal prescription for cannabis to treat mental health. 'To be clear, I tested positive for cannabis, a drug I do not abuse and a drug that I have a legal prescription for in the state of Florida,' Every said in a statement. Every will be eligible to return Jan. 7 and will miss only three tournaments for which he would have been eligible — the Bermuda Championship, the Mayakoba Classic in Mexico and the RSM Classic at Sea Island. Every said he knew cannabis was on the tour's list of banned substances and accepts the penalties. But he offered no apologies for the violation. Every, a two-time winner at Bay Hill, did not disclose the nature of the mental health condition. He says cannabis, which is legal in Florida only for medicinal purposes, was prescribed by his doctor who has managed his health for 30 years. He said it was determined that he is neither an acceptable candidate to use prescription 'Z'' class drugs nor benzodiazepines, drugs he said could be highly addictive and harmful to the body and mind. 'For me, cannabis has proven to be, by far, the safest and most effective treatment,' Every said. 'With that being said, I have no choice but to accept this suspension and move on. I knew what WADA's policy was and I violated it. I don't agree with it for many reasons, mainly for my overall well-being, but I'm excited for what lies ahead in my life and career.' The PGA Tour does not comment beyond standard reporting of violations detected through its anti-doping policy, which began in 2008. Every is the seventh player to be suspended under the policy, not including Vijay Singh, whose suspension was withdrawn. Singh later sued the tour and it was settled before going to trial. Before his back-to-back victories at the Arnold Palmer Invitational, Every was arrested on a misdemeanor charge of drug possession after agents were called to a casino hotel because of a strong odor of marijuana coming from the room he was in. Every said he was in the wrong place at the wrong time, though confirmed the tour suspended him for three months.
  • Drugmaker Sanofi is recalling its over-the-counter heartburn drug Zantac in the U.S. and Canada because of possible contamination. The French company Friday joined other drugmakers that have recently recalled their versions of the popular heartburn and ulcer drug. In September, the Food and Drug Administration said a potentially cancer-causing chemical had been detected at low levels in prescription and over-the-counter versions of Zantac. The federal agency said consumers could consider taking another heartburn medicine or contact their doctor. Several drugstore chains have already removed Zantac and generic versions from store shelves.
  • Negotiations aimed at reaching a major settlement in the nation's opioid litigation reached an impasse Friday. Key differences were between state attorneys general and lawyers representing local governments, rather than with the drugmakers and distributors they are suing. One of the negotiators, North Carolina Attorney General Josh Stein, said late Friday that local governments did not accept a deal worth $48 billion in cash, treatment drugs and services. 'We're disappointed that the cities and counties refused to go along with that deal,' he said during a news conference in Cleveland after talks under the watch of a federal judge had ended for the day. 'This would have helped the entire nation, not just a few counties, not just a few cities.' Stein and attorneys general for Pennsylvania, Tennessee and Texas led the talks on behalf of the states. They said going to trial would mean that the first local governments to win cases would get relief, rather than having money and treatment drugs distributed equitably across the country. Paul Farrell, a lead lawyer for the local governments, told The Associated Press that one hang-up was the states' desire to be in charge of dividing the money. They said that the deal would provide free Suboxone, a drug used to treat opioid addiction, across the country. State and local governments have been at odds for during the litigation. Ohio's attorney general even tried to get the federal trial put on hold, arguing the state's claims in state court should go first. Earlier in the day, another of the lead lawyers, Paul Hanly, told The Washington Post that the drugmakers Teva and Johnson & Johnson as well as the distributors AmerisourceBergen, Cardinal Health and McKesson were not willing to increase their offer. In a statement, the lead lawyers for the local governments said their goal with a settlement would be one that would ensure 'these resources will be directed exclusively toward efforts to abate the opioid epidemic.' Talks can continue, but opening statements are scheduled for Monday in the first federal trial over the opioid epidemic, which has contributed to the deaths of 400,000 Americans over the past two decades. 'When the first day of trial starts Monday, we look forward to sharing the facts — and the facts will show that opioid makers and distributors conspired to create and benefit from the worst public health crisis in decades,' the lawyers said. In a statement, Cardinal Health expressed disappointment. 'The attorneys general and the distributors reached common ground. We worked hard all day and into the evening to find a path forward, for everyone. Unfortunately, some parties to this litigation, and their lawyers, would not agree,' the company said. 'Those parties asked for more, and we dug deep. They would not accept our good faith efforts.' That trial involves claims by two Ohio counties, but it's considered a test case for similar lawsuits from governments across the country. The defendants in the case are Teva, the three major distributors, the smaller distributor Henry Schein, and Walgreens. Johnson & Johnson previously settled with the two counties. Three other manufacturers also settled with the counties and another, OxyContin maker Purdue, is attempting to reach a deal to end all its lawsuits through bankruptcy court; on that, about half the states and many local governments oppose accepting the offer as it stands. U.S. District Court Judge Dan Polster has said he wants the parties to strike a settlement in such a way that it would make a real difference in resolving the crisis. He invited state attorneys general to participate in the negotiations even though their lawsuits against the industry were filed in state courts.
  • The World Health Organization says the ongoing Ebola outbreak in Congo still warrants being classified as a global emergency, even though the number of confirmed cases has slowed in recent weeks. The U.N. health agency first declared the epidemic, the second-deadliest Ebola outbreak in history, to be an international emergency in July. On Friday, it convened its expert committee to reconsider whether the designation is still valid and decide if other measures are necessary. WHO's director-general, Tedros Adhanom Ghebreyesus, said the situation remains 'complex and dangerous' and that officials must continue to treat every case like it's the first. 'Every case has the potential to spark a new and bigger outbreak,' he told reporters. To date, there have been 3,113 confirmed cases and more than 2,150 people have died since the epidemic was first declared last August. While only 15 new Ebola cases were confirmed last week, WHO noted the vast majority were not in people previously identified as contacts of others infected, suggesting health officials still have difficulty tracking where the virus is spreading. Dr. Michael Ryan, who heads WHO's Ebola response, said that some of the most recent cases have been detected in a remote area where there is both legal and illegal mining and is difficult for health officials to reach. 'We still don't have a full picture of where the virus may be, but we don't believe we're dealing with a catastrophic situation,' he said, adding it may be another week or two before officials have a better understanding. WHO also said nearly a third of people are dying outside of Ebola treatment centers, potentially exposing families and loved ones to the disease. 'When your new cases are not coming off your contact list, that means you don't have things under control,' said Dr. Armand Sprecher, an Ebola specialist at Medecins Sans Frontieres, or MSF. Sprecher lamented that attempts to build trust among the wary local population are still failing. 'We have not communicated very well over the last year, so can we really do this now? I don't know.' Efforts to curb the outbreak have been hampered by violence against health workers — some have been killed — and some local residents suspect international responders of transmitting Ebola rather than stopping it. Misunderstandings have been high in communities that had never experienced the disease before. In June, the virus spilled into Uganda when a Congolese family, including some already infected, crossed into the country. Two later died of Ebola and the others were sent back to Congo for treatment. The outbreak currently is contained in Congo. The declaration of this outbreak as an international emergency was expected to bring increased funding and attention to combat the disease. This week, WHO reported that of the $287 million it estimates is needed until December, it has received only about $69 million, although additional funds have been pledged. This is the first Ebola outbreak to unfold in what has been called a war zone. Eastern Congo is home to numerous armed groups, and their attacks have halted response efforts many times, interrupting efforts to vaccinate people and monitor suspected cases. This outbreak is second only to the 2014-16 Ebola epidemic in West Africa that left more than 11,300 people dead. Also on Friday, the European Medicines Agency recommended that the Ebola vaccine being used in this outbreak be licensed. More than 270,000 people have received it. The use of experimental Ebola vaccines in the past year has been a welcome development in fighting one of the world's most notorious diseases. Last month, MSF called for an independent committee to oversee Ebola vaccination efforts after alleging WHO was unjustifiably restricting use of the Merck-made vaccine. MSF said the fact that so many people have been vaccinated — and yet the outbreak continues to spread — was a damning assessment of response efforts. Officials are testing a number of Ebola treatments but none is yet licensed.
  • Johnson & Johnson on Friday recalled a single batch of its baby powder as a precaution after government testing found trace amounts of asbestos in one bottle bought online. The recalled lot covers 33,000 bottles, which were distributed last year. J&J said the U.S. Food and Drug Administration found minuscule amounts of asbestos in one bottle during routine testing and notified the company on Thursday. J&J said it immediately began investigating with the FDA. 'The FDA's testing on prior occasions, and as recently as last month, found no asbestos,' said spokesman Ernie Knewitz. J&J said it was checking where the bottles were shipped, if the tested bottle is counterfeit or authentic and whether the sample might have been contaminated during testing. The recall comes as J&J fights thousands of lawsuits in which plaintiffs claim its iconic baby talcum powder was contaminated with asbestos and that it caused ovarian cancer or mesothelioma, a rare cancer linked to inhaling asbestos fibers. At multiple trials, J&J's expert witnesses have testified asbestos hasn't been detected in the talc in its baby powder in thousands of tests over the last 40 years. Several juries have reached multimillion-dollar verdicts against the company, nearly all of which are being appealed or have been overturned on appeal. Talc, the softest of minerals, is mined from deposits around the world, which can be contaminated with asbestos. J&J says the company and its talc suppliers routinely test their talc to ensure there's no asbestos. The talc is then crushed into a white powder and purified for use in personal care products to absorb moisture. The recalled lot of 22-ounce bottles is #22318RB. Consumers who have a bottle from that lot should stop using it; refunds are available through the company's website . The company's shares dropped 6.2% to $127.70 on Friday, following the recall news and, just a day earlier, the announcement of a $117 million settlement with 41 states over allegations the company deceptively marketed its pelvic mesh products by concealing risks. ___ Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma ___ 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 European Medicines Agency has recommended that the world's first Ebola vaccine be approved, after it was administered to hundreds of thousands of people in Africa. The agency on Friday described licensing the vaccine as 'an important step toward relieving the burden of this deadly disease.' The Ebola vaccine was originally developed in Canada and is now marketed by Merck as Ervebo. More than 270,000 people in Africa have received it as officials try to stop Congo's ongoing outbreak. A second vaccine made by Johnson & Johnson, which is not yet licensed, will soon be used in parts of Congo where Ebola is not actively spreading. Also Friday, the World Health Organization is convening a meeting to consider whether the epidemic in Congo should still be designated a global emergency.
  • House Speaker Nancy Pelosi is plowing ahead with her bill to allow Medicare to negotiate prescription drug prices despite a breakdown in relations with her chief bargaining partner on the issue — President Donald Trump. The nonpartisan Congressional Budget Office has estimated the legislation would save Medicare $345 billion over seven years, partly because some seniors would no longer have to skimp on costly medicines, and they'd stay healthier. A separate estimate from nonpartisan analysts at the Department of Health and Human Services found that households would save $158 billion over 10 years. But the budget office also cautioned that squeezing drugmakers could mean that some new medications — 3% to 5% — won't make it to market. Such trade-offs were front and center Thursday as House committees considered the legislation. The Energy and Commerce committee as well as the Education and Labor panel voted largely along party lines to advance the bill. Ways and Means held a hearing. Democrats and Republicans say Pelosi is moving quickly to get the bill ready for a floor vote. 'These are jaw-dropping savings,' said Rep. Anna Eshoo, D-Calif., who chairs the health subcommittee of Energy and Commerce. 'This is legislation that is going to make a true, tangible difference in the lives of the American people.' Eshoo said the money could be used to provide dental, vision and hearing benefits for Medicare recipients or could be reinvested in drug research at the National Institutes of Health. But at another hearing before Ways and Means, Rep. Kevin Brady, R-Texas, caustically dubbed the Pelosi bill the 'Fewer Cures for Patients Act.' Brady said the budget office finding that one consequence could be fewer drug approvals should be a stop sign for lawmakers. Although supporters of the legislation note that the CBO said only a small share of new drugs would be affected, Brady said, 'One cure lost is one cure too many.' The legislation from Pelosi, D-Calif., would authorize Medicare to negotiate prices for the costliest drugs — including insulin — using lower prices paid in other economically advanced countries as the reference point. The budget office says that could result in price cuts of 40% to 55% for pharmacy drugs subject to negotiations. The bill would allow private insurance plans to also get Medicare's price. As a hammer to force companies to negotiate, Pelosi would impose steep sales taxes on the medications at issue. Overall, budget analysts estimated the legislation would cut industry revenues by $500 billion to $1 trillion over 10 years. The CBO says those numbers are preliminary. Congressional Republicans are broadly opposed to allowing Medicare to negotiate drug prices, so the legislation has no chance in the Senate unless Trump gets behind it. As a candidate, Trump called for Medicare negotiations, and as president, he's repeatedly complained that countries with cheaper medicines are taking advantage of U.S. consumers. Pelosi's office has been in communication with top White House officials for months. Congressional Republicans say negotiations are best left to insurers that administer Medicare's prescription drug benefit. If Trump's anger over the Pelosi-initiated impeachment probe sinks the effort, lawmakers of both parties would face voters next year with nothing to show on a top consumer issue. The White House had no comment on the budget estimates. A poll this week found broad public support for Medicare drug negotiations, as well as for Pelosi's idea of taxing companies that won't come to the table. But the survey from the nonpartisan Kaiser Family Foundation also showed that support can shift to opposition if people are told there could be limits on research or access to new medications. A leading policy expert on drug costs said Pelosi has framed a crucial question: What's the right balance between fostering innovation and keeping drugs affordable? 'The savings are so large that you can't pretend for a second we don't have to look at this,' said Peter Bach, director of the Center for Health Policy and Outcomes at New York's Memorial Sloan Kettering Cancer Center. CBO hasn't said what kinds of new drugs could be kept off the market — whether they would be copycat medications or if life-changing medications would be affected, too. 'We reduce average prices by 55%, and we will lose some new drugs — between 2.5% and 5% — that's the estimate,' said Bach. 'Some people will say we want everything.' Economist Douglas Holtz-Eakin, head of the center-right American Action Forum public policy group, said he's not so sure that only drugs of marginal value will be sacrificed. He said he's not worried about major drug companies but rather about smaller research-oriented outfits that have to raise considerable sums from private investors to keep going. Will their money dry up? 'The guys sitting out there in the venture capital world are going to say, 'We're not going to do drugs anymore,'' said Holtz-Eakin. 'And you can't get that money back.
  • Vaping-related illnesses in the U.S. are still rising, though at a slightly slower pace. Health officials of Thursday said there have been 1,479 cases and at least 33 deaths in the mysterious outbreak. The Centers for Disease Control and Prevention has been releasing new case counts each week. The latest jump — 180 cases — was the lowest increase since mid-September. But CDC officials say there's no indication that the outbreak is waning. The outbreak appears to have started in March. Symptoms of the illness include severe shortness of breath, fatigue, and chest pain. No single ingredient, electronic cigarette or vaping device has been linked to all the illnesses. Most who got sick said they vaped products containing THC, the high-inducing ingredient in marijuana. Investigators say they are increasingly focused on black-market THC products. About 1 in 10 of the outbreak cases said they used only nicotine but that percentage has been falling. It was 13% last week. In some cases, people who initially claimed they had used only nicotine admitted later they had vaped THC. Until a cause is pinpointed, the CDC is advising Americans to refrain from vaping. Forty-nine states and one U.S. territory have reported illnesses. Only Alaska has not seen a case. The vast majority of cases are people in their teens, 20s or early 30s, according to the CDC. ___ 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.