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The Environmental Protection Agency is widely expected to announce plans to change the definition of which waters in the United States are protected under the Clean Water Act on Tuesday -- a change President Donald Trump has been working toward since the beginning of his presidency.The EPA released a statement saying it would make a major water policy announcement on Tuesday.The announcement is expected to be a policy shift from former President Barack Obama's 2015 Waters of the United States regulation. Obama's rule changed the definition of which bodies of water the federal government had authority over to include streams and wetlands so that the government could ensure that those waterways remained pollution-free. It altered the definition from the initial one established by the EPA and Army Corps of Engineers in the 1980s.Obama's regulation was created under the Clean Water Act, which regulates discharges of pollutants into waters in the US. Under the Clean Water Act, it's illegal to discharge pollutants from a source into "navigable waters," according to the EPA. 1092
The FDA continued on Monday to warn the public about using methanol-based hand sanitizers that the agency calls “dangerous.”The FDA has published a “Do Not Use” list of products. As of Monday afternoon, 87 products are on the do not use list. Adding to the confusion for consumers, many of the products do not have methanol on the label.Methanol can be toxic when absorbed through the skin as well as life-threatening when ingested, the FDA said. Retailers are being encouraged to recall these products.Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death, the FDA warns."Practicing good hand hygiene, which includes using alcohol-based hand sanitizer if soap and water are not readily available, is an important public health tool for all Americans to employ. Consumers must also be vigilant about which hand sanitizers they use, and for their health and safety we urge consumers to immediately stop using all hand sanitizers on the FDA's list of dangerous hand sanitizer products," said FDA Commissioner Stephen M. Hahn, M.D. "We remain extremely concerned about the potential serious risks of alcohol-based hand sanitizers containing methanol. Producing, importing and distributing toxic hand sanitizers poses a serious threat to the public and will not be tolerated. The FDA will take additional action as necessary and will continue to provide the latest information on this issue for the health and safety of consumers."The FDA’s warnings come following a hand sanitizer shortage in the consumer and commercial markets. Amid the shortage companies that do not ordinarily produce hand sanitizers began bottling products before obtaining FDA approval. 1771

The Centers for Disease Control and Prevention have changed its definition of a “close contact,” which impacts the agency’s recommendation on who should quarantine amid the coronavirus pandemic.Previously, the CDC recommended that those who were within 6 feet for 15 minutes of someone infected with the coronavirus should quarantine for two weeks. Now, the CDC recommends that those who are in contact with someone infected for 15 minutes over a 24-hour period should quarantine.The CDC offers the following recommendations for those who have been in contact with someone recently infected with the coronavirus:Stay away from others, especially people who are at higher risk for getting very sick from COVID-19, such as older adults and people with other medical conditions, if possible.If you have been around someone with COVID-19, stay home and away from others for 14 days (self-quarantine) after your last contact with that person and monitor your health.If you have a fever, cough or other symptoms of COVID-19, stay home and away from others (except to get medical care or testing, if recommended).If you need support or assistance while in self-quarantine, your health department or community organizations may be able to provide assistance. 1258
The Food and Drug Administration says it is re-examining the safety of a medication that was approved despite concerns that not enough was known about the drug's risks.In response to questioning at a budget hearing last week, FDA Commissioner Scott Gottlieb told members of Congress that he would "take another look" at Nuplazid, which is the only drug approved to treat hallucinations and delusions associated with Parkinson's disease psychosis.The medication has been cited as a so-called "suspect" medication in hundreds of deaths voluntarily reported by caregivers, doctors and other medical professionals since it hit the market, as highlighted in a recent CNN report.The FDA told CNN this week that the agency had already begun conducting a new evaluation of the medication when Gottlieb was questioned about it at the hearing. The agency said the review had started several weeks ago."What does it take for a drug like this to be taken off the market?" asked US Rep. Rosa DeLauro, a member and former chair of the congressional subcommittee responsible for funding and overseeing the FDA.DeLauro pressed Gottlieb for answers on his agency's response to the safety concerns surrounding Nuplazid."How many more adverse events do we have to have reported? How many people, quite frankly, have to die? Why does the industry always take precedence over public health and safety?"Tracked by the FDA, the adverse event reports cited by DeLauro do not mean that a suspected medication has been ruled the cause of harm and are typically not the result of official investigations. But the FDA uses the information to monitor potential issues with a drug and can take action as needed: updating a medication's label, for instance, or restricting its use. In rare cases, the agency can even pull a drug off the market.When asked by CNN about what prompted the FDA's new evaluation of Nuplazid, the agency said the decision was based on a number of factors but wouldn't say what those factors were. Instead, it would only comment generally, saying that it identifies "potential signals of serious risk/new safety information" in part by using adverse event data and that the agency is not suggesting physicians stop prescribing the drug or take patients off of it while a safety evaluation is taking place.The FDA has noted that the death reports citing Nuplazid have typically involved elderly patients with advanced-stage Parkinson's disease who suffered from numerous medical conditions and often take other medications that can increase the risk of death.But physicians, researchers and other medical experts told CNN that the high number of reports deserved a closer look to determine whether they were related to the drug. They also recommended further testing of Nuplazid, worrying that the drug had been approved too quickly, based on too little evidence that it was safe or effective.Nuplazid's review was expedited by the FDA because it had been designated a "breakthrough therapy," meaning it demonstrated "substantial improvement" in patients with serious or life-threatening diseases compared to treatments already on the market.Dr. Paul Andreason, the physician who led the FDA's medical review of Nuplazid, warned that patients taking the drug during the company's clinical trials experienced serious outcomes, including death, at more than double the rate of those taking the placebo. But the FDA ruled that the potential benefits outweighed the risks, agreeing with an advisory committee that cited a lack of safe alternatives and the pleas from family members who claimed the drug was already helping or could help their loved ones.At that advisory committee meeting two years ago, one woman said that her grandmother had been part of the clinical trials for the drug and that Nuplazid had been life-changing."We didn't know what to expect or even if she was on the drug" or a placebo, said Zoey Wade. "We soon realized that she must be taking the drug, because she really returned to herself. Her hallucinations reduced, and she better understood what was real and what was imaginary."Shortly after Nuplazid's release, however, patients' family members, doctors and other health care professionals started reporting "adverse events" possibly linked to the medication -- including deaths, life-threatening incidents, falls, insomnia, nausea and fatigue.During the first 10 months Nuplazid was on the market, 244 deaths were reported to the FDA in which Nuplazid was a "suspect" medication, according to an analysis conducted by the Institute for Safe Medication Practices. FDA data now show that the number of reported deaths has risen to more than 700. In more than 1,000 reports, patients continued to experience hallucinations while on Nuplazid.After CNN published its investigation on Nuplazid, reporters were contacted by family members who said the drug helped tame hallucinations with few apparent side effects and others who said they believe Nuplazid contributed to their family member's decline or death. Some said they had not yet reported these experiences to the drugmaker or the FDA.While the FDA has long been criticized for being too slow to approve drugs, DeLauro seized on its push to streamline the process, lambasting the agency for putting industry interests and efficiency above public health and safety.DeLauro described the number of adverse events and deaths as "staggering" and "unprecedented." She also expressed concern that the drugmaker, Acadia Pharmaceuticals, is attempting to get the drug approved for a larger population: patients who suffer from dementia-related psychosis."I don't know why it should stay on the market, especially when the FDA has not determined it to be safe and while the number of adverse events continues to soar," she told Gottlieb.In response to the congresswoman's remarks, Acadia told CNN that adverse event data alone are "not a comprehensive and accurate indicator of the safety profile of any drug." In response to CNN's earlier report on the drug, Acadia said there are a number of reasons for the higher volume of death reports, including the fact that the company distributes Nuplazid through a network of specialty pharmacies that puts the company in more frequent contact with both patients and caregivers -- meaning Acadia is more likely to receive reports of death, which it is required to pass along to the FDA.Commissioner Gottlieb told the committee that the FDA is careful about the decisions it makes and that there may be a higher tolerance for risk in situations where there is an unmet medical need, "so long as the patient is properly informed of what those risks are." This echoed what he told CNN's Dr. Sanjay Gupta in an interview earlier this month.The FDA previously told CNN that it was aware of Nuplazid's "complex safety profile" at the time of approval and required the drugmaker to place warnings on its labeling. The agency also said that, though it was continuing to monitor available information about Nuplazid, it had "not identified a specific safety issue" not already reflected on the medication's label.DeLauro's office told CNN that it plans to follow up with the FDA about its inquiry into Nuplazid. 7224
The founder of Twitter says the platform will soon remove the ability to "like" tweets.According to the Telegraph, Jack Dorsey spoke at a Twitter event last week where he said the feature would be gone "soon."The intent of this move is to improve the quality of debate on the social network.Twitter responded to the Telegraph's report with the following. 367
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