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Supporters of right-to-try argue that the legislation is needed because most terminal patients are too sick to be selected to participate in clinical trials and it takes too long for promising treatments to be approved.Joffe argued that the right-to-try approach to providing access to unapproved drugs early in their development could put patients in harm's way, as patients receiving the drug are often in very fragile health, doctors often lack the information needed to administer the drugs safely, and little may be known about their risks and benefits, he said.Joffe pointed to certain stem cell therapies as treatment approaches that appear promising but have turned dangerous when unregulated."Another thing I'm worried about is that there's going to be a bunch of shady actors that are going to pop up that are going to start to try to take advantage of the right-to-try law to say 'we can provide these sort of experimental therapies, if you want to call them that, to patients without needing to go through the FDA,'" Joffe said."We've already seen some of that in the stem cell clinics popping up around the country that try to provide stem cell treatments for a host of problems: eye problems, heart problems," he said. "While there are legitimate efforts to develop effective stem cell therapies, a lot of these clinics that are popping up around the country that are poorly regulated are taking people's money and they are hurting people."On the other hand, the treatments available under right-to-try laws are already in clinical trials, Coleman said, adding that "this law isn't replacing the existing FDA expanded access program; it's just opening up another avenue.""No person is going to be forced to take an investigational drug. No doctor is going to be forced to request an investigational drug, and no drug company is forced to provide an investigational drug, if they don't think it's the right fit for a patient," she said."It's only for people who say, 'I understand the risk. I know this drug is not fully approved. It may not help me, but my doctor and the drug company think it could, and I want to try,'" she said. "Basically, if the FDA says that a drug is safe enough to be used in trials on humans, then it's safe enough for a dying person to make their own choice about whether or not they would like to try it when they can't get into a clinical trial." 2395
Southbound I-805 at E St. in Chula Vista (2:45 a.m.): A car spun out on the rain-slicked road and slammed into a guardrail. The driver suffered what was described as minor injuries. 181
Student Leslie Ortiz said she feels sorry for the teen who drove the car, knowing he will carry this with him for the rest of his life. 135
submitted his resignation to the White House on Friday, a source tells CNN.A source familiar with McAleenan's thinking tells CNN that the acting secretary felt he had accomplished all he could given the political realities of today -- specifically the unlikelihood that any legislative deal on immigration will happen in an election year. Moreover, with the numbers of undocumented immigrants apprehended or turned away at the border coming down for the fourth consecutive month -- 52,546 in September, a 65% drop from May -- the lack of crisis is dissuading members of Congress to act and compromise. McAleenan also has two young daughters and a wife with whom he wants to spend more time.The announcement has been planned for weeks, sources close to McAleenan say, and has nothing to do with the Ukraine scandal in which Trump and several other Cabinet officials are currently enmeshed.A source close to the process told CNN that White House officials tried to talk McAleenan out of resigning.Sources close to McAleenan insist the decision has more to do with his feeling of having done all that he can do on the job as well as feeling the frustrations of someone who perceives his job to be non-partisan and does it from the perspective of a law enforcement officer.McAleenan has also been in the position of working for a President who -- critics say --seems to see immigration in starkly political and often racist terms.The President appointing hardliners to leadership positions in his department hasn't made his job any easier.In an interview with The Washington Post published on October 1, McAleenan -- whom Trump never formally nominated for the Cabinet position -- said that while he controls his department, "What I don't have control over is the tone, the message, the public face and approach of the department in an increasingly polarized time. That's uncomfortable, as the accountable, senior figure."Other acting figures in the department whose tone and tenor are more Trump-like -- acting commissioner of US Customs and Border Protection Mark Morgan and acting director of US Citizenship and Immigration Services Ken Cuccinelli -- have caused him difficulties, sources tell CNN, both by seemingly openly campaigning to replace him and by pushing rules that have seemed harsh to many in the public.McAleenan found himself needing to respond to some of Cuccinelli's actions, such as ending consideration for most deportation deferrals for undocumented immigrants with serious medical conditions and ending automatic citizenship for children born abroad to certain US servicemembers and others.Still, the acting secretary has been able to point to concrete accomplishments. Border apprehensions have declined significantly, numbers that included Central Americans and families crossing the border, representing the heart of the crisis. A source familiar with McAleenan's thinking says that he is proud of working with the governments of Mexico and the three Central American "Northern Triangle" countries -- El Salvador, Guatemala and Honduras -- to crack down on human smugglers and block caravans heading north."It felt like the layers are now in place to prevent a similar surge sparking this Fall," the source said.A former DHS official said McAleenan understood the urgency of the situation."Starting with security partnerships first, McAleenan built a foundation of trust with the Northern Triangle countries that resulted in new bilateral agreements based on a shared commitment to confront irregular migration and eventually restore aid," the former official said. "The President's threat of tariffs on Mexico provided McAleenan with more opportunity to engage with an historically intractable partner on border security, resulting in a precipitous decline in apprehensions along the southern border."McAleenan is also proud of having pushed DHS to declare unequivocally that white supremacists pose a growing threat to the American people, a statement the White House previously refused to make in as stark a way, the source close to the acting secretary said. "The El Paso shooting hit close to home," the source said, noting that six of those killed were family members of five agents and officers who work for the Department of Homeland Security. 4274
So perhaps it's an investment in himself? An elaborate marketing ploy? The move had Twitter users hypothesizing if it's a bold business move or just Jay-Z being Jay-Z: 167