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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

So instead, they spent the majority of their vacation in the cruise ship’s infirmary. But all those days under medical care on board the Norwegian Sun racked up a hefty bill.“It was ,200, close to ,000,” said Nicole.A bill Nicole says had to be paid before they got off the ship. That’s when people from all over the country got word of their stress and rallied together, raising thousands of dollars for the Mejias family. “We paid ,000. We don’t have full access to the Facebook funds yet,” said Nicole.Nicole says Norwegian Cruise Line did let them off the ship this morning, on the condition the Mejias family pays the bill in full within 10 days.As far as Roman’s condition, an Orlando hospital is monitoring him with hopes the infection didn’t travel to his brain.“He’s a little more alert, he’s playing with his toys, he’s still sleeping a lot more than normal,” said Nicole.We reached out to Norwegian Cruise Line for comment and haven’t heard back. 965

Shortly after 11 p.m. Wednesday, a couple driving on eastbound I-8 saw a fire burning off the freeway near Chimney Rock Lane and got out to try to douse the flames. The couple used water bottles, soda and a couch cushion to stomp out the blaze before a fire crew arrived at the scene. 284

SPRING VALLEY, Calif. (KGTV) - A man allegedly involved in a road rage incident was taken into custody early Monday morning following a standoff in a Spring Valley neighborhood. 177

Since 2014, there have been 15 vehicular attacks in the West by jihadist terrorists, killing 142 people, according to a count by New America, a nonpartisan research institution. Those figures include Tuesday's attack in Manhattan. 230