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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
Specialist Nicholas Panipinto, 20, died last week when the Bradley Fighting vehicle he was in overturned. Panipinto was from Bradenton, Florida, and joined the Army in January of 2018.His family gathered as the plane arrived with his casket.Strangers inside the plane waited as strangers inside the airport watched.The procession started at the airport and continued to Manatee County. Hundreds lined the streets, waving American flags.Kieth Stonestreet says he grew up with Panipinto's father. They attended the same high school."Freedom is not free. We're able to live the way we do because of the American soldier, not all of them make it back alive," Stonestreet said. "I know the family just from growing up around here. Nick's father was actually my mentor in high school. A great family from what I remember."Anthony Panipinto, Nick's father, said he his son loved to laugh, fish and hunt."I never imagined any of this. He was supposed to be safe on a base, training on a base," Panipinto said.The burial will be held on Wednesday, Nov. 20, at 2 p.m. at Sarasota National Cemetery.This story was originally published by Julie Salomone on 1145
t, an expedited process put in place in 2014. Certain ingredients can be marketed without going through the new drug application process because they are generally considered to be safe.Keep using sunscreen, experts adviseThe proposed regulation would allow for some ingredients and formulations to continue to be marketed without new drug approvals, including zinc oxide, titanium oxide and sunscreens sold as sprays, oils, lotions, creams, gels, butters, pastes, ointment and sticks.Two ingredients -- PABA and trolamine salicylate -- would not be on the 557
Starting Oct. 1, 2020, Californians will be required to have a REAL ID-complaint license or identification card, or passport, to fly within the U.S. 148
The activists told WCCO that any thought of removing the chief without community input would cause further protest. Fletcher pointed to tensions between the city and police union, amid calls for the city’s police union head to step down. The Minnesota AFL-CIO issued calls earlier this week calling for Bob Kroll, the Minneapolis Police Union President to step down after he sent a letter to his members calling Floyd a 420