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A cadre of former FDA commissioners under Republican and Democratic presidents say that President Donald Trump has undermined the credibility of the FDA.Robert Califf, Scott Gottlieb, Margaret Hamburg, Jane Henney, David Kessler, Mark McClellan and Andy von Eschenbach pinned a joint op-ed in the Washington Post on Tuesday.Among the group who signed the letter, Gottlieb was Trump’s longest service FDA commissioner, heading the agency for nearly two years until April 5, 2019.The former commissioners said Trump has inserted himself into the vaccine approval process.“But a safe and effective vaccine will not be enough; people will also have to choose to take it,” the former commissioners wrote. “This depends on widespread confidence that the vaccine approval was based on sound science and not politics. If the White House takes the unprecedented step of trying to tip the scales on how safety and benefits will be judged, the impact on public trust will render an effective vaccine much less so.”Last week, Trump said it’s possible he would overrule the FDA if the agency uses stricter guidelines to give an emergency use authorization for a coronavirus vaccine candidate.The group of former commissioners blasted Trump for his comments.“The implications of the recent shift are potentially dire,” they wrote. “When the FDA warns about a risk from contaminated food, will people heed it? When a new drug for cancer or heart disease is approved, will clinicians and families trust it to work? And most urgent for today: When the FDA approves a COVID-19 vaccine, will Americans accept it?”Trump has been at odds with many government public health experts on the timing of when a vaccine would be available to the public.There are several vaccines in Phase 3 testing. Even though a vaccine could be approved by year’s end, trials will be expected to continue for over a year to monitor for possible side effects.According to the FDA, a typical Phase 3 trial would take one to three years. 2000
A conservative website called “Keep and Bear” that offers up pro-Donald Trump and pro-Second Amendment merchandise is now taking orders for a “MAGA” building block set.The new toy encourages children to “Build the wall” with LEGO knock-off blocks.According to the website, the starter set comes with more than 100 pieces including a “President Trump in a MAGA hard hat.”Part of the toy's description reads “A mob of 10,000 Central American migrants is marching through Mexico and heading toward El Paso, Texas. Mexican border agents attempted to stop them at the Mexican border, but to no avail.”The set is selling for .95 and will begin shipping on November?23. 688
A day after General Motors announced plant closures and job cuts, President Donald Trump has taken to Twitter saying his administration is looking into cutting the automaker's subsidies.Trump tweeted the following Tuesday afternoon: 240
A high-profile actor recently came clean about a problem millions of Americans are struggling with right now.After 16 years of sobriety, Dax Shepard says he relapsed on a painkiller he was prescribed after a motorcycle accident and surgery. He says he's getting help to stay clean.“At the end of the day, there is still too much stigma out there when it comes to substance abuse disorders and the opioid epidemic,” said Dr. Anand Parekh, Chief Medical Adviser at the Bipartisan Policy Center. “This a public health challenge. We need to support our friends and families, so that they can get the treatment they need.”The Bipartisan Policy Center recently came out with an in-depth look at the billions in federal money going to fight the opioid epidemic. While the amount being spent on prevention, treatment and recovery is increasing, sadly, so are the numbers of drug overdose deaths. The group believes that's in part due to opioid misuse evolving.Synthetic opioids like fentanyl are driving more deaths. More people are using multiple substances. Usage rates among communities of color are increasing.While federal dollars are flowing to areas experiencing the highest numbers of overdose deaths, there's concern it may not be reaching the highest risk groups.“We still don’t have the majority of Americans who have opioid use disorder on the gold standard medication assisted treatment, so that’s really important,” said Parekh.Those who are incarcerated, pregnant women, new moms, IV drug users, and communities of color are some of the highest risk groups.The center believes curbing America’s growing opioid epidemic will require a national addiction treatment system.Their report makes several recommendations, including allowing opioid crisis funding to address multiple substances like cocaine and methamphetamine, putting grant money in to address treatment gaps in diverse communities, and expanding access in correctional settings.They also say we should keep regulatory changes made during the pandemic to give people easier access to medication, and we should remove certain special requirements, so more health care providers can prescribe and treat opioid addiction with medication. 2209
A custody battle has been raging over the large mammal. The question at hand: Where should a 7,000-pound elephant live?The legal issue pits an elephant sanctuary in Hohenwald, Tenn. against the woman who raised Tarra the elephant since she was a baby.The case went to trial just this week and ended with a hung jury, so the fate of Tarra -- perhaps the best known of the Sanctuary's elephants -- remains in limbo.Tarra is an Asian elephant. Many remember the story from a decade ago of Tarra and her loyal canine companion, Bella. She was the first elephant at the Sanctuary in Hohenwald, brought there by co-founder Carol Buckley in 1995.Years earlier, Buckley took ownership of Tarra from a businessman in California."It was an instantaneous attraction to each other. She needed a mother. She was a baby, and I was happy to fill that role," Buckley said.This led to Buckley starting the sanctuary, but after several years, Buckley was ousted. She left Tarra there knowing it was the best place for her at the time.Now, Buckley operates a new sanctuary in Georgia. She said she never surrendered Tarra, has worried about her welfare in Hohenwald, and is suing to get her back."The lawsuit is very simple. It says I own Tarra," said Buckley.Legal expert Jim Todd said this is the first-of-its-type case in Tennessee.Todd said there's the custody issue, but he added there's also the question of whether Buckley abandoned Tarra.She said no and added her concern has always been what's best for the elephant."I'm going to put her wherever it is best. If Georgia is better for her, I would move her to Georgia," Buckley said. "If Tennessee is better, I would leave her in Tennessee."The two-day trial this week in Lewis County ended with a hung jury. Ten jurors voted to return Tarra to Buckley with two others saying no. A retrial likely won't happen until 2019.Asian elephants typically have a lifespan of 48 years. Tarra is 44 years old.The Elephant Sanctuary issued the following statement saying in part, "We remain fully committed and exist to provide home, herd and individualized lifetime care to all residents of the Sanctuary, as we have done for the past 23 years." 2211