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SAN DIEGO (KGTV) - Surveillance pictures were released Tuesday of a woman who San Diego Police believe struck a parked car and critically injured her passenger in Lincoln Park.The crash happened just before 5 a.m. on the 500 block of South 47th St.A woman driving a gray 2010 Mazda 3 moved to the right side of the road and struck an unoccupied, parked SUV, police said.The crash caused a 79-year-old man who was in the back seat of the Mazda to be thrown forward, striking the front passenger’s seat. The man was not wearing a seatbelt. Police said he is not expected to survive significant head and neck injuries.A 39-year-old man who was sitting in the back seat of the Mazda suffered minor injuries.Police said the female driver walked away from the scene before officers arrived. She is described as African-American and in her 50s. She was wearing a long-sleeve purple shirt, gray ripped jeans, black socks, and no shoes.Anyone with information is asked to call San Diego Police or Crime Stoppers at (888) 580-8477. 1034
SAN DIEGO (KGTV) — The Food and Drug Administration has released new guidelines to vaccine makers with added safety measures that experts say will push back the timeline, making the release of a COVID-19 vaccine before the election highly unlikely.The guidelines lay out what it will take for companies to secure a fast-tracked authorization for a vaccine, known as an emergency use authorization or EUA.The new guidelines require vaccine makers to follow the volunteers in their clinical trials for a median of two months after their final dose.It’s an important step to see if anyone has a bad reaction, says Dr. Christian Ramers of Family Health Centers of San Diego.“Some of the safety issues that people like me are concerned about might take months actually to develop,” Dr. Ramers said. “My analysis of this is that it's the FDA standing up and saying, ‘We're going to adhere to our rigorous scientific process.’”The White House had resisted the new guidelines from the FDA for more than two weeks. After their release, President Trump described them as a “political hit job.”“New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” the president wrote on Twitter Tuesday night.It’s hard to gauge exactly how the two-month buffer affect the vaccine timeline because clinical trials do not start all at once; volunteers are enrolled on a rolling basis. But Dr. Sydney Wolfe of the consumer group Public Citizen said the drug makers have offered clues.“The companies one-by-one are saying, ‘We can’t get anything in until the end of November or the end of December or the beginning of January,’ and that’s a relief,” he said.In a clinical trial, half of the volunteers get the vaccine and half get a fake drug called a placebo.The updated guidelines require companies to have an estimated effectiveness of at least 50 percent, meaning there are 50 percent fewer cases of infection in the group receiving the vaccine compared to the placebo group.The guidelines also instruct companies to have a plan to continue collecting data in their clinical trial even after they get an EUA and the vaccine hits the market.“The worst thing that could happen here is something meets that minimum bar of 50% efficacy, meaning it works pretty well, but then the bottom just falls out from these clinical trials and we don't get the information we need,” he said.Dr. Ramers was initially skeptical of fast-tracking a vaccine with an EUA rather than waiting for full approval since it’s only been done once before, but he’s supportive of the process under the updated guidelines.“I think that's the best way to balance speed and safety,” he said.Still, experts like Dr. Wolfe think going with an EUA over a full approval could backfire. He points out the new guidelines allow up to half of the people in the clinical trial to be tracked for less than two months after their final dose.“All things aren’t equal [between an EUA and full approval] because you don’t have all the information and B, people know that,” he said.Dr. Wolfe is concerned the public will be reluctant to roll up their sleeves and embrace the vaccine if it just has an emergency authorization. Now that the FDA has made the EUA guidelines more rigorous, he thinks waiting for full approval might take just a few more months.The FDA’s new guidance notes that an Oct. 22 meeting of its Vaccines and Related Biological Products Advisory Committee will not be to discuss specific vaccine candidates.Trump previously said he would consider overruling the FDA on its vaccine guidelines in hopes of speeding up the process. There is both health and economic pressure for a vaccine to be developed as the coronavirus continues to claim an average of 800 US lives a day, according to Johns Hopkins University data.However, Dr. Wolfe said the possibility of the president overruling the FDA is unlikely to have an impact now because the vaccine developers themselves have indicated they will follow the FDA guidelines.Additional reporting by Justin Boggs 4090
SAN DIEGO (KGTV) - The Food and Drug Administration is responding Friday to a Team 10 investigation launched after San Diego women complained about Monat Global hair care.Dana Sohovich talked exclusively with 10News, saying the company’s hair products caused severe hair loss and bald spots. Sohovich has filed a class action lawsuit against the company, alleging it falsely promised her “longer, fuller, stronger” hair. Her suit accuses Monat of “false and deceptive advertising”.Other women have shared pictures of scalp sores, breakage and clumps of fallen strands.RELATED: San Diego woman sues trendy hair care companyMultiple women say they went to their doctors, and there was nothing pointing to a reason, other than product use. Many consumers who complained were told it was normal and part of a detox process that was documented in the company’s own sales literature. “We no longer do that. We don’t do it,” said Monat Spokesperson Gene Grabowski during a taped phone interview.Grabowski said all the complaints don’t add up. “To have this happen in such a short period of time, statistically is impossible,” he added.At the time of Team 10's original report, about 200 adverse event reports were filed with the FDA.The FDA issued a new statement: 1265
SAN DIEGO (KGTV) -- The Del Mar Fairgrounds get transformed into a small, mobile city during the traveling performance of Cirque du Soleil as the focus shifts to feeding hundreds of artists, technicians and staff. Each Cirque du Soleil audience is transported to another world watching art unfold on the stage, but behind the scenes is another form of art. “Culinary is one of those few fields left in the world where you can be artistic, can be a form of expression every day.” Chef Scott Veneklase is one of Volta’s four chefs, creating eclectic menus featuring food from all corners of the world. “We try to do a bit of everything, German food, Japanese food, today Italian.” Because the performers come from 25 different countries, their meal is often the closest connection they’ll have to their home. Each day is a brand new menu. “Even if it’s just a little flavor from home for them it makes all the difference in the world.” “It’s so important to feed artists and to provide something they’ll like, that way they won’t feel so far from home.” Chef Veneklase and his team are responsible for feeding over 126 athletes and artists. each with unique dietary needs. “The artists are always going to be very, very clean, say we’re designing a menu have to be incredibly conscious about it.” “It’s basically opening and closing a restaurant every month, so it’s a huge challenge of creativity.” The kitchen staff is always first to arrive on sight and the last to leave.Then they do it all over again in 10 days in a new city. “We’re a close group. We all ran away and joined the circus.” It’s a fast paced lifestyle they live for. “We get to explore, we get to travel the world.” Creating new art in every stop. 1727
SAN DIEGO (KGTV) -- The mayor of Temecula has announced his resignation after facing raging criticism over an email stating he didn't “believe there’s ever been a good person of color killed by a police officer." James "Stew" Stewart's comments went viral June 2 and drew a firestorm of calls for his resignation and threats of protests. Stewart made the racist remark in a reply to a constituent "concerned about our police officers and their sensitivity training.""As you know the City of Temecula does not have its own Police Department," Stewart said in his email. "We contract with Riverside County Sheriff's Department.""And I don't believe there's ever been a good person of color killed by a police officer," said Stewart.Stewart posted a copy of the email on his own Facebook page explaining that he is dyslexic and uses voice text, and that he published the note without proofreading what was recorded."I may not be the best writer and I sometimes misspeak, but I am not racist. I deeply regret this mistake and I own it, entirely. I am truly sorry," Stewart said in his resignation letter posted on Facebook late Thursday night.Stewart's comments brought tension to the small tourist destination city during a time in which the nation is seeing daily demonstrations and protests against police killings and racism. A Change.Org petition has started circulating demanding that city officials acknowledge that "systemic racism and police brutality exist in Temecula and the need for reform and consequence."Temecula, a city of about 115,000 residents in Riverside County, is located about 85 miles north of San Diego. The area is a popular Southern California destination known for its dozens of wineries, hot air balloon rides, and festivals similar to Northern California's wine country.Stewart's biography remains published on the city's website. It says that Stewart moved to Temecula in 1991 with his wife and three children from Oswego, Illinois. According to his page, the businessman owns eight barbershops in the area and that he has worked as a dentist during mission trips to Haiti pulling teeth and conducting eye glass clinics in Ethiopia.The city has not released plans to fill his vacant seat. He was elected to a four-year term in 2016.Here is Stewart's resignation announcement:Temecula StewCity of Temecula, I hear you, I agree with you, and I am deeply sorry. I owe everyone an apology including our citizens of all backgrounds and ethnicities, City staff, and my respected colleagues on the City Council. You have every right to be hurt and offended. My typos and off-the-cuff response to an email on a serious topic added pain at a time where our community, and our country, is suffering. I may not be the best writer and I sometimes misspeak, but I am not racist. I deeply regret this mistake and I own it, entirely. I am truly sorry.I understand that even my sincerest apologies cannot remedy this situation. Because actions speak louder than words, I will step down as your Mayor and City Council Member effective immediately. It has been a true honor to serve this great City and its citizens. My love for Temecula and its residents is beyond expression.”Mayor Pro Tem Maryann Edwards states, “Stew is a hard-working and honest man, and the City accepts his resignation. Temecula is poised to close this chapter, and continue our long-term commitment to preventing racial injustice in any form. On this day of Mr. George Floyd’s memorial service, and on behalf of my council colleagues, the City of Temecula offers our prayers and heartfelt condolences to his family.” 3623