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GLP-1 Meds Linked to 265 Reports to FDA of Suicidal Ideation: Reuters

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GLP-1 Meds Linked to 265 Reports to FDA of Suicidal Ideation: Reuters

The FDA says it is looking into reports related to semaglutide and liraglutide, branded for weight loss and diabetes.

Since 2010, the US Food and Drug Administration has received 265 reports of suicidal ideation in patients taking a glucagon-like peptide 1 (GLP-1) receptor agonist marketed for diabetes or weight loss, a Reuters analysis has found.

Moreover, Novo Nordisk, the manufacturer of semaglutide (Wegovy/Ozempic) and liraglutide (Saxenda/Victoza), was responsible for filing 180 of the reports to American regulators. Tirzepatide (Mounjaro), the GLP-1 receptor agonist sold by Eli Lily, also was named in the adverse event reports.

Demand for GLP-1 receptor agonists is soaring, particularly for weight loss, with cardiologists excited about the implications for cardiovascular health. Top-line results from the SELECT trial were released last month showing that semaglutide 2.4 mg reduces the risk of major adverse cardiovascular events in adults with overweight or obesity; full findings are due out at the upcoming American Heart Association 2023 Scientific Sessions in Philadelphia, PA.

According to Reuters journalists Robin Respaut and Chad Terhune, 36 of the documents filed with the FDA involved deaths due to suicide or suspected suicide. “In a statement to Reuters, the FDA said it is evaluating such reports and will decide on what action, if any, to take after a thorough review,” their news story notes.

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As reported by TCTMD, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) announced in July that it was investigating reports of suicidal thoughts or thoughts of self-harm after three patients taking liraglutide or semaglutide in Iceland reported thinking about suicide or self-injury. Regulators in Canada and the UK are also reviewing the drugs for suicidal ideation, the Reuters article notes.

For their story, Respaut and Terhune filed public records requests to obtain 113 more-detailed descriptions for individual incidents within the 265 database reports. These indicate that suicidal thoughts typically surfaced around the time patients started on the agents, or increased their dosage, as noted in more than half of the “narrative summaries.” One-fifth of these 113 more-detailed summaries—91 of which were filed by Novo Nordisk—mentioned that the suicidal thinking disappeared when patients stopped taking the agent or lowered their dose.

The Reuters story notes that the possibility of suicidal thinking is specifically mentioned in the labelling for the weight-loss drugs Wegovy and Saxenda, but not on the label for Ozempic, which is the brand name of the formulation indicated for diabetes.

Statements from both Novo Nordisk and Eli Lilly cited in the article emphasize that the companies take all reports of adverse events very seriously. 

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What to know about the Secret Service's Counter Sniper Team

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What to know about the Secret Service's Counter Sniper Team

WASHINGTON (AP) — A U.S. Secret Service sniper killed the would-be assassin of former President Donald Trump in a split-second decision, taking out the man perched on an adjacent rooftop.

Secret Service Director Kimberly Cheatle has publicly praised the sniper’s quick work on Saturday. But the Counter Sniper Team is now subject to a review by the Office of the Inspector General, which aims to determine how well the team is “prepared to respond to threats at events.”

The Secret Service was already subject to a more general probe from the Inspector General as well as congressional subpoenas regarding the shooting at the Trump campaign rally, in what has become the most intense scrutiny the agency has faced since President Ronald Reagan was shot in 1981.

Here’s what to know about the agency’s elite sniper group.

Sniper team is ‘very elite and difficult to get into’

The Counter Sniper Team was established in 1971. It provides intelligence and observations of potential threats from far away in an effort to protect U.S. presidents, vice presidents, first ladies and others, according to a 2020 report by the Government Accountability Office on federal tactical teams.

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Those who join the team have already worked for the Secret Service for at least two years, according to the agency’s website. They must undergo 11 weeks of counter sniper selection and basic training, along with a color vision test. Counter snipers must have excellent eyesight and hearing.

“It’s very sought after, it’s very elite and difficult to get into,” Pete Piraino, who spent 23 years with the Secret Service, including five years in the presidential protective division, told The Associated Press on Thursday.

They typically work in pairs

The counter snipers are on the look out for threats from far away, even beyond the established security perimeter, said Piraino, who is now vice provost for academics and a criminal justice professor at Tiffin University in Ohio. They often work outdoors, focusing on rooftops and the windows of surrounding buildings.

They typically work in teams of two — one serves as a spotter while the other trains their rifle’s sight on the same area.

“They’re trained to scan an area, remember what they see and come back to scan it again and see if there’s any change,” Piraino said. “It’s not just a matter of picking up their binoculars and looking around. They are trained very thoroughly and specifically with rangefinders and their equipment.”

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If they don’t qualify, they don’t work

The counter snipers, code named “Hercules,” can respond to a threat from a distance with their .300 Winchester Magnum rifles, according to Ronald Kessler’s 2009 book, “In the President’s Secret Service.” And they have to prove they can do so on a monthly basis.

What to know about the 2024 Election

“Counter-Snipers are required to qualify shooting out to a thousand yards each month,” Kessler wrote. “If they don’t qualify, they don’t travel or work.”

The snipers shoot with a rifle called a JAR, said Paul Eckloff, a retired Secret Service agent who served on details protecting three different presidents during his 23-year career.

“You’ve never heard of it because the Secret Service makes them,” Eckloff said.

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It stands for “just another rifle” and they’re built specifically for each counter sniper by the Secret Service’s armorer to take into account things like the length of the shooter’s arms, wrists and trigger finger.

Eckloff wouldn’t disclose how many counter sniper teams there are but noted that it’s a finite resource and they could always use more.

What happened?

Police learned of a suspicious character outside the fairgrounds in Butler, Pennsylvania, before Trump took the stage. Minutes into his speech, shots were fired.

A counter sniper shot and killed Thomas Matthew Crooks in the seconds after he opened fire from a rooftop some 150 yards (135 meters) from the stage. Secret Service agents threw themselves on top of the former president before hustling him off stage.

Stephen Colo, who retired from the Secret Service in 2003 as an assistant director, told The AP on Sunday that presidential candidates and former presidents don’t typically get the same level of protection as the sitting president.

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Colo said he was surprised that the agency had staffed the event with a counter sniper team because there are not many of those highly trained operatives and they are usually reserved for the president.

Kessler told the AP that the Counter Sniper Team should not be the focus of all of the scrutiny and investigations. He said the Secret Service members working closer to Trump should have called off the speech and moved him to safety as soon as they heard reports of a suspicious person in the crowd and then on a nearby rooftop.

“They should have just evacuated as soon as there was any hint of danger,” Kessler said.

Trump was not seriously injured and two days later he arrived in Milwaukee, with his right ear bandaged, to the adulation of his supporters at the Republican National Convention.

The shooting had more serious ramifications for others at the rally. Former fire chief Corey Comperatore was shot and killed and two other people were wounded.

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Cheatle, the Secret Service director, told ABC News on Tuesday that the sniper who shot Crooks made a “split-second decision.”

“They have the ability to make that decision on their own. If they see that it’s a threat and they did that in that instance,” she said.

“And I applaud the fact that they made that decision and didn’t have to check with anybody and thankfully neutralized the threat.”

___

Finley reported from Norfolk, Virginia.

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South Korea's top court issues landmark ruling recognizing some rights for same-sex couples

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South Korea's top court issues landmark ruling recognizing some rights for same-sex couples
  • South Korea’s Supreme Court ruled that the state health insurance agency’s refusal to provide spousal insurance coverage for gay couples violated the constitutional principle of equality in a landmark verdict.
  • The legal battle began when a gay couple, So Seong-wook and Kim Yong-min, sued the state insurance agency after it revoked So’s registration as a dependent of Kim.
  • Critics say South Korea still has a long way to go compared with other developed countries. South Korea does not legally recognize same-sex marriages.

South Korea’s top court ruled Thursday that same-sex couples are eligible to receive the same health insurance benefits as heterosexual couples, a landmark verdict hailed by human rights groups.

The Supreme Court said it ruled that the state health insurance agency’s refusal to provide spousal insurance coverage for gay couples was an act of discrimination that violates the constitutional principle of equality.

Thursday’s ruling is final and cannot be appealed.

FORMER CIA ANALYST CHARGED FOR ACTING AS SECRET AGENT FOR SOUTH KOREAN INTEL IN EXCHANGE FOR GIFTS

“Today’s ruling is a historic victory for equality and human rights in South Korea,” Amnesty International said in a statement. “The court has taken a significant step towards dismantling systemic discrimination and ensuring inclusivity for all.”

A legal battle between a gay couple, So Seong-wook and Kim Yong-min, and the National Health Insurance Service began after the insurance agency revoked So’s registration as a dependent of Kim, prompting So to file an administrative suit.

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Gay couple So Seong-wook, left, and Kim Yong Min, right, leave the Supreme Court building in Seoul, South Korea, on July 18, 2024. (Suh Dae-yeon/Yonhap via AP)

In 2022, the Seoul Administrative Court ruled in favor of the insurance agency. But in February 2023, the Seoul High Court overturned the earlier verdict, saying that denying So’s spousal coverage rights without reasonable grounds was discriminatory because such benefits are given to heterosexual spouses.

Public views on gender issues in South Korea have gradually changed in recent years, but critics say the Asian country still has a long way to go compared with other developed countries. South Korea doesn’t legally recognize same-sex marriages.

“While this decision is a major milestone, the case itself is a sobering reminder of the lengthy judicial processes that same-sex couples must endure to secure basic rights that should be universally guaranteed,” Amnesty International said.

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So and Kim welcomed the ruling.

“When I listened to the verdict, I was so moved that I couldn’t hold back my tears,” So told reporters outside the court. He said he hopes the ruling will lead to South Korea legally accepting same-sex marriages.

Kim said he is “very happy” because he thinks the court recognized his love for So.

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Trump to take RNC stage for first speech since assassination attempt

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Trump to take RNC stage for first speech since assassination attempt

Former United States President Donald Trump is set to take the stage at the Republican National Convention (RNC), where he will deliver a speech as the party’s standard bearer just five days after surviving an assassination attempt.

The address on Thursday night will cap a convention that has largely been a reminder of how Trump’s brand of populist, pugilistic politics has transformed the Republican Party.

But surrogates have said Trump will embrace a more unifying message in the wake of Saturday’s attack, in which he was grazed in the ear by a gunman’s bullet.

Trump has said he rewrote his speech after surviving the incident at a Pennsylvania campaign rally. His family and close allies have maintained the president has been profoundly changed as Trump and his supporters at the RNC have repeatedly referred to the near-miss as an act of God.

“I think you may see a bit of a different version of Donald Trump tonight, perhaps a bit softer version than maybe some of the people at home have seen in the past,” Republican National Committee co-chair and Trump’s daughter-in-law Lara Trump told CBS News on Thursday.

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“I don’t think you can go through what he went through on Saturday, really a near-death experience, and not come out on the other side impacted,” she said.

Donald Trump Jr echoed the sentiment.

“He’s going to be tough when he has to be. We’ve seen that. He’s never gonna change,” the former president’s eldest son said at an event for the Axios news site. “But I think there will be something. I think these are momentous occasions that change people permanently.”

Political observers have questioned what a more unifying message from Trump will actually look like and to whom it will apply.

While Trump told the Washington Examiner this week that the attack is a “chance to bring the whole country, even the whole world, together”, he and his supporters have also mixed their message with one of defiance.

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Trump’s recently announced running mate, Senator JD Vance, said shortly after the shooting that the rhetoric from President Joe Biden’s campaign had led to the assassination attempt although he has since veered away from the claim.

Attendees at the RNC have seized on Trump’s yelled appeal in the moment after the attack with “fight, fight, fight” becoming a rallying cry. Wearing a bandage over an ear like Trump has become a symbol of solidarity.

In a continuation of the theme, Trump will also be introduced by Ultimate Fighting Championship President and CEO Dana White and former professional wrestler Hulk Hogan on Thursday.

Reporting from the convention in Milwaukee, Wisconsin, Al Jazeera’s Patty Culhane said the party’s platform, which has been heavily influenced by Trump, has yet to reflect the promised change in tone.

“He is expected to say he’s going to unify the country, but the platform – what the party says they’re going to run on – is deeply divisive,” she said.

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It includes promises to expel millions of undocumented immigrants, reinstate travel bans on some Muslim majority countries, close the federal Department of Education and cut funding to schools depending on how they teach about race and gender.

The party’s platform also pledges to “hold accountable those who have misused the power of government to unjustly prosecute their political opponents”, which appears to be a reference to Trump’s conviction in a New York court in May on charges related to hush money payments made to an adult film star as well his two other criminal trials related to efforts to overturn the results of the 2020 presidential election, which Trump lost to Biden.

Democrats divided

Thursday’s speech comes after a string of political victories for Trump in recent weeks.

On Monday, a judge in Florida threw out a federal case related to his hiding and hoarding of classified documents after he left the White House. That came after the Supreme Court ruled that US presidents enjoy broader immunity from prosecution than previously defined.

Democrats have also become increasingly divided over the viability of Biden’s candidacy after a weak debate performance last month.

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On Thursday, US media reported that several top Democrats, including former President Barack Obama and former Speaker of the House of Representatives Nancy Pelosi, have put pressure on Biden to reconsider his run.

That news came just hours after the White House announced Biden had tested positive for COVID-19 while campaigning in Las Vegas on Wednesday.

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