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Yahoo
25-04-2025
- Politics
- Yahoo
Massachusetts parents outraged after middle school gives explicit health survey to students despite opt-out
A Massachusetts school district is at the center of a battle over parental rights after it administered a health survey to middle school students in late March that asked children as young as 11 sexually explicit questions despite parents opting their child out. Burlington Public Schools (BPS) notified parents on March 6 via an app called ParentSquare about its plans to administer the 2025 Youth Risk Behavior Survey to students at Marshall Simonds Middle School. The survey, which is part of a national initiative developed by the Centers for Disease Control and Prevention, asked students sensitive questions about alcohol, drug use and gender identity. One question in the 2025 survey asked students if they've ever had sexual intercourse, describing the act in detail and providing the definitions of oral and anal sex. It also asked about the use of sex toys. The Supreme Court Appears To Side With Parents In Religious Liberty Dispute Over Storybooks Fox News Digital spoke with three parents whose children took the controversial survey, two of whom opted their child out and have since filed federal complaints with the U.S. Department of Education with the help of the Massachusetts Liberty Legal Center (MLLC), an organization that defends free speech, religious liberty and parental rights. Read On The Fox News App "I felt absolutely sick to think that they were asking such explicit questions to children," said Adrianne Simeone, a Burlington mother who opted her 13-year-old son out of the survey. "I've talked to my kids about sex. My children know about sexual reproduction, but I have not talked to them about anal sex or oral sex or sex toys. I don't think those were appropriate for minors of any age, let alone children as young as 11." MLLC alleges that BPS violated the Protection of Pupil Rights Amendment (PPRA), which stipulates that K-12 schools that receive federal funding must notify parents and allow them to opt their children out of surveys involving sensitive topics. "In not opting out students who had been opted out by their parents, [they] actually violated federal law," said Sam Whiting, legal counsel for MLLC. "We're very hopeful that the Department of Education, especially under the Trump administration, will follow through and enforce that law against the district." Some students who had been opted out of the survey by their parents were still forced to take it, despite protesting, because their names were not on the opt-out list. Teachers did not inform students that the survey was voluntary, according to a demand letter sent to members of the BPS School Committee by MLLC. David Hanafin told Fox News Digital he's furious with the school district after his 11-year-old son was also forced to take the survey despite being opted out. "We don't send our kids to school to be indoctrinated. We don't send our kids to school to have these discussions. You don't need to open their mind. You need to teach them to read, to write, math, accurate history, accurate science, and you send them home, and we'll take care of the rest," he said. Hanafin, who has six children in the school district between elementary, middle and high school, said he had an agreement with Superintendent Eric Conti and Assistant Superintendent Laura Chen about opting his children out of all surveys that touch on sensitive topics. "My daughter's 11 years old. She still writes her list to Santa Claus every year and she can't wait for Santa Claus to come and bring her presents. And then they're asking her questions about anal sex and about sex toys and that — how anybody in their right mind could say this is in any way shape or form appropriate, or what information they're trying to glean from it, makes no sense," he told Fox News Digital. Group Of Dei Workers Sue To Stop Trump Executive Orders The Youth Risk Behavior Survey has been used nationwide since 1991 to monitor health behavior changes over time and to collect data to guide policies on issues like teen substance abuse, suicide and sexual health. The 2023 version had questions about alcohol and prescription drug use, as well as questions about gender identity, but the definition of sexual intercourse was changed in 2025 to be more inclusive of the LGBTQ+ community, according to JSI, the healthcare research and consulting organization that created the survey. Simeone and Hanafin have both signed onto federal complaints filed with the Education Department. They also spoke out against the survey alongside more than a dozen other parents at a school committee meeting on April 1. A third parent who spoke with Fox News Digital but requested anonymity out of fear of backlash said she hasn't signed onto the federal complaint but plans to do so. She missed the notification in ParentSquare about the survey due to the large number of messages the school sends in a day, so her daughter took it. She said she felt "sick" after seeing the questions. Superintendent Conti apologized at the April 1 meeting for the opt-out policy not being honored, saying it was a "mistake." He claimed that some of the definitions in the survey were changed and added without BPS' consent after their Wellness Committee had reviewed them. Conti also stated that he was informed by Marshall Simonds Middle School Principal Tim McMahon that only four opt-out policies were not honored, a claim disputed by other parents and MLLC. School Committee Member Christine Monaco told parents that she found some of the survey definitions "awful," "inappropriate" and "disgusting." "Some students knew their parents' wishes and advocated for themselves, only to be ignored, which is totally unacceptable. This cannot happen again. We as a committee need to revisit our policies and explore greater protections for our students and their families regarding student surveys and parental consent," said another member. The school committee voted unanimously on April 8 to suspend all student surveys until a new policy is adopted and to remove all funding for JSI from the upcoming budget. BPS announced additional steps it was taking in the wake of the survey fallout, including hiring an independent consultant to review the administration of the 2025 survey. "We remain committed to transparency, accountability, and the well-being of all students, and we value our continued collaboration with families and the broader community," read an announcement on the district's website. One parent at the April 8 meeting made it clear that she didn't have a problem with the survey questions, nor did she find them "disgusting," only a little "surprising." "I believe in the positive information the survey provides," she said, arguing for more representation of all groups of people. Hanafin and Simeone told Fox News Digital the school district has a history of disrespecting parental rights and pushing inappropriate content on students, and they want someone to be held accountable. "I'm really exhausted by the lack of respect for parents and our right to decide when and how we talk to kids about these things," said Simeone. She recalled her push for greater transparency from the school district regarding the Spectrum Club, a student organization that promotes LGBTQ+ rights. Simeone said the club was not listed publicly on the ParentSquare app and she had to fight to make it publicly listed and to require parental permission. "I think what's most important for parents to take home from this is that you need to be an advocate for your child. Don't wait for something to go wrong," she told Fox News Digital. "Take this lesson right here, this example, and bring it to your school system, your school committee, your superintendent, your principal, and say to them, 'I want to know exactly what's going on in our school system if you're participating in activities like this.'" Hanafin echoed similar sentiments about the power of parents' voices, arguing they shouldn't be afraid to speak up for their children. "People are so afraid to speak out against the orthodoxy, and they make that very, very clear. And so, the school is always pushing this one side of the gender, and parents are afraid to speak out against it because they're going to be labeled bigoted, they're going to be labeled homophobic, transphobic, whatever it is," he said. Superintendent Conti and Assistant Superintendent Chen did not immediately respond to requests for comment about the incident. Julie Hartman, a spokeswoman for the Department of Education, said the federal agency is committed to protecting parental rights: "Children do not belong to the government; they belong to parents. Parents should be the primary decision makers when it comes to their child's education. The Department will not tolerate abuse of parents' rights – or of students who are victims of predatory behavior by adults who are supposed to protect them."Original article source: Massachusetts parents outraged after middle school gives explicit health survey to students despite opt-out
Fox News
25-04-2025
- Politics
- Fox News
Massachusetts parents outraged after middle school gives explicit health survey to students despite opt-out
A Massachusetts school district is at the center of a battle over parental rights after it administered a health survey to middle school students in late March that asked children as young as 11 sexually explicit questions despite parents opting their child out. Burlington Public Schools (BPS) notified parents on March 6 via an app called ParentSquare about its plans to administer the 2025 Youth Risk Behavior Survey to students at Marshall Simonds Middle School. The survey, which is part of a national initiative developed by the Centers for Disease Control and Prevention, asked students sensitive questions about alcohol, drug use and gender identity. One question in the 2025 survey asked students if they've ever had sexual intercourse, describing the act in detail and providing the definitions of oral and anal sex. It also asked about the use of sex toys. Fox News Digital spoke with three parents whose children took the controversial survey, two of whom opted their child out and have since filed federal complaints with the U.S. Department of Education with the help of the Massachusetts Liberty Legal Center (MLLC), an organization that defends free speech, religious liberty and parental rights. "I felt absolutely sick to think that they were asking such explicit questions to children," said Adrianne Simeone, a Burlington mother who opted her 13-year-old son out of the survey. "I've talked to my kids about sex. My children know about sexual reproduction, but I have not talked to them about anal sex or oral sex or sex toys. I don't think those were appropriate for minors of any age, let alone children as young as 11." MLLC alleges that BPS violated the Protection of Pupil Rights Amendment (PPRA), which stipulates that K-12 schools that receive federal funding must notify parents and allow them to opt their children out of surveys involving sensitive topics. "In not opting out students who had been opted out by their parents, [they] actually violated federal law," said Sam Whiting, legal counsel for MLLC. "We're very hopeful that the Department of Education, especially under the Trump administration, will follow through and enforce that law against the district." Some students who had been opted out of the survey by their parents were still forced to take it, despite protesting, because their names were not on the opt-out list. Teachers did not inform students that the survey was voluntary, according to a demand letter sent to members of the BPS School Committee by MLLC. David Hanafin told Fox News Digital he's furious with the school district after his 11-year-old son was also forced to take the survey despite being opted out. "We don't send our kids to school to be indoctrinated. We don't send our kids to school to have these discussions. You don't need to open their mind. You need to teach them to read, to write, math, accurate history, accurate science, and you send them home, and we'll take care of the rest," he said. Hanafin, who has six children in the school district between elementary, middle and high school, said he had an agreement with Superintendent Eric Conti and Assistant Superintendent Laura Chen about opting his children out of all surveys that touch on sensitive topics. "My daughter's 11 years old. She still writes her list to Santa Claus every year and she can't wait for Santa Claus to come and bring her presents. And then they're asking her questions about anal sex and about sex toys and that — how anybody in their right mind could say this is in any way shape or form appropriate, or what information they're trying to glean from it, makes no sense," he told Fox News Digital. The Youth Risk Behavior Survey has been used nationwide since 1991 to monitor health behavior changes over time and to collect data to guide policies on issues like teen substance abuse, suicide and sexual health. The 2023 version had questions about alcohol and prescription drug use, as well as questions about gender identity, but the definition of sexual intercourse was changed in 2025 to be more inclusive of the LGBTQ+ community, according to JSI, the healthcare research and consulting organization that created the survey. Simeone and Hanafin have both signed onto federal complaints filed with the Education Department. They also spoke out against the survey alongside more than a dozen other parents at a school committee meeting on April 1. A third parent who spoke with Fox News Digital but requested anonymity out of fear of backlash said she hasn't signed onto the federal complaint but plans to do so. She missed the notification in ParentSquare about the survey due to the large number of messages the school sends in a day, so her daughter took it. She said she felt "sick" after seeing the questions. Superintendent Conti apologized at the April 1 meeting for the opt-out policy not being honored, saying it was a "mistake." He claimed that some of the definitions in the survey were changed and added without BPS' consent after their Wellness Committee had reviewed them. Conti also stated that he was informed by Marshall Simonds Middle School Principal Tim McMahon that only four opt-out policies were not honored, a claim disputed by other parents and MLLC. School Committee Member Christine Monaco told parents that she found some of the survey definitions "awful," "inappropriate" and "disgusting." "Some students knew their parents' wishes and advocated for themselves, only to be ignored, which is totally unacceptable. This cannot happen again. We as a committee need to revisit our policies and explore greater protections for our students and their families regarding student surveys and parental consent," said another member. The school committee voted unanimously on April 8 to suspend all student surveys until a new policy is adopted and to remove all funding for JSI from the upcoming budget. BPS announced additional steps it was taking in the wake of the survey fallout, including hiring an independent consultant to review the administration of the 2025 survey. "We remain committed to transparency, accountability, and the well-being of all students, and we value our continued collaboration with families and the broader community," read an announcement on the district's website. One parent at the April 8 meeting made it clear that she didn't have a problem with the survey questions, nor did she find them "disgusting," only a little "surprising." "I believe in the positive information the survey provides," she said, arguing for more representation of all groups of people. Hanafin and Simeone told Fox News Digital the school district has a history of disrespecting parental rights and pushing inappropriate content on students, and they want someone to be held accountable. "I'm really exhausted by the lack of respect for parents and our right to decide when and how we talk to kids about these things," said Simeone. She recalled her push for greater transparency from the school district regarding the Spectrum Club, a student organization that promotes LGBTQ+ rights. Simeone said the club was not listed publicly on the ParentSquare app and she had to fight to make it publicly listed and to require parental permission. "I think what's most important for parents to take home from this is that you need to be an advocate for your child. Don't wait for something to go wrong," she told Fox News Digital. "Take this lesson right here, this example, and bring it to your school system, your school committee, your superintendent, your principal, and say to them, 'I want to know exactly what's going on in our school system if you're participating in activities like this.'" Hanafin echoed similar sentiments about the power of parents' voices, arguing they shouldn't be afraid to speak up for their children. "People are so afraid to speak out against the orthodoxy, and they make that very, very clear. And so, the school is always pushing this one side of the gender, and parents are afraid to speak out against it because they're going to be labeled bigoted, they're going to be labeled homophobic, transphobic, whatever it is," he said. Superintendent Conti and Assistant Superintendent Chen did not immediately respond to requests for comment about the incident. Julie Hartman, a spokeswoman for the Department of Education, said the federal agency is committed to protecting parental rights: "Children do not belong to the government; they belong to parents. Parents should be the primary decision makers when it comes to their child's education. The Department will not tolerate abuse of parents' rights – or of students who are victims of predatory behavior by adults who are supposed to protect them."
Yahoo
10-02-2025
- Business
- Yahoo
Tempest Granted Fast Track Designation from the U.S. Food and Drug Administration for Amezalpat to Treat Patients with Hepatocellular Carcinoma
Fast Track Designation highlights potential of amezalpat to address unmet need for patients with HCC Amezalpat builds momentum with both Fast Track and Orphan Drug Designations BRISBANE, Calif., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist for the treatment of patients with hepatocellular carcinoma (HCC). 'We are thrilled to receive Fast Track designation from the FDA,' said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D of Tempest. 'This designation, following the Orphan Drug designation granted last month, reinforces the promise of amezalpat as a potential treatment option for patients affected by HCC. We look forward to working closely with the FDA and foreign regulatory agencies to develop amezalpat with the goal of bringing this promising therapy to patients.' This is the second regulatory designation granted to amezalpat. The company announced in January that the U.S. FDA granted amezalpat with Orphan Drug Designation (ODD) following positive data across multiple key study efficacy and safety endpoints in a global randomized Phase 1b/2 clinical study evaluating amezalpat plus standard-of-care atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in the first-line treatment of patients with unresectable or metastatic HCC. Notable positive outcomes of the randomized comparison include a six-month improvement in median overall survival (OS) with a hazard ratio (HR) of 0.65 for patients receiving the amezalpat combination therapy. In addition, a survival benefit from the addition of amezalpat was preserved in key sub-populations including PD-L1 negative disease, which is consistent with amezalpat's proposed mechanism of action to target both the tumor cells directly and the patient's immune system. About Hepatocellular Carcinoma HCC is an aggressive cancer with rising mortality and is projected to become the third leading cause of cancer death by Every year, more than 900,000 people worldwide are diagnosed with Incidence and mortality are highest in East Asia and are increasing in parts of Europe and the In the US, HCC represents the fastest-rising cause of cancer-related death. iii Nine out of ten cases of HCC are caused by chronic liver disease, which includes chronic hepatitis B and C infection, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), alcohol-related liver disease (ALD) and cirrhosis resulting from these conditions.v Even if diagnosed in the early stage, an estimated 70-80% of people with early-stage HCC experience disease recurrence following Early recurrence is associated with poorer prognosis and shorter survival. v,vii Tumor size, number of tumors, and portal vein invasion are associated with an increased risk of About Amezalpat Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist. Data suggests that amezalpat treats cancer by targeting tumor cells directly and by modulating immune suppressive cells and angiogenesis in the tumor microenvironment. In a global randomized phase 1b/2 study in first-line HCC patients, amezalpat in combination with atezolizumab and bevacizumab showed clinical superiority across multiple study endpoints, including overall survival in both the entire population and key subpopulations, when compared to patients receiving atezolizumab and bevacizumab alone, the standard of care. These randomized data were supported by additional positive results observed in the Phase 1 clinical trial in patients with heavily pretreated advanced solid tumors, including renal cell carcinoma and cholangiocarcinoma. About Fast Track Designation Fast Track designation is intended to help rapidly advance the development and review processes for promising therapeutic candidates for serious conditions that may fill an unmet medical need. Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process and may also be eligible for accelerated approval and priority review when relevant criteria are met. About Tempest Therapeutics Tempest Therapeutics is a clinical-stage biotechnology company advancing a diverse portfolio of small molecule product candidates containing tumor-targeted and/or immune-mediated mechanisms with the potential to treat a wide range of tumors. The company's novel programs range from early research to later-stage investigation in a randomized global study in first-line cancer patients. Tempest is headquartered in Brisbane, California. More information about Tempest can be found on the company's website at Forward-Looking Statements This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (the 'Securities Act')) concerning Tempest Therapeutics, Inc. These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Tempest Therapeutics, as well as assumptions made by, and information currently available to, management of Tempest Therapeutics. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as 'may,' 'will,' 'should,' 'would,' 'could', 'expect,' 'anticipate,' 'plan,' 'likely,' 'believe,' 'estimate,' 'project,' 'intend,' and other similar expressions. All statements that are not historical facts are forward-looking statements, including any statements regarding: the design, initiation, progress, timing, scope and results of clinical trials, including the anticipated Phase 3 study for amezalpat; anticipated therapeutic benefit and regulatory development of the Company's product candidates the Company's ability to advance into a late-stage clinical company; and the Company's ability to achieve its operational plans. Forward-looking statements are based on information available to Tempest Therapeutics as of the date hereof and are not guarantees of future performance. Any factors may cause differences between current expectations and actual results, including: unexpected safety or efficacy data observed during preclinical or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied are discussed in greater detail in the 'Risk Factors' section of the Company's Quarterly Report on Form 10-Q filed for the quarter ended September 30, 2024 and other documents filed by the Company from time to time with the Securities and Exchange Commission. Except as required by applicable law, Tempest Therapeutics undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Tempest Therapeutics' views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Tempest Therapeutics. Investor & Media Contacts: Sylvia WheelerWheelhouse Life Science Advisorsswheeler@ Aljanae Reynolds Wheelhouse Life Science Advisorsareynolds@ i If approved by the FDAii Rahib, L. et al. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 74, 2913-2921 (2014).iii World Health Organization. Liver Cancer Factsheet. Globocan. 2020. Available at: Last accessed: April Llovet, J. M., Kelley, R. K., Villanueva, A., et al. Hepatocellular carcinoma. Nature Reviews Disease Primers. 2021, 7(1), 6.v Office for Health Improvement & Disparities. Liver disease profiles: November 2021 update. Available at: Last accessed: April Hack SP, Spahn J, Chen M et al. IMbrave 050: a Phase III trial of atezolizumab plus bevacizumab in high-risk hepatocellular carcinoma after curative resection or ablation. Future Oncology. 2020 May;16(15): Saito A, Toyoda H, Kobayashi M et al. Prediction of early recurrence of hepatocellular carcinoma after resection using digital pathology images assessed by machine learning. Modern Pathology. 2021. 34, in to access your portfolio
