Member of RFK Jr's new vaccine panel withdraws over conflict of interest
A member of the health secretary Robert F Kennedy Jr's newly overhauled federal vaccine advisory panel withdrew after a conflict of interest review, a spokesperson has told the Guardian.
Dr Michael Ross, who was involved in multiple private healthcare companies, withdrew after review of his financial holdings.
Kennedy unilaterally fired all 17 members of the Centers for Disease Control and Prevention's (CDC) advisory committee on immunization practices (ACIP) in June, arguing they had too many conflicts of interest.
Related: Who are the eight new vaccine advisers appointed by Robert F Kennedy?
Ross was among eight of Kennedy's ideological allies appointed to the committee, after the secretary argued the old members of the committee were subject to too many conflicts of interest.
'Yesterday, Dr Michael Ross decided to withdraw from serving on ACIP during the financial holdings review,' a spokesperson for the Department of Health and Human Services (HHS) said.
'The sacrifice to serve on ACIP varies from member to member, and we appreciate Dr Ross's willingness to go through this rigorous process.'
The spokesperson made the comments after Guardian inquiries about conflict of interest disclosures for new members of ACIP. Although the Trump administration and Kennedy developed a conflict of interest tracker specifically for ACIP members, Kennedy's appointees have not been added.
The HHS spokesperson did not respond to Guardian inquiries about when and where new, written conflict of interest disclosures would be published.
Instead, the spokesperson said the department has, 'comprehensively reviewed all newly appointed ACIP members for conflicts of interests in accordance with federal law, regulations and departmental polices', and that the members were provided 'ethics training prior to discharging their duties'.
The new members of the committee were asked to disclose conflicts of interest before the meeting began on Wednesday. The committee chair Dr Martin Kulldorff and committee member Dr Robert Malone omitted widely reported work in vaccine litigation, and nurse Vicky Pebsworth said she was 'asked to read' a statement disclosed ownership of a healthcare stock but said it was below the government ethics office threshold for reporting.
Ethics review of the new members was also the subject of Senate testimony on Wednesday.
Under questioning by the Democratic senator Patty Murray of Washington, the Trump nominee to head the CDC, Dr Susan Monarez, said she was 'not familiar whether or not the members that are participating in the meeting this week have or have not gone through the ethics review necessary to allow them to participate in those meetings'.
'If it is known that they have not gone through the ethics process and they issue recommendations, would you accept them as valid?' asked Murray.
'If they have not gone through an ethics approval process, they shouldn't be participating in the meetings,' said Monarez.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Bloomberg
35 minutes ago
- Bloomberg
RFK Jr.'s Vaccine Panel Is Turning Misinformation Into Policy
Save Health and Human Services Secretary Robert F. Kennedy's dismantling of Americans' trust in — and ultimately, access to — vaccines isn't happening with one sweeping policy that grabs the public's attention. It's unfolding quickly and quietly, in bland conference rooms where hand-picked appointees make decisions that will have far-reaching consequences for our health. Inside one of those nondescript rooms last week, the Advisory Committee on Immunization Practices (ACIP), an independent panel that makes vaccine recommendations to the Centers for Disease Control and Prevention, offered a glimpse of what's to come. The group, few of whom have any expertise in vaccines, infectious diseases or epidemiology, at times cast aside evidence-based science and sowed doubt in some of our most valuable public health tools.
Associated Press
35 minutes ago
- Associated Press
Mineralys Therapeutics Announces Journal of the American Medical Association (JAMA) Publication of Pivotal Phase 3 Launch-HTN Trial for Lorundrostat
– The Launch-HTN trial is the largest trial of an aldosterone synthase inhibitor completed in participants with uncontrolled or treatment resistant hypertension – –Lorundrostat 50 mg once daily demonstrated clinically meaningful reductions in systolic blood pressure, with a 16.9 mmHg reduction at Week 6 and a 19.0 mmHg reduction at Week 12– –Lorundrostat was generally well-tolerated; and treatment-emergent adverse events were mostly mild, transient, and resolved without intervention – RADNOR, Pa., June 30, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced the publication of the positive results from the pivotal Phase 3 Launch-HTN trial in the Journal of the American Medical Association (JAMA). The manuscript titled 'Lorundrostat in Participants with Uncontrolled and Treatment-Resistant Hypertension' is featured in the June 30, 2025 issue. The Launch-HTN trial evaluated the efficacy and safety of lorundrostat, a novel aldosterone synthase inhibitor (ASI), when added to existing background treatment in 1,083 participants with uncontrolled or treatment resistant hypertension. The trial demonstrated that lorundrostat significantly reduced systolic blood pressure (BP) with a favorable safety and tolerability profile. 'Hypertension remains the most prevalent and preventable driver of cardiovascular disease globally, yet a significant proportion of patients continue to struggle with inadequate blood pressure control. We believe lorundrostat has the potential to be a best-in-class treatment for patients with uncontrolled or treatment resistant hypertension,' said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. 'We are pleased to have the results of Launch-HTN published in a medical journal as prestigious as JAMA. The consistency of results seen in the lorundrostat development program – which includes multiple trials across differentiated patient populations – supports its potential to have a broad role in future hypertension care.' 'Launch-HTN was the largest Phase 3 trial of an ASI in patients with uncontrolled or resistant hypertension, designed to reflect usual clinical practice. It demonstrated consistent blood pressure lowering efficacy and safety with the aldosterone synthase inhibitor, lorundrostat, across a diverse group of patients,' said Dr. Manish Saxena, MBBS, Deputy Clinical Co-Director of Queen Mary University of London's William Harvey Heart Centre, and Hypertension Specialist at Barts Health NHS Trust and lead investigator on the study. 'Dysregulated aldosterone, a key factor in driving hypertension in up to 30% of all hypertensive patients, is a consistent feature of treatment-resistant hypertension and related cardiovascular morbidities, such as heart failure and chronic kidney disease, making aldosterone synthase inhibition an attractive treatment target. Lorundrostat, a novel ASI therapy, is a promising development that could help address unmet clinical needs for patients who remain hypertensive despite multiple medications.' Key Findings from Launch-HTN The Launch-HTN trial was a global, randomized, double-blinded, placebo-controlled Phase 3 trial, which enrolled 1,083 eligible adult participants who failed to achieve their BP goal despite being on two to five antihypertensive medications. Launch-HTN reflects the real-world setting for clinicians by utilizing automated office blood pressure (AOBP) measurements and allowing participants to stay on their existing medications. Authors noted that the trial recruited a diverse population as reflected in the high proportion of females, Black or African American and elderly participants. When added to existing background treatment, lorundrostat 50 mg dosed once daily demonstrated clinically meaningful, statistically significant mean reductions in AOBP with a 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted; p-value < 0.0001) that was sustained with a reduction of 19.0 mmHg at Week 12 (-11.7 mmHg placebo adjusted; p-value < 0.0001). These benefits were consistent across age, sex, race, body mass index, and baseline medication regimen. Lorundrostat demonstrated a favorable safety and tolerability profile in the Launch-HTN trial. The anticipated on-target effects on serum electrolytes, increased serum potassium and reduced serum sodium were modest and rapidly reversible upon discontinuation of lorundrostat. A confirmed serum potassium level of greater than 6.0 mmol/L occurred in three subjects (0.6%) on lorundrostat 50 mg once daily, as compared to one subject (0.4%) on placebo. Suppression of cortisol production was not observed, and there was a very low incidence of drug-related serious adverse events resulting in discontinuation or dose-adjustment of study medication. About Hypertension Having sustained, elevated BP (or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States.1 In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause.2 Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019.3 Less than 50% of hypertension patients achieve their BP goal with currently available medications.4 Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients.5 About Lorundrostat Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as CKD and OSA. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive subjects. About Mineralys Therapeutics Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD, and OSA. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit Follow Mineralys on LinkedIn, Twitter and Bluesky. Forward Looking Statements Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the Company's expectation that ASIs with an SGLT2 inhibitor may provide additive clinical benefits to patients; the Company's expectation that Advance-HTN and Launch-HTN may serve as pivotal trials in submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA); the Company's ability to evaluate lorundrostat as a potential treatment for CKD, OSA, uHTN or rHTN; the planned future clinical development of lorundrostat and the timing thereof; and the expected timing of commencement and enrollment of participants in clinical trials and topline results from clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for an NDA submission or regulatory approval of lorundrostat; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading 'Risk Factors' in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. References 1 CDC. Facts About Hypertension. Centers for Disease Control and Prevention. Updated September 27, 2023. Accessed June 2025. 2 CDC. Underlying Cause of Death, 1999–2022 Results. CDC WONDER Online Database. Accessed June 2025. 3 Centers for Disease Control and Prevention. Health and Economic Benefits of High Blood Pressure Interventions. National Center for Chronic Disease Prevention and Health Promotion. Updated November 20, 2023. Accessed June 2025. 4 Carey RM, et al. Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement from the AHA. Hypertension. 2018;72(5):e53-e90. 5 Brown JM, et al. Primary Aldosteronism and the Pathogenesis of Hypertension. Physiol Rev. 2018;98(1):103-137. Contact: Investor Relations [email protected] Media Relations Melyssa Weible Elixir Health Public Relations Phone:1-201-723-5805 Email: [email protected]
Yahoo
an hour ago
- Yahoo
Research Says This Way Of Eating May Impact Your Fertility—Doctors Reveal The Truth
"Hearst Magazines and Yahoo may earn commission or revenue on some items through these links." Time-restricted eating (TRE) is having a moment in the sun, to say the least. The eating method—which involves consuming all your daily calories within a set number of hours—can help manage weight, but it may impact another unexpected aspect of your health: your fertility. New research has shown that TRE, a form of intermittent fasting (IF), may improve fertility for those with polycystic ovary syndrome (PCOS). A 2025 review in Metabolism Open examined three studies to determine the relationship between IF, fertility, and PCOS and found that IF helped those with PCOS achieve more predictable ovulation schedules, which can increase the likelihood of pregnancy. Plus, since fasting can help with weight loss, it can potentially improve fertility for those who are obese and may have hypertension and high cholesterol, which can negatively affect fertility, says Joshua Hurwitz, MD, an OB-GYN and reproductive endocrinologist at Illume Fertility in Connecticut. However, fasting can also lead to nutritional deficiencies, which may disrupt one's hormonal balance and decrease egg quality, according to a 2024 study in Cureus Journal of Medical Science that looked at the association between nutritional deficiencies and subfertility. "Human health should be optimal going into pregnancy, and that can be hard to achieve when you are in a caloric deficit,' says Brittany Brown, RD, the founder of Feeding Babies, Nourishing Souls in Nova Scotia, Canada. So, what's the real correlation between fasting and fertility? Experts weigh in on TRE and how it can affect your chances of conceiving. Meet the experts: Joshua Hurwitz, MD, is a board-certified OB-GYN and reproductive endocrinologist and partner at Illume Fertility in Connecticut. Brittany Brown, RD, is the founder of Feeding Babies, Nourishing Souls in Nova Scotia, Canada. Suzanna Chatterjee, MD, is an OB-GYN based in Russellville, Arkansas. Eve Feinberg, MD, is a reproductive endocrinology and infertility specialist at Northwestern Medicine. Mel Spinella, RD, is a New York-based dietitian specializing in fertility and pregnancy nutrition and the founder of Well by Mel Nutrition. A 2023 study in Free Radical Biology and Medicine looked at older mice to see how intermittent fasting impacts reproduction, and found that one month of fasting every other day improved the quality of developing eggs. The fasting lowered the amount of free radicals, molecules that can interfere with cellular processes, including cell division and reproduction, says Brown. Still, Brown points out that this study was done in mice, and there's not enough evidence yet to claim that fasting could have the same effect on humans. 'Future research will hopefully uncover how this works, but for now, we need more data before making recommendations," she says. A 2021 study in the Journal of Translational Medicine looked at 15 women between the ages of 18 and 31 who didn't ovulate. They participated in time-restricted feeding for five weeks, and afterward, 11 of the 15 participants experienced improved menstrual regularity. Many people with PCOS produce high levels of insulin, which can lead to excess male hormones in the body (such as testosterone), preventing ovulation, Suzanna Chatterjee, MD, an OB-GYN based in Russellville, Arkansas explains. Eating stimulates insulin, so with fewer meal times, those with PCOS could experience fewer spikes of insulin, which could help manage those excess hormones. TRE may help restore ovulation and improve fertility outcomes without the need for medication for those with PCOS, adds Eve Feinberg, MD, a reproductive endocrinology and infertility specialist at Northwestern Medicine. Still, fasting won't help everyone with PCOS—in the aforementioned study, four of the 15 women with the condition didn't experience better menstrual regularity. So, more research is needed on the connection between PCOS and fasting. Those with obesity are predisposed to have conditions such as hypertension, high cholesterol, and diabetes, which can 'impair natural fertility, as well as lower the success rates of fertility treatment,' says Dr. Hurwitz. 'Even a modest weight loss of 5 to 10 percent can improve ovulation and hormone balance.' Still, weight loss is only one piece of the puzzle. 'Not everyone who is overweight will have trouble conceiving,' and vice versa, he adds. Plus, studies on TRE's effectiveness as a weight loss tool are conflicting. A 2021 study in Nutrition & Diabetes, which followed 78 men and women with obesity, found subjects had 'meaningful weight loss' after following a TRE plan for eight weeks. But a 2023 study of 547 adults over six months in the Journal of the American Heart Association found that TRE did not help subjects lose weight. So, more research is needed. Experts say those with PCOS and those who are obese may benefit from TRE. But for the general population, there are other better ways to improve one's fertility, such as exercising and eating healthy, balanced meals. 'Eating enough, especially nutrient-dense foods throughout the day, is essential for a healthy menstrual cycle,' as well as ovulation, says Mel Spinella, RD, a New York-based dietitian specializing in fertility and pregnancy nutrition and the founder of Well by Mel Nutrition. Brown also advocates for a more natural, eat-when-you're-hungry approach to mealtimes for those who are actively trying to conceive—even for those with PCOS—and particularly once pregnancy is possible or confirmed. 'Reliable and consistent energy intake is essential for reproductive health, especially in the early moments of pregnancy,' she says. She says that her female clients generally find more success conceiving when they follow less restrictive diets that focus on consuming healthy foods. Plus, the research on fasting and fertility is still in the early phases. 'Ultimately, there is a need for large-scale, long-term randomized control trials to truly understand the long-term impacts of TRE on fertility,' Spinella says. When it comes to intermittent fasting, there are a ton of different schedules breaking down when to eat, from the more flexible 14:10 (14 hours of fasting and 10 hours of eating), to the more restrictive 20:4 plan (20 hours of fasting and four hours of eating). Brown says intense schedules like 20:4 can make it difficult to meet daily nutrient needs, which are essential before getting pregnant. Meanwhile, a 12:12 approach is more flexible and easier to follow for success. For instance, eating only between 7 a.m. and 7 p.m. might naturally reduce late-night snacking on ultra-processed foods without being overly rigid. However, Dr. Chatterjee recommends following a 16:8 schedule, particularly for women with PCOS who are hoping to regulate their cycle. Before beginning any fasting schedule, it's always recommended that you check in with your medical provider to see what they think, Dr. Hurwitz says. At the end of the day, everyone is different and 'there's no one-size-fits-all answer,' to how your body will feel during your fertility journey, Brown says. The way you eat is totally up to you and what will make your body feel best. You Might Also Like Jennifer Garner Swears By This Retinol Eye Cream These New Kicks Will Help You Smash Your Cross-Training Goals
