Postural Orthostatic Tachycardia Syndrome

LOS ANGELES, April 29, 2025 /PRNewswire/ -- Solve M.E., the Brain Inflammation Collaborative (BIC), ChronicleBio, the Complex Disorders Alliance, and CareEvolution have launched a powerful new collaboration to advance research on myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS), Long Covid, and other infection-associated chronic conditions and illnesses (IACCIs). This partnership unites decades of data, insights, and expertise to accelerate breakthroughs. By sharing knowledge and building on existing work, it aims to deliver faster diagnoses, better treatments, and improved outcomes for the millions affected by these conditions worldwide. Central to the collaboration is Solve M.E., a national nonprofit dedicated to making ME/CFS, Long Covid, and IACCIs widely understood, diagnosable, and treatable. Since 2010, Solve has collected patient-reported data, most recently through Solve Together—a dynamic platform created by CareEvolution. It allows users to track symptoms, sync wearables, generate reports for providers, and opt into clinical studies, and it's the largest database of its kind in the U.S. The Brain Inflammation Collaborative, a patient-centered nonprofit, will take over the management of the Solve Together platform. BIC will expand the platform to include pediatric populations, additional diagnoses, and assessments aimed to illuminate the links between brain inflammation and mental health. The goal: more diverse and inclusive research across rural, marginalized, and underserved communities, with all materials translated into Spanish to further broaden access. "This collaboration will ultimately benefit our growing patient communities and deliver the big breakthroughs they deserve," said Emily Taylor, CEO of Solve M.E. "It will allow for the collection and processing of more data from a broader population and ensure that principal investigators from multiple fields of study can access the open source data via a secure and vetted application process. By joining forces and tearing down research silos, we can leverage our shared resources to expedite progress and find treatments and cures for these complex conditions." As part of the collaboration, Solve M.E. will share data with both the Complex Disorders Alliance—a patient-founded nonprofit that drives the development of diagnostics and treatments—and ChronicleBio, a biotech company advancing research on chronic illnesses including POTS, ME/CFS, and Long Covid. ChronicleBio will apply Solve's patient data to deepen insights and fuel transformative clinical trials. Solve M.E.'s database is uniquely valuable for containing pre- and post-COVID-19 health information, enabling comparisons between individuals with ME/CFS triggered by COVID-19 and those with other origins. This insight helps researchers better understand how the pandemic has impacted long-term health. Christy Jagdfeld, CEO of BIC, said, "The Brain Inflammation Collaborative sees this collaboration and addition to our organization as a tremendous opportunity to catapult us to a place to immediately create meaningful research opportunities. We are very humbled and respectful of this opportunity and know the importance of doing justice to the work ahead of us." Amy Rochlin, CEO of the Complex Disorders Alliance, added: "Patients cannot afford for us to work in silos or duplicate efforts. This partnership is about uniting—pooling data, insights, and expertise—to drive the breakthroughs that put patients first. By learning from one another and building on existing knowledge, we can turn research into real solutions—faster diagnoses, better treatments, and improved lives for those living with complex disorders." Rohit Gupta, Co-Founder and CEO of ChronicleBio, stated: "There have been a number of barriers and promises made in bringing research findings to bedside. This collaboration aims to finally break down the silos and ensure each group is working in concert to drive new discoveries across medical, research, and advocacy. At the heart of our efforts is a mutual vision to empower those impacted by chronic illness, leading to more opportunities for all to be part of the path to cures." A full roll-out of the new Solve Together platform under BIC leadership is expected in 2025. For information on accessing data, participants and researchers may contact the BIC team at [email protected]. About Solve M.E.: The Solve ME/CFS Initiative (Solve M.E.) is a non-profit organization that serves as a catalyst for critical research into diagnostics, treatments, and cures for ME/CFS, Long Covid, and other infection-associated chronic conditions and illnesses (IACCIs). Our work with the scientific, medical, and pharmaceutical communities, advocacy with government agencies, and alliances with patient groups around the world are laying the foundation for breakthroughs that can improve the lives of millions who suffer from various "long haul" diseases. About the Brain Inflammation Collaborative: The Brain Inflammation Collaborative (BIC) is a non-profit organization that is committed to investigating the connection between mental health and neuroinflammation caused by infections, autoimmune diseases, allergies, and injuries. Our mission is to advance treatments for neuroinflammation through research, advocacy, and education. To achieve this, we develop scalable partnerships and collaborations, sustainable research strategies, and tools to support researchers, patients, and clinicians. We advocate for a collective, longitudinal approach to studying infection-associated chronic conditions, recognizing that research insights from one condition can drive progress across many others, through every stage of life. Complementing the work of advocacy groups that focus on single conditions, populations, and/or age groups, we work to connect patient communities, ensuring individuals with any of 30+ related diseases can contribute to and benefit from research. About CareEvolution: With over 15 years of experience in healthcare interoperability, CareEvolution is a leading provider of health data and digital clinical research platforms. The CareEvolution Health Data Platform has enabled leading health plans, provider networks, and health information exchanges to unlock the value of their healthcare data assets. Payor, provider, and consumer-sourced data is liberated, aggregated, and standardized—enabling many advanced use cases. About ChronicleBio: Founded by leading biotech professionals directly impacted by complex disorders, ChronicleBio is focused on building the richest, AI-ready data platform for chronic illness to empower patients, providers, and pharma. With its network of physician and clinical partnerships, ChronicleBio is uniquely positioned to build the world's most comprehensive longitudinal dataset for those living with these debilitating conditions and fuel the next-generation of AI tools that accelerate discovery and expand access to meaningful clinical trials. About Complex Disorders Alliance: Complex Disorders Alliance is a 501(c)(3) patient-founded nonprofit organization accelerating groundbreaking research, clinical innovation, and patient-centered solutions for complex disorders. CODA collaborates with best-in-class researchers, medical institutions, and industry leaders to accelerate the development of diagnostic tools, targeted therapies, and evidence-based interventions that transform outcomes and improve lives. Media contacts: Karman Kregloe [email protected] 323-828-1655 Christy Jagdfeld [email protected] 262-391-9578 SOURCE Solve M.E. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

In winning its motion for summary judgment, Merck has knocked out more than 200 lawsuits in the nationwide Gardasil safety communication litigation. In what’s shaping up to be a red-letter week for Gardasil, Merck & Co. has simultaneously opened a massive new manufacturing facility for the human papillomavirus (HPV) shot in the U.S. and put hundreds of lawsuits to bed alleging that the company downplayed the safety risks of its blockbuster vaccine.In a decision signed Monday, North Carolina federal judge Kenneth Bell granted Merck’s motion to dismiss the claims of plaintiffs who argued that Merck failed to warn that Gardasil—first approved in 2006 to prevent cervical and other cancers linked to HPV—could cause recipients to develop certain health conditions.In particular, the plaintiffs contended that Merck should have added safety warnings to its Gardasil label in 2011 and 2013 detailing the risks of recipients developing postural orthostatic tachycardia syndrome (POTS) or primary ovarian insufficiency (POI), respectively.POTS is a condition that leads to multiple symptoms, such as dizziness and fast heart rate when a person moves from lying down to standing up. POI, otherwise known as premature ovarian failure, occurs when the ovaries stop working before age 40, often leading to infertility.Judge Bell specifically ruled that Merck lacked the power to add safety warnings to its Gardasil label under federal law, which pre-empts the plaintiffs’ state-based claims.In winning its motion for summary judgment, Merck has knocked out more than 200 lawsuits in the nationwide safety communication litigation, according to court documents filed this week.Given the lack of solid evidence on a causal relationship between Gardasil and the two conditions, Merck didn’t possess the authority to simply change the vaccine’s label of its own accord, the judge ruled.“As of 2013, when plaintiffs contend that the latest of the warnings should have been given, more than a hundred million doses of Gardasil had been administered worldwide,” the judge said in his decision. “However, by that time, there had been only one published, verified case of POTS and four published case reports of POI.”In turn, Judge Bell argued that “no scientist could reasonably conclude there is a causal association between POTS and POI and Gardasil based on this paucity of evidence, even putting aside the fact that the FDA was made aware of all these cases and studies.” Further, it would have ultimately been up to the U.S. FDA, rather than Merck itself, to approve any label updates for the vaccine. Bell also warned about the inherent risks that come with adding “unwarranted warnings” to potentially life-saving vaccines, arguing that they could sway people to forgo immunizations or “crowd out” legitimate safety risks that should be monitored.In summarizing his position, the judge stressed that “[f]ederal law requires more than speculative inferences prior to adding dire warnings to lifesaving vaccines that discourage their use.”In an emailed statement, a Merck spokesperson said that the company is “extremely pleased” with the court’s decision and stands by the safety of its vaccine.“The evidence that Gardasil does not cause POTS and its associated symptoms or POI is consistent and overwhelming,” the spokesperson said, citing data from clinical trials, real-world epidemiological studies and global regulatory decisions.Gardasil, which is now approaching two decades on the market, remains one of Merck’s top selling products. The shot’s global sales in 2024 dropped 3% overall but still landed at $8.6 billion for the entire year.Meanwhile, despite ongoing struggles in the key Chinese market, Gardasil has notched a number of recent wins in the U.S. Late last month, a California jury trial over Gardasil side effects was put on hold until September, in a move Merck chalked up to its strong body of safety data on the vaccine. One of the lawyers for the plaintiff in that case told Reuters that it was difficult to run the trial alongside Robert F. Kennedy Jr.’s confirmation hearing for HHS secretary. Kennedy—a noted vaccine skeptic who has since been confirmed for the HHS post—previously disclosed in an ethics agreement that he stood to receive a payout for referring successful cases to one of the law firms representing Gardasil plaintiffs.Separately, Merck on Tuesday announced the opening of a new $1 billion, 225,000-square-foot manufacturing facility in Durham, North Carolina, that is slated to crank out bulk drug substance for Gardasil. 

Merck convinced a federal judge to toss claims alleging that it failed to properly warn patients of potential risks related to its Gardasil HPV vaccine. District Judge Kenneth Bell in North Carolina concluded that the plaintiffs’ claims are preempted by federal law because Merck was not permitted to add the warnings to Gardasil’s label without prior approval from the FDA. Plaintiffs in the multidistrict litigation before the US District Court for the Western District of North Carolina allege that Gardasil caused them to suffer one of two conditions called POTS or POI. As of December, more than 225 Gardasil cases were pending against Merck in either federal or state court. It’s unclear how many of those cases remain. “The evidence that Gardasil does not cause POTS and its associated symptoms or POI is consistent and overwhelming,” a Merck spokesperson told Endpoints News on Tuesday. POTS, or postural orthostatic tachycardia syndrome, causes the heart to beat faster than normal when standing up, while POI refers to premature ovarian failure. Plaintiffs in the multidistrict cases argued that Merck should have added warnings to Gardasil’s label for POTS and POI in 2011 and 2013, respectively. While prior approval from the FDA is typically required to make label changes, the plaintiffs said Merck could have made the changes without the FDA’s clearance based on “newly acquired” evidence. However, Merck argued that there is no evidence Gardasil causes either condition. Bell sided with the pharma company on Tuesday, concluding that the evidence “falls far short” of establishing that Merck had newly acquired information indicating a link between Gardasil and POTS or POI. He pointed out that plaintiffs cited just one published case of POTS and fewer than 20 unverified reports of POTS among the tens of millions of people who have received Gardasil. Thus, the company “did not have the authority under federal law” to add the requested warnings to the label, Bell wrote. The plaintiffs “ignore the real harm that is risked by adding unwarranted warnings to a vaccine,” he added. “First, of course, anyone unnecessarily discouraged from taking a potentially lifesaving vaccine could suffer dire consequences,” Bell wrote. “Also, adding ‘warnings’ for every diagnosed malady that befalls a vaccine recipient within months or years after vaccination will crowd out the impact of those warnings that truly need to be given.” Bell had previously dismissed several claims brought by a group of initial “bellwether” plaintiffs, including manufacturing and design defect claims. Bell’s Tuesday order dismisses the remaining claims brought by bellwether plaintiffs. The order states that the decision “shall be applied to Plaintiffs in the MDL other than the Bellwether Plaintiffs in accordance with the prior orders of the Court and/or the agreement of the Parties.” The Merck spokesperson said the company is “extremely pleased” with the verdict and “will seek to have this applied more broadly.” Editor’s Note: This story has been updated to include comment from Merck.