Latest news with #patientadvocacy
Forbes
23-05-2025
- Health
- Forbes
Human Rx: Empathetic Guidance Remakes Healthcare Outcomes
Beyond the buzz of technological innovation, a significant shift is gaining momentum in healthcare: the recognition of human connection as a core driver of positive outcomes. Increasingly, personalized advocacy and care coordination are demonstrating that informed, empathetic support in navigating complex medical journeys is crucial for achieving better patient results. This trend highlights the enduring importance of the human element in an evolving healthcare landscape. MedCompanion is one company demonstrating that truly impactful healthcare isn't just about cutting-edge devices or complex algorithms but about something fundamentally human: better their personalized patient advocacy and care coordination services, they are proving that navigating the complexities of modern medicine with informed, empathetic support leads to demonstrably better outcomes for patients. TURNING TRAGEDY INTO INNOVATION Marly Brodsky recognized a crucial gap in healthcare. While technology has advanced, communication ... More between patients and providers has suffered. Her company MedCompanion is proving that better outcomes start with better conversations. Marly Brodsky dreamed of helping people. Born in Panama, she moved to the US with her family when she was just 10 months old to seek medical care for her dad after he was injured in a fishing accident. Life in the U.S. wasn't easy for her family, who became homeless for a few months when Brodsky was 12. But she knew how life-changing access to healthcare can be, and that stayed with her. She wanted to be a doctor. She went to college and completed all the pre-med requirements. As part of her studies, she went to live with the Nobe-Buglé tribe in the jungle of Panama for two months, researching how cultural practices impacted access to healthcare, tuberculosis treatment, and prevention. But tragedy struck. Brodsky was diagnosed with a brain tumor at 18. Her grades plummeted, and medical school became out of reach. She learned firsthand how hard it is for Americans to navigate a crumbling healthcare system with a challenging diagnosis that requires intensive treatments. After beating the tumor, Brodsky became a traveling medical scribe. She implemented medical scribe programs in outpatient settings across the US, Canada, and Australia, strategizing how to provide better care and better insurance reimbursement. While technology plays an integral role, MedCompanion relies on human interpretation to get results ... More for patients. A live medical professional virtually attends every appointment along with the patient – advocating, taking notes, and asking critical questions. After the medical appointment, the Medcompanion team periodically checks in with the patient to make sure they understand the doctors' instructions, medications, and follow-up care, even arranging follow-up appointments. Fifteen years later, she burnt out. Her daughter, just a toddler at the time, was diagnosed with serious health issues, so Brodsky left the company. Then, her grandmother died unexpectedly a few months after being diagnosed with cancer, and Brodsky was once again personally reminded of how broken the system is. Struggling to keep track of her daughters' appointments and medications, she was filled with desperation, anger, and grief. One night in 2021, Brodsky woke up in the middle of the night. She knew that many people needed more support, not just her family. But there was no service that provided patient support, advocacy, and education – so she decided to build it herself. Dr. Rich Brodsky is the Chief Medical Officer of MedCompanion She began to write out her entire business plan on the back of an electricity bill that very night. Her husband Dr. Rich Brodsky, a board-certified pediatric emergency doctor, soon became her #1 supporter and investor. He's now the Chief Medical Officer of MedCompanion. And Brodsky is the CEO. Together with a small, mostly-female staff, they work directly with over 100 patients in 12 different states, helping to make sense of their medical appointments, insurance requirements, and treatment plans. A live medical professional virtually attends every appointment along with the patient – advocating, taking notes, and asking critical questions. After the medical appointment, the Medcompanion team periodically checks in with the patient to make sure they understand the doctors' instructions, medications, and follow-up care, even arranging follow-up appointments. Brodsky recognized a crucial gap in healthcare. While technology has advanced, communication between patients and providers has suffered. Her company is proving that better outcomes start with better conversations. A CRISIS IN CARE There is a growing need to increase engagement between healthcare providers and patients, without increasing burn out. But demand is outpacing supply. The Centers for Disease Control and Prevention (CDC) estimates that 60% of Americans have at least one chronic disease. 'Doctors are getting reimbursed less and less every year and then must see more and more patients. ... More It is not a good situation for either the patient or the doctor,' said Dr. Peter Wishnie 'Imagine being sick and then having to decipher all this medical terminology that sounds like another language entirely. Then there's all the red tape – needing referrals, waiting for authorizations, fighting surprise bills, and feeling rushed during their appointments,' shares podiatrist and business coach Dr. Peter Wishnie. 'Many patients and families came to the emergency room as a last resort because their care was so fractured,' adds Brodsky's husband, an emergency pediatrician and current Chief Medical Officer of MedCompanion. Dr. Richard Brodsky shares 'I have witnessed so many patients fall through the gaps in healthcare. Marly and I created MedCompanion to help close those gaps so that patient care can be more efficient and effective." "The system is so frustrating that many people are simply choosing to avoid it altogether,' comments ... More Derek Berkey of Invigor Medical, a company specializing in outcome-focused treatments for a few common health conditions. Patients wait months for appointments, only to spend a few minutes with a doctor and not understand what they are told. "The system is so frustrating that many people are simply choosing to avoid it altogether,' comments Derek Berkey of Invigor Medical, a company specializing in outcome-focused treatments for a few common health conditions. THE ROLE OF INSURANCE COMPANIES Insurance company practices are one of the main culprits of the broken system. They frequently lack transparency, and navigating whether treatment is covered leaves patients feeling alienated and distrustful. 'Doctors are getting reimbursed less and less every year and then must see more and more patients. It is not a good situation for either the patient or the doctor,' added Dr. Wishnie. Doctors are asked to do more with less, creating an electronic medical record, and filling in the gaps in care where patients aren't getting support from their insurance. This includes navigating missing lab work, and a lack of access to specialists and medication. 'Instead of fighting with insurance or waiting months for an appointment, patients are turning to self-education, digital health platforms, and alternative providers,' says Berkey. A WIN-WIN SOLUTION "Centers for Medicare and Medicaid Services (CMS) recognize the importance of helping patients stay ... More on top of their prescriptions, follow-up appointments, and education regarding their illnesses,' says Dr. Blake Hampton, a specialist working with MedCompanion. MedCompanion is now partnering with three health systems to leverage Medicare reimbursement for their services. 'Centers for Medicare and Medicaid Services (CMS) recognize the importance of helping patients stay on top of their prescriptions, follow-up appointments, and education regarding their illnesses,' says Dr. Blake Hampton, a specialist working with MedCompanion. 'It's a win for everyone, as patients have better support and outcomes, practices can unlock additional revenue, and the taxpayer saves dollars that would otherwise be spent on preventable disease states.' While technology plays an integral role, MedCompanion relies on human interpretation to get results for patients. A recent client was suffering from a chronic gastrointestinal illness, unable to work due to severe symptoms, and not getting better. Their assigned MedCompanion collected all of their medical records and lab results, set up a new priority appointment with a specialist whose experience aligned with the patients' symptoms, and gave clinical notes to the specialist during the appointment. Now the patient is back to work, with a significant relief of symptoms. Another recent client had diabetic retinopathy and glaucoma. They were taking multiple medications prescribed by multiple providers, missing doses, and unable to refill prescriptions before they ran out due to delays in insurance approvals. Thanks to their Medcompanion, they now not only are able to better control their illness through a streamlined medication regimen, they also are on a meal plan paid for by insurance. PATIENT CARE OF THE FUTURE Based on current demand, MedCompanion is projected to grow significantly in the coming years. Seeing the potential, investors have approached them about scaling the business. 'I believe we're just starting to see how technology will transform patient care, and it will only get better from here. The future of healthcare belongs to those who recognize this shift and make care simpler, faster, and more transparent," shares Berkey. Ultimately, the path forward in healthcare will be paved by those who prioritize not just innovation but genuine human understanding and support.
CBS News
21-05-2025
- Health
- CBS News
Years after a tampered IV bag became deadly, no new rules are in place. Survivors want to change that.
More than a year after a former Dallas anesthesiologist was convicted of tampering with IV bags, survivors and their families say they are still waiting for the medical industry to take action. "We almost lost him," Dovi Alderstein told the CBS Texas I-Team, referring to his son, Jack, who he says suffered a near-fatal cardiac event following a routine procedure at a surgical center in North Dallas. "It was the scariest experience of our lives." In late 2024, Dr. Raynaldo Ortiz was sentenced to 190 years in federal prison for secretly injecting dangerous drugs into IV bags at Baylor Scott & White Surgicare North Dallas. His actions harmed ten patients and led to the death of Dr. Melanie Kaspar, a fellow anesthesiologist who used one of the compromised bags to treat her own dehydration at home. Now, victims are seeking accountability from the manufacturer of the IV bags themselves. A lawsuit and a familiar warning Attorney Bruce Steckler filed a lawsuit on behalf of Kaspar and her husband, John, against Baxter International, the manufacturer of the IV bags. The suit argues that the design of the bags allowed Ortiz to tamper with them without being detected, and that it didn't have to be that way. "This could have been avoided with a tamper-resistant design," Steckler said in an interview with the I-Team. "You can inject any kind of medication into that port without any sign of entry. That's exactly what happened here." Baxter is the largest producer of IV bags in the U.S., according to the lawsuit. The suit claims the company manufactures fixes — after-market foil seals and tamper-evident caps — that could deter or at least reveal tampering. In a statement to the I-Team from 2022, the FDA confirmed that standard IV bags "do not normally contain tamper-proof or tamper-evident features." Nearly three years later, despite the high-profile nature of the Ortiz case, the agency told the I-Team it has "no new information" regarding any regulatory changes. The Texas State Board of Pharmacy and the National Association of Boards of Pharmacy also confirmed they have "no new information" regarding guidelines. Echoes of the Tylenol murders The allegations have drawn comparisons to the 1982 Tylenol poisonings in Chicago, where seven people died after ingesting cyanide-laced capsules that had been placed on store shelves. In the wake of those murders, the pharmaceutical industry adopted strict packaging requirements, including triple-sealed bottles and tamper-evident warnings. "Why didn't Baxter get the message?" Steckler said. More than 40 years later, most over-the-counter medications still bear those protections; however, in medical settings, IV bags, which are often administered when patients are unconscious or sedated, appear to remain more vulnerable. Dr. Marvin Shepherd, the former director of the University of Texas College of Pharmacy, predicted in a 2022 I-Team interview that the FDA would impose new mandates after the Ortiz case. "It's highly probable," he said at the time. "Very probable." But so far, nothing has changed. IV bags vs "a jar of pickles" At the center of the lawsuit and the public call for reform is Melanie Kaspar. "She's the one that's not here. And we are," said Melody Naylor, a dentist who also suffered cardiac arrest after undergoing a minor procedure at the same surgical center. "So we have to speak for her." Naylor said her family now insists on inspecting IV bags before they're administered. They look for punctures, leaks or any signs of tampering. She said patients should remember they have a right to ask questions and to see the bags. But not all signs are visible. Ortiz tampered with the IV bags in a way that was subtle and left no clear puncture mark. Even Kaspar, a trained anesthesiologist, could not detect it. "There is no reason that you should have greater confidence in the fact that the jar of pickles that you buy at the supermarket hasn't been tampered with than you are that your IV bag hasn't been tampered with," Alderstein said. The father said he believes a basic safety seal, the kind used on common foods and household items, might have saved lives. "It would have prevented it entirely," Alderstein said. "Jack wouldn't have gone through that. None of the victims would have. And most importantly, Dr. Kaspar would still be with us." Baxter responds Baxter International sent the I-Team the following statement: "As a matter of course, Baxter does not comment on pending litigation." In court documents responding to the lawsuit, Baxter issued a general denial stating, among its defenses, the incident was "caused solely by … criminal acts… ." It also states the IV bags were "designed, manufactured, and sold in compliance with all applicable codes, standards, regulations, and … laws." North Texas hospitals The I-Team reached out to seven major hospital systems in North Texas to ask whether the Ortiz case prompted changes to how IV bags are stored, monitored or sourced. Four of the facilities, including Methodist Health System, UT Southwestern, Texas Health Resources and Parkland Health did not respond despite repeated inquiries. Medical City Healthcare and JPS Health Network replied but did not answer the questions. Baylor Scott & White, where the tampering occurred, issued the only statement: "Immediately upon determining an IV bag had potentially been compromised, Surgicare North Dallas ceased all operations, notified local and federal authorities and engaged several experts to review its protocols and procedures. The facility decided to resume operations more than four weeks later, only after extensive investigation and the issuance of the Department of Justice's criminal complaint against Dr. Raynaldo Ortiz, which noted investigators' belief that the problem was limited to one individual. Our priorities in the matter were always the safety and wellbeing of our patients and seeing justice served. It is important to note that anesthesiologists, like Dr. Ortiz, are authorized users of IV fluids and medications in a surgical care setting, and IV fluids and medications must be made readily available to authorized users for safe patient care. The handling and storage of IV bags and medications at the facility was reviewed and deemed appropriate by experts and in line with industry standards. And we continuously review processes and safeguards to assure the highest levels of patient safety. Surgicare North Dallas is accredited by The Joint Commission, licensed by the Texas Department of Health and Human Services, and it is certified and approved by the Centers for Medicare and Medicaid Services." What can patients do? IV bags vary in design. Some include protective caps on both ports, while others do not. Most of them arrive in a plastic overwrap with a printed warning to inspect for damage. Patients should remember they are also customers and have the right to ask to see the bag. Ask who is preparing and administering the IV: Hospitals should be transparent about who is handling medication. Patients can ask that an IV be prepared in their presence or by a licensed professional under supervision. Hospitals should be transparent about who is handling medication. Patients can ask that an IV be prepared in their presence or by a licensed professional under supervision. Look for clean, sealed packaging: IV bags should come in sealed plastic wraps. If a bag appears opened, cloudy or is leaking, ask for a new one. IV bags should come in sealed plastic wraps. If a bag appears opened, cloudy or is leaking, ask for a new one. Do not hesitate to speak up: If anything seems off, from the appearance of the IV to the person administering it, or how you're feeling after receiving it, let someone know immediately. Ask for a supervisor or patient advocate if needed. If anything seems off, from the appearance of the IV to the person administering it, or how you're feeling after receiving it, let someone know immediately. Ask for a supervisor or patient advocate if needed. Have a family member or advocate present: For patients who are sedated or cannot monitor their own care, having someone at bedside who can observe, ask questions and raise concerns can be critical. For patients who are sedated or cannot monitor their own care, having someone at bedside who can observe, ask questions and raise concerns can be critical. Request documentation: Patients can ask for a record of what medications were administered and when. This can help in follow-up care or in the event of complications. Patients can ask for a record of what medications were administered and when. This can help in follow-up care or in the event of complications. Report concerns: If a patient suspects something went wrong, they can report it to the hospital's patient safety office. These reports can trigger investigations that protect others. Even for someone who follows all of this advice, there is no guarantee. That is why the victims of the Ortiz case are hoping the lawsuit inspires a change with Baxter as well as the entire industry. "You'd like to think after all of this that they would've done the right thing," Steckler said. The case is scheduled to go to trial in May of 2026.
Yahoo
20-05-2025
- Health
- Yahoo
Patient-centric trials: progress but gaps remain
Patient-centricity has become a buzzword in recent years, with companies touting more inclusive trial designs and bringing patients and advocates into early planning stages. On Clinical Trials Day 2025, the Clinical Trials Arena team asks: has the push for patient-centricity truly changed the way trials are run? Most clinical trial conferences now have a stream dedicated to patient engagement or patient centricity, and these streams are always filled with delegates who are ready to openly speak about how they can improve designs for patients, showing that the industry is starting to consider this way of thinking. These approaches have been more heavily adopted in the rare disease space, where enrolment is already a challenge. Ensuring that patients' opinions are considered in the protocols means it will likely be easier to enrol patients into the clinical trial. Sponsors need to understand why patients take part in research to really focus on patient-centricity, says Dr. Dominique Demolle, CEO of Cognivia, a company that develops analytical tools to optimise and accelerate clinical development. 'Patients who agree to participate in a clinical trial are doing it for the benefit of others and it has to represent what would be the real world,' Demolle explains. Demolle believes that change is happening, and this benefits both patients and stakeholders. In the past, strict protocols made finding eligible patients difficult. Today, sponsors are working with patient advocacy groups and patient leaders from the outset. While this has been an issue, Dr. Stacie Bell, chief clinical research officer of Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, says she has seen a push by sponsors to get to know what patients need and want from clinical trials to improve enrolment. 'Whether that be looking at a clinical trial protocol before it is actually finalised, or companies meeting those with a particular condition, that perspective can be incorporated into a clinical development programme,' Bells explains. According to Medable's Vice President of Patient Engagement, Jena Daniels, the onus cannot solely be on the sponsor. 'It's on every vendor, every partner, every CRO that they then choose to work with within their trial,' Daniels explains. That includes the regulators. Rare-disease patient Suzanne Harris, who works for marketing in SubjectWell notes that regulators including the US Food and Drug Administration (FDA) are pushing patient-centricity but have a way to go. 'The issue becomes, not many people know how to actually make it happen. I feel like companies are on the cusp, but the industry doesn't know how to pull it all together.' Not only in the US are regulators pushing this approach, but in Europe, advocacy groups and patient representatives have historically been included in European Medicines Agency (EMA) scientific review panels for protocols, showing the regulator's desire for sponsors to adopt patient-centric designs. While this has primarily been in rare diseases, it is now also happening in oncology. Not only is this something the regulators are providing guidance in, but in some cases will be considered in a drug approval, adds Cardiologist and CMO of Clinical Ink, an eSource solution company, Dr. Nicholas Alp. 'Many regulatory authorities now require evidence that you've done that as a sponsor – that you have had input from individual patients and advocacy groups and other experts to seek their feedback on what is proposed in the study, design the assessments that are planned to be used,' says Alp. Promising therapeutics have failed in the clinic not due to an initial lack of enrollment but due to patients dropping out of studies, highlighting the importance of retention when considering patient centricity. 'If we have poor adherence and poor retention, then we are at risk of having missing data, incomplete data or incorrect data and that is the focus of every scientific experiment,' Alp explains. The key to continuing the positive trend is to engage patients even earlier – in the pre-protocol stage to learn what endpoints are meaningful for patients, according to Harris. 'An example that I like to use is, if it's a headache trial and the medication makes you drowsy, but patients want to be able to live and work then sponsors are missing what a patient needs,' Harris says. 'They need to understand patient motivation – that is critical.' Bell agrees, adding that conversation with patients will help sponsors better understand how to design protocols. 'One example in lupus is that patients suffer fatigue or brain fog which is something that unless you're living with lupus, it's difficult to understand. If you're looking at a clinical trial endpoint that's looking at joints or skin manifestations and those types of things, not that they're not important, but sponsors need to understand what that lived experience is. There are things that are impactful and meaningful to those living with the disease.' Sponsors also need to find more ways to connect to patients to make more people aware of clinical trials, Bell continues. 'Sponsors need to hear the individual's voices about what they really need in clinical trials. That can come from meeting patients and that is critically important to having clinical trials be effective.' While it is important at an early stage to engage, keeping patients engaged throughout the study is also important, primarily by removing patient burden. Technology has been helping to improve patient-centricity and remove patient burden in trials by reducing site visits, Alp worries that some sponsors go too far when using decentralised models, which ends up adding burden again on patients. 'When it's possible to capture data from patients remotely, there is a temptation to just add more and more assessments remotely. While you think you're making life easier for the patient, actually, you're loading them up with assessments, and you're increasing the burden. Even in the hybrid and decentralised model, it's important that we follow what I think is like the first principle of clinical trial design - keep it simple and just collect the necessary data.' Not only are the patient's needs important, however, adds Daniels, who believes that sponsors and stakeholders also need to consider caregivers more to make trials more patient-centric. 'There's a whole support army behind every person participating in a trial, but these people can be unsung heroes behind the scenes supporting them. To round out that patient-centric approach, you must recognise the impact, influence, and participation that the caregivers have,' Daniels explains. 'Caregivers don't sign the consent form and may not be getting compensated for their time, but they are often just as invested as the patients, and it's such an important role and something we also need to highlight as part of that patient-centric approach.' Harris adds that sponsors also need to support sites and patients throughout the clinical trial because if sites are busy with administrative tasks, they have less time to focus on patient care. Daniels agrees that sites should also be at the centre if a sponsor wants to make a trial more patient-centric. Daniels says: 'If the sites themselves aren't fully supported, they end up spending time figuring out the technology and less time with the patient. When we talk about patient centricity, we're doing a disservice unless we also talk about supporting sites.' While patient centricity is important, it needs to be balanced by conducting an effective trial. 'A sponsor cannot embark on a protocol if it impacts efficacy and safety so if there is some pushback to that from a patient advocacy organisation, they would say no,' Demolle concludes. "Patient-centric trials: progress but gaps remain" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. 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