Senators Mull Ways to Stop Patent 'Abuse' by Pharma Companies

By Shannon Firth - Senators and experts on Tuesday examined the range of tools that brand-name drug manufacturers have used to keep generic and biosimilar competition at bay -- from patent thickets and product hopping to "pay-for-delay" settlements -- and wrestled with how to prevent such abuses. Read Full Article…

HVBA Article Summary

1. Manipulated Prices Over Scientific Progress: Senator Dick Durbin highlighted the disconnection between pharmaceutical prices and genuine scientific advancements, attributing inflated costs to legal maneuvering rather than innovation. Using AbbVie's adalimumab (Humira) as a prime example, he pointed out how the exploitation of intellectual property laws resulted in prolonged monopolies and exorbitant revenues, hindering fair competition and access to essential medications.

2. Legislative Responses to Patent Abuse: The Senate Committee on the Judiciary has proposed bipartisan bills targeting various forms of patent abuse within the pharmaceutical industry. These bills aim to address practices such as pay-for-delay agreements, sham citizen petitions, product hopping, and the creation of patent thickets. Despite unanimous committee approval, these measures await a full Senate vote, indicating ongoing efforts to rectify systemic flaws in drug pricing and market competition.

3. Balancing Innovation and Access: While acknowledging the importance of patents in fostering innovation, critics argue that rampant patent abuse stifles genuine progress and affordability in healthcare. Calls for stricter regulatory oversight, including enhanced coordination between the FDA and the U.S. Patent and Trademark Office, reflect a broader push to curb exploitative practices. However, stakeholders emphasize the need to strike a balance, ensuring that reforms promote competition without impeding the development of life-saving treatments and medical advancements.

Bipartisan scrutiny of health care mergers

By Ben Leonard and Chelsea Cirruzzo - CONSOLIDATION FEARS INCREASE — A growing wave of hospital mergers, large firms buying physician practices, pharmacy benefit manager consolidation and private equity’s acquisitions of nursing homes and hospitals are drawing increasing bipartisan scrutiny from Congress. Read Full Article…

HVBA Article Summary

1. Economic Impacts of Consolidation: Economists highlight rising prices and reduced access to care due to consolidation in the healthcare sector, emphasizing its role in driving up costs for patients. While efficiency gains are touted as potential benefits, evidence suggests consolidation primarily leads to higher prices, raising concerns about affordability and quality of care.

2. Policy Responses and Legislative Efforts: Policymakers are exploring measures to address healthcare consolidation, including transparency requirements and site-neutral payments to mitigate the financial incentives for hospitals to acquire doctors' practices. However, debates over the scope and potential impacts of such reforms persist, with hospitals opposing measures that could affect access to care.

3. Regulatory Actions and Future Outlook: The Biden administration, through the Federal Trade Commission, has taken steps to scrutinize mergers in the healthcare industry. Looking ahead, the House Budget Committee's hearing is set to examine the budgetary implications of consolidation, with a focus on potential cybersecurity risks following recent ransomware attacks, signaling continued legislative and regulatory attention to the issue.

Why Healthcare Data Is Vital for Employers

By Marissa Plescia - At Delta Air Lines, healthcare data is taken “very seriously,” according to Dr. Henry Ting, senior vice president and chief health and wellness officer of the company. Read Full Article…

HVBA Article Summary

1. Data as the Backbone of Decision-Making: Ting emphasized the critical role of data in shaping insights and information about populations and employees. Without data, essential management tools like knowledge management, AI, and predictive analytics are rendered ineffective. This underscores the fundamental importance of data in modern healthcare management.

2. Delta Air Lines’ Data Platform: Delta Air Lines serves as a model example of leveraging data for employee healthcare optimization. By integrating data from various external sources, including third-party administrators and healthcare providers, Delta has created a comprehensive platform for understanding and improving employee health. This approach enables informed decision-making aimed at optimizing health and wellness rather than merely reacting to sickness.

3. Challenges in Data Accessibility for Employers: Despite the evident value of data, many employers face obstacles in accessing and utilizing their healthcare data effectively. Cheryl Larson highlighted the struggle for transparency and access to data, labeling Delta Air Lines as an exception rather than the norm. This raises broader questions about the accessibility and ownership of healthcare data, emphasizing the need for innovative solutions to empower employers in making informed healthcare decisions.

Cyberattacks are soaring—and more lucrative for criminals than drugs. It’s time to treat them as an ‘act of war,’ health care exec warns

By Beth Greenfield - The Change Healthcare cyberattack that disrupted nationwide health care systems earlier this year—affecting a third of Americans at a total loss of $100 million—was a major wake-up call: Such attacks in the health care industry are on the rise. And they should be treated with utmost seriousness, agreed a panel at Fortune’s Brainstorm Health conference in Dana Point, Calif., on Tuesday. Read Full Article…

HVBA Article Summary

1. Elevating the Response: Stephen Gillett emphasizes the need for a paradigm shift in addressing cyber threats, likening the severity of attacks on infrastructure to acts of war. He suggests that responses should mirror the gravity of international incidents, stressing the importance of considering cyber threats as more than just technical issues.

2. Shift in Security Mindset: Traditional notions of security, focused on erecting perimeters to keep threats out, are outdated. Gillett advocates for a comprehensive approach that acknowledges the presence of threats within organizational perimeters. This requires a shift towards safeguarding critical data and intellectual property, necessitating a cultural transformation towards security and privacy consciousness across all levels of an organization.

3. Global Collaboration for Defense: Highlighting the sophistication and global nature of recent cyber attacks, Gillett proposes a collaborative defense strategy akin to a NATO for security. He argues that no single entity can combat cyber threats alone and emphasizes the need for international cooperation across industries and nations to effectively address the evolving landscape of cyber warfare.

The Mental Health Crisis Within the Mental Health Crisis

By Drew Altman - I remember meeting one evening many years ago with families of patients in one of our largest state psychiatric hospitals when I was Human Services Commissioner in New Jersey. I expected to see maybe 10 or 20 family members there that night, but hundreds came to express their frustration and outrage that more was not being done for their spouse, parent, child, or relative who was a patient there. Read Full Article…

HVBA Article Summary

1. Inadequate Mental Health Facilities and Care: The article highlights the dire state of mental health facilities, citing concerns about the quality of care, outdated facilities, and understaffing. Many patients, often from the correctional system, faced complex issues of substance use alongside mental illness, further exacerbating their conditions. Despite efforts to improve staffing and close dangerous facilities, systemic issues persisted, with mental health remaining a low funding priority in government allocations.

2. Impact on Families: Families bore the brunt of the mental health crisis, with their anguish palpable due to inadequate care and support systems. A significant portion of families faced severe crises, such as institutionalizing loved ones, dealing with drug overdoses, homelessness, self-harm, and even suicide. These events not only strained familial relationships but also had profound impacts on mental health, finances, and overall well-being.

3. Addressing the Crisis: The article underscores the urgent need to address the mental health crisis, emphasizing the importance of supporting families grappling with severe mental health-related events. While organizations like NAMI provide crucial advocacy and support, systemic changes and expanded services are essential to effectively address the crisis. Additionally, the article highlights the need for better access to mental health services and a shift in societal attitudes towards mental illness to truly tackle the problem.

Many people using GLP-1s for weight loss stop treatment too soon, research shows, and results are not one-size-fits-all

By Deidre McPhillips - Demand for Wegovy and other GLP-1 drugs used to treat obesity and diabetes has skyrocketed, but a new report suggests that many people may not be sticking with their weight-loss treatment long enough. Read Full Article…

HVBA Article Summary

1. Short Treatment Duration and Dropouts: The analysis of health insurance claims reveals that a significant portion of individuals prescribed GLP-1 medications for weight management fall short of the recommended treatment duration. Approximately 58% of users adhere to their treatment plan for less than 12 weeks, while more than 30% discontinue treatment within the first four weeks. This premature cessation often occurs before reaching the targeted dose, reflecting challenges in treatment adherence and continuity.

2. Factors Influencing Discontinuation: Various factors contribute to treatment discontinuation, including impatience with results, perceived ineffectiveness, and adverse side effects such as nausea and diarrhea. Lack of frequent interactions with healthcare providers and socioeconomic disparities exacerbate early discontinuation rates. However, the analysis underscores the pivotal role of provider support and comprehensive care services in enhancing treatment adherence and mitigating deterrents.

3. Real-world Efficacy and Long-term Benefits: While GLP-1 medications demonstrate substantial efficacy in clinical trials, real-world outcomes vary considerably. Reports indicate an average weight loss of approximately 1.4% after three months, gradually increasing to 3% after a year of consistent treatment. Despite heterogeneous individual responses, the medications offer potential benefits beyond weight loss, including cardiovascular and metabolic improvements. Thus, a nuanced approach to treatment evaluation, focusing on long-term health outcomes rather than solely on weight reduction, is essential in guiding patient-provider decision-making.

Reports of telehealth’s death have been greatly exaggerated

By Owen Tripp and Robin Glass - “Telehealth is collapsing.” “Telehealth is going through a contraction.” “There is a dark cloud hovering over virtual care.” These are just a few of the doomsday views sparked by the news that Optum and Walmart are shutting down their virtual care businesses. Many industry observers, connecting the dots to the current struggles of legacy telehealth providers, have concluded that virtual care is in trouble. Read Full Article…

HVBA Article Summary

1. Telehealth 1.0's Demise Signals Market Recognition of True Value: The collapse of Telehealth 1.0, the aftermarket telehealth solutions tethered to our fragmented health care system, signifies a welcome shift in focus towards more sophisticated virtual-first models. This shift validates the market's understanding of where genuine value lies in virtual care, moving beyond transactional, one-off interactions towards holistic, integrated approaches.

2. Access, Not Demand, Diminishes Post-Pandemic Telehealth Usage: Contrary to claims that patients are disinterested in telehealth, the decline in usage post-pandemic is primarily due to reduced access, not decreased demand. Patient satisfaction with virtual care remains high, with many preferring it when available. However, insurers' rollback of coverage and providers' reluctance to embrace virtual care contribute to this decline, emphasizing the importance of accessibility in sustaining virtual care utilization.

3. Virtual Care's Role in Cost Reduction and Equitable Healthcare: Despite concerns about overuse and increased costs, evidence suggests that virtual care can actually reduce healthcare expenses while improving outcomes, particularly among underserved populations. Studies, such as the one conducted with Walmart, highlight the potential of virtual primary care to lower costs, improve health outcomes, and address disparities. Far from driving up costs, virtual care emerges as a crucial tool for promoting equitable and efficient healthcare delivery.

Most weight loss drug users quit before seeing benefits, BCBS Association finds

By Jakob Emerson - A majority of patients taking weight loss drugs discontinue use of their medication before reaching a clinically meaningful health benefit, according to new research published May 21 by the Blue Cross Blue Shield Association. Read Full Article…

HVBA Article Summary

1. High Discontinuation Rates: 58% of patients discontinue GLP-1 use before experiencing clinically meaningful health benefits, highlighting challenges in treatment adherence.

2. Early Treatment Discontinuation: Shockingly, 30% of patients cease using weight loss drugs within the first month of treatment, indicating significant barriers to sustained engagement with therapy.

3. Prescriber Influence on Adherence: The source of the prescription plays a crucial role; patients receiving prescriptions from endocrinologists or obesity medicine specialists exhibit higher adherence rates compared to those prescribed by primary care providers, emphasizing the importance of specialized care in obesity management.

GSK whistleblower claims drugmaker cheated US government over Zantac cancer risk

By Jonathan Stempel - GSK (GSK.L), has been sued by an independent Connecticut laboratory that accused the drugmaker of defrauding the U.S. government and taxpayers by concealing cancer risks in Zantac, once a blockbuster heartburn drug. Read Full Article…

HVBA Article Summary

1. Concealment of Health Risks: Valisure alleges that GSK violated the federal False Claims Act by withholding information about the cancer-causing potential of Zantac (ranitidine) for nearly four decades. Despite knowing about the risks associated with the formation of NMDA, a carcinogen, GSK allegedly failed to disclose this information to regulatory authorities such as the FDA, while Medicare, Medicaid, and other health programs continued to cover prescriptions totaling billions of dollars.

2. Legal Battle and Seeking Damages: Valisure is seeking billions of dollars in damages from GSK, including civil fines of up to $11,000 per violation, through a complaint filed in Philadelphia. This legal action is based on the False Claims Act, which allows whistleblowers to sue on behalf of the federal government. GSK, in response, has labeled the lawsuit as "meritless" and criticized Valisure's testing methods, claiming the FDA found them "scientifically flawed and unreliable."

3. Ongoing Litigation and Public Health Concerns: The Zantac controversy has led to a surge in private lawsuits, with over 70,000 cases pending in U.S. courts. Despite a federal judge dismissing thousands of claims due to scientific disputes, the issue remains contentious, with ongoing trials addressing Zantac's alleged link to cancer. Additionally, the FDA's directive in April 2020 to remove Zantac and its generic equivalents from store shelves due to NDMA contamination underscores persistent public health concerns surrounding the drug.

ECG-Based AI Could Reduce Hospital Mortality

By Heidi Splete - An artificial intelligence (AI) system that sends text messages to alert hospital physicians about the high risk for mortality in their patients reduces the number of deaths, according to a study published in Nature Medicine. Read Full Article…

HVBA Article Summary

1. AI-Driven Risk Identification: Chin-Sheng Lin and his team developed an AI system trained on over 450,000 ECGs to identify patients at high risk of mortality. This system aims to detect deteriorating patients based on nuanced signs not easily discernible to human medical staff, potentially enabling timely intervention and intensified care.

2. Impactful Intervention: In a randomized controlled study involving 15,965 patients and 39 doctors, the AI intervention group received detailed reports and warning messages regarding high mortality risk, prompting closer monitoring or transfer to the intensive care unit. This proactive approach led to a significant reduction in overall mortality, particularly in cardiac deaths, compared to the control group.

3. Enhanced Patient Management: The study highlighted that AI warning messages were particularly effective for patients with high-risk ECGs, leading to increased transfers to the ICU, more frequent administration of medications like amiodarone, and greater utilization of additional diagnostic tests. While the exact mechanism behind the mortality reduction warrants further investigation, the findings underscore the potential of AI in early risk detection and improving patient outcomes through timely clinical intervention.