Pharmaceutical Industry Support of US Patient Advocacy Organizations: An International Context.

OBJECTIVES: To examine whether the share of pharmaceutical industry funds allocated to patient advocacy organizations (PAOs) is disproportionately large in the United States relative to other industrialized countries and to compare pharmaceutical companies' disclosure practices across industrialized countries. METHODS: We examined funding of PAOs among the 10 largest pharmaceutical companies in 2016. We compared funding allocated to organizations across 8 large industrialized countries and pharmaceutical companies' disclosure practices in each country. RESULTS: Only 6 of the 10 largest pharmaceutical companies disclosed their financial transactions with PAOs in the United States. All 10 companies disclosed transactions in France, Germany, and the United Kingdom, with varying levels of disclosure in other countries. In 2016, the 6 companies that disclosed transactions in the United States allocated 74% of their patient advocacy funding ($88 million) in the United States. CONCLUSIONS: The disproportionate funding of US PAOs in the absence of any disclosure requirements suggests that the United States should consider adoption of regulatory actions to enhance the transparency of relationships between the pharmaceutical industry and PAOs, and to ensure the integrity of public health decision-making.

Industry Support of Patient Advocacy Organizations: The Case for an Extension of the Sunshine Act Provisions of the Affordable Care Act.

Patient advocacy organizations (PAOs) have long been regarded as important representatives of patient and caregiver interests in health policy debates. Recently, however, PAOs have attracted increased scrutiny over their financial ties to drug and device companies. In the past year, researchers and policymakers have called for the creation of a "sunshine law" requiring mandatory public reporting of industry payments to PAOs. Others have suggested that increased transparency would do little to address, and may even exacerbate, underlying concerns about proindustry bias among industry-funded PAOs. To date, however, the benefits of a sunshine law have not been well articulated, nor have objections to the idea been carefully addressed. In particular, little attention has been paid to clarifying the merits of statutorily mandated disclosure relative to those of increased voluntary disclosure by PAOs. I examine arguments for and against a sunshine law and conclude that the balance of reasons supports the enactment of such a law.

The path to successful commercialization of cell and gene therapies: empowering patient advocates.

Often, novel gene and cell therapies provide hope for many people living with incurable diseases. To facilitate and accelerate a successful regulatory approval and commercialization path for effective, safe and affordable cell and gene therapies, the involvement of patient advocacy groups (PAGs) should be considered early in the development process. This report provides a thorough overview of the various roles PAGs play in the clinical translation of cell and gene therapies and how they can bring about positive changes in the regulatory process, infrastructure improvements and market stability.

Impact of the increased adoption of prenatal cfDNA screening on non-profit patient advocacy organizations in the United States.

The 'Stakeholder Perspectives on Noninvasive Prenatal Genetic Screening' Symposium was held in conjunction with the 2015 annual meeting of the International Society for Prenatal Diagnosis. During the day-long meeting, a panel of patient advocacy group (PAG) representatives discussed concerns and challenges raised by prenatal cell-free DNA (cfDNA) screening, which has resulted in larger demands upon PAGs from concerned patients receiving prenatal cfDNA screening results. Prominent concerns included confusion about the accuracy of cfDNA screening and a lack of patient education resources about genetic conditions included in cfDNA screens. Some of the challenges faced by PAGs included funding limitations, lack of consistently implemented standards of care and oversight, diverse perspectives among PAGs and questions about neutrality, and lack of access to training and genetic counselors. PAG representatives also put forward suggestions for addressing these challenges, including improving educational and PAG funding and increasing collaboration between PAGs and the medical community. © 2016 John Wiley & Sons, Ltd.

Disparate Patient Advocacy When Facing Unaffordable and Problematic Medical Bills.

Importance: People in the US face high out-of-pocket medical expenses, yielding financial strain and debt. Objective: To understand how households respond to medical bills they disagree with or cannot afford. Design, Setting, and Participants: A retrospective cohort study was carried out using a survey fielded between August 14 and October 14, 2023. The study included a random sample of adult (aged ≥18 years) survey respondents from the Understanding America Study (UAS). Participant responses were weighted to be nationally representative. The analysis took place from November 3, 2023, through January 8, 2024. Main Outcomes and Measures: Respondents reported if their household received a medical bill that they could not afford or did not agree with in the prior 12 months, and if anyone contacted the billing office regarding their concerns. Those who did reach out were asked about their experience and those who did not were asked why. Results: The survey was sent to 1233 UAS panelists, of which 1135 completed the survey, a 92.1% cooperation rate. Overall, 1 in 5 of the 1135 respondents received a medical bill that they disagreed with or could not afford. Leading bill sources were physician offices (66 [34.6%]), emergency room or urgent care (22 [19.9%]), and hospitals (31 [15.3%]), and 136 respondents (61.5%) contacted the billing office to address their concern. A more extroverted and less agreeable personality increased likelihood of reaching out. Respondents without a college degree, lower financial literacy, and the uninsured were less likely to contact a billing office. Among those who did not reach out, 55 (86.1%) reported that they did not think it would make a difference. Of those who reached out, 37 (25.7%) achieved bill corrections, better understanding (16 [18.2%]), payment plans (18 [15.5%]), price drop (17 [15.2%]), financial assistance (10 [8.1%]), and/or bill cancellation (6 [7.3%]), while 32 (21.8%) said that the issue was unresolved and 23.8% reported no change. These outcomes aligned well with respondents' billing concerns with financial relief for 75.8% of respondents reaching out about an unaffordable bill, bill corrections for 73.7% of those who thought there was mistake, and a price drop for 61.8% of those who negotiated. Conclusions and Relevance: This cross-sectional survey of a representative sample of patients in the US found that most respondents who self-advocated achieved bill corrections and payment relief. Differences in self-advocacy may be exacerbating socioeconomic inequalities in medical debt burden, as those with less education, lower financial literacy, and the uninsured were less likely to self-advocate. Policies that streamline the administrative burden or shift it from patients to the billing clinician may counter these disparities.

The development of practice guidelines for independent living donor advocates.

The practice recommendations discussed here are based on the findings of the national survey as well as the opinions of the authors. The recommendations that are proposed here are not exhaustive and are aspirational in intent and are likely to evolve with time. Practice guidelines are recommended for legal and regulatory issues (e.g., state or federal laws), consumer or public benefit (e.g., improving service delivery, avoiding harm to the patient, decreasing disparities in underserved or vulnerable populations), and for professional guidance (e.g., new role, professional risk management issues, advances in practice). Without such practice guidelines, donors, and indirectly the candidates, may be at increased risk for possible bias or undue harm.

The evolution of advocacy and orthopaedic surgery.

BACKGROUND: The future direction of American health care has become increasingly controversial during the last decade. As healthcare costs, quality, and delivery have come under intense scrutiny, physicians play evolving roles as "advocates" for both their profession and patients via healthcare policy. Hospital-physician alignment is critical to the future success of advocacy among orthopaedic surgeons, as both hospitals and physicians are key stakeholders in health care and can work together to influence major health policy decisions. QUESTIONS/PURPOSES: We (1) define the role of advocacy in medicine, specifically within orthopaedic surgery; (2) explore the history of physician advocacy and its evolution; (3) examine the various avenues of involvement for orthopaedic surgeons interested in advocacy; and (4) reflect on the impact of such activities on the future of orthopaedic surgery as it relates to hospital-physician alignment. METHODS: We performed a comprehensive review of the literature through a bibliographic search of MEDLINE(®) and Google Scholar databases from January 2000 to December 2010 to identify articles related to advocacy and orthopaedic surgery. RESULTS: Advocacy among orthopaedic surgeons is critical in guiding the future of the American healthcare system. In today's world, advocacy necessitates a wider effort to improve healthcare access, quality, and delivery for patients on a larger scale. The nature of physician advocacy among orthopaedic surgeons is grounded in the desire to serve patients and alleviate their suffering. Participation in medical societies and political campaigns are two avenues of involvement. CONCLUSIONS: The increasing role of government in American health care will require a renewed commitment to advocacy efforts from orthopaedic surgeons. The role of advocacy is rapidly redefining the continuum of care to a trinity of clinical excellence, innovative research, and effective advocacy. Failure to recognize this growing role of advocacy limits the impact we can have for our patients.

[Briefing and accusation of medical malpractice--the second victim]. / Aufklärung und Behandlungsfehlervorwurf--Das zweite Opfer.

In June 2012, the German Medical Association (Bundesärztekammer) published the statistics of medical malpractice for 2011 [1]. Still ENT-specific accusations of medical malpractice are by far the fewest in the field of hospitals and actually even in the outpatient context. Clearly most of the unforeseen incidents still occur in the disciplines of trauma surgery and orthopedics. In total, however, an increasing number of errors in treatment can be noticed on the multidisciplinary level: in 25.5% of the registered cases, an error in treatment was found to be the origin of damage to health justifying a claim for compensation of the patient. In the year before, it was only 24.7%. The reasons may be manifold, but the medical system itself certainly plays a major role in this context: the recent developments related to health policy lead to a continuous economisation of medical care. Rationing and limited remuneration more and more result in the fact that therapeutic decisions are not exclusively made for the benefit of the patient but that they are oriented at economic or bureaucratic aspects. Thus, in the long term, practising medicine undergoes a change. According to the §§ 1, 3 of the professional code of conduct for doctors (Musterberufsordnung für Ärzte; MBO-Ä) medical practice as liberal profession is principally incompatible with the pursuit of profit, however, even doctors have to earn money which more and more makes him play the role of a businessman. Lack of personnel and staff savings lead to excessive workloads of physicians, caregivers, and nurses, which also favour errors. The quality and even the confidential relationship between doctor and patient, which is important for the treatment success, are necessarily affected by the cost pressure. The victims in this context are not only the patients but also the physicians find themselves in the continuous conflict between ethical requirements of their profession and the actual requirements of the realities in the healthcare field. But also the technical and scientific progress bear new risks beside the therapeutic successes, further especially bigger hospitals require high efforts regarding organisation favouring errors in cases of deficiencies. Even the increasing juridification of the medicine that is expected to achieve a provisional highlight with the planned law of patients' rights leads to an important focus on the quality of medical care [2]. The explicit legal regulation of patients' rights, which have never been out of question up to now, confirms the impression of patients who have to be protected from their doctors. This development favours a natural mistrust in the quality of the treatment and the desire of legal verification in cases of treatment failures. A totally perfect and error-free treatment, however, will never occur. Already this fact leads to the obligation to do everything possible to reduce the risk to an absolute minimum. The risks that might arise from a relation of treatment are manifold. Not only may the patient undergo risks that arise in particular from lacking or insufficient briefing, complications, or medical malpractice. Also the doctor has to fear legal consequences if he does not stick clearly to the increasing requirements that jurisdiction and legislation impose - not least by the planned law of patients' rights. In the following, the basic principles and particularities will be described that apply for the patients' briefing. Further the different types of medical malpractice will be explained in relation to the resulting procedural consequences. Finally some current problematic fields will be described with regard to other possible liabilities or responsibilities of physicians in hospitals or doctor's offices.

Local and national advocacy support.

Decisions by third-party payors that are restricting delivery of appropriate IgG treatment for primary immunodeficiency disease (PIDD) are summoning action from patients, physicians, and their organizations to ensure that high quality treatment remains accessible. Some of the strongest advocacy to date is from patient organizations, such as the Immune Deficiency Foundation (IDF), which strive to educate stakeholders on key issues that determine patient access to appropriate IgG treatment. These issues include the ability to choose the appropriate site of care based on a patient's experience and circumstance and greater awareness of product choice. Advocacy by physicians on these issues at the local level is needed, as are national efforts by organizations such as the American Academy of Allergy, Asthma & Immunology and their regional societies.

Building global advocacy for nutrition: a review of the European and U.S. landscapes.

BACKGROUND: An estimated two billion people globally suffer from undernutrition, and yet, despite consensus that improving nutrition is one of the best investments for promoting health and alleviating poverty, nutrition remains chronically underfunded and under-prioritized. Successfully scaling global efforts to address undernutrition requires an understanding of the landscape of potential donors and partners that can be mobilized toward improving nutrition globally. OBJECTIVE: To conduct independent reviews of the European and US landscapes of donors and partners focused on undernutrition, and identify opportunities to leverage outreach and advocacy efforts toward increased engagement and funding for nutrition. METHODS: We present the primary findings from two independent landscaping studies conducted between September 2010 and March 2011. Research methods included desk-based research and interviews with stakeholders in bilateral and multilateral organizations (n=19), private industries (n=46), private funders (n=16), and civil society organizations (n=29). We report the key thematic findings by sector and the challenges and opportunities for increased engagement and funding for nutrition. RESULTS: Nutrition is a growing priority for a number of stakeholders across sectors. Strategic commitment to nutrition is emerging across multilateral and bilateral donor agencies; the private sector is increasingly interested in engaging in addressing undernutrition; and nongovernmental and civil society groups are engaged in nutrition advocacy. Key opportunities to increase funding and partnership across sectors include leveraging bilateral and multilateral investments for nutrition across development priorities while ensuring sound commitments within donor policies, focusing on engaging the private sector across the food value chain, mobilizing new resources from private funders through effective communication and outreach, and continuing to prioritize ongoing impact assessment across a range of interventions. CONCLUSIONS: Understanding the current European and US landscape of nutrition stakeholders helps to inform efforts to scale the type of investments and partnership needed to make effective impacts on undernutrition globally. Turning the existing opportunities into results will require effective coordination, strong communication, and active participation across sectors.

Patient advocacy in the community and legislative arena.

Nurses have hundreds of patient experiences upon which to draw in order to impact public policy. It is our obligation to strengthen skills that enable us to influence public policy so we can better serve patients. This article provides examples of how nurses can translate their hands-on experience with patients into steps that will influence policy. We begin by describing advocacy and providing examples of how nurses can advocate in the community, specifically in economic matters and the educational and healthcare systems. Then we describe the process for advocating in the legislative arena. We conclude by noting that the public needs the voice of nursing in public policy and that now is the time to move forward to advocate for patients in these various arenas.

Management of serious adverse drug reactions: proposals from a victims' organisation.

Amalyste is a French patient-advocacy group for victims of two very serious adverse drug reactions: Lyell and Stevens-Johnson syndromes. The aims of this organisation are to represent the interests of patients who have experienced these syndromes; to better inform the public about these syndromes; to provide analyses of drug-related risks; and to demand collective compensation for victims of serious adverse drug reactions. The following text is our translation of an Amalyste position statement on drug-related risks. It provides valuable food for thought, both for healthcare professionals and for drug regulatory agencies, and has the potential to improve practice (a).

Deprivation of Liberty Safeguards in England: implementation costs.

BACKGROUND: The Deprivation of Liberty Safeguards (DoLS), introduced into the Mental Capacity Act 2005, were fully implemented on 1 April 2009 in England and Wales. The government estimated 20 000 assessments for DoLS at a cost of £600 per assessment. Aims To estimate the costs likely to be incurred with the implementation of DoLS in England. METHOD: The cost of conducting a single DoLS assessment was estimated using resource-utilisation data ascertained from 37 professionals, secretarial staff and independent mental capacity advocates involved with DoLS assessments in six diverse local DoLS offices. RESULTS: The estimated average cost of a single DoLS assessment was £1277. CONCLUSIONS: The estimated average cost of a single DoLS assessment was significantly higher than the £600 estimated by the government. However, the allocated budget, based on 20 000 estimated DoLS assessments in the first year of its implementation, is likely to be adequate because a significantly lower number of assessments (only 5200) were conducted in the first 9 months after its implementation.