Five years of pharmaceutical industry funding of patient organisations in Sweden: Cross-sectional study of companies, patient organisations and drugs.

BACKGROUND: Many patient organisations collaborate with drug companies, resulting in concerns about commercial agendas influencing patient advocacy. We contribute to an international body of knowledge on patient organisation-industry relations by considering payments reported in the industry's centralised 'collaboration database' in Sweden. We also investigate possible commercial motives behind the funding by assessing its association with drug commercialisation. METHODS: Our primary data source were 1,337 payment reports from 2014-2018. After extraction and coding, we analysed the data descriptively, calculating the number, value and distribution of payments for various units of analysis, e.g. individual companies, diseases and payment goals. The association between drug commercialisation and patient organisation funding was assessed by, first, the concordance between leading companies marketing drugs in specific diseases and their funding of corresponding patient organisations and, second, the correlation between new drugs in broader condition areas and payments to corresponding patient organisations. RESULTS: 46 companies reported paying €6,449.224 (median €2,411; IQR €1,024-4,569) to 77 patient organisations, but ten companies provided 67% of the funding. Small payments dominated, many of which covered costs of events organised by patient organisations. An association existed between drug commercialisation and industry funding. Companies supported patient organisations in diseases linked to their drug portfolios, with the top 3 condition areas in terms of funding-cancer; endocrine, nutritional and metabolic disorders; and infectious and parasitic disorders-accounting for 63% of new drugs and 56% of the funding. CONCLUSION: This study reveals close and widespread ties between patient organisations and drug companies. A relatively few number of companies dominated the funding landscape by supporting patient organisations in disease areas linked to their drug portfolios. This commercially motivated funding may contribute to inequalities in resource and influence between patient organisations. The association between drug commercialisation and industry funding is also worrying because of the therapeutic uncertainty of many new drugs. Our analysis benefited from the existence of a centralised database of payments-which should be adopted by other countries too-but databases should be downloadable in an analysable format to permit efficient and independent analysis.

Predicted economic damage from a quick, simple Alzheimer's disease cure.

The estimated 5.8 million Alzheimer's disease patients in the U.S. require an enormous share of national healthcare expenditures. Other nations face similar economic burdens. There have been great efforts, thus far unsuccessful, to discover an effective therapeutic, with 1081 Alzheimer's disease drug trials completed as of May 2019. The pessimism thus engendered has forestalled contingency planning for the potential major economic repercussions of a simple, quick cure. Yet, promising new research spotlighting the possible "trigger" role of infectious agents might allow some or all cases of Alzheimer's disease to be halted, reversed, or prevented with an antibiotic or antiviral compound, possibly even one already approved by drug regulators for other uses. The sudden advent of such an unexpected therapy would theoretically have dramatic impacts, both detrimental and beneficial, on the American economy. The damages would include a $414 billion shrinkage of Medicaid, Medicare and other revenues to all six sectors comprising the healthcare provider category. Nursing homes and skilled nursing facilities are projected to suffer the greatest loss of annual revenue: $51 billion and $16 billion, respectively. This would cause the loss of an estimated 654,000 jobs. Facility mortgage and commercial loan repayments could stop. Other adverse consequences would include detrimental effects on reserves for Social Security and pensions, cutbacks in dementia research funding, and reduced donations to Alzheimer's disease advocacy groups. Insurance company reserves for fixed payment annuities already sold could be jeopardized. However, an Alzheimer's disease cure would also create economic beneficiaries. Medicare and Medicaid would save up to a projected $195 billion annually. Life insurance companies and unpaid caregivers would also benefit financially. By identifying the healthcare sectors likely to be detrimentally impacted by a simple, quick Alzheimer's disease cure, contingency plans can be made in the U.S. and other countries to assist the foreseeable painful transitions for staff and facilities.

The Role of Physicians in the Allocation of Health Care: Is Some Justice Better than None?

Physicians' advocacy obligations are best understood as going beyond advocacy on behalf of individual patients, which I call the "individualistic view," to include advocacy for intelligent research-based allocation schemes that promote good outcomes and cost-effective care for all patients, which I call the "systemic view." This systemic view includes moving beyond self-interest to promote less-wasteful and more cost-conscious allocation decisions and the setting of priorities at all levels to expand health care access. It includes physician involvement in discussions with patients in the context of clinical care, involvement in the formulation and administration of benefit structures and other allocation policies, and, finally, involvement in promoting public dialogue about health care priorities. This involvement is based on a concept of a deliberative process that can result in "just enough" decisions within systems for the preservation and promotion of health care and other societal goods.

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.

Ethical Framework for Risk Stratification and Mitigation Programs for Children With Medical Complexity.

Those in hospitals and health care systems, when designing clinical programs for children with medical complexity, often talk about needing to develop and implement a system of risk stratification. In this article, we use the framework of an ethical evaluation of a health care program to examine what this task of risk stratification might entail by identifying specific and detailed issues that require particular attention and making a series of recommendations to help ensure that programs for children with medical complexity avoid potentially ethically problematic situations and practices.

Patient-Centered Drug Approval: The Role of Patient Advocacy in the Drug Approval Process.

Recent approval of eteplirsen for Duchenne muscular dystrophy (DMD), a rare disease with few treatment alternatives, has reignited the debate over the U.S. drug approval process. The evolution of legal and regulatory restrictions to the marketing and sale of pharmaceuticals has spanned more than a century, and throughout this history, patient advocacy has played a significant role. Scientific evidence from clinical trials serves as the foundation for drug approval, but the patient voice has become increasingly influential. Although the gold standard for establishing safety and efficacy through randomized controlled trials has been in place for more than 50 years, it poses several limitations for rare disorders where patient recruitment for traditional clinical trials is a major barrier. Organized efforts by patient advocacy groups to help patients with rare diseases access investigational therapy have had a legislative and regulatory effect. After approval by the FDA, patient access to therapy may still be limited by cost. A managed care organization (MCO) with the fiduciary responsibility of managing the health of a population must weigh coverage decisions for costly therapies with questionable effectiveness against alternatives within the constraint of a finite budget. Even when the FDA deems a drug safe and effective, an MCO may determine that the drug should only be made available at a tier level where out-of-pocket costs are still too high for many patients. This limitation of availability may be due to cost, other treatment alternatives, or outcomes from existing clinical evidence. However, if the MCO makes a costly new treatment for a rare disease readily available, it may temporarily satisfy a small contingency at the cost of all of its members. This article examines the risks and benefits of patient-centered drug approval and the potential economic effect of patient-centered drug approval on population health. DISCLOSURES: There is no funding to disclose. Mattingly reports advisory board fees from Summit Therapeutics and an educational grant from ALK, outside of this article. Simoni-Wastila has nothing to disclose. Mattingly took the lead in conceptualizing this Viewpoint article and writing the manuscript, along with Simoni-Wastila. Both authors contributed equally to manucript revision.

Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest.

Importance: Patient advocacy organizations (PAOs) are influential health care stakeholders that provide direct counseling and education for patients, engage in policy advocacy, and shape research agendas. Many PAOs report having financial relationships with for-profit industry, yet little is known about the nature of these relationships. Objective: To describe the nature of industry funding and partnerships between PAOs and for-profit companies in the United States. Design, Setting, and Participants: A survey was conducted from September 1, 2013, to June 30, 2014, of a nationally representative random sample of 439 PAO leaders, representing 5.6% of 7865 PAOs identified in the United States. Survey questions addressed the nature of their activities, their financial relationships with industry, and the perceived effectiveness of their conflict of interest policies. Main Outcomes and Measures: Amount and sources of revenue as well as organizational experiences with and policies regarding financial conflict of interest. Results: Of the 439 surveys mailed to PAO leaders, 289 (65.8%) were returned with at least 80% of the questions answered. The PAOs varied widely in terms of size, funding, activities, and disease focus. The median total revenue among responding organizations was $299 140 (interquartile range, $70 000-$1 200 000). A total of 165 of 245 PAOs (67.3%) reported receiving industry funding, with 19 of 160 PAOs (11.9%) receiving more than half of their funding from industry. Among the subset of PAOs that received industry funding, the median amount was $50 000 (interquartile range, $15 000-$200 000); the median proportion of industry support derived from the pharmaceutical, device, and/or biotechnology sectors was 45% (interquartile range, 0%-100%). A total of 220 of 269 respondents (81.8%) indicated that conflicts of interest are very or moderately relevant to PAOs, and 94 of 171 (55.0%) believed that their organizations' conflict of interest policies were very good. A total of 22 of 285 PAO leaders (7.7%) perceived pressure to conform their positions to the interests of corporate donors. Conclusions and Relevance: Patient advocacy organizations engage in wide-ranging health activities. Although most PAOs receive modest funding from industry, a minority receive substantial industry support, raising added concerns about independence. Many respondents report a need to improve their conflict of interest policies to help maintain public trust.

Two decades of nation-wide community-based stroke support - The Singapore National Stroke Association.

The Singapore National Stroke Association, registered in 1996, offers support and information to stroke survivors and caregivers, and aims to raise public stroke awareness. In the last 20 years, we have developed programs to equip stroke survivors and caregivers with knowledge, life skills, comfort, and opportunities for socialization and reintegration. We have on-going public education and advocacy initiatives. Obtaining funding, member recruitment, volunteer retention, and leadership renewal are on-going challenges. Singapore National Stroke Association will continue to strive for the betterment of stroke survivors, their caregivers, and the public.

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.

Financial Health and Mental Health Among Clients of a Community Mental Health Center: Making the Connections.

OBJECTIVES: This study evaluated financial challenges, satisfaction with financial-management supports, and interest in additional or alternative supports among clients of a mental health center. METHODS: Six focus groups were held with 39 clients of an urban community mental health center who reported having difficulty with their finances. Five focus groups were held with direct-care staff who provided services to the clients. Investigators used an inductive analytical approach to distill themes from notes taken during the focus groups. RESULTS: Clients emphasized the challenges of living in poverty and described using complex strategies to sustain themselves, including negotiating benefits systems, carefully planning purchases, and developing and relying on social relationships. They spoke of having uneven access to tools and services for managing their money, such as advice from direct-care staff, representative payees, and bank accounts, and had varying opinions about their value. Noting concerns similar to those of clients, direct-care staff expressed frustration at the lack of support services for helping clients manage their finances. Both clients and staff expressed the need for more services to help clients with their finances. CONCLUSIONS: Findings suggest a need for more services to support people with mental illness to manage their finances, particularly a more flexible and broader range of options than are provided by current representative-payee mechanisms.