Healing an ailing pharmaceutical system: prescription for reform for United States and Canada

Gaffney, Adam; Lexchin, Joel

doi:10.1136/bmj.k1039

Cited by 24 publications

(28 citation statements)

References 80 publications

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“…It is also important to consider whether the public interest is served by our current system of drug development. At present, incentives encourage companies “to generate new patents on minor variations in order to charge patent protected prices” and there is no requirement for evidence that new products provide evidence of value above existing therapies . This is a regrettable waste of money and talent that could be used to develop truly beneficial and novel treatments.…”

Section: Discussionmentioning

confidence: 99%

Safety Problems With a Transdermal Patch for Migraine: Lessons From the Development, Approval, and Marketing Process

2018

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Objective We sought to analyze publicly available information about patient harm associated with an iontophoretic sumatriptan patch, to identify what went wrong and to suggest ways in which similar problems might be prevented in the future. Background The Zecuity® sumatriptan iontophoretic transdermal system was marketed for acute treatment of migraine. The patch was withdrawn less than 10 months after its introduction because of multiple reports of scarring and burning. As of 2018, the FDA Adverse Event Reporting System public dashboard lists a total of 2889 reports of safety problems with the patch, 904 of which were classified as serious. Methods For this narrative review, we examined US Food and Drug Administration documents related to the new drug application for this product and its approval. We searched Clinicaltrials.gov, PubMed, Google, Facebook, Twitter, and Instagram public posts for relevant information relating to the patch, its approval, marketing, and complications. Results The FDA knew about problems with burns and scarring prior to approval of the product, and turned down the initial new drug application for this reason and because of other quality problems with the patch. The reapplication was approved despite continued concerns of several FDA reviewers about safety. The approval required the manufacturer to comply with enhanced postmarketing safety reporting. However, product information and labeling did not mention the possibility of burns or scarring. Approval was based on 1 clinical trial and 2 open label studies in which reporting of adverse events was suboptimal. The clinical trials had been prospectively registered but outcomes had been changed around the time the trial concluded. Aggressive marketing efforts and social media activity may have contributed to inaccurate perceptions of safety and efficacy, but social media also provided a written and photographic record of burns and other harm suffered by patients who used the patch. Conclusions Our review identified several problems with the development, testing, approval, and marketing of the Zecuity patch. To improve the process of developing headache treatments, it is important to consider the lessons that can be drawn from an examination of this high‐profile failure of the drug development and regulatory system.

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Section: Discussionmentioning

confidence: 99%

Safety Problems With a Transdermal Patch for Migraine: Lessons From the Development, Approval, and Marketing Process

2018

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“…Lower drug spending is typically the second largest source of savings with single-payer, and predicts large net savings. The US Veterans Administration (VA) gets a 30% discount on prescription medications compared to private Medicare Advantage Plans [38,39]. US per-capita drug spending exceeds that of any other country [38,39].…”

Section: Empirical Evidence For Model Assumptionsmentioning

confidence: 99%

“…The US Veterans Administration (VA) gets a 30% discount on prescription medications compared to private Medicare Advantage Plans [38,39]. US per-capita drug spending exceeds that of any other country [38,39]. Drug prices are the primary driver of higher cost, with the US spending $1,011 annually per capita on prescription drugs compared to the OECD average of $422 [11].…”

Section: Empirical Evidence For Model Assumptionsmentioning

confidence: 99%

Projected costs of single-payer healthcare financing in the United States: A systematic review of economic analyses

et al. 2020

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Background The United States is the only high-income nation without universal, government-funded or-mandated health insurance employing a unified payment system. The US multi-payer system leaves residents uninsured or underinsured, despite overall healthcare costs far above other nations. Single-payer (often referred to as Medicare for All), a proposed policy solution since 1990, is receiving renewed press attention and popular support. Our review seeks to assess the projected cost impact of a single-payer approach. Methods and findings We conducted our literature search between June 1 and December 31, 2018, without start date restriction for included studies. We surveyed an expert panel and searched PubMed, Google, Google Scholar, and preexisting lists for formal economic studies of the projected costs of single-payer plans for the US or for individual states. Reviewer pairs extracted data on methods and findings using a template. We quantified changes in total costs standardized to percentage of contemporaneous healthcare spending. Additionally, we quantified cost changes by subtype, such as costs due to increased healthcare utilization and savings due to simplified payment administration, lower drug costs, and other factors. We further examined how modeling assumptions affected results. Our search yielded economic analyses of the cost of 22 single-payer plans over the past 30 years. Exclusions were due to inadequate technical data or assuming a substantial ongoing role for private insurers. We found that 19 (86%) of the analyses predicted net savings (median net result was a savings of 3.46% of total costs) in the first year of program operation and 20 (91%) predicted savings over several years; anticipated growth rates would result in long-term net savings for all plans. The largest source of savings was simplified payment administration (median 8.8%), and the best predictors of net savings were the magnitude of utilization increase, and

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“…The “American Patients First” roadmap and accompanying FDA initiatives will not bend the curve of rising drug prices in the near or long term . Some of the proposals hint at reducing health‐care benefits and cutting safety nets for the poor, and increasing profits in the private market (eg, stopping Medicaid and Affordable Care Act programs from raising prices in the private market; reforming the Medicaid Drug Rebate Program and the 340b Drug Discount Program).The 50 broad points of the blueprint can be distilled to six relevant ones (Table ).…”

Section: The “American Patients First” Blueprintmentioning

confidence: 99%

“…Can the “American Patients First” blueprint, as proposed, succeed? Most health‐care experts conclude it cannot in its present form . The blueprint, intended to deliver on campaign promises, has deviated from the promises that could have had the most impact.…”

Section: How Should the “American Patients First” Blueprint Be Modified?mentioning

confidence: 99%

The “American (cancer) patients first” plan to reduce drug prices—A critical assessment

Kantarjian

Light

2018

American J Hematol

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Healing an ailing pharmaceutical system: prescription for reform for United States and Canada

Abstract: Our pharmaceutical systems are broken, and only fundamental reform can ensure universal access to safer, more innovative, and more affordable drugs

Cited by 24 publications

References 80 publications

Safety Problems With a Transdermal Patch for Migraine: Lessons From the Development, Approval, and Marketing Process

Safety Problems With a Transdermal Patch for Migraine: Lessons From the Development, Approval, and Marketing Process

Projected costs of single-payer healthcare financing in the United States: A systematic review of economic analyses

The “American (cancer) patients first” plan to reduce drug prices—A critical assessment

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