Publications by authors named "Frazer A Tessema"

Background: Direct-to-consumer (DTC) pharmacies sell generic prescription drugs, often at lower prices than traditional retail pharmacies; however, not all drugs are available, and prices vary.

Objective: To determine the availability and cost of generic drugs at DTC pharmacies.

Design: Cross-sectional study.

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  • CAR T-cells are a powerful immunotherapy for blood cancers, but their high cost makes them unaffordable for many countries.
  • As the demand for CAR T-cells rises and new therapies emerge, there’s a pressing need for strategies to lower costs and funding options.
  • The text discusses various factors contributing to the high expenses of CAR T-cell treatments and suggests potential reforms to address these issues.
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In July 2012, tenofovir disoproxil fumarate-emtricitabine (TDF-FTC, brand name Truvada) was approved by the Food and Drug Administration (FDA) to prevent HIV infection. To estimate the extent of the US government's direct financial contribution to the discovery and development of Truvada, we identified National Institutes of Health awards using FDA documents, peer-reviewed literature, patent records, court filings, and other publicly available materials. We classified seventy-three federal government awards to eleven researchers as being directly linked to the development and clinical testing of Truvada for prevention therapy, through which the US government spent an estimated $143 million.

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  • * The large number of potential patients poses significant financial challenges for healthcare systems.
  • * This situation could worsen health disparities, particularly for Black patients, who represent most of the sickle cell population in the U.S.
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Sickle cell trait (SCT) has historically been considered a benign condition, but SCT-positive patients have increased baseline risk of venous thromboembolism and chronic kidney disease, as well as increased risk of sickled erythrocytes in settings of hypoxia, acidosis, and hypovolemia. Multisystem traumatic injuries are a common clinical scenario, in which hypoxia, acidosis, and hypovolemia occur; however, little is known about how SCT-positive status impacts outcomes in multisystem trauma. We conducted a scoping literature review to investigate what was known about SCT in the setting of multisystem trauma.

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List prices for brand-name drugs have risen steeply, often despite the introduction of competition from other brand-name drugs in the same therapeutic class. List prices, however, do not reflect any rebates that manufacturers provide payers. To understand how net prices (after rebates and other discounts) respond to competition, we compared changes in inflation-adjusted, revenue-weighted mean list and net prices of a one-month supply of three classes of diabetes drugs: glucagon-like peptide 1 (GLP1) agonists, dipeptidyl peptidase 4 (DPP4) inhibitors, and sodium glucose cotransporter 2 (SGLT2) inhibitors.

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  • REMS programs aim to improve the safe use of FDA-approved drugs, but there is ongoing debate about their effectiveness.
  • This study focused on analyzing changes in the prescription of erythropoiesis stimulating agents (ESAs), specifically darbepoetin alfa and epoetin alfa, among cancer patients after a REMS warning against their use in patients with hemoglobin levels above 10 g/dL.
  • The results showed a decline in the initiation rates of both drugs among cancer patients, yet the changes observed post-implementation and enforcement of the REMS program were not statistically significant.
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The approval of sofosbuvir (Sovaldi) in 2013 transformed chronic hepatitis C virus (HCV) care, but its high cost was criticized in part because of reports of substantial public involvement in its development. We developed a methodology to assess the public's contribution through the National Institutes of Health (NIH) in developing sofosbuvir. Using key terms from the timeline of sofosbuvir, we identified articles in PubMed; linked them to federal funding using the NIH RePORTER; reviewed the title, organization, and investigator of each resulting award for relatedness; and converted related awards to 2018 US dollars.

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Importance: Market exclusivity for daily injections of glatiramer acetate, a disease-modifying therapy for multiple sclerosis, expired in 2015. In 2014, the manufacturer launched an alternate 3-times-weekly version that was widely adopted, sustaining market dominance of brand-name glatiramer until late 2017.

Objective: To estimate excess US spending associated with the transition from daily to 3-times-weekly glatiramer.

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  • Recent court rulings have challenged FDA rules on promoting prescription drugs for unapproved uses, prompting a study on how different types of information affect physicians' views on drug efficacy.
  • The study involved surveys sent to cardiologists, internists, and endocrinologists, presenting them with scenarios about a hypothetical drug based on real FDA guidance for Vascepa, a fish oil approved for certain off-label promotions.
  • Findings showed that doctors receiving off-label promotion information prescribed it significantly more often, but those exposed to thorough evidence context were less likely to believe in its unproven cardiovascular benefits compared to those who received basic disclaimers.
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Background: Step therapy policies that require prescribers to follow an ordered protocol for drug choices are widely used by public and private insurers to manage medication costs; however, the perceptions of prescribing physicians regarding these policies have not been studied.

Objective: To determine physician attitudes toward step therapy policies and the correlation of these beliefs with physician characteristics.

Methods: A sample of clinically active physicians specializing in internal medicine, cardiology, or endocrinology received a survey administered online or via mail.

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Drug Safety Communications (DSCs) are used by the Food and Drug Administration (FDA) to inform health care providers, patients, caregivers, and the general public about safety issues related to FDA-approved drugs. To assess patient knowledge of the messaging contained in DSCs related to the sleep aids zolpidem and eszopiclone, we conducted a large, cross-sectional patient survey of 1,982 commercially insured patients selected by stratified random sampling from the Optum Research Database who had filled at least two prescriptions for either zolpidem or eszopiclone between July 1, 2012 and June 30, 2013. Among the 594 respondents (32.

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  • Noninferiority trials in oncology evaluate whether a new cancer treatment is at least as effective as an existing one in terms of patient survival, with specific acceptable margins for performance.
  • A systematic review was conducted on published noninferiority trials, focusing on those that used overall survival as their primary outcome, while excluding non-drug therapies.
  • Of the 74 trials examined, 31% justified the noninferiority design, and the study aimed to analyze the relationship between trial funding and both the justification and success of achieving noninferiority.
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  • A nationwide survey was conducted among US primary care internists and medical specialists.
  • The survey aimed to gauge physicians' opinions on the FDA's standards for drug approval.
  • It also examined their views on the practice of off-label drug marketing.
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