Browsing by Subject "Food and Drug Administration"

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    HOW DO DIRECT-TO-CONSUMER DRUG ADVERTISEMENTS MEASURE UP?
    (Office of the Vice Chancellor for Research, 2012-04-13) Hamid, Abdelaziz; Cox, Tony; Cox, Dena
    Prior to the 1980's, it was illegal for prescription drug manufacturers in the United States to advertise directly to consumers. Instead, these compa-nies only advertised to medical professionals. Several prescription drug companies began direct-to-consumer (DTC) advertising during the 1980s. However, this advertising faced strict limitations from the Food and Drug Administration. However, in 1997, the FDA relaxed some of these limita-tions, and DTC advertising began to grow rapidly. By 2009, drug companies' expenditures on DTC advertising had grown to $4.5 billion. Nonetheless, DTC advertisements continue to face criticism. One criticism of direct-to-consumer advertisements is that product benefit and risk information is of-ten not communicated clearly to consumers, e.g., that the ads contain inad-equate information regarding risks, or vague descriptions of medication ben-efits. The present study seeks to assess the merits of these criticisms. This research is being conducted in two stages. First, secondary research is being conducted to determine what other researchers have concluded re-garding the representation of risk and benefit information in direct-to-consumer advertisements. Past studies have examined several aspects of DTC ads, including the balance between benefit and risk information, and the specificity of the information expressed. Second, primary research will be conducted, in which current DTC advertisements will be content-analyzed. This research will involve collecting DTC advertisements, develop-ing a system of coding the information in these ads, and assessing and cri-tiquing the ways in which product benefits and risks are presented to con-sumers through such advertisements.
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    Lecanemab: Appropriate Use Recommendations
    (Springer, 2023) Cummings, J.; Apostolova, L.; Rabinovici, G. D.; Atri, A.; Aisen, P.; Greenberg, S.; Hendrix, S.; Selkoe, D.; Weiner, M.; Petersen, R. C.; Salloway, S.; Neurology, School of Medicine
    Lecanemab (Leqembi®) is approved in the United States for the treatment of Alzheimer's disease (AD) to be initiated in early AD (mild cognitive impairment [MCI] due to AD or mild AD dementia) with confirmed brain amyloid pathology. Appropriate Use Recommendations (AURs) are intended to help guide the introduction of new therapies into real-world clinical practice. Community dwelling patients with AD differ from those participating in clinical trials. Administration of lecanemab at clinical trial sites by individuals experienced with monoclonal antibody therapy also differs from the community clinic-based administration of lecanemab. These AURs use clinical trial data as well as research and care information regarding AD to help clinicians administer lecanemab with optimal safety and opportunity for effectiveness. Safety and efficacy of lecanemab are known only for patients like those participating in the phase 2 and phase 3 lecanemab trials, and these AURs adhere closely to the inclusion and exclusion criteria of the trials. Adverse events may occur with lecanemab including amyloid related imaging abnormalities (ARIA) and infusion reactions. Monitoring guidelines for these events are detailed in this AUR. Most ARIA with lecanemab is asymptomatic, but a few cases are serious or, very rarely, fatal. Microhemorrhages and rare macrohemorrhages may occur in patients receiving lecanemab. Anticoagulation increases the risk of hemorrhage, and the AUR recommends that patients requiring anticoagulants not receive lecanemab until more data regarding this interaction are available. Patients who are apolipoprotein E ε4 (APOE4) gene carriers, especially APOE4 homozygotes, are at higher risk for ARIA, and the AUR recommends APOE genotyping to better inform risk discussions with patients who are lecanemab candidates. Clinician and institutional preparedness are mandatory for use of lecanemab, and protocols for management of serious events should be developed and implemented. Communication between clinicians and therapy candidates or those on therapy is a key element of good clinical practice for the use of lecanemab. Patients and their care partners must understand the potential benefits, the potential harms, and the monitoring requirements for treatment with this agent. Culture-specific communication and building of trust between clinicians and patients are the foundation for successful use of lecanemab.