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Circ Cardiovasc Qual Outcomes ; 12(11): e006073, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31707825


BACKGROUND: Recent court decisions have thrown into question the Food and Drug Administration's rules limiting manufacturer promotion of prescription drugs for unapproved uses. We assessed how providing pro forma disclosures or more descriptive evidence context about the data supporting an off-label claim affected physicians' beliefs about drug efficacy. METHODS AND RESULTS: In online and mailed surveys, we randomized national samples of board-certified, clinically active cardiologists, internists, and endocrinologists to receive 1 of 3 information scenarios about a hypothetical drug derived verbatim from excerpts on the website for Vascepa, a prescription fish oil for which Food and Drug Administration specially permitted off-label promotion after a manufacturer lawsuit. The scenarios presented information about the approved on-label indication (severe hypertriglyceridemia), off-label claim + pro forma disclaimers (suggestive but not conclusive evidence for use as an add-on to a statin for patients reaching low-density lipoprotein goal but with persistent moderate hypertriglyceridemia), and off-label claim + evidence context (eg, reports on 3 trials failing to demonstrate cardiovascular benefit of other triglyceride-lowering drugs for such patients). Among 686 respondents (48% response rate), 29% reported receiving off-label information about Vascepa (ie, use as an add-on to a statin) from the manufacturer, and 16% had prescribed it off-label for this purpose. Off-label prescribing was 5 times higher among physicians who received such off-label information (38% versus 7%, P<0.001). For the hypothetical drug, the proportion of physicians endorsing the unproven claim that the drug reduced cardiovascular risk was similar among those randomized to the on-label and off-label claim + pro forma disclaimers scenarios (35% versus 37% [95% CI, -6% to 11%]), but substantially lower among those randomized to the off-label claim + evidence context scenario (21% [95% CI, -24% to 7%]). CONCLUSIONS: Physicians who received company information about the unapproved use of Vascepa were more likely to report prescribing it off-label. Supplementing off-label claims with evidence context improved the prescribers' knowledge and reduced enthusiasm for the unproven, off-label indication of reducing cardiovascular risk.

J Manag Care Spec Pharm ; 25(11): 1210-1224, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31663459


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. Five-point Likert scale questions assessed physicians' opinions of clinical, economic, and implementation elements of prior authorization policies; physician demographic characteristics; and the extent of their interactions with the pharmaceutical industry. RESULTS: 686 physicians (48%) responded to the survey, which was evenly divided among primary care physicians, endocrinologists, and cardiologists. Many respondents (70%) had interactions with industry, including receipt of meals or gifts and use of medication samples. Physicians reported that step therapy policies could improve the affordability of medication use (55% agree vs. 26% disagree) and its clinical appropriateness (59% agree vs. 19% disagree). By similar margins, however, physicians stated that step therapy policies were implemented inefficiently and inflexibly and often did not incorporate relevant patient-specific information. Physicians in subspecialties, especially endocrinology, and those who had interactions with the pharmaceutical industry were more likely to hold negative views of step therapy policies. CONCLUSIONS: Most physicians recognize the potential of step therapy to improve the quality and cost-effectiveness of prescribing, although interactions with industry may affect these opinions. Physician perception of ineffective implementation of these policies, however, undermines their acceptability. DISCLOSURES: The American Board of Internal Medicine (ABIM) funded the survey used in this study. The ABIM had no role in the design and conduct of the study or development and preparation of the manuscript. Survey honoraria was provided by the Consumers Union. Kesselheim and Avorn's work is funded by the Laura and John Arnold Foundation. Kesselheim is also supported by the Harvard-MIT Center for Regulatory Science, Arnold Ventures, and the Engelberg Foundation. Ross is employed by the ABIM. Fischer, Lu, and Tessema have nothing to disclose.

J Law Med Ethics ; 47(3): 430-441, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31560634


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 (32.7% response rate), two-thirds reported hearing generally about drug safety information prior to starting a new drug, with the remaining one-third "rarely" or "never" hearing such information. Providers and pharmacists were primary sources of drug safety information. Two-thirds of zolpidem users and half of eszopiclone users reported having heard about the related DSC messages, ability to accurately identify the major factual messages was limited (overall median 2 correct out of 5, with men and those reporting higher educational level scoring higher [2/5 vs. 1/5, p=0.001]). Respondents reacted to new drug safety information about their sleep aids by reporting that they would want to learn about alternative ways to help them sleep (70%) and seek out more information about the safety of their specific sleeping pill (59-78%). Opportunities may exist for the FDA to work with providers and pharmacies to help ensure the DSC information is more widely received and is more fully understood by those taking the affected medications.

JAMA Netw Open ; 2(8): e199570, 2019 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-31469391


Importance: Noninferiority trials test whether a new intervention is not worse than the comparator by a given margin. Objectives: To study the characteristics of published randomized noninferiority trials in oncology with overall survival as an end point, to assess the association of justification and success in achieving noninferiority with the funding of these trials, and to evaluate the association of such trials with patient survival. Data Sources: A systematic search of PubMed and Google Scholar databases was conducted in March 2018, with no date restrictions. Study Selection: Randomized noninferiority trials of cancer drug therapies with overall survival as an end point were included. Trials of decision support, supportive care, and nondrug treatment in both arms were excluded. Data Extraction and Synthesis: This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines for meta-epidemiological studies. Studies were screened for eligibility criteria, and data on criteria for noninferiority, funding, success (achieving noninferiority), and hazard ratios with confidence intervals for overall survival were extracted. Hazard ratios for overall survival were pooled across trials using a random-effects model. Main Outcomes and Measures: Associations of the justification for using a noninferiority design and success in achieving noninferiority with the source of funding were assessed. Overall pooled hazard ratios and confidence intervals for overall survival were calculated. Results: Among 74 noninferiority trials of cancer drug therapies, 23 (31%; enrolling 21 437 patients) used overall survival as the primary end point. The noninferiority margins for the hazard ratio of overall survival ranged from 1.08 to 1.33. Noninferiority design was justified in 14 trials (61%) but not in 9 (39%). Overall, 18 trials (78%) concluded with a finding of noninferiority. Industry funding was associated with lack of justification for noninferiority design (P = .02, assessed using the Fisher exact test) but not with success in proving noninferiority (P = .80, assessed using the Fisher exact test). When the hazard ratios across the trials were pooled, there was no beneficial or detrimental association with overall survival, with a pooled hazard ratio of 0.97 (95% CI, 0.92-1.02). Conclusions and Relevance: The findings suggest that a substantial fraction of noninferiority trials in oncology, most of which are industry funded, lack justification for such a design. Greater attention to the use of noninferiority designs in randomized clinical trials of cancer drugs from local and national regulators is warranted.