Responding Rapidly to FDA Drug Withdrawals: Design and Application of a New Approach for a Consumer Health Website

Abstract

Background Information about drug withdrawals may not reach patients in a timely manner, and this could result in adverse events. Increasingly, the public turns to consumer health websites for health information, but such sites may not update their content for days or weeks following important events like Food and Drug Administration (FDA) drug withdrawal actions. There is no recognized standard for how quickly consumer health websites should respond to such events, and reports addressing this issue are lacking.Objective The objective of this study was to develop and implement an approach to enhance the efficiency with which a consumer health website (NetWellness.org) responds to FDA drug withdrawal actions.Methods Evaluation of the current approach used by NetWellness staff to update content affected by FDA action revealed a slow process driven by the goal of performing thorough and comprehensive review and editing. To achieve our desired goal of accurately updating affected content within 24 hours of FDA action, we developed a strategy that included rapid updating of affected Web pages with warning boxes and hyperlinks to the information about the withdrawal. With the next FDA withdrawal event, that of valdecoxib (Bextra) on April 7, 2005, we applied this new approach, observed the time and resource requirements, and monitored the rate at which consumers viewed the updated information to gauge its potential impact.Results Application of the new approach allowed one person to modify the affected Web pages in less than 1 hour and within 18 hours of the FDA announcement. Using the old strategy, response to a similar event, the withdrawal of rofecoxib (Vioxx) 6 months earlier, had taken over 3 weeks and the efforts of several personnel. Updated valdecoxib content received 188 hits within the first month and 4285 hits within 1 year.Conclusions Rapid updating of a consumer health website's content in response to an FDA drug withdrawal event was easily accomplished by applying the approach described. This allowed consumers to view accurate information regarding the withdrawn drug much sooner than would otherwise have been the case. Given that consumers increasingly turn to websites for their health information, adoption of a rapid response standard for important health events like FDA drug withdrawals should be considered by the consumer health informatics community.

Scope, Completeness, and Accuracy of Drug Information in Wikipedia

“…As yet, there are no standards or studies in this area and this aspect deserves further investigation. 26 The proliferation of quality initiatives in the form of checklists, instruments, tools, rating schemes, codes of ethics, seals, and accreditation over the past decade reflects the concern of consumers and health professionals over quality when it comes to online health content. 27-30 These quality control measures have had limited success in practical terms, as they are largely unenforceable, unscalable, and variable in their application.…”

Do product innovation and news about the R&D process produce large price changes and overreaction? The case of pharmaceutical stock prices

“…The issue of stock market overreaction is not a new one (Beaver and Landsman, 1981;DeBondt and Thaler, 1985), and two measures for large price changes have been established: firstly, daily rates of returns are greater/less than or equal to predetermined trigger values (for example, ±10%). Using this methodology, authors such as Atkins and Dyl (1990), Bremer and Sweeny (1991), Cox and Peterson (1994), Bremer et al (1997), Challet and Stinchcombe (2003), Farmer et al (2004), Weber and Rosenow (2006) and Zawadowski et al (2006), 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 all daily rates of return that were significantly greater/less than their sample mean returns of about 2.5% as large price increases/decreases over the period.…”

“…Although there may be some delay in the circulation of news to patients and doctors (Embi et al, 2006), market watchers tend to get information quickly. We therefore assumed that market reactions began on the same day as news disclosures, but we also checked for possible leads and lags of two trading days.…”