AdverseEvents.com: Start-Up Website Releases Drug Reports
Highlights AdverseEvents.com: Start-Up Website Releases Drug Reports By: Sara Weiner and Remy Wainfeld, November 2011 AdverseEvents.com is a Key Informationstart-up website that provides AdverseEvents.com (hereafter referred to as AE.com) wasinformation on drug side effects. recently released to the public. The website provides searchable information on drugs’ side effects. The founders behind AE.com, AdverseEvents.com collects who have a data and research background, created the websitedata from the FDA, user because they felt the current FDA system is neither user friendlysubmissions, and comments nor accurate. Their new website is intended to provide morefound on social networking accurate data that is easier to navigate and easier to understandwebsites to build a drug’s side than the FDA’s. AE.com is free and open to the public, but aeffects profile. more robust version for pharmaceutical companies and healthcare professionals is available for a subscription fee. Basic information is free In order to improve upon the FDA’s system, AE.com has taken aand open to the public, but a different approach. It has expanded the criteria required formore robust version is available someone to report side effects. It has also expanded thefor a subscription fee. The method of data collection used to compile a drug profile.latter version is intended forpharmaceutical companies To clarify, the FDA has strict standards and paperwork thatand doctors. consumers, professionals and manufactures can/must submit regarding side effects—this information is collected and sourced AdverseEvents.com is in the FDA’s Adverse Events Reporting Systems (AERS/VAERS).controversial because it is using AE.com, by contrast, gets its information from a variety ofuntested sources of data and its sources. It collects data from the FDA’s AERS/VAERS, and onlinesystem is not monitored by the user submissions, and commentary found in online social mediaFDA or any regulating third party. forums. These extra sources of data are controversial because they are not regulated by a governing body, there are no set criteria, and specifically in regards to social media, user AdverseEvents.com has comments can often be out of context, inaccurate andalready published data analyses misleading. AE.com has let us know that while they arewhich contradict FDA findings on collecting information from these two latter sources, they dothe safety of large not include them in their analysis; in fact they don’t currentlypharmaceutical drugs publish the social media findings on the site.* It will take time to understand AE.com has been met with mixed reviews—some feel itthe full implications of this new provides a basic consumer right; others fear the implications ofplatform—it has been received an outsider producing data about drug efficacy and side effects.with a range of opinions, AE.com and the FDA are not working together on this new website, and as of November 2011 the website has limited traffic.including fear, skepticism,support and gratitude.
AdverseEvents.comDetails and SpecificsTraditionally, side effect information is collected by the FDA through a number of programs (these includeprofessional, manufacturer and consumer programs). Anyone can submit a report for a serious adverse event(“any undesirable experience associated with a medical product,”1 including death, hospitalization, disability,etc.). Criteria for submissions to the FDA are standardized and detail-oriented. The information is compiled intoa mass database, often without scrubbing, which means the same drug might be entered many different ways—under different brand names, generic names and/or side effects. Some have argued this makes the FDA’s systemdifficult for users to navigate.One of the founders of AE.com happened upon these issues while researching drug concerns for a spouse, anddecided that the FDA’s system was not effectively managing important data. Thus began the side effectsdatabase known as AdverseEvents.com.Collecting Side Effect Reports: Different StandardsThe FDA and AE.com have different standards for accepting side effect reports. The FDA requires four piecesof information with any report (an identifiable patient, an identifiable reporter, a drug, and an adverseexperience resulting from the drug2) and this information is submitted through specific forms that requireadditional criteria and detail. Consumers, healthcare providers and pharmaceutical companies are all able,and in some cases are required, to do this.AE.com has looser standards for collecting reports and additional sources. It compiles data in three ways: By organizing FDA data. AE.com takes the FDA’s raw data and scrubs and configures it so that is searchable and consolidated by drug product. For example, in the AERS system Ambien is listed more than 400 ways; in the AE.com system it is listed one way.3 The FDA’s data is AE.com’s main source of data; revisions to how this data is organized and analyzed is what is most readily available on AE.com, and in their published reports.* By accepting online consumer submissions. AE.com allows people to fill out a form online that asks for information about the patient, the drug and the outcome experienced. No doctor is required to verify the report, and many fields are optional. There are no set criteria. AE.com verifies these submissions on the back end and combines the data with the FDA data that they have reorganized. This data is not included in AE.com’s published reports, and if users wish, they can filter it out while looking through the website.* By analyzing social media comments. AE.com pulls user-generated comments about drugs and side effects found in social media forums into its database. While AE.com collects this information, it does not currently publish it on their site or in their reports.*1 U.S. Food and Drug Administration. What is a Serious Adverse Event? Retrieved from:http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm (2011)2 FDA. Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines.Retrieved from:www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm092257.pdf (2001)3 Heisel, William. Q& A with Keith Hoffman: Keeping the FDA Honest with Adverse Events Data. Reporting On Health: TheCalifornia Endowment Health Journalism Fellowship. (October 2011) Retrieved from:http://www.reportingonhealth.org/blogs/2011/10/10/qa-keith-hoffman-keeping-fda-honest-adverse-events-data RTCRM Proprietary Page 2
AdverseEvents.comIndustry ResponseFrom a safety standpoint, AE.com’s approach to reporting on side effects has created concern in thepharmaceutical and marketing industries because it is circulating drug information without any governmentoversight. While AE.com is getting vetted data from the FDA, its other sources of information are consideredquestionable. At first glance AE.com’s online form requires little information, making it important thatAE.com assesses and vets user reports for validity and accuracy on the back end. It would be easy forAE.com to misreport or manipulate findings (we are not suggesting that it does this, only pointing it out as apossibility). While they have positioned them self as an unbiased entity, AE.com has already publishedreports showing analyses that differ from FDA’s reports; specifically, they released reports which indicatedthat two drugs, Lamictal and Keppra4, were more dangerous than the FDA reports. Regarding theinformation AE.com is extracting from social media, this commentary is at best directional, and rarelyprovides enough information to be considered statistically significant or comprehensive. In light of thesepoints, it’s understandable why the healthcare industry would be wary of this third-party entrant.From a business standpoint, whether AE.com is successful depends on how actively consumers,pharmaceutical companies and healthcare professionals utilize and trust the data. AE.com has clearlydefined an opportunity in the digital space and is providing a better user experience than what is currentlyavailable to the public at large. However, the trust component could be the biggest hurdle for AE.com. Theonline healthcare space is already dominated by longstanding sites such as WebMD, HealthLine andDrugs.com. A new entrant will take time and marketing efforts to get a foothold on the consumer market.And gaining usage among paying professionals will only come if AE.com continues down a path of usingunbiased data and accurate assessment—most importantly, it will need to position itself as a partner, not anopponent, of the pharmaceutical industry.It will take time to understand the full implications of this new platform and see if it takes off. As of November2011, AE.com’s site traffic has not made a dent in Quantcast’s Web analytics reports or in Google’s search termvolume.*Corrections made to the original document on 12/7/2011.Additional Resources: www.AdverseEvents.com Heisel, William. Q& A with Keith Hoffman: Keeping the FDA Honest with Adverse Events Data. Reporting On Health: The California Endowment Health Journalism Fellowship. (October 2011) http://www.reportingonhealth.org/blogs/2011/10/10/qa-keith-hoffman-keeping-fda-honest-adverse- events-data Gurley, Jan. Did a scrappy little start-up just pwn the FDA? San Francisco Chronicle Online: http://blog.sfgate.com/gurley/2011/09/27/did-a-scrappy-little-start-up-just-pown-the-fda/ FDA.com o www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ Guidances/Vaccines/ucm092257.pdf o www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm o www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm090385.htmAbout the Digital Integration and Innovation Team4 Gurley, Jan. Did a scrappy little start-up just pwn the FDA? San Francisco Chronicle Online:http://blog.sfgate.com/gurley/2011/09/27/did-a-scrappy-little-start-up-just-pown-the-fda/ RTCRM Proprietary Page 3
AdverseEvents.com The RTCRM Digital Integration and Innovation team is tasked with keeping track and making sense of the ever-changing digital world. It’s our job to understand the nuances of how and why different types of people use technology and what thattells us about them. More importantly, it’s our job to help our clients apply this knowledge to bettercommunicate with their customers. We help clients translate business goals into marketing campaigns that buildrelationships with customers. In the 21st century, understanding how and why someone uses technology is asimportant as understanding where they live, what gender they are and how old they are. That’s where we comein. From ensuring that digital behavior is considered in the research phase, to tactical plans that align digital,print and broadcast tactics, we work with clients and internal partners to make sure it all works.About RTCRMRTC Relationship Marketing (RTCRM) is a full-service direct marketing and relationship marketing agency basedin Washington, D.C., in the heart of Georgetown, with an additional office in New York. RTCRM boasts morethan 40 years’ worth of innovative, targeted solutions that grow its clients’ brands and help them forge lasting,valuable relationships with their customers. What distinguishes RTCRM is its unique ability to analyze data andresearch on both a rational and emotional level. RTCRM’s clients include major brands in the telecom,technology, pharmaceutical, and other business sectors such as AARP, BlackRock, Eli Lilly, and Novo Nordisk.To learn more about RTCRM, please visit www.rtcrm.com or follow the Twitter feed @rtcrm. RTCRM Proprietary Page 4