1. Highlights
AdverseEvents.com:
Start-Up Website Releases Drug Reports
By: Sara Weiner and Remy Wainfeld, November 2011
 AdverseEvents.com is a
Key Information
start-up website that provides AdverseEvents.com (hereafter referred to as AE.com) was
information 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 website
data from the FDA, user because they felt the current FDA system is neither user friendly
submissions, and comments nor accurate. Their new website is intended to provide more
found on social networking accurate data that is easier to navigate and easier to understand
websites to build a drug’s side than the FDA’s. AE.com is free and open to the public, but a
effects 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 a
and open to the public, but a
different approach. It has expanded the criteria required for
more robust version is available someone to report side effects. It has also expanded the
for a subscription fee. The method of data collection used to compile a drug profile.
latter version is intended for
pharmaceutical companies To clarify, the FDA has strict standards and paperwork that
and 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 of
untested sources of data and its sources. It collects data from the FDA’s AERS/VAERS, and online
system is not monitored by the user submissions, and commentary found in online social media
FDA 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 and
already published data analyses misleading. AE.com has let us know that while they are
which contradict FDA findings on collecting information from these two latter sources, they do
the safety of large not include them in their analysis; in fact they don’t currently
pharmaceutical 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 it
the full implications of this new provides a basic consumer right; others fear the implications of
platform—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.

2. AdverseEvents.com
Details and Specifics
Traditionally, side effect information is collected by the FDA through a number of programs (these include
professional, 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 into
a 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 system
difficult for users to navigate.
One of the founders of AE.com happened upon these issues while researching drug concerns for a spouse, and
decided that the FDA’s system was not effectively managing important data. Thus began the side effects
database known as AdverseEvents.com.
Collecting Side Effect Reports: Different Standards
The FDA and AE.com have different standards for accepting side effect reports. The FDA requires four pieces
of information with any report (an identifiable patient, an identifiable reporter, a drug, and an adverse
experience resulting from the drug2) and this information is submitted through specific forms that require
additional 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/ucm09
2257.pdf (2001)
3
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) Retrieved from:
http://www.reportingonhealth.org/blogs/2011/10/10/qa-keith-hoffman-keeping-fda-honest-adverse-events-data
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3. AdverseEvents.com
Industry Response
From a safety standpoint, AE.com’s approach to reporting on side effects has created concern in the
pharmaceutical and marketing industries because it is circulating drug information without any government
oversight. While AE.com is getting vetted data from the FDA, its other sources of information are considered
questionable. At first glance AE.com’s online form requires little information, making it important that
AE.com assesses and vets user reports for validity and accuracy on the back end. It would be easy for
AE.com to misreport or manipulate findings (we are not suggesting that it does this, only pointing it out as a
possibility). While they have positioned them self as an unbiased entity, AE.com has already published
reports showing analyses that differ from FDA’s reports; specifically, they released reports which indicated
that two drugs, Lamictal and Keppra4, were more dangerous than the FDA reports. Regarding the
information AE.com is extracting from social media, this commentary is at best directional, and rarely
provides enough information to be considered statistically significant or comprehensive. In light of these
points, 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 clearly
defined an opportunity in the digital space and is providing a better user experience than what is currently
available to the public at large. However, the trust component could be the biggest hurdle for AE.com. The
online healthcare space is already dominated by longstanding sites such as WebMD, HealthLine and
Drugs.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 using
unbiased data and accurate assessment—most importantly, it will need to position itself as a partner, not an
opponent, 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 November
2011, AE.com’s site traffic has not made a dent in Quantcast’s Web analytics reports or in Google’s search term
volume.
*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.htm
About the Digital Integration and Innovation Team
4
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/
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4. 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 that
tells us about them. More importantly, it’s our job to help our clients apply this knowledge to better
communicate with their customers. We help clients translate business goals into marketing campaigns that build
relationships with customers. In the 21st century, understanding how and why someone uses technology is as
important as understanding where they live, what gender they are and how old they are. That’s where we come
in. 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 RTCRM
RTC Relationship Marketing (RTCRM) is a full-service direct marketing and relationship marketing agency based
in Washington, D.C., in the heart of Georgetown, with an additional office in New York. RTCRM boasts more
than 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 and
research 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.
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