Impact of Social Media adverse event reporting

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Impact of social media on adverse event reporting

Example: Potential Copaxone AE cases on patientslikeme

By Silja ChouquetOwner and managing director of whydot

Basel, April 21st, 2009

whydotpharma presentation – www.whydotpharma.com

Capturing AEs via online communities will help to increase patient safety

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“Patients like you are becoming more and more influential in their treatment decisions. No longer are you simply consumers of pharmaceuticals and medical products, you are customers. In this emerging world, you have become better educated about your treatment options, the risk and benefits of different treatments, and your overall quality of health. Now you have the opportunity to tell the FDA if you’ve had an adverse event.”

David S. Williams IIIFounding Executive, Marketing and Business DevelopmentPatientslikeme

Source: www.fda.gov,, http://blog.patientslikeme.com/2009/04/15/patientslikeme-offers-adverse-event-reporting-for-ms-patients/

An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported when the patient outcome is:

• Death• Life-Threatening• Hospitalization (initial or prolonged)• Disability• Congenital Anomaly.• Requires Intervention to Prevent

Permanent Impairment or Damage

Definition of Adverse Event (AE) Patientlikeme rationale for reporting AEs

• FDA estimates that AEs are currently under reported with only 10% of serious and 2-4% of non-serious AEs getting captured

Is the systematic reporting of AEs via online communities going to improve the amount and quality of cases reported?


Copaxone number one MS treatment on patientslikeme

Provigil

Avonex

Gabapentin

Baclofen

Copaxone

0 500 1000 1500 2000 2500

757

820

903

1413

2129

Top 5 prescription drugs in patientslikeme MS community n= number of patients

Source: http://www.patientslikeme.com/multiple-sclerosis/treatments/

Therefore, used Copaxone as example to analyze impact on number and type of potential AEs


Majority of Copaxone AE cases in FDA database have been reported by patients

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1000

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# of Copaxone cases reported in FDA database by …N= 2854

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63% of AE cases are currently reported by

patients

Source: fdable copaxone AE report

Example

Copaxone


HCPs report AEs on a voluntary* basis to the appropriate source, most often the manufacturer.

Currently patients report mainly via pharma and HCPs

Source: http://www.fda.gov/medwatch/articles/medcont/postrep.htm#und *Note: AE reporting by an individual Healthcare professional is voluntary, except for specified vaccines **as well as distributors of FDA approved pharmaceuticals (drugs and biologics) and medical devices, plus pharmaceutical packers and device user facilities

5

regulatory responsibility for ensuring the safety of all marketed medical products. Patient experiences

adverse event (AEs)

Manufacturers** receive AEs

from patie

nts and HCPs, have

mandatory reportin

g

requirements to

the FDA

Patient

HCPs

Pharma

http://www.fda.gov/medwatch/articles/medcont/postrep.htm%23und


Patientslikeme opens up a new “AE reporting channel” for patients

Source: http://blog.patientslikeme.com/2009/04/15/patientslikeme-offers-adverse-event-reporting-for-ms-patients/

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Patient

HCPs

Pharma

helps patients submit treatment-related AEs directly to the FDA through their site.

Will FDA require pharma to collaborate

with site on AE reporting?

How will physicians react to patients reporting AEs?

Patient experiences adverse event (AEs)

Will FDA require pharma to collaborate

with site on AE reporting?

How will physicians react to patients reporting AEs?


Patientslikeme has more patients on Copaxone than the product’s label data

Number of patients on Copaxone (glatiramer acetate)

Example

Copaxone

Label

Patientslikeme

0 500 1000 1500 2000 2500

900

1601 528 2129

Source: http://www.patientslikeme.com/multiple-sclerosis/treatments/show/823-copaxone, Copaxone lable, http://www.fda.gov/medwatch/articles/medcont/postrep.htm#und

Currently treated Discont’d

• AEs in Copaxone label based on data from 900 patients, but 2129 patientslikeme members have taken the product

Will the data captured in patientslikeme impact the current label?

http://www.patientslikeme.com/multiple-sclerosis/treatments/show/823-copaxone



Potentially, reporting via patientslikeme could increase AE cases by up to 23% for Copaxone

Example

Copaxone

Number of Adverse events0

500

1000

1500

2000

2500

3000

3500

4000

2854

Moderate SE on treatment

Severe SE on treatment

Discontinuation due to sever SE

Current FDA database

484-667* potential additional AE cases=

17-23%* increase

Source: http://www.patientslikeme.com/multiple-sclerosis/treatments/show/823-copaxone, Copaxone lable, http://www.fda.gov/medwatch/articles/medcont/postrep.htm#und *Note: not sure whether discontinued patients were counted in side-effect analysis

3521

Number of Copaxone (glatiramer acetate) AE cases

How is a sudden 23% increase of AE cases going to be perceived by FDA? P

atie

ntsl

ikem

e





A potential 7% increase of cases could come from patients that discontinued treatment due to severe SEs

2129

•Currently, 2854 Copaxone related AEs have been reported to FDA•36% or 198 of Copaxone patients on patientslikeme discontinued due to severe side effects, representing a potential 7% increase in reportable AEs

Example

Copaxone





Another 16% increase of AEs could come from severe and moderate side-effects reported by patients

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• 22% of Copaxone patientslikeme members report severe or moderate side-effects

• If severe side-effects can be seen as a proxy for serious AEs, while moderate side-effects can be taken as a proxy for non-serious AEs

Example

Copaxone


•Please note that only 299 out of 2129 patients on Copaxone within patientslikeme community chose to disclose details about their side effects, percentages were then applied to entire Copaxone patientlikeme population

Side effects captured by patients in patientslikeme community




Open questions on impact

• Under reporting: Actual increase in AE cases reported dependent on transformation rate of severe and moderate side-effects to a reported AE.

How many AE cases will patients report, especially the non-serious ones?

• Biases: patientlikeme population might not be representative of total patient population

Are inherent biases in patientlikeme population (ie. Age, educational level etc.) likely to skew the AE reported?

• Clinical impact: new AE cases reported might reveal new or more reactions than currently captured

Will increase of AE cases have an impact on Copaxone current label? Are patients going to report reactions currently not part of label? Are they going to report more on certain reactions vs. others?


What does this mean for pharma?

• For right now, only one social media online community is reporting AEs, but many more will follow, if patientslikeme pilot is successful

Set up social media monitoring now to find out about side-effects and AEs discussed online

• If large number of online communities start to report AEs, FDA might turn to Pharma to

• check AEs for accuracy and quality as it done for HCPs reported events

• evaluate impact and need for follow up studies

Be proactive and start setting up processes to deal with FDA requestGet data on how many of your patients are active in online communities

and what the potential impact could beTalk to online communities and FDA about potential implications of

patient-driven AE reporting


Contact

Silja Chouquet

Owner and managing director of whydot GmbH

Blogger whydotpharma

E-mail: [email protected]