In this new era of patients, caregivers, physicians, pharmacists, companies and others expressing and sharing their thoughts and opinions, it is imperative to understand their perceptions on therapy areas and various treatment options. Typically, triggers generate series of discussions and comments. In this case, Public Citizen Petition to FDA to ban the 23 mg dose of Aricept has been the trigger. The news generated some buzz on social media platforms, blogs, forums and news websites. The discussions were around various issues concerning efficacy, side effects and cost concerns for Aricept 23 mg.

1. Social Media Monitoring and Analysis –Despite the petition filed by Public Citizen to FDA to ban Aricept 23 mg used for treatment of AD (marketed by Eisai and Pfizer), there are Aricept 23 mg patients who have seen the benefit.Key Take-away: Even though Aricept 23 mg seems to work for a few, it doesn’t seem to work for most! And for those for whom it works, there are opinions indicating that 2x10mg generic will work just as well! Tanmay Saraykar Manager – Social Media Analytics

2. Public Citizen asks FDA to ban Aricept 23 mg dose Background information About this analysis Donepezil 23 mg, used for treatment of Alzheimer's disease, is marketed under brand name Aricept by Eisai and Pfizer Aricept has been approved by the FDA in a dose of 5 or 10 mg for patients with mild to moderate cases of Alzheimer’s disease, and in a dose of 10 or 23 mg for patients with moderate to severe Alzheimer’s Data shows that the 23 mg dose of donepezil, known as Aricept 23 and approved last July, is significantly more toxic than the 10 mg dose Public Citizen filed a petition to the FDA for banning 23 mg dose and suggested that the drug should be immediately withdrawn from the market Analysis of data from May 18, 2011 to May 29, 2011 All data for USA Trigger identified as Public Citizen filed a petition to the FDA (USA) for putting a ban on 23 mg dose of Aricept (donepezil) of Pfizer and Eisai Data sources include News websites, Facebook, Google, Twitter, YouTube, Blogs and Forums

3. SMMA is structured around automated systems & human insights to turn raw data into actionable information

4. Trigger

5. Event timeline for Aricept Aricept, which inhibits acetylcholines-terase, approved as once daily 5 mg or 10 mg dose Additional indication of moderate to severe disease added to the labeling FDA granted approval for Aricept 23 mg to treat dementia in moderate to severe Alzheimer’s disease FDA agreed to accept Eisai’s request to submit single clinical study for once daily dose of 23 mg Public Citizen filed petition to the FDA to ban Aricept 23 mg Nov 1996 2006 March 2007 July 2010 May 2011 Aricept 5 mg and 10 mg have been on the market for more than a decade

7. News was tweeted and shared on Facebook but these two social networking platforms did not contribute significantly to comments

11. Amen to that, Jared. The last thing Alzheimer's victims need is something that adds physical torture to their emotional agony. My Mother was in her 70s when she had it – it must be so sad for your Dad and you to watch your Mom go through this at such a young age. God Bless – and know that many like myself who read your post will be keeping you and yours in thought and prayer. I am a neurologist. I agree there is no need for the Aricept 23 mg pill. It’s a brand name drug and expensive. The 10 mg pill is generic. I can’t imagine that giving 23 mg would be any different than giving two 10 mg tabs – and it would be cheaper. So, even if there’s evidence that 23 mg tab were better than 10 mg, I wouldn’t prescribe it when I could have patients take 2 of the 10 mg tabs.. I am so glad that this worked for your father. It's wonderful to see results from all these drugs. I am a nurse who has worked in an Alzheimer's facility for nine years. A lot of these drugs specify that older adults with dementia or Alzheimer's should not take them due to the risks yet physicians continue to prescribe. By the time a patient gets to us, usually stage 2 or later, drugs like Aricept or Namenda aren't making a difference and families are wasting their money. This is my opinion based on working with this population. I don't believe family doctors are educating themselves about this disease and are very quick to "prescribe" to this population which is sad. Empathizing/Supportive Criticizing – Drug/Company I am a pharmacist and the 23mg dose of Aricept has changed my father's quality of life tremendously. He wasn't talking, now he is. He couldn't feed himself, now he is. He wasn't walking, now he is. His experience may be more positive than most, but it has been wonderful for him, my mother, and our family. I understand all the vitriol from other commenters, but don't yet your disgust with the pharmaceutical industry blind you to the benefit some patients and families are receiving Criticizing – Doctors/FDA Supporting the Drug/Company Comments – Examples

12. Rollo, Well, we don't euthanize people in our country, even if they specify before they get sick what they would not want to be subjected to. Thanks to Christians, we can't even have an honest conversation about such topics. Our laws are a representation of their 2000-year old mythology. Based on the side effect of Aricept, is that it is super dried which will cause pneumonia... internal bleeding, maybe liver damage, & heart damage in the long term. you can take supplement Asparagus toot to treat the side effects. No eating asparagus will not prevent the side effects. With my Mom stuck in a nursing home for the rest of her life I can clearly see there is NO drug that will reverse this. I tried desperately for years to hope she just suffered from severe depression but now she no longer can even walk without help and is a total vegetable. This is a very cruel disease and no one should be subject to it. I wish we had assisted suicide in this country as I am sure my Mom would much prefer to be relieved from her current state. I do have a DNR on her so when she can no longer eat she will starve to death, a very sad way to go. XOXO Mom!!!! Religious Hi Julie, although I'm glad you have been told and were able read a few things about a drug I think you would be in better position to make a educated decision if you read and were told medical things every day for at least 6 years (doctors). Let look in his/her position, if you say it was not helping her Alzheimer's do you mean it was not making her better? Because that's not going to happen. Lets say the doc stopped the drug after a year or two and immediately following there was a significant decline in your mothers mental status, something that could have been prevented if she stayed on the drug, sounds like negligence towards standard of care = lawsuit. Doctors prescribing habits are based upon peer reviewed scientific evidence not YouTube videos or articles random doctors publish. Or you may have just gone to a bad doctor. Suggesting/ Advising Seeking help/information Supporting Doctors/FDA Comments – Examples

13. Analysis of comments – Tone I am a pharmacist and the 23mg dose of Aricept has changed my father’s quality of life tremendously. We made the decision to take my Mom off of Aricept after 4 years of the medication. It's no longer helping her Alzheimer's in any way. 7 Recommendations against the drug – 4 out of these specific to 23 mg dose 2 Recommendations for the drug – both specific to 23 mg dose; however, one says 2x10 mg generic would work as well 24 39 7 Positive Negative Neutral

14. Sentiment analysis comments – Aricept (not specific to 23 mg dose) Switch over mentioned to Exelon/Namenda Side effects mentioned in various comments Switch Over x 1 Slowed pulse rate Nausea Fatigue Dizziness Agitation Gastrointestinal conditions Hemorrhage Diarrhea Confusion Price/Cost of treatment x 3 Side Effects x 7 Efficacy of Aricept 12 3 - ve comments + ve comments

15. Findings (specific to Aricept 23 mg dose as well) Comments showed overall acceptance of the idea that Alzheimer’s disease is regenerative and non-curable and dementia is irreversible, at best can be slowed Comments indicate that Aricept’s 23 mg dose has negligible or marginal improvement in efficacy as compared to 10 mg Aricept 23 mg has severe and sometimes fatal side effects that hardly justify administration of the drug to patients with moderate to severe condition Cost of the drug and the treatment is perceived to be far higher as compared to its benefits No strong suggestions to switch to other drugs were evident Comments indicating benefits of Aricept’s 23 mg dose also seen However, opinions on 2x10 mg generic as substitute for Aricept’s 23 mg highlight Aricept 23 mg is not relevant for patients, given the cost burden and side effects experienced

16. For further information on this document, please contact: Tanmay Saraykar Manager, Social Media Analytics +91 7829909766 tanmay.saraykar@pharmarc.com