PharmARC SMMA Case Study on Aricept 23 mg - Public Citizen Petition

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

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Public Citizen filed a petition to the FDA for banning 23 mg dose and suggested that the drug should be immediately withdrawn from the market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

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

Trigger

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

Activity overview – May 18 to May 29, 2011
Social Media Activity – Insights
User participation and comments were found mainly in comment sections of news and forums
News was tweeted and shared on Facebook but these two social networking platforms did not contribute significantly to comments
Moderate search activity and YouTube video views found

Where are conversations happening?
Total Comments – 70

Participants in the discussion can be classified into three categories
Classification of comments – Insights
Comments from patients themselves are not available due to severity and nature of disease
Participant profile identified only in cases where the discussion participant explicitly mentioned his/her relation to the patient or role in treatment (otherwise, classified as Observer)

No. of comments received by category

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

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

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

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

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

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

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PharmARC SMMA Case Study on Aricept 23 mg - Public Citizen Petition

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