pharmarc smma case study on aricept 23 mg - public citizen petition

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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

© PharmARC Analytic Solutions Pvt. Ltd., 2011. All Rights Reserved. Slide 2

Public Citizen asks FDA to ban Aricept 23 mg dose

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Public Citizen filed a petition to the FDA for banning 23 mg dose and suggested that the drug should be immediately withdrawn from the market

Background information About this analysis

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

Nov 1996

Additional indication of moderate to

severe disease added to the

labeling

2006March 2007

FDA granted approval for

Aricept 23 mg to treat dementia in moderate to

severe Alzheimer’s

disease

July 2010

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

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

Blo

g

Ne

ws

Pu

blis

he

d

Yo

uT

ub

e V

iew

s

Fa

ceb

oo

k L

ike

s

Tw

ee

ts

Se

arc

h

0

50

100

150

200

250

300

2

32

155

278

118

73

Instances (May 18 to May 29, 2011)

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

Social Media Activity – Insights


Where are conversations happening?

Blog

News Published

YouTube Views

Facebook Likes

Tweets

Search

0

200

400

Instances

Total Comments – 70


Participants in the discussion can be classified into three categories

Doctor/Nurse/

Pharmacist, 9, 13%

Observer, 40, 57%

Patient's Relative/

Caretaker, 21, 30%

Discussion participant profile

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)

Classification of comments – Insights


No. of comments received by category

Em-pathising / Support-

ive13%

Criticiz-ing Co./Drug33%

Supporting Co./Drug 13%

Criticiz-ing Doc-tors/FDA

9%

Support-ing Doc-tors/FDA

10%

Suggest-ing/ Ad-vising14%

Seeking Informa-

tion/ Help1%

Religion 7%

Number of Comments 70


Empathizing/Supportive

Criticizing – Drug/Company

Criticizing – Doctors/FDA

Supporting the Drug/Company

Comments – Examples

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.

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


Religious

Suggesting/Advising

Seeking help/information

Supporting Doctors/FDA

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!!!!

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.


Analysis of comments – Tone

PositiveNegative Neutral

24 39 7

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

I am a pharmacist and the 23mg dose of Aricept has

changed my father’s quality of life tremendously.

2 Recommendations for the drug – both specific to 23 mg dose; however, one says 2x10 mg generic would work as well


Sentiment analysis comments – Aricept (not specific to 23 mg dose)

- ve comments + ve comments

Efficacy of Aricept

Side Effects

Price/Cost of treatment

Switch Over

x

x

1

3

7

12 3

Switch over mentioned to

Exelon/Namenda

Slowed pulse rate

Nausea

Fatigue

Dizziness

Agitation

Gastrointestinal conditions

Hemorrhage

Diarrhea

Confusion

Side effects mentioned in various comments

x


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

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© PharmARC Analytic Solutions Pvt. Ltd., 2011. All Rights Reserved.

For further information on this document, please contact:

Tanmay SaraykarManager, Social Media Analytics

+91 7829909766

[email protected]

mailto:[email protected]

pharmarc smma case study on aricept 23 mg - public citizen petition

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