Great News For Alzheimer's Posters

[Lucky]

Not to make fun of folks with Alzheinmer's, a truly awful thing to have, but I see a big ad today in my favorite magazine, Parade, for those who have a moderate to severe form of the disease. A large pharmaceutical company has now issued a larger dose of their medicine designed to slow the progression of the disease. Previously only a 5 or 10 mg tablet was available, but the great news is that a 23 mg is now provided.

The article claims that the pill, Aricept, has been proven to slow the progression of Alzheimer symptoms.

Yet it is not for everybody, certainly not for those who don't have the disease. But it's also not for those allergic to Aricept or medicines containing piperidines, not that I know if any of my meds have those.

It can also cause fainting and a slow heartbeat, and, you guessed it, this is more common in people with heart problems, which is probably a significant portion of Aricept's target market. Call the doctor right away if you faint, assuming you can use the phone.

And, if you are one of those seniors with lung problems, you should know that Aricept may worsen them.

But, if you are lucky enough at the onset of Alzheimers not to have lung or heart problems, and have a phone in case you faint, then this drug may be for you. Just be sure to watch out for trouble urinating. If you are of a light weight, say under 123 pounds, you might have increased nausea, vomiting, and decreasing weight when taking Aricept. Don't fret! Comfort yourself with the fact that you are one of those who can take the drug! Just be careful if you are having surgery, anesthesia,or dental procedures while on the drug,

Now, for those off you over 123 pounds, you can still have the nausea, vomiting that the lighter folks have, and studies show those on the 23 mg version have more of that. (Sorry, the ad doesn't mention if all side effects get worse on the higher doses.) We didn't mention diarrhea, difficulty sleeping, or muscle cramps, but if you read our ad you'll see it there. Think about the tiredness you might feel, or the loss of appetite, but don't think too hard, because these things might get better after being on Aricept for awhile. (We also don't mention that a generic form of Aricept becomes available on December 11th.)

Now, how did the drug studies show the effectiveness of Aricept? They were relatively short, 13 to 24 weeks from my quick inquiry. Aricept does stop working after a while even in the most favorable studies. You just don't know when.

But, when seeing a loved one declining due to Alzheier's, the average son or daughter is going to want some help. Aricept may provide some, but the side effects are troubling, and the fact remains that even with Aricept there is no cure for the disease. To see worsening heart and lung problems, not to mention the other side effects, all for a nebulous gain against Alzheiers only indicates to me the eagerness of pharmaceutical companies to profit.

(and, if you read this far, I am not picking on Aricept in particular. So many drugs are now advertised like cigarettes used to be, that it's a shame the side effects are also passed over pretty quickly.)

Take out the words "Salem" and "taste' and substitute Aricept and mind:

[Lucky]

From the website eldercareteam:

FDA Slaps Aricept Ads

The Food and Drug Administration (FDA) has recently chastized two television commercials for Aricept, the most popular medication for Alzheimer's Disease, as "misleading," "deceptive," and "not supported by the available research data."

In a letter dated February 3, 2010 to Eisai Co., Ltd and to Pfizer, Inc., who co-market Aricept (donepezil hydrochloride), the Food and Drug Administration (FDA) stated that the two commercials imply that as a result of taking Aricept a patient's cognitive abilities and daily functioning, including attention and focus, orientation, communication, and social interaction and engagement, will be restored to normal. They pointed out that respected clinical trials of the drug have indicated only a small degree of improvement in some subjects taking Aricept, and that some subjects have shown no measurable improvement at all. They requested that the advertisements in question be pulled from television.

Commercials for Aricept Overstate It's Efficacy

According to the FDA letter, promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience. They found that the two commercials described below fit the description of "misleading:"

The "Beach" TV ad for Aricept presents an elderly man staring off into space, appearing distant, confused, and disinterested, while the rest of his family walks on the beach, and the man's daughter has a look of concern on her face. While this beach scene is taking place, the man's daughter makes the following statements:

• "Dad had been repeating things and acting disoriented for a while, like something was stealing him away from us."

• "We wanted to be there for him, to hold on to him." (While this statement is being made, a young boy clasps the man's hand.)

The ad then shows the man and his daughter discussing Aricept with his doctor. Specifically, the daughter states:

• "Dad's doctor said his symptoms were signs of Alzheimer's, a type of dementia, and that prescription Aricept could help." (While this statement is being made, the daughter poignantly clasps her father's hand.)

After the patient and his daughter discuss Aricept with the doctor, the man's behavior changes dramatically. The man is shown happily interacting with his family members, moving more quickly and with greater focus. For example, he pats his grandson on the head while pouring cereal, winks while feeding the dog under the table, energetically cheers and points at a soccer game while following the plays, and clasps his daughter's hand. While these scenes are taking place, the ad makes the following statements:

• "Studies showed Aricept slows the progression of Alzheimer's symptoms."

• "It improves cognition and slows the decline of overall function."

• "If it helps Dad be more like himself longer, that's everything to us."

• "Don't wait. Talk to your doctor about Aricept."

The "Garden" TV ad presents an elderly woman looking away from family members, appearing confused, aloof, and disoriented. While these scenes are taking place, the woman's daughter makes the following statements:

• "We'd been noticing mom acting forgetful and confused, like she was drifting away."

• "We wanted to be there for her, to hold on to her." (While this statement is being made, a young girl clasps the woman's hand.)

Similar to the "Beach" ad, this ad then shows the woman and her daughter discussing Aricept with her doctor.

After the woman and her daughter discuss Aricept with the doctor, the woman's behavior changes dramatically. The woman is shown interacting happily with her daughter and her grandchildren, trying on a hat, helping them plant seeds, and working with them in the garden. At the end of the ad, the daughter looks at her mother, smiling and hugging her, and the woman clasps her daughter's hand.

According to the FDA letter, which was posted to their website on Friday, February 19, 2010 "...the totality of the above claims and presentations misleadingly overstates the efficacy of Aricept, implying a greater benefit than has been supported by substantial evidence or substantial clinical experience. As described above, the beginning segment of each ad presents patients with Alzheimer's disease looking blank, confused, distant, and walking off apart from their family members. However, after talking to their doctors about treatment with Aricept, the patients are seen interacting and communicating with their family members, happily and actively involved in activities with them. These presentations imply that, as a result of Aricept treatment, patients' cognitive and daily functioning, specifically aspects of attention and focus, orientation, communication, and social interaction and engagement, will be restored to normal.

"The results from the Aricept efficacy trials in patients with mild to moderate and severe Alzheimer's disease do not support such a drastic improvement.

"...the claims and presentations in both TV ads are not representative of the results from the clinical trials for Aricept, and misleadingly overstate the efficacy of the drug. The inclusion of the superimposed text, "Individual results may vary," does not mitigate these misleading presentations."

The full text of the Aricept letter is available on the FDA website.

[MsGuy]

Lucky, try as you may, you will never convince me a major pharmaceutal company would try to sell worthless products with nasty side effects just to make a buck.

After all, we are trusting these people with our lives!