Wednesday, August 19, 2009

Where is the FDA?

In a previous post, I fretted that grand aspirations for personalized medicine don't gibe with drug companies' histories of doing whatever they can to expand sales, even to people who won't benefit. You would hope that this would not include clearly deceptive marketing, though, since in the U.S. this is supposed to be monitored for accuracy by the Food and Drug Administration.

You be the judge.

To set the stage, here's a current ad for Aricept, a drug that is approved and widely prescribed for Alzheimer's Disease:

Here's the critical quote:

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

That statement has a clear meaning: if you take this drug you'll decline less than you otherwise would have. Of course this claim (which I've heard repeated by a doctor) is critical, because it implies that you're losing ground every month you don't take this drug, so you'd better get on it soon and stay on it (for the rest of your life). It is not the same thing as saying "Aricept relieves Alzheimer's symptoms," which would mean you could try it for a while and see if it helps.

Fortunately, those ultra-fine-print sheets that come with prescription drugs are now available online. Here's a pdf of the prescribing information for Aricept, from the website, which I'm confident was checked by the FDA. Go ahead and follow the link; it's tough reading, but a good habit, as you'll see.

At the top of the first page, in Figure 1, is a plot of the average cognitive scores over time, with and without the drug. (The shifts are small compared to the spread of individual responses, though, so many people who try it may not notice any effect). Here's the key: after patients are taken off the drug, their scores rapidly decline until they are indistinguishable from those of patients who never took it. But don't take my word for it, here's the conclusion in the fine print:

"This suggests that the beneficial effects of ARICEPT® abate over 6 weeks following discontinuation of treatment and do not represent a change in the underlying disease."

Am I missing something?


  1. My mother showed some improvement after starting Aricept. Of course, that's a subjective judgment, and only one data point. I recognize the limitations.

    However, during this period of improvement, it was possible for her to interact better with her family and friends. That's worth something, no?

    Aricept isn't especially expensive, either.

    In the end, the final decline was rapid. That's not such a bad thing, is it? It allowed us to have several years of reasonable time with her, instead of a slower, emotionally painful decline.

  2. Thanks, Charles,

    I'm glad to hear it helped for your mother. That is worth a lot, even though, as you recognize, we will never know what would have happened without it.

    My post addressed a slightly different issue: does it slow the disease, or just improve the symptoms? The ad says one thing, the data sheet says the opposite. If it slows the disease, as the ad implies, you are virtually compelled to take it even it doesn't seem to work.

  3. Don,

    You and I understand that Aricept is an acetylcholinesterase inhibitor, meaning it helps maintain levels of a neurotransmitter needed for memory. We also know that only slowing the actual death of neurons (from causes still unclear) could slow the disease.

    So it's as clear as anything could be that Aricept only relieves symptoms. A doctor who prescribes the drug should make these facts clear to the patient and family. That's their job, though not all might do it well.

    Indeed, for just about any type of therapy, cancer chemo for example, there are all kinds of qualifications a physician needs to explain about expectations for success. I don't see how this is any different.

    Regarding the ad, your critical quote speaks only of symptoms, so I'm not sure why you consider it to contradict the data sheet, although it's admittedly worded so as to be less than perfectly clear. That's the way just about all advertising is.

    The FDA does spend a lot of time policing claims made in drug ads. It's a judgment call how far to go. Unfortunately, no business can be trusted not to make its product seem better than it is.

    What's really too bad is that gov't can't come down harder on all those "alternative" herbs and supplements that aren't carefully tested to do anything useful at all. They aren't all especially cheap either.

  4. Charles,
    no argument on the alternatives.

    But I still think that "slows the progression of Alzheimer's symptoms" will be taken by most people to mean "slows the progression of Alzheimer's." For example, this second, incorrect interpretation was repeated quite unambiguously to me by a doctor involved in treating older patients, who should have known better. Of course that is how I came to study the data sheet.

    So we disagree on this. I assert that it's not worded so as to be "less than perfectly clear," it's worded deliberately to leave the wrong picture--and one that locks patients in. If they wanted to communicate accurately, or if the FDA required it of them, they could just say "relieves Alzheimer's symptoms." They didn't.

    I think this violates the law that "requires that advertising for prescription drugs be accurate and not misleading," although there are certainly worse offenders.

    Of course, part of the difference in our reaction may be that my relative who is suffering from dementia does not seem to have gotten any relief from even the symptoms, and is still going downhill fast. But the doctor continues to prescribe Aricept.

  5. OK, well I guess it's up to a court to decide. I don't deny that the company worded things artfully.

    I do still think it's up to a physician to advise the patient and/or family appropriately. That's why they're given the authority to prescribe in the first place. If anything, I'd say the main complaint is with the physician.

    For that matter, a reputable pharmacist could give proper advice too.

    I certainly had enough experience with physicians doing a bad job in my mother's case, though not regarding Aricept.

    I'm sorry to hear your relative isn't doing well. I'd hope there is a power of attorney for health care that allows someone else to object to use of Aricept if that's his/her best judgment.