November 12, 2008

New Version Of Abilify For Depression TV Ad Running

Last night, I saw a new version of the Abilify for depression ad on TV. As with the first version of the ad, nowhere is it mentioned that the drug is actually an antipsychotic. Instead, all the language is about anti-depressants, usually in reference to the well-known anti-depressant black box warning. Thus Bristol-Myers Squibb is effectively marketing an antipsychotic as an anti-depressant. This is just so bizarre. Sadly, I cannot find a Web version of the ad to post.

Of note is that instead of a single white woman, the ad now features several shots of a tension-filled white man--of course he's smiling at the end of the ad as he goes to get the mail--and brief shots of an African-American woman. I note that for what it's worth. I'm fascinated by the social imaging around psych meds ads.

Still no word from the FDA on whether it has reviewed the Abilify for depression TV ad and what the agency thinks of BMS marketing the drug as an anti-depressant.

Once again, let me point out that the Abilify for depression clinical trials showed using the drug for depression resulted in a better chance of causing akathisia than of improving depression.

Posted by Philip Dawdy at November 12, 2008 02:33 PM
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Comments

All pharma ads most go through a review process before it is allowed to be on television. I'm not sure how it is connected to the FDA or if it is, but it exists. You can't just write anything and put it on television.

J

Posted by: Jason at November 12, 2008 02:56 PM

The Abilify advertisements reflect a tragic irony. Where televised anti-depressant ads say nothing about them not working, the first Abilify ad states that two out of three people in treatment for depression don't see improvement, despite trying multiple medications. Of course, the solution to anti-depressants not working is an antipsychotic, i.e. Abilify prescribed adjunctively. And where it has been estimated that only ten percent of prescribers follow the ADA/APA monitoring guidelines for metabolic syndrome this could result in the use of one more or more medications for metabolic syndrome related illnesses. There is something very wrong here.

Moreover, it is long past time that pharmaceutical advertising be banned from TV once again. How in all good conscience can psych meds be advertised using the same "slice of life" approach associated with household cleansers, mouthwash, etc? Doubtless the pharmaceutical firms would then redeploy these funds to create new psychotropics - increasingly found to be mere patent extenders.

Posted by: Joe at November 13, 2008 02:12 AM

I just saw one of these ads during Good Morning America. The ad had black women and white couples and a 50 something white man in it. Theatrically the ads are interesting in the way the actors show "depression." Pulling a sweater around one, looking despondent in a grocery store, sitting behind a disorganized desk, or, yes, curled up on a sofa watching television, are all apparently outward manifestations of depression, and then the cured people, truly cured walk around patio parties with Chinese lanterns. Apparently participating in an outdoor party with Chinese lanterns is as much a part of mental health as being in the woods with a Golden Retriever.

Meanwhile, the warning ads seem to play the entire time. As the happy people wander among Chinese lanterns and golden retrievers and place big envelops in mailboxes (a sure sign of mental health), the deep male voice reads a litany that goes something like this:

"IMPORTANT SAFETY INFORMATION:
Elderly people with psychosis related to dementia (for example, an inability to perform daily activities as a result of increased memory loss), treated with atypical antipsychotic medicines, are at an increased risk of death compared to placebo. ABILIFY is not approved for the treatment of people with dementia-related psychosis (see Boxed WARNING).

Antidepressants may increase suicidal thoughts or behaviors in some children, teenagers, and young adults, especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are themselves associated with an increase in the risk of suicide. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Such symptoms should be reported to the patient's healthcare professional right away, especially if they are severe or occur suddenly. ABILIFY is not approved for use in pediatric patients with depression (see Boxed WARNING).

CONTRAINDICATION: Patients should not use ABILIFY if they are allergic to aripiprazole or any of the ingredients in ABILIFY. Allergic reactions have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue

Serious side effects can occur with any antipsychotic medicine, including ABILIFY. Tell your healthcare professional right away if you have any conditions or side effects, including the following:

* An increased risk of stroke and ministroke has been reported in clinical studies of elderly patients with dementia-related psychosis
* Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. These may be signs of a condition called neuroleptic malignant syndrome (NMS), a rare but serious side effect which could be fatal
* Abnormal or uncontrollable movements. These may be signs of a serious condition called tardive dyskinesia (TD), which may be permanent
* Diabetes, risk factors for diabetes (for example, obesity, family history of diabetes), or unexpected increases in thirst, urination, or hunger. Increases in blood sugar levels (hyperglycemia), in some cases serious and associated with coma or death, have been reported in patients taking ABILIFY and medicines like it. Ask your healthcare professional about the need to monitor your blood sugar level before and during treatment

Lightheadedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting or lying position (orthostatic hypotension) has been reported with ABILIFY.

Medicines like ABILIFY can affect your judgment, thinking, or motor skills. You should not drive or operate hazardous machinery until you know how ABILIFY affects you.

Since medicines like ABILIFY can impact your body's ability to reduce body temperature, you should avoid overheating and dehydration.

If you have suicidal thoughts, you should tell your healthcare professional right away.

Medicines like ABILIFY have been associated with swallowing problems (dysphagia). If you had or have swallowing problems, you should tell your healthcare professional.

Tell your healthcare professional if you have a history of seizures, or are pregnant or intend to become pregnant, and about all prescription and non-prescription medicines you are taking or plan to take.

Most common side effects (≥10%) from all clinical trials involving adults or pediatrics include:

ADULTS: Nausea, vomiting, constipation, headache, dizziness, an inner sense of restlessness or need to move (akathisia), anxiety and insomnia.

PEDIATRICS (10-17 years): Uncontrolled movements, headache, sleepiness and nausea.

While taking ABILIFY, avoid:

* Drinking alcohol
* Breast-feeding an infant

It is important to contact your healthcare professional if you experience prolonged, abnormal muscle spasm or contraction which may be signs of a condition called dystonia."

Bizarre, the visual message is that these drugs will make you more physically comfortable, better looking, more popular, richer, more appealing to Golden Retrievers, while the voice over tells you the drugs are poison that can't help. And people still request the drugs and are legally forced to take them at times. Humans!

Posted by: Sally at November 13, 2008 05:40 AM

I'm starting to think that it just does not matter what the chemical is; it's going to be marketed, pimped out to consumers and whether or not it's an anti psychotic or anti depressant, in the end, a name is a name, a chemical a chemical, the damage will be done to bodies and brains, and all for pharma-profit.

i thought Grassley or someone was going to put a stop to DTC ads?

our government, as a health watch dog sucks.(the FDA is worthless!)

Posted by: Stephany at November 13, 2008 06:17 AM

I finally saw the ad after reading your critique. I pointed it out to my husband that it was an ad for an antipsychotic med. We actually had the sound muted as we usually do during commercials. The images were very interesting as I could just imagine the words and warnings being rattled off. Kind of like the ad for bipolar use that has been on lately. After hearing all that, who would volunteer to take such a drug. It rotted my teeth due to dry mouth, I'll bet they didn't mention that.

Posted by: Jen at November 14, 2008 10:42 AM

Just saw a piece in Pharmalot (? I think) that the use of DTC ads is going down. But my point in posting is that this is an off-label promotion and is against the law. Where is the FDA and where are the attorneys general?

Posted by: Sorrowful at November 14, 2008 03:12 PM

I took Abilify for psychosis. Side effects I experienced on a low dose included panic attacks, irregular heartbeat, pacing, and racing heart. I do not believe that it should be marketed for anyone who does not suffer from psychosis. If a person has major depression with psychosis, I imagine it could be used, but it is an atypical antipsychotic and should not be used in people who are not psychotic, in my opinion. It is not an antidepressant, and it is a very serious drug.

Posted by: Stephanie at November 19, 2009 08:51 PM
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