November 17, 2008

The Almost Useless FDA Refuses To Comment On Antipsychotic Being Advertised As Anti-Depressant

Most of you are aware that for the last few weeks I've been noting the presence of the Abilify for depression TV ad, which has been running late nights. Abilify is an atypical antipsychotic, carries black box warnings for all manner of problems associated with that class of drugs, and yet nowhere in the ad is it mentioned that the drug is an antipsychotic. Instead, throughout the ad it's only referred to as an anti-depressant.

Last week, I asked the FDA if the agency had reviewed the ad or if it had plans to. The reply I got this morning from Sandy Walsh (who I know is doing her job within institutional constraints), the agency's spokeswoman for psychiatry products, speaks volumes about just how useless the FDA has become and how it clearly represents the needs of industry but not of consumers:

"We don't comment publicly about currently running ads, so there's nothing we can say specifically about Abilify's TV ads.

"Generally, individual ads for prescription drugs are not required to include information about all of a drug's indications, but may instead be limited to promotion of one of the drug's approved indications.

"And, generally, if the FDA were reviewing an ad and the agency is going to take action against a company for a certain advertisement, we would not be able to discuss that publicly until after the agency took an action.

"For more information on the regulation of prescription drug advertisements, please see our DDMAC web site at http://www.fda.gov/cder/ddmac/faqs.htm

"For information about warning letters that have been issued to companies about their ads, please see our Warning Letters site at http://www.fda.gov/cder/warn/warn2008.htm"

It's not clear to me if the agency's no comment is a result of federal law or of agency policy. Walsh hasn't answered my question on that point nor did she or anyone at the agency address the sticky issue of an antipsychotic being marketed as an anti-depressant. So how is the public to tell the difference between an Abilify TV ad and a Cymbalta TV ad? Surely, the FDA ought to be concerned about that, especially since the approval trials for Abilify as an add-on treatment for depression make it clear that the drug causes akathisia in about 25 percent of patients.

I asked Walsh where readers could direct their concerns about the Abilify for depression ad. You can direct whatever comments you wish to make to:

Food and Drug Administration
Center for Drug Evaluation and Research
Division of Drug Information
5600 Fishers Lane, HFD-240
Rockville, MD 20857
Telephone number: (301) 827-4573 or 1-888-INFOFDA (463-6332).
E-mail address: druginfo@fda.hhs.gov

At a minimum, the agency should review this ad, which I consider to be highly deceptive. The reality is that antipsychotics are not anti-depressants, pure and simple.

UPDATE: If you call the above number/s, the nice person on the other end will ask you to fill out a Med Watch report. You can do that at www.fda.gov/medwatch and press on "begin." You don't need to include patient information or date of event since you are complaining about a TV ad. Or you can just send email to the above email address.

Seems like a rather complex system for the public to report concerns about a TV ad.

Posted by Philip Dawdy at November 17, 2008 11:33 AM
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Comments

The FDA doesn't require any drug ad mention what specific "class" it is in. So if you watch a regular Abilify commercial for bipolar disorder (which you can do on YouTube), you also won't hear the words "atypical antipsychotic" mentioned.

Not sure if the ad in question specifically says, "Abilify is an antidepressant..." but I'd be very surprised if it did. If, instead, the ad mentions adding Abilify to existing antidepressants (which it's approved for), then that seems like an appropriate and not all that surprising ad.

Posted by: Gary Regis at November 17, 2008 11:56 AM

The labels "antipsychotics" and "antidepressants" are simply marketing ploys anyway and I think you are actually dignifying them too much by getting into this discussion on semantics. Both so called antipsychotics and so called antidepressants are not really truly indicated for either psychosis or depression. They work by sedation or stimulation and darn serious sedation or stimulation. Let's not dignify them by implying they are actually a "cure" for either psychosis or depression. All they do is knock you for a real loop so you don't even remember what your condition really was. If you want to read more on this way of viewing these medications read Joanna Moncrieff who has written an excellent book about the very great importance of calling a spade a spade -- The Myth of the Chemical Cure. Let's stop calling these drugs anti-anything and call them by what they really do -- either a stimulant or a sedative.

Posted by: Sara at November 17, 2008 12:55 PM

That's the same address and number (and nice person) I spoke to when I called to report Lamictal withdrawal side effects.

It all goes to the same dump bin.

Posted by: Stephany at November 17, 2008 06:04 PM

I used the email function. I probably won't get a reply. I don't expect a reply. Okay, honestly? I don't care if I get a reply. I am just tired of seeing that junk advertising on TV.

If/when they take the Abilify commercial off TV, can they take Smilin' Bob and his junk (pun intended) off too?

Posted by: Stiff Man at November 18, 2008 01:07 AM

The reality is that antipsychotics are not anti-depressants, pure and simple.

Not so pure and surely not so simple, really. Don't get hung up on the original label or class a particular medication is filed under. It is an antidepressant if it works as one, and if it's found to be useful for people with schizophrenia, it can also act as an antipsychotic. What's the big deal?

No one is forcing you to take a medication if you don't want to take it.

Posted by: A Believer at November 18, 2008 04:49 AM

Dear Philip:

Now why the FDA would respond to any question or inquires from the public is beyond me; just because they are supposed to work for us (each and every Citizen). That would go against everything they stand for as a bought and paid for agency; like being in the pockets of Big Pharmaceutical, and under the influence of any corrupt Politian that happens to throw a bone their way.
Drug ads are absolutely ridiculous, dangerous, propaganda taken to its outer limits, and should be banned; but then Big Pharmaceutical Companies and Medical Corporations would just go under the table and directly market these drugs and treatments to doctors anywise. Isn’t it nice they can have it both ways, they can actually get Mr. Joe uninformed public to walk into a doctor’s office and ask to be poisoned.
This is beyond marketing genius and a power grab; it's the pinnacle of all business dreams and aspirations. When you have the government in your pocket, no one can touch you, and you’re free of all ethics, morals, boundaries, and conscious.
Isn’t uncontrolled greed just grand?

Yours truly,
Stan

Posted by: stan at November 18, 2008 08:24 AM

Don't wait for reply.
They will never reply! But they need to know that people care about it.
They will never reply!
But they need to know that people care!

Posted by: Ana at November 18, 2008 09:06 AM

These ads put a psych-drug side by side with Coke and a toothpaste.
It's obscene.

Posted by: Ana at November 18, 2008 09:08 AM

For me, the issue isn't whether Abilify is "really" an antidepressant versus an antipsychotic, but that it is far more dangerous and expensive than other antidepressants. I'm always glad to hear about something that helps relieve suffering. But Abilify is way, way down my list of medications to consider for (non-psychotic) depression.

Choosing psychiatric medications based on their marketing materials -- now that's crazy.

Posted by: Steven Reidbord MD at November 18, 2008 04:39 PM

"No one is forcing you to take a medication if you don't want to take it."
--'a believer'

Well, 'a believer'; there are people every single day in locked down psych wards and outpatient treatment care who suffer forced injections, forced ECT (Ray Sandford)and people who innocently trust doctors....then try and go off the meds and suffer withdrawals not acknowledged by the FDA, doctors and especially the pharma companies.

I would like to say one thing: fuck off.

Posted by: Stephany at November 18, 2008 07:41 PM

People are not forced to take psych-drugs but they are told that:

- you'll feel fine;
- side effects are mild and disappear with time;
- the drugs are not addictive;
and many informations that conceal what is really at stake taking an anti-depressant or anti-pyschotic.

Now we are being told that the difference between an anti-depressant and an anti-psychotic is not relevant and the use off-label is normal.
If this is scientific I don't know.
All I known is that it's getting harder and harder to believe that psychiatrist really know what they are doing.
It's appalling that side effects are seen as diseases; diagnoses change during the treatment; little is known about the origin of diseases; withdrawal is not a concern; people fell long-term damage after quitting drugs...


Posted by: Ana at November 18, 2008 11:27 PM

Actually Ana, some people ARE forced to take drugs against their will. In my state they can force you to be on meds for up to five years, renewable as many times as the powers that be deem "necessary". I have met people in this situation and it's some scary.

Posted by: Sherry at November 19, 2008 09:55 AM

Sherry,
I was trying to stress that by not telling about side effects and withdrawal problems - I've tapered Effexor for 19 months and after 3 months off the drug I had to take it again - is not a honest way to prescribe this drug.
I'll be forced to take Seroquel, Effexor and Rivotril for life due to withdrawal problems.
Nobody told me that these drugs are addictive. I have been on many psychiatrists blah blah blah...
I've seen lots of treatments being imposed to people.
There's a discussion on ECT going on here.

Posted by: Ana at November 19, 2008 04:34 PM

People ARE forced to take psych meds in group homes and outpatient in their own homes if on a court order, which in Washington state for example, is called an LRO (least restrictive order) and it can be a 90 day, or 180 day order. IF the person is not med-compliant they can end up back in a locked down psych ward, where the LRO was part of discharge plan.

My daughter was on an LRO to get out of the psych ward when I fought in court. It was either that 90 day court order or the state institution locked up forever.,

She is off the order now.

Posted by: Stephany at November 19, 2008 04:36 PM
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