December 14, 2007

FDA Issues Warning Letter On Effexor Ad

So the FDA just issued a warning letter to Wyeth, makers of the SNRI anti-depressant Effexor, over spurious claims made in an ad for the drug. In the ad, the company claims that Effexor remitted depression in 60 percent of patients who'd been taking an SSRI yet still had depression symptoms. The FDA claims in a letter to the company that such a claim in not supported by evidence and that the company used an open label trial (ie, not randomized or placebo-controlled) to back its claim. That's the wrong kind of study to use.

What's interesting is that just last year the NIH-funded STAR-D study reported that in patients taking an SSRI (Celexa) who then switched to Effexor only 25 percent saw remitted symptoms. So Pfizer's 60 percent claim is certainly a bold one.

Guess we'll be seeing a new Effexor ad soon. The ad in question is stunning for other reasons: it targets women (do men not get depression?) and shows the subject in a typical family setting in a prosperous-seeming home. If you know much about American culture these days (fewer than half of women married, and a much smaller percentage likely to be in prosperous homes in the 'burbs), you've just got to wonder exactly what kind of drugs Wyeth's marketing team and its ad agency are taking. You've also got to wonder why pharma execs think they can get away with this sort of excessive claim.

(Via Pharmalot.)

Posted by Philip Dawdy at December 14, 2007 09:51 AM
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Pharma execs think they can get away with this sort of excessive claim because they have done it before and they were successful. Ask the millions of survivors of Prozac/SSRIs and they will most likely agree.

Posted by: Rosie at December 14, 2007 02:43 PM

As we all know, the most valuable knowledge possessed by a culture is conveyed through middle of the night infomercials. Millions are doubtless making fortunes on eBay, buying homes for pennies on the dollar with no money down, and having their lives improved through the acquisition of all sorts of gadgets so it was not surprising that I caught the final ten minutes of an Effexor ER infomercial. It was followed by a commercial for Extenze, a pill the claims to well, er, lengthen part of the male anatomy. Ah, two rigorously tested scientific advancements neatly juxtaposed.

The Effexor ER infomercial made mention of two sites, mythrealitly.com and stillhavesymptoms.com. Given that the FDA's Warning Notice for Effexor ER advertising cited over statement of efficacy, the use of the mythreality.com domain is ironic. In the warnings at the end of the infomercial I found that my blood pressure should have been monitored when I took Effexor. Of course, my blood pressure wasn't monitored by the prescribing psychiatrist. This too often is reality not myth.

Posted by: Joe at December 15, 2007 07:20 AM

Joe, I'm not surprised they didn't monitor your bp. They didn't ever check mine either, and I was on a high dose of Effexor. In fact, never once did my physician address increased bp as a risk of Effexor (even after having telling him I had a family hx of stroke). But, then he worked for Wyeth (I later found out) so why would he tell me the risks of the med when he was getting big bucks for promoting it?

Posted by: Lisa at December 16, 2007 01:03 PM

Geez, I was never monitored, either. In fact, other than "dry mouth and weight gain", I was never told about ANY potential side effects or dangers about ANY of the many drugs I swallowed in the thirty years these idiots failed to recognize my hypothyroidism and PTSD. When I gained 30 pounds on a tricyclic I was treated as if I was being very, very uncooperative to complain about it. Prior to that time, I had been underweight all of my life. I got off it by lying to my psychiatrist and telling him my husband and I were planning to have a baby (as if!) so I needed his help in getting off the meds. The truth is, this *doctor* thought I should have a baby and all would be well. What a moron! He even offered to come visit me in the hospital post partum because I was "at such high risk for post partum depression". I cannot tell you how hard it was for me to maintain a straight face upon hearing this nonsense. I hate to lie, I really do, but I really needed to get off these pills that did nothing but make me gain weight.

Here's how I got off Effexor, which actually did help a bit for a while: I had my gall bladder out. By the time I came out of my post-surgical fog and remembered I even had a prescription for the stuff I was feeling so much better from dumping my poisonous gall bladder that I never bothered to take it again. I wasn't entirely well, to be sure, but I did feel a lot better. I felt so crappy coming out of the surgery I never noticed any withdrawl. That time, once I escaped the drug mill, I never looked back. I hope I never have to set foot in a psychiatrist's office again.

My biggest fear in life is that I'll end up drugged in a nursing home--not an idle fear with my 60th birthday coming up. I'm thinking of going to a lawyer to see if I can use some HIPPA clause to erase my record of mental illness, especially since so much of it was actually misdiagnosis and treatment of physical ailments (mainly gall bladder and thyroid). I realize it's my word against all those psychiatrists so I'm hoping to find a statute of limitations or something. Just how long to I have to tote these stigmatizing diagnoses around, anyway??? I haven't been in a nuthouse in over 8 years, haven't taken a psych med in almost that time. I still have tons of PTSD symptoms, which I manage on my own and need no help with--mainly because there really *isn't* any help beyond symptom management. I consider my remaining symptoms my own business and nothing I need any medical "help" for, not a medical problem.

I find the local ER a dangerous place for anyone with any record of mental illness. The moment they find you have a mental "health" record, they put you in a rubber room with a uniformed guard at the door and ignore any physical complaints. If you complain you end up in handcuffs in the back of a cruiser on your way to the state hospital. I was with a friend when this happened to her. She was there because her blood pressure was spiking from a bad drug reaction. She was in serious danger of a stroke, but got no treatment other than handcuffs. Oddly, the uniformed guard was the most sympathetic person of the lot. They released her immediately from the state hospital because sher "didn't belong here".

I avoid doctors of any kind now as I consider them a clear and present danger to my well being. It always amazes me when people view them as a potential source of help. They managed to kill another friend, who died alone after four days in restraints on a locked ward. Her doc pulled her off a drug known to cause heart attacks upon withdrawl. I can't recall the name.

If there were subway tunnels under the medical profession, I'd be one of those weird gopher people living down there, coming out under cover of night to pick a dumpster or two. Sigh.

Posted by: Sherry at December 16, 2007 01:40 PM

Sherry, Bravo! Bravo! you have said it ALL!!!

Posted by: Stephany at December 16, 2007 07:15 PM

Thank you, Stephany. I often feel like such a bitch, especially here--the only place where I can really tell my story or express my anger at what's happened to me. Most of the time I think that at best I must be boring the heck out of everyone here with my one-note samba.

So, thanks. It means a lot. This blog means a lot. It's nice to not be alone, to be amongst people who share my perceptions. We're probably not right about every little thing, but I seriously doubt we're wrong about most of it.

Another little tale from Mental Health Land: my husband and I used to see a really neat guy for marriage counselling. As you can imagine, our relationship has more stresses than many, plus we each came to the task of marriage spectacularly ill equipped.

Anyway, Mr. Marriage Counsellor (Mr.MC) was really great for years. Until NAMI moved into the office next door to his. Our local NAMI is a bunch of REALLY nice people, but I have never liked or trusted that organization. I'm the only one I know who feels this way locally.

Prior to NAMI moving next door Mr. MC would often tell us "You need to take a stand together to not serve the abuse any more." This is a very helpful thing to say to an abuse survivor and spouse. It united us in a common and healthy cause. It caused us to examine the effects of what we'd each learned in our families of origin and chart a new, healthier course together for OUR marriage.

Within a year of NAMI moving in next door, Mr. MC's song changed to "You (my spouse) need to attend NAMI's group meetings to learn how to manage Sherry's disability." I went from equal participant in my own marriage and marital counselling to being the "problem" in a matter of months.

This is such an easy trap for us because my sweetie is a quiet man, one of those people who just looks soooo good and does it easily. (And he is a genuinely good person, just not as good as he's able to look.) I, on the other hand, am a real bitch a lot of the time. If my sweetie disagrees with you, he'll smile sweetly and say "I'll have to think about that". If I disagree, I'll argue back. Guess who pleases therapists the most? I'm trying to learn to behave like my sweetie at times advantageous to me (um, like SS reviews--not a time you want to piss off the shrink).

Mr. MC is still a neat guy. But he's no longer our marriage counselor. Actually, our marriage has now outlasted those of at least two of our previous marriage counselors, including Mr. MC's. Our relationship is hardly perfect, but we've learned to manage our differences and each of us has grown towards greater health than either of us could have imagined initially. And certainly we've accomplished far more as a team than had we followed NAMI's/Mr. MC's advice and demoted me to the status of a problem to be managed by my so-called healthier spouse.

This blog is the only place I've found in real life or on the net where people see what I see about NAMI. I've been feeling pretty crazy about this for years.

Best wishes to you in your struggles, Stephany.
Sherry

Posted by: Sherry at December 17, 2007 08:12 AM

Thanks Sherry,for the support. and yes you were smart to question NAMI and the "kind and concerned care" being taught to family members on how to "deal" with us/kids,friends, and don't forget they back up forced medication paradigm, and receive pharma funding. I was asked by one of the Exec' directors at a large NAMI group to teach advocacy for them, as "we've never heard of an advocate like you.", I'm pretty sure they won't like my approach. First, treat people with dignity, make sure they understand [like teach a class to patients]Civil Liberties, and make sure each board member or volunteer who works for NAMI sees the inside of a locked down psych ward.
I have steered clear of that group. I've done my own thing, and mostly was inspired to do so, once I heard a bunch of NAMI moms whining in mental health court. I got up and sat across the aisle, and read my notes on civil liberties and reminded myself that some of the houses NAMI supports for clients, have applications to fill out and one of the main questions is: how do you feel about meds? med compliance is mandatory for those NAMI supported and created homes. I think that's wrong. It's the underhanded attachment to Pharma that ppl. need to know NAMI is based on, seriously stigmatizing mental illness all the while appearing to want to help. Like you found out.

Posted by: Stephany at December 17, 2007 09:55 AM

NAMI pushed for a bill in Congress about ten or fifteen years ago that had the state childhood sexual abuse survivors' group, of which I was president, quite exercised at the time. They wanted the right to be told when/if a loved one was in the hospital! Hello? I didn't realize being schizophrenic means you lose all right to privacy.

One of my best friends has a schizophrenic brother. This man is kind and gentle and sweet and she is his biggest advocate. It would wrench all of our hearts out if Brother disappeared and we didn't know where he went. Sure, it would be helpful--to my friend and her family--to be told where he is. But would it be helpful to HIM? Not to mention we already have guardianship laws (creepy, but true) so why would we need a special law depriving one class of people of their right to privacy?

As an abuse survivor, you can bet your bippy I don't need or want my perps to know where I am in the most vulnerable time in my life. The only proviso I made when I entered a hospital in my late twenties was that my mother would not be allowed to know I was there (she lived four miles away in the same tiny town) or be allowed to visit. The doc, who'd known me since I was 14 and who sensed problems beneath the surface of this model family, agreed. My aunt (on my stepfather's side) took care of me with kindness and professionalism and never said a word. This was in a small general hospital and is the only really healing experience I've ever had in a hospital. Only a weekend, but it gave me much needed time and space. Trust me, it wouldn't have been the same with Morher in my face.

I've had trouble with NAMI from the time I found out their acronym meant "National Alliance FOR the Mentally Ill", but it was started by FAMILIES of mentall ill people. Big, fat difference, folks. (Yes, I know they changed their name since. But I somehow doubt they've changed their priorities.)

Sherry (still marvelling at how cold it is here in NH these days. My chickens' water was frozen in their bucket today, poor babies.)

Posted by: Sherry at December 18, 2007 05:29 PM
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