Hirschfeld developed MDQ for GSK

“GlaxoSmithKline, one of the world’s leading research-based pharmaceutical healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better, and live longer.”

Quetiapine articleOK, I’ll be honest. I can’t keep up with my own posts and have no idea whether or not I’ve posted on this yet. Judging from the fact that I still have this bp booklet, I’m going to guess not. If I have, then there’s more.

When my psychiatrist diagnosed me with bipolar disorder in November, he handed me a bunch of material: a mood tracker (PDF), an article touting the benefits of Seroquel, and a booklet titled, “Bipolar Disorder,” which refers the reader to www.1on1.health.com.

The booklet seems pretty harmless to a patient newly diagnosed with bipolar disorder:

“Highs and lows can be part of life. But, with bipolar disorder, they can be severe. You may feel too depressed to get out of bed one day. Soon after, you may feel full of energy. You may have normal times between the highs and lows. When people have mood symptoms, it’s more likely to be depression.

Mood swings can be hard to predict. But you may have warning signs. You may even learn what can trigger your symptoms. You’ll read about this and more in this booklet.

Bipolar disorder is complex. Doctors docn’t know what causes it. They know that genes play a role. The illness may be linked to brain chemicals. These chemicals can get out of balance.

There are treatments to help control the symptoms. Learn about your condition. Get help for it. This booklet is a good first step.”

Thank you, GlaxoSmithKline.

GSK, the provider of such psych drugs as Lamictal, Paxil, and Wellbutrin, issues a series of booklets for patients referring them to 1on1health.com. The topics include depression, anxiety disorders, epilepsy, type 2 diabetes mellitus, high cholesterol, among others. The tips seems pretty simple and straightforward:

“Health and lifestyle chances may trigger your symptoms. Some common changes are:

Not having a sleep schedule
Misusing alcohol or drugs
Stopping your medicine, or starting medicine for depression or another illness
Having thyroid or other health problems”

Then it gets into the general stuff about the difference between mania, depression and further clarifies what hypomania and mixed moods are. Then, the kicker follows:

“If you think you may have bipolar disorder, fill out the checklist on the next two pages. Share it with your doctor. He or she can use it to help diagnose you.”

Bipolar questionnaireFurious Seasons posted a link about a fake drug named Havidol (which I totally got suckered into because I skimmed the post and missed the “OK, it’s a gag” part), but the hilarity stems from similarly stupid (and vague) questions. I’ve put a screenshot of the PDF GSK provides on their Web site to the right. My issue is not so much with the questions necessarily, but with the lead-in to them:

Has there been a time when...” [emphasis mine]

It doesn’t matter whether you were 3 years old or 46 years old, if you answered “yes” to more than one “there’s ever been a time when” question, guess what? You MAY qualify for bipolar disorder! A sampling:

Has there ever been a time when…

  • You were easily angered that you shouted at people or started fights?
  • You felt much more sure of yourself than usual?
  • You talked or spoke much faster than usual?
  • You were so easily distracted that you couldn’t focus?
  • You had much more energy than usual?
  • You were much more active or did many more things than usual?
  • You were much more social than usual?
  • You were much more interested in sex than usual?

Guaranteed everyone reading this said “yes” to at least TWO questions. If not, I question whether you’re breathing. (Sadly enough, this makes me realize how easy it was for me to get fooled by the phony Havidol quiz.)

The follow-up to the questions above asks, “If you checked YES to more than one of the questions above, have several of these things happened during the same period of time?” Then, “How much of a problem did any of these things cause you (like not being able to work, or having money or legal troubles)? Choose one[:]

  1. No problem
  2. Minor problem
  3. Moderate problem
  4. Serious problem”

The multiple choice question above may not matter. Answering some of the lead-in questions in the affirmative may qualify you for the disorder.

Here’s a nice little tidbit. The questionnaire was “adapted with permission from Robert M.A. Hirschfeld, M.D.” So as an uninformed patient reading this (which I was at the time), I’m thinking, “Oh, this must be legit since they got permission from a doctor to use this checklist.” There’s more than meets the eye here.

On the surface, Dr. Hirschfeld seems like an awesome doctor – and he very well may be. Dr Hirschfeld’s bio from the University of Texas Medical Branch at Galveston (UTMB) extols the “Professor and Chair” of its psychiatry deparment. He has history of working with various national organizations such as the National Depressive and Manic-Depressive Association,  National Institute of Mental Health (NIMH), and National Alliance for Research on Schizophrenia and Depression (NARSAD). He’s written all kinds of articles and blah blah blah. He’s considered a leader in his research of bipolar disorder.

In fact, because Dr. Hirschfeld is so great, he’s a member of pharmaceutical boards and has acted as a consultant for pharmaceutical companies, according to ISI Highly Cited.com. Some of our favorite guys appear here: Pfizer, Wyeth, Abbott Labs., Bristol-Myers Squibb, Eli Lilly, Forest Labs, Janssen, and – lookee here! – GSK.

The duration of Dr. Hirschfeld’s affiliations with these pharmaceutical companies are unspecified. All other “appointments/affiliations” have assigned years, i.e. 1972-1977, 2001-Present. His consulting affiliations follow his internship in 1968-1969. It looks a bit misleading to follow the consulting jobs after, oh say, 1969, and not provide dates of when he became a consultant for all of these pharma companies. Toward the end of the document that I found, his affiliations from 1986-Present are listed with various boards, associations, journals, and a slew of pharmaceutical companies.

Hello, hello, hello. He is a MEMBER of the Zyprexa U.S. Bipolar Academic Advisory Board, the Celexa/Excitalopram [sic] Executive Advisory Board, the Lamictal National Advisory Board, and the Zoloft Advisory Board.

Humor me here. His clinical trials include:

  • 1994 Paroxetine for Dysthymia (SmithKline Beecham)
  • 1995-97 Several (I found five) double-blind studies on sertraline and imipramine in patients qualifying for the DSM-III definition of major depressive disorder
  • 1996-98 Gabapentin therapy for bipolar patients

And the list, including mirtazapine, fluoxetine, venlafaxine, lamotrigine, goes on. You can also find the “grants” pharma companies gave to fund these clinical trials.

From 1997-2000, Hirschfeld received a $100K grant from Abbott Labs to develop “a new checklist for bipolar symptoms.” (I’m not sure what the old one was.) In 2001, he received a $142K grant for the “Bipolar Prevalence and Impact MDQ Project.”

I don’t even need to look MDQ up. It’s Mood Disorder Questionnaire. The grant came from GSK, who “adapted” the questionnaire with Hirschfeld’s “permission.” That sounds simply gravy.

To understand more about bipolar disorder, you can listen to the stories of Greg, Stuart and Leslie – all your classic bipolar cases and how medication and/or therapy has helped them so much. You can also watch the bipolar
disorder animation
that regurgitates all the things that we’ve become skeptical about.

In the meantime, remember the instructions included in Seroquel’s safety information that no one reads (excuse the crappy “Paint” job):

Seroquel warnings

intueri hits the spot

Oh. My. Goodness.

Abilify phone booth (side view)Intueri originally wrote the post about seeing Abilify on the side of a phone booth. I thought it was pretty funny and pretty stupid.

I still find it stupid, but even more so now.

I was on the bus heading to work today (I don’t normally take it) . When it reached a red light near the subway, I saw a telephone booth – akin to the one that you see on the right – draped in an Abilify ad. The ad is exactly what you see here. (If you can’t see it, go to Abilify.com and click on the “see our print adverisement!”)

I work near two major colleges with students who all have cell phones. Adults in the area are too busy thinking about their own problems while heading into the subway. (They, too, are likely to own cell phones.) Public telephones are rarely used anymore. So who’s going to read an ad on Abilify, let alone on a public telephone booth?

Some marketing person at Bristol-Myers Squibb probably thought it would be awesome to have an ad for Abilify near two major colleges. “All the college kids that walk by will see it!”

The readable text – from the bus, anyway – was “Treating bipolar disorder takes understanding.”

Understanding of what? Who’ll actually stand there and go, “Yeah, I need understanding” and walk right up to it to read more.

    • “where you’ve been
    • where you want to go
    • how you want to get there”

I’m ready to understand my history, my future, and the plans I should make. Uh-huh, Abilify will help me do that.

“Ask your doctor or health care professional if ABILIFY is right for you.” [emphasis mine]

The bus didn’t stay there long enough for me to see if they included the safety information, but here’s the gist of what they provide:

    • “Acute manic and mixed episodes associated with Bipolar I Disorder
    • Maintaining efficacy in patients with Bipolar I Disorder with a recent manic or mixed episode who had been stabilized and then maintained for at least 6 weeks “

Someone can explain the last part to me a little better? I’m a mixed-episode case, do I qualify for Abilify?

I was under the impression that Abilify (aripiprazole) is an atypical antipsychotic. Antipsychotics should be prescribed for those who have psychosis. (I may be wrong here; I’m still trying to figure out the difference between typical and atypicals.) I don’t have psychosis. I don’t need Abilify. But the few bipolar people who will read that ad – they’re likely to be homeless – will be misled into thinking that they need Abilify to help them. They’ll go their doctors, saying, “I’ve heard Abilify helps people with bipolar disorder, could I perhaps try it?” PCPs will immediately churn out prescriptions and uneducated psychiatrists (yes, they are out there despite their degrees) will say, “Sure, Abilify works for bipolar disorder. Let’s see if it works for you.” The smart psych would say, “I’m not sure if it would be right for you. It’s an atypical antipsychotic that targets Bipolar I patients who have symptoms of psychosis. Let’s try something else instead.”

So I went on my soapbox. Again. But it angers me to see:

    • An Abilify ad on a phone booth. Period.
    • A misleading advertisement geared to all people with bipolar disorder (it doesn’t specify until you get to the fine print) that says, “Try this; it may work for you.”
    • An advertisement for medication. At all.

What’s next? A marketing blitz by Eli Lilly? “Zyprexa doesn’t cause diabetes! Check out zyprexafacts.com for more information!”

Big Pharma never fails to surprise me.

Pristiq gains ground with FDA

FDA approval for Pristiq (I'll refer to it as Pq occasionally) is contingent upon Wyeth's handling of "quality control problems… made to the satisfaction of federal inspectors." As I'd previously mentioned before, Wyeth has built an amazingly similar medication based on Effexor. Wyeth is trying to market Pristiq as an antidepressant and treatment for vasomotor symptoms (hot flashes during menopause). Wyeth is significantly banking on Pristiq since their $3.5 billion Effexor XR will lose its patent in a few years, allowing other companies to make venlafaxine generics.

Some of the "quality control" problems Wyeth is experiencing:

  • unclear whether Pq keeps depressive episodes at bay
  • efficacy at low doses and in young kids
  • severe nausea in 50 percent of patients in the clinical trials

Reuters' article notes this, though:

"But the studies do not need to be completed prior to approval of the new depression pill."

While Wyeth has admitted that Pq is "structurally related" to Effexor, it "has not yet disclosed if Pristiq has any advantages over Effexor XR, other than to say it would be an alternative to existing treatments."

But it has acknowledged the newer drug caused nausea in about one-half of patients in clinical trials.

Wyeth is banking on patients sticking out the nausea for one week (it supposedly subsides after that) or a 50 mg pill that would be more effective than the whopping 400 mg they used in earlier phases of the clinical trials.

"The company said it will not launch Pristiq until it obtains results from the low-dose trials. Moreover, Wyeth said the timing of the launch also will depend on progress of the FDA's ongoing review of Pristiq as a possible non-hormonal treatment for hot flashes. The FDA is scheduled to decide on the hot flashes indication in April."

Wyeth wants to be absolutely sure they can cover all of their bases in an effort not to lose a single portion on their market share — from those who can tolerate low doses at 50 mg to those who need to go 400 mg and up.

"A G Edwards analyst Joseph Tooley has predicted Pristiq will garner annual sales of $1.4 billion by 2011 — about $1 billion from use against depression and the remainder for menopausal symptoms."

Getting not only psychiatrists to prescribe the drug, but also OB/GYNs is a clever move on their part.

Loose Screws Mental Health News

Surprise, surprise — the likelihood of suicide attempts increases with antidepressants.

     “Suicidal patients taking antidepressants have a ‘markedly increased’ risk of additional suicide attempts but a "markedly decreased" risk of dying from suicide, a large Finnish study has found.
     “The research into nearly 15,400 patients hospitalized for suicide attempts between 1997 and 2003 showed that ‘current antidepressant use was associated with a 39 percent increase in risk of attempted suicide, but a 32 percent decrease in risk of completed suicide and a 49 percent reduced risk of death from any cause,’ the authors wrote in a report published in the Dec. 4 issue of Archives of General Psychiatry.
      “The Finnish study analyzed 15,390 suicidal patients of all ages for an average of 3.4 years. The authors said they did this ‘because previous suicide attempts are the most important risk factor for predicting suicide.’”

I think 15,390 patients is a sizeable, significant study that could probably yield semi-accurate statistics.

      “Among the 7,466 males and 7,924 females examined, there were 602 suicides, 7,136 suicide attempts requiring hospitalization and 1,583 deaths recorded during follow-up. The risk of completed suicide was 9 percent lower among those taking any antidepressants than among those not taking antidepressants.
     “But the picture was not so bright for all those who took SSRIs. It was for those taking fluoxetine (Prozac), who had a 48 percent lower risk of suicide than those not taking medication. But the study found that those taking another SSRI, venlafaxine hydrochloride (Effexor XR), had a 61 percent increased risk.”

So Prozac is better than Effexor XR in terms of suicidal risk. Nice, considering that I've had a 10-year history of suicidal attempts and this study seems to show that venlafaxine increases the risk of suicide attempts. Perhaps Effexor should be prescribed to those who aren't/have never been suicidal?

Continue reading “Loose Screws Mental Health News”

An Interesting Observation

Time’s Quote of the Year:
“Actually, I thought we were going to do fine yesterday – shows what I know.” – President Bush on the midterm elections

CLASSIC.


An interesting observation I don’t know if anyone has already made or if anyone will pay attention to – Time‘s 2006 POTY issue carried 14 medically- or pharmaceutically-related ads. Two of those ads were full-color spreads related to two major pharma companies: AstraZeneca (an ad letting you know they can help/care) and Eli Lilly (touting the benefits of Cymbalta). I couldn’t help but stop and stare at Ambien CR’s ad pages. Ambien CR, a version of the popular sleep aid developed sanofi aventis has a WHOPPING 3.5 pages. Three-quarters of the first page is the Ambien CR color ad and the bottom quarted is  “Important Safety Information” in a blue box. Turn the page and there is nothing but fine print black text streaming across TWO pages. As if a quarter-page of safety information and a FULL two pages weren’t enough, flip the page again, and more “information for patients” continues for a half-page. I’d like to  know someone that’s actually read ALL those warning/safety information things. How many people actually READ all two and three-quarters (2 3/4) of safety information? I’ll be honest with you; I sure don’t. I skip all that stuff. But it’s there so when people suffer side effects, the company can say, “Hey! We  included this in our advertisement! It’s everywhere; you have no basis to sue.”

AstraZeneca, the maker of antipsychotic drug, Seroquel, writes in its ad (click on the thumbnail to see the modified scanned version):

AZ“A pharmaceutical company saving you the money on the medicines it makes.Imagine that. [larger font]

If you take any AstraZeneca medicines, you may be surprised that there’s someone you can turn to for help if you can’t afford them: Us. A family of four without prescription covrage making up to $60,000 per year may qualify for patient assistance. The AstraZeneca Personal Assistants can assist you in signing up for programs that can provide you free medicines or significant savings IF you qualify. [emphasis mine]
We’ll be the first to admit we don’t have all the answers. But as a pharmaceutical company, we recognize that when you trust us to help you, we feel we owe you the same trust in return. That’s what AZ&Me is all about. A place we’re creating to put the personal touch back into healthcare.

Please visit AZandMe.com or call 1-800-AZandMe.”

AstraZeneca Personal Assistants??? What is this? A department store? I can hear it over the loudspeaker now: “Now, calling all patients who use AstraZeneca medicines, we have personal assistants who can help you select the right care and plan to help you get the medicines you need.” And the cute slogan AZ&Me slogan. How adorable. It just makes you want to cuddle right up to Big Pharma! Because remember, they’re putting the “care” back in “healthcare.”  (sarcasm)

If anyone has used AZ&Me to get Seroquel for free or at a discount, e-mail me ASAP at suicidal.recovery AT gmail.com. I’d love to communicate with you.

Well-intentioned but not completely right

medicating the brainI read this commentary from the Philly Inquirer on mental illness and the author insists that mental illnesses are all “chemical imbalances.” While I do think many mental illnesses are the result of chemical imbalances, some mental illnesses are not physical. Some mental illnesses come from a spiritual and/or psychological battle. There are many people who recover from mental illness without medication. If a chemical imbalance was the case for these people, they would never get better. Pharma companies have sold the American public and countless mental health organizations on the idea that millions of people suffer from a “chemical imbalance.” I don’t buy that – well, come to think of it, actually, I do – my dollars contribute to Wyeth and GlaxoSmithKline‘s profits.

After suffering from bipolar disorder (or depression, depending on which psychiatrist I listen to) for 10 years, my husband and I are leaning toward the “chemical imbalance” theory that many doctors and pharmaceutical companies push. But a person who is depressed over a temporary situation does NOT have a chemical imbalance and simply may need psychological counseling.

America is overmedicated, drugged-up, and the victims of the smartest ad campaigns from pharma companies. What concerns me even more is that the FDA and mental health organizations like NIMH buy into many of the pharmaceutical companies’ lies and tactics. What further concerns me are the doctors involved in clinical trials who fail to disclose their affiliations with many of these pharmaceutical companies.

So yes, chemical imbalances do exist for many people. Millions? It’s possible. But unlikely. And I could go off on another rant about how PCPs shouldn’t be prescribing psych meds, but I’ll leave that argument for another day.

Absolutely crazy

PfizerThis has nothing to do with psych meds but I recently learned through the Clinical Psychology blog and Pharma Marketing blog that Pfizer supposedly spent more than $800 million on what was supposed to be their own competitor to Lipitor. The new drug, torcetrapib, needed to be halted because of safety concerns. It seems that quoted cost for the new drug is shady but it prompts the question of how much money pharmaceutical companies invest in new drugs.

Just another day: Part II

Originally written October 16, 2006 (Updated edits in bold red)

On the heels of discussing my cynicism about pharmaceutics and pharmaceutical companies (namely, psychiatric-related), I have a few questions regarding the approach of psychiatric evalutations:

1. Why aren’t people tested for biochemical imbalances?
2. Is there a way to determine from blood work or an MRI what kind of mental illness a person is suffering from (in conjunction with the patient’s psychiatric assessment)?
3. How do doctors know the appropriate dosage for a patient? Does s/he start a patient off on what is considered “normal” for an average person and then increase or reduce the dosage based on reactions and side effects?
4. How does a doctor know when to increase a dosage? (Figuring out when to reduce a dosage SHOULD be much easier.)


Psychiatry is an inexact science. For the most part, I think much of it — regarding medication, Freud, and now, the pharmaceutical industry — is a crock.

Continue reading “Just another day: Part II”