… the makers of Seroquel XR. Just sayin’. (Click on the image to bring it full size.)
As reported by The New York Times, people with bipolar disorder have a higher risk of suffering from fatal illness according to a study (that reviewed 17 other studies involving more than 331,000 people) reported in the February issue of Psychiatric Services.
Gianna at Beyond Meds provides here take here.
Some crazy nurse in Minnesota convinced a Canadian college student to kill herself and walked her through the process of appropriately hanging herself. Ed Morrissey of Hot Air calls the nurse "the first serial suicide-inciter of the modern age." Couldn't have said it better myself.
Philip Dawdy at Furious Seasons is on a roll, holding AstraZeneca accountable for its actions regarding hidden information about Seroquel and now he hosts the Seroquel documents — alongside Lilly's Zyprexa documents — that indicate buried studies. Dawdy's also running a spring fundraiser and I suggest you get your butt in gear and donate to him if it's important to you that someone holds pharmaceutical companies accountable for their actions. I've already done my part.
Sorry this post isn't filled with my normal snark and cynicism. I'm behind on a lot personally — still trying to get the hang of this self-employment thing — and this is what I can throw out for now.
Eli Lilly seems to be passing along its misfortune off to AstraZeneca, which now appears to be having issues with masking evidence of Seroquel side effects. From Furious Seasons:
According to researchers at Stockholm's Karolinska Institute, schizophrenia and bipolar disorder may have common genetic causes. Researchers studied 9 million Swedish people during a 30-year period and discovered that "relatives of people with schizophrenia or bipolar disorder had an increased risk of both disorders." The study may also suggest that "the two conditions may simply be different manifestations of the same disease."
The article from Reuters also points out that Seroquel and Zyprexa are used to treat both disorders, which may lead people in the psychiatric industry to further investigate the link between the two illnesses. Here are some interesting discoveries from the study:
* If a sibling had schizophrenia, full siblings were nine times more likely than the general population to have schizophrenia and four times more likely to have bipolar disorder.
* If a sibling had bipolar disorder, they were eight times more likely to have bipolar disorder and four times more likely to have schizophrenia.
* Half siblings who shared the same mother were 3.6 times more likely to have schizophrenia if their half sibling had schizophrenia and 4.5 times more likely to have bipolar disorder if their half sibling had bipolar disorder. Half siblings who shared the same father had a 2.7-fold increase in schizophrenia risk and a 2.4-fold increase in bipolar disorder.
* Adopted children with a biological parent with one of the disorders had a significant increase in risk for the other.
Creepy. My father's schizophrenia didn't begin to manifest itself until he was in his 40s. The same is true for my two other aunts as well. It may be silly but I live in fear that I may have the same problem. I'll eventually get a psychiatric advance directive in place just in case that day ever comes. After seeing three family members with debilitating schizophrenia/paranoia, sometimes it gets to the point where the benefits of being drugged up outweigh the risks.
Mood rating: 6
These documents are all in PDF form. You will need Adobe Acrobat Reader to view them. Download Adobe Acrobat here.
If you prefer, you can view the Patient Safety Information in HTML at the official Food & Drug Administration website.
The New York Times has reported that a recent study found atypical antipsychotics, which include the friendly family of Clozaril, Abilify, Risperdal, Zyprexa, and Seroquel (maybe Saphris soon), can increase a patient’s risk of dying from cardiac arrest twofold.
The study published in The New England Journal of Medicine also concluded that the risk of death from the psychotropic medications isn’t high. However, an editorial also published in the same issue “urged doctors to limit their prescribing of antipsychotic drugs, especially to children and elderly patients, who can be highly susceptible to the drugs’ side effects.”
A U.S. News & World Report article linked to the FDA’s atypical antipsychotics page for further patient information. If you’re on an atypical, I’d recommend reading each word in the patient safety info that applies to you. Proofreaders like me shouldn’t be the only ones tortured with reading all the fine print. *winks*
Mental Health Blogs Going Bye-Bye?
As I noted earlier, there’s a spate of mental health blogs that are going on hiatus of some kind. Now, it’s my sad duty to report that Gianna Kali’s Bipolar Blast blog is going on an indefinite hiatus as well. You can read her post "Quitting?" for the details. Bottom line: all those years of very high doses of psych meds seem to have injured her body. I cannot even begin to send her enough good wishes. I cannot even begin to express my disgust with some of the bad doctors she ran into over the years.
Also, the Psych Survivor blog, written by a man I only know as Mark, was taken down a few weeks ago, and from what I gather he is in the hospital with heart problems. His was/is a good and strident voice on these issues we all care about and his work is missed.
All of this kind of makes me feel glum, since the two people above had been at the blogging game for well over a year and I sensed that they’d both be around long-term. These are people I care about and it sucks that they won’t be the presence they once were.
Why is it that mental health blogs are so difficult to do and keep going? Why is it so hard for them to find the substantial audiences they deserve? The Internet is crowded with blogs about politics, technology, gadgets, gossip and parenting and many of these seem to do quite well and have huge audiences and long lives, despite the fact that many of them are merely echoes of one another. Are readers of blogs that simple-minded that all they need is the latest news and opinion on Apple’s or Microsoft’s latest bit of software or Obama’s or Hillary’s latest gaffe?
You’d think in a country where 10 percent of the population is on anti-depressants and another 5 percent to 10 percent is likely on some other psych med that there would be a substantial audience for these issues (regardless of what one makes of the dominant mental health paradigm), especially given how wildly popular neuroscience is on the Net. It makes me wonder if we all–and here I include myself–have done something wrong in how we analyze these issues (are we too contrarian?) or if we all simply haven’t been crowded out of the big search engines (that’s how most people find mental health information online) because the Net is so over-populated with pharma sites and allied pro-pharma health websites. I can certainly say that the mainstream media–which usually loves writing about characters on the Net who push against life’s many intellectual tides–has given very little attention to sites like this one, despite the fact that sites like mine have been a very real service to many in the media.
Or maybe the mainstream approach to mental health care is right and the public is just trying to tell us something.
What do you think?
I’ll tell you what I think.
I recently wrote about the MOTHERS Act and the unnecessary scare tactics surrounding it. A Dallas-Fort Worth TV station picked up on the story and provided a short one-sided view of the issue, continuing to purport that the bill is solely about drugging new moms. I don’t discount Ms. Philo’s terrible experience with her medication. In fact, I’d be against the act if its sole purpose was to force treatment on pregnant women – medicated or not. Again, I’d like to reiterate that the bill’s purpose is to educate moms about postpartum depression and postpartum psychosis – not to shove unnecessary pills down women’s throats.
If you have sleep apnea, your CPAP (Continuous Positive Airway Pressure) machine may alleviate depression symptoms. My husband has sleep apnea and hasn’t been able to use the CPAP machine because of sinus problems. When he doesn’t use it (he hasn’t for a while), he’s noticeably moodier and prone to depressive symptoms. But then again, anyone who doesn’t get good sleep for several days is pretty moody.
AstraZeneca (AZ) is going after Teva Pharmaceutical Industries and Novartis AG’s Sandoz unit after the two companies applied to make cheaper version of Seroquel available. AZ’s patent on Seroquel expires in 2011. The trial date for patent litigation is August 11. In the meantime, according to the Bloomberg report, the FDA is considering approval of Seroquel XR for bipolar depression and bipolar mania.
What is it about the U.K. that they seem to take pharma’s power more seriously than the U.S.? The UK Medicines and Healthcare products Regulatory Agency (MHRA) charged GlaxoSmithKline (GSK), the maker of Seroxat (Paxil in the U.S.), with not fully disclosing their clinical trial data that downplayed serious side effects such as increasing suicidal tendencies among those 18 years and younger. The MHRA also asserts that Seroxat didn’t alleviate depression as much as GSK’s initial data showed. GSK, of course, denied manipulating the data to show favorable results:
GSK denies withholding data, claiming the risks did not come to light until the results of nine studies were pooled.
The UK minister of public health, Dawn Primarilo, promised to address the issue of Big Pharma hiding negative clinical trial data.
“Notwithstanding the limitations that may exist in the law, pharmaceutical companies should disclose any information they have that would have a bearing on the protection of health,” she says.
In other news, I shouldn’t be a successful writer or novelist. The correlation between creative writers and suicide is ridiculously high. More than 70 well-known writers and poets have successfully committed suicide. How much more “unknown” writers and poets have as well?
(Image from Monthly Prescribing Reference)
Pink, a magazine for business women, has an article in its April/May 2007 issue titled, “The Magic Pill.” (The only way to read this article is to get a hard-copy of the mag.) No, this isn’t about birth control. The subhead: “Antidepressants are now used for everything from migraines to menopause. But are women getting an overdose?”
Good question. The article, well-written by Mary Anne Dunkin, does a nice job of trying to present both sides of the coin. One subject, Pam Gilchrist, takes tricyclic antidepressants to relieve her fibromyalgia symptoms. “One of the [antidepressants] that allows her to keep going” is Effexor (venlafaxine). God forbid the woman should ever have to come off of that one. (It works well when you’re on it, but withdrawal is sheer hell.)
The other subject mentioned in the article, Billie Wickstrom, suffers from bipolar disorder, but had a therapist who diagnosed her with obsessive-compulsive disorder. The psychiatrist she was referred to promptly put her on Anafranil (clomipramine). We all know what antidepressants tend to do for those with bipolar disorder. Wickstrom blanked out at an interview that she says she normally would have aced. In another incident, she veered off-course after leaving town and spent the night on the side of the road with her daughter. “Search parties in three states” were out looking for them.
“Three years and three hospitalizations later, Wickstrom is finally free of clomipramine and has a job she loves as PR director for a $300 million family of companies. She says she’s happy, she’s focused and she feels great – consistently.”
Dunkin’s article uncovers a large, problematic use – by my standards, anyway – of off-label usage by doctors.
“Gilchrist… is one of the estimated one in 10 American women taking some type of antidepressant medication. And a considerable percentage of these prescriptions, particularly those for tricyclic antidepressants, are not used to treat depression at all.
A growing number of doctors today prescribe antidepressants for a wide range of problems, including anxiety, chronic pain, insomnia, migraines, high blood pressure, irritable bowel syndrome, premenstrual syndrome, menopausal hot flashes and smoking cessation.”
I’m sure the list goes on, but magazines have but oh so much space.
Dr. Melissa McNeil at the University of Pittsburgh points out three things:
- Since depression is a prevalent (see common) condition, doctors are better detecting it.
- Since antidepressants have proven their safety and efficacy, primary care physicians have no reservations prescribing them.
- Clinical studies are finding that antidepressants can aid a number of medical issues apart from depression.
My take on McNeil’s points (I’ll try to keep them brief):
- Depression is way too common to be abnormal. If a woman has a rough patch in life for 2 weeks or more, she’s got depression. As for doctors being better at detecting depression? Studies consistently show that doctors are great at overlooking depression in men.
- Antidepressants haven’t proven jack squat. Placebos have proven more safety and efficacy than antidepressants. PCPs have no reservations prescribing them because they only know about the positive facts that pharma reps tell them instead of researching the potential side effects.
- Clinical studies aren’t finding all those things out. Seroquel has FDA-approval to treat psychiatric symptoms (psychosis, for one). As far as I know, Seroquel is not FDA-approved to treat insomnia or crappy sleeping patterns. There are no specific clinical studies to see if Seroquel can treat insomnia. Seroquel is prescribed to treat insomnia/restless sleep because doctors have found that a major side effect of the drug is somnolence. If this is the case, Effexor should be prescribed for weight loss. It’d be the new Fen-Phen.
Dunkin cites two widely used antidepressants for nonpsychiatric uses: Wellbutrin (bupropion) and Prozac (fluoxetine). Zyban, used for smoking cessation is, well, bupropion. Sarafem, used to treat PMS symptoms is – you guessed it – fluoxetine.
Dr. Viktor Bouquette of Progressive Medical Group thankfully takes a more cautious approach:
“The widespread use – mostly misuse – by physicians of antidepressants to treat women for far-ranging symptoms from insomnia, chronic fatigue and irritability to PMS and menopause is merely another unfortunate example of the pharmaceutical industry’s tremendous influence on the practice of modern medicine. Take enough antidepressants and you may likely still have the symptoms, but you won’t care.”
Kudos to Dunkin for landing that quote. Since Bouquette is part of an alternative medicine group, he’s got a good motive for slamming pharma companies.
McNeil goes on to sound anti-d happy in the article. Not that it matters, but she is also a section editor for the Journal of Women’s Health, which has several corporate associates representing pharmaceutical companies. (She is also the only source in the article who sings anti-d’s praises.) Dunkin tracked down Dr. Scott Haltzman, a clinical professor at the Brown University Department of Psychiatry, who advocated patient responsibility.
“Just because antidepressants work for depression does not mean they should always be used. People need to learn skills to manage their depressive symptoms instead of depending on medication. When you take medicine for every complaint, you lose the opportunity to learn how to regulate your mood on your own.”
Oh, for more doctors like Haltzman and Bouquette.
OK, 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.”
Furious 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[:]
- No problem
- Minor problem
- Moderate problem
- 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):