Eli Lilly today released its financials for all of 2006. Zyprexa sales totaled $4.363 billion up from $4.2 billion in 2005. Cymbalta, the company's newish SNRI anti-depressant, had sales of $1.316 billion, way up from 2005 sales of $679 million. That's a 94 percent increase in the drug's second full year on the market.
In other news, in 2006 this site experienced a 94 percent increase in comments about Cymbalta. Most of them were negative.
So I took a drive in the sun yesterday afternoon in my lovely neighborhood of Capitol Hill. Yes, it's occasionally sunny in Seattle in January. Anyhow, I drove by the phone booth where I saw an ad for Abilify last week. The ad is gone. As it is from another booth a few blocks away. I have no idea why the ads disappeared or whether someone tore them down. Possibly my faithful readers at BMS--they read this site, but don't return phone calls--could offer an explanation.
CL Psych has really been tearing up all the news on Paxil (Seroxat) and adding his own original analysis. Go read it here. Now for some highlights of his take on the BBC show on Paxil and the involvement of Martin Keller, a psychiatrist at Brown University, in one of the key Paxil studies in kids:
"According to Panorama (and documents I’ve obtained), the paper was written by a ghostwriter. Keller’s response to the ghostwriter after he saw the paper? 'You did a superb job with this. Thank you very much. It is excellent. Enclosed are some rather minor changes from me, Neal, and Mike.' And let’s remember that Keller apparently did not wish to bother with looking at numbers. It would also appear that he did not want to bother much with the words based upon those numbers."
And:
"It is relatively well-known that Keller makes much money from his consulting and research arrangements with drug companies. In fact, several years ago, it was documented that Keller pulled in over $500,000 in a single year through these lucrative deals. When looking at how he stuck his name on a study he did not write, endorsing conclusions that were clearly far from the actual study data, can one seriously believe that Keller operated as an independent researcher? Can you believe that this is an isolated incident?"
The remainder of his analysis is just as aggressive. Now, for my two cents: Keller's colleagues at Brown should investigate this situation and, where justified, should censure Keller. The American Psychiatric Association should do the same. And, while I not a big believer in Congressional investigations, if the Dems are going to have a look-see at the Zyprexa scandal, then they should also take a look at Paxil. And Prozac. And Risperdal. And Seroquel. And Cymbalta. And the ADD drugs. And....You get the idea.
It is high time patients and clinicians got complete and total transparency about how drugs are designed, studied, approved and marketed. Last time I checked, patients are the ones paying the freight of the American (and European) mental health systems in brain, mind, body, spirit, soul and pocketbook. What's going on with Paxil and Zyprexa are serious issues and they deserve serious answers.
The time for excuses, obfuscation, prestidigitation and intellectual chicanery is over. It is time for complete honesty. And, keep in mind, I am pro-psychiatry, but what's going on is simply indefensible and bad for the long-term health of both the medical profession and patients.
A reader asks: "What I want to know [is] why guides to coming safely off meds are not widely available in the states?" Great question. Most likely because patients are not well-organized over here and because that's just not something most advocacy groups would ever do. In addition, there are all manner of legal issues for someone who publishes such information to consider, given our litigious society. What's more, each patient seems to respond to coming off a particular med differently. Interestingly, most docs don't know much about tapering patients either.
I think this situation is a big problem because a lot of patients who do come off med X or Y, for whatever reason, end up doing so on their own. In many cases, they cause themselves serious problems. God knows, I felt like hell coming off Lexapro and Risperdal. A buzzing neck and lightning bolts in the head are not much fun.
Anyhow, said reader offered this resource for information on tapering off meds. I cannot assess its accuracy, but pass it along for what it's worth to anyone.
Let me be clear on this: anyone coming off any medication should only do so after talking with their doctor. A doctor might try to talk you into staying on the med, etc., but if you put your foot down, then the doctor has an obligation to help you come off the medication. I am only talking about outpatient settings here, not inpatient. Different story there.
As a further caution, cops I know tell me that the mentally ill folks they really worry about having to deal with are those who have just come off their meds--not people who've been off meds for a decent time--as they can be highly delusional and highly combative.
A reader left this comment earlier:
"I used Seroquel at 200 mg for over two years. It took me 4 months to quit because of insomnia. I ended up reducing the dose 25mg every two or three weeks before i had success. It was an extremely difficult time."
Yikes. I bet it was. Four months to taper off a med is ridiculous--there are, of course, infamous cases where it's taken people years to get off Paxil and other drugs--and makes me wonder in an intellectual kinda way about questions being floated in the academic journals about possible dependency cropping up with Seroquel.
Any thoughts, AstraZeneca? You guys read my site almost daily. It's time for you share.
I've joked before that AstraZeneca is trialing Seroquel for every malady under the sun. Now, CL Psych has a post about AZ testing it for use in anorexics with hyperglycemia. Bipolar disorder, depression, schizophrenia, children, autism, ODD, ADD, addiction, public speaking and anorexia. You've got to hand it to the AZ folks--they cover the waterfront. How an atypical might help hyperglycemia, given the sugary track record of these meds, is beyond me.
Speaking of covering the waterfront, PharmaGossip has turned up yet another odd pharma marketing event that's shown up on You Tube. This one appears to be a bikini contest in Latin America brought to you by Viagra.
Over the weekend, I was reading the first part of David Healy's Let Them Eat Prozac, the British psychiatrist's account of how Prozac and other SSRIs such as Paxil screwed up some patients, weren't particularly good anti-depressants at all and how Eli Lilly and other pharma companies worked to cover up all of that with the assistance of various "independent" academics.
Not too far into the book, Healy recounts the bad experiences of several patients in the initial clinical trials for Prozac as well as the dicey experiences of some of his own patients to whom he gave the drug in the late-1980s. Patients who couldn't sit still after taking Prozac. Patients who developed worse depression than they had previously after having their dose of Prozac increased. Patients whose minds began racing. Patients who had suicidal ruminations. Patients who attempted suicide. And so on.
I saw myself in these patients. (For newcomers, here's a recent post in which I finally went into my experiences on Prozac and Paxil.) I want to stress to readers that the following is in no way an attempt to scare you off-meds or anything of the sort. It is an invitation, however, to be educated about what you take and to take what docs and pharma companies and advocacy groups tell you with a grain of salt.
For the past 13 years or so, I have been trying to account for the days of 1991 to 1994 when I was wildly suicidal, couldn't focus on work, had all kinds of odd images in my mind and had such intense suicidal ruminations that I could literally taste gun metal in my mouth.
This was also the same time during which I had a doc--who frankly knew no better, given the information available at the time--jerking me around on Prozac from 20 mgs. to 80 mgs, and, then, giving me Paxil later on.
What I have been trying to account for is whether it was the meds or me or some combination thereof. Here's how I put it to my parents in a recent email:
"While I don't yet fully buy bad side effects as a description of what went on with me, what Healy reports does indeed overlap with many of my experiences between 1991 and 1994 when I was on Prozac, Paxil and Zoloft, and then in 2002 and 2003 when I was on Lexapro. I don't blame the docs. Since Eli Lilly (and others) was suppressing clinical trials information and thought leaders in psychiatry were denying these symptoms were the drug's fault--or even could be, but that instead it was the illness at work--there was no way my very overwhelmed docs could have picked up on this. And I didn't know enough as a patient to bring the symptoms I was having to their attention.It is chilling after all these years to realize that I almost killed myself over the side effects of a drug. It should also tell you a great deal about who I am that I was able to not do that. Quite a few people--as in thousands--have killed themselves while on these drugs, or right after beginning to take them. They do work well for about 25 percent to 30 percent of the people who take them, but, for the remainder, they are risky in a way that doctors have been slow to acknowledge. Neither are they quite the suicide prevention technology that some researchers claim. The SSRIs and SNRIs are remarkably weak technology and hardly worth basing a medical revolution upon. (Revolution? What revolution? you ask. Ah, that'd be the psychopharmacological revolution. The one that was supposed to end depression and redeem schizophrenics and so on.)
What's interesting also is that in either late-94 or early-95 I figured that these anti-depressants weren't doing much for me so I stopped taking them. I didn't touch another SSRI long-term--there are other anti-depressant types out there--until 2002, when I tried a new one, Lexapro, which my doc assured me had none of the problems of the earlier SSRI anti-depressants. It worked OK for me for a time, and in an experiment in the spring of 2003, I went off-meds for the first time in 14 years as a diagnosed bipolar (it was an experiment to see what my baseline was like). But, then, I started having small bouts of depression and, panicking, called my then-doctor. He promptly restarted my earlier regime of Depakote, Lexapro and Risperdal. The very next day, my heart started racing so much and I was so wound up internally--and like the docs told us patients, I blamed the disease--that I almost took myself to an ER for monitoring. I went off Lexapro and another drug (Risperdal) the next day (my then-doctor agreed with that move when I saw him soon after). The problem disappeared. My current drivers license picture, taken a few days after the 2003 problems, shows just how screwed up Lexapro and Risperdal made me. My face was fat, puffy and I looked completely frazzled. And this was after being on these meds for two or three days."
Years later, I am fairly convinced that SSRIs caused too many problems for me to escape the uncomfortable fact that they were part of the problem, perhaps the key part. I am not bitter about that. I am not angry. I am at peace. I have the luxury of having survived it all. Others have not been so lucky. There's not much I can do about any of it now, except to tell the truth about SSRIs and atypical antipsychotics the best way I know how. Perhaps that will help out someone else.
As many of you know, the BBC's "Panorama" (essentially Britain's "60 Minutes" or "Frontline") had a program last night on Paxil (Seroxat, as it's known in the UK). It's not the first time the program's reporters have hammered on all kinds of alleged corporate misbehavior by Glaxo SmithKline, its maker, and the horrendous side effects of the drug. I know these side effects personally and will get into that in a separate post.
First, here's a link to the show's website where you can stream a video of the program. I wasn't able to watch it myself since the BBC has yet to learn of a little old video program called Quick Time. I'll get to it eventually. The gist is this:
"Panorama reveals that GlaxoSmithKline (GSK) attempted to show that Seroxat worked for depressed children despite failed clinical trials. And that GSK-employed ghostwriters influenced 'independent' academics."
In addition, there is this lovely nugget:
"Child psychiatrist Dr Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329 [a Paxil study in kids]. In 2002 he also gave a talk on childhood depression at a medical conference sponsored by GSK. He said that Seroxat could be a suitable treatment for children and later told Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates."
I cannot even get into that bit except to say that doctors have an ethical charge to work in the best interests of patients--especially children--and that Ryan has failed in that ethical charge. (It's basically a lot like the "protect and serve" charge that cops have or the "If your mother says she loves you, check it out" charge that journalists have.) I hope his colleagues at Pitt find an appropriate manner in which to censure him, and if they don't, then the APA should.
GSK's response to the program can be found here. PharmaGossip has this post on the show (and thanks to the "Insider" for linking to me lately. I love his/her blog but would really like to see the cheerleaders-gone-phamra-reps thing hit a little harder. Like every day).
In addition, I find it heartening that the editor-in-chief of the British Medical Journal, Fiona Godlee, has issued a strongly-worded statement on this matter. It's so good that here it is in full:
"Panorama's account of GlaxoSmithKline's successful attempts to market Seroxat for use in children, despite the fact that its own published trial found evidence of serious adverse effects and failed to show benefit, is fascinating but depressingly familiar. What is even more depressing is that such behaviour is still so widely tolerated within medicine.There has been no shortage of outcry or official condemnation - including clear statements from the World Association of Medical Editors, the International Committee of Medical Journal Editors, and industry itself through its Good Publication Practice guidelines - that undeclared conflicts of interest and ghost writing are unacceptable. But, you might reasonably ask, what use are such huffings and puffings in the face of the individual rewards on offer from drug companies.
Let's be clear what is and is not acceptable. There is nothing wrong with getting help from medical writers, provided they and their source of funding are clearly acknowledged. Nor is there anything wrong with academics or clinicians working with industry, provided they remain personally accountable for everything they say.
What is clearly wrong is writers, academics, or clinicians concealing under their coat tails an army of company spin doctors intent on distorting the scientific record. Legislation is not going to happen soon - the powerful industry lobby will make sure of that. Regulation is still inadequate.
So what can we do to change the blind-eye culture of medicine? In the interests of patients and professional integrity I suggest intolerance and exposure. We shouldn't have to rely on investigative journalists to ask the difficult questions. So at meetings, why not slow hand clap any speaker who does not begin their talk with a sentence or slide declaring their conflicts of interest? And if journals discover authors who are guests on their own papers, they should report them to their institution, admonish them in the journal and probably retract the paper.
Reputations for sale are reputations at risk. We need to make that risk so high it's not worth taking."
The day we get similar statements from the APA and AMA....Ah, I am dreaming there. And, as one British psychologist has found out recently, there is a very high price to pay for breaking from the establishment, a price that David Healy, a psychiatrist knows far too well. Scientific Misconduct and, on this side of the pond, CL Psych have been pounding on this matter. I will soon join them as soon as I have time to learn more about the case, along with all the other little bits of pending news I am juggling here of late.
A local blog--and a popular one, to boot--had some nice things to say about this here blog the other day. Flattering.
On another front, the term "pornography of the self," which I used last month to describe much of the Web 2.0 world, seems to have taken on a life of its own. A small life. This guy quoted it and attributed it to me--thanks. And if you search it on Google, all kinds of references come up, leading back to my cranky post on the Web 2.0 and narcissism.
Sounds like it's time for me to get cranky again.
I've seen my share of stupid--OK, misapplied--studies in the psych world over the years. This one is a new contender for stupidest and you just knew it had to involve Seroquel. AstraZeneca is on a mission, after all, to get their atypical antipsychotic trialed for--and thus used for--damn near every DSM condition under the sun, as I noted a few months ago.
Now, comes this new study: "The Use of Quetiapine (Seroquel) in the Treatment of Social Phobia: Public Speaking Environment." Yes, that's right, Seroquel will be studied as to how it affects the social phobia of people giving public speeches before a "virtual audience." I've barked plenty about psychiatry's over-reach into literally every corner of human existence and feeling, but the idea of medicating away a fairly common phobia--a phobia is a fear, not a mental disorder per se--is about as intelligent as giving Seroquel to four year olds. It's the proverbial nuclear-bomb-to-clear-a-field-of-stumps solution. Man, if this isn't social engineering or lifestyle engineering, then I don't know what is.
Whatever happened to imagining the audience in their underwear? Whatever happened to Toastmasters? Will we soon see the day when a senior executive turns to a junior executive to say what a great job they are doing and how they are on the greased skids to the executive suite except that they are too nervous when they speak in public? "But, boss, I've tried everything," says the junior executive.
"Oh, but you haven't tried Seroquel!" responds the all-knowing senior executive. "It's not just for bipolar disorder and schizophrenia anymore."
I noted recently, a federal government study found, after reviewing the scientific literature, that there was not enough evidence to support the off-label--ie, unapproved use--use of atypical antipsychotics. At the time, I mentioned that another government study had determined that only moderate evidence existed for using atypicals for approved use, primarily schizophrenia and bipolar disorder.
The study--OK, it's a report--by the Drug Effectiveness Review Project at Oregon Health & Science University can be found here. It's a massive document, so go to page 132 for this:
"The evidence is remarkable for its lack of real world effectiveness outcomes important for patients, those relating to social successes and economic independence....Very few of these [studies] studied such outcomes."
Given the hundreds--if not thousands--of trials of atypicals already performed over the last 15 years, it's amusing that no one has studied such questions. But, then, I have long contended that psych researchers have no interest in studying people who do well or in examining the hallmarks of true recovery. Big Pharma won't fund it and researchers aren't exactly asking them to either. After all, what could possibly be interesting about a well patient?
Even more interesting to my mind is that beginning on page 133 of the report, the authors outline the case for effectiveness (long-term) and efficacy (short-term-ish) of the atypicals in schizophrenia and bipolar disorder. Effectiveness for Abilify in schizophnreia? Very Low. Evidence for effectiveness of Seroquel, Risperdal and Zyprexa in schizophrenia? Low to moderate. And so on.
You say you want efficacy? Low to moderate in schizophrenia. Same thing in bipolar disorder.
Whatever evidence there is or isn't comes too late for many patients, including the thousands who've recently had their lawsuits against Eli Lilly settled for injuries suffered while taking Zyprexa. Yesterday, the Eugene Register-Guard, one of the country's best small newspapers, ran this article on one of the plaintiffs. Read it.
And people wonder why I bitch about the wonder drugs.
As I noted last week, Intueri had an item on her blog about ads for Abilify appearing on phone booths in Seattle. I finally dragged my sorry ass down to Broadway the other evening and, lo, there was an ad for Abilify on a pay phone--you can hardly call these phone booths anymore!--next to a Taco Bell.
The ad doesn't exactly jump out at you and it looks much like ads Bristol-Myers Squibb ran for Abilify in the Seattle Times in 2005. A woman standing on a grassy hill stares off into the distance.
"Treating Bipolar Disorder takes understanding: You have been up and down with mood swings. You want to move forward. Maybe ABILIFY can help."
And so on.
I've long been critical of direct-to-consumer ads for psych meds. As a rule, they are not presenting completely factual information about a drug and a disease, then they make it sound as if there is a big postive benefit when the benefits are far smaller. The ads are targeted at an extremely vulnerable population who will glom onto any sliver of hope even if it is in a pharma ad or on a pharma website. Or on a phone booth. If I owned a camera, I would've taken a picture. I think DTC advertising for psych meds should be banned. As much as I am all for free speech, even for corporations, I think DTC ads aimed at a psychologically vulnerable population are unethical, especially given the fact that there is only a little bit of information out there to counter, or balance, Big Pharma's propaganda.
I'm not sure who BMS--or its ad agency--is targeting with such ads. That stretch of Broadway is peopled with passersby, homeless youth and late-nite creatures looking for a bean burrito. I called BMS to ask them about the ad. My request for comment was not returned. BMS just announced their 2006 financial results though, so perhaps they were busy telling the press about how Abilify is now a $1.282 billion drug (worldwide) with US sales of about $1.1 billion. Worldwide sales are a 41 percent increase over 2005.
So I was being a good boy last night, when Google Alerts alerted me to the following You Tube of an early version of the "Depression Hurts" campaign ad for Cymbalta by Eli Lilly. I've poked fun of this ad oh, like, many times already.
Now, someone has recorded and posted a home video of their dog howling at the Cymbalta commercial. Some of you know how this dog feels.
Major credit goes to Mo!, who is a pretty funny guy. In other news, I have finally figured out how to embed You Tube code.
Last week, I noted that I'd been receiving lots of negative comments about patient experiences with Cymbalta. I asked if there were positive reports and got a few responses which I've posted below. In addition, several more bad reports trickled in and I have posted a selection. Thanks to everyone for their help. If anyone wants to add to this collection, send in your thoughts on Cymbalta.
"Since we're sharing anecdotal evidence, I'll share mine. I've been taking Cymbalta for about six weeks now. It's the only thing that's made a dent in my anxiety. Over the past two years I've tried Wellbutrin, which gave me panic attacks, Zoloft, Buspar, and Lexapro. Nothing helped except Cymbalta. I've had no side effects from it and I feel like myself again."
And:
"Cymbalta has saved my life. Enough said."
And:
"I've been on Cymbalta for over a year. It's been effective and the only side effect I've had is an increased tendency to bruise."
Now for some bad:
"I have been taking Cymbalta (30mg increasing up to 60mg) for 10 days now. I did not have success with Zolfoft due to daily crying spells. I was reluctant to change but my doctor said I should not be having these spells and suggested Cymbalta for my PPD. Since switching, I have had vision problems, pressure headaches and feel very anxious. The light headedness and dizziness never goes away. My fear is have I caused some sort of permanent damage? Is this normal in the ramp up time of this medication. I feel clumsy and like my muscle coordination is suffering."
And:
"I JUST WANTED TO WRITE BACK AND UPDATE SINCE MY POSTING ON JAN 13, 2007. I HAVE STOPPED TAKING THE CYBALTA DUE TO A START OF REALLY BAD DEPRESSION--WHICH I HAVE NEVER HAD BEFORE. ( I HAVE ANXIETY.) I FEEL GREAT NOW--I AM NOT DEPRESSED NOT SLEEPY, AND I HAD NO WITHDRAWL SYMPTOMS! I AM BACK ON MY WELLBUTRIN, WHICH WAS WORKING FINE FOR ME--MY DOCTOR KEPT PUSHING ME TO TRY CYMBALTA DESPITE ME NOT WANTING TO HE FINALLY HAD PRESSURED ME."
I wonder what kind of pressure the doctor used. One more:
"I WENT ON CYMBALTA FOR MILD DEPRESSION 3 MONTHS AGO... I AM NOW SEVERLY DEPRESSED AND HAVE BEEN HAVING THOUGHTS OF SUICIDE... I CALLED MY DR. TO GET AN APOINTMENT BUT THEY TOLD ME I COULDN'T BE SEEN AT THIS TIME AND THAT I HAVE TO WAIT 3DAYS! I CAN NOT BELIEVE THIS IS MY LIFE! I HAVE BEEN AVOIDING MY PARENTS AND FAMILY BECAUSE I AM SO ASHAMED... MY FRIENDS THAT I HAVE LET SEE ME LIKE THIS DON'T KNOW WHAT TO DO WITH ME.... I JUST HOPE THAT I CAN FIND A CURE TO HEAL THIS PAIN."
I hope you were able to cajole your doc into seeing you sooner. You will find a cure, most likely within yourself.
There is now online a complete transcript of the two-day hearing on January 16th and 17th concerning Eli Lilly's attempt to end dissemination of the recently-leaked Zyprexa documents. If you are legal dork, and I am, then they are fascinating reading. In the midst of being asked how she obtained the documents, Vera Sharav, who heads the Alliance for Human Research Protection, gave answer that went much further:
VERA SHARAV: "My interest is the content because the documents document the fact that Eli Lilly knew that the -- that Zyprexa causes diabetes. They knew it from a group of doctors that they hired who told them you have to come clean. That was in 2000. And instead of warning doctors who are widely prescribing the drug, Eli Lilly set about in an aggressive marketing campaign to primary doctors. Little children are being given this drug. Little children are being exposed to horrific diseases that end their lives shorter. Now, I consider that a major crime and to continue to conceal these facts from the public is I think really not in the public interest. This is a safety issue."MR. LEHNER [Lilly's lawyer]: "I move to strike as being nonresponsive to my last question and I would like to ask the court reporter if he is able to -- I think I remember my last question. I'll repeat my last question. Nonetheless, I'll make a motion to strike the last answer."
THE COURT [Judge Weinstein]: "Denied."
Judge Weinstein is reviewing briefs from the various parties to Lilly's attempt to unring the bell that was rung when the documents were leaked to the New York Times and is expected to issue a final ruling on the status of the documents from what's now called the Zyprexa I case (the 2005 settlement with 8,000 plaintiffs) in the next couple of weeks. Here is AHRP's brief, which is smoking hot.
One other thing that struck me from Sharav's testimony is that she provided copies of the documents to the Wall Street Journal and the Bloomberg wire service. To date, I don't know of any thorough, original reporting done by either organization based upon the documents. If anyone knows differently, let me know.
I know there's been a lot of noise again about Zyprexa what with five states investigating Eli Lilly and an article in the Times of London, based upon the leaked Zyprexa documents, which alleges that Eli Lilly was concerned about diabetes in patients using Zyprexa as far back as 1998. Both of these items are very interesting. So, too, is the following.
On July 27, 2003, Bradley Hawkins emailed a group of 10 fellow Lilly employees "re: Zyprexa Best Practices," as reads the subject line of the email, according to a copy of the document that I reviewed. It is unclear what Hawkins' position was in Lilly at the time, although the email is, to my eyes at least, a marketing communique. Hawkins begins the email by declaring "Producers!!!"
In the email, Hawkins summarizes highlights from a meeting he'd attended the week before. "There are definitely some pearls," he writes. From the text of his email, it is apparent that he was mostly concerned with sales strategies for Zyprexa Zydis, a quick-dissolving formulation of Zyprexa approved in 2000 for use in schizophrenia. Quick-dissolving formulations of tablets are typically given to chronic schizophrenics who are not med compliant and have a history of tucking away tablets in the corner of their mouth and, then, spitting them out later when medical personnel are not around. If the quick-dissolving route doesn't work (and such formulations are not available for every pill), then patients are typically given injectable drugs such as Haldol, Risperdal and Zyprexa.
Two weeks before Hawkins' email went out, Zyprexa had received further approval from the FDA for use in acute mania in combination with Lithium or Depakote. Zyprexa had been approved in 2000 for use in acute mania. Hawkins had something else in mind, according to the documents.
"With the new indication, we should be mentioning that when a drug goes before the FDA for a new indication, they open up the entire label," writes Hawkins. "If they wanted to change anything with Zyprexa's labeling, they could at that time. The FDA left our label exactly the same. So if they had concern with diabetes or glycemic conditions, they would have put it in there."
At the time, the FDA and Lilly officials were going back and forth over proposed label changes to Zyprexa and other atypical antipsychotics over concerns about diabetes and hyperglycemia attributed to use of the drugs. The next year, the FDA ordered that a black box warning be placed on the entire class of drugs.
In his email, Hawkins makes it clear that he's trying to develop tactics to sell Zyprexa Zydis "as a great option for the patient with symptomatic problems." He states that sales efforts should be focused on "shot clinics" (translation: large clinics, typically serving low-income chronically-ill patients who often have med adherence problems) with each member of the sales force to focus on one community mental health clinic per quarter. Sales efforts should "focus on treatment teams" with "lunches and/or programs designed for treatment team members." Treatment teams are commonly comprised of social workers, counselors, nurses and so on. These are the mental health workers to whom often falls the task of working with chronically-ill patients to get them to take their meds as prescribed.
"Zydis should be used as a create action tool, not a different patient type," writes Hawkins in the email. "If they use it GREAT--but as long as they use Zyprexa."
In one section of the email entitled "diabetes," Hawkins stresses: "Don't fight the war alone. If the issue is there, bring in a speaker to challenge the customer on the issue." One approach, according to the email, would be for sales reps to ask customers raising the diabetes issue, "What is the mechanism for Zyprexa causing diabetes. Ask doctors/treatment teams to ask other reps [from competing companies such as Janssen and AstraZeneca] why when they say Zyprexa causes diabetes." In addition, Hawkins writes that sales reps should utilize diabetes nurse educators (either Lilly employees or nurses on contract) and Solutions for Wellness. The latter is an education program Lilly undertook to counteract concerns of weight gain amongst patients and their doctors to educate patients on how to manage their weight through food and nutrition. In October 2005, actress Linda Hamilton famously appeared on "Larry King Live" to discuss her experience with bipolar disorder and to raise awareness of the Solutions for Wellness program. I've written about her appearance here.
The email concludes with Hawkins recommending "possible speakers to bring to NYC," although for what event is unclear. He lists Terry Bellnier (Assistant Clinical Professor, The State University of NY at Buffalo, Department of Pharmacy Practice), Mark Fry (Hawkins identifies Fry as the director of bipolar research at UCLA, but I cannot find a listing for him), Evan Zimmer (a clinician in the Miami area) and James Oberwetter (an endocrinologist in Boulder, Colo.). Hawkins notes that the "Miami district has used [Zimmer] to challenge doctors on diabetes, great sense of humor."
"Good selling!!!" is how Hawkins concludes his email.
Two Lilly colleagues responded to his email, according to the document I reviewed. "Thanks, Brad," writes Eileen Sidaros on July 28, 2003. "To the stage!!!"
"Thanks, Brad, for sharing--let it rip!" replies Daniel Williams on the same day. It is unclear what positions Sidaros and Williams held at the time with Eli Lilly.
There was an interesting story last week in Psychiatric Times. It was a curtain raiser on what the reporter promises will be a big year of data for psych MDs. Lots of studies on using atypicals in kids and adolescents--I predict that these short-term studies will show limited efficacy with big weight gain in the kiddos. More clinical data on what anti-depressant combos work best--as if the dead horse hasn't been beaten enough. More data from the STEP-BD study on long-term treatment of bipolar disorder--even though I thought all the main papers came out last year and were pretty much a wipe out. In addition, there will be a recalculation of data from the CATIE study establishing which antipsychotics are most effective in treating schizophrenia--um, why are they going back to restate what the CATIE PIs have made clear over the last 18 months, namely that the atypicals don't work so swell for treating schizophrenia and have a host of gnarly side effects? Whatever.
But what really caught my eye was this:
"And new data on one drug, Zyprexa (olanzapine), will likely be submitted to the FDA this year in anticipation of earning a pediatric indication for either schizophrenia or bipolar disorder."
Oh my. After all the problems that have cropped up around Zyprexa's use in adults, Eli Lilly is pushing to have it approved for kids? That ought to be one very interesting filing with the FDA.
The other atypicals for which data is expected in treating kids are Seroquel, Geodon and Abilify. Not long ago, I ran into a study of Seroquel in kids led by Joseph Biederman, a professor of psychiatry at Harvard and a member of the advisory board for the pharma-funded Child and Adolescent Bipolar Foundation. Here are some highlights of the ongoing study from the clinical trials registry:
"This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of Quetiapine [Seroquel], in the treatment of preschool children aged 4 to 6 years with bipolar and bipolar spectrum disorder. This is an exploratory, pilot study, seeking to determine whether Quetiapine is efficacious and well tolerated in the treatment of preschoolers with pediatric bipolar and bipolar spectrum disorder in this age group." (Emphasis mine.)
And:
"Subjects must have a DSM-IV diagnosis of bipolar I, bipolar II disorder or bipolar spectrum disorder and currently displaying manic, hypomanic, or mixed symptoms (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders and Schizophrenia Epidemiological Version). Bipolar spectrum disorder (or sub-threshold bipolar disorder) is operationalized as having severe mood disturbance, which meets DSM-IV Criteria A for bipolar disorder but meet fewer elements in criteria B (only require 2 items for elation category and 3 for irritability)."
This shit is fucked up on so many levels that you almost don't know where to begin. Here goes.
I am against sticking four to six year olds full of an antipsychotic, especially Seroquel. It's well known to cause weight gain in adults and creates so much cognitive slowing and the fifth of whiskey head the next morning that it is utterly unfair to give this to children. In fact, I think it's unethical, especially given concerns that the drug might cause dependency in some adults. The kiddos won't be doing so hot at pre-school the next day, methinks. The study's prospectus doesn't get into what dosage range will be evaluated.
But here's where things get bizarre to my way of thinking. There is no official DSM diagnosis for bipolar disorder in kids, so I am confused as to how you can even do a trial like this with a straight face much less with approval of Harvard's human subjects committee. "Bipolar spectrum disorder" doesn't exist in the DSM--it's a term being batted about by researchers like Fred Goodwin to capture even more people in the bipolar nexus than the docs already can with BPI, BPII and cyclothymia. Even more irksome is that the kids don't have to hit the same kind of manic/hypomanic highs that adults hit in order to get into Biederman's study.
Although Biederman's criteria looks tighter than most studies, I find it bothersome--irritating, even--that the general thumbs-up that this study will no doubt provide AstraZeneca will then be used by clueless PCPs and desperate parents to medicate kiddos who hit the ridiculous standards floating out there that kids only have to have certain traits of bipolar disorder for moments at a time in order to be considered as profoundly manic, for example, as the same symptoms in adults would. Except the adults would need the same constellation of symptoms over a two-week period.
Or am I the only one bothered by such inconsistencies?
I was at a local Barnes & Noble yesterday and ran into at least five books on bipolar disorder in kids. I couldn't even find a copy of The Bipolar Child, the book that kicked off the whole "your irritable child throwing rocks at other kids is bipolar and must take antipsychotics" silliness that's bouncing through our culture these days. I think studies like the above and Eli Lilly's expected FDA submission of Zyprexa for treating bipolar disorder and schizophrenia in kids show us just how far off the peg we are getting in America these days.
Angela Holland settled her lawsuit with the King County Sheriff's Office yesterday, 18 months after suing her former employer for discrimination and wrongful termination. Holland, for those of you new to this story, was a veteran KCSO deputy who, in June 2004, revealed she had bipolar disorder. She'd done nothing wrong on the job and, in fact, was considered a good cop and had numerous commendations (that speaks well to how bipolars can adapt and do damn near anything they choose). She outed herself because she'd had some meds go south on her, needed to make a switch, and had to have time off to make it work. For this, she was fired four months later--a very fast turnaround for firing a cop.
Meanwhile, the same department didn't fire and, as it turns out, hardly disciplined a veritable rogue's gallery of other KCSO deputies who did some very bad things on and off-duty. Think I am making that up? Read this series by the Seattle Post-Intelligencer. If you want to read about the whole Holland story, read this article, which I wrote in 2005.
Holland's case is, to the best of my knowledge, unprecedented. When I was reporting on her situation two years ago, I talked to lots of disability and mental health lawyers and not one could think of a case where someone with bipolar disorder or schizophrenia had won a court case against a discriminating employer or had walked away with money in a settlement. I looked at a legal database and the academic journals. I talked with the Equal Employment Opportunity Commission, which administers the ADA. The outcome was the same. Bipolars never win discrimination claims. (Let me know if you know of cases where they have.)
Holland, three weeks before her case was scheduled to go to trial, walked out with money, an agreement by the Sheriff to reclassify her firing from "medical termination" to "medical retirement," and an agreement by the Sheriff to provide Holland with a letter of recommendation. She won. The Sheriff lost. Holland's attorney, Jeff Herman, won. King County Deputy Prosecuting Attorney Don Porter, defending the Sheriff, lost. The people who doubted the story I wrote about Holland, or felt it was too activist-ish, have been proven wrong. They can go fuck off now.
Straight-up, Holland made history yesterday. And although there is lots of mental health news the last few days about states investigating Eli Lilly, Pfizer melting down and another examination of some of the Zyprexa documents (not a very revealing examination, in my mind) in the Times of London, this is truly the only story that matters. I'll get back to that other shit another day.
Holland's story has broader implications. It's a story of treatments that don't work well, bad doctors (and a good doctor, too, in the end), medication side effects, social discrimination, employment discrimination and so on. It establishes just how far we haven't come since 1993 when, pardon the self-referential crap for a moment, I was fired from a job after revealing that I was bipolar. The same dynamic was at work as with Holland. I could do my job well, had had meds go south on me and, once the bureaucracy caught on, all of America's unfounded assumptions about the mentally ill came crashing down upon me. Same deal with Holland, except almost 15 years later she came out with a better, but not enough better, result. Perhaps 15 years from now, things will work out much better for the next bipolar who gets jammed up by a moronic employer and their paranoid bureaucratic fantasies.
One other common thread is that Holland and I got screwed by the legal system. In my case, i didn't even have access. In hers, the Prosecuting Attorney's Office pushed its defense so aggressively that it was clear to Holland that going to trial on this case would be a huge roll of the dice. They were going to paint her with every bad thing any bipolar had ever done in history. Enough members of a jury would likely believe DPA Porter's fear-mongering to make a trial unwinnable for Holland. She had to settle. Someday, I will share some of the details from Holland's deposition in this case, in which Porter crossed so many ethical boundaries in his questioning and said so many ugly and false things that he must be held to account.
And he will be. As will others. Stay tuned.
Hi. I probably won't post anything today. Or maybe I will. But I went to a memorial last night for someone whose work I admired and it just left me feeling crummy. So, yeah. Not much to say.
I would be remiss if I didn't pass along some links to interesting posts that others are doing on mental health and such. Especially since CL Psych has several posts up that are amazing. Just read them here, here and here. See what I mean for yourself.
Also, Intueri has this on an ad for Abilify on phone booths in Seattle. I've known about this for a few days but in the rush of other stuff haven't posted on it myself. Ads for antipsychotics on a phone booth? BMS has got to be fucking kidding.
And Liz Spikol is leaving her post as managing editor of Philadelphia Weekly next month to work for the Pennsylvania Prison Society. I think that's spectacular fit for her. She'll continue to do her fine blog and the column in Philadelphia Weekly.
Greetings. Last evening, my friend Jerome and I dinked around with some of the CSS code on this site. Some fonts have changed and so on. More to come very soon. Let me know if anyone runs into something that's changed which they don't like.
Regardless of your thoughts on smoking, here's a study that claims it can connect smoking with a heightened risk of suicide in patients with bipolar disorder. Anyone who knows much about suicide and suicidality knows that there are a constellation of factors at play in most suicides. Sigh. I am not even going to spend time bashing this study, except to note: the study was done by Harvard researchers; I cannot wait to see to what end the anti-smoking crowd puts this study; it reminds me of a conversation I had with a Drug Enforcement Agency agent last summer. I was reporting a story on medical marijuana and, as I always do, called the other side for a comment. Our conversation went kind of like this towards the end:
DEA Agent: "Drugs are bad. Don't do drugs."Me: "How is medical marijuana bad?"
DEA Agent: "Marijuana causes schizophrenia."
Me: "I've read those studies and don't think it's a very strong correlation."
DEA Agent: "Well, that's what they say."
Me: "Can I tell you something?"
DEA Agent: "Sure."
Me: "I should be the most schizophrenic guy in America."
Sometimes I cannot help myself.
From the Alliance for Human Research Protection's blog, Vera Sharav offers her account of Wednesday's court hearing on the Zyprexa documents. Her account of the proceedings is interesting, especially since no reporters of any kind were present (talk about a blown opportunity), especially since there was testimony to the effect that Eli Lilly had slapped a confidential stamp on literally every document in the case. OK, most of them. The judge is asking Eli Lilly's lawyers to now justify why the court documents that slipped out into the world last month should continue to come under the court's seal. Good call by the judge. More to come at month's end.
MindFreedom's David Oaks, named by Eli Lilly in court documents for allegedly spreading the leaked Zyprexa documents around the Internet, has an interesting account of yesterday's court hearing on the matter.
Here we have yet another round of bad news for the atypical antipsychotics. In this case, the federal government's Agency for Research Healthcare and Quality is out with a study claiming that there is not enough evidence to support off-label use of the atypicals--licensed for schizophrenia and, mostly, acute mania in bipolar disorder--in depression, dementia, OCD, PTSD and personality disorders. States the report:
"Overall, however, researchers found that much of the scientific evidence for off-label use of antipsychotics was of insufficient quality because studies were too small or lacked scientific rigor. Review authors evaluating the potential benefits and risks of the medications also found strong evidence that atypical antipsychotics can increase chances of adverse events. Some of the drugs increase risks of stroke, tremors, significant weight gain, sedation, and gastrointestinal problems."
I don't think there is very good evidence for the long-term use of these drugs in bipolar disorder, although its clear they have a role to play in managing acute mania. But that would make these alleged "wonder drugs" essentially the same as the old antipsychotics, and that would really cut into Big Pharma's revenues if the drugs were only used short term. In addition, there are now several studies establishing that these drugs are no better than older antipsychotics for the long-term treatment of schizophrenia. Here's what the report said about using them in depression:
"For patients who don't benefit from selective serotonin reuptake inhibitors (SSRIs), the supplemental use of atypical antipsychotics was not helpful, according to research. No studies showed the drugs provided a clear benefit for patients with major depressive disorder with psychotic features. Evidence is conflicting for bipolar depression."
Seroquel is approved for use in bipolar depression (and acute mania) while Zyprexa is licensed for maintenance of bipolar disorder (ie, treating acute mania and bipolar depression), but it sounds like one branch of the federal government isn't buying the FDA's licensing. Soon, I will post on another government-funded review of these meds which shows that the evidence for how well the wonder drugs work in schizophrenia and mania is moderate, meaning not as overwhelming as the pharma companies and many researchers and docs would like patients to believe.
I think it's time for the use of these drugs to be de-emphasized, given their expense, nasty side effects and limited scientific evidence for their use. And would someone please explain to me why we are using these drugs in children without appropriate scientific evidence for their use.
This is the kind of story you see once in never. In November, former Philadelphia Eagles safety Andre Waters killed himself after grappling with depression for a few years. A pathologist in Pittsburgh examined Waters' brain and came away saying that Waters' depression and suicide were likely the result of years of concussions suffered while playing football. Waters was a bad ass safety. His death was just bad. I doubt that there are an amazing breakthrough realizations here, but the whole scenario is fascinating in a scientific way and discouraging in a human way.
The article is amazing. A must read, regardless of your feelings about football.
Knock on wood, I think my ISP is back for good and I am at work on some longer posts for tomorrow. In the meantime, please take a look at CL Psych's roundup of commentary on federal court proceedings concerning Eli Lilly's attempts to kill the nascent Internet campaign to spread the leaked Zyprexa documents around the web. In addition, it appears that Lilly sent a threatening letter to the British Medical Journal concerning its potential use of the documents. Lilly is kidding itself if it thinks it can intimidate press outlets into silence since said press outlets did nothing illegal in obtaining the documents. But who knows? We do live in interesting times. Speaking of which, I am continuing to review the documents and I am finding them, um, very interesting.
A federal court hearing on the documents is being held today, a continuation of yesterday's hearing. Stay tuned.
My lovely ISP Comcast is now back and functioning. Seems they were doing something with their digital voice service, which I don't have, and that knocked out most standard cable Internet subscribers. I love utilities. I may post something later, but since I am way out of my usual posting routine I might not.
I've had huge Internet connection problems in the last 24 hours. As a result, I won't post anything until this gets resolved.
Interesting little op-ed in today's New York Times about...well, it's kind of a tangled up mess of an argument about incarceration rates, rates of hospitalization of the mentally, crime, public policy and so on. It's copy that could've used a haircut, as one of my old editors would put it. I think the learned academic who wrote it is troubled by the number of mentally ill in our nation's prisons--coming late to the party are you?--but it's entirely unclear to me whether he's calling for more state mental hospital beds or what. You tell me.
Maybe it's copy that needs a full-on shave with a straight razor.
I am not at all shocked that an evaluation of Britain's mental health system found that patients were being over-medicated, 36 percent of patients, as it turns out. It's not that they are being given too many meds--polypharmacy--but that they are being given dosages above the recommended amount. Goes on every day, here and there and everywhere. Ain't nothing but a G-thang as far as some docs are concerned.
"In research undertaken by the Prescribing Observatory for Mental Health, 36% of people were found to have been prescribed more than the maximum recommended dose of anti-psychotic medicines."
OK, that shocks me. Why is that the antipsychotics--and by this is meant the atypicals--are always at the center of overmedication? An article on the matter doesn't get into that question at all and it leaves alone the matter of what diagnoses are being over-medicated. So I'll assume schizophrenia and bipolar disorder, just for fun. I'll also assume that the British drug licensing system is similar to ours in that drugs are approved for treating certain conditions at certain doses, but that there are no restrictions on how high a doc may go with a certain med as long as the doc deems it beneficial to his patient.
I was one of those patients, although the drugs in question were anti-depressants. Prozac had been approved by the FDA based on studies mostly performed using 20 mg. doses of the med. I began taking the drug in early 1990, mere weeks before the legendary Newsweek cover with my good homey Prozac sitting there like a messenger from God. My starter dose was 20 mgs., but a year or so later I began working for another employer, my insurance coverage changed, and I came under the care of a doctor at Kaiser Permanente in San Diego.
By 1993, I had become massively depressed (Lithium was doing a fairly decent job on the manic end of things) and my doctor boosted the Prozac to 40 mgs. I responded for a time, then slumped again (washout effect anyone?). My doctor upped the dose to 60 mgs. I became suicidal. In response, my dose was upped to 80 mgs.--yes, doctors were in the finger painting stage then, more doses of the same being the solution du jour. I was still suicidal and, even worse, was unable to do my job. At the same time, my Lithium dose had exploded to 3,000 mgs.
Back then, if a doc said to up a dose, you upped a dose because as a patient your information base--pre-Internet and pre-long-term studies of psych meds--was kind of limited. I swear if my doc had told me the end for my depression could be found in a bag of crack, then I would've been rolling around town looking for fellows who were slinging within an hour.
In those days, I worked as an accountant for a junior high school in San Diego's Linda Vista neighborhood. It was a shit day job while I figured out my shit life. The job was essentially bookkeeping and, with an MBA in Finance, I was wildly overqualified for the job. The kids were cool, however. I used to let them come and hang in my office before and after school, even though it was against our hidebound principal's rules, otherwise the kids would be running the streets in a gangster-ridden part of town. One morning before the first class bell rang, a group of kids performed a prayed circle around the flag pole in front of the school. I watched from my office window. Soon, they were surrounded by another group of kids who taunted them. I am not a softie when it comes to religious displays, but I wasn't going to watch that kind of bullshit go down, so I escorted the kids to my office. Stuff like that went on every day.
But in the summer of 1993, I suddenly began having huge problems reconciling my books each month. My response was to write a series of adjustments--we weren't talking serious money here--which would lead to other adjustments the next month. It was stunning to me that this was going on: I'd gotten an A in calculus in college and here I was unable to properly count a few hundred dollars of cash. Must be me, I told myself, not once thinking that it could be the meds scrambling me. Patients didn't think like that in those days.
Soon, the school district decided to audit my books and sent me home on leave. Before leaving, I tried a Hail Mary play and went to see my principal. The Americans with Disabilities Act had become law two years before, so I sat down with her and told her that I was manic-depressive. A few days later, I received a letter at home from the superintendent of schools informing me that the district was terminating me. In the letter, the superintendent wrote that my principal had deemed me a threat to the students. (I fought back for a year, but was eventually forced to resign.)
I haven't yet been able to tease out whether it truly was me or the meds at work in all of this. But I have my hunches. When 80 mgs. of Prozac didn't fix what ailed me, my doctor dropped that in favor of Paxil and lowered my dose of Lithium. I am convinced that Prozac made me pretty damn suicidal, but Paxil was a whole other ball game. The shit gave me akathesia and spun me up. I wound up desperate and alone, sitting in my apartment night after night trying to figure out what the hell was going on with me. I didn't last long on Paxil. Even my sorry ass doctor figured it was not benefitting me so he took me off it, this at a time before the Paxil withdrawal syndrome business was acknowledged. Let me tell you: everything people say about how bad it is coming off of Paxil is true. Mostly, I felt like a dead lump as I was being weaned and had those lightning bolt zaps in my brain. Not pleasant.
All of that is why the British example I pointed to above troubles me greatly. In my opinion, antipsychotics are far more aggressive meds than anti-depressants. Whichever you consider the dicier class of medication, patients are often left in the ridiculous bind that if they embrace treatment--or if treatment is thrust upon them--and their symptoms worsen, then they are put on higher doses of the same med/s. And if that doesn't work, then up go the doses some more. I wonder what a similar study to the British one would turn up in this country. Oh wait. Big Pharma would have to fund it, so, um, scratch that idea.
Patients have almost no power to push back against this business. And that ain't right.
A comment came in over the weekend, concerning one person's recent experience with Cymbalta, a newish anti-depressant made by Eli Lilly. I thought it was worth posting on the main page and I'll leave it in its original all-caps form:
"I HAVE BEEN TAKING CYMBALTA FOR A LITTLE OVER A WEEK NOW, AND AFTER THE SICK TO MY STOMACH FADED, I HAVE BEEN GETTING MORE AND MORE DEPRESSED- I DON'T EVEN HAVE DEPRESSION! I HAVE REALLY BAD ANXIETY- WHICH THIS MED DID HELP WITH, BUT WHEN YOU CAN'T GET OUT OF BED IN THE MORNING OR THE AFTERNOON, IT'S REAL EASY NOT TO BE ANXIOUS. I HAVE BEEN IN BED AGAIN ALL DAY TODAY CRYING- FOR NO REASON, AND I JUST CAME ON THE COMPUTER TO SEE IT OTHERS FELT THIS WAY, AND I AM SO CONVINCED AFTER READING EVERYONE'S THOUGHTS, THAT AS OF RIGHT NOW I QUIT THIS DANGEROUS DRUG AND AM GOING BACK ON WELLBUTRIN."
Interesting, especially since it's in response to a 7-month-old post on the drug. As I have noted before, that should tell you something. Cymbalta was expected to hit about $1 billion in sales in 2006, its second full year of approval in treating depression, making it a major anti-depressant in the marketplace. What concerns me is that I have heard nothing but bad things from readers about this drug. If anyone has good experiences to report about Cymbalta, I'd like to hear them.
Until then, I am beginning to wonder if we don't have another Prozac or Paxil situation on our hands.
Today's New York Times has a nice account of the legal whirlwind and legal issues around the Netroots' attempt to circumvent the court seal on Eli Lilly's Zyprexa documents and make them accessible to interested parties via all manner of Internet sites. I've written about this matter before, so I'll leave it at that. Except to say that I think it is essential that we begin to have some transparency in the mental health world about how drugs are marketing, researched and licensed, both from Big Pharma itself and psych researchers. The corporations and the docs all say they are acting in patients' best interests. Cool. Then prove it.
There's another court hearing on the documents tomorrow.
Over the weekend, I ran into an article from a SoCali newspaper--the link is dead sadly--writing in very level terms about how electro-convulsive therapy is making a comeback, gaining an odd vogue due to Kitty Dukakis' book and is generally safe for one and all. Like Liz Spikol, I am troubled by this trend. It should tell you a great deal about just how rotten anti-depressants are in treating long-term chronic depression that patients and docs are willing to turn to ECT after a decade or so of its being out of fashion. There are clearly some desperate folks out there and that's beyond sad.
Personally, I wouldn't do ECT if you held a loaded Glock against my temple. The few people I know who've had the procedure tell me that it left them in a fog for months on end and that they lost certain bits of memory. And let's not forget that Ernest Hemingway claimed that ECT put him "out of business" as a writer and, then, he went off and killed himself.
But if a well-informed patient in a position to give informed consent wants to give it a go, be my guest. Good luck.
Liz Spikol was far too kind to me the other day, thinking aloud that I might have something intelligent to say about a move afoot in Congress to create a process--ah, there's a Democratic word--whereby Big Pharma would have to negotiate lower costs for its products with the MediCare system. Since the proposal is still in the hammering-out stage, there aren't many specifics for me to nitpick (for another day!). But it does strike me that given the complexities of how MediCare now does business, it will be difficult for Congress to create a mechanism with enough leverage to carve out the kind of discounts enjoyed by the VA system (about 25 percent off list wholesale prices).
What I will say is that I don't trust the politics of such affairs. Everyone knows we need a global solution to the cost of prescription drugs in this country, especially given that these same drugs are often vastly cheaper 100 miles north of me in British Columbia. We need massive reform of how health care is paid for in this country because our present system of private payers and all these odd government programs has created a kluge of a marketplace that is deeply inefficient, fails to provide its products and services in an equitable manner, blocks access to all sorts of people, and is generally a cluster-fuck. This has, of course, worked much to Big Pharma's advantage--divide and conquer, baby--and has made it the most profitable industry in America. Big Pharma will fight like tigers anything Congress proposes and get things their way in some fashion. I have watched enough state-level formulary deals go down over the years to know that pattern. The Pharma companies are very, very smart business people.
BTW, if anyone thinks these folks will let too much cost-cutting and profit-squeezing hit the psych meds realm, then they need to keep in mind that anti-depressants and antipsychotics are the second and fourth-largest classes of patented medications by revenue in this country. Perhaps fighting like tigers was put it too gently.
But, like I said, we do need a larger, grander solution to the messy healthcare market in this country. I could care less whether that comes from a governmental or free market approach. I just know that it needs to happen.
In the meantime, I think that perhaps one approach would be to force Big Pharma to offer the same prices to MediCare that it negotiates with the VA. That would be pretty damn simple to put into law.
How's that Liz?
My cold moved into my sinuses yesterday, my head felt like it would explode, so I have little to post right now of any degree of thoughtfulness. Yesterday, this blog received a comment from an anonymous commenter--I approve anonymous comments if they look legit--who was apparently a loved one of Traci Johnson, who killed herself after taking Eli Lilly's Cymbalta during a clinical trial. Reading this person's comment shook me because, as I have noted here before, I know several people who have become suicidal soon after beginning to take Cymbalta and this post from last May keeps getting traffic from people having problems with the med. Here's what the commenter wrote:
"I knew and loved Traci Johnson all of my life. Her smile could brighten any room. She was one of the most optimistic people I knew and would NEVER have hung herself with the poisonous Cymbalta running through her veins. I am relieved that her death is finally bringing light to the dangers of SSRIs, especially connected with youth."
I hope this person will contact me by email (in the upper left corner). I want to know more. I am simply hearing from far too many readers and personal friends about problems with this med. Something is up. And "sorry" doesn't even cover my feeling on the commenter's loss. Except that I had so many problems of my own with Prozac and Paxil that I understand. I just need to understand more like how the hell did this happen in a laboratory during a clinical trial. Not only do I have many questions about the medication, but about the people who were running the trial.
Eli Lilly just launched a new website, www.zyprexafacts.com, apparently to counteract recent coverage of the company's star drug in the New York Times. I have skimmed the site, but have little to say about it yet. CL Psych, who was kind enough to pass along the site, has already commented on it. Read his post, look at the site, and draw your own conclusions.
I do agree with one of Lilly's assertions on its new site. The documents that were made available to the Times and, subsequently, to other journalists do indeed represent only a fraction of the 11 million pages of Lilly documents currently under a court seal. If Lilly would like to rectify that, I would be happy to inspect the remainder of the documents. Meanwhile, I know there are several Lilly employees who monitor this site--as do AstraZeneca and J&J employees--and if they'd care to share any thoughts with me about the hullabaloo around Zyprexa, then they know where to find me.
Soon after New Year's I began noticing some depression ads running on TV. One ad was specifically about Eli Lilly's Cymbalta and the company's sugary "Depression Hurts" ad campaign, in which even the family dog is encouraging you to get some help so you guys can go running in the park again. I have made fun of this ad before.
The other ad is more generic, asking if the viewer has tried anti-depressants before but had poor results. If so, this could be "Your Time for Change." The ad notes that in a recent long-term government study (i.e., STAR*D) many patients saw no remission of depression symptoms despite taking three or four different meds. Then, the ad directs viewers to a website, www.yourtimeforchange.com, the implication being that whatever is at that site has got to be a whole lot better than the poop from the government study.
The site is the usual benign symptoms checklist, depression survey, print-this-out-and-take-it-to-your-doctor who-ha. You can get DVDs containing patient stories. The site is owned by Wyeth Pharmaceuticals, which makes the Effexor family of anti-depressants, although the latter isn't noted on the site. I've yet to receive my DVD in the mail, but I am guessing it contains nothing about the really rotten discontinuation effects of Effexor.
What really bugs me, however, is that Effexor-XR was one of the drugs trialed in the STAR*D study. For patients who'd gone through the first round of the study and gotten no relief from Celexa, Effexor only remitted symptoms 25 percent of the time during a 14-week period. That is stunningly poor performance, and it is stunningly deceptive of Wyeth to refer to STAR*D without noting that their anti-depressant was one of the worst performers in the study.
Doesn't the FDA have to approve these ads or something? Why do they let such non-disclosure go on? Is it because the ad points viewers to a website that doesn't directly advertise a drug? I swear, direct-to-consumer marketing needs to be banned for psych meds because these pharma companies are preying on an extremely vulnerable group of people. If they wish to do so, then they can at least be honest about what they are peddling and how well it works. I am sure NAMI will start holding them accountable tomorrow.
BTW, Marissa Miller who authors the fine depression introspection blog had a post yesterday in which she talked about going on 10 mgs. of fluoxetine (generic Prozac) in an attempt to knock down the brain farts she's experiencing while coming off Effexor. Seems to be helping so far. Sounds like it was her time for change.
When I was a child and teen, my family lived variously in a semi-rural part of the San Francisco Bay Area, near Saint John, New Brunswick, in a suburb of Salt Lake City right up against the Wasatch Mountains and in Holmdel, N.J. which was still a mix of farm country and 'burb in those days. Depending on the time of year and where we lived, I could be found playing baseball, basketball, football, ice hockey, running track, riding horses, chasing chickens, having dirt clod fights, sailing, swimming, throwing apples at cars, hiking, skiing (a blue collar sport back then), skating on a frozen river or pond and basically running around and carrying on as kids have since eons ago. I took music lessons, too (I gave up the trumpet at 10-years-old but played hockey into college). Most of my schoolmates were similarly active. It was a time when kids were not diagnosed with depression, ADD or bipolar disorder. I don't think I ever heard of anyone taking a psych med until I was well into college in the 1980s and that was Lithium.
My unbringing was not privileged. The back side of our house in the Bay Area always needed a coat of paint and we had an uninsulated bathroom in Canada, for example. Nowadays, though, I guess I would count as privileged due to all the activities that were either right outside my door or, like school sports and Little League, were available at low-cost. Apparently, most kids just don't have similar access anymore.
I point this out because, last week, the Seattle Post-Intelligencer had an article about nature deficit disorder and a youth program designed to address it (yeah, I am just getting around to it). I cannot even guess at the reasons, beyond our rampant urbanization in America (even in the 'burbs), that keep kids inside and in front of the TV or computer monitor when they should be skinning-up their knees or painting Becky Thatcher's fence. I have heard that parents won't let their kids run in the woods due to fears of criminals and that most sports are incredibly sanitized due to legal concerns. And so on.
So why would anyone let their kids romp in a field?
"Scientists are finding that contact with nature can benefit kids in numerous ways, reducing symptoms of hyperactivity and attention-deficit disorders and leading to inner-city girls acting with better self-discipline. Kids in California performed better on science tests after a week in the woods. A survey found that conservation-minded adults traced those concerns to time spent in the wilderness."
Somehow I think it's far better to take a risk on having a kid encounter a bear in the woods than it is to let them sit in front of an electronic device of some kind for six hours a day--the national average--and wind up all zonked out on atypical antipsychotics and anti-depressants. But that's just me.
What amuses me about the article is that a psychologist who's studied nature deficit disorder says that although she agrees that nature and play have benefits for human psychology and development, she is incapable of saying so definitively because not all the scientific evidence is in. More study is needed. Why have we become a culture where everything must be studied to death and expert panels called upon to offer their sober consensus opinion before anyone can do anything different anymore? Are academics incapable of common sense? Was it the judgment of an expert panel that got us this crazy cultural shift to kids and adults sitting in front of CRTs and flat screens for much of their waking lives? Um, no.
Of course, the State of Washington, being the useless tools that they are, is asking the legislature for $2.5 million in the forthcoming state budget to study outdoor education. The only thing that needs studying is the cultural imperialism of science which, in essence, argues that common sense must be studied to death and proven out before it is allowed to be common knowledge. OK, that's a rant, but if there's one thing I have learned from being a reporter, it is that you should never trust the government. I don't mean that in an ideological manner, but from the sheer deficit of results and benefits that we we get from our tax dollars. Besides, keep in mind that it is the federal government, plus state and local governments and the public health policy wonks who feed them all, that has played lapdog to Big Pharma on each and every step of America's transition into becoming the medicated nation that we have become.
A couple of years ago, when Richard Louv advanced the nature deficit disorder thesis, I giggled at his idea. Then, I took a look around. Millions of kids on psych meds, including the truly nasty atypicals which are barely fit for adult consumption. Millions of kids being diagnosed with bipolar disorder, where the diagnosis is as much fiction as fact (because we all know what a good idea the big wave of ADD diagnosis in the 1990s was!). And so on. Hopefully, I don't sound like Tom Cruise there, but when a nation goes within 20 years from almost no kids being on medication to millions of kids on medication (with doctors clamoring to diagnose more kids), then you know something is up. If you don't think that there is, then you are delusional yourself.
I know there is something to Louv's thesis, and I would hope that when the DSM masters get around to writing the new manual in 2011 that they include Little League deficit disorder. Or perhaps Golden Gloves deficit disorder. Or equestrian deficit disorder. I am only half kidding. Nature is good for kids (and adults). So are sports. And for boys in particular, as I pointed out to a friend yesterday, these have got to be contact sports not just soccer. There is something in the male psyche that benefits from beating the hell out of one's fellow males in a competitive setting, shaking hands afterwards and walking away. I cannot explain the dynamic, except to say that it is true. Should I ever have kids, I hope I have the ability to follow through on everything I just wrote.
I've noted on this site in the past how the media regularly screws up reporting on mental health issues--everything from the prevalence of bipolar disorder to what meds fall into which class of treatments. Here are two examples.
In the first, a doctor writes in his advice column that bipolar disorder affects "between 3 percent and 8 percent of the population." Last year, NIMH upped its prevalence number to 2.6 percent from 1 percent--and 2.6 percent seems about right if you understand that most of that number is comprised of bipolar 2, cyclothmia, etc. Then again, I have seen actual researchers in actual published papers claim that bipolar disorder affects up to 11 percent of the American public. I think such grandiose claims are without foundation and are based on sloppy community surveys.
And, then, my good pals at the Associated Press have had an article out the last couple of days concerning a solider in Iraq who reportedly was diagnosed with homicidal tendencies, given some Seroquel and sent back into battle. Allegedly, he then went and murdered some Iraqi civilians. Disgusting...both the alleged act and sending him back into action. The AP commits an error of its own in describing Seroquel as a "mood regulator." Apparently, the AP is buying the hype that Seroquel is now a mood stabilizer, not that it has been approved for maintenance of bipolar disorder. I have long complained about the AP's many mistakes in its mental health coverage primarily because the AP isn't supposed to make mistakes of fact and because its wire stories show up in hundreds of papers around the country and the world. I guess the rigor they apply to political reporting doesn't apply to health reporting.
But such flawed nonsense is rampant is the blogosphere as well. "People with bipolar disorder are constantly on a roller coast ride between severe depression and mania" and "As mystery writers, we might tend to think of characters with bipolar disorder as our villains. When they are on the manic end of their cycle, these people are more likely to behave impulsively and commit arson, theft, take drugs, or engage in reckless driving. Most patients with bipolar disorder have little capacity for insight into themselves and what motivates them, and so they are frequently a pain in the ass to deal with."
The above is from a writers blog entitled Working Stiffs. Perhaps someone might wish to email the poster and let them know just how wildly off-base they are. Unless of course they plan to write mysteries with African-American characters as villains due to their over-representation in the criminal justice system. I'd write them myself but I think I might to prove to be a pain in the ass. For real.
My cold hasn't exactly lifted, but the flu piece of it seems to have departed. I spent a long evening on the couch watching episodes from the third season of The Wire, an excellent HBO series. All of which has nothing to do with the following.
On Monday, a federal court judge in New York expanded his ruling from last week concerning the leaked Zyprexa court documents to include an anonymous person who'd made links to the documents available at pbwiki.com. There will be another hearing in the case next week. I think the judge made a poor ruling in this case, because providing links to whatever on the Net is no more a violation of Eli Lilly's rights and the court's seal on the documents than is Google allowing you or I to plug in the search term "Zyprexakills.tar.gz" and find many references, links and whatnot to the documents. Go to Google, or Yahoo for that matter, and try it for yourself.
So why aren't Lilly's attorneys going after Google? I wouldn't even begin to guess.
As for the documents themselves, I am concerned that some in the mental health world are using the documents and their separate conclusions they've reached upon reading the various New York Times articles on Zyprexa to assert that Lilly, in allegedly withholding information from doctors and patients about a possible link between the drug and diabetes/hyperglycemia and in allegedly engaging in off-label marketing of the drug, has committed murder. That's a wild assertion, at this point, and people would be wise--as pissed-off as this whole situation makes them--to back off making criminal accusations and focus on something else. That would be calling for complete transparency about Lilly's behavior, be it good or bad, and complete accountability for the company's actions.
Meanwhile, I have to admit that I feel sorry for Lilly on a certain level. Doctors I have spoken with recently tell me that Zyprexa came very close to being the perfect molecule for addressing psychosis, but that, as with Clozaril, the drug's side effects have brought its utility into question. One doc told me that four or five years ago he used to prescribe Zyprexa all the time to schizophrenics, but that now he only uses it when no other drug will work. And that's just got to suck for Lilly.
More to come.
I came down with a nasty sore throat/cold last night. Besides, "the Other Project" needs my attention again all of a sudden. In a good way. So make me feel better and go vote for my silly blog. Link over on the right.
I spent some of this past weekend talking with a 20-something bipolar friend of mine. She's not doing so swell, after a couple of years or so of treatment and currently being on six different medications. Part of the reason she's on a half-dozen meds has to do with the fact that she's seeing a psychiatrist for those asinine 15-minute med management appointments during which said doc answers messages on his Blackberry. I say fire the piece of shit.
But, perhaps the primary reason she's doing poorly has to do with the fact that she's not eating regularly and her family relationships are a huge trigger for her moods. I've pounded on the food pulpit before, so I'll make this short: you simply must eat three meals a day. I am not talking fancy nutrition here either. For years, I have watched fellow bipolars and depressives literally starve themselves and, then, they wonder why they are falling apart and at the doctors eager to take whatever "maybe this will work" pill the doc is handing out that week. God knows, it happened to me that way, too. For years, I have watched social workers and case managers have to literally force-feed some of the most hardcore schizophrenics I have ever seen and stay on them day after day to eat, drink water, stop smoking crack, stop drinking whiskey and so on. (For this, they got an MSW?)
Anyhow, the global point here is that if you don't eat and take care of your body, then your mind will surely follow. And your moods and behaviors will take off in whatever direction they please and you'll be sitting there like a bit of human wreckage wondering why you don't off yourself. Not feeling like eating is no excuse either because the costs of not doing so are simply too high. There is a level of personal responsibility here that falls squarely on the shoulders of the patient.
Which brings me to families. I am constantly struck by how many people with mental illness often have episodes kicked off by something gnarly going down between them and mom and dad. Or with the boyfriend. Or wife. Et cetera. Look, this one is simple: if you've got a family member who consistently sets you off, then you need to do one of two things. Get said family member, significant other, friend and so on out of your life altogether, or know that they are a trigger--an enabler of bad psychic voodoo--and stay the hell away from them when you are on shaky ground. The price of not doing so is way too high--unless you think winding up at the doc's and walking out with a scrip of 300 mgs. of Seroquel is your idea of a fun time.
Then, there's the whole business of allowing yourself to become over-stimulated. The Internet. Ten IMs going at a time while you're answering an email and listening to Clap Your Hands Say Yeah (or, Clap Your Hands Say Ehhh, in my opinion). The TV. If you are getting wound up, turn these things off. It's not hard, but it sure seems boring in a world where the You that really matters is allegedly your inauthentic self on the Net. Try it out anyway. You might be surprised.
What I have just written about food, families and stimuli requires self-knowledge on the part of the patient and personal responsibility for how you act upon that knowledge. I know that kind of talk isn't popular amongst either patients or psych MDs because it takes human behavior and feeling out of the realm of a blameless brain disorder and puts individuals in a position where they are responsible for something other than slamming pills every day. So what? Would you prefer to be captain of your own fate or be a slave to your docs and Big Pharma?
And, if anyone wonders if there is any scientific validity to what I just laid out, yes there is. Self-knowledge and trigger management are at the core of such modalities as cognitive behavioral therapy and dialectical behavior therapy.
By writing about borderline personality disorder, the flip side of narcissism. It's interesting stuff, although it probably won't make too many people happy:
"Note the difference: the narcissist is a character: an invented but well scripted, complete with backstory, identity. The narcissist is trying to be something-- which already has a model. Perhaps he thinks himself an artist type, or a tough guy, or the type interested in spiritualism, or like the guy in the Matrix. Types, characters. The borderline is no one: the borderline waits for the script to define her. Her? Yes. Narcissists are mostly hes, and borderlines hers. (Not always, sure.)"
And:
"If a borderline is dating a guy who loves the Dallas Cowboys, then for sure, she will love the Dallas Cowboys. If, however, she breaks up with him, and then dates a guy who loves the Giants, then she'll love the Giants. But here's what makes her a borderline: she will actually believe the Giants are better. She's not lying, and she's not doing it for him; she actually thinks she thinks it's true. Everyone else on the outside sees that it is obviously a function of whom she's dating, but she is sure she came up with it on her own. And she's not play acting: at that moment that she believes, with every fiber of her being, that the Giants are better."
There is also a great bit in the post about shoes. Check it out. As for the Cowboys: better luck next year, losers.
One teen murdered another teen at their high school in Tacoma, Wash. last Thursday. As it turns out, the alleged murder had been in a psych hospital a couple of years before for treatment of schizophrenia. Still, he had easy access to a handgun at home--apparently his parents are complete fools who didn't keep the family's sidearm away from their mentally ill son. Then, he goes to school and shoots one his best friends in the face. I hope his parents wind up being charged with criminally negligent homicide.
It's understandable why a family might want a home defense weapon. Tacoma is dicey like that--and is the homeland of Ted Bundy and it's where the D.C. snipers got their start.
But, Jesus H. It's called a gun safe, people. Buy one. Don't let the kids know the combo. Or clear the house of guns altogether lest we wind up with more tragedies like the ones here and in Fairfax, Virg. last May. Oh yes, the Tacoma teen was taking his meds. I wonder what the fine folks at the Treatment Advocacy Center will make of that.
First, if you haven't already, please consider casting a vote for my blog as Best Patient Medical Weblog or vote for one of the other fine blogs out there.
Second, here's an interesting, although wildly biased, review of Peter Kramer's Against Depression and Joshua Wolf Shenk's Lincoln's Melancholy. In it, Bruce Levine, the reviewer points out:
"It may surprise those Americans who believe that modernity is synonymous with progress that in 1860 the U.S. public and press had compassion—and even respect—for Abraham Lincoln’s depression. According to Shenk, Lincoln’s depression may have actually helped him politically more than it hurt him, as it gained him sympathy and drew people toward him. Shenk discovered that Lincoln’s depression 'seemed not a matter of shame but an intriguing aspect of his character, and indeed an aspect of his grand nature'.Public compassion for Lincoln’s depression in 1860 stands in clear contrast to 1972 when George McGovern’s vice presidential running mate Thomas Eagleton was shoved off the ticket because of his history of depression. Today it continues to be unlikely that anyone with Lincoln’s temperament would receive a presidential nomination. One wonders whether the medicalization of depression—which the psychiatric establishment claimed would eliminate the stigma of “character defect”—instead created the stigma of 'biochemical defect'."
It's an interesting thought, flawed in one respect. Not only did our culture view depression differently by 1972 than it had in 1860, but much of the intense response to Eagleton's depression was because he had been hospitalized and had twice received ECT treatments. I suspect that if ECT had existed in Abe's time that he would've run into similar political problems. There is still much public distrust around people who have been hospitalized much less received ECT. That's just a fact.
In addition, Levine totally gets it wrong when he says "Kramer also attempts to revive the chemical imbalance theory of depression, specifically the serotonin-deficit theory, an idea that much of mainstream medicine now rejects." I would say that only a minority of mainstream doctors have rejected the chemical imbalance theory. If anyone can find me evidence that "much" has rejected it, let me know as it will be news to me. And, yes, I do find the fact that docs continue to cling to a still-unproven theory, um, depressing. Brain chemistry has something to do with it, of course, but the fact is that if it were a complete accounting of the source of depression then a) anti-depressants would work with a high degree of effectiveness and no side effects (sadly, they do not) and b) we'd all be cured. Which we are not.
Thanks to Sara for passing along the review.
Eli Lilly yesterday announced that it would settle 14 lawsuits against it over its drug Zyprexa. Total tab: $500 million. That brings to $1.2 billion the amount that Lilly has shelled out of the last 18 months to settle lawsuits relating to its star drug. I wonder how long it will be before evidence starts trickling out of that case.
Speaking of the evidence that has trickled out of the earlier 2005 settlement, Lilly now has a court order that it got expanded on Wednesday to include 8 individuals as well as MindFreedom and the Alliance for Human Research Protection. Lilly's attorneys claim that the individuals have made copies of some of the evidence from the 2005 case available illegally, have hosted it on websites, or, in the groups' case, have linked to such websites from their own websites. There will be another hearing in this case on Jan. 16. Stay tuned.
In addition, an attorney representing Eli Lilly has gone after a site called pbwiki.com for allegedly hosting some of the evidence from the same case. As best as I can tell, the site is refusing to take it down so far. Stay tuned to this one, too.
Yesterday, I noted that a recent letter to AJP had reported on prisoners snorting Seroquel and asking whether they weren't becoming addicted to the drug. In the same issue, another letter reports on a prisoner who created a "Q Ball" by combining cocaine and Seroquel and injecting them. That's a riff on the old "8-ball" of cocaine and heroin, which killed John Belushi.
Man, this Seroquel stuff is just weird. That's got to be an ugly way to exist. Reason #101 why crime doesn't pay.
The New York Times is back with another article on the use of Zyprexa and its consequences for patients. In this case, the article is about a mother in Georgia who believes her son died from heart disease as a result of gaining 80 pounds on Zyprexa. Her son was bipolar, the story is sad, so I'll let you read it for yourselves. In it, Alex Berenson aptly sums up the dynamic around Zyprexa:
"For many patients, the side effects of Zyprexa are severe. Connecting them to specific deaths can be difficult, because people with mental illness develop diabetes and heart disease more frequently than other adults. But in 2002, a statistical analysis conducted for Eli Lilly found that compared with an older antipsychotic drug, Haldol, patients taking Zyprexa would be significantly more likely to develop heart disease, based on the results of a clinical trial comparing the two drugs. Exactly how many people have died as a result of Zyprexa’s side effects, and whether Lilly adequately disclosed those risks, are central issues in the thousands of product-liability lawsuits pending against the company, and in state and federal investigations."
As the article also notes, some in the psych world say Lilly downplayed the weight gain caused by its star drug as well as the consequent risks around weight gain, especially explosive weight gain. Let's face facts: some people who've taken Zyprexa have ballooned and rapidly. I've heard reports of 100 pounds in one year.
I am reviewing the documents in the Zyprexa case, which were made available to me, but I have yet to draw any firm conclusions. That will happen after I go do something all the schmancy Web 2.0 propagandists and bloggers seem to have problems grasping the mechanics of--reporting. I can assure readers that I have lots of questions based upon my reading of the documents to date. I will do what I can to get answers. Now that "the Other Project" is out of my life for a couple of weeks that may happen rather soon.
I appreciate the Times' attention to this story and the fact that Berenson's editors are letting him have a good run at it. Now, for some nitpicking.
Berenson's article states:
"No one would say Mr. Kauffman had an easy life. Like millions of other Americans, he suffered from bipolar disorder, a mental illness characterized by periods of depression and mania that can end with psychotic hallucinations and delusions."
I am so sick and tired of that being the thumb nail sketch of bipolar disorder. It's accurate, but only in the sense that it brackets the range of symptoms of bipolar. There is a whole lot of other shit going on inside those brackets. After a good year or so of going through various data on bipolar disorder, I am convinced that the hallucinations and delusions on the manic side of things happen far less often than researchers argue and are of fairly short duration when they do. If you buy the claim that 10 million or so Americans are bipolar, then you've got to break down what is meant by bipolar. Is it BP1, BP2, cyclothymia, BP NOS, bipolar spectrum disorder? The bad voodoo of mania--I am talking about the full-blown hallucinations and delusions, not the far tamer symptoms of hypomania that a lot of researchers call "manic" but which don't even cross the bridge into psychosis--probably only applies to one-third of what's considered bipolar disorder these days. About 3 million people. The classic 1 percenter situation. All the rest will likely never experience true psychosis, even though many like to kid themselves that they have in a kind of machismo boasting about bad times. So that leaves maybe 2 percent to 3 percent of the populace who is called bipolar but isn't really bipolar in the classic manic-depressive sense.
There are different kinds of mania or near-mania and that's what most bipolars have got. If the media is really interested in this disorder, in how it is treated and over-treated, then they ought to pay attention to the many bipolars who wouldn't know a hallucination if they took a hit of blotter. End of rant.
There is a remarkable letter to the editor in this month's American Journal of Psychiatry about Seroquel abuse in an Ohio prison, especially involving the snorting of crushed up tablets. In the joint, the atypical antipsychotic has earned the street name "quell." Here's much of the letter:
"Quetiapine [Seroquel] is not a controlled substance and is not considered addictive. Yet there are several reports describing abuse among inmates in jails and prisons....The authors have treated a number of inmates who have engaged in drug-seeking and sometimes illegal behavior to obtain this medication. The following case is illustrative:
A 39-year-old incarcerated male with hepatitis C and a history of opiate abuse was treated for generalized anxiety disorder. When seen by the prison psychiatrist, he was receiving quetiapine 800 mg and clonidine 0.9 mg at bedtime. The psychiatrist was concerned about the risks of prescribing an antipsychotic medication for a patient with hepatitis without a serious mental disorder. The patient refused to discuss other treatment alternatives stating, 'I need my Seroquel.' Efforts to enlist his cooperation for a quetiapine taper were unsuccessful. He abruptly left a treatment team meeting and informed staff that he would purchase quetiapine illegally from other inmates and had done this before.(Emphasis mine.)
We have treated other prisoners who have threatened legal action and even suicide when presented with discontinuation of quetiapine. We have