Furious Seasons

Risperdal And Abilify Lead To Hundreds Of Adverse Events Reports For Kids, Teens

Yesterday, I posted an item wherein the FDA says it accepts as valid the diagnosis of pediatric bipolar disorder, despite much controversy within psychiatry about the validity of the disorder. I also noted that a Harvard child psychiatrist had written to a newspaper stating that Risperdal and Abilify, two atypical antipsychotics, are "safe and effective" for youngsters. Let's see what the FDA's adverse events database has to say about that.

First, let's forget about whether pediatric bipolar disorder even truly exists for a moment because Risperdal and Abilify have both been approved by the FDA for use in kids aged 10 to 17 who allegedly have pediatric bipolar disorder. There is some level of consensus in psychiatry that bipolar disorder can appear in the early teen years--somewhere around 12 or years old--so this 10 to 17 business is kind of an overlap diagnosis for both children and teens. What's more, Risperdal has been approved for use in treating autism in children since 2006. The two drugs are also approved for use in schizophrenia in children. Further, we know that some doctors have been prescribing these two drugs off-label for several years in advance of their recent approvals. Abilify was approved for use in treating pediatric bipolar disorder in 10 to 17 year olds in 2007. Risperdal was approved for use in 2007.

What this means is that, regardless of what the clinical trials showed for these drugs (does anyone trust short-term clinical trials as a measure of safety anymore? I sure don't), there are several years of real world experience in the use of these drugs that will be captured in the FDA's adverse events database. And, the nice folks at Psychdrugdangers.com have compiled the FDA's adverse events database for various psych meds at least through 2006.

For Abilify used in kids aged 10 to 14 from 2003 to 2006, we find 227 adverse events reports. For teens aged 15 to 19 (so we are getting a bit into adult use here, but that's how the database is organized), there are 215 adverse events reports. Keep in mind this is for a time period when the drug was mostly being used off-label for ANY indication in children under 18 in this age group. There are reports of suicidal ideation, deaths, attempted suicides (that the doctor involved in the case found worthy of passing along to the FDA), aggression, drooling, tremors, heart problems and so on. Taken together, that's 442 adverse events reported in advance of the drug's approval for use in pediatric bipolar disorder.

For Risperdal used in kids aged 10 to 14 from 2004 to 2006, we find 103 adverse events reports. For 15 to 19 years old, there are 92 reported cases in those years. There are reports of suicidal ideation, attempted suicides, deaths, completed suicides, aggression, mania induction, paralysis, tremors, diabetes, heart problems (including cardiac arrests causing death), pancreatitis and so on. Taken together, that's 195 adverse events reports.

Yes, these drugs are safe for use in youngsters.

Even more stunning on the safety front is what turns up when we look at adverse events reports for the use of these drugs in children aged 0 to 4 (where most of the use would be accidental or in utero) and ages 5 to 9.

For Abilify exposure (as opposed to intended use) and use (as in prescribed to the kiddo) in kids 0 to 4 from 2003 to 2006, we find 22 adverse events reports. Loss of consciousness, convulsions (in the case of a 4-year-old girl with alleged child bipolar disorder), hyperglycemia and so on.

For Risperdal exposure in kids aged 0 to 4 from 2004 to 2006, we find 19 adverse events reports. There are reports of babies experiencing drug withdrawal syndromes, cardiac problems, respiratory problems and so on.

For Abilify used in kids aged 5 to 9 from 2004 to 2006, we find 122 adverse events reports, mostly in kids being given the drug for alleged child bipolar disorder and ADHD. Dystonia (abnormal muscle movement), weight gain, tardive diskinesia, tremors, aggression and blurred vision and so on.

For Risperdal used in kids aged 5 to 9 from 2004 to 2006, we find 56 adverse events reports, mostly in kids being given the drug for alleged child bipolar disorder, ADHD and oppositional defiance disorder. There are cases of white cell counts being decreased, convulsions, aggression, weight gain and tardive diskinesia. There's even one death reported.

How Harvard's Wozniak can claim these drugs are safe is beyond me. Why do I say that? The clinical trials for Risperdal for use in pediatric bipolar disorder in kids aged 10 to 17 involved 169 patients, a very small number by clinical trials standards. Yet, as noted above, over a three year period of the drug's use off-label and for autism, there are 195 adverse events reports, more than were even in the clinical trials. If I were a doctor I'd use the term safe very carefully. A lawyer might ask you what you mean by that term someday.

As for the FDA, I'd say that what exists in its adverse events database as real world experiences in advance of the approval for the use of these drugs in kids aged 10 to 17 raises all sorts of questions about whether the FDA is aware of its own data. And that's regardless of whether pediatric bipolar disorder exists or not.

FDA Says Pediatric Bipolar Disorder Is Valid

Earlier today, I asked the FDA to respond to a statement made by Harvard child psychiatrist Janet Wozniak, wherein the doctor claimed that the FDA accepted the validity of the hotly-debated child bipolar disorder. That was news to me, since the diagnosis does not exist in the DSM and many child psychiatrists such as Jack McClellan and Larry Diller, both affiliated with major medical schools, even claim that the child bipolar diagnosis is not real.

From FDA spokeswoman Sandy Walsh comes the following reply:

"I just heard from Dr. Tom Laughren, head of psychiatry products. He said that Dr. Wozniak is correct. The FDA does accept the validity of pediatric bipolar disorder, as evidenced by our issuing Written Requests for pediatric studies for this disorder and approving both Risperdal and Abilify for use in pediatric bipolar disorder."

I'll likely be talking with Laughgren in the next few days so he can explain how it is that a disorder that doesn't exist in the DSM and doesn't exist in the minds of experts in the field actually can exist in the minds of the FDA.

Stay tuned.

Controversial Harvard Child Psychiatrist Claims FDA Affirms Child Bipolar Disorder

There was a recent op-ed in the Boston Globe by an emeritus Harvard med school professor criticizing the many financial conflicts of the group of child psychiatrists headed by Joseph Biederman. Among other things, he pounded on the meds given to children for the alleged child bipolar disorder.

Now, Janet Wozniak, a Harvard child psych doc and one of the Biederman clan, defends the use of meds in kids and makes an interesting claim about the FDA, in a letter to the paper that appears today.

"The FDA approvals of Risperdal and Abilify for this purpose not only suggest that at the proper dose, these atypical antipsychotic medications are safe and effective for use as indicated, but affirm that the FDA accepts the validity of pediatric bipolar disorder and the need to treat it."

The approvals she refers to are both within the last year or so. What's weird is her claim that the FDA accepts the validity of pediatric bipolar disorder since the alleged disorder does not appear in the DSM-IV and it seems a bit of a stretch to suggest that drug approvals mean that the FDA has validated a condition that is not accepted by the central diagnostic manual for psychiatry.

I've queried the FDA to learn its view on this matter, but have not heard back yet.

Wozniak also states the following:

"When patients suffer, and available treatments are lacking, it is the job of experts to innovate and explore new options for hope....Families faced with the anguish and disruption of bipolar disorder need reassurance that steady progress is being made in understanding and treating this complex diagnosis."

Last year, Wozniak described her fellow child bipolar disorder propagandists as working in "uncharted water." Now they are the harbingers of hope.

I guess when you are at Harvard you get to break out all the heroic metaphors to describe yourself.

Thanks For The Record

I knew something was up early Tuesday morning when I noticed the post I did on the Lenzer/Brownlee media list was getting a lot of attention and a lot of hits. But nothing could have prepared me for what was an epic flood of readers, mostly from reddit.com and all very interested in learning which medical experts aren't bagmen for Big Pharma. By mid-evening, as things were cooling down, this site had well over 3,000 hits (or visits, to be more precise), far eclipsing its previous record of about 1,750 visits last December when Google screwed me out of $600 and some of the posts I wrote about it got a bit of attention. (Here's hoping the brand new search engine Cuil.com, founded by former Googleites, does really, really well. :))

Thanks wang-banger.

I'll be mostly offline today, tending to other matters, but might post a tasty little item here in a bit.

Media List Of Non-Pharma Whore Medical Experts Now Online

Thanks to the ridiculous number of you who swung by the original post on the Lenzer/Brownlee list of unbiased medical experts earlier today for your patience. A semi-complete copy of the list is now online here. It's missing a few names like psychiatrists David Healy and Erick Turner (for reasons that escape me), but it's mostly all there. Enjoy.

Out Of Control Psychiatrist Diagnoses Woman With Bipolar Disorder Due To Home Improvements, Nervousness Plus Reaction To An Anti-Depressant

I've criticized the softening of bipolar disorder in the DSM in 1994 to include bipolar disorder type 2--meaning there's no mania involved whatsoever--and I've certainly said some sharp things about how common every day behaviors that in some contexts would count as healthy behaviors can be turned by incompetent psychiatrists into symptoms of full-blown mental illnesses, requiring a lifetime of medication, but this example out of Canada utterly takes the cake.

From a woman who identifies herself as "saviabella" and whom I have also exchanged emails with comes:

"At the end of September, when the antidepressant I was on made me go wonky, I asked my doctor to refer me to a psychiatrist."

This is in Canada's single payer, socialized medicine system, so the woman ends up waiting many months to see a psychiatrist, whom her GP assures her is the best around, empathetic and so on. Then look what happens:

"By the time my appointment came up, I was feeling fine. My drugs were working and I wondered if I even needed a psychiatrist after all. But, given my family history, I decided to go anyway. It couldn’t hurt, right? Wrong. Oh, so very wrong."

Then:

"I was determined to have a positive attitude and to be open-minded. Sitting in that waiting room, I tried not to be nervous and instead psyched myself up (hah), telling myself: this is something I’m doing to make my life better and ensure I am going to be healthy long into the future.

"I quickly figured out that this appointment wasn’t what I was hoping it would be, no matter how much positive energy I tried to throw at it. The moment I told Dr. R my family history and the adverse reactions I had to the Effexor and Wellbutrin, she decided I was Bipolar II and tried to fit everything I said into that diagnosis.

"I’m not disputing the diagnosis itself; it’s a fair hypothesis, and one that I have considered myself. However, I have a huge problem with a doctor diagnosing a patient within five minutes and then 'accusing' her of all kinds of behaviour that doesn’t exist.

"As the 'interview' (or interrogation, as it became) went on, the two of us got more and more frustrated, and the conversation grew heated. She was frustrated because I refused to just accept what she was telling me about myself, and I was frustrated because she wasn’t listening to me or considering my explanations for my decisions or behaviours.

"And then it just got plain weird.

"Dr. R: Do you ever spend large amounts of money?

"Savia: Sure. I have a house. I’m doing home renovations right now.

"Dr. R: How are you paying for that?

"Savia: A line of credit.

"Dr. R: That’s hypomanic, irresponsible financial behaviour.

"Savia: But I’m making an investment in my home, and my house value has quadrupled in the past seven years.

"Dr. R: Going into debt for any reason is hypomanic.

"Savia: What? But it’s not just any debt. It’s good debt.

"Dr. R: There is no such thing as good debt."

It gets even more fun:

"At the beginning of the appointment, I was quite succinct in my answers. But then, she would jump in and fire several more at me, obviously looking for more context. So, I started giving more thorough answers. She never smiled and she cut me off a lot, which made me really nervous and uncomfortable. I started talking faster and being less concise. At one point, she stopped, tilted her head, smirked at me and said:

"Dr. R: You’re talking fast and circumventing the question. That’s hypomanic.

"Savia: I’m nervous!

"Dr. R: [cutting me off] There you go, rationalizing your behaviour again."

I won't even get into how wrong-headed and unethical this kind of diagnosing is. As the woman notes, if going into debt of any kind is hypomanic, then a good chunk of the North American population needs to be diagnosed from President Bush on down. I recommended that the woman report this doctor to the appropriate provincial licensing board and get another opinion from another psychiatrist.

There's one big problem with that. She lives in a smallish big city in Canada and there are only three psychiatrists in town. The woman went back to her initial doc who told her this psychiatrist was clearly unacceptable and so he faxed off her paperwork to another psychiatrist in town, asking him to see her. But this second psychiatrist informed the woman's doc that he wouldn't see her. The second psychiatrist has a policy of not seeing patients who've already seen one of the other psych docs in town for reasons that are unclear to me.

Talk about double jeopardy. Talk about how capricious and unobjective psychiatry can get. Gee, and we wonder why we are seeing all these false positive diagnoses around bipolar 2?

The woman has an appointment with the initial psychiatrist soon. It'll be interesting to see how that turns out.

Media List Of Medical Experts Who Aren't Pharma Whores Goes Public, Controversy Ensues

See update at the bottom of this post.

Many of you already know the work of journalists Jeanne Lenzer and Shannon Brownlee, who among other things authored this lovely takedown of "The Infinite Mind" radio show a few months ago (I was also critical of conflicts of interest in guests on the show who appeared to praise anti-depressants and deny that there was suicidality attached to their use). Around the same time, the pair put together a list of 100 medical experts who hadn't received funding from Big Pharma in five years or who separately pretty much were critical of pharma despite having gotten money from them within five years. The list was intended for media sorts only, the pair's way of getting the pharma influence out of health stories in the American media.

Now the list has gone public through the British Medical Journal, for whom the two sometimes write. The list went public basically to blunt criticism of who was on it and who wasn't by some in the medical community as well as by pharma defenders in the blogosphere.

Before I go further and since this whole affair is about conflicts, I should probably clear the decks concerning possible ones on this end. I was a fairly early recipient of the list, defended the hell out of the pair when they were criticized over their criticism of the radio show and am friendly with both in a journalists trading emails every so often sort of way. As a journalist, I was heartened to see some of my colleagues try to provide others in the field with a list of medical experts who wouldn't be tainted by questions of pharma influence and whom, in turn, the public could rely on to at least have clean hands (their medical opinions likely vary in quality, but that's almost beside the point). I can assure you that a list like this is handy to have especially for reporters on deadline and for reporters who are trying to get unbiased views of medical treatments.

Not long after the list began to circulate, Lenzer and Brownlee were attacked and their list was savaged as being filled with doctors allegedly tainted by plaintiff's attorneys expert witness fees. The attacks dogs were over at drugwonks.com (a site with immense conflicts of its own) and PointofLaw.com.

It's worth noting that one of drugwonks.com's authors is Peter Pitts who was one of the guests on the much-criticized radio program. Makes this whole affair even tastier.

Anyway, the list must have gotten some attention in medical circles--both pro and con--and so the BMJ published it last week, presumably so the public could see for itself and reach its own conclusions. I've not been able to turn up links to the list itself and I won't post my own copy. Obviously, the BMJ also published the list as a mild "oh really?" to its critics. Many of the doctors on the list are people I know and I think they are a legitimate group, so it's not clear what the critics' point is--aside from exercising their vocal cords--especially since, as far as I know, most psychiatrists on the list have never taken a penny from plaintiffs attorneys. I'm not sure I can get into too much detail about who is on the list or not yet because I haven't seen the list on the BMJ site so far. Although this blog entry by the BMJ's editor notes its public existence and also notes that I went to bat for Lenzer and Brownlee during the radio show fracas. (Nice to find myself linked to by BMJ on what had to be one of the worst Mondays for me in recent years. It amuses me no end that I get more links from British blogs than I do from media, with an exception or two, in Seattle where I am based.)

I suspect much of the heat directed at the list was principally due to the inclusion of British psychiatrist David Healy (OK, he's the one name I'll mention), who is a longtime critic of anti-depressants and has testified for plaintiffs in various trials involving safety allegations around SSRIs. There are other names on the list that no doubt would raise the hackles of critics, but part of what PointofLaw.com was cheesed off about was that he couldn't get a copy of the list because he's affiliated with the American Enterprise Institute, a generally pro-pharma think tank, so that the blog could then post on who had appeared on behalf on plaintiffs.

All's fair in love, war and advocacy I suppose, but I think critics of the few docs on the list who may have appeared on behalf of various plaintiffs suing pharma companies have missed a key aspect of what it is expert witnesses do. They lend credibility to plaintiffs' cases because they are able to walk through clinical and scientific evidence of misconduct by Company X or Y and, in some cases, convince juries and judges that they know exactly what they are talking about. That's the exact opposite of various medical experts in, say, the mental health world where too often the academic researcher being quoted on a story is on the pharma dole, but never ever tells the reporter that.

Why critics have a problem with transparency of sources is lost on me.

UPDATE: A copy of the list, mostly complete, is now available right here.

Is Marinol (Pot Pill) An Anti-Depressant?

A recent case report from the journal Cannabinoids identifies two patients with depression and "burnout syndrome" (I'll not even get into the irony of that term in reference to cannabis) who had not been well-treated by conventional anti-depressants and were instead given a daily dose of Marinol, the so-called pot pill, for several years and this successfully treated the patients. So here pot is established as having anti-depressant effects. The doctor is working in Austria, which explains why you've not heard of this before. You can read the report here and draw your own conclusions.

Obviously, all the usual cautions around case reports apply--limited sample size, no controls, no randomization, etc. But then, at least in the US, the government has worked for decades to block clinical trials of marijuana and various pill derivatives for use in treating depression and just about anything else, so case reports here and there are almost all we have to go on.

Here's how the Austrian doctor assesses some of the evidence. The clinical trials he refers to were conducted in patients suffering from other conditions such as AIDS and cancer.

"In several clinical studies, during which subjective parameters were monitored, cannabinoids not only improved physical symptoms but also improved well-being and produced measurable antidepressant effects . A study by Musty (2002) with healthy volunteers, smoking cannabis showed a positive correlation with the ratings on a scale of depression (MMPI), indicating an antidepressant effect. These indications of a therapeutic potential of symptoms of depression encouraged the author to start administering dronabinol [Marinol] to select patients suffering from depression."

The MMPI isn't exactly a clinical scale of depression, so I'd be more impressed with results measured with the HAM-D or other scales, but still it's suggestive of some level of effect.

And apparently there are all manner of effects. In one of the cases, the doctor reports that not only did his patient's depression abate, but that the patient was able to break their benzo dependence.

Let me just say, once again, that given how much depression--and burnout syndrome for that matter--we have in this country, and given how poorly and unpredictably officially-sanctioned anti-depressants work, then it makes sense that the feds should stop blocking researchers from using marijuana, or whatever pill form of cannabis molecule makes sense, in research into treating depression. NIMH has already been allowed to use ketamine is some trials of depression treatment, so why not pot too?

Maybe we can one day get the good folks at Eli Lilly back into the cannabis tincture business and out of the SSRI/SNRI business.

Slow Enforcement Of Off-Label Marketing Laws By FDA

A report issued by the General Accounting Office asserts that it takes the FDA seven months to catch instances of off-label marketing by pharma companies and issue a warning to the company and another four months for the company to correct its actions. Well, isn't that sweet?

Off-label marketing goes on all the time (20 percent of prescriptions are said to be for drugs Rx'd off-label), despite companies' instance that it doesn't (why all the Zyprexa lawsuits then?) and that's troubling for all kinds of reasons. It allows drug companies to make illicit profits and puts patients at risk. It also boosts the cost to taxpayers through Medicare and Medicaid.

"The FDA 'isn't keeping track of how drugs are marketed for off-label use, even though marketing for off-label use is illegal and it's the FDA's job to enforce that law,' [Sen. Charles] Grassley said in a statement. 'As a result, drug makers aren't being held accountable for promoting unapproved use of medicine and patient safety is diminished.'"

So who is minding the store?

What's Going On

Over the weekend and on Friday as I was thinking through the future of this site and my own future, I received many comments and emails. Some were supportive, some abusive, someone called me depressed (nah, I was just good and pissed off which I hope will make its way into the DSM-V as GPOD, good and pissed off disorder) and someone else called me a narcissist. I appreciate the kind comments on my work, while the rest just confuses the heck out of me. It causes enough of a fracas around here when some commenter thinks another is applying the DSM to them and I can assure you it's doubly fucked-up when someone breaks it out on me based on something I'd written about trying to maintain some order on this site and being a bit frustrated at the economy and my personal life. Even Fuller Torrey wouldn't dx someone based upon that.

Oh, yes, someone also bet me $500 that I couldn't walk away from this site for six months. They are right. Glad I didn't take the bet.

I am going nowhere and not much is going to change around here. I am not going to let about five people who simply cannot get along ruin this site for everyone else not to mention myself. The next time this crew gets in a fight I am just going to ban both sides and leave it at that. I have better things to do than referee adults arguing like children. What people who dislike one another's views so much should realize is that, by now, they simply aren't likely to change the other side's views at all since both sets of you are pretty damn entrenched, and, two, it's highly likely that anyone who comments on this site is highly frustrated with the mental health system in the first place. So you agree on something right out of the chute. You seem to disagree on everything else though.

I know there are several readers who would like me to censor various extreme statements that get made on this site from time to time, but I'm not going to play games with free speech that way. Sure, I know allowing extremists on either side to post comments likely drives off more reasonable and measured voices and that does trouble me. I simply find it more troubling to censor individual comments. If people cause trouble, I'll just ban them. If people abuse me personally, I'll ban them and see if I can get them sent to bed without dinner.

As long as things stay within a zone of propriety, then I'm fine with whoever having whatever opinion. Even if I disagree.

Compared to a lot of other websites and forums out there, there's very little banning that goes on around here. There's no censorship. There is the occasional (as in pretty much never) comment deletion. Keep that in mind. Also, keep in mind that I take the First Amendment very seriously, for myself and others.

In the meantime, I am going to take things semi-slow this week as I have personal matters to attend to. And sometime in August, I am going to take an entire week off and hopefully get the hell out of town. I haven't had a real vacation since 2005 and I am burned out.

I'm Done...Maybe

I've really grown weary of the drama around this site over the last couple of months. Let's just say it's taking the fun out of doing a blog like this and, frankly, I have to do some serious thinking about whether it's worth continuing this site and continuing to be a journalist in general. It's clearly a dying profession and I'm nearing my 46th birthday and getting a lot of encouragement from various friends to move on with my life and do something else because the free market has spoken in loud and clear terms that it does not value people like me very highly at all.

And, I'm not at all convinced that blogging and doing independent websites is where the value in the information market is going to shift. If I were doing partisan politics or tech news or celebrity gossip, maybe, but the Net doesn't truly want to support niche subjects the way Web 2.0 propagandists would have you think. The ironic thing to me is that writing about mental health is clearly tech news, because I am most definitely narrating about the problems in our culture with a flawed technology. The trouble is that 90 percent of the people who participate in that technology act as if it's still working, even when they know damn well that it isn't. Besides, it really isn't technology in America anymore unless it involves computers and the widgets that make them go zing.

Wasn't there a bestseller out once called "The March Of Folly?" Or one called "And The Band Played On?"

Anyway, none of this bodes particularly well for the next 20 years or so of my life, which I would prefer be charming and enjoyable rather than the financial car crash I'm experiencing each month. It'd be nice to have health insurance once again as well.

I'm also growing sick of Seattle. Too many interesting people have left the city over the last two years, replaced by people who aren't as interesting to me in a city that becomes more expensive each day, thanks partly to a local government that clearly wants to tax the working class right out of a city that was built by the working class. Think I'm joking? The city council and regional transit authority here have stuck a bunch of measures on the fall ballot that would increase taxes and fees I pay by over $100 a year. And that's after they boosted taxes here locally by about $50 last year. And people are voting for these increases. Meanwhile, the city council is set to approve a measure that would tax me 20 cents for each bag, plastic or paper, that I take home from a grocery store. Bags from Nordstrom's and the Apple Store will be untaxed however. Many citizens are in favor of this stupidity. This tells me a lot about the class shift afoot in this city, one analogous to what's gone on in San Francisco and NYC over the last 15 years.

So I'm going to do a lot of thinking over the weekend. And I don't like the thinking I am having to do.

I wish you all more serenity than I'm experiencing.

Respect

So last evening I was sitting around getting ready to write posts for today when a small flame war broke out. It was again involving some readers who dislike psychiatrists intensely and the commenter known as Therapy First who is an actual psychiatrist. I won't get into what was said. I deleted a few comments, emailed a few readers and hopefully got everyone to chill out. I don't want to go through another series of crappy online fights like we had around here last month. It is exhausting to me personally and is a waste of my time. You all are over 18 years of age and it's time those of you who want to engage in name calling and cheap tricks started acting your age. It's also wildly disrespectful of the time and energy I put into this site. And sucked up enough of my time last evening that I didn't have the brain power left to write anything fresh for the early morning crowd.

I'd appreciate it if some of you would try to show me some respect and not play these little games. If you cannot show me some respect, then I am going to turn off all the comments on this site. I don't think anyone wants that.

It'd be really awesome if some readers could simply agree to disagree with each other and just not communicate with one another on comment threads here.

UPDATE: I'd just finished writing this note when I got an email from one of the doctor haters pretty much calling me a piece of shit who's devalued this site by allowing docs to comment and that I've basically been bought off by docs. If only.

Can I just say right now that some of you in the anti-psychiatry camp need to grow up and get some perspective that you are not the only people whose views and concerns are valid in this world? Yes, I know you have suffered at the hands of psychiatry more than anyone else on this planet and you are morally superior to everyone else. So what? Get over yourselves.

If there's anyone on this site who should want to carve up psychiatrists for what they've done to them, it is me. Eighteen years of meds I probably didn't need. A possible wrong diagnosis. Those are big things. In fact, I was going to write something for today about how I think the way psychiatry defines and talks about people with bipolar disorder encourages social discrimination, unemployment and public paranoia, but since I had to get wound up playing referee I kind of lost my writerly oomf. Thanks.

I'll limit my sharp words for psychiatry to the likes of Fuller Torrey and the researchers who want to dope up America's kids.

For now, I'm going to take a walk and chill out.

Pharma Companies Get Billion Dollar Windfall From Medicare Reform

Remember when Congress reformed Medicare two years ago and enacted a deeply compromised law with prescription coverage for older Americans? Well, you just had to know Big Pharma--which lobbied very hard for the bill--was going to make billions off the new law and they have. A Congressional study puts it at $3.7 billion in additional revenues, all of courtesy of us the taxpayers.

One of the big winners was J&J which saw an additional $500 million in Risperdal sales, most likely related to selling the antipsychotic for use in treating dementia. I'm sure no off-label marketing was involved!

Injectable Risperdal For Bipolar Disorder

Things have clearly reached a pretty weird pass when Janssen/J&J asks the FDA to approve Risperdal CONSTA for bipolar disorder. Has anyone ever heard of someone with that diagnosis being giving an injectable antipsychotic? I sure haven't and the idea makes me shake with rage.

Apparently, the company also asked the FDA to approve CONSTA in April for, get this, "requently relapsing bipolar disorder." A novel term if I've heard one.

How I Got Off-Meds

I wanted to clear up a few misconceptions that seem to have cropped up around my posting on being off-meds for bipolar disorder for one year.

First, it is not a path I am suggesting others follow. There's no way I could make that kind of suggestion from a distance for other people (I should note that if I did pro-meds advocates would likely call me irresponsible and a murderer, but one wonders what I should call them when they press people to take medication, especially when it's medication that isn't working, without knowing much about the person they are suggesting it for. We see this all the time, don't we? Paging Fuller Torrey, paging NAMI). If there's any implication in my own experience, it's that others should be open to this possibility for themselves or others, regardless of where they stand on the on-meds/off-meds divide. Doctors and other mental health providers should have an open mind as well.

Second, some people think this is a path I chose for myself. Not really. My doctor pressed it upon me, two times in separate appointments before I agreed to give it a go. Yes, psychiatrist haters, a psychiatrist did this. That said, my own case and my own choices about what I would and wouldn't take certainly backed my psychiatrist into a clinical corner. I didn't do this wittingly. It was the by-product of my frustrations with anti-depressants and antipsychotics, and in the end that's what guided my treatment.

When I began seeing a new psychiatrist in 2004, I was taking Depakote and Wellbutrin. I wasn't doing very well, but I wasn't doing very badly either. I was very clear with the new doc that Wellbutrin wasn't working for me at all and that I was tired of Depakote. Did I want to try another anti-depressant? he asked. I told him I didn't think that made much sense since I'd already been on six different ones, none of them had worked and several of them had fucked me up. Why would a new one be any different?

He took me off those meds and I went onto Lamictal and a low dose of Seroquel. He also gave me a small scrip of Ativan to take as needed, and I promised him I wouldn't let myself get addicted to benzos (the scrip was small enough to where that wouldn't happen). One thing I should mention is that after years of bouts of suicidal ideation--largely driven by anti-depressants in my opinion--I hadn't had a suicidal image in my head for about a year. I'd driven them out somehow. Or maybe being off anti-depressants ended them. Who cares which?

The next year, I lost my patience with Seroquel--the weight gain, the bad dreams, the agitation, the fifth of whiskey head in the morning, the TD and so on were too much to tolerate--and I took myself off it before visiting my doctor to discuss the situation. He felt I should be on a low dose of an atypical and I told him I'd give it a try and so I took Geodon for about three weeks until I was so agitated and hypomanic that I couldn't sleep (lost a lot of weight though). I took myself off that particular poison pill on my own also.

And so, in late August of 2005, there I was talking with my psychiatrist and he said, "What do we do now?" I was on Lamictal and taking Ativan perhaps twice a month.

"Nothing," I said. I was sick and tired of polypharmacy and my gut hunch was that I wanted to simplify things and see what happened. I already knew how more meds and more meds worked out. "Let's see how I do on Lamictal alone."

And when I did very well on Lamictal only over the next 18 months or so that's when my psychiatrist started pressing me to get off meds altogether. That's how I got off-meds.

I hope other patients can work out a similarly beneficial relationship with their docs.

And, I hope I cleared things up instead of muddying the waters further.

The Zyprexa Chronicles: Zyprexa Judge Slams FDA, Eli Lilly

Late last week, US District Court Judge Jack Weinstein shot off his mouth in an opinion he filed in the midst of a merry-goround of opinions being filed as various Zyprexa cases under his purview are shaped up to march toward trial or settlement. Recently, Weinstein pressed Eli Lilly to settle all outstanding Zyprexa claims and various estimates put that figure at over $7 billion. Lilly has already settled about $1.3 billion in claims over its handling of Zyprexa.

Anyway, the judge let the FDA have it right in the kisser over Zyprexa, which, as most of you know, has been linked to thousands of cases of diabetes, hyperglycemia, massive weight gain, deaths and other problems:

"Compared to its peer agencies in other parts of the world, the FDA has arguably failed consumers and physicians by over relying on pharmaceutical companies to provide supporting research for new drug applications; by allowing them, through lax enforcement, to conduct off-label marketing; by acquiescing to industry pressure on drug labels; by not requiring doctors-the main line of defense against misusing prescriptions-to be adequately informed; and by leaving information dispersal and control largely to industry-influenced medical journals and non-governmental associations. The result of such claimed governmental failures arguably causes overuse and overpricing of pharmaceuticals, resulting in mass litigations such as this one for Zyprexa."

Weinstein's opinion is well-supported by the facts and he had more to say about the FDA in his opinion, which you can read here (pdf file). As he notes elsewhere in the opinion, the drug regulators in other countries were not fooled by Lilly's various smokescreens, but the FDA was.

He also went after Lilly:

"Lilly’s alleged lack of transparency, failure to warn, and deceptive or illegal marketing practices are but some of the factors that a juror could find led to this litigation....Lilly exaggerated the utility of the drug, both on and off-label, and de-emphasized its dangers, in order to support an excessive price. Evidence of defendant’s alleged failure to disclose its products’ side effects, its violation of obligations of transparency, and its deliberate encouragement of off-label use, permits-but just barely-a jury finding of liability under RICO."

RICO is the federal Racketeer Influenced and Corrupt Organizations statute that was designed to prosecute various mafia families. That acronym coming out of the judge's pen should have Lilly running for its settlement checkbook.

I must say that after documenting the Zyprexa scandal for much of the last two years, it is nice to have the judge overseeing many of the cases basically agree with most of my assertions about how Lilly handled the drug and lied to millions of Americans. The RICO bit is just icing on the cake.

Via Pharmalot.

Viagra, Now For Depressed Women

A study out in JAMA went after the tricky problem of women going off anti-depressants due to sexual dysfunction side effects by giving a group of women Viagra while another group got placebo. According to the study, 72 percent of women saw improved sexual functioning while only 27 percent did who got a placebo. Of course, at about $10 a pill, taking Viagra would be a very expensive proposition. And, given studies of just how long-lasting sexual dysfunction is for so people taking anti-depressants and how long it can last once the drugs are discontinued, then it'll be Viagra for life for some patients.

Researchers summed up their findings thus:

"'By treating this bothersome treatment-associated adverse effect in patients who have been effectively treated for depression, but need to continue on their medication to avoid relapse or recurrence, patients can remain antidepressant-adherent, reduce the current high rates of premature medication discontinuation, and improve depression disease management outcomes,' wrote lead author George Nurnberg of the University of New Mexico School of Medicine."

Or perhaps they could ditch the anti-depressant altogether and try CBT or other therapies. Just a thought.

Many Thanks

Thanks to you all for the many comments and emails in the last 24 hours over my one year off-meds post. I appreciate all the kind thoughts more than I can get into.

I'd planned on having a bunch of posts up by now, but it was simply too lovely an evening to be inside, so I went out and had some fun. We only get about two and one-half months of truly nice weather in Seattle and you've got to grab them when you can.

I'll play catch up later this morning.

Losing My Religion

Yesterday was the first anniversary of the last day I took a psych med--Lamictal--after 18 years of being in the mental health system, taking meds with a 99 percent compliance rate after being diagnosed with bipolar disorder in 1989. Today is the first anniversary of my first meds-free day--one sanctioned by my own psychiatrist--since I was 26 years old, excepting 3 months back in 2003.

In the year since, I have had fellow bipolars tell me--in emails usually--that my chances for success were slim to none. One told me I'd wind up dead. I'm in too generous a mood to get into who said this and, besides, I am doing quite well and were I to get into who these Nostradamuses of the mental health world are, then I'd have to point out how poorly some of them are faring despite being "experts" in bipolar disorder.

I'm comfortable saying that if I were going to crash and burn and wind up back at square one, it likely would've happened by now. Things haven't been perfect--there was a bout of depression/seasonal affective disorder a few months back, and my metabolism went haywire after I got off Lamictal and I put on 20 pounds--but I did come through an extremely cold, gray winter (one of the worst ever in Seattle), have been under loads of professional and life stresses and so on. And, yet, things are pretty good.

This isn't supposed to be happening, not by the standards of medicine and psychiatry. Bipolar disorder is a lifetime diagnosis and you take medications pretty much forever. If you don't follow through, you are dangerous, a person best kept at arm's length by one and all.

I know I am lucky, but luck only accounts for so much. The rest is all questions: Did I ever have bipolar disorder? Was my initial diagnosis wrong? Am I a false positive? Did I cure myself? Am I simply a bipolar who does well without meds? Am I in a lengthy remission that will crumple on me someday? Is the diagnosis of bipolar disorder bullshit to begin with? Does the disorder ebb with time? Or am I just a medical freak show, the lone exception that proves the rule?

There are likely other questions worth asking as well. They are worth asking because I suspect that what's going on with me isn't restricted to me alone. There's recent research indicating that 50 percent of diagnoses of bipolar disorder are wrong and I've had psychiatrists tell me they've been saying the same thing for a decade. Let's assume the 50 percent figure is on the high side and use 25 percent. With anywhere from 6 million to 12 million American adults diagnosed with some flavor of bipolar disorder (the low number is from NIMH, the higher number is from pharma ads), then we are talking anywhere from 1.5 million to 3 million bipolar diagnoses that are in doubt.

I suppose I could be deeply bitter about my own experience--18 years of meds I may not have needed is enough for a sea of bitterness, as is all the lovely social discrimination around being tagged with the disorder--and declare psychiatrists body snatchers and psychiatry a thought crime. That's not going to happen. I'm not into the whole anti-psychiatry, identity politics thing.

I've seen enough true positives in my life to where some things about psychiatry make sense, but perhaps for shorter periods of time than doctors think. I've also seen enough people being pounded by treatments that aren't working for them--or are flat out injuring them--that you have to wonder how humane some doctors are. I've also seen a fair number of false positives.

I've had almost 19 years of seeing my life and experiences through the lens of a disorder. And, now what? How do I reconcile and correlate who I was when I was 25 and 26 with who I am now? I don't know because I cannot even remember who that guy was, but it is like losing my religion in a way. Replacing it with I don't know what.

This all raises several issues for the practice of psychiatry. I'll get to those in a later post.

For now, it's almost a birthday and I deserve a drink.

From The New York Times: Voices Of Patients With Bipolar Disorder

The New York Times has an interesting feature up on its website wherein about 10 people diagnosed with bipolar disorder detail their experiences. It's not really possible for me to sort all of this out since the audio interviews are short and I really don't know the life stories and such of the people involved, except for one. That would be Randy Revelle, who was diagnosed with bipolar disorder in 1977 while he was a Seattle City Council member. He was later elected King County Executive. He didn't go public with his condition until he was running for that position and somehow won election. Randy, who is a friend, is a true pioneer, and one of the few bipolars I've ever encountered who's done well on Lithium alone for all those years.

One other person among this group is a reader of this site. That's Steven Morgan, who's been off-meds for three years and is doing well. On his clip, he describes himself as the impossible patient. I know exactly what he means.

The one thing that makes me pause is that a few of the patients on here are late-diagnosed bipolars, a trend that's all the rage like the bipolar child business, and for reasons I don't completely understand myself, I am suspicious of this late DX business. But that's just me. I've become skeptical about everything. But, then, I've earned the right.

Ironically, this bit on the nytimes.com site pops up two days before my one-year anniversary of being off-meds. Ironically, I am planning something of a major post on Monday about my own thoughts on where being off-meds for a year puts me. Like Morgan, I feel impossible somehow and I mean that in as sane and sober a manner as possible.

See you Monday.

Baseball's Other Drug Problem: ADHD Drugs

I've noted before that some sportswriters have dug into the numbers surrounding banned drug use in baseball--human growth hormone, steroids, ADHD drugs, etc.--and come away finding that about 100 Major Leaguers got exemptions from the ban on ADHD drugs in 2007 and are allowed to use the drugs as long as a doctor reups their authorization as having been diagnosed with ADHD each year. But that number of players is a huge increase over 2006, leading some who follow baseball to think that ADHD meds could be the new performance-enhancing drug scandal in baseball.

This recent article in the Pioneer Press does an admirable job of getting ballplayers on the record on the issue.

"Twins infielder Brendan Harris, who has been with five big-league organizations, said he had heard of players without ADHD taking medications prescribed for the disorder.

"'There's a dependency that guys get when they use it, I'm sure, like anything that's a drug of addiction,' Harris said. 'They wouldn't take it if it didn't help in some way. The season's so long, it's such a grind, concentration — day game after a night game, whatever — is a problem. Maybe it helps and then ... when they don't need it, they take it again, and it's a dependency issue.'"

One hundred and sixty-two games plus spring training and whatever off-season training a player does is a hell of grind, the toughest in terms of day-to-day focus of any big league sport. I played the game long enough myself to where I can see how stimulants such as Adderall might be a boost for some players. Of course, all of this makes me admire old time players all the more: Babe Ruth and Mickey Mantle both played drunk or had raging hangovers much of their careers, Red Sox great Bill "The Spaceman" Lee used to pitch stoned and then there's the infamous (and much disputed) account of Doc Ellis pitching a no-hitter while on acid.

Anyway, with the big jump in ADHD exemptions, you do have to wonder how legit all these ADHD diagnoses are.

"'It certainly raises the questions (of abuse),' [Gary Wadler of the World Anti-Doping Agency] said. 'You don't want somebody with a handicap being prohibited from playing elite sports, (but) you don't want somebody developing a pseudo-disorder as a way of taking a prohibited substance.'"

It'll be interesting to see where this all ends up in a year or so. And, it's also further proof of how deeply enmeshed psych meds have become in American culture.

Busy

Nothing new for today. I'm facing looming deadlines for some outside projects the next couple of days, so I'll mostly be offline and off email as well.

Be well.

ADHD, Autistic Kids Being Restrained, Killed By Teachers

There is appalling story in today's New York Times by Ben Carey. Having worked with "special needs" kids in public schools in the 90s, it was difficult for me to read and is difficult to recount to you all now. Suffice to say, there are multiple cases around the country of kids with autism, Asperger's and ADHD being physically restrained by teachers--held to the ground no less--and winding up suffocated and dead, or surviving and needing years of therapy to deal with the trauma. Read the article.

Carey tries to sort out what should be done and what this all means for the mainstreaming of kids diagnosed with mental illnesses. He doesn't really come up with any answers because there really aren't any.

What I can tell you is that in the three years I spent around these kids I never once saw a teacher or aide restrain a kid in such a fashion, even though we dealt with some gigantic outbursts. Maybe some of these schools need to change their methods.

Senate Going After Controversial Brown Univ. Psychiatrist

Pharmalot is reporting that Sen. Charles Grassley (R-Iowa), who's been going whole hog on connections between Big Pharma and researchers and their conflicts, is now looking into Brown University's Martin Keller. Among other things, Keller is infamous for Paxil Study 329 which found no benefit to using the anti-depressant in children yet was cooked by Keller and others into a research paper that claimed Paxil was good for kids.

More later.

Drew Carey And Reason TV Ask Why We Are Banning Everything

Regular readers know that I both hate the emerging Nanny State in the US and have written about Seattle's version elsewhere. As it happens, the Aug./Sept. issue of Reason is devoted to a roll call of America's nanny cities, or local municipalities that like to clamp down on the activities of free citizens in the name of public health (smoking and food bans) or morals (sex, gambling, guns). Seattle came in as 34 of 35 on the mag's list of nanny cities, meaning it is the second most-restrictive major city in America, placing behind only Chicago, and there's a piece in the mag in which I describe how gnarly it's gotten in Seattle--we have the country's most draconian smoking ban (one citizens feel compelled to enforce on their own), the food police are out in full force, gambling is banned, online poker is banned and yet pot is virtually legal and you can have all the anonymous bath house sex you want. Did I mention that if you swear at Mariners games, an usher will ask you to stop and if you don't will escort you out of the stadium (try that at any other MLB park)? Weird city.

Oh yes, the top 5 freest American cities are: Las Vegas, Miami, Denver, Louisville, Ky., and Kansas City.

My piece isn't online yet, but the print edition is on the streets, so check it out if you are so inclined.

Some of you may wonder what any of this has to do with mental health. Quite a bit actually. You see, hating smokers is quite trendy in Rain City these days (the fact that I smoke means that about 70 percent of the single women in this city would never consider dating me) and I know of cases where folks diagnosed with schizophrenia have been booted out of their housing because they smoke. Doesn't sound too fair to me, especially since these guys are all military veterans.

More to the point, this Nanny State business is typically done in the name of public health. Given that public health wonks across the country have successfully zeroed in on smoking and food with various bans and "educational" campaigns, how long do you think it'll be before they go whole-hog on depression, anxiety and ADHD? Those of you who follow this site know that various public health types are forever putting cost figures on productivity allegedly lost to depression and ADHD, much as they've attached cost figures to smoking and body weight, and it's a real slippery slope to mandated depression treatment or ADHD treatment if the government and all-knowing advocacy groups hook up with the public health wonks on these issues. It'll be for your own good, of course. Just like banning foie gras.

And, it's not just the dollars and cents talk that convinces me we could see a drift towards a "ban" on depression. A recent study linked a father's depression (post-partum depression for men) with their children's language acquisition skills. Apparently kids with depressed dads know fewer words by age two than other toddlers. One of the prime arguments of nanny statists and public health officials is that they are taking such-and-such a measure to protect children. Why wouldn't they apply that thinking to depression and mandate screening and treatment for new dads?

Even Eli Lilly has gotten into the game. Two years ago, I noted that its "Depression Hurts" ad for Cymbalta said that having depression meant you were hurting your own families.

We'll see how this sort of thing plays out. Who knows? Maybe I'm wrong.

Anyhow, what really PO's me about these Nanny State bans is that they are an attack on individual liberties and since I have family members who have been killed and wounded defending the liberties of all Americans, I take this crap very seriously.

So does Drew Carey in this piece for the mag's Reason TV. You'll be amazed at what's been banned in this country. Even outdoor grilling.

Owner Says No To Vet Pushing Prozac For Kitty "Depression"

Susan left this comment yesterday in response to all the news around the Prozac for puppies movement. It sounds like some vets are going to get as pushy with the anti-depressants for animals as some doctors have been with humans.

"Earlier this year my vet, who has been my vet for the last 15 years, saw my cat for her yearly physical. I was depressed at the time, and she said my depression was making the cat depressed and wanted to put her on kitty Prozac. I had a miserable time on Prozac, and frankly, the only thing I would ever want my cat to take is catnip.

"I've given kitty lots of love, tlc and Pounces, and she is fine. No Prozac needed, and one happy and loved pussy cat."

This makes me wonder if there is now a feline DSM and a feline Hamilton Depression Scale.

BTW, I wodner if all the proponents of medicating animals with psych meds have thought through withdrawal issues. I bet they haven't.

Sedatives Being Used By Cops To Make Arrests

Thanks to Mark for making me aware of this: cops in Nashville, Tenn. have ditched using Tasers on combative subjects and are instead, in some cases, calling in paramedics to administer a bolus of Versed, a powerful sedative. In one case a Nashville TV station uncovered, it had been given to a man who was threatening to jump from a bridge. It's apparently being given to people experiencing "excited delirium."

I can see all sorts of arguments for and against this procedure--and I agree with all of them. I suppose as long as the drug isn't used to abuse people (ie, on misdemeanor suspects, as Tasers have been) and the medical emergency is genuine and the only other way to gain control of someone is via Taser, ass-whupping or gunshot, then my civil liberties concerns go right out the window. But you could see where a drug like this could misused very easily. And, inevitably, someone is going to have a tragically bad reaction to the drug, but people also have bad reactions to being Tased, shot and beaten.

All the same, there is something that's creepy about this too. It is the State after all that is giving folks these injections and that just weirds me out.

Take The Pets On Prozac Poll

First, for those who didn't check in over the weekend, I had a piece up on Saturday on the widening Senate investigation of the relationship between psychiatry and pharma companies. This time out it's the American Psychiatric Association itself getting a look-see. Make sure you read it because this is important.

Second, the New York Times Sunday Magazine had a lengthy, fascinating piece yesterday on the accelerating trend of giving pets various meds--especially psychiatric ones--to deal with various animal behavior issues. Instead of my usual tut-tutting of the process and wonderment at how weirdly intertwined psych meds continue to be with daily life, I thought I'd put up a poll.

The Twitter Experiment

So most of you know that Twitter is a semi-new messaging cum social networking thingamajig that lots of people have now. I'm inherently suspicious of all these new ways to push information around--how many people need to know what my mood is and whether or not I am getting coffee? Damn few, I'd assume--because I'm just not convinced that all the IMs and MySpace/Facebooks of the world have done much to really create community and human closeness in the way that all the Web 2.0 proponents claim. It's just organized us all in communication pools at great distances and given advertisers a new way to shove products at us. Yeah, I'm jaded.

Anyway, I have heard from a few that Twitter (and, maybe, Tagged) have helped them cut down on their email volume and so, herewith, I now announce that I have Twitter. Feel free to add me or whatever the hell it is people do with the thing.

This is an experiment on my end. If it pans out over the next few weeks, cool. If not, I'll drop it as yet another useless Internet technology.

Senate Investigating Pharma Funding Of American Psychiatric Association

The New York Times is out today with an article on Sen. Charles Grassley's (R-Iowa) investigation of the deep ties between medicine and Big Pharma and in particular of the field of psychiatry. As the paper's Ben Carey and Gardiner Harris note, Grassley has found all kinds of low-hanging fruit in the psych world. But, first, this an article about the fact that the senator is now poking into the relationship between Big Pharma and the American Psychiatric Association, a relationship I've long criticized. If there's low-hanging fruit elsewhere in the mental health industry, here the senator will find a virtual killing floor of incestuous relationships and industry influence over the treatment and diagnosis of tens of millions of average, workaday Americans.

"In 2006, the latest year for which numbers are available, the drug industry accounted for about 30 percent of the association’s $62.5 million in financing. About half of that money went to drug advertisements in psychiatric journals and exhibits at the annual meeting, and the other half to sponsor fellowships, conferences and industry symposiums at the annual meeting.

"This weekend in Chicago, the psychiatry association’s board will meet behind closed doors, in part to discuss how to respond to the increasingly intense scrutiny and questions about conflicts of interest."

That works out to about a cool $20 million in pharma money funding the APA. The $10 million or so in journal ads is on one level a big whatever--as long as the ads present scientifically valid claims, then ads are fine--and on another level, it's indicative of how out of touch many psychiatrists are. I don't want to guess at how much surplus revenue the APA journals (there are four of them) generate for the mothership, but it's remarkable to me that in 2008 the APA hasn't gone completely online with their journals and, thereby, reduced its need for pharma ads and saved a few trees in the process (the journals are online now, of course, and have a remarkable archive). The trouble is that many, many doctors still haven't fully transitioned to getting their medical research on the Net and are dependent on the printed copies of the journals, which they then don't read until many months later. I'm not joking. Many, many docs are lazy like that and it's to the detriment of their patients and their practice.

As for the other $10 million, it's blood money as far as I am concerned and I'm truly pleased to see Grassley pressing to connect the dots. Earlier this year, I noted that Eli Lilly had given the APA over $600,000 in the first quarter of 2008 (Lilly also gave generously to Harvard and NAMI). I wonder what other companies gave.

The APA needs to do a big round of soul searching on how it's funded and how it does business. Fortunately, one former president of the group gets that, while the incoming president of the group seems more comfy with the present relationship.

"'With every new revelation, our credibility with patients has been damaged, and we have to protect that first and foremost,' said Dr. Steven S. Sharfstein, a former president of the association and now president of the Sheppard Pratt Health System in Baltimore. 'I think we need to review all arrangements between doctors and industry and be very clear about what constitutes a conflict of interest and what does not.'

"One of the doctors named by Mr. Grassley is the association’s president-elect, Dr. Alan F. Schatzberg of Stanford, whose $4.8 million stock holdings in a drug development company raised the senator’s concern. In a telephone interview, Dr. Schatzberg said he had fully complied with Stanford’s rigorous disclosure policies and federal guidelines that pertained to his research.

"Blocking or constraining researchers from trying to bring medications to market 'will mean less opportunities to help patients with severe illnesses,' Dr. Schatzberg said, adding, 'Drugs that are helpful may not be developed by big pharmaceutical companies, for a variety of reasons, and we need some degree of communication between academia and industry' to expand options for patients."

A couple of years ago, when he was the group's president, Sharfstein delivered a stinging attack on the bio-bio model of psychiatry and how the industry has come to influence the practice of medicine. I was quite hopeful when I read his words that Sharfstein's thoughts, coming from the president of the association, would lead to a certain amount of introspection and, perhaps, reform in the APA (his thoughts also led to this attack from some Pfizer employees). But, no. Since then, we've gotten as APA presidents Nana Stotland, a delusional defender of anti-depressants and the status quo, and now Schatzberg. Schatzberg's words speak for themselves.

So do Stotland's. She told the Times:

"In an interview on Wednesday, Dr. Nada L. Stotland, president of the psychiatric association, said the group had studied Mr. Grassley’s letter and Stanford’s response and agreed with Stanford. Dr. Schatzberg will take over as president of the association as planned, she said.

"'The larger issue here is that there’s a revolution going on' in how medicine handles industry money, said Dr. Stotland, a psychiatrist at Rush Medical College in Chicago. 'That’s good, that’s what we need, and I believe we’ve been on the cutting edge of that revolution in many ways.'

"Dr. Stotland said that the association began reviewing the income it received from pharmaceutical companies last March, to identify potential conflicts."

Oh, please. The APA seems just fine with having conflicts, so there's no revolution going on there at all. After all, the majority of its members who are working on the forthcoming DSM-V have pharma ties. I think it's time for Grassley to start asking questions about the DSM authors and how their definitions of what's up with the American mood may or may not have been influenced by the pharma gods. It would be one of the grandest public services in a long time.

Globally, the Times piece is excellent and does a fine job of connecting the dots around all sorts of pharma influence in the psych world. So read it.

I first briefly noted Sharfstein's call for change in 2005. I've linked to his speech before. Here it is again. I've noted the conflicts of DSM authors previously as well.

Mostly Off Today

Things are mostly quiet on the news front and it is promising to be a very sunny and warm Friday in Seattle, so I'm mostly going to be away from the site and my computer today. Comment approval will be sporadic so please be patient. And have a nice weekend.

Politics In The Suicide Black Box Decision For Bipolar, Epilepsy Meds

As some of you know, yesterday the FDA's psychopharmacology advisory committee declined to approve the FDA's recommendation that a black box warning be added to 11 anti-seizure drugs used to treat bipolar disorder and epilepsy. I've not seen a lot of press on the decision yet, so the committee's reasoning is not clear to me, but you can glean a bit from this early piece by the Dow Jones News Service:

"Panel members raised concerns about the unintended consequences of adding a black-box warnings to epilepsy [drugs], saying such a move would make doctors wary of prescribing the drugs.

"Panel member Sean Hennessy, a doctor, said he thinks there should be an additional warning on epilepsy drug labels, but added the FDA's analysis shows suicidal risks are 'modest.'

"'To me (the data) says there ought to be a warning, but given what we know about the effects on prescribing, I don't know if they rise to the level of a black box,' Hennessy said.

"GlaxoSmithKline Plc's (GSK) Jack Modell, vice president of clinical development, said his company believes additional warnings should be included on the label. An FDA analysis showed that Glaxo's epilepsy drug Lamictal had a higher increased risk of suicidal behavior and suicidal thoughts than other drugs."

Basically what went down is the committee ended up voting to approve warning language for suicide risks--I've not seen the language--but felt that a black box was going too far and that adding a black box would dilute the meaning of other black boxes because the level of risk of suicide wasn't high enough. I'm curious if Hennessy and his colleagues have in mind a number of suicides that would justify a black box because they clearly don't get that one suicide is one suicide too many.

What's more, I'm confused as to what effect on prescribing Hennessy means because I don't see any data to support the notion that anti-depressant use or atypical antipsychotic use has decreased as a result of the black boxes added to those drugs in 2004. In fact, prescriptions for both classes of drugs are now higher than in 2004. So what the hell were they thinking? And wouldn't warning language say the same thing as a black box warning sans the bordered box? I find these kind of political semantics discouraging.

Suicide is suicide and if it can be connected to the use of a drug, then the public and doctors should be warned and the appropriate method is via a black box. Anyway, it'll be interesting to see how the lone consumer representative on the panel voted.

One side note: it's interesting to me that most of the press coverage in advance of the committee hearing acted as if the anti-seizure drugs "epilepsy drugs." I hate to nitpick my colleagues in the press, but at least 50 percent, if not more, of the sales of these drugs are for their use in treating bipolar disorder.

Breaking: FDA Committee Rejects Suicide Warning For Bipolar, Epilepsy Meds

In an unusual move, the FDA's psychopharmacological advisory committee denied the FDA's request to have a black box warning added to labels of various anti-seizure drugs that are used to treat millions of Americans with bipolar disorder or epilepsy. I'm not sure what the committee's rationale was and how their finding serves the patients and doctors they are supposed to represent.

More on this later.

First Lawsuit Filed Over Chantix Suicides

From the journalism machine that is Pharmalot we learn of the first lawsuit filed against Pfizer over allegations that Chantix, its stop smoking drug that's acting a whole lot like Paxil in some cases, caused the suicide of a man:

"On January 3, David Collins killed himself with a shotgun, three months after he began taking Chantix, Pfizer’s controversial smoking-cessation pill. Now, his widow, Linda, has filed what may be the first product-liability lawsuit against the drugmaker over Chantix side effects and an alleged failure to provide sufficient warnings. And her lawyer predicts many more such lawsuits are on the way.

"In her lawsuit, which was filed in federal court in Indianapolis, Collins claims Pfizer failed to adequately study Chantix; delayed publication of studies containing Chantix risk info; failed to update Chantix labeling sooner, and denied Chantix is explicity to blame for suicide by instead suggesting such behavior may be the result of nicotine withdrawal....

"'The magnitude of the safety signal associated with the risk is alarming,' Kristian Rasmussen, one of Collins’ lawyers, tells us. Prior to the suicide, David Collins exhibited aggression and had strange dreams, but had no history of mental illness. Pfizer has been criticized for not including people with mental illness in its clinical trials, because the drug causes neuropsychiatric side effects."

There's more over at Pharmalot. I've been all over Chantix going back to last summer. I'm sure there are more lawsuits to come because quite a few people have gotten dinged up by this drug, which almost makes smoking look healthy by comparison.

Women Use Seroquel To Murder Man In Threesome Gone Bad

This is one of those weird, sad stories I pass along in order to track just how strangely psych meds have become embedded in our culture. In Florida, two women have pleaded guilty to murder and gotten 30 year sentences.

"Selby died of asphyxiation inside the home he shared with the women on Clear Lake Drive in Moon Lake. Samion told investigators she laced Selby's beer with eight 200-milligram pills of Seroquel, a psychotropic drug used to treat schizophrenia and bipolar disorder. Abbott has been diagnosed with both those conditions.

"After Selby lost consciousness, the women smothered him with a pillow and strangled him with a swimsuit string. They then hit him on the head with a pot, burned his chest with a cigarette and tied garbage bags over his head."

Police dubbed this a "ménage a trois gone bad." No kidding.

New Details Emerge On Northern Illinois Shooter

Esquire has apparently poked around the life, death and massacre shooting of Steven Kazmierczak, who killed five students, wounded 15 and then killed himself this past Feb. 14, and come out with a story that is being much summarized on the Net. It's not on the mag's website as of yet.

What I can glean is that Kazmierczak was even more troubled than thought earlier.

"Three of his [four] suicide attempts came while he was a student at Elk Grove Village High School. He once told a school nurse after an overdose attempt that 'I want to die. Life sucks,' according to Esquire. Kazmierczak, who was treated for bipolar and obsessive-compulsive disorders, had suffered psychotic episodes, reporting hearing voices and hallucinations, the article says.

"Before opening fire inside NIU's Cole Hall, the former graduate student at the school listened to Marilyn Manson's "The Last Day on Earth" in his white Honda Civic, according to the article. Then he stood emotionless on stage, opening fire while dressed in a black T-shirt with an image of a red AK-47 assault rifle and the word "Terrorist"—a shirt Kazmierczak had joked with friends about wearing to an airport, Esquire reports."

Hearing voices and having hallucinations is pretty extreme for bipolar disorder, unless they are very infrequent, and this makes me wonder what his true diagnosis was. I'm not dismissing the bipolar dx here, just saying it strikes me as suspect. And so do the meds he was on before the shooting.

"Kazmierczak, a graduate student at the University of Illinois at the time of the shootings, had seen a psychiatrist on campus and been prescribed Prozac and the anti-anxiety drug Xanax. Police have said he stopped taking psychiatric medications before the shootings, and an autopsy found only trace amounts of Xanax in his system."

If he was truly bipolar, then someone wasn't offering him anything close to appropriate treatment. An anti-depressant (Prozac in this case) just stirs up bipolars and there's no indication that he was on a mood stabilizer of any kind or that he'd been prescribed one in the past. That said, if bipolar disorder is an accurate description of his situation, then I am now more suspicious than I have been previously about a possible connection to medication withdrawal and his deeply bizarre behavior. There have already been indications before that he was on-meds, off-meds kind of guy for years and, regardless of where you stand on matters of meds, that's a very dangerous game to play. It simply cannot be good for one's brain and emotional balance over time.

If there's one thing I've learned from knocking around the bipolar universe for 19 years, it's that you have to pick whether you are on-meds or off-meds and you have to be self-aware and very responsible. It's also kind of handy if people do an appropriate job of withdrawing themselves from meds too.

Previous NIU coverage is here.

SSRIs, Lack Of Oxygen In Utero Linked To Autism?

I'm definitely putting that out there with a big question mark, but a neurologist who's blog I like is openly speculating on that front. He's Michael Merzenich, professor emeritus at University of California at San Francisco and Chief Scientific Officer at Posit Science. He's previously tackled the doping up of kiddos caught in the bipolar child paradigm.

And here he is on autism. He only briefly hints that he's going to have much more to say about SSRIs and autism down the road:

"The discussion of SSRIs is complicated, and because we (led by a collaborating scientist from the University of Mississippi, Dr. Rick Lin) are preparing a research report on this subject, I am going to hold it back when I can discuss it in more detail in a later blog. One important consideration: These drugs are used to help mothers in very important ways that contribute POSITIVELY to stable pregnancies and to successful infant nursing and rearing. Any potentially negative impacts that they may have on their infants must be weighed against these important counter-balancing positive factors.

"Which brings us to perinatal anoxia. We have published compelling evidence that peri-natal anoxia meets all of the other criteria for adding to “noisy” brain processing. It can have strong, selective impacts on cortical inhibitory processes, and degrades the ability of the cortex to develop normally-selective characteristics of response (see Strata, Merzenich et al, PNAS, 2005). At the same time, we had dismissed perinatal anoxia as a likely factor contributing to autism’s apparent rise because we could not see how ITS incidence could be growing over the past several decades.

"However, it has recently been argued that the especially high susceptibility of the highly metabolically active auditory brainstem to brief periods of anoxia that we and others have documented comes into play in the few to many tens of seconds of oxygen starvation that can stem from very rapid umbilical cord clamping— practices for which have changed (more rapid clamping has been adopted) over the past several decades."

I don't know how much credence to place on his thoughts and I sure don't know enough about labor and delivery practices to get into cord clamping, but these are certainly both interesting and perhaps plausible explanations for what's been going on with all these kids. And worth putting out there so you all know more.

Thanks to the reader who brought this to my attention.

Pharma Exec Resigns From English National School Board

This just in via Seroxat Sufferers: Paul Blackburn, a vice president with GlaxoSmithKline in the UK, quietly resigned from the board of Ofsted--an oversight board for English schools--over the weekend. The move apparently came in response to the heated press his appointment received and an unstinting email campaign by various victims of Paxil (Seroxat) in the UK.

Amazingly enough, there seems to be a pharma exec with a sense of shame. Who knew?

Posts Late Today

The last couple of days have been long and I was burned out last evening, so I'll catch up with posts later this morning. One thing I am trying to force myself to do this summer is to not push myself too hard. We'll see how long that lasts.

Drinking Due To PTSD Apparently Way Up Among Iraq War Vets

An interesting piece in today's New York Times that details drinking problems among returned troops and the utter lack of substance abuse and mental health services available to help out vets with PTSD. It's worth a read and it's kind of clear that there's a problem out there.

I've made the point before on this site that we are going to be paying the price for the Iraq War for a long time in terms of returned troops with PTSD (a term I know some readers don't like and which I use merely for convenience). It's beginning to sound like the Iraq War will make what went down with Vietnam vets look like a warm up. We need to heed the experiences of that era and the homelessness and psychological wreckage it caused and get things right this time. We've put these folks through a real meat grinder and we need to help them get whole again.

The trouble is I don't think anyone knows how you do that in an effective, predictable fashion and we've certainly already seen cases of troops dying as a result of PTSD treatments (generally a mix of anti-depressants and antipsychotics) and, as Time reported last month, we are sure medicating the hell out of our troops. And those approaches sure don't seem to be working very well.

FDA Wants Suicide Warning On Bipolar, Epilepsy Meds

As I noted in February, the FDA issued an advisory to doctors on data showing an increase in suicidality in patients taking anti-seizure drugs such as Depakote and Lamictal, drugs commonly used in treating bipolar disorder and epilepsy. Now the agency is asking its psychopharmacological drugs committee--staffed mostly by docs--to approve a full black box warning for these drugs when it meets on July 10. I assume the committee will follow through. Here's the FDA's public filing on the matter.

From the perspective of someone who took these drugs for 10 years, I can certainly attest to the fact that they caused me a high amount of agitation, which is thankfully gone now.

Anti-Depressants Linked To Internal Bleeding

Or, in this case, gastro-intestinal bleeding, according to a study in the current Archives of General Psychiatry. From the study itself:

"Antidepressants with a relevant blockade action on the serotonin reuptake mechanism increase the risk of upper gastrointestinal tract bleeding. The increased risk may be of particular relevance when these drugs are associated with nonsteroidal anti-inflammatory drugs."

The study seems pretty straightforward in its findings, but psych researchers seem torn by the implications, according to the wire service Health Day News:

"'Certainly, doctors should be advising patients of this finding, but it's far from definitive,' said Dr. Ewald Horwath, professor of psychiatry, epidemiology and public health at the University of Miami Miller School of Medicine. 'The risk of discontinuing antidepressants and getting depression and its consequences are much greater than this drug.'

"But, other experts said that the public health impact of the new finding, if confirmed, could be significant.

"'SSRIs are the most commonly prescribed psychotropic drug in the U.S.,' said Dr. Norman Sussman, a psychopharmacologist at New York University Langone Medical Center and associate dean of the post-graduate program at New York University School of Medicine. 'This could be a major pharmaceutical issue.'"

Methinks Horwath hasn't the foggiest what his patients are putting up with and certainly doesn't sound too familiar with "rebound depression," as it's known. But how big of any issues G-I bleeding and anti-depressant use is in the real world remains to be seen.

From where I sit, it's one more reason--among many--to be skeptical of these drugs.

Review Of Side Effects, A Book On Paxil

Alison Bass was once the mental health reporter at the Boston Globe and in her new book, Side Effects, she rehashes several key stories she first covered in that paper. Those would be all the dirty business surrounding Martin Keller, a psychiatrist at Brown University, and Paxil Study 329 (which I've written about many times), as well as dirty business by GlaxoSmithKline, Paxil's maker, and the lawsuit by New York State against Glaxo over its attempts to hide various problems with the anti-depressant. The book also delves into the rise of anti-depressants in American culture and the role of Martin Teicher, a Harvard psychiatrist, in first raising the issue of suicidality connected with anti-depressant use.

For those who aren't intimate with the Paxil story or of how Big Pharma has ginned-up academic research to suit its ends (by not publishing unfavorable efficacy trials, for example), this page-turner will likely be eye-opening. There's loads of detail about how Glaxo and Keller created one of the most corrupt trials of an anti-depressant ever, one for the use of Paxil in children that even somehow got published in an academic journal. There's also loads of detail about Teicher (a hero in my book), Donna Howard (a Brown University employee turned whistleblower) and Rose Firestein, a staff attorney in the New York AG's office, who doggedly pressed the Glaxo suit.

But for those who already know a good deal about these issues, the book may prove disappointing. It has hardly any narrative dealing with people who actually took this drug and were maimed by it (but there's plenty of detail about Teicher's handmade desk and Firestein, who had vision problems, struggling with her disability), but it feels very strange to read a book about Paxil and not get into the worlds of people who took the drug. The one person who took the drug whom Bass profiles, Tonya Brooks, makes but a few brief appearances in the narrative.

Also, you could easily walk away from the book thinking that suicidality was the drug's only problem--which is to say that Bass ignores the horrible withdrawal problems associated with the drug, its tendency to cause akathisia and flip people into mania (the number of people diagnosed with bipolar disorder after having a bad reaction to the drug is astonishing), sexual dysfunction and the fact that the drug doesn't work at preventing depression very well expect in a minority of patients. What's more, Bass doesn't explore why it is our culture now leans so heavily on anti-depressants in spite of their shortcomings, how the medical profession has been in complete denial about the inefficacy of the drugs and what it is Americans--and of course others in the world--are so depressed about to begin with.

Side Effects is a good book. But, sadly, there is a great book on Paxil and anti-depressants and the depression industry sitting in its pages that simply did not get told. That doesn't make this a bad book by any means and there's certainly plenty of dirt on how Big Pharma and some psych researchers operate these days (as well as a classic bit about a NAMI-Rhode Island board member who is taking money from pharma companies for making speeches). It's simply not the epic tale I would've liked to read. But, then, I know a bit too much about Paxil and anti-depressants, so maybe I am a jaded reader.

But the book at Amazon.com.

Eli Lilly: From Pot To Prozac And Zyprexa

I've been doing some reading lately about the history of pharmacology in the US and ran into an interesting bit of history. Eli Lilly once made a tincture of cannabis--used for treating muscle spasms and aches and pains back before marijuana was declared illegal--and so did many other companies. For fun, here's a pictoral history of where Eli Lilly has gone in the last 100 years or so in treating depression, psychosis and the aches and pains of life. With the exception of the tincture, all of these products carry black box warnings and have been connected with suicides and other problems.

It's fascinating to me how the pharmaceutical industry has changed over the years.

Cholesterol Drugs Recommended For Kids

Cholesterol-lowering drugs aren't typically part of my brief around here, but there's a piece out in today's New York Times on a growing movement in medicine for kids to be given statins such as Lipitor and I'm sure interested in this drugs-for-kids push among doctors, seeing as it's worked out so well on the behavioral front. New guidelines are due out from the American Academy of Pediatrics later today, calling for much younger kids to have their cholesterol levels checked and for statins to be used to treat the kids, despite a lack of evidence for safety and efficacy in using these drugs in kids.

What's driving all of this is America's obesity "epidemic"--or alleged epidemic, depending on how you view these things--and when public health officials get on a jihad, then science often goes out the window.

"'We are in an epidemic,' said Dr. Jatinder Bhatia, a member of the academy’s nutrition committee who is a professor and chief of neonatology at the Medical College of Georgia in Augusta. 'The risk of giving statins at a lower age is less than the benefit you’re going to get out of it.'

"Dr. Bhatia said that although there was not 'a whole lot' of data on pediatric use of cholesterol-lowering drugs, recent research showed that the drugs were generally safe for children.

"Surprisingly, the paper published in the medical journal Pediatrics that explains the new guidelines notes that among adolescents, average total cholesterol levels as well as LDL and HDL cholesterol have remained stable, while triglyceride levels have dropped, based on data collected from 1988 to 2000."

Statins have only been around since the 1980s, so there's no evidence that meds given to youths prevent heart disease in later years. So what are these docs basing their claims upon? I've got no idea.

But I know Big Pharma has got to like this idea.

Report: Anti-Depressants Don't Work In 40 Percent Of People Due To Four Genes

File this under "well now they tell us": Mayo Clinic psychiatrists announced last week at a conference in Britain that 40 percent of people who take an anti-depressant cannot respond to the medication owing to a genetic "abnormality."

"They [Mayo docs] have identified four genes that interfere with the efficacy of antidepressant medication, including two that prevent metabolising the drug (CYP2D6 and CYP2C19) and two more that prevent the brain from absorbing or transporting serotonin.

"Professor David Mrazek, chair of the Department of Psychiatry at the Mayo Clinic College of Medicine, said: 'One in 10 of our patients have abnormal CYP2D6, the gene most commonly implicated in treatment-resistant depression. This means that they are poor at metabolising some common anti-depressant medication including Prozac and Seroxat [Paxil's UK name]. As a result, they may get adverse effects including nausea, headache, vomiting and sexual problems, from a regular or even low dose of the drug.'"

Oh, so this is why Prozac, Paxil, Zoloft, Wellbutrin, Lexapro and Luvox screwed me up. Kinda nice to know this 18 years after I took my first anti-depressant. Who do I see for a refund?

Smartassery aside, if the Mayo docs are correct that 40 percent of patients cannot respond to anti-depressants, then that's a real kick in the pants to pharma's sales and perhaps merits some kind of FDA advisory, because the implications of their findings are that on the order of 40 percent of people taking anti-depressants probably shouldn't be. What's more, it also brings to the fore the need for people to have appropriate genetic testing before being put on an anti-depressant or to be tested if they are having poor responses to these drugs. The trouble is that a test for just one gene can run about $300, so it's not clear who'd pay to have all four genes tested--the patient? An insurance company? Drug makers themselves?

It'll be interesting to see if further research replicates these findings and how the mental health industry sorts out making appropriate gene tests available to patients.

Pharma Exec, Cervical Vaccine Maker Appointed To English National School Board

And since the exec is from GlaxoSmithKline, people in the UK are pissed at the weird conflict of a national body called Ofsted--somewhat akin to a state school board in the US--appointing someone whose company has a vested interest in its products being used by school kids to a school oversight board.

"Paul Blackburn, 53, is a senior vice-president at GlaxoSmithKline, which is being sued by hundreds of parents and patients who claim its drugs have caused suicide and psychosis.

"His appointment came two weeks before the company won a reported £100million contract to vaccinate all schoolgirls of 12 and 13 against the sexually transmitted virus linked to cervical cancer. Family campaigners argued that the jabs would ‘normalise’ childhood sex."

Not only is there concern in the UK about the vaccine--Gardasil, the supposed cervical cancer vaccine that's been very controversial in the US--but also about Paxil (Seroxat in the UK) and Dexedrine (the company's ADHD drug) somehow finding their ways into schools' standards. Keep in mind that not long ago there was a huge blow up in Texas over requirements that young girls be forced to take Gardasil, which is made by Merck, so it's not like school boards or the government are much brighter on this side of the pond.

Glaxo is being sued by many Brits over suicidality and withdrawal problems with Paxil, ones the company has long hid.

Via Seroxat Sufferers.

The New York Times Attempts To Understand Suicide

There's a long piece in this week's New York Times Sunday Magazine pondering why people commit suicide and, in particular, how society can limit impulsive suicides. It's an OK article, but I'm pondering why the mag even ran the piece since it really doesn't add to our understanding of the phenomenon--and it weirdly echoes a few articles of mine is recent years--and it sure doesn't seem to be driven by any particular news. But then it's the Times and, as the saying goes in journalism, it's not news until it's in the Times.

I do admire the author for pointing out that given how many suicides are impulsive acts--jumps, gunshots--you have to wonder how much the argument that suicide is driven almost exclusively by mental illness is as true as the 90 percent some in the mental health industry claim. I also admire his pointing out that the suicide rate now is roughly where it was in 1965 despite 20 years of sticking Americans on anti-depressants and the like, and that once some would-be jumpers are stopped, they never again try to kill themselves.

Where you take any of that is a bit beyond me, as it was for the author. It'll be interesting to see what kind of letters the paper gets in response.

Citing "Excessive Claims," Federal Judge Presses Lilly To Settle All Zyprexa Cases

Of course this comes out right ahead of the holiday: US District Court Judge Jack Weinstein, who's been overseeing various class action lawsuits against Lilly over Zyprexa, today urged Lilly to settle all outstanding cases against it...worldwide. The company has already settled about $1.3 billion worth of cases.

"In a draft order filed today in federal court in Brooklyn, N.Y., Weinstein said he found 'reliable information' that Lilly made excessive claims about Zyprexa's usefulness, and recommended off-label uses for such conditions as panic and anxiety disorder, agitation and dementia, Bloomberg said. Zyprexa is approved for schizophrenia and bipolar disorder.

"'A global settlement for the overpricing claims and any other claims is desirable,' Judge Weinstein wrote, according to Bloomberg. He added that plaintiffs are seeking between $4 billion and $7.7. billion in damages, or about 25 percent of the amount they spent on Zyprexa since 1996."

Reportedly, Lilly is reviewing the order and a July 17 hearing is set for Weinstein's court. Whatever settlement is reached will likely be the largest ever.

In Advance Of The 4th...

The holiday is approaching, Seattle seems to have emptied out and I am burned out. In honor of all that I am going to take today and tomorrow off with perhaps a post or two if anything newsy pops. Comment approval will be intermittent. I hope you all have a nice holiday.

Meanwhile, there is a thoroughly disgusting story out of New York, where a woman died in a psych ER and basically was left on the floor for hours. It's a sickening story.

YouTube Vid: Woman Hospitalized For Physical Symptoms Of Paxil Withdrawal

This is a fresh video of Shelly Hart, who's presently in the University of Arizona Medical Center Hospital in Tucson. She's been withdrawing from Paxil for a long time and has run into such problems with coming off the drug, which she was originally given for anxiety, that she's been admitted to a hospital. The hospital hasn't placed her in a psych unit, but on a medical floor. Doctors ruled out other medical and psychological causes of her distress and are now dealing with her case as one of drug withdrawal.

The video is long, wanders a bit, includes some gossip about paxilprogress.org, but is part of an attempt to document the poorly understood phenomenon of withdrawal from psych meds. The reason for this is because doctors routinely deny that there are withdrawal problems with anti-depressants and some docs even insist that patients are lying. Pharma companies try to soften the withdrawal stigma connected with their drugs by calling the whole business "discontinuation syndrome." Other patients will attack people who've experienced problems with these drugs as being frauds. And so on.

Well, here sits a patient at UMC in Tucson. I think the time for denial is over. If you want, you can go comment on her blog. Or here.