Furious Seasons

The Insanity Of Daily Kos, Or "Sarah Palin's Bipolar Disorder"

Once upon a time, Daily Kos used to be a pretty good political blog, given to the extremes of progressive-liberalism but doing a decent job of calling BS on the Bushies and the mainstream media. I'm not much of a prog-lib, but I used to check in on the site often as an antidote to the general mush of political coverage elsewhere. The site is kind of influential--last year, several Democratic presidential candidates rubbed shoulders with the Kossacks at Yearly Kos and it generates on the order of 500,000 hits a day. That's traffic and readership that any mainstream news organization would relish.

With that kind of visibility, you might expect a wee bit of gravitas, but no. This year the site and its users (or diarists) seem to have gone completely insane in the service of getting Sen. Obama elected President. Seriously, I think there are posters on Kos (main pagers or not) who when they aren't using Rovian swift-boating tactics are clinically delusional.

There was the whole dust-up earlier this year where Sen. Clinton's supporters were chased from the site after enduring some of the most vile abuse I've seen on the Net (nothing is more fun that a knife fight amongst lefties), Kossacks regularly deride Sen. McCain over his age (this from diversity-embracing liberals who hold non-discrimination as their pole star?) and it was on Kos where, last month, the baseless rumors began rocketing through the Net (and then the mainstream media) that Gov. Sarah Palin hadn't actually had a baby in April but had faked a pregnancy in order to cover up for one of her daughters who'd had the baby instead.

I'm neutral on this election so far, but I'm struggling to decide what bothers me more about this cycle: Sarah Palin's VP candidacy or the way the Left, and Kos in particular, has gone after the Alaska Governor. I'm thinking it's the latter. As unqualified as I think Palin is to be President and as off-base as I find many of her positions, when you read crap like this on Kos, you almost wind up feeling a touch of sympathy for Palin and anger with the crazies on Kos. Last week, you see, someone on Daily Kos went and declared that Palin has bipolar disorder:

"As more comes to light on Sarah Palin, it’s becoming increasingly clear that Palin exhibits the classic symptoms of bi-polar disorder, and has, for the past few years, been primarily on the manic side of the bi-polar scale.

"Consider the record: impulsively switching colleges six times in six years; impulsively entering a "Ms. Alaska" beauty contest, then just as quickly denigrating the choice; impulsively eloping to marry husband Todd. Even her acceptance of the VP offer was impulsive and irresponsible--exhibiting the extreme optimism, inflated self esteem, and increased drive to perform or achieve goals that are classic bipolar symptoms.

"Then there are the frantic speech patterns, the manic need for physical activity, the agitation and aggressiveness as evidenced by Troopergate, her turning on former allies, and her curt dismissals of those who do not agree with her."

It goes from there.

Interestingly, impulsiveness is but one of several symptoms required for a diagnosis, but I'm not sure if spur of the moment decisions such as eloping qualify. Perhaps impulsively posting on mental health matters in an attempt to carve up a political candidate might count as bipolar disorder on the poster's part.

As much as you might be tempted to write this off as BS fluff, it was taken seriously enough that someone put out a press release denouncing the whole thing and announcing the launch of a site called Bipolar Watch to monitor how the media and public portray bipolar disorder:

"Increasingly, she claims, lay people feel free to sling the term bipolar around as a pejorative, and seem to believe they have, through pop culture osmosis, become experts on this very complex illness. 'The term bipolar has become contemporary cultural shorthand for anything we interpret as extreme or obnoxious in light of our own personal belief system.'"

Interesting.

Anyway, the Palin-hating Kossack concludes:

"Bipolar disorder is a serious affliction and sufferers need all of our help and support, but do we really want a bipolar disorder sufferer to be Vice President of the United States?"

Sure, why not? In fact, we may have already had someone with bipolar disorder serve as both Vice President and President, depending on how much credence you place on the kind of post-mortem diagnosing of historical figures that goes on these days. Teddy Roosevelt is the person in question.

Last time I checked, he seemed to have worked out pretty well. But then he was a Republican, so why would the Daily Kos crew even know?

Monday, Crazy Monday

I well remember Black Monday in October 1987: I was about a year out of grad school and was working for a pharma company, driving around San Diego listening to the radio as the stock market crashed by a huge percentage and the US attacked Iranian oil derricks in the Persian Gulf. To my young ears, it felt as if the world were ending.

Almost exactly 21 years later, the stock market cratered yesterday. You know why. And there's so much blame to go around that collectively all of us don't have enough fingers. Republican, Democrat, Bush, Clinton, Wall Street, WaMu, etc., etc.--all of these idiots are at fault for allowing America's financial markets to run along unchecked and create havoc for average Americans, havoc that the average American simply doesn't deserve and did little to merit.

I hope the havoc is small on your end of things. Although I am unscathed, none of us know how this will ripple or crash through the economy and our politics. Let's hope whatever goes on is fairly short-lived and that the market bounces back as strongly as it did after 1987 and 2001.

All of that is a long way of saying that the usual mental health news on this site is a bit inconsequential right now (and did yesterday's financial news ever drive down this site's traffic). We'll see where things are at later today. But right now I recognize that there are other things that are more important than what I usually write about.

We Need To Talk About Comments

Yesterday, when I posted about post-combat PTSD and said what I thought were fairly non-controversial things a flurry of comments erupted, including some that called for violence against psychiatrists and bombing the FDA. As I made clear back in February, this site does not support violence against anyone and I will do my best to root out comments and ban commenters who do support it. Regardless of how much an individual may hate certain forces in the medical world, it makes utterly no sense to argue for violence against anyone. You wouldn't do it in a public place, so don't do it on my site.

In the future I will not post warnings like this anymore. Any calls for violence (as in murder or bombing and so on) against anyone will result in an immediate and irrevocable ban. Period.

If other readers run into comments they consider violent, let me know about it.

Why America Has To Address Post-Combat PTSD

There is an excellent and harrowing article in the current New Yorker about a Marine staff sergeant and his brother and it ends in a murder-suicide in the Arizona desert, or double suicide, take your pick. I'm not going to recount the piece, which you should read for yourself, except to note that the Marine, Staff Sgt. Travis Twiggs, was a bad ass Marine who had a profoundly bad case of post-combat PTSD. From the article, it's clear to me that Twiggs didn't get particularly thoughtful treatment, but instead was doped up on loads of psych meds that seem to have made things worse, or didn't improve matters much.

"His sergeant major recognized the symptoms, and, in June, sent him to a physician’s assistant, who prescribed the antidepressants Zoloft and trazodone. Antidepressants and antipsychotics are the main drugs used to control P.T.S.D. But, while his medications were being evaluated and adjusted, Twiggs was, by his own account, blunting their effect by mixing them with alcohol. He told Kellee that he couldn’t stand to look in a mirror. He was racked with guilt, in particular over the deaths of two young lance corporals in his platoon. The only thing that really helped, he wrote, was returning to Iraq. He went, in late 2006, on a weapons-testing mission for the Warfighting Lab, and, once again, his symptoms vanished. He wasn’t fighting, but at least he was in theatre. He was also good at his job.

"But once he was home, in January, 2007, 'he went batshit,' Kellee said.... At one point, he wrote, he was taking twelve different medications a day—Kellee recalls the number reaching nineteen, and says that the drugs turned her husband into 'a zombie'-—'and I was experiencing visual and audible hallucinations that I firmly believe were a direct result of being overmedicated. On any given day I was sad, mad, or depressed.'"

It goes from there.

The big point to be made here is that an estimated 20 percent of Afghanistan and Iraq veterans are suffering from some level of PTSD and that works out to several hundred thousand troops. Current PTSD treatments don't seem to be having a lot of success. So what are we going to do as a culture about this? Continue giving these guys medications that don't work well and, in some cases, may be causing the sudden deaths of these troops? Or something else?

I don't pretend to know what would work well for PTSD, especially in severe cases, but I know that this is a pressing issue before our country (there are other Twiggs sorts of stories out there) that will only get more pressing as time goes on and soldiers go on their fourth and fifth deployments to Iraq. As I've said before, we are going to be reaping the whirlwind of that war for a long time to come.

It stands to reason that the US needs to undertake a very aggressive research effort on treating post-combat PTSD and find something that works instead of trying to tweak psychopharmacological treatments that are clearly miserable failures. (See clinicaltrials.gov for current PTSD trials and you'll get my point.)

These guys deserve nothing less.

Today

I'm mostly going to be offline today and will have little to add to the site unless there's something truly newsy shaking. I'm a bit burned out and, like probably everyone else, a bit blown away by what's going on with our economy and the politics around getting things straightened out. Some of that bad business hit Seattle yesterday when the feds took over part of WaMu, headquartered here, and sold it off to JP Morgan.

How did these various banks and mortgage companies get away with writing such bad loans for so long under both Clinton and Bush? Well, we know the answer. But why was Wall Street crazy enough to go along for the ride and not call BS on all of this long ago? Probably for the same reasons they like pharma stocks despite the voodoo many of them are based upon.

Author Discusses "The Bipolar Puzzle"

Jennifer Egan, who wrote the problematic "The Bipolar Puzzle" concerning the bipolar child paradigm in the New York Times Sunday Magazine two weeks ago, was a guest on KQED-FM's "Forum" program yesterday. KQED is the main NPR station in the San Francisco Bay Area and, full disclosure, once upon a time I interned at the station before deciding I was a print guy and not a radio guy.

Anyway, I think Egan did a much better job of getting at the complexities of things with allegedly bipolar kids than she did in her article, which I previously hashed apart here. You can hear the program here on streaming audio.

Still, I was disappointed with Egan on a few points she made. She called it a "pretty hard fact" that 10 percent to 15 percent of kids with alleged bipolar disorder commit suicide and that's simply not true. What she and the host were doing was conflating adult statistics--which I've argued before are deeply overstated--for child stats. That's dumb.

She also admitted that she had interviewed several parents who were going it without meds but had kept them out of the article because she was more compelled by little boys beating up their little sisters. Seriously, she said that shit. That's a very odd motivation and some weird journalism there.

Study: US Kids Get Two To Three Times As Much ADHD Meds, Anti-Depressants As Euro Kids

A new study is out in Child and Adolescent Psychiatry and Mental Health (abstract here, full paper here). In it, authors compare use of ADHD meds, anti-depressants and antipsychotics in children and youths aged 0 to 19 years old in the US, the Netherlands and Germany and come away with about what you'd expect: children and youths in the US get psych meds far more often than do Dutch and German children and youths.

The short story is that anti-depressant and stimulant use in the US was three times greater or more than in other countries and antipsychotic use was about twice as much.

As cross-cultural studies do, this one has its limitations--ADHD is defined a bit more tightly (good) in Western Europe than in the US, access to health care is different, psych med use overall is different, and so on. What's more, the study's US subjects were all clustered in one Middle Atlantic state (unidentified in the paper) and were all in that state's CHIP program (which the authors claim mirrors children and youths in private insurance, but I'm not so sure of that). It would have been preferable for the study to have used US data from a sampling of US states east, west, north and south. From what I know anecdotally, psych med prescribing patterns and attitudes differ across the US (more so on the East Coast, less so on the West Coast). It would also have been nice if the study had had some British data, since that country is much more culturally close to the US than Western Europe per se. The study also only examined data from one year, 2000. As a result, the study is likely not capturing the rise of the bipolar child paradigm and is likely missing the spike in antipsychotic use in America which really happened after 2000.

Those caveats aside, the study's results are dramatic and certainly point to how the US is willing to diagnose children and youths with mental disorders and slap them with the psych meds. This is, as the authors speculate, as a result of how drugs are advertised and regulated in the US compared with other countries. For example, in France stimulants were banned for kids until recently and that country does not allow DTC ads. Neither do the Netherlands and Germany.

I wish the authors had also pointed to differences in how mental disorders are marketed to Americans in ways that they are not in other countries. In the US, we have several non-profits and affiliated activists and flag wavers for almost all of the major DSM diagnoses and their job is to raise awareness and lobby the media to cover their cause. I don't know of a correlate for these sorts of groups in Germany, especially when it comes to children.

Julie Zito, the lead author, noted:

"'Direct to consumer drug advertising, which is common in the US, is also likely to account for some of the differences. The increased use of medication in the US also reflects the individualist and activist therapeutic mentality of US medical culture.'"

Oh, but you wanted to see the study's results I bet, so here they are by drug class and percentage use among children and youths:

ADHD stimulants:

US--4.29 percent
Germany--.71 percent
Netherlands--1.18 percent

Antipsychotics:

US--.76 percent
Germany--.34 percent
Netherlands--.51 percent

Anti-depressants:

US--2.71 percent
Germany--.17 percent
Netherlands--.53 percent

Lithium:

US--.15 percent
Germany--0 percent
Netherlands--.01 percent

It's worth noting that antipsychotic use was skewed heavily toward males, as was stimulant use. This was true in the US, Germany and the Netherlands.

BTW, for those of you who pay close attention to the paper, there is a bit of a labeling problem on Table 6.

Clay Aiken On Paxil For "Stress Of Fame"

So Clay Aiken came out and admitted yesterday that he was gay, which was the worst kept secret in the solar system. But the real news is that the former "American Idol" star has been taking Paxil:

"He also revealed that he had turned to the prescription drug Paxil to cope with anxiety, and explains how it helped him deal with the stress of fame.

"'It's hard to do this business without maturing a little,' he said. 'I'm much more savvy now. I'm much more aware of my surroundings, of business. I was showing vacation pictures, and there comes a point where I've realized, you know, give them an inch, they'll take a mile!'"

Wow, that Paxil sure is a magic drug. And all those damaged sperm cells are not going to be an issue for Clay.

Third Anniversary

Today is the 3rd Anniversary of this blog. I am pretty much staggered and humbled by where this site has gotten: 1,783 posts and 12,250 comments going into today. Also, sometime today this site will pass 30,000 hits (or visits, technically) for the month, which bests the previous best month record of May (where I beat my 25,000 hits for one month sometime this year goal) with several days left in this month. I need a new goal since I have pretty much surpassed readership goals.

A lot of blogs and websites don't make it more than a year much less three. In the beginning, I thought I'd really have to struggle to find mental health news worth writing about. I was wrong: these days, there's more than I can contend with.

I thank all of you many readers for helping make all of this happen.

British Docs Advised To Stop Ritalin, Adderall In Kids

Yesterday, Britain's National Institute for Health and Clinical Excellence (NICE) and the National Collaborating Centre for Mental Health (NCCMH) issued new guidelines for the treatment of ADHD in kids and recommended that kids with ADHD be given therapy and their parents be given training before doctors prescribe stimulants.

What's more, NICE recommends that ADHD meds only be used in severe cases--approximately one-fourth of cases of ADHD diagnosed in the UK--and never be given to children under 5-years-old. NICE advised the British national health service. Obviously, there would need to be a huge uptick in psychological services available to British children, and the same would be true in the States were such guidelines adapted here.

This marks the second time in recent years that NICE had taken a look-see at standard treatment paradigms for mental health issues, which were imported from the US, and decided that their country was relying too much upon meds and that the benefits of the same were somewhat dubious. In 2004, NICE issued guidelines on the treatment of depression and anxiety and advised a therapy-first approach along with exercise and watchful waiting in advance of prescribing anti-depressants. The move came after a decade of SSRIs-first in the UK which produced spotty results and loads of problems for patients.

It's worth noting that in the wake of NICE's move on depression and anxiety, guidelines in the US were not altered one bit. It kind of makes you wonder if British and American psychiatrists are living on the same planet and looking at the same evidence. It will be interesting to see if the groups' ADHD recommendations have any impact on these shores.

Meet Chemicalimbalance.org

It's not often that I introduce readers to a new website with a dedicated entry, but not every website is authored by Jonathan Leo and Jeffrey Lacasse. An osteopath (and dean at Lincoln Memorial University) and a psychologist (at Arizona State University) by trade, the pair are responsible for defanging the chemical imbalance theory of depression in a seminal paper in PLoS in 2005 and of another paper in which they document the media's reliance on incorrect or overstated (take your pick) chemical imbalance theories. The two are a bit of a SWAT team.

The name of their site is Chemicalimbalance.org, appropriately enough, and it's chock full of evidence and resources for interested readers. And, if you've never read their PLoS paper, get reading. Much of their research is collected here.

Study: Paxil Damages Sperm

Reuters has brief coverage of a forthcoming study from Cornell researchers asserting that Paxil damages sperm cells in healthy men.

" A study of 35 healthy men given paroxetine--sold as Paxil or Seroxat by GlaxoSmithKline--found that, on average, the proportion of sperm cells with fragmented DNA rose from 13.8 percent before treatment to 30.3 percent after just four weeks.

"Similar levels of sperm DNA damage have been linked to problems with embryo viability in couples trying to have children. The research by Peter Schlegel and Cigdem Tanrikut of the Cornell Medical Center in New York was reported in New Scientist magazine and is due to be presented in November at a meeting of the American Society for Reproductive Medicine."

Gee, I wonder how defenders of the anti-depressant faith will spin this bit of research. Man, if this doesn't drive men into therapy before taking an anti-depressant, then nothing will.

Researchers offered these thoughts:

"'The fertility potential of a substantial proportion of men on paroxetine may be adversely affected by these changes in sperm DNA integrity,' the experts concluded."

Do you think?

More on this when the full study is presented.

Sen. Grassley Busts Yet Another Texas Psych Researcher

Sen. Charles Grassley (R-Iowa) has gone and done it again: poked into a major psych researcher's payouts from Big Pharma, compared it against other required disclosures, and found some underreporting going on. This time out the bustee is none other than University of Texas psych researcher John Rush, who recently blasted off to Singapore to become a muckety-muck at Duke's new medical school in he land of caning, and is one of the big shots in depression research. He was one of the principal investigators on the NIMH STAR-D study of depression treatment. Grassley's broad point in going after Rush and other researchers is that if they and their universities are going to take pharma money on the one hand and federal research dollars on the other, then they'd better be accurate in disclosing what they take from private industry or someone should lose some federal research dollars.

Rush's haul and subsequent underreporting isn't anything like what Grassley unearthed from the Harvard child psychiatrists, but it's cute that Rush was getting money from Lilly.

"While a psychiatrist at UT-Southwestern, Dr. Rush disclosed $3,000 in payments from Eli Lilly in 2001, a year the company reported paying him nearly $18,000, according to records obtained by Mr. Grassley. Two years later, Dr. Rush received a federal grant to run a clinical training program related to medical ethics.

"Between 2000 and 2007, Dr. Rush failed to report another $12,000 from various drug companies, the records show."

It's interesting that his Lilly money came in 2001, a year that Prozac went off patent and three years before Cymbalta, the company's next anti-depressant, went on the market. I wonder what drug Rush was pimping for.

Rush was also director of the infamous and riddled-with-corruption Texas Medication Algorithm Project. He recently left his post there.

Rush is the second UT psych researcher to get Grassley's attention in recent weeks. The other was Karen Wagner, who took $160,000 in consulting fees from GlaxoSmithKline, but only reported $600 to the university.

Griffey, Jr. Hits 610th Homer, 5th On All-Time List, Best Suicide Survivor Story Ever

Last night, former Seattle Mariner and now Chicago White Sox Ken Griffey, Jr. hit his 610th home run, passing Sammy Sosa to become 5th on the all-time homer list. He did it without steroids unlike Barry Bonds and two decades after trying to kill himself, as I remind readers in this repeated post from earlier this year when he passed the epic 600 homer mark.

Last night, Ken Griffey, Jr., a right fielder with the Cincinnati Reds and a former star center fielder with the Seattle Mariners hit his 600th home run in the Majors. Although it's not getting much fanfare, the feat puts him in rarefied company: Aaron, Mays and Ruth (Bonds and Sosa also have 600-plus homers but they were steroid cheaters and are dead to me). Griffey never cheated with performance enhancing drugs or corked bats a la Sosa.

What hasn't shown up at all in the press accounts of The Kid's career, which have been coming out the last few days, is that when he was 17 years old, he tried to kill himself and somehow cheated death.

Think I am joking. Here it is in this 1992 article in the Seattle Times.

"In January 1988, Junior swallowed 277 aspirin, by his own count, and wound up in intensive care in Providence Hospital in Mount Airy, Ohio. He thought about killing himself a couple of times, he said, 'with my father's gun or something.'

"'The aspirin thing was the only time I acted,' he said. 'It was such a dumb thing.'

"The story emerged during a recent wide-ranging interview, in which Griffey spoke about some of the ups and downs of his teenage years. He agreed to make it public in the hope it might dissuade someone else from seeing suicide as a solution.

"'Don't ever try to commit suicide,' Griffey said he wants to tell kids. 'I am living proof how stupid it is.'"

It's not clear to me when Junior will retire--maybe this year, maybe next--but he will surely go into the Hall of Fame on the first ballot five years after he does retire. His suicide attempt happened a year before he took his first AB in the Big Leagues, the result of some kind of panic and psychic pain he was in is my nearest guess. So, in a way, he'd already won a very large fight before he ever faced down a 98 MPH fastball. And, 20 years later he'll remain one of the biggest symbols against the empty solution of suicide.

For those of you who want to dork out on his career stats, go here. The amazing thing--and the sad thing--is that Junior has missed about three-and-one-half years of games due to various injuries over the years and he could just as easily have topped 700 homers. Somehow, I bet he doesn't care.

Here's one of his many classic Nike commercials from the 1990s. All the background scenes are in Seattle.

Eli Lilly To Go Public With Payouts To Doctors

Eli Lilly, one of the world's largest pharma companies and the largest maker of psych meds, today announced that it is going to publicly reveal payments to doctors for consulting and speaking on behalf of its drugs beginning next year. The move comes in advance of enactment of a proposed federal sunshine law on the matter.

It's nice to see Lilly step up on this because such payments have certainly twisted how research and marketing are done in the US and, at a minimum, the public has a right to know what doctors are being paid what monies to shill for what drugs.

If you think such payments are small and inconsequential, check this recap of recent revelations from the New York Times:

"Minnesota and Vermont are among the few states that have been keeping a record of those payments. Between 1997, when Minnesota began its database, and 2005, drug makers made payments to more than 5,500 doctors, nurses and other health care workers in the state, totaling at least $57 million, the state found. Another $40 million went to clinics, research centers and other organizations. More than 20 percent of the state’s licensed physicians received money from drug makers.

"Vermont reported last year that from July 2005 to June 2006, 81 drug manufacturers spent a total of $2.25 million on 'fees, travel expenses, and other direct payments to Vermont physicians, hospitals, universities and others for the purpose of marketing their products.'"

I look forward to seeing the details of Lilly's payouts.

Student Newspaper Details Controversies Around Brown University Psychiatrist

Well this is classic: the Brown University student newspaper is spreading the word on campus that Martin Keller, the controversial Brown psychiatrist behind Paxil Study 329 and other pleasures, is under investigation by the Senate Finance Committee. The article breaks no new news, but I simply love the fact that Keller is now dodging student reporters.

I hope some students over at the medical school read about all of this and ask some highly-localized questions in their medical ethics class and during whatever instruction it is they might get on research methods.

Generic Wellbutrin To Get FDA-Sponsored Human Trial Over Safety Concerns

The Wall Street Journal is reporting that generic Wellbutrin XL is going to be the subject of a human trial sponsored by the FDA in hopes of getting at the cause of patient reports that the generic version of the anti-depressant either doesn't work or has awful side effects. The move comes five months after the FDA responded to earlier reports that the generic drug, distributed by Teva, was causing all manner of problems by declaring the drug safe.

Suspicions centered on Teva using a different time-release coating than the patented version of the drug employed, resulting in too much of the drug being delivered at once. The new drug ended up causing all sorts of problems for people whose insurance companies forced them to switch to the generic version of the drug.

Once the FDA declared the generic version safe, patient reports started pouring into the authors of the excellent People's Pharmacy, which is both a syndicated column and website.

From Pharmalot:

"Joe Graedon, a pharmacologist and co-founder of the People’s Pharmacy, wasn’t satisfied with the FDA review and tells the paper complaints about the generic are still being logged on his Web site. He argues the agency probe was unsatisfactory because it was based on data from the 150-milligram version of the drug, not the 300-milligram dose that is at the center of the complaints.

"This past summer, Graedon and others were granted a meeting with senior officials from the FDA’s Center for Drug Evaluation and Research, and he tells the paper there was a 'consensus' by the end of the meeting that the two sides could collaborate on a study that would involve patients who reported problems with the generic after taking the branded version. But he can’t begin a recruitment effort until he is given the details of the study design, and is still waiting to hear from the FDA.

"The FDA spokeswoman says the agency still supports conclusions released in April. While it believes that critics 'are attributing the wrong cause for the problem,' the agency also believes the complaints are “sincere” and is therefore prepared to do more work on the matter. 'The FDA agrees it is important to study further if there is some specific reason…for the product to be not effective in these patients,' she tells the paper."

I'll give the FDA credit for being willing to study the issue, but standing by its earlier claims of safety looks a bit silly to me at this point.

Study: More Than 50 Percent Of Drug Approval Trials Go Unpublished

A new study is out in PLoS Medicine wherein researchers present evidence that 57 percent of drug studies submitted to the FDA for approval of a drug go unpublished. Conversely, 43 percent of drug studies examined by the researchers were published. The study examined 909 studies related to 90 drugs approved by the FDA between 1998 and the end of 2000.

This study was apparently spurred in part by recent studies establishing that half of anti-depressant approval trials had gone unpublished. It looks like the same kind of publication bias that exists there exists with all drugs. So you have to wonder if the effects sizes of all drugs are wildly overstated, as were anti-depressants.

To me, this is simply unacceptable. I hope this study gets a lot of attention.

That Tricky Time Of Year, Or Depression Hacks

Yesterday was the autumnal equinox and, on my street, a maple tree began to turn color last week. It's the first tree in the neighborhood each year. Last year it changed in late August, so perhaps this winter will be slightly more merciful than last winter. But that's at least six weeks off--winter in Seattle begins in November--and right now I'm up against that tricky time of year when the daylight cuts off earlier and earlier and, classically, I've slid into a nice, nasty round of depression (or disthymia, depending on the year). I'm sure it's triggered by the seasonal change and it had been going on with varying degrees of severity (sometimes for a few days, sometimes into the two week clinical depression land) since I was a teen.

Except that two years ago it stopped happening altogether. I'd been on Lamictal only for a year in 2006 and last year was my first year off-meds. This will be go-round number two without any dope in my system. I still can't account for why it stopped in '06, but I suspect a fair amount of it was related to the fact that I simply stopped worrying about what was coming my way. I employed some other strategies too in attempt to war off depression or seasonal affective disorder or whatever the hell it is that goes on for me--or used to--this time of year.

I know this is a tricky time of year for more than a few people who read this site and I wanted to throw out a few bits of advice that I do my best to follow when September begins to feel like November in my soul.

The first thing is to eat. I've watched too many people I know with depression have things spiral out of control because they weren't eating. Or drinking any fluids. Yes, I know food tastes like gruel when times are tough, but you've got to find that one dish you can always eat no matter what. I'm pretty certain that if you are starving yourself, then your brain and body cannot function well, putting you at a distinct disadvantage, regardless of whether or not you take meds.

The second thing is you've got to sleep. That's the other big spiral out-of-control thing that you've got to be on top of.

The third thing is you--well, at least, I--have got to get outside. I know that just sitting in my apartment and working and staring at the Mac simply doesn't lead to anything good psychologically, so I try to get my butt outside and take a brief walk four to six times day. Especially when it's sunny out, even if the sun is only out for a few hours like it was in Seattle yesterday.

The fourth thing is socializing. Self-explanatory.

And, the fifth, as I mentioned above, is to stop worry and let it all go. I don't know how to tell anyone else to go about that process, but it's damn helpful if you get there. My experience is if I am not falling into despair over the possible onset of depression then I don't get depressed. Which I suppose proves something about all this mindfulness talk you read in depression recovery circles.

Anyway, my thoughts--or depression hacks--for what they are worth.

You Know The Bipolar Child Thing Is Huge When NPR Gets Involved

You know this whole bipolar child thing is getting a ton of interest in the popular culture when National Public Radio feels the need to put a podcast online offering "Tips For Parenting A Child With Bipolar Disorder." I cannot even make myself listen to the thing, which features the collective wisdom of Ellen Leibenluft, an NIMH child psych researcher, Carl Bell, a psych prof at the University of Illinois-Chicago and Cassandra Joubert, author of "Losing Control: Loving a Black Child with Bipolar Disorder." I'm simply tired of playing journalism police for the time being. If anyone wants to listen to it and give me a rundown, I'll be happy to post the same.

I'm not sure what prompted the podcast. If anyone has caught anything on NPR about the bp kiddos in the last day or so, let me know.

Human Example Of Why Psych Med Withdrawal Needs To Be Researched

I know some of you read the excellent Beyond Meds blog which often documents the travails of its author's journey in getting off psych meds for bipolar disorder after being on said meds for two decades and at very high doses, at times. I won't even try to recap her story. Anyway, Gianna Kali, the author, has fought just about every setback you could possibly have to in the process and found that her body has become so habituated--if I can use the term--to meds that coming off them is a huge years-long process, and that there is virtually no scientific guidance on how to go about things. She's paying a heavy price for the knowledge gap out there, a price heavier than anyone I've ever seen get clean of heroin. I'm not exaggerating. I'll get back to Kali in a moment because I think she's onto something important in the withdrawal from chronic psych med use despite going through a very tricky phase right now.

Any doctor, psychiatrist or not, who tells a patient that coming off a psych med is a problem-free process is lying. Some people do get lucky and have a smooth ride, but far too many don't.

Unlike opiate withdrawal, which is well-researched, psych med withdrawal is pretty much unresearched. It makes no sense at all that researchers would invest so much time and money in researching how to get people off street drugs, but are far more silent when it comes to allegedly-ethical drugs we take in our own homes. I've written before about why I think psych med withdrawal should be a legitimate object of research and should be appropriately funded by NIMH, foundations and, hell, by pharma companies too. Given the high rates of misdiagnosis of bipolar disorder and the simple fact that some people need to come off certain meds for health reasons (ie, Paxil making them manic; meds making people sick; etc.), it's not even possible to argue that how to withdrawal people from psych meds shouldn't be researched. My casual guess is that 5 million to 10 million people a year have to go through some kind of withdrawal process for these drugs--that's about 12 percent to 25 percent of all people on psych meds in America--so the need for good research on this issue is obvious.

Of course, I am not ignoring the contributions of Peter Breggin, who's written extensively about anti-depressant withdrawal.

Anyway, people can talk about recovery and getting off-meds and how to achieve whatever goals all they want in the mental health world. Mindfulness and all of that. But it really boils down to something far more simple. Writes Kali:

"I keep on plugging on for some godforsaken reason that is unclear to me. Somewhere deep inside I really do believe I will find health one day. I don’t know why or how I feel this way."

This the essential motivation--finding health--that's got to be in the core of anyone going through a process like Kali is. Without wanting it that badly, your chances of getting to the goal line are lessened. And it's exactly why I think she'll get to her goal.

Acupuncture As Good As Effexor

I ran across a fascinating study today showing that acupuncture is as good as Effexor in treating breast cancer patients experiencing hot flashes and other menopausal symptoms, the primary advantage being a lack of side effects. Kind of makes you how acupuncture would fare in treating depression.

Right on cue, here's a Chinese study in the Journal of Affective Disorders showing acupuncture can be effective in treating depression. Another study in the 90s showed similar results.

Hm, I wonder why acupuncture isn't being more routinely used as a treatment for depression.

Pediatric Mania: The FDA's Definition

As most of you know, last week the FDA sent me what it's calling the official definition of pediatric bipolar disorder, at least to the degree that the agency will use the definition to approve drugs for the alleged disorder. What the FDA is leaning on for its definition is a paper published in 2007 called "Practice Parameter for the Assessment and Treatment of Children and Adolescents With Bipolar Disorder."

Keep in mind that the FDA says it is relying upon "science" in making its determination that pediatric bipolar disorder is a valid diagnosis. I think it's relying upon politics.

As I noted last week, the paper does not discuss or in any way delineate depression in pediatric cases of alleged bipolar disorder. I find that very strange, particular when it comes to discussing bipolar disorder in teens (still technically pediatric cases). The paper, and one assumes the FDA's definition, is almost entirely focused on what the authors call mania or manic-like symptoms. Despite that focus and a lengthy discussion of relevant literature, the authors never arrive at a firm description of the clinical features of "mania" in pediatric cases. In other words, they never trot out in DSM fashion the symptoms of the alleged disorder nor define its precise duration. If that's science, then the FDA also believes in cold fusion.

In reality, I have no problem with the validity of bipolar disorder in 12 year olds or above, so the teen/adolescent piece of pediatric bipolar disorder is non-controversial to me. (How accurate those diagnoses may be in the real world and how much wrong diagnosing is, or isn't going on, is another story.)

It's the juvenile, or child, piece that to me is off the rails. The paper's authors offer the following:

"A consensus conference of experts advised the U.S. Food and Drug Administration (FDA) to only extend medication treatment studies down to age 10 years, given concerns about the challenge of accurate diagnosis in younger children (Carlson et al., 2000). Until the validity of the diagnosis is established in preschoolers, caution should be taken before making the diagnosis in anyone younger than age 6 years."

What about the 6 to 9 year olds? And, to be clear, this is almost entirely about boys:

"Although overall bipolar disorder affects both sexes equally, early-onset cases are predominantly male, especially in cases with onset before age 13 years."

So what is meant by this boyhood mania that gets kids diagnosed with pediatric bipolar disorder?

"Changes in mood, energy levels, and behavior are often markedly labile and erratic rather than persistent. Irritability, belligerence, and mixed manic-depressive features are more common than euphoria. High rates of comorbid disruptive disorders are commonly found. Studies vary somewhat in their descriptions of early-onset cases. Findling et al. (2001) found that bipolar disorder in both children and adolescents is cyclical, had high rates of rapid cycling, and had low rates of interepisode recovery. In a series of studies by Biederman and colleagues (Biederman et al., 2004a,b; Wozniak et al., 1995), children with juvenile mania most often present with mixed episodes (primarily irritability and explosiveness), with chronic impairment, including some patients for whom the illness represents their baseline functioning."

So that's it. The Harvard bipolar child army has won, despite the heavy funding of their research by pharma companies and despite the deep controversy in the field over the existence of mania in children. What's being described here sounds to me more like hypomania than mania per se, except that hypomania, per the DSM, has to last for a week in adults.

How long should an episode of kiddie mania last to be considered mania?

"Using the investigators` criteria that require the presence of elation and grandiosity, a cycle of manic symptoms may be as short as 4 hours, with at least one cycle daily for 2 weeks defined as meeting DSM-IV criteria for mania."

And:

"Recommendation 2. The DSM-IV-TR Criteria, Including the Duration Criteria [i.e., 7 days], Should Be Followed When Making a Diagnosis of Mania or Hypomania in Children and Adolescents."

And:

"Recommendation 3. Bipolar Disorder NOS Should Be Used to Describe Youths With Manic Symptoms Lasting Hours to Less Than 4 Days or for Those With Chronic Manic-Like Symptoms Representing Their Baseline Level of Functioning."

So there you go folks. That's what the FDA considers pediatric bipolar disorder. I don't have much to say for now, but I'm interested in seeing your comments. If you are interested, the paper is here.

Reactions To "The Bipolar Puzzle" Article

I've run into a few online reactions to Jennifer Egan's "The Bipolar Puzzle" article from last Sunday's New York Times Sunday Magazine. The article was about the alleged bipolar child diagnosis.

I won't even try to characterize CL Psych's take on the piece except to say that he finds holes in it all over the place and points out how the author's acceptance of genetic theories is off-base. And, in a two-fer, CL points out that recent unpublished evidence claiming--I'll call it a claim until the work is published--that antipsychotics reduce brain tissue in people treated with the drugs long-term--well, it all really amounts to an ironic twist on the old "This Is Your Brain On Drugs" TV commercial. I think he's right.

Alison Bass, author of Side Effects, notes on her blog that Egan omitted the fact that psych docs who've championed the alleged disorder are lining their pockets with pharma love and that the US Senate is onto them over it.

John Grohol at Psych Central likes the article better than either of those two, but has his doubts about whether child bipolar will make its way into the upcoming version of the DSM. I hope he's right.

Danny Carlat liked the article globally, but tosses cold water on the author's acceptance of the kindling theory, which Carlat regards as "wishful thinking."

Liz Spikol found the article annoying in its acceptance of unmerited diagnoses in kids.

The Banana Peel Project has an intelligent critique of the piece.

Egan herself did a podcast for the Times. I've not listened, but I'd love to hear from readers who do.

For those of you who remember, I raised the point (see #12) that Egan had possibly made an error in her copy, requiring a correction or clarification, when discussing bipolar disorder in adults. I made the magazine aware of the issue and I know they are looking into the matter. Stay tuned.

Suicide And Psychological Stamina

It's been a week since the novelist David Foster Wallace hanged himself in California and I simply cannot shake that the most inventive writer of my generation did that to himself. From the New York Times:

"His father said Sunday that Mr. Wallace had been taking medication for depression for 20 years and that it had allowed his son to be productive. It was something the writer didn’t discuss, though in interviews he gave a hint of his haunting angst....

"James Wallace said that last year his son had begun suffering side effects from the drugs and, at a doctor’s suggestion, had gone off the medication in June 2007. The depression returned, however, and no other treatment was successful. The elder Wallaces had seen their son in August, he said.

"'He was being very heavily medicated,' he said. 'He’d been in the hospital a couple of times over the summer and had undergone electro-convulsive therapy. Everything had been tried, and he just couldn’t stand it anymore.'"

I have a pretty good idea of what that place is like, excepting the ECT piece, and yet I'm alive and Wallace is dead. Both of us were largely play-by-the-rules types when it comes to depression treatment and it sure doesn't say much for approved depression treatments that someone like Wallace stays the course and kills himself, while someone like me walks away from treatments that damn near killed me or did very little for me and I am fine.

It's of course inexplicable, the why him and not me of it all. I'm sure some will ascribe Wallace's end to the meds and some will ascribe it to the ECT and the profound hopelessness that ECT seems to pound into some patients post-procedure. It's certainly worth noting that Wallace is the second generation-making American novelist to whack himself after a course of ECT. Ernest Hemingway is the other one, a very, very different writer from Wallace and a better one in my mind. The even more devilish bit in all of this is that Wallace, according to various rumors, had a new novel in the works that was better than "Infinite Jest," and, of course, Hemingway was working on "The Garden Of Eden" when he shot himself. (It was published in the 1980s and clearly needed a lot more work from the master.)

The obvious thing to say is that depression is a ruthless bitch and sometimes it's too much for a human soul to take, regardless of what you think of meds and ECT. That's a true story, of course, but it also ignores the fact that the overwhelming majority of people with depression do not kill themselves (they may rip themselves apart in other ways, but that's another story). The other truth in all of this is that people who kill themselves simply give up on life somewhere in their souls (I'm referring here to people with long-term chronic depression, not someone driven to kill themselves due to a reaction to a med). I don't know another way to describe the phenomenon. Depression is like that--it sucks everything out of you when it's doing its work. And then you give up.

I know this because it happened to me several times and yet each time I found a way to suck it up and keep going. I suspect a lot of my ability to suck it up psychologically comes from decades of playing sports and having to suck it up physically when everything in your body and mind is screaming at you to give up.

Once, when I was playing hockey in high school my sophomore year, a defenseman on an opposing high school team was sent onto the ice to "goon" me (I learned this later), as the saying goes, apparently to teach me a lesson about parking in front of his team's net and being fairly immovable. He waited until the refs had skated off and then turned around and clubbed me in the face with his stick and opened a large gash on my chin, an obvious attempt to take me out of the game. The crowd went nuts, someone called the sheriff's department to prevent a riot, the defenseman went unpenalized and I was escorted off to a locker room where a Band-Aid was applied. My chin was swollen and my mouth hurt. My coach asked if I wanted to be taken to the hospital and I replied that I wanted to continue playing. I returned to the game after about five minutes and ended up scoring the winning goal. The cut took six stitches to close when I finally did get to a doctor. Seriously, this really happened.

I've had a scar on my chin ever since, although it's become less noticeable over the years.

I know a lot of people dislike the sports-as-a-metaphor-for-life jazz, but there is simply some truth to it all. I'm not saying sports are a cure or anything like that, except that there is something about what you pick up psychologically in the process that is fairly useful in later life. I'll call it psychological stamina. All I know is its part of what got me to the other side of depression a few years ago, helping me succeed where anti-depressants and all that other chemical voodoo had failed me.

I wish Wallace had found that in himself somehow because, after all, the sun also rises.

New York Times Editorializes On Antipsychotics, Misses The Point

It's unusual for the New York Times' editorial board to offer its opinion on anything concerning psych meds--in fact, today's editorial may be a first--but today the papers editorial board weighs in on the recent TEOSS study that found atypical antipsychotics worked no better than older antipsychotics and were much less safe than the older drugs in an eight-week study of the drugs use in treating symptoms of psychosis in children and teens.

While I appreciate the paper taking the time to discuss an issue dear to my heart, it would've been a whole lot better if they'd actually understood what the hell is going on with these drugs in American culture.

"Parents, psychiatrists and other physicians will need to rethink whether the newer antipsychotics should still be deemed the first line of treatment for most youngsters. Many might do better on an older drug."

First, the older drugs (ie., Thorzazine, Haldol, etc.) are not safer than the newer drugs per se. Their dangerous and disabling side effects apparently take longer to show up than the dangerous and disabling side effects of the atypicals. Second, to restrict the conversation to schizophrenia, as the paper does, kind of misses the real point of how atypicals are being used in kids. They are being used for ADHD, autism and for what the FDA calls pediatric bipolar disorder. Schizophrenia is actually quite uncommon in children and younger teens, but these other diagnoses are getting to be as regular as rain in our country and that's where the real danger lurks--antipsychotics being given to kids off-label (ADHD, conduct disorders) or for controversial diagnoses such as pediatric bipolar disorder.

It would've been nice if the paper had captured that somehow in what it wrote as well as the wide use of these drugs in adult populations, off-label or on.

The bottom line is that damn few people should be taking these drugs, especially given recent news on how the long-term use of these drugs can cause brain shrinkage.

Psychiatrist And Neuroscientist Says Antipsychotics Cause Brain Shrinkage

I've been writing about the dirtiest little secret of antipsychotics for some time now, namely that they cause brain shrinkage in some (I'm assuming it's not all) patients and animal studies, so it was rather bracing yesterday to read this New York Times interview with Nancy Andreasen, a neuroscientist and psychiatrist at the University of Iowa who does nervous system research on people diagnosed with schizophrenia with MRIs.

"Q. AND WHAT HAVE YOU FOUND?

"A. I haven’t published this yet. But I have spoken about it in public lectures. The big finding is that people with schizophrenia are losing brain tissue at a more rapid rate than healthy people of comparable age. Some are losing as much as 1 percent per year. That’s an awful lot over an 18-year period. And then we’re trying to figure out why. Another thing we’ve discovered is that the more drugs you’ve been given, the more brain tissue you lose.

"Q. WHY DO YOU THINK THIS IS HAPPENING?

"A. Well, what exactly do these drugs do? They block basal ganglia activity. The prefrontal cortex doesn’t get the input it needs and is being shut down by drugs. That reduces the psychotic symptoms. It also causes the prefrontal cortex to slowly atrophy.

"If I were developing new drugs, I’d switch targets. Till now it’s been chemically formulated targets. I believe we should be thinking more anatomically and asking, 'With schizophrenics, which brain regions are functioning abnormally?'

"Q. ARE YOU WORRIED YOUR FINDINGS MIGHT BE MISUSED?

"A. The reason I sat on these findings for a couple of years was that I just wanted to be absolutely sure it was true. My biggest fear is that people who need the drugs will stop taking them.

"Q. WHAT ARE THE POLICY IMPLICATIONS OF THIS FINDING?

"A. Implication 1: that these drugs have to be used at the lowest possible dose, which often doesn’t happen now. There’s huge economic pressure to medicate patients very rapidly and to get them out of the hospital right away. Implication 2: we need to find other drugs that work on other systems and parts of the brain. Implication 3: whatever medications we use need to be combined with more nonmedication-oriented treatments, like cognitive or social therapies."

It is extremely unusual for a researcher to share his or her findings ahead of publication, so I do have to wonder why she agreed to do the interview. I'm not implying anything bad here, just wondering.

Losing 1 percent of brain tissue a year over 18 years, as one reader put it to me in an email yesterday, sounds a whole like a slow lobotomy. And people wonder why there's so much controversy around giving these drugs to people long-term, including children, for non-psychotic disorders. At this point, I'd say it's controversial--or at least very conflicting--to force these drugs on people with schizophrenia or bipolar disorder (the kind of BP that gets psychotic), especially at high doses and for long periods of time. It will be interesting to see how Andreasen wrestles with this issue in whatever paper she's having published. It will also be interesting to know what meds her subjects were on. I suspect it was a mix, over time, of typical and atypical antipsychotics.

The trouble is, if antipsychotics come to be deemed inhumane to use, then what would you do for someone with schizophrenia, particularly someone who is a danger to self or others? And, perhaps more pressing, what about people who are no danger to self or others? Do we force these drugs on them too? I'm looking forward to reading how Fuller Torrey and my pals at TAC handle that question.

Either way, evidence like this has huge implications for non-psychotic conditions which are being treated with atypical antipsychotics in vast numbers these days. And by non-psychotic disorders I mean bipolar disorder (most is non-psychotic or the psychoses are brief), depression, anxiety, dementia, ADHD and what the FDA is calling pediatric bipolar disorder. And there are of course other concerns about the use of these drugs, as the CATIE study and the TEOSS study more recently have made clear.

I suppose one could make the argument that in non-psychotic cases that the drugs are being used at lower doses than in schizophrenia. But would 5 mgs. of Zyprexa really be so much safer (or less injurious) than, say, 15 mgs.? I don't even have a guess. And I may as well ask, if someone goes off these drugs, do they experience a regrowth of brain tissue?

But, like Beyond Meds, I've got a brain case full of concerns. I took these drugs for four and one-half years to treat agitation and depression (anti-depressants are next to useless for me) and in retrospect I am convinced that the clinical symptoms of agitation my then-docs and I were addressing were caused by anti-seizure drugs and anti-depressants. And, yes, I do shake my head from time to time at the stupidity of it all and why I was daft enough to go along for the ride.

But I did take them at low doses--Risperdal at from anywhere from .5 mg. to 1.5 mgs., Seroquel at 25 to 50 mgs. and Geodon at I forget what dose since I took it for such a short period of time.

Did I lose 4.5 percent of my brain tissue over that period of time? I don't know. Have I regained it in the three years since I said "Adios" to the atypicals? Again, I have no idea. And that bothers me a great deal.

Sarah Palin, Court Documents, Seasonal Affective Disorder And Tanning Beds

I was talking to a friend on the phone last Thursday morning when my call waiting lit up. The caller ID read, "Isikoff, Michael" so, of course, I took the call. And I spent much of that day and the next stringing for Newsweek, which consisted of me going through records of an Alaska federal court case (2,500 pages or so) that happened to be in the National Archives in Seattle and that happened to involve a defendant named Sarah Palin. The lawsuit was filed by the police chief of Wasilla after Palin fired him after she took over as mayor in 1996. The former chief, who was an at-will employee, lost the suit in 2000.

But anyway I was looking for whatever context--smoking gun or not--could be added to the Palin story from the documents, which the Seattle Times had written about at length a few days before. I didn't find much (because there wasn't much in the fairly average civil suit) and you can read the resulting article here. (Link fixed.)

One impression of Palin that I got from the lawsuit, its depositions and various bits and pieces that are part of the court file is that she sure pissed off a lot of people in Wasilla. The take-away for me was that some of the ire was as a result of Palin crashing what sounded like a fairly comfy old boys network in town and the rest was because Palin is fairly hardcore in doing what she does. People don't always respond so well to such characters in such contexts.

One of those banging on Palin in the national media is Keith Olberman at MSNBC. I'm not much of a fan of MSNBC (it makes CNN and Fox News look non-partisan by comparison) and I dislike Olberman in particular (I'm an old-fashioned journalist and Olberman's style and methods just rub me wrong) and Olberman has apparently been going nuts on Palin. In fact, he apparently recently branded Palin as an elitist because she has a tanning bed at the Governor's mansion.

Palin may not be the only enthusiast of tanning beds in Alaska. As it turns out, folks up there sometimes use them to fight off Seasonal Affective Disorder:

"Anyways, my wife, born, bred, and of Alaska, laughed very heartily when I told about this [the Olberman thing] when she woke up. She has a very dark complexion (a fair bit of native Alaskan blood) and she used a tanning bed when she lived in Alaska. So did her whole family. And most of her friends. Why? Its not for the tan, because as you might guess, not much skin ever gets seen anyways. It is to try and fight Seasonal Affective Disorder (SAD). Perhaps Obermann is unaware, but Alaska is at a very northern latitude and even when it is summer, there are lots of clouds. Thus, depression. A lot of people preferred the tanning beds to the strange 'light box' thing."

I'm no expert on tanning bed treatment for SAD--sounds a lot more fun than Prozac, however--but there are some accounts of people using them for just that purpose. The nice folks at The Huffington Post missed that angle altogether and played up an elitist-cum-skin-cancer angle. Whether Palin uses the tanning bed for fashion or treatment of SAD is beyond me (and I truly don't care), but it is an interesting example of how the press is spinning out the Palin story from any possible angle (including this New York Times piece on how Tina Fey got her hair done up Palin style for SNL. Someone got paid to write this? Really? When journalists are being laid off all over the country?).

And, for those of you who haven't seen it, here's Tina Fey doing a send-up of Palin on "Saturday Night Live" this past weekend.

I simply cannot wait until this election is over.

Sadness, Depression And Forgetting Human History

Yesterday, Ronald Pies, a psychiatrist and researcher, published a piece in the New York Times attacking critics who believe that psychiatrists have pathologized normal, situation sadness into clinical depression and, as a result, needlessly doped up Americans on anti-depressants. The piece was not labeled as an opinion piece, so unknowing readers were left to assume that they were reading the words of an unbiased scientist as he tries to put the beatdown on some who claim that depression is, in essence, overdiagnosed and overtreated. I can assure you that the piece was a classic opinion piece and certainly Pies, who writes well, is welcome to his opinion.

It's when he writes like this that I wonder about his biases:

"[P]erhaps most troubling, is the implication that a recent major loss makes it more likely that the person’s depressive symptoms will follow a benign and limited course, and therefore do not need medical treatment. This has never been demonstrated, to my knowledge, in any well-designed studies. And what has been demonstrated, in a study by Dr. Sidney Zisook, is that antidepressants may help patients with major depressive symptoms occurring just after the death of a loved one."

I'm not sure what Zisook study Pies refers to, but Zisook has written a lot about bereavement and if that's the argument Pies wants to make, then so be it. My problem with his statement that the "sadness resolves itself" argument hasn't been tested in "well-designed studies" is that it ignores evidence from a little thing called human history. For thousands of years, humans have had much experience letting sadness resolve itself--and here I am speaking of true sadness--and the claim that it hasn't been scientifically tested is silly. People worked things out long before anti-depressants appeared on the scene and will continue to work out their sadness long after anti-depressants fade away. If people want to take an anti-depressant to in hopes of helping themselves out a bad patch, then go right ahead. Just don't expect grand results and watch out for the side effects.

If Pies is going to wrap his arguments in appeals to science and well-designed research, then Pies should tell readers about how mixed the evidence base is for depression treatment whether we are talking about sadness or severe depression. What's more, an editor at the paper should have insisted upon this, especially since it's the Times that's been out front in reporting the good and the bad of depression treatment. Simply put, anti-depressants are a weak technology.

In January, there was a study by Erick Turner which established that many of the approval trials for anti-depressants had gone unpublished (and most of the unpublished trials had negative outcomes) and for the last decade or so pharma companies and some researchers have been wildly inflating the effect size of anti-depressants. Then, in February, there was the Irving Kirsch study which claimed that the approval trials of four anti-depressants (some published, some not) showed that the drugs were no better than placebo. And, then, in August a study by Arif Khan showed that the placebo effect in anti-depressant treatment of depression is much higher and much longer-lasting than was previously thought and that, conversely, the effect size of anti-depressants is pretty darn small. While I cannot tease out if subjects in these studies suffered from sadness as opposed to major depression, I'm not sure that it matters. Depression is depression regardless of its wellspring.

"For example, a patient who had a stroke a month ago may appear tearful, lethargic and depressed. To critics, the so-called depression is just “normal sadness” in reaction to a terrible psychological blow. But strokes are also known to disrupt chemical pathways in the brain that directly affect mood. What is the 'real' trigger for this patient’s depression? Perhaps it is a combination of psychological and neurological factors. In short, the notion of 'reacting' to adverse life events is complex and problematic."

It's curious to me that defenders of anti-depressants keep returning to the example of post-stroke depression (something Peter Kramer does all the time these days) and while I'm sure there is research showing anti-depressants are useful treatments in these cases, it's worth pointing out that the vast majority of depression (or sadness) is not related to a stroke. In other words, Pies's point is moot.

Speaking of wellsprings, the paper identified Pies thus:

"Ronald Pies is a professor of psychiatry at Tufts and SUNY Upstate Medical Center in Syracuse."

Oh, but Pies is much more than that. He's the editor of Psychiatric Times and earlier this month announced that he'd ask members of his editorial board to report various monies they've received from Big Pharma. While I was unable to find a recent disclosure statement for Pies himself, I know that his publication is filled with pharma ads (or at least it was last time I saw a print copy and last evening the website had ads for Adderall and Vyvanase) and CME ads. It's a safe bet that some of that ad money trickles through to Pies' bank account.

Does that affect how he writes about the nexus between depression and sadness and treatment and non-treatment? You tell me.

Thanks Again

Again, thanks to all of you for making the fundraiser a success. It is especially important to me personally because this site is but eight days away form hitting its third anniversary.

I'll be catching up on posts during the day--I was detained last evening helping a good friend of mine deal with breaking-up with his girlfriend--but I know some of you wanted to see my cats/office assistants make an appearance, so with no further delay and by popular demand, here are Katie and KC.

One of these days I'll stop being lazy and resize these photos.

Fall Fundraiser--It's Over

I'm thrilled to tell you all that due to a bunch of contributions today--including a very generous one--the goal of $3,000 was exceeded about an hour ago. I'm more than overwhelmed by all the contributions and kind thoughts. So pay no attention to that thermometer on the right which I will up date later!

BTW, many of you have sent along that piece by Richard Pies from today's New York Times. I've read it and I promise you all that I will deal with it for tomorrow.

FDA Defines Pediatric Bipolar Disorder, Holds The Depression

Going through the American Academy of Child and Adolescent Psychiatry's guideline, "Practice Parameter for the Assessment and Treatment of Children and Adolescents With Bipolar Disorder," which the FDA is citing as its definition of pediatric bipolar disorder, is a tough go. I've never read an assessment and treatment tool before in psychiatry that contains so many caveats and so much equivocation. And that's when it comes to the "manic"--or irritable--side of pediatric bipolar disorder.

As for depression, the document is virtually silent. It contains no definition of the depressive side of pediatric bipolar disorder--and as far as I know, for bipolar disorder to be present in adults or teens, then there's got to be a presentation of depression at some point. So why is depression virtually absent from the FDA's de facto definition of pediatric bipolar disorder? Are the FDA and AACAP suggesting that depression doesn't exist in pediatric cases? Is the FDA's definition of pediatric bipolar disorder incomplete?

I have no idea. But I intend to find out.

For those of you who've not seen the document, you can download it here.

Fall Fundraiser--Getting There

A bunch of contributions came in yesterday--$405 to be exact--and that brings the total for the fundraiser so far to $1,925. That leaves $1,075 to go to reach the goal of $3,000. I thank all of you for your support so far.

Ideally, I'd like to end this fundraiser as planned at the end of tomorrow, so it'd be really nice to have a bunch more contributions come in today so that the goal can be hit on time. As usual, there's a PayPal button on the right or you can shoot me an email and I'll send you my mailing address.

I was going to do a bunch of posts for today but two events conspired to prevent that. One, the FDA revealed its definition of pediatric bipolar disorder after much pressure from this site and its readers (see adjoining post). I'm still contemplating the FDA's reply and how to make sense of it. And, two, it was quite hot in Seattle yesterday--OK, by Seattle standards--and my apartment was unbearable most of the day and evening. We've been getting a good-bye kiss from summer the last five days or so and in a week or two, the jet stream is going to shift down from the North and Seattle will be gray and rainy for the next eight months or so. As a result, I'm getting as much outside time as possible.

If I don't, I'll kick myself in January.

The FDA (Finally) Responds (Sort Of) To Questions About Pediatric Bipolar Disorder

Yesterday, just as I was about to fax the agency a FOIA request in response to the FDA's continued silence on defining pediatric bipolar disorder, I got an email from Sandy Walsh, a press officer at the agency, stating the following:

"The FDA does accept the validity of pediatric bipolar disorder. The FDA agrees with peer-reviewed journal articles, academics and clinicians that say that pediatric bipolar disorder can occur in children and adolescents and is a serious, chronic illness which causes shifts in a person's mood, energy, and ability to function.

"Understanding the effects of bipolar disorder early in life may lead to better treatments and improve long-term outcomes as children and adolescents become adults. The FDA, a science-based agency, puts a priority on children's health and believes it is important to study medicines and diseases in pediatric patients.

"According to the National Institute of Mental Health: Research findings, clinical experience, and family accounts provide substantial evidence that bipolar disorder, also called manic-depressive illness, can occur in children and adolescents. Bipolar disorder is difficult to recognize and diagnose in youth, however, because it does not fit precisely the symptom criteria established for adults, and because its symptoms can resemble or co-occur with those of other common childhood-onset mental disorders. In addition, symptoms of bipolar disorder may be initially mistaken for normal emotions and behaviors of children and adolescents. But unlike normal mood changes, bipolar disorder significantly impairs functioning in school, with peers, and at home with family. More information about symptoms can be found here: http://www.nimh.nih.gov/health/publications/child-and-adolescent-bipolar-disorder/summary.shtml

"Emerging evidence from pediatric bipolar research suggests that various phenotypic presentations are manifest in children with pediatric bipolar disorder. Based on the interpretation of the DSM-IV TR criteria, the current literature appears to support two phenotypic presentations of pediatric bipolar disorder: a "narrow" phenotypic presentation that manifests with classic mania symptoms and a "broad" phenotype. Regardless of the phenotypic presentation, however, all diagnoses of pediatric bipolar disorder used in the pediatric bipolar clinical trials for Abilify and Risperdal were made using the current DSM-IV TR criteria. The FDA expects that the next edition of the DSM, DSM-V, will address issues over pediatric bipolar phenotypes.

"The FDA notes that different phenotypic presentations of illness is not unique to the field of psychiatry and in fact have been described for other medical disorders such as the inherited connective tissue disease called Marfan Syndrome (Loeys B et al "Genotype and Phenotype Analysis of 171 Patients Referred for Molecular Study of the Fibrillin-1 Gene FBN1 Because of Suspected Marfan Syndrome" Arch Intern. Med 2001; 161:2447-2454)

"The FDA makes decisions to approve medicines based on science and clinical evidence. In the cases of the approvals of Risperdal and Abilify to treat symptoms of bipolar I disorder in children, the data show that the patients taking drug therapy had fewer symptoms of their illness. The pediatric studies of Risperdal and Abilify provided an opportunity to assess the effectiveness, proper dose, and safety of using these products in the pediatric population.

"The FDA thinks evaluating the diagnosis of and response to therapy in a controlled study situation where information will be systematically recorded and evaluated is far superior to having children exposed to unknown doses in a continous uncontrolled process. The latter is what happens when products are used in children because they are available for adults but never evaluated in a population which is know to also have the disease.

"Also helpful in explaining pediatric bipolar disorder is a 2006 study from the National Institute on Mental Health, available at [here] and the American Academy of Child and Adolescent Psychiatry's guideline, Practice Parameter for the Assessment and Treatment of Children and Adolescents With Bipolar Disorder (attached)."

That AACAP guideline is right here. I've been reading it and will comment on it later, since it's hardly what one might consider a DSM kind of definition of pediatric bipolar disorder.

After almost two months of pushing the agency to define a disorder it accepts as valid in the face of controversy within (and without) child psychiatry, I don't know what finally pushed the FDA's button. But I'm sure that the emails many of you sent to the agency last week certainly helped. I thank you all for writing the agency and helping to force the issue.

I'll have more on this later today.

NIH Study: New Antipsychotics More Risky For Kids Than Old Antipsychotics

Results of the long-awaited TEOSS trial, sponsored by NIMH, were released today by the American Journal of Psychiatry. The study randomly assigned 119 children and teens aged 8 to 19 diagnosed with psychotic symptoms to receive either Zyprexa or Risperdal--two new generation antipsychotics--or molindone, an old antipsychotic, in an 8-week study. The results were very bad for the newer drugs and, in fact, were so bad for Zyprexa that a government oversight panel ordered that kids taking Zyprexa be taken off the drug due to explosive weight gain, an average of 13 pounds in 8 weeks. (Where have we heard that story before with Zyprexa?)

These results (pdf here) need to be understood not only in the context of psychotic symptoms but in the context of these new drugs' use in children and teens being treated for autism (Risperdal is FDA approved there), pediatric bipolar disorder (the FDA has approved Risperdal and Abilify there) and ADHD (no FDA approval for the drugs there) where these drugs are commonly used off-label. Risperdal is approved for use in schizophrenia in adolescents, but not in children. Zyprexa's schizophrenia approval is for adults only.

In my opinion, the TEOSS study results are the death knell for the common and far too casual use of these drugs in kids. Not that the picture is any more pretty in adults.

So what did the study show?

"No significant differences were found among treatment groups in response rates (molindone: 50%; olanzapine: 34%; risperidone: 46%) or magnitude of symptom reduction. Olanzapine [Zyprexa] and risperidone [Risperdal] were associated with significantly greater weight gain. Olanzapine showed the greatest risk of weight gain and significant increases in fasting cholesterol, low density lipoprotein, insulin, and liver transaminase levels. Molindone led to more self-reports of akathisia."

Conversely, that means that large numbers of kids receiving each drug either saw no response or stopped taking the drug due to problems with its use: 50 percent in molidone, 66 percent in Zyprexa and 54 percent in Risperdal.

These results are not wildly different--in fact, they are worse--from what was seen in the 2005 CATIE study of the new antipsychotics used in treating schizophrenia in adults.

What did researchers tell the press?

From the New York Times:

"Dr. Jon McClellan of the University of Washington, a co-author of the new study and of the current guidelines for treating childhood schizophrenia, said in a telephone interview that older schizophrenia drugs should now be considered as an alternative in some cases.

"'Some of the children in this study gained 15 pounds or more in eight weeks,' Dr. McClellan said. 'That’s as much as adults gain in a year on these medications. Children are especially susceptible to these side effects, and this has broad implications across the board, for the use of these agents to treat any disorder.'...

"'I think the reason the use of these newer drugs has gone up so fast is that there was this widespread assumption that they were safer and more effective than what we had before,' Dr. McClellan said. 'Well, we’re seeing now that that’s not the whole story.'

Approximately 2 million children--and maybe more--are being given these drugs for various disorders. It's time to reconsider their use.

Moreover, I'm not sure how much an advantage would be gained by using older drugs such as molindone, as the 8-week trial was too short to capture the various side effects that crop up later with use of first-generation antipsychotics such as Parkinsonism, aka zombieism.

I suspect I'll have more on this study soon.

Fall Fundraiser--Forging Ahead

Another $95 came in over the weekend, bring the total for the fundraiser to date to $1,520. I appreciate the contributions that have come in so far, but I fear that the fundraiser won't make its goal of $3,000 by the end of Wednesday. That said, I know that things have been really nasty out there weather-wise in some parts of the country (not to mention our nation's economy), so I'll let you all know how I plan to address things in a day or so.

Until then, I would sure appreciate any contributions readers make.

12 Problems With The Sunday Times Magazine Piece On Child Bipolar Disorder

I read the New York Times Sunday Magazine piece on alleged child bipolar disorder over the weekend. It wasn't quite as big a piece of crap as I heard from readers initially, but Jennifer Egan's article was, in my opinion, incomplete and, at times, deeply flawed. On one point, I think the magazine either needs to issue a correction or clarification (see number 12 for that). As much as I am tired of playing journalism police in recent weeks, I'm going to dive into this one role one more time and hope that no other major articles pop up for a few weeks.

It's clear to me that the article's author has swallowed the Kool-Aid on the bipolar child business. It's also clear to me that the author--a novelist cum journalist--is trying to cover her ass from criticism by attempting to cover both sides of the debate on the bp kiddos business but that she nonetheless has a point to make and that point is that bipolar disorder is a valid diagnosis in children and that medicating the crap out of small kids is A-OK. Over the last decade or so, I have written about 50 similarly-long, similarly-complicated articles (And have read thousands of others) and I can tell you that the author almost always front loads an article with what they consider to be the truth, or at least the most plausible version of reality. And Jennifer Egan's piece is front-loaded with a remarkably messed-up young boy, the son of wealthy parents, who is diagnosed as bipolar and what the field of psychiatry has to say about kids like that.

On one level I don't even know why I'm bothering to flap my arms much about the article--it's not much different from some other articles that have appeared well before it (for example, this bit of tripe in Newsweek earlier this year) and it doesn't add much to anyone's understanding of the alleged disorder nor does it break any new ground journalistically. But it's in the Times magazine and 1 million or so people will likely at least thumb through it, so that alone makes it important. I will also note that it is a bit more judicious than I'd thought from what some readers told me on Friday.

All the same, the article still has what I consider to be some deep flaws and here you go in no particular order.

1. Throughout the article, "therapy" is to be understood as "taking medication" except for a brief mention towards the end of family focused therapy (extolled by Stanford's bp kids proponent Kiki Chang no less). You could walk away from the article if you were uninitiated into what's up with child psychiatry these days thinking that meds are the only answer. That's simply not true and there is a body of evidence that FFT, to mention one modality, is quite useful with troubled kids. CBT is apparently useful too.

2. There's not much exploration in the article of the environment the article's subjects are in, except for what you might pick up from the naturalistic observations the author makes, and there is certainly no quoting of credible child psychiatry experts, like the University of Washington's Jon McClellan, who argue that much of what's up with these kids can be tied to their environments.

3. The article, at least to my eyes, totally accepts the brain basis, genetically-linked, victims of biology clatrap around bipolar disorder in kids and adults. Sure, some of that explains adult bipolar (and I include teens in that), but it's hardly the whole deal.

4. Egan acts as if Lithium is more dangerous than Risperdal and Abilify. Certainly, Lithium is no party, of course, but why did Egan fail to mention the many, many adverse events reports to the FDA that have been generated by just a few years' use of Abilify and Risperdal in kids?

5. The boy who opens the story, James, is 10-years-old and to me appears to be desperate for a place to put all his aggravation and impulses. What's remarkable to me is that there's no indication in the article of whether or not his parents had tried to stick him into sports of any kind. That's just odd. I'll go out on a limb here: I think kids like James should be forced to play football or hockey or learn how to box--some kind of intense contact sport--as part of their treatment plan. That's right I consider Pop Warner Football and pee wee hockey to be safe and efficacious for boys (girls, too), but I know such pursuits have fallen out of favor with urban and suburban families (soccer is another story) for a multitude of reasons despite the fact that such activities used to be the first option for handling troubled kids only a generation or so ago. And really, if you are willing to put your son on an antipsychotic and if you are willing to spend $20,000 a year on a "shadow" to follow him everywhere, then why the hell wouldn't you have him on a field or rink somewhere slamming other boys around? And, if you are a psychiatrist, why wouldn't you push that on the parents before doping the kid on Risperdal or Abilify?

6. The article is heavily-weighted toward proponents of the bp kids paradigm, including the Harvard crew and the folks at Pitt, which is to say the usual suspects. Meanwhile, critics of the bp kids paradigm are quoted (deep in the article), but are hardly the most vociferous of the alleged disorders critics. If you are going to quote one of the Harvard crowd, then you should quote someone who's openly attacked them. Larry Diller at UCSF, for example.

7. Egan leans heavily on a Birmaher co-authored study on whether kids diagnosed with bipolar disorder continue to have bipolar disorder as adults. Birmaher claims they continue to have psychological problems as adults, ones Egan's article don't specify (which is sort of avoiding the question, then, of whether what these kids have is bipolar or something else), but there are certainly child psychiatrists who point to evidence that claims that the bp kids don't go on to become bp adults. Not including this counter-evidence is an oversight.

8. At one point, readers are briefly introduced to Boris Birmaher, a psych prof at Pitt and apparent proponent of the bp kids paradigm, but no mention is made of the fact that he was a co-author of Paxil Study 329, which is one of the most heavily-criticized, most-controversial and, frankly, most fraudulent studies in the history of psychiatry. Readers of the Times have the right to know about the backgrounds of the people pushing this paradigm where it is relevant and I'd say Study 329 is highly relevant.

9. Janet Wozniak, a psych prof at Harvard and part of the Biederman group, is quoted in the article, but no mention is made of the fact that some in the Biederman group is being investigated by the Senate Finance Committee for underreporting their earnings from Big Pharma. In fact, several child psychiatrists have gotten caught up in various controversies around pharma funding of their work, but this is not included in the article. The bp kids researchers are not exactly a typical group of friendly neighborhood scientists.

10. Earlier this summer, the FDA announced that pediatric bipolar disorder is a valid diagnosis despite the controversy in the field over whether what's up with these kids isn't something else. There is no mention in the article of the FDA's determination nor of the fact that the agency now refuses to define what precisely it means by pediatric bipolar disorder. That's really weird and it's really weird that this didn't find its way into the piece.

11. There is no mention of kids who were once diagnosed as bipolar and medicated into the ground whose parents, after observing that meds were hurting their children, successfully got their kids off-meds and whose kids are doing fine today. So if bipolar truly exists in children, then these kids would count as false positives and you have to wonder why Egan didn't reach out to them? It would have helped balance her piece at a minimum.

12. Egan accepts the softening of classic manic depression into BP1 and BP2 in adults and even seems warm to subthreshold bipolar disorder and cites a recent study by NIMH researcher Kathleen Merikangas. "That comes to nearly 10 million American adults with some form of bipolar disorder, only a small percentage of whom, the study found, were receiving appropriate treatment." Egan stepped in real do-do here, since she must have missed that Merikangas had to publish a correction to her study on SBD, making it clear that to have alleged subthreshold bipolar disorder didn't necessarily mean that one had to be treated with medication. So what exactly is Egan's point about appropriate treatment here? Maybe, she might need to issue a correction or clarification of her own.

Others of you will likely find other nits to pick with Egan's article, but for now I am going to leave it at that.

Novelist David Foster Wallace Hangs Self

The novelist David Foster Wallace was found dead at his Claremont, Calif. home last night after he had reportedly hanged himself. Foster, 46, was all the rage among the literary smart-set in the 90s and 00s and is best known for his sprawling novel "Infinite Jest." He'd also won a MacArthur "Genius" grant. Sounds like a guy who likely had a lot to live for, so you have to wonder what the hell happened here.

Tragic.

The New York Times Sunday Magazine On The Bipolar Child

I'm very busy today with an outside project, but I wanted to pass along news that the New York Times Sunday Magazine has a major piece out (online now, runs on Sunday in the paper) on the bipolar child. I've not had time to read it myself, but I just spoke with a reader who had.

He characterized the article as totally buying the Biederman/Harvard line and that it failed to note objections within psychiatry until approximately page 10 of a 10-page online article. What's more Biederman appears in the article and apparently explains that chronic irritability counts as mania. I wonder if the author was brave enough to offer the science base for that.

One quote from the article my friend passed along:

"The Diagnostic and Statistical Manual of Mental Disorders (the current edition is referred to as D.S.M.-IV) describes bipolar disorder as a condition whose average age of onset is 20, but virtually all the leaders in the field now say they believe it exists in children too."

This is complete bullshit of course and it tells me that the article's author, Jennifer Egan, is a lame reporter, and joins Judith Warner, a columnist for the Times, as being yet another woman in favor of medicating small children for a disorder that doesn't exist in the DSM and which the FDA refuses to define. Awesome.

British FDA Report Finds Healthcare Blogs As Influential As Old Media

Earlier this year, the MHRA--Britain's FDA--got a report from a British web consulting firm analyzing the influence and popularity of various online information sources for people interested in learning more about Seroxat (Paxil's UK name) and the MHRA. It's not clear why the MHRA commissioned the study, but apparently the agency realized it was being pounded by numerous British bloggers over its role in letting a problematic anti-depressant stay on the market with few warnings for consumers about withdrawal problems and other side effects, so the agency apparently wanted to learn how much impact all these newfangled blogs were having.

What the MHRA learned from this report (6.4 MB pdf) is that blogs and the people who write them are as influential as many traditional media websites and traditional corporate websites and are more influential than are many well-financed healthcare websites such as WebMD. The report only looked at how influential blogs were as regards the MHRA and Seroxat (as opposed to the FDA and Paxil) to give the whole thing a British slant.

Included among influential and popular blogs in no particular order were Pharmalot (US), Seroxat Sufferers (UK), Seroxat Secrets (UK), the Carlat Psychiatry Blog (US), Furious Seasons (my All-American blog), Clinical Psychology and Psychiatry (US) and Health Care Renewal (US). For popularity and influence, we ranked right up there with wire services, the London Times and the Wall Street Journal and only slightly trailed the BBC and the New York Times. This is all quite astonishing when you think about it--underfinanced blogs having as much influence as the WSJ! Unthinkable! US blogs that barely mention the MHRA (and usually write about Paxil not Seroxat) being more influential than WebMD--the world has come undone for sure!

You can skim the report for yourself and draw your own conclusions. Obviously, there are going to be biases in how the report's analyses were done and what search terms were used and so on (you'd get different results if the consultants had gone after the FDA and Paxil), but what the MHRA has learned reminds me of what political parties and the mainstream media learned about US political blogs in 2004 and that is that they cannot ignore them. The reading public has voted with its eyeballs and has decided that blogs matter, and matter in some cases much more than Big Pharma's own websites and more than pharma-funded health care sites like WebMD. And that my friends smells like victory.

I simply cannot wait until the FDA figures this phenomenon out for itself. Advertisers too.

Fall Fundraiser--Day 10

Another $200 came in yesterday and that brings the total for the fundraiser to $1,415, leaving $1,585 to go by the end of next Wednesday. So the fundraiser is almost halfway to its goal. It'd be really super if that thermometer on the right were over $2,000 by Monday because I would really like to end this fundraiser by the end of next Wednesday.

Ordinarily, I'd have a couple of other new posts up by now but yesterday I got dragged off by a major news organization to do what's called stringing for them. That doesn't mean I was writing anything. Just helping with some on the ground reporting on something in Seattle. I'll tell you what it was when I can (hint: politics).

As a result, I am completely burned out and am going to bed early since I am likely going to be stringing again part of tomorrow (note: thank God for politics). With luck, I'll have a very interesting post up in the morning about the growing influence of blogs like this on how the public gets information about psych meds.

The AP Finds Even More Pharma Products In America's Water Supply

Back in March, the AP's investigative unit uncovered the fact that the water supplies of many American cities contained small amounts of pharmaceutcials, including hormones and mood stabilizers. Now, the AP has uncovered even more medications in urban water supplies, adding 17 more big cities to its list (for example, Reno, Nev., Savannah, Ga., Colorado Springs, Colo., and Huntsville, Ala.) and effecting the water supplies of 46 million Americans. The cities went off and did the testing on their own, spurred by the AP's excellent reporting in March. The usual suspects showed up on the meds front, but the only psych med to make the list this time was Tegretol (carbamazapine).

"Chicago, for example, found a cholesterol medication and a nicotine derivative. Many cities found the anti-convulsant carbamazepine. Officials in one of those communities, Colorado Springs, say they detected five pharmaceuticals in all, including a tranquilizer and a hormone."

Some cities turned out to have fairly clean water, one of them being Seattle. That's not a surprise, given that my city's water comes from high up in the Cascade Range where the pharma gods apparently do not reign. Apparently, other US cities are not so fortunate. One city water supply remains untested at this point: New York City.

While the risks of drugs in the water supply aren't known, it's is known that Prozac in small concentrations in streams makes fish not want to eat and make them swim weirdly. I imagine this cannot be good for small children much less adults.

Pharmaceuticals in the water supply. As Sen. McCain put it last night, America is an "exceptional" country.

Fall Fundraiser--Day Nine

Another $130 came in yesterday and that brings the total for this fall's fundraiser to $1,215 raised to date. That leaves $1,785 to be raised to meet the goal of $3,000 by the end of next Wednesday. You can see where things are at via the handy thermometer on the right.

I appreciate all the contributions that have come in so far, but things are going a lot more slowly than I'd like, so let me point out to you all that if this fundraiser doesn't hit its goal by the end of Sept. 17, then I'm going to have to scale back how much time I put into this site (it's on the order of 60 hours a week) because I've got to be able to pay my rent and other bills each month. Unlike some other sites, I am not underwritten by a health care web company, I am not supported by a newspaper as Pharmalot is, and I don't have reams of ads on my site as does Psych Central (not that I would mind be supported by a newspaper or having reams of ads). I've reached out to ad agencies that handle blog ads over the summer but have gotten no response--likely because this site is considered far too radical and "unsafe," which is kind of odd since my views are fairly moderate compared to the anti-psychiatry and pro-psychiatry camps. It's also kind of odd given the amount of traffic that this site gets.

I already subsidize a significant amount of my time here with outside freelance work, but I can assure you it's pretty slim pickings for me in that world lately. Yesterday, I had an article idea on bipolar disorder shot down by a major magazine and the nice folks at another major magazine haven't even bothered to respond to a recent pitch I sent them. Trust me, if I could land a big-paying article somewhere I wouldn't be asking you all for money (or I'd ask for less). But I can't and I am.

As usual, there's a PayPal button on the right. Or if you prefer snail mail, drop me an email and I'll send you my mailing address. Thanks for your support.

Brit Paxil/Seroxat Activist Meets With Brit FDA, Gets Concessions

Many of you know Bob Fiddman who writes the Seroxat Sufferers blog in the UK. Seroxat is the UK name for Paxil. Fiddy was utterly ripped apart by the drug and especially by his withdrawal from it, and for the last few years he's been hounding GlaxoSmithKline, the drug's maker, and the MHRA, Britain's FDA over why the drug is still on the market and why it's still on the market with almost no information about withdrawal issues with the drug. He's not the only activist in the UK to have taken their frustrations with both parties online--oddly, in the US there is much less anger directed at Paxil than in the UK, for reasons I really cannot account for--but he's the one who got the attention of the MHRA's chief Prof. Kent Woods.

Last week, Fiddman had a sit-down with Woods and has posted the minutes of their meeting online. Fiddaman got some results from his meeting: the MHRA has agreed to meet with David Healy, a British psychiatrist and vocal critic of SSRIs, and presumably Healy will provide the agency will all sorts of information about Paxil and its problems. What's more, the MHRA will work with the British physician formulary--kind of like their Merck drug guide I suppose--to include information on withdrawal from Paxil/Seroxat.

This is a substantial victory for Fidders, a man of many cognomens, and I congratulate him. It's of course a victory for all of us in a way.

Most especially, however, I wish to thank Prof. Woods and the MHRA for meeting with Fiddaman. Would that our own FDA would be as forthcoming with patients on this side of the Atlantic who have similar concerns and inquiries about various drugs and the agency's role in making up psychiatric diagnoses on its own.

In the near future, I will be able to offer you all some interesting evidence of just how influential websites like this one, and Fiddaman's and some of yours have become when it comes to matters concerning certain psych meds. This evidence will also show how comparatively weak is the influence of various health care websites such as WebMD and how the bloggers are now almost as influential as such traditional media powerhouses as the BBC and the New York Times. I cannot wait until the FDA sees that evidence.

Sen. Grassley Nails Yet Another Psych Researcher

Sen. Charles Grassley (R-Iowa) has nailed yet another university and yet another psych researcher for underreporting of monies received from a pharma company. This time out its the University of Texas and Karen Wagner, a psychiatry professor at UT-Galveston.

From the Wall Street Journal:

"Some major universities are reviewing the way they handle funding from drug companies in the wake of criticism from Sen. Chuck Grassley, who is pressing the federal agency that controls government health-research money to get tougher on universities that don't disclose ties to the industry.

"Late Tuesday, Mr. Grassley (R., Iowa) fired the latest salvo, stating in a letter that a researcher for the University of Texas who worked on a National Institutes of Health study involving the GlaxoSmithKline PLC antidepressant Paxil did not disclose more than $150,000 in consulting and speaking fees paid to her by the company. Mr. Grassley has raised similar criticism of other universities, including Stanford, Harvard and University of Cincinnati."

Among other things, Wagner is one of the co-authors of the infamous and much-discredited Paxil Study 329, which claimed that Paxil was efficacious and safe in treating depression in adolescents when in fact the study's stats had been so jury-rigged that, in actuality, the drug hadn't beaten placebo and cases of suicidality encountered in the underlying clinical trial went unreported.

Ironically, Wagner did her child psychiatry residency at Harvard's McLean Hospital. Birds of a feather apparently underreporting pharma money together.

Good for Sen. Grassley and his Senate Finance Committee staff for continuing to press forward on this front. I've written about other efforts by the Senator to clean up psych research here.

And for those of you who are newbies to the Study 329 story, Healthy Skepticism has the background here.

Wisconsin Man With OCD Eats 23,000 Big Macs Since 1972

It's next to impossible to find a good, humorous mental health story--Lord knows, I've tried--but here's one out of the AP's odd news file about a man with OCD.

"Talk about a Big Mac attack! Don Gorske says he has eaten 23,000 of the burgers in 36 years. The Fond du Lac man said he hit the 23,000 milestone last month, continuing a culinary obsession that began May 17, 1972, and is fed by his obsessive-compulsive disorder.

"'I enjoy them every day,' said Gorske, 54. 'I need two to fill me up.'"

"Gorske has kept every burger receipt in a box. He says he was always fascinated with numbers, and watching McDonald's track its number of customers motivated him to track his own consumption.

"Despite a diet some would call unhealthy, Gorske says he keeps himself in good shape. He says he's 6-foot-2 and weighs 185 pounds, and walks as many as 10 miles a day."

This guy has been eating Big Macs every day since he was 18! And to keep himself from missing a day due to work irregularities and snow storms, he keeps several Big Macs in a freezer at home. Now that's dedication.

Tell The FDA To Answer Questions About Pediatric Bipolar Disorder

Many of you are aware that in late July the FDA announced, in response to an inquiry I made, that pediatric bipolar disorder was a valid diagnosis. This came despite the fact that the controversial disorder (sometimes known as child bipolar disorder or juvenile bipolar disorder) is not in the DSM, is not an accepted diagnosis by public and private insurers and is a matter of much debate among child psychiatrists. The alleged disorder has also gotten quite a bit of attention in the press and it's my understanding that a major publication will have an article on the bipolar child business in the next few days.

Some background.

Since July, I have repeatedly asked the FDA to make Thomas Laughren, chief of its psychiatry products division, available to explain what exactly the disorder is--its precise scientifically-developed symptomology and episode durations--since it was Laughren who decided the diagnosis is valid. The FDA declined to let me interview Laughren (odd since I've interviewed him before on other matters and odder still since he helped Big Pharma design trials for the alleged diagnosis) and has since refused to answer my repeated requests that the agency explain, verbally or in writing, how it defines pediatric bipolar disorder. You'd think it would be an easy thing for the agency to do since it has approved two drugs recently to treat the alleged condition (ones that have led to hundreds of adverse events reports in children) and you wouldn't be crazy to wonder that if they approve drugs for a condition, then the agency must know what the condition is and should, in its capacity as a public health agency, tell the public what's going on.

Yesterday, I made a final request for an explanation and got no reply. Apparently, the agency must assume that the public isn't very interested in this matter and that I am simply a wingnut blogger who can be easily ignored by the mighty FDA.

To help correct this misapprehension, I think the FDA needs to hear from all of you who read this post. It doesn't matter whether you are pro-meds, anti-meds, a true believer that kids are psychiatrically ill at birth or that they are victims of bad environments explained by other DSM diagnoses--we all have a stake in having the FDA explain what pediatric bipolar disorder is, how it's measured, what its symptoms are, what its episodic duration is and so on. Otherwise, we run the risk of what Psych Central has dubbed diagnosis by government decree. Since when has the government been in the business of dreaming up psychiatric diagnoses?

The public information officer for the FDA's psychiatry products division is Sandy Walsh. You can shoot her an email at sandy.walsh@fda.hhs.gov. Tell her that the agency needs to answer legitimate questions about the diagnosis. Be polite, please. And thanks for your help.

Perhaps, we can all get some answers.

Burned Out

I took last evening off after trying to write for a bit and finding myself all mushy in the head. Simply put, I am burned out and will be back later this morning with some new posts.

As for the fundraiser, you can see where things are at via the dandy thermometer on the right.

Fall Fundraiser--Day Seven

Another $113.74 came in yesterday and that brings the total for this fall's fundraiser to $880 raised to date. That leaves $2,120 to be raised to meet the goal of $3,000 by the end of next Wednesday. I've even added a handy thermometer on the site so you can see what's up.

I appreciate all the contributions that have come in so far, but things are going a bit more slowly than I'd like, so let me point out something to the many of you who have supported this site by reading and contributing over the last year or so: yesterday, this site got over 7,500 visits. That utterly smashes the previous one-day record of 3,400 set in late July. I'm not pointing this out to brag, but to let readers know that the central message of this site--and that would be accountability for the mental health industry--is starting to gain a serious audience, one that is just as frustrated and skeptical about what's going on as the rest of us are. If you don't believe me, check out this comment thread over on reddit.com where people were responding to yesterday's post on the placebo effect.

Without your support, it wouldn't be possible for this site to reach so many readers. It would be great if you could help it reach more, because as one pretty well-known journalist who reads this site told me the other day, You are making public an evidence base that the mainstream media can't ignore. Or words to that effect.

As usual, there's a PayPal button on the right. Or if you prefer snail mail, drop me an email and I'll send you my mailing address.

Study: 50 Percent Of US Anti-Depressant Use Not Tied To An Identifiable Diagnosis

You read that headline right despite its clunkiness. In a study presented at the Canadian Psychiatric Association annual meeting yesterday, University of Winnipeg researchers asserted that more than 50 percent of Americans surveyed who took an anti-depressant did so "without possessing any indication for such treatment, according to accepted medical guidelines," said one of the researchers.

Before I go further, let me offer some cautions. This study has not been published yet (given its conclusions, I assume it will be), so it has not stood up to formal juried academic peer review, aside from whatever responses the authors got at the meeting. I don't want to conclude too much from this study until it's been published, but the fact that it cleared the various hurdles, including some form of peer review, to be presented at an academic conference gives me some confidence that the study is relatively kosher. Second, the study is based on surveys which can be somewhat unreliable (about 15,000 people were surveyed). Third, the one press account I read didn't give too much detail on what diagnostic criteria people taking anti-depressants weren't clearing hurdles for--depression? dysthymia? bipolar? anxiety? OCD? Fourth, only the barest of data is available to me at this point.

All of that said, I've previously documented on this site the crisis of overdiagnosis, or misdiagnosis, of bipolar disorder in America. Apparently, there are problems with other diagnoses as well, if I understand the implications of this study correctly. Perhaps that is because 80 percent of anti-depressant prescriptions written in the US are by non-psychiatrists (I have a friend whose cardiologist gave her anti-depressants) and your friendly neighborhood PCP isn't exactly a walking DSM. Certainly, a study like this makes you raise your eyebrows when you consider that 30 million Americans take anti-depressants and more than 230 million anti-depressants Rxs were written in 2007. If 50 percent or more of that use is somewhat baseless, then why exactly are 30 million people taking anti-depressants?

Especially when, as I noted yesterday, there is now evidence that the placebo effect is much larger and much longer lasting than was previously thought.

I'm not offering any of this information as an attempt to scare anyone off their meds or to press them to challenge their diagnoses. I'm certainly not saying depression isn't real or serious (I know too well how real and serious it can be). I'm just using it to offer some skepticism about where we are at in our culture as regards the use of anti-depressants. Like our nation's politics, it's all very mixed up out there.

(Thanks to Joe for passing along the study.)

Texas Man Sues Doctor After Off-Label Rx Of Geodon Disables Patient

From the Southeast Texas Record:

"A Beaumont man has filed a suit against a local psychiatrist, alleging the doctor prescribed a medication for an off-label use that has left him permanently disabled."

The drug: Geodon, one of the least used atypical antipsychotics. The off-label use: depression and anxiety. Geodon is approved for use in schizophrenia (not that it's such a great performer there) and bipolar mania and mixed episodes in bipolar disorder. The disability: tardive dyskinesia and tardive blepharospasm (drooping eyelids to the point where the patient can't drive a car).

Even weirder: "The suit states that Moss continued the regimen of Geodon for two years, 'even after plaintiff had a transient ischemic episode or minor stroke.'" Makes you wonder if the doc insisted that the meds couldn't be responsible so the patient kept taking the drug.

Geodon is made by Pfizer. Once upon a time, I took this drug for about three weeks and it agitated me so badly that I took myself off it before talking to my doctor. Not being able to sleep will make a patient do that. Lost a lot of weight on it though.

Fall Fundraiser--Day Six

Another $195 came in since Friday and that brings the total for this fall's fundraiser to $766.26. The total goal for the fundraiser is $3,000, so there's another $2,233.74 to go by the end of Sept. 17 when I hope to wrap up the fundraiser.

I appreciate the contributions that have come in to date from 20 kind contributors.

If any of you have questions about the validity of this site or the judgment of its author, you need look no further than Friday's court order that the Zyprexa documents--which I posted on this site in Feb. 2007--be unsealed because Eli Lilly's rights to confidentiality are, in the judge's opinion, outweighed by the public's right to know about the drug and how the company handled it.

Since I made those documents publicly-availble, thousands of people have downloaded them and so have many law firms, state attorneys general offices, insurance companies, pension funds, newspapers, TV networks and so on. To date, not one single entity that made use of my free public service has made a contribution to this site. You'd think some of those AG's offices and such would be willing to at least toss a contribution my way...perhaps the equivalent of what they bill for an hour's worth of a legal researcher's work. Just an idea.

Anyway, as usual, the PayPal button is on the right. Or if you prefer snail mail, send me an email and I'll shoot you my mailing address.

Placebo Effect In Depression Treatment Much Larger Than Previously Thought

CL Psych made me aware of an explosive study in the August Journal of Psychiatric Research which contends that the placebo effect in anti-depressants is much larger than I think anyone in the research world expected. It's a meta study re-analyzing eight anti-depressant trials comprising 3,063 people diagnosed with depression. The study was done by Arif Kahn et al. Kahn is well known in the research world and runs a large clinical research facility in the Seattle area. So he's a long way from being an anti-meds advocate.

In the study, which looked at trials that went longer than 12 weeks (some went as long as 12 months), Kahn found that 79 percent of patients on placebo remained well compared to 93 percent of anti-depressant responders. That would give an overall effect size of the anti-depressants studied of 14 percent, well under the usual 25 percent to 30 percent in shorter anti-depressant trials. I cannot tell from the abstract what specific anti-depressants were involved, but for a sugar pill to perform nearly as well over time is astonishing. Eye-opening even.

One caution in interpreting these results is that there is no way to determine from the placebo responders how many were simply having their depression remit naturally. Then again, you can't tell how many taking anti-depressants were remitting naturally as well (that'd be kind of hard to tease out, of course).

CL Psych offers this thought:

"So yeah, people on drugs did a bit better, but about 4 in 5 people taking a freaking sugar pill were still doing well in the long-term. Anyone still want to seriously argue that the vast majority of the antidepressant effect is not the placebo effect?"

I sure wouldn't, but I'm sure some pharma companies would. In his study, Kahn offered this assessment:

"The widely held – and probably erroneous – belief that the placebo response in depression is short-lived appears to be based largely on intuition and perhaps wishful thinking."

Wishful thinking in mental health treatment? Never.

"I Kill For God" And Other Thoughts For The Washington State Legislature

On Friday, the alleged mass murderer Isaac Zamora, who killed six during a shooting rampage in Skagit County, Wash. last week, was arraigned. He told the judge, "I kill for God. I listen to God." Variously described as having schizophrenia (my guess as well) or bipolar disorder, Zamora also has a long history of drug use (cocaine mostly), arrests, and as a guy who almost completely evaded the mental health system (he was hospitalized a few times, but largely blew off medications, treatment and any aftercare).

On Sunday, the Seattle Times' editorial board chimed in with an editorial demanding that the state legislature hold hearings on the state's civil commitment laws and outpatient commitment. Compared to the Seattle Post-Intelligencer's deeply biased and flawed reporting on outpatient commitment last week, the editorial was low-key, but one does worry about turning this whole tragedy into a political football. Then again, a cop was killed, so this is a natural outcome.

"The Legislature has a duty, however belated, for the six deceased and their loved ones, to look at the state's mental-health system and civil-commitment laws and procedures. Zamora's record put him into the orbit of state Department of Corrections supervision. How credible and useful was the monitoring of this multiple-slaying suspect?

"Is the current threshold for involuntary treatment too high? If the standard is imminent danger, does that ignore the menace who is a persistent threat and always just beyond the reach of a satisfactory outcome for those threatened? Does failure to have treatment available speak to the strictness of the law, or inadequate options and a lack of available residential space and professional help?"

Like it or not, the Legislature is going to get this whole mess dumped in its lap, despite the fact that most of the next legislative session, which begins in January, will be taken up with an inevitable budget deficit and all the other usual complications of running a state. People want something done and the leg will be pressed to do something.

The Zamora case is probably not the best one upon which to base arguments in any direction for change. There's too much about it that's sui generis--the guy had been living in the woods for months apparently, among other things. But there are questions the leg should be asking.

First, how did this guy get his hands on a gun or guns (he's a convicted felon and had been committed once before for more than 14 days, both of which mean he couldn't legally buy a gun)? Were they laying around the family's house or did he steal them or something else? Second, when he appeared before a judge back in May, why didn't the judge order an outpatient commitment hearing (the state does have an outpatient commitment law) or some other form of mental health intervention, given Zamora's long rap sheet and documented mental health history? Why did the judge simply parole him and turn him over to the corrections department? Third, what kind of follow-up did DOC do? Did anyone there have doubts about Zamora's ability to live in the workaday world?

I'm raising questions about both the judge and DOC because it seems like a ball may have been dropped somewhere in that chain. The reality is that Zamora's rampage could've been headed off months ago with some kind of appropriate intervention.

Beyond that, legislators will hear a lot of passionate arguments from advocates on all sides of the issue about how they believe Washington State's civil commitment laws are too loose and how the state's outpatient commitment law needs to be employed more frequently. Both arguments are bogus. The state's civil commitment law requires that a person be an imminent danger to self or others in order to be committed involuntarily. It also allows a person to be committed involuntarily if they are too gravely disabled to take care of themselves, a provision of the law that is hardly ever used. Obviously, there's much debate over what "imminent" means, but the reality is that this law has worked fairly well for the decade since it was last updated with a glaring exception. It is very difficult to get someone committed in this state for more than a few days simply because there are no beds available at the two state hospitals (generally filled to bursting) and shorter-term psychiatric facilities such as Harborview are generally maxed out as well. More beds are needed, plain and simple. And I say this as someone who is no fan of long-term psychiatric hospitalization.

As for outpatient commitment laws, in the real world they are often rendered unnecessary because mental health facilities often put their patients under something called an LRA or least restrictive alternative. It's essentially a contract entered into between patient and institution, requiring the patient to undergo treatment in exchange for their release for the institution (if a patient violates the LRA, then off to court they go). My experience is that this practice is pretty effective for the most part and certainly saves an overburdened court system time and resources.

One thing the leg may want to ask about are the so-called CDMHPs or county designated mental health professionals. Under state law, these are the only people who can order a patient committed involuntarily to an institution--doctors and the police cannot. Having been involved in the mental health field as both a reporter and social worker (briefly), I can say a lot of people in the system are deeply confused about how CDMHPs define danger to self or others, as there seems to be wildly different outcomes each time a person is sent to them for an evaluation. Let me offer one personal example: Earlier this year I worked at a homeless shelter in Seattle. One day, a young woman appeared at the shelter and was admitted. Soon after, I briefly interacted with her and noted she was not capable of responding to questions and appeared to be zonked, for lack of a better term. A few hours later, she punched another client in the face. Police were called. All the workers encouraged the woman, who was buggy-eyed and removed from reality, to voluntarily go with the police to Harborview for an evaluation. She refused and the cops cuffed her and took her away. Most of us were convinced she would be held in the psych unit there. But within two hours, she was on the sidewalk in front of the shelter on a very cold night with a group of crack dealers circling her. We couldn't readmit her to the shelter since the woman had broken the rules by assaulting another client. That episode has never made sense to me and it's my understanding that she was not held at Harborview because the CDMHP who examined her disagreed with both the social workers and the police as to whether or not she was a threat to anyone. This kind of thing goes on with the CDMHPs all the time and the way they make their determinations needs to come under review. There are numerous documented instances in this state where CDMHPs have released people who were dangers to the public.

The leg will hear a whole bunch about "treatment" and how all people with serious mental illnesses need is to be forced into treatment and violence will be prevented. To be clear, when the term treatment is floated we aren't talking about anti-depressants and mood stabilizers but antipsychotics. It's ironic that legislators will be hearing about them at a time that a rolling scandal about the dangers of these drugs for people with schizophrenia (and many others) is taking place and several states are already suing Eli Lilly, AstraZeneca and Johnson & Johnson over safety issues with the drugs. Washington State is likely to be one of the states joining a multistate action against Lilly if it's not settled earlier. It's even more ironic that Lilly recently hosted a party for Washington State delegates to the Democratic National Convention.

Beyond that, advocates for antipsychotic use--even doctors--should be quizzed about how well and consistently these drugs actually work. There is a growing body of research showing that their performance is highly inconsistent (see the 2005 CATIE study among others) and that the drugs do such things as cause brain shrinkage and other side effects such as strokes, diabetes and heart attacks. If advocates are going to demand treatment, then it would be grand if they advocated for treatments that work.

What's more, the leg is likely to be lobbied by a group called the Treatment Advocacy Center and its head E. Fuller Torrey. Feel free to listen to their arguments, but ask them where the data they cite comes from and whether it's been published in peer-reviewed journals. TAC and Torrey have a long history of twisting data, using unreliable data sources and they commonly do not submit their claims to the scrutiny of academic peer review (why newspapers such as the P-I buy their claims in open to debate). Also, the leg should know that Torrey is deeply reviled within mental health circles, not just by patients but by actual researchers as well. You might even ask him why his group cites violence done by people not taking medications, but ignores violent acts committed by people who were on medications and why so many of the studies the group cites are decades old. For example, TAC has recently floated claims that 1,000 homicides a year can be tied to people with schizophrenia and bipolar disorder. But the group cites no source for its claim, one that was accepted by the P-I as legit and published in its pages.

I'm putting all of this into the public realm in hopes that, if the leg is going to take up these issues in the wake of last week's tragedy, then legislators watch out very carefully for the spin and wild overstatements that come with tragedy. If you are going to make changes to a system, make the ones that are truly needed, not the ones that advocates say are needed.

Judge Orders Zyprexa Documents Unsealed

About an hour ago I learned that District Court Judge Jack Weinstein had ordered that numerous confidential documents be unsealed in the class action lawsuit, settled in 2005, against Eli Lilly over accusations about its antipsychotic Zyprexa. It's not clear to me yet how many documents are being unsealed--more than the original set of documents that were leaked and have been sitting on this site since February 2007, or just the initial leaked set?

Either way, the judge had this to say in his order, echoing something I wrote on this site 19 months ago:

"A federal judge in Brooklyn decided on Friday to unseal confidential materials about Eli Lilly’s top-selling antipsychotic drug Zyprexa, citing 'the health of hundreds of thousands of people' and 'fundamental questions' about the way drugs are approved for new uses....'Lilly’s legitimate interest in confidentiality does not outweigh the public interest in disclosure at this stage,' Judge Weinstein wrote."

In addition, Weinstein certified an ongoing lawsuit against Lilly by insurance companies, pension funds and unions for class action status. Lilly will reportedly appeal that decision, but will not appeal the unsealing of the documents.

Weinstein's decision certainly shoots the hell out of Lilly's earlier claims that the documents were cherry-picked by David Egilman, a plaintiff's expert witness, from among millions of pages of documents in order to provide a distorted picture of Zyprexa's safety and the company's behavior. Through a very convoluted set of moves, Egilman got the documents to Jim Gottstein, an Alaska lawyer who was not covered by the initial court seal, who then provided them to the New York Times and some activists in the mental health world. Somewhere in there I got my hands on the documents and made them public, something even the paper didn't do as it reported on some of their contents.

The Times included some thoughts from Egilman and Gottstein in its article for Saturday's edition of the paper:

"Dr. Egilman said on Friday that he felt vindicated.

"'The public can now decide for itself what these documents stand for,' he said. [Um, they have been for 19 months, David. Or did he forget that part?]

"Mr. Gottstein said he still disputed Judge Weinstein’s rulings that he had obtained the documents illegally.

"'I think I did get them properly,' he said, adding that the new order unsealed only a small number of the Zyprexa documents that Lilly has provided to the court. 'There are a lot of other documents that are hidden.'"

I should know more soon on when the documents will be released and, if they are a larger set than the initial documents, I'll work to make them available to the public.

Cymbalta, Seroquel Being Investigated By FDA For Overdose, Urinary Problems

The FDA is just out with a list of drugs it identified as having major issues which the agency needs to investigate, based upon data from the first quarter of the year. Two psych meds make the list of 20 drugs and I list them below with their approved use and the problem being investigated:

"Cymbalta, for depression and other conditions, urinary retention.

"Seroquel, for bipolar disorder, overdose due to sample pack labeling confusion."

Urinary retention sounds like a perfectly awful side effect of an anti-depressant. But then so do overdoses of Seroquel. Other drugs on the list are OxyContin, Heparin and Dilantin.

It'll be interesting to see what the FDA turns up.

Fall Fundraiser--Day Three

Over the last 24 hours $300 more has come in, bringing the amounted raised so far to $570. The goal for the fundraiser is to raise $3,000 by Sept. 17.

Thanks to all of you for your contributions so far.

For those of you who'd like to support the work I do here, there's a PayPal button on the right. Or, if you prefer snail mail, send me an email and I'll shoot you my mailing address.

Suicide Rate Unchanged In 2005

I've not seen this reported elsewhere, but the CDC's annual mortality report is out and it shows that the suicide rate in the US for 2005 remained unchanged from 2004 at 11.0 deaths per 100,000 people (see page 29 of this 2.2 MB pdf), or 32,637 people. Preliminary reports last year suggested that there would be a slight decrease in 2005, so this news is disappointing. (Last year the CDC reported that the rate in 2004 was 10.9, but its current report lists it at 11.0. I cannot account for this adjustment.)

Although there were slight decreases in suicide among groups aged younger than 45 years old, there were slight increases in groups aged 45 and above. Seventy-nine percent of suicides were by men (see page 42). Ninety percent of suicides were by whites. Fifty-two percent of suicides were by firearm, the majority of those being men.

It's a bit early yet to know how any of this will be dissected and spun by various interests in the mental health industry. One interesting bit is that anti-depressant prescriptions increased in 2005 by 10 percent (previous reports claimed it had fallen slightly), so the "anti-depessants prevent suicide" theory isn't looking so rosy (personally, I think that the suicide rate and anti-depressant use are likely independent of one another, measured on a culture wide basis).

One other point worth making is that in 1999, the feds announced a national goal of reducing the rate of suicide by 50 percent by 2010. The rate of suicide in 1999 was 10.5 per 100,000 people, so the rate has actually increased by about 5 percent during that time.

5 Percent Of American Kids Taking Psych Meds

New data out from the CDC shows that 5.1 percent of American kids are now taking medications for various mental health diagnoses. Approximately twice as many boys as girls are on meds (6.6 percent versus 3.4 percent). Most of the diagnoses are for ADHD. It's not clear to me from the CDC's report how much of a change this was from previous years.

Seroquel Touted For Anxiety

The press release machine that is WebMD has this on a new study of Seroquel in anxiety:

"In the new study, 854 generalized anxiety disorder patients were given either Seroquel XR, Lexapro (a prescription drug approved to treat generalized anxiety disorder and depression), or a placebo without knowing which pill they were receiving.

"For eight weeks, the patients took their assigned pills daily. During that time, Seroquel XR and Lexapro beat the placebo at reducing anxiety, according to surveys completed by the patients."

No information on how big of a benefit was received. No information on what doses patients took. Interestingly, AstraZeneca itself hasn't put out a press release on this study which was presented at a conference in Europe earlier this week. Antipsychotics for anxiety? Sounds awesome to me.

AZ submitted data earlier this year to the FDA for approval of Seroquel for anxiety and depression.

TMAP Boss Departs

I don't have much to add here, but via Pharmalot we learn that John Rush--the much-published, influential University of Texas psychiatry professor--has left his role as the head of the controversial Texas Medication Algorithm Project. He's taking a job as a dean of Duke's medical school in Singapore, the land of caning. Perhaps Rush will find a more receptive audience for his dogmatic, pharma-funded, lawsuit-riddled TMAP there.

Seattle Newspaper Advocates For Fuller Torrey

Today's Seattle Post-Intelligencer has a lengthy article examining "another failure" of Washington State's system for handling people with mental illnesses. The article was spurred by the recent mass murder north of Seattle. In some respects, the article does a decent job of capturing the mess that is the public mental health system, but unfortunately the reporters turn for solutions to outpatient commitment and the Treatment Advocacy Center, the ultimate ambulance chasers in mental health advocacy.

I'm no fan of playing journalism police, especially in my own town and especially with a paper I generally like, but if I am going to do it with the Wall Street Journal, the Washington Post and wire services, then I've got to do it here as well.

The basic premise of the article is that the mental health system is in disarray, much money is spent but positive results are few, too many people diagnosed with mental illnesses ignore their treatments, so they should be forced into taking treatments because the treatments are safe and effective and always work and this will prevent violent acts committed by the mentally ill. Oh boy.

Here's the lede:

"The shooting rampage that left six dead Tuesday in Skagit County is the latest tragic incident involving a person with apparent mental illness who didn't get treatment in time to prevent violence."

And, then, off to the slippery slope we go.

"People with untreated schizophrenia and bipolar disorders committed about 1,000 of the estimated 16,000 homicides in the United States last year, according to figures kept by the Treatment Advocacy Center."

Given TAC's long history of sloppy data collection and questionable methodology (it mostly relies upon press accounts for its information and the media isn't doing unbiased science) and the fact that data like this hasn't stood up to peer review, it's odd that the P-I would just swallow this assertion whole.

Then comes an absolute error:

"Currently, about 40 percent of the 4.5 million individuals with schizophrenia and bipolar disorder in the United States are not getting treatment, said Torrey."

Only 4.5 million people with schizophrenia and bipolar disorder in the US? NIMH estimates peg schizophrenia at a little over 2 million adults, whereas bipolar disorder affects anywhere from about 4 million adults to as many as 8 million adults (even higher according to some estimates), so this 4.5 million figure is in error and should be corrected.

Then this:

"In this state, more people don't get treatment -- or stay in it -- for a complex array of reasons: shortages of beds and housing, overextended mental health care workers and no legal means to treat people early on in the progression of their disease." (Emphasis mine.)

Actually, a lot of people get treatment in this state--in the private health care system. I suspect the authors mean people in the public mental health system, but that's not what the article says. That's something an editor should've caught.

More troubling is the paper's assertion that there's no legal means to treat people early on, a line that's straight out of TAC's playbook. First, there is no particularly solid science on the progression of schizophrenia and bipolar disorder over a lifetime. Some people do well using standard treatments, some do horribly (both Charles Barber and I have written about the fact that perhaps 20 percent of seriously ill schizophrenics simply don't respond to medication of any kind), some people do OK over time by blowing off treatments, and there is now published data establishing that bipolar disorder is being wrongly diagnosed at about a 50 percent rate. There's even some research showing that bipolar disorder tends to fade with time. Second, research seeking answers to how well early interventions work in schizophrenia have come away with very mixed results and a swamp of ethical issues. Third, two decades into the psychopharmacological revolution, there is little consensus among researchers as to what actually causes schizophrenia, bipolar disorder and depression. And any source who tells a reporter they know what causes these disorders should be immediately suspect.

Given all of that, why would the P-I be advocating for a system of early intervention, since it's not even clear such a system would work consistently or that it would be humane? I think any reporter or newspaper editor (or doctor) who is going to adopt the line that all people need is treatment should experience that treatment for themselves by taking 10 mgs. of Zyprexa (or Risperdal or Seroquel) each day for a month and then get back to me on how fine they feel and how their blood sugars are doing. Perhaps they will learn that treatments cause about as many problems as they solve.

Another thing the paper missed is that TAC ignores the fact that acts of violence are committed by people who are on-meds (and, here, I am not even thinking of shootings and SSRIs) and that the group sometimes tells the public that someone was off-meds when they were in fact on-meds. That really makes for a weird evidence base for an advocacy group.

Perhaps even weirder is that the paper's reporters seem to have missed the news that drugs used to treat schizophrenia and bipolar disorder are, in some cases, causing deaths or injuries or other problems to the very people who these drugs are supposed to be helping. In the 18 months since the Zyprexa documents have been in the public realm, I have not read one mention of the scandal involving that drug in the P-I and I read the paper every day (I could've missed something though). I've not seen the paper acknowledge that other psych meds like Risperdal and Seroquel are causing deaths and injuries as well much less that they are being wildly over-used in adults and children (and that Seroquel has turned into a street drug). And, apparently, the paper has completely missed the news that anti-depressants don't work so well and are, in fact, believed to be behind the lack of success some patients with bipolar disorder experience.

Then the article gets onto a theme I first flagged locally four years ago:

"A shortage of places to discharge patients also keeps them in the hospital longer than necessary.

"'Today we have 120 people at Western State who are clinically cleared for discharge -- no longer at risk to self or others -- but who have significant support needs, and nowhere to go,' said Richard Kellogg, head of the mental health division of the state Department of Social and Health Services.

"'We wouldn't have backups if we had patient flow -- if we could get people out in a timely manner," he said. 'In the short term, what is significantly lacking is housing alternatives -- housing connected to support services, employment and social networks.'"

Ah, welcome to the show, daily newspaper reporters.

Fall Fundraiser--Day 2

So far $270 has come in for the fundraiser, so things are off to a good start. The total goal for the fundraiser is $3,000 over the next two weeks. For those of you who'd like to help support my work here, there's a PayPal button on the right. If you prefer using mail, then drop me an email and I'll give you my mailing address.

Yesterday, I put up a post blabbering on about the work I do here and why I think it merits the support of readers.

Thanks again for your support.

Eli Lilly Once Again Goes After Alaska Lawyer Over Zyprexa Documents

As I noted a few weeks ago, the Bloomberg wire service fought to get some documents unsealed in the Alaska v. Lilly lawsuit, settled earlier this year, over allegations that the company's antipsychotic Zyprexa had serious problems and that the company covered up the facts, among other allegations. One group of documents was unsealed and I wrote about them here.

Meanwhile, Alaska lawyer Jim Gottstein has been fighting to get even more documents from the case unsealed. Gottstein is of course the lawyer who leaked an earlier set of Lilly Zyprexa documents, which were under court seal in a federal court case, to the New York Times and others. Lilly got a judge to sanction Gottstein and David Egilman, the initial leaker who settled with Lilly earlier for $100,000, but, so far, Gottstein has fought the judge (and Lilly, of course) on that sanctioning.

Anyway, among the documents Gottstein is trying to get unsealed in Alaska are the same set of Zyprexa documents that led to much bad press for Lilly (and are housed on my site). Why they would be under a court seal in Alaska when they were already in the public realm is a bit beyond me, and now Lilly is fighting Gottstein's attempt to get them unsealed. If I understand its lawyer's argument in this filing (4 MB pdf), it's making the case that since Gottstein was already sanctioned over leaking these documents by a federal judge, then the state court in Alaska shouldn't honor his request for the documents. I'd say that Lilly's legal point is moot. The documents have been in the public realm since early 2007, so the company is doing little with its filing but messing with Gottstein.

In fact, the company's outside counsel in the case is now threatening Gottstein with further legal sanctions and the company itself is pretty obviously trying to find a way to bleed him financially so that no one will ever again dare cross mighty Lilly when it makes a drug that is poisoning innocent people and lies about it by doing something like telling the public about it. Here's the threat:

"Mr. Gottstein's actions, along with his abuse of the Alaska subpoena power and his willful violation of MDL Orders, are the subject of an appeal pending before the Second Circuit, and may be the subject of further sanctions proceedings before Judge Weinstein. Granting this application would have the unintended--but nevertheless real--effect of nullifying, in part, Judge Weinstein's efforts to enforce his orders, and would allow Mr. Gottstein to effectively modify an injunction entered as a result of his willful violation of another court's order. Such an action by this Court would raise thorny issues of comity and federal-state court relations. But those issues can be avoided if this application is denied or, in the alternative, stayed pending disposition of the federal proceedings."

My view on this is that it is time for Eli Lilly to grow up and shut up and discontinue its scorched earth policy towards those who ruffle its feathers. Zyprexa has killed thousands and given tens of thousands of others diabetes and other serious health problems and the company actively worked to conceal all of this from its customers. The fact that Gottstein continues to point this out--and let's remember, he is trading in true statements as far as I can tell--costs Lilly nothing. The company continues to see over $4 billion a year in sales of the drug, roughly the same as before the documents were leaked. So exactly what injury is Lilly trying to address at this point?

Mentally Ill Man Kills Six, Wounds Four North Of Seattle

On Tuesday afternoon, a deranged man named Isaac Zamora went on a shooting and stabbing rampage in and around the small town of Alger, Wash., which is about one hour north of Seattle. He killed six people, including a Skagit County Sheriff's deputy who'd tried to help him in the past. Zamora was identified by his own mother in press accounts as being mentally ill and increasingly psychotic. It's not clear what mental illness he is diagnosed with or why he had access to a gun since he'd been convicted of crimes in the recent past and was under supervision of the state's corrections department.

I held off writing about this yesterday because I wanted to see what facts would come out around this man and this tragic episode, especially since it happened not far from where I live. It's always a bit rough writing about things like this in your own area. And it's going to get even rougher since the Seattle Post-Intelligencer has a story in today's paper basically adopting the Fuller Torrey line on treatment for the seriously mentally ill. I will deal with that article later today.

Otherwise, the press has done a decent job of getting the basic story out (I've not watched the TV coverage so far). Some of Zamora's victims seem to have been chosen at random, including one man he murdered as he drove down I-5 and a state trooper he shot on the same road (the trooper survived). More details will come out later, but since there are several separate crime scenes that may take a while.

The story as I understand it now is that Zamora has an unspecified mental illness, did not take his medication, his family couldn't get him committed to a hospital, he lived in the woods in Skagit County, he was busted with cocaine recently, he attacked the car of a man who wouldn't give him some pot and so on. Also:

"Zamora was under state supervision and considered a high-risk offender, with convictions for theft and drug possession. While Zamora was regarded as a nonviolent offender, he was supervised at a high level because of his long-standing mental-health issues, according to DOC records. Zamora last reported to his probation officer in Mount Vernon on Aug. 21.

"In a news release, DOC Secretary Eldon Vail said Zamora had been released from jail during the first week of August. He had been serving time for felony drug possession, according to court records. After his release, Zamora had reported to his community corrections officer twice as instructed, DOC said. A urine analysis indicated no drug or alcohol consumption."

Tragically, Zamora snapped on Tuesday. He turned himself into authorities after a lengthy chase and is being held in jail in lieu of $5 million bail.

I'm sure more details about what happened here will emerge soon. I'll be especially curious to learn how he got a gun, why his family had been unable to commit him, how tightly DOC was monitoring him, what diagnosis he had and what his course of treatment had been like.

I have a real fear that we have another case of a man for whom meds and other treatments didn't do much, but that the local media will go down the path of assuming that all meds work at all times for all people when that isn't the case.

Fall Fundraiser

It's been a little over three months since I began the last fundraiser for this site and so I come before all you dear readers again to ask you to contribute what you can to helping fund my work on this site. The goal for this fundraiser is $3,000 over the next two weeks. There's a PayPal button on the right. If you prefer snail mail, send me an email and I'll give you my mailing address.

I appreciate your support.

Since the late spring fundraiser one thing has become apparent to me about media coverage of mental health issues in the US--it's disappearing. What with repeated layoffs at newspapers across the country (approximately 3,500 print reporters have lost their jobs since January 1) and the consequent reshuffling in how newspapers cover issues other than politics and sports, mental health issues have been pushed to the backburner at almost every newspaper I can think of (excepting the New York Times). It's been quite a while since I've read regular coverage of these issues in the Washington Post or the Los Angeles Times, for example. TV news is of course a lost cause on this front. The AP and Reuters and the Wall Street Journal do cover bits and pieces here and there, but when it comes to day-in, day-out coverage of mental health, it's pretty much fallen to the Times and this website plus a few others to keep tabs on what's going on out there.

Among other things, since June 1 I've outed researchers for seeking to link depression to every physical malady in human kind, noted attempts to get Cymbalta approved for pain treatment, got the FDA to publicly reveal that it considers pediatric bipolar disorder to be a valid diagnosis, reported on adverse events experienced by pediatric patients taking antipsychotics (data the FDA is apparently ignoring), outed an FDA official over conflicts of interest around pediatric bipolar disorder, continued to press the FDA to define pediatric bipolar disorder, reported on new details of how Lilly marketed Zyprexa to PCPs, and smacked up the Wall Street Journal for an article on schizophrenia. It was a busy summer, so busy I didn't even take a vacation.

I'm a long way from perfection, but I'm doing my best to fill an unacceptable information gap that's grown up around mental health issues in our culture. Hopefully, I'm doing it in such a way that it merits your support of this site's fall fundraiser.

Yes, I know it's still summer, but Labor Day is over and the weather in Seattle has sure felt like fall for two weeks, so I'm calling this the fall fundraiser.

Alaska And Gov. Sarah Palin Sued Over Drugging Kids

A lawsuit was filed yesterday in an Alaska superior court seeking to stop the de facto forced medication of children under the state's care (foster kids, juvenile detainees) and children covered under state health programs with psychiatric medications. Named as defendants were the State of Alaska, Gov. Sarah Palin and a host of officials with various state agencies. The suit was filed by Psych Rights, the Alaska-based mental health law project, which has vigorously fought the forced drugging of adults in the state's psychiatric hospital. Jim Gottstein, the president of the group, was instrumental two years ago in ensuring that the leaked Zyprexa court documents reached the public. A press release from Psych Rights can be found here.

The lawsuit is sweeping and seeks to go after the age-old practice of giving psych meds to children and teens in the custody or care of various state programs, at times without the knowledge of the children's parents (if there are any) and without the informed consent of the child or teen. Gottstein argues in his filing (2.2 MB .pdf here) that such practices violate the constitutional rights of children. I'm not going to put on a law class here (to the degree that I could), but here are some snippets from the suit.

Gottstein wrote to Gov. Palin in February 2008:

"It is a huge betrayal of trust for the State to take custody of children and youth and then subject them to such harmful, often life-ruining, drugs. They have almost always already been subjected to abuse or otherwise had very difficult lives before the State assumes custody, and then saddles them with a mental illness diagnosis and drugs them. The extent of this State inflicted child abuse is an emergency and should be corrected immediately. Children and youth are virtually always forced to take these drugs because, with rare exception, it is not their choice. PsychRights believes the children and youth, themselves, have the legal right to not be subject to such harmful treatment at the hands of the State of Alaska. We are therefore evaluating what legal remedies might be available to them. However, instead of going down that route, it would be my great preference to be able to work together to solve this problem. It is for this reason that I am reaching out to you again on this issue."

Gottstein got a mealy-mouthed answer to this letter from an agency head, but there's no indication that Palin, who is Sen. John McCain's vice-presidential choice and quite the advocate for families, ever saw the letter. There was no response from her office. I'm not criticizing Palin, but am simply noting the irony that she's named in this lawsuit given her sudden emergence on the national political scene.

In his filing, Gottstein notes that over 4,500 Alaska children and teens were being given various psych meds under the state's Medicaid program.

Among other things, the suit cites problems with the FDA approval process, the influence of drug companies upon prescribing practices, the lack of safety and efficacy research on psych meds in children (the vast majority of trials are done in adults), and the troubles with anti-depressants, antipsychotics, stimulants and anti-seizure drugs used in children as part of the basis for the lawsuit. The lawsuit asks the court to a "declaratory judgment that Alaskan children and youth have the constitutional and statutory right not to be administered psychotropic drugs unless and
until":

"[E]vidence based psychosocial interventions have been exhausted, rationally anticipated benefits of psychotropic drug treatment outweigh the risks, the person or entity authorizing administration of the drug(s) is fully informed, and close monitoring of, and appropriate means of responding to, treatment emergent effects are in place."

This is a highly original and potentially landmark case. It will be interesting to see where it winds up.

I've written about Gottstein winning a landmark ruling regarding forced medication of adults here.

Study: If Depressed Moms Don't Take Their Meds Then Their Kids Will Go Crazy

That's pretty much the broad argument being made by this new study published in this month's American Journal of Psychiatry. The study was part of the NIH-funded STAR-D study of depression treatment in adults and is known at STAR-D Child. This new study (.pdf here) sought to assess the relationship between maternal depression and the symptomology of their children. Children were not being treated with medications as part of this study (at least not so far as I could glean from the paper).

Fifty-seven percent of mothers saw their depression remit during the study. There was no placebo arm to this study, so you could infer a placebo effect of perhaps 20 percent for this group and you'd get an effect size of about 37 percent (arguably better than other treatment outcomes elsewhere in the STAR-D trial itself). It is not clear what medications the moms were taking as STAR-D was a multi-year, multi-stage trial with several different anti-depressants employed. There was even an arm that included psychotherapy.

So researchers here weren't examining whether Med X worked for mom and child, but whether addressing a mother's depression had an effect on the child's psychosocial functioning.

Study authors concluded:

"The STAR*D study showed that continued efforts to treat depression until remission is achieved are likely to benefit adults with nonpsychotic major depressive disorder. The present study revealed that continued treatment of maternal depression until remission is achieved is associated with decreased symptoms and improved functioning in the offspring. Clinicians who treat adult patients might choose to inform depressed mothers about the potential benefits of remission for their children. Child clinicians may consider recommending treatment for maternal depression as an adjunct to child treatment when children of depressed mothers seek treatment."

The results of STAR-D were not nearly as clear cut as researchers paint them here and in fact were the subject of much hand-wringing by some in the mental health world. That said, I can easily see pharma companies using the "take anti-depressants for the good of your child" line in advertisements and I can easily envision doctors telling this to patients, despite the fact that improvements for the children seemed to be rather small scale and despite the fact that the best anti-depressant in the STAR-D trial only worked 30 percent of the time.

According to the study, children self-reported fewer psychological symptoms as their moms improved and their mothers reported the same basic trend with their offspring.

But perhaps most telling is that researchers assessed the children for themselves.

Table 5 of the study shows how children's psychological status, as measured by the Children’s Global Assessment Scale, progressed during the study as their mom's depression remitted or didn't. Kids whose moms were early remitters (the study's terminology) had a baseline C-GAS of 70.26 and had improved to 78.68 at 12 months. Kids whose moms were described as late remitters went from 68.37 to 73.88 while kids whose mom did not achieve remission thru STAR-D depression treatments went from 69.61 to 72.71.

I'm not particularly adept with kid's psychosocial rating scales, but I find it astonishing that the researchers are touting the positive benefits of treatment when kids whose moms improved and kids whose moms didn't largely wound up in the same assessment category on the C-GAS:

"80-71 No more than slight impairments in functioning at home, at school, or with peers; some disturbance of behaviour or emotional distress may be present in response to life stresses (eg., parental separations, deaths, birth of a sib), but these are brief and interference with functioning is transient; such children are only minimally disturbing to others and are not considered deviant by those who know them."

So if all three groups of kids wound up in largely the same place on what's a fairly loose assessment scale, then the researchers argument amounts to what exactly?

I'm certainly not arguing against depression treatment of any kind here, but I am pointing out that its effects aren't as great as you might expect. For moms and their kids.

It'll be interesting to see if others in the media pick up on this study and, if they do, how they report its results.

Psych Journal To Reveal Conflicts Of Interest, Including Its Own

Ronald Pies, editor of Psychiatric Times, has announced in an editorial that his journal (which is one of the APA's journals, tellingly) will ask its editorial board members to report various pharma monies they've received. Presumably, this information will then be reported publicly as well.

This is a decent enough idea and comes after much noise has been made by Sen. Charles Grassley (and this site and many in the media) over epic conflicts of interest in psych research and academic publication.

Integrity in Science Watch notes:

"[T]he move only raises further questions about who is calling the shots at leading psychiatric journals. The International Committee of Medical Journal Editors' Uniform Requirements for Manuscripts Submitted to Biomedical Journals says editors who make final decisions about manuscripts should have no personal financial involvement in any of the issues they might judge. Top editors of psychiatric journals, though, frequently have such ties and include Pies, Robert R. Freedman, editor-in-chief of the American Journal of Psychiatry, Jan Fawcett, medical editor of Psychiatric Annals, and Alan J. Gelenberg, editor-in-chief of the Journal of Clinical Psychiatry, all of whom receive education grants or consulting fees from pharmaceutical companies that sell psychiatric medicines."

Nice to see so many folks with clean hands deciding what gets published and what does not in the psych world.

(Via Pharmalot.)

Study: Older Dads Tied To Bipolar Disorder In Offspring

I'm really not sure what to make of this Swedish study, so here's what's being reported by the AP:

"Children born to older fathers face a greater chance of developing bipolar disorder, according to one of the largest studies linking mental illness with advanced paternal age. Previous research has connected schizophrenia and autism with older dads, and a Danish study published last year added bipolar disorder to the list. The new study led by researchers at Sweden's Karolinska Institute strengthens the evidence.

"The leading theory is that older men's sperm may be more likely to develop mutations. Even so, the odds of a person becoming bipolar are so low that the study's authors said it shouldn't dissuade older men from becoming fathers.

"Researchers analyzed Swedish national-registry data from more than 80,000 people, including 13,428 with bipolar disorder who were born between 1932 and 1991. The risks started increasing around age 40 but were strongest among those 55 and older. Children born to these dads were 37 percent more likely to develop bipolar disorder than those born to men in their 20s."

What with the degree to which bipolar disorder is misdiagnosed, I have to wonder what the researchers did to control for that problem in their study. You also have to wonder how applicable Swedish data is to the US and other countries.

And here's what really left me wondering from one press account:

"Though the finding doesn't explain what might cause some older men to have bipolar children, it 'reinforces the notion that there's a strong biological component to this,' said Dr. Harold Pincus, vice chairman of psychiatry at Columbia University."

Does it?

Weirdly, in its account of the study, Reuters used the occasion to pimp for Seroquel:

"Last month, an international research team linked two genetic variants to an increased risk for the disease, which is often treated with AstraZeneca Plc's blockbuster drug Seroquel. The condition often runs in families."

It's really weird for a wire service to single out a drug in such a manner since the study isn't about a drug or treatment in any way. But, then, we live in weird times.

Your Seroquel Crime Blotter Roundup

I continue to be fascinated by how psych meds--and particularly the atypical antipsychotic Seroquel--have wormed their ways into American culture and in how Seroquel has become a drug that, when snorted or shot, can get people low in a way they really seem to dig. As I've reported before, this drug seems to be replacing--or supplementing--OxyContin as a new hillbilly heroin.

And here's a new example: dude gets busted in Massachusetts for, among other things, having hundreds of Seroquel pills that he didn't have an Rx for. Clearly, he or his friends are slinging this drug and taking this drug (which simply staggers me given how gnarly this drug is when taken as intended) and, as I recently noted, some folks are so attracted (dependent? addicted?) to Seroquel that they will fake symptoms of schizophrenia in order to get a "legitimate" Rx.

Seroquel is on the verge of being approved for depression and anxiety in the US--it was just approved for anxiety in the EU--so I expect this street drug life of Susie Q, as it's sometimes called, to become even weirder and more widespread. Just wait until the drug goes generic in a few years. Hell, things are so weird now that there are reported instances of the drug being used as a roofie.

BTW, I need to make it clear that I don't blame AstraZeneca, the drug's maker, for this situation. This is merely a quirk of molecular structure and their molecule happens to appeal to people looking for that heroin-ish low. You do have to wonder who it is who figured out that the drug worked like this and how much they experimented with snorting other psych meds before hitting on a winner.