Furious Seasons

On Vacation Until Jan. 5

I'm finally getting out of town later today, weather gods willing, and don't plan to do any posts until Jan. 5, unless something truly newsworthy crops up. I might also do a year end post of some kind if the spirit moves me.

I will be approving comments in the meantime, although please note that comment approval will be very slow today and on Dec. 29.

I plan to use the next two weeks to unwind. I hope the rest of you do the same.

Merry Christmas, Happy Holidays and a Happy New Year's to all of you.

Seattle Snowball Fight

I was going to do a couple of posts for today (my vacation actually starts on Tuesday), but Seattle basically got snowed in and shut down over the weekend by a big dump of snow and I have far too much cabin fever to sit in front of my computer for long. In fact, it's still snowing as I write this on Sunday evening, more snow than Seattle has seen in a decade.

But on Saturday night, I happened to join several other cabin-fevered-out guys from one of my favorite bars as we challenged another neighborhood bar to a snowball fight. Someone even shot video of some of the fight, which went on for 20 minutes and ended up with the forces of good triumphing over the forces of hipsterdom. I haven't felt like a 14-year-old in a long time.

Then, some poor fellow tried to escape the melee on skis. He didn't get far!

BTW, skier dude was laughing his butt off while we pelted him with snowballs.

If some of you are wondering why this all went on, the answer is because it was there.

"Katrina's Hidden Race War"

That's the title of a piece, which I encourage one and all to read, appearing in The Nation. It's an investigation of the lawless days after Hurricane Katrina hit New Orleans in 2005 when, according to the article, several white vigilantes shot at African-Americans whom they didn't want in their neighborhood and who were presenting no threat to anyone. It's clear that several people died, but to date there has been no investigation of these deaths or how they happened. Murder is a crime that has no statute of limitations and I hope someone in federal law enforcement launches an investigation into the matter, because it is obvious that local law enforcement has no interest in getting after the truth.

I guess I should note that the article was reported by a close friend of mine, A.C. Thompson, who is on the staff of Pro Publica, a non-profit investigative reporting outfit based in New York City. He did some outstanding reporting in the piece and I hope it gets some results.

Fixing Abilify Post

I'm not sure what happened, but yesterday's post on former Abilify spokespatient Andy Behrman was fine when I posted it but now has developed a problem where about half the text is cut off and is missing from my blog software as well. I've never had this happen with a post before. I've taken the post down and am working to fix it. I'll repost it shortly. Sorry for any hassle.

Ex-Abilify Spokesman, Ripped Apart By Drug, To Author Tell-All Book

This is a repost of what was originally posted on Dec. 19, 2008. Sometime after the original post something went wacky in my blog sfotware and the last three paragraphs of the original post were cut off and missing from my site. I have no explanation for why this occurred, as nothing like this has happened before. Anyway, I've re-written the last three grafs and restored the links and reposted the whole thing on Dec. 20, 2008, but have left the original posting date and time intact.

A month ago, I wrote of news that Andy Behrman, the author of Electroboy, was rumored to be contemplating a book about his experiences working as a paid spokesman for Bristol-Myers Squibb's Abilify, an atypical antipsychotic that's often advertised on TV. Behrman, who was diagnosed with bipolar disorder many moons ago, was a spokespatient for BMS in 2005 and 2006. At the same time as he was doing this, Behrman was also taking Abilify.

Behrman, who I interviewed the other day, cannot discuss his experiences representing the drug and company in much detail as he's covered by a non-disclosure agreement until the end of this year. But he can discuss his experiences taking Abilify, a latecomer to the antipsychotics for everything market.

Behrman describes the drug as the worst drug he ever took for bipolar disorder and complained to his psychiatrist soon after he began taking the drug.

"I complained to my doctor that my side effects were horrible" three to four months into taking the drug, says Behrman, whose movie script of Electroboy is set to begin shooting early next year. "I said the akathisia was horrible. I was kicking my leg and had a creepy crawling feeling under my skin. My cognitive skills were impaired, too. Someone who worked for me came into my office one day and I had no idea what her name was."

Instead of taking Behrman off the drug, his psychiatrist--then a well-known researcher at UCLA--wanted to keep Behrman on the drug and chose to prop him up with Inderal, a hypertension drug, and by increasing Behrman's dosage of Klonopin. In 2006, Behrman stopped taking Abilify after finding the drug-induced akathisia intolerable. He wrote about his experience for about.com, which removed his article soon after posting it. I later reposted the article on this site.

I contacted BMS to ask what the company thought of the prospect of a former spokespatient possibly writing a book about his adventures in the pharma world and whether the company had ever had a spokespatient go off the reservation on them before. Sonia Choi, spokeswoman for BMS' neuroscience products, said, "I don't have an answer." She promised to check with other company officials and get back to me with a fuller response to Behrman's plans, but she never contacted me again.

I also asked Choi what the company knew about akathisia on Abilify and what percentage of patients experienced the condition when taking Abilify.

"I don't know," she said, an interesting response from the company's spokeswoman for Abilify.

When the drug was approved for use in kids aged 10 to 17 years of age, the company reported that 10 percent of patients taking the drug experienced akathisia in company-sponsored clinical trials of the drug. In two clinical trials of Abilify as an add-on treatment for depression, akathisia was reported in 23 percent and 26 percent of patients taking the drug.

Third quarter 2008 sales of Abilify were $564 million, a 34 percent increase over third quarter 2007 sales, so the drug is on track to crack $2 billion this year. Sales of the drug in 2007 were $1.6 billion and just under $1.3 billion in 2006.

It will be interesting to see what Behrman's possible book winds up covering and what BMS has to say about it then.

DSM-3 Creator Criticizes DSM-5 Secrecy

Most of you are aware that the American Psychiatric Association is at work developing DSM-5, slated for release in 2011 or 2012. There's already been criticism of odd new disorders proposed for the new edition of psychiatry's Bible. And now, via an article in yesterday's New York Times, comes word that Robert Spitzer, the creator of DSM-3, which in 1980 reclassified mental illnesses into disorders and is the most influential edition of the DSM ever, is pretty pissed off about how DSM-5 is being put together in near total secrecy.

"Some critics, however, say the secrecy is inappropriate.

"'When I first heard about this agreement, I just went bonkers,' said Dr. Robert Spitzer, a psychiatry professor at Columbia and the architect of the third edition of the manual. 'Transparency is necessary if the document is to have credibility, and, in time, you’re going to have people complaining all over the place that they didn’t have the opportunity to challenge anything.'"

Psychiatrists who are working on the new DSM are allowed to accept up to $10,000 a year from pharma companies.

Look, it's my view that the APA is out of its mind if it thinks it's going to run a secretive process that will likely end up producing new disorders for kids and adults and not have that process have some level of public review much less review by psychiatrists outside of the DSM committees. The APA is even crazier to allow DSM authors to continue to take pharma money during the process.

Under current procedures, DSM-5 will be a tainted, deeply-conflicted document and will embarrass the profession further at a time when it could probably use less embarrassment.

Charles Nemeroff Writes Self To Pay Self

Amidst the many bizarre revelations around the conflict of interest scandal around academic psychiatric researchers and Big Pharma being probed by Sen. Charles Grassley (R-Iowa) comes the oddest revelation of them all. In 2000, Emory University psychiatrist Charles Nemeroff wrote himself a letter--the salutation is "Dear Me"--on letterhead of the journal Depression and Anxiety, which he then edited, inviting himself to author a supplement article celebrating the fifth anniversary of Effexor, and noting that he would be paid $3,000 for his efforts. The monies apparently came from a university fund that was filled with money by Wyeth, maker of Effexor.

You can download this for yourself over at the WSJ Health blog.

At this point, I am simply unshockable when it comes to the Nemeroffs, Biedermans, Rushes and Goodwins of the academic world.

Speaking of Fred Goodwin, he apparently sent a letter defending himself to Liz Spikol, who published it on her blog. Goodwin has sent me nothing, which tells you a lot.

Allegation: J&J Defrauded Texas In Risperdal Use

Many of you are already aware of the two-year-old lawsuit brought by the State of Texas against J&J/Janssen over allegations that the drugmaker worked to influence the Texas Medication Algorithm Project to favor its star atypical antipsychotic Risperdal and made payoffs to state officials, among other allegations. A similar children's medication project is under investigation by state officials.

Yesterday, the state amended its complaint to include allegations that the company gave out false marketing materials and used fake advocacy groups to get its then-expensive drug (which is now a generic) used in the state MedicAid program. Although the state isn't naming names in its complaint (who is the mysterious fake advocacy group?), the complaint is worth reading. You can download it from the Dallas Morning News' website.

I've read the complaint and it's the usual set of allegations that J&J/Janssen took a drug designed to treat schizophrenia--not a very efficacious drug at that--and pressed to have it used off-label in adults and children for a number of other indications. In the process, the company used state officials as pitchmen for its drug and somehow got its drug on the children's list--which was never implemented and was recently suspended altogether--eight years before it was approved for use in kids and teens by the FDA. Earlier this year it was revealed that Texas officials and researchers wanted to use McDonald's gift certificates as inducements to get kids on medication trials.

According to the paper, Janssen strongly denies the allegations.

"Janssen officials vehemently deny they have done anything improper in Texas and are fighting the suit, in which the state seeks to recover millions of dollars. Kara Russell, a spokeswoman for the New Jersey-based company, said that Janssen is cooperating with the investigation, but that the allegations are untrue.

"'We are committed to high ethical standards and responsible behavior,' she said. 'We take this obligation very seriously.'"

It'll be interesting to see where this all winds up. Earlier this year, the former head of TMAP, John Rush, slinked off from Texas to Singapore.

Jim Carrey Criticizes Extended Anti-Depressant Use

Interesting exchange between CNN's Larry King and actor Jim Carrey last night, wherein Carrey basically said long-term Prozac use is for suckers:

KING: Didn't you suffer from depression?

CARREY: Yes, yes. I'm on a manic high right now. Can't you tell?

KING: How did you get through that to this?

CARREY: Well, that's another thing. You know at the risk of like opening up the whole Tom Cruise Prozac argument, you know, I don't disagree in many ways. I think Prozac and things like that are very valuable to people for short periods of time. But I believe if you're on them for an extended period of time, you never get to the problem. You never get to see what the problem is, because everything is just kind of OK. And so, you don't deal. And people deal when they get desperate.

KING: So how did you do it?

CARREY: I take supplements.

KING: Vitamins?

CARREY: Yes -- well, it's not -- well, it is vitamins. But it's also certain elements of the brain like Tyrocine (ph) and hydroxy tryptophan that they're treating depression with now. It is a natural substance that's in your brain. Instead of being a Serotonin inhibitor, which just uses the serotonin you have and Prozac and things like that -- it just uses the Serotonin you have and it doesn't allow it go back into the receptor. It metabolizes your serotonin after a while and you have to keep taking more and more to feel good.

This actually creates dopamine and creates serotonin. It's a wonderful thing. It's amazing. I'm going to talk a lot about it in the near future.

KING: You're going to write about it?

CARREY: Yes.

I'm not sure what to make of the whole supplement thing, but I do agree with Carrey's central thesis that anti-depressants cover up who you are and what you have to do to address depression in the long-term. Of course, Carrey is no psych researcher, but what he kind of represents here is the push-back from patients (especially on anti-depressants) that's been percolating in the mental health world for some time now. It's interesting to see it pop up on prime time TV.

FDA Orders Suicide Warning For Bipolar, Epilepsy Drugs

According to Reuters, the FDA today ordered that a warning--and it's not clear if this is in black box form--be placed on anti-seizure drugs such as Lamictal, Depakote and Topamax alerting doctors and patients to suicidal thoughts and actions that might be triggered by the use of these drugs. The 11 drugs in the class are commonly used to treat epilepsy and bipolar disorder and account for about $6 billion a year in sales.

What's interesting is that the FDA first proposed this warning last January, but this summer an FDA advisory panel said a black box was excessive. Anyway, here's some of what the FDA noted today:

"'The risk of suicidal thoughts or behavior was generally consistent among the eleven drugs analyzed and was observed in patients who were treated for epilepsy, psychiatric disorders, and other conditions,' the Food and Drug Administration said in a statement on its website."

I've not been able to locate that statement, as the FDA has one of the most illogical websites on Earth and its search engine isn't much better.

I think it's pretty safe to say that, taken together, psychotropic medications have more warnings and black boxes on them than any other therapeutic group of drugs. Pretty staggering when you consider how widely they are used.

Another Seroquel Related Arrest

This time out it's in Louisian:

"Authorities went to Rugley’s residence Thursday to place him under arrest, at which time Rugley was allowed to get his coat. A search of the coat pockets revealed a pill bottle containing 150 Seroquel tablets.

"Seroquel is a mood-stabilizing medication approved by the FDA to treat symptoms of schizophrenia and bipolar disorder.

"Rugley allegedly told authorities that the prescription belonged to his recently deceased grandmother. He said he had scratched the label off of the prescription bottle and had been taking the medication himself."

What is so damn attractive about the downer effect of this antipsychotic that people are willing to take it absent a prescription and then snort it or shoot it?

Just wait until this drug gets approved for depression and anxiety. Incidents like the above will escalate.

Minnesota Forced ECT Case Hits NPR Airwaves

Yesterday, a reporter for Minnesota Public Radio had a piece on Ray Sandford, who is fighting his own forced, involuntary treatment with ECT, that was carried on National Public Radio and was likely heard by millions. You can hear audio of the piece here or read a transcript here. I've written about Sandford's case twice before.

The basics are that Sanford, diagnosed with schizoaffective disorder, doesn't like the ECT treatments given him weekly because they've wiped out his memory. He contacted MindFreedom, which has been beating the drum for his cause ever since--and I tip my hat to them for doing so.

I am against forced, involuntary ECT, although I could see a few exceptions where a patient had behaved in any extremely violent manner toward innocent persons. But, in Sandford's case, the worst the reporter could turn up is that Sandford urinated whenever and wherever he felt like it and smeared shit on hospital walls. I'm not sure that's the kind of evidence that lends itself to the forced shocking of a man's brain, especially since it's being done on a very unusual outpatient basis. If Sanford is such a danger to self and others that he merits forced ECT by court order, then why isn't he institutionalized as well?

Interestingly, Sandford's elderly mother is all in favor the forced ECT. What is it about some people with mental illnesses, especially psychotic disorders, and their families?

Anyway, Sandford has a court hearing this week on whether the forced electroshock will continue. Stay tuned.

Fundraiser Over

Thanks to all of you, the winter fundraiser ended successfully yesterday. Seventy readers contributed to this fundraiser, roughly a 50 percent increase over the number of contributors to the fall fundraiser. That pleases me. Even more pleasing, the fundraiser was a success during what is the single worst economic downturn I've seen in my life. I thank all of you for your contributions large and small.

For myself, I'm exhausted. This has been a very stressful year for me personally and I've taken no vacations this year at all, aside from a day off during the week here and there. Next week, this site will mostly be silent and I'll be in Arizona seeing my parents and hopefully enjoying a few hours of sunshine and warmth each day. The following week, the last of the year, will be quite light as well on this site as New Year's falls in the middle of the week. So from next Monday until Jan. 5, 2009, this site will be on semi-vacation.

Until this weekend, however, it'll be as noisome as ever.

Thanks again to all of you for your support.

Boston Globe Reports Sexual Problems With SSRIs As High As 50 Percent

The Boston Globe has a good article out today delving into sexual side effects of SSRIs--Prozac, Paxil, etc.--and how the prevalence of these problems is much higher than the pharma companies ever let on. The paper reports that side effects are seen in as many as 50 percent of patients who take the drugs while the pharma companies themselves report sexual problems for anywhere from 4 percent of patients (Prozac) to 28 percent in some cases (Paxil). The article also gets into the disturbing problem of people who stop taking SSRIs and yet are rendered impotent by the drugs for years and years. Sad.

It's time the FDA, at a minimum, required SSRI makers to properly label this problem on their drugs, because it's clear that the labels wildly understate the problem.

I've written about this trickiest of all side effects several times.

Winter Fundraiser, So Close It's Not Even Funny

Another $470 came in yesterday, meaning that this fundraiser is now $68.74 short of reaching the overall goal of $3,000. The goal is to reach that amount before midnight PST today. I think that can happen, but I'll leave it to two or three or four of you to make it happen, or help push it over the top.

As usual, the PayPal address is over on the right.

Thanks to all of you for your support.

Two Child Physicians Criticize ADHD Meds, The Bipolar Child, Pharma Influence

Ironically, two separate op-eds by two different children's doctors appeared yesterday. Each made similar and different points.

First up was Leonard Sax, a psychologist and physician and author of Boys Adrift: The Five Factors Driving The Growing Epidemic of Unmotivated Boys and Underachieving Young Men, who is controversial in some quarters for his call for single-sex education. Writing in the New York Daily News, he noted:

"When I first began writing prescriptions for children 22 years ago, it was unusual for a child to be taking powerful psychiatric drugs. Today it's common. How did we get here?....Dr. Joseph Biederman is part of the answer."

Biederman is of course the controversial Harvard child psychiatrist and Sax went on to also excoriate former "The Infinite Mind" host Fred Goodwin and Charles Nemeroff, an Emory University psychiatrist, and their links to a scandal of conflict of interest with Big Pharma. Then he moved onto the question of meds for kids:

"Are the medications recommended by these opinion leaders risky for children? We don't know for sure. Researchers at Harvard have reported that giving medications such as Ritalin and Concerta to young laboratory animals results in those animals displaying a loss of drive when they grow up. There could be a similar phenomenon in our children.

"I've seen many young men in my own practice who took these medications as children or teenagers and are now content, as twentysomethings, to live in their parents' homes, work a few hours a week at the coffee shop, and spend most of their free time playing video games.

"So the verdict is out. Maybe the drugs are harmful to children. Maybe they aren't. Would you like to volunteer your child for the experiment?...

"The traditional rule for good medical practice has been 'First, do no harm.' For parents, that translates: 'When in doubt, say no.' Don't let anyone push you into giving your child a drug whose long-term risks are uncertain."

I've not seen the connection to listless, unmotivated young men before, but if Sax has got the evidence to back that assertion, then OK.

Meanwhile, writing in the Los Angeles Times, Laurel Williams, program director of the Menninger Clinic's adolescent treatment program and assistant professor in the Menninger department of psychiatry and behavioral sciences at Baylor College of Medicine, related the story of one mother so convinced of her young son's alleged bipolar disorder that she ignored Williams' assessment of her son (which didn't support bipolar disorder) and medicated her son with eight (8!) medications.

"The reasons for the surge in bipolar diagnoses are complex. Despite advances in neuroscience, the brain, especially the developing brain, is still much of a mystery. More is unknown than known when it comes to effective treatment for children and adolescents with serious mental health problems. But that doesn't stop doctors and parents from desperately wanting to believe there are simple solutions, and what could be simpler than a pill?

"Since the 1980s, when pharmaceutical companies were granted permission to market their products directly to consumers, Americans have started believing that there is a drug to solve every discomfort and every mood. In my own practice, I've seen how determined parents can be to procure medication for their children that they have read about or seen advertised."

Beyond pharma consumer ads and people looking for quick answers, Williams notes that doctors are so pressed for time that they sometimes cannot do appropriate evaluations of children's psychological issues. Sounds like Williams took plenty of time with the above-mentioned boy:

"So what happened with the boy whose mother wanted me to refill his prescriptions? After an initial two-hour assessment at our clinic, he didn't return for his next appointment. When the clinic called to ask why, the boy's mother said that she had returned to his previous doctor. "Your doctor discriminated against me because I'm poor," she said, "and my son needs those pills for his bipolar."

"Psychiatric assessment and treatment of a child can be hard. It often entails setting up educational testing to discover why he or she is failing in school, weekly individual and family therapy, and -- sometimes -- medication. I thought that my lengthy conversation with the boy's mother had convinced her that the above plan would actually provide her son with better care than refilling all eight medications at once.

"Unfortunately, families often put more faith in what they see and hear in advertising than they do in physicians. As physicians, we need to win them back."

Perhaps, I am too much of a skeptic on these issues, but I think that doctors like Williams (and Sax) need to spend a bit of time working on their own colleagues and convincing them of the various diagnostic and medication fallacies around kids these days before they have much of a shot at winning back public confidence.

Nonetheless, I am thrilled to see these two opine about how managing children's behavior in America has gone completely adrift.

Michael Phelps: "I Didn't Want To Take Ritalin Anymore"

Michael Phelps, winner of eight gold medals at this past summer's Olympics, was on "Hannity & Colmes" the other night, talking about being Michael Phelps and his new book, No Limits: The Will to Succeed. In the midst of all of that, Alan Colmes asked him about growing up with ADHD/ADD:

COLMES: What's interesting, what's inspirational about this book, too, is how you talk about how you had ADD, and you felt as a kid the pool was a safe place to be.

PHELPS: Well, you know, it's — it's — I'm still a very, like, hyperactive child. But...

COLMES: You still have ADD?

HANNITY: See, I have LDD, Liberal Derangement Disorder. I don't like liberals.

COLMES: Yes, because when I'm around him, he gets deranged.

HANNITY: That's right. It's true.

COLMES: So — so the pool was a safe place, right?

PHELPS: I was able to, you know, really calm down and focus when I was in the pool. And, you know, when I was in middle school I, you know, found a way to, you know, turn that into anything that I did, you know, whether it was in the classroom, whether it was on the playing field. You know, I was able to do that. And that's when I sort of told my mom I didn't want to take Ritalin anymore; I wanted to do it all on my own. And...

COLMES: I liked the way that you could channel this and — into what you've done.

PHELPS: Yes. You know — and it's something I love, and it's something I was talented in and found at a very young age. And, you know, I was able to channel, you know, all my emotions and everything into the sport. And, you know, after doing that, I figured well, I can do this in anything I do."

I'm not sure what Phelps' situation is these days vis a vis stimulants, but it sounds like he's been off them for a long time. And, good for him and his approach to channeling his energies and distractability into sports, although he was obviously medicating and swimming at once for a time as well.

I've been saying on this site for a long time that sports were my salvation as a child and that I just shake my head at the de-emphasis of physical activity in kiddie culture these days. And people are OK with on the order of 5 percent of American kids being on stimulants while they aren't being pushed into sports every month of the year?

Makes you wonder who benefits from all the pushing.

I wrote about an interview with Phelps' mother earlier this year.

Winter Fundraiser, Oh So Close

Just a quick update: $230 came in yesterday and early this morning, and that means there's only $538.74 left to reach the $3,000 goal on or about Dec. 15 (Monday). Thanks to all of you for your support.

I'd love to see that $538 figure get chipped away at some more over the weekend.

As usual, the PayPal button is on the right, or send me an email and I'll send you my mailing address.

Winter Fundraiser, Inching Closer

Another $110 came in yesterday, and that leaves $768.64 to go to reach the $3,000 goal on around Dec. 15. That means there are roughly four days to go in this fundraiser and it would be great if the goal gets reached on time, or sooner.

Sixty-one people have contributed to date. If you'd like to join them, the PayPal button is on the right. Or send me an email and I'll shoot you my mailing address.

Thanks to all of you for your contributions to date.

On a side note, a big wet windstorm is expected the hit Seattle today, so there's at least a small chance that I could lose power and that will affect comment approval and so on. Just letting you know.

10-Year-Old Who Killed Father After Beginning Prozac Gets New Trial

Now, before everyone rolls their eyes and thinks "Here we go again," keep in mind that this is a complex case, involving Prozac (actually Prozac Weekly), a fractious family battle, a massive screw up by Texas' CPS department, the Texas Court of Appeals and on and on.

The basics are that in 2004, a 10-year-old boy known only as ECL shot and killed his father, Rick Lohstroh, an emergency physician in Texas. Lohstroh and his ex-wife were engaged in a very ugly separation, and there were allegations by ECL that he was being beaten and sexually abused by his dad when he and his brother stayed with him. CPS investigated several times and the kids were allowed to continue seeing their father. ECL began seeing a psychiatrist in July 2004 and was given Prozac, but the next month that was changed to Prozac Weekly, a large dose, slow-release version of Prozac. That's because ECL mom's feared that Lohstroh wouldn't give ECL his Prozac during the weeks he stayed with his dad. These details come from a Texas Court of Appeals ruling in the case which was issued yesterday.

Keep in mind that a 10-year-old was being given Prozac and, according to a Texas Court of Appeals ruling, "Dr. Treadwell-Deering determined that E.C.L. suffered some signs of depression, but was not clinically depressed." So this is weird and gets even weirder.

In late August 2004, ECL was given his second dose of Prozac Weekly and was taken to a psychologist to discuss problems with his dad. It's pretty clear to me from reading the court ruling that the kid had legitimate fears of his father. Later that day, his father came over to his mother's house to collect ECL and his other son. ECL shot and killed his dad in the driveway. (How such a young boy would have access to a gun those circumstances boggles my mind.) He was later found guilty of delinquent conduct and sentenced to 10 years at the Texas Youth Commission with the possibility of being transferred to an adult facility when he hit 18.

But a Texas Court of Appeals has found that the original trial judge erred in not allowing testimony from Joseph Glenmullen, a Harvard psychiatrist, as to evidence that ECL had cause to be in imminent fear of his father. The court ordered a new trial for ECL on Dec. 11, 2008. How the original judge could've excluded such testimony is beyond me. Texas sure does seem to have an interesting justice system.

Anyway, in the appeals court ruling, the judges state:

"He said that he does not like the way the Prozac makes him feel and that it makes him more talkative and '[a] little on the side of angry.'"

I've never before seen an appeals court include such information as fact about Prozac or any other anti-depressant, especially knowing it was connected to a violent incident. Typically, appeals courts are careful about what they include in rulings as facts of a case.

I'm not saying that Prozac caused this boy's behavior. There was clearly an overwhelmingly bad family dynamic at work. But it is nonetheless interesting that the boy killed his father only weeks after beginning Prozac and one week after beginning Prozac Weekly. The boy was certainly within the window of where you'd look for erratic behavior upon beginning a course of anti-depressants, especially the high doses of Prozac Weekly.

I'm not claiming that Prozac caused the violence, but there is a connection as big as daybreak sitting there and I won't ignore it.

Scientific American Interview: Is Depression Overdiagnosed?

Jonah Lehrer, an editor of Mind Matters at Scientific American, asked Allan Horwitz, professor of sociology at Rutgers University, and Jerome Wakefield, professor of social work at New York University, about their book, The Loss of Sadness: How Psychiatry Transformed Normal Sorrow into Depressive Illness. The full interview can be found here.

"LEHRER: In your book, you take a critical look at major depressive disorder (MDD), a mental illness that will afflict approximately 10 percent of individuals at some point during their life. In recent decades, the number of cases of MDD has sharply increased. Are we currently experiencing an epidemic of depression? Or is this surge due to changes in diagnosis?

"HORWITZ AND WAKEFIELD: Our book argues that, despite widespread beliefs to the contrary, the rate of depressive disorders in the population has not undergone a general upsurge. In fact, careful studies that use the same criterion for diagnosis over time reveal no change in the prevalence of depression. What has changed is the growing number of people who seek treatment for this condition, the increase in prescriptions for antidepressant medications, the number of articles about depression in the media and scientific literature, and the growing presence of depression as a phenomenon in popular culture. It is also true that epidemiological studies of the general population appear to reveal immense amounts of untreated depression. All of these changes lead to the perception that the disorder itself has become more common.

"In fact, we think what has really changed is that since 1980 psychiatry and the other mental health professions have used a definition of depression that conflates genuine depressive disorder with intense, but normal, states of sadness."

I won't even try to summarize the remainder, since it is lengthy and detailed. A depressing subject and a debate that is at the heart of one of the biggest land grabs of all time by psychiatry and pharmaceutical companies. I take depression very seriously, but it does make me shake my head that 30 million Americans take an anti-depressant each day.

Winter Fundraiser, Day 11

Yesterday was by far the most successful day of the fundraiser to date, bring in another $590. That brings the total to $2,121.26, leaving $878.74 to go to reach the goal of $3,000 on or about Dec. 15, which is Monday. I cannot even begin to thank you all who've contributed already. Which is not to say that I don't fire off "thank you" emails, but in two cases yesterday I had trouble there. Someone from Back East mailed me a check, but I don't have an email address for you, so if it's you send me an email please. Another person contributed via PayPal, but the email I sent them bounced back.

Anyway, the fundraiser has just under $900 to go and it would be great to chip away significantly at that amount today. As usual, the PayPal button is on the right, or if you prefer snail mail, send me an email and I'll send you a mailing address.

Thanks again to all of you for your support.

Paxil Documents Online

Yesterday, I learned that Christopher Lane, whom I'm sure many of you are familiar with as the author of Shyness: How Normal Behavior Became a Sickness, has posted online a small collection of GlaxoSmithKline documents from 1998 when the company was working to expand markets for Paxil/Seroxat. The two documents currently available do not contain any startling revelations, in my opinion, but they do show how intensely GSK planned to pursue new indications for Paxil beyond depression. That said, I'm alerting you all to their existence because I've seen very few GSK Paxil documents before.

I expect more documents to be available soon.

"Prozac Nation, Prozac Violence?"

The following is an op-ed by Christopher Lane, Professor of English at Northwestern University, and the author most recently of Shyness: How Normal Behavior Became a Sickness. He wrote it soon after the tragic NIU massacre of Feb. 2008 and submitted it to several newspaper editorial pages. Not a single one would publish it, even though Lane is a well-respected scholar, a fine writer and has a solid track of publishing op-eds. He recently published it to his own website. I have preserved his own links in the piece and will let his work speak for itself. Let me add, however, that I am deeply discouraged that my colleagues in the media would blow off Lane's contribution and that they continue to largely ignore the very crucial questions surrounding anti-depressants and violence, and the far more widespread problems of anti-depressant withdrawal. I interviewed Lane about his book last year.

March 1, 2008

"Prozac Nation, Prozac Violence?"

Five days after the February 2008 shooting rampage at Northern Illinois University, which killed six and wounded eighteen, the Chicago Tribune ran a headline that caught my eye: “Doctors: Prozac, Violence Rarely Linked.”

Given the ambiguous grammar, it was difficult to tell if the headline was warning doctors about links between the antidepressant and violence or was quoting doctors as saying the links should not concern us.

A complete ruling on the matter would of course be reassuring. It might calm nationwide jitters that the cocktail of drugs—-Prozac, Xanax, and Ambien—-that Steven Kazmierczak had abruptly stopped taking, days before he went on his shooting spree, was connected with the violence that followed.

The Tribune headline implied that although there was a connection between Prozac and violence, it wasn’t a significant one. When I read the article, however, I learned that Jeremy Manier, its author, wasn’t quite so sure. Quoting deep-seated concern by experts at renowned local hospitals, including the University of Chicago Medical Center and Northwestern’s Feinberg School of Medicine, he wrote: “About one-fifth of people who halt a course of Prozac-like drugs report symptoms associated with a condition known as discontinuation syndrome, which can include abdominal pain, dizziness, crying spells, irritability and even a sensation similar to an electrical shock in the patient’s arms or legs.”

A disturbingly large number of studies corroborate Manier’s statement. Warnings from experts about a host of problems tied to ending S.S.R.I. (selective serotonin reuptake inhibitor) treatment have spotlit other areas of concern about this class of medication—-areas that will need exhaustive investigation before they can be considered resolved. These include the drugs’ effectiveness relative to placebo, and their published track record. The New England Journal of Medicine recently disclosed that the drugs’ successes have been consistently exaggerated over a period of seventeen years. As a result of such distortion, drugs like Zoloft appear in the pharmacological literature to be 70 percent more effective than the data tell us they actually are.

Given the prevalence of discontinuation syndrome and the erratic effect of mixing different classes of medication, no one should rush to judgment. Many variables are in play, including how differently people respond to S.S.R.I. medication; how severely disordered they were before taking it; and whether they are using it in combination with other drugs like Xanax and Ambien. But the sheer amount of guesswork surrounding such combinations, and how common they have become, should give us pause. The current concern about S.S.R.I. medication intensifies when one considers how many patients are cycling through other kinds of drugs at the same time, interactions that are not fully known or studied.

Not all discontinuation symptoms result in self-inflicted or externalized violence, a point I mention rather than minimize. But the reason the Food and Drug Administration added black-box warnings to S.S.R.I.s, alerting physicians to the risks of prescribing them to children and adolescents, was concern about their spotty track record and, in particular, indications of a link to violence. Numerous studies over the years pointed to a significant number of patients on the drugs who either attempted suicide or obsessed about doing so. The agency decided that it needed to take action. No one wanted a disturbing pattern to balloon into an established trend.

The drug companies want to relabel these symptoms as a resurgence of the original disorder. The problem they face in doing so is that discontinuation syndrome is entirely drug related. Prozac’s maker, Eli Lilly, has fought several protracted legal battles trying to dislodge evidence that its psychotropic is linked to violence—-and Lilly is not the only drug maker that has had trouble making its case convincing.

As the Tribune’s Manier reminds us, Eric Harris and Dylan Klebold, the shooters at Columbine High School, abruptly stopped taking the same class of antidepressant medication days before they opened fire on their classmates. Jeff Weise, the Red Lake High School killer in Minnesota, was taking Prozac before he killed nine people and then himself. Pekka-Eric Auvinen, the eighteen-year-old who began shooting in Jokela High School, Finland, had a history of S.S.R.I. use. According to investigators, so did Seung-Hui Cho, who killed thirty-two people at Virginia Tech and wounded dozens more.

The list of other killings involving S.S.R.I. psychotropic medication is troublingly long. It includes Michael McDermott, the software engineer who went on a rampage in Wakefield, Massachusetts, killing seven; Byran Uyesugi, who shot eight of his colleagues in Hawaii (seven of them fatally); and Charles Carl Roberts IV, who assassinated five Amish school girls before shooting himself.

Such incidents may, in the end, amount to nothing more than an awful set of coincidences. The trouble is, few people-—and even-fewer reporters and editors—-are willing to investigate either way. All the same, many people are sufficiently alarmed by signs of a pattern to suggest that the repeated use of psychotropic medication is involved—-that drugs are part of the problem here, rather than, as commonly assumed, its solution. From the disturbing pattern that is emerging, the standard defense by psychiatrists and drug companies—-that patients’ quitting medication before such violence merely demonstrates how much they needed it in the first place-—holds less water, especially in light of the black-box warnings, added to these drugs by the FDA, that indicate the drugs can increase aggressiveness and suicide ideation in patients, including those who stop taking their medication abruptly.

Was the Tribune headline correct, then, when it called Prozac and violence “rarely linked”? The answer to that complex question depends in large measure on how one defines “rarely” and “linked.” Some would say that “rarely” is not a word to generate much concern, because the number it refers to is statistically insignificant. Yet according to the International Review of Psychiatry, more than 67.5 million Americans-—almost a fifth of the country-—have taken a course of S.S.R.I. medication. Twenty percent of them constitutes a sizable crowd—-roughly the metropolitan populations of New York City and Los Angeles combined.

What about “linked”? Interestingly, Manier’s statement about the one in five patients who experience discontinuation syndrome on Prozac corroborates the exact words of Paul N. Jenner, who in 1998 distributed a confidential memo on this subject to executives at GlaxoSmithKline. Jenner was at the time the company’s Director and Vice President of Worldwide Strategic Product Development, so he was well placed to warn that Paxil too presented a “20 percent relapse rate.” Nevertheless, when highlighting what his report dubbed “Issues Management,” Jenner assured colleagues that “our highly skilled sales and marketing efforts” would spin “the discontinuation issue,” deflecting negative publicity by playing up Paxil’s “flexibility and control.”

In the report, at least, Jenner voiced not a shred of concern that one in five patients on Paxil was experiencing mild-to-serious side effects. (A later health report from GSK would list these as including risk of coma, birth defects, blood aggregation problems, and renal failure.) He was far more worried about the “fight for market share,” with competitors like “Lilly and Pfizer resorting to aggressive tactics to undermine Seroxat/Paxil’s growth.”

“Lilly,” Jenner complained, was “currently focusing on the issue of discontinuation, on trying to turn a disadvantage into an advantage by playing to the supposed strength of [Prozac’s] long half-life . . . providing an in-built tapering mechanism. This is clearly a marketing ploy,” he concluded, “already seen through by most psychiatrists, and a sign of desperation in the fight for market share.”

Coming from the makers of Paxil, such complaints might sound like the pot calling the kettle black. But Jenner was correct that Lilly had tried to sugarcoat grave concern among clinicians and researchers about Prozac’s discontinuation syndrome—-concern that helped prompt the FDA to take action, but that has not gone away, because discontinuation syndrome afflicts all ages.

As there are still so many “unknown unknowns” about S.S.R.I. antidepressants, what is needed now is a frank, open dialogue about the evidence we do have, including the efficacy and erratic effects of these medications when combined with other drug treatments. Longer clinical trials representing the full spectrum of patient reaction over six months—-rather than, as is common, two weeks-—would give us a clearer picture of how the brain and central nervous system react when patients come off this class of medication. As the Tribune article and a litany of studies make disturbingly clear, the evidence is mounting that these psychotropics have far more worrisome, unpredictable effects than large numbers of prescribers and drug makers would have us believe.

Mental Health, Celebrities Get New Website

Via the New York Times' Well blog, of which I am a fan, comes word that PsychCentral.com has begun a new blog called Celebrity Psychings. It's dedicated to celebrities, their mental health issues, and the broader treatment of mental health issues on TV shows and the like. It's authored by Alicia Sparks, who used to write the Mental Health Notes blog, which I've actually read and linked to in the past.

The blog is new enough to where I cannot tell whether it's good or bad, but it's an interesting idea to devote time and money to celebs in such a fashion. My own view is that too many Americans spend far too much time digesting information about celebs. I've never been one of them, likely because I am jaded by the many years I spent doing theatre work in the 1980s and early-1990s and dealing with actors and actresses who ran the gamut from asshole to wonderful.

My prejudices aside, people do pay closer attention to whatever social phenomenons celebs are attached to and, perhaps, absorb more information about whatever is at stake. So in a social reality sense what PsychCentral is doing makes perfect sense. It'll be interesting to see how this plays out over time. I certainly wish Sparks luck and it sure must be nice to get an intro from the Times.

Which brings me to another point. Despite the fact that I have linked to the paper and its website like a billion times and despite the fact that I've fallen all over myself to praise the paper's good work on mental health matters (and occasionally damn its missteps), the paper has never linked to me once, has never mentioned this site or my work here (even where it probably owed me a courtesy attribution), has actively ignored me when it wrote about people writing about mental health issues on the 'Net (even though some of the people profiled in that piece actively pointed the writer in my direction) and so on. Meanwhile, the Well blog has mentioned PsychCentral on several occasions, which is fine because I am globally OK with PsychCentral and they've supported and encouraged my work here and I've linked to them a ton.

I mention this not because I am bitter, but because I find the situation odd and because it actually amuses me. But, from time to time, it sure does make me wonder what the hell is behind the dynamic, because I know for fact that there are people at the paper who read this site and like my work. I'm sure I'll never know.

Are ADHD Meds Making Boys Behave Like Girls?

An interesting column appeared on forbes.com yesterday by Lionel Tiger, a columnist for the website and professor of anthropology at Rutgers University. In his column, Tiger cites the example of France hardly permitting the use of Ritalin and other stimulants in kids, which I've noted before myself, gets into the various conflict of interest scandals around child and adult psychiatry, and then asks:

"The overwhelming proportion of children fed Ritalin--as high as 90% by some estimates--are boys.

"Is it possible that because girls do much better in the school system than boys, boys are being drugged to behave more like girls? Are boys who enjoy large-muscle movements and jolty social interactions being drugged to render them more manageable in classes calibrated to female patterns of behavior and attention? Is this an example in the early years of a feminization of the school system that later on in college yields a ratio of women to men of about 63% to 37%?"

I have no idea if Ritalin does indeed represent the "sissification" (as a friend of mine calls it) of American boys in an educational system that was once built around their needs and behavioral patterns (perhaps excessively so), but is now apparently tilted towards girls (or so I'm told), but it is a provocative question. I don't see American culture and education in such stark terms. The needs of girls are important, too.

That said, there's something truly strange about the fact that most of the children being slammed with ADHD drugs and various meds for alleged child bipolar disorder are in fact boys (among teens, it appears that girls wind up taking more anti-depressants). Prior to the 1990s or thereabouts, it was unheard, except in unusual circumstances, to medicate children for much of anything beyond colds and various vaccines. Nowadays, on the order of 5 percent and more of American kids are medicated for some form of mental disorder, a sea change that ought to give everyone pause regardless of where they line up on medication issues.

Because when you make an epic shift in how you deal with an issue of any kind in a culture and let it play out for a generation or so, it's time to start asking questions about how it's all worked out, measure results and figure out if it's been a worthwhile way of doing things. Presently, I don't think anyone is asking those questions and digging into the data, but it's about time someone did ask, "How has a generation of drugging little boys turned out for us as a culture? Are the kids better and smarter? Is our nation better off? Have we made boys more like girls?" And so on.

Winter Fundraiser, Day 10

Another $145 came in yesterday, bringing the total raised so far to $1,531.26, leaving $1,468.74 to go by about Dec. 15 to reach the overall goal of $3,000. Thanks to the 47 people who've contributed so far.

Let me level with you all: this fundraiser is going slower than I had hoped. Yes, I know the economy is a mess, but there is nothing better than the power of a whole bunch of people chipping in to fix a mess. And this site has a whole bunch of people who red it each and every day. Well over 1,200 people read this site yesterday, but only a few contributed. That's got to change.

I already subsidize this site with other freelance work I scrape up here and there, but there's only so much of that I can do or justify. The reality of things is that the rest of you need to step up and support this site. If you don't, then I cannot justify doing it anymore. And I know there are plenty of people who write me each day to thank me for this or that issue I've addressed or for helping them get off a bad medication which has hurt them, but they'll give their local barista or bartender a buck before they'll offer a nickel here. I appreciate that sort of thing but the thing is it costs me time and money to run this website.

Without your support, I simple cannot continue. So please contribute today.

Thanks.

America The Weird, America The Hateful

From time to time, I stop to ponder where this amazing, weird country of ours is as a culture, trying to connect some of the dots as it were, and then I shoot off my mouth about it. I promise this will eventually connect with mental health issues. Let's start with the weird.

I simply cannot wrap my small mind around revelations that Illinois' Governor was trying to sell to the highest bidder his right to nominate Obama's Senate replacement. Not only is that criminal, it's utterly bizarre and delusional. The Guv I don't feel like naming also wanted to force the Tribune company into firing editorial writers who criticized him and also wanted to withhold state funding from a children's hospital where an official had refused to make a donation (to what I'm not sure). I'm glad this creep was busted because what he was trying to get in exchange for a Senate nomination of whomever was either a job running HHS, an ambassadorship and corporate board jobs for his wife.

Can you imagine if this goon had ended up running HHS? Can you imagine the deals he would've cut with Big Pharma? Can you imagine who he'd put in charge of the FDA? The mind boggles.

I sure hope this scandal is limited to him and his chief of staff, but you never know.

Speaking of President-Elect Obama, did you catch that he was grilled by Tom Brokaw on "Meet The Press" the other day over his closet smoking habit? Yes, the soon-to-be most powerful man on Earth was forced to answer questions about whether he'd smoke in the White House (he said he'd obey Hillary Clinton's ban on smoking there. I think he should do whatever he wants and if he wants I'll buy him a box of cigars). That's how extreme the smoker hating thing has gotten in America. The economy is in total meltdown, we are involved in two wars, there's bailouts for crooks on Wall Street, there's much hate percolating in our culture on all manner of subjects, and that's what Brokaw carves out time to ask him about? Wow, that's weird.

But there is all sorts of weird hate in America these days. Out here in Washington State, you may have heard that an atheist group put up a sign in our state capitol in Olympia as a response to a Christian manger display. Last week, Bill O'Reilly and others on Fox News went off on Gov. Christine Gregoire for allowing the atheist display and denounced my state as being as nutty as California (admittedly, this state can be pretty weird). Gregoire had little choice but to allow the display or the atheists would've taken her to court and would've wound up with the display permitted by a judge, so it's not fair to bang on her.

Nonetheless, I do partly understand why the O'Reilly's of America are teed off. The language on the atheist sign was quite extreme, calling religion a myth and superstition that "hardens hearts and enslaves minds." I'm as about as lapsed Catholic as you can get and have long been open to atheist views, but that phrase alone is filled with such contempt and hate for religion that it even bugs me. I'm not sure it's worthy of all the contempt and hatred it's generated in return--it is a sign, one that will be up for perhaps three weeks, after all--but, yeah, I actually sort of understand what Christians are mad about. Is it too much to ask atheists to be classy about their contempt for religion and maybe choose their words a bit more carefully?

Meanwhile, religious folks could probably stand to chill out on gay marriage. I'm a lukewarm supporter of gay marriage, and I don't get what bugs the right about gay marriage so much. Neither do I think it's the most burning issue before our nation--it's the economy, stupid!--but ever since Prop 8 passed in California on election day, there has been an epic backlash against the Mormon Church, Mormons and churches in general and I simply don't get that either. The backlash is completely hateful and, I think, out of proportion to Prop 8, which will either be overturned in the courts or by yet another initiative. In my dear old homeland, there are gay activists openly harassing people who supported Prop 8 and I've read of one case where a woman was harassed at her job at a cafe, her employer was picketed and customers were hassled. Now, that's hate and it's pretty excessive. I'm not sure that there's a chill pill big enough for that level of excess--going into peoples' workplaces over a vote you didn't like? Really?--but I'm sure Big Pharma would like to sell one.

And, if you want some more obsessive hate, can you top the people who are still kicking Gov. Sarah Palin around one month after the election? Look, Palin wasn't qualified to be Vice-President, but she lost, the election is over and folks should really move onto something else. And yet Palin is so hated that people simply will not let it go. I've simply never seen anything quite like it before. That hate is just weird. I don't understand it because it seems so irrational and disconnected from anything she's done as Alaska Governor or said on the campaign trail.

Is this how we are doing things in America now? Carving to pieces people we don't like even when they present zero threat to ourselves and our families? Kicking them in the teeth when they have no power at all because they represent something someone doesn't like? Whatever happened to healthy, spirited debates and people agreeing to disagree and going their separate ways and so on? Maybe, I'm a bit of a weirdo moderate on these sorts of things because my orbit of friends runs from atheist, lefty, dope-smoking, gay hippies all the way to conservative, God-fearing right-wing gun nuts. Strangely, I get along with all of them.

All of which brings me right back to the mental health world. I write some very tough stuff on this site about psychiatrists, medications, research and so on, but at the end of the day I don't hate psychiatrists and medical research (I am skeptical of both however) and if someone wants to go take medication X and claim it saved their lives, then I'd not do a single thing to stop them. I'm actually fairly moderate on these issues, but sometimes I get judged as an extremist simply by dint of the fact that I am deeply skeptical in a field where too many people like to look at emperors wearing no clothes and call them fashion plates.

But there's one man out there on the 'Net who simply cannot get past his hatred for me. I won't name him, but I'm sure many of you who read this site remember a man of many faces (there's your hint) commenting here and taking issue with almost everything I wrote and starting odd fights with other commenters. Earlier this year, several readers alerted me to this person and denounced him as someone who adopted strange identities on the 'Net and hassled women and basically told me that I should cut him off from commenting on my site. I wrote to this person asking about the veracity of these claims and he denied them, so I decided to give him a chance and respect his views and so on. Eventually, he lashed out at me in a personal manner and I banned him from this site.

Well, guess what? Old what's-his-name-the-obsessed-depression-activist is still reading this site and is now going around to other sites and leaving comments attacking me and suggesting that other bloggers lash out at me, too, and using anonymizing software. This is like two months after I banned him from commenting on this site, but such is this man's hate for me that yesterday he apparently read my post on the smoker haters coming after me, and then went to another mental health site and left a comment asking that that blogger denounce me for smoking. That person didn't approve his comment, but instead shared them with me. Simply jaw dropping, people. The kind of hate where you scratch your head and go, "Why's this dude so obsessed with me? What can I do about it?"

I certainly don't know what to do to stop it, but I do actually feel pity for this man.

Biederman Defends Himself

I don't have much to add here, but Joseph Biederman--the controversial Harvard child psychiatrist caught up in a conflict of interest scandal--has written a letter to the Boston Globe. There's an account of it in this article here, wherein the doctor notes in part that:

"'The center's goal was to advance science; as a business, J&J sought commercial applications for our work,' Biederman wrote. 'But any implication that J&J's interests interfered with the center's work is wrong. Indeed, I have published research critical of J&J compounds. I never owned J&J stock, and whether the company succeeded financially had no importance to me. What does matter to me is the treatment of children and families experiencing great suffering.'

"Biederman also denied that he engaged in 'ghostwriting.'"

I've written about the Biederman/J&J business previously.

Winter Fundraiser, Day 9 And A Side Note On Exhaustion

Another $125 came in yesterday and that brings things to $1,386.26, leaving $1,613.74 to go to reach the fundraiser's goal of $3,000 around about Dec. 15. I appreciate all the contributions to date.

So we are in the homestretch here and I hope I can count on some of you who've not contributed yet to help fund the work I do here. This site has about 5,000 regular readers a month--meaning people who read it daily or several times a week--and to date 44 readers have contributed. I'd like to get the latter number much higher over the next few days, especially today and tomorrow. Tuesdays and Wednesdays are usually the busiest days of the week on this site.

I was planning on a writing a spirited pitch for why my work here deserves your support, but as I write this at around 9.30 p.m. on Monday, I am utterly exhausted and worried sick about being forced from my apartment of six years. I smoke, you see, and while I am in complete compliance with the terms of my lease, some new people have moved into my building over the last couple of months and are raising a ruckus not because smoke from my unit is getting into theirs (I can assure you it's not), but because they don't like the smell of smoke they encounter for about one second each time they pass my door--and that's perhaps three times a day at the most. Although I've taken steps to ensure that they can't smell smoke on the other side of the door, they claim they still can (even though I had a friend come over yesterday who is a non-smoker and he told me he can't smell a thing) because they truly hate smokers and smoking and are completely hysterical about it. Last week, one of them left me one of the most hateful notes I've ever gotten from a neighbor in my entire adult life.

I've lived in this building for six years and this has never been a problem before. When I told that to my property manager last night and admitted to him that I felt more than a little side-swiped, he launched into a lecture about smoking. Now that the manager is clearly working on me, there's no way I can win since he can have my lease changed with 30 days notice and I'll be screwed. Either way, he's not an unbiased, neutral observer of whether one can smell smoke by my apartment door.

Going outside to smoke isn't an option since the same smoker haters will just complain about it then. It's not enough for the people in Seattle who hate smoking to have kicked us out of the bars, clubs and private clubs of this city and banned us from within 25 feet of literally everything except private residences, now they want to kick us out of our housing. As my father, a former smoker and Korean War combat vet, once put it to me, "This is not the same country I fought for." No kidding, Dad.

So it's beginning to look like I'll be moving. Not sure when or where, but the chances of me not moving in the next month or so are about 20 percent. And I hate moving more than just about anything in life. Except maybe Prozac.

Anyway, I'm played out emotionally, but will be back in the morning with some other posts--not long after I have some coffee and a smoke.

Psychiatrist Slams Psychiatry

The following was written by Gene Combs, a psychiatrist in Illinois who has also written books about narrative therapy, including "Narrative Therapy: The Social Construction of Preferred Realities." Combs is also an associate professor of psychiatry at Loyola University, Chicago. He wrote these thoughts to a friend and then passed them along to me and I am printing them here with his permission because it's refreshing to see someone be so reflective about his profession and the huge issues around "corporate psychiatry" and the bipolar label.

Share your thoughts in comments and please be polite.

"I'm a psychiatrist. I don't always like being a psychiatrist, largely because it seems my colleagues are either greedy, self-important, unreflective bozos (like I imagine Dr. Biederman to be) or ordinary people who have huge responsibilities and are caught up in a system that they don't know how to question, who assume that the very poor excuse for science that they get in their professional literature can be trusted and should be followed.

"Being a psychitrist, I'm caught up in the same web of discourses. Being a psychiatrist, the huge bulk of referrals I get involve questions about psychotropic medications. These days it's rare for a person to come with the question of whether or not to take a medication. It's usually that they want some advice as to WHICH medication. Often, it's not even that; it's that their teacher has told them they need Adderall, or they heard on television that Paxil would help them win friends and influence people.

"Being a psychiatrist, I prescribe medications many times a week. I try to do this thoughtfully. I try to stay up on which medication might do the most good for which constellation of symptoms, and to notice those time when the best choice might not involve medication.

"Being a psychiatrist who is also a family therapist and a student of postmodernism/poststructuralism, and of the history of my profession, I am deeply an disturbingly aware of how easily we delude ourselves. I try to cultivate an awareness of the many conflicting purposes at work in the world, and to find ways of acting that move the discourse toward 'the good' as far as I'm able to discern that.

"WHEW! That was quite a preface. Are you still with me?

"What I'm trying to say is, I'm not anti-meds. I am against corporate capitalism masquerading as science. I am, I think for good reason, highly suspicious of any and everything that comes from organized psychiatry these days. This Biederman thing is just the tip of the iceberg. Big Pharma is just one of the forces that is at play in the takeover of the University by corporate capitalism. The whole DSM project is a bitter joke, an embarassment to the name of scientific inquiry. Then there is the insurance industry, which treats the DSM as if it's real, and demands that if I'm going to be paid I have to put each person I see in a DSM pigeonhole whether they really fit it or not. This further contributes to the dumbing-down of my profession. I'm full of bile about this. I foam at the mouth about it at the slightest provocation. SEE? I'm doing it again, even though I'm trying to be reasonable here.

"Because of the over-reach of Biederman, and the bad effects of his influence I see several times a week in my own office, I'm very cautious about using the word 'Bipolar' in reference to anybody, adult or child, these days. The label used to have a meaning, but now, in my part of the country at least, it is being applied to anyone who shows any strong emotion in a way that causes anyone discomfort."

We need more people in psychiatry like Combs.

Winter Fundraiser, Day 8

Another $50 came in after I posted yesterday on the fundraiser's progress, so that brings things to $1,261.26 raised so far, leaving $1,738.74 to go before the fundraiser's $3,000 goal is met around Dec. 15. That puts the fundraiser at about 42 percent of goal and with another week to go I hope you'll all help it get there.

Thanks to the 42 readers who've contributed so far. If you'd like to join them, the PayPal button is on the right or send me an email and I'll send you my mailing address.

I mentioned yesterday that Dec. 7 is always a tricky day for me and a few readers wrote to ask what Dec. 7 was and why it bugs me.

Dec. 7 is Pearl Harbor Day. My grandfather, a Lt. Commander and naval aviator, was stationed on Ford Island, which sits in the middle of the harbor right off of what's now known as Battleship Row. With him were my grandmother, mother (aged 6) and aunt (aged 9). They were on their way to church at 7:50 a.m., when my aunt saw the first of the Japanese planes coming in and said, "Daddy, what are those funny planes?"

My grandfather told my grandmother to get herself and their kids to a bomb shelter and then sped off in the family's car and was the first officer to show up at Luke Field, a combined Army Air Corps/Navy air base on the island. He got strafed by the Japanese, got to the base and got people to work on saving fighter planes from spreading fires, putting out fires and tending to wounded and shell-shocked personnel. There may be more to it than that. I don't know. He was killed six months later.

What I do know is that I talked to my mother last night and she told me how their bomb shelter was turned into a triage unit for the wounded and how my grandmother worked to clean wounded military personnel while the kids watched. My mom says she's still stunned that in the midst of all this, injured fliers and ground crew and sailors would come over to her and her sister and ask how they were doing.

There were about 2,400 deaths that day, 9 ships sunk, 20 damaged beyond repair, and hundreds of airplanes were lost. It was America's worst military loss and the next day the US declared war on Japan and, then, Germany and Italy. It's always been a source of pride mixed with anguish that my family is so tightly tied to one of those moments that changed the world. (In an unrelated irony, my grandmother was a young girl in San Francisco on the day of the great earthquake there.)

There's much more to it, but I'll leave it at that.

Psychiatrists, Scientists Editorialize In Favor Of Legal Use Of ADHD Drugs In Healthy People

Two psychiatrists, some neuroscientists, ethicists and the editor of Nature opined in the journal yesterday that America needs to grapple with the "responsible" use of performance-enhancing brain drugs in healthy people. One of the authors is Ron Kessler, a psychiatrist and public health wonk at Harvard who has previously argued that roughly 50 percent of Americans have a DSM condition of some type. He was also behind a study that came out this year and asserted that adults with ADHD/ADD cost their employers 22 workdays a year. The other authors are largely unknown to me.

A summary of the piece reads:

"Society must respond to the growing demand for cognitive enhancement. That response must start by rejecting the idea that 'enhancement' is a dirty word, argue Henry Greely and colleagues."

The piece itself begins:

"Today, on university campuses around the world, students are striking deals to buy and sell prescription drugs such as Adderall and Ritalin — not to get high, but to get higher grades, to provide an edge over their fellow students or to increase in some measurable way their capacity for learning. These transactions are crimes in the United States, punishable by prison."

And, then it goes behind the subscription firewall, so I hope to see the full piece later today (someone send it on over please).

It sure is funny, though, that they begin their argument citing the examples of college students illegally using ADHD drugs (meaning they aren't prescribed by a doctor for ADHD/ADD). College students like to smoke a lot of pot too and that's illegal. Are Greely and colleagues going to call for the legalization of weed? Or is that off limits because it's not considered an "ethical" pharmaceutical? And isn't this the same age cohort that psychiatrists claimed last week had an almost 50 percent prevalence of mental disorders? And they are the springboard for this argument? The kids doing "college crack?"

The AP had a bit more of the commentary:

"'We should welcome new methods of improving our brain function,' and doing it with pills is no more morally objectionable than eating right or getting a good night's sleep, these experts wrote in an opinion piece published online Sunday by the journal Nature."

Interesting point, but it'd be a lot more interesting if the drugs in question weren't ADHD stimulants--the use of which has led to dependency, withdrawal issues, addiction to other drugs, heart problems and psychosis--and Provigil, the narcolepsy drug about which we know very little in long-term use. I'd be a lot more comfortable if they were talking about natural compounds which no one could patent, because these kinds of arguments are Big Pharma's wet dream.

One of the authors told the AP that demand is out there among middle-aged sorts who want to improve their memory and multitasking workers, and that everyone would want to take Adderall, Ritalin and newer versions of the same kind of drugs. So college students and corporate types will now be the justification for making psych meds available to one and all, even absent an identifiable psych disorder? Sounds pretty damn weird to me. And others.

"But the commentary didn't impress Leigh Turner of the University of Minnesota Center for Bioethics. 'It's a nice puff piece for selling medications for people who don't have an illness of any kind,' Turner said."

Can you imagine what the advertising would look like for these drugs? It'll likely be a variation on Viagra and other ED drug ads, only this time with one's brain and not one's pecker as the concern.

The authors also called for:

"While supporting the concept that healthy adults should be able to use brain-boosting drugs, the authors called for:

— More research into the use, benefits and risks of such drugs. Much is unknown about the current medications, such as the risk of dependency when used for this purpose, the commentary said. Also, according to the Food and Drug Administration, Adderall, for example, is an amphetamine that carries warnings about possible sudden death, heart attack and stroke, especially for people with heart problems.

— Policies to guard against people being coerced into taking them.

— Steps to keep the benefits from making socio-economic inequalities worse.

— Action by doctors, educators and others to develop policies on the use of such drugs by healthy people.

— Legislative action to allow drug companies to market the drugs to healthy people if they meet regulatory standards for safety and effectiveness."

While this is all provocative and interesting and wonk-worthy, didn't America go through a period of time when doctors handed out stimulants to fairly normal people looking for a boost? Yes, those were the 1960s, when Benzedrine and other stimulants (which certainly resemble speed or cocaine in their actions, because they are similar in their structures) were handed out like candy by doctors. Soon enough we had an epidemic of people hooked on "uppers" and the feds moved to sharply curtail their use (they were made controlled substances).

Personally, I don't know where I come down on this issue because I am generally OK with intelligent adults making decisions about what compounds to put in their bodies, but at the same time I see tons of problems with the thrust of the authors' argument. Can't we just be who we already are and leave it at that?

I guess this whole thing boils down to what one considers enhancement and what price they are willing to pay to be enhanced, or if they are willing to do the hard work of improving themselves without a booster drug. If these scientists can make the case for uppers, then what's to stop them from also making the case for "downers" and arguing that it's OK for otherwise healthy people to be given some Seroquel? What about Oxycontin?

Ah, the possibilities are endless.

NIMH Head, Agency Refuse To Answer Questions

Some of you may recall that not long ago Tom Insel, director of NIMH, was quoted by the New York Times as saying psychiatry is:

"'[T]he only field where the doctors are more stigmatized than the illness.'"

I took Insel to mean psychiatrists were more stigmatized than their patients--after all, who has the illness?--and contacted NIMH and asked to talk with Insel so I could understand what he was getting at. I found it difficult to believe that psychiatrists could possibly be more put upon by society than patients, but maybe Insel had something to enlighten me. Maybe he was joking.

I spoke with one of his spokeswomen, who assured me, "Oh, he's not joking." She took down the name of this site, my phone number and email and told me she'd get right back to me. The same day there was a small flurry of visits to this site from nih.gov and I never heard back from NIMH. So I called them again last Wednesday and another spokeswoman told me they'd get right back to me with an answer. As before, I've not heard from NIMH. Insel and his agency refuse to explain what Insel meant.

As impossible as I find Insel's claim to be--has he seen how psych patients get dealt with by American society?--I'm bothered by something else. Insel is the head of a federal government agency, funded by over $1 billion a year in tax dollars. He's a public official. If he's going to make public pronouncements about psychiatrists and patients, then he needs to be accountable for what he's said, regardless of whether his agency likes who's posing the question or not.

While I understand that websites like mine make the mental health establishment nervous that doesn't remove Insel and NIMH from the obligation they have to the public, in this case to explain what Insel meant when he opened his mouth in such a fashion.

Winter Fundraiser, Update Plus Interesting Item

Counting Friday, Saturday and Sunday morning, another $316.26 came in. That brings the total contributed so far to $1,211.26, leaving $1,788.74 to go to reach the fundraiser's overall goal of $3,000 around Dec. 15.

Thanks to everyone for their support. If you'd like to contribute, the PayPal button is on the right or send me an email and I'll send you my email address.

The "pony" challenge wasn't reached, but I may try it again during the week sometime.

Amusingly, John McManamy has now written his third defense of former "Infinite Mind" radio host Fred Goodwin on his blog at HealthCentral.com. It's also his third attack on the New York Times. As I noted the other day, McManamy made actual errors in his claims about what the paper wrote. This time out, McManamy seems to be working to fix his own reputation among readers in addition to trying to patch up Goodwin's reputation:

"Many bloggers exploded in rage, as did a number of posters to this site. A fair number directed their anger at me, for defending Dr Goodwin. If you are one of these individuals - I don't blame you. You have every right to be angry. This is your life. People are messing with it, placing you in jeopardy. For obvious reasons, we need to monitor this site against inappropriate posts, but, again, I understand your anger."

That's the first time in this lengthy Goodwin pharma payouts scandal that McManamy has actually evinced concern for the patients who Goodwin and others lied to. It's pretty amazing that it's taken him so long to get around to this. But then he does have a slew of pharma ads on his HealthCentral.com blog and on his mcmanweb.com site. Not that they determine the content of his writing, but they do pay his bills.

This site: no ads for psych meds of any kind.

I'll be back in the morning with more items. Posts might run a bit late, as December 7 is always a bit of a tough day for me.

AstraZeneca Busted By FDA For Off-Label Marketing Of Seroquel For Depression

News is just out that the FDA has caught AstraZeneca marketing its star atypical antipsychotic Seroquel off-label for depression. Under federal law, drug companies are not allowed to directly market drugs to doctors or to consumers for anything other than FDA approved uses. Seroquel is approved for the treatment of schizophrenia, acute mania in bipolar disorder and bipolar depression.

From the FDA's letter to the company, dated Dec. 1, 2008:

"On Thursday, January 3,2008, at approximately 3:00 p.m., a sales representative from AZ in the [location redacted] made an unsolicited sales call to a physician at his office. The representative stated that Seroquel was approved for treatment of major depressive disorder (MDD). This representation was not made in response to a request for such information by the physician. As a result of this representation, the physician requested that AZ provide written information to support the claim that Seroquel has been approved for the treatment of MDD. In response to this request, AZ sent the physician a mailing dated January 4, 2008.

"The mailng contained information about Seroquel and Seroquel XR's use for MDD, and
included summaries of eight clinical trials with referenced citations. This mailng was not the result of an unsolicited request by the physician, but rather was prompted by the sales representative's statements....

"[T]he oral statements made by the sales representative and the information provided in the January 4, 2008, mailng, misleadingly suggest a new 'intended use' for Seroquel and Seroquel XR. Because the Pis for Seroquel and Seroquel XR lack adequate directions for this use, the drugs are therefore misbranded. Although the letter to the physician states that '(AZ) does not recommend the use of SEROQUEL or SEROQUEL XR in any other manner than as described in the enclosed prescribing information,' this disclaimer is insufficient to mitigate the promotion of a new 'intended use' for which the products lack adequate directions.

Seroquel was not then and is not now approved for use in treating depression. The company has an application currently before the FDA to gain approval of the drug's use in depression, as well as anxiety.

This has to count as one of the more egregious off-label marketing efforts by a pharma company that I've ever seen. The 97 pages of promotional material AstraZeneca sent the doctor can be viewed on the FDA's website (5 MB pdf). I've not had a chance to review the material myself.

The FDA is requesting that AstraZeneca halt distributing such materials and reply to the FDA by Dec. 15 as to whether it intends to comply with the request. I would hope that the FDA would do more than just ask the company to stop marketing the drug off-label, but would take other action as well, since off-label marketing allegations have been swirling around Seroquel and other atypical antipsychotics for several years and here the FDA has caught one of the companies red-handed. The agency ought to step up for the integrity of drug approval and post-approval marketing regulations.

You've got to wonder how many doctors were similarly approached by company sales reps touting the drug's use in depression and, possibly, other disorders where the use would be off-label.

An AstraZeneca spokeswoman tells Pharmalot that the company:

"takes these allegations seriously and we are conducting a full investigation. We have a robust compliance program that calls for responsible sales and marketing practices that comply with applicable laws, regulations and industry standards, as well as AstraZeneca internal policies.

"AstraZeneca has policies and procedures in place that provide direction to its employees about the appropriate promotion of our products and the appropriate handling of requests from physicians for clinical information about our products. Although the allegations related to one isolated incident, AstraZeneca is taking steps to reinforce with the sales force the application of relevant AstraZeneca policies and standards, to continue to reinforce appropriate interactions with physicians."

If the company's compliance program is so robust then how did such materials get sent to a doctor?

Report: AstraZeneca Knew Of Diabetes Problems With Seroquel As Early as 2000

Bloomberg is reporting that AstraZeneca officials knew of diabetes risks associated with the use of its atypical antipsychotic Seroquel as far back as 2000. The news comes thanks to a small set of documents presented in open court yesterday in Tampa, Fla. as part of pre-trial arguments in a federal lawsuit against the drug company.

"AstraZeneca Global Safety Officer Wayne Geller concluded there was 'reasonable evidence to suggest Seroquel therapy can cause' diabetes and related conditions, according to documents presented yesterday in federal court in Tampa, Florida. Geller drew his conclusions following a review of available studies and internal trials, according to the documents.

"The internal documents were shown publicly for the first time during a hearing over the qualifications of expert witnesses the plaintiffs plan to use at trial. They are to testify in a lawsuit over the drug’s effects when the proceeding begins in February. While portions of the documents were shown in court, the filings remain sealed at the request of the London-based pharmaceutical company."

Interestingly, the FDA last January asked AstraZeneca to provide an analysis of its clinical trials of Seroquel.

"AstraZeneca responded June 26 with an analysis that showed 2.4 percent of people who began treatment with normal levels of sugar in the blood became technically diabetic after 52 weeks. Normal levels are less than 100 milligrams per 10 deciliters. Someone is labeled diabetic with a reading of 126 milligrams, said Laura Massey Plunkett, a human risk assessment specialist, who read in court from the company report.

"That result, compared to 1.4 percent of patients given a placebo who showed the same increase in blood-sugar levels, Plunkett testified, makes it almost 70 percent more likely that people taking Seroquel would develop diabetes than people who weren’t taking the drug.

"'It’s clear this compound Seroquel can cause diabetes,' she said. 'I don’t think there is any real controversy about that.'"

Seroquel had over $4 billion in sales last year and is commonly used on-label in treating schizophrenia, bipolar disorder and bipolar depression. Off-label, the drug is widely used to treat dementia, anxiety, sleep problems and depression. It's used in adults and children. The company has applications before the FDA to have the drug approved for depression and anxiety.

A company spokesman told Bloomberg that it won't settle pending cases against it, as has Eli Lilly to the tune of about $1.3 billion in connection with Zyprexa lawsuits, but that it will "litigate these cases on the merits."

Winter Fundraiser, Day 5

Another $335 came in yesterday, bring the total for the fundraiser so far to $895 and leaving $2,105 to go by about Dec. 15 to meet the fundraiser's overall goal of $3,000. Thanks to everyone for their contributions to date.

My challenge for 15 new contributors of yesterday wasn't met, so no pony picture today, but I'll make a deal with you all. If 10 people who've not contributed to this fundraiser so far contribute at least $10 a piece by midnight PST, then I'll get the me-as-a-kid-on-a-pony picture up over the weekend. Trust me, it's a very, very, very cute pony.

As usual, the PayPal button is on the right. If you prefer snail mail, then shoot me an email and I'll send you my mailing address.

I'll be back later this morning with an interesting note on NIMH, so stay tuned for that.

Thanks to you all for your support.

Lancet Editorial Slams Atypical Antipsychotic Safety, Efficacy As "Spurious"

A fascinating study and accompanying editorial just came out in The Lancet yesterday. In the NIMH-funded study, researchers performed a meta-analysis of 150 studies of atypical antipsychotics--Zyprexa, Risperdal, Seroquel, etc.--where they had been trialed against a first generation antipsychotic in treating schizophrenia. Much as with the landmark 2005 CATIE study and the CUTLASS study of 2006, researchers found almost no advantage of using atypicals instead of the older, vastly-cheaper drugs (atypicals run anywhere from 10 to 20 times the cost of generic antipsychotics). Researchers also found that study subjects gained more weight on some of the atypicals, a potentially troubling sign of diabetes and the metabolic syndrome.

So why, you may ask, are we using the atypicals for schizophrenia and a host of other mental disorders? How did the atypicals become a $14 billion market over the last decade when their efficacy was never that hot? For two main reasons: one, as far as schizophrenia goes, the atypicals do offer fewer problems with extrapyramidal symptoms (ie, zombieism) and tardive diskinisia than do the older drugs, which are rightly infamous for their Parkinson-like effects; and, two, everyone has been sold an immense bill of goods by the pharmaceutical companies which make these drugs and lied openly (as is coming out in numerous lawsuits) as to the efficacy and safety of the atypicals and by an elite group of opinion leaders in psychiatry, who argued that the atypicals were, in essence, silver bullets for schizophrenia, plus that they were such gentle drugs that they could be used where doctors would hardly ever use the old antipsychotics--in bipolar disorder long term (the old ones were sometimes used short term here), in dementia, in ADHD, in depression, in anxiety and so on.

In retrospect, this now all looks a bit crazy.

And, that's pretty much the point an editorial accompanying the study makes. I've not seen the full paper or the full editorial, but here's this from medpagetoday.com:

"In an accompanying editorial, two British researchers went further, calling the notion that newer agents are more effective or safer than older drugs spurious.'

"'As a group they are no more efficacious, do not improve specific symptoms, have no clearly different side-effect profiles than the first-generation antipsychotics, and are less cost effective,' wrote Peter Tyrer, M.D., of Imperial College London, and Tim Kendall, M.D., Ph.D., of the National Collaborating Centre for Mental Health in London."

From the teensy bit of the editorial I could pinch from the online version, Tyrer and Kendall stated:

"Clinicians are familiar with studies that claim to show major advances in therapy. They tend to greet early reports of such advances with a touch of scepticism and wait, usually for at least 10 years, for a raft of independent studies that show that the advance is genuine and not just another minor ripple in the treatment stream. In The Lancet today, Stefan Leucht and colleagues deviate from this pattern by suggesting that what was seen as an advance 20 years ago—-when a new generation of antipsychotic drugs [Clozaril in 1989] with additional benefits and fewer adverse effects was introduced-—is now, and only now, seen as a chimera that has passed spectacularly before our eyes before disappearing and leaving puzzlement and many questions in its wake."

That's some of the toughest language--chimera, spurious--that I've ever seen doctors use in criticizing these drugs. To be fair, the study authors are a bit more positive about the comparative advantage of some atypicals versus some old antipsychotics, but without seeing the entire paper it's a bit hard to determine what is what. I also think the researchers are trying very hard to leave some frosting on the cake, as it were.

Either way, I've been waiting three years since I began this site and launched into my own attack on the atypicals and their broad use in American culture (and I was virtually alone in the media in this criticism) to see respected researchers lower the boom on these poison pills. Perhaps now, someone will also make the point that the bill for much of this unjustifiable use of these drugs has been borne by the American taxpayer through MedicAid to the tune of billions of dollars a year. Thousands of people have died as a direct result of taking these drugs, many thousands more have wound up with diabetes, and even a few stray teen boys have developed breasts and required mastectomies thanks to Risperdal.

These drugs' day in the sun is now over. Isn't it interesting that it comes only a few years before the end of most of their patent lives? (Risperdal actually went off-patent earlier this year.)

Just to give readers a sense of how discredited the atypicals have become by researchers in peer-reviewd journals, consider:

The CATIE study.

The infamous PRIME study of Zyprexa used to allegedly prevent psychosis in kids.

A 2006 study showing that the use of atypicals in treating agitation in Alzheimer's was no more effective than placebo.

The 2006 CUTLASS study.

A 2007 subset of the CATIE study showing that atypicals only provided small cognition gains versus older drugs.

A 2007 study showing atypicals were not better than placebo in treating Alzheimer's.

A 2008 study showing that placebo outperformed atypicals in treating aggression in what were dubebd low IQ patients.

A 2008 study showing atypicals did not outperform older drugs in treating first episode psychosis.

A 2008 study showing that atypicals were detrimental to patients with dementia.

A 2008 study showing that atypicals were killing elderly patients at a shocking rate.

A 2008 study showing that atypicals are very risky drugs for children versus older antipsychotics.

That's 11 major studies in three years showing just how moronic the use of these drugs has been. Show me a class of drugs, aside from anti-depressants, that has been so thoroughly discredited in such a short period of time.

It's time for the use of these drugs to be severely curtailed, especially in non-psychotic disorders. If anyone--doctor, patient, parent, etc.--wishes to write something defending the wide use of these drugs in our culture (as opposed to their "Oh, they work for that guy over their" use), then I'll publish it.

Winter Fundraiser, Day Four

Another $225 came in yesterday, bring the total for the fundraiser to $560. That leaves $2,440 to go to reach the goal of $3,000 around about Dec. 15. I appreciate the contributions to date.

So far, 18 readers have contributed to the fundraiser out of approximately 5,000 regular readers of this site. During September's fall fundraiser, 48 readers contributed. I'd feel ever so much better about this fundraiser if another 15 readers, who've not yet contributed to this fundraiser, contributed at $10 or more before the end of today. If that happens, I'll post a picture of myself and my sister atop our pony way back when. Trust me, it's a very, very cute pony.

For those of you who aren't into dorky pictures of me as a tyke on a Shetland pony, please consider today's postings on Risperdal and the attempted defense of Fred Goodwin as inducement to contribute. They are pretty decent work, if I do say so myself.

As usual, the PayPal button is on the right. If you prefer snail mail, send me an email and I'll send you a mailing address.

Thanks again for your support.

Risperdal Had Only One Approval Study For Pediatric Bipolar Disorder, Study Remains Unpublished

Recently, I was poking through the package insert for Risperdal, an atypical antipsychotic made by Johnson & Johnson/Janssen, when I noticed that in its discussion of clinical studies for the drug's use in treating pediatric bipolar disorder, only one study was mentioned, consisting of 169 participants. I've been writing about pharmaceutical products for years and have been told by the FDA and sources in the medical world that the FDA requires two positive trials (meaning efficacy over placebo is demonstrated) for a drug to be approved for any indication. It struck me as odd that the FDA would approve such a tricky drug--it has black box warnings and plenty of lawsuits on its tail--with only one approval study for a disorder that is the source of much controversy within psychiatry itself and which the FDA only announced this summer was a "valid diagnosis" in its estimation.

Risperdal has been in the news lately over claims that a Harvard child psychiatrist, Joseph Biederman, pressured the company to give him hundreds of thousands of dollars to fund a center to study the use of psych meds in kids (that news came out of a Risperdal lawsuit), over evidence that the drug is causing breast development in some teenaged males, and over concerns voiced by an FDA panel of outside experts that the drug is being prescribed for conditions such as ADHD for which it has no approval.

Even worse, documents for a lawsuit against J&J recently revealed that the company termed clinical trials for the drug's use is kids as "growth opportunities."

With all of that in my head, I queried the FDA about why the drug had been approved with only one clinical trial for pediatric bipolar disorder. From Sandy Walsh, who's the press officer for the agency's psychiatry products division, comes this explantion:

"Yes, we do generally require 2 studies for a new indication, as we did with Risperdal for irritability of autism (as there were no prior approvals of any other age group for this claim). But it's a different story for pediatric claims that come after adult approvals for the same claim. Here we generally accept a single study to extrapolate from the adult data, i.e., Risperdal already had adult claims for schizophrenia and bipolar as discussed in the Pediatric Written Requests we issued. There was no special consideration here. This is a common situation, not just with psychiatric drugs.

"However, if one looks at the Pediatric Written Requests that have been issued for many of the SSRI's you will note that they require 2 studies for depression because of the noted many failures, but only 1 pediatric study for other conditions such as OCD or SAD. This is because the adult indication is the same and we have evidence of its effectiveness in adults and do not wish to enroll children unnecessarily (of course a big ethical issue as children cannot offer consent) in just repeating a trial when we already have other data in adults and will get the dosing and safety information from the pediatric efficacy study.

"The burden is to be as effective as possible with the data we have in designing pediatric trials. The FDA always looks to see what we can learn from adults. In some situations we can extrapolate efficacy data, not safety or dosing, from adult trials IF we can meet 2 basic assumptions concerning the similarity of the disease and the response to therapy between adults and children. Sometimes we are not certain if we can extrapolate and we take a middle road of exposure-response studies to test the hypothesis that we can extrapolate. In that case you may not even have a single efficacy trial as was used for the atypicals. I have enclosed the algorithm that is used by FDA in deciding what type of trial to conduct- it is slide 32 in the enclosed set of slides which are public. It also goes through the many questions the FDA asks in deciding if how to do trials in the pediatric population."

So there you have the FDA's explanation.

What's puzzling to me is that the trial described on page 11 of the insert (.pdf here) refers to a study involving 169 kids and teens taking the drug for "mania" (or who were getting a placebo), but I cannot locate a published study involving Risperdal's use to treat mania in a pediatric age group. Only 111 kids or teens took the drug in the study, some at what I consider ridiculously high dosages of from 3 mgs. to 6 mgs. a day. That's a pretty small group of patients upon which to rest a drug's approval in my opinion.

Feel free to do your own PubMed search here. What's more, I can find no news release around Risperdal's FDA approval for pediatric bipolar disorder--or mania, if you prefer--nor can I find a reference to a published study on Janssen's website. Janssen is the J&J subsidiary that handles Risperdal. It's common for companies to trumpet clinical studies to the heavens once a drug is approved for an indication or when it is published somewhere. They even like to put out press releases for poster sessions at conferences. But total silence when it comes to Risperdal for kiddie mania. The only mention I can find on J&J's main website is an investor's note from June 2007 when the company received an approvable letter for childhood schizophrenia and pediatric mania and even there there's no mention of clinical results for pediatric mania. The drug was approved (.pdf here) for use in kids with those conditions in August 2007.

But the FDA has not posted online, as required by law, the approval package for Risperdal for pediatric mania. That package is supposed to be put online 30 days after a drug is approved for a new indication. As you'll see right here, there's no approval package for those two indications.

Absent a published study of the drug for pediatric mania or its approval package being made available to the public, there's no way to assess what efficacy the drug demonstrated in its single clinical trial.

So, something weird is going on here.

A Dirty, False-Lighted Place

John McManamy, who blogs over at HealthCentral.com on bipolar disorder and depression, has for the second time gone after the New York Times and its crack reporter Gardiner Harris, who covers public health for the paper in its DC bureau, in defense of Fred Goodwin and "The Infinite Mind" debacle and an article Harris wrote recently that linked Goodwin to over $1 million in payouts from pharma companies while at the same time Goodwin was saying false things on the now-cancelled radio show about anti-depressants, suicide, suicidality and violence.

I need to spell out a fair amount of background for newcomers and tell you why this is important: McManamy is essentially doing PR for Goodwin, who apparently feels that his reputation has been injured by the initial Times piece and a later editorial in the paper, according to informed sources. McManamy is basically claiming that the paper put Goodwin in a false light, and that's pretty darn close to claiming libel, a very serious assertion.

Goodwin is much admired by McManamy (Goodwin wrote a cover blurb for McManamy's book "Living Well with Depression and Bipolar Disorder"), and by other researchers in psychiatry. He's a former director of NIMH and is currently a professor of psychiatry at George Washington School of Medicine. Goodwin is also the primary author of what's considered by many observers to be the definitive medical textbook on bipolar disorder. He's as big of a big shot as a big shot can be in psychiatry.

But Goodwin has come under harsh criticism of late. On Sunday, the Times opined that conflicts of interest between psychiatric researchers and pharma companies had to be cracked down upon by medical professional societies and Congress. The editorial noted Goodwin's presence in the boiling conflict of interest scandal, and curtly noted that Goodwin "earned at least $1.3 million by giving marketing lectures for drug makers who potentially stood to benefit from the recommendations he made on the program. He has rightly been removed from the air."

The next day, Tufts University psychiatrist Danny Carlat wrote on his influential blog that the revelations around Goodwin and Harvard University's Joseph Biederman, a controversial child psychiatrist, were "bringing the profession of psychiatry to its knees." McManamy didn't mention Carlat in his recent defense of Goodwin, nor did he mention my own reporting on an episode of "The Infinite Mind" from last March, where I noted that Goodwin and his guests had lied about questions around anti-depressants, suicide, suicidality and violence. Nor did McManamy mention two pieces the next month, one by Slate.com and one by yours truly, which first delved into conflicts of interest Goodwin and the show itself had.

I mention all of that because if McManamy is going to throw around false light claim innuendoes and if Goodwin is torqued about such things, then the pair ought to be slamming myself, Slate.com and Carlat as much as the Times. What's more, both Goodwin and McManamy ought to be criticizing Sen. Charles Grassley (R-Iowa), who's been highlighting these dirty conflicts of interest on the Senate floor and who made public the dollar amounts Goodwin was getting from GlaxoSmithKline and other companies while taking to America's public radio airwaves to proclaim that all is well with the psychopharmacological paradigm and that its critics are essentially loons.

It'll sure be interesting to read McManamy's piece on how Sen. Grassley unfairly characterized Goodwin's money-taking and radio propagandizing.

But McManamy's big beef is with the Harris article of Nov. 22 (it appeared online on Nov. 21) that reported on Grassley's accusations, the demise of the radio show and detailed what money Goodwin was getting from whom when he was saying what on the radio show.

McManamy notes, "Defamation is not simply about facts. It's about (sic) innuendos." In McManamy's case tossing around innuendoes about the Times and Harris might work out better for him if he had some of his basic facts straight.

McManamy points out on his HealthCentral.com blog, for which he is paid, that the editorial cast aspersions on Goodwin when it stated, according to McManamy, that:

"Dr Goodwin 'potentially stood to benefit from the recommendations he made on the program.'"

The only trouble is that that's not what the editorial said. It said:

"Goodwin 'earned at least $1.3 million by giving marketing lectures for drug makers who potentially stood to benefit from the recommendations he made on the program.'"

In other words, the paper said the drug companies benefitted from what Goodwin said on air, an odd slip in McManamy's case against the paper, but a nice stab at PR spin.

McManamy steps further into PR spin weirdness when he writes of the initial Harris piece.

"Dr Goodwin tells a far different story. In a public statement he just released, Dr Goodwin reports that prior to the story, he talked for nearly an hour on the phone with NY Times reporter Gardiner Harris, and in an email exchange. According to Dr Goodwin, 'most of the important information I provided was left out of the story.'

"According to Dr Goodwin: 'The article implied that I asserted on the air that 'there is no credible scientific evidence linking antidepressants to violence and suicide' because of my ties to drug companies.'

"But Dr Goodwin points out that he never received income for promoting Paxil. Moreover, his comments were made in the context of the debate surrounding an FDA black box warning. Dr Goodwin and other experts took issue with the term, "suicidality," which they felt embraced a range of behaviors far too wide to show a credible link. Dr Goodwin was in favor of a less-loaded term."

I don't recall Goodwin ever saying he was in favor of a less-loaded term on the show. And suicidality sure strikes me as being less-loaded than, say, suicide or violence. There is ample evidence for a connection between all three and anti-depressant use, although there is evidence that points in other directions as well.

The above McManamy passage, which appears to be at the heart of Goodwin's frustrations with the Times, has another problem as well. Goodwin defended modern anti-depressants on the March radio episode as an entire class--all 12 of them, Prozac, Paxil and the rest--and defended them against links to various problems. Here's what Harris wrote:

"He said that he had never given marketing lectures for antidepressant medicines like Prozac, so he saw no conflict with a program he hosted in March titled 'Prozac Nation: Revisited.' which he introduced by saying, 'As you will hear today, there is no credible scientific evidence linking antidepressants to violence or to suicide.'

"That same week, Dr. Goodwin earned around $20,000 from GlaxoSmithKline, which for years suppressed studies showing that its antidepressant, Paxil, increased suicidal behaviors."

I'm not in a position to say whether or not Goodwin ever spoke on behalf of Paxil. Apparently, the Glaxo money he received recently was for his work on behalf of Lamictal, an anti-seizure drug that is FDA-approved as a maintenance mood stabilizer for bipolar disorder as well as epilepsy. Interestingly, on Jan. 31, 2008, the FDA issued a warning about suicidality reported in anti-seizure drugs including Lamictal. An FDA advisory committee later declined to recommend a full black box warning to that effect for the drugs, but it's ironic that the FDA's warning came almost two months before Goodwin's show defending anti-depressants from similar claims and about two months before Goodwin got a $20,000 check from Glaxo for Lamictal-related activities.

Lamictal is not approved to treat bipolar depression, but it's used quite commonly off-label for that purpose. It's interesting to me that Goodwin didn't mention that during his anti-depressant defense radio show.

McManamy does make one interesting point, but again it fails to work in his and Goodwin's favor:

"Dr Goodwin's long-standing - and highly public - track record reveals he is anything but a pusher of antidepressants. In his definitive book, 'Manic-Depressive Illness,' and in his talks to psychiatrists, Dr Goodwin has come through loud and clear on 'the overuse of antidepressants, especially in children.'"

"Dr Goodwin took pains to point all this out to Mr Harris, but this was left out of the story. Instead, according to Dr Goodwin, 'a casual reader will be left with the impression that I was somehow involved in suppressing data on Paxil.'"

Let's review what Harris wrote again:

"Dr. Goodwin earned around $20,000 from GlaxoSmithKline, which for years suppressed studies showing that its antidepressant, Paxil, increased suicidal behaviors."

I'm not sure how a casual reader would be left with the impression that Goodwin had been involved in suppressing data on Paxil when Harris specifically wrote that the company itself, GlaxoSmithKline, had done so. Maybe a stupid reader would be, but even careful journalists such as Harris cannot protect the world from inferences drawn by stupid readers and McManamy.

And, if Goodwin is such a skeptic of anti-depressants, then why didn't he say so on "The Infinite Mind?" And, why didn't Goodwin, in the statement McManamy refers to (and which I've been unable to find a copy of), question the suicidality-Paxil connection that Harris asserted in his November article? I don't have answers for either question, so I'll simply note the inconsistency.

With such off-base assertions as McManamy makes in attacking the Times, you've got to wonder who is editing his copy on HealthCentral.com, a site that as a whole attracts over 1.1 million readers a month, according to Quantcast.com and is littered with ads for pharmaceutical products of all kinds. According to McManamy's blog there, he is an "expert patient." McManamy may have all kinds of useful thoughts to offer in his writing about depression and bipolar disorder, but as a media expert and quasi-legal analyst he's strictly inexpert.

Winter Fundraiser, Day 3

Another $210 came in yesterday, bringing the total raised so far to $335 and leaving another $2,665 to go to reach the $3,000 goal around about Dec. 15. So far, 16 readers have contributed to the fundraiser. Thanks to all of them for their support to date.

No hard sell today about how fabulous this site is. Except to point out that a few of you sure do get a kick out of seeing my cats appear at the end of fundraisers past. The sooner things end, the sooner my cats appear. As usual, the PayPal button is on the right, or send me an email and I'll send you my mailing address.

Speaking of cats, last night a post of mine got linked on some chat forum and I followed the link and ran into one of the funniest .gifs I've seen in forever, a chimpanzee washing a cat in a bathroom sink.

Now what other site brings you quality stuff like that? Even Liz Spikol, queen of the cute animal pictures, does not offer you a chimpanzee washing a cat.

Psychiatrist Criticizes College-Age Americans Are All Crazy Study

A young psychiatrist I know--just out of residency and now on a fellowship Back East--was as appalled as I was by Monday's Archives of General Psychiatry study asserting that about half of college-age Americans have a psychiatric disorder in a one-year period, including about 20 percent with a personality disorder. Like me, the author of intueri, who prefers anonymity, was troubled by just how broad the reach of psychiatric disorders has become in American culture:

"Instead of expressing umbrage about the high percentage of people with psychiatric conditions, why not reassess if the definition of 'psychiatric conditions' means anything? If 50% of college-aged people 'have something wrong with them,' perhaps we should scrutinize the words we use to define 'wrong.' We should question why there is this huge discrepancy between DSM prevalences and those listed in the paper. (For what it is worth, personality disorders are generally diagnosed over time and cannot be diagnosed if someone is under the age of 18. This was a cross-sectional study—that is, a study that looked at a thin slice of time and did not follow people over the course of a year or two or ten. And, by the way, I’m also not warmly endorsing the DSM; I’m highlighting discrepancies.)

"I’m not against the idea of mental health and hygiene. I’d rather focus and build upon strengths that are individually tailored. Focusing on general pathology that is ill-defined, however, is hugely problematic. One of the purposes of diagnosis is to guide treatment. If the process of diagnosis is unclear, the process of treatment is unclear. If the diagnosis itself is vague, the treatment is also hazy (hence the rash of psychotropic prescriptions). If the diagnosis encompasses too much of the variation of normal, we’re doing more harm than good. Whatever happened to 'Primum non nocere?' ('First, do not harm.')

"DSM-V is in the works (and cloistered, at that). I don’t know what anyone has to gain if 50% of the population has a mental disorder. Sure, the cynics will remark that shrinks and pharmaceutical companies will have lots of financial gain (because that’s all that matters, right?), but really, what pride is there is believing that 50% of the population has a mental disorder? And doesn’t that really say more about the culture than the 'patients'?"

She also notes that personality disorders are classically supposed to be fairly rare, all of which makes me wonder about how accurate this study really is. Sure has gotten a ton of media attention, however.

Babies, Thousands Of Australian Kids Getting Anti-Depressants

The Australian reports that 4,000 Australian kids under 10 years old are being given anti-depressants. The total includes 553 children younger than 5 and 48 babies. Last year, I wrote about kids and babies being given anti-depressants in New Zealand.

The Australian numbers cover kids in that nation's public health insurance program, so there's a good possibility that even more children are getting anti-depressants under private insurance schemes.

Anti-depressants aren't approved for use in kids in Australia for depression and the drugs come with warnings about their use in anyone younger than 18. Two anti-depressants are approved for use in kids 6 and older with OCD.

No one the paper interviewed could offer an answer for why children so young might be given these drugs.

"Asked what circumstances might lead to a baby being treated with an anti-depressant drug, the spokesman for the pediatric division of the Royal Australian College of Physicians, John Wray said: "None that come to mind. The college would like to know who is prescribing these drugs to such young children and why.'"

I'd like to know why as well. In three years of doing this site and running into similar stories of anti-depressant use in young children, I've never once encountered a doctor or any other medical authority who offered a medical reason for their use. Keep in mind that it's likely the drugs are being prescribed by non-psychiatrists.

No doubt tots are being given these drugs in the US and UK and Canada as well.

Winter Fundraiser, Day Two

$125 came in yesterday via PayPal, so that leaves $2,875 to go to reach the goal of $3,000 by Dec. 15. I appreciate the contributions to date.

Yesterday, I wrote about several examples where this site has kicked major butt over the last few months, hopefully giving readers some incentive to chip in to the fundraiser. I hope they do, because this site now has a little over 20,000 unique readers a month. Among them, longtime readers will likely be amused to learn, are many readers at several major pharma companies (including over two dozen from Eli Lilly and I hope that's not just in-house lawyers), several HMOs, Massachusetts General, various medical schools, a major Catholic archdiocese, numerous state agencies, law firms and insurance companies, the FDA, Microsoft, Amazon.com and, drum roll, the Citizen's Commission on Human Rights (aka, the Church of Scientology). It amuses me no end that the institutional readership of this site runs the gamut from medicate-the-children advocates to, well, Scientologists.

Anyway, my larger point is that about 5,000 of those readers read this site several times a week, some several times a day. If just 10 percent of those regulars contributed $10 apiece, this fundraiser would be over in about 10 minutes.

If you'd like to be one of the 10 percent, the PayPal button is on the right. Or send me an email and I'll send you a mailing address.

Thanks for your support.

Study: Depakote Linked To Autism

This study just out in Neurology (sadly, there's not even an abstract online) is preliminary in its findings (small sample size), but shocking in its conclusions. The study, according to Reuters:

"showed children whose mothers took Epilim [Depakote's UK name] during pregnancy were seven times more likely to develop the condition [autism] compared with babies whose mothers did not take an epilepsy drug."

Depakote is also known as valproate in generic form. It is an anti-seizure drug that is commonly used in both epilepsy and bipolar disorder, in the latter case as a so-called mood stabilizer. Increasing the risk of autism by seven times should really give women pause who take this drug.

There are other known problems for women who take Depakote, including the development of ovarian cysts as was found in this study last year. Earlier this year, the FDA issued a warning about suicidality connected with the use of Depakote and other anti-seizure drugs.

Study: Almost Half Of College-Age Americans Have A Psychiatric Disorder

You read that headline right. A new study came out yesterday in the Archives of General Psychiatry asserting that about half of college-age Americans have a psychiatric disorder of some kind during a one-year period. The study abstract is not well-detailed and I've not seen the full study, but this does strike me as a wildly distorted finding and part of an effort by some forces in psychiatry to diagnose and "treat" virtually every American at some point in their lives. This of course would be very good for business and very good for psychiatry's sometime masters at Big Pharma and the major public health agencies.

And, of course, the big take away message that researchers and talking head psychiatrists pushed upon the press was that not enough young people were getting treatment, an argument that is almost always the first refuge of psychiatrists. Not to be cynical here, but perhaps the public has heard that psychiatry's treatments often aren't much fun, don't have much efficacy and come loaded with side effects aplenty.

Overall, 45.8 percent of college students and 47.7 percent of non-college students crossed the Rubicon into psychiatric diagnoses, which kind of gives new meaning to abnormal behavior or means that psych diagnoses are describing fairly normal states of existence.

The study's underlying surveys were done in 2001 to 2002 and involved 5,092 people aged 18 to 25, some attending college and some not. From a few different press accounts, the following results were found:

Twenty-one percent had an alcohol use disorder, apparently measured by failing to fulfill an obligation, having a legal problem, doing something "dangerous" or causing social problems. I cannot wait to see what the study considered dangerous or an obligation.

Personality disorders were apparently big as well with 18 percent meeting criteria for OCD and the like (a finding I think is pretty damn dubious).

Smoking caught the eye of researchers as well with 20.7 percent of non-college students allegedly "nicotine dependent." Gee, I didn't know cigarettes had made their way into the DSM.

I was not able to find an account of the study that detailed more classic Axis-1 mental disorders such as depression and bipolar disorder. Hopefully, I can update that later.

According to the AP, "The [personality] disorders include obsessive, anti-social and paranoid behaviors that are not mere quirks but actually interfere with ordinary functioning." In 18 percent of college-aged Americans? Please, that doesn't even pass the sniff test.

Meanwhile, one psychiatrist offered this well-worn metaphor:

"Dr. Sharon Hirsch, a University of Chicago psychiatrist not involved in the study, praised it for raising awareness about the problem and the high numbers of affected people who don't get help.

"Imagine if more than 75 percent of diabetic college students didn't get treatment, Hirsch said. 'Just think about what would be happening on our college campuses.'"

Well, Dr. Hirsch, diabetes isn't OCD or depression and your metaphor is so out of place that I cannot even get into it.

Amidst all of this, I say thank God for Joseph Glenmullen, and the reporter who was smart enough to call him up and quote him:

"The study's findings that about half of those surveyed had a psychiatric disorder 'seems extraordinarily high,' Joseph Glenmullen, a psychiatrist at Harvard Medical School in Boston, said today in a telephone interview.

"The results may reflect 'a watering down of the diagnostic criteria such that they capture more people with milder symptoms,' said Glenmullen, the author of 'The Antidepressant Solution,' and a critic of the overuse of psychiatric medications."

I've seen some press accounts of this study where the reporter wasn't adept enough to fish out at least one critic of these kinds of numbers.

I think Glenmullen's point that the DSM has gotten incredibly broad is apt. Need an example? Consider what's gone on with bipolar disorder among adults in recent years or with the highly dubious social anxiety disorder (differentiated from generalized anxiety) or what's going on right now with the secretive, Pharma-connected process around the forthcoming DSM-V.

Yesterday, psychiatrist Danny Carlat noted that psychiatry as a profession was on its knees. Today, I think it's fair to point out that psychiatry is also on a bit of a power trip and ought to get out of the lives of young people.

And NIMH head Tom Insel wonders why psychiatry is a stigmatized profession? Perhaps, it's the psychiatrists--OK, some of them--who need their heads examined.

Don't Post Personal Information About Other Commenters On This Site

I'm really amazed that I need to point this out to a few of my readers, but recently a few of you posted personal information on a comment thread concerning a commenter with whom you were in disagreement. While the Internet is an interesting tool for letting us dig up all kinds of information about whomever, posting information about where a rival commenter works and studies and so on without the individual's specific permission is out of bounds and will not be allowed on this site. Please refrain from doing this in the future.

Biederman, Goodwin "Bringing The Profession Of Psychiatry To Its Knees"

Danny Carlat, a Tufts University psychiatrist, writes of the conflict of interest scandals around Harvard child psychiatrist Joseph Biederman and leading bipolar disorder researcher Fred Goodwin today. Of particular interest to me was Carlat's account of Goodwin's response to a panel Carlat and others were on at the APA convention last year, where they had presented on problems with research and pharma company sponsorship.

"Finally, Dr. Goodwin came to the podium as the 'discussant,' presumably to comment on our presentations.

"But instead of discussing our talks, Goodwin decided to use Marcia Angell's book, The Truth about Drug Companies, as target practice. Angell was not on the program, and her book was only mentioned in passing by one of the presenters. But Goodwin seemed to despise her and her book. He went through her main points, rebutting them systematically, arguing that pharmaceutical companies are wonderful, that medications are very helpful, that there is nothing wrong with making money, and that drug companies are not as profitable as everybody thinks. Then, he went on a bizarre tangent about how one of the major networks is filled with scientologists....

"He, and Biederman, and Nemeroff, and many other less well known hired guns are bringing the profession of psychiatry to its knees."

Indeed, they are and it's both sad and hilarious to watch.

What strikes me as interesting, too, is that recently HealthCentral.com featured a post by John McManamy in which he stridently defended Goodwin, attacked the New York Times for exposing Goodwin and claimed that Goodwin was actually critical of pharma companies and anti-depressants. Contrast that with Carlat's account above.

Winter Fundraiser Begins

As I do every three months, today I'm beginning this site's winter fundraiser. The goal is to raise $3,000 over the next two weeks. The fall fundraiser was a big success and ended early, and I hope that's the case this time. I know full well how badly the economy stinks right now--I can assure you that the market for freelance writing of any kind is a disaster right now. I have a thing or two in the works right now, but I won't be paid for them until February.

Meanwhile, several issues that I've pounded on on this site have come full circle in recent weeks. Fred Goodwin, host of "The Infinite Mind" radio show, was exposed for taking over $1 million in pharma payouts and for not revealing those conflicts and his show was cancelled. Some of you know that back in April I was the first to report on how during one episode of the show Goodwin and several of his guests openly lied about suicidality and anti-depressants, an issue in some ways more important than unreported financial conflicts. What's more, Harvard child psychiatrist Joseph Biederman was recently outed for his ties to J&J and for basically working the company for tons of money to start a "research" center to advance J&J's commercial goals. If there's one bad apple in psychiatry whom I've focused on on this site, it's Biederman, the prime architect of the bipolar child business and a huge pusher of ADHD diagnoses on kids. I've been writing about Biederman for two years. I've also been the one alerting the public to the deceptive Abilify for depression ads on TV and how the FDA refuses to comment on whether it has or ever will review them.

In addition, I'll have more news soon on one antipsychotic used in kids.

For me to continue to go after these issues, I need your support. Unlike John McManamy, I won't accept ads for Seroquel and other psych meds on my website. I'm sure he's making a pretty penny for those ads, but for myself I prefer to have clean hands in that regard.

Anyway, as always, the PayPal button is on the right. If you prefer using snail mail, drop me an email and I'll shoot you a mailing address.

Thanks for your support.

Risperdal Causing Breast Development In Boys

As I noted two weeks ago, there are now solid reports of teen boys who developed breasts as a result of taking the atypical antipsychotic Risperdal. The WSJ Health blog reported on this last week as well:

"One particularly troubling side effect is the growth of breasts in some male patients taking Risperdal. Steve Sheller, a lawyer in Philadelphia, represents six teenage boys seeking compensation from J&J after they developed breasts while taking Risperdal. Sheller says their problems stem from prolactin, a hormone involved in lactation, that can be elevated in males and females who take the medicine. Two of the boys he represents required mastectomies to get rid of their bosoms.

"The company has denied in court papers that it is culpable for the plaintiffs’ injuries, has taken part in any 'misrepresentations, omissions, suppression or concealment' of negative information about possible side effects from the drug in their warnings to consumers."

I spoke with Sheller last week and he told me of some other side effects from Risperdal, one of which is such an explosive allegation that I'm going to wait for further evidence of its presence or for it to show up in a legal complaint before I write about it here. But, trust me, it will make your head spin.

I haven't the faintest as to when Sheller's clients were taking the drug or what J&J was describing as issues with the drug's use at the time.

The drug's package insert reports cases of gynecomastia--breast development in males--in 2.3 percent of kids and teens taking the drug (see page 9 of the insert). It's not clear me if this same phenomenon is present in adults, but the insert does note gynecomastia in some adults (see page 7 of the insert), or what the situation is with girls taking the drug.

What troubles me about all of this should perhaps be obvious: it isn't right, fair or appropriate to give boys a drug that can cause them to grow breasts. It's simply so against Nature and human development that I cannot even get into it. It's difficult to imagine the psychological trauma these boys must have experienced--and perhaps still are experiencing--in the name of treating ADHD, bipolar disorder or whatever else they were being given Risperdal for. If you assume that perhaps 500,000 male boys and teens are taking Risperdal--a number I'm using for illustration only--then you'd expect to see 11,500 boys developing breasts. That's a problem and as side effects percentages generally run even higher in the general population--as opposed to those in the clinical studies--it makes me wonder what the hell is going on out in America.

All in all, I see this issue with gynecomastia and prolactin levels and Risperdal as validating a lot of my concerns about giving antipsychotics to youngsters. One of my concerns is how these drugs can affect the physical and sexual organ development of youngsters.

If you think such concerns are excessive or misplaced (God knows, some people have dubbed me as a Scientologist and anti-psychaitrist for flagging these concerns), then consider this paper which identifies decreased bone density in patients diagnosed with schizophrenia who've taken antipsychotics long-term. A separate paper by the same researchers indicates that some women taking antipsychotics become hypogonadal, "a medical term for a defect of the reproductive system that results in lack of function of the gonads (ovaries or testes)."

Obviously there are differences in amount of medication taken and length of time on a medication, but if those kinds of mechanisms are at work in adults, then how could anyone possibly argue that they would not be a source of grave concern in kids and adults being given antipsychotics for non-psychotic disorders.

A I noted on this site recently, the best rule of thumb for approaching antipsychotic use is to not give them to kids for anything other than childhood schizophrenia and, perhaps, extreme autism. I'd argue that the same rule should be applied to adults, and I'm sure not very comfortable about the long-term use of these drugs in adult schizophrenia.

New York Times Calls For Crack Down On Research Conflicts

On Sunday, the New York Times' editorial page went after the twin conflict of interest sagas of Harvard child psychiatrist Joseph Biederman and leading bipolar disorder researcher Fred Goodwin, conflicts that have been well-documented on this site as well. The editorial called for action:

"More evidence has emerged of appalling conflicts of interest that throw into doubt the advice rendered and the research performed by two prominent psychiatrists who have received substantial funding from the pharmaceutical industry. The revelations prove, once again, the need for universities and professional societies to crack down on conflicts of interest, and for Congress to pass legislation that will bring hidden conflicts into the open."

I don't have much to add here, except to note that it pleases me greatly that the paper has editorialized on this matter and that, all in all, these kinds of conflicts shouldn't only be in the open, they simply shouldn't exist. We've got to fund psychiatric research and all medical research in this country differently.

My own view is that no researcher taking over, say, $10,000 a year from pharma companies to do research or make speeches on behalf of their products should turn around and pass themselves off as unbiased scientists. Their papers should be rejected by professional journals and the media should decline to quote them and patients of every stripe should rebel against their evidence. Psychiatrists make plenty of money as it is already. If they can't live on $180,000, the average yearly earnings of a psychiatrist in the US, then they need to pursue another career.

Doctors are supposed to have their patients' best interests at heart, but it's clear to me that a discouragingly large number of psychiatrists have been more interested in their own bank accounts than in their patients' well-being. That's got to change.

I certainly hope that Congress, the various medical societies and research universities heed the call for a crack down on these conflicts of interest. The public has been fed enough bull already and it's got to stop.