I almost don't understand why Lilly would need a long-term indication approval for Cymbalta because who's seen a psych doc who does short-term medication treatment of depression? i think docs and pharma companies both have a lot of vested interest in having long-term customers. But anyway, here's the press release. I am too tired and jet-lagged to say much, but one of the sad stories I heard while in Florida was from a student who has a close family member who has been hooked on Prozac for 20 years. Can't get off it.
A reporter at a Dallas TV station did some good digging and requested data on complaints filed with the FDA related the stop-smoking drug Chantix. Here's what the FDA reported:
" After an initial report on Albrecht's death, News 8 requested, through the Freedom of Information Act, all the complaints filed with the FDA about Chantix. A computer disc was sent with 5,157 complaints, which were all filed in just one week after the News 8 report aired."Suicide was reported 55 times. Suicidal thoughts were mentioned in 199 cases and 417 people complained of depression."
I've had written about this drug numerous times now. It is a problem drug and the FDA is doing a safety review of Chantix, less than two years after it hit the market. That's lightning speed by FDA standards. I'm sure there will be much more to come on this story.
Chantix strikes me as being another Paxil. I wonder what the anti-smoking advocates make of this.
Another thirty Zyprexa patients sued Eli Lilly this week:
"The attorneys represent 30 plaintiffs from Illinois, Missouri, Indiana and New Jersey who claim Zyprexa negatively affected their blood sugar and endocrine system gradually over time and duration. The plaintiffs specifically allege they became diabetic after using Zyprexa, and seek damages for personal and economic injuries."According to the complaint, plaintiffs did not possess sufficient information to cause them to inquire about their diabetes-related injuries associated with Zyprex until the drug's label changed on Oct. 6."
I don't know much about these patients, but I have to wonder why their doctors wouldn't have informed them of diabetes-related issues with Zyprexa before the recent label change. Are doctors really that out of touch?
I just returned from Florida. My flight from Atlanta to Seattle took 6 hours due to very strong headwinds and am I ever pooped. I'll have some posts up for the morning. Hope you all are well.
Jonathon Leo, who among other things was the co-author of the PLoS paper on the serotonin hypothesis of depression, offered these thoughts on Daniel Carlat's recent piece "Dr. Drug," which was in the New York Times on Sunday:
"I am pleased that Dr. Carlat has finally seen the light, but I think his piece highlights how insular the psychiatry profession was during the last decade. At the time Carlat was making his rounds there was plenty of information out there pointing to the problems with these drugs and to the problematic ethics of the relationship between doctors and the pharm companies. He provides a great example of how gullible and malleable the profession is. It seems that neither he nor his colleagues were exposed to any form of critical thinking about the nature of the profession. It always surprises me when you get into a discussion with a psychiatrist and discover how little exposure they have had to the primary literature and to the critics of the literature."About four years ago I was scheduled to give a lecture in a class to medical students on the relationship of the SSRIs to suicide. The course director cancelled the talk and said that the information was "dangerous" -- because the students might not write as many prescriptions when they entered practice. The students persisted and I ended up giving the talk as a seminar. At the time, I imagine that the course director would have welcomed Dr. Carlat to come and speak. The silver lining in all this is that the coming generation of doctors is much more aware of these issues and is less likely to be duped."
I hope the coming generation of doctors is far more skeptical about many things in medical research and its relationship with Big Pharma, not only when it comes to psychiatry. I think Carlat--and Leo--may well be helping to blaze a path in that direction.
My lecture at the New College of Florida last evening went quite well. I cannot even thank them and particularly Natalie Paul enough for pulling the whole thing off. Seventy-five people or so attended--10 percent of the student body as Paul noted--and I have to say that the student body is very smart, not only on mental health issues but in general.
I'll get into more of what I talked about after I get back to Seattle late on Thursday, but for now my time clock is somewhere between East Coast and West Coast times and I need to get some rest.
One fun moment during the Q&A: I invented a new DSMable disorder as I was stammering out an answer to a question in a very jet-lagged state. "Writer Talking Disorder," or WTD. OK, maybe you had to be there.
I doubt that my comptuer access will be very good between tomorrow morning and Thursday night, so bear with me in the meantime.
Bruce Levine, whose work I've linked to before, has an excerpt of his book Surviving America's Depression Epidemic online. The central thesis is that America's worship of consumerism and technology is making us depressed. Ironic of course that this bit of news appears on the Internet.
I was pretty concerned when I went on the road Sunday night about whether anyone would read this site on Monday--yes, the blog and I are joined at the hip--but my concerns have been allayed. Thirty comments from you fabulous readers on a day when I have one newsish post up because I am stuck in planes and cars and then in bed (I don't sleep on planes) until well into evening is very heartening. So thanks. And go read Bruce Levine's excerpt!
Vaughan at Mind Hacks had a good post on the looming battle between makers of atypical antipsychotics and the various states who have sued them (11 so far), and the ones who are expected to in a multi-state action (25 more states or so). Here's an interesting bit:
"The most recent lawsuit from the state of Arkansas [pdf] alleges that, among other things, the drug company deliberately rigged their clinical trials to show less side-effects, failed to warn clinicians about the dangers and promoted their drug illegally."While people like psychiatrist David Healy have been making these allegations for years, the fact that a large number of US states are willing to take the allegations to court signals that we are about to see a huge battle, and hopefully a period of significant reform, in how drug companies develop, test and market their products."
As I've noted before, I consider it hugely significant that Arkansas made that allegation, as the state presumably has evidence to back up its assertion. I hope that evidence eventually becomes public in some fashion.
But my fear is that it won't, and that there may not be much of a battle at all. Why? Risperdal goes off patent in about one month--except for some extra and short-lived pediatric indications--so I'm not sure that Janssen/J&J has a huge incentive to fight Arkansas and the other states that are suing it in order to protect what is soon to be a generic product. It's likely much cheaper for the companies to settle the case (liability insurance will cover much of the cost), write an agreement in which they admit no fault and manage to deep six any documents and other evidence of bad behavior, and move onto Invega.
Zyprexa goes off-patent in 2011 and Seroquel is off-patent the same year as well (not sure about patents on Seroquel XR), so one wonders how much incentive those companies have to fight the state suits, or whether they will just settle the cases and move onto whatever is next for them.
Maybe I am a bit too cynical, but it wouldn't shock me if that's how things played out. After all, Lilly has already settled about $1.3 billion in lawsuits over Zyprexa. Why stop now?
As for reform in how pharma companies develop, test and market their drugs, that's only going to happen in the US if Congress and doctors raise a stink. So far, doctors and Congress are batting .000 on this one.
I was tied up yesterday getting ready to leave town, so here's something I haven't done in two months or so--links to things I've found interesting recently. Not that there aren't about a bazillion other things I could link to.
I neglected to link to a recent post by CL Psych in which a new Abilify for dementia study is exploded.
A scientist writes about faith and orthodoxy in the New York Times. Strikes me that some of his thoughts apply to the world of mental health care and research.
For reasons known only to its editors, the Boston Globe let a psychiatrist try to define schizophrenia on its op-ed page.
A music writer at The Stranger writes a smart article about seasonal affective disorder, depression, suicide, and meds, somehow making sense of it all through baking cookies.
One blogger likens ADHD drugs as "Brave New World." Interesting.
Kansas Sunflower uses large doses of Seroquel to sleep. Sounds as if her boyfriend doesn't dig that.
The Pittsburgh Tribune-Review writes a newsmaker piece on David Lewis, a Pitt psychiatrist, in which he says:
"For the past 50 years since medications were first identified as being useful for the treatment of schizophrenia, all available medications have been found by accident, rather than understanding the nature of the disease process. The exciting things about our program is that we're beginning to get enough of an understanding about the nature of the alterations in the brain that we can actually design medications based upon a hypothesis of what we think is wrong."
Hm, OK. And what are people with schizophrenia supposed to do for the next few decades while your hypothesis of what's wrong becomes a treatment modality? Assuming it's correct and every enters clinical use.
Many of you know that I will be on the road from Sunday evening through Thursday evening traveling to Florida to deliver a lecture at the New College of Florida. I'll have limited computer access in Florida, so I don't expect to do any posting--except perhaps for something small--from the road. My pal Puckett will handle comment approval for a few days this week, so be nice to him. If anyone wants to write something for the site this week, crank something out and send it to me by email.
I should only have a couple of posts for Monday of this week, which I'll be doing before I leave for the airport.
I'll be back in the saddle on Friday. Have a nice week.
Daniel Carlat, known to many readers as author of the Carlat Psychiatry Report, a professor of psychiatry at Tufts Medical School, and author of his own blog, has a long essay in tomorrow's New York Times Sunday Magazine about his experiences working for Wyeth as a paid lecturer for the company. He spoke to his colleagues for a year about Effexor, one of the nastiest anti-depressants on the market, and made $30,000 for doing so. Then he had a crisis of conscience in the face of evidence showing that Effexor--which he sometimes still prescribes--had caused blood pressure problems in some patients, and didn't really perform much better than standard SSRIs over time.
"Looking back on the year I spent speaking for Wyeth, I’ve asked myself if my work as a company speaker led me to do bad things. Did I contribute to faulty medical decision making? Did my advice lead doctors to make inappropriate drug choices, and did their patients suffer needlessly?"Maybe. I’m sure I persuaded many physicians to prescribe Effexor, potentially contributing to blood-pressure problems and withdrawal symptoms. On the other hand, it’s possible that some of those patients might have gained more relief from their depression and anxiety than they would have if they had been started on an S.S.R.I. Not likely, but possible."
The article is excellent and painfully honest. On his blog the other day, Carlat took up the matter of Abilify's recent approval as an adjunctive treatment for depression:
"How effective are these drugs for depression? Not terribly. The Abilify data, for example, shows a remission rate of 26% vs. 16% for placebo augmentation, meaning that 1 out 10 patients would be expected to respond to an Abilify-induced boosting of their current antidepressant. The design of this study was somewhat manipulated in order to make sure Abilify beat placebo, a fact brought to my attention by this excellent post in Cl Psych. Nonetheless, the Risperdal data are very similar, and I'm convinced that atypicals provide a small antidepressant effect. Enough of an effect to overcome the potential side effects? That's unclear."What is abundantly clear is that drug companies are going to be pushing both psychiatrists and primary care doctors to think of "antipsychotics" as "antidepressants." Look closely at the data before you buy the message!"
I hope that anyone who might be tempted to take an anti-psychotic for depression only does so for a short period of time. Repackaging anti-psychotics as anti-depressants is a very bad trend in depression treatment (the drugs mess people up, pure and simple), but I have no doubt that many docs will follow along because I think many docs have zero idea just how harsh these drugs are on their patients. What's more, I don't think they even care.
Thankfully, Carlat does.
The Pittsburgh Post-Gazette the other day had an op-ed by Elizabeth Roberts, a child psychiatrist in California and author of Should You Medicate Your Child's Mind? Roberts is deeply critical of the increase in diagnosis of bipolar disorder in kids, of her colleagues in the mental health world, and of parents. I think she's a bit too rough on parents. Anyway here are some bon mots from her piece:
Yet a 4,000 percent increase in childhood mental illness, specifically bipolar disorder, is simply implausible and difficult to justify based solely on improved diagnostic techniques. To the contrary, in the 30-plus years that I have been treating, educating and caring for children -- half of that time as a child psychiatrist -- I have found that the approach to diagnostics in psychiatry clearly has deteriorated over time, not improved."There was a time when doctors insisted on hours of evaluation with a child and his parents before venturing a psychiatric diagnosis or prescribing a medication. Today many of my colleagues brag that they can complete an initial assessment of a child and write a prescription in less than 20 minutes. Many parents have told me it took a previous doctor less than five minutes to diagnose and medicate their child."
And:
"Yet the arguments of skeptics are being dismissed by academics in psychiatry. Research psychiatrists appear to be more invested in defending their research conclusions--funded by pharmaceutical companies--than engaging in a meaningful discussion to examine these preposterous demographics."
I agree with her criticism of some in the academic research community who seem to be conveniently blinded and dismiss critics.
"What I find more astounding than the claim that there are 800,000 American children with bipolar disorder is the fact that there are that many children whose conduct is so aberrant that their parents are seeking psychiatric treatment for them."The symptoms, which are regarded as evidence of bipolar disorder, usually are what most people recognize as ordinary belligerence. Children who have anger outbursts, who refuse to go to bed, who are moody and self-centered under the current standard of care in child psychiatry are being diagnosed with bipolar disorder. To most rational human beings, these behaviors describe an ill-mannered, immature and poorly disciplined child. Nonetheless, the temper tantrums of belligerent children are increasingly being characterized by doctors as the mood swings of bipolar disorder."
And, then, a nuclear weapon of an accusation:
"The permissive parents of spoiled children seek refuge from blame by using the excuse that their child's angry outbursts are the result of a chemical imbalance. Since a psychiatric condition is completely beyond a parent's control, a diagnosis of bipolar disorder is the perfect alibi. Once a child has been diagnosed with bipolar disorder, a parent feels absolved of guilt or responsibility for the child's misbehavior and therefore, the parents' discipline practices cannot be called into question."Parents looking for a psychiatric explanation for their child's misbehavior will find an abundance of support in the media and on the Web for the conclusion that their child's temper tantrums are due to a psychiatric disease rather than the result of bad parenting. Psychiatrists, for their part, are more than willing to accept, without question, the assessment offered by a parent. Doctors have found it easier and less contentious to comply with a parent's wish to have their child diagnosed with a psychiatric condition than to confront the parent with the notion that their own weak parenting is the root cause of the child's aberrant behavior."
I'm not sure I buy placing the blame on parents and permissive child-rearing for what's afoot in our land. What do you guys think?
One of the things I am thankful for this holiday season is Seattlest (a local blog owned by the Gothamist folks), and specifically Michael van Baker. He's literally the only other person in the media in Seattle--a big media market--who pays any consistent attention to mental health issues, and more pointedly the work I do here (almost completely ignored by the rest of the media in town). Since I left Seattle Weekly a little over a year ago (and actually I'd had to stop covering mental health in that paper nine months earlier due to the wishes of the new owners of the paper), there has been a virtual blackout of coverage of mental health issues in this area and no one in the mainstream media locally will take on the "meta think" articles on these matters that need to be done. Not even the columnists at the local papers for whom these issues should be front and center when they are looking for human interest fodder. Readers do live by more than politics and sports.
In a city of 600,000 people where depression and suicide are at some of the highest rates in the entire US, you'd think the media would be a wee bit more reflective about these matters and realize that maybe their readers might be kinda interested in some coverage. And not just your classic "Wow, look at the homeless schizophrenic guy, he needs some meds" article, but something that reflects the lives of average folks.
Van Baker makes the point most pointedly:
"Critical local coverage of this kind of thing is close to non-existent. Are reporters unwilling to look into medications because they, their family or friends are on them? Why the circus around Knox [local college student currently jailed in Italy as part of a murder investigation], and the silence about so many people being injured and killed? The mis-prescription of under-tested medications is the big medical story of our time, with slow-motion effects for the next generation and their children."
Yeah, Amanda Knox sure speaks to the lives most of us are living, in particular an acquaintance of mine who stopped me on the street last night to ask me something.
"Hey, I'm thinking of trying Effexor. What do you think?"
"I think you're looking at the potential for some serious withdrawal problems if you take that drug." I then laid out for him that drug's many well-known and well-documented problems.
"My doctor didn't tell me that."
"They never do."
He pressed me hard for a specific med recommendation--I told him I wasn't real comfy with that, but he kept asking--and so I just told him about anti-depressants I know of that have serious problems attached to their use (Paxil, Cymbalta, etc.) and suggested he and his doctor work it out through a process of elimination.
When that kind of thing is going on in the streets of Seattle (and having lived all over the Western US, I can assure you that Rain City is by far the most depressed of them all) and the media is mostly silent on these issues, it kind of makes you wonder why the media is that deeply out of touch. When perhaps 25 percent of their readership is on anti-depressants or mood stabilizers (and, given these times, anti-psychotics repackaged as anti-depressants and mood stabilizers), then you have to wonder if the reporters, editors and news directors out there are really that dumb or if they are really that chicken.
To be fair, there are papers in this country that do a fine job of covering mental health. The New York Times does it damn near all the time-- even when I have issues with some of its writers, at least the paper is actively trying. And that means there are editors there who actually give a damn. The Wall Street Journal does a decent job when it chooses to take up the subject. The Washington Post does a mediocre job and has the bad habit of quoting Fuller Torrey. The Los Angeles Times' editorial board seems to be little more than a think tank for forced medication. Among smaller metro papers, the St. Petersburg Times has done first-class work of late. And the Oregonian does fine work too, although it's a wee bit too much of the NAMI-clone variety to take seriously at times.
Yes, I read lots of mental health coverage in this country, thanks to the magic of Google Alerts.
NPR? They've had the Zyprexa documents for almost an entire year and they have a $100 million endowment from Joan Kroc, and they haven't done squat. I know there are some local NPR-affiliate programs that do better (I just don't hear them being in Seattle).
TV? Oh, it starts off bad with "Oprah" and gets worse from there. Magazines? I cannot think of anything more predictable and usually more wrong than a piece on depression, say, in Time or Newsweek.
So on this Thanksgiving Eve, I for one am thankful for the Internet and those like van Baker who use it the way DARPA intended. (Um, well maybe DARPA didn't count on skeptical citizens using the 'Net, but whatever.)
Ah, what Gilbert and Sullivan hath wrought. Special appearance by Charles Nemeroff.
Thanks to The Last Psychiatrist.
As I reported earlier, the State of Arkansas yesterday sued Janssen and its parent J&J over allegations concerning its atypical anti-psychotic Risperdal and how the company developed and marketed the drug. The lawsuit is a real eye-opener and confirms many things I've been saying on this site for over two years and for two years before that in print: there's something wrong with the atypicals and how deeply they've ended up embedded in American culture.
The suit alleges that, among other things, Janssen/J&J put a drug it knew to be defective on the market in 1994, even though it knew the drug was defective and after the company had, in the AG's account, cooked and jury-rigged results of pre-marketing clinical trials to make it look as though the drug had fewer extra-pyramidal side effects (EPS) than older anti-psychotics when in fact it had virtually the same EPS profile as older drugs. There are other allegations--off-label marketing for use in children and the elderly, a campaign of covering up the drug's side effects, allegations of kickbacks to doctors and so on--but they almost pale in comparison to the EPS allegations, which ought to make anyone wonder how the heck this drug got approved in the first place.
One of the charges against Janssen/J&J is for fraud. Sales of the drug in 2006 were $4.2 billion. Depending on who is estimating, Risperdal is the most used anti-psychotic in the world.
The EPS allegation, the first I've seen in any of the ongoing lawsuits against J&J, goes right to heart of why atypicals became so popular amongst doctors: they were supposed to cause fewer side effects (a la SSRIs versus older anti-depressants in the 1980s), and therefore docs could safely give them to patients of every stripe for long-term use. Use of the older anti-psychotics was tightly restricted by docs (except among schizophrenics) because they were felt to cause so much EPS (aka zombieism) that it would be unethical to hand them out to anyone but the very sickest of patients. But atypicals like Risperdal were supposed to be safe for one and all.
As it turns out, that was not the case. As a result, millions of people have paid a heavy price for using Risperdal--I am one of them--including at least 1,000 people who died as a result of using the drug, according to the FDA's adverse events database, as I have previously reported.
J&J and Janssen lied. People died, or were injured and sickened by the willful action of one of the largest pharmaceutical companies on Earth. That's the view of the Arkansas Attorney General Dustin McDaniel. Other states including Texas are suing J&J over Risperdal as well.
Anyone who thinks I have been too harsh in my commentary on these drugs, too rough on the pharma companies who make and market them, too tough on the doctors who gave them to patients like me and, as a a result, wrote me off as a wingnut, ought to read this (and other) lawsuits against the makers of these drugs and see just how wingnutty McDaniel is. Because he isn't. And neither am I. The lawsuit is here (.pdf 1.5 MB). The lies and deception that have gone with the atypicals' use in America are right up there with the lies propagated about the use of cigarettes by American tobacco companies.
Now for a few particulars from the suit. First, the EPS allegations:
"Risperdal's pre-marketing clinical trials did not support an assertion that it is less likely to cause EPS than traditional antipsychotics....Defendants' trials were designed to produce similar rates of EPS in patients sorted into placebo groups and those taking Risperdal. In order to produce their desired result, defendants selected patients for the placebo groups that were already in the course of treatment with high doses of typical antipsychotics...."Defendants claimed in their marketing that patients taking Risperdal were as likely to develop EPS as patients taking nothing and thus less likely to develop EPS than patients taking traditional antipsychotics."
That is a staggering accusation and I assume McDaniel has documents to back it up. So far Janssen and J&J have not commented on the suit or its allegations.
In 2002 and 2003, I experienced mild EPS on Risperdal after being on it at .5 mgs a day since December 2000, and took myself off the drug against my then-doctor's wishes (he insisted that EPS and other problems didn't occur on Risperdal). Just so you know my bias on this issue.
Other allegations:
"Janssen heavily marketed and promoted Risperdal [in the mid-1990s] for its approved indication, treatment of adult with schizophrenia, and for multiple non-medically necessary uses of the drug, for example, ADHD, depression, anxiety, mood disorder, bipolar disorder, and aggression associated with late-onset dementia."
I was pressed to take the drug off-label (my then-doctor never explained that part) three years before the drug received approval for use in bipolar disorder in 2003. Just so you know how I felt when I read the following:
"Despite having been on notice for years of the potential for deadly diabetes-related side effects, defendant opted for the bare minimum of clinical trials, of limited duration, such that no side effects were likely to be revealed."
The suit further alleges that J&J knew of weight gain and resultant diabetes issues with the drug but worked to conceal the drug's true safety profile. The state introduces evidence that in 1999, the FDA busted Janssen for marketing Risperdal for off-label use in the elderly and that the FDA informed Janssen it was engaged in "false and misleading" practices (see pages 9 and 10).
As part of its strategy in the 1990s to expand Risperdal's market beyond its approved use in schizophrenia, the suit alleges that:
"Defendants sough ghost written research and paid 'key opinion leaders' to support defendant's marketing aims. These 'key opinion leaders' were nothing more than third-party consultants and researchers who were put on defendants' payroll to support and lend credibility to defendants' specious scientific and marketing representations."
Can't wait to find out who the researchers were who helped them with bipolar disorder.
There is more evidence and allegations contained in this lawsuit. I'll get into those later.
For now, this: Attorney General McDaniel alleges that Risperdal was "defective, unreasonably dangerous and hazardous" and that Janssen/J&J knew this and put the drug on the market anyway. "At the time Risperdal was sold or placed on the market, it was in a defective condition and unreasonably dangerous to users and consumers."
In addition to allegations that the companies violated the state's Medicaid fraud laws, the state alleges that the companies violated the state's deceptive trade practices act, engaged in negligent behavior, and engaged in fraud and misrepresentation and "unjust enrichment."
In today's Holy Shit Dept., Abilify, the as-seen-on-TV atypical anti-psychotic targeted to women, has just been approved by the FDA as an add-on treatment for depression. I don't even have time today to go after this in any thorough way. Suffice to say that somewhere in America an advertising agency is very happy.
Much credit to Ed Silverman at Pharmalot for getting this out there, as today the FDA announced that it has begun a safety review of the smoking cessation drug Chantix, made by Pfizer, over reports of suicidality and erratic behavior connected with use of the drug. For over two months, I have been receiving similar reports from people who've taken the drug, so I am glad to see the FDA taking a look at the drug's safety profile.
As a reader noted just the other day, "There is something awfully strange about this pill."
Gee, wouldn't it be ironic if taking Chantix (Champix in the EU) turned out to be riskier than smoking? Nah, that could never happen, because we all know Nanny State thinking is always correct and you must be mentally ill if you do not accept Nanny Statist commandments.
For those readers (and the inevitable newbies who'll swing by to defend the drug and lambast smokers yet again) who criticized me for describing this drug as SSRI-like in earlier posts, now you know what I was talking about. And so does the FDA. Feel free to read what other readers have offered about their experiences with Chantix--good and bad--in comments on these posts.
Just as a general warning to whomever might read this post: be very careful when taking Chantix about drinking alcohol. The two don't go together as well as cigarettes and bourbon.
The State of Arkansas today filed a lawsuit against Janssen and J&J over allegations that the company "engaged in a direct, illegal, nationwide program of promotion of the use of Risperdal for non-medically necessary uses." In other words, off-label marketing--specific charges would likely include allegations of the drug being marketed for use in elders and children, as well as in depression and anxiety, conditions and age groups for which the drug does not have FDA approval (it did get two pediatric approvals over the last two years, but this suit concerns allegations in prior years). This lawsuit had been expected for some time. The state did not specify damages sought, but it would likely be over $100 million in damages and penalties. The state has also made it clear that it intends to sue Eli Lilly, makers of Zyprexa, and AstraZeneca, makers of Seroquel, over similar allegations. I'll have more on this once I've seen a copy of the state's complaint, which I have requested, against Janssen/J&J.
According to the AP, Janssen had no comment.
Recently, I've had a few exchanges with new readers who feel that my criticism of the mental health paradigm in this country is somehow designed to scare people off their meds, or to scare them away from ever taking meds. My usual objection to such silly assumptions (I've had these exchanges before) is that I believe in a free market of ideas and believe fiercely in patients having complete and unfettered access to legitimate information and opinions, so they can make their own darn choices about their health care. It's their bodies and their minds and they deserve accurate information instead of rhetoric based upon distorted statistics.
Besides, as a I pointed out to one reader, isn't it possible that one of the totems of mental health care--the argument you can't argue with that you will kill yourself if you are not treated, a line repeated by everyone from pharma marketers to the doc in the neighborhood clinic--could be designed to scare people into taking meds that have very unpredictable outcomes and to scare them into a panic about their fates each time they feel poorly? That reader never answered me, and has likely written me off as a kook (fair enough), but I think I was onto something.
Almost any mental health resource will offer the argument that 10 percent to 20 percent of people with depression, schizophrenia or bipolar disorder will commit suicide. But when you look at the numbers, that doesn't exactly pencil out very neatly.
Consider:
2 million with schizophrenia (1 percent prevalence amogn US adults)
7 million with bipolar disorder (2.2 percent prevalence)
20 million with depression (10 percent prevalence)
Rounding up, that works out to 30 million people at a 10 percent to 20 percent chance of killing themselves. Obviously, I know some researchers estimate depression and bipolar disorder in America at even higher prevalences.
If 20 percent of these folks will kill themselves at some point in their existence, that's 6 million people. We know already that suicides in America average about 30,000 people a year and has for several years, give or take. For 6 million people to kill themselves at a rate of 30,000 people a year--and that's assuming that all 30,000 suicides are a result of schizophrenia, bipolar disorder and depression, and I don't buy that assumption 100 percent--it would take 200 years for that to transpire (this doesn't allow for population growth). If the 10 percent number is used, it would take 100 years.
Clearly, both suicide risk assertions don't measure up. You'll never, ever hear that talk from anyone in the mental health establishment however--possibly because they believe these numbers or because they are religious sorts to begin with.
But something is clearly wrong with these numbers and the kind of marketing through fear used by researchers, advocacy groups, pharma companies and so on. I'm not asserting that suicide is not a problem--it's a problem and a half and I've written about it extensively--but I've grown very weary of the mental health establishment in this country using these numbers to literally scare people onto their meds.
My own casual guesstimate is that suicide rates among the mentally ill likely hover around 5 percent to 7 percent. That's still a sizable problem--one I would like to see solved--but it's not a problem that's going to go away by using false numbers, bad logic and leaning on weak technology (ie, anti-depressants). Because that's just really scary.
Anyway, I'm not throwing this out there as an absolute, but in order to generate some thoughts among readers. Think away in comments.
Yes, I thought I'd do no more posts for today, but this one sort of had to be written.
I had a bad bit of news yesterday--unexpected and deeply disappointing, professionally and financially--and so I had to spend much of yesterday afternoon and evening doing all the mindfulness, self-awareness kinds of things that those of us who've actually learned to live with a mental illness (and we are out there, not that researchers ever bother to ask us any questions about how we do it) have to do in order to keep from falling into a bad cycle instead of rushing to the doc to get medicated into the next time zone, so I have no posts to offer this morning. Probably none at all today. I am fighting a lot of stress and have been working myself too much lately, and I need to back off. Besides, it being a holiday week in the States, hits are already way down.
Anyhow, it is the kind of crap that is forcing me into a reckoning with myself about the future and what the hell it is exactly that I seem to be doing with my life. Things just aren't adding up particularly well for me this year, just like last year.
But I prefer sucking it up and moving forward on my own terms to allowing anyone to turn me into a victim, or to their telling me, "Oooh, poor baby, you're depressed, you're upset. Mental illness is very dangerous, please see your health care provider." Nah, folks it's just life in its omnipresent screwiness. I'll take my life meds-free and my side-effects all natural, thanks.
Speaking of omnipresent screwiness, the Treatment Advocacy Center has named a new executive director, someone with bipolar disorder. See what he has to say for himself here.
In other weirdness, Jonah Lehrer, who writes the Frontal Cortex blog and whom many in the blogosphere have been cooing over lately, is seriously dumb enough to believe that 44 percent of all cigarettes smoked in the US are smoked by the mentally ill. Not only does such an assumption not pencil out (2 million adults with schizophrenia plus 7 million or so adults with bipolar disorder plus gets us to 9 million people. It's not clear to me whether to include depression in this calculation or not. But there's no way on Earth that so few people could smoke that many cigs. Hell, i know several schizophrenics who don't smoke at all, same with bipolars), but it carries with it the implicit Nanny State message (not made by him but sure to be made by others) that we must medicate these "people beset by a woefully unpredictable mind" for their own good. Please. The typical thumb-sucking of a 25-year-old who's had the anti-smoking nazi message pounded into his head since Grade 1.
Unless, the antis can somehow prove that Zyprexa is healthier than a Marlboro. Maybe some of the antis can go take 10 mgs. of Zyprexa each day for a year, and I'll go off and smoke a pack a day, and we'll compare notes and have a 40-yard sprint to see who's doing better. I know who will win that race.
With current treatments for schizophrenia turning out to be a disaster--or am I a delusional, scare-people-off-meds guy for citing NIMH-funded research showing that anti-psychotics don't have robust efficacy?--some researchers are turning to fairly novel ideas to address schizophrenia. And the treatment of schizophrenia could really stand to see some novel ideas.
Anyhow, two researchers are using a therapy called Social Interaction and Cognition Training (SCIT). It uses videos, computers, role-playing and other methods to help people with schizophrenia understand social cues and intentionality coming from others. These are big problems in paranoid schizophrenia, of course, where schizophrenics are assaulted by the idea that everyone is out to get them, they are being persecuted, etc., when nothing of the sort is going on. Reportedly, SCIT has had some success in getting patients to stop inferring hostile intent to the acts of others.
I hope others take up this kind of research, because I don't think any of the drug-based remedies for schizophrenia are going to be getting us much further than they already have.
The St. Petersburg Times had a fine and well-balanced article yesterday on just how well the use (off-label, I must stress) of atypical anti-psychotics in the elderly is going in America: not really well. The article quotes David Graham, an FDA safety official and one of the bravest people in government, as estimating that the use of atypicals such as Zyprexa in the elderly results in about 15,000 nursing home deaths each year. That's a stunning estimate, so stunning that I don't even know what to say, except to promise my parents that they will never, ever be placed on these drugs as long as I am alive and the Second Amendment is in force.
One in four nursing home residents get these drugs, according to the article.
Just as I suspect we are heading down the wrong road in aggressively medicating kids, I think we are heading into dangerous territory in giving anti-psychotics to the elderly. I know there are individual cases that argue for their use, but speaking more broadly I think doctors who support the use of these drugs--some of them are quoted in the piece--are a bit too interested in compliant patients over physically healthy ones and are out of touch with the evidence base.
The paper had access to the Zyprexa documents--hm, I wonder where they got them?--and quotes extensively from them in outlining how Eli Lilly allegedly violated federal and state laws in its marketing campaign to get Zyprexa embedded into nursing home culture. How legal Lilly's behavior was will be tested in a series of lawsuits filed by several states against the company.
What also knocked me over was that the paper's reporter, Kris Hundley, uncovered data showing that use of atypicals in the elderly account for about 20 percent to 25 percent of the sales of all atypicals, so right around $3 billion a year. Not bad for a marketplace where the pharma companies have no FDA approval for the use of these drugs, and a recent NIMH-sponsored study of the long-term use of these drugs in the elderly found that they were no more effective than placebo. Needless to say, placebos are safer to use. I only wish the paper had included that recent study, which would've been the perfect coup de grace.
I was also surprised at the disconnect between the black box warnings on the use of these drugs in the elderly and what seems to be standard practice for nursing homes in Florida. Do any of these doctors actually read medical journals and newspapers?
BTW, if we are so willing to aggressively use these dangerous drugs in our elders because they can become agitated and combative, why aren't we using Ativan, Xanax and other benzos first in this same population? Benzos address the same behavioral issues and are comparatively safer. Food for thought at any rate.
A week after news came out around a couple of studies with implications for the ADHD debate--or the Ritalin Wars, if you prefer--I figured that the hubub would have died down. I was wrong. On the heels of Judith Warner's love letter to drug companies everywhere on Friday on the New York Times' website and my response to the same, the British press had a go at the implications of the two studies. In fact, articles and editorials cascaded out of the Brit press over the weekend. Here's a sampling. Oh, yes, all of these are headlines from thoroughly legitimate British news organizations.
"ADHD drugs 'used to silence rowdy children'"
"We need inquiry into ADHD kids"
"Ritalin: The scandal of kiddy coke"
There others, of course. Some of the articles were over-the-top, some them quoted David Healy to great effect and so on. I think some of them engaged in fearmongering--kiddy coke? Oh, come on--and it takes a lot for me to be use that term, but I think that globally the Brits have caught the big takeaway message from these studies--ADHD drugs aren't particularly needed long-term (short-term may be another story) and may indeed retard brain development, and this is mostly about the boys. One opinion piece got into the question of boys so well that I'll take it up in a separate piece today or tomorrow.
The intensity of it all reminds me of earlier this year when the US press had a run at the bipolar child paradigm. The Brits have braver headline writers, however. I'm a bit surprised that I remain the only commentator here or over there to poke at the idea that the bipolar child who-ha and the ADHD noise are deeply intertwined.
As outrageous as the Brit press can be, they have done a fine job of sounding the alarum that something is up out there in Western culture and in our souls, our societies and our behaviors. Good for them for banging away on it, however crude some might find the results.
By comparison, commentary in the US has been a wee bit quieter (so far, at any rate). But that's probably because the media in this country are still trying to figure out what it all out means. And I certainly don't know what it all means yet, but given that we are medicating the hell out of a generation of children and given that it doesn't seem to be producing particularly robust results for us as a culture by just about any yardstick I can use, I have to think that it means we've gone too far with a modern technology and we really, really need to take a timeout and reassess the situation.
Someone using the handle I Am The Brain has recently begun a new blog called the Fascism Advocacy Center, a clear reference to Fuller Torrey's Treatment Advocacy Center which advocates for laws to force powerful, unsafe medications upon people diagnosed with schizophrenia or bipolar disorder. As you might expect, Brain spends a good bit of time flaying TAC and Torrey as well as the National Alliance on Mental Illness (NAMI), an advocacy group/pharma front Torrey founded in the 1980s and, then, later broke with because he felt they weren't pushing hard enough for forced medication of free Americans. The blog is a mix of satire and serious analysis.
Among patients, Torrey is the most controversial figure in psychiatry and is routinely denounced as evil. The media still regularly quotes Torrey, who believes, among other things, that cat feces cause schizophrenia and that anyone diagnosed with schizophrenia or bipolar disorder is inherently violent (regardless of data that says they are no more prone to violence than the general population). Torrey's group regularly twists studies and statistics to make their point, and they are very influential with lawmakers in some states. Among non-NAMI advocacy groups, Torrey is also viewed as evil, or so I am told by people affiliated with these groups. Why they won't say so publicly is beyond me.
I have written many times about TAC and Torrey. If you are interested, you can read those posts here.
Thanksgiving dinner no less. Yep, Stephany who writes the soulful sepulcher blog--much of it about her child who was misdiagnosed, mismedicated and may have been harmed forever as a result--has invited the New York Times' Judith Warner to dinner. The only question is has Warner, a medicate-kids-for-everything advocate, ever been outside the DC-New York axis?
I think this lawsuit may be a first over withdrawal problems from a licensed drug: 600 British patients have filed a lawsuit against GlaxoSmithKline, makers of Paxil (Seroxat in the UK), alleging that the company issued no warning of withdrawal problems with the drug and that the drug in a defective product under British consumer protection laws. The suit seeks about $60 million in damages. Good for these patients for stepping up and suing GSK over Paxil's notorious withdrawal problems.
For those of you who might think that it's not possible for someone to take an anti-depressant and wind up hooked on the drug, take a look at this site. For those of you who take Paxil, be very, very careful when you decide to discontinue use of the drug.
The New York Times' Judith Warner had an interesting blog post yesterday on what she calls the Ritalin Wars, Ritalin being shorthand for medicating any and all children with behavioral "deficits." She's responding to the news earlier in the week regarding ADHD and how recent studies had shown slightly-slower, but eventually-the-same brain development in ADHD kids compared with their coevals and that ADHD kiddos diagnosed at five-years-old turned out to do just as well academically as their peers by 10 years of age. The findings, first reported by her colleague Ben Carey, have exploded all over the 'Net and mainstream media, because many view them as a real kick in the teeth to the social hysteria here and in Britain around over-active children, especially little boys.
And there have been some stunning interpretations of the two studies--everything from meds are ruining kids brains to kids grow out of ADHD to us ADHD docs are being misunderstood again to ADHD is a fraudulent diagnosis--running 'round the Web. As I said earlier this week, I think that the results here will confound the experts for some time, offer hope to some parents, and lead to a heck of a lot of controversy. Right yet again.
Warner gives some researchers ample opportunity to backpedal away from the implications of their work, which is amusing. What I find startling is that Warner pays little attention to recent news that not only are we giving these little boys stimulants, which indisputably affect their brain development, but we are giving many of these same ADHD boys--and let's be clear, it's the boys who are getting doped up and maybe that's the way women like Warner want it--anti-psychotics. The use of anti-psychotics in adults is flat-out dangerous in long-term use and of limited effectiveness, and the use of these drugs in children comes with a wafer-thin evidence base and just as much danger. Perhaps Warner should begin asking her very important researcher sources about that instead of offering us her continual defense of a broken paradigm.
In other words, take Warner's views with several shakers of salt. She is as deeply biased as I am on these issues, but the difference is that she's at the most important paper in the world, has a best-selling book and a show on satellite radio. Me? I ain't jack shit when it comes to impacting the insanity that writers such as Warner propagate. I'll just keep pointing out that it's insane. Warner has made an earlier appearance on this site as an apologist for the bipolar child paradigm, which is of course joined at the hip with the ADHD diagnosis (at the time, her columns were behind the Times Select now-defunct firewall).
As poisonous as I find Warner's views, she is correct that the Ritalin Wars verge on a religious war. And that's very funny and very sad when one considers that we are supposed to be talking about improving peoples' existence on Earth. Warner closes:
"There’s a sense that greater powers, profit-driven and amoral, are pulling the strings in our children’s lives. There’s a sense that those who should best protect us — our government and our doctors — are so corrupted that they can no longer do the job. There’s a sense that childhood has, in many ways, been denatured, that youth has been stolen, that the range of human acceptability has been narrowed for our kids to a point that it has become soul-crushingly inhuman."
A sense? Oh, boy.
"I share all these feelings. I think that most of us do. But where I differ (now) from those eager to pile onto the anti-ADHD bandwagon is that I’m not willing — anymore — to sacrifice real children and their parents on the altar of ideology."
Apparently, Warner and her intellectual pals are willing to sacrifice real children and their parents on the altar of a science that looks more and more like an ideology each and every day.
P.S. Just so we're clear, I don't consider the ADHD diagnosis to be bogus. I consider it to be grossly over-applied in American and British culture, and consider the treatments for the diagnosis to be dangerous.
I was flattered this morning to learn that I'd been given a Health Leader award for my work on this here site. The award is given out by the folks behind the Irritable Bowel Syndrome site as a means of giving their many readers recommended patient-centered sites to go read for other maladies. I like getting kudos from other patients, so thanks. I'll put the logo up on my site later. More on the awards here.
Earlier today, the FDA approved Seroquel XR--the extended release version of the atypical anti-psychotic Seroquel--for use as a maintenance treatment in adults with schizophrenia. What with all the new FDA approvals going on or imminent for the atypicals--Abilify for kids last week, Zyprexa on the horizon--you'd almost think there must be something magical about these drugs. But there isn't.
I'm sure we are going to see some new and novel marketing campaigns for these drugs, which ought to be more novel than the drugs themselves.
Or shall we say it dramatically increases the risk of depression in these people? This from the Guardian UK:
"People taking the weight-loss drug rimonabant have an increased risk of mental health problems, according to a study of more than 4,000 patients in four clinical trials. Those taking the drug were 40% more likely to suffer conditions such as depression and anxiety than people taking a placebo."
Isn't losing weight supposed to make you happy? Actually, Acomplia has been deemed unsafe for patients already taking an anti-depressant by the European Medicines Agency.
Clinical psychologist and author Bruce Levine had a nice post yesterday on The Huffington Post on how important the very old concept of morale is in treating depression. It's difficult to talk about that concept in a culture where we've been instructed that all we need to address to treat depression is a chemical imbalance (there may be some level of serotonin dysfunction involved in depression, but it's far from a sole driver), so that alone makes his piece worth a look.
I'll be writing more about depression, hope, persistence and psychological self-care in the near future.
Last week, Abilify was approved for use in youths aged 10 to 17 years of age who are being treated for schizophrenia. Now, the drug is set to receive priority review for use in bipolar disorder in youths aged 10 to 17 years of age. I would be shocked if the drug is not approved for bipolar disorder (it's already approved for adults), although it's hard to understand why the drug merits priority review. It's not like Abilify performs particularly well in research in adults, so it would be important for youths because why?
All the same, this drug will be approved. For the folks at Bristol MyersSquibb, this will increase their ability to market the drug and pay off their $515 million settlement with the feds over prior allegations of off-label marketing of this drug and others BMS drugs, as well as allegations of payoffs to doctors. BMS has shown itself willing to market this drug very aggressively to adults, including running the first known television ad for an anti-psychotic, targeting women with its advertising, and having special wraparound phone booth ads near college campuses in some of the most annoying DTC ads I have ever seen for a psych med. Soon, BMS will be able market the drug even more widely to consumers. I'm sure that's good news for an ad agency somewhere.
I and the readers of this website will be watching very carefully how BMS markets this drug to youngsters.
This came in yesterday from a reader, a patient writing of her experience on Effexor and trying to come off the drug and running into the dreaded brain zaps:
"After finding out I was Bipolar, the first medication the doctor's put me on was Depakote, and when that didn't work they tried the dreaded Effexor. At first I noticed nothing. I received no warning signs about this drug from my doctor either. After about a month I started getting even more depressed, and my mood swings were unbelievable. I couldn't take it any more so I decided to take myself off. Little did I know that the withdrawals from this medication could make someone want to die. I heard voices, which I have never heard before, I had horrific "brain shocks", (please google that and Effexor), and lastly I had horrible psychosis. I didn't know what was worse, being on the drug or off. The point of my comment was doctor's shouldn't just hand this kind of stuff out to people. It's awful."
I appreciate this reader sharing that. Here's what Googling "brain shocks" and Effexor gets (click on this).
I know of only one person for whom Effexor has worked long-term. He is scared to even try coming off the drug. That tells you something because it's not the depression that might recur he fears, but this drug's infamous withdrawal problems.
Why can't Wyeth make an anti-depressant that doesn't cause these kinds of problems? Does the company even care?
OK, we've all run into those free pens and notepads emblazoned with the name of Drug X or Y that pharma sales reps give away to doctors who then pass them onto patients. Well, I have now run into the one of the dumbest giveaways ever: The fine folks at Eli Lilly will send you--yes, you!--a free pedometer if you go to the Cymbalta website--which reps the company's really dodgy anti-depressant--and sign up for an email newsletter that will tell you all about the joys of taking Cymbalta. My hunch is the emails will not delve into liver problems, suicidality and withdrawal problems people are running into on the drug. You can sign up for the newsletter and pedometer right here. I think readers should go sign up for the pedometer and to get the Cymbalta info by snail mail, so we can run up the company's postage costs. Oh wait, did I say that?
Hey, Lilly: youse guys got a Zyprexa blood sugar monitor I can have?
Isn't DTC pharma marketing just grand?
In addition to the lecture I am doing at the New College of Florida on Nov. 27, I am now also doing a "talk" (er, informal lecture) for honors students at the University of Washington on Dec. 5. I'll be talking about consensus, controversies and chaos in the world of mental health. More on this later.
Ever since the Internet hit the mainstream in 1995, there has been concern about people on the 'Net hectoring someone into killing themselves. It's a concern of mine and one reason why I closely monitor comments on this site. You never know what kind of creep might happen along and decide to mess with people and what might end up happening. Of course, there are the suicide cults on the 'Net in Asia and there have been reports in the Seattle area of teens talking each other into killing themselves via instant messenger. This case is different. It's one that makes me shake with rage. It is a very upsetting story, so make sure you can handle it if you click on the link.
This time out a full grown adult, a woman no less, created a fake MySpace profile and used it to trick a depressed friend, a girl, of her teen daughter into thinking she was liked by a hot boy. This happened in Dardenne Prairie, Mo. Then she turned the tables on the girl, who happened to be on meds and whose parents tried to monitor her MySpoce use, and told her that everyone hated her and she needed to die. And so the 14-year-old girl proceeded to hang herself. This happened in October 2006.
"She [a neighbor in the know] told the Meiers [the parents] that Josh Evans [fake hot boy] was created by adults, a family on their block. These adults, she told the Meiers, were the parents of Megan's former girlfriend, the one with whom she had a falling out. These were the people who'd asked the Meiers to store their foosball table...."Megan had gone on vacations with this family. They knew how she struggled with depression, that she took medication.
"'I know that they did not physically come up to our house and tie a belt around her neck," Tina says. "But when adults are involved and continue to screw with a 13-year-old - with or without mental problems - it is absolutely vile.
"'She wanted to get Megan to feel like she was liked by a boy and let everyone know this was a false MySpace and have everyone laugh at her.
"'I don't feel their intentions were for her to kill herself. But that's how it ended.'"
When the Meiers found out about this after their daughter's death, they chopped up the table and dumped it in their neighbors driveway (if it were me, I would've broken something else). The neighbors had the nerve to report the damaged table to the police. The local paper has not named these people due to the fact that there is a teen girl at home, who's an innocent in this. I hope this family has the good sense to leave town because sooner or later their identities will get out. As they should. Because they are not going to face any criminal charges.
This is the most disgusting account of the misuse of social networking sites that I have ever encountered. It's worse than all the pedophiles on MySpace and Facebook and NBC "Dateline" stuff put together. It's precisely the kind of thing I've worried could happen on MySpace--adults creating fake identities and harassing vulnerable people into doing regrettable things. I've been worried about it because something vaguely similar happened to me. (I'm not trying to take away from the Missouri story and the Meiers' pain. Just trying to illustrate how malicious some adults can be and how easily this shit goes down on the 'Net.)
Two years ago, I was a very active user of MySpace, especially of the support groups on there for bipolar disorder, depression and suicide because I figured it was my place as an older bipolar who's somehow gotten through all the hell of it to the other side to help out all the others (because their doctors, families and the mental health system don't seem to be particularly helpful to them). I wanted to encourage them that there was hope and that that hope was staring them in the mirror each morning. Once, I talked a teen out of killing himself. Another time, a suicidal teen found some words I had written in a thread on suicide and wrote to tell me that I had saved his life. All positive stuff.
And, then, one day several guys--of course, it was guys!--began showing up in the bipolar groups and set about harassing posters in various threads. Stuff too ugly to repeat (the group moderator did a good job of taking down posts but it took time and so the posts would sit there and work their rot in the meantime). Some of the members of the groups are, shall we say, extremely vulnerable, fragile plants (often on way too many meds). As a longtime Nethead, I knew that the best way to handle flamers such as them was to ignore them completely. I tried that approach, but unfortunately others in the group couldn't ignore them and began falling apart in that surreal way that support groups are heir to. These guys were openly telling 15-year-olds to go overdose on meds. No lie.
So I began responding to the flamers' posts. They began emailing me on MySpace, saying deeply nasty shit. One of them began saying racist crap--he must've known my deep hatred for skinheads that goes all the way back to my punk days in the 80s--and I fired back. Then they stole my profile information and pictures and created several fake profiles of me. They turned me into a man who had sex with cats--yes, they stole my cats' pics--and a Chinese woman and I don't even remember what else. They created a phony tribute group on MySpace, which at one point had something like 400 members (mostly teens who will apparently click "Approve" to every group invite they get). They hassled people on my friends list. And so on.
I reported them to MySpace customer service, which did not respond to me. Since I was still working as a reporter fulltime, I contacted MySpace's media department, which also blew me off (nice group you've got there, Tom). As odd as it sounds, I became scared to log onto MySpace. God only knew what awaited me that day and while I had a bit of adult distance from it, I wondered how less experienced souls might do under a similar onslaught. Finally, customer service got a hold of me, and started giving me the third degree about proving my identity and the accusations I was making. It took me two days to convince them I was on the up-and-up. They deleted all the flamers accounts and blocked them.
A day later, the flamers were back and we went through another two rounds of fun over the next week before they disappeared for good. As it happened, someone claiming to be a friend of theirs wrote me and asked me why I was giving them such a hard time. They were just bored guys looking for some cheap fun, she told me. It was all a big joke that I wasn't cool enough to get. I asked her if they'd done this before and she said that, yes, they done the same kind of thing in a cancer survivors group on MySpace (no idea if that was true).
After that experience, I have little trouble believing that there are adults evil enough and warped enough to tell a troubled teen to go die.
I'm not sure if these two separate stories have a moral aside from serving as a warning--for the millionth time--to people to be very leery of what they run into on the 'Net. Because the Web 2.0 can be very real even when it is at its most fake. That's something the wealthy, privileged propagandists of the Web 2.0 have yet to figure out a way to grapple with. And that's why I hardly use MySpace anymore. Or Facebook. Or Tribes. Or Bebo. Or Friendster. Or....
On Tuesday, CBS News had an investigation on just how many active military and veterans are committing suicide, and the numbers are sobering, if not shocking. There were 188 suicides among active personnel in 2006, and most news organizations would've stopped there because at a rate of about 50 percent greater than the general population that's staggering enough. But CBS went a step further, got suicide data from 45 of the 50 states and found that in 2005 there were 6,256 suicides among those CBS ID'd as being current or former military. That would account for about 20 percent of all suicides in the US for 2005.
Their data analysis also turned up this discouraging fact:
"Veterans committed suicide at the rate of between 18.7 to 20.8 per 100,000, compared to other Americans, who did so at the rate of 8.9 per 100,000."
So veterans kill themselves at twice the rate of civilians. The rate was even higher among vets aged 20 to 24 years old. What the heck is going on here? Is there something about serving in the military--whether someone saw combat or not--that drives men to despair? I have no idea. Just asking the question.
The military is reportedly rushing to hire psychiatrists and mental health workers, but it's not clear to me that improved mental health care will fix this problem more than a little bit. Readers of this site are well aware of the controversies around just how efficacious our present anti-suicide technologies--anti-depressants, atypical anti-psychotics, therapy, etc.--actually are (or aren't).
I don't even begin to know what the answer here is. But I do know that a big piece of America's suicide problem is connected to military service. But what do you do with that bit of information that might make things better?
Previous coverage here and here.
Psych Central yesterday handed out awards for the best 10 blogs on depression. I'll run down the list for those of you who didn't catch it. Most of these blog will already be familiar to regular readers.
Depression: Art and Expression
Congrats to all of the awardees. One major oversight on the part of Psych Central would have to be Storied Mind.
Researchers at Oregon Health and Science University and the Oregon National Primate Research Center report today that they have extracted stem cells from cloned monkey embryos. The results are being reported in Nature. Should this research be replicated, then it will be a scientific breakthrough and will also open up a huge can of worms around whether you could do the same thing with human embryos, whether you would want to, and would the government have to pay for such research. And so on.
The implications for mental health research and neuroscience are a bit down the road, but they are huge in all directions.
OHSU has been the forefront of the monkey cloning business for years, especially due to the work of Don Wolfe and Gerry Schatten (now at Pitt), whom I wrote about eons ago.
It's not all a good news day for OHSU and the primate center: PETA is on their ass over various allegations of mistreatment of research monkeys, which echo allegations made about the center's monkeys in 2000 and 2001.
One assumes PETA has no position on cloned embryos.
That's the question posed in an editorial on MSN UK, coming on the heels of recent news that kids with ADHD essentially turn out just fine over the long-term. I'm still not clear on what the implications of those studies are for the meds-or-no-meds debate, but the author has her views. And a charming lede:
"It was probably nailing my teacher’s coat to the desk while he was still wearing it that did it. That and glueing his packet of peanuts to the classroom ceiling, at a precisely-calculated five millimetres beyond his furthest reach."It was the climax of what I – and most of my pre-teen classmates – considered a sustained comedy campaign, a bit of light-hearted high-jinx designed to redress the teacher-student balance of power. It wasn’t my first and nor would it be my last, even though this particular incident triggered a catastrophic sense of humour failure in said faculty member, who mysteriously vanished overnight.
"Had I been born a decade or so later, I doubt I’d be writing this today. Rather than spending almost 20 years inventing new ways to terrorise a succession of teachers, lecturers and employers – fuelling other forms of creativity, including writing, in the process – I’d have been given a massive dose of Ritalin and left in a corner to rot."
Ah, yes. Like this author, I have aired my concerns about how I would've been doped into oblivion had I been born 20 years later. Unlike her, I don't really think parents are to blame for all the ADHD, bipolar child craziness afoot in Western culture these days. But here's how she went after it:
"There are, of course, some children who genuinely need pharmaceutical intervention. However, more often than not, this so-called disorder is really the result of combining excessively spirited children with criminally sub-standard parenting skills – quite the Molotov cocktail. In cases where a child becomes disruptive due to lack of parental care, affection or stimulation, the impairment belongs not to the child, but to the surrounding adults."
Elsewhere, she quotes a doctor who states that ADHD is the biggest healthcare fraud in history. While I think there's a lot to criticize about how ADHD and bipolar disorder have been applied to children, I sometimes worry about the source of the more extreme assessments.
I'm a bit puzzled that a journalist from a fairly reliable news outlet would set about using Fred Baugham as a supportive interview. Baugham may be right on some of his points--ones other docs such as Larry Diller make--but he's also the medical advisor for the Citizens Commission on Human Rights, a front group for the Church of Scientology. CCHR and CoS claim that mental illness doesn't exist at all, and while I am a big skeptic of much of what goes down with mental health diagnosis and treatment in Western Culture, I think it's fair to say that mental illness is real, it actually exists and if anyone needs proof of that, then I can take you on a walking tour of Seattle's streets and jails. Whether mental illnesses exist to the degree doctors like Harvard's Joe Biederman claim--or whether they even exist in small kids--is another matter entirely. Bipolar disorder at 2 percent I buy. Bipolar disorder at 5 percent or more strikes me as an example of social hysteria and doctor self-justification disorder.
You can take all this up on a message board on this topic that MSN UK has going. It was up to 43 pages when I looked. Go join the fun.
A press release from something called the Society for Women’s Health Research was sent along by a reader yesterday. She had some thoughts on it which are below. The society's corporate advisory council includes AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, J&J, and Wyeth. I wonder what kind of advice they offer the group aside from funding. But I digress.
So the group put out a press release claiming that only 10 percent of women think it is safe for women to take meds for depression while they are pregnant while 68 percent of doctors think it's safe. As far as the postpartum period, 50 percent of women thought meds were safe compared to 97 percent of doctors. That's a major disconnect despite the huge push and publicity around new state laws such as in New Jersey where women are now required to be screen by their caregivers for postpartum depression. I'm not a big fan of TeenScreen, but postpartum depression screening makes sense--so muc hso that one wonders why it requires a law.
Anyway:
"'Many pregnant and postpartum women falsely think that depressive symptoms, and even clinical depression, are part of the normal experiences of being pregnant and delivering a baby,' said Kimberly Yonkers, M.D., an associate professor of psychiatry and obstetrics and gynecology at the Yale University School of Medicine in New Haven, Conn. 'Moreover, they often assume that these symptoms will spontaneously go away when that is not always the case. There are a range of treatments available to women and we need to get the message out and encourage depressed women to access care for their emotional symptoms.'"
Obviously, the questions around pregnancy and depression and postpartum depression are big ones, but I have to scratch my head a bit over docs telling would-be moms that, in essence, an SSRI goes just fine with pregnancy. Isn't that the sort of arrogance women have complained about from the mostly male OB/GYNs for decades?
I'm a guy so I don't have a ton of credibility on pregnancy issues, so what I can say is that the evidence on risks from anti-depressant use during pregnancy--aside from the common risks attached to anti-depressant use--is mixed. Some studies say, "Birth defects." Others say, "Stillbirths." Other studies say, "Take the Paxil." I couldn't begin to sort out these conflicts. And as a single male, maybe I'd better just turn that over to readers.
But what I find striking is that we, as a culture, push expectant mothers very hard to eat properly, not smoke, not drink alcohol and so on yet doctors are pushing anti-depressants on them when we, as a culture, know that these are problematic pills and that the evidence of birth defects is mixed. If I were an expectant father, I would be deeply suspicious. After all, the FDA now specifically advises docs to discuss risk around Paxil and pregnancy with would-be moms. And then there's the small issue of reported pulmonary hypertension in newborns connected with SSRI use, accord to this New England Journal of Medicine study. Hypertension in the lungs of newborns is a very bad thing.
That said, postpartum depression happens quite a bit and is very, very intense--and with more erratic behavior attached to it--from what I've read and two examples I've seen of the phenomenon in real life. I literally watched one friend of mine fall apart about four months after giving birth. I know a man in Seattle whose wife killed herself soon after giving birth to their first child. She killed herself two days after starting Prozac.
All things to consider. The reader who passed along the society's release--a young mother, BTW--had these thoughts about this study:
"What women need after pregnancy, like they have in some European countries (government-sponsored), are post-partum doulas, so they have some more help and can get some sleep. Women used to have mothers or mothers-in-law in the house and other female relatives. And some emotional support, etc. during pregnancy could help, too. Like MIDWIVES, who offer that, not MDs who have only two seconds for a visit. Women need people and emotional and practical support not drugs, Sheesh! this study shows that women don't want drugs that can harm them and their babies."
Sheesh, indeed.
I don't know how to make this point except to say it: The way we live our lives in this country these days puts so much pressure on expectant mothers--we actually expect them to be at work until soon before they deliver--and is so dominated by the medical model of doing childbirth that one wonders when American women will embrace midwifery more--not that there aren't problems there, too--and doulas and the like. I know the present system works just fine for some women, but there are others for whom it is a rotten scene. Where are they supposed to turn?
I don't know how many of you know about the story of Carol Gotbaum, a rich, well-connected New Yorker from an influential family who died in police custody in a holding cell at Phoenix Sky Harbor Airport in late September. She was a chronic alcoholic heading to rehab, flying alone, friends who were supposed to meet her in Phoenix weren't there to meet her. Gotbaum ends up slipping into an airport bar while waiting for a connecting flight, gets very drunk, misses the boarding call, later tries to board the plane and is denied her seat, and then she just comes unlgued. Cops try to arrest her, she fights the cops, they drag her off to a holding cell where, still behaving erratically, she manages to hang herself by the cuffs and chain behind her back, as she's been connected to a hook in the cell's wall. At least, if I remember the whole story. More details are here.
Now it comes out that Gotbaum was on Cymbalta and Celexa in addition to being drunk. One doctor who's examined her case thinks the two drugs played a part in her demise.
"'We are not talking about a drug death, but a death where drugs made her more susceptible,' said pathologist Cyril Wecht on Monday."Wecht says he essentially agrees with the Maricopa County medical examiner that the death was an accident, but the police should have gotten medical help soon after they encountered Gotbaum, the pathologist argued.
"Phoenix Police Department has repeatedly argued that there was no way for officers to know that Gotbaum had health problems when she was arrested."
I think the doctor, a pathologist hired by Gotbaum's family for an inevitable lawsuit, is missing a key point. Drugs like the ones she was on don't only cause oxygen transport problems (I assume he's right on this point), as the doctor argues, but they have a long track record of making some people behave very erratically. It's puzzling that he's not saying so.
Gotbaum, who was flying through Phoenix on her way to Tucson for rehab, had a blood alcohol level of .24 percent--thrice the legal limit to drive--and I'm sure that contributed to many of her problems that day. But Cymbalta and Celexa could well have made her behave even more erratically than just the booze alone.
There are so many contributing factors in this woman's death--including choices made by the woman herself and her family--that I doubt anyone can ever tease out how much anti-depressants could've contributed to her eventual death. It's clear they had a role in her death, however.
I've been thinking about her case since I first heard about it in September, primarily because I've had to write about vaguely similar deaths in holding cells and jails before and I've really had it up to here with these very preventable tragedies.
Knowing what the world knows about how booze and some anti-depressants can produce very bad reactions in some people--as in making them completely crazy and suicidal--why was this woman flying alone? And why the hell was she flying out to Arizona to go to rehab? Is New York State lacking in rehab facilities for the rich and well-connected?
What part of health problem do Phoenix cops fail to understand when confronted with the case of a woman who is clearly drunk off her ass, behaving very erratically and fighting them? Are cops in Phoenix that unsophisticated and naive to not think that a woman like that--whom I'm sure they must've backgrounded while she in that cell--without a criminal record wouldn't have something seriously the matter with her to account for all of what was happening? Why would you shackle a woman like that to the wall and not monitor her more closely? Haven't there been enough similar tragedies in jails and holding cells in this country to keep this sort of stupidity from playing out? Answer: yes.
My point isn't that the cops killed Gotbaum, it's that the cops screwed this case up badly. They were this woman's last chance and they failed. Whenever the Phoenix police do an after action report on what happened and it becomes public, it will make for interesting reading. I hope other departments review it and do what they can to prevent similar episodes because this phenomenon of people dying in holding cells or in the back seat of patrol cars has simply got to stop.
And so, too, do the bad reactions to anti-depressants and booze.
Some posts I did a ways back about possible weird reactions to the smoking cessation drug Chantix (Champix in Europe) continue to bring in disturbing accounts from people who've taken the drug. Here's one:
"I'm a healthy 36 year old woman with 3 kids. I've been taking Chantix for 6 1/2 weeks and was ordered by my doctor to discontinue taking this medication this a.m. Over the last two weeks, I have had six panic attacks---one that landed me in the hospital as I thought I was having a heart attack and a separate one actually caused me to scratch up my husband's car. Since the first panic attack, I was placed on Celexa and then Ativant (like Xanax) was added after my 3rd one. Yesterday, I had two more panic attacks so the doctor is pulling me off the drug. There is something awfully strange about this pill. I had virtually ALL of the side effects mentioned in the PI which seems statistically odd, in addition to this more severe psychiatric side effect that resembles a heart attack. I strongly think Pfizer needs to continue testing this drug for its side effects using a population with various backgrounds and health conditions."And from another reader:
"I took chantix for two days. Severe depression, mood swings,and similer feelings also came from the wellbutrin I tried. Be forewarned, anylize your thoughts and moods daily while being on this drug. I did not use anything else and smoked as normal as instructed by the directions.I had severe anger also. I had to distance my self from my family until it passed out of my system."
Any other people who've taken this drug have experiences, good or bad, to share?
In what's got to be a gigantic brain shake for many in the psych research world, the New York Times is reporting today on two studies involving kids with ADHD. Both studies will confound experts in the field who've long claimed that ADHD kids were basically screwed for life and that they would develop poorly and be problems forever. Once again, psych researchers who claim mental illness is forever and that people are stuck with debilitating lifetime conditions have had cold water thrown on their party. Perhaps it's time they bought life jackets.
The first paper is from Developmental Psychology and in it researchers found that kids who are disruptive in kindergarten--when loads of kids get dubbed ADHD, etc.--performed about as well as their peers in later academic testing. The paper is here (link goes to .pdf).
From the Times:
"Kindergartners who interrupted the teacher, defied instructions and even picked fights were performing as well in reading and math as well-behaved children of the same abilities when they both reached fifth grade, the study found."
The paper quotes one source saying the journal article is “very controversial among developmental psychologists who have seen the paper.” Good.
I haven't had a chance to review the paper itself so I cannot speak to what role medications did or did not have with the 16,000 children studied.
In the second study, published in the Proceedings of the National Academy of Sciences researchers took up the question of brain development in ADHD kids. It's been asserted for years that kids with ADHD had abnormal brain development, would never catch up with their peers, and needed a butt load of meds to help them out. I cannot locate the PNAS paper yet.
What this study found was that kids with ADHD--and many of the kids in the study were on ADHD meds--had the same basic brain development patterns as other kids, except that the process was a bit slower.
From the Times:
"'The basic sequence of development in the brains of these kids with A.D.H.D. was intact, absolutely normal,' Dr. Shaw said. 'I think this is pretty strong evidence we’re talking about a delay, and not an abnormal brain.'"
Take that Joe Biederman! For parents of kids with ADHD and other problems, these studies have got to be good news.
I'll likely have more on these studies later. In the meantime, I want to note that the Times' Ben Carey has done an absolutely spectacular job of reporting on mental health issues--the best I have ever seen in the mainstream media.
John at Storied Mind has an excellent, gut-wrenching post on his war with depression and what it's done to his career:
"One of the hardest admissions I have had to make about the effect of depression was to say bluntly to myself, after years of denial, that my performance in my profession had steadily deteriorated under the impact of this illness. The truth had been obvious for some time to colleagues depending on me to be a consistently outstanding performer, but it only came home when facts kicked me in the teeth. The experience was a bit like what alcoholics describe as hitting rock bottom."
His post is remarkable for its candor and I wish the man much luck. I am a bit jealous, as bizarre as it might sound, that apparently his employer was willing to deal with his depression within the confines of the Americans with Disabilities Act, and gave him various job accommodations. He didn't like how that felt, and I can understand that. But try telling your employer you're diagnosed with bipolar disorder, and out the window goes the ADA and accommodations, regardless of the law.
I got chased out of job on that basis twice in the 1990s, and as most readers remember there is the famous case of the bipolar cop here in Seattle (who eventually won a settlement from her former employer) and as well as a Seattle Stabucks barista, whom the EEOC got an $85,000 award for. Well, maybe times have changed from the 1990s.
Maybe depression is easier for human resource departments to wrap their minds around, since there are no harum-scarum figures like Fuller Torrey telling lies about how people with depression act. Either way, with 30 million or so Americans with depression--and, yes, I do believe the number to be that high--maybe American employers have had to grapple with social reality.
(Storied Mind post via Beyond Blue.)
The FDA announced yesterday that it would undertake a study of data from 500,000 patients who took ADHD drugs between 1998 and 2005. About 5 million children and adults take drugs such as Adderall, Concerta, Strattera, Ritalin, clonidine and the like each year in the US. Total US sales are about $4 billion a year. There have been reports of heart problems connected with the use of these drugs for years, and that's what the agency is looking into.
One hopes they look really hard.
"While case reports have described the heart complications, 'it is unknown whether or not these events are causally related to treatment,' said Gerald Dal Pan, director of FDA's office of surveillance and epidemiology, in a statement posted on the FDA's Web site. 'The goal of this study is to develop better information on this question.'"
What else would they be related to, especially in youngsters?
Fortunately, the FDA did slap a black box warning on ADHD drugs in May 2006 due to the drugs' potential--and let me stress it: potential--to cause heart problems and, in some cases, produce psychosis in patients taking the drugs. So I find it difficult to believe the FDA wouldn't find some sort of causal relationship in this new study.
But, perhaps, it will be like the lengthy battles over SSRIs and suicides, where the FDA over the last few years has fundamentally tried to have it both ways--claiming that there is suicidality in SSRI use in persons less than 25 years old, but not enough suicidality to merit warning in patients 25 and older.
A CDC report earlier this year stated that 2,500 children went to ERs after taking ADHD drugs. One in 4 of the kids had heart problems, blood pressure problems or fainted. Some of these adverse events were related to overdoses of the drug--but then ADHD drugs are very tricky and very easy to overdose on. I was unable to quickly find this report on the CDC's website. I'll try to update this later.
We shall see where this study winds up.
Here's a link to today's BBC "Panorma" program on ADHD drugs--and how therapy works better over time--and the use of anti-psychotics in little boys with ADHD. It's not a permalink, so try and watch it soon.
A quick note to let you all know that I could lose my power for a time today due to a very strong windstorm just hitting Seattle. My part of town has done fairly well power-wise during these storms the last couple of years, so we'll see if that holds. If I lose power, comment approval, etc. will be shot to hell for a while. Just letting you know.
This evening British time, the BBC's "Panorama" program--which kicks ass the way "60 Minutes" did back in the day--is taking on ADHD treatments for kiddos. As usual, researchers will come off looking dumb. Says William Pelham of the University of Buffalo in a promo for the piece:
"'We had thought that children medicated longer would have better outcomes. That didn't happen to be the case.'"'The children had a substantial decrease in their rate of growth so they weren't growing as much as other kids both in terms of their height and in terms of their weight.'"
Stunted growth? No problem, because there were other benefits for kids taking these drugs, right?
"'And the second was that there were no beneficial effects--none.'"
Oops.
Turns out that after three years kids saw better results from therapy than from meds. Hm, that's not something they tell parents on that annoying adhdroadmap.com commercial. I wonder why.
ThisisLondon.co.uk notes that "Panorama" will also talk about how anti-psychotics such as Zyprexa are being given to thousands of kiddos with ADHD. As I noted on this site two weeks ago, about 50 percent of kids getting anti-psychotics in Florida's Medicaid program are getting them for ADHD, a condition for which anti-psychotics are not FDA-approved much less researched at all. Seventy-five percent of those meds are going to little boys. If that doesn't piss off every adult who reads this, then...I just don't know what to say.
I'll post a link to the streaming version of the program later today.
A week or so ago, an Australian newscaster, Charmaine Dragun, killed herself, jumping from a coastal cliff. She'd been suffering from major depression for years, and had apparently switched to a new anti-depressant two weeks before she took her own life. As many of us know too well, it's soon after beginning a new anti-depressant or soon after a dose change that things can be very dicey. Here's an interesting article talking about problems with SSRIs, although the article in the Sydney Morning Herald seems to spend much of its time bending over backwards to let doctors praise the drugs.
Here's how the writer put the thorny matter of SSRIs' place in Western culture:
"Days before she died, she had reportedly been feeling anxious and stressed, expressing concerns about how the medication was making her feel."There is no doubt that antidepressants have saved countless desperate lives, but there is increasing awareness that they can also cause some people to kill themselves."
I'm glad to see the newspaper even allowing this discussion to happen, but I'd like to know why writers and medical authorities are so quick to credit pills as "lifesaving" when we know they have very serious problems attached to them. There is just so much bogus romanticism attached to SSRIs. Think of it another way: When the press writes about an OxyContin overdose death--and there are hundreds of them each year in America, as far as I know--do they point out that, properly used, the drug saves peoples' lives who would otherwise be crippled by pain? Um, no they don't. So why are they so inclined to literally write advertising copy for pharma companies each time they examine the SSRI debate?
Anyway, this from the medical establishment in Oz:
"But Michael Dudley, chairman of Suicide Prevention Australia and a senior lecturer in psychiatry at the Univ