I'm preparing to go out of town for the weekend later this morning, so I'm going to hold off posting until Monday. It's also pretty much the second anniversary of the day I walked out of my old job and the realization is hitting me rather hard. I had the best job in my life and lost it because I had ethics and standards. Since then, I've watched as thousands and thousands of journalists have been pushed out of their jobs due to stone cold economics and the Internet--and that means there are no jobs for me or anyone--and that's hitting me over the head as well. Various media companies have announced about 4,000 layoffs and buyouts in the last week alone. And there's more to come.
I'm off to see my parents for the weekend and sit in the sun in Arizona. It's their 50th wedding anniversary. Comment approval will be sporadic most of the day.
Meanwhile, a new study is out asserting that a combination of Zoloft and CBT is good for youths with anxiety disorders. The New York Times has written about it here. Apparently, some people think it's an important study. I'll offer my two cents on Monday.
Have a nice weekend.
Paul Rubin, an economist at Emory University, had a very weird op-ed published in the Atlanta Journal Constitution the other day. In it, he decried attacks upon psych researchers and their conflicts of interest wherein the docs take money from pharma companies and NIH at the same time and then call their research unbiased and science-based.
It begins:
"Traditionally, the “war on drugs” was aimed at illegal substances. But Sen. Charles E. Grassley (R-Iowa) has reinvented this war as a war on pharmaceuticals. He is continuing his campaign to restrict the amount of information about drugs available to doctors and patients."
He's calling Grassley's efforts a war on drugs? Really? For the record, Rubin has a long career as lecturer, author, lawyer, economist and former Reagan Administration official. He's consulted for Pfizer and also recently authored a brief in the preemption Supreme Court case involving Wyeth. You don't need to guess whose side he took.
Anyway, his basic argument for why there is no problem with the relationship Nemeroff and many other psych researchers have worked out with Big Pharma while also taking NIH research money is:
"[T]here is no evidence at all that any of the alleged interactions between doctors and pharmaceutical companies has had any harmful effect on any patient."
It's not clear where Rubin gets his information--perhaps from out of his ass--but there is clear evidence of the harmful effects of such relationships. For example, 4-year-old Rebecca Riley died in 2006 in Massachusetts after being given various psych meds by her mother. Riley was diagnosed as having pediatric bipolar disorder. The controversial disorder was ginned up by researchers at Harvard who were taking money from pharma companies and NIH at the same time--and are also subjects of Grassley's campaign--and this drove the diagnosis of alleged bipolar disorder in children who were then given drugs absent research into their effects on children. Riley's psychiatrist trained under the Harvard group.
Yes, it's clear that allowing docs to be in bed with pharma and NIH at the same time clearly helped in the dissemination of information.
There are other examples of this sort of outcome in the land, but I'll leave it at that for now. Except to note that if Rubin thinks psychiatrists who have openly lied in their research about anti-depressant efficacy hasn't created a problem in America (30 million people on anti-depressants, many of them running into problems with said drugs, etc., etc.), then I want what Rubin is smoking. The connection between the wide use of psych meds in our culture (sponsored by Big Pharma) and people being harmed (Zyprexa, Paxil, you name it) is so well known that I won't even bother to repeat the details.
What sort of stuns me about Rubin's piece is that the AJC published it at all. Yes, I know op-ed pages are biased in favor of important-sounding academics, but it's so easy to poke holes in his argument and claims of evidence that you'd think even the people running the paper's op-ed page could do it and turn down Rubin's knee-jerk appeal to free market principles. But no.
Yesterday I noted that David Foster Wallace had been on several psych meds at the time of his suicide last month and that he had played by the rules of psychopharmacology and depression treatment for two decades and that that paradigm had failed him. I didn't blame the meds for his death, but I pointed out that they sure didn't help matters.
Now, the nice folks at Gawker.com--one of the biggest websites going--have looked over the same Rolling Stone article (now online) and autopsy report I did and have come to an even more aggressive conclusion than mine.
"Why is all this important — why obsess over the details of what exactly happened? It seems inescapable that Wallace's battle with Nardil, which he took for decades, was the principal cause of his death. In that fight, Wallace had every treatment available to him and still succumbed. Maybe it was going off Nardil in the first place that doomed him, and maybe staying on the drug wouldn't have changed anything, either. But whatever did occur, whatever medical and therapeutic treatment he received, could conceivably tell us how to save another depressed genius. This one we already lost." (Emphasis mine.)
It's interesting that one day I write about DFW's death and yet another tragic outcome for the psychopharm paradigm and get attacked by some readers for, in essence, being a Scientologist and the next day someone at Gawker essentially comes to the same conclusion.
I wonder if people will pound that site for daring to question the efficacy of depression treatment.
Yesterday's post on the death of David Foster Wallace got quite a bit of attention, some of it quite nasty. I even got some, um, interesting emails from readers who insisted that psych meds are always life saving and beneficial and that I was sowing false information by claiming a far more mixed track record for meds. It was a bit more than I had bargained for (some well-meaning sort is even advising me on "resources" for my site, convinced that many readers are out of their heads) and in the midst of it all I banned Herb of VNS fame from commenting on this site after he attacked me personally.
Much of the ire was generated by this graf:
"At the time of his death, Wallace was on Nardil (an MAOI anti-depressant), Klonopin and Restoril, both benzos. I point this out because so every so often you encounter someone--a doctor, a researcher, an advocate, a patient, etc.--who will tell you most intensely that psych meds are life saving. Well, no they aren't. By their astrology, Wallace should be alive, but he's not."
I stand by my statement, although I wish I had acknowledged a bit more directly that there are cases where meds do work as advertised, not enough but some. Why? Because even though that's something I point out from time to time, a lot of new readers came through yesterday and literally went off-meds on me. Someone wrote to ask me my relationship to Scientology (seriously).
So let's be clear about things: Psych meds and the standard paradigm for diagnosing and treating mental disorders don't work nearly as well as most people would expect. I know some advocates who like to claim an 80 to 90 percent success rate for meds, but I know of zero clinical data to prove that point. What's more realistic is to say that meds work about 30 to 50 percent of the time, depending on the disorder and the med. My own view is that that number is closer to 30 percent--and there is gobs of clinical evidence to back that assertion. STAR-D, STEP-BD, CATIE, CUTLASS and on and on.
What's more, I know advocates, researchers and so on like to claim that meds save lives, or prevent suicide. If that were true, then the suicide rate in this country would be much less than it is now, instead of the last two decades of very little change in that rate (depending on the year you look at). If it were true, there would be no black box labels warning of suicidality on anti-depressants and anti-seizure drugs. If it were true, we wouldn't be seeing numerous cases of people committing suicide who'd been on meds.
Even worse, there's evidence that the rate of misdiagnosis of bipolar disorder runs about 50 percent and the explosion of diagnoses of mental disorders in kids should give everyone pause.
Worse still, the amount of outright corruption in psychiatric research at universities such as Harvard, Brown, Emory, Texas and Stanford is beyond comprehension.
Reasonable people can disagree about the degree to which they are bothered by all of this, but I don't think they can argue with the basic facts that the psychopharmacological paradigm is deeply troubled and that the DSM is being turned into a joke--and that innocent people attempting to work out some problems in their lives are dragged into a very big ugly machine that consumes far too many lives and far too many years of peoples' lives.
Why writing about all of this leads some people to attack me is beyond my understanding. Perhaps I do push the envelope a bit hard around here journalistically, but when we get to the day that this country isn't spending $40 billion or so a year on meds, I'll chill out. When this country gets off its game of medicating little boys for being little boys, then I'll relax. When we stop killing people diagnosed with schizophrenia with antipsychotics, I'll shut up. When my colleagues in the media start doing a better job, I'll walk into the sunset and take a job in public relations.
Until then, no dice.
Besides, compared to Keith Olberman, Bill O'Reilly and Lou Dobbs I am a goddamned Zen Buddhist.
As much as I'd like to be writing today, my back is acting goofy once again after several days of improvement, so I am going to go tend to it. Enjoy the snow if you are Back East.
There's a new article out in Rolling Stone detailing the last days of author David Foster Wallace's life. Wallace, the author of "Infinite Jest," hanged himself in September after decades of struggling with depression. The article isn't online yet, but I did skim it at a magazine stand. What impressed me--beyond the overall sense of gloom and depression from a life lost--is that Wallace played by the rules of psychiatry and depression treatment to the Nth degree. He took anti-depressants and other psych meds for many years and he underwent ECT at least 12 times.
Sadly, none of this worked in the final analysis. His recently released autopsy report makes that clear. At the time of his death, Wallace was on Nardil (an MAOI anti-depressant), Klonopin and Restoril, both benzos. I point this out because so every so often you encounter someone--a doctor, a researcher, an advocate, a patient, etc.--who will tell you most intensely that psych meds are life saving. Well, no they aren't. By their astrology, Wallace should be alive, but he's not.
And, no, I am not arguing that the meds he was on killed him. But they clearly didn't help.
BTW, some of you will wonder at why his autopsy report is public and that's because in California such reports are public information. Other states release much less information.
Earlier today I noted that the Dallas Morning News had dug up some new gems surrounding Texas' controversial Children's Medication Algorithm Project, which was pretty much designed to dope up children younger and older for just about any behavioral abnormality, including news that CMAP (and TMAP) officials had sought and received funding from pharma companies after saying it was an ethical problem. Later this morning, an attentive reader in Texas sent me a scan of the article from the paper's print edition, which differs slightly from the online version.
In the "At A Glance" section (pdf here), the paper reports that Texas researchers and state mental health officials:
"Discussed the need to defeat a bill in the Legislature that would have banned the use of psychotropic drugs in foster children younger than 5.""Reduced information on child suicide risks in one of their published papers at the request of a prestigious medical journal. 'Please drastically prune this section' an editor at the Journal of the American Academy of Child and Adolescent Psychiatry wrote in an effort to shorten the report. 'Even the detailed discussion of risk factors for suicide is out of place in a paper reporting a medication algorithm.'"
"Accepted complaints and feedback on an adult psychiatric drug list from Eli Lilly and Janssen."
"Considered incentives to get children enrolled in drug plan trials, including offering gift certificates to Blockbuster and McDonald's. It's unclear whether the incentives were ever offered."
Gee, that would be one unhappy Happy Meal.
And the JAACAP asked them to limit suicidality information? I don't know what drugs or drugs docs and officials were discussing in the paper, but what do you want to bet we're talking Paxil Study 329 here which the JAACAP published and allowed to stand despite its false assertions about safety and efficacy?
The Dallas Morning News continues to unearth new gems in its continuing coverage of how messy the conflicts have gotten between pharma companies and psychiatric researchers. This time out the paper reports that researchers behind the controversial Children's Medication Algorithm Project actively sought and received funding directly from pharma companies after first deciding that seeking the money would be an ethical breach.
"By June 1999, researchers needed more grant money and had changed their minds. CMAP's director, M. Lynn Crismon, head of the University of Texas College of Pharmacy, wrote to at least 10 drug companies, asking for donations."'Although we have received grant funding in support of this effort,' he wrote, 'these amounts fall short of the funds required to complete this important outcomes project.'
"By late that year, CMAP budgets included pledges for $10,000 a year from Wyeth and Pfizer, an $80,000 one-time grant from Forest Laboratories, and $70,000 from Eli Lilly. While a few of the line items seem to limit the grant to CMAP's "patient and family education" program, others are listed as unrestricted CMAP "research gifts."
"When, in 2006, questions surfaced about drug company connections to the adult drug plan, however, CMAP researchers were again cautious about drug company money. And as recently as this spring, Dr. Crismon assured top state health officials there was no pharmaceutical link to CMAP, saying that any drug company money was used for a patient and family education study unrelated to CMAP.
"'No pharma funding has ever been received for CMAP to the best of my knowledge,' he wrote. The Eli Lilly and Forest money 'was not for CMAP.'
Eli Lilly officials, however, confirmed that the company donated $70,000 to the state for a CMAP education program."
What amuses me is that CMAP--the kid brother of TMAP--was supposed to be the very best, evidenced-based science that would guide clinicians in how to appropriately and consistently treat mental disorders and now TMAP and Johnson & Johnson are embroiled in a lawsuit brought by the State of Texas, and the guidelines have been so seriously compromised--and produced crappy results--that it's like these researchers threw away 10 years of their lives.
I guess they got paid well for their efforts.
An interesting bit of research was just published in Biological Psychology--the paper is not online yet--claiming that post-mortem analysis of the brain of 10 people with severe depression who committed suicide and compared them with the brains of 10 people who died of other causes. According to the BBC:
"They found that the DNA in the suicide group was being chemically modified by a process normally involved in regulating cell development, called methylation."It is methylation which shuts down the unwanted genes in a cell - so the necessary genes are expressed to make a cell a skin cell rather than, for example, a heart cell. The rate of methylation in the suicide brains was almost 10 times that of the other group, and the gene that was being shut down was a chemical message receptor that plays a major role in regulating behaviour.
"In the paper, the researchers suggest this reprogramming could contribute to the 'protracted and recurrent nature of major depressive disorder.'
"Previous research has suggested that changes to the methylation process can be caused by a combination of genetic and environmental factors called epigenetics."
I don't particularly understand the significance of this finding, but it does strike me as interesting.
Reports out of New York claim that former Detroit Pistons star and former Knicks coach Isiah Thomas OD'd on 10 sleeping pills last night--Lunesta to be specific--and his wife called police. While I don't have the best opinion of Thomas after last year's very odd sexual harassment suit--which he lost--I do wish him well.
And wonder why the hell someone in his position would OD on sleeping pills.
Ok, so that's the New York Times' headline and the study involved 679 internists and rheumatologists and it was based on a survey of such docs, randomly chosen. But that's it for the caveats: studies similar to the new one in the BMJ, which has apparently dumped its more formal British Medical Journal name, in other countries have found that roughly half of doctors prescribe placebos from time to time, and the new study claims that this is true of the US as well.
Someone call me a plaintiff's attorney because, if this practice is true (I don't have any reason to doubt the study but I've not encountered placebo prescribing myself) then it likely violates a lot of ethical and, perhaps, legal precepts. Here's what the study itself found:
"679 physicians (57%) responded to the survey. About half of the surveyed internists and rheumatologists reported prescribing placebo treatments on a regular basis (46-58%, depending on how the question was phrased). Most physicians (399, 62%) believed the practice to be ethically permissible. Few reported using saline (18, 3%) or sugar pills (12, 2%) as placebo treatments, while large proportions reported using over the counter analgesics (267, 41%) and vitamins (243, 38%) as placebo treatments within the past year. A small but notable proportion of physicians reported using antibiotics (86, 13%) and sedatives (86, 13%) as placebo treatments during the same period. Furthermore, physicians who use placebo treatments most commonly describe them to patients as a potentially beneficial medicine or treatment not typically used for their condition (241, 68%); only rarely do they explicitly describe them as placebos (18, 5%)."
While I've not seen the full study and cannot glean what conditions docs were prescribing placebos--or more precisely rather harmless meds--for, I'll bet you that a lot of this Rxing was for pain and discomfort (or something a doc might consider psychosomatic) as opposed to, say, depression and heart disease. I doubt that too many docs encountering those latter conditions would prescribe an aspirin. But then why would they prescribe an anti-biotic when the patient is complaining of pain? Either way, the question is fascinating.
According to the Times, some docs see ethical concerns in all of this:
"'This is the doctor-patient relationship, and our expectations about being truthful about what’s going on and about getting informed consent should give us pause about deception,' said Dr. [Franklin] Miller, director of the research ethics program in the department of bioethics at the National Institutes of Health [and study co-author]."
And:
"Dr. Howard Brody, director of the Institute for the Medical Humanities at the University of Texas Medical Branch, in Galveston, said the popularity of alternative medical treatments had led many doctors to embrace placebos as a potentially useful tool. But, Dr. Brody said, doctors should resist using placebos, because they reinforce the deleterious notion that 'when something is the matter with you, you will not get better unless you swallow pills.'"
But pills are always good, right? Is that what all true Americans believe?
Anyway, I am sure this study is going to get a ton of media attention--despite major media's fascination with Gov. Sarah Palin's wardrobe--so I'm sure we haven't heard the last of it.
I've written previously about how the placebo effect in depression treatment is much larger than most anyone thought before.
Sanofi-aventis today announced that it was temporarily pulling Accomplia, its anti-obesity drug, from the market in Europe due to reports of side effects problems with the drug, including suicidality and depression. The drug has only been on the market in Europe a short time and is not approved for sale in the US.
From the BBC:
"There have always been concerns over the risks of depression and suicide associated with the drug, and in July last year, the EMEA warned it may be unsafe for patients also taking anti-depressants."Doctors were also told not to give it to patients with a history of major depression, and to be alert for new symptoms of depression in patients taking the drug. But data from more recent studies, and from Sanofi-Aventis itself, has shown there is around double the risk of psychiatric disorders in obese or overweight patients taking rimonabant compared to those taking dummy pills.
"And between June and August 2008, there were five suicides among patients taking part in a trial who were on the drug, compared with one among those taking the dummy version."
Five suicides in a clinical trial is a lot, even more so because the drug wasn't being trialed for a psychiatric condition. Makes you wonder what the drug's mechanism is that's uncorking all of this.
Psych Central yesterday announced its top ten bipolar blogs. Last year, this site was #2. This year it's #1, which I appreciate more than I can get into.
"There simply could not be a top bipolar blogs list without Philip Dawdy. He’s an excellent journalist whose blog has become synonymous with unrestrained investigative writing on bipolar disorder, mental health treatments and the pharma industry. He does not hesitate to call out BS when he finds it, and he digs for it harder than any other popular writer. Furious Seasons is an invaluable service to the mental health community."
There's a list of the other fine blogs that were also recognized at the above link. Congrats to all.
Chantix, Pfizer's stop smoking drug, topped the list of drugs causing problems that led to adverse events reports being filed with the FDA in the first quarter of 2008. The stop smoking drug, which sure unglues people like a bad old SSRI, racked up a total of 1,001 adverse events reports and reports of another 50 deaths linked to the use of the drug, according to the Institute for Safe Medication Practices. That's simply astonishing for a drug that's barely two years old--and which I was one of the first in the media to identify as a problem drug last year.
You can read ISMP's report here.
Other problem drugs included heparin and OxyContin.
I'd planned to write a bunch more yesterday than I did, but my back is still a bit dodgy, so I am opting for doing as little sitting in front of my computer as possible until things clear up more. Which I hope is very soon.
Yesterday, Lilly announced that it's on the verge of settling federal claims over accusations involving the company's handling of Zyprexa:
"Eli Lilly & Co. said it is having ``advanced discussions'' to settle investigations by U.S. and state authorities over marketing the antipsychotic Zyprexa and will take a $1.42 billion charge in the third quarter."
The settlement, which federal authorities wouldn't comment upon, would be a record. It would also apparently not affect other claims by 32 states and the District of Columbia, nor other states lawsuits against Lilly.
Lilly has already settled about $1.3 billion in class action cases involving Zyprexa.
My back is much better although it's not back to normal, but I should be able to begin posting again today.
My back is still out of commission and hopefully improves enough to where I can write something for tomorrow. But, for now, taking care of myself is more important than writing.
Via the New York Times' Well blog comes news of a newish study--and a small study, I'll caution--asserting that kids who took a brief walk in a park were able to concentrate better than kids who tok a walk in the city:
"A small study conducted at the University of Illinois at Urbana-Champaign looked at how the environment influenced a child’s concentration skills. The researchers evaluated 17 children with attention deficit hyperactivity disorder, who all took part in three 20-minute walks in a park, a residential neighborhood and a downtown area."After each walk, the children were given a standard test called Digit Span Backwards, in which a series of numbers are said aloud and the child recites them backwards. The test is a useful measure of attention and concentration because practice doesn’t improve the score. The order of the walks varied for all the children, and the tester wasn’t aware of which walk the child had just taken.
"The study, published in the August issue of The Journal of Attention Disorders, found that children were able to focus better after the 'green' walks compared to walks in other settings.
"Although the study is small, the data support several earlier studies suggesting that natural settings influence psychological health. In 2004, a survey of parents of 450 children found that 'green' outdoor activities reduced A.D.H.D. symptoms more than activities in other settings."
You don't want to read too much into a study involving 17 kids, but this sort of finding certainly tracks with the whole nature deficit disorder theory of what's up with some kids these days.
This short article from the UK speaks for itself:
"A postal driver who was prescribed an anti-depressant 'wonder drug killed himself four weeks later, an inquest heard. Hampstead-born Ian Fox, 65, died in July after throwing himself in front of a train at Finchley Road Tube station."He had been prescribed the anti-depressant Citalopram [Celexa] for just one month before taking his life and he had expressed a wish to come off it, complaining of confusion and anxiety.
"At his inquest on Thursday, Mr Fox’s wife, Maria Fox, blamed her husband’s sudden death on the drug, and a coroner ruled the 'adverse effects' of Citalopram had played a part.
"'I felt Citalopram was to blame for my husband’s death,' Mrs Fox told St Pancras Coroner’s Court.
"According to medical research, confusion and anxiety are known side effects in around one in every 100 patients, although it has more generally known for its wonder drug qualities in successful treatments."Mrs Fox, from Edgware, said her husband’s action was completely out of character. She described how until he began taking Citalopram he had only been suffering from mild depression, brought on by retirement from his Royal Mail job and a foot injury.
"Coroner Dr Andrew Reid said he accepted that Mr Fox had jumped in front of the train, adding: 'I’m satisfied he did so while the balance of his mind was disturbed while suffering the adverse effects of Citalopram.'"
Confusion and anxiety are precisely the kinds of side effects of SSRIs that myself and a bunch of other people have been raising a ruckus about for years--and it just staggers me that there are so many doctors who deny that it's even possible and who don't warn their patients about this sort of possibility in advance. Yes, I know there are label warnings in the UK (and the US), but doctors have got to reinforce them and get their patients the hell off the drug the minute a problem crops up. It's one way of avoiding tragedies.
I well know that some people who take SSRIs don't experience such problems, but such incidents as the above go on far too often for anyone to legitimately claim that there are not serious problems with these drugs.
Or at least that's what the BBC claims, relying upon various polls and surveys for its evidence. I'm generally leery of trend stories like these which the media--especially the British media--tends to exaggerate. But it's clear that something is up both in the US and the UK.
Two decades ago, when I was an undergrad, the use of speed as a study aid was very uncommon--the dope of choice was caffeine pills--but these days the use of Adderall and Ritalin as brain enhancers has gotten to the point where Adderall has been called "college crack." Needless to say, much of this use is of drugs acquired on the street or repurposed from their intended use. Provigil is another well-used/abused performance enhancer and is reportedly used by some in academia and the business world.
Meanwhile, over in the UK:
"Professor Sahakian said given the increasing use of these drugs outside of their intended clinical setting, safety trials were urgently needed."'We do not really have long-term efficacy and safety data in healthy people. These are studies that really need to be done. The use of these cognitive enhancing drugs is spreading to younger and younger people. That's a concern.'
"'Methylphenidate does have substantial abusive potential so we have to be worried about substance abuse problems and the use of these drugs in the developing brain in children.'
"John Harris, professor of bioethics at the University of Manchester said people should be allowed to make their own minds up about these drugs. He said: 'If these cognitive enhancing drugs make our lives better and make us better able to concentrate and better able to perform, this would surely be a good thing.'"
I can see both side of this argument. Certainly, there are all manner of reasons to be concerned about long-term ADHD drug use--possible future drug addiction and possible cardiac problems being but two concerns. I know much less about Provigil and I don't think researchers know much about its long-term use either.
That said, if someone wants to stick themselves full of Adderall in order to get more work done, then be my guest. Just know what you are getting into.
Personally, I wouldn't want to take drugs, prescribed or not, that removed me from my authentic self just to do well at work or school. Then again, I've never had to (aside from Rx'd bipolar meds, but that's a different context than "performance enhancement" per se and was actually more like "performance reduction" for me), so what do I know? What I do know is that my own experience and beliefs don't give me the right to limit the choices and freedoms of other consenting adults.
Last night's debate was fairly boring--at least to me--but I watched out of habit. While I'm sure there was plenty for partisans on both sides to seize upon, I was interested in one of the rare moments of agreement between Sen. McCain and Sen. Obama came in response to a question about GOP VP candidate Gov. Sarah Palin:
"McCain [in part]: She understands that autism is on the rise, that we've got to find out what's causing it, and we've got to reach out to these families, and help them, and give them the help they need as they raise these very special needs children. She understands that better than almost any American that I know. I'm proud of her."And she has ignited our party and people all over America that have never been involved in the political process. And I can't tell how proud I am of her and her family. Her husband's a pretty tough guy, by the way, too."
"Schieffer: Do you think she's qualified to be president?"
"Obama: You know, I think it's -- that's going to be up to the American people. I think that, obviously, she's a capable politician who has, I think, excited the -- a base in the Republican Party.
"And I think it's very commendable the work she's done on behalf of special needs. I agree with that, John."I do want to just point out that autism, for example, or other special needs will require some additional funding, if we're going to get serious in terms of research."
I cannot think of anytime that a mental disorder--much less a disability--has popped up in a Presidential debate and I am noting it for that reason alone.
I don't often write about straight neuro matters here, but this new report out of the University of Washington is fascinating. Researchers, according to this report in Nature, trained monkeys to work around a paralyzed wrist by using a single brain cell. I don't understand the ins and outs of this kind of thing very well, but it's all called functional electrical stimulation, or FES, and apparently the UW research represents something of a breakthrough.
"Scientists had put a probe in the animals' brains that monitored how often a single brain cell was firing electrical signals. Once the wrists were paralyzed, that firing rate was converted into an electrical stimulation that went to the wrist muscles."Different firing rates made the hand press downward or upward, or relax. The monkeys quickly learned to use the brain cells to control their wrist muscles and continue playing the computer game."
There are obvious implications for research on people with paralysis.
Of course, I always wonder what implications such research might have in the realms of, say, depression and schizophrenia because neuro research keeps coming back with the basic finding that the brain is far more plastic (ie, malleable and fixable) than was thought even a decade ago. So could you retrain the brain, via some stimulus (electrical or otherwise), to think and feel differently? I don't really know.
Of course, some readers will seize upon the example of ECT and point to its well-known problems, as they should. But what I am talking about here is quite different, since the UW research is focused on making a single brain cell do its thing as opposed to ECT which is a jolt to an entire brain region.
My back problem flared up again yesterday, so I was off the computer last night, as sitting in a chair is painful. I'll catch up with posts later this morning.
There was a fascinating short profile of Charles Nemeroff, the embattled Emory University psychiatrist in the Atlanta Journal Constitution over the weekend. Nemeroff is in all kinds of hot water due to his allegedly nasty habit of taking millions from Big Pharma for pimping their anti-depressants, reporting much less to his university, possibly running afoul of NIH rules and so on. Minor stuff like that which has caught the notice of Sen. Charles Grassley (R-Iowa).
Nemeroff declined to comment for the AJC story, but he sure had his defenders.
"Tom Johnson, retired CEO of Atlanta’s CNN, said Nemeroff was able to treat his severe, chronic depression after other physicians failed. He called Nemeroff 'a brilliant physician.'"'I’m doubtful I’d be alive today without the care I received from Charlie,' Johnson said last week."
And:
"Dr. Jeffrey A. Lieberman, chairman of the department of psychiatry at Columbia University, hails Nemeroff’s many contributions."'Overall, Dr. Nemeroff has been a seminal figure and leader in the field of academic psychiatry, both through his research as well as his other scholarly activities,' Lieberman said in an e-mail to a reporter."
Out come the critics:
"Dr. Daniel Carlat, a psychiatrist in Newburyport, Mass., gave Nemeroff the nickname 'Dr. Bling-Bling' on a blog he produces. Carlat, in an interview, said Nemeroff has come to personify the 'culture of greed that I believe permeates psychiatry and the rest of medicine.'"
Carlat is right, and notes on his own site a call for psychiatry to clean up its act. Sigh. The field's problems are not limited to conflicts of interest.
Bernard Carroll, a co-author the Health Care Renewal blog, is also quoted in the article:
"Dr. Bernard Carroll, now with the Pacific Behavioral Research Foundation in Carmel, Calif., was Nemeroff’s department chairman at Duke for six years. Carroll, a longtime critic, called Nemeroff 'a shill' for drug companies and said some people regard him as an 'arrogant academic bully.'"When Emory’s then-dean of the School of Medicine was considering hiring Nemeroff as psychiatry chairman, Carroll said, 'I warned him, "You’re taking a big risk."'"
It's interesting to me that the paper didn't mention Nemeroff's academic bullying of British psychiatrist David Healy, whom Nemeroff said some chilling things to a day after Healy had delivered a lecture in Canada and briefly pointed out suicidality connected with SSRI use.
The recent revelation around Dr. Bling Bling have resulted in editorials in the New York Times and the AJC over the weekend.
Roy Poses at Health Care Renewal has even more.
Earlier this month a young boy named Semaj Booker beat a burglary rap after a judge ruled that the boy couldn't tell the difference between right and wrong. Semaj is 11 years old and apparently suffered a loss of contact with reality due to Adderall.
"A number of people have testified in the hearing, including, Dr. Michael Comte, on whom the defense called as an expert."Comte, based on his evaluation of the defendant, told the court Semaj was 'unable to form the requisite mental capacity to "intend" to commit a crime,' according to court documents. Comte said Semaj did cause damage to the property, but did so without the intent to commit a crime.
"The psychologist argued Semaj was in a disassociative state as a result of insomnia and/or reaction to his ADHD medication, Adderall, which could cause amphetamine toxicity as a side effect. The mere fact that Semaj was awake at 4 a.m. on the morning of July 5 supports this, Comte said."
No kidding. One of the oddest kids and meds stories I've heard in ages.
I know a few of you will wonder what the hell I am doing printing the boy's name. The reality is that Semaj is well-known, by name: two years ago, aged 9, he walked out of his home on his own, caught a bus to Sea-Tac International, got past TSA security without a boarding pass or ticket (nice security), and was only nabbed as he tried to board a flight. The story was all over the news locally and nationally, as was Semaj again a few months later when he pulled the same trick again. His mom even went on "Inside Edition" to discuss her son (one wonders why).
It's not clear if he was taking Adderall or some other ADHD med during his attempted fly-boy days. Of course, there may be more going on here than meds-problems:
"Comte also listed a number of adverse childhood traumas that may attribute to Semaj's cognition and impulse control, including fetal alcohol exposure in utero, predisposition to acute mental illness and repeated physical abuse and neglect. Court documents state Semaj was hospitalized at least once as a result of corporal punishment inflicted by his mother."
Why is he still living with his mother? It's one thing to spank a kid, it's quite another to knock them into a hospital. Poor kid is getting it from all sides.
The FDA last week approved the NeuroStar Transcranial Magnetic Stimulation therapy system for the treatment of major depression. This is a new therapeutic modality and it is the first TMS device approved by the FDA for depression treatment in patients who'd already seen no improvement after trialing four different anti-depressants. I'm generally a fan of non-medication approaches, but this is new enough where I simply don't know what to make of it. Time will tell I suppose.
Thoughts?
Today is a holiday of sorts--not so much in this part of the country unless you work for the government or a bank--so I'm going to observe the holiday. I might throw up a post or two later.
BTW, thanks for the many kinds thoughts regarding my journalistic Mendoza Line. One commenter noted that this blog is likely getting in the way of my employment prospects, even within the allegedly open-minded media industry. I think this person is right. And that saddens me.
That's right folks. The FDA just approved a new injection site for Risperdal CONSTA--in the biceps instead of the previously-approved gluteus.
There's progress.
And Seroquel XL--the newish extended release version--was just approved by the FDA for bipolar depression and acute mania. I wonder if a special marketing campaign will erupt.
Still waiting to hear if old Susie Q has been approved for one of three depression indications or anxiety. I'd expect we'll know soon.
A large number of you have passed along Judith Warner's latest "Domestic Disturbances" column from today's Times. Thanks.
In it, Warner, who is generally a pharma defender and author of a forthcoming book on children's mental health (which I simply cannot wait to see), carves up Emory University's Charles Nemeroff. You know the guy: big depression researcher in the news in the last week for taking millions from Big Pharma for marketing their ineffective drugs and possibly running afoul of federal research regulations, since he's also been taking NIH money at the same time.
Judy sees the Nemeroff affair as:
"....yet another iteration of the ever-unfolding saga of greed and how the deregulation of absolutely everything has brought our country to this painful season of reckoning. Because Nemeroff’s story – which is hardly unique – belongs uniquely to this time in our nation’s history."It is a product of legislative and cultural changes that have altered the practice of medicine, the work of research universities and the relationship between those universities and industry. And it is marked, like so much of what’s gone off the rails in our era, by the failure of our government to step in to protect citizens.
"Nemeroff didn’t bring down any banks, didn’t freeze the American credit markets, hasn’t plunged the world economy into recession. But his extensive, excessive and untransparent ties to the pharmaceutical industry are all too common, unfortunately, among his cohort of “thought leaders” in psychiatry and other medical specialties. And these relationships have led to a dangerous crisis of confidence in the basic integrity and validity of America’s medical research."
Wow, welcome to the party, Judy, and thanks for restating what people like me, CL Psych, Health Care Renewal and others have been saying for years about greed, bogus psych research and lazy regulators--not to mention our incredibly lazy culture that refuses to peek behind the curtain and continues to take these yo-yos' advice and drugs in record amounts. I know it's a big deal that she writes for the Times and whatnot and I'm sure there are readers who will bump into her column and think she's a rock star for chipping up Nemeroff. But old Charlie is an easy target at this point, a punching bag that's losing its stuffing, Exhibit A for rotten research the way Jayson Blair (of the Times!) was once Exhibit A for rotten journalism. And the deep irony is that earlier this year Warner was actively defending some of psychiatry's charlatans and accusing their critics--such as myself--of engaging in "narrative" (which is to say fiction).
Now, Warner senses that some of what we've been saying is right. How convenient for her to put her finger in the air, feel a change in wind direction and start opinionating differently than before. She's doing so because Nemeroff was outed on A-1 of the paper last week as having major problems, but you have to wonder why the fuck someone like Warner had to wait for this news to appear in the paper before she jumped all over it. The news on Nemeroff and his conflicts and his dubious "research" has been out there for some time. Of course, she'll get the money, the credit, the high-fives at DC cocktail parties and the air kisses when she drops her kids off for soccer practice, or wherever it is smart Beltway moms drop off the kiddos these days. But, in reality, Warner has done little but trade on the work and critiques of others, now that the times are a-changing and the Nemeroff saga fits a broader cultural critique of Wall Street meltdowns and whiny preppies looking for bailouts of their banks.
Permit me some whining of my own: in the last three months I've pitched several major magazines on mental health stories and in each case I've been shot down. I can't put my finger on the why of it--except maybe I do suck, except maybe I'm not part of the East Coast writer mafia, etc.--but it's getting to the point where I'm beginning to ask myself who I've got to have sex with in order to get published these days. Twelve years ago, back when I was freelancing by choice, my article pitch success average was pretty close to 1.000 and I didn't have to wonder about dropping my pants. Nowadays, I'm under the Mendoza Line of .200 and that just isn't something that I can handle much longer.
Even worse: in the last three months, I've applied for and been seriously interviewed for a couple of the few quality job openings in journalism. In each case, the job has gone to someone else. The most recent no-thanks was probably the most heartbreaking: an editor/newspaper owner I know was looking for a managing editor (ie, number two) and I made the cut to the final five candidates. It was a good fit, but that's as far as I got.
Even worser: I recently had to break off writing for a magazine out this way--one of those big urban glossies--because said magazine was unreliable in its payments, despite being fat with ads, and wasn't about to change its ways. Another biggish mag out this way keeps shooting down my pitches because my stories don't lend themselves to nice glossy photos. Sorry, I'm a reporter, not an art director.
This bullshit has been going for two years for me, ever since I resigned from Seattle Weekly after the paper was taken over by a company I didn't care for. It's gotten to the point where I am feeling so snake-bit that I understand what major leaguers feel like during a batting slump or what All-Star pitchers feel like when they are getting shelled or perhaps what stock brokers feel like during a financial meltdown. Of course, they get paid no matter what. I only get paid when I hit and lately there's been a lot of Ks on my scorecard. Too many.
Things have reached the point where bitterness alternates with despair and where I am actively thinking--once again--of walking on journalism altogether. Aside from doing this website (which continues to grow each month), there's simply nothing for me out there anymore and sometimes you just have to know in life when it's time to move on to whatever it is that's next.
I hope to God I find it soon. That's because my latest article pitch was shot down this morning by one of the biggest, most prestigious mags in the land and I feel ever so fine about that.
But I bet you if Judith Warner took the same pitch and ran it by the same mag, she'd get a "Yes" and more air kisses than she could handle.
There's a reason for the Harvard bit in the headline: the Harvard ADHD/Bipolar Child--that would be child psychiatrists Tim Wilens and Joe Biederman, both objects of a Senate investigation into not properly disclosing their Big Pharma funding--are out with a new bit of covering-their-asses research. Most of you likely know that some studies have shown that kids on ADHD drugs have an increased risk of drug abuse and that just hasn't sat well with some forces in child psychiatry (mostly the true believers at Mass. General) who continue to ask the question: "Do ADHD meds lead to drug abuse in kids with ADHD?"
Certainly, the street would answer "Yes." Scratch a teen with ADHD and you'll find a smoker, a joker and a midnight toker.
Recently, Biederman had a paper out in the American Journal of Psychiatry, claiming that 10 years of stimulant therapy didn't up the risk for substance use disorder in male adults with ADHD. Now, his colleague Wilens has a study--114 teen girls--out in the Archives of Pediatrics & Adolescent Medicine wherein he and co-author Biederman found:
"There were no differences in SUD risk factors between naturalistically treated and untreated groups other than family history of ADHD. We found no increased risks for cigarette smoking or SUDs associated with stimulant therapy. We found significant protective effects of stimulant treatment on the development of any SUD (hazard ratio [HR], 0.27; 95% confidence interval [CI], 0.13-0.60; {chi}2113 = 10.57, P = .001) and cigarette smoking (HR, 0.28; 95% CI, 0.14-0.60; {chi}2111 = 10.05, P = .001) that were maintained when controlling for conduct disorder. We found no effects of time to onset or duration of stimulant therapy on subsequent SUDs or cigarette smoking in subjects with ADHD."Conclusion: Stimulant therapy does not increase but rather reduces the risk for cigarette smoking and SUDs in adolescents with ADHD."
I've not seen the full paper, so I cannot speak to what substance use was found, but I've got my guesses. Literally every single teen or 20-something I've run into over the last decade who takes stimulants smokes cigarettes, drinks more than the docs would likely approve of, and smokes weed, too. And of course the 20-somethings had been on the ADHD meds for years. As for the "protective effects" claim, whenever a psychiatrist uses that term, I've learned it's best to run for the hills.
Wilens told Reuters:
"Wilens said any finding that a medication reduces the odds of smoking is important. If you smoke and have ADHD, over half of those kids ultimately go on to have a substance abuse problem,' he said in a telephone interview."
Yes, cigarettes are gateway drugs. What's interesting about the study is that cigarette smoking has gone so much over the last 10 years or so that I'm not surprised by his finding on smoking at all. It's much harder for teens to lay hands on cigarettes than in, say, 1995 and the indoctrination--oops, I mean public health education--of teens on smoking is far more aggressive than it was in earlier research environment on the stimulant-smoking question.
All the same, I'm sure their findings apply to some people and not to others. But it sure is fun to watch how hard these guys will fight to protect their medicate the rowdy, inattentive kids paradigm. So hard that you wonder if they had more than an academic interest in the question they are asking. The current study was funded by Eli Lilly, makers of Strattera, and NIMH.
Didn't Sen. Charles Grassley find that the Harvard crew was pulling down millions from Big Pharma? Oh, yes.
"Biederman: $1.6 million from 2000 to 2007"Wilens: $1.6 million from 2000 to 2007"
At the same time, these researchers were not fully disclosing these Big Pharma payoffs--oh wait, that's research funding to do objective science--which makes life really tricky for researchers who are also getting federal research funding concurrently.
That's some serious coin and if ADHD drugs were deeply-connected to drug abuse, you can bet the whole paradigm would take a hit and so would Wilens and Biederman's objective science.
And that almost makes me want to send the pair a box of Cubans. Except I'm sure they can afford to buy their own and have them shipped in from Switzerland.
I'm a bit late with this, but last week the animal rights/veganism for all group PETA began floating its claim of a link between the consumption of milk and autism. The group even put up a billboard making the same claim in New Jersey. But, interestingly, according to ABC News, the research cited by PETA didn't even make the claim that autism is caused by milk consumption:
"The animal rights group cites two studies by researchers at the University of Rome as reason for the purported "link," even though the studies themselves do not prove any connection between milk and autism."Dr. Susan McGrew, associate professor of pediatrics at Vanderbilt University, said the billboard looks more like a scare tactic rather than an evidence-based statement.
"'I'm concerned more about the people who don't have autism,' McGrew said. 'They will be scared that they'll get autism if they drink milk.'"
Ah, I simply love PETA, which has been trying to use scare/gross you out tactics to get Americans to walk away from meat and dairy consumption since the 1980s. It's clearly had a big impact. The group is about as legit as an ACORN voter registration drive.
Whatever anyone makes of PETA, the group discredits itself by playing games with mental disorders this way. I mean what's next? "Milk causes schizophrenia."
This is truly annoying: USA Today reports that a study of health insurance data shows that kids and teens aged 6 to 17 get psychotherapy plus an anti-depressant about 40 percent of the time and get anti-depressants alone about 60 percent of the time. This, even though therapy plus anti-depressants is supposed to be the ideal protocol for treating depression (I have my own doubts about how ideal anti-depressants are, but I'll set them aside for the moment). So, clearly, America's kids and teens are getting less than ideal depression treatment.
I wonder what advocates of screening kids for depression make of this state of affairs. Obviously, there are all kinds of insurance coverage and financial reasons at work here, but if I were a parent and a doctor really, really wanted my kid on an anti-depressant then I'd be pushing really, really hard for my kid to have psychotherapy. But that's me.
In reality, depression is so tricky to treat and given that these are youngsters who are likely experiencing something that scares them by its very novelty, it would sure make sense to ramp up the use of psychotherapy--if only to help them gain some perspectives on themselves. You don't get that from Prozac and Paxil.
I've written before about how meds have driven psychotherapy out of psychiatry over the last 20 years or so.
A new British study has reportedly found that St. John's Wort is as good as Prozac at treating depression:
"'The herbal remedy St John’s wort can be as good at lifting depression as drugs like Prozac,' the Daily Express reported. It said that scientists had pooled data from 29 studies that compared the effect of the plant Hypericum perforatum to placebos and anti-depressants in treating people with depression. The Daily Mail said this was the most thorough study of the plant yet, and found it not only to be just as effective as Prozac, but to also have fewer side effects. However, cautions are made that some St John’s wort products are more effective than others."
I've not been able to locate the study yet, so I'll try to update this once I've seen the study.
I know that the effectiveness of St. John's Wort has long been controversial and that it's generally been found to be somewhat useful for mild depression but it's otherwise not a very robust treatment. That said, millions in Germany, where St. John's Wort is especially popular, take the treatment and find it to be effective. Maybe they know something we don't.
A 1998 study, led by one of the researchers of the new study, found more mixed results, but generally concluded that St. John's Wort was about as effective as anti-depressants in treating mild to moderate depression.
Every so often a reader passes on something that utterly surprises me and this is one of those times. According to the American Association for Health Freedom, researchers are seeing promising results using hyperbaric oxygen therapy--yes, those big chambers sometimes used for treating burns, non-healing wounds and scuba divers--as a treatment for military vets who've suffered traumatic brain injuries and PTSD suffered as a result of concussive blasts in combat. Given how rotten the results are from using standard psych meds for treating PTSD, this sure does sound interesting.
"This year Dr. Harch [an LSU researcher] applied HBOT 1.5 to five combat veterans of the current war who have traumatic brain injury and post traumatic stress disorder (PTSD) from concussive blasts. So far, all of the veterans treated have had significant recovery. Eighty percent no longer have PTSD and all are improved."Recently, Dr. Harch testified in front of the Surgeon General of the Navy and the Deputy Commandant of the Marine Corps. He told the stories of the five combat veterans he treated with HBOT 1.5; three of those veterans were in the room.
"One of them, a judge who served as a general in the Army Reserves, endured a year of treatment failures at Walter Reed. He is now back on the bench, fully recovered in 120 days, after 80 HBOT 1.5 treatments. The Health Freedom Foundation, sponsored a Marine machine gunner who experienced seven concussive events from roadside bombs during two tours in Iraq. Now, after HBOT treatments, his migraine headaches have disappeared, his sleep is restored, his PTSD is gone. He is now actively employed. He has his life back, as do other veterans who have undergone HBOT treatment."
Harch is the principal investigator on a new study of HBO in traumatic brain injury cases. I have no idea of how effective this treatment is or how it might pan out over time.
All of that said, a 2003 review of using HBO in brain injuries and strokes concluded that the use of the therapy was not supported.
It'll be interesting to see what Harch's research turns up.
My back is still out, so briefly I want to make you aware of an article in today's New York Times about how Pfizer allegedly cooked the books on neurontin, an anti-seizure drug the company was all hot to have used for bipolar disorder, headaches and so on.
"The drug maker Pfizer earlier this decade manipulated the publication of scientific studies to bolster the use of its epilepsy drug Neurontin for other disorders, while suppressing research that did not support those uses, according to experts who reviewed thousands of company documents for plaintiffs in a lawsuit against the company."Pfizer’s tactics included delaying the publication of studies that had found no evidence the drug worked for some other disorders, “spinning” negative data to place it in a more positive light, and bundling negative findings with positive studies to neutralize the results, according to written reports by the experts, who analyzed the documents at the request of the plaintiffs’ lawyers."
Pfizer did most of this in the early years of this decade and, separately, settled off-label marketing claims with the feds for $430 million in 2004.
A brief note to let you know that I may not post anything other than the Zyprexa states suit update today. My chronic back problem has reared its wicked head and I'm going to have to be offline much of the day I fear, as sitting in front of a computer simply makes things worse. It's classic sciatica or periformis crap for those of you who know about such things. And really, I hope you don't know about such things. Not fun.
Then again, it could all clear up in a few hours, but something tells me it won't.
I spoke yesterday with representatives from the Illinois and Oregon AG's offices, trying to clarify a few matters about yesterday's $62 million settlement with Lilly over off-label marketing of Zyprexa. The settlement covers 32 states plus the District of Columbia. You can read the settlement agreement for the State of Oregon here.
The settlement does not cover any claims by the states that might arise from injuries caused by Zyprexa--diabetes being the prime example--and allegations that Lilly lied about side effects caused by the drug and advised its sales force to play down, said Jan Margosian, a spokeswoman for the Oregon AG's office. She declined to confirm whether Oregon or other states are investigating the injuries caused by Zyprexa, as it's a amtter of policy not to comment on on-going investigations.
Margosian said, "They (Lilly) lied to health professionals about the use" of Zyprexa, marketing it directly to doctors for unapproved uses such as dementia and children. She said that while most Zyprexa use in Oregon was general adult use, the state did encounter cases of pediatric use.
I asked her if Oregon were looking into AstraZeneca and J&J/Janssen over similar issues with Seroquel and Risperdal. "There are many more (claims) to come down the road," she said. "We're monitoring all of the companies. If they were operating the way Lilly was, we'll probably be talking to them."
AZ and J&J have already been sued by other states such as Montana and Arkansas over how they allegedly marketed their drugs and how forthcoming they were about problems with the drugs.
She said the collective of 32 states AGs and DC's AG were continuing to talk about these matters.
To date, Lilly has already settled over $1.3 billion in claims arising from its handling of Zyprexa, a drug that generates over $4 billion a year in sales.
News is just out via the New York Times that Lilly and a combine of 33 states--which were pondering suing the pharma giant over off-label marketing of Zyprexa--have settled those claims for $62 million. It's not clear to me if this settlement covers potential claims by the states involving Lilly's alleged hiding of injuries caused by the drug such as diabetes or whether it only covers off-label marketing. If it does cover both, then Lilly got off cheap.
The Times' Alex Berenson reports that:
"The agreement may also be a sign that a much larger deal is near in a separate but related civil and criminal investigation led by federal prosecutors in Philadelphia. In that case, Lilly is expected to pay more than $1 billion in fines and restitution to states and the federal government and may also plead guilty to a misdemeanor criminal charge related to off-label marketing of Zyprexa."
We shall see. There are still outstanding lawsuits by about 10 other states. Alaska settled its claims with Lilly for $15 million earlier this year. Lilly has settled about $1.3 billion worth of class action claims by individuals since 2005 and is facing trial in large case in New York federal court brought by various unions, pension funds and insurance companies. It'll be interesting to see if Lilly settles or goes to trial.
More when I know about it.
After reading the full paper a few times, I am concerned about this paper and its conclusions and how it may well be spun by the press for many reasons. The study was funded by an NIMH grant. The lead researcher was Barbara Geller, a child psychiatrist at Washington University.
I suppose studies like this are open to a range of interpretations and quibbles. Here are mine. BTW, I am not asserting that something isn't wrong with these teens, just pointing out that I have real questions about just how aggressive we've gotten in American culture in softening bipolar disorder away from its classic manic-depression roots.
1. The media is already spinning this as a study showing that child bipolar disorder (the formal term is pediatric bipolar disorder per the FDA) persists into adulthood. Bloomberg does so here. Geller has contributed to the problem by entitling her paper "Child Bipolar 1 Disorder and arguing that her study "strongly support[es] continuity between child and adult BP-1." Her study does something different since it doesn't measure outcomes once these kids hit 18 year of age with adult measures.
2. The study isn't really about kids per se--and certainly not the toddlers and 6-year-olds who are at the center of all the controversy around the diagnosis--but it's mostly about teens. Children had a first episode of what Geller calls mania at an average of 11.1 years of age, and the 8-year follow-up study ends at about 20 years old. Some of the kids entered--meaning they had their first "manic" episodes--at about 8.5 years old, but globally this study is about adolescents which sort of argues for calling all of this "teen bipolar disorder." Or teenage wasteland. Or something else. But child bipolar disorder is a stretch and pediatric bipolar disorder is a bit broad.
3. Teens who receive a higher level of "maternal warmth" fared better than teens who didn't, dramatically better in fact. It's unclear to me what Geller means by maternal warmth in a formal sense, but it's safe to assume that having a mother who gives a damn about their kid is--duh--important.
4. There is no mention in the study of paternal warmth. So is Geller arguing by implication that dads don't matter or are all these teens' fathers missing in action?
5. The study is male-heavy--67 percent male, 33 percent female. It is also a small study with 108 out of 115 initial enrollees finishing out their eight years. I hope people in the media pay attention to how small this study was and reign in their conclusions appropriately.
6. The conclusion that the evidence is "strongly supporting continuity between child and adult BP-1" is based upon her finding that 44.4 percent of study subjects who reached 18 years of age--or or 24 of 54 subjects--experienced some symptoms of mania. Twenty-four subjects only represents 22.2 percent of the 108 subjects who finished the study. That's a pretty small subset upon which to make broad claims. What's more, over half of the participants haven't hit 18 yet. Thin reeds, as the saying goes.
7. Study participants are 85.2 percent white. Geller notes that another limitation of the study is that it mostly drew from kids and teens of higher socioeconomic status. She then steers readers to the paper's "Methods" section where there is no discussion of what higher socioeconomic status beyond noting that study subjects had health insurance. That's sort of incomplete and sloppy.
8. There is no discussion whatsoever of what medications or psychotherapy or both these teens are receiving although Geller makes it clear they are receiving care in the community. Not sure what that means. It would've been nice to at least have this addressed in the paper's discussion section.
9. The term BP-1 mania as used by Geller isn't the same thing as adult BP-1 mania. It's a kiddie mania that instead of requiring 3 of 7 symptoms (sometimes four) to be present for the better part of seven days (outside a hospitalization) only requires that one of two "cardinal" symptoms be present--namely, either elation or grandiosity. Part of this watering down of BP-1 mania is to limit overlap with some of the more ADHD-ish symptoms of classic mania and to keep the "irritability" type of bipolar kids we hear so much about from the Harvard child psychiatrists either out of the study or their symptoms out of being counted as mania; ie, distractibility, increased goal-oriented activity, talkativeness and so on. Also out are flights of ideas and the classic "excessive involvement in pleasurable activities that have a high potential for painful consequences." So no spending sprees or sexual indiscretions.
Separately, I have to wonder why they are using a mania proxy designed for adolescents and measuring it in young adults and calling that proof of the transition to adult mania (meaning real full-blown DSM BP-1 mania). Wouldn't you use adult measures of mania (both the DSM and the Young Mania Rating Scale) as your end point to prove the transition? In this study, Geller hasn't and I can find no discussion of this point in the paper. The editor and peer reviewers didn't query her on this point? She didn't feel it necessary to explain going with the Children's Global Assessment Scale or the Global Assessment Scale for adult-aged subjects to the exclusion of the Y-MRS (at least on the adult end)? Weird.
The GAS isn't designed to capture mania per se. Psychological troubles and social functioning, yes.
10. It's not clear to me exactly what kinds of episode durations counted as manic episodes, but the episodes durations of this watered down mania that Geller leaned on were very long, hundreds of days long. Which makes me a bit suspicious. In some cases, the teens were having episodes of four hours in length several times a day. In some cases not.
11. Sixty-one percent of the kids were reported as experiencing psychosis upon entering the study. That's a troubling rate, but it's not clearly to me exactly what psychosis was going on and how it was delineated. Geller uses the WASH-U-KSADS scale and I cannot find a relevant copy of it.
12. The same day this study appeared a study based upon a survey of 199 child psychiatrists in Australia and New Zealand was published in the journal Child and Adolescent Mental Health.
"Opinion varied as to whether PBD was over-diagnosed (25%), appropriately diagnosed (42%), or under-diagnosed (28%) in Australia and New Zealand, 5% were unsure. In contrast there was a consensus of views that PBD was over-diagnosed in the USA (90%), whilst less felt it appropriately diagnosed (3%), or under-diagnosed (1%) and 6% were unsure."Conclusions: The majority view was consistent with classical descriptions of bipolar disorder."
13. Let's assume for a minute that I am wrong and Geller is right and that what we've got here is a type of bipolar disorder than persists into young adulthood. If that's the case, then the outcomes certainly don't speak very well of the prevention paradigm--in which the earlier you diagnose and treat mental disorders, the more successful you are at limiting its problems--because 44.4 percent of these young adults, diagnosed with BP-1 mania as adolescents or children, are still symptomatic with some form of what Geller calls mania and another 29.6 percent have some form of unipolar depression. So whatever treatment these teens are getting don't seem to be working especially well. Forty of the 54 now-adults are symptomatic for something, if I read the study correctly.
14. I find it difficult to believe that Geller has made her case of "strongly supporting continuity between child and adult BP-1." What she has done is made the case of continued psychological issues for these former teens at the cusp of adulthood but hasn't proved much else.
But then I am a skeptic. Or an Aussie or Kiwi child psychiatrist.
A new study by Washington University child psychiatrist Barbara Geller is just out. I'll have more on the study tomorrow when I've had a chance to review it in full. The basic claim is that 44 percent of 108 kids in the study--OK, so this is a smallish study--had bipolar disorder when they hit 18 by Geller's reckoning.
Meanwhile, Bloomberg has an article out that is simply stunning in one respect:
"About a third of the patients' time was in a manic episode. Manic children may commandeer a classroom, correct their own papers, or think they're entitled to tell their principals which teachers ought to be fired, Geller said."
Oh so this is all about keeping kids compliant at school? Manic one-third of the time? I assume that's by the very relaxed standards that docs are using for childhood mania, which focuses mostly on irritability and rage.
One note: the study wasn't looking at kids diagnosed as, say, 4-year-olds, so the study was looking at the upper age range of pediatric bipolar disorder.
More tomorrow.
In reporting on the recent passage of the federal mental health parity bill today, the New York Times's reporter Robert Pear stepped in a whole bunch of doo-doo. I know Pear isn't a science or health reporter (he's a government and politics reporter) and the article appears in the paper's Washington section not the Health section, so perhaps his editors aren't experts either, but the paper holds itself out as the paper of record and right now I'd say the record looks like a bit of car crash.
"The goal of mental health parity once seemed politically unrealistic but gained widespread support for several reasons:"¶Researchers have found biological causes and effective treatments for numerous mental illnesses."
OK, right there that is the author's and the paper's voice and opinions sanctifying the brain chemistry hypothesis of depression, schizophrenia, bipolar disorder, anxiety, ADHD and so on. The fundamental problem here is that there is no proof that biological causes are the chief drivers of mental disorders and making such a sweeping statement absent any considerations of environment and behavior is a staggering omission on the paper's part. In fact, it represents a political statement and quite possibly a religious one.
I hate to step through this stuff once more, so here's the short version: the science on the serotonin hypothesis of depression is very mixed. Sometimes, serotonin is connected, other times it's not and the general theory that a lack of the brain chemical causes depression has not been replicated in research. At best, it's a weak explanation for causality.
If you have questions about this, check out this paper by Jonathan Leo and Jeffrey Lacasse from PLoS.
As for non-depression disorders, I don't think too many researchers run around claiming that a lack of dopamine causes schizophrenia, for example, or bipolar disorder. I've had real life mental health researchers tell me that, at the end of the day, they have no clue what truly drives schizophrenia.
Besides, if these disorders were truly biologically-based, then anti-depressants, antipsychotics, mood stabilizers, stimulants and so on would work at all times for all people. They'd be "effective treatments," as the paper put it. But this is not the case. The effect size of anti-depressants runs from roughly 15 percent to 30 percent (other drug classes are loosely the same)--yes, they sure are biological cures in a pill.
Then, we come to the opinion of a researcher:
"Dr. Steven E. Hyman, a former director of the National Institute of Mental Health, said it was impossible to justify insurance discrimination when an overwhelming body of scientific evidence showed that 'mental illnesses represent real diseases of the brain.'"'Genetic mutations and unlucky combinations of normal genes contribute to the risk of autism and schizophrenia,' Dr. Hyman said. 'There is also strong evidence that people with schizophrenia have thinning of the gray matter in parts of the brain that permit us to control our thoughts and behavior.'"
It's fine to quote researchers and let them state their opinion, despite the fact that the evidence on genetic causes of brain changes in people with mental disorders is fairly erratic. Which gene is it that causes bipolar disorder? Which regulatory region of the genome? There's nothing approaching a consensus here even though researchers have been pushing very hard on this front for the last 30 years or so. That really makes me think they are bumping along the walls of a blind alley, especially given the sophistication and speed of newer gene analysis tools. But perhaps there will be a breakthrough discovery someday. Perhaps.
I'm not denying that there's some level of connection here, but until I see rock-solid proof, I'd say the jury is still out.
As for physical brain structure arguments, I find them interesting but ultimately unsatisfying--again, because of the lack of solid consensus. Also, I think the thing that makes me suspicious is that there's plenty of evidence--see Eric Kandel for this--that the brain is a highly plastic (meaning changeable) structure and that whatever deficits arise can be changed over time.
The question is how.
I think we all collectively knew that sexual problems caused by anti-depressants affected a much higher percentage of users than the pharma companies ever admitted to, but this is ridiculous. From the People's Pharmacy column:
"When Prozac-like drugs were first introduced, no one knew how common sexual side effects might be. Pre-market testing suggested that such complications were relatively rare. Now we know that sexual problems may actually range from 30 percent to 70 percent of patients."Drugs like Celexa, Effexor, Lexapro, Paxil, Prozac and Zoloft are prescribed for anxiety, bulimia, depression, chronic fatigue syndrome, hot flashes, obsessive-compulsive disorder, PMS and post-traumatic stress disorder.
"Many people report that such drugs can reduce libido, interfere with arousal, delay or block orgasm and cause erectile dysfunction. A recent article suggests that sexual side effects may sometimes persist indefinitely, even after the drugs are discontinued (The Open Psychology Journal, Vol. 1, Pages 42-50, 2008).
"There are no obvious antidotes for this problem, though some doctors have tried drugs like Viagra. An antidepressant such as bupropion is less likely to cause sexual dysfunction."
70 percent is a major wowie.
I wrote about the Open Psychology Journal article earlier here.
Perhaps this ought to be filed under self-evident research findings, but a new study in the American Journal of Psychiatry has found that infamous, fat-producing Zyprexa is better at packing the pounds on patients with anorexia than placebo. The study was small--only 34 patients between the two arms--and lasted 10 weeks. Researchers reported no diabetes cases developed among the patients. A grant from Eli Lilly, Zyprexa's maker, supported the research.
A few of you have probably already caught the news elsewhere: yesterday, Charles Nemeroff resigned as chair of the psychiatry department at Emory University. The move came on the heels of revelations that he'd taken in $2.8 million in pharma consulting monies since 2000, but had only reported less than half of that--all while taking NIH research grants on the other hand and assuring his university that he was taking in less than $10,000 a year in pharma dough.
For those of you who don't know, Nemeroff is one of the biggest depression researchers in the world and his work is hugely influential in the field. But as CL Psych has repeatedly detailed, Nemeroff's work is often scientifically compromised.
Emory University has issued a statement:
"Dr. Nemeroff is recognized internationally as a leader in psychiatric research, education and practice. He has made fundamental contributions to the field over many years. The length and complexity of the history outlined by Senator Grassley will require careful review of underlying payment records from the pharmaceutical companies, which we have requested from Senator Grassley’s office. We have also requested that Dr. Nemeroff provide us with relevant information and documentation so that we will have all the facts before us."Dr. Nemeroff has assured us that: 'To the best of my knowledge, I have followed the appropriate University regulations concerning financial disclosures. I have dedicated my career to translating research findings into improvements in clinical practice in patients with severe mental illness. I will cooperate fully and work with Emory to respond to the alleged conflicts of interest issues raised by Senator Grassley and his staff.'"
Whatever, dude.
You just had to know that Sen. Charles Grassley's (R-Iowa) inquiries into psych researchers taking federal research money on one hand and pharma money on the other and not honestly reporting the conflict would eventually reach Charles Nemeroff, a professor of psychiatry at Emory University and one of the top dogs in depression research. And, wow, has it ever!
Between 2000 and 2006, Nemeroff took in almost $1 million in consulting fees and whatnot from GlaxoSmithKline but copped to making less than $35,000 on university disclosure forms. And that's just for one company. Nemeroff was reportedly on the advisory boards of 12 pharma companies. He took in about $1.8 million between 2000 and 2007 from other companies for a total of $2.8 million. That works out to $400,000 a year.
I'd say Chuck is going to be in hot water over this, since he was taking money from NIH at the same time and NIH allows its grantees to only rake in $10,000 a year from private companies. And while he was taking in the big bucks from Glaxo, Nemeroff was openly lying to his university that he would take in less than $10,000 a year. Seriously. This is one of the most blatant examples of pharma whoring I have ever seen.
Nemeroff didn't have the guts to respond to question from the New York Times.
At this point, you have to wonder when Grassley is going to call for public hearings. And you've got to wonder when NIH is going to start withholding research grants from universities in order to force them to clean up the dirty world of research.
Psychiatrist Danny Carlat has some thoughts on all of this. Add yours in comments.
Some of you regulars are aware of a commenter who sometimes uses the handle "Poe." He's an Australian anti-psychiatrist who drinks far too much and has a very bad temper and is utterly obsessed with me and this site. I've tried to ban him numerous times and have sent him numerous cease and desist warnings, but since he's in Oz he's beyond my reach. What's more, he uses a wireless Internet connection, so banning his IP address is ineffective. Even more, he's begun using US-based proxy servers so he can get around whatever I might try to impose on Aussie addresses.
I'm not sure what this boy's problem is with me, but apparently my refusal to declare psychiatry a crime and call for violence against doctors and my use of psychiatric diagnoses (or "labeling" as he calls it) angers him to no end, even though I am highly critical of psychiatry and so on. Obviously, his attacks are designed to ruin this site and drive off readers. Some of the things he's said in comments I've managed to catch are so off the charts that I won't even try to describe them. He's a very angry, bitter drunk who was likely diagnosed with schizophrenia and stuck in a hospital for ages and thinks his version of identity politics will improve humanity.
Why he's taking his anger out on me and all of you instead of starting his own blog is beyond me. Why he doesn't just grow up and get on with his life is beyond me.
I'm just telling you about this so you know what's up. Some of his comments will leak through from time to time, some I'll catch, but basically I'm done trying to stop him. He's so obsessed and net savvy that it's simply not possible for me to monitor him anymore.
Talk about unintended consequences: a recently-enacted law in Nebraska that was designed to prevent so-called dumpster babies has resulted in more than a dozen children and teens being turned over by their parents to the state. According to this article in the New York Times:
"Officials have called the abandonments a misuse of a new law that was mainly intended to prevent so-called Dumpster babies — the abandonment of newborns by young, terrified mothers — but instead has been used to hand off out-of-control teenagers or, in the case of the father of 10, to escape financial and personal despair."The spate of abandonments has prompted an outcry about parental irresponsibility and pledges to change the state law. But it has also cast a spotlight on the hidden extent of family turmoil around the country and what many experts say is a shortage of respite care, counseling and especially psychiatric services to help parents in dire need."
Is there some kind of special stress on parents and their kids going on out there--outside of the economy--that has changed things so dramatically in our culture that parents will just dump their kids? Maybe I'm old-fashioned or naive, but I simply don't recall this kind of crap going on much in the past. Sure, troubled kids entered the juvenile justice system and so on, but this strikes me as highly unusual.
Any ideas?
Just how insane are things getting in Congress around attempts to pass a financial bail out/giveaway to preppies who don't know how to run financial markets? Very insane.
In addition to approximately $150 billion in tax breaks for things like wooden arrows that have been added to the Senate version of the bill to buy votes, senators have now added the mental health parity bill, which has been sitting in the Senate awaiting passage, to the bill. I assume this is so the bill, which passed the Senate last night, will cause mental health advocates to go to work on House members and lobby for passage of the financial bail out or they'll kill off parity for another session.
This is simply nutso. I'm in favor of parity, but this is ridiculous.
Yesterday evening I was preparing to go for a walk in the sun when my phone rang. A friend of mine who's diagnosed with schizophrenia (anti-psychiatrists note: she's the real deal. Seriously) was on the other end, suicidal, despondent and very, very angry. Not your typical suicidal depression sort of thing.
I managed to get her calmed down, didn't have to call the cops (she was openly threatening self-harm), and a half-hour later some family members came home and dealt with her. The experience was so draining that I wasn't able to write last evening. I was simply overwhelmed and exhausted. It's something that needs to be slept off.
More later today.
As I note in another post, I am utterly exhausted, so I'll defer to classic cut-and-paste methods:
From the Minneapolis Star-Tribune:
"In a settlement approved Tuesday in U.S. District Court in Minneapolis, British drugmaker GlaxoSmithKline agreed to pay $40 million to reimburse health plans that paid for children and adolescents to receive the antidepressant Paxil."The agreement brings to a close the long-standing class-action litigation against Glaxo, which was sued for allegedly withholding negative information about the safety and efficacy of Paxil for teenagers and children. In 2007, Glaxo agreed to pay $63.9 million to consumers in another class-action settlement. In both cases Glaxo did not admit wrongdoing. "
I'm not up to speed on the history of other Paxil lawsuits, but a combined $103.9 million strikes me as a fairly significant amount. I wonder if the infamous Paxil Study 329 played a part in this case.
From the main law firm in the case:
"Baum, Hedlund, Aristei & Goldman originated the class actions and litigated the heart of the case based on internal GSK (GlaxoSmithKline) documents showing that GSK promoted Paxil as an effective medication for children and adolescents despite internal communications acknowledging that Paxil’s pediatric depression clinical trials failed to out-perform sugar pills, yet had higher suicidality rates than sugar pills. Notwithstanding, GSK promoted Paxil as being 'remarkably safe and effective' for depressed children."Paxil was never approved for children, so there were no explicit warnings for pediatric use on Paxil’s warning label. Thus, the prescription and sale of Paxil to children was all 'off label,' which is permitted, but with severe restrictions on such 'off-label' promotion and marketing.
"'Off-label marketing of drugs is prohibited, with limited exceptions that allow scientific trial results to be presented as long as they are truthful and accurate,' stated Michael Baum, senior partner at Baum, Hedlund, Aristei & Goldman. 'Here GSK should not have promoted Paxil for kids’ use when GSK’s own pediatric clinical trials showed Paxil was no more effective than sugar pills and, in fact, caused pediatric Paxil patients to experience increased suicidality. Litigation like this helps remove the incentive for drug companies to take advantage of the off-label marketing loophole.'"
I'll believe it when I see it.
I suspect there will be more coverage of this case later today. I'll add more to this if it makes sense.
There's an interesting study out today in JAMA, a meta study asserting that psychoanalysis is more effective at treating complex mental disorders such as anxiety and borderline personality disorder than are other psychotherapies such as CBT. And by psychoanalysis the authors apparently mean the old-fashioned Freudian stuff, or long-term psychodynamic psychotherapy to the study authors who claim that:
"According to comparative analyses of controlled trials, LTPP showed significantly higher outcomes in overall effectiveness, target problems, and personality functioning than shorter forms of psychotherapy.... [Results] indicated that after treatment with LTPP patients with complex mental disorders on average were better off than 96 percent of the patients in the comparison groups."
Not bad for a treatment paradigm that has been almost completely eclipsed by medications and other psychotherapies over the last 30 years or so. In fact, psychoanalysis is so out of favor, even in counseling circles, that it is virtually untaught these days to young therapists and medical students in psychiatry and has pretty much become a historical artifact.
Or as one researcher told the New York Times:
"Dr. Barbara L. Milrod, a professor of psychiatry at Weill Cornell Medical College, who like Dr. Gerber is a clinical practitioner of psychodynamic therapy, said further research was crucial as a matter of survival for a valuable treatment."'Let’s be real,' Dr. Milrod said. 'Major medical centers have been shutting down psychodynamic training programs because there isn’t an adequate evidence base.'"
Another added:
"'If you define borderline personality broadly as an inability to regulate emotions, it characterizes a lot of people who show up in clinics, whether their given diagnosis is depression, pediatric bipolar or substance abuse,' said Dr. Andrew J. Gerber, a psychiatrist at Columbia. For some of those patients, Dr. Gerber said, 'this paper suggests that you’ve got to get into longer-term therapy to make improvements last.'"
Obviously, meta studies aren't direct measures of effectiveness per se and some of the small studies grouped in this larger study go back to the early 1960s. And, since psychoanalysis is highly individualized in the hands of each practitioner, I would assume that researchers offer various cautions about over-interpreting the study's data.
Nonetheless, score one for Freud. And couch salesmen everywhere.
Photographer Eugene Richards has a new book out today with some of the roughest photos that I've seen in ages. He traveled to Mexico, Hungary, Paraguay, Kosovo and Armenia and documented conditions in psychiatric hospitals. It's pretty rough stuff and due to obvious copyright issues I won't reproduce his work here. You can go to Newsweek's website, which has published them, and check them out for yourself.
For as long as I can remember, conduct disorder (sometimes known as anti-social disorder in adults), a slippery diagnosis to begin with, has been parked securely among Axis 2 disorders in the DSM and is commonly thought of as a personality disorder. But now, according to the Telegraph (UK), British researchers are claiming that "anti-social behaviour 'is a mental illness'" and results from, brace yourselves, an imbalance of brain chemistry. I suppose there will now be a hue and cry to shift conduct disorder over to Axis 1, where the true mental illnesses currently reside.
I've not seen this research published yet and the paper doesn't point to a publication, so this falls into wait and see country, but here's how the paper described the research:
"There were 70 boys with a diagnosis of conduct problems and 95 with no history of behaviour problems or psychiatric disorders to compare to the first group. All were aged between 14 and 18."They all played a video game in which the pre-recorded opponent always failed to cooperate and sent antagonistic messages. The boys had to play a game under time pressure with the video opponent and the experimenter watching and the opponent continually giving negative assessments of their performance.
"Normally, in these situations, the body increases levels of the stress hormone cortisol which makes people focus more, behave more cautiously and regulate their temper and violence. But in the boys with severe anti-social behaviour problems, the cortisol levels actually went down.
"The scientists, led by Dr Graeme Fairchild and Professor Ian Goodyer, said: 'If we can figure out precisely what underlies the inability to show a normal stress response, we may be able to design new treatments for severe behaviour problems. We may also be able create targeted interventions for those at higher risk.'
"'A possible treatment for this disorder offers the chance to improve the lives of both the adolescents who are afflicted and the communities in which they live.'
"These results suggest that antisocial behaviour may be more biologically-based than previously considered, just as some individuals are more vulnerable to depression or anxiety due to their biological make-up."
Perhaps these kids ought to get cortisol injections then. Kidding aside, this is the kind of study that would need to be replicated many times before anyone should buy its conclusions, especially the creepy social control suggest that "treatment" will benefit the community at large. It's not like these kids are murderers after all.