This will be the only post today because it's pretty much getaway day and after doing this site for three years, I know that traffic craters today and tomorrow. I may be back on Friday, but maybe not.
Thanks to all of you for reading this site. For the third month in a row, it will clear 30,000 visits for the month, and in recent days something like 7,000 people have read the various posts on "The Infinite Mind" fracas and the Biederman/Harvard scandal. I'm not pointing this out to brag, but to let you regulars know that information we care about is finally penetrating the public mind.
Have a nice Thanksgiving Day.
There was quite a bit of media coverage of revelations yesterday that controversial Harvard child psychiatrist Joseph Biederman, who is also at Massachusetts General Hospital and is the primary creator of the bipolar child paradigm and is one of the chief researchers of ADHD, had pressured Johnson & Johnson, makers of the atypical antipsychotic Risperdal, to contribute hundreds of thousands of dollars in research money to him and got the company to underwrite a center at Mass. General to study psychiatric medications in kids in order to "move forward the commercial goals of J&J," according to documents in a lawsuit released to the media. J&J gave the center $700,000 in 2002 alone.
Details of those documents are stunning. Here's a sampling of their contents from the Philadelphia Inquirer:
"The court papers show Johnson & Johnson:"Budgeted $6.4 million to hold 'educational summits' and sponsor advisory panels in part to counter negative media reports on the research, diagnosis and treatment of children with mental illness;
"Was actively involved in drafting research that Biederman was to present at a medical conference and asked him how to deal with unfavorable research results suggesting that a placebo worked as well as Risperdal;
"Discussed clinical trials for drugs as 'growth opportunities' and tied trial proposals to sales potential."
According to the New York Times, Biederman was actually willing to slap his name on a J&J study of Risperdal in kids where placebo had performed as well as the drug, but a draft abstract of the paper said only that kids taking Risperdal improved.
Between a company that allegedly saw clinical trials as growth opportunities instead of the testing of a scientific hypothesis and a researcher who was allegedly willing to sell himself to J&J, is it any wonder that child psychiatry is such a controversial mess. And is it any wonder that lawmakers and the public have become very dubious of pharmaceutical companies and their compromised researchers.
As I noted yesterday, I wonder what proponents of the bipolar child paradigm now make of the "science" behind the paradigm. I'm still waiting to hear.
Yesterday a reader informed me that Fred Goodwin, at the center of the recent controversy around "The Infinite Mind" radio show, had been involved in a very messy incident back in 1992. Goodwin, author of the primary medical text on bipolar disorder and the author of many papers on mental illness and a major consultant for drug companies, was reportedly at the center of a storm around questions of race, violence and genetics.
From the New York Times:
"Dr. Breggin said his accusations were based on remarks made by Dr. Frederick Goodwin, director of the National Institute of Mental Health, at a meeting of the National Mental Health Advisory Council on Feb. 11. Controversy over a statement by Dr. Goodwin at that meeting, which seemed to compare inner cities to jungles, led to his resignation as head of the Alcohol, Drug Abuse and Mental Health Administration."At the meeting, Dr. Goodwin spoke of planning for a 'violence initiative,' which, among other goals, would seek to find biological correlates of violence in males, detecting them early in life, and seeking to prevent their expression. He also asserted that adoption studies had shown that genetic factors in violence and aggression were 'very strong.' Dr. Goodwin declined to be interviewed."
This account by Breggin offers more explanation of what turned into a very complex situation with, reportedly, the Wall Street Journal and Washington Post editorializing in favor of Goodwin's free speech rights.
I find it very odd that one of the presumed good guys in psychiatry would make a proposal, however casual, to go after inner-city youths (ie, African-American males) in such a fashion. I wonder what his defenders such as John McManamy of mcmanweb.com and HealthCentral.com now make of Goodwin. You can read McManamy's defense of Goodwin here.
Meanwhile, Bill Lictenstein, who produced "The Infinite Mind" radio show, has released a statement about the show's demise in the wake of revelations of immense financial conflicts between Goodwin and various pharmaceutical companies who gave him well over $1 million to speak on behalf of their drugs. Goodwin did not reveal these conflicts, even in the midst of a March 2008 radio episode in which he and his guests claimed that there was no credible scientific evidence of a link between anti-depressants and suicide as well as other violent acts and suicidality.
Lictenstein stated:
"Dr. Goodwin’s acceptance of these fees was in direct violation of his written contract with LCM, which states, in part: 'You agree to disclose to LCM existing and any new business relationships as they occur that could potentially be perceived as representing a conflict of interest with your role as a public radio commentator or journalist. You also agree to disclose to LCM any business relationships that existed during your time as host since 1997 which may have presented a conflict of interest as defined above.' There was no gray area. Fred Goodwin was legally bound to inform LCM of any conflicts of interest. And he didn't."
I simply cannot understand why someone of Goodwin's standing in medical science wouldn't appropriately identify his conflicts to Lictenstein and his radio audience, especially when some of those conflicts were identified in various academic publications of Goodwin's. Then again, I am confused as to why Lictenstein hadn't read Goodwin's published articles and identified the conflicts for himself.
Two sordid affairs involving one of the key thought leaders in psychiatry inside of two decades.
Gardiner Harris of the New York Times has done it again. In a piece just out on the paper's website, he details emails and other documents from an ongoing lawsuit against J&J over the use of its antipsychotic Risperdal in kids, which offers insight into how Joseph Biederman, a Harvard child psychiatrist, worked J&J for money. Biederman is of course the godfather of the whole pediatric bipolar disorder (aka, child bipolar disorder) business. The details are stunning.
"[E]-mails and internal documents from Johnson & Johnson made public in a court filing reveal that Dr. Biederman pushed the company to fund a research center at Massachusetts General Hospital whose goal was 'to move forward the commercial goals of J&J,' the documents state. The documents also show that Johnson & Johnson wrote a draft summary of a study that Dr. Biederman, of Harvard University, was said to author."
Keep in mind that this is the researcher whose science the FDA said it was leaning upon when it decided that pediatric bipolar disorder was a valid diagnosis back in July.
"In one November 1999 e-mail, John Bruins, a Johnson & Johnson marketing executive, begs his supervisors to approve a $3,000 check to Dr. Biederman in payment for a lecture he gave at the University of Connecticut."'Dr. Biederman is not someone to jerk around,' Mr. Bruins wrote. 'He is a very proud national figure in child psych and has a very short fuse.'
"Mr. Bruins wrote that Dr. Biederman was furious after Johnson & Johnson rejected a request that Dr. Biederman had made to receive a $280,000 research grant. 'I have never seen someone so angry,' Mr. Bruins wrote. 'Since that time, our business became non-existant (sic) within his area of control.'
"Mr. Bruins concluded that, unless Dr. Biederman received a check soon, 'I am truly afraid of the consequences.'"
Sounds like Biederman is an adult version of the little boys he urges Americans to medicate.
But wait, there's more:
"A series of documents described the goals behind establishing the Johnson & Johnson Center for the study of pediatric psychopathology, for which Dr. Biederman still serves as chief."A 2002 annual report for the center stated that its research must satisfy three criteria: improve psychiatric care for children, have high standards and 'move forward the commercial goals of J&J,' according to court documents.
"'We strongly believe that the center’s systematic scientific inquiry will enhance the clinical and research foundation of child psychiatry and lead to the safer, more appropriate and more widespread use of medications in children,' the report stated. 'Without such data, many clinicians question the wisdom of aggressively treating children with medications, especially those like neuroleptics [ie, antipsychotics], which expose children to potentially serious adverse events.'"
More:
"A February 2002 e-mail from Georges Gharabawi, a Johnson & Johnson executive, stated that Dr. Biederman approached the company 'multiple times to propose the creation' of the center. 'The rationale of this center is to generate and disseminate data supporting the use of risperidone in' children and adolescents, the e-mail stated."Johnson & Johnson gave the center $700,000 in 2002 alone, documents show."
And apparently Biederman was willing to slap his name on a ginned-up study of Risperdal in kids:
"A June 2002 e-mail from Dr. Gahan Pandina, a Johnson & Johnson executive, to Dr. Biederman included a brief abstract of a study of Risperdal in children suffering disruptive behavior disorder. The study was intended to be presented at the 2002 annual meeting of the American Academy of Child & Adolescent Psychiatry, the e-mail stated."'We have generated a review abstract, but I must review this longer abstract before passing this along,' Dr. Pandina wrote. One problem with the study, Dr. Pandina wrote, is that the children given placebos and those given Risperdal both improved significantly, 'so, if you could, please give some thought to how to handle this issue if it occurs.'
"The draft abstract that Dr. Pandina included in the e-mail, however, stated that only the children given Risperdal improved, while those given placebos did not. Dr. Pandina asked Dr. Biederman to sign a form listing himself as author so the company could present the study to the conference, according to the e-mail.
"'I will review this morning,' Dr. Biederman responded, according to the documents. 'I will be happy to sign the forms if you could kindly send them to me.' The documents do not make clear whether Dr. Biederman approved the final summary of the brief abstract in similar form or asked to read the longer report on the study."
Biederman is the gift that keeps on giving. I wonder what apologists for the bipolar kids paradigm make of these revelations.
Some of you may remember that earlier this year, New York Times columnist Judith Warner accused critics of slamming kids with psych meds of engaging in "narrative," which I suppose means that they were making up stories of overmedicated kids in our culture and flapping their arms about nothing. Now, it appears that Warner, in her most recent piece, is engaging in some narrative of her own, or at any rate trying to back away from her accusation that people such as myself were exaggerating what was afoot in American culture, even when folks like me were presenting actual solid evidence of what was going on such as 50 percent of antipsychotic use in kids in Florida being tied to ADHD diagnoses and all that stuff I totally made up about side effects of these meds in kids.
Warner's shift comes because last week an FDA panel of outside experts slammed the FDA and, by implication, American doctors for overusing atypical antipsychotics in kids and stating that something needed to be done about this situation.
The other day, Warner opined on "tough" kids:
"[T]hinking hard about these kids — instead of merely moralizing about them and their psychotropic drug use — may well lead to a situation in which atypical use can be greatly reduced...."It won’t solve the problem of the drug companies’ predatory marketing practices, or of thought leaders in psychiatry renting out their minds for the sake of fancy vacations and top-flight meals. But the fact that efforts are being made, in a concerted way, to figure out what lies behind the scary-sounding statistics about drugs like Risperdal argues, I think, for hope. After a period in which drug companies have had way too much power in determining how children with psychiatric issues are treated, the pendulum may be swinging back."
Well, no shit, Judy. Welcome to the show, although calling a small blowback by a few docs hope is a bit of a stretch. Besides, I'm not sure what "hard thinking" needs to be done here. Psych meds are rough on adults, rougher on children, and strip them of their souls in many cases, as they do adults too. (Don't believe me, Judy? Go take some Zyprexa!) Diagnostic criteria is often a joke--one Warner continues by refusing to call BS on pediatric bipolar disorder, or even hint that anyone in psychiatry has--and we've gone from a culture where 20 years ago, say, kids with behavioral problems that required psychiatric intervention were few and now, a generation later, they suddenly are mentally ill, suffering from brain damage if they don't get medicated and there are millions of them.
This isn't just as a result of drug companies marketing away or a few key opinion leaders saying it's so, it's because doctors have bought into this nonsense, almost across the board. And it's because the parents of these kids have accepted their views. So while I appreciate Warner suddenly getting all concerned about the FDA panel's warning and kids with ADHD being slapped with Risperdal, she's so late to the party that the drinks have all been drunk. Interestingly, I gather than Warner has a book coming out next year on children's mental health issues, a book she wrote earlier this year. Something tells me it won't reflect her recent backing away from a feminist-says-it's-cool-to-medicate-little-boys approach to hard thinking. Can't wait to read it.
Not that Warner can get beyond her earlier prejudices in her column the other day:
"This will not satisfy the critics of today’s biological psychiatry for whom no drug use is good drug use, nor the critics of today’s culture of parenting who are sure that all the aggression, irritability and out-of-control behavior that psychiatrists call mental illness is actually nothing more than a state of 'toddlerhood in perpetuity' caused by ineffective parenting practices, as the conservative family psychologist and writer John Rosemond and his coauthor have asserted in his new book, 'The Diseasing of America’s Children.'"
Interesting.
Even more interesting, in her column Warner quotes NIMH director Thomas Insel as saying psychiatry is:
"'[T]he only field where the doctors are more stigmatized than the illness.'"
While I assume Insel was trying to be amusing, I'm not sure I can appreciate his humor. Psych docs make on average $180,000 a year, some of them far, far more than that. Psych docs have tons of power with peoples' lives and often offer them treatments that don't work very well and hurt them. Psych docs often ignore evidence in the field of problems with treatments. Meanwhile, patients are regularly denied employment, romance and the fruits of American life based upon their psychiatric diagnoses. Last time I checked that's not what psychiatrists were experiencing.
It's time for Insel to stop making dumb jokes.
I have corrected this post at NPR's request as I had incorrectly identified "The Infinite Mind" as being NPR-distributed when in fact it was only on NPR's Sirius channel. I've changed the description to "NPR-connected." To clarify further for readers, the show was not funded in any way by NPR, even though it is strongly associated in the public's mind with NPR by dint of the fact that it aired on some NPR-affiliated stations. I regret the error.
As many of you know, news came out on Friday that the plug had been pulled on the NPR-connected "The Infinite Mind" radio show, which reached as many as 1 million listeners a week. Controversy erupted around the show this past Spring when the show, produced by Bill Lictenstein and hosted by Fred Goodwin, who among other things authored the principal medical text on bipolar disorder with Kay Redfield Jamison, aired an episode on anti-depressants and suicide, claiming that there was no evidence of a connection between anti-depressants and suicidality much less violence of any kind. These claims, which I consider to be lies (and I called them that back in April when I was the first to report on this show's BS), were made by Goodwin and several guests, all of them with complicated ties to pharmaceutical funding, on a show that was receiving funding from pharma companies. None of these conflicts were disclosed on the show, but were made public by an article on Slate.com in May.
Matters spiraled from there and last week Sen. Charles Grassley (R-Iowa) went after Goodwin for taking pharma money and not revealing those conflicts while presenting his show as scientific and unbiased on public airwaves. Soon after, Lictenstein pulled the plug on the show, ending its long run. This led to an article in the New York Times in which Lictenstein claimed he'd asked Goodwin about conflicts and was told he had none and in which Goodwin pretty much defended his actions by claiming this is what doctors all do, plus that he took funding from all kinds of pharma companies so that canceled out his conflicts.
I'm tempted to be kind to Goodwin. I know some of his current patients and they revere him. I know one of his former patients who dislikes him intensely. John McManamy, who authors the Mcmanweb.com website on bipolar disorder and depression (which now features a prominent ad for Seroquel) and does a blog for HealthCentral.com, has written a very spirited defense of Goodwin and attacked the Times. Among other things (such as once again defending the bipolar child nonsense), McManamy offers evidence that Goodwin is openly critical of pharmaceutical companies and is suspicious of anti-depressants and overmedicating patients. News to me.
If that's the case, then I have to question Goodwin's sense of proportion. He does a show in which he is religiously defensive of anti-depressants yet criticizes them in other quarters. He's critical of pharma companies yet took $329,000 from Glaxo in 2007 for doctor talks on behalf of Lamictal, according to the Times. He reveals his pharma funding in academic papers, but won't do it on a publicly-aired radio show. Something doesn't add up here, but it sure does display how unthoughtful Goodwin has been on these matters.
Something else doesn't add up. Lictenstein claims that he didn't know of Goodwin's conflicts, but I was able to easily identify them by searching through Goodwin's published papers. It makes me wonder about his other claims.
As I noted in May:
"Here's Goodwin's financial disclosure from a 2004 paper in the Journal of Clinical Psychiatry (.pdf here) touting Lamictal:'Dr. Goodwin has received research support from Abbott, GlaxoSmithKline, Solvay, Janssen, Pfizer, Eli Lilly, Forest, Sanofi and Bristol-Myers Squibb; has received honoraria and participated in speakers/advisory boards for Solvay, GlaxoSmithKline, Pfizer, Janssen, Eli Lilly, AstraZeneca, and Bristol-Myers Squibb; and has been a consultant for GlaxoSmithKline, Eli Lilly, Pfizer, Bristol-Myers Squibb, Solvay and Novartis.'"
What's more, Goodwin had openly helped Eli Lilly promote Zyprexa when it was approved as a maintenance med for bipolar disorder in 2004 (so much for McManamy's claim that Goodwin loves Lithium alone). I doubt that he said "It is good news that the FDA has now approved Zyprexa as a new tool for physicians to use to delay relapse and prolong periods of stability and wellness" for free. It's amazing to me that Lictenstein couldn't find the statement for himself.
In fact, I informed Lictenstein in a May 2008 email exchange that Goodwin had revealed his pharma ties in academic articles. Why he didn't do some poking around at that point is far beyond me, especially when he now says he pressed Goodwin on the matter.
But what really blows my mind is that Lictenstein did nothing to rectify the false information put forth on the "Prozac Nation" episode in March. I know that a few readers from this site wrote to him and so did I. At length, I walked him through the evidence for problems with anti-depressants and suicidality and violence. The implicit push I was making was that he should take up the issue again on his program and do it in a more nuanced manner. His replies to me were short and polite, but dismissive.
At this point, it's clear to me that either Goodwin or Lictenstein are lying about the disclosure issue. Possibly both of them are. You can make your own decision. What's more, it's clear to me that both of them don't care about having put false information into the public realm because they have issued no correction or clarification of the March program.
So while I am tempted to feel bad for both of them losing their show--and for NPR ending up with some mud on its face--nah: They are getting what they deserve.
Speaking of deserving, the Times has updated its original article to appropriately reflect that Slate.com had first reported the show's pharma ties (I added even more on Goodwin soon after). Unfortunately, the paper failed to note that a certain website was first to raise the issue of the show's misinformation on anti-depressants, an issue that is even more important than financial conflicts.
This story is way beyond sad in just about every sense of the word. Sandra May McIntyre, who grew up in Maine and later changed her name to Paula Goodspeed, had an obsession with singing and becoming a star and was apparently obsessed with Paula Abdul, one of the weirdo judges on "American Idol." Goodspeed, who moved to Los Angeles to follow her dream, had some issues, shall we say. She was diagnosed with bipolar disorder and an eating disorder--a very tricky psychological combination--and had her two kids taken away by the State of California.
She'd also been a contestant on "Idol" where she was trashed for being a lousy singer and wearing braces (gee, I'm guessing that nasty Simon picked up on that). Goodspeed was also obsessed with being in contact with Abdul for some reason, sent her flowers and so on.
On Nov. 11, Goodspeed was found dead in her car, which was parked near Abdul's home. According to Goodspeed's family:
"He doesn't believe Goodspeed knowingly would cause her own death. She may have been taking too much prescribed medicine -- Seroquel and Prozac -- for her body size, he said."'They said she OD'd on Seroquel. They said it slowed her heart right down till it stopped. They did do a blood test and that's how they found out it was an overdose.'"
Whatever anyone wants to make of someone with Goodspeed's obsessions, it sure doesn't speak highly of the allegedly safe Seroquel that someone could OD on the drug.
Today's New York Times has news that Sen. Charles Grassley has caught yet another researcher in his conflict of interest probe. This time out, it's Fred Goodwin--perhaps the most influential researcher and writer in the world of bipolar disorder--and the well-known radio show "The Infinite Mind." As a result of these new revelations, the show is going off the air.
"Dr. Goodwin’s radio programs have often touched on subjects important to the commercial interests of the companies for which he consults. In a program broadcast on Sept. 20, 2005, Dr. Goodwin warned that children with bipolar disorder who are left untreated could suffer brain damage, a controversial view [Pretty much bull, as far as I know.]. 'But as we’ll be hearing today,' Dr. Goodwin reassured his audience, 'modern treatments — mood stabilizers in particular — have been proven both safe and effective in bipolar children.'"That very day, GlaxoSmithKline paid Dr. Goodwin $2,500 to give a promotional lecture for its mood stabilizer drug, Lamictal, at the Ritz Carlton Golf Resort in Naples, Fla. Indeed, Glaxo paid Dr. Goodwin more than $329,000 that year for promoting Lamictal, records given Congressional investigators show.
"In an interview, Dr. Goodwin said that Bill Lichtenstein, the program’s producer, knew of his consulting activities but that neither he nor Mr. Lichtenstein thought that 'getting money from drug companies could be an issue. In retrospect, that should have been disclosed.'
"But Mr. Lichtenstein said that he was unaware of Dr. Goodwin’s financial ties to drug makers and that he called Dr. Goodwin earlier this year 'and asked him point-blank if he was receiving funding from pharmaceutical companies, directly or indirectly, and the answer was, "No."'"
"'The fact that he was out on the stump for pharmaceutical companies was not something we were aware of. It would have violated our agreements,' Mr. Lichtenstein said in an interview."
NPR is pulling the show from its satellite service next week. Lictenstein told the paper that the show is going off the air, although no notice of such a move is on the show's website at the moment.
I wouldn't pretend to know who's right about who knew what when and who disclosed what to whom--I assume all involved are honorable human beings!
Here's some more on Goodwin:
"Dr. Goodwin has authored an influential textbook on bipolar disorder and is an adjunct professor at George Washington University. In an extensive interview, Dr. Goodwin blamed a changing ethical environment for any misunderstandings between himself and Mr. Lichtenstein about his consulting arrangements."'More than 10 years ago when he and I got involved in this effort, it didn’t occur to me that my doing what every other expert in the field does might be considered a conflict of interest,' Dr. Goodwin said.
"He defended the views he expressed in many of his radio programs and said that, because he consults for so many drug makers at once, he has no particular bias.
"'These companies compete with each other and cancel each other out,' he said. This view is dismissed by industry critics, who say that experts who consult widely for drug makers tend to minimize the value of non-drug or older drug treatments.
"In the fine print of a study he authored in 2003, Dr. Goodwin reported consulting or speaking for nine drug makers. Mr. Grassley only asked for payment information from Glaxo. Dr. Goodwin said that in recent years Glaxo paid him more than other companies.
"He said that he has never given marketing lectures for antidepressant medicines like Prozac, so he saw no conflict with a program he hosted in March titled 'Prozac Nation: Revisited' that he introduced by saying, 'As you will hear today, there is no credible scientific evidence linking antidepressants to violence or to suicide.'
"That same week, Dr. Goodwin earned around $20,000 from Glaxo, which for years suppressed studies showing that its antidepressant, Paxil, increased suicidal behaviors."
The anti-depressants and suicide show in March is what started steering attention to conflicts of interest around the show. In April, I was the first media outlet to report on the show's bogus claims of no linkage between anti-depressants and suicidality. In May, first Slate.com and then I rolled out evidence that Goodwin and the show's producer had not been revealing pharma funding and conflicts of interest. Lictenstein defended the program to me and others. Soon after, Slate.com responded to Lictenstein.
I'm completely blown away that such immense conflicts of interest made their way onto a public radio show and for so many years. I'll have some more thoughts on Goodwin soon.
Sen. Grassley has his own thoughts on this whole business:
"'We know the drug companies are throwing huge amounts of money at medical researchers, and there’s no clear-cut way to know how much and exactly where,' Mr. Grassley said. 'Now it looks like the same thing is happening in journalism.'"
Well put, but such conflicts won't be appearing on this website, which as ever is pharma-free and reader supported.
Although there are likely many, many examples of lamery on the part of the FDA--this year's salmonella outbreak, for example, which it took the agency months to track down--I wanted to point readers to some recent examples of inanity at the agency which merit a thorough housecleaning by incoming President Barack Obama. Two are biggies, one is a small hassle.
1. Earlier this week, it came out that FDA scientists are accusing agency managers of engaging in "serious misconduct" in approving medical devices for sale where the devices were unsafe or ineffective. It's not clear what devices are in question, but it's so unusual for scientists to voice their concerns that you know something serious is up.
2. In late July, the FDA determined on its own that pediatric bipolar disorder was a valid diagnosis, despite much controversy within psychiatry about the alleged disorder and the fact that it's not even in the DSM. The move is one of the most bizarre I've ever seen from the agency, diagnosis by government decree. Earlier, the agency's psychiatry products chief had been involved in helping academic researchers--many with pharma funding--to design clinical trials to measure the disorder. A very weird conflict.
3. Recently, the FDA told me if wouldn't comment on whether it had or would review a questionable TV ad for the drug Abilify, an antipsychotic being marketed to consumers as an anti-depressant. I then asked an FDA press official where I could file my concerns about the ad. I was told to write one arm of the department or call an 800 number. I did both. The woman at the 800 number told me to go online and file out a form (I did). After a few days, someone at the email address wrote me to tell me they weren't the right branch of the agency, but to write a separate department altogether. When one of the agency's main press officers has no clue as to where to point the public to simply air concerns about a drug TV ad, then you've got an agency with some problems, big and small.
I hope people in the new administration are planning on making big changes at the agency such as possibly returning it to its mission as a consumer agency, not one that works for pharma companies.
I happened to be watching Fox News yesterday afternoon--relax readers, I watch all the news networks--and there was reporter Douglas Kennedy, virtually the only national TV journalist to take on suicidality and anti-depressants, reporting on the recent blow up at an FDA committee hearing. That happened Tuesday, when outside researchers decried the overuse of antipsychotics in kids--especially for conditions like ADHD and alleged child bipolar disorder--and said the FDA needed to provide tougher label warnings about the use of these drugs in kids.
Sadly, I've not been able to run down a video or transcript of Kennedy's piece, but it also included comments from a lawyer in Pennsylvania who's sued J&J on behalf of kids who got messed up by Risperdal (some boys apparently developed breasts) and then Kennedy went after FDA psychiatry products chief Thomas Laughren. Kennedy accused him of, in the past, ghost-authoring studies for pharma companies and of working hand-in-hand with his "friends" at pharmaceutical companies. I wish I had the exact copy because it's certainly one of the most heated and opinionated pieces of reporting I've ever seen directed at an FDA division head (usually criticisms by name are aimed at the commissioner in charge).
I'm glad to see Kennedy going after these issues. What's interesting to me is that I have never (as in ever) seen MSNBC, NBC, CNN or CBS go after psych meds and their misuse in our culture. ABC has before. It's interesting that it's the two most conservative news networks that are while the more liberal ones are virtually silent. I don't want to conclude too much from that, but it sure does make you wonder.
If anyone stumbles across a video or transcript, let me know.
UPDATED: A reader located the video and passed it along. Thanks.
Some of you may remember a horrific murder in Arkansas in August--a man stormed into the office of the state's Democratic Party and killed the party chairman, Bill Gwatney, apparently choosing him at random. Through some back channels at the time, I learned that the murderer--who was killed by police later that day--had been taking Effexor. I didn't write about the incident at the time because I wanted to wait for a final inquiry, which came out yesterday. From the AP:
"A police report said an autopsy found Effexor, an antidepressant, in [Timothy Dale] Johnson's blood. Investigators said the drug may have played a part in his 'irrational and violent behavior....'"Johnson had first been prescribed Effexor in 2005 after complaining of anxiety and sleeplessness. He saw his doctor two months before the attack but there was no notation of any side effects from the drug."
I'll leave it at that, except to note that Effexor is well-known as causing erratic behavior in some people who take the drug.
Some of you may know of Andy Behrman, who wrote Electroboy, which was published in 2002. It's a good memoir of mania, bipolar disorder and craziness and his rough experiences undergoing ECT. A few years later, Behrman began taking Abilify and even became a paid spokesman for Bristol-Myers Squibb, the drug's maker. Then Behrman, in 2006, ran into serious problems with the drug and, somewhere in there, severed his relationship with BMS.
Since then, he's been working in Los Angeles to get Electroboy made into a movie. Yesterday, I learned that there's some interest in Behrman writing a book about his experiences as an Abilify spokesman. According to the New York Daily News, actors Brad Pitt and Matt Damon are interested in movie possibilities.
I talked to Behrman briefly yesterday, but he couldn't tell me much about his plans for the Abilify thing, as he's still under a non-disclosure agreement with BMS.
"I traveled around the country" for BMS, he said, to states like Florida and Texas. He did talks for doctors and nurses, focusing on his experiences with bipolar disorder and then-experiences with Abilify. He says he even made videos for the company. All very interesting, especially since he no longer takes the drug. The details of all of this will have to wait for the expiration of his agreement with BMS on Dec. 31.
Behrman did remind me of his experience writing for About.com about bipolar disorder. He had a few articles under his belt when, in May 2006, he wrote an article that was critical of Abilify. About.com posted the article, but then quickly took it down. I found out about this through the grapevine and asked Behrman to let me post it on my site, as a bit of a protest against his handling by About.com. Here are a couple of excerpts:
"The first disastrous side effect I noticed on Abilify was a serious bout with akathisia, a frequent and common adverse effect of treatment with antipsychotic drugs. The clarity that I first felt on Abilify had progressed to an edgy agitation which could not be quieted. I felt a terrible feeling of inner restlessness and an urge to constantly stay moving, as well as "kicking my legs around" (whether it be underneath my desk or while I was trying to fall asleep in bed). All of this eerily reminded me of the darkness of my old mania."
It got worse:
"Another horrible side effect for me were the problems that I experienced with my cognitive skills, which actually reminded me so much of my experience after electroshock therapy. One day while at lunch, I gazed blankly at a friend and could not for the life of me remember her name although I had known her for more than a couple of years. I was often confused and agitated over simple things: a misplaced piece of paper, whether I had taken my dogs out for a walk or not, and even focusing on a simple conversation. Abilify, my new "wonder drug" was failing me and I was embarrassed to tell anyone, even my wife (because we had an infant) and frighteningly, my own psychopharmacologist. What would he say? Because Abilify was relatively new, I figured it just had to work for me. But soon, after doing my own research, hearing from other people whose experiences were similar to mine as well as other mental health care professionals, and conferring with my own psychopharmacologist, it was clearly time to get off Abilify."
While Behrman may not be able to say much for his writing plans next year, I'm guessing that whatever book and, maybe, movie comes out of his experiences with Abilify and speaking on behalf of BMS won't make the pharma company very happy. But I bet it'll be a good read.
OK, maybe not ever, but this from Emory University psychiatrist Goug Bremner is pretty good on the topic of educating other doctors on the use of antipsychotics in kids:
"OK, here's your education:"Stop giving antipsychotics to kids who don't have the diagnosis of childhood schizophrenia."
That was in response to the FDA saying on Tuesday that it couldn't do much about the wild overuse of the drugs in kids--hm, maybe the agency should stop making up diagnoses for kids then--by doctors and suggesting that it was up to medical societies to educate its membership about all of this.
Of course, there are cases where the use of these drugs is justifiable, and Autism Vox points to the case of the author's own son, who was banging his head against walls:
"I really didn’t want to put Charlie on medication. And truly, it’s not the “answer” in and of itself for addressing aggressive or “problem behaviors.” Even as he wrote the first prescription for Risperdal for Charlie, our pediatric neurologist told us sternly that Charlie also had to have behavior therapy; that we had to keep his education in mind first."Charlie was 7 1/2 when he started taking Risperdal — since then, mostly via this post, I’ve heard of younger and younger children being prescribed Risperdal. The federal panel’s concern seems very much justified."
I'd wager that a very small percentage of kids being given these drugs are anywhere close to Charlie's situation.
As I noted on Monday, an FDA committee of outside experts was set to review the use of the atypical antipsychotic Zyprexa in teens. The meeting, according to the New York Times, turned into quite the affair with doctors denouncing safety labeling for the Lilly drug and Risperdal, a similar J&J product, "saying that far more needed to be done to discourage the medicines’ growing use in children, particularly to treat conditions for which the medicines have not been approved."
It's really heartening to hear this kind of talk from researchers on an FDA committee, since I've been making this same basic point on this site and in print for over three years (in adults and kids) and plenty of readers have attacked me as a loon. I assume they'll be warmer to the same criticism coming from researchers. Perhaps, they'll also stop calling me an anti-psychiatrist and Scientologist. Or is that what they are going to start calling members of the FDA panel?
As I've noted before, a lot of this antipsychotic use in youngsters seems to be going on with ADHD, at times a proxy diagnosis for child bipolar disorder (which doesn't exist in the DSM or insurance codes and so ends up being officially coded as ADHD).
"More than 389,000 children and teenagers were treated last year with Risperdal, one of five popular medicines known as atypical antipsychotics. Of those patients, 240,000 were 12 or younger, according to data presented to the committee. In many cases, the drug was prescribed to treat attention deficit disorders."But Risperdal is not approved for attention deficit problems, and its risks — which include substantial weight gain, metabolic disorders and muscular tics that can be permanent — are too profound to justify its use in treating such disorders, panel members said.
"'This committee is frustrated,' said Dr. Leon Dure, a pediatric neurologist from the University of Alabama School of Medicine who was on the panel.'And we need to find a way to accommodate this concern of ours.'"
I'd suggest they start by reaching out to their peers who give kids Risperdal, Zyprexa, Seroquel, Abilify and the whole shooting gallery of antipsychotics and ask them what the hell they are thinking and to justify taking these kinds of risks with kids (or adults, for that matter). In my opinion, this isn't so much a matter of a labeling issue with the FDA (the committee wants stronger label warnings, but there's good evidence that docs ignore these), as it is a medical culture issue and a problem with our broader culture.
The problem with medical cultural is currently under investigation by the US Senate, including the roles of prominent psychiatric researchers at Harvard, Emory University, the University of Texas and the University of Cincinnati. Exhibit A when it comes to antipsychotic use in kids would be Joseph Biederman, a professor of psychiatry at Harvard and inventor of child bipolar disorder, who's been pimping for the use of these drugs in kids way beyond their approved indications for years. At the same time that he's barking for pharma companies, he's been taking NIH research money, possibly in violation of federal research rules.
Meanwhile, the FDA this summer decided to declare pediatric bipolar disorder a valid diagnosis all on its own, one of the most bizarre moves I've ever seen at that agency.
And for anyone who wants to argue that these drugs are actually OK and I am spreading misinformation about their use and how block-headed doctors are in prescribing them, read this:
"From 1993 through the first three months of 2008, 1,207 children given Risperdal suffered serious problems, including 31 who died. Among the deaths was a 9-year-old with attention deficit problems who suffered a fatal stroke 12 days after starting therapy with Risperdal."
I've also identified other deaths and serious problems with anti-psychotic use in kids and teens.
"Dr. Dure said he was concerned that doctors often failed to recognize the movement disorders, including tardive dyskinesia and dystonia, that can result from using these medicines."'I have a bias that extra-pyramidal side effects are being under-recognized with these agents,' Dr. Dure said.
"Dr. Laughren of the F.D.A. said the agency could do little to fix the problem. Instead, he said, medical specialty societies must do a better job educating doctors about the drugs’ side effects."
That's some really interesting talk from Thomas Laughren, director of the FDA's psychiatry products division, who was in charge of deciding that pediatric bipolar disorder was valid and who, as it turned out, had been working hand-in-hand with some researchers (who of course run trials for Big Pharma) to develop clincial trials for pediatric bipolar disorder several years ago, while employed at the FDA. Laughren has refused to answer questions about pediatric bipolar disorder and his role in its development and the agency has ignored repeated requests for information about Laughren's participation in the same.
As I did recently in regards to forced, involuntary ECT, if anyone wants to write something defending the use of antipsychotics in kids for non-psychotic disorders, send it to me and I'll post it.
I'll be back later this morning with some thoughts on just how screwed up things are at the FDA.
Thanks to a reader for passing along this fascinating and saddening article from Chicago about an Iraq War veteran who's wound up homeless due to PTSD and for whom the Veteran's Administration has had a classic, All-American response:
"Larson has been treated at Veterans Administration medical centers in Monterey, Calif., and Raleigh, N.C., and has sought treatment at the Jesse Brown VA Medical Center in Chicago."However, he claims, not a single one of these facilities has offered him the care he needs.
"'All the psychiatrist was ever there to do was to give me this prescription paper and tell me to go to the pharmacy,' he said, adding that VA psychiatrists had put him on a battery of pharmaceuticals, including Geodon, Zoloft, Zyprexa, Seroquel and Lithium, but nothing helped.
"'I didn't want pills,' he said. 'I just wanted someone to hold my hand and tell me it was going to be OK. I know it sounds weird, but I just needed to talk to someone.'
"Larson is one of a growing number of young veterans who, faced with record-high levels of depression, post-traumatic stress disorder and traumatic brain injury, are suffering invisible but often debilitating scars and, according to emerging reports, are all too often falling through the cracks of a system unable-or unwilling-to provide them with care."
I've argued before on this site that we've got to do a better job of addressing the needs of our returning vets, 20 percent or so of whom are returning with PTSD or some level of psychological distress. What's more, it's got to be a comprehensive psychological approach, not just meds, meds, meds. But that's what soldiers are getting:
"Hughes, who has met hundreds of veterans of the wars in Iraq and Afghanistan in recent years, says it is an all-too-common response."'They are doping people up instead of treating them,' he said.
"Brett Keen, an Afghanistan veteran and former Army reservist, echoed Hughes' criticisms. After he 'hit rock bottom,' Keen said, he went to the Elgin VA clinic and was only offered a monthly, 15-minute session with an online psychiatrist.
"'And all he wanted to do was give me drugs,' Keen said. 'He didn't want to talk about anything useful, like how's it going or are you trying to kill yourself. They just kept changing the dosage or adding new meds.'"
Sigh. There's only so much one can say about this situation, but as our nation goes around rescuing banks and, maybe, automakers and homeowners who took out insane loans, you'd think we could put some resources and effort into helping these folks out. But, then, this is America, isn't it?
Given the number of cases of vets killed or wounded all over again by some of the meds the VA is passing out for PTSD, we've simply got to do better.
The American College of Physicians, the big internal medicine group, yesterday released its clinical practice guidelines for the treatment of depression with anti-depressants. Non-psychiatrists prescribe about 80 percent of anti-depressants and most of those would be written by internists and GPs and family medicine docs, so these guidelines are important in that presumably a high percentage of the docs who prescribe anti-depressants might actually read them.
They are important in another regard: the guidelines assert that there is virtually no difference in efficacy among second generation anti-depressants (SSRIs, SNRIs, etc.), so in other words the differences among anti-depressants are pretty much like the differences between brands of gasoline; and, the guidelines assert that there is solid evidence for suicidality in some people taking anti-depressants, something that come as a shock to members of the American Psychiatric Association.
First, I do want to point out what I consider some omissions in the guidelines. One, while I know the title is "Using Second-Generation Anti-Depressants to Treat Depressive Disorders," there is no recommendation for psychotherapy or CBT, which is odd considering that Britain's NICE has determined that there is plenty of evidence to make CBT a first line treatment (after diet, exercise and watchful waiting). The ACP guidelines do state that the psychotherapies are effective, but leave it at that (then again, what do you expect from MDs?). But it is 2008 now, not 1993.
There is also no discussion whatsoever in the guidelines of withdrawal or how to get patients off of anti-depressants. That's an interesting omission considering that the ACP guidelines do not call for lifetime treatment of depression with anti-depressants. More on that in a bit.
As to anti-depressant efficacy, the guidelines state:
"The results of individual studies showed no significant differences between SSRIs or between SSRIs and SNRIs, SSNRIs, or other second-generation antidepressants. Some evidence from meta-analyses showed statistically significant differences between treatments; however, the effect sizes were small and the results were probably not clinically significant."
After two decades of companies trying to carve out comparative advantages for their anti-depressants, that's a stunning bit of news.
"Studies evaluating the risk for suicidality (suicidal thinking or behavior) in patients showed no differences among second-generation antidepressants (90–94). However, 1 meta-analysis showed that although no evidence indicated an increase in the risk for suicide with SSRIs (odds ratio, 0.85 [CI, 0.20 to 3.40]), the risk for nonfatal suicide attempts did increase (odds ratio, 1.57 [CI, 0.99 to 2.55]) (91). Another meta-analysis of published data (95) showed similar results, with SSRIs associated with an increased risk for suicide attempts compared with placebo (odds ratio, 2.25 [CI, 3.3 to 4.6])."
So there you have it: a fairly learned group of doctors has determined that, based upon the scientific evidence available to them, anti-depressants can cause suicidality. Someone ought to alert the producer of "The Infinite Mind" radio show, after this year's show where several docs claimed there is no evidence for suicidality.
Feel free to review the guidelines yourself and see what they say about other problems associated with anti-depressant use. I'm sure some readers, who I know truly hate anti-depressants, will find their assessments incomplete, but it's fairly honest document, as these sorts of things go.
As far as how long doctors should treat a patient with anti-depressants, the guidelines state:
"Patients who achieve remission with acute-phase treatment should continue receiving antidepressant therapy for 4 to 9 months to prevent relapse. No evidence indicates differences among second-generation antidepressants in preventing relapse (loss of response during continuation-phase treatment) or recurrence (loss of response during maintenance-phase treatment). Patients who have had 2 or more episodes may benefit from a longer duration of therapy (years to lifelong)."
While I appreciate that the guidelines do leave open the possibility of lifetime treatment with anti-depressants, it's clear to me that this isn't the emphasis. That's a huge change from generally-accepted principles circa-1995. It's not perfect, but it's sure better.
What puzzles me, however, is that since the ACP guidelines admit that patients will want to go off anti-depressants and that that would be clinically desirable, there is no discussion or advice whatsoever relating to how to get patients off anti-depressants.
I wonder why.
Most of you are aware that for the last few weeks I've been noting the presence of the Abilify for depression TV ad, which has been running late nights. Abilify is an atypical antipsychotic, carries black box warnings for all manner of problems associated with that class of drugs, and yet nowhere in the ad is it mentioned that the drug is an antipsychotic. Instead, throughout the ad it's only referred to as an anti-depressant.
Last week, I asked the FDA if the agency had reviewed the ad or if it had plans to. The reply I got this morning from Sandy Walsh (who I know is doing her job within institutional constraints), the agency's spokeswoman for psychiatry products, speaks volumes about just how useless the FDA has become and how it clearly represents the needs of industry but not of consumers:
"We don't comment publicly about currently running ads, so there's nothing we can say specifically about Abilify's TV ads."Generally, individual ads for prescription drugs are not required to include information about all of a drug's indications, but may instead be limited to promotion of one of the drug's approved indications.
"And, generally, if the FDA were reviewing an ad and the agency is going to take action against a company for a certain advertisement, we would not be able to discuss that publicly until after the agency took an action.
"For more information on the regulation of prescription drug advertisements, please see our DDMAC web site at http://www.fda.gov/cder/ddmac/faqs.htm
"For information about warning letters that have been issued to companies about their ads, please see our Warning Letters site at http://www.fda.gov/cder/warn/warn2008.htm"
It's not clear to me if the agency's no comment is a result of federal law or of agency policy. Walsh hasn't answered my question on that point nor did she or anyone at the agency address the sticky issue of an antipsychotic being marketed as an anti-depressant. So how is the public to tell the difference between an Abilify TV ad and a Cymbalta TV ad? Surely, the FDA ought to be concerned about that, especially since the approval trials for Abilify as an add-on treatment for depression make it clear that the drug causes akathisia in about 25 percent of patients.
I asked Walsh where readers could direct their concerns about the Abilify for depression ad. You can direct whatever comments you wish to make to:
Food and Drug Administration
Center for Drug Evaluation and Research
Division of Drug Information
5600 Fishers Lane, HFD-240
Rockville, MD 20857
Telephone number: (301) 827-4573 or 1-888-INFOFDA (463-6332).
E-mail address: druginfo@fda.hhs.gov
At a minimum, the agency should review this ad, which I consider to be highly deceptive. The reality is that antipsychotics are not anti-depressants, pure and simple.
UPDATE: If you call the above number/s, the nice person on the other end will ask you to fill out a Med Watch report. You can do that at www.fda.gov/medwatch and press on "begin." You don't need to include patient information or date of event since you are complaining about a TV ad. Or you can just send email to the above email address.
Seems like a rather complex system for the public to report concerns about a TV ad.
I was reviewing an FDA staff document this morning, wherein FDA staffers recommend additional warnings for Zyprexa for pediatric cases (ie, teens) and ran across a startling statistic. According to the agency's own adverse events database summarized in the report, the controversial atypical antipsychotic has killed 3,455 people (see page 7 of the above document) between 1997 and early 2008.
Roughly half of the deaths are known to have occurred in the US while the remainder are from unidentified locations (likely a mix of US and foreign deaths).
What startles me is that last fall I reported on a study of the FDA's adverse events database in which researchers reported that Zyprexa had killed 1,005 people from 1998 to 2005, so this new accounting represents a large increase in deaths associated with the drug. Even more, according to that same study, Vioxx had killed 932 people. So why do Vioxx cases get all the media attention while Zyprexa does not? Why is Zyprexa still on the market and raking in $4 billion or so a year in sales while Vioxx is off the market?
Why on earth has this drug been marketed for casual use far beyond its initial use as an antipsychotic?
As of now, Zyprexa is not approved for use in children and teens, but Eli Lilly has an application before the FDA to gain approval for its use in teens diagnosed with schizophrenia. Amazingly, one published study of Zyprexa in teens found that in a three-week trial of the drug patients gained an average of eight pounds, which is a lot for such a short time period. That's why the FDA staff in the above document is recommending additional warnings about weight gain in pediatric populations.
(Via Pharmalot.)
From MindFreedom I learned yesterday that Ray Sandford, whom I wrote about last week, has been given a one-week reprieve from the forced, involuntary ECT treatments he's had to endure in recent months. The bad news is that he's scheduled for another go-round next Wednesday, the day before Thanksgiving.
Nice touch.
Christopher Lane, a professor of English at Northwestern University and author of last year's "Shyness: How Normal Behavior Became a Sickness," had an excellent op-ed in yesterday's Los Angeles Times, flagging for the public just how contentious matters have become around the development of DSM-V.
"The bone of contention: whether the next revision of America's psychiatric bible, the "Diagnostic and Statistical Manual of Mental Disorders," should be done openly and transparently so mental health professionals and the public could follow along, or whether the debates should be held in secret."
DSM-IV, which came out in 1994, was rife with researchers flush with pharma funding devising new psychiatric disorders, none more prominent than bipolar disorder type 2, introduced in that edition of psychiatry's so-called Bible. DSM-V is due in 2012 or 2011 (depending on which account one is reading at what time) and it's now come out that Robert Spitzer, a professor of psychiatry at Columbia University, is hopping mad about what he characterizes as a closed door around the creation of DSM-V. It's already been reported that DSM-V's creators have deep ties to Lord Pharma.
When someone like Spitzer gets riled-up about the DSM, then you know something goofy is going on. Spitzer was the main creator of 1980's DSM-III, which introduced the concept of disorders to mental illness and tried to cast the whole thing as science-based, and has remained influential in the psych establishment ever since.
As it turns out the current DSM writing crew is refusing to let Spitzer have a look-see at their deliberations and minutes. Perhaps that's because word is the APA-assembled crew is considering some wacky new disorders to become fully enfranchised as mental illnesses. As Lane notes:
"Hanging in the balance is whether, four years from now, a set of questionable behaviors with names such as "Apathy Disorder," "Parental Alienation Syndrome," "Premenstrual Dysphoric Disorder," "Compulsive Buying Disorder," "Internet Addiction" and "Relational Disorder" will be considered full-fledged psychiatric illnesses...."Behind the dispute about transparency is the question of whether the vague, open-ended terms being discussed even come close to describing real psychiatric disorders. To large numbers of experts, apathy, compulsive shopping and parental alienation are symptoms of psychological conflict rather than full-scale mental illnesses in their own right. Also, because so many participants in the process of defining new disorders have ties to pharmaceutical companies, some critics argue that the addition of new disorders to the manual is little more than a pretext for prescribing profitable drugs."
Those are some very odd disorders indeed and sure are consistent with a push I've seen in other quarters of psych research to have 50 percent of Americans diagnosed with some form or other of mental illness--at which point the term abnormal psychology will have lost all meaning.
I'm pleased Lane flagged this squabble within the academy because as goes the DSM so goes psychiatry, courts, social work and education the world over. What's going on with the new DSM deserves much more media attention then it's gotten to date, but unfortunately with 5,000 or so journalists in the US having been laid off in the last few months there may not be anyone around to bird dog the process in the press. That'd kind of suck because it sounds like it's going to be a grand show.
Like Lane, I'm not interested in embarrassing anyone, but apathy disorder? Really? Once that's defined, "treated" and "cured," where will the world look for a source of literature and popular music? What's the need to have one and all in line with the mainstream social order and all hyper-effecient at work? Strikes me as a boring arrangement.
One small nit I have with Lane's op-ed--and this is really more addendum than nit--is that he didn't mention that bipolar disorder is once again going to be on center stage in debates around the new DSM. Serious consideration is being given to including a new bipolar disorder type 3 or subthreshold bipolar disorder. Also up for inclusion is child bipolar disorder, which is a very controversial diagnosis. This summer, you may recall, the FDA went off on its own and declared pediatric bipolar disorder a valid diagnosis, and then offered a very sloppy set of consensus statements by researchers to support its conclusion. What's more, the FDA's chief of psychiatry products had been intimately involved in helping researchers and pharma companies design the diagnosis--and that's the kind of conflict of interest that no one should support.
It will be interesting to see where the APA takes concerns like Spitzer and Lane's (and mine and yours). You can read the original exchange of letters between Spitzer and APA President Nana Stotland--who incidentally doesn't believe that anti-depressants can induce suicidality--here and here.
I interviewed Lane about his book last year.
I was out on a walk yesterday afternoon and ran into a friend in the neighborhood, one who I don't run into so much these days. She's in her late-20s and told me she was feeling crappy. Why? I asked.
"Oh, I finished tapering off my anti-depressant and I feel all slowed down."
The anti-depressant in question was citalopram (Celexa in branded form) and she'd tapered down from 10 mgs. over four weeks, a bit too fast in my experience. But she wanted off the drug, which she'd been on for two years, because she felt it wasn't doing much for her, so she went for it. We talked and as it came out she'd experienced some of the buzzing in the back of the neck that many people experience coming off an SSRI. No brain flashes though.
I assured her the sluggishness she was feeling was fairly common following SSRI withdrawal and that hopefully it would clear up in a week or two. But it could take longer. She was worried about having to go back on citalopram. I told her about some I know in Seattle who's been hooked" (his term for it, not mine) on Prozac for 20 years, despite several lengthy attempts to taper off the drug.
I sensed she hadn't looked into any outside resources for managing her withdrawal--Peter Breggin would've argued for a much longer taper--and I told her that what she was experiencing was almost entirely unresearched by researchers. She asked if I was kidding.
"No, I'm not," I said. "Kind of weird for drugs that are taken by 30 million people every day."
One of these days, researchers and the pharma companies will take psych med withdrawal as a serious issue and do appropriate research about how to get people off a med, should the patient want it or should the medical need arise.
Until then, I am going to keep banging on this issue. I'm sick of watching people I know go through hell when they try to come off these meds while the mental health industry stands by and acts as if nothing is happening.
A reader passed along a fascinating article from this week's New Yorker. It concerns a University of New Mexico cognitive neuroscientist named Kent Kiehl, who is using fMRIs to scan the brains of hundreds of prisoners at a state prison in New Mexico. Kiehl is trying to nail down the neurological roots of psychopathy, or sociopathy as it's more commonly known. Your amoral, remorseless killers in other words.
Kiehl's basic thesis is that psychopathy is caused by a defective paralimbic system in the brain and that it's likely not a personality disorder, as it's currently classified in the DSM. The article states that as much as one-quarter of prisoners in North America have psychopathy and that it exists in about 1 percent of American men (women are thought to be much rarer), many of whom never commit crimes. Those who do, of course, are legendary due to their epic destructiveness, the Ted Bundy's and Charles Manson's of the world.
I've written about two murderers before who I'm convinced were psychopaths (so the article interests me in many ways) and I've encountered a few people in real life who fit the bill. What the article says about something being up with their eyes and how they look at you is true in my estimation.
The article does a good job of delving into the history of psychopathy as a diagnosis and the test used to rate peoples' psychopathy. Kiehl's mentor also makes an appearance and makes it clear he doesn't necessarily buy all this fMRI business:
"Hare is less gung ho about using fMRI as a diagnostic tool. 'Some claim, in a sense, this is the new phrenology,' Hare said, referring to the discredited nineteenth-century practice of reading the bumps on people’s heads, 'only this time the bumps are on the inside.' (Hare himself is a 'strong proponent' of brain-imaging technology, but he noted that scans in isolation will always be insufficient.)"
The crux is if psychopathy can be proven to be a mental illness--loosely put, as a result of being born with a disordered brain--as opposed to a personality disorder--which it is, as the DSM currently calls it antisocial personality disorder--then that will open a huge trap door of consequences.
"Like many in the field of psychopathy research, Kiehl is aware of the enormous social implications of accepting psychopathy as a form of mental illness. What, for example, would you do with the young psychopaths who don’t respond to treatment? The stigma would be profound. It’s not hard to imagine a day when everyone’s personal psychopathy risk will be assigned early in life—a kind of criminal-potential index. Kiehl was recently appointed as a scientific member of the MacArthur Foundation’s Law and Neuroscience Project, which will study some of the legal implications of neuroimaging."
I sure as hell hope that whatever scientific evidence might be eventually used is vastly more science-based than what's come our way in the mental illnesses. As if in recognition, Kiehl says:
"'It used to be the case that it was very hard to meet clinical criteria for depression in the fifties and sixties. However, the definition of depression has been broadened so much with DSM-IV that nearly every person will meet the criteria at some point in their lives. One reason for this is that drug companies have lobbied to change the criteria-—because they have a treatment, a drug, that can help people even with moderate levels of depression. It’s a completely different issue whether this is appropriate.' He added that 'even moderate levels of psychopathy may someday be considered a disorder—-especially if we can treat it.'"
Interesting to hear a neuroscientist slamming the DSM so casually.
The reader who passed this article along--thanks!--surmised that much the same thing has gone on with the softening of manic-depression/bipolar disorder over the last two decades, a softening I expect to continue with DSM-V in 2012. While I cannot say for certain that the pharma companies were intimately involved with the softening of bipolar disorder, it's well-known that most of the researchers responsible for putting together DSM-IV in 1994, when the big softening occurred, had deep ties to Big Pharma. The writing group for DSM-V is deeply tied to pharma as well.
Draw your own conclusions. And read the above article. It's a good one.
I've been following the discouraging saga of Iraq War vets diagnosed with PTSD who've died suddenly in their sleep, apparently as a result of some of the psych meds they were being given or due to an interaction between the drugs. The Washington Times has a nice feature out today on the father of one of four vets who died in West Virginia. So far, according to the paper, nine vets have been identified as dying due to PTSD meds.
"'Our goal was to find out if the medications are safe,' said Mr. White, who, with his wife, continues to grieve the loss of his son. 'If they are, that needs to be publicized. But if they are not, that also needs to be publicized as well.'"'I believe there are many more soldiers and Marines who have died in their sleep just like the four in West Virginia,' said Mr. White, a retired high school principal. 'I think what we have found is just the tip of the iceberg, but we need more national publicity to help us find others who have lost loved ones and are looking for answers.'"
The four vets who died in West Virginia were on Seroquel and Paxil and that gave one longtime critic of psych meds reason to reach out to the Whites.
"'The drugs and the occurrence there in the four vets in West Virginia really jumps out at you,' said Dr. Fred Baughman of El Cajon, Calif. 'They are seemingly OK, and then they go to bed and they die in their sleep.'"'The constant drugs that all four of them are on are the Paxil [paroxetine] and Seroquel [quetiapine],' said Dr. Baughman, who has long had his own concerns about PTSD drug prescriptions in the military."
Our troops deserve a whole lot better than what they are getting here and--gosh, I hope this doesn't com across as anti-psychiatry--we've got to stop leaning on treating them with psych meds.
This matter is quite pressing since, if President-Elect Obama is to be taken at his word, we'll be out of Iraq 16 months after he takes office and there will be lots of troops coming home with PTSD-ish issues.
I've written about PTSD and our veterans many times. You can read those pieces here.
There's a semi-interesting article in today's New York Times on people, reportedly delusional, who've found aid and comfort via Internet groups that support their views of mind control and gang stalking. Having dealt with a few of these sorts over the years--they have a habit of showing up at newspaper offices and demanding that reporters investigate X or Y group that is following them--this strikes me as a rather benign activity, certainly no more harmful than some of the extreme political discussions or sci-fi discussions or role playing groups on the Net.
But some find cause for concern:
"Dr. Ralph Hoffman, a psychiatry professor at Yale who studies delusions, said a growing number of his research subjects have told him of visiting mind-control sites, and finding in them confirmation of their own experiences."'The views of these belief systems are like a shark that has to be constantly fed,' Dr. Hoffman said. 'If you don’t feed the delusion, sooner or later it will die out or diminish on its own accord. The key thing is that it needs to be repetitively reinforced.'"
OK, if that's the best the author can offer to support the "oh so scary" thesis, then we have nothing to fear at all. You have to wonder what prompted the article in the first place, as in is there a news hook here at all.
Vaughan Bell, a UK psychologist and author the Mind Hacks blog, offers:
"Dr. Bell and some other mental health professionals say that even if the users of such sites are psychotic, forging an online connection to others and being told — perhaps for the first time — 'you are not crazy' could actually have a positive effect on their illnesses."'We know, for example, that things like social support, all of these positive social aspects are very good for people’s mental illness,' Dr. Bell said. 'I wouldn’t say it’s entirely and completely positive, but it can be positive.'"
And:
"'These people lead quietly desperate lives,' said Dr. Jeffrey A. Lieberman, chairman of the Department of Psychiatry at Columbia University. 'And if they are reinforcing each other and pulling people toward something, if they are using the Internet and getting reinforcement, that’s good.'"
Anyway, an interesting slice of where the Net is taking our culture, even our more extreme elements.
It all sort of reminds me of this group of people who once pestered the hell out of newspaper I worked at. They were believers in "chemtrails," or the belief that the government was seeding the sky with chemicals to keep Americans under control. I couldn't deal with these folks at all but mentioned it to a colleague of mine who got one of the best features out of it that I've ever read. It's still good reading today. Enjoy.
It's interesting to me in a rather ironic way to see how many people (lots) now read this site and its comments and walk away with the conclusion that you and I are all a bunch of bitter nutbags who don't accept our true reality and the help being offered to us by doctors and pharmaceutical companies. For example, yesterday I was denounced as an anti-psychiatrist on a major Internet list--which is amusing since some anti-psychiatrists think I am a pro-psychiatry pharma whore--and this morning this comment was left by a new reader who'd been referred to my site by its inclusion on a top mental health blogs list. In part:
"All I see from this blog is bitterness and judgment and people who would rather place blame than take responsibility for their actions. Doctors and Pharmaceutical companies are trying to help us with the knowledge and tools they have and I, for one, am thankful that they do."I will not be returning to this blog and would never recommend it to anyone interested in truly educating themselves about depression and the available methods to treat it."
I'm pleased this person won't be returning and I've banned their IP address so they cannot comment further. They were upset over criticism of the Abilify for depression TV ad. In a weird way I guess it's flattering and an indication of this site's reach on the Net--and the influence (actual or feared) of all of you as a community--that "critiques" along these lines have become something I have to contend with on a daily basis.
Just thought I'd share.
From the AP:
"PORTLAND — Authorities say Mitch Mitchell, drummer for the legendary Jimi Hendrix Experience of the 1960s, has been found dead in his Portland hotel room."Erin Patrick, a deputy medical examiner in Multnomah County, says Mitchell was found dead a little after 3 a.m. today in his room at the Benson Hotel in downtown Portland.
"She says Mitchell apparently died of natural causes at 62. An autopsy is planned."
"He was in Oregon to play with the Experience Hendrix Tour. Now all the members of the Jimi Hendrix Experience, certainly one of the great bands in rock history, are dead. Hendrix died in 1970. Bassist Noel Redding died in 2003.
Sad.
Last night, I saw a new version of the Abilify for depression ad on TV. As with the first version of the ad, nowhere is it mentioned that the drug is actually an antipsychotic. Instead, all the language is about anti-depressants, usually in reference to the well-known anti-depressant black box warning. Thus Bristol-Myers Squibb is effectively marketing an antipsychotic as an anti-depressant. This is just so bizarre. Sadly, I cannot find a Web version of the ad to post.
Of note is that instead of a single white woman, the ad now features several shots of a tension-filled white man--of course he's smiling at the end of the ad as he goes to get the mail--and brief shots of an African-American woman. I note that for what it's worth. I'm fascinated by the social imaging around psych meds ads.
Still no word from the FDA on whether it has reviewed the Abilify for depression TV ad and what the agency thinks of BMS marketing the drug as an anti-depressant.
Once again, let me point out that the Abilify for depression clinical trials showed using the drug for depression resulted in a better chance of causing akathisia than of improving depression.
CNS Response reported today the results of a study presented at the U.S. Psychiatric and Mental Health Congress by Daniel Hoffman, Chief Medical Officer for CNS Response. The poster presentation was an analysis of SSRI as a first-line treatment in children or adolescents.
"'Due to the FDA's warning of suicide risk, coupled with the popularity of SSRI prescriptions for children and adolescents, we reviewed the CNS Response rEEG database and associated reports, in combination with our own patient data, to look for any trends in this age range that might provide further insights in consideration of these medications. The results beg for a larger analysis, as the findings give credence to SSRIs not being the drug of choice for some children and adolescents with depression.'"
Anyone who thinks these drugs have loads of efficacy--and that I am a fool for insisting that the effect size of SSRIs runs at about 30 percent or less--might want to pay attention to this:
"One conclusion of this analysis was that, at most, 26 percent of these patients might be expected to sustain a good response to an SSRI. Seventy-four percent would not be expected to be responders, or their response probability would be so low as to question the risk of negative response to the probability of positive response."
Oh, yes, these are wonder drugs.
A fascinating article in yesterday's New York Times on how two researchers are introducing what some experts consider a huge development in understanding brain development and human behavior.
"Their idea is, in broad outline, straightforward. Dr. Crespi and Dr. Badcock propose that an evolutionary tug of war between genes from the father’s sperm and the mother’s egg can, in effect, tip brain development in one of two ways. A strong bias toward the father pushes a developing brain along the autistic spectrum, toward a fascination with objects, patterns, mechanical systems, at the expense of social development. A bias toward the mother moves the growing brain along what the researchers call the psychotic spectrum, toward hypersensitivity to mood, their own and others’. This, according to the theory, increases a child’s risk of developing schizophrenia later on, as well as mood problems like bipolar disorder and depression.In short: autism and schizophrenia represent opposite ends of a spectrum that includes most, if not all, psychiatric and developmental brain disorders. The theory has no use for psychiatry’s many separate categories for disorders, and it would give genetic findings an entirely new dimension."
You can read the rest for yourself, since none of this is concrete enough to know what to do with it yet, or even how to criticize it. But let me offer my usual skepticism: for at least two decades psych researchers and biologists have been saying that mental disorders are genetically-determined and that they are on the verge of unlocking the secrets of human genetics in this regard. I've seen zero results and until I do, I'll continue to consider their theories to largely be a bunch of bull.
Some of you know that yesterday Google announced that it was working with the CDC to monitor flu-related searches in its search engine ("flu," "flu symptoms," "muscle aches") and, further, to pinpoint what part of the country the searches are/were coming from and turn the results over to the CDC, otherwise known as the federal government.
Although both parties are offering assurances that the data won't be used to pinpoint individuals, I simply don't trust either Google or the CDC enough to be comfortable with said assurances. Anytime the feds gather personal data beyond basic income and tax information I get worried. I also don't trust public health agencies to limit their interests to relatively benign efforts to track possible flu outbreaks. If tracking the flu by Internet searches works to their taste, what's to stop them from monitoring other searches in the name of public health? You could seriously see a day when the CDC monitors America's mind via the Internet for suicide searches, depression symptoms searches, cheap cigarettes searches and so on and agency officials would come kicking down someone's door with an offering of Prozac or Seroquel (or Chantix) or they'd demand that such and such a teen undergo a mental health screening or go to counseling or he'll be taken away for the good of society.
"We've seen your son's Google searches, sir."
I worry about that kind of thing, from time to time when the government and high tech companies start working hand in glove. The Internet used to be a place for freedom of expression, now it's trending towards a place where our simplest impulses are observed. Google execs hinted that there's more to come:
"'From a technological perspective, it is the beginning,' said Eric E. Schmidt, Google’s chief executive."
Nice.
Here's how the CDC justified the program:
"Some public health experts say the Google data could help accelerate the response of doctors, hospitals and public health officials to a nasty flu season, reducing the spread of the disease and, potentially, saving lives."'The earlier the warning, the earlier prevention and control measures can be put in place, and this could prevent cases of influenza,' said Dr. Lyn Finelli, lead for surveillance at the influenza division of the C.D.C. From 5 to 20 percent of the nation’s population contracts the flu each year, she said, leading to roughly 36,000 deaths on average."
It'll be interesting to see how this all works out. And where it all goes.
Ironically, yesterday I spiked a small fever in the late morning, but I didn't need a Google search to tell me what to do: rest, fluids, aspirin, don't go out into the wind and rain for a walk (I'm already pounding vitamins). By mid-afternoon, the fever was gone and I took it easy on myself last night, although it was tempting to get out. It was a long, dark rainy day and an even bigger storm moved in during the evening, one that will apparently hammer the Seattle area for the next 24 hours or so.
Maybe the CDC would like to bring me an umbrella?
Yesterday when I wrote about a case of forced, invountary ECT--outpatient no less--being imposed on a man in Minnesota, I noted that if anyone wanted to write a defense of involuntary ECT, then I'd post the result. Well, an anonymous neuroscientist in the UK who writes the Neuroskeptic blog took me up on my offer and wrote a post on his end.
His basic argument, which I find weak, is that ECT worked for his grandfather back in the days before anti-depressants in the 1940s. And, then, he continued:
"* Sometimes consent is a luxury"My argument is that involuntary ECT is sometimes justified because in psychiatry, involuntary treatment is sometimes necessary, and ECT is sometimes the only treatment that works. Some people object to all forced treatments, whether ECT, or medication, or anything else. I respect this, and I agree that in principle, treatment should only ever be given with consent. Adults should not be treated if they have made an informed choice not to be - as patients we have a right to autonomy, including a right to refuse treatment and even a right to die.
"However - in psychiatry, things are not so simple. It's often those who are most ill, those who have the most to gain from treatment, who are most likely to refuse it. From my own experience I know how even moderate depression can warp your thinking - severe illness can lead people to be, temporarily, unable to make informed decisions. They may not know that they are ill, or they may not be able believe that there is any hope of recovery.
"If someone is in such a state - whether they are extremely depressed, manic, or psychotic - it would be cruel and neglectful not to treat them, by any means necessary. Surely that's common sense - if your friend was blind drunk and tried to drive home because he thought he was completely sober, you'd be responsible for his safety if you didn't try to stop him. If I got drunk and started acting stupidly I'd want my friends to look after me, and when I woke up the next morning, I'd be angry if they hadn't."
Oh and it wouldn't be cruel and neglectful to take a procedure that has very unpredictable results and then zap someone's brain and scrub off their short-term memory?
Perhaps, I look at this too much as an American (we tend to take our civil liberties a bit more seriously than Brits do, sad to say), but consent is never a luxury, it is essential when it comes to ECT (I could make that argument for about 98 percent of mental health care, too) because ECT is so risky and even psychotic people have a right to not run the risk of having their brains zapped. If you think it's not important, read this post by someone who had it done to them, somewhat voluntarily.
Voluntary ECT, as I noted yesterday, is a different matter altogether.
Anyway, offer your thoughts in comments here or over at Neuroskeptic's blog.
In September, I noted press coverage of a forthcoming study asserting that Paxil damages sperm. The study was presented over the weekend at the annual meeting of the American Society for Reproductive Medicine in San Francisco. It's not clear to me when the study will be published, but one assumes it'll be fairly soon.
Meanwhile, read it and weep, men (and women):
"[T]he five-fold increase in the number of men who developed abnormal sperm DNA while being treated with paroxetine is 'troubling' and 'suggests an adverse effect on fertility,' co-investigator Dr. Cigdem Tanrikut, from Harvard Medical School in Boston, told Reuters Health."In a clinical trial she described as 'the first study to assess the impact of an SSRI on semen parameters in healthy men,' 35 men took paroxetine for 5 weeks. The drug was administered in once-daily doses of 10 mg the first week, 20 mg in the second week, 30 mg the third and fourth week, and 20 mg in the fifth week.
"Tests were conducted on semen samples obtained prior to starting paroxetine and after 4 weeks of treatment. The average DNA fragmentation score increased from 13.8 percent before paroxetine was begun to 30.3 percent at week 4, a statistically significant amount.
"The percentage of men who had a fragmentation score of 30 percent or higher before treatment rose from 10 percent to 50 percent.
"Semen analyses conducted throughout the study, however, showed normal volume, concentration, movement and appearance.
"Paroxetine was also associated with significant sexual dysfunction, with one third of men reporting problems with erectile function and nearly half reporting ejaculatory difficulties...."
"The sperm appears to be damaged by a slowing down of their transport through the body, 'a novel mechanism of damage,' [another researcher] said. 'Most agents affect fertility by knocking down sperm production. Slowing down sperm transport can allow sperm to be damaged (by higher temperatures, or just "getting too old" -- being ejaculated after they should have been).'
"'We have seen severe cases where the sperm are slowed down so much that almost no sperm appear in the ejaculate.'"
Oh, wow, none of that sounds very good.
I took Paxil for six months to a year in the mid-1990s (I don't recall how long exactly) and other SSRIS from 1990 to 1995 and again in 2002 and 2003. Needless to say, I've got some worries now, especially since study researchers offered no thoughts on whether all this sperm damage is reversible upon discontinuation of the drug.
I sure hope it is.
I stupidly thought yesterday was Veteran's Day and did a big old post about it, but as it turns out today is the day. It's a holiday and I'll be trying to keep myself away form the computer most of the day, so comment approval will be sporadic.
Have a nice day.
I saw the Abilify for depression TV ad again over the weekend and I continue to be concerned about how Bristol-Myers Squibb is very craftily making the drug, an atypical antipsychotic, sound as if it's an anti-depressant. Nowhere in the TV is it mentioned that the drug is an antipsychotic, at least not in what I've caught on-air.
I've written about the ad previously here and have also written about how the drug's clinical trials for depression show a greater chance for a patient to experience akathisia than to have his or her depression improved.
On the Abilify for depression website, which viewers are directed to, the drug is described thus:
"If an antidepressant alone isn't enough, maybe ABILIFY can help. ABILIFY is the first medication approved by the FDA for add-on treatment to antidepressants for adults with MDD. In clinical studies, when ABILIFY was added to an antidepressant treatment, many people experienced significant improvement of their depressive symptoms."If you're currently on antidepressant therapy and are wondering if adding ABILIFY could help you achieve additional symptom relief, ask your healthcare professional if ABILIFY could be right for you."
The site also includes text of the black box warning for anti-depressants.
It's only when the website details some of the warnings for atypical antipsychotics that there's even a hint that the drug is an antipsychotic:
"Elderly people with psychosis related to dementia (for example, an inability to perform daily activities as a result of increased memory loss), treated with antipsychotic medicines including ABILIFY, are at an increased risk of death compared to placebo."
That's it. Not much of a clue of what kind of drug potential consumers are dealing with--certainly not enough for them to make informed decisions in my opinion--and one they'd have to work pretty hard to find.
It's interesting to me that BMS is, in its advertising for Abilify for depression, now ignoring the fact that the drug is an antipsychotic when in other TV commercials for the drug (those would be the bipolar disorder ones targeted at women) it mentions that the drug is an antipsychotic. Why the difference now?
Regardless of the company's motivation, antipsychotics as a class have a host of problems associated with their use: diabetes, metabolic syndrome and heart problems to name a few. The drugs, including Abilify, are subject to black box warnings for diabetes and early deaths among seniors. That sort of information should be included prominently in the TV ad and the drug should be identified as an antipsychotic. That's my opinion.
I'm going to let the FDA know of my concerns.
Over the weekend, I learned from David Oaks at MindFreedom that Ray Sandford, a Minnesota resident, was being forced to endure weekly ECT "treatments" against his will and without his consent. What's even more remarkable about this situation is that the court order is being enforced upon him as an outpatient--it's almost always enforced on an inpatient basis--and that's a situation such as I've never heard of before.
It's not clear to me what psychiatric condition Sandford is allegedly being treated for.
I am officially neutral on voluntary ECT--if someone wants it, it's their brain--but involuntary ECT is barbarous and amounts to torture. If anyone would like to defend involuntary ECT, let me hear from you. If you make a good argument, I might even post it.
More from a MindFreedom dispatch (slightly edited for length) here, including how you can help end this nonsense being imposed on Sandford:
"Ray says the weekly forced electroshocks are 'scary as hell.' He absolutely opposes having the procedure. He says it's causing poor memory for names such as of friends and his favorite niece. 'What am I supposed to do, run away?'..."I [David Oaks] confirmed Ray's story by calling two staff at Victory House as well as his court-appointed conservator, Tonya Wilhelm of Luthern[an?] Support Services of Minnesota.
"Ms. Wilhelm said, 'We are following the letter of the law.' She said the State of Minnesota had secured a variety of court orders that require Ray to have forced electroshock against his expressed wishes. Ms. Wilehlm says it's all legal and she can't do anything about it.
"I pointed out to Conservator Wilhelm that the public -- when they find out about forced electroshock -- is passionately opposed to their taxpayer money being used to force such brutality on citizens.
Ms. Wilhelm did let slip that what is happening to Ray -- involuntary outpatient electroshock -- is not that uncommon in Minnesota."But when Ms. Wilhelm found out we at MindFreedom are issuing one of our public human rights alert to you and others, at Ray's repeated request, she said something chilling. Ms. Wilhelm claimed she had a legal right to stop MindFreedom!
"Ms. Wilhelm told me, 'Only I can give you permission legally to say anything publicly about this.'
"I pointed out we are not a medical facility, and that if she falsely claims we're doing anything illegal then this is defamation. Which really is illegal.
"Ms. Wilhelm laughed loudly in the phone, said 'let our lawyers talk,' and hung up on me. I hope she hung up to read the First Amendment."
Wilhelm is completely full of crap on this and I congratulate MindFreedom for taking up Sandford's cause.
MindFreedom is asking people to email Minnesota Governor Tim Pawlenty and ask him to investigate Sandford's case. Please be polite when you do so. His email is: tim.pawlenty@state.mn.us or you can write to him through a Web form here.
What's more you can also write to Lutheran Social Service of Minnesota by using the Web form here. Again, please be polite.
But tell them and the Governor that this involuntary use of ECT must stop and that the law must be changed.
Update: Oops. Veteran's Day is actually tomorrow, according to the feds. But I'll let this post stand.
Although Veteran's Day--or Remembrance Day elsewhere--is technically Nov. 11, it's celebrated today in the US, a move of the 1970s that allegedly saves the feds money or something like that. After three years of doing this site, I know traffic will be down today, so I'll only have this and another post today.
The last few weeks have been pretty damn tumultuous for our country, in terms of the economy and the general election and a sense of either joy and celebration or of fear and loathing. But the one big constant in America is the fact that there are people who willing to put their butts on the line in the military for our freedom and that's what Veteran's Day is about. So I'd ask you, regardless of where you are on politics, the Iraq and Afghanistan wars and the election and so on, to take a moment to remember those people who do put their butts on the line for this country.
I've got plenty to remember on my end. My father is a combat vet, so are several of my older cousins and relatives (the wars skipped my generation), and my mother's father was a man from the streets of Brooklyn who somehow got appointed to the US Naval Academy, became a naval aviator and, from what little information I have, behaved heroically at Pearl Harbor on December 7, 1941 and was killed in a flight accident about six months later when my mother and aunt were little girls and my grandmother was suddenly widowed only months after having evacuated her daughters to California from Hawaii following the Pearl Harbor attack. My grandfather wasn't even piloting the plane that crashed, apparently as a result of a mechanical failure. I can assure you I think of that whole bit of business and the sacrifice involved on a rather regular basis.
My other grandfather was a flying mechanic in the Army Air Corps in the 1920s and was too old for active duty in the 1940s, a fact that rankled him his whole life, but for which I am thankful. At least I knew him.
When I was a kid, my grandmother, who struggled on a war widow's pension and taught piano lessons to local kids, used to make me get dressed up and then she'd take me and my sister down to Alameda to show us whatever aircraft carrier was on display or to an air show at the air station there. I can remember how on a couple of occasions she introduced me to various Navy brass (mostly admirals) who were classmates of my grandfather at Annapolis or knew him in the service and they'd pretty much stop what they were doing--shaking hands with the public basically--and take me off to show me something about a ship, submarine or airplane. I was four, five and six years old and really didn't know what any of that gesture was about. Now I do.
For the last few weeks, I've been asked and sometimes pestered by neighbors about how I was voting for President and who I voted for on election day. Here, in uber-liberal Seattle, it's social lubricant to blather on and on about politics and to find new ways in which to point out to whomever you are talking to just how progressive-liberal you are and how seamlessly you fit into the urban archipelago zeitgeist around here. The only problem is I am not and I don't exactly fit in, as I am something of a moderate and social Libertarian wrapped into one. I haven't been enamored with the takeover of the Republican party and the Presidency during the last eight years (and more) by big government Neo-Cons and I am a bit nervous about what's coming from President-Elect Obama and the bigger government Democrats and that's rather tough to talk about with Seattleites since they voted overwhelmingly for Obama and also voted in favor of a sweeping set of local tax increases in the midst of a recession. It's especially tough when I refuse to get into who I voted for with anyone except for friends.
Last week I was getting pushed rather hard on all of this by a few people one evening and I finally reached my limit on this new tradition that one's vote is not a private affair. "Look," I said, "my grandfather died for your and my right to vote, my dad got shot at for your and my right to vote and I'll vote for whoever I want, write whatever I want and be whatever I want without having to explain it to anyone."
I've been a bit worked up about such things recently, not only because of the election but because this site has found even more new readers, some of whom have slammed me pretty hard for my views on mental health, psychiatry, depression treatment and so on. The basic thrust has been: "How can you say such things? What gives you the right?"
Well, you see, there's this thing called the First Amendment and over the years many Americans have served in the military and died in order to see that it and the rest of the Constitution aren't shredded by anyone for any reason. That's what gives me the right.
And as for how I can say such things about dear old Prozac and Zyprexa (and all the rest of it), it's because I know I am right. Politics have nothing to do with it.
Have a nice day. See you tomorrow.
Seriously, that's what this new study in the Archives of Pediatrics & Adolescent Medicine asserts, after researchers looking for environmental triggers of autism ran the numbers on autism rates in counties in California, Oregon and Washington and found that counties with higher rainfall also had higher rates of autism.
"Results: County-level autism prevalence rates and counts among school-aged children were positively associated with a county's mean annual precipitation. Also, the amount of precipitation a birth cohort was exposed to when younger than 3 years was positively associated with subsequent autism prevalence rates and counts in Oregon counties and California counties with a regional developmental services center."Conclusions: These results are consistent with the existence of an environmental trigger for autism among genetically vulnerable children that is positively associated with precipitation. Further studies focused on establishing whether such a trigger exists and identifying the specific trigger are warranted."
The researchers aren't silly enough to suggest that the rain alone is causing autism, but that there is likely some underlying environmental trigger that's connected somehow with rainfall.
"Perhaps infants and toddlers are kept are kept indoors in front of the TV more in rainy climates, and that somehow causes brain changes, they said. Or perhaps they breathe in more harmful chemicals while indoors. Vitamin D deficiency caused by insufficient time in the sun might also be a trigger, they said."'Finally, there is also the possibility that precipitation itself is more directly involved,' they wrote. Perhaps a chemical or chemicals in the upper atmosphere are transported to the surface through rain or snow."
I'm not so sure I'd buy the "poison rain" theory and I've not seen the full study yet. When I do and if there's anything interesting in it, I'll post it. I'll be especially interested to see the county by county breakdown since I know all three states intimately
Meanwhile, the study has its critics, however:
"Dr. Michael Fitzpatrick, a London physician who wrote "Defeating Autism: A Damaging Delusion", expressed doubt, noting that autism diagnoses are on the rise in all climates."
Anyway, interesting stuff.
I noted the other day that Bristol-Myers Squibb has begun rolling out TV ads touting its atypical antipsychotic Abilify as an add-on treatment for people who've done poorly on anti-depressants. Doug Bremner, a psychiatrist at Emory University, caught my post and went me one better, noting that clinical trials of Abilify as an add-on depression treatment show high rates of akathisia and only about an 11 percent improvement in depression outcomes. That strikes me as small justification for the risks associated with taking an antipsychotic--and I should note that the TV ad never mentions that the drug is an antipsychotic. Lame.
What's more, for such an expensive drug, you'd expect some kind of performance, but it looks like you've got a better shot at developing akathisia than in nuking depression. At over $400 a month for the 10 mg size of Abilify, that kind of sucks (in the below trials patients were on anywhere from 2 mgs. to 20 mgs. of the drug each day).
Yes, Abilify is definitely, as its website notes, a "medicine to help you move forward."
Here's Bremner's summary of the clinical trials:
"In the first study of Abilify, 362 patients were randomly assigned to Abilify or placebo for six weeks after a failed trial of antidepressants. There was a -8.8 v -5.8 change on the Montgomery Asberg Depression Rating Scale (MADRS), a difference of 11.5%. 23% of patients on Abilify versus 5% on placebo had akathisia, a potentially very disturbing side effect where you feel like you are jumping out of your skin or cannot sit still. Restlessness was seen in 14% v 3%. Fatigue was also more common."In the second study of Abilify, 381 patients who had failed at least one antidepressant medication trial were treated for eight weeks with an antidepressant followed by the addition of Abilify or a placebo for six weeks. Abilify showed an -8.5 change on the 26 item Montgomery Asberg Depression Rating Scale (MADRS) versus -5.7 for placebo, a difference of 2.8 points, a difference of 11%. 26% of patients on Abilify versus 4% on placebo had akathisia, and 10% versus 1% had restlessness.
"Conclusions? Abilify is more likely to make you want to jump out of your skin than it is to cure your depression. An 11% improvement over placebo is not that great and is set off by the fact that Abilify has a lot of nasty side effects and doesn't work better than other treatments of refractory depression like lithium (which also can have nasty side effects)."
I hope doctors, mental health workers and patients adopt the appropriate skepticism when watching these ads, visiting the Abilify for depression website, or when reading the various print ads.
BTW, according to Quantcast, the Abilify website is being visited by just under 200,000 people each month.
Shannon Cote, a Brampton, Ont. mother, has filed suit against GlaxoSmithKline, alleging that heart defects suffered by her 10-year-old son were as a result of her being given Paxil while pregnant:
"In August 1997, Cote became pregnant at which time her lawyers say she began to suffer from low self-esteem and depression."The woman claims her family physician prescribed the drug and was assured at the time that Paxil, unlike the other antidepressants, was suitable during pregnancy.
"Subsequently, Cote's child was born with heart defects that Brampton-based NAPAL Law Chambers (NLC) argues is directly linked to use of the antidepressant.
"Zain Rizvi, litigation consultant for NLC, charged the drug manufacturer failed to ensure that a proper warning was placed on the drug's prescription label, as well as proper usage instructions.
"'Birth defects were caused solely as a result of the negligence of the defendant manufacturer. As a result of (the child's) heart defects, the plaintiffs have been forced to live with severe psychological problems that have affected their daily lives,' Rizvi said. 'The manufacturer was aware that knowledge must be provided to patients as to the possible side effects of the drug but ignored all of these matters.'"
Glaxo issued a rather lame statement that's in the above-linked article.
Therese Borchard, who authors Beyond Blue, was asked by the fine folks at Blogs.com to put together a top 10 mental health blogs list and yours truly is on it, along with a lot of the other usual suspects. You can read the list here. I appreciate the inclusion.
This is way outside this site's usual balliwick, but news is just out that federal prosecutors have decided to not charge former New York Governor Elliott Spitzer in connection with his use of a call girl ring. Spitzer resigned as governor earlier this year.
I have a hard time imagining a more common citizen, er, getting off this lightly, so you really have to wonder what politics were at work here.
Further proof, once again, that the rich are truly very different from you and I.
In the ongoing saga of members of Congress looking into pharma payouts to various researchers, Sens. Charles Grassley (R-Iowa) and Herb Kohl (D-Wisc.) have asked J&J to turn over details of its payouts to physicians in regards to its antipsychotic Risperdal. I'm sure the senators will find some tasty stuff because the drug has been used and allegedly promoted off-label for a host of indications that have nothing to do with schizophrenia and mania--namely, ADHD and dementia.
It occurs to me that, with a new administration coming in and Congress being more Democrat than before, it is high time for formal Congressional hearings on how Big Pharma has corrupted academia and screwed up patients with its off-label marketing schemes.
Sorry for the late start today, folks, but this ought to get your heart pounding faster: Pharmalot, which apparently got tipped off, reports that:
"An AstraZeneca regional sales manager allegedly directed the sales reps in her region to use some of Winnie the Pooh’s well-known friends - specifically, Tigger and Eeyore - to promote the Seroquel antipsychotic. We are told the idea was conveyed at a national sales meeting and on field rides with sales reps, who were told to use Tigger as a bipolar patient and Eeyore - the down-in-the-mouth donkey - as a depressed patient. The reps were allegedly encouraged to use Tigger dolls as giveaways, for instance."
And here I thought Tigger just had ADHD.
Seriously, though, AZ says it's investigating the allegations and won't comment further. Whomever cooked this up should be fired for outright stupidity. Why the hell would you adopt Disney characters to market a bloody antipsychotic to, the clear target, children?
Big Pharma reaches a new low.
As I'm sure many of you suspect, uber liberal Seattle was a bit of a party last night and yours truly is extremely hungover today. I'll catch up with posts in the morning.
Be well.
Last night, quite late actually, I saw an ad for Abilify, an atypical antipsychotic, on TV. The ad, filled with hopeful string-section music, touted the use of this drug--primarily intended as a treatment for psychosis--as an add-on treatment for depression. I didn't have my notebook out, but the ad made the claim that two out of three people in treatment for depression don't see improvement, despite trying multiple medications. It's not clear to me if the drug's maker, Bristol-Myers Squibb is including psychotherapy in that two out of three assessment.
"If an anti-depressant alone is not enough," says the voiceover. The ad directs viewers to a website called abilifytreatment.com and then continues to rattle off a list of side effects and black box warnings that's longer than the pitch itself. The website is simply a redirect for the main Abilify site and takes people to a page where they can request more information about the drug. You bet I registered. Can't wait to get my materials in the mail. On the website the drug is promoted as a "medicine to help you move forward."
Abilify was approved as an add-on treatment for depression in November 2007. This is the first time I've seen the ad air.
We have reached avery pretty pass in our culture and in depression treatment when a pharma company pimps an antipsychotic on TV as a treatment for depression. I'll leave it at that.
That's right, a study just out in the new issues of Pediatrics notes that the use of medications for "chronic" conditions in kids exploded between 2002 and 2005. Among the big gainers were diabetes meds at a 100 percent growth rate and ADHD meds at a 40 percent increase (anti-depressant scrips went up by only 1.8 percent.
Considering how rapidly ADHD meds use grew amongst kids in the 1990s--I don't have the exact figures, but as I recall it was huge growth, like 400 percent or so--this hardly represents a leveling off. Much of the increase was among girls.
You've got to wonder what is going on in American culture when drugs that were already widely used had their use increase by 40 percent in just three years. It's like we've become ADHD nation.
Or maybe I ought to say ADHD-diabetes nation.
I've made it back to Seattle where it is pouring cats, dogs and hamsters. I am exhausted and while I have a whole bunch of posts to do for tomorrow, I may only have one or two up for the early morning crowd amongst you all. And there are some wild bits of news in the mental health world out there, which I'll try to catch up to during the day, depending upon on how dear old election day goes.
Speaking of which, I could care less who or what you vote for, but please remember to vote.
Or, more accurately, in the sky again--which is to say that in a bit I am heading to the airport in Tucson and will be flying back to Seattle where it's about 40 degrees colder and much, much wetter. Comment approval will be non-existent from about 12.30 pm EST to about 6.30 pm EST, so please keep that in mind.
I hope to be back to normal for tomorrow although with that little election going on, who knows if anyone will be paying attention to anything other than election results.
Last week an interesting study of anxiety treatment in kids and teens came out in the New England Journal of Medicine and it's gotten quite a bit of press attention. The study involved using Zoloft, an SSRI, and cognitive behavioral therapy to treat anxiety disorders in teens and kids as young as seven and as old as 17. Look, I know how much some readers hate SSRIs and how strongly they react to any news about the drugs, pro or con, but for the moment put those kinds of concerns aside. My point in picking apart this study isn't to argue that no kid should ever be diagnosed with anxiety or that they shouldn't take meds of that therapy is useless or anything of the sort. My point is that this study isn't quite all that it's cracked up to be, although it does have its moments.
In the study the authors assert that the findings have major public health implications, meaning the findings can be extrapolated to the entire population of kids and teens diagnosed with a range of anxiety disorders. If true, it would affect approximately 7.5 million to 15 million kids and teens in America (the authors claim that anxiety disorders affect 10 percent to 20 percent of Americans under 18). That's a whole lot of kids. The authors also claim that anxiety disorders in youth lead to anxiety and depression as the kids turn into adults--one of the usual arguments for giving kids psychiatric treatment.
Certainly, the degree to which CBT was shown to be useful is valuable information as was the fact that CBT-only treatment outperformed Zoloft-only therapy by about 10 percent. But the fact that Zoloft had a fairly typical effect size of about 30 percent over placebo was hardly a ringing endorsement of meds-alone treatment, which is much the standard in America these days for kids (and adults).
The study involved 488 kids and teens diagnosed with social phobia, generalized anxiety disorder and separation anxiety and lasted for three months (there will be a longer term version of this study published later). Patients given placebo improved--the authors' terminology--23.7 percent of the time; patients given Zoloft improved 54.9 percent of the time; patients given CBT improved 59.7 percent of the time (so psychotherapy beat an SSRI); and, patients given a combination of Zoloft and CBT improved 80.7 percent of the time. In other words, the SSRI plus psychotherapy approach had a 57 effect size over placebo and a 20 percent to 25 percent effect size over either meds or therapy alone.
The result for Zoloft plus CBT is one of the most robust I have ever seen in any psychiatric study, so robust that it gives me doubts.
My concern about this study and the way it's being portrayed in the media, however, involves a problem in the study design, which overall is actually quite good. But here's the deal: if you are going to go around claiming that Zoloft plus CBT is now indicated for anxiety disorder in kids and teens--and that's what the study authors claim--then you need a way to compare the Zoloft plus CBT arm of the study to a placebo plus CBT group of patients in order to allow for whatever placebo effect--likely 20 percent or more--was present in the Zoloft plus CBT group. There was no such group in the study. Instead, we got a placebo-only group, a Zoloft-only group, a CBT-only group and a CBT plus Zoloft group.
It's a bit remarkable to me that if, as the authors note, they were trying to tease out of this study how powerful a therapy plus meds approach was that they didn't include a placebo plus therapy group. It would make comparisons and conclusions much easier and more powerful. What's more, my guesstimate is that such a group would've ended up with about a 65 percent to 70 percent "improvement" rate, leaving the Zoloft plus CBT group (at about an 80 percent improvement rate) with a 10 percent to 15 percent effect size. In the real world, that isn't much.
As a result of this, I don't think the study's conclusions on meds plus therapy are nearly as conclusive as some commentators do.
"The new study, paid for by the National Institute of Mental Health, is the largest examining treatment of childhood anxiety disorders, said co-author Dr. John March of Duke University. Dr. Thomas Insel, the institute's director, said the study provides strong evidence that combined treatment is 'the gold standard,' but that sertraline or therapy alone can be effective."
Yes, but the question is how effective.
Doug Bremner, a psychiatrist at Emory University, argues that the results are not remarkable at all:
"So now let's turn to the "incredible" results of this week's study of sertraline (Zoloft) in kids. Although there was a difference in "responders" based on much improved on the CGI of 60% versus 24% for placebo, when you look at the actual data, the Pediatric Anxiety Scale, a 30 point scale, went from 18.8 at baseline to 9.8 in the zoloft group, and from 19.6 to 12.6 in the placebo group, a difference of 9%."
While I'm no expert on this particular scale, it does strike me that the results of this study aren't nearly as far-reaching as some would like them to be, or as some fear they might be.
Then, there's the whole tricky issue of giving SSRIs to kids as young as eight--fully 75 percent of the study participants are 13 or younger. While I'm not 100 percent opposed to giving SSRIs to kids, I'm like 90 percent against it, especially for minor cases of anxiety such as some kids in this study had (you're going to, as a parent, willingly give your kid Zoloft for social phobia or separation anxiety? Whatever). I don't think the fact that there were few side effects in any of the study's arms should give anyone too much peace--there were perhaps 200 kids on meds in the study (so it's hardly population based) and it's clear the docs did a commendable job of titrating the kids onto Zoloft (real world docs tend to be a lot more sloppy and I think that leads to all sorts of problems). I certainly wouldn't use the low side effects outcome of this study to project onto, say, 50,000 kids with anxiety disorders. And it's when you get into populations of that size that you begin to see the real problems with SSRIs, even if they are relatively few on a percentage basis.
Nonetheless, I think the study authors did a commendable job of monitoring and reporting side effects--the paper is certainly the most aggressive on this point that I've seen in recent years in the use of SSRIs. While I know some of you will want to nitpick me over that assessment, please remember how studies like this used to address side effects issues in the past--hardly at all. So this new study represents an improvement on that front. For what it's worth to you all, CL Psych agrees with me on this point and there is no sterner judge of research methodology than that anonymous blogger.
All the same, my jaw is simply on the floor over something else that underlies the study's social context. Twenty years ago, children were not medicated for anxiety disorders (can you imagine giving an MAOI or tricyclic to a child for any disorder?), except perhaps in rare instances, nor were they packed off to a psychiatrist if they exhibited signs of anxiety. And yet here we are today with psych researchers talking about implications for American kids as a whole and while I am pleased to see a solid emphasis on psychotherapy, I am very leery of the broader message getting out there that kids with anxiety should be on an SSRI and CBT. Because in the real world of our wonderful economy and broken health care system, the kids aren't going to end up getting psychotherapy unless their parents are fairly well off. Zoloft in generic form is quite cheap. CBT can easily run $120 or more a session. Guess which option insurance companies will go for?
And after 20 years of our culture pushing SSRIs and other psych meds down the throats of adults with depression, anxiety and other disorders, can anyone point me to where this has improved things and what the argument would be for thinking it'll be any better for kids?
As usual, perhaps I am pushing the envelope a bit hard by asking these questions and raising these issues, but someone has to do it.
There is an excellent and lengthy article on just how screwed up the FDA has gotten in yesterday's New York Times Sunday Magazine and how many of the problems stem from the inability--if not unwillingness--of the FDA to police Chinese drug and food plants. I've long been critical of the agency for its lazy approach to psychiatric drugs--Zyprexa scandal anyone? or how about SSRIs and suicide?--but the problems are far broader and much deeper and extend into aspirin and foodstuffs.
Here's just one measure of how fouled up people think the agency has become:
"Even the F.D.A.’s staunchest defenders now acknowledge that something is terribly wrong. Among them is Peter Barton Hutt, who served as the agency’s general counsel during the Nixon administration and is widely considered the dean of the F.D.A. bar in Washington. I’ve interviewed Hutt dozens of times over the years, and he has always defended the F.D.A. No more. 'This is a fundamentally broken agency,' Hutt told me earlier this year, 'and it needs to be repaired.'"
I'm not sure that it can be, especially with so many drugs, drug ingredients, food and food ingredients being made in China. I seriously doubt our ability to make the Chinese government play ball with us on food and drug safety and we are fools if we don't think we should be bringing the bulk of our drug and food manufacturing back home.
Gardiner Harris' article is excellent and I encourage one and all to read it.
This is amazing to me: the Therapeutic Goods Administration, Australia's FDA, is reportedly conducting a review of problems with anti-depressants in secret with no public input, unlike what's gone on in the US and UK.
"Sydney psychiatrist Yolande Lucire, who has reported between 300 and 400 cases to the TGA in which she claims patients have had serious reactions to the anti-depressants, including some who had committed suicide, said the inquiry must be made public. 'This is being done in secret,' Dr Lucire said. 'We have no terms of reference, no opportunity for people to make submissions; it's a scandal.'"Federal Health Department secretary Jane Halton wrote to Dr Lucire recently, informing her the inquiry was under way and the panel would report back at the end of this year.
"'This only happened after,' Dr Lucire said. 'In frustration at being fobbed off by the TGA, I personally sent the head of the department 100 cases detailing what had actually happened to people who went from being fully functioning members of the community to patients with serious mental health problems and some who in fact killed themselves after being put on these drugs for stress-related disorders.'"
This is complete nonsense and I hope Australian readers of this site will contact their MPs and hound the TGA until this is set right. Otherwise, the opportunity for a whitewash is simply too great.